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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 5, 2025 has been entered.
Election/Restrictions
Applicant’s election of Group I, drawn to a method of treating a vascular disease or condition in a subject in need thereof, and a method of promoting vascular health in a subject; and the following species:
Rosmarinic acid as the elected species of vascular disease associated polyphenol.
Ischemic injury as the elected species of vascular disease or condition.
are maintained.
Claims 5-13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on December 5, 2025, wherein claims 1-2 are amended; claims 3 and 17 are cancelled; claims 4-16 and 18 are unchanged; and claims 19-20 are newly added.
Claims 1-2, 4-16 and 18-20 are pending.
Claims 5-13 remain withdrawn.
Claims 1-2, 4, 14-16 and 18-20 are under examination in accordance with the elected species.
Priority
The instant application 17/558,402 filed on December 21, 2021 is a continuation of U.S. Patent Application No. 17/450,446 filed on October 8, 2021, which claims priority to, and the benefits of U.S. Provisional Application No. 63/090,161 filed on October 9, 2020, and a continuation-in-part of U.S. Patent Application No. 17/595,185 filed on November 10, 2021, which is a 371 of PCT/US2020/034299 filed on May 22, 2020 that claims priority, and the benefits of U.S. Provisional Application No. 62/852,800 filed on May 24, 2019.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, U.S. Patent Application No. 62/852,800, Application No. 63/090,161 and Application No. 17/595,185, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed applications fail to provide adequate basis to support a method of treating a vascular disease or condition in a subject in need thereof; and a method of promoting or supporting vascular health in a subject comprising orally administering to the subject an effective amount of the vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, wherein the subject has been diagnosed as having the vascular disease or condition. Therefore, the claims are not entitled to the benefit of these prior-filed applications and will receive an effective filing date of October 8, 2021, which is the filing date of U.S. Patent Application No. 17/450,446.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/29/2026 and 2/3/2026 was filed after the mailing date of the Final Office Action on August 5, 2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Action Summary
Acknowledgement is made of the receipt and entry of the amendment to the drawing filed on December 5, 2025, which corrects the typographical error of “polphenol” to “polyphenol” on Fig. 5A; and the typographical error of “sponclylitis” to “spondylitis” on Fig. 9A.
Applicant’s amendment to the claims overcome each and every objection previously sets
forth in the Final Office Action mailed on August 5, 2025.
Claims 1, 2, 4, 14-16 and 18 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liao et al. are withdrawn in light of the claim amendments.
Claims 1, 2, 4, 14-16 and 18 rejected under 35 U.S.C. 103 as being unpatentable over Gow et al. (US 2004/0202730 A1) are withdrawn in light of the claim amendments.
Specification
The disclosure is objected to because of the following informalities:
the disclosure contains an embedded hyperlink and/or other form of browser-executable code. See page 51-52 of the specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
the use of the terms “Chrono-Lume®”, “Chrono-Log®”, “AGGRO/LINK®”, “BioLegend®”, “Thermo Scientific TM”, “RIPA Lysis Buffer System®”, “Santa Cruz®”, “Alexa FluorTM”, “CytekTM”, “PROTEAN TGXTM”, “Bio-Rad”, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. While the Examiner has made every attempt to check the specification for trade name or mark compliance, Applicant is required to carefully check the entire specification for any and all issues regarding trade name or mark.
Appropriate correction is required.
Claim Interpretation
The claim term “ischemic injury”, when reasonably construed in light of paragraph [0087] of the specification, is taken to include “injuries caused by cardiovascular ischemia, cerebrovascular ischemia, renal ischemia, hepatic ischemia, ischemic cardiomyopathy, cutaneous ischemia, bowel ischemia, intestinal ischemia, gastric ischemia, pulmonary ischemia, pancreatic ischemia, skeletal muscle ischemia, abdominal muscle ischemia, limb ischemia, ischemic colitis, mesenteric ischemia and silent ischemia”.
The claim term “treating”, when reasonably construed in light of paragraph [0085] of the specification, is taken to include “inhibiting the disease or condition (e.g., as by slowing or stopping its progression or causing regression of the disease or condition), and relieving the symptoms resulting from the disease or condition”.
The claim phrase “has been” in the recitation of “wherein the vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, has been identified as associated with the vascular disease or condition” (see claims 19 and 20) is in the present perfect form, thus, given it broadest reasonable interpretation, the identification of the wherein the vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof is an action that started in the past and continues.
