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
Acknowledgment is made of applicant's claim for foreign priority based on the application EP22216126.7 filed in on 12 December, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 25 July, 2024 and 25 February, 2026 are acknowledged and have been considered.
Status of Claims
Acknowledgement is made of claims filed on 18 December, 2023; Original, 1-3, 9 and 13; amended 4-8, 10-12 and 15; cancelled 14 and 16. No new matter was introduced.
Claims 1-13 and 15 are currently under examination.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code. Applicant is reminded that inclusion of hyperlinks or browser executable codes such as ʺ< >ʺ and ʺhttp://ʺ followed by a URL address, as is the case in this disclosure is not permissible (Background information, pages 1-4). Applicant is required to delete the embedded hyperlinks 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 listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The use of the term PerkinElmer®, which is a trade name or a mark used in commerce, has been noted in this application (Specification, Page 52). The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
While the Examiner had made effort to check the Specification for trade mark compliance, Applicant is required to carefully check entire Specification for any and all issues regarding trade mark use compliance.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-12 and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Veal et al. WO 2024/020517 (cited in IDS, Priority date, 22 July, 2022), hereinafter Veal.
Regarding claims 1-5, and 7-9, Veal teaches compounds 1, 2, 4, 40 and 47, shown below (‘517, Pg. 36, 45 and 46), which are fully encompassed in Formula (I) as in the instant claims 1, 7 and 8 (A1a – 6- or 9-membered heteroaryl ring, and R1, R2 or R3 - H or halo), claim 2 (pyridinyl), claim 3 (pyridinyl or 3-H-imidazo[4,5-b]pyridinyl radical), claim 4 (R1d - H), claim 5 (R2 - H, F, Cl, methyl) and claim 9 (species shown).
Veal et al. WO 2024/020517
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Abstract
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Pg. 36
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Page 45
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Page 46
Regarding claims 10-12 and 15, Veal teaches a pharmaceutical composition comprising a compound of pharmaceutically acceptable salt and / or solvate of the disclosed compounds. He teaches a method of treating a disease associated with the expression of QPCT or QPCTL, such as a cancer, neurodegenerative disease, atherosclerosis, inflammatory or autoimmune disease (‘517 pgs. 283-284).
Thus, claims 1-5, 7-12 and 15 rejected because they contain species anticipated by Veal.
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.
Claims 1-5, 7-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Veal (WO 2024/020517, cited in IDS) in view of Wermuth et al. 2008, ( “The Practice of Medicinal Chemistry” (Fourth Edition) Chapter 8: Molecular Variations Based on Isosteric Replacements. Academic Press, 2008, Pages 181-241, ISBN 978-0-12-417205-0).
The prior art differs from the instant claims as follows: While Veal teaches example 34 (pg. 43);
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wherein the R1 position is a H. Veal does not specify a halo substitution as is the case instant claim 9 wherein R1 is a F.
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Per MPEP § 2144.09 (I) and (III), (a) “prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities”. (b) “Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie.”
The replacement of an atom by another representing the same physiochemical properties – isosterism - is known in the art. Wermuth teaches on fluorine-hydrogen isosterism. He teaches that fluorine mimics hydrogen because it is considerable smaller than other halogens; fluorine being the most electronegative halogen particularly forms very stable bonds with carbon; it is rarely ionized or displaced and in additional it has no d-orbitals. His teachings reveal that the chemical inertia of fluorine explains why fluoro derivatives are more resistant to metabolic degradation and thus, the F-H isosterism serves to give analogues that have improved properties and more resistant to metabolic degradation (Wermuth et. al 2008, pages 226-227).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with reasonable expectation of success because, the unique properties of fluorine as known from prior art have led to its application as an isostere for hydrogen; fluorine’s small size and chemical inertness render it to be compared to hydrogen. Additionally, fluorine forms stable bonds with carbon atoms which would be expected to give analogs that are more resistant to metabolic degradation among other improved properties. Therefore, the one of ordinary skill in the art would be motivated to make the substitution of H for F to harness the benefits that come from such a substitution.
Likewise, Veal teaches the following compound, (example 120, page 59);
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The instant claim has a methoxy – OCH3, in place of a hydroxy group -OH. Simple substitution of one known element for another to obtain predictable results is a basis of prima facie case of obviousness - MPEP § 2143.01. A hydroxy to methoxy change is a simple substitution.
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with reasonable expectation of success because -OH and -OCH3 are common functional groups and the change is chemically straightforward and predictable. The functional difference is well known to those of ordinary skill in the art and the substitution is a routine modification that is obvious. Therefore, an artisan would arrive at the same invention as presently claimed through a routine simple substitution.
Allowable Subject Matter
Claims 6 and 13 are objected to as being dependent upon rejected base claims, 1 and 12 respectively, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-5, 7-12 and 15 are rejected.
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.
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 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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