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 11/25/25.
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 15 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 15 is drawn to a labeled gastrin analogue according to claim 14, which itself is drawn to a labeled gastrin analogue according to claim 11, where the formula for the labeled by a formula: 68Ga-Y-DGlu-DGlu-DGlu-DGlu-DGlu-DGlu-Ala-Tyr-Gly-Trp-Nle-Asp-Phe-NH2, wherein Y is a moiety chelating 68Ga; however, claim 15 recites this formula as 177Lu-DOTA-DGlu-DGlu-DGlu-DGlu-DGlu-DGlu-Ala-Tyr-Gly-Trp-Nle-Adp-Phe-NH2, wherein DOTA is 1,4,7,10-tetraazacyclodecane-1,4,7,10-tetraacetic acid. As can be seen the formula of claim 15 is not the same formula of claim 11, from which is it dependent. The formula of claim 15 has a different radiometal label, and a specific chelating material. This formula is inconsistent with the formula of claim 11. It is unclear if claim 15 is attempting to claim a species of the formula of claim 11 or a separate additional compound. The meets and bounds of the claim cannot be determined and clarification 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) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klinger et al (Cholecystokini-2 receptor targeting with radiolabeled peptides: current status and future directions, Curr Med Chem, 27(41): 7112-7132, 2020 January 01 hereafter Klinger) in view of Behe et al (EP 3 459 559 A1 hereafter Behe).
Klinger disclose various labeled gastrin analogue represented by a formula: DOTA-PP-FR11N, DOTA-DGlu-DGlu-DGlu-DGlu-DGlu-DGlu-Ala-Tyr-Gly-Trp-Nle-Asp-Phe-Nh2 [Table 2]. PP-F11 and its derivative PP-FR-11N can be labeled with a variety of radiometals including 68Ga, 111I and 117Lu [page 8-9], meeting the limitations of claims 11-13. The compounds are applied to image tissues, including cancers selected from mall-cell lung cancer, and medullary thyroid cancer [page 2, 9] meeting limitations of claim 14 and 15. Images are confirmed with CT imaging for several weeks [page 9] meeting limitations of claim 16. Gallium-68 is a preferred radiometal for use in PET scans [page 2], meeting limitations of claim 17. A kit comprising a gastrin analogue of the formula Y-DGlu-DGlu-DGlu-DGlu-DGlu-DGlu-Ala-Tyr-Gly-Trp-Nle-Asp-Phe-NH2 where y can be a radiometal such as 68Ga [page 7, 8].
The reference discloses a labeled gastrin analogue useful in a kit formulation for targeting cholecystokinin-2 receptor in tumors. The reference discloses a kit comprising the labeled gastrin analogue, but however is silent to the excipients and their relationship to the radiolabel and the peptide, whether they are separate or packaged together. The packaging of such materials for the express purpose of targeting CCK2 receptors is known in the art as seen in the Behe patent.
Behe discloses radiometal labeled peptides in the form aa kit where the comprising at least the peptide, DOTA-PP-FN11N in a buffer along with water as an excipient [0044]. The kit solution comprising the radiometal can be 68Ga is provided where the excipients are mixed with the peptide [0045-0046, claims 2-5], meeting limitations of claims 19 and 20. It would have been obvious to include these features of the kit with those of Klinger as they solve the same problem.
With these aspects in mind it would have been obvious to combine the prior art in order to provide a stable labeled gastrin formulation useful in labeling tumors. It would have been obvious to apply the structure of the kit of Behe to the formulations recited in Klinger as they solve the same problem as they both use the same compounds for the same purpose. One of ordinary skill in the art would have been motivated to combine the prior art to provide a stable labeled gastrin compound.
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/25/25, with respect to the rejection(s) of claim(s) 11-20 under 35 USC 102 (a1,2) and 103 (a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejections.
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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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618