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 .
DETAILED ACTION
Claims 138-157 of J. Hurt, US 18/839,364 (Jan. 23, 2023) are pending. Claims 141-156, to non-elected inventions of Groups (II) - (VI), are withdrawn from consideration pursuant to 37 CFR 1.142(b). Claim 140 of the elected group is withdrawn as not reading on the elected species. Claims 138-139 and 157 are under examination on the merits and are rejected.
Election/Restrictions
Applicant elected Group (I), claims 138-140 and 157, drawn to a composition for treating a reduced amount of tactile sexual function, without traverse in the Reply to Restriction Requirement filed on December 22, 2025. Claims 141-156, to non-elected inventions of Groups (II) - (VI), are withdrawn from consideration pursuant to 37 CFR 1.142(b). The restriction/election requirement is made FINAL.
Pursuant to the election of species requirement Applicant elected, without traverse, the following species:
(1) Valine, which is at least one positive GABAergic treatment substance that Applicant finds reads on claims 141, 142, and 143;
(2) N-acetyl-cysteine, which is at least one negative glutamatergic treatment substance that Applicant finds reads upon claims 141 and 142; and
(3) Piperine, which is at least another positive GABAergic treatment substance that Applicant finds reads upon claims 141 and 142.
for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Claims 138, 139 and 157 read on the elected species. The elected species was searched and determined to be free of the art of record. The search/examination was extended to the additional species cited in the § 103 rejection, where examined claims 138-139 and 157 are rejected. MPEP § 803.02 (III)(C)(2). The provisional election of species requirement is given effect and claim 140 of elected Group (I) is withdrawn from consideration as not reading on the elected species. MPEP § 803.02(III)(A).
Rejections 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. — The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Pursuant to 35 U.S.C. 112, the claim must apprise one of ordinary skill in the art of its scope so as to provide clear warning to others as to what constitutes infringement. MPEP 2173.02(II); Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention. MPEP § 2173.05(a).
Unclear Functional Terms
Claims 138-139 and 157 are rejected pursuant to 35 U.S.C. 112(b), as indefinite because the following, functionally defined claim 138 chemical Markush genera (labeled by the Examiner below as (a), (b) and (c)) are unclear:
138 . . . (a) at least one positive GABAergic treatment substance,
[That performs the function of] wherein the at least one positive GABAergic treatment substance increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance;
(b) at least one negative glutamatergic treatment substance,
[That performs the function of] wherein the at least one negative glutamatergic treatment substance promotes the activation of the mGlu2 receptor, the mGlu3 receptor, or a combination thereof; or
(c) at least another positive GABAergic treatment substance,
[That performs the function of] wherein the at least another positive GABAergic treatment substance activates a TRPV1-Receptor and activates a KCC2 transporter;
Claim 139 . . . the positive glutamatergic treatment substance that activates at least one NMDA receptor, decreases KCC2 activity, or a combination thereof”.
Each of the chemical Markush groupings of (a), (b) and (c) are defined in fully functional terms. MPEP § 2173.05(g).
A functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used. MPEP § 2173.05(g). The use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. Id. For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Id. Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise. MPEP § 2173.05(g).
The specification does not provide a limiting definition for these terms. Each these terms (e.g., “at least one positive GABAergic treatment substance”) appears to be new terminology, particular the instant application. MPEP § 2173.05(a). Thus, the specification should provide a clear definition for each term. MPEP § 2173.05(a). The plain language of these terms is not helpful in determining their meaning, for example, with respect to “at least one negative glutamatergic treatment substance”, the specification does not teach what negative impact is required on glutamatergic neurotransmission. MPEP § 2173.05(g).
The specification provides confusion over the meaning of these terms by teaching that they are interchangeable as follows:
[0019] In some embodiments, the at least one positive cysteineic treatment substance comprises N-acetyl-cysteine, cysteine, cystine, or a combination thereof. In other aspects, the at least one positive cysteineic treatment substance comprises N-acetyl-cysteine . . .
[0020] In particular embodiments, the at least one positive GABAergic treatment substance also is a negative glutamatergic treatment substance, the at least one positive cysteineic treatment substance, or a combination thereof, are at least one negative glutamatergic treatment substance. In some embodiments, the positive GABAergic treatment substance also is a negative glutamatergic treatment substance . . .
Specification at page 6, [0019]-[0020].
Thus, per the specification the “at least one positive GABAergic treatment substance” also is “a negative glutamatergic treatment substance”. And per the specification the elected species N-acetyl-cysteine (which is disclosed in the specification as an “at least one positive cysteineic treatment substance”) can be either of the “at least one positive GABAergic treatment substance” or the “at least one negative glutamatergic treatment substance”; where per the Reply, Applicant assigned it as the “at least one negative glutamatergic treatment substance”.
Particularly confusing is the claim 138 recitation of:
a) at least one positive GABAergic treatment substance, wherein the at least one positive GABAergic treatment substance increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance;
because neither claim 138 nor the specification specifies what “GABAA receptor agonist” is referred to that increases after the ingestion.
