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 .
Election/Restrictions and
Application Status
Applicant’s election without traverse of Group I (claims 1-9 and 15-17), in the reply filed on May 12, 2026 is acknowledged with appreciation.
3. Applicant additionally elects species of the single cholinesterase inhibitor: Rivastigmine; the single SNRI: Duloxetine; and the single NMDA receptor modulator: Memantine hydrochloride, without traverse. Therefore, the nonelected species are presently withdrawn from consideration, i.e., claims 4, 6 and 7 are withdrawn in full.
4. Claims 10-14 are canceled.
5. Claims 1-3, 5, 8, 9 and 15-17 are under examination with the elected species and are the subject of this office action.
Information Disclosure Statement
6. The information disclosure statement (IDS) submitted on April 16, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 form, attached herewith.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-3, 5, 8, 9, and 15-17 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 claims contain 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.
9. In particular, support cannot be found for a composition comprising any cholinesterase inhibitor, any serotonin and norepinephrine reuptake inhibitor (SNRI), and optionally any N-methyl-D-aspartate (NMDA) receptor modulator, as instantly claimed.
10. The MPEP §2163 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 by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.
11. In the instant case, it is evident that the genus of formulations embraced by “a composition comprising a cholinesterase inhibitor and a SNRI inhibitor” has substantial variance. The genus of possible compositions is extremely broad, embracing thousands of potential combinations of any cholinesterase inhibitor and any SNRI inhibitor, and optionally any NMDA receptor modulator, which combinations bear little to no resemblance to one another what-so-ever. Yet, the instant Specification fails to disclose the preparation of any composition(s) whatsoever.
12. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that Applicant’s disclosure does not adequately describe a genus of compositions embracing hundreds of thousands of possible combinations of cholinesterase inhibitors, SNRIs, and optionally NMDA receptor modulators. That is, the Specification does not disclose a sufficient variety of compositions to reflect the extreme variance in the genus of compositions that embrace the combination of any cholinesterase inhibitor and any SNRI, and optionally any NMDA receptor modulator of claim 5.
13. 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.
As such, claims 1-3, 5, 8, 9 and 15-17 are rejected.
Claim Rejections - 35 USC § 102
14. 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.
15. Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seed et al., U.S. 2005/0143350 A1.
Claim 1 is drawn to a composition for the treatment of mild cognitive impairment and dementia, comprising:
(a) a cholinesterase inhibitor (more specifically, rivastigmine (claim 2));
(b) a serotonin and norepinephrine reuptake inhibitor (SNRI), (more specifically duloxetine (claim 2).
16. Seed et al. teaches and recites a pharmaceutical composition comprising the combination of a cholinesterase inhibitor and an SNRI antidepressant, specifically the cholinesterase inhibitors rivastigmine, donepezil, and galantamine, and the SNRI antidepressants duloxetine, Venlafaxine, and desvenlafaxine:
“The pharmaceutical composition of claim 40, wherein Said one or more cholinesterase inhibitor is selected from the group consisting of rivastigmine, galantamine, and donepezil, and said one or more antidepressants is selected from the group consisting of Venlafaxine, citalopram, escitalopram, fluvoxamine, paroxetine, duloxetine, Sertraline, bupropion, S33005, DVS-233 (desvenlafaxine), DVS-233 SR, and mixtures thereof.”
(see Claim 47).
17. Regarding the preamble of claim 1, i.e., “for the treatment of mild cognitive impairment and dementia,” Applicant is additionally reminded that a preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case, the composition comprising both a cholinesterase inhibitor and an SNRI taught by Seed et al. is the same as those recited by the instant claims.
18. As such, claims 1 and 2 are anticipated.
Claim Rejections - 35 USC § 103
19. 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.
20. 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.
21. 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.
22. Claims 3, 15 and 16 are rejected as being unpatentable over Seed et al., U.S. 2005/0143350 A1, as applied to claims 1 and 2, above.
Claims 1 and 2 are addressed in detail, above.
Claim 3 is drawn to the composition for the treatment of mild cognitive impairment and dementia of claim 2, and limits wherein:
(a) the cholinesterase inhibitor is rivastigmine.
Claim 15 is drawn to the composition for the treatment of mild cognitive impairment and dementia of claim 2, and limits where:
(b) the serotonin and norepinephrine reuptake inhibitor is duloxetine.
Claim 16 is drawn to the composition for the treatment of mild cognitive impairment and dementia of claim 2, comprising:
(a) the cholinesterase inhibitor rivastigmine; and
(b) the serotonin and norepinephrine reuptake inhibitor duloxetine.
23. Seed et al. teaches and recites a pharmaceutical composition comprising the combination of a cholinesterase inhibitor and an SNRI antidepressant, wherein the cholinesterase inhibitor is selected from rivastigmine, donepezil, and galantamine, and the SNRI antidepressant is selected from duloxetine, Venlafaxine, and desvenlafaxine, but does not explicitly teach a composition comprising the cholinesterase inhibitor rivastigmine and the SNRI antidepressant duloxetine.
24. However, considering that the genus of cholinesterase inhibitors recited by Seed et al. comprises only three compounds, and the genus of SNRIs comprises only eleven compounds, it would have been obvious for one skilled in the art to select rivastigmine as the cholinesterase inhibitor and duloxetine as the SNRI antidepressant in the composition specifically recited in claim 47, with a reasonable expectation of success.
As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating 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; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.”
25. Regarding the preamble of claim 1, i.e., “for the treatment of mild cognitive impairment and dementia,” Applicant is additionally reminded that a preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case, the composition comprising both a cholinesterase inhibitor and an SNRI taught by Seed et al. is identical to those recited by the instant claims.
As such, claims 3, 15 and 16 are prima facie obvious.
