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 .
Status of Claims
The preliminary amendment of 08/24/2023, which appear to be the corrected English translation that Applicant has referenced in their Remarks (p. 7), is acknowledged. Additionally, the Remarks/Amendments filed on 12/23/2025 are acknowledged. Applicant’s previous election of Group I (claims 1-8) and species of (a)-(c) still stand.
Claims 1 and 9 are currently amended and claim 3 is canceled. Claims 5, 7, 9, and 10 remain withdrawn as being directed to a non-elected invention and species. Additionally, the unelected species are being treated as withdrawn from their corresponding claims. Claims 1-2, 4, 6, and 8 are examined on the merits herein.
Priority
The instant application filed 08/24/2023, is a 371 filing of PCT/JP2022/004420, filed 02/04/2022, which claims foreign priority to JP2021-032265, filed 03/02/2021.
Withdrawn Objections/Rejections
Claims 4, 6, and 8 were objected to under 37 CFR 1.75(c) as being in improper form. In view of the amendments of 08/24/2023, which Examiner was not previously aware of, the objections have been overcome and are withdrawn.
Claims 1-3 were rejected under 35 U.S.C. 112(b) for the use of ellipses. Applicant’s current amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1-3 were rejected under 35 U.S.C. 103 as being unpatentable over Yamashita. Applicant’s current amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1-3 were rejected under 35 U.S.C. 103 as being unpatentable over Hayashi. Applicant’s cancellation of claim 3 has rendered this rejection moot and the rejection of claim 3 is withdrawn.
The following rejections are necessitated by amendment:
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.
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 1-2, 4, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Yamashita, K., et al. (JP 2017176821 A, 10/05/2017, IDS dated 11/29/2024, PE2E translation used, PTO-892), hereinafter Yamashita, in view of Hyuugaji, S., et al. (US 20180217294 A1, 08/02/2018, IDS dated 08/24/2023), hereinafter Hyuugaji.
Yamashita teaches providing a polymer that enables long-term persistence of characteristics such as water wettability and easy slidability on surfaces of various medical devices including ophthalmic lenses, and a method for producing various medical devices including ophthalmic lenses with improved surface characteristics at a low cost (abstract). Specifically, a coating having an interpenetrating network structure is formed by the hydrophilic side chain of the medical polymer and the polymer network of the medical device, whereby the aqueous surface layer is lubricated, water-retained and stabilized (description, final para.). As such, Yamashita teaches a coated medical device comprising a medical device and a hydrophilic polymer layer coating the surface, as instantly recited in claim 1. The interpenetrating network structure defined above further reads on the mixed layer of claim 2. The medical polymer of Yamashita is a chain structure having a structural unit derived from an unsaturated group-containing monomer as a main chain and 7 to 30 alkylene oxide repeating units connected to each structural unit. The polymer may also be a copolymer of the above structural unit and a unit such as another monomer (i.e., comonomer) (description, para. 8). The unsaturated group of the first structural unit is preferably a (meth) acryloyl group. The monomer containing an unsaturated group is selected from various methoxypolyethylene glycol methacrylates (Examples; description, para. 13), which reads partially on the instantly elected compound a2 of claim 1 (i.e., methacrylate rather than acrylate). The term “(meth) acrylate” represents both a methacrylic acid ester and an acrylic acid ester, and the same applies to (meth) acrylamide and (meth) acryloyl (description para. 5). The first structural unit is preferably present at a content rate of 50-100 mol%. However, when the content rate is 100 mol%, it is not a copolymer but a homopolymer. When the structural unit is less than 50 mol%, it may be difficult to impart sufficient water wettability and slidability to the medical device surface (description, para. 9).
Examples of preferred hydrophilic comonomers for use in the medical polymer include methyl chloride quaternary salts. In one embodiment where the medical device is a soft contact lens, dimethylaminopropyl (meth) acrylamide methyl chloride quaternary salt (DMAPAA Q) or dimethylaminopropyl (meth) acrylate methyl chloride quaternary salt is preferred (description, para. 18). Such methyl chloride quaternary salts read on the instantly elected compound a1 of claim 1. When the medical device is an ophthalmic lens, it is preferably a contact lens, more preferably a soft contact lens. Suitable hydrogel lens materials are known and can be used. Examples include comfilcon A, lotrafilcon A, balafilcon A, and the like (description, para. 28).
The teachings of Yamashita differ from that of the instant invention in that Yamashita does not explicitly teach methoxypolyethylene glycol acrylate (i.e., elected compound a2), an additional compound having an amide group, nor and the copolymerization ratios of claim 1.