Additional confusion stems from the fact that species disclosed in the specification as performing the respectively claimed functions are highly structurally divergent. In this regard, the specification provides example species of (a), (b), and (c) that are asserted to perform the claimed function as follows:
138 . . . (a) at least one positive GABAergic treatment substance,
[That performs the function of] wherein the at least one positive GABAergic treatment substance increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance;
GABA
Page 3, [0012]
homotaurine
Page 3, [0012]
a Withania somnifera preparation
Page 3, [0012]
valine
Page 3, [0013]
leucine
Page 3, [0013]
Isoleucine
Page 3, [0013]
nicotinoyl-GABA
Page 3, [0013]
Boswellia serrata preparation, a Crocus sativus preparation, a Piper methysticum
preparation, theanine, baicalin preparation
Page 4, [0014]
138 . . . (b) at least one negative glutamatergic treatment substance,
[That performs the function of] wherein the at least one negative glutamatergic treatment substance promotes the activation of the mGlu2 receptor, the mGlu3 receptor, or a combination thereof; or
Fasoracetam, Biphenylindanone A, Pomaglumetad, Eglumegad, Possibly Noopept
Page 63, Table (mGlu2)
Fasoracetam, Eglumegad, Pomaglumetad, Pomaglumetad Methionil
Page 63, Table (mGlu3)
MagT [Magnesium L-Threonate], NAC/Cys, saffron, cat's claw bark/ cat's claw bark extract, pyroglutamate
Page 242. Specification does not state whether these “promote the activation of the mGlu2 receptor, the mGlu3 receptor”
138 . . . (c) at least another positive GABAergic treatment substance,
[That performs the function of] wherein the at least another positive GABAergic treatment substance activates a TRPV1-Receptor and activates a KCC2 transporter;
piperine
Specification at page 47, Table (“piperine”)
“vanilla preparation”
Id. at page 224 (“vanilla preparation”)
These disclosed species are highly structurally divergent, and several are complex mixtures of compounds. One of skill can infer no common structural core from the disclosed species so as to predict which species (aside from the disclosed species) will perform the claimed function.
In summary, the cited language is ambiguous because there is a clearcut indication of the scope of the subject matter covered by the claimed species; the language does not set forth well-defined boundaries; and one of skill would know from the cited claim terms what structures are encompassed by the claims; the boundaries defining the claimed species are not clear and precise. MPEP § 2173.05(g).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
§ 112(d) Rejection of Claim 139
Claim 139 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of claim 138 upon which it depends, or for failing to include all the limitations of the claim upon which it depends for the following reasons. Claim 139 is reproduced below.
139. The composition of claim 138, further excluding:
at least one negative GABAergic treatment substance, a positive glutamatergic treatment substance, or a combination thereof;
wherein the negative GABAergic treatment substance comprises a carbonic anhydrase inhibitor;
wherein the positive glutamatergic treatment substance activates at least one NMDA receptor, decreases KCC2 activity, or a combination thereof;
and wherein the at least one negative GABAergic treatment substance, the positive glutamatergic treatment substance, or the combination thereof is in an effective amount to reduce tactile sexual function, increase the time to ejaculation, or both.
The plain language of claim 138 excludes one or both of the “at least one negative GABAergic treatment substance” and the “a positive glutamatergic treatment substance”. Both of these components are required elements of base claim 138. Claim 139 therefore fails § 112(d) because it does not include all the limitations of claim 138 upon which it depends.
Claim Rejections 35 U.S.C. 112(a) – Written Description
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.
For an originally filed claim, 35 U.S.C. 112(a) requires that the specification shall contain a written description of the invention demonstrate that the inventor was in possession of the invention that is claimed.1 MPEP § 2163(I); MPEP § 2163(II)(A)(3)(a). Possession may be shown by disclosure of drawings or structural chemical formulas that show that the invention was complete. MPEP § 2163(I).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. MPEP § 2163(II)(A)(3)(a)(ii). A "representative number of species" means that the species which are adequately described are representative of the entire genus. MPEP § 2163(II)(A)(3)(a)(ii). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. MPEP § 2163(II)(A)(3)(a)(ii) (citing AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
The § 112(a) rejection
Claims 138-139 and 157 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement because neither the application as filed nor the art of record disclose either: (1) sufficient species of, per claim 138, each of:
138 . . . (a) at least one positive GABAergic treatment substance,
[That performs the function of] wherein the at least one positive GABAergic treatment substance increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance;
(b) at least one negative glutamatergic treatment substance,
[That performs the function of] wherein the at least one negative glutamatergic treatment substance promotes the activation of the mGlu2 receptor, the mGlu3 receptor, or a combination thereof; or
(c) at least another positive GABAergic treatment substance,
[That performs the function of] wherein the at least another positive GABAergic treatment substance activates a TRPV1-Receptor and activates a KCC2 transporter;
wherein the at least one positive GABAergic treatment substance and the at least one negative glutamatergic treatment substance, at least another positive GABAergic treatment substance, or a combination thereof: are in an effective amount to achieve pleasurable tactile sexual function just before the beginning of orgasm, just after the beginning of orgasm, or both, in a person.
or; (2) a structure-function correlation between the structure and the claimed function such that one of skill can recognize which of each species (a), (b) and (c) meet the limitations of claim 138.
The same issue and reasoning apply to claim 139 with respect to the below-highlighted functional language:
139. The composition of claim 138, further excluding:
at least one negative GABAergic treatment substance, a positive glutamatergic treatment substance, or a combination thereof;
wherein the negative GABAergic treatment substance comprises a carbonic anhydrase inhibitor;
wherein the positive glutamatergic treatment substance activates at least one NMDA receptor, decreases KCC2 activity, or a combination thereof;
and wherein the at least one negative GABAergic treatment substance, the positive glutamatergic treatment substance, or the combination thereof is in an effective amount to reduce tactile sexual function, increase the time to ejaculation, or both.
Guidance and Predictability
What is conventional or well known to one of ordinary skill in the art need not be disclosed in detail. MPEP § (II)(A)(3)(a). Thus, the state of and predictability in the art is a relevant consideration in determining compliance with § 112(a), written description. MPEP § (II)(A)(3)(a) (citing Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1085 (Fed. Cir. 2005) ("The ‘written description’ requirement must be applied in the context of the particular invention and the state of the knowledge…. As each field evolves, the balance also evolves between what is known and what is added by each inventive contribution”).
