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 .
Priority
The instant application is a 371 National Stage Entry of PCT/KR2023/001123 filed on January 25, 2023 which claims priority to foreign application Nos. KR10-2023-0009492 (filed January 25, 2023), KR10-2023-0009490 (filed January 25, 2023), KR10-2022-0009015 (filed January 21, 2022), and KR10-2022-0009014 (filed January 21, 2022).
No English Translation
Examiner notes that no certified translation of the Foreign Applications KR10-2023-0009492 (filed January 25, 2023), KR10-2023-0009490 (filed January 25, 2023), KR10-2022-0009015 (filed January 21, 2022), or KR10-2022-0009014 (filed January 21, 2022) has been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required (see 35 U.S.C. 119(b)(3), 37 CFR 1.55(g)(1)-(4)). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file.
Information Disclosure Statement
The information disclosure statements filed on July 19, 2024 and April 29, 2026 have been considered.
Status of Claims
Acknowledgement is made of original (1-4, 6-8, 10-15, 17-18), amended (9, 16), cancelled (5) claims filed on October 4, 2024. Claims 1-4, 6-18 are pending in instant application.
Claim Objections
Claims 1, 6, 9, 15 are objected to because of the following informalities:
Claims 1, 6, 9 recite “A method for preventing or treating of cancer” (emphasis added) but should read “A method of treating or preventing cancer”, omitting “of”.
Claim 15 recites “The method of claim 9, wherein the composition increases Faecalibacterium sp. strains and decreasing Proteobacteria Phylum strains” (emphasis added) which has mixed tenses and should read “The method of claim 9, wherein the composition increases Faecalibacterium sp. strains and decreases Proteobacteria Phylum strains”
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 6-18, 16 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 claims 9-18, Claim 9 is drawn to a method for preventing or treating cancer comprising administering a composition, but does not specify a subject or patient population. Claims 10-14, 16-18 also do not specify what is receiving the composition. Claim 15 says “in cancer patient groups” which is unclear, are multiple subjects receiving the composition? Is the subject a single cancer patient?
Regarding claims 6-8, the term “improved” in claim is a relative term which renders the claim indefinite. The term “improved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As a consequence, it is unclear who the patient population is. For the purposes of applying, the patient population is assumed to be anyone with cancer.
Regarding claim 16, claim 9 recites “comprising administering a composition comprising butyrate or a microbiome as an active ingredient”. Claim 16, which depends from claim 9, further recites the same active step, “comprising administering a composition including butyrate or a microbiome as an active ingredient to a subject”. It is unclear if this is a second administration, a typographical error, or an unfinished limitation. For the purposes of applying art, it is assumed to be a typographical error and ignored.
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.
Claim(s) 9-13, 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et. al.1
Regarding claim 9, 13 and a method of treating cancer, Liu teaches butyrate is a known anti-cancer treatment (see Liu at p. 23 left col. "Butyrate functions as an HDAC inhibitor"). Liu teaches the anticancer activities of butyrate include inhibition of cell proliferation, induction of cell differentiation or apoptosis, and induction or repression of gene expression (see id). Liu teaches as an HDAC inhibitor, butyrate regulates cytokine expression in T cells (see id). An artisan would appreciate that a known anticancer treatment would been to be administered to a subject with cancer to perform its known function.
Regarding claims 10-12, 16-18, the instant specification shows that it is the administration of butyrate that results in these limitations (see instant spec. at p. 33 lines 15-20). Administering butyrate resulted in decreased expression of PD-L1 and IL-10 in macrophages (see id), reading on “inhibiting expression of PD-L1 and IL-10” (see claims 11, 17) and “wherein the APC are macrophages” (see claims 11-12, 17-18).
Accordingly, these functional limitations are the result of the active step of administering butyrate to a subject with cancer, whether or not the art was aware of it at the time.
Claim(s) 9-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0029871 A1 to Kovarik et. al.2
Regarding claims 9, 13-14 and a method of treating cancer, Kovarik teaches administering a composition comprising Faecalibacterium prausnitzii to treat colorectal cancer (see Kovarik claim 1).
Kovarik teaches that the administration of the composition results in increased butyrate production (see Kovarik at claim 7).
Regarding claim 15, Kovarik teaches wherein administering the composition reduces pathogenic resident microbes in the gut (see Kovarik at claim 13). Kovarik teaches lowering the amount of gut microbiomes of Proteobacteria (see Kovarik at p. 13 ¶[0090]).
Regarding claims 10-12, 16-18, the instant specification shows that it is the administration of butyrate that results in these limitations (see instant spec. at p. 33 lines 15-20).
Administering butyrate resulted in decreased expression of PD-L1 and IL-10 in macrophages (see id), reading on “inhibiting expression of PD-L1 and IL-10” (see claims 11, 17) and “wherein the APC are macrophages” (see claims 11-12, 17-18).