Hyuugaji discloses a method of surface treating a medical device with a solution containing a polymer having a repeating unit (A) and a repeating unit (B), wherein (A) is a hydrophilic repeating unit (abstract; claim 1; [0038]-[0040]). The modified medical device of Hyuugaji has excellent hydrophilicity, lubricity and antifouling properties ([0045]). The device is a silicone hydrogel contact lens ([0036]; [0045]; claim 10), which reads on the material of claim 4 and the ophthalmic lens of claim 8. The hydrophilic repeating unit (A) is one or more selected from various examples which include (A-1) through (A-8), with the preferred example of (A-3) being various (meth)acrylamides ([0065]; [0116]), which read on the compound having an amide group. Example 7 teaches the synthesis of copolymer (N-7) using dimethylacrylamide (DMA), which reads on the compound having an amide group, dimethylaminopropyl-acrylamide methyl chloride quaternary salt (DMAPAA-Q), which reads on compound a1, and lauroxy polyethylene glycol (30) monomethacrylate (LPEGM), which reads partially on compound a2 ([0298]). The content of the repeating unit derived from DMA was 85% by mass ([0299]).
Regarding instantly claimed compound a2, Yamashita teaches the first monomer to comprise an unsaturated group derived from a (meth)acryloyl and 7 to 30 alkylene oxide repeating units. Yamashita defines the term (meth)acrylate/(meth)acryloyl to encompass both a methacrylic acid ester and an acrylic acid ester. Thus, it would have been obvious to substitute any of the methoxypolyethylene glycol methacrylates of the invention with their respective methoxypolyethylene glycol acrylate, since it entails no more than simple substitution of one known element for another to yield predictable results. See MPEP 2143. One of ordinary skill in the art would have had a reasonable expectation of success in substituting a methoxypolyethylene glycol methacrylate with its acrylate equivalent since they are interchangeable as reasonably suggested by Yamashita. It would have been further obvious to provide a copolymer comprising the methoxypolyethylene acrylate in combination with DMAPAA Q since such a combination is suggested and encouraged by Yamashita, specifically when the medical device is a soft contact lens. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Regarding the additional compound having an amide group, it would have been prima facie obvious to adopt a ternary system copolymer by adding an additional acrylamide, such as the dimethylacrylamide of Hyuugaji, into the copolymer of Yamashita since it is a known and routine monomer in the art. Hyuugaji teaches acrylamides as known and effective monomers used to impart excellent hydrophilicity, lubricity and antifouling properties onto a silicone hydrogel contact lens. Yamashita teaches hydrophilic polymer coatings for medical devices, preferably a contact lens. Thus, one of ordinary skill in the art could have added a monomer compound having an amide group as taught by Hyuugaji, into the copolymer of Yamashita, according to known polymerization methods to predictably generate a hydrophilic coated contact lens. See MPEP 2143. Additionally, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding the monomer ratios of claim 1, Yamashita teaches mol% ratios between structural units while Hyuugaji teaches the content of different repeating units derived by mass%. While the ratios taught by Yamashita and Hyuugaji do not fall within the instantly claimed ranges it is well within the abilities of an ordinary artisan to optimize the amount of each monomer unit in the polymer depending on the desired structure and properties (i.e., hydrophilicity, lubricity and antifouling) of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed ranges of claim 1 through no more than routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As discussed above, both Yamashita and Hyuugaji teach hydrophilic polymer coatings for ophthalmic lenses (i.e., contact lenses). As such, the combined product of Yamashita and Hyuugaji would also be an ophthalmic lens such as that of claim 8. Hyuugaji specifically teaches a silicone hydrogel contact lens and Yamashita teaches that known hydrogel lens materials include comfilcon A, lotrafilcon A, and balafilcon A, all of which read on the elected materials of claims 4 and 6. It would have been prima facie obvious to select a silicone hydrogel, specifically, comfilcon, lotrafilcon, or balafilcon, as taught by Hyuugaji and Yamashita since such materials are known and routine in the art of contact lenses. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since both Yamashita and Hyuugaji teach hydrophilic coating polymers for surface treating contact lenses. Additionally, Hyuugaji teaches that the dimethylacrylamide monomer discussed above, may be used in combination with other hydrophilic monomers such as the PEG (meth)acrylates and DMAPAA Q monomers of Yamashita.
As such, the prior art teaches all the components of the instant invention as claimed. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi, N., et al. (US 20160102213 A1, 04/14/2016, IDS dated 08/24/2023), hereinafter Hayashi.