Guidance in the Specification for the “at least one positive GABAergic treatment substance”
Claim 138 requires this species perform the function of:
[That performs the function of] wherein the at least one positive GABAergic treatment substance increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance;
The “at least one positive GABAergic treatment substances” disclosed in the specification that that “increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance” are tabulated by the Examiner as follows, however, not all of these are stated by the specification to also function such that upon ingestion they increase the amount of “a GABAA receptor agonist”. In fact, the specification does not state what particular “a GABAA receptor agonist” has its amount increased upon ingestion. See § 112(b) rejection above.
“at least one positive GABAergic treatment substance” that “increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance”
GABA
Page 3, [0012]
homotaurine
Page 3, [0012]
a Withania somnifera preparation
Page 3, [0012]
valine
Page 3, [0013]
leucine
Page 3, [0013]
Isoleucine
Page 3, [0013]
nicotinoyl-GABA
Page 3, [0013]
Boswellia serrata preparation, a Crocus sativus preparation, a Piper methysticum
preparation, theanine, baicalin preparation
Page 4, [0014]
Thus, claim 138 requires a relationship between the “at least one positive GABAergic treatment substance” such that upon ingestion it increase the amount of an unspecified “a GABAA receptor agonist”. The only disclosed species of “a GABAA receptor agonist” that also increase the amount of an unspecified “a GABAA receptor agonist” appear to be preparations of Withania somnifera (Ashwagandha) and the genus of Active(s) withanolide. Specification at page 28, lines 1-5. However, neither the art nor the specification teaches any structure-function relationship between the “at least one positive GABAergic treatment substance” and the “a GABAA receptor agonist”, such that one of skill can recognize (aside from the disclosed substances) which other species of “at least one positive GABAergic treatment substance” perform the function of “increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance”. Indeed, one of skill cannot glean from the disclosure or the art of record which other substances (aside from the disclosed substances) are even “at least one positive GABAergic treatment substance” in the first place.
Guidance in the Specification for the “at least one negative glutamatergic treatment substance”
Claim 138 requires this species perform the function of:
[[That performs the function of] wherein the at least one negative glutamatergic treatment substance promotes the activation of the mGlu2 receptor, the mGlu3 receptor, or a combination thereof
With respect to substances that perform the “negative glutamatergic treatment substance” function, the specification teaches that
For example, it is contemplated that a treatment substance that increases extrasynaptic Glu, such as a positive cysteineic, may activate a mGlu2/mGlu2 extrasynaptic receptor on a presynaptic neuron to reduce the release of synaptic Glu to reduce synaptic glutamatergic signaling.
Specification at page 61, [0090] (emphasis added).
The specification teaches that the following substances are “at least one negative glutamatergic treatment substance”:
Fasoracetam, Biphenylindanone A, Pomaglumetad, Eglumegad, Possibly Noopept
Page 63, Table (mGlu2)
Fasoracetam, Eglumegad, Pomaglumetad, Pomaglumetad Methionil
Page 63, Table (mGlu3)
MagT [Magnesium L-Threonate], NAC/Cys, saffron, cat's claw bark/ cat's claw bark extract, pyroglutamate
Page 242. Specification does not state whether these “promote the activation of the mGlu2 receptor, the mGlu3 receptor”
In view of the very different chemical structures of the above exemplified species, neither the art nor the specification teaches a structure-function relationship between the “at least one negative glutamatergic treatment substance” such that one of skill can recognize (aside from the disclosed substances) the full scope of which other species of “at least one negative glutamatergic treatment substance” sufficiently perform the function of “promotes the activation of the mGlu2 receptor, the mGlu3 receptor or a combination thereof”, such that they can be used in the claim 138-139 compositions in an “effective amount”. That is, what degree of MGlu2/MGlu3 activation is required? Indeed, one of skill cannot glean from the disclosure or the art of record which substances (aside from the disclosed substances) are even “at least one negative glutamatergic treatment substance” in the first place. That is, this is new term particular to the instant application and the specification does not teach what negative impact the claimed “negative glutamatergic treatment substance” is required to have on glutamatergic neurotransmission or what chemical structure accomplishes this function. MPEP § 2173.05(g).
Guidance in the Specification for the “at least another positive GABAergic treatment substance”
Claim 138 requires this species perform the function of:
[That performs the function of] wherein the at least another positive GABAergic treatment substance activates a TRPV1-receptor and activates a KCC2 transporter;
The specification discloses that piperine and “vanilla preparation” activates both the TRPV1-Receptor and activates a KCC2 transporter. Specification at page 47, Table (“piperine”); Id. at page 291, Table (“piperine”); Id. at page 224 (“vanilla preparation”).
However, neither the art nor the specification teaches a structure-function relationship between the “at least another positive GABAergic treatment substance” such that one of skill can recognize (aside from the disclosed substances) the full scope of which other species of “at least another positive GABAergic treatment substance” sufficiently perform the function of activating both the TRPV1-Receptor and KCC2 transporter, such that they can be used in the claim 138-139 compositions in an “effective amount”. That is, what degree of activation is required? Indeed, one of skill cannot glean from the disclosure or the art of record which substances (aside from the disclosed substances) are activators of both the TRPV1-Receptor and KCC2 transporter. For example, the art teaches that it is unclear how the TRPV1 agonist piperine enhanced KCC2 levels or activity. B. Tang et al., Cells, 1-15 (2020) (“Tang”) (see, Tang at page 8, 2nd full paragraph). Tang further teaches that CLP290 enhances the plasma membrane expression of KCC2, while compounds that target TRPV1, FLT3, or GSK-3 also modulates KCC2 expression (dotted arrows), but the mechanisms involved are unclear. Tang at page 7, Figure 1. As such, one of skill cannot even functionally predict (absent trial and error experimentation) which compounds activate both the TRPV1-receptor and activate a KCC2 transporter. In another example, Y. Dong teaches that how piperine interacts with the activate the capsaicin receptor TRPV1 ion channel remains unclear. Y. Dong et al., 516 Biochemical and Biophysical Research Communications, 365-372 (2019) (“Dong”) (see Abstract).
