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Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
Countervailing Duty Order
at least 85 percent by weight of threads Act, duties shall be assessed on subject (9) Narrow woven ribbons constructed merchandise entered, or withdrawn from pile fabrics (i.e., fabrics with a surface effect formed by tufts or loops of after the date of publication of the ITC’s of material injury. Section 706(b)(1) of the Act states, ‘‘If the Commission, in its as a gift bag, gift box, gift tin, greeting 705(b), finds material injury or threat of card or plush toy, or affixed (including Termination of the Suspension of
Liquidation
working component of such non-subject liquidation of which has been the ITC’s notice of final determination, 701(a).’’ In addition, section 706(b)(2) of December 14, 2009 (i.e., the date of Preliminary Determination) and the date determination in the Federal Register.
subject merchandise, such as a ‘‘belly the ITC’s final determination is threat- band’’ around a pair of pajamas, a pair the threat of material injury and is not (13) Narrow woven ribbon(s) included published in the Federal Register,
a scrapbook kit, in which the individual As a result of the ITC’s determination, Act and 19 CFR 351.211(b). and in accordance with section 706(a)(1) Ronald K. Lorentzen,
Deputy Assistant Secretary for Import (‘‘CBP’’) to assess, upon further the kit does not exceed 48 linear inches, [FR Doc. 2010–21978 Filed 8–31–10; 8:45 am] included in the kit is on a spool, and the amount of the net countervailable BILLING CODE 3510–DS–P
subsidy for all relevant entries of narrow DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO–P–2010–0055]
the ITC’s notice of final determination Examination Guidelines Update:
in the Federal Register, and to require
Developments in the Obviousness
a cash deposit for each entry of subject Inquiry After KSR v.Teleflex
Narrow Woven Ribbons With Woven Selvedge AGENCY: United States Patent and
From the People’s Republic of China: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Countervailing Duty ACTION: Notice.
Determination With Final Antidumping Duty Determination, 74 FR 66090 (December 14, 2009). SUMMARY: The United States Patent and
The Department instructed CBP to discontinue the suspension of liquidation on April 13, 2010, in issuing an update (2010 KSR Guidelines accordance with section 703(d) of the Act. Section Update) to its obviousness guidelines 703(d) states that the suspension of liquidation pursuant to a preliminary determination may not remain in effect for more than four months. hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
Guidelines Update highlights case law The 2007 KSR Guidelines pointed out, as had the Supreme Court in KSR, that developed as a matter of internal Office (Supreme Court) in KSR Int’l Co. v. Graham v. John Deere, 383 U.S. 1, 17– Teleflex Inc. These guidelines are create any right or benefit, substantive 18 (1966) (scope and content of the prior ordinary skill in the art; and secondary obviousness. It remains true that ‘‘[t]he on the 2010 KSR Guidelines Update. personnel to follow this 2010 KSR Guidelines Update is neither appealable dependent on the facts of each case.’’ Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1089 (Fed. Cir. 2008) (citing Graham, 383 U.S. at 17–18 (1966)). As reflected in the Manual of Patent for the reasoning required to support an DATES: Effective Date: This 2010 KSR
Examining Procedure (MPEP), this 2010 obviousness determination, the 2007 KSR Guidelines Update addresses a KSR Guidelines noted that the teaching- suggestion-motivation (TSM) test was but one possible approach. The 2007 ADDRESSES: Comments concerning this
2010 KSR Guidelines Update may be KSR Guidelines identified six other sent by electronic mail message over the concepts discussed are grounded in or submitted with existing Office policy as used. The six other rationales identified in the 2007 KSR Guidelines are: (1) obviousness will be discussed in detail. be submitted by mail, the Office prefers FOR FURTHER INFORMATION CONTACT:
Laufer, Legal Advisors, Office of Patent Circuit and precedential decisions of the (4) applying a known technique to a predictable results; (5) obvious to try— (571) 272–7754 or (571) 272–7726; by identified, predictable solutions, with a 2. Principles of Obviousness and the Guidelines. In response to the Supreme Court’s April 2007 decision in KSR, the either the same field or a different one SUPPLEMENTARY INFORMATION:
1. Introduction. The purpose of this Federal Register and Official Gazette.
the Supreme Court in KSR Int’l Co. v. U.S.C. 103 in View of the Supreme Teleflex Inc., 550 U.S 398 (2007) (KSR), Court Decision in KSR International Co. v. Teleflex Inc., 72 FR 57526 (Oct. 10, 2007), 1324 Off. Gaz. Pat. Office 23 Court of Appeals for the Federal Circuit (Nov. 6, 2007) (2007 KSR Guidelines). using one of the rationales suggested by (Federal Circuit) since KSR. This body The 2007 KSR Guidelines have been incorporated in the MPEP. See MPEP discussed in the 2007 KSR Guidelines, 2007). The purpose of the 2007 KSR Guidelines was to give Office personnel necessary factual findings. However, the 2007 KSR Guidelines also stressed that while the Graham inquiries and the cases begin to clarify the contours of the Court’s instruction in KSR. The 2007 obviousness inquiry after KSR, and help KSR Guidelines also alerted Office Supreme Court in KSR did not place any considering rebuttal evidence submitted taken to formulate the line of reasoning. hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
In other words, the KSR decision is not to be seen as replacing a single test for seven rationales listed in the 2007 KSR decisions, as can be seen in a review of Guidelines. See MPEP §§ 2141 and 2143 MPEP § 2144. This section provides and appropriately supported. See MPEP § 2144.04. So, for example, automating a condoned the use of particular examples duplication of parts, or purifying an old policy that appropriate factual findings sense or ordinary routine practice (e.g., should not be treated as per se rules, but of the required factual findings, and in response to the rejection a practitioner KSR has long been a part of the patent examination process. See MPEP § 2144. Although the KSR approach is flexible (e.g., ‘‘art recognized equivalent,’’ ‘‘structural similarity’’) without including all required factual findings. be applied, the 2007 KSR Guidelines 3. The Impact of the KSR Decision. and MPEP § 2143 state: ‘‘The Supreme applicability to the facts of the case at Court in KSR noted that the analysis foundational principles of Graham coupled with its abrogation of the strict § 2143. In Ball Aerosol v. Limited Brands, 555 F.3d 984 (Fed. Cir. 2009), instruction as to the need for an explicit in the post-KSR era. Since it is now analysis. The Federal Circuit explained, as is consistent with the 2007 KSR the only way to establish a prima facie Guidelines, that the Supreme Court’s practitioners have been required to shift constant in the aftermath of KSR. Guidelines, the Office acknowledged [T]he analysis that ‘‘should be made claimed invention by the prior art, lack explicit’’ refers not to the teachings in the prior art of a motivation to combine, but to wake of the KSR decision. That footnote the court’s analysis * * *. Under the flexible also stated that it was ‘‘not clear which inquiry set forth by the Supreme Court, the district court therefore erred by failing to take importance in view of the recognition in their viability’’ after KSR. See 2007 KSR account of ‘‘the inferences and creative KSR of a variety of possible rationales. Guidelines, 72 FR at 57,528 n.2. The steps,’’ or even routine steps, that an inventor motivation to combine related pieces from Ball Aerosol, 555 F.3d at 993. The Federal Circuit’s directive in Ball prior art does not have to be expressly stated Aerosol was addressed to a lower court, issue in KSR involved the relatively expressly or impliedly contained in the prior art or it may be reasoned from knowledge Office personnel are to continue to make vehicle pedal assemblies, the decision generally available to one of ordinary skill in appropriate findings of fact as explained was relevant only to such fields. The the art, established scientific principles, or legal precedent established by prior case law. such a notion, stating that KSR applies Aug. 2006) (citing five pre-KSR Federal This court also declines to cabin KSR to the ordinary skill in the art at the time of ‘‘predictable arts’’ (as opposed to the ‘‘unpredictable art’’ of biotechnology). In fact, this record shows that one of skill in this in which Office personnel may properly advanced art would find these claimed ‘‘results’’ profoundly ‘‘predictable.’’ In re Kubin, 561 F.3d 1351, 1360 (Fed. pronouncement in KSR has at the same When considering obviousness, Office Cir. 2009). Thus, Office personnel personnel are cautioned against treating viability of cases such as In re Lee, 277 any line of reasoning as a per se rule. Lee appears to require a strict basis in discussed in this 2010 KSR Guidelines hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
Update provide Office personnel as well are not the focus of separate discussions problem which had suggested use of the as practitioners with additional in this 2010 KSR Guidelines Update, it examples of the law of obviousness. The will be noted that obviousness concepts The case of In re Omeprazole Patent purpose of the 2007 KSR Guidelines Litigation is one in which the claims in invention is not obvious, and to provide selected cases. The cases included in reinforce the idea, presented in the 2007 coatings to a drug in pill form for the KSR Guidelines, that there may be more factual scenario. The selected decisions also illustrate the overlapping nature of 2010 KSR Guidelines Update to contrast the lines of reasoning that may be employed to establish a prima facie case included two layers of coatings over the of obviousness. Although the 2007 KSR Guidelines presented the rationales as Guidelines Update in conjunction with district court rejected Apotex’s defense the 2007 KSR Guidelines (incorporated recognize that real-world situations may that the patents were invalid for into MPEP §§ 2141 and 2143) to provide require analyses that may not be so a more complete view of the state of the A. Combining Prior Art Elements. In provides a ‘‘teaching point’’ for each discussed case. The ‘‘teaching point’’ elements, identified as Rationale A, the 2007 KSR Guidelines quoted KSR and of the case in this 2010 KSR Guidelines Update. Nor should any case in this 2010 KSR Guidelines Update be applied elements in the way the claimed new or cited in an Office action solely on the invention does.’’ KSR, 550 U.S. at 401. basis of what is stated in the ‘‘teaching In view of the cases decided since KSR, Federal Circuit Cases. The impact of the elements in a known manner to obtain Supreme Court’s decision in KSR can be predictable results is when the had not been recognized in the prior art. expenditure of time, effort, or resources person of ordinary skill in the art would district court’s decision that the claimed rationales identified in the 2007 KSR subcoatings for enteric drug formulation been the subject of a significant number of post-KSR obviousness decisions. The well as practitioners are reminded of the Example 4.1. In re Omeprazole Patent though the modification could have Litigation, 536 F.3d 1361 (Fed. Cir. 2008). Teaching point: Even where a different modification even if he or she discussed in the 2007 KSR Guidelines hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