Hayashi teaches a surface treatment (i.e., coating) method for treating a surface formed of an inorganic material by using a polymer. The polymer contains a repeating unit (A) and a repeating unit (B). Also taught is a tool or device having a modified surface (abstract). The tools and devices coated with the polymer of Hayashi includes tools and devices for medical application or culturing ([0132]). As such, Hayashi teaches a coated medical device comprising a medical device and a hydrophilic polymer layer coating the surface, as instantly recited in claim 1. A polymer which is chemically bonded to the surface material of the medical device, as taught above, further reads on the mixed layer of claim 2.
Repeating unit (A) is preferably represented by the following formula (3):
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, wherein X is:
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([0028]-[0029]).
R5 represents a hydrogen or methyl group. As R6, *--(C=O)—NH—is preferred ([0034]). R7 represents a divalent organic group with 1 to 8 carbon atoms ([0029]), 2 to 3 carbons is preferred ([0035]). R1, R2, and R9 each independently represent an organic group with 1 to 10 carbon atoms ([0025];[0030]), 1 or 2 carbons is preferred ([0026];[0038]), specifically a methyl group ([0027]). Examples 1 and 6, specifically teaches the following structure as the monomer for repeating unit (A) ([0158]):
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(i.e., DMAPAA-Q), which reads on instantly elected compound a1 of claim 1.
Repeating unit (B) is preferably represented by the following formula (5):
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([0062]).
R12 represents a hydrogen atom or a methyl group ([0063]). Among R13, **--(C=O)—O--- is preferred ([0065]). R3 represents an alkanediyl group with 2 to 8 carbon atoms ([0051]), preferably 2 carbon atoms, such as an ethane-1,1-diyl group ([0052]). R4 is an organic group with 1 to 40 carbon atoms ([0051]), a 1 to 3 carbon alkyl group is preferred, such as a methyl group ([0053]-[0055]). Examples 1 and 6, specifically teaches the following structure as the monomer for repeating unit (A) ([0158]):
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(i.e., MPEGM), which reads partially on the instantly elected compound a2 of claim 1 (i.e., methacrylate rather than acrylate).
The polymer may further include a repeating unit (C) in a side chain thereof for the purpose of controlling a hydrophilicity of the coated surface, in addition to the repeating units (A) and (B) described above ([0069]). Examples of the monomer from which the repeating unit (C) is derived include amide group-containing monomers ([0014]). Example 6, specifically teaches acryloylmorpholine as the monomer for repeating unit (C) ([0183]-[0184]), which has the following structure:
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(i.e., ACMO). Such a compound reads on the compound having an amide group of claim 1.
The final copolymer structure of example 6 is as follows:
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(N-1-6). In the copolymer (N-1-6), the content of the repeating unit derived from ACMO was 37.9% by mass, the content of the repeating unit derived from DMAPAA-Q was 4.6% by mass, and the content of the repeating unit derived from MPEGM was 57.5% by mass ([0186]). The content of the ACMO (i.e., 37.9% by mass), which reads on the compound having an amide group, falls within its corresponding ratio range as recited in claim 1 (i.e., 3-80% by mass). The content of the MPEGM (i.e., 57.5% by mass), which reads partially on elected compound a2, also falls within its corresponding ratio range as recited in claim 1 (i.e., 10-90% by mass). While the content of DMAPAA-Q in Example 6, which reads on compound a1, does not fall within its corresponding claimed range, it is broadly taught that a total content of the repeating unit (A) in the whole repeating units is preferably 0.01 to 50% by mass ([0048]).
The teachings of Hayashi differ from that of the instantly claimed invention in that Hayashi teaches a methacrylate rather than an acrylate in repeating unit (B), which corresponds to compound a2 of claim 1. Additionally, Hayashi fails to explicitly teach the ratio of compound a1, as recited in claim 1.
As discussed above, repeating unit (B) is represented by formula (5):
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, wherein R12 represents a hydrogen or methyl group. As such, it would have been obvious to one of ordinary skill in the art to select a monomer unit that produces a hydrogen at R12 since it would have been “obvious to try” given the teachings of Hayashi. Generally, choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is considered prima facie obvious. See MPEP 2143. As discussed above, Hayashi teaches methoxypolyethylene glycol methacrylate as the monomer used to generate repeating unit (B). If one of ordinary skill in the art was looking to provide a hydrogen at R5 they would have known to select methoxypolyethylene glycol acrylate as the monomer instead. Thus, the instantly elected compound a2 of claim 1 would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. One of ordinary skill in the art would have had a reasonable expectation of success in selecting methoxypolyethylene glycol acrylate as the monomer from which repeating unit (B) is derived since changing between a hydrogen and methyl at R12 would not result in a significant difference in the final polymer, and both are taught by Hayashi as acceptable options.
