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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/28/24 and 2/11/26 were filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claim 16 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.
The claim recites multiple peptides including CB-TE2A-AR06 peptide, BAY 864367 peptide, RM2 peptide, SB3 peptide, and NeoBOMB1 peptide with the parenthetical (with H4noneunpaX substituted for DOTA). This limitation is unclear it isn’t clear if the parenthetical serves as instructions or descriptions of the listed peptides, since DOTA is not part of the CB-TE2A-AR06 peptide structure. Clarification of these limitations is required.
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.
Claim(s) 1-7, 9, 10, 12, 14, 16, 18, 20-23, 27, 28 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Wharton et al (Chemical Promiscuity of Non-Macrocyclic Multidentate Chelating Ligands for Radiometal Ions: H4neunpa-NH2 vs H4noneunpa; Inorganic Chemistry, 2021, 60, 4076-7092) in view of Li et al (WO 2020/186328 A1 hereafter Li).
Wharton discloses a chelator having a structure
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, which is a positional isomer of the instant structure of the claims, specifically claim 2,
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[Chart 1]. The chelator can further comprise an amide linker [pg 4078, Scheme 1]. The chelator further comprises a radio metal such as 225-Ac and 111-In [Table 1]. The construct comprises a targeting moiety for PET scan imaging, octreotate [pg. 4082]. These compounds have the same linkers, backbone and arms, simply rearranged as an isomer, and as such it would have been obvious that such isomers would behave similarly. Further the compounds form constructs with the same radiometals and targeting moieties.
While Wharton discloses a chelating compound, the reference is silent to a specific in vivo radiometal construct as described in the instant claims comprising a targeting moiety. However such constructs are known in the art as seen in the Li patent.
Li discloses a construct comprising a chelator, a radiometal and a targeting moiety [abstract]. The chelators can have a structure similar to those of Wharton as they are commonly known and would have been obvious substitutes
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[Chart 1]. The radio metals include 225-Ac [0047, 0062]. The construct comprising a targeting moiety such as a monoclonal antibody like trastuzumab [0005]. The construct can be delivered to the body in a method that comprises delivery to a specific area of the body where the constructs can accumulate such as the gut or gastrointestinal tract to treat different cancers [[0005-0006]. The construct is formed in a method comprising incubating the ingredients at a temperature between 15-25 oC at a pH from 6.8-7.5 [0064-005-65]. The method for delivery comprises the constructs killing cancer cells under radiation such as targeted alpha radiation [0077-0081]. It would have been obvious to substitute the chelator of Wharton into the formulation and method of Li as the chelator compounds are sim lar and have similar structures.
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable chelator construct. It would have been obvious to substitute the chelator of Wharton into the formulation of Li in order to treat cancers as the compounds have similar structure and are used to solve similar problems such as imaging and drug delivery. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable chlelating construct useful in treating and killing cancer cells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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