DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, presently claims 1-16, in the reply filed on 3/23/2026 is acknowledged.
Claims 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/23/2026
Claims 1-16 are under consideration on the merits.
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 7, 10, and 14 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.
Claims 7, 10, and 14 are indefinite because the claimed molar ratios recite repeating sequences A, C, or E in both the numerator and denominator, and so it is entirely unclear how any molar ratio is derived or what prior art would or would not read on these claims. While the denominator is plainly understood as the sum of both claimed repeating sequence(s), the recited equation(s) do not set forth any relative ratios of repeating sequences, A, C, or E to repeating sequences B, D, and F. In this context, molar ratios are conventionally represented as “ a ratio of A to B of 1:1” or “a molar ratio range of A to B of 0.5:1 to 2:1”. The Examiner’s examples are not meant to be limiting of claim scope, only indicative of exemplary language of molar ratios that would be reasonably clear under 35 U.S.C. § 112(b). Correction is required.
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.
Claims 1-3, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xue et al. (Materials (2018), 11(1), 95; provided in the IDS dated 6/30/2025).
Xue teaches a composition comprising poly(L-ornithine) conjugated to-NH2 and -NHCONH2 with a UCST (Tp) of 32 °C (Polymer 1), or <10% -NH2, >80% -NHCONH2, and 10% -NHCONHCH3 with a UCST (Tp) of 38 °C (Polymer 2), or <<10% -NH2, <80% -NHCONH2, and 10% NH-CONHCH3 with a UCST (Tp) of 39 °C (Polymer 2 (Table 1 and Figure 1) and wherein Polymers 1-3 are capable of detaching cells (subheading 2.3), anticipating claim 1, the embodiment of the terminal amine for the amino group of claim 2, the embodiment of poly(L-ornithine) for the polypeptide of claim 3. Polymer 1 of Xue anticipates claims 12 and 13, wherein 1) the -NHCONH2 of Xue maps to formula 12/sequence E of claims 12 and 13 wherein c = 0 and d = 3, and 2) the -NH2 of Xue maps to formula 13/sequence F of claims 12 and 13 wherein e = 0 and f = 3.
Claims 1-3, 9, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimida et al. (Biomacromolecules (2011), 12(10), 3418-3422; provided in the IDS dated 6/30/2025).
Shimida teaches compositions comprising a poly(allylamine)-co-poly(allylurea) polymer (Figure 1) and having specific values of UCST (Tp) between 4-40 °C dependent upon the molecular weight of the polymer (Table 1), anticipating claims 1, the terminal amine for the amino group of claim 2, the polyallylamine of claim 3, and the copolymer of claim 9, and the embodiment of 0.38 for claim 10 for compound C150K93 (i.e. [95/(95+149) = 0.38 and being < 0.5). Shimida teaches the copolymer having main chain molecular weights of 1.5 x 105 (i.e. 150K or 150,000; see Table 1 and page 3419, right column, the sentence starting “Figure 2b…”), anticipating claim 16.
Regarding claim 1, Shimida is silent regarding the ureido-containing polymer being capable of detaching generic cells from a generic separation carrier. However, M.P.E.P. § 2112.01 recites, "Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the ureido-containing polymer is reasonably presumed capable of meeting the intended use of the composition claim absent any showing to the contrary.
Claims 1, 2, 4-7, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujihara et al. (Soft Matter (2015), 11, 5204-5213; Reference U).
Fujihara teaches a composition comprising poly(2-ureidoethyl methacrylate) (PUEM, Un), having a UCST of 36 and 40 °C in an aqueous solution and a molecular weight of 97,000 (Fig. 2 and the paragraph spanning pages 5207-5208), anticipating claims 1, the terminal amine for the amino group of claim 2, and the ureido-containing polymer of claim 4 wherein R1 = a methyl group (i.e. -CH3), A1 = O, a = 2, and claim 16.
