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
Election/Restrictions and Status of the Claims
Applicant’s election of Group II, comprising claims 34-44 and “a compound of formula V” as the single specific compound in the response filed on February 24th 2026 is acknowledged. Claims 34-44 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on May 19th 2022 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Objections
Claim 35 is objected to because of the following informalities: Claim 35 recites “The compound of claim 42 which comprises a pharmaceutical composition and a pharmaceutically acceptable carrier.” For the purpose of examination, the claim will be read as “A pharmaceutical composition comprising the compound of claim 42 and a pharmaceutically acceptable carrier.” Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 39, 40, 42, 44 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 39 is indefinite for the phrase “A method of treatment by administering to a subject an effective amount of the composition of claim 35,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim. Specifically, the transitional phrase “by” is not a standard phrase used to define the scope of the claim. Thereby it is unclear whether the claim is intended to be open or closed in scope. For the purpose of examination, the claim will be treated in an open-scope format and the phrase “by” will be treated as “comprising.”
Claim 40 is indefinite for the phrase “wherein the subject is suspected of having cancer,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the patient population in the claim. The specification does not provide any criteria for defining a patient population “suspected of having cancer,” (nor any mention of such a patient population) and one of ordinary skill in the art would not reasonably be able to determine the full scope of patients “suspected of having cancer” without further clarification.
Claim 42 is indefinite for the phrase “R1 is an end group of a carboxylic acid,” because one of ordinary skill in the art could not reasonably determine the structural metes and bounds of the claim from the phrase. The phrase is not defined in the specification and, as written, leaves the R1 group open for any substituent that terminates the left-side of the molecule. As such, the full scope of molecular structures encompassed by claim 42 is indefinite, as one of ordinary skill in the art could not reasonably determine groups that are allowed in the R1 position from groups that are not allowed in the R1 position.
Claim 44 is indefinite for the phrase “the amino side chain forms a three-member ring with an amino acid of the amino acid.” The phrase is unclear and Examiner is unable to determine the meaning or intended meaning of the phrase as written.
Claim Rejections - 35 USC § 112(a)
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 40, 42, 44, and their dependent claims 35-41 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.
Claim 40 recites a patient population of “subjects suspected of having cancer.” Such a patient population is not found in the specification and is considered to be new matter.
Claim 42 is directed to:
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241
448
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.
In support of this compound genus, the specification describes:
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143
305
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(Figure 9A).
Regarding R2, the written description, as shown in figure 9A, includes 16 possible linker groups in the position described in claim R-2 position. The particular side chains described are not mentioned anywhere in the specification. As written, R2 would be assumed to encompass 20 possible side chains (i.e. the 20 standard amino acid side chains). As such, there are necessarily 4 side-chains of which there is no support for a proper compound genus in the application. Without further clarification, proper support can only be assumed for amino acid side chains for which embodied compounds are present. As such, applicant will be assumed to have possession of compounds of claim 42 wherein the amino acid side chain is CH3.
Regarding R1, the written description, as shown in figure 9A, describes “480 acids” as fragments in the R1 position. The particular acids described are not mentioned anywhere in the specification. Without further clarification, proper support for the R1 group can only be assumed for end groups for which embodied compounds are present. As such, applicant will be assumed to have possession of compounds of claim 42 wherein the end group is biphenyl.
Claim 44 is directed to:
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162
634
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.
In support of this compound genus, the specification describes:
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143
305
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(Figure 9A).
The written description, as shown in figure 9A, includes 16 possible linker groups in the position described in claim 44. The particular side chains described are not mentioned anywhere in the specification. Claim 44 describes 20 possible side chains. As such, there are necessarily 4 side-chains of which there is no support for a proper compound genus in the application. Without further clarification, proper support can only be assumed for amino acid side chains for which embodied compounds are present. As such, applicant will be assumed to have possession of compounds of claim 44 wherein the amino acid side chain is CH3.
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.
Claims 42 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haskell (U.S. Patent No. 4,382,089 issued on May 3rd 1983).
Haskell teaches the compound,
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206
500
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(Haskell, col. 15, example 6, first paragraph).
Haskell’s compound is anticipatory of claims 42 and 44.
Claim 35 is directed towards a pharmaceutical composition comprising the compound of claim 42 and a pharmaceutically acceptable carrier. Haskell teaches such compositions (Haskell, col. 22, claim 19), anticipating claim 35.
Claim 39 is directed towards a method of treatment by administering to a subject an effective amount of the composition of claim 35. Haskell teaches a method for treating a bacterial infection comprising administration of an effective amount of a pharmaceutical composition of the compound (Haskell, col. 22, claim 20).
Allowable Subject Matter
Claim 34, directed to the compound,
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153
416
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,
is free of the prior art.
Similar compounds are found in U.S. Patent No. 4,382,089 (above) and U.S. Patent No. 4,404,201. However, the singular compound recited in claim 34 is not found in the art, nor would it be predictable from the art.
Claim 34 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629