Patentable vs Non-Patentable Flashcards

Question

PATENTABLE or NON-PATENTABLE? Polyaxial pedicule screw used in spinal surgery Included compression member for pressing screw head into receiving member Prior Art: - Puno-all elements of claim except compression member screw head separated for shock absorber effect, allowing some motion bet. Receiving member & vertibrae - Anderson – external fracture immobilization splint for large bones w/ swivel clamp….secured by a compression member

Answer 1

PATENTABLE Combination of >2 PA elements according to known methods → predictable results Assertion: OS would recognize that adding Anderson’s compression member to Puno’s device…the claim Was successfully argued that Puno “teaches away” from rigid screw (Puno warned rigidity increases failure rate..rendering device inoperable) Didn’t merely express general preference for screw w/ shock absorber, but expressed concern for failure OS would have been deterred from combining based on teachings from Puno and Anderson Secondary Consideration evaluated by Fed. Circuit: Both supported that combo wasn’t obvious Failure by others & Copying DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314(Fed. Cir. 2009)

Answer 2

NOT Patentable Simple Substitution of One (Known Element for Another→ predictable results) Court found that ““[b]ecause both Pagliaro and Waterman teach a method for separating caffeine from oil, it would have been prima facie obvious to substitute one method for the other. Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious.” Id. at 301, 213 USPQ at 536 In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)

Answer 3

NOT Patentable Simple Substitution of One (Known Element for Another→ predictable results) Would have been obvious to OS to replace the prior art gene w/ another gene known to lead to protein production, because OS would have been able to carry out such a substitution, and the results were reasonably predictable. “Obviousness does not require absolute predictability of success.” Id. at 903, 7USPQ2d at 1681. In re O'Farrell, 853 F.2d 894, 7 USPQ2d 1673 (Fed. Cir. 1988)

Answer 4

NOT Patentable Simple Substitution of One (Known Element for Another→ predictable results) Nature of problem to be solved: underpinning unstable foundations; Need to connect the member to the foundation to accomplish goal Problem would have led OS to choose an appropriate load-bearing member and a compatible attachment, therefore… Obvious to OS use a metal bracket (Gregory) in combo w/ a screw anchor (Fuller) to underpin unstable foundations Ruiz v. AB Chance Co., 357 F.3d 1270, 69 USPQ2d 1686(Fed. Cir. 2004) Case also listed in in Subsection A Example 2

Answer 5

NOT Patentable Simple Substitution of One (Known Element for Another→ predictable results) Board found that… Each of claimed elements … within the scope & content of PA OS could have combined elements as claimed by methods known at the time of the invention OS would have recognized at the time invention was made that the capabilities or functions of the combo were predictable Citing KSR: “substitution of the continuous, two-ply seam of Dick for the folded seam of Wyant thus is no more than the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.” Ex Parte Smith, 83 USPQ2d 1509 (Bd. Pat. App. & Int. 2007

Answer 6

NOT Patentable Simple Substitution of One (Known Element for Another→ predictable results) NOTE: useful example for understanding the scope of analogous art-…view the art in light of the prior art teachings concerning the problem to be solved On reexamination- Examiner rejected 103 based on a combo of references including Damark and Teague Federal Circuit- addressed propriety of making the combo since Teague comes from a different field than the invention Teague was found to be reasonably pertinent to the problem addressed in app because folding mechanism didn’t require any particular focus on treadmills, but rather generally addressed problems supporting the weight of such a mechanism and providing a stable resting position In re ICON Health & Fitness, Inc. 496 F.3d 1374 (Fed. Cir. 2007)

Answer 7

NOT Patentable Simple Substitution of One (Known Element for Another→ predictable results) Fed. Circuit- the claims simply substitute a resistive electrical switch for the function of …well known and predictable that it could be used for pest control. Also, the problem solved using the resistive electrical circuit also pertained to PA device. “a textbook case of when the asserted claims involve a combination of familiar elements according to known methods that does no more than yield predictable results.” Also- analogous art is not limited to the field of applicant’s endeavor NOTE: Cattle prod is not really the proper use here, because the rat trap was to kill and the cattle prod was not, so should be improper use (different purpose), but the Examiner could have used other prior art such as electric chair to still call it obvious Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008)