Regarding the ratio of compound a1, Hayashi teaches that a total content of the repeating unit (A) in the whole repeating units may be between 0.01 to 50% by mass, which overlaps with the instantly claimed ratio range of claim 1 (i.e., 10-90%). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Additionally, while the 4.6% of DMAPAA-Q in the polymer of Example 6 does not fall within the instantly claimed range, it is well within the abilities of an ordinary artisan to optimize the amount of this monomer in the composition depending on the desired structure and properties of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed range of claim 1 through no more than routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As such, the prior art teaches all the components of the composition as claimed. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
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.
1. Claims 1-2, 4, 6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,360,397 in view of Hyuugaji. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Hyuugaji.
Conflicting claim 1 recites a method for manufacturing a coated medical device comprising: (A) a contacting step of housing a medical device in a container, and bringing said medical device into contact with a solution a containing a hydrophilic polymer A; wherein said hydrophilic polymer A is a polymer containing, as a monomer unit, a compound a1 having a quaternary ammonium cation group represented by the same general formula as claimed as (I) of instant claim 1. The hydrophilic polymer A of the conflicting claims further contains, as a monomer unit, a compound a2 having a structure represented by the same formula as (II) of instant claim 1 (conflicting claim 1). The R groups are also the same in the conflicting claims as those defined in the instant claims. The content of compound a1 is 5% by mass or more and 90% by mass or less, and a content of the compound a2 is 10% by mass or more and 80% by mass or less (conflicting claim 1). Such mass percents provide ranges that overlap or fall within those defined in instant claim 1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. While the conflicting claims define a method and the instant claims define a product, the product of the instant invention is made obvious by the method of the conflicting claims since such a method introduces all of the elements as instantly claimed and would necessarily result in a product which comprises such elements.
The conflicting claims differ from the instant invention in that they don’t define an additional monomer having an amide group at a ratio of 3 to 80% by mass as defined in claim 1.
Hyuugaji discloses a method of surface treating a medical device with a solution containing a polymer having a repeating unit (A) and a repeating unit (B), wherein (A) is a hydrophilic repeating unit (abstract; claim 1; [0038]-[0040]). The modified medical device of Hyuugaji has excellent hydrophilicity, lubricity and antifouling properties ([0045]). The hydrophilic repeating unit (A) is one or more selected from various examples which include various (meth)acrylamides ([0116]), which read on the compound having an amide group. Example 7 teaches the synthesis of copolymer (N-7) using dimethylacrylamide (DMA), which reads on the compound having an amide group, dimethylaminopropyl-acrylamide methyl chloride quaternary salt (DMAPAA-Q), and lauroxy polyethylene glycol (30) monomethacrylate (LPEGM) ([0298]). The content of the repeating unit derived from DMA was 85% by mass ([0299]).
It would have been prima facie obvious to adopt a ternary system copolymer by adding an additional acrylamide, such as the dimethylacrylamide of Hyuugaji, into the copolymer of the conflicting claims since it is a known and routine monomer in the art. Hyuugaji teaches that acrylamides are known and effective monomers used to impart excellent hydrophilicity, lubricity and antifouling properties onto a medical devices, preferably a silicone hydrogel contact lens. Thus, one of ordinary skill in the art could have added a monomer compound having an amide group as taught by Hyuugaji according to known polymerization methods to predictably generate a hydrophilic coated medical device. See MPEP 2143. Regarding the ratio at which to incorporate said amide containing compound, Hyuugaji teaches a ratio of 85% by weight which one of ordinary skill in the art could have optimized to be within the instantly claimed range, depending on the final polymer structure and properties desired. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
2. Claims 1-2, 4, 6, and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18,278,738 in view of Hyuugaji. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Hyuugaji.
Copending claim 1 recites a coated medical device comprising a medical device and a hydrophilic polymer layer coating the surface of said medical device; wherein said hydrophilic polymer layer contains a hydrophilic polymer A, said hydrophilic polymer A containing, as monomer units, a compound a1 represented by the same formula as defined by (II) of instant claim 1; and a compound a2 having an amide group, which reads on a compound having and amide groups as recited in claim 1. The copolymerization ratio of said compound a1 to said compound a2 is 1/99 to 99/1 by mass. Such a mass ratio encompasses the mass ratios of compound a2 and the amide compound of claim 1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
The copending claims differ from the instant claims in that they do not explicitly define a quaternary ammonium monomer corresponding to instant compound a1 of claim 1.
