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 .
Renumbering of Claims
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 42 has been renumbered 41.
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 2/9/2026 wherein claims 1-24 were canceled; claims 25-27 were amended; and claims 29-41 were added.
Note(s): Claims 25-41 are pending. Specifically, it should be noted that claim 42 in the amendment filed 2/9/2026 was incorrectly numbered as claim 42 instead of claim 41.
Priority
This application claims benefit to PRO 63/650,984 filed 5/23/2024.
Note(s): The earliest effective filing date is 5/23/2024 as the pending invention is fully disclosed in the provisional application.
Claim Interpretation
Independent claim 25 is directed to a radiolabeling kit comprising: (a) gozetotide and D-mannose as a lyophilized powder in an amount of 20-30 µg gozetotide and 5-15 µg D-mannose; (b) about 100 mg to about 200 mg anhydrous sodium acetate in 0.150-0.350 M HCl solution; and (c) about 200 mg/mL to about 300 mg/mL ascorbic acid solution.
Claim 26 is directed to a method of detecting a prostate tumor or cancer as set forth therein.
Claim 36 is directed to a method of radiolabeling gozetotide with a metal radionuclide as set forth therein.
Applicant’s Election
Once again, Applicant's election with traverse of Group III (pending claims 25 and 29-35) filed 9/15/2025 was acknowledged. The traversal was found non-persuasive for reasons of record in the restriction requirement mailed 7/15/2025 and those of record in the office action mailed 10/8/2025. Hence, the restriction requirement was still deemed proper and made FINAL.
Once again, Applicant elected the species wherein the chelate-functionalized targeting agent is Glu-urea-Lys-CC; stabilizer is ascorbic acid; radionuclide is gallium-68; metal inhibitor (co-chelating agent) is a sugar; and buffering agent is acetate. Prior art was found and the claims were rejected. Currently, the claims are amended.
Withdrawn Claims
Claims 26-28 and 36-41 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement filed 12/15/2025 was considered.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 2/9/2026 to the rejection of claim 25 made by the Examiner under 35 USC 102, 103, 112, and/or 101 has been fully considered and deemed persuasive because Applicant amended the claims to overcome the rejections. . Therefore, the said rejection is hereby WITHDRAWN.
Election By Original Presentation
In the previously examined claims, a required component is gallium-68 radioactive metal; thus, the radioactive metal is a required component that was removed from the claim and the claim amended to a radiolabeling kit comprising: (a) gozetotide (Glu-urea-Lys or PSMA-11)) and D-mannose as a lyophilized powder in an amount of 20-30 µg gozetotide and 5-15 µg D-mannose; (b) about 100 mg to about 200 mg anhydrous sodium acetate in 0.150-0.350 M HCl solution; and (c) about 200 mg/mL to about 300 mg/mL ascorbic acid solution.
The claim was examined as follows which incorporated the required component (gallium-68 radioactive metal) which is necessary for the radiolabeling kit.
(Examined claim 25) A radiolabeling kit comprising: (a) gallium-68 radioactive metal; (b) gozetotide and D-mannose as a lyophilized powder in an amount of 20-30 g gozetotide and 5-15 µg D-mannose; (c) about 100 mg to about 200 mg anhydrous sodium acetate in 0.150-0.350 M HCl solution; and (d) about 200 mg/mL to about 300 mg/mL ascorbic acid solution.
In other words, the radiolabeling component (gallium-68 radioactive metal) was inadvertently omitted in the amended claim.
Written Description Rejection
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 25 and 29-35 are 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.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what it was before. The inventor must be able to describe the item patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates to the absence of the gallium-68 from the radiolabeling kit (for example, see specification, page 3, lines 9-13; pages 15-17 (Aspect 25 - Aspect 34). Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
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 25 and 29-35 are 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.
Claims 25 and 29-35: Independent claim 25 is ambiguous because it is directed to a radiolabeling kit but does not include a radiolabeling component (gallium-68 radioactive metal). The metal was previously in the claim; however, gallium-68 appears to have been inadvertently deleted in the amendment filed 2/9/2026.
Since claims 29-35 depend upon independent claim 25 for clarity, those claims are also vague and indefinite.
Claim 25, line 16: Did Applicant intend to write ‘0.150’ and ‘0.350’ instead of values with comma? The commas should be replaced with decimal points.
Claims 30-34: The claims are ambiguous because they refer to subject matter that appear in ‘i)’, ‘ii)’, and ‘iii)’. Those sections are not present in independent claim 25 from which all the claims depend.
Claims 30 and 31: The claims are ambiguous because of the phrase ‘a from’ appearing in line 2. Did Applicant intend to replace the phrase with ‘an amount of’?
Claim 34: The claim is ambiguous because of the phrase ‘about 15 to about 40 mg’. In particular, the units ‘mg’ are not consistent with that of claim 25 from which it dependents. In claim 25, the amount of ascorbic acid is given in ‘mg/mL’.
Claim 35: The claim is ambiguous because it is a product claim that incorporates active steps and the intended use of the product. Specifically, the active step in the claim is ‘after radiolabeling with Ga-68,Vial 1 contains up to about 500mCi of gallium-68 radiolabeled gozetotide for use as a multiple dose vial for injection into subjects’.
According to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product (kit), the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has a product comprising gallium-68, gozetotide, D-mannose, sodium acetate, HCl, and ascorbic acid or when after radiolabeling with Ga-68the amount of gallium-68 reaches about 500 mCi or when the radiolabeled gozetotide is injected as a multiple dosage.
Claim 35: The claims recites the limitation "gallium-68" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Comments/Notes
For clarity of the claims, the following suggestions are respectfully made: (1) in claim 29, line 2, replace ‘a lyophilized powder’ with ‘the lyophilized powder’; (2) in claim 30, line 2, replace ‘a from’ with ‘an amount of’; (3) in claim 31, line 2, replace ‘a from’ with ‘an amount of’; and (4) claim 32, lines 1-2, replace ‘a lyophilized powder’ with ‘the lyophilized powder’
It should be noted that the full scope of claims 25 and 29-35 was searched. It should be noted that the claim was searched with gallium-68 which is the radiolabeling components that appeared to be inadvertently deleted in the amendment filed 2/9/2026. Please see the detailed explanation supra.
Applicant is reminded that it has been held that the recitation that an element is ‘capable of’ performing a function is not a positive limitation but only requires the ability to perform that function. Thus, such terminology does not constitute a limitation in any patentable sense (In re Hutchison, 69 USPQ 138). ‘Capable of’ terminology is found in examined claim 25, lines 3-4 and 10-13).
Note(s): In claim 25, lines 1-2, the intended use of the radiolabeling kit is ‘for producing a radiolabeled chelate-functionalized targeting agent with an activity of at least about 50 mCi’.
Conclusion
Claims 25 and 29-35 are rejected. Claims 26-28 and 36-41 are withdrawn.
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 replying 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.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley can be reached at (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
August 20, 2026
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