Unpredictability in the Art
Further, the art teaches significant unpredictability regarding whether any particular compound or substance mixture is per claim 138, any of (a), (b) or (c):
(a) at least one GABAergic treatment substance wherein the at least one positive GABAergic treatment substance comprises
at least one precursor of GABA,
at least one GABA prodrug,
at least one GABAA receptor agonist, or a combination thereof;
(b) at least one negative glutamatergic treatment substance; or
(c) at least another positive GABAergic treatment substance
and that can function together in combination, per claims 138-139, an “effective amount”.
For example, G. Sanacora et al., 7 Nature Review Drug Discovery, 426-437 (2008) (“Sanacora”) teaches that that glutamatergic neurotransmission is multi-step pathway where glutamine (Gln) is converted to glutamate (Glu) by glutaminase, which is then Glu is packaged into presynaptic vesicles by the vesicular Glu transporters (VGLUTs) and released from the neuron in an activity-dependent manner through interactions with soluble N‑ethylmaleimide-sensitive factor attachment receptor (SNARE) proteins. Sanacora at page 427, Figure 1. Sanacora teaches that glutamate can be found throughout the brain and tight control over glutamatergic neurotransmission is required to maintain optimal neuronal function and multiple levels of regulatory processes have evolved to ensure that glutamatergic excitation is maintained within narrow boundaries. Sanacora at page 428, col. 1 (referencing Figure 1).
Claim Breadth
Claim breath is relevant to the instant § 112(a) written description rejection. The written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. MPEP § 2163(II)(A)(3)(a)(ii) (citing Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021)).
The species encompassed within the genera of: a), (b) or (c):
(a) at least one GABAergic treatment substance wherein the at least one positive GABAergic treatment substance comprises
at least one precursor of GABA,
at least one GABA prodrug,
at least one GABAA receptor agonist, or a combination thereof;
(b) at least one negative glutamatergic treatment substance; or
(c) at least another positive GABAergic treatment substance
are uncountable because they are completely functionally defined (no chemical structure) within claim 138.
Claim 138-139 and 157 Lack an Adequate Supporting Written Description
Claims 138-139 and 157 fail to comply with 35 U.S.C. 112(a) because neither the application as filed nor the art of record discloses either: (1) sufficient species of
(a) at least one GABAergic treatment substance wherein the at least one positive GABAergic treatment substance comprises
at least one precursor of GABA,
at least one GABA prodrug,
at least one GABAA receptor agonist, or a combination thereof;
(b) at least one negative glutamatergic treatment substance; or
(c) at least another positive GABAergic treatment substance
and that meet the respective functional requirements and that also can function together in combination, per claims 138-139, an “effective amount”.
Here, Applicant is not in possession of the full claim scope because neither the specification nor the art of record provides sufficient guidance (representative species or a structure-function relationship) allowing one of skill to correctly predict these species, aside from those disclosed. A "representative number of species" means that the species which are adequately described are representative of the entire genus. MPEP § 2163(II)(A)(3)(a)(ii); see also, Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1164 (Fed. Cir. 2019) (“[a]s a result, a POSA is deprived of any meaningful guidance into what compounds beyond the examples and formulas, if any, would provide the same result”).
Further, neither the art nor the specification shows a well-established correlation between the structure of each of:
(a) at least one GABAergic treatment substance wherein the at least one positive GABAergic treatment substance comprises
at least one precursor of GABA,
at least one GABA prodrug,
at least one GABAA receptor agonist, or a combination thereof;
(b) at least one negative glutamatergic treatment substance; or
(c) at least another positive GABAergic treatment substance
and their respective function. Claims 138-139 recite no chemical structure and are defined completely in functional terms. The limited number of species disclosed within each class of (a), (b) and (c) do not have any common structural features that one of skill can ascribe to the claimed function. Here, one of skill is limited to the specification species because the art of record provides insufficient guidance in this respect. MPEP § 2164.03. Disclosure of function and minimal structure may be sufficient when there is a well-established correlation between structure and function. MPEP § 2163(II)(A)(3)(a)(i). In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. MPEP § 2163(II)(A)(3)(a)(i) (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406). Accordingly, a “sufficient description . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010).
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 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.
Claims 138-139 and 157 are rejected under 35 U.S.C. 103 as obvious over G. Olivier et al., FR 3012039 (2015) (“Olivier”) in combination with A. Shamsa et al., 16 Phytomedicine, 690-693 (2009) (“Shamsa”); H. Ranjbar et al., 9 Avicenna Journal of Phytomedicine, 419-427 (2019) (“Ranjbar”) and S Dongre et al., BioMed research international, 1-9 (2015).
G. Olivier et al., FR 3012039 (2015) (“Olivier”)
An English-language machine language translation (Google Translate) is attached as the second half of reference Olivier. Olivier thus consists of 24 total pages (including the English-language portion). Accordingly, this Office action references Olivier page numbers in the following format “xx of 24”.
Olivier teaches a medicinal product or dietary supplement intended to prevent or treat sexual dysfunctions in men or women. Olivier at page 14 of 24, lines 1-2. Olivier teaches a medicinal product or dietary supplement containing, in combination, nitric oxide donor activity and hydrogen sulfide donor activity. Olivier at page 16 of 24, lines 29-30.
Such a medicinal product contains, in combination, L-Arginine, a natural donor of nitric oxide, and a natural donor of hydrogen sulfide such as L-Cysteine, L-Cystine, or N-acetylcysteine.
Oliver at page 14 of 24, lines 4-6. Olivier teaches that L-cysteine can be used as salts, for example sodium and potassium hydrochlorides, or other cysteine salts and that N-acetylcysteine (NAC) can be used directly. Olivier at page 5, lines 24-25.
