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 .
Acknowledgment of Papers Received: Amendment/Response dated 11/05/25
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/5/25 was filed after the mailing date of the previous Office Action on 8/8/25. 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 § 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) 1-5 and 7-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Maina-Nock et al (US 9,839,703 hereafter Maina) in view of Li et al (US 2010/0015058 hereafter Li).
Maina discloses a method for treating GRPC-positive tumors in a human subject comprising administering to the subject a pharmaceutical composition of a radiolabeled gastrin-releasing peptide receptor (GRPR)-antagonist, wherein pharmaceutical composition comprises a GRPC-antagonist of the following formula MC-S-P identical to the instant claims (col. 3, lin. 20-25, 30-col. 4, lin. 5). The M is a radiometal suitable for therapy, C is a chelator which binds M, where the M can be 68Ga or 177Lu (col. 6, lin. 1-10, claims), meeting the limitations of claim 4. P is of the general formula: Xaa1-Xaa2-Xaa3-Xaa4-Xaa5-Xaa6-Xaa7-Z, where Xaa1 is not present, Xaa2 is Gln, Asn, or His, Xaa3 is Trp or 1,2,3,4-tetrahydronorharman-3-carboxylic acid (Tpi), Xaa4 is Ala, Ser, Val, Xaa5, Val, Ser, Thr, Xaa6 is Gly, sarcosine (Sar), D-Ala, Beta-Ala, Xaa7 is His or (3-methylhistidine (3-Me)His, Z is selected -NHOH, -NHNH2, -NH-alkyl, N(alkyl)2, and O-alkyl or
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, wherein X is NH or O (col. 3, lin. 30-col. , lin. 5), meeting the limitation of claim 1. The method is applied is a solution for infusion (col. 24, lin. 53-68), meeting limitations of claim 5. The subject has GRPR positive tumors such as breast, lung and prostate (col. 24, lin. 55-65; Fig. 1E).
The reference while disclosing a method of treating tumors GRPR-positive tumors, the reference is silent to initial PET or MRI scans to determine the uptake potential of the tumors before administration. The use of control images to determine up take is known in the art as seen in the Li patent.
Li discloses a method of treating tumors with GRPR binding that show uptake of 68Ga [0133]. A first PET scan is made as a control to image the tumors, before injection of the GRPR [Figure 17A, 26A]. The uptake is monitored over time to assess the uptake of the compounds to the tumors [Fig 26A]. It would have been obvious to scan the patient before treatment to ensure proper delivery to the specific tumors.
Regarding percentage of tumors that are scanned in the subject and their uptake, it is the position of the Examiner that the while the prior art does not explicitly recite a percentage, all of the tumors treated have various degrees of uptake of the [68Ga]-GRPR-antagonist uptake determined by PET/MRI [Figures 17, 26]. The tumors all exhibit uptake of the GRPR antagonist and based on the organ, can have higher degrees of uptake than others. The prior art appears to disclose that 100% of the tumors at least uptake the compounds. The Office does not have the facilities for examining and comparing applicant’s product with the product of the prior art in order to establish that the product of the prior art does not possess the same material structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed products are functionally different than those taught by the prior art and to establish patentable differences. See Ex parte Phillips, 28 U.S.P.Q.2d 1302, 1303 (PTO Bd. Pat. App. & Int. 1993), Ex parte Gray, 10 USPQ2d 1922, 1923 (PTO Bd. Pat. App. & Int.) and In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
With these aspects in mind, it would have been obvious to combine the prior art with an expected result of a stable and precise method for treating various cancer. It would have ben obvious to include the scanning and monitoring of Li into the method of Maina in order to more precisely treat tumors as they spread as they use the same compounds applied for the same purpose. One of ordinary skill int heart would have been motivated to combine the prior art with an expected result of a stable treatment method.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 7-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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