DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Formal Matters
Applicant’s claim amendments and arguments in the reply filed on 02 December 2025 are acknowledged and have been fully considered. Claims 1-21 are pending. Claims 19-21 are under consideration in the instant Office action. Claims 1-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Applicant’s claim amendments and arguments did not overcome the rejections set forth in the previous office action under 35 USC 103 on claims 19-20 for reasons set forth in the previous office action and herein below.
Information Disclosure Statement
The information disclosure statement (IDSs) submitted on 05 February 2026, 26 September 2025, 30 July 2025 are noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the information disclosure statement. Signed copies are attached herein.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Objection to claim 21
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Rejections Maintained
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Note: The elected species for examination was hexadecyltriethoxysilane and hexadecenylsuccinic anhydride.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Feuillette et al. (WO2013160440, previously cited) and EIERDANZ et al. (DE 4238032, English machine translation is provided, previously cited).
Applicant Claims
Applicant claims a composition comprising the ingredients as recited.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Feuillette et al. teach the present invention relates to a cosmetic process for treating hair comprising the application to the hair of a cosmetic composition comprising: - one or more fatty-chain silanes of formula (I) below and/or oligomers thereof: R1Si(OR2)z(R3)x(OH)y (I) in which formula (I): • R1 represents a linear or branched alkyl or alkenyl group comprising from 7 to 18 carbon atoms, • R2 and R3, which may be identical or different, represent a linear or branched alkyl group comprising from 1 to 6 carbon atoms, • y denotes an integer ranging from 0 to 3, • z denotes an integer ranging from 0 to 3, preferentially from 1 to 3 and better still equal to 3; and • x denotes an integer ranging from 0 to 2, • with z+x+y=3, - one or more propellants. The invention also relates to the use of said composition for shaping and/or fixing keratin fibres, such as human keratin fibres and in particular the hair (see abstract). Feuillette et al. teach in claim 1 Cosmetic process for treating hair comprising the application to the hair of a cosmetic composition comprising:
- one or more fatty-chain silanes of formula (I) below and/or oligomers thereof: R1Si(OR2)z(R3)x(OH)y (I)
in which formula (I):
• Ri represents a linear or branched alkyl or alkenyl group comprising from 7 to 18 carbon atoms,
• R2 and R3, which may be identical or different, represent a linear or branched alkyl group comprising from 1 to 6 carbon atoms,
• y denotes an integer ranging from 0 to 3,
• z denotes an integer ranging from 0 to 3, and
· x denotes an integer ranging from 0 to 2,
• with z+x+y=3,
- one or more propellants.
Feuillette et al. teach Process according to Claims 1 to 4, characterized in that it comprises at least one silane of formula (I) chosen from octyltriethoxysilane, dodecyltriethoxysilane, octadecyltriethoxysilane and hexadecyltriethoxysilane (see claim 5). The applicant has now discovered that, surprisingly, a particular fatty-chain silane in a pressurized composition makes it possible to give the hair an improved cosmetic feel, with good uniformity of the result over the entire head of hair (see page 2).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Feuillette et al. do not teach the incorporation of hexadecenylsuccinic anhydride. These deficiencies are cured by the teachings of EIERDANZ et al.