Olivier teaches the combination of L-arginine with L-cysteine or N-acetylcysteine yields favorable results in the prevention and treatment of disorders of the physiological and anatomical response to sexual stimulation in humans (male or female), and thus combats said disorders, thanks to a synergistic effect. Olivier at page 16 of 24, lines 24-27.
Olivier teaches that L-cysteine can be used as salts, for example sodium and potassium hydrochlorides, or other cysteine salts. N-acetylcysteine (NAC) can be used directly. Olivier at page 5, lines 24-25. Olivier teaches:
For example, a dose of 8 to 10 grams of arginine aspartate and 3 to 4 g of NAC can be administered as a single dose to adults, approximately 1 to 2 hours before 15 anticipated sexual intercourse (so-called on-demand or spot treatment), or as one dose per day, 3 to 5 times per week (short course).
Olivier at page 19 of 24, lines 13-16.
Olivier further teaches that:
The drug or dietary product of the invention has produced significant favorable results compared to placebo in men suffering from transient erectile dysfunction and in subjects with chronic erectile dysfunction not severe. In women, improvements were observed, in particular, for at least one of the following disorders: loss or decrease of sexual desire, absence of orgasm or difficulty achieving orgasm, clitoral lubrication, vaginal dryness, decrease in the intensity of sexual pleasure.
Olivier at paragraph bridging pages 17-18 of 24.
In summary, Olivier teaches that L-cysteine and N-acetylcysteine are both useful to prevent or treat sexual dysfunctions in men or women.
With respect to Olivier’s L-cysteine and N-acetylcysteine, the specification teaches that these are both (per claim 138) “positive GABAergic treatment substances”:
[0019] In some embodiments, the at least one positive cysteineic treatment substance comprises N-acetyl-cysteine, cysteine, cystine, or a combination thereof.
0020] In particular embodiments, the at least one positive GABAergic treatment substance also is a negative glutamatergic treatment substance, the at least one positive cysteineic treatment substance, or a combination thereof, are at least one negative glutamatergic treatment substance. In some embodiments, the positive GABAergic treatment substance also is a negative glutamatergic treatment substance. In some aspects, the negative glutamatergic treatment substance comprises magnesium threonate. In other aspects, the magnesium threonate is about 9.8 mg per kilogram body weight to about 84.0 mg per kilogram body weight. In some facets, the negative glutamatergic treatment substance comprises positive cysteineic treatment substance.
Specification at page 6, [0019] and [0020] (emphasis added).
Because N-acetyl-cysteine and cysteine are disclosed as specific specification examples, either is asserted to meet the claim 138 functional language of:
138 . . . (a) at least one positive GABAergic treatment substance,
[That performs the function of] wherein the at least one positive GABAergic treatment substance increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance;
MPEP § 2112(V) (citing In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Differences between Olivier and the Claims
Olivier differs from claim 138 in that it does not teach the following additional components (b) and (c) in the composition:
138 . . . (b) at least one negative glutamatergic treatment substance,
[That performs the function of] wherein the at least one negative glutamatergic treatment substance promotes the activation of the mGlu2 receptor, the mGlu3 receptor, or a combination thereof; or
or
138 . . . (c) at least another positive GABAergic treatment substance,
[That performs the function of] wherein the at least another positive GABAergic treatment substance activates a TRPV1-Receptor and activates a KCC2 transporter;
A. Shamsa et al., 16 Phytomedicine, 690-693 (2009) (“Shamsa”)
Shamsa teaches a study where the effect of Crocus sativus (saffron) was evaluated on male erectile dysfunction (ED). Shamsa at Abstract. Shamsa teaches that twenty male Patients with ED were followed for ten days in which each morning they took a tablet containing 200 mg of saffron. Id. Patients underwent the nocturnal penile tumescence (NPT) test and the international index of erectile function Questionnaire (IIEF-15) at the start of the treatment and at the end of the ten days. Id. After the ten days of taking saffron there was a statistically significant improvement in tip rigidity and tip tumescence as well as base rigidity and base tumescence. Id.
The specification teaches that saffron is a “negative glutamatergic treatment substance”:
For example, various negative glutamatergic treatment substances (e.g., MagT [Magnesium L-Threonate], NAC/Cys, saffron, cat's claw bark/ cat's claw bark extract, pyroglutamate, etc.), particularly a negative NMDA-R glutamatergic treatment substance as described herein . . .
Specification at page 242, [0154] (emphasis added). Because saffron is disclosed as a specific specification example, it is asserted to meet the claim 138 functional language of:
138 . . . (b) at least one negative glutamatergic treatment substance,
[That performs the function of] wherein the at least one negative glutamatergic treatment substance promotes the activation of the mGlu2 receptor, the mGlu3 receptor, or a combination thereof
MPEP § 2112(V) (citing In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
H. Ranjbar et al., Effects of saffron (Crocus sativus) on sexual dysfunction among men and women: A systematic review and meta-analysis, 9 Avicenna Journal of Phytomedicine, 419-427 (2019(“Ranjbar”)
Ranjbar reports a systematic review and meta-analysis study on the effect of saffron (Crocus sativus) on sexual dysfunction and its subscales (dimensions) among men and women. Ranjbar at Abstract. Ranjbar teaches that in general, saffron (Crocus sativus) was proven effective in improving sexual dysfunction and its subscales among participants (men and women); this effect was different on different dimensions of sexual dysfunction and further studies are required to extend these initial findings. Ranjbar at Abstract.
Ranjbar teaches that in a double-blind clinical trial study, 34 women with severe depressive disorder (treated with fluoxetine for at least 6 weeks) and sexual dysfunction entered the intervention and control groups. Ranjbar at page 422, col. 1. The intervention group received saffron capsule and control group received placebo capsule daily for 4 weeks. Id. In general, the findings indicated the beneficial effects of saffron on sexual dysfunction among women. Id.