Claim Objections
Claims 1-2 and 19-20 are objected to because of the following informalities:
Regarding claims 1-2 and 19-20, the term “comprises” is not being consistent throughout the claim(s), and should read –comprising—for the sake of consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-2, 4, 14-16 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for orally administering an effective amount of rosmarinic acid for treating ischemic injury of the heart and brain, does not reasonably provide enablement for orally administering an effective amount of each and every “vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof” for treating the full scope of vascular disease or condition in any subject diagnosed as having said vascular disease or condition; and for promoting or supporting vascular health in the full scope of subject diagnosed as having any vascular disease or condition. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and, (8) the quantity of experimentation necessary. All of the Wands factors have been considered and discussed below:
(1, 5) The breadth of the claims and the Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
Instant claims 1 recites “[a] method of treating a vascular disease or condition in a subject in need thereof”, and claim 2 recites “[a] method of promoting or supporting vascular health in a subject”, and each of these methods comprising “identifying a vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, as associated with the vascular disease or condition by: generating a candidate disease list based on proximities of proteins associated with a plurality of diseases and proteins associated with a therapeutic chemical in a protein-protein interaction network, wherein the candidate disease list comprises the vascular disease or condition; applying gene expression information associated with the therapeutic chemical to generate enrichment scores for diseases of the candidate disease list; and identifying at least one therapeutic chemical associated with the vascular disease or condition based on the enrichment scores, wherein the therapeutic chemical is the vascular disease associated polyphenol, or the pharmaceutically acceptable salt thereof; and orally administering to the subject an effective amount of the vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, wherein the subject has been diagnosed as having the vascular disease or condition”.
Instant claim 19 recites “[a] method of treating a vascular disease or condition”, and claim 20 recites “[a] method of promoting or supporting vascular health” in a subject that has been diagnosed as having the vascular disease or condition, and each of these methods comprising “orally administering to the subject an effective amount of a vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, wherein the vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, has been identified as associated with the vascular disease or condition” by generating the candidate disease, applying the gene expression information to generate the enrichment scores, and identifying the therapeutic chemical based on the enrichment scores.
In sum, the breath of the claims encompass orally administering any effective amount of the full scope of “vascular disease associated polyphenol” or any pharmaceutically acceptable salt thereof for treating the full scope of “vascular disease or condition” or promoting or supporting the full scope of “vascular health” in any subject diagnosed as having said vascular disease or condition, and the claims also encompass identifying the full scope of the vascular disease associated polyphenol, or any pharmaceutically acceptable salt thereof by generating a candidate disease list containing any of the vascular disease or condition based on proximities of any proteins associated with a plurality of any diseases and any proteins associated with any therapeutic chemical; applying any gene expression information associated with the therapeutic chemical to generate enrichment scores for diseases of the candidate disease list; and identifying at least one therapeutic chemical that is the vascular disease associated polyphenol, or the pharmaceutically acceptable salt thereof associated with the vascular disease or condition based on the enrichment scores.
(2, 3, 4) The state of the prior art, the level of skill in the art, and the predictability or lack
thereof in the art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the
art would have known, at the time the application was filed, about the subject matter to which the
claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art
refers to the skill of those in the art in relation to the subject matter to which the claimed invention
pertains at the time the application was filed.”
At the time the application was filed, according to Luan et al. (Journal of Neuroinflammation, 2013. Vol. 10: 28), one skilled in the art would have known rosmarinic acid at doses of 25, 50, 100 and 200 mg/kg decreased neurological deficit score, reduced cerebral infarct volume and brain water content dose-dependency, but did not reduce blood glucose levels in diabetic cerebral I/R rats (see e.g., p. 6, left column, “Effects of RA on brain infarct volume, brain water content and neurological deficit scores in cerebral I/R rats”, 2nd paragraph; and p. 6, right column, “Discussion”, 1st paragraph). In other words, the cited reference demonstrates the relative skill of those in the art with respect to administering any effective amount of a vascular disease associated polyphenol (e.g., rosmaricic) for treating the full scope of “vascular disease or condition” (including diabetes mellitus) would have been low, because rosmaricic acid is the vascular disease associated polyphenol that cannot treat diabetes mellitus as the vascular disease or condition by reducing glucose levels.