Fujihara teaches a composition comprising poly(2-methacryloyloxyethyl phosphorylcholine)-block-poly(2-ureidoethyl methacrylate) (MmUn) and having a UCST of 30 °C in an aqueous solution (Fig. 6, M95U149, and noting that Fujihara defines he UCST as being the initial point temperature where %T begins to drop at the paragraph spanning pages 5207-5208), anticipating claims 1, the terminal amine for the amino group of claim 2, and the ureido-containing polymer of claims 5 and 6 wherein R2 = a methyl group (i.e. -CH3), A2 = O, b = 2, and X = formula 4, and the embodiment of 0.38 for claim 7 (i.e. [95/(95+149) = 0.38 and being < 0.5).
Regarding claim 1, Fujihara is silent regarding the ureido-containing polymers being capable of detaching generic cells from a generic separation carrier. However, M.P.E.P. § 2112.01 recites, "Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the ureido-containing polymer is reasonably presumed capable of meeting the intended use of the composition claim absent any showing to the contrary.
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.
Claims 1-3, 12-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Xue et al. (Materials (2018), 11(1), 95; provided in the IDS dated 6/30/2025).
The teachings of Xue are relied upon in rejecting claims 1-3, 12, and 13 as anticipated under 35 U.S.C. § 102.
Regarding claim 14, Xue does not teach the claimed molar ratio range. However, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Xue teaches that the percentage ureido content (i.e. formula 12/sequence E) is result effective variable with respect to the UCST of Polymer1 and Polymer 2 (see Table 1). Thus, the burden is shifted back to establish criticality of the claimed molar ratio range by objective evidence.
Regarding claim 16, Xue does not teach the claimed molecular weight range in sufficient specificity. However, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976);
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Xue as applied to claims 1 and 12 above, and further in view of Terumo (JPH07136505A; provided in the IDS dated 3/14/2024) and Thermo Scientific (TR0046.1 (2009); Reference V).
The teachings of Xue are relied upon as set forth above.
Regarding claim 15, Xue does not teach Polymer 1 or 2 further comprising biotin functionalization on the side chain of the ureido group.
Terumo teaches a composition comprising an affinity separation material having a specific affinity for a target substance, supported on a surface comprising a stimulus-responsive polymer via a spacer comprising a conjugate of at least two compounds capable of binding each other ([0009]). Terumo teaches affinity separation material comprising antigen-antibody or enzyme-substrate ([0012]), target substances comprising cells ([0012]), stimulus-responsive polymer comprising N-isopropylacrylamide ([0015]), and the two compounds capable of binding each other comprising biotin-avidin ([0013]), reading on claim 15.
Thermo Scientific teaches biotinylation reagents containing N-hydroxysuccinimide (NHS) esters are widely used to label proteins at primary amino groups (-NH2), and teaches an exemplary method of biotinylating a peptide (see the single page), reading on claim 15.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the biotin of Terumo to Polymer 1 and/or Polymer 2 of Xue in view of Thermo Scientific. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Terumo and Xue are directed towards stimuli-responsive polymers as cell detachment agents, and because Thermo Scientific teaches that NHS esters are known in this to label primary amino groups and Xue’s Polymer 1 and 2 comprise primary amino groups. The skilled artisan would have been motivated to do so because Terumo teaches that the addition would be predictably advantageous when paired with avidin as an affinity separation material for detaching/separating cells, and thus improve Xue’s polymers as cell separating agents.
Claims 1-3, 9, 10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shimida et al. (Biomacromolecules (2011), 12(10), 3418-3422; provided in the IDS dated 6/30/2025).
The teachings of Shimida are relied upon as set forth above in rejecting claims 1-3, 9, and 16 as anticipated under 35 U.S.C. § 102.
Regarding claim 10, Shimida does not teach the claimed molar ratio range. However, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Shimida teaches that the percentage ureido content (i.e. formula 10/sequence C) is result effective variable with respect to the UCST of the poly(allylamine)-co-poly(allylurea) polymer (see Table 1). Thus, the burden is shifted back to establish criticality of the claimed molar ratio range by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shimida as applied to claims 1 and 9 above, and further in view of Terumo (JPH07136505A; provided in the IDS dated 3/14/2024) and Thermo Scientific (TR0046.1 (2009); Reference V).