Ranjbar teaches that in three clinical trials, the effect of saffron on erectile dysfunction in men was studied. Ranjbar at page 422, col. 2. In summary, the findings indicated that saffron had a statistically significant effect on erectile function improvement (p=0.001), and intercourse satisfaction (p=0.001) among men. Id.
For the same reasons above for Shamsa saffron is asserted to meet the claim 138 functional language of:
138 . . . (b) at least one negative glutamatergic treatment substance,
[That performs the function of] wherein the at least one negative glutamatergic treatment substance promotes the activation of the mGlu2 receptor, the mGlu3 receptor, or a combination thereof
MPEP § 2112(V) (citing In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
S Dongre et al., Efficacy and safety of Ashwagandha (Withania somnifera) root extract in improving sexual function in women: a pilot study, BioMed research international, 1-9 (2015)
Dongre teaches that that oral administration of HCARE may improve sexual function in healthy women. Dongre at Abstract. Dongre teaches that high-concentration ashwagandha (Withania somnifera) root extract (HCARE) supplementation for improving sexual function in healthy females. Dongre at Abstract.
The specification teaches that the “least one positive GABAergic treatment substance” that that increases the amount of a GABA receptor agonist comprises a “Withania somnifera Preparation”. Specification at page 3, lines 7-8.
In some aspects, the at least one positive GABAergic treatment substance comprises a Withania somnifera Preparation.
Specification at page 4, lines 1-3.
Because “Withania somnifera Preparation” is disclosed as a specific specification example, it is asserted to meet the claim 138 functional language of:
138 . . . (c) at least another positive GABAergic treatment substance,
[That performs the function of] wherein the at least another positive GABAergic treatment substance activates a TRPV1-Receptor and activates a KCC2 transporter;
MPEP § 2112(V) (citing In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Obviousness Rationale
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. MPEP § 2144.06 (I) (citing In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted); see also, In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (holding that the two claimed types of active agents, GABA-a agonists and angiotensin II receptor blocker, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine), for its legal principle.
Claim 138 is obvious because one of ordinary skill is motivated to prepare a composition for treating a reduced amount of tactile sexual function comprising L-arginine, N-acetyl-cysteine or cysteine, saffron and Withania somnifera thereby meeting each and every limitation of claim 138 because: (1) Olivier teaches that the combination of L-arginine with L-cysteine or N-acetylcysteine yields favorable results in the prevention and treatment of disorders of the physiological and anatomical response to sexual stimulation in humans (male or female), and thus combats said disorders, thanks to a synergistic effect (Olivier at page 16 of 24, lines 24-27); and (2) Shamsa and Ranjbar teach that saffron (the claimed “at least one negative glutamatergic treatment substance”) enhances sexual experience in men and women. See e.g., Shamsa at Abstract. One of ordinary skill is further motivated to further include ashwagandha (Withania somnifera), a root extract (a claimed “at least another positive GABAergic treatment substance”, for such treatment because Dongre teaches that that its oral administration may improve sexual function in healthy women. Under this practice, of ordinary skill also meets each and every limitation of claim 138.
Claim 139 is obvious for the following reasons. Claim 139 recites as follows:
139. The composition of claim 138, further excluding: at least one negative GABAergic treatment substance, a positive glutamatergic treatment substance, or a combination thereof;
wherein the negative GABAergic treatment substance comprises a carbonic anhydrase inhibitor;
wherein the positive glutamatergic treatment substance activates at least one NMDA receptor, decreases KCC2 activity, or a combination thereof;
and wherein the at least one negative GABAergic treatment substance, the positive glutamatergic treatment substance, or the combination thereof is in an effective amount to reduce tactile sexual function, increase the time to ejaculation, or both.
Following the plain language of claim 139, if one of ordinary skill excludes from base claim 138 the “at least one negative GABAergic treatment substance” and thus does not include the claim 139 alternative of “a carbonic anhydrase inhibitor”, the two components required to meet claim 139 are component (a) and component (c):
(a) at least one positive GABAergic treatment substance,
[That performs the function of] wherein the at least one positive GABAergic treatment substance increases the amount of a GABAA receptor agonist after the person ingests the at least one positive GABAergic treatment substance;
(c) at least another positive GABAergic treatment substance,
[That performs the function of] wherein the positive glutamatergic treatment substance activates at least one NMDA receptor, decreases KCC2 activity, or a combination thereof;
Claim 139 is obvious because one of ordinary skill is motivated to prepare a composition for treating a reduced amount of tactile sexual function comprising L-arginine, N-acetyl-cysteine or cysteine (“at least one positive GABAergic treatment substance”), as taught by Olivier and include Withania somnifera (“at least another positive GABAergic treatment substance”), as taught by Dongre for the same reasons discussed above thereby meeting each and every limitation of claim 139.
Claim 157 is obvious because one of ordinary skill is motivated to include the above proposed composition of comprising L-arginine, N-acetyl-cysteine or cysteine, saffron and Withania somnifera in a kit along with a condom in expectation that the composition will lead to or facilitate the need for a condom.
Claim Rejections - 35 USC § 101
Claims 138-139 and 157 are rejected under 35 U.S.C. 101 on the grounds that the claimed invention is directed to patent ineligible subject matter. The claims recite a multi-component product of nature that lacks markedly different characteristics from its naturally occurring counterpart. MPEP 2106.04(b)(II). The claims are therefore directed to a judicial exception under Step 2A, Prong 1. MPEP 2106.04(b)(II). Continuing the analysis, under Step 2A, Prong 2, the claims do not integrate the recited judicial exception into a practical application of the product of nature exception. 2106.04(II)(A)(2). Finally, under Step 2B, the claims do not recite more than well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, which are not sufficient to establish subject matter eligibility for the recited judicial exception. MPEP § 2106.05(II). For a § 101 analysis of a similar multi-component, natural-product-based claim see non-binding, non-precedential opinion in, Ex Parte Ellery, Appeal No. 2022-000389, 15/045,130 (PTAB 2022).
