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
This application, filed 04/27/2023 is a National Stage entry of PCT/JP2021/040137, International Filing Date: 10/29/2021. PCT/JP2021/040137 claims foreign priority to 2020-182813, filed 10/30/2020. A certified copy of the foreign priority application is of record.
Status of Claims
Claims 1-2, 6-8, 10, 14-15, 18-19, and 24-26 are pending as of the response filed on 10/29/25. Claims 3-5, 9, 11-13, 16-17, 20-23, and 27-30 have been canceled.
Applicant’s election without traverse of invention I, claims 1-2, 6-8, 10, 18-19, and 24; and the species shown in the reply filed on 10/29/25 is acknowledged:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
.
Applicants have stated claims 1-2, 6-8, 10, 18-19, and 24 of the elected invention read on the elected species. The elected species is included within formula (I), having A=-CHR7-; R7=-CH2-phenyl substituted with -OP(=O)(OH)2; G=-NR6-; R6=methyl; R1=-Ra-R10; Ra=methyl; R10=quinoline; R2=-W21-W22-Rb-R20; W21=-(CO)-; W22=-NH-; Rb=methyl; R20=phenyl; R3=methyl.
Claims 14-15 and 25-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/29/25.
Claims 1-2, 6-8, 10, 18-19, and 24 were examined and are rejected.
Claim Rejections-35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8, 18-19, and 24 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.
Claims 8 and 18 depend directly from claim 1 and refer to “the composition”. However, claim 1 doesn’t recite a composition. There is insufficient antecedent basis for this limitation in the claims, and the claims are indefinite. Claim 19 is rejected for depending from claim 18, and not providing further clarity.
Claim 24 depends from claim 1 and refers to “substance, or agent”, however, claim 1 doesn’t recite the terms “substance” or “agent”. There is insufficient antecedent basis for this limitation in the claims.
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.
Claim 19 is 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 19 depends from claim 18, however, claim 19 recites checking the status of one of the recited genes as alternative, as indicated by “and/or” before “wherein the sarcopenia related disease, disorder, or symptom…”. This is improper, since claim 18 requires verifying the status of one of the recited genes. 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 § 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) 1-2, 6-8, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kouji, WO 2014061823 A1, publ. 4/24/2014, cited in an IDS.
Kouji discloses a method for treating type I and II diabetes by administering an inhibitor of beta-catenin that is possesses an alpha-helix mimetic structure, and a pharmaceutical composition comprising the above (title & abstract; para [0014]). Kouji discloses treatment of diabetes by administering to a subject in need thereof an effective amount of an alpha helix mimetic beta-catenin inhibitor (para [0035]). Oral administration is disclosed (para [0059]). Kouji discloses administering compound A, also known as 4-(((6S,9S,9aS)-1-(benzylcarbamoyl)-2,9-dimethyl-4,7-dioxo-8-(quinolin-8-ylmethyl)octahydro-1H-pyrazino[2,1-c][1,2,4]triazin-6-yl)methyl)phenyl dihydrogen phosphate or OK-1 as an inhibitor of the Wnt signaling pathway, which meets the elected species, to patients with type II diabetes, who were also administered metformin HCl (para [0076-0088]). Type II diabetes is included as a sarcopenia related energy tmetabolism disorder, as evidenced by Applicants’ specification (see para [0020]). Therefore, Kouji meets the limitations of the instant claims, and anticipates the claims.
Claim(s) 1-2, 10, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishikawa et. al., Int. J. Molecular Sci., vol. 19, 3103 (1-12), publ. 2018 as evidenced by Pacifico et. al., Frontiers in Pediatrics, vol. 8, pp. 1-8, publ. 4/15/2020; and Kleszcz et. al., Cellular Oncology, vol. 42, pp. 505-520, publ. 2019.
Although a species election was made, this rejection is made over the broader scope of formula (I) to provide compact prosecution.