Additionally, according to Bai et al. (J Immunol Res, 2022. Vol. 2022: 7909971), one skilled in the art would have also known low dose gallic acid administration (administration by oral gavage at a daily dosage of 20 mg/kg body weight) produces no significant benefit against diet-induced hyperlipidemia; specifically, said administration did not exert significant effects on plasma total cholesterol, high-density lipoprotein cholesterol, low density lipoprotein cholesterol, or triglyceride levels during high-fat western-type diet (WTD) feeding (see e.g., p. 2, right column, “3.1. Low-Dose GA Administration Produces No Significant Benefit against Diet-Induced Hyperlipidemia”, 1st paragraph; p. 3, left column, line 1-5). The cited reference further demonstrate the relative skilled on those in the art with respect to administering any effective amount of each and every “vascular disease associated polyphenol” for
treating post-prandial lipemia as the vascular disease or condition would have been low, because 20 mg/kg of oral gallic acid cannot treat diet-induced hyperlipidemia.
Therefore, it is uncertain whether the administration of each and every species of vascular disease associated polyphenol at any effective amount can successfully treat the full scope of vascular disease or condition; and promote or support vascular health in any subject diagnosed as having each and every vascular disease or condition.
(6, 7, 8) The amount of guidance given, the presence of working example and the quantitation
of experimentation required:
In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the claimed invention. In the present case, the specification discloses 27 out of 65 polyphenols were found to have associations to vascular diseases; and among these polyphenol, the targets of three polyphenols, gallic acid, 1,4-naphthoquinone, and rosmarinic acid are identified to have direct links between biological process related vascular health via network analysis (see e.g., [00143]); specifically, based on the network-based framework, gallic acid targets SERPINE1 human protein (see e.g., [00144]); 1,4-naphthoquinone targets MAP2K1 human protein (see e.g., [00145]); and rosmarinic acid targets FYN, MCL1, and AKR1B1 human proteins (see e.g., [00146]). The network utilized in the working examples is developed using the proximity between polyphenol targets and proteins associated with 299 diseases as described in Example 3. The enrichment score was generated as described in Example 4. To validate the predictive powder of the developed framework, rosmarinic acid is chosen and its influence on platelet activation activity was evaluated in vitro; specifically, the platelets were pretreated with rosmarinic acid and then activated with Collagen/CRPXL, TRAP-6, U46619, and ADP (see e.g., [00149]). The in vitro results of rosmarinic acid was then compared with the prediction based on the developed framework (see e.g., [00149]). It is noted that the working examples does not discloses the oral administration of any polyphenol, including rosmarinic acid, to a subject diagnosed as having any vascular disease or condition, aside from the in vitro assay showing rosmarinic acid can inhibits collagen-mediated platelet aggregation and impairs dense granule secretion induced by CRPXL, TRAP-6 and U46619. The working examples also does not disclose the biological activity of other polyphenol against other vascular disease, aside from identifying potential target(s) of gallic acid, 1,4-naphthoquinone and rosmarinic acid based on the network-based framework generated using computer. Based on the limited disclosure, the quantity of experimentation necessary to carry out the entire scope of claimed invention is high. In order to carry out the claimed invention, one skill in the art not only need to identify the effective amount of each and every “vascular disease associated polyphenol or a pharmaceutical acceptable salt thereof” that can be orally administered to a subject to sufficiently produce the desired therapeutic effect with acceptable side effects; the skilled artisan would also need to further identify which of the “vascular disease associated polyphenol or a pharmaceutical acceptable salt thereof” species encompassed by the claims can successfully treat the entire scope of “vascular disease or condition” or promoting or support the full scope of vascular health in any subject diagnosed as having the vascular disease or condition; as well as identify which of the “vascular disease or condition” species encompassed by the claims can successfully be treated using the vascular disease associated polyphenol or a pharmaceutical acceptable salt thereof.
Accordingly, the method of treating the full scope of “vascular disease or condition”, and “promoting or supporting” the full scope of vascular health in any subject diagnosed as having said vascular disease or condition comprising orally administering to the subject any effective amount of the full scope of vascular disease polyphenol, or a pharmaceutically acceptable salt thereof identify by generating a candidate disease list containing any of the vascular disease or condition based on proximities of any proteins associated with a plurality of any diseases and any proteins associated with any therapeutic chemical; applying any gene expression information associated with the therapeutic chemical to generate enrichment scores for diseases of the candidate disease list; and identifying at least one therapeutic chemical that is the vascular disease associated polyphenol, or the pharmaceutically acceptable salt thereof associated with the vascular disease or condition based on the enrichment scores is not enabled by the instant specification. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
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 1-2, 4, 14-16 and 18-20 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.
