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 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, 3-5, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Colak Atan et al. (US 2019/0194250) taken in view of the evidence given by Hussain et al. (US 2008/0138415) and Parish et al. (US 2023/0255992).
Regarding claims 1 and 3-4, Colak Atan et al. disclose a porous substrate with a polymer disposed thereon (see paragraph 0008) where the polymer is made from monomers including those of the formula:
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307
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where R1 is H or methyl, X is O or NR3 where R3 is H, R2 is alkylene or heteroalkylene, Z is iminocarbonylimino (NHC(O)NH) or oxycarbonylimino (NHC(O)O), n=0 or 1, and L is phosphate (-OPO3H2). This corresponds to the formula (I) of claim 1 when presently claimed R2 is H or methyl, X is O or NH, R3 is alkylene or heteroalkylene, Q is NHC(O)NH or NHC(O)O, m= 0 or 1, R4 is alkylene, and R1 is H and corresponds to formula (I-C) in claim 3 when presently claimed R2 is H or methyl, R3 is alkylene or heteroalkylene, X1 is O or NR5 where R5 is H, R4 is alkylene or heteroalkylene, and R1 is H (see paragraphs 0034 and 0091-0102).
Colak Atan et al. also discloses a monomer of the formula:
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480
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which corresponds to formula (I-D) of claim 4 when presently claimed X1 is O, R4 is C2 alkylene, and R1 is H (see paragraphs 0091-0102 and paragraph 0127). The composition is used to separate aggregated proteins from monomeric proteins in a biological solution (see paragraph 0007), i.e. medical composition. Colak Atan et al. disclose a homopolymer made from the above monomers (see paragraph 0134), i.e. polymer made from 100 mol% of the monomer. The polymer is made by polymerizing the monomers using a polymerization solvent such as polyethylene glycol (see paragraphs 0139 and 0143-0144) in the presence of a porous substrate made from polylactic acid (see paragraphs 0148 and 0150). As evidenced by Parish et al., polyethylene glycol is therapeutically acceptable (see paragraph 0270) while as evidenced by Hussain et al., polylactic acid is therapeutically acceptable (see paragraph 0120).
It is calculated that the monomer in paragraph 7 above has a molecular weight of 265 g/mol and phosphonate has a molecular weight of 81 g/mol, and therefore, it is calculated that the above formula contains 30 wt% (81/265) phosphonate. Therefore, there is 0.30 g of phosphonate per 1 g polymer or 0.0037 moles (0.30/81) of phosphonate per 1 g polymer or 3.7 mmoles phosphonate per 1 g polymer.
In light of the overlap between the claimed composition and the composition disclosed by Colak Atan et al., it would have been obvious to one of ordinary skill in the art to use a composition that is both disclosed by Colak Atan et al. and encompassed within the scope of the present claims, and thereby arrive at the claimed invention.
While there is no explicit disclosure that the composition prevents, mitigates, or treats a microbial infection, the recitation in the claims that the composition is “for preventing, mitigating, or treating a microbial infection” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Colak Atan et al. disclose composition as presently claimed, it is clear that the composition of Colak Atan et al. would be capable of performing the intended use, i.e. for preventing, mitigating, or treating a microbial infection, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
Regarding claim 5, Colak Atan et al. disclose the polymer can be a copolymer using additional monomers including those having a (meth)acryloyol group, i.e. ethylenically unsaturated group and hydroxy or amino group, i.e. polar group (see paragraph 0136).
Regarding claim 10, the composition is used as a coating (see paragraphs 0148 and 0163).
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 6,309,221).
