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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation the pharmaceutical composition comprises chlorogenic acid and 3- coumaroylquinic acid, with a weight ratio of 100:(0.01-0.5). However, it is unclear if the weight ratio describes the ratio of chlorogenic acid to 3- coumaroylquinic acid or the ratio of 3- coumaroylquinic acid to chlorogenic acid, since it is not specified in the claim.
Claim 4 recites the phrase "preferably," which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 recites the limitation low molecular weight dextran. The term “low” is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, it is unclear what molecular weight the dextran must have to be considered low molecular weight.
Claim 9 includes the limitation of the use according to claim 8, characterized in that the medicament improves the learning and memory abilities of patients with early Alzheimer's disease, delays the progression of Alzheimer's disease, and raises the life quality of patients, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
Claims 3 and 5-7 are rejected based on their dependency on claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al., (WO 2019/206159 A1, Oct. 31, 2019) (hereinafter Zhang) in view of Pond (US 2021/0244786 A1, filed Feb. 04, 2021) (hereinafter Pond), as evidenced by Prasad (US 2018/0028482 A1, Feb. 01, 2018) (hereinafter Prasad).
Zhang discloses a pharmaceutical composition comprising chlorogenic acid and coumaroyl quinic acid (Claim 7), wherein chlorogenic acid is the active ingredient in addition to auxiliaries (Claim 2). The mass ratio of chlorogenic acid to coumaroyl quinic acid is 100:0.01 to 0.5 (Claim 8). The composition is an oral preparation or an injectable preparation (Claim 9). The chlorogenic acid and coumaroyl quinic acid are compressed with auxiliary ingredients to obtain tablets ([0039]) or are injected intravenously ([0066]). The composition comprises an antioxidant ([0048]).
Zhang differs from the instant claims insofar as not disclosing wherein the coumaroyl quinic acid is 3-coumaroyl quinic acid.
However, Pond discloses compositions in which a plurality of chemically distinct polyphenols inhibit multiple enzymes in pathways associated with health and healthy ageing. Preferred compositions are derived from colored plant materials that are commonly found in the Mediterranean diet and provide the biochemical basis for the health benefits of the Mediterranean diet. Notably, the enzyme inhibition observed with the combined polyphenols was synergistic with respect to not one but a significant number of enzymes in the pathways associated with health and healthy ageing, thus providing an amplified desirable effect (Abstract). The compositions are used for nutritional supplements and other nutritional products, compositions, and uses in medicinal food, and even use in medicine and the specific combinations of polyphenol-containing materials strongly modulate numerous biomarkers associated with the beneficial effects of the Mediterranean diet ([0075]). Compositions will include a large number of polyphenols, such as chlorogenic acids and the particular choice of a plant material will depend on the desired (polyphenolic) component in the plant material and its effect on a particular biological system and/or signaling pathway ([0089]). Suitable chlorogenic acids include 3-Coumaroylquinic acid and 5-Caffeoylquinic acid (i.e., known as chlorogenic acid) (Table 6). The plant materials will be complex mixtures to provide a combination of desired biological effects on a number of distinct molecular entities where at least some of the biological effects are synergistic ([0090]). The composition is formulated in single dosage units for oral administration ([0016]). The composition may be administered as a pharmaceutical or nutraceutical composition to the individual in need thereof for direct administration via injection and infusion ([0182]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Zhang discloses wherein the composition comprises coumaroyl quinic acid. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 3-coumaroyl quinic acid into the composition of Zhang since it is a known and effective coumaroyl quinic acid for use in medicine as taught by Pond.
Regarding the limitation of claims 1 and 8 reciting for treating early Alzheimer's disease and for use in the manufacturer of medicaments for the treatment of early Alzheimer's disease, this is merely a recitation of the intended use of the composition. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the pharmaceutical composition of Zhang comprises chlorogenic acid as the active ingredient. As evidenced by Prasad, compositions comprising chlorogenic acid are used in the treatment of Alzheimer's disease (Abstract), including early Alzheimer's disease ([0058]). Therefore, since compositions comprising chlorogenic acid are used in the treatment of early Alzheimer's disease, the composition of Zhang is capable of being used for treating early Alzheimer's disease and for the treatment of early Alzheimer's disease.
Regarding the claim 1 reciting wherein 3-coumaroylquinic acid is an auxiliary ingredient used to enhances the efficacy of chlorogenic acid in the treatment of early Alzheimer’s disease, this is merely a recitation of the intended use of 3-coumaroylquinic acid. Since the prior art comprises substantially the same 3-coumaroylquinic acid as claimed, the 3-coumaroylquinic acid of the prior art is capable of being used to enhance the efficacy of chlorogenic acid in the treatment of early Alzheimer’s disease.
Regarding the limitation of claim 9 reciting characterized in that the medicament improves the learning and memory abilities of patients with early Alzheimer's disease, delays the progression of Alzheimer's disease, and raises the life quality of patients, as noted on page 4, lines 18-19 of the instant specification, the medicament of the instant invention improves the learning and memory abilities of patients with early AD, delays the progression of AD, and raises the life quality of patients. Accordingly, since the pharmaceutical composition of Zhang comprises substantially the same ingredients (i.e., chlorogenic acid and coumaroyl quinic acid ) as the claimed invention in substantially the same amount of the claimed invention (i.e., mass ratio of chlorogenic acid to coumaroyl quinic acid of 100:0.01 to 0.5), the composition of Zhang would necessarily improve the learning and memory abilities of patients with early Alzheimer's disease, delay the progression of Alzheimer's disease, and raise the life quality of patients like the claimed invention.
2. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al., (WO 2019/206159 A1, Oct. 31, 2019) (hereinafter Zhang) in view of Pond (US 2021/0244786 A1, filed Feb. 04, 2021) (hereinafter Pond), and further in view of Razna et al., (Properties of Ginkgo biloba L.: Antioxidant Characterization, Antimicrobial Activities, and Genomic MicroRNA Based Marker Fingerprints, April 27, 2020) (hereinafter Razna).
As discussed above, Zhang and Pond make obvious the limitations of claim 1 but do not teach wherein the pharmaceutical composition further comprises other active ingredients selected from one or more of donepezil, galantamine, rivastigmine, memantine, prednisone, rofecoxib, nimesulide, diclofenac, rhodanine, Ginkgo biloba leaf extract, ginsenoside, huperzine A, stilbene glycoside, levodopa, carbidopa, benserazide, trihexyphenidyl, benzotropine, procycline, prdenamhe, butylphthalide, dipyridamole, low molecular weight dextran, heparin, urinary kallidinogenase, citicoline, butylphthalide, edaravone, nimodipine, or aspirin.
However, Razna discloses that Ginkgo biloba leaf extracts can be used as antioxidant additives (Abstract) and that extracts from the leaves of Ginkgo have been used in Chinese medicine from ancient times (page 2, Introduction). Table 1 discloses 15 Ginkgo biloba leaf extracts and Table 2 indicates that all the extracts showed antioxidant activity (bottom of page 3 – top of page 4). Ginkgo biloba leaf extracts comprises flavonoids which have protective effects against cancers (page 6, first paragraph).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Zhang discloses wherein the composition comprises antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated Ginkgo biloba leaf extract into the composition of Zhang since it is a known and effective antioxidant additive as taught by Razna.
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 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. US 12,156,861 B2 in view of Pond (US 2021/0244786 A1, filed Feb. 04, 2021) (hereinafter Pond), as evidenced by Prasad (US 2018/0028482 A1, Feb. 01, 2018) (hereinafter Prasad).
Patent claims 1-2 are directed to a pharmaceutical composition, comprising chlorogenic acid, coumaroylquinic acid, and a targeted drug, wherein a mass ratio of chlorogenic acid to coumaroylquinic acid is 100:0.01-10.
The patent claims differ insofar as not disclosing wherein the coumaroylquinic acid is 3-coumaroylquinic acid and that the 3-coumaroylquinic acid is an auxiliary ingredient used to enhance the efficacy of chlorogenic acid.
However, Pond discloses various compositions for nutritional supplements and other nutritional products, compositions, and uses in medicinal food, and even use in medicine comprising specific combinations of polyphenol-containing materials that strongly modulate numerous biomarkers associated with the beneficial effects of the Mediterranean diet ([0075]). Most notably, the compositions had substantial and synergistic effects on a number of biomarkers associated with proper CNS function and longevity, and showed further significant effect on additional biomarkers associated with inflammatory responses, adverse effects of cardiovascular disease, and/or amyloid beta plaque formation, such as BACE1 ([0076]). In an example, beta-secretase 1 (BACE1) was shown to be essential for the generation of β-amyloid in Alzheimer's disease and has also been reported to be associated with cognitive decline and decline in central nervous system (CNS) function. β-amyloid accumulation is a hallmark of ageing, and as such inhibitory compounds are thought to beneficially decelerate or even stop β-amyloid accumulation and as such preserve or maintain cognitive abilities and CNS function. The compositions show remarkable, strong, and even synergistic effect with regard to BACE 1 inhibition ([0079]). Compositions will include a large number of polyphenols, such as chlorogenic acids and the particular choice of a plant material will depend on the desired (polyphenolic) component in the plant material and its effect on a particular biological system and/or signaling pathway ([0089]). Suitable chlorogenic acids include 3-Coumaroylquinic acid and 5-Caffeoylquinic acid (i.e., known as chlorogenic acid) (Table 6).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. The patent claims disclose wherein the composition comprises coumaroylquinic acid. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 3-coumaroylquinic acid into the instant claims since it is a known and effective coumaroylquinic acid as taught by Pond.
Regarding the limitation of claims 1 and 8 reciting for treating early Alzheimer's disease and for the treatment of early Alzheimer's disease, this is merely a recitation of the intended use of the pharmaceutical composition. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, patent claims comprise chlorogenic acid as the active ingredient. As evidenced by Prasad, compositions comprising chlorogenic acid are used in the treatment of Alzheimer's disease (Abstract), including early Alzheimer's disease ([0058]). Therefore, since compositions comprising chlorogenic acid are used in the treatment of early Alzheimer's disease, the composition of the patent is capable of being used for treating early Alzheimer's disease and for the treatment of early Alzheimer's disease.
Conclusion
Claims 1-9 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./ Examiner, Art Unit 1614
/TRACY LIU/ Primary Examiner, Art Unit 1614