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 .
Priority
Instant application 18/572,614 filed on 12/20/2023 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1-56 are pending.
Information Disclosure Statement
IDS has not been provided.
Election/Restrictions
Applicant’s election without traverse of Group I (directed to a composition comprising a compound of Formula (I) and a fatty acid) in the reply filed on 06/08/2026 is acknowledged.
Claims 33-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/08/2026.
Regarding species election, Applicant’s election without traverse of capsaicin and oleic acid in the reply filed on 06/08/2026 is acknowledged.
Capsaicin (PubChem-1548943)
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falls under instant Formula (I):
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wherein a is a double bond, n1 is 1, n2 is 2, n3 is 1, X is N, R1 is OR1A, R1A is independently hydrogen and C1 alkyl, R2 is unsubstituted C3 alkyl.
Claims 5-13, 17-28 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/08/2026.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
In the instant case, composition comprising capsaicin and oleic acid has been identified in prior art, thus, the search was not extended to additional species.
Claim Objections
Although claims 17-28 are withdrawn from present consideration, those claims should be objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n).
Accordingly, the claims have not been further treated on the merits.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1-4 ,14 and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims 1-4 and 14 are drawn to compounds of Formula (I) or a “metabolite thereof”, and instant claim 30 is drawn to capsaicin a “metabolite thereof”.
The compounds of Formula (I) are structurally defined. However, the genus of “a metabolite” of Formula (I) is not fully structurally defined.
It is unclear what structures are encompassed by the term “metabolite”.
Reilly (Reilly and Yost, Drug Metab Rev. 2006; 38(4): 685–706) teaches capsaicin and related capsaicinoid analogs (see Figure 1)
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Further, Reilly teaches: “Initial studies on the metabolism of capsaicin by P450 enzymes demonstrated the formation of multiple products arising from aromatic and alkyl hydroxylation (Lee, 1980; Kawada et al.,1984; Gannett, 1990; Surh et al., 1995; Surh and Lee, 1995)”.
Furthermore, Reilly teaches: “a number of new metabolites arising from multiple and novel metabolic processes were identified (Reilly et al.,2003a). Metabolites arising from alkyl dehydrogenation and oxygenation, aromatic hydroxylation, and O-demethylation were described. Based on extensive characterization of the metabolites by liquid chromatography-tandem mass spectrometry (LC/MS/MS), UV visible absorbance spectroscopy, and 1D- and 2D-proton and carbon-13 NMR, a scheme for the metabolism of capsaicin by human liver microsomal P450 enzymes was proposed (Fig. 2).” (See pages 2 and 3, the section titled “Metabolism of Capsaicin by P450 Enzymes: Past and Present” and Fig. 2 on page 17):
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Reilly teaches: “Products included the formation of an unusual macrocyclic metabolite (M1) that was postulated to be formed through covalent bond formation between the amide nitrogen of capsaicin and a uniquely stable tertiary allylic carbocation at the penultimate (ω-1) carbon of the alkyl sidechain, a dehydrogenated alkyl diene (M4), and a dehydrogenated imide metabolite (M9). The formation of ω-, and ω-1 alcohols (M2 and M3, respectively), two aromatic phenols (M5 and M7), and an O-demethylated metabolite (M6) was also observed. Tentative structural identification for a metabolite that was formed by N-dehydrogenation and subsequent aromatic hydroxylation (M8) was also presented. M8 exhibited UV-visible absorption characteristics consistent with a molecule with extended conjugation. The proposed structure and a potential mechanism for the formation of M8 via sequential oxidation processes involving the imide M9 as the secondary substrate are presented in Fig. 3.” (See pages 2 and 3, the section titled “Metabolism of Capsaicin by P450 Enzymes: Past and Present” and Fig. 3 on page 18).
Applicant’s specification provides no examples of a “metabolite” of the compounds of Formula (I). Therefore, it is not clear if all the structures disclosed by Reilly are encompassed by the instant claims. Further, it is not clear what additional structures are encompassed by the instant claims. Given advancements in modern bioanalytical technologies, additional metabolites of capsaicin may be discovered in the future.
Methods of synthesizing compounds are, in general, known to the person of ordinary skill, however methods of making the myriads of compounds embraced by the instant claims is beyond the skill of the artisan, particularly when certain elements, such as “a metabolite”, are merely described partially.
As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the metabolite of Formula (I).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Dependent claims 2-4, 14 and 30 do not resolve these issues, since these claims do not further limit or provide further structure of the “metabolite”. Accordingly, these claims are also rejected.
The rejection would be overcome by amending the claims to remove the term “metabolite”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 ,4, 14, 29, 30 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilcox (WO-03077885-A2).
The instant claims recite composition comprising a compound of structural Formula (I) and a fatty acid in a range of about 1:5 to about 1:1000.
MPEP 2111.02 states that “The transitional term "comprising" (and other comparable terms, e.g., "containing," and "including") is "open-ended" in that it covers the expressly recited subject matter, alone or in combination with unrecited subject matter. See, e.g., 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."); 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")”.
