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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
The amendments filed on July 8, 2026 have been entered. Claims 12-15 are pending in the application. Claims 13-15 and 24-25 are withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Group III, which encompasses claim 12 and newly-added claims 16-23, in the reply filed on July 8, 2026 is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 8, 2026.
Newly submitted claims 24-25 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claims 24-25 are directed toward a radioactive polymerizable solution, which is distinct from the method of claims 12 and 16-23 because the shared technical features do not make a contribution over the prior art in view of Läppchen et al ("3D printing of radioactive phantoms for nuclear medicine imaging", EJNMMI PHYSICS, Vol. 7, No. 1, 22 April 2020 (2020-04-22), page 1-13), for the reasons set forth in the rejection below.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 24-25 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
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 12 and 16-23 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.
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 12 recites the broad recitation “the ratio of carbon atoms and/silicon atoms is ≥ 2:1” in lines 13-14, and the claim also recites “particularly ≥ 2.5:1, more particularly ≥ 3:1” in lines 14-15, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claims 16-23 are indefinite due to dependence on indefinite claim 12.
Claim 12 recites the broad recitation “ the mass of the complex-forming lipophilic ligand is < 5000 g/mol” in lines 19-20, and the claim also recites “particularly < 1500 g/mol” in line 20, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 12 recites the broad recitation “an initiator” in line 39, and the claim also recites “particularly a photoinitiator, more particularly phenylbis(2,4,6-trimethylbenzoyl)phosphine oxide” in lines 39-40, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 16 recites the broad recitation “Ge, Na, Co, or Lu” in line 2, and the claim also recites “particularly 68Ge, 22Na, 57Co or 177Lu” in line 2, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 18 recites the broad recitation “a gallate” in line 3, and the claim also recites “particularly an alkyl gallate” in line 3, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 18 recites the broad recitation “a gallate…alkyl chains” in lines 3-17, and the claim also recites “in particular from a gallate…alkyl chains” in lines 17-31, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 18 recites the broad recitation “a gallate” in line 18, and the claim also recites “particularly an alkyl gallate” in line 18, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 20 recites the broad recitation “a hydrophobic amine” in lines 1-2, and the claim also recites “particularly a mono-, di-, or trialkylamine” in line 2, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 22 recites the broad recitation “a mono-acrylate, a di-acrylate, and a tri-acrylate” in lines 2-3, and the claim also recites “particularly tricyclodecane dimethanol diacrylate, mono-, di-, or tr- ethylene glycol diacrylate, bisphenol A ethoxylate diacrylate” in lines 3-5, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 22 recites the broad recitation “a mono-methacrylate, a di-methacrylate and a tri-methacrylate” in lines 7-8, and the claim also recites “particularly tricyclodecane dimethanol di(meth)acrylate, mono-, di-, or tri-ethylene glycol di(meth)acrylate, bisphenol A ethoxylate dimethacrylate” in lines 9-11, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 23 recites the broad recitation “an acrylate, a methacrylate, and acetate or a mixture thereof” in line 2, and the claim also recites “particularly from an alkylacrylate, alkylmethacrylate and alkylacetate or a mixture thereof” in lines 3-4, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt 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.
Claim 17 recites the limitation "the radiometal-complex" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of further examination, it is taken to read as “a radiometal-complex formed by the cationic radionuclide and the complex-forming lipophilic ligand.”
Claim 17 recites the limitation "the extraction" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of further examination, this is taken to refer to the separating and collecting of the radioactive organic phase in step (c) of claim 12.
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.
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.
Claims 12 and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Läppchen et al ("3D printing of radioactive phantoms for nuclear medicine imaging", EJNMMI PHYSICS, Vol. 7, No. 1, 22 April 2020 (2020-04-22), page 1-13), as evidenced by Cyclotron Co., Ltd (Cobalt-57, webpage, archived 17 June 2016) and PubChem (Compound: Trioctylphosphine, Created 26 March 2005, p.1).
Regarding Claims 12, 16, 18, and 22: Läppchen teaches a method of preparing a radioactive polymerizable solution, comprising a step of providing an aqueous radionuclide solution (TcO4), a complex-forming lipophilic ligand (trioctylphosphine), an organic solvent (n-butyl acetate), and a monomer solution comprising triethylene glycol diacrylate, tricyclodecane dimethanol diacrylate and a photoinitiator, which is not miscible with the aqueous radionuclide solution (p.3, Methods), a step of mixing the radionuclide solution with the ligand and the organic solvent, separating and collecting the organic phase/extracting the radionuclide into the organic solvent, and adding the monomer solution to the organic phase (p.4, para. 1), followed by polymerization by using UV light (p.5, Post-printing treatment). PubChem teaches that the lipophilic ligand, trioctylphosphine, contains one or more carbon atoms and a phosphorus heteroatom, wherein the ratio of carbon atoms to heteroatoms is 24:1, and wherein the molecular weight is 370.6 g/mol (p.1, Molecular Formula and Molecular Weight).
Läppchen does not teach that the radionuclide is a cationic radionuclide with a half-life of greater than 5 days; however, Läppchen teaches that radionuclides such as Ge-68 and Co-57, which have half-lives of 271 days and 272 days, respectively, may be used in place of the Tc-99 for use in site qualification in multicenter clinical trials and for longitudinal measurements on a single PET/CT scanner (p.11, para. 2). Ge-68 and Co-57 are readily available, usually in cationic forms. For example, Cyclotron Co., Ltd teaches that a typical cobalt-57 is a Co(II) chloride salt (p.1, Chemical form). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the Tc-99 in the invention of Läppchen with a cationic radionuclide such as Co-57 to create a radioactive phantom for use in site qualification in multicenter clinical trials and for longitudinal measurements on a single PET/CT scanner.
Regarding Claim 17: The instant specification defines the distribution coefficient of a species as the ratio of the concentration of said species in the organic phase to its concentration in the aqueous phase (p.12, lines 5-10); as such, it is taken to be equivalent to the radioactivity concentration ratio taught by Läppchen.
Läppchen teaches a radioactivity concentration ratio between the organic and aqueous phase of greater than 2000:1 (p.1, first paragraph).
Regarding Claim 19: Although Läppchen teaches that modification of the lipophilic ligand is not necessary in the radiometal complex containing Tc-99, Läppchen teaches that adding acrylate moieties to the phosphine ligand covalently anchors the ligand in the resin through copolymerization (p.11, para. 1). Since Läppchen does not teach the immobilization of a Co-57 or Ge-68 complex in the resin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add acrylate moieties to the phosphine ligand to ensure its immobilization in the resin matrix.
Regarding Claim 20: Because the additive is not positively claimed, the limitations of claim 20 are considered optional.
Regarding Claim 21: In the case of using Co-57 as the radionuclide (taught at p.11, para. 2), this claim is considered optional.
Regarding Claim 23: Läppchen teaches an acetate solvent (p.1, para. 1, n-butyl acetate).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN N ILLING whose telephone number is (571)270-1940. The examiner can normally be reached Monday-Friday 8AM-4PM.
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, Mark Eashoo can be reached at (571)272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.N.I./Examiner, Art Unit 1767
/MARK EASHOO/Supervisory Patent Examiner, Art Unit 1767
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