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 .
Claim Interpretation
The prefix “m” (e.g. mCi, etc.) is understood to be “milli” rather than “micro”, especially given the claims’ use of the prefix “µ” (micro), even within the same claim (e.g. clms. 10-14).
Response to Arguments
Applicant's 12-5-25 arguments vis-a-vis 35 U.S.C. 112 rejections, simply stating that the rejections were addressed by the 12-5-25 amendments, have been fully considered and are persuasive in view of said arguments. These rejections are withdrawn.
Applicant's 12-5-25 arguments vis-a-vis prior art rejections over KR20230066382A (published 5-15-23) (incl. machine English transl’n, “EMT”) (“’382”), simply stating that the rejections were addressed by the 12-5-25 amendments, have been fully considered and are persuasive in view of said arguments. These rejections are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d)/4th par. as being of improper dependent form for failing to include all the limitations of the claim upon which it depends. Claim 20 recites a 15-25 Ci amount/concentration of 64Cu, but claim 1 recites a 16-110 Ci 64Cu range. See MPEP 608.01(n)III; see also Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1362 (Fed. Cir. 2016) (stating that “A dependent claim that contradicts, rather than narrows, the claim from which it depends is invalid” under 35 U.S.C. 112(d)/4th par.).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6, 14, and 22-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the 2010 Bokhari et al. article (see applicant’s 12-26-25 IDS) (“Bokhari”). Regarding claims 1, 4, 6, 14, and 22-30, Bokhari discloses ~58.89 Ci Cu64 of ≥95% radiochemical purity and a 3.83 mCi 64Cu/mg Cu specific activity, which converts to 3,830 mCi 64Cu/µg Cu. See Bokhari at, e.g., p. 268 (1st-2nd full par.); Table 2 (12 hr data column; values converted from mCi to Ci).
Claim 20 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Pipes et al., US 2022/0064015 (published 3-3-22; filed 9-3-21; US Prov’l Appl’n filed 9-3-20) (“Pipes”). Regarding claim 20, as the claim’s limitations are considered additional limitations upon claim 1’s (notwithstanding the 35 U.S.C. 112(d)/4th par. rejection of claim 20 detailed above for contradicting claim 1), Pipes discloses a composition comprising ~2-15 Ci of 64Cu having a specific activity of ≥3800 mCi 64Cu/µg Cu. See Pipes at, e.g., par. 18 and 92; clms. 1 and 6-7.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
In considering the obviousness rejections below, the applicant should note that the person having ordinary skill in the art at the time of the effective filing date of the claimed invention has the capability of understanding the scientific and engineering principles applicable to the claimed invention. The references of record in the application reasonably reflect this level of skill.
Claims 5 and 15-19 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Bokhari. Regarding claim 5, Bokhari’s teaching of a composition comprising ~58.89 Ci Cu64 of ≥95% radiochemical purity is as detailed above. While Bokhari’s ~58.89 Ci of 64Cu lies slightly below the claimed minimum, this is nevertheless not considered to connote patentability, as the former is considered to be close enough to the latter (i.e. 60 Ci) such that those of ordinary skill in the art would reasonably have considered Bokhari’s composition to have similar properties and performance to that claimed- a prima facie case of obviousness exists where the claimed and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties (or results). See MPEP 2144.05 I; Titanium Metals Co. of Am. v. Banner, 778 F.2d 775 (Fed. Cir. 1985); Accord, In re Kirsch, Barnby, and Potts, 182 USPQ 286, 290 (CCPA 1974) (finding that prior art teachings lying slightly outside of a claimed range nevertheless negate non-obviousness, especially in the absence of any criticality statements regarding the claimed range).
Regarding claims 15-19, Bokhari’s Table 2 12h data column appears to show a total amount of 145 ppm of the claimed impurities. While this is above the claimed ranges, it nevertheless would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to purify Bokhari’s product to remove impurities to achieve a desired purity level, such as those claimed, via routine experimentation. MPEP 2144.05, citing In re Aller, 220 F.2d 454, 456 (CCPA 1955). Without more (such as a showing of unexpected properties upon purification, etc.- see MPEP 2144.04 VII), the mere step of purifying a prior art product is an obvious and ubiquitously performed step within the chemical arts and otherwise. See, e.g., In re Spatz and Koral, 387 F.2d 663, 668 (CCPA 1967) (Kirkpatrick, J., concurring). See also MPEP 2143 B (Ex. 8), citing Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 1301 (Fed. Cir. 2007).
Claims 1-2, 6-20, and 25 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Pipes. Regarding claims 1-2 and 25, Pipes teaches a composition comprising ~4-15 Ci of 64Cu at a radionuclidic (i.e. radiochemical) purity of >98.5%, >99%, >99.5%, or >99.9%. See Pipes at, e.g., par. 18, 21-23, and 92. While Pipes’ 15 Ci maximum lies slightly below the claimed ranges, this is nevertheless not considered to connote patentability, as Pipes’ cited maximum is considered to be close enough to the claimed minimum (16 Ci) such that those of ordinary skill in the art would reasonably have considered Pipes’ composition to have similar properties and performance to those claimed- a prima facie case of obviousness exists where the claimed and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties (or results). See MPEP 2144.05 I; Titanium Metals; Accord, In re Kirsch, Barnby, and Potts.
Regarding claims 6-14, Pipes’ composition has a specific activity of ≤3800 mCi 64Cu/µg Cu; ranges of ~100-500, ~500-1000, ~1000-1500, ~1500-2500, ~3000-3800 mCi 64Cu/µg Cu are also specifically taught. See Pipes at, e.g., par. 10, 18, 24, and 92.
Regarding claims 15-17, Pipes’ composition comprises impurities within the claimed ranges. See id. at, e.g., par. 25.
Regarding claims 18-19, and additionally and/or alternatively regarding claims 15-17, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to purify Pipes’ composition to achieve/maintain desired impurity levels, such as those claimed, via routine experimentation. MPEP 2144.05, citing In re Aller. Without more (such as a showing of unexpected properties upon purification, etc.- see MPEP 2144.04 VII), the mere step of purifying a prior art product is an obvious and ubiquitously performed step within the chemical arts and otherwise. In re Spatz and Koral (Kirkpatrick, J., concurring); see also MPEP 2143 B (Ex. 8), citing Aventis Pharma.
Regarding claim 20, Pipes teaches a composition comprising ~2-15 Ci of 64Cu having a specific activity of ≥3800 mCi 64Cu/µg Cu. See Pipes at, e.g., par. 18 and 92; clms. 1 and 6-7.
Claim Objections/Potentially Allowable Subject Matter
Claims 3 and 21 are objected to as being dependent upon rejected base claims, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claims 3 and 21, the most pertinent prior art of record appears to be Bokhari and Pipes, whose teachings and suggestions are detailed above. Neither reference, however, is considered to anticipate or render prima facie obvious a composition comprising 25-50 Ci of 64Cu.
Conclusion
Applicant's amendments and/or 12-26-25 submission of an IDS under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) prompted the/any new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b) & 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 DANIEL BERNS whose telephone number is (469)295-9161. The examiner can normally be reached M-F 8:30-5:00 (Central). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Zimmer can be reached at (571) 270-3591. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL BERNS/ February 11, 2026
Primary Examiner
Art Unit 1736