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
The first step is Step 2A, which is a two-prong inquiry, in which in Step 2A, Prong One it is determined whether a claim recites a judicial exception (which for natural products requires a markedly different characteristics analysis), and if so, then determine in Step 2A, Prong Two whether the recited judicial exception is integrated into a practical application of that exception. MPEP § 2106.04(II)(A).
Step 2A, Prong 1: The Current Claims Recite a Judicial Exception
In Prong One of Revised Step 2A, evaluation is conducted to determine whether the claim recites a judicial exception. MPEP 2106.04(II)(A)(1); Federal Register, 2019 Revised Patent Subject Matter Eligibility Guidance, 50-57 (2019) (“Federal Register 2019”) (see page 54 col. 1).
Claims 138, 139 and 157 all encompass at least following nature-based products, valine, N-acetyl-cysteine, and piperine, which are the elected species: L-Valine is a natural amino acid. N-acetylcysteine (NAC), a plant antioxidant naturally found in onion. S. Salamon et al., 8 Antioxidants, 1-16 (2019). Piperine, is the principle pungent compound in black peppers. Y. Dong et al., 516 Biochemical and Biophysical Research Communications, 365-372 (2019) (“Dong”)
MPEP § 2106.04(b)(II) (laws of nature and natural phenomena, as identified by the courts, include nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature).
Step 2A, Prong 1-- Markedly Different Characteristics
When a claim recites a nature-based product limitation, the markedly different characteristics analysis is applied to determine if the claimed nature-based product is a judicial exception (Step 2A, Prong 1). MPEP 2106.04(b)(II); MPEP § 2106.04(c)(I)(A). If the claim includes a nature-based product that has markedly different characteristics from the naturally occurring counterpart, then the claim does not recite a product of nature exception and is eligible. MPEP § 2106.04(c).
Further, where the claims (as in the current facts) are to a nature-based product produced by combining multiple nature-based components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. MPEP § 2106.04(b)(II); MPEP § 2106.04(c)(I)(A).
Performing the markedly different characteristics analysis, includes (a) selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation, (b) identifying appropriate characteristics for analysis, and (c) evaluating characteristics to determine whether they are "markedly different". MPEP § 2106.04(c)(II).
(a) Selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation
Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product. MPEP § 2106.04(c)(II)(A). In the current case, the closest nature-based are the compounds themselves, all of which occur in nature
(b) Identifying appropriate characteristics for analysis
Because the markedly different characteristics analysis is based on comparing the characteristics of the claimed nature-based product and its counterpart, the second step in the analysis is to identify appropriate characteristics to compare. MPEP § 2106.04(c)(II)(B). Changes in physical form or structure and form, whether chemical, genetic or physical are examples of appropriate characteristics to be analyzed. MPEP § 2106.04(c)(II)(B). 2
However, in Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. MPEP § 2106.04(c)(II)(C)(2) (citing Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75).
Here the claims recite the following characteristics presumably stemming from their combination in a single composition in an “effective amount”.
138 . . . wherein the at least one positive GABAergic treatment substance and the at least one negative glutamatergic treatment substance, at least another positive GABAergic treatment substance, or a combination thereof, are in an effective amount to achieve pleasurable tactile sexual function just before the beginning of orgasm, just after the beginning of orgasm, or both, in a person.
139 . . . wherein the at least one negative GABAergic treatment substance, the positive glutamatergic treatment substance, or the combination thereof is in an effective amount to reduce tactile sexual function, increase the time to ejaculation, or both.
See footnote 1.
(c) Evaluating characteristics to determine whether they are "markedly different"
Here, the claimed basic, novel concept is the mixture itself (that is concept of having at least three different compounds, each of a distinct Markush genus, present in a single composition). The specification teaches the claimed composition’s utility is the compositions and methods for treating sexual dysfunctions including a reduction of sexual sensation in the genitals, delayed ejaculation and/or failure to ejaculate, premature ejaculation, anorgasmia, and/or sexual anhedonia (collectively termed by the Examiner as “sexual enhancement”). Specification at page 1, [0006]. 3
Thus, the current claims must be analyzed to determine whether exhibition of the following biological or pharmacological functions or activities, by the claimed “effective amount” of the combination is markedly different over the naturally occurring counter parts in isolation.
Respecting the following underlined functional language of claim 138:
138 . . . wherein the at least one positive GABAergic treatment substance and the at least one negative glutamatergic treatment substance, at least another positive GABAergic treatment substance, or a combination thereof, are in an effective amount to achieve pleasurable tactile sexual function just before the beginning of orgasm, just after the beginning of orgasm, or both, in a person
no specific effective amount is recited. More significantly, the effect of “pleasurable tactile sexual function just before the beginning of orgasm, just after the beginning of orgasm, or both, in a person” would be achieved regardless of whether the claimed composition was ingested. That is, in view of the claim 138 language itself, there is no markedly different characteristic that can reasonably be considered.
Respecting the following underlined functional language of claim 139:
139 . . . wherein the at least one negative GABAergic treatment substance, the positive glutamatergic treatment substance, or the combination thereof is in an effective amount to reduce tactile sexual function, increase the time to ejaculation, or both.
no specific effective amount is recited. More significantly, the specification provides only prophetic examples. That is, there is no teaching or showing in the specification that the claimed combination provides any different effect that the innate effect of the compounds in isolation. To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. MPEP§ 2106.04(c)(II)(C). The inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart. MPEP§ 2106.04(c)(II)(C).
