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
Acknowledgement is made of the Application’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e), U.S. Provisional Application Serial No. 63/476861, filed on December 22, 2022.
Information Disclosure Statement
Two information disclosure statements (IDS) submitted on April 8, 2024 and June 26, 2024 are acknowledged and have been considered.
Status of the Application
Receipt is acknowledged of the Applicant’s invention, Application No. 18/393,205 filed on 21 December 2023. Claims 2-6, 8-11, 13-17, 20-24, 26-29, 31-32, 34, 36-40, 42-43, 46, 48-50, 52-54, 56-57, 59-60, 62-67, 72-82 are cancelled.
Claims 1 and 71 are original; and claims 7,12, 18-19, 25, 30, 33, 35, 41, 44-45, 47, 51, 55, 58, 61, 68-70 are amended. No new matter was introduced.
Thus claims 1, 7, 12, 18-19, 25, 30, 33, 35, 41, 44-45, 47, 51, 55, 58, 61, 68-71 represent all the claims currently under examination.
Claim Rejections - 35 USC § 112a
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, 7, 12, 18-19, 25, 30, 33, 35, 41, 44-45, 47, 51, 55, 58, 61, 69-71 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn towards a compound of formula (I) with three rings A, B, and C that are connected to form a macrocyclic compound as recited and shown in claim 1. Applicant claims rings A, B and C as aryl or heteroaryl (claim 1). The terms aryl and heteroaryl as understood by a skilled artisan in the field encompass a variety of different aromatic ring sizes, monocyclic or polycyclic, and with different variations / combinations of hetero atoms for the heteroaryls. While the claimed invention broadly claims rings A, B and C as aryl or heteroaryl in claim 1, the specification only discloses examples of compounds with only phenyl rings for ring A and either phenyl or 5-membered heteroaryl for rings B and C ( Specification, Table 1 - pg. 27, and 2 - pg. 49).
There is no written description or examples of preparation other variations of ring sizes and/ or combinations of other variations of aryls or heteroaryls as broadly recited in claim 1. Claims 7, 30, 33, 40 and 41 recite these limitations; wherein ring A is phenyl (claim 7), or wherein ring B is phenyl (claim 30), or is 5-membered heteroaryl (claim 33), or wherein ring C is phenyl (claim 40), or 5-membered heteroaryl (claim 41); However, these limitations are dependents of the broad parent claim 1 and specifying wherein one ring is a phenyl or 5-membered heteroaryl does not resolve the fact that the other two rings are still broadly claimed in the parent claim 1.
A thorough search of the prior art in the field of alpha4 beta7 integrin antagonists revealed compounds that are targeted towards inhibition of α4β7 generally contain substituted or unsubstituted phenyls, biphenyls and /or heteroaryl rings, which may or may not be cyclized into macrocycles. Thus, there is a wide variation in the kinds of compounds reported as α4β7 integrin inhibitors/ antagonists. For example, Bursavich et al. (WO2021/076890A1, cited in the IDS) discloses α4β7 integrin inhibitors such as;
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As seen below, a sample of some compounds reported in the field, confirms that α4β7 integrin inhibitors/ antagonists are very unpredictable in their structures. This affirms the need for a properly written description of applicant’s invention to ascertain that applicant was in possession of the claimed invention at the time of filing and further that the compounds can perform the claimed functions recited in claims 70 and 71.
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Bursavich et al. 2019 (WO 2021/200202 A1
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Pgs. 26 & 40
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Reilly et al. WO 2023/220741 A1
pg. 147 & 150
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Blomgren et al. WO 2021/030438A1
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Boer et al. J. Med. Chem. 2001, 44 (16), 2586-2592 (Abstract)
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Dubree et al. J. Med. Chem. 2002, 45(16), 3552-3457 (Abstract)
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Vazquez et al. US 2020/016530 A1 (Abstract)
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Roughton et al. WO 2022/002781 A1 (Abstract)
Additionally, Applicant’s general schemes 1 and 2 in the specification (page 118 -119) are generic, illustrating general methods without sufficient details to perform the illustrated reactions. However, Examiner notes that the Applicant has proper written description in the specification (pages 120-465) for the examples shown in Tables 1 and 2 (page 27 and 49). These compounds show structures wherein ring A is phenyl and rings B and C are either phenyl or 5-membered heteroaryl. Thus, Applicant can overcome this rejection by moving claims 7, 30, 33, 40 and 41 to be part of parent claim 1 as that will fulfill the written description requirement.
Allowable Subject Matter
Claim 68 is free of prior art. The compounds shown in the claim appear to be novel and are thus allowable.
Conclusion
Claims 1, 7, 12, 18-19, 25, 30, 33, 35, 41, 44-45, 47, 51, 55, 58, 61, 69-71are rejected.
Claim 68 is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULINE ONDACHI whose telephone number is (571)272-9419. The examiner can normally be reached Mon - Fri 8:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. 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.
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/P.O./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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