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 .
Priority
The instant application, filed 01/21/2022, is a 371 filing of PCT/US2020/043141, filed 07/22/2020, which claims domestic priority to provisional U.S. Application Nos. 62/933,655, filed 11/11/2019, 62/910,764, filed 10/04/2019, and 62/877,039, filed 07/22/2019.
Amendments and Claim Status
The amendment filed on 10/10/2025 is acknowledged and entered. Claim 1 is amended. Claims 2-22, 26-34, 37, 38, 41, 42, 45-62 are cancelled; Claims 1, 23-25, 35, 36, 39, 40, 43, 44, and 63-72 are pending and are under prosecution.
Information Disclosure Statement
An information disclosure statement (IDS) has not been received.
Response to Arguments
Applicant’s arguments filed 10/10/2025 with respect to the claim objections and claim rejections under 35 U.S.C. § 112(a) and nonstatutory double patenting have been fully considered.
With respect to the objection to claims 69-71, the objection is withdrawn. However claims 69-71 are now included in the existing rejection of claim 1.
With respect to the rejection of claims 1, 5, 11, 13, 23-25, 35, 36, 39, 40, 43, 44, and 51 under 35 U.S.C. § 112 (a) as failing to comply with the written description requirement, the cancellation of claims 5, 11, 13, and 51 are sufficient to render the rejection against said claims moot. However, Applicant’s arguments have been fully considered but are not persuasive for the reasons set forth below. The arguments made by Applicant are herein addressed as follows.
The following section of the MPEP is relied upon for response to Applicant’s arguments. According to MPEP § 2163.02, the standard for determining compliance with the written description requirement is as follows,
Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"
Applicant asserts that, in view of the high level of ordinary skill in the art, less specificity is required in the specification to satisfy the written description requirement. Applicant relies on MPEP §2163 and cited case law for the proposition that well-known information need not be described in detail.
Applicant’s argument is found unpersuasive, because written description requires possession, not merely feasibility. While the level of skill in the art is relevant, it cannot substitute for written description to demonstrate possession of the claimed compounds. The written description requirement is satisfied only when the specification reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. General statements of feasibility or references to what could be made by a skilled artisan do not establish possession.
Applicant further argues that the art referenced in the remarks (WO 2021155288 A1, WO 2009026177, and other publications) demonstrates the feasibility of making compounds with similar Q groups, heterocycles, linkers, chelators, and substituents including quinoline and boronic-acid -containing FAP ligands.
Applicant’s argument is found unpersuasive because reliance on references does not cure the deficiency of the specification in providing written description. These references do not disclose the specific claimed compounds, nor do they demonstrate that Applicant had possession of the claimed genus or species. Incorporating concepts from the prior art does not establish that Applicant possessed the instantly claimed compounds, particularly where the specification lacks corresponding structural disclosure.
Applicant furthermore contends that the specification, together with the cited references, demonstrates that various linkers, spacers, and chelator groups were known and could be incorporated into the claimed compounds.
Applicant’s argument is found unpersuasive because the specification fails to provide representative species, working examples, or structural features that correlate with the full scope of the claimed compounds. The cited examples and figures in the prior art do not map to the claims in a manner that would demonstrate possession of compounds encompassing the claimed substituents, Q groups, linkers, and chelators.
Finally, Applicant argues that actual synthesis or characterization of the claimed compounds is not required, in that possession can be shown through a combination of disclosure and knowledge in the art.
Applicant’s argument is found unpersuasive because the asserted possession is unsupported. The specification does not describe the claimed compounds with sufficient specificity to distinguish them from the universe of possible conjugates and substitutions that can be theoretically made.
Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Thus, all arguments presented by Applicants have been addressed and are found unpersuasive for the reasons presented herein and in the previous non-final rejection. Applicants are reminded that “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Accordingly, applicant has not demonstrated the possession of the claimed compounds as required under 35 U.S.C. § 112 (a). The rejection is therefore maintained. However, the Examiner acknowledges that claims 68-71 were inadvertently not included with the list of claims indicated as rejected under 35 U.S.C. § 112 (a). Since claims 68-71 depend upon claim 1 and are broadly drawn to a compound of claim 1 as indicated in the previous rejection, said claims are herein included in the updated 112a rejection although not previously indicated. Accordingly, claims 68-71 are added to the list of claims rejected under 35 USC § 112(a). Applicant is invited to amend the claims to correspond to subject matter that is adequately supported by the specification, or to provide persuasive evidence demonstrating possession of the claimed compounds as of the effective filing date.
