DETAILED ACTION
Status of the Claims
Claims 1-3, 5-6 and 11-17 are pending in the instant application. Claims 16 and 17 have been withdrawn based upon Restriction/Election as discussed below. Claims 1-3, 5-6 and 11-15 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction/Election
Applicant's election with traverse of Group I drawn to compositions of matter, currently claims 1-3, 5-6 and 11-15, in the reply filed on 11/25/2025 is acknowledged. The traversal is on the ground(s) that the available evidence does not indicate there will be a serious burden to consider the claims of all three groups at the same time. This is not found persuasive because the "lack of unity" standard is different from the "independent and distinct" standard and does not require consideration of a serious burden. PCT Rule 13 provides a requirement for "unity of invention" which is applied where international applications are filed under the Patent Cooperation Treaty, and U.S. stage applications under 35 U.S.C. 37, as is the case in the instant application. The requirement for "lack of unity" is different than the "independent and distinct" requirement used in non-provisional applications filed under 35 U.S.C. 111(a). And the "unity of invention" requirement must be used instead of the "independent and distinct" requirement used in 111(a) applications. Applicants are advised that MPEP chapter 800 is directed to restriction practice for US applications filed under 111(a) and MPEP Chapter 1800 discusses the Patent Cooperation Treaty (PCT), particularly MPEP § 1850 discusses "lack of unity" of invention and does not make any "serious burden" requirement for establishing "lack of unity" of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16 and 17 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/25/2025.
Priority
The U.S. effective filing date has been determined to be 05/09/2022, the filing date of PCT/CN2022/091766. Applicant's claim for a foreign priority date of, 05/11/2021, the filing date of document CN2021-10509462.6, is acknowledged, however no English translation of the foreign priority document has been provided such that the examiner can verify written description (112(a)) support therein. Accordingly, foreign priority to this document is cannot be afforded at this time.
Information Disclosure Statement
The information disclosure statement submitted on 10/23/2025 was filed before/after the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim recites “A pharmaceutical composition comprising chlorogenic acid, vitamin, pharmaceutically acceptable excipient, and a trace element […].” wherein “vitamin” and “pharmaceutically acceptable excipient” each lack a proper article such as “a” “at least one” etc. Appropriate correction is required.
Claim Rejections - 35 USC § 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.
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 2 and 3 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 pre-AIA the applicant regards as the invention.
Claim 2 is rejected as being indefinite because the claim recites “wherein chlorogenic acid, the vitamin, and the trace element are the only active ingredients.” where it is unclear in the context of the claim what exactly the scope of an “active ingredient” should be considered. Particularly, it is unclear what should be considered outside the scope of “active ingredient” when, e.g. vitamins and minerals, which produce no physiological response, are considered as active ingredients in the context of the claims. See, e.g., US 2021/0330626 A1 (by the same Applicant) regarding vitamins as an excipient ([0013], claim 9). Appropriate clarification is required.
Claim 3 is rejected as being indefinite because the claim recites “the vitamin is selected from vitamin C, vitamin E, vitamin B6, vitamin B12 and mixtures” where the term “vitamin” is singular, therefore “and mixtures” in unclear in the context of the claims. Appropriate clarification is required.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, 6, 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by GRAUS (2004/0097584; published May, 2004).
Applicant Claims
Applicant claims a pharmaceutical composition comprising chlorogenic acid, vitamin, pharmaceutically acceptable excipient, and a trace element selected from zinc gluconate, manganese gluconate, chromium chloride, copper gluconate and combinations thereof (instant claim 1).
Claim interpretation: The examiner is interpreting “chlorogenic acid” as the single chemical species 3-(3,4-Dihydroxycinnamoyl)quinic acid (PubChem CID 1794427).