Regarding claim 1-2 and 19-20,
the phrase “a plurality of diseases” in the recitation of “generating a candidate disease list based on proximities of proteins associated with a plurality of diseases and proteins associated with a therapeutic chemical in a protein-protein interaction network” renders the claim indefinite, because the term “diseases” is already the plural form of the noun "disease". Therefore, by reciting “a plurality of diseases”, it can be interpreted such that is referring to (i) a plurality of “more than one disease” and that means there should be at least 2 sets of “2 diseases”, which gives a total of at least 4 diseases, or (ii) it is referring to more than 2 diseases. The metes and bounds of the phrase “a plurality of diseases” is not ascertainable, because one of ordinary skill in the art cannot reasonably determine which interpretation applies.
the phrase of “identifying a vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, as associated with the vascular disease or condition” in claims 1-2; and the phrase of “the vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, has been identified as associated with the vascular disease or condition” in claims 19-20 renders the claim indefinite. Said phrase already recites “vascular disease associated polyphenol”, meaning a polyphenol is linked to a vascular disease; and therefore, by reciting “as associated with the vascular disease or condition” thereafter is looping back onto itself. It is not clear if applicant is (i) reidentifying a polyphenol that already has an association with a vascular disease or condition, or simply just (ii) identifying a vascular disease associated polyphenol. The metes and bounds of said phrase is not ascertainable, because one of ordinary skill in the art cannot reasonably determine which interpretation applies.
The term “therapeutic chemical” is recited multiple times in the claim shown below:
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, and it is not clear if the term “the therapeutic chemical” in line 9-10 is referring to the “therapeutic chemical“ employed in the protein-protein interaction network (see line 1-3 above), or is it referring to the “at least one therapeutic chemical” set forth in line 8? The lack of clarity renders the claim indefinite, because one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
the recitation of “identifying a vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, as associated with the vascular disease or condition by:” (see claims 1-2) or “the vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, has been identified, as associated with the vascular disease or condition by:“ (see claims 19-20)“ identifying at least one therapeutic chemical associated with the vascular disease or condition based on the enrichment scores, wherein the therapeutic chemical is the vascular disease associated polyphenol, or the pharmaceutically acceptable salt thereof” is indefinite. First, the claim established that the term “therapeutic chemical” is the “vascular disease associated polyphenol, or the pharmaceutically acceptable salt thereof”. Reciting a singular vascular disease associated polyphenol is identified by identifying one or more vascular disease associated polyphenol based on the enrichment scores is confusing, because it is not clear if applicant is (i) identifying just one vascular disease associated polyphenol or (ii) applicant is identifying more than one vascular disease associated polyphenol. If applicant is referring to scenario (ii), then it is not clear if applicant is administering a singular vascular disease associated polyphenol or more than one vascular disease associated polyphenol to the subject. Additionally, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim recites the broad recitation “at least one therapeutic chemical” (one or more therapeutic chemical), and the claim also recites “a therapeutic chemical”, which is singular and is the narrower statement of the range/limitation as shown below (see shaded):
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The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Accordingly, claims 4 and 14-16 are rejected based on their dependency on a rejected base claim. In order to advance prosecution, the claim is examining in light of the elected species of vascular disease associated polyphenol (Rosmarinic acid), and the elected species of vascular disease or condition (Ischemic injury).
