DETAILED ACTION
Claims 1-65 are currently pending in the instant application. Claims 1-29, 41, 43, 45, 46, and 56 are rejected. Claims 30-40, 42, 44, 47-55 and 57-65 are withdrawn from consideration as being for non-elected subject matter.
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
Applicant’s election without traverse of Group I and the species of compound 2:
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in the reply filed on 26 March 2026 is acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable. Therefore, the search and examination has been extended to the compounds of claims 1-28, 43, and 46 which are allowable over the prior art of record, and further to the compound:
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which is not allowable.
Claims 1-29, 41, 43, 45, 46, and 56have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compounds. It has been determined that the entire scope claimed is not patentable.
Information Disclosure Statement
The instant information disclosure statement is filed 3/26/2026 is 35 pages long and cites over 366 references. The applicant has an obligation to call the most pertinent prior art to the attention of the U.S. Patent and Trademark Office in a proper fashion. Burying one reference in one hundred other IDS references is like citing nothing. PENN YAN BOATS, INC. v. SEA LARK BOATS, INC., et. al. 175 USPQ 260 (S.D. Fla. 1972). Golden Valley Microwave Foods, Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (U.S. District Court Northern District of Indiana, July 22, 1992), Molins PLC v. Textron, Inc., 48 F.3d 1172, 1184, 33 USPQ2d 1823 (Fed. Cir. 1995).
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 1-29, 41, 43, 45, 46, and 56 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 claim(s) contains 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. Specifically, the claims are drawn to products of the formula I or formula II or a pharmaceutically acceptable derivative thereof. The only discussion of the “derivatives” is on page 4 of the specification, paragraph [0021] which provides:
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which is non-limiting. Besides this non-limiting definitions of “ pharmaceutically acceptable derivative” there is no written description for how to make or use any “pharmaceutically acceptable derivative” as there is no written description other than the definition on page 4. There is no direction or written description on how to determine a particular reaction scheme to produce a derivative, how much the derivative can be derivatized, how to determine the substantial toxic effects, or how to determine if pharmaceutically active. There is no written description on how far from the original starting product, the derivative can be in regards to structure, i.e. what is required in the moiety that is the resulting product, that will be able to be administered to animals or humans without substantial toxic effects and either are pharmaceutically active or are prodrugs. It is suggested that “a pharmaceutically acceptable derivative” of the claims be amended to “ a pharmaceutically acceptable salt, ester, enol ether, enol ester, acetal, ketal, orthoester, hemiacetal, hemiketal, acid, base, clathrate, solvate or hydrate thereof.”
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16, 20, 22, 23, 41, and 43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Specifically claims 16, 20, 22, 23, 41, and 43 have undefined variables or contain variables defined that are not on the formula claimed. Specifically, claims 16, 20, 22, 23, and 43 contain formula with the variable “Ar” and/or “R16” which is not defined in the instant rejected claims, or in parent claim 1. Claim 41 further defines “Ar1”, however, there is not “Ar1” on the formula of the compound of claim 29 which renders the claim indefinite as it is unclear what on the formula of the compound of claim 29 is being further limited.
Claim 45 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 45 claims the compounds 1-146 which are found in Table 1 of the specification and not listed in claim 45. Claims must, under modern claim practice, stand alone to define an invention, and incorporation into claims by express reference to the specification is not permitted. Ex parte Fressola, 27 USPQ 2d 1608 (1993).
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)(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.
Claim(s) 29, 41, and 56 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2012/0101110.
US Pre-Grant Publication 2012/0101110 discloses the formula I on page 1:
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. Pharmaceutical compositions are disclosed on pages 23-24 including with a carrier. A specific compound of formula (I) disclosed is the compound of example 117:
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. , page 65. The compound of example 117 corresponds to the formula II of instant claim 29:
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wherein, for example, R21 is heteroaryl; a is 0; X11 is a bond; X13 is bicyclic heteroarylene; b is 1; X14 is (CH2)3; c and g are both 2; d is 0; X12 is a bond; f is 0; and R22 is a substituted heteroaryl. Claim 41 is included in the rejection as it is unclear what Ar1 is being limited in claim 41. As pharmaceutical compositions are disclosed on paged 23-24 of the prior art reference, claim 56 is also anticipated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 16 June 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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