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 .
Claim Status
Claims 1, 5–8 and 12 are pending. Claims 1, 5-8 and 12 are rejected.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 9th, 2025 has been entered.
Response to Amendment/Arguments
Applicant’s amendments have overcome the rejections under 35 USC 101. Applicant traverses the rejections under 35 USC 103 and argues that the current claims which are directed to a method for improving sleep comprising orally administering a composition comprising freeze-dried or hot-air dried powder or extract from Solanum melongena having a particular choline ester content are not product-by-process claims. Applicant further highlights that the disclosure of Iwatsuki et al. teaches use of Curcubita or squash seed extract as a sleep improving agent. This argument is unpersuasive because the limitations reciting a composition comprising an extract from Solanum melongena containing a choline ester are still reciting a product-by-process. Regarding product-by-process claims, MPEP 2113(I) states:
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
The extract of the instant claims constitutes a product-by-process wherein the final product, i.e. the composition containing the choline ester content is the product which must be unobvious in view of the prior art. The method of obtaining the choline ester content, such as extracting the choline ester from Solanum melongena in the instant claims or Curcubita as in the prior art makes no difference when the final product only requires a particular choline ester content and additionally an excipient. Therefore, the composition of Iwatsuki et al. comprising choline ester content derived from pumpkin seed extract would still be embraced by the claim.
Claims 1, 5-8 and 12 are rejected in light of the new amendments, as set forth below.
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.
Claim(s) 1 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2012206943 A by Iwatsuki et al. (cited in the IDS filed 08/25/2021) in view of Briguglio et al. Dietary Neurotransmitters: A Narrative Review on Current Knowledge. Nutrients. 2018;10(5):591. as evidenced by United States Department of Agriculture. Food Data- Seeds, pumpkin and squash seed kernels, dried. Published April, 1st, 2019, obtained from https://fdc.nal.usda.gov/fdc-app.html#/food-details/170556/nutrients on June 6th, 2024.
Citations of JP 2012206943 A refer to the machine translation.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art discloses a sleep-improving agent containing Curcubita seed extract (abstract).
Iwatsuki et al. report that the prior art composition of squash seed extract may be formulated for oral intake and added to processed foods and consumed (paragraph [0031]). Iwatsuki et al. further specify that the composition can by prepared by various drying methods and formulated into tablets, capsules, etc. (paragraphs [0026] and [0028]). Regarding the limitation in claim 1 wherein the composition comprises a freeze-dried or hot dried powder or extract containing a particular choline ester content, the prior art teaches that the extract can be made into a dry powder, by methods such as spray-drying, drum drying, a freeze-drying method, etc. (paragraph [0026]). Additionally, Iwatsuki et al. disclose acceptable excipients for an oral dosage form such as crystalline cellulose (paragraph [0029]). In the “sleep improve conformation tests” of the prior art, Iwatsuki et al. report that the prior art composition was consumed between 1 hour before bedtime to bedtime which embraces the limitation of instant claim 1 wherein the composition is administered to the subject just before 2 hours before turning in (paragraph [0046]).
Regarding instant claim 7, the prior art discloses a daily dose of 50 mg to 1000 mg (0.5 g to 1 g) of solid content (paragraph [0027]). The United States Department of Agriculture (USDA) reports that 100 grams of pumpkin or squash seeds contains approximately 63 mg of choline; therefore the 50 mg to 1000 mg would be expected to contain 315 ug to 630 ug of choline in accordance with the instant claim as evidenced by the USDA.
Instant claim 8, recites the method of improving sleep wherein improving sleep is an increase in sleeping time. Said increase in sleeping time is an additional benefit that would flow from performing the method of Iwatsuki et al. MPEP 2145(II) states:
"The fact that appellant has recognized another advantage which would
flow naturally from following the suggestion of the prior art cannot be
the basis for patentability when the differences would otherwise be
obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.
1985)
A person of ordinary skill performing the prior art method in the disclosed dosing ranges could expect to observe an increase in sleeping time as instantly claimed.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Iwatsuki et al. disclose a method of improving sleep by administering a “sleep improving agent” but do not specify that said agent comprises a choline ester or teach that the choline ester is comprised in an extract from Solanum melongena.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding the limitation wherein the composition comprises a choline ester, Iwatsuki disclose the use of the leaves, stems, roots, seeds, etc. of Cucurbita pepo. In (title) “Dietary Neurotransmitters: A Narrative Review on Current Knowledge”, Bruguglio et al. disclose that “extracts from Cucurbita pepo L. contain a considerable amount of ACh” (page 2; Acetylcholine).
Regarding the limitations in claims 1 and 8 which recite that the pharmaceutical composition is an extract from Solanum melongena, as stated above, this limitation does not distinguish the instant composition from the prior art as the product, i.e. a composition comprising a choline in a particular dose, is the same despite a difference in the source of the compound. Accordingly, ingestion of the “sleep improving agent” taught by Iwatsuki et al. comprising Cucurbita pepo renders obvious the instant claims.
Instant claim 6 requires that the choline ester does not comprise lactoylcholine. The prior art is silent to the presence of lactoylcholine; however, the instantly claimed method of administering a composition comprising a choline ester does not exclude methods of administering wherein lactoylcholine may be present outside of said composition. Therefore, the prior art method of administering remains obvious over instant claim 6.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Iwatsuki et al. and Briguglio et al. Dietary Neurotransmitters: A Narrative Review on Current Knowledge. Nutrients. 2018;10(5):591. as evidenced by United States Department of Agriculture. Food Data- Seeds, pumpkin and squash seed kernels, dried. Published April, 1st, 2019, obtained from https://fdc.nal.usda.gov/fdc-app.html#/food-details/170556/nutrients on June 6th, 2024. as applied to claims 1 and 5-8 above, and further in view of Thoorens et al. "Microcrystalline cellulose, a direct compression binder in a quality by design environment—A review." International journal of pharmaceutics 473.1-2 (2014): 64-72.