Regarding claim 4,
where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “modification of cardiovascular risk” is used by the claim to mean a “vascular disease or condition”; However, the accepted meaning is “increased cardiovascular risk”, as evidenced by Gronik et al. (Cleve Clin J Med, 2006. Vol. 73 Suppl 4: S30-S37)(see e.g., p. 30, right column, “Why is risk-factor modification critical?”. In other words, the term “modification of cardiovascular risk” is not used in the art to refer to a specific vascular disease or condition. The term is indefinite because the specification does not clearly redefine the term, and it is not clear what it is. Additionally, the term “modified platelet aggregation” is used by the claim to mean a “vascular disease or condition”; However, the accepted meaning is a “test used to investigate maximum aggregation in response to ADP, collagen, adrenalin and arachidonic acid”, as evidenced by Eder et al. (Hamostaseologie, 2007. Vol. 27(3): abstract). In other words, the term “modified platelet aggregation” is not used in the art to refer to a specific vascular disease or condition. The term is indefinite because the specification does not clearly redefine the term, and it is not clear what it is.
a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the recites the broad recitation “ischemic injury”, and the claim also recites “cerebral ischemia”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 14-15 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The members of the improper Markush grouping do not share a substantial feature and/or a
common use that flows from the substantial structure feature for the following reasons:
Instant claim 14 recites “the vascular disease associated polyphenol is pruetin, daidzin, punicalagin, kaempferol 3-o-galactoside, juglone, kaempferol 3-oglucoside, 4-methylcatechol, rosmarinic acid, xanthotoxin, daidzein, umbelliferone, 1,4-naphthoquinone, 3-caffeoylquinic acid, isoliquiritigenin, chrysin, cinnamic acid, caffeic acid, genistein, 3-phenylpropionic acid, butein, myricetin, piceatannol, piceatannol, ellagic acid, (-)-epigallocatechin 3-o-gallate, phenol, or quercetin, or a pharmaceutically acceptable salt thereof”; and claim 15 recites “wherein the vascular disease associated polyphenol is gallic acid, 1,4-naphthoquinone, or rosmarinic acid, or a pharmaceutically acceptable salt thereof”.
The Markush grouping of the “vascular disease associated polyphenol” are improper, because the alternated compound species do not share a substantial structural similarities and do not share a common use that flows from the substantial structure feature. For instance, 1,4-naphthoquinone has the chemical structure of:
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, as evidenced by Widhalm et al. (Hortic Res, 2016. Vol. 3: 16046)(see e.g., Figure 1). According to Baudry et al. (US 5,180,400), 1,4-naphthoquinone is a compound of formula (I) useful for dyeing keratinous fibres and in particular human keratinous fibres, such as hair (see e.g., Col. 1, line 63 to Col. 2, line 11). Gallic acid has the chemical structure of:
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and it is known to provide effective protection against oxidative damage by reactive species, and be useful for inhibiting proliferation, migration and invasiveness of cancer cells, as evidenced by Karas et al. (Food and Chemical Toxicology, 2017. Vol. 105: 223-240). Genistein has the chemical structure of:
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with and medical effects, such as antioxidant, antitumorigenic, antiatherosclerosis, and antiangiogenic, as evidenced by Wu et al. (J. Chem. Eng. Data, 2010. Vol. 55: 5286-5288). It is noted that these alternated members of vascular disease associated polyphenol do not share a substantial structure feature in common, and do not share a common use.
Each of these findings demonstrate that not all members recited in the Markush grouping share a substantial structure feature in common, and a common use that flows from the substantial structure feature.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
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.
Claims 1, 2, 4, 14-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gow et al. (US 2004/0202730 A1), in view of Han et al. (Front. Pharmacol, 2017. Vol. 8: 456), and Guney et al. (US 2017 /0270254 A1).
Gow et al. teaches a product, such as powder, that is particularly well suited for delivery in the oral cavity of human subjects, e.g., via a rapid dissolve tablet (see e.g., [0014]), that has unexpected benefit of treating or reducing heart conditions by, inter alia, ameliorating the effects of ischemia, improving blood circulation, resolving blood stasis, inhibiting platelet aggregation, and preventing restenosis (see e.g., [0001];[0008]). Gow et al. further teaches the dry flowable powder contains rosmarinic acid, borneol and a ginsenoside selected from group consisting of ginsenoside Rg1 and ginsenoside Rb1, wherein said rosmarinic acid component is between about 0.05% to about 85% of the sum of the masses of these three components (see e.g., claims 1-2 and 6; [0012]). Gow et al. further teaches the total weight of the active components in the form of a dry flowable powder in a single oral dosage is typically in the range of about 80 mg to about 600 mg (see e.g., [0023]). Please note the dry flowable powder taught Gow et al., which contains about 0.05% to about 85% of rosmarinic acid as one of the active components and about 80 mg to about 600 mg of the active components, is a pharmaceutical composition that contains an effective amount of rosmarinic acid.
