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 .
Receipt is acknowledged of Applicants Amendments and Arguments filed on 04/08/2026.
Claim 16 has been amended. Claims 15-18 are pending and presented for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/02/2026 was noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Any previous rejections and/or objections not reiterated herein have been withdrawn. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
Claim limitation “means” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. No association between the structure and the function can be found in the specification. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. The rejection is maintained for reasons of record in the previous office action filed on 11/26/2025.
Claim Rejections - 35 USC § 112
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 15-18 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. Claims are drawn to a composition comprising; (a) means for treating prostate cancer or a metastasis thereof and (b) a pharmaceutically acceptable carrier. However, the claims are devoid of any structural elements or compounds that correlates to the function which is to be achieved for treating prostate cancer or a metastasis thereof. The specification provides insufficient written description to support the genus of compounds that interact with PSMA or have high affinity for PSMA, encompassed by the claim, since there is no description of the structural relationship of these compounds provided in the specification and Applicant has not provided a description as to how the base molecule may be changed while remaining a derivative. The person of ordinary skill in the art could not predict whether a particular molecule possesses the function of treating prostate cancer or a metastasis other than the species disclosed in specification. In the instant case, a definition by function alone does not appear to sufficiently describe the claimed invention because it is only an indication of what the agent does, rather than what it is. The rejection is maintained for reasons of record in the previous office action filed on 11/26/2025.
Applicant arguments filed on 04/06/2026 have been fully considered but they are not persuasive. Applicant argues that that structure corresponding to the "means for treating prostate cancer or a metastasis thereof" is that identified by Applicant in the Preliminary Amendment, i.e. (i) compounds represented by formulae (la) and (lb) (including the species described in the specification and examples), (ii) wherein the compounds are complexed to a radionuclide via the chelator as described in the specification. This argument is not persuasive since claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language as it would be understood by one of ordinary skill in the art. Importing limitations from the specification cannot read into claims for treating prostate cancer or a metastasis thereof or a non-structural term having no specific structural meaning for performing the claimed function. The claim limitation(s) recited with functional language without reciting sufficient structure to perform the recited function for treating prostate cancer with the claimed composition. For example, a vast numbers of potential vector moieties have an affinity for an abnormally expressed target in prostate cancer may be found in the art to be capable of having the claimed function. Applicant may: (1) amend the claim by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function on its own. The compounds described in the specifications encompasses three principle components; the hydrophilic PSMA binding motfit (Glu-Urea-Lys; = Gly-NH-CO-NH-Lys), a variable linker and the variable chelators are very specific with each of these components. The person of ordinary skill in the art could not predict whether variable linkers and chelators combinations with specific radionuclides complexed to the chelator possesses the same function of treating prostate cancer as recited in the claims. In the instant case, a definition by function alone does not appear to sufficiently describe the claimed invention because it is only an indication of what the agent does, rather than what it is.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pomper et al. (US 2012/0009121) are maintained for reasons of in the previous office action filed on 11/26/2025.
Pomper discloses prostate specific membrane antigen (PSMA) binding compounds, chemical precursors of PSMA binding compounds and imaging methods of using the compounds (abstract and 0004). In embodiment include methods of treating a tumor comprising administering a therapeutically effective amount of a compound, where the compound includes a therapeutically effective radioisotope. The tumor cells may express PSMA, such as prostate tumor cells or metastasized prostate tumor cells (0189). In embodiment, includes method of treating a tumor comprising administering a therapeutically effective amount of a compound of the structure (claim 1)
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The compounds can be formulated into various compositions, for use in diagnostic, imaging or therapeutic treatment methods, which comprises a compound and pharmaceutically acceptable carrier. Some suitable pharmaceutical carriers include, e.g., water (including sterile and/or deionized water), suitable buffers (such as PBS), physiological saline, cell culture medium (such as DMEM), artificial cerebral spinal fluid, or the like (0193-0194). Thus, prior art composition comprising prostate specific membrane antigen (PSMA)binding compounds, chemical precursors of PSMA binding compounds could clearly anticipates the instantly claimed composition for treating prostate cancer or a metastasis thereof.
Claim(s) 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chandran et al. (US 2011/0200677) are maintained for reasons of in the previous office action filed on 11/26/2025.
Chandran discloses a method for treating or preventing a disease or disorder in a subject, the method comprising the step of administering to the subject a nanoparticle composition, such that the administration of the nanoparticle composition is effective to treat or prevent said disease or disorder, wherein the nanoparticle composition comprises a) a prostate specific membrane antigen (PSMA) inhibitor; b) a linker, c) a biologically active agent; and d) a nanoparticle; or a nanoparticle composition of formula I:
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(abstract), wherein the disease is prostate cancer or metastasis (claims 50-53). In certain preferred embodiments, provides a kit containing a composition, in combination with a pharmaceutically acceptable carrier. The composition and carrier may be provided in solution or in lyophilized form. When the composition and carrier of the kit are in lyophilized form, the kit may optionally contain a sterile and physiologically acceptable reconstitution medium such as water, saline, buffered saline, and the like (0202). Thus, prior art composition comprising prostate specific membrane antigen (PSMA) binding compounds, chemical precursors of PSMA binding compounds could clearly anticipates the instantly claimed composition for treating prostate cancer or a metastasis thereof.
Claim(s) 15-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Babich et al. (US 2013/0034494) are maintained for reasons of in the previous office action filed on 11/26/2025.
Babich discloses a pharmaceutical composition of a complex of a radionuclide and a Formula I compound or a Formula II compound and method of using the compounds for treating or diagnosis of a disease or a condition associated with PSMA activity (abstract).
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The pharmaceutical composition includes pharmaceutically acceptable carrier such as a liquid or solid filler, diluent, excipient, or solvent encapsulating material and buffering agents such as magnesium hydroxide and aluminum hydroxide; alginic acid; pyrogen-free water; isotonic saline; Ringer's solution; ethyl alcohol; pH buffered solutions; and other non-toxic compatible substances employed in pharmaceutical formulations. Thus, prior art composition comprising prostate specific membrane antigen (PSMA) binding compounds could clearly anticipate the instantly claimed composition for treating prostate cancer or a metastasis thereof.
Applicant further argues that the office has performed a functional analysis but the 102 rejections does not address the structural differences between the compounds of Pomper, Chandran, and Babich and those corresponding to the claimed means for treating prostate cancer or a metastasis thereof as required for a means-plus-function analysis. This argument is not persuasive since, claims for treating prostate cancer or a metastasis thereof or a non-structural term having no specific structural meaning for performing the claimed function. The claim limitation(s) recited with functional language without reciting sufficient structure to perform the recited function for treating prostate cancer with the claimed composition. Further prior art compositions of Pomper, Chandran, and Babich, comprising prostate specific membrane antigen (PSMA) binding compounds, chemical precursors of PSMA binding compounds could clearly anticipates the instantly claimed composition for treating prostate cancer or metastasis thereof.
Conclusion
No claims are allowed at this time.
THIS ACTION IS MADE FINAL. 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 JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Hartley G Michael 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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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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