EIERDANZ et al. teach the invention concerns succinic acid derivatives of the formula I: R<1>O(CnH2nO)xCO-CHR<2>-CHR<3>-CO(OCnH2n)yOR<4>, in wich R<1> is an alkyl, akenyl, monohydroxy- or dihydroxyalkyl group or a hydroxyalkenyl group with 6 to 22 C-atoms; one of the groups R<2> and R<3> is hydrogen and the other an alkyl or alkenyl group with 12 to 22 C-atoms; n = 2 or 3; x and y are mean degrees of oxalkylation, x ranging from 0 to 20 and y ranging from 1 to 20 and R<4> is hydrogen or the group R<1>O-(CnH2nO)x-CO-CHR<2>-CHR<3>-CO- or is the same as R<1>. Such derivatives can be prepared from appropriately substituted alkyl- or alkenyl succinic acid anhydride by reaction with alcohols to give the mono-ester, adding (x + y) moles of ethylene oxide and propylene oxide and optionally hydrogenating. They have properties analogous to those of lipids, making them suitable for use as skin-moisture-regulating component in cosmetic or therapeutic skin-treatment preparations (see abstract). To keep the skin healthy and to promote a cosmetic speaking, smooth appearance and supple skin feel primarily maintaining natural moisture content of the stratum corneum. There are many skin moisturizing and moisturizing additives for cosmetic and therapeutic skin means of action, which are mostly what Water-soluble or water-binding substances, often even hygroscopic Connections. These substances usually have the disadvantage that they With frequent use, the skin dries out even more contribute (see description). Both cosmetic oils and aerosol tubes are suitable as carriers riding as well as aqueous, emulsion-shaped systems. In usual Oil components, e.g. B. in paraffin oil, vegetable oils and fatty acid esters dissolve clearly. They can be used both alone and in Mixture with usual cosmetic oil components using known emulsifiers emulsify with water, depending on the ge chose emulsifier and emulsification process oil-in-water, water-in-oil or mixed emulsion systems can be obtained. The invent Succinic acid derivatives according to the invention can be pro without hesitation z. B. in skin creams, lotions, skin oils, sunscreens, Body aerosols, hair lotions and bath oils can be incorporated (see description). In the example EIERDANZ et al. teach a mixture of 275.5 g (0.85 mol) of hexadecyl succinic anhydride (distilled briefly) were stirred at 80 ° C. for 1 h with 297.6 g (1.1 mol) of stearyl alcohol.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to modify the teachings of Feuillette et al. by incorporating an alkyl succinic anhydride because EIERDANZ et al. teach the invention concerns succinic acid derivatives of the formula I: R<1>O(CnH2nO)xCO-CHR<2>-CHR<3>-CO(OCnH2n)yOR<4>, in wich R<1> is an alkyl, akenyl, monohydroxy- or dihydroxyalkyl group or a hydroxyalkenyl group with 6 to 22 C-atoms; one of the groups R<2> and R<3> is hydrogen and the other an alkyl or alkenyl group with 12 to 22 C-atoms; n = 2 or 3; x and y are mean degrees of oxalkylation, x ranging from 0 to 20 and y ranging from 1 to 20 and R<4> is hydrogen or the group R<1>O-(CnH2nO)x-CO-CHR<2>-CHR<3>-CO- or is the same as R<1>. Such derivatives can be prepared from appropriately substituted alkyl- or alkenyl succinic acid anhydride by reaction with alcohols to give the mono-ester, adding (x + y) moles of ethylene oxide and propylene oxide and optionally hydrogenating. They have properties analogous to those of lipids, making them suitable for use as skin-moisture-regulating component in cosmetic or therapeutic skin-treatment preparations (see abstract). One of ordinary skill in the art would have been motivated to do so because EIERDANZ et al. teach the alkyl succinic anhydride containing cosmetic compositions keep the skin healthy and to promote a cosmetic speaking, smooth appearance and supple skin feel primarily maintaining natural moisture content of the stratum corneum. There are many skin moisturizing and moisturizing additives for cosmetic and therapeutic skin means of action, which are mostly what Water-soluble or water-binding substances, often even hygroscopic Connections. These substances usually have the disadvantage that they With frequent use, the skin dries out even more contribute (see description). Both cosmetic oils and aerosol tubes are suitable as carriers riding as well as aqueous, emulsion-shaped systems. In usual Oil components, e.g. B. in paraffin oil, vegetable oils and fatty acid esters dissolve clearly. They can be used both alone and in Mixture with usual cosmetic oil components using known emulsifiers emulsify with water, depending on the ge chose emulsifier and emulsification process oil-in-water, water-in-oil or mixed emulsion systems can be obtained. The invent Succinic acid derivatives according to the invention can be pro without hesitation z. B. in skin creams, lotions, skin oils, sunscreens, Body aerosols, hair lotions and bath oils can be incorporated (see description). In the example EIERDANZ et al. teach a mixture of 275.5 g (0.85 mol) of hexadecyl succinic anhydride (distilled briefly) were stirred at 80 ° C. for 1 h with 297.6 g (1.1 mol) of stearyl alcohol. One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of Feuillette et al. and EIERDANZ et al. because both references teach cosmetic compositions. