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 .
Amendments
Applicants’ amendments to the claims filed 12/2/2025 have been entered. Any objection\rejections from the previous office action filed 6/6/2025 not addressed below has been withdrawn.
Claim Rejections - 35 USC § 112
Claims 1,3-4,7 and 9 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 and 7 recite the limitation, “derivative” in reference to a radiopharmaceutical used in the methos claimed. Applicant has not described the claimed genus of "derivative" in a manner that would indicate they were in possession of the full scope of this genus, or even to describe what this genus is comprised of. The instant specification does not describe these derivatives or their methods of preparation. Applicant has not described the claimed genus "derivative" in a manner that would indicate they were in possession of the full scope of this genus.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
In the instant case, the claimed " derivative" encompasses any compound that contains the identical core as the instantly claimed compound, with a differing of substituents quoted for the identical purpose. Applicants describe no "derivative" in the specification. Therefore, it is not described adequately enough to allow one skilled in the art to ascertain that Applicant is in possession of the entire scope of that genus. Applicants have not described this genus in a manner that would allow one skilled in the art to immediately envisage the compounds contemplated for use. As such, the claims lack adequate written description for the claimed " derivative." Claims 3-4 and 9 incorporate the formality issue. This new rejection was necessitated by amendment.
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 1,3-4,7 and 9 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.
See 2173.05(s).
The recitation of "derivatives " found in claims 1 and 7 when referring to the type of radiopharmaceutical renders the claim indefinite. The term “derivatives” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is encompassed and excluded by the limitation "derivative”. The Merriam-Webster’s Dictionary defines “derivative” as “a chemical substance related structurally to another substance and theoretically derivable from it” ([online], retrieved on 2015, at: http://www.merriamwebster.com /dictionary/derivative. Hence, one of ordinary skill would clearly recognize that derivatives or analogues of the radiopharmaceuticals claimed in claims 1 and 7, would read on any of those compounds having any widely varying groups that possibly substitute the compounds claimed. One of ordinary skill could not ascertain and interpret the metes and bounds of the patent protection desired as to these terms. Thus, it is unclear and indefinite as to how the “derivatives or analogues thereof” herein are encompassed thereby. Claims 3-4 and 9 incorporate the indefiniteness by dependency. This new rejection was necessitated by amendment.
Furthermore claims 3-4 and 9 do not agree with the independent claims from which they depend upon. Note that for claim 3 the type of cancer in claim 1 is closed to only hepatic metastases, the Markush group of other cancers no longer agrees. The claim is a remnant claim based on broader limitations of the types of cancer previously presented and should be canceled.
Similarly claims 4 and 9 do not agree from the base claims from which they depend. The radionucleotide in claims 1 and 7 is closed to 18F or 68Ga only, the Markush group of other radionucleotides no longer agrees. The claims are remnants based on broader limitations of the types of radionucleotides and should be canceled.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1,3-4,7 and 9 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kesler et al. “68Ga-Labeled Prostate-Specific Membrane Antigen Is a Novel PET/CT Tracer for Imaging of Hepatocellular Carcinoma: A Prospective Pilot Study”, THE JOURNAL OF NUCLEAR MEDICINE • Vol. 60 • No. 2 • February 2019.
Kesler discloses 68Ga-Labeled Prostate-Specific Membrane Antigen binding agents as an imagining agent for imagining hepatocellular carcinoma (HCC). See entire disclosure, especially abstract and conclusion. Kesler discloses “Current guidelines of the American Association for the Study of Liver Disease and the European Association for the Study of the Liver recommend HCC surveillance with abdominal ultrasound every 6 mo in patients at high risk of developing the disease. Patients diagnosed in early stages of HCC are eligible for potentially curative therapy. Therefore, early diagnosis and accurate staging are critical. Curative-intent therapies for HCC include surgical resection, liver transplantation and, for small tumors, radiofrequency ablation.” See ¶ bridging pages 185-186. Thus, applicants claimed method of early intervention with imaging and therapy if tumor is present would be readily envisaged by one of ordinary skill from this disclosure on the importance of early intervention for HCC therapy.
Claim(s) 1,3-4,7 and 9 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Dondi et al. “Radiolabelled PSMA PET/CT or PET/MRI in hepatocellular carcinoma (HCC): a systematic review”, Clinical and Translational Imaging (2020) 8:461–467.
Dondi reviews radiolabeled PSMA binding agents, including 68Ga in PET/CT or PET/MRI imagining of HCC. See entire disclosure, especially abstract, table 1. Dondi notes “Patients with early HCC, who receive potentially curative therapy (liver transplantation or resection) reach 5-year survival rates near 70%; on the other hand patients with advanced HCC have a median survival of less than 1 year. An early diagnosis is therefore fundamental to improve survival. Imaging is pivotal in the management of HCC allowing screening populations at risk, confirming the diagnosis, guiding therapy, following up and aims. Surgical resection and liver transplantation are the mainstay of treatment, offering the best chance of cure and early diagnosis usually results in a better outcome.” See page 462 1st and 2nd ¶. Thus, applicants claimed method of early intervention with imaging and therapy if tumor is present would be readily envisaged by one of ordinary skill from this disclosure on the importance of early intervention for HCC therapy.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1,3-4,7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kesler et al., cited above.
Kesler is disclosed above. While the examiner believes applicants claimed early detection is anticipated it would also be obvious when the teachings of the reference are considered. Kesler clearly teaches the importance of using detection methods every 6 months in patients at high risk for developing HCC. Patients diagnosed in early stages of HCC are eligible for potentially curative therapy. Therefore, early diagnosis and accurate staging are critical and one of ordinary skill in the art would find it obvious from this teaching and suggestion to use radiolabeled PSMA for early detection.
Claim(s) 1,3-4,7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dondi et al., cited above.
Dondi is disclosed above. While the examiner believes applicants claimed early detection is anticipated it would also be obvious when the teachings of the reference are considered. Dondi teaches the importance of early detection in regards to mortality rates and early detection of HCC reach 5-year survival rates near 70%; on the other hand patients with advanced HCC have a median survival of less than 1 year. Therefore, one of ordinary skill would find it obvious from this teaching and suggestion to use early detection methods with radiolabeled PSMA to diagnose early HCC to improve mortality.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,3-4,7 and 9 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.
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 JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael 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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/JAMES W ROGERS/Primary Examiner, Art Unit 1618