However, a monomer comprising the instantly claimed quaternary ammonium cation group is taught by Yamashita. Specifically, Yamashita teaches coating a medical device such as a soft contact lens in a hydrophilic polymer which comprises repeating units of a methoxy polyethylene glycol (meth)acrylate and repeating units derived from a comonomer. In one embodiment where the medical device is a soft contact lens, dimethylaminopropyl (meth) acrylamide methyl chloride quaternary salt (DMAPAA Q) is preferred (description, para. 18), which reads on compound a2 as defined in instant claim 1.
Hyuugaji discloses a method of surface treating a medical device with a solution containing a polymer having a repeating unit (A) and a repeating unit (B), wherein (A) is a hydrophilic repeating unit (abstract; claim 1; [0038]-[0040]). The modified medical device of Hyuugaji has excellent hydrophilicity, lubricity and antifouling properties ([0045]). Example 7 teaches the synthesis of copolymer (N-7) using dimethylacrylamide (DMA), dimethylaminopropyl-acrylamide methyl chloride quaternary salt (DMAPAA-Q), which reads on instantly claimed compound a1, and lauroxy polyethylene glycol (30) monomethacrylate (LPEGM) ([0298]). The content of the repeating unit derived from DMAPAA Q was 2.5% by mass ([0299]).
It would have been prima facie obvious to adopt a ternary system copolymer by adding an additional acrylamide, such as the DMAPAA Q of Hyuugaji, into the copolymer of the conflicting claims since it is a known and routine monomer in the art. Hyuugaji teaches that DMAPAA Q is a known and effective monomers used to impart excellent hydrophilicity, lubricity and antifouling properties onto a medical devices, preferably a silicone hydrogel contact lens. Thus, one of ordinary skill in the art could have added DMAPAA Q as taught by Hyuugaji according to known polymerization methods to predictably generate a hydrophilic coated medical device. See MPEP 2143. Regarding the ratio at which to incorporate said DMAPAA Q, Hyuugaji teaches a ratio of 2.5% by weight which one of ordinary skill in the art could have optimized to be within the instantly claimed range, depending on the final polymer structure and properties desired. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive:
(i) Applicant asserts that the specific proportion requirements of claim 1 are not arbitrary and that they define a ternary copolymer composition with enhanced inhibition of bacterial adhesion and improved lubricity and antifouling properties. Yamashita nor Hayashi disclose or suggest that controlling the monomer content would produce the benefits described in the specification (p. 9 of Remarks).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., enhance inhibition of bacterial adhesion, and improved lubricity and antifouling) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, if Applicant intends to claim unexpected results or criticality in the instantly claimed proportions, an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). In this case, applicant has not provided a comparison to the closest prior art nor pointed to a specific example in the specification to sufficiently show unexpected results.
(ii) Applicant argues that Yamashita does not disclose the simultaneous inclusion of compound a1, compound a2, and an amide-containing monomer, nor does it provide any teaching or suggestion to incorporate these components in the specific proportions now recited. Applicant also argues that the relative amounts of the monomers in Example 6 of Hayashi fall outside of the scope of amended claim 1. Applicant argues that Hayashi does not suggest that adjusting these ratios would yield any improvement in antifouling, lubricity, or inhibition of bacterial adhesion.
In response to the arguments against Yamashita, the rejection now also relies on the teachings of Hyuugaji. Yamashita teaches a copolymer comprising monomers corresponding to compounds a1 and a2. Hyuugaji teaches ternary copolymers comprising monomers corresponding to a compound having an amide group, compound a1, and a compound reading partially on compound a2. Both polymers are used for the same purpose of forming a hydrophilic coating on a medical device, such as a contact lens. Thus, would have been prima facie obvious to add the amide containing compound of Hyuugaji into the copolymer of Yamashita according to known polymerization methods to predictably yield a hydrophilic coating polymer.
In response to the arguments against Hayashi, differences in concentration will generally not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, the improvement in antifouling, lubricity, or inhibition of bacterial adhesion is not required by the claims, as discussed above, nor has the Applicant provided data that such monomer ratios are critical to achieve said effect. Lastly, while Example 6 teaches a ratio of DMAPAA Q outside of the instantly claimed range, Hayashi broadly teaches that a total content of the repeating unit (A) in the whole repeating units may be between 0.01 to 50% by mass, which overlaps with the instantly claimed ratio range of claim 1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Conclusion
No claims are allowed.
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.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616