DETAILED ACTION
Claims 1, 4-8, 10-11 and 13-16 are currently pending. Claims 1 and 15 are currently under examination.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/08/2025 has been entered.
Examiner’s Note
Applicant's amendments and arguments filed 08/08/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 08/08/2025, claim 1 had been amended and no new matter is added.
Modified Rejection:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim(s) 1 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5,408,022 (previously applied) as evidenced by Ataman Chemicals (previously applied).
Regarding claim 1, the limitation of an antimicrobial polymer for use in contact lenses, comprising at least one antimicrobial monomer, wherein the at least one antimicrobial monomer is a quaternary ammonium-based salt monomer selected from the group which includes DMAE-CB and at least one other monomer selected from a hydrophobic acrylic monomer, a vinyl monomer and/or a collagen monomer is met by the ‘022 patent teaching an antimicrobial polymerizable composition comprising ethylenically unsaturated monomer, a specific monomer having anti-microbial activity and a polymeric initiator (abstract, claim 1). The ethylenically unsaturated monomer is selected from monofunctional monomers which include 2-hydroxyethyl (meth)acrylate (column 8, lines 1-10), which is a vinyl monomer as evidenced by Ataman Chemicals (page 7, first paragraph). The composition is taught to be used for soft contact lenses and hard contact lenses which often suffer from growth of bacteria (column 7, lines 35-45). DMAE-CB structure is taught as being used an antimicrobial monomer (column 5, lines 15-25):
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Wherein R1 is taught to be methyl, X is oxygen and Z is chlorine (column 2, lines 60-67, column 3, lines 45-55) and wherein n is 2 and m is 15, as is evidenced by the instant specification (page 6-7, [0021]).
Regarding claim 15, the limitation of wherein the antimicrobial polymer is clear is met by the ‘022 patent teaching the elected monomers HEMA and DMAE-CB, as discussed above. The ‘022 patent teaches the claimed structure of the polymer and therefore must contain the functional feature of being clear, absent factual evidence to the contrary. Additionally, the polymer is taught to be used for a contact lens (column 7, lines 35-45).
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, DMAE-CB monomer with the chloride salt form and HEMA monomer to form a copolymer) from within the prior art disclosure of the ‘022 patent, to arrive at the instantly claimed antimicrobial polymer “yielding no more than one would have expected from such an arrangement”.
Claim(s) 1 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5,408,022 as evidenced by Ataman Chemicals as applied to claims 1 and 15 above and in further view of US 4,261,875 (previously applied) and Xiao (Xiao, Yu-Hong, eg al., J Biomed Mater Res Part B: Appl Biomater 90B: 813-817, 2009).
As mentioned in the above 103(a) rejection, all the limitations of claims 1 and 15 are taught by the US 5,408,022.
The ‘022 patent does not specifically teach the antimicrobial polymer is clear (claim 15).
The ‘875 patent polymers useful in contact lenses (abstract). 2-hydroxyethyl methyl methacrylate (HEMA) is taught to be used for contact lenses. The resulting lenses were clear. The hydrated lenses were clear, transparent, flexible, hydrophilic and suitable for use as contact lenses (column 5, lines 33-46).
Xiao teaches antibacterial effect of adhesive containing an antibacterial monomer DMAE-CB (methacryloxylethyl cetyl dimethyl ammonium chloride) wherein DMAE-CB is taught to have bacteriostatic properties (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to form a clear polymer using monomers taught by the ‘022 patent as the ‘022 patent teaches the desire for the polymers to be used as contact lenses and the ‘875 teaches the desire for contacts to be clear. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘022 patent teaches the use of HEMA as a monomer in the polymer wherein the polymer is used contact lenses and the ‘875 patent teaches the use of HEMA monomers to form clear contact lenses.
One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use specifically DMAE-CB in the polymer taught by the ‘022 patent because the ‘022 patent teaches antimicrobial polymers which contains a monomer having antimicrobial activity (abstract) which has a quaternary ammonium structure as disclosed (Column 5, lines 15-25) and Xiao teaches a specifically named antibacterial monomer DMAE-CB, which falls within the structure of the ‘022 patent. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the specifically named DMAE-CB as the antimicrobial monomers in the ‘022 patent because the ‘022 patent teaches a structure of an antimicrobial monomer and Xiao discloses a specifically named antibacterial monomer.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US patent 12,023,405, previously copending Application No. 17/001,953 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘405 patent are directed to antimicrobial polymers for use in ophthalmic implant comprising at least one antimicrobial polymer selected from a group including DMAE-CB and at least one other monomer including collagen monomers wherein the polymer is clear.
Claim 1 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 and 23 of copending Application No. 16/954,322 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ’322 application are directed to antimicrobial polymers for use in ophthalmic implant comprising at least one antimicrobial polymer selected from a group including DMAE-CB and at least one other monomer including acrylic monomers (vinyl monomer) wherein the polymer is clear.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,792,245. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘245 patent are directed to antimicrobial polymers for use in ophthalmic implant comprising at least one antimicrobial polymer selected from a group including DMAE-CB and at least one other monomer including acrylic monomers (vinyl monomer) wherein the polymer is clear.
Claims 1 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,307,369. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘369 patent are directed to antimicrobial polymers for use in ophthalmic implant comprising at least one antimicrobial polymer selected from a group including DMAE-CB and at least one other monomer including acrylic monomers (vinyl monomer) wherein the polymer is clear.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: the ‘022 patent
Applicant argues the art of record does not teach, suggest or otherwise make obvious the formation of an antimicrobial polymer comprising an antimicrobial monomer selected from DMAE-CB, MAE-HB and IDMA-1. Applicant points to formulas I to III which does not teach the claimed antimicrobial monomer.
In response, Applicant is referred to the newly applied rejection above. The ‘022 patent teaches DMAE-CB structure is taught as being used an antimicrobial monomer (column 5, lines 15-25):
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Wherein R1 is taught to be methyl, X is oxygen and Z is chlorine (column 2, lines 60-67, column 3, lines 45-55) and wherein n is 2 and m is 15, as is evidenced by the instant specification (page 6-7, [0021]).
Applicant argues the ‘875 patent is specifically directed to the formation of a hydrophilic silicone polymer and does not teach or remotely suggest the formation of an antimicrobial polymer comprising a quaternary ammonium monomer.
In response, the ‘022 patent teaches the polymer comprising the two claimed monomers as discussed above. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to form a clear polymer using monomers taught by the ‘022 patent as the ‘022 patent teaches the desire for the polymers to be used as contact lenses and the ‘875 teaches the desire for contacts to be clear. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘022 patent teaches the use of HEMA as a monomer in the polymer wherein the polymer is used contact lenses and the ‘875 patent teaches the use of HEMA monomers to form clear contact lenses.
Double Patenting:
Applicant requests the double patenting rejection be held in abeyance.
In response, Applicant has presented no substantive arguments and thus the rejections are maintained for reasons of record.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613