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). With regard to the limitation reciting “wherein the composition forms a protective elastic outer layer when applied to hair and dried” it will be an inherent property of the composition as the combination teachings of the references met the claimed composition for similar purpose “[I]nherency may supply a missing claim limitation in an obviousness analysis." PAR, 773 F.3d at 1194-1195 ; see also Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374 , 1381 , 127 U.S.P.Q.2D (BNA) 1409 (Fed. Cir. 2018) ("An inherent characteristic of a formulation can be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan."). It is long settled that in the context of obviousness, the "mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art." In re Oelrich, 666 F.2d 578 , 581 (C.C.P.A. 1981). The Supreme Court explained long ago that "[i]t is not invention to perceive that the product which others had discovered had qualities they failed to detect." Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242 , 249 , 66 S. Ct. 81 , 90 L. Ed. 43 , 1946 Dec. Comm'r Pat. 611 (1945). We too have previously explained that "an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations," because "[t]o hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property." Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 , 1354 (Fed. Cir. 2012). In In re Kao, we found that the claimed controlled-release oxymorphone formulation was obvious because an inherent pharmacokinetic property of oxymorphone that was present in controlled-release oxymorphone "add[ed] nothing of patentable consequence." In re Huai-Hung Kao, 639 F.3d 1057 , 1070 , 98 U.S.P.Q.2D (BNA) 1799 (Fed. Cir. 2011). In In re Kubin, we found an inherent property obvious, explaining that "[e]ven if no prior art of record explicitly discusses the [limitation], the . . . application itself instructs that [the limitation] is not an additional requirement imposed by the claims on the [claimed protein], but rather a property necessarily present in [the claimed protein]." In re Kubin, 561 F.3d 1351 , 1357 , 90 U.S.P.Q.2D (BNA) 1417 (Fed. Cir. 2009). Our predecessor court similarly concluded that it "is not the law" that "a structure suggested by the prior art, and, hence, potentially in the possession of the public, is patentable . . . because it also possesses an [i]nherent, but hitherto unknown, function which [the patentees] claim to have discovered." In re [*1191] Wiseman, 596 F.2d 1019 , 1023 (C.C.P.A. 1979). Inherency, however, is a "high standard," that is "carefully circumscribed in the context of obviousness." PAR, 773 F.3d at 1195 . Inherency "may not be established by probabilities or possibilities," and "[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient." Oelrich, 666 F.2d at 581 (emphasis added) (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939); see also In re Rijckaert, 9 F.3d 1531 , 1533-1534 (Fed. Cir. 1993). Rather, inherency renders a claimed limitation obvious only if the limitation is "necessarily present," or is "the natural result of the combination of elements explicitly disclosed by the prior art." PAR, 773 F.3d at 119511 -96; see also Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 , 1369 (Fed. Cir. 2012) (relying on inherency where the claims recited "a property that is necessarily present" in the prior art). "If . . . the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient" to render the function inherent. Oelrich, 666 F.2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939)). On appeal, Persion contends that the district court erred in applying the inherency doctrine in its obviousness analysis because Devane does not teach administering its hydrocodone-only formulation to patients with mild or moderate hepatic impairment. Thus, Persion asserts, "'the natural result flowing from the operation as taught' in Devane cannot be the claimed [pharmacokinetic] values for [hepatically impaired] patients." Appellant's Br. 37 (quoting Oelrich, 666 F.2d at 581 ); Reply Br. 19. To the extent Persion contends that inherency can only satisfy a claim limitation when all other limitations are taught in a single reference, that position is contrary to our prior recognition that "inherency may supply a missing claim limitation in an obviousness analysis" where the limitation at issue is "the natural result of the combination of prior art elements." PAR, 773 F.3d at 1194-1195 (emphasis added, internal quotations omitted). Here, the district court specifically found that Devane, together with Jain, the state of the prior art at the time of invention, and the Vicodin and Lortab labels, taught the combination of elements that inherently result in the claimed pharmacokinetic parameters. The district court found that a person of ordinary skill in the art would have been motivated, with reasonable expectation of success, to administer an unadjusted dose of the Devane formulation to hepatically impaired patients. There was also no dispute that the Devane formulation, which was identical to the Zohydro ER formulation described in the patents in suit, necessarily exhibited the claimed parameters under these conditions. Pernix, 323 F. Supp. 3d at 607 , 610 . In this context, the district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Applicant’s Arguments