26. Claims 1-3, 5, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Barlow et al., U.S. 2011/0319386 A1 (cited on Applicant’s IDS of April 16, 2014).
Claim 1 is drawn to a composition for the treatment of mild cognitive impairment and dementia, comprising:
(a) a cholinesterase inhibitor (more specifically, rivastigmine (claims 2, 3, 16 and 17));
(b) a serotonin and norepinephrine reuptake inhibitor (SNRI), (more specifically duloxetine (claims 2, and 15-17)),
and optionally further comprising
(c) a N-methyl-D-aspartate receptor modulator (more specifically, memantine hydrocholoride (claims 5 and 17)).
27. Barlow et al. teach a pharmaceutical composition comprising a cholinesterase inhibitor in combination with a serotonin and norepinephrine reuptake inhibitor (SNRI) (paragraphs [0011]-[0012] and [0362]). Barlow et al. specifically name rivastigmine in a small genus of four preferred cholinesterase inhibitors (paragraph [0038]) and duloxetine in a small genus of three SSNRI inhibitors (paragraph [0362]). Barlow et al. additionally teach that the composition comprises a glutamate modulator (i.e., a NMDA receptor modulator), specifically naming memantine hydrochloride (paragraphs [0395] and [0406]).
Barlow et al. teach that said composition is intended for treating neurodegenerative diseases including mild cognitive impairment (MCI) and dementia (see paragraph [0062]).
28. Barlow et al. do not teach a single disclosed composition comprising each of rivastigmine, duloxetine, and memantine hydrochloride.
29. However, considering that the genus of cholinesterase inhibitors taught by Barlow et al. comprises only four compounds, and the genus of SSNRIs comprises only three compounds, it would have been obvious for one skilled in the art to select rivastigmine as the cholinesterase inhibitor, duloxetine as the SSNRI antidepressant, and memantine hydrochloride as the NMDA receptor modulator for combination in a composition for the treatment of mild cognitive impairment and dementia, with a reasonable expectation of success.
As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating 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; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle”; Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012): finding a “strong case of obviousness based on the prior art references of record [wherein the claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent for another”).
As such, claims 1-3, 5 and 15-17 are prima facie obvious.
30. Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Barlow et al., U.S. 2011/0319386 A1, as applied to claims 1-3, 5, and 15-17, above, and further in view of Held et al. U.S. 20130296324 A1 (cited on Applicant’s IDS of April 16, 2014).
Claim 1 is addressed in detail, above.
Claim 8 is drawn to the composition of claim 1, wherein the composition comprises:
about 0.25 wt. % to about 55 wt. % cholinesterase inhibitor; and
about 45 wt. % to about 99.75 wt. % SNRI.
Claim 9 is drawn to the composition of claim 1, wherein a therapeutically effective dosage of the composition comprises:
about 1 mg to about 12 mg cholinesterase inhibitor; and
about 10 mg to about 400 mg SNRI.
31. Barlow suggests a pharmaceutical composition comprising the cholinesterase inhibitor rivastigmine in combination with the serotonin and norepinephrine reuptake inhibitor (SNRI) duloxetine and the glutamate modulator memantine hydrochloride, wherein said composition is intended for treating neurodegenerative diseases including mild cognitive impairment and dementia, but do not teach the recited amount(s) of cholinesterase inhibitor and SNRI.
32. Yet, Held teaches a pharmaceutical composition for the treatment of mild cognitive impairment and dementia comprising a cholinesterase inhibitor (CI) and a serotonin and norepinephrine reuptake inhibitor (SNRI) (see paragraphs [0016], [0047] and [0194]), wherein the CI is employed in the composition in an amount of from 5 mg-200 mg and the SNRI is employed in the composition in an amount of from 5 mg -500 mg (paragraphs [0150], [0153]). The amount of CI and SNRI taught by Held overlap the range of weight percent by weight of the CI and the SNRI of: “about 0.25 wt. % to about 55 wt. % cholinesterase inhibitor; and about 45 wt.% to about 99.75 wt.% SNRI” required by claim 8. For example, a composition comprising 5 mg CI in combination with 500 mg SNRI is equivalent to about 0.99 wt % CI and about 99.01 wt% SNRI, which is within the range required by claim 8.
Held additionally teaches wherein the composition comprises: the Cognex inhibitor (cholinesterase inhibitor) at a dosage ranging from 5 mg to 60 mg/day, (paragraphs [0072], [0075]), which overlaps the range of from “about 1 mg to about 12 mg cholinesterase inhibitor required by claim 9, and the SNRI at a dosage of from 5-500 mg per day (paragraph [0150]), which fully embraces the range of “about 10 mg to about 400 mg SNRI” required by claim 9.
32. And, optimization of parameters such as amounts of ingredients by weight is a routine practice that would be obvious for a person of ordinary skill in the art to employ. The determination of known effective amounts of known agents to be administered to treat the same disease is considered well in the competence level of one skilled in the art, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. As Held teaches effective dosage ranges of both the cholinesterase inhibitor and the SNRI used to treat mild cognitive impairment and/or dementia, dosage variation in composition is considered a result effective variable. Thus, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method disclosed by Barlow, by optimizing the effective dose amount of the SNRI and the effective dose amount of the cholinesterase inhibitor, based on the teachings of Held, thereby providing an improved composition for treating dementia and mild cognitive impairment, with a reasonable expectation of success.
As such, claims 8 and 9 are prima facie obvious.
Conclusion
33. Claims 1-9 and 15-17 are present in the application, and claims 4, 6, and 7 are presently withdrawn as directed to non-elected species. Claims 1-3, 5, 8, 9 and 15-17 are rejected. No claim is presently allowed.
34. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/Examiner, Art Unit 1628
/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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