Answer 8

NOT Patentable Simple Substitution of One (Known Element for Another→ predictable results) Fed. Circuit -Analogized this case to Leapfrog Case*, which involved a determination of obviousness based on application of modern electronics to a PA mechanical children’s learning device In Leapfrog-court noted market pressures would have prompted OS to use modern electronics in PA device In this case-market pressure would have prompted OS to use a conventional Web browser in a method of auctioning municipal bonds Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed.Cir. 2008)

Answer 9

NOT Patentable Simple Substitution of One (Known Element for Another→ predictable results) Question before court -whether purified single isomer would have been obvious over known mix District Court - Saw it as a close case, as no clear motivation in PA to isolate (S)-ramipiril Fed. Circuit – disagreed. Said that “Requiring an explicit teaching to purify the 5(S) stereoisomer from a mixture in which it is the active ingredient is precisely the sort of rigid application of the TSM [Ed.: Teaching /suggestion/ motivation] test that was criticized in KSR.” Also, relied on settle principle: In chemical cases, structural similarity can provide the necessary reason to modify prior art teachings Requisite motivation can come from any # of sources-need not be explicit Addressed kind of teaching that would be sufficient (in absence of explicit teaching)- an expectation of similar properties in light of prior art can be sufficient “Lead compounds”-important subgroup of obviousness cases based on substitution Simple Substitution of One (Known Element for Another→ predictable results)

Answer 10

PATENTABLE Simple Substitution of One (Known Element for Another→ predictable results) Teva – argued obviousness on basis of structural similarity to 2-pyr EHDP, which is a positional isomer of risedronate Court – found no reason to select 2-pyr EHDP as a lead cmpd in light of unpredictable nature of the art & no reason to modify it so as to obtain risedronate. Also, unexpected results (potency & tox) Teva had not made a prima facie case, and if it is had, was rebutted by evidence of unexpected results Fed. Circuit – Affirmed. If 2-pyr EHDP is presumed an appropriate lead cmpd, there must be both a reason to modify it so as to make risedronate and a reasonable expectation of success. No evidence modification were routine so no reasonable expectation of success Properties of risedronate were not expected Researchers did not predict either potency or low effective dose Superior properties were unexpected and could not be predicted Testing of risedronate cf PA cmpd-outperformed by substantial margin Unexpected superiority

Answer 11

NOT Patentable Simple Substitution of One (Known Element for Another→ predictable results) Examiner considered cmpds of Altana’s PA to be relevant during prosecution of the patent in suit Experts had opined that OS would have selected 12 to pursue further investigation as PPI inhibitors Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., 566 F.3d 999 (Fed. Cir. 2009)

Answer 12

Simple Substitution of One (Known Element for Another→ predictable results) Prima facie case of obviousness of the claimed compound might exist if… OS would have known how to synthesize such a cmpd, and The structural and/or functional result could reasonably have been predicted

Answer 13

Simple Substitution of One (Known Element for Another→ predictable results) Might be properly found to have been obvious if… There would have been a reason to link the two If OS would have known how to link If resulting cmpd would have been the predictable result of the linkage procedure

Answer 14

NOT Patentable Known technique to improve similar device/method/product…in same way → predictable results Court - “it would have been obvious to one of ordinary skill in the art to use the threshold signal produced in the USSR device to actuate a cutoff switch to render the inverter inoperative as taught by Kammiller.” In re Nilssen, 851 F.2d 1401, 7 USPQ2d 1500 (Fed. Cir.1988)

Answer 15

NOT Patentable Known technique to improve similar device/method/product…in same way → predictable results NOTE: Same as Example 2 in subsection A-Combining Nature of problem to be solved: underpinning unstable foundations Need to connect the member to the foundation to accomplish goal Problem would have led OS to choose an appropriate load-bearing member and a compatible attachment, therefore… Obvious to OS use a metal bracket (Gregory) in combo w/ a screw anchor (Fuller) to underpin unstable foundations Also Example 2 of subsection C- Known Technique: The nature of the problem to be solved may lead inventors to look at references relating to possible solutions to that problem Therefore, it would have been obvious to use a metal bracket (as shown in Gregory) with the screw anchor (as shown in Fuller) to underpin unstable foundations Ruiz v. AB Chance Co., 357 F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004)