Nishikawa discloses the compound PRI-724 as a CBP/beta-catenin inhibitor, was administered for reducing liver fibrosis in mice, and that administration of this compound induced expression of MMP-2 (p. 6, see both para under PRI-724). PRI-724 has the following chemical structure, as evidenced by Kleszcz (p. 510, see Fig. 3):
PNG
media_image2.png
200
400
media_image2.png
Greyscale
. Nishikawa further discloses administration of PRI-724 in therapeutically effective doses for the treatment of advanced solid tumors (pp. 7-8, bridging para 4.1). Liver fibrosis is a sarcopenia related disease, as evidenced by Pacifico (p. 1, all para; p. 4, right col., beginning with Discussion section-p. 5, left col., 2nd para). Therefore, Nishikawa discloses treatment of sarcopenia related diseases, liver fibrosis and solid tumors, by administering the compound of Chemical Formula 50 as recited by instant claim 1. Nishikawa further discloses confirming modulation of at least one gene recited by the claims, Mmp-2. Nishikawa therefore anticipates the claims.
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.
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kouji, WO 2014061823 A1, publ. 4/24/2014, in view of Lum et. al., WO 2014186450 A2, publ. 11/20/2014.
The teachings of Kouji as discussed previously are incorporated herein. Although Kouji teaches treatment of diabetes by administering the beta-catenin/Wnt inhibitor, 4-(((6S,9S,9aS)-1-(benzylcarbamoyl)-2,9-dimethyl-4,7-dioxo-8-(quinolin-8-ylmethyl)octahydro-1H-pyrazino[2,1-c][1,2,4]triazin-6-yl)methyl)phenyl dihydrogen phosphate, treatment of osteoporosis as recited by claim 10 is not explicitly taught or suggested.
Lum teaches inhibitors of the Wnt signaling pathway for the treatment of diseases such as cancer, type II diabetes, and osteoporosis; in particular, Lum teaches slowing the onset and/or progression of osteoporosis (title & abstract; p. 7, line 26-p. 8, line 6).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated osteoporosis as recited by instant claim 10 by administering the elected species, 4-(((6S,9S,9aS)-1-(benzylcarbamoyl)-2,9-dimethyl-4,7-dioxo-8-(quinolin-8-ylmethyl)octahydro-1H-pyrazino[2,1-c][1,2,4]triazin-6-yl)methyl)phenyl dihydrogen phosphate, in consideration of the combined teachings of Kouji and Lum. Kouji teaches the elected species as a beta catenin/Wnt inhibitor, while Lum teaches Wnt inhibition is therapeutically beneficial for the treatment of osteoporosis, and particularly for slowing the onset and/or progression of this disease. As such, one of ordinary skill in the art would have been motivated to have treated the sarcopenia related condition, osteoporosis, and more particularly slowed the onset or progression of osteoporosis by administering the elected Wnt inhibitor, 4-(((6S,9S,9aS)-1-(benzylcarbamoyl)-2,9-dimethyl-4,7-dioxo-8-(quinolin-8-ylmethyl)octahydro-1H-pyrazino[2,1-c][1,2,4]triazin-6-yl)methyl)phenyl dihydrogen phosphate, and have had a reasonable expectation of success.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim refers to more than one structural formula for the same chemical structure. For instance, formula (I) is also referred to as [Chemical Formula 39], and formula (II) is also referred to as [Chemical Formula 40]. For the sake of clarity and to avoid confusion it is suggested that each chemical formula be associated with a single chemical structure. Appropriate correction is required.
Claim 1 also includes open parenthesis within a description of a variable without closing parenthesis, and a closed bracket without an open bracket. For example, R1 is -Ra-R10 is followed by an open parenthesis, but doesn’t include a closed parenthesis at the conclusion of the definition for R1. The definition of R3J has a closed bracket at the end, but doesn’t include an open bracket.
Objection to Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See para [0021], [0256], [0262], [0338], [0370] of 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.
Information Disclosure Statements
The IDS filed on 4/27/23 and 12/17/24 have been considered.
Correspondence
Claims 1-2, 6-8, 10, 18-19, and 24 were examined and are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH PIHONAK/Primary Examiner, Art Unit 1627