the Federal Circuit stated that even if all foam, friction between the strap and the been taught by the prior art, the claims maintain its position after pivoting. In other words, the foam strap did not fall apparent reason. This is not the same as under the force of gravity to a position adjacent to the heel of the base section. Crocs serves as a reminder to Office prior art is not a complete statement of expectations of those of ordinary skill in Aqua Clog, which was a shoe that the art, adding the subcoating would not corresponded to the base section of the footwear of the ‘858 patent. The second final product. Rather, the final product flexible material. In the ITC’s view, the predictable to a person of ordinary skill the prior art Aqua Clog differed from the in the art. MPEP § 2143 A(3). If results Federal Circuit stated that the prior art DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008). Teaching point: A actually counseled against using foam as claimed invention is likely to be a material for the heel strap of a shoe. The record shows that the prior art would prior art elements that would reasonably actually discourage and teach away from the use of foam straps. An ordinary artisan in respective properties or functions after because the prior art of record failed to this field would not add a foam strap to the foam Aqua Clog because foam was likely to Sundance involved a segmented and stretch and deform, in addition to causing discomfort for a wearer. The prior art depicts Example 4.2. Crocs, Inc. v. U.S. International Trade Commission, 598 F.3d 1294 (Fed. Cir. 2010). Teaching point: A claimed combination of prior known in the prior art, the claims still loose fit of the heel strap made the shoe The case of Crocs, Inc. v. U.S. International Trade Commission is a wearer’s foot. In the claimed footwear, footwear was held by the Federal Circuit wearer’s foot only when needed to help reposition the foot properly in the shoe, person of ordinary skill in the art would segments as taught by the first reference obviousness issue were from Crocs’ U.S. desirable feature was a result of the Patent No. 6,993,858, and were drawn to friction between the base section and Thus, the Sundance case points out foot opening of the upper, such that the ‘‘yielded more than predictable results.’’ Id. at 1310. Aguerre had taught that prior art elements is that one of ordinary Achilles portion of the wearer’s foot. that allowed it to be in contact with the respective properties or functions after base section, and to pivot relative to the hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
Example 4.4. Ecolab, Inc. v. FMC parameter disclosed in the Bender patent Corp., 569 F.3d 1335 (Fed Cir. 2009). with the PAA methods disclosed in FMC’s KSR ‘‘directs [it] to construe the scope of Id. If optimization of the application analogous art broadly.’’ Wyers, slip. op. prima facie obvious if an ordinarily at 12. For these reasons, the court found that Master Lock’s asserted references outcome of the Ecolab case may well elements and would have known how to have been different. Example 4.5. Wyers v. Master Lock In the case of Ecolab, Inc. v. FMC Co., No. 2009–1412, —F.3d—, 2010 WL Corp., an ‘‘apparent reason to combine’’ in conjunction with the technical ability Teaching point: The scope of analogous Graham inquiries, and also emphasized the ‘‘expansive and flexible’’ post-KSR ‘‘deny factfinders recourse to common sense.’’ Wyers, slip op. at 13 (quoting KSR, 550 U.S. at 415 and 421). The In the case of Wyers v. Master Lock Co., the Federal Circuit held that the KSR and our later cases establish that the reference had taught all of the elements of the claimed invention, except for the used to secure trailers to vehicles were include recourse to logic, judgment, and pressure limitation of ‘‘at least 50 psi.’’ common sense, in lieu of expert testimony The court discussed two different sets * * *. of claims in Wyers, both drawn to Thus, in appropriate cases, the ultimate inference as to the existence of a motivation to combine references may boil down to a question of ‘‘common sense,’’ appropriate for of a second reference that had taught the removable sleeve that could be placed advantages of spray-treating at pressures over the shank of the hitch pin lock so of 20 to 150 psi when treating meat with that the same lock could be used with Id. at 15 (citing Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed. Cir. 2009); Ball Aerosol, 555 F.3d Disagreeing with the district court, the each of several prior art references Federal Circuit stated that ‘‘there was an sleeve and the external covering. Master pointed out that the need for different additional bacteria off the meat surface.’’ elements, would have rendered the pressure to improve the effectiveness of analogous prior art. As to the reference court concluded that it dealt specifically external seals were well-known means with using a vehicle to tow a trailer, and to protect locks from contaminants. The pressure and would have known how to endeavor as Wyers’ sleeve disclosed in FMC’s patent are invalid as retained their respective functions when The court cited In re O’Farrell, 853 F.2d person of ordinary skill. In Ecolab, the Ecolab’s expert admitted that one skilled in observed that even if sealed padlocks the art would know how to adjust application parameters to determine the optimum although the Federal Circuit invoked the parameters for a particular solution. The question then is whether it would have been hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
result’’ discussed in KSR refers not only ordinary skill in the art at the time of elements are capable of being physically including an advertisement (Damark) for combined, but also that the combination a folding treadmill demonstrating all of purpose. In this case, it was successfully spring, and a patent (Teague) with a gas The key to supporting any rejection under argued that Puno ‘‘teaches away’’ from a 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would rigidity increases the likelihood that the dual-action spring that reverses force as KSR noted that the analysis supporting a rendering the device inoperative for its intended purpose. In fact, the reference made explicit. The Court quoting In re Kahn, pushing the bed closed at all times. The (Fed. Cir. 2006), stated that ‘‘[R]ejections on ‘‘shock absorber’’ effect, but rather required to open the bed from the closed expressed concern for failure and stated conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal ‘‘decrease[s] the chance of failure of the because ‘‘it prevent[s] direct transfer of interface.’’ Thus, the alleged reason to Example 4.6. DePuy Spine, Inc. v. of the screw—ran contrary to the prior Medtronic Sofamor Danek, Inc., 567 art that taught that increasing rigidity F.3d 1314 (Fed. Cir. 2009). Teaching point: Predictability as discussed in KSR failure. In view of this teaching and the addressed problems of supporting the prior art, the Federal Circuit determined providing a stable resting position. especially strong where the prior art’s Circuit relating to failure by others and directs one skilled in the art not to use ordinary skill would have combined the the combination would not have been satisfy the claim limitations as the dual- B. Substituting One Known Element for Another. As explained in the 2007 used in spinal surgeries that included a away from using single-action springs to an element of a prior art invention. The opening force provided by gravity. As to would have been predictable. See MPEP were so broad as to encompass anything that assists in stably retaining the tread Example 4.7. In re ICON Health & Fitness, Inc., 496 F.3d 1374 (Fed. Cir. to support a case of obviousness (i.e., is modifications that one skilled in the art The claimed invention in ICON was storage position, including a gas spring ICON is another useful example for the upright structure to assist in stably art. The art applied concerned retaining In conducting its analysis, the Federal retaining the tread base in the storage Circuit noted that the ‘‘predictable hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
endeavor, it is necessary to consider the Circuit noted that ‘‘[t]he asserted claims simply substitute a resistive electrical Web browser. At trial, the district court device. Id. at 1344. In this case, the prior argued that the claimed invention However, in ICON, the ‘‘treadmill’’ browser into a prior art auction system, device. According to the Federal Circuit, skepticism by experts, copying, praise, ‘‘Teague and the current application the references that taught the hand-held both address the need to stably retain a folding mechanism,’’ id. at 1378, and because ‘‘nothing about ICON’s folding complete a circuit for the generation of Federal Circuit disagreed. It noted that focus on treadmills,’’ id. at 1380. known in the prior art.’’ Id. Finally, the ICON is also informative as to the solved by using the resistive electrical coextensive with the claims at issue. For combine. ‘‘Indeed, while perhaps not determined that Muniauction’s evidence dispositive of the issue, the finding that also pertained to the prior art stationary case to Leapfrog Enterprises, Inc. v. Agrizap as ‘‘a textbook case of when the Fisher-Price, Inc., 485 F.3d 1157 (Fed. Cir. 2007), cited in the 2007 KSR of familiar elements according to known Guidelines. The Leapfrog case involved predictable results.’’ Id. Agrizap here indicates a reason to incorporate its exemplifies a strong case of obviousness prior art mechanical children’s learning teachings.’’ Id. at 1380–81. device. In Leapfrog, the court had noted ICON also makes clear that if the device. Similarly in Muniauction, must not ‘‘ignore the modifications that generation of an electric charge was not device borrowed from the prior art.’’ Id. Example 4.9. Muniauction, Inc. v. Deutschland v. Lupin Ltd., 499 F.3d Thomson Corp., 532 F.3d 1318 (Fed. 1293 (Fed. Cir. 2007). Teaching point: A Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008). Teaching point: Because Cir. 2008). Teaching point: Analogous information, it would have been obvious artisan had reason to believe that some The invention at issue in Muniauction claimed compound, and separating the Agrizap involved a stationary pest control device for electrocution of pests In Aventis, the claims were drawn to and the prior art stationary pest control bid comprising a price and interest rate possible for the interested buyer to bid on a portion of the offering. The claimed the ramipril molecule are in the S rather electrical switch was taught in two prior parameters to determine the best bid. It operated on conventional Web browsers ramipril had been taught by the prior whether the purified single stereoisomer hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
lipophilicity, so a skilled artisan would related drug enalapril (SSS enalapril) as Eisai concerns the pharmaceutical compound rabeprazole. Rabeprazole is a drug for treating stomach ulcers and The Federal Circuit affirmed the district upon consideration of all of the facts of was no clear motivation in the prior art particular opinion can have a contextual motivation in the prior art to isolate 5(S) lansoprazole as a ‘‘lead compound.’’ The pharmaceutical chemist might use the ramipril ran counter to the Supreme Court’s decision in KSR. The court chemistry, the term ‘‘lead compound’’ Requiring an explicit teaching to purify the 5(S) stereoisomer from a mixture in which it has a trifluoroethoxy substituent at the is the active ingredient is precisely the sort of rigid application of the TSM test that was substituent. The trifluoro substituent of modifications in order to improve potency, selectivity, or pharmacokinetic Id. at 1301. The Aventis court also parameters;’’ ‘‘[a] compound that chemical cases, structural similarity can lipophilicity to the compound. The which suggest its development;’’ and ‘‘a ability of a person of ordinary skill to prior art teachings. The Federal Circuit also addressed the kind of teaching that would be sufficient in the absence of an the predictability of the result were not expectation of similar properties in light Circuit did not find any sufficient of the prior art can be sufficient, even compound will have a particular utility. The Federal Circuit in Eisai makes it Obviousness based on structural similarity involving so-called ‘‘lead compounds’’ thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead lead compound: ‘‘Obviousness based on compound) in a particular way to achieve the structural similarity thus can be proved inquiry, KSR Int’l Co. v. Teleflex Inc., 550 skill in the art to select and then modify U.S. 398, 127 S.Ct. 1727, 1739, 167 L.Ed.2d 705 (2007), the requisite motivation can come compound) in a particular way to achieve the claimed compound.’’ Eisai, necessarily be explicit in the art. See Aventis 533 F.3d at 1357. Thus, Office personnel Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301 (Fed. Cir. 2007). Rather ‘‘it is sufficient to show that the claimed and prior art compounds possess a ‘sufficiently Example 4.11. Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353 (Fed. expectation,’ in light of the totality of the Cir. 2008). Teaching point: A claimed prior art, that the new compound will have ‘similar properties’ to the old.’’ Id. (quoting Eisai, 533 F.3d at 1357. The prior art hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