Disclosure of the Prior Art
GRAUS disclose “In a much preferred embodiment, the preparation comprises 2-300 mg/day, and a most preferably 10-200 mg/day, of one or more CA-compounds and 50-2000 mg/day N-acetylcystein, plus optionally one or more of the other compounds in an amount as can be deducted from Table 1.” ([0052], Table 1), wherein “CA-compounds” includes chlorogenic acid. GRAUS further discloses that: “In a preferred embodiment the preparation may be in a more or less solid form such as a capsule, a tablet […].” ([0058]). GRAUS discloses an example tablet comprising Ascorbic Acid (Vitamin C), Cupric Gluconate (copper gluconate), and chlorogenic acid (Dried extract of artichoke (globe artichoke extract 5% chlorogenic acid) – (providing 9 mg chlorogenic acid))(instant claims 1, 3, 6, 11 and 15).
Claims 1, 3, 6, 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by MOSHREFI (US 2015/0335604; published November, 2015).
Applicant Claims
Applicant claims a pharmaceutical composition comprising chlorogenic acid, vitamin, pharmaceutically acceptable excipient, and a trace element, as discussed above.
Disclosure of the Prior Art
MOSHREFI discloses chromium and chlorogenic acid weight control formulations (title), particularly a fruit drink prepared with 200 mg chlorogenic acid, 60 mg Vitamin C, 15.93 mg zinc gluconate, 0.71 mg copper gluconate ([0055]-[0066])(instant claims 1, 3, 6, 11 and 15).
Claims 1, 3, 6, 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by LIU (CN 111195298 A; published 05/26/2020; Machine English language Translation attached and relied on herein).
Applicant Claims
Applicant claims a pharmaceutical composition comprising chlorogenic acid, vitamin, pharmaceutically acceptable excipient, and a trace element, as discussed above.
Disclosure of the Prior Art
LIU discloses “The invention relates to a composition for regulating intestinal flora and preventing food allergy and preparation method thereof, the composition comprises the following components in terms of parts by weight: oligomerization polysaccharide 15-35 weight parts of bamboo shoot, oligomeric acid polysaccharide, 5-25 parts of stachyose,15-25 parts by weight Moringa seed polyphenol extract, 1-20 parts of cordate houttuynia extract, 1-20 parts of chlorogenic acid, 1-10 parts of fucoxanthin, 0.1-1.5 parts of zinc gluconate and 0.1-1.5 parts of vitamin C, 0.1-1.5 parts by weight. the compositions of the present invention can reach the efficacy for preventing food allergy by improving intestinal flora and repair of intestinal barrier function.” (Abstract)(instant claims 1, 3 and 11). LIU further discloses that: “The invention also protects the nourishment composition comprises the adjusting intestinal flora and preventing food allergy, health food or medicine, its form can be powder, tablet, granule, capsule, or pill.” (p. 3, 1st paragraph)(instant claims 6 & 15).
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 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 6 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over BOK (WO 2000/015215 A1; published March, 2000) in view of YEGOROVA (US 2002/0176900; published November, 2002).
Applicants Claims
Applicant claims a pharmaceutical composition comprising chlorogenic acid, vitamin, pharmaceutically acceptable excipient, and a trace element, as discussed above.
Determination of the scope
and content of the prior art (MPEP 2141.01)
BOK teaches compositions containing cinnamic acid derivatives for preventing or treating elevated blood lipid level-related diseases (title, see whole document), and particularly “A pharmaceutical composition for treating or preventing an elevated blood lipid level-related disease such as hyperlipidemia, arteriosclerosis, angina pectoris, stroke and hepatic disease in a mammal, which comprises an effective amount of a cinnamic acid derivative of formula (Ia) or (lb), or a pharmaceutically acceptable salt thereof, as an active ingredient together with a pharmaceutically acceptable carrier […].” (abstract).
BOK teaches that: “The present inventors have endeavored to develop a novel pharmacological use of bioflavonoids which are abundantly present in herbs, foodstuffs, vegetables and fruits. As a result, it has been discovered that cinnamic acid and hydrocinnamic acid derivatives, which are employed as precursors in the biosynthesis of bioflavonoids and forms a backbone structure of bioflavonoids, are effective in treating or preventing elevated blood lipid level-related diseases. Specifically, it can greatly reduce plasma cholesterol level; prevent the activities of HMG-CoA reductase and ACAT; inhibit the accumulation of macrophage-lipid complex on the endothelial wall of an artery; and prevent hepatic dysfunctions in a mammal.” (paragraph bridging pp. 3-4). BOK teaches that: “Representative but not limiting examples of the cinnamic acid derivatives of formula Ia or lb include compounds of the following structures:” including chlorogenic acid (p. 6, 3rd paragraph; p. 7, chlorogenic acid chemical structure).
