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 .
Status of Claims
Claims 1-7 are pending in the instant application.
Priority
Acknowledgement is made of Applicant’s claim for foreign priority based on the JP2022-018618 application filed in Japan on February 9th, 2022.
Information Disclosure Statement
The Information Disclosure Statements filed on August 5th, 2024 and March 27th, 2026 have been fully considered by the examiner, except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
Drawings
Acknowledgement is made of the drawings received August 5th, 2024. These drawings are acceptable.
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 1-5 and 7 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 5-(3,5-dihydroxyphenyl)-γ-valerolactone or a salt thereof, does not reasonably provide enablement for any conjugate of 5-(3,5-dihydroxyphenyl)-γ-valerolactone. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a cancer-cell proliferation inhibitor comprising at least one of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof and an immune checkpoint inhibitor. The invention is also drawn to a method of use thereof.
Breadth of the invention:
The scope of the claimed invention is broad, as the recitation of a conjugate of 5-(3,5-dihydroxyphenyl)-γ-valerolactone encompasses a myriad of compounds with distinct structures readily envisaged by a person having ordinary skill in the art.
State of the prior art and predictability in the art:
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F. 2d 833, 839, 166, USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Beginning at Page 7, Paragraph 0018 of the instant specification, Applicant contemplates sulfate conjugates of 5-(3,5-dihydroxyphenyl)-γ-valerolactone. At Paragraph 0019, Applicant states sulfate conjugates can be obtained via sulfonation of at least one hydroxy group. No guidance is provided as to which hydroxy group(s) or how many hydroxy groups should be sulfonated, nor is any motivation provided such that a person having ordinary skill in the art would readily understand the benefit of generating such a conjugate within the context of the instant invention.
Beginning at Page 8, Paragraph 0020, Applicant contemplates glucuronic acid conjugates of 5-(3,5-dihydroxyphenyl)-γ-valerolactone. Applicant states these conjugates can be obtained via substituting at least one hydroxy group for the substituent containing glucuronic acid or salt of glucuronic acid. No guidance is provides as to which hydroxy group(s) or how many hydroxy groups should be substituted, nor is any motivation provided such that a person having ordinary skill in the art would readily understand the benefit of generating such a conjugate within the context of the instant invention.
Beyond these non-limiting examples, a sufficient definition of the term “conjugate” has not been provided such that a person having ordinary skill in the art would readily understand how to make and use the plurality of conjugates of 5-(3,5-dihydroxyphenyl)-γ-valerolactone readily envisaged, nor would it be readily understood based on the instant disclosure the benefit of generating a conjugate of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, rather than utilizing 5-(3,5-dihydroxyphenyl)-γ-valerolactone or a salt thereof. Further, these non-limiting examples are insufficient to enable the breadth of the scope encompassed by the broadly recited “conjugate”.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims.” Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP 608.01(p).
MPEP § 2164.01 (a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F. 2d 1557, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here that Applicant is not enabling for the broadly claimed conjugates of 5-(3,5-dihydroxyphenyl)-γ-valerolactone.
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.
Claim 6 is 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 6 is drawn to a method for enhancing the effect of an immune checkpoint inhibitor, but fails to set forth any steps involved in the process thereof. Claim 6 recites “wherein anticancer effect of the immune checkpoint inhibitor is enhanced by using the immune checkpoint inhibitor and a cancer-cell proliferation inhibitor…”, but does not positively recite any steps by which to practice “using” as recited.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 is drawn to a medicine for inhibiting cancer-cell proliferation containing the cancer-cell proliferation inhibitor according to Claim 1. The recitation of “A medicine for inhibiting cancer-cell proliferation”, however, is merely a statement of intended use, and therefore does not further limit Claim 1, from which it depends. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” That is the case here, as the recitation of “A medicine for inhibiting cancer-cell proliferation” in the preamble does not further limit the cancer-cell proliferation inhibitor as recited at Claim 1.
Claim 5 is drawn to a supplement for inhibiting cancer-cell proliferation containing the cancer-cell proliferation inhibitor according to Claim 1. The recitation of “A supplement for inhibiting cancer-cell proliferation containing the cancer-cell proliferation inhibitor”, however, is merely a statement of intended use, and therefore does not further limit Claim 1, from which it depends. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” That is the case here, as the recitation of “A supplement for inhibiting cancer-cell proliferation” in the preamble does not further limit the cancer-cell p0roliferaiton inhibitor as recited at Claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 6 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 although the Claim is nominally drawn to a method, as recited, the method is drawn to “using the immune checkpoint inhibitor and a cancer-cell proliferation inhibitor…” Therefore, the claim is directed to non-statutory subject matter, as the claim is drawn to the use of an immune checkpoint inhibitor and cancer-cell proliferation inhibitor. Per MPEP 2173.05(q), “"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").”