Applicants argue Feuillette is directed to a cosmetic composition which may be applied to the hair and which must contain fatty-chain silanes and one or more propellants: the compositions in Examples 1-9 of Feuillette all contain a propellant containing one or more alcohols. It is clear that the purpose of adding a propellant is because the composition is packaged in an aerosol device (page 32, line 12). However, such components are not desirable for the end user of the composition, because adding alcohol and volatile propellants will increase the risk of exposure of such chemicals to both the hairdresser and to the customer. In addition, the evaporation of propellants can cause significant allergic reactions to people with sensitive skin conditions. Preferably, the composition of Feuillette contains one or more fixing polymers, which may be an anionic, cationic, amphoteric, or non-ionic polymer (page 4,lines 5-12), these components are taught to give a shape to the head of hair or hold the hair in an “already acquired form.” There is no teaching or suggestion in Feuillette that compositions containing no copolymers would be effective for hair treatment. Furthermore, Applicants argue Eierdanz is directed to the application of succinic acid derivatives for skin care purposes; the use in “hair lotion” is mentioned only one time. In such a case the derivative is combined with “suitable carriers,” which are explained to be paraffin oil, vegetable oils and fatty acid esters. As well understood in the art, the solubility of succinic acid derivatives is different from the solubility of the presently claimed succinic acid anhydride due to the presence of different functional groups. Applicants note that Eierdanz is silent as to the solubility of succinic acid anhydride in fatty-cham silanes (which is clearly different from all the examples of “suitable carriers’), and therefore there would be no expectation that combining succinic acid derivatives and fatty-chain silanes, which would result from the combination proposed by the Examiner, would have acceptable solubility and would have any favorable results based on the teachings of Eierdanz. Then Applicants argue about claim 21.
The above assertions are not found persuasive because with regard to claims 19-20 the examiner maintains that the inclusion of other agents and ingredients is not excluded by Applicant’s claim language. Applicant uses the transitional phrase “comprising” in claim 19 where claim 20 depend. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended."). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) ("The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps."); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) ("Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts"). In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to "a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades" encompasses razors with more than three blades because the transitional phrase "comprising" in the preamble and the phrase "group of" are presumptively open-ended. "The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended." Id. In contrast, the court noted the phrase "group consisting of" is a closed term, which is often used in claim drafting to signal a "Markush group" that is by its nature closed. Id. The court also emphasized that reference to "first," "second," and "third" blades in the claim was not used to show a serial or numerical limitation but instead was used to distinguish or identify the various members of the group.
Applicants argue Further, Eierdanz is completely silent as to how succinic acid derivatives behave under high temperatures conditions as the reference is directed to skin care applications; in most cases, the lotion is applied at room temperature, different from the presently claimed hair care compositions, as described in the present application and examples. Applicants have discovered that a combination of long chain alkyltriethoxysilanes and succinic anhydrides is particularly effective, as the heat significantly contributes to the coordination of the product to the hair. Eierdanz does not teach the incorporation of such compounds into a cosmetic or hair product, but rather the monoester ethoxylate derivative of the succinic acid anhydride. There is no teaching or suggestion in Eierdanz of employing a succinic acid anhydride. Applicants argue that including succinic anhydrides in the composition taught by Feuillette in an aerosol bottle as the reaction described above can result is dangerous pressurization in the bottle.
The above assertions are not found persuasive because when using the transitional phrase “comprising” the inclusion of other ingredients and steps is not excluded.
