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 6/01/26.
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) 11-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Klinger et al (Cholecystokini-2 receptor targeting with radiolabeled peptides: current status future direction, Curr Med Chem, 27(41): 7112-7132, 2020 January 01 hereafter Klinger) in view of Sauter et al (Targeting of the Cholecytokinin-2 Receptor with the Minigastrin Analog 177Lu-DOTA-PP-F11N: Does the Use of Protease Inhibitors Further Improved in Vivo Distribution?, J Nucl Med 2019, 60:393-399 hereafter Sauter).
Klinger discloses various labeled gastrin analogue represented by a formula: DOTA-PP-FR11N, DOTA-DGlu-DGlu-DGlu-DGlu-DGlu-DGluAla-Tyr-Gly-Trp-Nle-Asp-Phe-Nh, [Table 2]. PP-F11 and its derivative PP-FR-11N can be labeled with a variety of radiometals including ⁶⁸Ga, 111 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].
While the reference discloses a compound of the formula of claim 11 and a suggestion of a 177Lu labeled compound, the reference is silent to a specific kit comprising the labeled gastrin and excipients. Such kits are found in the prior art such as Sauter.
Sauter discloses a method for treating a patient that would benefit from a treatment with a compound of a formula: 177Lu-DOTA-(DGlu)6-Ala-Tyr-Gly-Trp-Nle-Asp-Phe-NH2 where the compound is administered, and an image of body parts and tissue to be examiner is obtained where the image is of a tumor (page 395). The tumor is a medullary thyroid cancer (abstract). The imaging is accomplished with SPECT/CT imaging (page 397). The formulation comprises excipients such as a sodium lactate buffer (page 394). It would have been obvious to include the compound onto the method of treatment of Klinger.
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 Sauter into 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 with respect to claim(s) 11-29 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. Klinger continues to render the claims obvious over the claims. Applicant argues that the state of the art at the time of the invention would not have used the compounds of the claims as intended and thus is a surprising or unexpected result. Applicant references a study from Roosenberg (see IDS) that these compounds, specifically the gallium labeled variations show uptake by surrounding tissues and thus would not be useful for targeting imaging. However, the claims are not limited to a method of imaging a specific organ or tissue. The claims recite a compound (claims 11-15) and method of obtaining an image of body parts or tissue (16-25). The compound claims merely recite that the compound comprises the gallium labeled gastrin and at most with excipients. Klinger discloses such a compound along with an excipient. The method of treatment by obtaining an image merely states that an image is obtained, again, accomplished by the Klinger and now Sauter. Applicant argues that since there is uptake by other organs, there would be no reason or motivation to use the compound of the instant claims. However, Roosenberg states that the uptake by surrounding tissues is “negligible” at best. In fact, Roosenberg states on page 3936 that” The 68Ga-labeled DOTA-PP-F11 seems to have optimal characteristics for imaging CCK2 receptor-positive tumors…” and noting that the compound is “a promising radiopharmaceutical for PET/CT imaging of CCK2 receptor expressing tumors such as MTS and SCLC.”. While the rejection is new, the claims remain obviated at least by Klinger et al.
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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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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