Iwatsuki et al. disclose a method of improving sleep by administering a composition comprising a choline ester and excipients such as crystalline cellulose (paragraph [0029]) but do not specify microcrystalline cellulose.
Thoorens et al. provide a review of microcrystalline cellulose in pharmaceutics and state, “[m]icrocrystalline cellulose (MCC) is one of the most important tableting excipients thanks to its outstanding dry binding properties, enabling the manufacture of tablets by direct compression (DC). DC remains the most economical technique to produce large batches of tablets” (abstract). Accordingly, a person of ordinary skill preparing the composition of Iwatsuki et al. comprising a choline ester and crystalline cellulose would have been motivated to test microcrystalline cellulose to optimize formulation of the composition and further improve the sleep aid effect of the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 7-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 16-19, and 26 of copending Application No. 16/341,748 in view of Thoorens et al. "Microcrystalline cellulose, a direct compression binder in a quality by design environment—A review." International journal of pharmaceutics 473.1-2 (2014): 64-72. and Wening et al. Oral drug delivery in personalized medicine: unmet needs and novel approaches. Int. J. Pharm., 404 (2011), pp. 1-9.
The copending application discloses a formulation for oral ingestion comprising 5 ug to 50 mg of a choline ester prepared from hot air-dryed powder of Solanum melongena, corresponding to instant claim 1 (claims 14 and 19).
Copending claim 19 does not suggest an oral dosage form aside from reciting that the formulation may be a dry powder. Wening et al. discuss oral drug delivery in personalized medicine and report that tablets are the most accepted and cheapest oral dosage forms (page 3). Thoorens et al. provide a review of microcrystalline cellulose in pharmaceutics and state, “[m]icrocrystalline cellulose (MCC) is one of the most important tableting excipients thanks to its outstanding dry binding properties, enabling the manufacture of tablets by direct compression (DC). DC remains the most economical technique to produce large batches of tablets” (abstract). Accordingly, a person of ordinary skill preparing the copending oral composition would have been motivated to explore popular solid dosage forms such as tablets, prepared with excipients such as microcrystalline cellulose to administer the copending formulation.
Regarding the preamble of claim 1 “for improving sleep”, MPEP 2111.02(II) notes: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In this situation, the preamble is not considered limiting; the instantly claimed method of improving sleep by administering a composition compromising a choline ester would be rendered obvious by a person of ordinary skill using the oral formulation of the copending claims.
Instant claim 8, recites the method of improving sleep wherein improving sleep is an increase in sleeping time. Said increase in sleeping time is an additional benefit that would flow from administering the oral composition of the copending application. MPEP 2145(II) states:
"The fact that appellant has recognized another advantage which would
flow naturally from following the suggestion of the prior art cannot be
the basis for patentability when the differences would otherwise be
obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.
1985)
A person of ordinary skill using the copending composition in the disclosed dosing ranges could expect to observe an increase in sleeping time as instantly claimed.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 5, 7-8 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, 14, 17-18 and 21-22 of copending Application No. 17/776,939 in view of Thoorens et al. "Microcrystalline cellulose, a direct compression binder in a quality by design environment—A review." International journal of pharmaceutics 473.1-2 (2014): 64-72. and Wening et al. Oral drug delivery in personalized medicine: unmet needs and novel approaches. Int. J. Pharm., 404 (2011), pp. 1-9.
The copending application discloses a composition for oral ingestion comprising 5 ug to 50 mg of a choline ester, corresponding to instant claims 1 and 7 (claim 5).
The instant claims do not suggest an oral dosage form aside from reciting that the composition may be a dry powder. Wening et al. discuss oral drug delivery in personalized medicine and report that tablets are the most accepted and cheapest oral dosage forms (page 3). Thoorens et al. provide a review of microcrystalline cellulose in pharmaceutics and state, “[m]icrocrystalline cellulose (MCC) is one of the most important tableting excipients thanks to its outstanding dry binding properties, enabling the manufacture of tablets by direct compression (DC). DC remains the most economical technique to produce large batches of tablets” (abstract). Accordingly, a person of ordinary skill preparing the copending oral composition would have been motivated to explore popular solid dosage forms such as tablets, prepared with excipients such as microcrystalline cellulose to administer the copending composition.
Regarding the preamble of claim 1 of “for improving sleep”, MPEP 2111.02(II) notes: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In this situation, the preamble is not considered limiting; the instantly claimed method of improving sleep by administering a composition compromising a choline ester would be rendered obvious by a person of ordinary skill using the orally ingestible composition of the copending claims.
Copending claim 18, discloses the copending composition wherein the choline ester is selected from any one of acetylcholine, butyrylcholine and propionylcholine as required by instant claim 5.
Instant claim 8, recites the method of improving sleep wherein improving sleep is an increase in sleeping time. Said increase in sleeping time is an additional benefit that would flow from administering the oral composition of the copending application. MPEP 2145(II) states:
"The fact that appellant has recognized another advantage which would
flow naturally from following the suggestion of the prior art cannot be
the basis for patentability when the differences would otherwise be
obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.
1985)
A person of ordinary skill using the copending composition in the disclosed dosing ranges could expect to observe an increase in sleeping time as instantly claimed.
Regarding instant claims 1 and 9-10, claim 1 describes the pharmaceutical composition as a product-by-process. Therefore, if the product in the product-by-process claim is the same as or obvious from a product of the copending product, the claim would be obvious even if the copending product was made by a different process.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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/A.A.C./Examiner, Art Unit 1626
/JOSEPH K MCKANE/Supervisory Patent Examiner, Art Unit 1626