With regard to the limitation reciting “wherein the composition forms a protective elastic outer layer when applied to hair and dried” it will be an inherent property of the composition as the combination teachings of the references met the claimed composition for similar purpose “[I]nherency may supply a missing claim limitation in an obviousness analysis." PAR, 773 F.3d at 1194-1195 ; see also Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374 , 1381 , 127 U.S.P.Q.2D (BNA) 1409 (Fed. Cir. 2018) ("An inherent characteristic of a formulation can be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan."). It is long settled that in the context of obviousness, the "mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art." In re Oelrich, 666 F.2d 578 , 581 (C.C.P.A. 1981). The Supreme Court explained long ago that "[i]t is not invention to perceive that the product which others had discovered had qualities they failed to detect." Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242 , 249 , 66 S. Ct. 81 , 90 L. Ed. 43 , 1946 Dec. Comm'r Pat. 611 (1945). We too have previously explained that "an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations," because "[t]o hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property." Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 , 1354 (Fed. Cir. 2012). In In re Kao, we found that the claimed controlled-release oxymorphone formulation was obvious because an inherent pharmacokinetic property of oxymorphone that was present in controlled-release oxymorphone "add[ed] nothing of patentable consequence." In re Huai-Hung Kao, 639 F.3d 1057 , 1070 , 98 U.S.P.Q.2D (BNA) 1799 (Fed. Cir. 2011). In In re Kubin, we found an inherent property obvious, explaining that "[e]ven if no prior art of record explicitly discusses the [limitation], the . . . application itself instructs that [the limitation] is not an additional requirement imposed by the claims on the [claimed protein], but rather a property necessarily present in [the claimed protein]." In re Kubin, 561 F.3d 1351 , 1357 , 90 U.S.P.Q.2D (BNA) 1417 (Fed. Cir. 2009). Our predecessor court similarly concluded that it "is not the law" that "a structure suggested by the prior art, and, hence, potentially in the possession of the public, is patentable . . . because it also possesses an [i]nherent, but hitherto unknown, function which [the patentees] claim to have discovered." In re [*1191] Wiseman, 596 F.2d 1019 , 1023 (C.C.P.A. 1979). Inherency, however, is a "high standard," that is "carefully circumscribed in the context of obviousness." PAR, 773 F.3d at 1195 . Inherency "may not be established by probabilities or possibilities," and "[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient." Oelrich, 666 F.2d at 581 (emphasis added) (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939); see also In re Rijckaert, 9 F.3d 1531 , 1533-1534 (Fed. Cir. 1993). Rather, inherency renders a claimed limitation obvious only if the limitation is "necessarily present," or is "the natural result of the combination of elements explicitly disclosed by the prior art." PAR, 773 F.3d at 119511 -96; see also Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 , 1369 (Fed. Cir. 2012) (relying on inherency where the claims recited "a property that is necessarily present" in the prior art). "If . . . the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient" to render the function inherent. Oelrich, 666 F.2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939)). On appeal, Persion contends that the district court erred in applying the inherency doctrine in its obviousness analysis because Devane does not teach administering its hydrocodone-only formulation to patients with mild or moderate hepatic impairment. Thus, Persion asserts, "'the natural result flowing from the operation as taught' in Devane cannot be the claimed [pharmacokinetic] values for [hepatically impaired] patients." Appellant's Br. 37 (quoting Oelrich, 666 F.2d at 581 ); Reply Br. 19. To the extent Persion contends that inherency can only satisfy a claim limitation when all other limitations are taught in a single reference, that position is contrary to our prior recognition that "inherency may supply a missing claim limitation in an obviousness analysis" where the limitation at issue is "the natural result of the combination of prior art elements." PAR, 773 F.3d at 1194-1195 (emphasis added, internal quotations omitted). Here, the district court specifically found that Devane, together with Jain, the state of the prior art at the time of invention, and the Vicodin and Lortab labels, taught the combination of elements that inherently result in the claimed pharmacokinetic parameters. The district court found that a person of ordinary skill in the art would have been motivated, with reasonable expectation of success, to administer an unadjusted dose of the Devane formulation to hepatically impaired patients. There was also no dispute that the Devane formulation, which was identical to the Zohydro ER formulation described in the patents in suit, necessarily exhibited the claimed parameters under these conditions. Pernix, 323 F. Supp. 3d at 607 , 610 . In this context, the district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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