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 .
Note for the Record
The examiner notes that if it is found that the instant application has allowable subject matter and a patent is granted, the order of the claims must be arranged in accordance with 35 U.S.C 112(d).
Claim Interpretation
Regarding claim 26 in reference to the weight of the components of the ink composition, the ink composition is taken to include the weight of the solvent. This is the broadest reasonable interpretation consistent with the instant specification, namely Table 1 of the instant specification.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claim 26 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. US 10996491 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the binder polymer of the instant application is a genus of the triblock polymer of the conflicting patent. Further, since the hydrophilic polymer of the conflicting application is only either reactive or nonreactive, a person having ordinary skill in the art, having only two choices of hydrophilic polymer, would have found it obvious to choose the nonreactive hydrophilic polymer.
Claim Rejections - 35 USC § 112
Claim 23 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.
Claim 23 recites the limitation "the repeating units of" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear of what is meant by “the repeating units” of the silicone containing macromer being present in the binder in the claimed range, for examination purposes it is interpreted to mean that the silicone-containing macromer is present in the binder polymer in the claimed amounts.
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.
Claims 2-4, 6-8, 11-26 are rejected under 35 U.S.C. 103 as being unpatentable over Alli (US 2018011222 A1) in view of Molock ( US 20020133889 A1).
Regarding claim 26, Alli teaches a silicone hydrogel for contact lenses (abstract; paragraph [0003]; Table 32, Examples 67, 68) comprising:
Greater than 1 wt.% poly(vinyl pyrrolidone) (PVP), a nonreactive hydrophilic polymer which is a cyclic polyamide;
29 wt.% binder polymer comprising
mono-(2-hydroxy-3-methacryloxypropyl)-propyl ether terminated mono-n-butyl terminated polydimethylsiloxane (OH-mPDMS) as a silicone-containing macromer;
mono-methacryloxypropyl terminated mono-n-butyl terminated polydimethylsiloxanes (mPDMS) as a silicone-containing macromer;
2-hydroxyethyl methacrylate (HEMA), as a hydrophilic monomer comprising hydroxyalkyl functionality;
43 2 wt.% 3,7-dimethyl-3-octanol (D3O) as a solvent.
Alli further teaches a contact lens composition which may comprise pigments such as well as the application of color to lens material (paragraphs [0045] and [0056]) and a method of producing a contact lens involving shaping the composition with a mold and curing the composition (paragraph [0184]). Alli further teaches that the contact lens composition is an interpenetrating network of polymers (paragraph [0047]).
Alli does not disclose a contact lens comprising the ink composition as claimed in claim 26, a method of producing tinted contacts as claimed in clam 25, nor the specific pigments described in claim 8.
Molock teaches contact lenses comprising colorants and a method of producing contact lenses comprising an ink composition (colorant composition) (abstract). Molock also teaches iron oxide black, iron oxide yellow, phthalocyanine blue, iron oxide red, and titanium dioxide wherein all pigments are added to the colorant composition in amounts of 2-25 wt.% (Table 1). The method of producing colored contacts according to Molock (paragraphs [0006] and [0033]) is as follows:
placing a clear prepolymer onto a half of a mold surface before the colorant is added (the mold may comprise two halves);
ii. the colorant composition is applied to the mold;
iii. the lens forming material is added to the mold;
vi. curing the composition.
Molock also discloses that layers of colorant composition may be added (paragraph [0006]). Molock further teaches a colorant (ink) composition capable of forming interpenetrating polymer networks with the lens material (paragraph [0005]) and that the binder polymer average molecular weight is a result-effective variable on the solubility of the colorant (ink) composition in the lens-forming material (paragraph [0013]).
A person having ordinary skill in the art as of the effective filing date of the instant application, in light of the teachings and disclosures of both Alli and Molock as described above, would have found it obvious to use the contact lens composition of Alli as a base material for an ink composition (since it can form interpenetrating polymer networks with the lens forming material of Alli), to add the suitable pigments as described in Molock to the to the ink composition, and to form a colored cosmetic contact lens according to the method taught in Molock and the results would have been predictable.
Regarding claims 2, 3, 7 and 11, the colored contact lens composition of Alli in view of Molock applies as described above regarding the nonreactive hydrophilic polymer PVP (poly(vinylpyrrolidone)).
Regarding claims 8, 25 and 29, the colored contact lens composition of Alli in view of Molock applies as described above regarding the method of producing a colored contact lens, the pigments used, and the addition of layers of colorant (pigment).
Regarding claims 4, 6, 12-14, 16, 17, 19-23, 27 and 28, the colored contact lens composition of Alli in view of Molock applies as described above regarding the components of the binder polymer (mPDMS contains a methacrylate functional group) and the solvent. Alli further teaches silicone-containing macromers with an average molecular weight between 800-1,000 g/mol (Daltons) (paragraph [0120]) and also teaches the silicone-containing macromer present in the range at 76.5% of the binder composition with the composition being free of a nonreactive hydrophilic polymer (the binder being the combination of the silicone-containing macromers and HEMA) (Table 2, CEx 1). Alli further teaches that PVP is a wetting agent (paragraphs [0071] and [0072]).
Regarding claims 15 and 18, the colored contact lens composition of Alli in view of Molock applies as described above and Alli further teaches the following structures for silicone containing macromers:
Formula XIVa:
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Wherein the substitutable groups are substituted in the same manner as in claim 15 (paragraph [0116]).
Formula VII-1:
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424
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Wherein the substitutable groups are substituted in the same manner as in claim 18 (paragraphs [0084-0089]).
The examiner notes that the structures of OH-mPDMS and mPDMS used as described above satisfy the claimed macromers of claims 16 and 18.
Regarding claim 24, the colored contact lens composition of Alli in view of Molock applies as above, Alli further teaches silicone-containing monomers suitable for the composition, including 3-methacryloxypropyltris(trimethylsiloxy)silane (paragraph [0119]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Alli (US 2018011222 A1) in view of Molock ( US 20020133889 A1) and further in view of Bas, et. al. (Synthesis, characterization and properties of amphiphilic block copolymers of 2-hydroxyethyl methacrylate and polydimethylsiloxane prepared by atom transfer radical polymerization).
Regarding claim 10, 11 the colored contact lens composition of Alli in view of Molock applies as described above, however Alli and Molock are silent as to the average molecular weight of the binder polymer.
Bas, et. al. (further referred to as Bas), discloses a polymer suitable as a binder according to claim 26 comprising PDMS and HEMA as poly(2-hydroxyethyl methacrylate)-b-polydimethylsiloxane-b-poly(2-hydroxyethyl methacrylate) (abstract). The average molecular weight of the disclosed polymers are between 13,400-41,600 g/mol (Table 1). Bas further teaches that the polymer produced could be used in inks and biomaterials and that the components of the polymer show good mechanical strength and biocompatibility (introduction).
A person having ordinary skill in the art as of the effective filing date of the instant application would have found it obvious to see the benefit of the polymer of Bas as biocompatible and useable in inks and substitute this polymer (having an average molecular weight in the claimed range) for the binder polymer of Alli in view of Molock and the results would have been predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KOLTON JONES whose telephone number is (571)272-9802. The examiner can normally be reached Generally Monday-Friday 8:00 am - 5:00 pm EST.
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/KOLTON JONES/Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
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