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 .
Election/Restrictions
Claims 1-21 are pending.
Applicant’s election without traverse of Group II, cl. 1-5, 12-15, in the reply filed on 04/02/2026 is acknowledged.
Applicant’s election of species of ACSS2 and fibrosis in the reply filed on 04/02/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-11, 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/02/2026.
Claims 12-15 are examined here, along with species of ACSS2.
Priority
The benefit to provisional applications to 63/382,255 and 63/382,261, both filed on 11/03/2022, is recognized.
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 application, Application No. 63/382,255, fails to provide adequate support or enablement for the elected species ACSS2 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. However, ‘261 provides adequate support for the elected species of ACSS2 (Acetyl CoA synthetase 2). Thus, all examined claims will enjoy benefit of ‘261 filing date.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/19/2024 was filed before the mailing date of this first Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
Drawings of 03/06/2024 are in color. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The drawings are objected to for following reasons:
Fig. 33B (pg. 91) is mislabeled as Fig. 30B.
Fig. 46A-46G, 47A-47K, 48A-K, 49A-L, 50A-V also have designation of Fig. 1A-G, Fig. 2A-K, Fig. 3A-K, 4A-L, and 5A-V, (pg. 102-106) respectively. The deletion of the latter designation is required since there are already Fig. 1-5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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 following locations have a reference to http:// or https://: pg. 10, line 10; pg. 118, line 19; pg. 121, lines 10, 13, 19, 31; pg. 129, line 31.
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 12-15 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 “treating or ameliorating”, does not reasonably provide enablement for “prevention”. 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.
It should be made clear that, the enabling specification must teach those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. “Although not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." Vaeck, 947 F.2d at 495, 20 USPQ2d at 1444; Wands, 858 F.2d at 736-37, 8 USPQ2d at 1404; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (the first paragraph of section 112 requires that the scope of protection sought in a claim bear a reasonable correlation to the scope of enablement provided by the specification).” In re Wright (CAFC) 27 USPQ2d 1510 at 1513. Although a working example is not required to enable an invention, the skilled artisan must be able to practice the claimed invention without undue experimentation. See also, MPEP §2164.02, which states in part: The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
Claims 12-15 explicitly encompass preventing a chronic kidney disease, and/or one or more complications thereof in a subject. Looking to the prior art for guidance, a search of the prior art did not identify any methods which effectively prevent a chronic kidney disease, and/or one or more complications thereof in a subject. The specification also does not provide any working example demonstrating prevention of a chronic kidney disease, and/or one or more complications thereof in a subject. Therefore, given the lack of knowledge present in the prior art and the lack of guidance provided in the specification with respect to preventing a chronic kidney disease, and/or one or more complications thereof, further experimentation would be required. Considering that the additional experimentation would require de novo experimentation without a guarantee of success, and further considering that any positive results (i.e., successful prevention of a chronic kidney disease, and/or one or more complications thereof in a subject) would amount to a significant advancement in the state of the art, the additional experimentation required is considered undue.
Furthermore, in In re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here, where there is a relatively incomplete understanding in the biotechnological field involved, as described above, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims.
Therefore, it is appropriate to reject the claims under 35 USC 112(a) for not being enabled to their full scope. It is noted that amending the claims to, for example, a method of treating or ameliorating a chronic kidney disease, and/or one or more complications thereof in a subject in need thereof (i.e., remove “prevention” from the claims), would obviate this rejection.
Thus, claims 12-15 are rejected.
Claim Rejections - 35 USC § 102/103
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 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.
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 12-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ma and Lu (CN110327341, 10/15/2019, Machine translated on 06/17/2026, both Google-machine English translation and original foreign-language are provided), as evidenced by Lim (2014, International Journal of Nephrology and Renovascular Disease, 7, 361–381).
Regarding instant cl. 12-13, Ma discloses “Application of the ACSS2 inhibitor in preparation prevention and/or treatment medicine for treating diabetic nephropathy” (title, relevant to instant cl. 12). “Diabetic nephropathy is a significant cause of chronic kidney disease”, as evidenced by Lim, see Lim abstract. Ma discloses that “[t]he main pathological features of renal tissue in diabetic nephropathy are thickening of tubular and glomerular basement membranes, hypertrophy of renal tubules and glomeruli, progressive accumulation of extracellular matrix in the mesangial area, and tubulointerstitial fibrosis” (pg. 3, relevant to instant cl. 13). Ma discloses the “ACSS2 inhibitor of the present invention can be used as a new target for diabetic nephropathy intervention” (pg. 2, relevant to instant cl. 14-15). Ma discloses purchasing a biomolecule of ACSS2 inhibitor (pg. 3, and see par. 5 of untranslated pub. for structure of ACSS2 inhibitor, relevant to instant cl. 12). Fig. 1 discloses that “expression level of ACSS2 in the renal tissue of the two diabetic animal models was higher than that of the normal control” (pg. 5; pg. 12 of untranslated pub.). Fig. 5 discloses a western blot with increasing ACSS2 inhibitor dose demonstrating a decrease in collagen-1 expression in podocyte cells (pg. 15 of untranslated pub.) As evidenced by Lim, collagen-1 expression is indicative of fibrosis; see Lim indicating that “[a]ccumulation of interstitial macrophages correlated strongly with proteinuria, interstitial fibrosis” (pg. 366) and fibrosis is related to “interstitial collagen deposition” (pg. 371). Thus, cl. 12-15 are anticipated.
Since, the rejection is based on a machine translation disclosure, there is uncertainty whether Ma explicitly discloses administering the inhibitor to a subject (anticipates the claims) or suggests administration (renders the claims obvious). Regarding the anticipation stance, Ma indicates 1) the ACSS2 inhibitor "used as a new target for diabetic nephropathy intervention;" see above, and cl. 8; 2) similarly in claim 3 of Ma, "the ACSS2 inhibitor is used to prevent and/or treat diabetic nephropathy" statement; 3) the language of "application of an ACSS2 inhibitor" throughout the disclosure, the term “application” can be broadly interpreted to encompass administer; and 4) based on the discussion of the Chinese population affected (11.6% of adults with diabetes, pg. 1) and discussion of "Mogensen staging method" of distinguishing DN (pg. 2, 1st full paragraph), it is interpreted to encompass treating a human subject. Thus, due to Ma's use of noted language above, Ma expressly teaches administration to a subject in need, wherein the subject is human (thus anticipates the claims). However, the same language and the disclosure overall also suggests to a skilled artisan of administering of the inhibitor to a subject in need, wherein the subject is human (renders the claims obvious). Thus claims 12-15 are rejected under 35 USC 102/103.
Allowable Subject Matter
No claim allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEYUR A. VYAS whose telephone number is (571)272-0924. The examiner can normally be reached M-F 9am - 4 pm (EST).
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/KEYUR A VYAS/Examiner, Art Unit 1637
/Soren Harward/Primary Examiner, TC 1600
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