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et. al. (“Green Tea Catechin Metabolites Exert Immunoregulatory Effects on CD4+ T Cell and Natural Killer Cell Activities”, Journal of Agricultural and Food Chemistry, 2016; cited on Applicant’s Information Disclosure Statement filed March 27th, 2026; hereinafter referred to as Kim).
Claim 7 is drawn to a cancer-cell proliferation inhibition effect enhancer comprising at least one of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof. The recitation of “A cancer-cell proliferation inhibition effect enhancer” is a statement of intended use and carries no patentable weight. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” That is the case here, as the intended use does not provide any structural limitations to the claimed composition of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof.
It is noted at Paragraph 0036 of the instant specification that (R)-5-(3,5-dihydroxyphenyl)-γ-valerolactone is referred to as EGC-M5.
At Page 3592, Figure 1A, Kim teaches the compound EGC-M5:
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Therefore, Kim anticipates the limitations as instantly recited at Claim 7.
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 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over by Kim et. al. (“Green Tea Catechin Metabolites Exert Immunoregulatory Effects on CD4+ T Cell and Natural Killer Cell Activities”, Journal of Agricultural and Food Chemistry, 2016; cited on Applicant’s Information Disclosure Statement filed March 27th, 2026; hereinafter referred to as Kim) in view of Khan et. al., (”NK Cell-Based Immune Checkpoint Inhibition”, Frontiers in Immunology, 2020; cited on Applicant’s Information Disclosure Statement filed March 27th, 2026; hereinafter referred to as Khan).
Claim 1 is drawn to a cancer-cell proliferation inhibitor comprising an immune checkpoint inhibitor and at least one of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof. The recitation of “A cancer-cell proliferation inhibitor” is a statement of intended use and carries no patentable weight. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” That is the case here, as the intended use does not provide any structural limitations to the claimed combination of an immune checkpoint inhibitor and at least one of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof.
As stated above, it is noted at Paragraph 0036 of the instant specification that (R)-5-(3,5-dihydroxyphenyl)-γ-valerolactone is referred to as EGC-M5.
As stated above, at Page 3592, Figure 1A, Kim teaches the compound EGC-M5:
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At the abstract, Kim teaches EGC-M5 increased the activity of CD4+ T cells and enhanced the cytotoxic activity of NK cells in vivo.
Kim does not teach a combination of EGC-M5 with an immune checkpoint inhibitor.
At Page 20, under Conclusions, Khan states “anti-PD-1 and anti-PD-L1 inhibitors have also been shown to enhance NK cell-mediated cytotoxicity. At the Abstract, Khan suggests “the combination of immune checkpoint inhibition with other NK cell cytotoxicity restoration strategies could also strengthen its efficacy as an antitumor therapy.”
At Page 18, beginning at the last paragraph of the first column, Khan teaches an anti-CTLA-4 antibody, as recited at Claim 3, may relieve suppressed NK cells in an indirect manner.
At Page 19, Second Paragraph of the Second Column, Khan teaches an anti-PD-1 antibody, as recited at Claims 3 and 4, enhanced NK cell-mediated cytotoxicity.
Applying KSR exemplary rationale C, it would have been prima facie obvious to a person having ordinary skill in the art to combine EGC-M5 with an immune checkpoint inhibitor, as it was known in the art at the time of filing that both immune checkpoint inhibitors, such as an anti-PD-1 antibodies, and EGC-M5 were both known to enhance NK cell cytotoxicity. Per MPEP 2144.06, I., “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Further, a person having ordinary skill in the art would have been motivated by Khan’s suggestion noted above that a combination of known NK cell-mediated cytotoxicity enhancement could strengthen the efficacy.
As noted above, Claims 4 and 5 do not further limit Claim 1, from which they depend. Therefore, Claims 4 and 5 are additionally obviated by Kim in view of Khan.
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.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of copending Application No. 18/723,053 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to a composition comprising 5-(3,5-dihydroxyphenyl)-γ-valerolactone, or a salt or conjugate thereof.
Instant Claim 7 is drawn to a cancer-cell proliferation inhibition effect enhancer comprising at least one of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof. The recitation of “A cancer-cell proliferation inhibition effect enhancer” is a statement of intended use and carries no patentable weight. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” That is the case here, as the intended use does not provide any structural limitations to the claimed composition of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof.
Similarly, Claim 1 of the reference application is drawn to a brain function improving agent for preventing onset of, treating, and/or ameliorating central nervous diseases containing at least one of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof. Further, Claim 9 of the reference application is drawn to an agent for enhancing acetylcholine release or increasing extracellular acetylcholine in the brain containing of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof. Just as in instant Claim 7, the recitation of “A brain function improving agent …” and “An agent for enhancing acetylcholine release…” in reference Claims 1 and 9, respectively, do not carry patentable weight, as they are statements of intended use and do not alter the structure of of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof. Therefore, instant Claim 7 and reference Claims 1 and 9 are all drawn to of 5-(3,5-dihydroxyphenyl)-γ-valerolactone, a salt thereof, or a conjugate thereof, and therefore are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-7 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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