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 .
Detailed Action
This application is a national stage application of PCT/CN2022/120315, filed September 21, 2022, which claims benefit of foreign application CN202111116447.1, filed September 23, 2021. Claims 1-12 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted March 25, 2024, is acknowledged wherein claims 1-7, 11, and 12 are amended.
Drawings
The drawings are objected to because figures 2 and 3 contain text which is of low resolution and therefore difficult to read. Specifically, the labels along the y-axes of these graphs should be of higher resolution. 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.
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 1-6 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 a method of treating specific metabolic disorders such as hyperlipidemia, atherosclerosis, nonalcoholic steatohepatitis, and related conditions, does not reasonably provide enablement for methods of treating any liver disorder whatsoever. 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.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth 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.
Nature of the invention: claims 1 and 6 are directed to a method of treating a disorder in a subject. In order to be enabled for treating the full scope of the disorder, one skilled in the art must reasonably be able to treat diseases representative of the full scope of the claimed genus based on the instructions provided in the disclosure.
The state of the prior art: It is well known in the prior art that there exist a wide variety of diseases based on either inborn or acquired metabolic defects. For example, forms of metabolic disorders described in the art can include dysregulation of cholesterol and glucose homeostasis. (Rottiers et al., included with PTO-892) Golden et al., (Reference included with PTO-892) describes metabolic disorders as including hypothalamic, thyroid disorders, bone metabolic disorders, diabetes and associated disorders, dyslipidemia, and obesity. Lake (Reference included with PTO-892) describes congenital metabolic disorders including lysosomal storage disorders, (p. 739 table 14.1) mucopolysaccharidoses, (p. 742 table 14.4) and glycogen storage diseases. (p. p. 754 table 14.7) In all of these cases, different diseases are caused by disruptions in specific metabolic enzymes which are not necessarily all related to one another. Saudubray et al. (Reference included with PTO-892) further describes a wide variety of other metabolic disorders including disorders causing intoxification with particular compounds, disorders of energy metabolism, and disorders of complex molecules such as lysosomal, peroxisomal, glycosylation, and cholesterol synthesis disorders.
Overall, the art indicates that there exist many different and unrelated conditions that affect metabolic processes. Nothing in the art would suggest a single common mechanism or method of treatment encompassing all metabolic disorders.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: Generally, metabolic systems are complex, and many different factors can affect a particular metabolic pathway. Given the wide number of metabolic disorders from which a subject could suffer, the ability of a particular intervention to treat all of these conditions is highly unpredictable.
The Breadth of the claims: The claimed invention is very broad, encompassing a wide variety of subjects suffering from unrelated conditions, as described under the state of the art.
The amount of direction or guidance presented: Applicant’s disclosure specifically describes the invention as a method of treating cholesterolemia, non-alcoholic steatohepatitis, liver fibrosis, and atherosclerosis, which are a narrow range of metabolic disorders related to energy and cholesterol metabolism. (p. 1, summary) The disclosure specifically describes the claimed compounds as activators of AMPK and inhibitors of ATP citrate lyase, (ACLY) which are the bases for their metabolic effects. (p. 8, “Beneficial effects”) While these effects are suggestive of methods of treating certain metabolic disorders, such as diabetes and hypercholesterolemia, they by no means suggest any ability to treat a broader scope of metabolic disorders, such as bone metabolic disorders or lysosomal storage diseases.
The presence or absence of working examples: Examples 3-4 on pp. 23-26 describe treatment of hyperlipidemia, hypercholesterolemia, and nonalcoholic steatohepatitis in animal subjects, but do not give any evidence of the ability of this treatment to affect other metabolic disorders.
The quantity of experimentation necessary: In order to practice the full claimed scope of the invention for all possible metabolic disorders, one skilled in the art would have to develop treatments using compounds having the claimed structure for disorders representing all possible metabolic disorders. As discussed above, neither the state of the art nor the present disclosure suggest that such a thing is possible, given the wide variety of different metabolic disorders recognized in the art and the fairly specific indications for which the presently claimed compounds are actually described as being beneficial. Therefore one skilled in the art would have to undertake an extensive program of unpredictable research in order to practice the claimed methods, with no reasonable expectation of success.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims and the narrowness of the guidance provided, Applicants fail to provide information sufficient to practice the claimed invention for methods of treating all possible metabolic disorders.
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.
Claims 1-4, 6, 8, 9, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nan et al. (US pre-grant publication 2019/0039989, cited in PTO-892)
Independent claim 8 claims a compound having a particular formula (I). Independent claim 1 claims a method for treating a metabolic disorder comprising administering such a compound to a subject in need thereof.
Nan et al. discloses compounds having a formula which encompasses the same formula (I) appearing in the present claims. (pp. 1-2 paragraphs 11-21) More specific examples falling within the scope of formula (I) are pictured on pp. 3-5. Regarding claim 1, p. 8 paragraph 74 of Nan et al. describes methods of using these compounds to treat obesity and diabetes, which are metabolic disorders.
Regarding claims 2-4, 6, 9, and 11, specific compounds described by Nan et al. such as compound 1 on p. 3 and compounds 27 and 29 on p. 5 anticipate the specific structures recited in these claims. Regarding claim 12, p. 9 paragraph 75 of Nan describes pharmaceutical compositions comprising these compounds.