BOK teaches that: “Thus, the formulations may be in the form of a tablet, pill, powder, sachet, elixir, suspension, emulsion, solution, syrup, aerosol, soft and hard gelatin capsule, sterile injectable solution, sterile packaged powder and the like.” (p. 8, lines 15-19)(instant claims 6 and 15). BOK teaches that: “In case of human, a typical daily dose of cinnamic acid derivatives may range from about 0.1 to 500 mg/kg body weight, preferably 1 to 100 mg/kg body weight, and can be administered in a single dose or in divided doses.” (p. 8, line 37 through p. 9, line 4).
BOK teaches inclusion of a Mineral mixture and Vitamin mixture (p. 12, Table 1) but does not teach specific vitamins and/or minerals therein. BOK teaches the inclusion of Vitamin C in a capsule formulation (p. 24, lines 17-26)(instant claims 1, 3 and 11).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of BOK is that BOK does not expressly teach: (1) the inclusion of manganese gluconate (instant claims 1 & 12); (2) the limitation “wherein chlorogenic acid, the vitamin, and the trace element are the only active ingredients” (instant claim 2), or the ratio of the chlorogenic acid, the vitamin and the trace element is 100:(1-5):(0.01-0.05)(instant claims 5, 13 and 14).
YEGOROVA teaches compositions and methods for promoting a healthy cardiovascular system and enhanced blood flow (title, see whole document), and particularly “Compositions and methods for promoting a healthy cardiovascular system and enhancing healthy blood flow by gently removing toxic buildup from the arterial walls and dilating and strengthening the arterial walls, in a mammal. The compositions comprise calcium; magnesium; selenium; manganese; zinc; potassium; vitamin E; vitamin A […].” (abstract).
YEGOROVA teaches that “The use of antioxidant vitamins for the prevention of coronary heart disease is becoming more prevalent as the proportion of the population seeking alternative therapies is increasing ([citation omitted]). As discussed supra, overwhelming evidence show that LDL cholesterol becomes harmful only in its oxidized form known as oxysterol ([citation omitted]). Excess free radicals present in plasma increase LDL oxidation ([citation omitted]) but can be inhibited by antioxidant vitamins. Animal studies have demonstrated that an increased intake of antioxidant nutrients may have a role in preventing coronary heart disease ([citation omitted]).” ([0047]).
YEGOROVA teaches that: “Manganese is found in high concentrations in bone, pituitary, liver, pancreas, and gastrointestinal tissue. This trace mineral is a constituent of essential enzyme systems and has been implicated in an important role as part of the natural antioxidant enzyme superoxide dismutase.” ([0055]). YEGORAVA teaches that: “Manganese, as described herein, includes the various forms of manganese available, including […] magnesium gluconate […].” ([0032]); and Zinc, as described herein, includes the various forms of zinc available, including […] zinc gluconate […].” ([0033]). YEGORAVA teaches that: “Zinc is present in most tissues, with the greatest amounts occurring in the liver, voluntary muscle and bone. Zinc is a constituent of insulin and is required in more than 300 enzymes in the body.” ([0057]; also see [0046]).
YEGOROVA teaches that: “Both the calcium and manganese of the present
invention preferably may be in the form of ascorbates, better known as vitamin C. Vitamin C is a powerful water-soluble antioxidant which complements vitamin E, a lipophilic antioxidant vitamin. Importantly, vitamin C increases the absorption of selenomethionine. Ascorbates serve a variety of other functions that promote cardiovascular health including: catalyzing the actions of phenylalanine and tyrosine; converting the inactive form of folic acid to the active folinic acid; protecting B-vitamin complex, as well as vitamins A and E against oxidation; stimulating calcium metabolism; and, stimulating the activity of oxidative enzymes to protect against oxidation.” ([0056]).