Gow et al. does not expressly teach generating a candidate disease list based on proximities of proteins associated with a plurality of diseases and proteins associated with a therapeutic chemical in a protein-protein interaction network, wherein the candidate disease list comprises the vascular disease or condition; applying gene expression information associated with the therapeutic chemical to generate enrichment scores for diseases of the candidate disease list; and identifying at least one therapeutic chemical associated with the vascular disease or condition based on the enrichment scores, wherein the therapeutic chemical is the vascular disease associated polyphenol, or the pharmaceutically acceptable salt thereof.
Han et al. teaches various immunoregulatory functions (e.g., antioxidant and anti-inflammatory) of rosmarinic acid have been reported, but very little is known regarding the multiple target of rosmarinic acid in therapeutic cardiovascular disease; therefore, there is a motive to explore the inhibition profile of rosmarinic acid on a huge panel of targets, also called “target deconvolution”, by using the computational or experimental method (see e.g., p. 2, left column, 3rd paragraph). Han et al. further teaches a study that used both in silico and in vivo experimental methods, which first predicted that rosmarinic acid could be an affective component for the treatment of cardiovascular disease using text mining, chemogenomic and chemometric approaches; then verified the effect and mechanism of rosmarinic acid in a rat model of Ischemia-reperfusion(I/R)-induced myocardial injury (see e.g., p. 2, right column, 1st paragraph); reading on the limitation of “identifying a vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, as associated with the vascular disease or condition”. Han et al. further teaches a high-quality, comprehensive list of cardiovascular drug-target interactions and genetic phenotype-gene associations as well as other cardiovascular disease-related information are all compiled and integrated into the database CVDSP, then the target of rosmarinic acid identified by in-silico approach were compared with these 429 cardiovascular-disease-associated proteins to select the potential cardiovascular disease-related target of rosmarinic acid (see e.g., p. 2, right column, “target identification” and “comparison Potential Targets of RosA with Cardiovascular-Disease-Associated Proteins”). Han et al. further teaches in the in vivo method, rosmarinic acid attenuates I/R-induced myocardial injury through inhibiting inflammation and cardiomyocyte apoptosis by activating PPARγ and down-regulating NF-kB-mediated signaling pathway (see e.g., p. 7, right column, “Discussion”, 1st paragraph; abstract).
Guney et al. teaches a computational framework to quantify the relationship between disease modules and drug targets using several distance measures that capture the network-based proximity of drugs to disease genes (see e.g., [0080]; specifically, a method of determining whether a drug corresponding to the first node group (includes representations of drug targets) is therapeutically beneficial to a disease corresponding to the second node group (includes representations of disease proteins) based on the determined proximity between the first node group and the second node group (see e.g., claim 4; Fig. 2). Guney further teaches determining a proximity between a first node group and a second node group in an interaction network; the interaction network can include representations of biological interactions between proteins, where the proteins include drug targets and disease proteins (see e.g., [0005], [0007]; Fig. 2). Guney et al. further teaches most drugs used for, inter alia, Alzheimer's disease (AD), cardiac arrhythmias, cardiovascular diseases, and diabetes are proximal to the disease (see e.g., [0004]); reading on the limitation of “generating a candidate disease list based on proximities of proteins associated with a plurality of diseases and proteins associated with a therapeutic chemical in a protein-protein interaction network”. Guney et al. further teaches similarity-based methods are powerful in discriminating known drug-disease pairs from unknown drug-disease pair, but they have two main drawbacks that can overcome by gene expression profile consistency based approaches (see e.g., [0057]). Guney further compares proximity to gene expression-based repurposing and teaches using drug and disease gene expression profiles to calculate an enrichment score based on Kolomgorov-Smirnov statistic (i.e., calculate ES function in the R package), corresponding to the strength of the anti-correlation of drug and disease profiles’; and further teaches proximity yields better accuracy than expression correlation-based prediction of drug-disease associations (see e.g., [0057]; [0130]); reading on the limitation of “applying gene expression information associated with the therapeutic chemical to generate enrichment score for disease of the candidate disease list”. Guney et al. further teaches proximity provides an alternative to the drug similarity and gene expression based repurposing approaches that can offer an interactome-based explanation towards the drug's effect on a disease; their combination, though, could offer increased predictive power, given the orthogonal nature of the information the two classes of methods use (see e.g., [0057]).