Regarding claim 1, Jensen discloses a dental adhesive composition used to prevent ingress by microorganism into an area of a tooth being treated, i.e. medical composition (see Abstract, col.2, line 66-col.3, line 4, col.5, lines 34-37 and 50-59). The adhesive composition comprises adhesive monomers and antimicrobial agent (Col.7, line 21 and col.8, line 40). Given that the adhesive composition is used to treat teeth, it is clear that the antimicrobial agent would necessarily be a therapeutically acceptable component. Jensen discloses that the adhesive monomers include including phosphate ester of 3-hydroxybutyl methacrylate, i.e. hydroxybutyl methacrylate phosphate (col.8, lines 2-3) which would have a formula of :
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and correspond to presently claimed Formula I when R2 is methyl, X is oxy, R3 is C4 alkylene, m=0, and R1 = hydrogen. Jensen discloses that the adhesive composition is polymerized using any curing means (col.11, line 64-col.12, line 1). Given that no other monomers are required in the adhesive composition of Jansen, the polymerization would result in a phosphonate-containing polymer made from the above monomer, i.e. polymer made from 100 mol% of the monomer.
It is calculated that the monomer in paragraph 15 above has a molecular weight of 238 g/mol and phosphonate has a molecular weight of 81 g/mol, and therefore, it is calculated that the above formula contains 34 wt% (81/238) phosphonate. Therefore, there is 0.34 g of phosphonate per 1 g polymer or 0.0042 moles (0.34/81) of phosphonate per 1 g polymer or 4.2 mmoles phosphonate per 1 g polymer.
In light of the overlap between the claimed composition and the composition disclosed by Jensen, it would have been obvious to one of ordinary skill in the art to use a composition that is both disclosed by Jensen and encompassed within the scope of the present claims, and thereby arrive at the claimed invention.
While there is no explicit disclosure that the composition prevents, mitigates, or treats a microbial infection, the recitation in the claims that the composition is “for preventing, mitigating, or treating a microbial infection” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Jensen discloses composition as presently claimed, it is clear that the composition of Jensen would be capable of performing the intended use, i.e. for preventing, mitigating, or treating a microbial infection, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 6,309,221) as applied to claim 1 above, and further in view of Fukagawa (US 2018/0142119).
Jensen discloses dental adhesive comprising a phosphonate-containing polymer as set forth above.
Jensen do not disclose that the phosphonate-containing polymer includes zwitterionic monomer as presently claimed.
Fukagawa et al. disclose dental adhesive (see paragraph 0161) comprising a polymer made from betaine monomers represented by the formula:
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which is identical to presently claimed formula (III) when R42 is H, R43 is O or NH, n4 is 1-4 (corresponding to C1-4 alkylene group), R41 is a methyl group, l4 is 1-4 (corresponding to C1-4 alkylene group) and M4 is carboxylate (COO-) or sulfonate (SO3-) (see paragraphs 0066 and 0069-0074). The betaine monomers produce a coating with excellent hydrophilicity (see paragraph 0068).
In light of the motivation for using a polymer obtained from betaine monomer disclosed by Fukagawa as described above, it would have been obvious to one of ordinary skill in the art to include a betaine monomer in the phosphonate-containing polymer of Jensen in order to produce a composition with excellent hydrophilicity.
Response to Arguments
In light of applicant’s amendment filed 3/19/2026, new grounds of rejection are set forth above. All arguments except for those set forth below are moot in view of the new grounds of rejection.
Applicant argues that Colak Atan et al. does not disclose a therapeutically acceptable component as now required in the present claims. Further, applicant argues that Colak Atan et al. requires the use of a porous substrate that is not therapeutically acceptable.
However, as set forth above, Colak Atan et al. disclose a polymer that is made by polymerizing monomers using a polymerization solvent such as ethylene glycol (see paragraphs 0139 and 0143-0144) in the presence of a porous substrate made from polylactic acid (see paragraphs 0148 and 0150). As evidenced by Parish et al., polyethylene glycol is therapeutically acceptable (see paragraph 0270) while as evidenced by Hussain et al., polylactic acid is therapeutically acceptable (see paragraph 0120). Therefore, Colak Alan et al. do disclose a therapeutically acceptable component as claimed.
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 Callie Shosho whose telephone number is (571)272-1123. The examiner can normally be reached Monday-Friday, 6:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Srilakshmi Kumar can be reached at 571-272-7769. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CALLIE E SHOSHO/Supervisory Patent Examiner, Art Unit 1787
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