case to consider the question of whether emphasized that whether there was a the Federal Circuit stated that if 2-pyr issues, or other business considerations. expectation of success. Here there was compound’’ merely exists. See Altana might envision a suggestion in the prior Pharma AG v. Teva Pharmaceuticals Procter & Gamble is also informative USA, Inc., 566 F.3d 999, 1007 (Fed. Cir. certain structurally defined moieties, or reason ‘‘to select and modify a known that no prima facie case of obviousness Pharmaceutical, Inc. v. Mylan Labs, Inc., 520 F.3d 1358, 1364 (Fed. Cir. analyze Procter & Gamble’s proffered evidence countering the alleged prima been predicted, then a prima facie case Example 4.12. Procter & Gamble Co. facie case in some detail, thus shedding v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989 (Fed. Cir. 2009). Teaching point: It is not necessary to select a The Federal Circuit noted in dicta that compound. As a second example, it single compound as a ‘‘lead compound’’ even if a prima facie case of obviousness could be possible to view a claimed trial, the witnesses consistently testified properly be found to have been obvious A chemical compound was also found compound was effective, and that the to be nonobvious in Procter & Gamble. Procter & Gamble’s osteoporosis drug Example 4.13. Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., 566 When Procter & Gamble sued Teva for effect, and was not lethal at the same F.3d 999 (Fed. Cir. 2009). Teaching Procter & Gamble’s earlier patents. The risedronate, but instead taught thirty-six that would have rebutted an with regard to osteoporosis. Teva argued claimed invention is shown to have prior art of record, nor is it necessary for the art, and no reason to modify it so as court pointed out that little weight was Federal Circuit in Altana involved a to obtain risedronate. In addition, there to be afforded to the commercial success motion for preliminary injunction and because the competing product was also did not include a final determination of and toxicity. Therefore the district court assigned to Procter & Gamble. However, found that Teva had not made a prima the Federal Circuit affirmed the district instructive as to the issue of selecting a facie case, and even if it had, it was court’s conclusion that risedronate met a long-felt, unsatisfied need. The court rejected Teva’s contention that because the competing drug was available before is the active ingredient in Altana’s district court’s decision. The Federal Circuit did not deem it necessary in this the invention satisfied. The court hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
that it encodes where the skilled artisan finding was not clearly erroneous.’’ Id. at expectation of success in deriving the C. The ‘‘Obvious to Try’’ Rationale. based on an ‘‘obvious to try’’ line of KSR applies to all technologies, rather reasoning has been explored extensively than just the ‘‘predictable’’ arts. question of invalidity for obviousness in by the Federal Circuit in several cases The Federal Circuit’s decision in In re light of one of Altana’s prior patents. since the KSR decision. The 2007 KSR Kubin was an affirmance of the Board’s Guidelines explain, in view of the decision in Ex parte Kubin, 83 USPQ2d Supreme Court’s instruction, that this 1410 (Bd. Pat. App. & Interf. 2007), and rationale is only appropriate when there the Board in turn had affirmed the 12. The district court found that one of identified, predictable solutions to the included in the 2007 KSR Guidelines. See 2007 KSR Guidelines, 72 FR at 57532. The claimed invention in Kubin Obviousness of a chemical compound of success. The case law in this area is in view of its structural similarity to a developing quickly in the chemical arts, The claim stated that the nucleic acid the art to select and modify the prior art a specified protein. A prior art patent to but did not disclose either the sequence need not necessarily be explicitly found decided since KSR have proved this fear isolated nucleic acid molecule. supported the district court’s finding to be applying the KSR requirement for predictable solutions’’ in a manner that Altana’s prior art patent claimed that its expectations of those of ordinary skill in molecule could be isolated. In view of Valiante’s disclosure of the polypeptide, nature of the task faced by the courts— isolating the nucleic acid molecule, the compounds of Altana’s prior art patent and likewise by Office personnel—when Board found that a person of ordinary to be relevant during the prosecution of to try argument: ‘‘The evaluation of the opined that one of ordinary skill in the Relying on In re Deuel, 51 F.3d 1552 understanding of how technical advance (Fed. Cir. 1995), Appellant argued that it was improper for the Office to use the science or technology.’’ Abbott Labs. v. the prior art must point to only a single Sandoz, Inc., 544 F.3d 1341, 1352 (Fed. that a ‘‘restrictive view of the lead suggesting a structurally similar nucleic test similar to the teaching-suggestion- acid molecule. Citing KSR, the Board question, ‘‘including the characteristics stated that ‘‘when there is motivation to explicitly rejected in KSR * * *. The of the science or technology, its state of choices, the specificity or generality of solutions, a person of ordinary skill has admittedly preliminary—and found that the prior art, and the predictability of results in the area of interest.’’ Id. Example 4.14. In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009). Teaching point: A success, it is likely the product not of common sense.’’ The Board noted that hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
case fails to present the type of situation contemplated by the Court when it stated there were a limited number of methods thiazolidinediones (TZDs) marketed by that an invention may be deemed obvious if available to do so. The Board concluded Takeda as a treatment for Type 2 it was ‘‘obvious to try.’’ The evidence showed that it was not obvious to try. reasonable expectation that at least one would be successful. Thus, isolating the Alphapharm had filed an Abbreviated rationale does not apply when the was ‘‘the product not of innovation but of ordinary skill and common sense.’’ The Board’s reasoning was substantially technical act of infringement of However, it is important to note that in the Kubin decision, the Federal Circuit solutions to the recognized need, and no held that ‘‘the Supreme Court in KSR reasonable expectation of success. There unambiguously discredited’’ the Federal Circuit’s decision in Deuel, insofar as it ‘‘implies the obviousness inquiry cannot known compound identified as ‘‘compound b’’ would have produced unsuitable as a starting point for further ‘obvious to try.’ ’’ Kubin, 561 F.3d at research, and taught the skilled artisan 1358. Instead, Kubin stated that KSR ‘‘resurrects’’ the Federal Circuit’s own wisdom in O’Farrell, in which ‘‘to compound b as a lead compound. There compound b, there had been no were a large number of similar prior art predictability or reasonable expectation of success associated with the particular try,’ ’’ the Federal Circuit ‘‘outlined two specifically identified in Takeda’s prior classes of situations where ‘obvious to that ‘‘hundreds of millions’’ were more obviousness under § 103.’’ Kubin, 561 have been ‘‘obvious to try’’ would have Pharmaceutical, Inc. v. Mylan Labs, Inc., 520 F.3d 1358 (Fed. Cir. 2008). possibly arrived at a successful result, Teaching point: Where the claimed anti- the district court would have taught the of research aimed at finding a new anti- district court found no prima facie case a prima facie case had been established, ‘‘obvious to try’’ was to explore a new decision of the district court, citing the reason for selecting a particular starting particular form of the claimed invention need for a reason to modify a prior art or how to achieve it. Id. (citing Industries, Ltd. v. Alphapharm Pty., The KSR Court recognized that ‘‘[w]hen Ltd., 492 F.3d 1350 (Fed. Cir. 2007). there is a design need or market pressure to solve a problem and there are a finite number Teaching point: A claimed compound of identified, predictable solutions, a person convulsant. As in DePuy Spine, whether of ordinary skill has good reason to pursue was not obvious to try to obtain it from technical grasp.’’ KSR, 127 S.Ct. at 1732. In effective for its intended purpose is part such circumstances, ‘‘the fact that a lead compound for further investigation, combination was obvious to try might show and the prior art taught away from using that it was obvious under § 103.’’ Id. That is treatment, the prior art disclosed a broad convulsant properties. Mylan’s defense could have been selected as a lead compound for further investigation. Significantly, the closest prior art compound (compound b, the Takeda is an example of a chemical 6-methyl) exhibited negative properties that would have directed one of ordinary skill in the art away from that compound. Thus, this hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
anti-convulsant drug. The district court Example 4.18. Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. was no apparent reason why a person of formulation to measure the ‘‘absolute bioavailability’’ of the drug. Bayer added been obvious where the claimed particular synthetic pathway that led to to that of the enteric-coated formulation expected to find that the enteric-coated The case of Sanofi also sheds light on the obvious to try line of reasoning. The than the enteric-coated tablet. However, claimed compound was clopidogrel, which is the dextrorotatory isomer of environment (supporting the belief that an enteric coating would be necessary to thrombotic compound used to treat or preserve bioavailability), the normal pill prevent heart attack or stroke. The characterization, does not present a finite (and small in the context of the art) number the same bioavailability. Following this obviousness * * *. KSR posits a situation with a finite, and in the context of the art, drospirenone in a normal pill, the basis small or easily traversed, number of options that would convince an ordinarily skilled artisan of obviousness* * * . [T]his clearly is having ordinary skill in the art would not the easily traversed, small and finite have considered the prior art result that number of alternatives that KSR suggested might support an inference of obviousness. Id. at 1364. Thus, Ortho-McNeil helps would nevertheless absorb in vivo, requirement in KSR for ‘‘a finite number’’ of predictable solutions when the D-isomer would have been prima drospirenone isomerizes in vitro when facie obvious over the known racemate. However, in view of the evidence of ‘‘finite’’ means ‘‘small or easily traversed’’ in the context of the art in district court found that any prima facie question. As taught in Abbott, discussed shortcomings, and would have verified above, it is essential that the inquiry be the findings as suggested by a treatise on testified that persons of ordinary skill in which would have then showed that no enteric coating was necessary. Example 4.17. Bayer Schering Pharma patent was invalid because the claimed exhibited different levels of therapeutic A.G. v. Barr Labs., Inc., 575 F.3d 1341 (Fed. Cir. 2009). Teaching point: A Circuit reasoned that the prior art would experts also agreed that the isomer with likely have had greater toxicity. Sanofi possibilities in a field unreduced by the prior art. The prior art was not vague in to have been productive, and experts for both parties agreed that it was difficult In Bayer the claimed invention was an either a normal pill or an enteric-coated invention. Nevertheless, when Sanofi they had the ‘‘rare characteristic of The prior art compound drospirenone large number of options does not in and ‘absolute stereoselectivity,’ ’’ whereby was known to be a poorly water-soluble, of itself lead to a conclusion of contraceptive effects. It was also known significant toxicity, while the L-isomer the art to a narrower set of options, then hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
this record, the district court concluded skill in the art to try a fan blade design initial recipient list; resending e-mails on the first attempt; and selecting a new disagreed with United’s assessment that possible choices exist, the obvious to try obvious based on an obvious to try on ‘‘simple logic,’’ selecting a new list of options for solving a problem must have on the first attempt. There had been no been ‘‘known and finite.’’ Id. at 1339, citing Abbott, 544 F.3d at 1351. In this Bayer, there were art-based reasons to recipient list, and no evidence that the expect that both the normal pill and the required by KSR, there were a ‘‘finite Federal Circuit concluded that changing number of identified, predictable obtained was not unexpected. In Sanofi, the sweep angle ‘‘would not have solutions,’’ and that the obvious to try presented itself as an option at all, let in the art, prior to the separation of the obvious to try.’’ Rolls-Royce, 603 F.3d at The Federal Circuit in Perfect Web 1339. The decision in Rolls-Royce is a obvious to try rationale can properly be The district court had cited KSR for the proposition that ‘‘[a] person of ordinary creativity, not an automaton,’’ and found Example 4.19. Rolls-Royce, PLC v. that ‘‘the final step [of the claimed United Technologies Corp., 603 F.3d invention] is merely the logical result of 1325 (Fed. Cir. 2010). Teaching point: Technologies, Inc. v. InfoUSA, Inc., 587 ‘try, try again.’ ’’ In affirming the district Teaching point: Where there were a finite. However, if the possible options finite number of identified, predictable were not either known or finite, then an In Rolls-Royce the Federal Circuit addressed the obvious to try rationale in sense may be used to support a legal the context of a fan blade for jet engines. conclusion of obviousness so long as it obviousness when it stated, ‘‘Common inform the analysis of obviousness if
explained with sufficient reasoning.’’