Answer 16

NOT Patentable Applying known technique …ready for improvement Court –“[u]nder respondent's invention, then, a general purpose computer is programmed to provide bank customers with an individualized and categorized breakdown of their transactions during the period in question.” Applying KNOWN TECHNIQUE to BASE: Supplementing account info w/ additional digits (cat. code) solved problem of category breakdown by effectively creating a single account that can be treated as distinct accounts for tracking/reporting Category code.allowed what might previously have been separate accounts to be …a single account, but with a number of sub-accounts The basic technique of putting indicia on data which then enabled standard sorting, searching, and reporting yielded no more than the predictable outcome which one of ordinary skill would have expected to achieve with this common tool of the trade and was therefore an obvious expedient. The Court held that “[t]he gap between the prior art and respondent's system is simply not so great as to render the system nonobvious to one reasonably skilled in the art.” Dann v. Johnston, 425 U.S. 219, 189 USPQ 257 (1976)

Answer 17

NOT Patentable Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success) Pfizer – argued that results of finding amlodipine besylate would have been unpredictable and therefore nonobvious Court – rejected notion that unpredictability could be equated with nonobvisouness here, because there were only a finite number (53) of pharmaceutically acceptable salts to be tested for improved properties OS having problems with machinability of amlodipine would have looked to forming a salt of the cmpd and would have been able to narrow the group of potential salt-formers to a group of 53 anions known to form pharmaceutically acceptable salts, which would be an acceptable # to form a “reasonable expectation of success”

Answer 18

NOT Patentable Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success) Court - Because absorption properties of oxybutynin would have been reasonably predictable at the time of the invention, there would have been reasonable expectation of successful dev’t of a sustained-release formulation The PA, as evidenced by the spec, had recognized the obstacles to be overcome in dev’t of sus-release of highly water sol. Drugs, and had suggested a finite # of ways to overcome the obstacles Claims were obvious because would have been obvious to try the known methods for formulating sus-release comp. w/ reasonable expectation of success Court was NOT swayed by a lack of absolute predictability

Answer 19

Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success) Board – OS would have had reasonable expectation that a nucleic acid molecule within the claimed scope could have been successfully been obtained Appellant – relying on In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) argued improper for Office to use the polypeptide of Valiante patent together w/ methods in Sambrook to reject a claim drawn to a specific nucleic acid molecule w/o providing a reference showing a structurally similar nucleic acid molecule Board – that "when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." Fed. Circuit- subsstantially adopted Board’s reasoning, BUT… SC in KSR unambiguously discredited Deuel decision, insofar as it implies the obviousness inquiry cannot consider that the combo of a claim’s constituent elements was obvious to try Instead, Kubin stated that KSR “resurrects” the Fed Circuit’s own wisdom in O’Farrell-”to differentiate between proper & improper applications of “obvious to try”, the Fed Circuit outlines two classes of situation where “obvious to try” is erroneously equated with obviousness under 103” Two classes where “obvious to try” is erroneously equated w/ obviousness: - When what would have been “obvious to try” would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at the successful result, where PA gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful - When what was “obvious to try” was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it. In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)

Answer 20

PATENTABLE Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success)

Answer 21

PATENTABLE Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success)

Answer 22

PATENTABLE Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success) Alphapharm – argued that a 2-step modification involving homologation & ring-walking of a known cmpd (Compound B) would have produced pioglitazone, so obvious District Court – would have been no reason to select cmpd B as a lead cmpd On top of Takeda’s 54 PA cmds, “100s of millions” of TZD cmpds were more generally disclosed Fed Circuit – Affirmed - KSR Court recognized “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.” KSR,127 S.Ct. at 1732. - In such circumstances, “the fact that a combination was obvious to try might show that it was obvious under § 103.” - Here though-rather than ID’ing predictable solutions for antidiabetic treatment, PA disclosed a broad selection of cmpds, any one of which could have been picked as “lead cmpd” (So no reason to select a “lead cmpd”) - Also, closest (cmpd B) exhibited negative properties>would have directed OS away - Evidence- It was NOT obvious to try - So, recognized need for treatment, but no finite # of identified, predictable solutions and no reasonable expectation of success Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007)