With respect to the rejection of claims 1, 5, 8, 11, 13, 23-25, 35-36, 39-40, 43-44, 51, 68 and 72 on the grounds of nonstatutory double patenting, Applicant’s arguments, filed 10/10/2025 are sufficient to overcome the rejection.
Claim Rejections - 35 U.S.C. § 112
9. 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 1, 23-25, 35, 36, 39, 40, 43, 44, and 68-71 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 1, 23-25, 35, 36, 39, 40, 43, 44 and 68 of the instant application are drawn to compounds having following substituents:
R1 and R1’ are H, alkyl, aryl, nitrile, COOH, B(OH)2, SO3H, and PO3H
R2 and R2’ are H, halo, dihalo, alkyl, aryl, and heteroaryl
R3 is H, CH3, alkyl, alkenyl, aryl, or heteroaryl
R4 is H, alkyl, alkenyl, aryl, heteroaryl, halo, dihalo, dialkyl, or diaryl
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LQ is polyethylene glycol, an alkyl chain, peptidoglycan, and oligopeptide, or a polypeptide
LX is
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35 U.S.C. § 112(a) and the first paragraph of pre-AIA 35 U.S.C. § 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
An Applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the absence of any working example of the invention as claimed, and the lack of predictability in the art.
In the instant specification, there is no disclosure of compounds with the following claimed substituents:
R1 and R1’ as alkyl, aryl, COOH, B(OH)2, SO3H, and PO3H
R2 and R2’ as halo, alkyl, aryl, and heteroaryl
R3 as alkyl, alkenyl, aryl, or heteroaryl
R4 as Fluoro, Bromo, Iodo, alkyl, alkenyl, aryl, dihalo, dialkyl, or diaryl
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LQ as an alkyl chain, peptidoglycan, and oligopeptide, or a polypeptide
LX as
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The instant specification (pages 42 and 43) teaches compounds which are characterized as having only the following substituents:
R1 and R1’ are H, nitrile
R2 and R2’ are H, dihalo
R3 is H, CH3,
R4 is H, Chloro
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LQ is oligoethylene glycol, polyethylene glycol
LX is
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Therefore, the compounds described in the instant specification detail only a limited number of the substituents claimed of the total (see 1-8, above). All working examples presented in the instant specification are related to the compounds containing a fraction of the total claimed substituents (see 17-23, above).
There are no working examples in the instant specification for the wide range of substituents claimed but for which evidence of possession has not been provided (see 9-16, above), and thus the instant specification does not provide any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012,10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.") Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021.
Thus, since Applicant has not described in adequate detail methods to synthesize compounds containing the claimed substituents, or provided evidence that said compounds have been characterized, or that they exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application. Thus, claims 1, 23-25, 35, 36, 39, 40, 43, 44 and 68 of the instant application are not supported by the instant specification and thus a rejection under 35 U.S.C. § 112 (a) for failing to comply with the written description requirement is proper.
Statement of Allowable Subject Matter
The following is a statement of allowable subject matter:
The claims 63-67 and 72 are drawn to six chemical compounds which are radiolabeled FAP targeting conjugates, comprising a defined (Q-LQ)m-Y-LX-X, wherein X is a radionuclide imaging agent covalently attached to the claimed linker configuration. In searches of the prior art, the teachings of Low and Roy (WO 2018111989 A1, published June 21, 2018) were identified. However, this reference lacks the essential element of the radiometal-based imaging moiety, and the corresponding chelation and attachment chemistry required for radionuclide imaging. While reference teaches FAP targeting conjugates suitable for optical imaging, this teaching is specific to fluorescent dyes and optical detection modalities. The instant application claims radiolabeled compounds of claims 63-68, which are structurally and functionally distinct from that of the prior art. Accordingly, the teachings of Low and Roy do not encompass the scope of the instantly claimed compounds, which are novel and nonobvious over the prior art at. This reference lacks identical or obvious limitations of the claims. A person of ordinary skill in the art would not have expected that modifying the fluorescent conjugates of the prior art to incorporate a radiometal imaging agent would retain the targeting and imaging characteristics as disclosed in the prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should clearly be labeled, “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 1, 23-25, 35, 36, 39, 40, 43, 44, and 68-71 are rejected.
Claims 63-67 and 72 are allowed,
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623