The teachings of Shimida are relied upon as set forth above. Shimida further teaches that poly(N-isopropylacrylamide) (PNIPAm) is a well-characterized stimuli-responsive polymer and is used to detach cells cultured on dishes, but few polymers show UCST-type behavior in aqueous media (page 3418, left column, paragraph starting “Stimuli-responsive polymers…” through the end of the next paragraph), reading in-part on claim 11.
Regarding claim 11, Shimida does not teach the poly(allylamine)-co-poly(allylurea) polymer further comprising biotin functionalization on the side chain of the ureido group.
Terumo teaches a composition comprising an affinity separation material having a specific affinity for a target substance, supported on a surface comprising a stimulus-responsive polymer via a spacer comprising a conjugate of at least two compounds capable of binding each other ([0009]). Terumo teaches affinity separation material comprising antigen-antibody or enzyme-substrate ([0012]), target substances comprising cells ([0012]), stimulus-responsive polymer comprising N-isopropylacrylamide ([0015]), and the two compounds capable of binding each other comprising biotin-avidin ([0013]), reading on claim 11.
Thermo Scientific teaches biotinylation reagents containing N-hydroxysuccinimide (NHS) esters are widely used to label proteins at primary amino groups (-NH2), and teaches an exemplary method of biotinylating a peptide (see the single page), reading on claim 11.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the biotin of Terumo to the poly(allylamine)-co-poly(allylurea) polymer of Shimida in view of Thermo Scientific. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Terumo and Shimida are directed towards stimuli-responsive polymers such as poly(N-isopropylacrylamide as cell detachment agents, and because Thermo Scientific teaches that NHS esters are known in this to label primary amino groups and Shimida’s poly(allylamine)-co-poly(allylurea) polymer comprises primary amino groups. The skilled artisan would have been motivated to do so because Terumo teaches that the addition would be predictably advantageous when paired with avidin as an affinity separation material for detaching/separating cells, and thus improve Shimida’s copolymer as a cell separating agent.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1, 2, 4-8, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujihara et al. (Soft Matter (2015), 11, 5204-5213; Reference U) in view of Terumo (JPH07136505A; provided in the IDS dated 3/14/2024).
The teachings of Fujihara are relied upon in rejecting claims 1, 2, 4-7, and 16 as anticipated under 35 U.S.C. § 102. Fujihara further teaches that poly(N-isopropylacrylamide) (PNIPAM) is a known species of stimuli-responsive polymer (1st paragraph of the Introduction on page 5204), reading in-part on claim 8.
Regarding claim 8, Fujihara does not teach the poly(2-methacryloyloxyethyl phosphorylcholine)-block-poly(2-ureidoethyl methacrylate) (MmUn) polymer further comprising biotin functionalization on the side chain of the ureido group.
Terumo teaches a composition comprising an affinity separation material having a specific affinity for a target substance, supported on a surface comprising a stimulus-responsive polymer via a spacer comprising a conjugate of at least two compounds capable of binding each other ([0009]). Terumo teaches affinity separation material comprising antigen-antibody or enzyme-substrate ([0012]), target substances comprising cells ([0012]), stimulus-responsive polymer comprising N-isopropylacrylamide ([0015]), and the two compounds capable of binding each other comprising biotin-avidin ([0013]), reading on claim 8.
Thermo Scientific teaches biotinylation reagents containing N-hydroxysuccinimide (NHS) esters are widely used to label proteins at primary amino groups (-NH2), and teaches an exemplary method of biotinylating a peptide (see the single page), reading on claim 8.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the biotin of Terumo to the poly(allylamine)-co-poly(allylurea) polymer of Shimida in view of Thermo Scientific. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Terumo and Shimida are directed towards stimuli-responsive polymers such as poly(N-isopropylacrylamide as cell detachment agents, and because Thermo Scientific teaches that NHS esters are known in this to label primary amino groups and Shimida’s poly(allylamine)-co-poly(allylurea) polymer comprises primary amino groups. The skilled artisan would have been motivated to do so because Terumo teaches that the addition would be predictably advantageous when paired with avidin as an affinity separation material for detaching/separating cells, and thus improve Shimida’s copolymer as a cell separating agent.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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