In the present case, Gow et al. clearly teaches a product comprising an effective amount of rosmarinic acid (a dry flowable powdering comprising about 0.05% to about 85% of rosmarinic acid by mass of the active ingredient; and has a total weight of about 80 mg to about 600 mg of the active components) that is particularly well suited for delivery in the oral cavity of human subjects to treat heart conditions by ameliorating the effects of ischemia. The difference between the method of Gow et al. and the claimed method is that Gow et al. does not expressly teach identifying rosmarinic acid as being associated with ischemic heart conditions using the proximities and the gene expression approach instantly claimed; However, the fact that Gow et al. teaches the oral product comprising rosmarinic acid is useful for treating heart conditions by ameliorating the effects of ischemia in human subjects, the active ingredients contain therein, including rosmarinic acid, would naturally be identified as being associated with the ischemic heart condition. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Gow et al. by combining said method with the method of Gueny et al. as the computational method to identify rosmarinic acid is therapeutically beneficial to ischemic heart condition. One would have been motivated to do so, because Han et al. teaches target deconvolution that combines in silico and in vivo experimental methods help explore the inhibition profile of rosmarinic acid on a huge panel of targets, in which rosmarinic acid is first predicted to be an affective component for treating cardiovascular disease, then confirmed said rosmarinic acid is useful for attenuating I/R-induced myocardial injury through inhibiting inflammation and cardiomyocyte apoptosis by activating PPARγ and down-regulating NF-kB-mediated signaling pathway in the in vivo method; and Guney et al. teaches a method that uses computational farmwork to quantify the proximity between drug targets and disease proteins, including cardiovascular diseases, that help determine whether the drug to the drug targets is therapeutically beneficial to the disease corresponding to disease proteins; and combining said method with gene expression-based repurposing approach, which uses drug and disease gene expression profiles to calculate an enrichment score, can increase predictive power. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that orally administering the dry flowable powder of Gow et al., which contains an effective amount of rosmarinic acid, would have successfully treat ischemic heart condition ameliorating ischemia through activating PPARγ and down-regulating NF-kB-mediated signaling pathway in a human subject diagnosed as having said ischemic heart condition; and therefore, said rosmarinic acid can successfully be identified as being associated with ischemia heart conditions using the combination of the proximities and gene expression based approaches taught by Gueny et al.
Regarding the limitation of “wherein the vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, has been identified as associated with the vascular disease or condition…” in claims 19 and 20, it is noted that the phrase “has been” is in the present perfect form, which appears to be claiming an action that started in the past and continues. The instant situation is amenable to the type of analysis set forth in Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) and also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946), where the court found that the selection of any order of performing process steps is prima facia obvious in the absence of new or unexpected results. As such, applying the same logic to the instant process claims, one of ordinary skill in the art would have a reasonable expectation that by orally administering the product of Gow et al. for treating ischemic heart condition in a subject with said condition after identifying rosmarinic acid as being associate with ischemic heart condition would successfully treat ischemic heart condition.
Regarding the limitation of “promoting or supporting vascular health in a subject” in claims 2 and 20, by practicing the method of Gow et al., Han et al., and Guney et al. set forth above, “promoting or supporting vascular health in a subject” would naturally flow from the fact that the heart condition with ischemia in the subject is being treated. In other words, by treating the heart condition that impacts vascular health, the vascular health of the subject would naturally be promote.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-2, 4, 14-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16-27 of copending Application No. 17/595,185 (reference application), in view of Han et al. (Front. Pharmacol, 2017. Vol. 8: 456), and Gow et al. (US 2004/0202730 A1).
The reference application is drawn to “[a] method of identifying a disease associated with a therapeutic chemical, comprising: generating a candidate disease list based on proximities of proteins associated with a plurality of diseases and proteins associated with a therapeutic chemical in a protein-protein interaction network; applying gene expression information associated with the therapeutic chemical to generate enrichment scores for diseases of the candidate disease list; and identifying at least one disease associated with the therapeutic chemical based on the determined enrichment scores”(see claim 1); and a method of treating a subject having a disease, the method comprising administering a therapeutic chemical, wherein the disease is a disease identified by the method above as being associated with the therapeutic chemical (see claim 17), wherein the therapeutic chemical is a polyphenol and the proteins associated with the therapeutic chemical are binding targets of the polyphenol (see claim 16).