Step 2A, Prong 2: The Claims do not Recite Additional Elements that Integrate the Judicial Exception into a Practical Application
Next, under analysis in Step 2A Prong Two, if the additional elements in the claim integrate the recited exception into a practical application of the exception, then the claim is not directed to the judicial exception (and thus is eligible. MPEP § 2106.04(II)(A)(2); MPEP § 2106.04(d). Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity. MPEP § 2106.04(d)(I). The specificity of the claim limitations is relevant to the evaluation. MPEP § 2106.04(d)(I).
The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, the analysis includes: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. MPEP § 2106(d)(II). Here the claims do no recite additional elements beyond the judicial exception. See MPEP § 2106.04(d)(I) (giving examples of integrating claim elements into a practical application). One consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two and whether a claim recites significantly more in Step 2B is whether the claim effects a transformation or reduction of a particular article to a different state or thing. MPEP § 2106.05(c). Here there is no application or transformation, each of the components merely exist together in the claimed composition.
Eligibility Step 2B: Whether a Claim Amounts to Significantly More
Under Step 2B the claims are further analyzed to determine if additional elements are recited that amount to significantly more than the judicial exception. MPEP § 2106.05(II). The analysis is conducted by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)). MPEP § 2106.05(II). That is, the claims are evaluated to determine whether any additional element or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. MPEP § 2106.05(II).
Here, claims 138 and 139 do not recite elements in addition to the judicial exception. The additional elements of the claim 157 kit are well-known, routing items and are incidental and thus do not factor into the analysis.
Combining or mixing specific compounds to form a mixture does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. As the claims involve no more than the judicial exception and well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which are not sufficient to establish that the claimed compound mixture is not more than the judicial exception; that is the claims do not establish and inventive concept over the judicial exception. MPEP § 2106.05(II).
In Considering the above Factors, the Claims are Patent Ineligible
Claims 138, 139 and 157 are properly rejected under 35 U.S.C. 101 on the grounds that the claimed invention is directed to patent ineligible subject matter because the claims recite a multi-component product of nature that lacks markedly different characteristics from its naturally occurring counterpart. MPEP 2106.04(b)(II). The claims are therefore directed to a judicial exception under Step 2A, Prong 1. MPEP 2106.04(b)(II). Further, under Step 2A, Prong 2, the claims do not integrate the recited judicial exception into a practical application of the product of nature exception. 2106.04(II)(A)(2). Finally, under Step 2B, the claims do not recite more than well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, which are not sufficient to establish subject matter eligibility for the recited judicial exception. MPEP § 2106.05(II).
Subject Matter Free of the Art of Record
Subject to the § 101 rejection, a claim to the elected species, for example, as follows:
A composition for treating a reduced amount of tactile sexual function, comprising:
(1) Valine
(2) N-acetyl-cysteine; and
(3) Piperine,
in an effective amount to achieve pleasurable tactile sexual function just before the beginning of orgasm, just after the beginning of orgasm, or both, in a person.
is free of the art of record. However, such claim would be rejected under § 101 for the same reasons given above. The Examiner cannot provide reasonable explanation of why one of ordinary skill is motivated to combine piperine with valine and N-acetyl-cysteine in a single composition. Piperine, is the principle pungent compound in black peppers, is known to activate the capsaicin receptor TRPV1 ion channel. Y. Dong et al., 516 Biochemical and Biophysical Research Communications, 365-372 (2019) (“Dong”) (see Abstract). No art of record teaches piperine for Applicant’s disclosed utility. Further the is no articulable rational to combine piperine with valine and N-acetyl-cysteine in a single composition for some alternate reason.
The closest art of record is Olivier et al., FR 3012039 (2015) (“Olivier”) as discussed above. Olivier teaches the combination of L-arginine with L-cysteine or N-acetylcysteine yields favorable results in the prevention and treatment of disorders of the physiological and anatomical response to sexual stimulation in humans (male or female), and thus combats said disorders, thanks to a synergistic effect. Olivier at page 16 of 24, lines 24-27.
Olivier further teaches that:
The drug or dietary product of the invention has produced significant favorable results compared to placebo in men suffering from transient erectile dysfunction and in subjects with chronic erectile dysfunction not severe. In women, improvements were observed, in particular, for at least one of the following disorders: loss or decrease of sexual desire, absence of orgasm or difficulty achieving orgasm, clitoral lubrication, vaginal dryness, decrease in the intensity of sexual pleasure.
Olivier at paragraph bridging pages 17-18 of 24. In summary, Olivier teaches that L-cysteine and N-acetylcysteine are both useful to prevent or treat sexual dysfunctions in men or women. However, neither Olivier nor secondary art motivates one of ordinary skill to combine N-acetylcysteine and piperine in a single composition as proposed in the claim above.
Conclusion
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ALEXANDER R. PAGANO
Examiner
Art Unit 1692
/ALEXANDER R PAGANO/Primary Examiner, Art Unit 1692
1 While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed, a question as to whether a specification provides an adequate written description may arise in the context of an original claim. MPEP § 2163.03 (V) (citing In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976)). An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. MPEP § 2163.03 (V) (citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) ("[e]ven if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed”).
2 The appropriate characteristics analyzed must be possessed by the claimed product, because it is the claim that must define the invention to be patented. MPEP § 2106.04(c)(II)(B) (citing Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility)). Characteristics possessed by the claimed products are identified by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product. MPEP § 2106.04(c)(II)(B). If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception. MPEP § 2106.04(c).
3 See e.g., MPEP§ 2106.04(c)(II)(C) discussing Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013). In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. The patentee in Myriad had discovered the location of the BRCA1 and BRCA2 genes in the human genome, and isolated them, i.e., separated those specific genes from the rest of the chromosome on which they exist in nature. As a result of their isolation, the isolated genes had a different structural characteristic than the natural genes, i.e., the natural genes had covalent bonds on their ends that connected them to the rest of the chromosome, but the isolated genes lacked these bonds. However, the claimed genes were otherwise structurally identical to the natural genes, e.g., they had the same genetic structure and nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.