For these reasons Nan et al. anticipates the present 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nan et al. as applied to claims 1-4, 6, 8, 9, 11, and 12 above, and further in view of Chalasani et al. (Reference included with PTO-892)
The disclosure of Nan et al. is discussed above. Nan et al. does not disclose a method of treating a subject suffering from one of the specific diseases such as nonalcoholic steatohepatitis (NASH) and liver fibrosis, recited in claim 7. However, Chalasani et al. discloses that nonalcoholic fatty liver disease (NAFLD) includes nonalcoholic steatohepatitis and can proceed to liver fibrosis. (p. 329 right column last paragraph) Obesity and type 2 diabetes mellitus are disclosed to be significant risk factors for these conditions. (p. 331 left column third-fifth paragraphs, also table 3) Weight loss is described as being a key to improvement in NASH. (p. 338 left column) It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapeutic compounds described by Nan et al. to an obese or diabetic subject suffering from nonalcoholic steatohepatitis or liver fibrosis. One of ordinary skill in the art would have seen the disclosure of Chalasani et al. as suggesting that treating obesity or diabetes with these compounds would also improve NASH or liver fibrosis as well.
Therefore the invention taken as a whole is prima facie obvious.
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Nan et al. as applied to claims 1-4, 6, 8, 9, 11, and 12 above, and further in view of Rui. (Foreign publication CN110054562, Reference included with PTO-1449)
The disclosure of Nan et al. is discussed above. Nan et al. does not specifically disclose deuterated derivatives of compounds of formula (I). However, Rui discloses deuterium substituted pentadecanedioic acid compounds which have improved pharmacokinetic properties compared to the parent compounds. (pp. 7-8 paragraphs 11-20)
It would have been obvious to one of ordinary skill in the art at the time of the invention to produce deuterated derivatives of the compounds described by Nan et al. One of ordinary skill in the art would have seen the disclosure of Rui as suggesting that deuteration would improve the pharmacokinetic propertied of this compound.
Therefore the invention taken as a whole is prima facie obvious.
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, 6, 8, 9, 11, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, and 8 of U.S. Patent No. 10414713. (Cited in PTO-892, herein referred to as ‘713) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘713 anticipate the present claims.
Specifically, claim 1 of ‘713 claims a compound having a formula (II) which anticipates the formula (I) in present claim 8. Dependent claim 2 claims a number of structures which anticipate the specific list in present claims 9 and 11. Claims 7 and 8 of ‘713 further claim pharmaceutical compositions and method for treating diabetes and obesity using these compounds. Since diabetes and obesity are metabolic diseases, these claims anticipate present claims 1, 2, 6, and 12.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, and 8 of U.S. Patent No. 10414713. (Cited in PTO-892, herein referred to as ‘713) in view of Chalasani et al. (Reference included with PTO-892)
The claims of ‘713 are discussed above. The claims of ‘713 do not specifically claim a method of treating nonalcoholic steatohepatitis or liver fibrosis. However, Chalasani et al. discloses that nonalcoholic fatty liver disease (NAFLD) includes nonalcoholic steatohepatitis and can proceed to liver fibrosis. (p. 329 right column last paragraph) Obesity and type 2 diabetes mellitus are disclosed to be significant risk factors for these conditions. (p. 331 left column third-fifth paragraphs, also table 3) Weight loss is described as being a key to improvement in NASH. (p. 338 left column) It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapeutic composition claimed by ‘713 to an obese or diabetic subject suffering from nonalcoholic steatohepatitis or liver fibrosis. One of ordinary skill in the art would have seen the disclosure of Chalasani et al. as suggesting that treating obesity or diabetes with these compounds would also improve NASH or liver fibrosis as well.
Claims 5 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, and 8 of U.S. Patent No. 10414713. (Cited in PTO-892, herein referred to as ‘713) in view of Rui. (Foreign publication CN110054562, Reference included with PTO-1449)
The claims of ‘713 are discussed above. The claims of ‘713 do not specifically claim a deuterated compound. However, Rui discloses deuterium substituted pentadecanedioic acid compounds which have improved pharmacokinetic properties compared to the parent compounds. (pp. 7-8 paragraphs 11-20)
It would have been obvious to one of ordinary skill in the art at the time of the invention to produce deuterated derivatives of the compounds claimed by ‘713. One of ordinary skill in the art would have seen the disclosure of Rui as suggesting that deuteration would improve the pharmacokinetic propertied of this compound.
Claims 1, 2, 7-9, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-22 of copending Application No. 18/694948 (reference application, US pre-grant publication 2025/0011272, cited in PTO-892, herein referred to as ‘948). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘948 anticipate the present claims.
Specifically, claims 12 and 20 of ‘948 claim a compound having a formula which substantially overlaps formula (I) in present claim 8. Dependent claims 13-16 and 21 of ‘948 further define the scope of this compound. Claims 17-19 claim pharmaceutical compositions and methods of treatment that anticipate the methods and compositions of present claims 1, 2, 7, and 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-22 of copending Application No. 18/694948 (reference application, US pre-grant publication 2025/0011272, cited in PTO-892, herein referred to as ‘948) in view of Rui. (Foreign publication CN110054562, Reference included with PTO-1449)
The claims of ‘948 are discussed above. The claims of ‘948 do not specifically claim a deuterated compound. However, Rui discloses deuterium substituted pentadecanedioic acid compounds which have improved pharmacokinetic properties compared to the parent compounds. (pp. 7-8 paragraphs 11-20)
It would have been obvious to one of ordinary skill in the art at the time of the invention to produce deuterated derivatives of the compounds claimed by ‘948. One of ordinary skill in the art would have seen the disclosure of Rui as suggesting that deuteration would improve the pharmacokinetic propertied of this compound.
Conclusion
No claims ae allowed in this action.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 6/26/2026
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