Answer 23

Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success) Mylan -defense of invalidity due to obviousness rested on an “obvious to try” argument Didn’t explain why it would have been obvious to begin w/ an anti-diabetic drug precursor, esp. the specific one that led to topiramate, if one was seeking an anti-convulsant Fed. Circuit – recognized an element of serendipity (runs counter to predictability) No apparent reason why OS would have chosen the particular starting cmpd or particular synthetic pathway to make the intermediate that was topiramate Also, no reason to test intermediate for anticonvulsant properties KSR posits a situation with a finite, and in the context of the art, small or easily traversed, number of options that would convince an ordinarily skilled artisan of obviousness Doesn’t present a finite # of options easily traversed to show obviousness Under case law: “Finite” means “small or easily traversed” in context of art in question Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc., 520 F.3d 1358(Fed. Cir. 2008)

Answer 24

NOT Patentable Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success) Fed. Circuit – PA would have funneled formulator to 2 options, so not required to try ALL possibilities. PA was not vague, but guided to use either normal pill or enteric-coated Mere existence of a large # of options doesn’t lead itself to conclusion of nonobviousness. Where PA leads OS to a narrower set of options, then reduced set is appropriate to consider to determine obviousness Compared to Sanofi case (#7): art-based reasons to expect both normal and enteric-coated would be therapeutically suitable, even though not all PA studies were in complete agreement. So, results were not unexpected. Bayer Schering Pharma A.G. v. Barr Labs., Inc., 575 F.3d 1341 (Fed. Cir. 2009)

Answer 25

Patentable Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success) Experts for both parties: OS couldn’t predict degree to which isomers would exhibit different levels of therapeutic activity & toxicity Isomer w/ greater therapeutic activity would most likely have greater toxicity It was difficult to separate isomers at time of invention Sanofi witness: They believed separation was unlikely to be productive “Rare case of absolute stereoselectivity”-D-isomer had all favorable activity and no tox, while L-isomer had no therapeutic activity but virtually all the toxicity District Court/Fed. Circuit -Apotex hadn’t met burden of proving by clear and convincing evidence that Sanofi’s patent was invalid for obviousness Even when only a small number of possible choices exist, the “obvious to try” line of reasoning is not appropriate when, upon consideration of all of the evidence, the outcome would not have been reasonably predictable and the inventor would not have had a reasonable expectation of success Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008)

Answer 26

PATENTABLE Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success) Fed. Circuit –disagreed with United In a proper “obvious to try” approach to obviousness, the possible options for solving a problem must have been “known and finite.” In this case, there had been no suggestion in the prior art that would have suggested that changing the sweep angle as Rolls-Royce had done would have addressed the issue of endwall shock. Thus, changing the sweep angle “would not have presented itself as an option at all, let alone an option that would have been obvious to try.” Rolls-Royce, PLC v. United Technologies Corp., 603 F.3d 1325 (Fed. Cir. 2010)

Answer 27

NOT Patentable Obvious to Try (Choosing from a Finite # of Identified, Predictable Solutions, with a Reasonable Expectation of success) Fed. Circuit: “Common sense has long been recognized to inform the analysis of obviousness if explained with sufficient reasoning.” the kind of strict evidence-based teaching, suggestion, or motivation required in In re Lee, 277 F.3d 1338, 1344 (Fed. Cir. 2002), is NOT an absolute requirement for an obviousness rejection in light of the teachings of KSR although“ a reasoned explanation that avoids conclusory generalizations” is required to use common sense, identification of a “specific hint or suggestion in a particular reference” is not Fed Circuit allowed common sense to be used here to supplement a missing element in the prior art-because it was unusually simple. Also see Randy vs Apple in MPEP (common sense doesn’t USUALLY get used to supply a missing element but only motivation. 103 usually requires all the elements to be in the prior art, unless as simple as resending an e-mail Perfect Web Technologies, Inc. v. Info USA, Inc., 587 F.3d 1324 (Fed. Cir. 2009)