Perfect Web, 587 F.3d at 1328 (emphasis obvious on the basis of an obvious to try provided a review of a number of obvious in light of United’s application, argument. In Perfect Web, the method including In re Bozek, 416 F.2d 1385, patent examiner may rely on ‘‘common Each fan blade has three regions—an inner, an intermediate, and an outer region. The repeating the first three steps if a pre- area closest to the axis of rotation at the hub is the inner region. The area farthest from the intended recipients had not received the without any specific hint or suggestion center of the engine and closest to the casing in a particular reference’’) and In re surrounding the engine is the outer region. Zurko, 258 F.3d 1379, 1383, 1385 (Fed. The intermediate region falls in between. The district court’s determination on intermediate region, and forward-leaning Failure to meet a desired quota of e-mail sense’’ in a case in which ‘‘basic the field of e-mail marketing. The prior based on any evidence in the record’’). hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
rebut the prima facie case of obviousness, testimony was contrary to the inventors’ acknowledged in Perfect Web that the Office personnel should specifically set forth admissions in the specification, as well the facts and reasoning that justify this suggestion, or motivation required in In re Lee, 277 F.3d 1338, 1344 (Fed. Cir. 2002), is not an absolute requirement for exemplify the continued application of an obviousness rejection in light of the teachings of KSR. The Federal Circuit Circuit and within the Office. Note that explained that ‘‘[a]t the time [of the Lee references.’’ However, Perfect Web went on to state that even under Lee, common Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007). Teaching point: Even though all evidence must be that the claimed method would have obviousness. Citing DyStar Textilfarben worked. Absolute predictability is not a GmbH v. C.H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006), and In re Kahn, 441 F.3d 977 (Fed. Cir. 2006), two cases predictability that one of ordinary skill Court’s decision in KSR, the Federal Circuit noted that although ‘‘a reasoned The claims at issue in PharmaStem generalizations’’ is required to use result in patentability.’’ Id. at 1364. Example 5.2. In re Sullivan, 498 F.3d 1345 (Fed. Cir. 2007). Teaching point: 5. Federal Circuit Cases Discussing Consideration of Evidence. Office compositions for treatment of blood and obviousness, must be considered when evidence that is timely presented by the It was found to be an error in Sullivan evidence submitted to rebut a prima comprising F(ab) fragments used to treat argument to demonstrate that the results obviousness or other grounds. On appeal, the Federal Circuit reversed the separate properties and utilities. There such evidence should not be considered PharmaStem’s own specification simply for its ‘‘knockdown’’ value; Once the applicant has presented rebuttal evidence, Office personnel should reconsider effective at neutralizing the lethality of any initial obviousness determination in view of the entire record. See, e.g., In re Piasecki, 745 F.2d 1468, 1472, 223 USPQ 785, 788 (Fed. Cir. 1984); In re Eli Lilly & Co., in humans. On appeal of the examiner’s rejection, the Board held that the claim (Fed. Cir. 1990). All the rejections of record reconstitution in mice. By extrapolation, the claimed composition were accounted for in the prior art, and that the composition taught by that prior art of ordinary skill in the art at the time rebuttal evidence for its ‘‘knockdown’’ value against the prima facie case, Piasecki, 745 F.2d at 1473, 223 USPQ at 788, or summarily dismiss it as not compelling or insufficient. described in PharmaStem’s patents. The If the evidence is deemed insufficient to hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
considered the evidence to relate to the the jury verdict, stating that in view of See MPEP § 706(I) (‘‘The standard to be Board had shown a prima facie case of ‘preponderance of the evidence’ test. In nonobviousness verdict was sufficiently other words, an examiner should reject a claim if, in view of the prior art and Shure appealed to the Federal Circuit, evidence of record, it is more likely than not that the claim is unpatentable.’’). making a determination of patentability. Example 5.4. Asyst Techs., Inc. v. jury that the Carlisle reference taught an Emtrak, Inc., 544 F.3d 1310 (Fed. Cir. 2008). Teaching point: Evidence of to fail. The declarations related to more and long-felt need may be insufficient to taught by Carlisle as being inside the ear overcome a prima facie case of obviousness if the prima facie case is testimony described as ‘‘rather sparse, and lacking in specific details.’’ Id. at a failure to link the commercial success factor of its composition is the statement particular reasons why one skilled in to combine the references.’’ Id. Finally, tracking articles such as silicon wafers the lethality of rattlesnake venom while to the next in a manufacturing facility. evidence that ‘‘the licensing fee for a with a central control unit. The Federal half immediately upon expiration’’ of Hesser was that the prior art had taught the use of a bus for this communication, while the claims required a multiplexer. Inc. v. Shure Inc., 600 F.3d 1357 (Fed. that persons of ordinary skill in the art Cir. 2010). Teaching point: Evidence covering for the portion of a hearing aid and the proffered evidence, and whether failed to consider the objective evidence that is inserted into the ear canal. The must always be withdrawn. See MPEP of three different combinations of prior the appropriate weight to be accorded to emphasizing that ‘‘Asyst’s failure to link hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
of its invention that were not disclosed Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007); Ryko Mfg. force of the evidence * * *.’’ Id. at 1316. Co. v. Nu-Star, Inc., 950 F.2d 714, 719– 20 (Fed. Cir. 1991); Newell Cos. v. others in the field praising the invention Kenney Mfg. Co., 864 F.2d 757, 768 they are reminded that every question of When considering obviousness, Office obviousness must be decided on its own argument to be unavailing in view of the personnel should carefully weigh any properly presented objective evidence of prior art, stating that ‘‘[w]hile the the prima facie case. If the asserted drew praise as a solution to a felt need, substitution of a multiplexer for a bus, David J. Kappos,
Under Secretary of Commerce for Intellectual 6. Conclusion. This 2010 KSR Property and Director of the United States invention.’’ Id. The Federal Circuit also Guidelines Update is intended to be reiterated, citing pre-KSR decisions, that used by Office personnel in conjunction ‘‘as we have often held, evidence of Appendix
The following table contains the cases set always overcome a strong prima facie the 2007 KSR Guidelines) to clarify the out as examples in this 2010 KSR Guidelines showing of obviousness.’’ Id. (citing contours of obviousness after KSR. It Update and the teaching points of the case. Combining Prior Art Elements
