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 .
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.
Current Status of 18/933,587
This Office Action is in response to the amended claims of 05/08/2025.
Claims 82-93 are new and are examined in this office action.
Information Disclosure Statement
No IDS was filed as of 08/05/2026.
Priority
Effected filing date is 09/18/2018.
Claim Rejections - 35 USC § 112
7. 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 87-92 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 treatment for gastrointestinal disease or condition, does not reasonably provide enablement for prevention of these diseases. 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.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include:
(a) Breadth of the claims:
(b) Nature of the invention;
(c) State of the prior art;
(d) Level of one of ordinary skill;
(e) level of predictability art
(f) amount of direction provided by the inventor;
(g) existence of working examples;
(h) and Quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth and nature of the claims and Nature of the Invention
Claims 87-92 are directed to prevention or treatment of condition or disease that is associated gastrointestinal. Claims 87-92 lists numerous diseases that are difficult to treat or prevent and each disease would require different prevention regimens.
State of the prior art:
The gastrointestinal diseases are numerous as stated in claims 87-92. There are no one method that can prevent all gastrointestinal diseases. For examples, IBD, Crohn’s diseases, ulcerative colitis etc. has no cure and patients commonly require a lifetime of care; thus effective preventive measures to reduce morbidity, hospitalization, and surgery are critical to improving disease free remission and quality of life(Ali et.al. World J Gastroenterol. 2016 Sep 14;22(34):7625-44). Therefore there are no known method for preventing IBD, Crohn’s diseases, ulcerative colitis etc.
Level of one of ordinary skill/ Level of predictability art
A person of ordinary skill in the art is an artisan who is a medicinal chemist and/or gastrologist that has experience in treating gastrointestinal diseases.
A person skilled in the art would not be able to envision preventing all the gastrointestinal diseases with the experiments disclosed in the specification (Wands factor (d)) because the specification does not provide guidance for method of preventing diseases of claims 87-92 with factor (e)). Moreover, preventions of gastrointestinal diseases are unpredictable because no one compound can prevent all the diseases (wands factor (e)).
Amount of direction provided by the inventor:
Although the specification and prior art teaches methods of treating gastrointestinal disease (spec, there is no working example that shows prevention these disease, in the specification The specification does not disclose a method of preventing diseases in claims 87-92. Moreover, prevention of diseases/condition are unpredictable because no one method can prevent a disease/condition from occurring.
It would require undue experimentation and be undue burden to practice the claimed method of treating and/or prevention for gastrointestinal diseases. Since no one method can treat or prevent all the diseases stated in 87-92. Moreover, some of the diseases are rare and difficult to diagnose.
Therefore, method claims 87-92 are rejected for lacking scope of enablement for prevention all gastrointestinal diseases. Applicant can overcome enablement rejection by deleting the phrase “preventing” from claim 87.
Double Patenting
8. 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.
9. Claims rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 1-2 and13-19 of U.S. Patent No. 11,773,094. Instant Claims of 05/08/2025 is used for this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-2 and13-19 discloses method of treating or preventing gastrointestinal diseases with compound
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and its pharmaceutically acceptable salt thereof (anticipating instant claims 82-86) same as instant claims 87-93. Reference claims 15-19 further disclose method of treating gastrointestinal disease or conditions is necrotizing enterocolitis, gastritis, ulcerative colitis(instant claim 93), Crohn’s disease(instant claim 90), inflammatory bowel disease(instant claim 91), irritable bowel syndrome(instant claim 92), gastroenteritis, radiation induced enteritis, pseudomembranous colitis, chemotherapy induced enteritis, gastro-esophageal reflux disease (GERD), peptic ulcer, non-ulcer dyspepsia (NUD), celiac disease, intestinal celiac disease, post-surgical inflammation, gastric carcinogenesis, graft versus host disease, or any combination thereof, anticipating claims 87-93.
Claims 82-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 13-14 of U.S. Patent No. 11,084, 817 B2. Instant Claims of 05/08/2025 is used for this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-2 and13-14 discloses pharmaceutical composition with compound
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and its pharmaceutically acceptable salt thereof anticipating instant claims 82-86.
Claims 82-93 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,491,160 B2. Instant Claims of 05/08/2025 is used for this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference reference claims 1-19 discloses a pharmaceutical compositions comprising of compound 4-((4-(1- (tert-butyl)-1H-pyrazol-4-yl)pyridin-2-yl)((4-(4-methoxy-3-methylphenyl)bicyclo [2.2.2]octan- 1-yl)methyl)carbamoyl)cyclohexyl 3 -hydroxyazetidine-trans- 1-carboxylate(
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)and its pharmaceutically acceptable salt thereof anticipating instant claims 82-86. Reference claims 20 further disclose method of treating gastrointestinal disease or conditions anticipating claims 87-93.