The reference application does not teach the elected vascular disease or condition. The reference application also does not teach the elected vascular disease associated polyphenol.
Han et al. teaches various immunoregulatory functions (e.g., antioxidant and anti-inflammatory) of rosmarinic acid, a phenolic compound (see e.g., p.2, left column, 3rd paragraph), have been reported, but very little is known regarding the multiple target of rosmarinic acid in therapeutic cardiovascular disease; therefore, there is a motive to explore the inhibition profile of rosmarinic acid on a huge panel of targets, also called “target deconvolution”, by using the computational or experimental method (see e.g., p. 2, left column, 3rd paragraph). Han et al. further teaches a study that used both in silico and in vivo experimental methods, which first predicted that rosmarinic acid could be an affective component for the treatment of cardiovascular disease using text mining, chemogenomic and chemometric approaches; then verified the effect and mechanism of rosmarinic acid in a rat model of Ischemia-reperfusion(I/R)-induced myocardial injury (see e.g., p. 2, right column, 1st paragraph); reading on the limitation of “identifying a vascular disease associated polyphenol, or a pharmaceutically acceptable salt thereof, as associated with the vascular disease or condition”. Han et al. further teaches a high-quality, comprehensive list of cardiovascular drug-target interactions and genetic phenotype-gene associations as well as other cardiovascular disease-related information are all compiled and integrated into the database CVDSP, then the target of rosmarinic acid identified by in-silico approach were compared with these 429 cardiovascular-disease-associated proteins to select the potential cardiovascular disease-related target of rosmarinic acid (see e.g., p. 2, right column, “target identification” and “comparison Potential Targets of RosA with Cardiovascular-Disease-Associated Proteins”). Han et al. further teaches in the in vivo method, rosmarinic acid attenuates I/R-induced myocardial injury through inhibiting inflammation and cardiomyocyte apoptosis by activating PPARγ and down-regulating NF-kB-mediated signaling pathway (see e.g., p. 7, right column, “Discussion”, 1st paragraph; abstract).
Gow et al. teaches a product, such as powder, that is particularly well suited for delivery in the oral cavity of human subjects, e.g., via a rapid dissolve tablet (see e.g., [0014]), that has unexpected benefit of treating or reducing heart conditions by, inter alia, ameliorating the effects of ischemia, improving blood circulation, resolving blood stasis, inhibiting platelet aggregation, and preventing restenosis (see e.g., [0001];[0008]). Gow et al. further teaches the dry flowable powder contains rosmarinic acid, borneol and a ginsenoside selected from group consisting of ginsenoside Rg1 and ginsenoside Rb1, wherein said rosmarinic acid component is between about 0.05% to about 85% of the sum of the masses of these three components (see e.g., claims 1-2 and 6; [0012]). Gow et al. further teaches the total weight of the active components in the form of a dry flowable powder in a single oral dosage is typically in the range of about 80 mg to about 600 mg (see e.g., [0023]). Please note the dry flowable powder taught Gow et al., which contains about 0.05% to about 85% of rosmarinic acid as one of the active components and about 80 mg to about 600 mg of the active components, is a pharmaceutical composition that contains an effective amount of rosmarinic acid.
The difference between the method of reference application and the claimed method is that the reference application does not expressly teach the polyphenol and the therapeutic chemical is rosmarinic acid, and does not expressly teach the disease associated with the polyphenol is ischemic injury; However, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application by selectively choose to incorporate rosmarinic acid as the therapeutic chemical and polyphenol for treating ischemic injury of the heart as the disease, because Han et al. teaches rosmarinic acid is a phenolic compound that is predicted to be effective for treating cardiovascular disease using text mining, chemogenomic and chemometric approaches, and said compound is verified and confirmed in a rat model of Ischemia-reperfusion(I/R)-induced myocardial injury; and Gow et al. teaches an oral product comprising rosmarinic acid useful for treating heart conditions by ameliorating the effects of ischemia. One would have reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the oral administration of an effective amount of rosmarinic acid can successfully treat ischemic heart condition in a subject diagnosed as having said condition, and therefore, said rosmarinic acid can successfully be identify as being associated with ischemic heart condition by using the method of reference application; and by treating ischemic heart condition, “promoting or supporting vascular health in a subject” would naturally flow from the fact that the heart condition with ischemia in the subject is being treated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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