Answer 28

NOT Patentable Known work in one field/endeavor prompting variations of an analogous device/product/method in same/different field based on Design incentives/other market forces …Variations are predictable to OS Court –“[u]nder respondent's invention, then, a general purpose computer is programmed to provide bank customers with an individualized and categorized breakdown of their transactions during the period in question.” Applying KNOWN TECHNIQUE to BASE: Supplementing account info w/ additional digits (cat. code) solved problem of category breakdown by effectively creating a single account that can be treated as distinct accounts for tracking/reporting Category code allowed what might previously have been separate accounts to be …a single account, but with a number of sub-accounts The basic technique of putting indicia on data which then enabled standard sorting, searching, and reporting yielded no more than the predictable outcome which one of ordinary skill would have expected to achieve with this common tool of the trade and was therefore an obvious expedient. The Court held that “[t]he gap between the prior art and respondent's system is simply not so great as to render the system nonobvious to one reasonably skilled in the art.” Example 1 of Subsection F: Court Problem addressed by applicant - the need to give more detailed breakdown by a category of transactions ~ was closely analogous to the task of keeping track of the transaction files of individual business units. Id. At 229, 189 USPQ at 261. Thus, an artisan in the data processing area would have recognized the similar class of problem and the known solutions of the prior art and it would have been well within the ordinary skill level to implement the system in the different environment. Dann v. Johnston, 425 U.S. 219, 189 USPQ 257 (1976)

Answer 29

NOT Patentable Known work in one field/endeavor prompting variations of an analogous device/product/method in same/different field based on Design incentives/other market forces …Variations are predictable to OS Court: Claimed invention would have been obvious in view of combo of 2 pieces of PA & knowledge of OS Claimed invention was but a variation on already known children’s toys Variation presented no nonobvious advance over other toys No technological advance beyond skill shown in SSR device “[a]ccomodating a prior art mechanical device that accomplishes that goal to modern electronics would have been reasonably obvious to one of ordinary skill in designing children’s learning devices. Applying modern electronics to older mechanical devices has been commonplace in recent years.” Leapfrog Enterprises, Inc. v. Fisher-Price, Inc., 485 F.3d1157, 82 USPQ2d 1687 (Fed. Cir. 2007)

Answer 30

NOT Patentable Known work in one field/endeavor prompting variations of an analogous device/product/method in same/different field based on Design incentives/other market forces …Variations are predictable to OS Court: “[t]he proper question to have asked was whether a pedal designer of ordinary skill, facing the wide range of needs created by developments in the field of endeavor, would have seen a benefit to upgrading Asano with a sensor.” Found that technological developments in the automotive design would have prompted a designer to upgrade Asano with an electronic sensor Next Q? Where to attach the sensor? OS would have known to place the sensor on a nonmoving part of the pedal structure and the most obvious nonmoving point on the structure from which a sensor can easily detect the pedal’s position was a pivot point Conclusion: it would have been obvious to upgrade Asano’s fixed pivot point adjustable pedal by replacing the mechanical assembly for throttle control with an electronic throttle control and to mount the electronic sensor on the pedal support structure. KSR International Co. v. Teleflex Inc., 550 U.S. __, 82USPQ2d 1385 (2007)

Answer 31

NOT Patentable Known work in one field/endeavor prompting variations of an analogous device/product/method in same/different field based on Design incentives/other market forces …Variations are predictable to OS Board: PA shows OS “…would have been familiar with using bioauthentication information interchangeably with or in lieu of PINs to authenticate users.” The OS in the art of consumer electronic devices would have found it obvious to update the prior art password device with the modern bioauthentication component and thereby gain, predictably, the commonly understood benefits of such adaptation, that is, a secure and reliable authentication procedure. Ex Parte Catan, 83 USPQ2d 1568 (Bd. Pat. App. & Int. 2007)

Patentable vs Non-Patentable Flashcards

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