Claims 82-93 are rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 1-8 of U.S. Patent No. 12,545,660. Instant Claims of 05/08/2025 is used for this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-4 discloses a pharmaceutical compositions comprising of compound 4-((4-(1- (tert-butyl)-1H-pyrazol-4-yl)pyridin-2-yl)((4-(4-methoxy-3-methylphenyl)bicyclo [2.2.2]octan- 1-yl)methyl)carbamoyl)cyclohexyl 3 -hydroxyazetidine-trans- 1-carboxylate(
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)and its pharmaceutically acceptable salt thereof anticipating instant claims 82-86. Reference claims 5-18 further disclose method of treating gastrointestinal disease or conditions is necrotizing enterocolitis, gastritis, ulcerative colitis(instant claim 93), Crohn’s disease(instant claim 90), inflammatory bowel disease(instant claim 91), irritable bowel syndrome(instant claim 92), gastroenteritis, radiation induced enteritis, pseudomembranous colitis, chemotherapy induced enteritis, gastro-esophageal reflux disease (GERD), peptic ulcer, non-ulcer dyspepsia (NUD), celiac disease, intestinal celiac disease, post-surgical inflammation, gastric carcinogenesis, graft versus host disease, or any combination thereof, anticipating claims 87-93.
Claim 82-93 provisionally rejected on the ground of obvious-type nonstatutory double patenting as being obvious over claims 1 and 30-33 of copending Application No. 17/906,580 (reference application). Instant Claims of 05/08/2025 is used for this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1 discloses method of treating gastrointestinal diseases with compound
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and its pharmaceutically acceptable salt thereof in the form of tablet (instant claim 86) (anticipating instant claims 82-86) same as instant claims 87-93. Reference claims 1 and 30-33 further disclose method of treating gastrointestinal disease or conditions is necrotizing enterocolitis, gastritis, ulcerative colitis(reference claims 30 and 32 instant claim 93), Crohn’s disease(, reference claim 31 same as instant claim 90), inflammatory bowel disease(reference claims 30-31 and 33 same as instant claim 91), irritable bowel syndrome(reference claims 30 and 33 same as instant claim 92), gastroenteritis, radiation induced enteritis, pseudomembranous colitis, chemotherapy induced enteritis, gastro-esophageal reflux disease (GERD), peptic ulcer, non-ulcer dyspepsia (NUD), celiac disease, intestinal celiac disease, post-surgical inflammation, gastric carcinogenesis, graft versus host disease, or any combination thereof, anticipating claims 87-93.
Claims 82-93 provisionally rejected on the ground of anticipatory nonstatutory double patenting as being anticipated over claim 17, 21-24, 57-64 and 66 of copending Application No. 19/385,121 (reference application). Instant Claims of 05/08/2025 is used for this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 17 and 21-24 discloses a pharmaceutical compositions comprising of compound 4-((4-(1- (tert-butyl)-1H-pyrazol-4-yl)pyridin-2-yl)((4-(4-methoxy-3-methylphenyl)bicyclo [2.2.2]octan- 1-yl)methyl)carbamoyl)cyclohexyl 3 -hydroxyazetidine-trans- 1-carboxylate(
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) same as instant claims 82-85. Reference claims 57-64 discloses tablet of compound 4-((4-(1- (tert-butyl)-1H-pyrazol-4-yl)pyridin-2-yl)((4-(4-methoxy-3-methylphenyl)bicyclo [2.2.2]octan- 1-yl)methyl)carbamoyl)cyclohexyl 3 -hydroxyazetidine-trans- 1-carboxylate(
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) same as reference claim 82-83. Reference claims 66 discloses a method of treating gastrointestinal disease or condition in a mammal, comprising administering to the mammal in need thereof the pharmaceutical formulation of claim 17, wherein the gastrointestinal disease or condition is necrotizing enterocolitis, gastritis, ulcerative colitis(instant claim 93), Crohn's disease(instant claim 90), inflammatory bowel disease(instant claim 91), irritable bowel syndrome(instant claim 89 and 92), gastroenteritis, radiation induced enteritis, pseudomembranous colitis, chemotherapy induced enteritis, gastro-esophageal reflux disease (GERD), peptic ulcer, non- ulcer dyspepsia (NUD), celiac disease, intestinal celiac disease, post-surgical inflammation, gastric carcinogenesis, graft versus host disease, same as instant claim 88-93
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable as written.
Smith et.al (US-12491160-B2) discloses a pharmaceutical compositions comprising of compound 4-((4-(1- (tert-butyl)-1H-pyrazol-4-yl)pyridin-2-yl)((4-(4-methoxy-3-methylphenyl)bicyclo [2.2.2]octan- 1-yl)methyl)carbamoyl)cyclohexyl 3 -hydroxyazetidine-trans- 1-carboxylate(
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)and its pharmaceutically acceptable salt thereof and method of treating gastrointestinal diseases including ulcerative colitis(instant claim 93), however the publication date of Smith is September 23, 2021 after the effective filing date of current application. Therefore, a person skilled in the art would not be enabled to propose the compound of independent claims 92,83 and 93, hence Smith et.al is a close art not a prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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