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 .
Applicant’s reply and amendment filed 11/13/2025, are acknowledged. Claims 18-37 are pending.
Response to Arguments
Applicant’s arguments have been fully considered and are persuasive. The rejection of 8/13/2025 has been withdrawn.
Claim Rejections - 35 USC § 112
Claims 27 and 34 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.
Regarding claim 27, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 27 recites the broad recitation “solid cancer,” and the claim also recites "the cancer is typically selected" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt, particularly with the use of the term “typically,” as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Also, claim 27 recites the limitation “the cancerous tumor and/or cancerous tumor vasculature”. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation “the disease or disorder.” There is insufficient antecedent basis for this limitation in the claim.
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) 18-22, 24, 25 and 29-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oudit et al. (US2019/0010202).
Regarding claim 18, Oudit et al. relates to apelin peptides and uses thereof. See Title. In this regard, Oudit et al. teaches that “[t]he peptide can also be labeled for detection using
fluorescence-emitting metals such as 152 Eu, or others of the lanthanide series. These metals can be attached to the peptide using such metal chelating groups as diethylenetriaminepentaacetic
acid (DTPA) or ethylenediaminetetraacetic acid (EDTA)” (current claim 19). Para. [0132]. Peptides include Apelin-13, which reads on Seq Id. No. 7. See para. [0040].
Regarding claims 20-22, metallic ions which can be bound to peptides include 68 Ga. See para. [0137].
Regarding claims 24, “[t]he labeled apelin peptide may also be utilized in vivo for diagnosis and prognosis, or for other types of in situ evaluations.” Para. [0125]. Oudit et al. also teaches that “Apelin is predominantly expressed in the endocardial and vascular endothelial cells while the APJ receptor (apelin receptor) is localized to endothelial and smooth muscle cells as well as cardiomyocytes. Para. [0172]. Further, Oudit et al. teaches “contacting the apelin receptor with an apelin peptide . . . or pharmaceutically acceptable salts thereof . . [wherein] the contacting step is performed in vivo.” Para. [0178].
Regarding claims 25 and 29, Oudit et al. teaches that “[t]he dose range for humans is generally from 5 mg to 2 g per day.” Para. [0117].
Regarding claim 30, Oudit et al. teaches apelin-13 ((Pry)RPRLSHKGPMPF (SEQ ID NO:1). See para. [0003]. This reads on SEQ ID NO. 1. Oudit et al. also teaches using a radionuclide for detectable radiation. See para. [0136].
Regarding claim 31, Qudit et al. teaches “treating various diseases and disorder of the cardiovascular system.” Para. [0007].
Regarding claim 32, Oudit et al. teaches that “[t]he dose range for humans is generally from 5 mg to 2 g per day.” Para. [0117].
Regarding claim 33, insofar as Oudit et al. does not teach “evaluating or monitoring the therapeutic effect of an angiogenic or anti-angiogenic treatment, or of an APJ receptor-targeting treatment,” granting a patent on the discovery of an unknown but inherent function (here the intended purposes of the claimed method) would remove from the public that which is in the public domain by virtue of its inclusion in or obviousness from the prior art. Here, Oudit et al. already teaches administering the claimed apelin conjugate, which reads on the only positive, active step of Applicant's claimed method i.e., administration. Thus, the method of Oudit et al. would naturally allow for the intended purpose of the claimed method. See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (“when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated.”)
Regarding claim 34, Qudit et al. teaches “treating various diseases and disorder of the cardiovascular system.” Para. [0007].
Regarding claim 35, Oudit et al. teaches that “[t]he dose range for humans is generally from 5 mg to 2 g per day.” Para. [0117].
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 23, 26, 28, 36 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oudit et al. (US 2019/0010202) as applied to claims 18-22, 24, 25 and 29-35 above, and further in view of Liu et al. (US 2019/0382504).
Teachings of Oudit et al. are discussed above.
Regarding claim 23, Oudit et al. does not teach the recited radionuclides .
Liu et al. relates to anti-EMC constructs. See para. [0044]. The constructs may be fused to a detectable moiety such as radioactive isotopes, e.g., 68Ga, 67Ga, 90Y and 177Lu. See id. and paras. [0503]-[0504].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the composition of Oudit et al. with the teachings of Liu et al, with the modification being the simple substitution of one known element for another to obtain predictable results. Here, where both Oudit et al. and Liu et al. teach 68Ga and 67Ga, and Liu et al. further teaches 90Y and 177Lu as obvious variants to 68Ga and 67Ga, one of ordinary skill in the art could have substituted one known radionuclide for another and the results of the substitution would have been predictable.
Regarding claim 26, Qudit et al. teaches “treating various diseases and disorder of the cardiovascular system.” Para. [0007].
Regarding claim 27, Liu et al. teaches
Regarding claims 36 and 37, Qudit et al. does not teach a kit wherein each component of a conjugate is held in “three distinct containers.” Although Qudit et al. does not teach or suggest any kit, packaging or containing a composition, particularly a pharmaceutical formulation, intended for administration to a subject would have been a factor for consideration generally by one of ordinary skill in the art. That said, Liu et al. generally describes kits in connection with the making and using of its construct which include various containers typically used for compositions for treating disease or disorders. See paras. [0049] and [0505]. For instance, “[t]he anti-EMC construct and the other agent(s) can be present in separate container or in a single container.” Para. [0509].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to contain the components of Qudit et al. in separate containers as taught and/or suggested by Liu et al. “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.” In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). Here, an advantage or expected beneficial result from the combination of references would have been simply the incorporation of means for containing and/or using components used to make Qudit et al.’s composition with such means being commonly known and used as suggested by Liu et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/ Primary Examiner, Art Unit 1614