Wilcox teaches composition 7B comprising 0.01% of capsaicin and 2% of oleic acid (see page 11, Table 2a):
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The composition comprising 0.01% (w/w) capsaicin to 2% (w/w) of oleic acid ratio (1:200 ratio) is a point within the range recited in instant claims (1:5 to 1:1000).
It should be noted that in addition to 0.01% (w/w) capsaicin and 2% (w/w) of oleic acid, composition 7B comprises also tetracaine and Versagel M200. However, as discussed above, instant claims allow for additional components (the transitional term "comprising" is "open-ended") thus, the composition 7B disclosed by Wilcox meet all limitations of instant claims.
Regarding instant claim 4, Table 2a lists weight/weight concentrations (% w/w), but it should be noted that composition 7B comprises 95.99 % (w/w) of Versagel M200 which is less dense than water. Therefore, the composition 7B comprising 0.01% (w/w) capsaicin reads on composition wherein capsaicin is present in an amount of less than 2% (w/v).
Claims 1 ,2, 4, 14, 29, 30 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muhammad (WO-2004/091521-A2).
Muhammad teaches composition comprising capsaicin, and a solvent system (see abstract).
Muhammad teaches:
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Specifically, Muhammad teaches formulation No 30 comprising 5.12% w/v capsaicin, 60% v/v 1,3-butanediol and 40% v/v oleic acid (see Table 4, page 75):
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[…]
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[…]
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It should be noted that the above composition comprising 40 v/v% of oleic acid (which is about 36.6 w/v of oleic acid) meet the limitation of instant claims. The instant claims require a ratio capsaicin to oleic acid of about 1:5 to about 1:1000. Therefore, the ratio of capsaicin to oleic acid (about 1:7) in formulation 30, is a point within the required range.
Regarding instant claim 4, Muhammad teaches composition comprising 1% of capsaicin (see Table 4, page 75):
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Further, it should be noted that instant claims allow for additional components (the transitional term "comprising" is "open-ended") thus, the compositions disclosed by Muhammad meet all limitations of instant claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-4, 14-16, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US-2014/0113971-A1).
Zhang teaches composition comprising capsaicin (0.01-0.25%) and emulsifier (polysorbate 60, 1-10%) (see Example 5, paragraph [0131]).
The composition disclosed by Zhang is comprising polysorbate 60 (fatty acid ester) as an emulsifier. The composition disclosed by Zhang does not comprise a fatty acid.
However, Zhang discloses various fatty acids that may be used as emulsifying agents (see paragraphs [0081] and [0083]):
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It should be noted that the ratio of capsaicin to emulsifier in Zhang’s example 5 falls under the range recited in instant claims.
Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one emulsifier (polysorbate 60 (fatty acid ester) disclosed by Zhang) for a different emulsifier (for example for oleic acid, suggested by Zhang) to arrive at the instant composition with a reasonable expectation of success. One of ordinary skill would have been motivated to prepare compositions comprising capsaicin and a different emulsifying agent. Applicant is reminded that “[I]t is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).” In the instant case, Zhang teaches fatty acids embraced within the present claims. As such, it would be obvious to select a fatty acid (for example oleic acid, disclosed by Zhang) from the list of emulsifying agents disclosed by Zhang, arriving at the presently claimed composition with a reasonable expectation of success. The resulting composition would comprise capsaicin (0.01-0.25%) and emulsifier (fatty acid, 1-10%). Therefore, the resulting composition comprising 0.01% wt. capsaicin to 1% wt. emulsifier (fatty acid) ratio, reads on a 1:100 ratio recited in instant claims 15. Composition comprising 0.1% wt. capsaicin to 6% wt. emulsifier (fatty acid) ratio, reads on a 1:60 ratio recited in instant claims 16.
Regarding claim 3, Zhang does not teach a composition comprising capsaicin in an amount of greater than about 10% (w/v). However, a person of ordinary skill before the effective filing date of the instant application would have been capable to adjust concentrations of capsaicin and fatty acid by routine experimentation. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Claims 1-4, 14-16, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Muhammad (WO-2004/091521-A2).
The teachings of Muhammad (WO-2004/091521-A2) have been discussed above and those teachings are incorporated herein by reference.
Muhammad teaches composition comprising capsaicin and a solvent system (see abstract).
Muhammad teaches:
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Further, Muhammad teaches the solvent system contains oleic acid:
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Muhammad teaches formulation No 30 comprising 5.12 % w/v capsaicin, 60 v/v% 1,3-butanediol and 40% v/v% oleic acid (around 1:7 ratio capsaicin: oleic acid), (see Table 4),
Furthermore, Muhammad teaches formulation No 1 comprising 15% w/v of capsaicin (see Table 4).
Regarding instant claims 4, Muhammad fails to teach composition comprising capsaicin and oleic acid in a ratio 1:5 to about 1:1000, wherein the amount of capsaicin is greater than 10% (w/v) in one single embodiment.
Regarding instant claims 16, Muhammad fails to teach composition comprising capsaicin and oleic acid in a ratio about 1:60 in one single embodiment.
However, Muhammad teaches and claims compositions comprising 1% to 20% of capsaicin:
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A person of ordinary skill before the effective filing date of the instant application would have been capable to adjust concentrations of capsaicin and oleic acid by routine experimentation. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
/I.S./Examiner, Art Unit 1621
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