By practicing the method taught by the prior art (administering Faecalibacterium prausnitzii to treat colorectal cancer, which produces butyrate, would expose a colorectal patient to butyrate), an artisan would also be performing the claimed functional limitations.
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.
Claim(s) 1-4, 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Morain et. al.3
Regarding claims 1, 4, 6-8 and treating cancer, Morain teaches the instantly claimed Chemical Formula 1 as shown below (see Morain at p. 733 Fig 1) has activity against 5-HT3 receptors in N1E-115 homogenates, neuroblastoma cells (see Morain at p. 737 Table 2).
Morain Formula
Instant Chemical Formula 1
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134
314
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Greyscale
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108
244
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32
578
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32
578
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The limitations of claims 2-3 are understood to be results of the active step of administering a compound of Chemical Formula I to a subject.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
It would have been obvious to an artisan to administer 2,4-difluoro PBG to a neuroblastoma patient because the prior art teaches it has anti-neuroblastoma properties (as taught by Morain).
Furthermore, it is well-within the ordinary skill in art to take a compound with anticancer properties and formulate for administration to a patient with said cancer.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim(s) 1-4, 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150126518 A1 to Kim et. al.4
Regarding claim 1, 6 and a compound of Chemical Formula 1, Kim teaches compound of Chemical Formula 7 (see Kim at claim 1) such as Example 59, also known as CAS# 101252-14-6 (see Kim at claim 9 and p. 21).
Kim
Chemical Formula 7
Kim Example 59
CAS# 101252-14-6
Instant Chemical Formula 1
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74
232
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156
252
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108
244
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Regarding claim 1 and a composition, Kim teaches compositions comprising the disclosed compounds (see Kim claim 11).
Regarding claims 1, 4, 6-8 and a method of treating cancer, Kim teaches a method of preventing or treating cancer, including uterine cancer, breast cancer, stomach cancer, brain cancer, rectal cancer, colorectal cancer, lung cancer, skin cancer, blood cancer, and liver cancer (see Kim at claims 12-13).
Regarding claims 1-3 and inhibiting cancer cell growth, increasing apoptosis or inhibiting PD-L1 expression, Kim teaches the composition inhibit cancer cell proliferation (see Kim at p. 9 ¶[0185]). The limitations of claims 2-3 are understood to be results of the active step of administering a compound of Chemical Formula I to a subject.
The prior art differs from the instant claims as follows: While Kim teaches CAS# 101252-14-6 for treating cancer, CAS# 101252-14-6 has chlorine substituents in lie of instant Chemical Formula 1’s fluorine.
However,
Kim teaches the R14 substituents of the phenyl biguanide core may be halogens, a recognized class in the art.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.06(II), a prima facie case of obviousness exists for substituting equivalents known for the same purpose. Halogens are a well-known, art-recognized class of functional equivalents which the prior art acknowledges (“wherein R14 is independently selected from…halogen”).
Furthermore, it is well-within the ordinary skill in art to incorporate one halogen in lieu of another.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim(s) 9-14, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dikeocha et. al.5
The Examiner refers Applicant to the No English Translation section above.
Regarding claims 9, 14 and a method of treating cancer, Dakeocha teaches Faecalibacterium prausnitzii produces butyrate in the gut and is known to treat colorectal cancer, and suggests incorporation as a probiotic supplement for the prevention and treatment of colorectal cancer (see Dakeocha at Abstract).
Regarding claims 10-12, 16-18, the instant specification shows that it is the administration of butyrate that results in these limitations (see instant spec. at p. 33 lines 15-20).
Administering butyrate resulted in decreased expression of PD-L1 and IL-10 in macrophages (see id), reading on “inhibiting expression of PD-L1 and IL-10” (see claims 11, 17) and “wherein the APC are macrophages” (see claims 11-12, 17-18).
By practicing the method taught by the prior art (administering Faecalibacterium prausnitzii, which produces butyrate, which treats colorectal cancer), an artisan would also be performing the claimed functional limitations.
Conclusion
Claims 1, 6, 9, 15 are objected to.
Claims 1-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Liu et. al. "Butyrate: A Double-Edged Sword for Health?" Adv Nutr. 2018 Feb 9;9(1):21–29. DOI: 10.1093/advances/nmx009. Hereinafter Liu.
2 Published January 31, 2019. Hereinafter Kovarik.
3 Morain et. al. "Biguanide Derivatives: Agonist Pharmacology at 5-Hydroxytryptamine Type 3Receptors in Vitro" Molecular Pharmacology 1994, 46, 4, 732-742. ISSN: 0026-895X. Hereinafter Morain.
4 Published May 7, 2015. Hereinafter Kim.
5 Dikeocha et. al. "Faecalibacterium prausnitzii Ameliorates Colorectal Tumorigenesis and Suppresses Proliferation of HCT116 Colorectal Cancer Cells" Biomedicines 2022, 10, 1128. DOI: 10.3390/biomedicines10051128. Published May 13, 2022. Hereinafter Dikeocha.
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