Regarding instant claim 2, the BOK clearly teaches chlorogenic acid as an active for lower lipids, and YEGOROVA teaches both vitamins including Vitamin C and Vitamin E, as well as minerals including zinc (gluconate) and manganese (gluconate) for the very same use. Therefore it would have been prima facie obvious to combine, as active ingredients, chlorogenic acid along with Vitamin C/E and a trace mineral such as manganese gluconate to form a composition for the treatment of cardiovascular disease and particularly for treating or preventing an elevated blood lipid level, as suggested by BOK.
Regarding instant claims 5, 13 and 14, as discussed above, each of the claimed chlorogenic acid, Vitamin C/E and trace minerals such as manganese gluconate, are each taught for the treatment of cardiovascular disease, therefore it would have been prima facie to optimize the amount of each of the ingredients for the best possible composition for treating or preventing an elevated blood lipid level, as suggested by BOK. MPEP §2144.05(II): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition such as an oral table comprising chlorogenic acid, Vitamin C/E and trace minerals such as manganese gluconate, as suggested by BOK and YEGOROVA, for the treatment of the treatment of cardiovascular disease, and particularly as a composition for treating or preventing an elevated blood lipid level, as suggested by BOK and YEGOROVA.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because it would have required no more than an ordinary level of skill to combine known constituent ingredients with known excipients to produce a formulation for the treatment of the treatment of cardiovascular disease, and particularly as a composition for treating or preventing an elevated blood lipid level, as suggested by BOK and YEGOROVA. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 5-6 and 11-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, and 10-14 of U.S. Patent No. 9,918,956 (hereafter ‘956) in view of BOK (WO 2000/015215 A1; published March, 2000) and YEGOROVA (US 2002/0176900; published November, 2002).
The instant claims are discussed above.
‘956 claim 1 recites a chlorogenic acid powder, comprising: chlorogenic acid, a supporting material, and an antioxidant […]. ‘956 claim includes excipients as “supporting material” (claim 2), and Vitamin C as the antioxidant (claim 10).
The difference between the instantly rejected claims and the claims of ‘956 is that the claim of ‘956 do not expressly claim the inclusion of a mineral or ratios of ingredients.
BOK teaches compositions containing cinnamic acid derivatives for preventing or treating elevated blood lipid level-related diseases, as discussed above and incorporated by reference.
YEGOROVA teaches compositions and methods for promoting a healthy cardiovascular system and enhanced blood flow, as discussed above, including manganese (gluconate) as part of the natural antioxidant enzyme superoxide dismutase.
Regarding instant claims 5, 13 and 14, as discussed above, each of the claimed chlorogenic acid, Vitamin C/E and trace minerals such as manganese gluconate, are each taught for the treatment of cardiovascular disease, therefore it would have been prima facie to optimize the amount of each of the ingredients for the best possible composition for treating or preventing an elevated blood lipid level, as suggested by BOK. MPEP §2144.05(II): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of ‘956 because the claims are directed to chlorogenic acid compositions, and include an excipient and vitamin C, and it would have been prima facie to include a trace mineral such as manganese gluconate as suggested by BOK/YEGOROVA. The skilled artisan would have been motivated to modify the claims of ‘956 and produce the instantly rejected claim because inclusion of a mineral in would have been prima facie obvious. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because it would have required no more than an ordinary level of skill to combine known constituent ingredients with known excipients to produce a formulation for the treatment of the treatment of cardiovascular disease, and particularly as a composition for treating or preventing an elevated blood lipid level, as suggested by BOK and YEGOROVA.
Conclusion
Claims 1-3, 5-6 and 11-15 are pending and have been examined on the merits.
Claim 1 is objected to; claims 2 and 3 are rejected under 35 U.S.C. 112(b); claims 1, 3, 6, 11 and 15 are rejected under 35 U.S.C. 102(a)(1); claims 1-3, 5, 6 and 11-15 are rejected under 35 U.S.C. 103; and claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 9,918,956. No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619