In re Omeprazole Patent Litigation, Even where a general method that could have been applied to make the claimed product was known and within the level of skill of the ordinary artisan, the claim may nevertheless be nonobvious if the problem which had suggested use of the method had been previously unknown. Crocs, Inc. v. U.S. Int’l Trade A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the claimed combination and the combination yields more than predictable results. Sundance, Inc. v. DeMonte Fabri- A claimed invention is likely to be obvious if it is a combination of known prior art elements that would rea- sonably have been expected to maintain their respective properties or functions after they have been Ecolab, Inc. v. FMC Corp., 569 A combination of known elements would have been prima facie obvious if an ordinarily skilled artisan would have recognized an apparent reason to combine those elements and would have known how to do so. Wyers v. Master Lock Co., No. The scope of analogous art is to be construed broadly and includes references that are reasonably perti- nent to the problem that the inventor was trying to solve. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning. DePuy Spine, Inc. v. Medtronic Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of being combined, as well as the expectation that the combination would have worked for its intended pur- pose. An inference that a claimed combination would not have been obvious is especially strong where the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements. Substituting One Known Element for Another
In re ICON Health & Fitness, Inc., When determining whether a reference in a different field of endeavor may be used to support a case of obviousness (i.e., is analogous), it is necessary to consider the problem to be solved. Agrizap, Inc. v. Woodstream Corp., Analogous art is not limited to references in the field of endeavor of the invention, but also includes ref- erences that would have been recognized by those of ordinary skill in the art as useful for applicant’s purpose. Thomson Because Internet and Web browser technologies had become commonplace for communicating and dis- playing information, it would have been obvious to adapt existing processes to incorporate them for Aventis Pharma Deutschland v. A chemical compound would have been obvious over a mixture containing that compound as well as other compounds where it was known or the skilled artisan had reason to believe that some desirable property of the mixture was derived in whole or in part from the claimed compound, and separating the claimed compound from the mixture was routine in the art. Eisai Co. Ltd. v. Dr. Reddy’s Labs., A claimed compound would not have been obvious where there was no reason to modify the closest prior art lead compound to obtain the claimed compound and the prior art taught that modifying the lead com- pound would destroy its advantageous property. Any known compound may serve as a lead compound when there is some reason for starting with that lead compound and modifying it to obtain the claimed compound. Procter & Gamble Co. v. Teva It is not necessary to select a single compound as a ‘‘lead compound’’ in order to support an obviousness rejection. However, where there was reason to select and modify the lead compound to obtain the claimed compound, but no reasonable expectation of success, the claimed compound would not have been obvious. hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
Teva Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select and modify a prior art lead compound in a particular way to produce the claimed compound. It is not necessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for the prior art to point to only a single lead compound. The Obvious To Try Rationale
In re Kubin, 561 F.3d 1351 (Fed. A claimed polynucleotide would have been obvious over the known protein that it encodes where the skilled artisan would have had a reasonable expectation of success in deriving the claimed polynucleotide using standard biochemical techniques, and the skilled artisan would have had a reason to try to isolate the claimed polynucleotide. KSR applies to all technologies, rather than just the ‘‘predict-able’’ arts. Takeda Chem. Indus. v. A claimed compound would not have been obvious where it was not obvious to try to obtain it from a broad range of compounds, any one of which could have been selected as the lead compound for fur- ther investigation, and the prior art taught away from using a particular lead compound, and there was no predictability or reasonable expectation of success in making the particular modifications necessary to transform the lead compound into the claimed compound. Ortho-McNeil Pharmaceutical, Inc. Where the claimed anti-convulsant drug had been discovered somewhat serendipitously in the course of research aimed at finding a new anti-diabetic drug, it would not have been obvious to try to obtain a claimed compound where the prior art did not present a finite and easily traversed number of potential starting compounds, and there was no apparent reason for selecting a particular starting compound from among a number of unpredictable alternatives. Bayer Schering Pharma A.G. v. A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and easily traversed number of options that was narrowed down from a larger set of possibilities by the prior art, and the outcome of obtaining the claimed compound was reasonably predictable. Sanofi-Synthelabo v. Apotex, Inc., A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits un- expectedly strong therapeutic advantages over the prior art racemic mixture without the correspondingly expected toxicity, and the resulting properties of the enantiomers separated from the racemic mixture were unpredictable. Rolls-Royce, PLC v. United Tech- An obvious to try rationale may be proper when the possible options for solving a problem were known and finite. However, if the possible options were not either known or finite, then an obvious to try ration- ale cannot be used to support a conclusion of obviousness. Perfect Web Techs., Inc. v. Where there were a finite number of identified, predictable solutions and there is no evidence of unex- pected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Com- mon sense may be used to support a legal conclusion of obviousness so long as it is explained with suf-ficient reasoning. Consideration of Evidence
PharmaStem Therapeutics, Inc. v. Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousness may be outweighed by contradictory evidence in the record or by what is in the specification. Although a reasonable expectation of success is needed to support a case of obviousness, absolute predictability is not required. In re Sullivan, 498 F.3d 1345 (Fed. All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when Hearing Components, Inc. v. Shure Evidence that has been properly presented in a timely manner must be considered on the record. Evi- dence of commercial success is pertinent where a nexus between the success of the product and the claimed invention has been demonstrated. Asyst Techs., Inc. v. Emtrak, Inc., Evidence of secondary considerations of obviousness such as commercial success and long-felt need may be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argu-ment for nonobviousness based on commercial success or long-felt need is undermined when there is a failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the prior art. [FR Doc. 2010–21646 Filed 8–31–10; 8:45 am] BILLING CODE P
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