DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/14/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 04/14/2026 is acknowledged. Claims 1 and 5-6 are amended and claims 3-4 and 7 are canceled. Claims 5 and 9-10 remain withdrawn as being directed to a non-elected invention. Applicant’s species election of the following species is maintained: Formula (I) having a propylene group for R1 and methyl group for R2 to R4; Formula (II) having H for L1, O for X, and methyl group for Y; and a silicone hydrogel as the medical device material. Claims 1-2, 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Withdrawn Rejections
Claims 1-2, 4, 6, and 8 were rejected under 35 U.S.C. 103 as being unpatentable over Yamashita in view of Hyuugaji. In view of Applicant’s amendments to claim 1 and upon further consideration, the rejection is withdrawn.
Claims 1-2 were rejected under 35 U.S.C. 103 as being unpatentable over Hayashi. In view of Applicant’s amendments to claim 1, the rejection is overcome and withdrawn.
Claim 4 was rejected under nonstatutory double patenting. Applicant’s cancellation of claim 4 has rendered such rejections moot.
Claim Rejections - 35 USC § 112(b)
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.
1. Claims 1-2, 6, and 8 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.
The terms “soft” and “hard” in claim 1 are relative terms which render the claim indefinite. The terms “soft” and “hard” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2, 6, and 8 are rejected by virtue of their dependency on claim 1.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Murphy, J., et al. (US 20170266353 A1, 09/21/2017, IDS dated 08/24/2023), hereinafter Murphy.
Murphy discloses methods for creating polymeric compounds comprising phenyl derivatives (PD), or PDp i.e., polymers modified with PD, with desired surface active effects which may be useful for antifouling coatings (abstract).
Regarding claim 1: Murphy teaches that a hydrophilic and water-soluble polymer backbone such as poly(ethylene glycol) (PEG) can be used to create a water soluble PDp ([0188]). A method of providing a biofouling resistant surface comprises providing a medical device surface having been functionalized with reactive amine groups; providing a multihydroxy phenyl derivative (DHPD)-poly(ethylene glycol) polymer comprising Formula I:
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; and applying said polymer and silver nitrate to said surface ([0113]-[0118]; Fig. 7; claim 10), thereby resulting in a hydrophilic polymer layer coating the surface of said medical device as claimed. Example polymers S-104 through S-107 in FIG. 8, comprise different “a” components, with MEA for the “b” component and DMAPMAmC12 as the “c” component (FIG. 8, Table 1). Component “a” is either DMA, VAMA, or DMHPEAMA, all of which are methacrylamide monomers (i.e., Rd = NH or NH-CH2) (Tables 1-2; FIG. 8), which read on a compound having an amide group as claimed. The MEA used for component “b” is ethylene glycol methyl ester acrylate (i.e., Rb=H, Re=O, Rj=CH3) (Tables 1-2; FIG. 8), which reads on the instantly elected compound a2 (i.e., Formula (II) wherein L1=H, X=O, Y=CH3, m=1). The DMAPMAmC12 used for component “c” is 3-(dodecyl-dimethylamino)propyl methacrylamide (i.e., Rc=CH3, Rf=N, Rk=CH2CH2, d=8) (Tables 1-2; FIG. 8), which reads on a non-elected species of compound a1 (i.e., Formula (I) wherein R1 is a C3 divalent organic group, R2 and R4 are C1 alkyl groups, R3 is a C12 alkyl group).
Regarding the ratios of each monomer compound, polymer S-104 may be used as an example. Surphys-104 was synthesized by combining 20.249 grams of DMAPMAC12, 2.663 g of DMA, and 2.605 g of MEA, along with AIBN and DMF (Example 10; [0223]). The total mass of monomers is approximately 25.5 g (i.e., 10.249 + 2.663 + 2.605). As such, the ratio of DMAPMAC12 (compound a1) to the total amount of the other monomers is 79.4% by mass (i.e., 20.25/25.5), which falls within the instantly claimed range (i.e., 10-90%). The ratio of MEA (compound a2) to the total amount of the other monomers is 10.2% by mass (i.e., 2.6/25.5), which falls within the instantly claimed range (i.e., 10-90%). The ratio of DMA (amide compound) to the total amount of the other monomers is 10.4% by mass (i.e., 2.66/25.5), which falls within the instantly claimed range (i.e., 3-50%).
Murphy specifically teaches catheter activation and coating of polyurethane catheters with the polymers discussed above (Example 19). Additionally, Surphys coating performance was determined by measuring polyurethane sheets coated with candidate Surphys polymers changes in contact angle and reduction in E. coli attachment ([0205]). Advancing contact angles of various hydrophilic PDp-coated surfaces decreased from that of uncoated polyurethane sheets, signifying that the antifouling coatings were successfully applied to the polyurethane sheets ([0206]). Such polyurethane catheters and sheets read on a low water content (soft or hard) material selected from a polymer having polyurethane in the main chain, as instantly recited.
Regarding claim 2: Figure 5 of Murphy shows how the antifouling polymer interacts with the substrate surface. It can be observed that the polymer and substate surface are mixed to form bonds at their interface which reads on comprising a mixed layer of the hydrophilic (antifouling) polymer and the medical device (substrate) discussed above.
Regarding claim 8: Murphy teaches activation and coating of polyurethane catheters with the polymers discussed above (Example 19).
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 1-2, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy, J., et al. (US 20170266353 A1, 09/21/2017, , IDS dated 08/24/2023), hereinafter Murphy, in view of Yamashita, K., et al. (JP 2017176821 A, 10/05/2017, IDS dated 11/29/2024, PE2E translation used, on record), hereinafter Yamashita.
The teachings of Murphy are discussed above.
Murphy further teaches a broader range of cationic monomers which may be used, that include the DMAPMAC12 discussed above or (3-acrylamido-propyl)trimethyl-ammonium having the structure:
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(Ex. 16, [0229]). Such a monomer reads on the elected structure of compound a1 (i.e., Formula (I) wherein R1 is a propylene group, R2-R4 are methyl groups).
Murphy also teaches that polymers for antifouling coating applications are designed to adhere to one surface while preventing other materials from adhering to the surface. For medical devices and implants, preventing proteins, cells, bacteria and other unwanted materials from attaching to the surface of a material is essential in maintaining the desired functionality, longevity, and safety of these devices. Proteins that non-specifically adsorb to material surfaces from extracellular fluids can trigger adverse biological responses, and may interfere with medical device function, as is the case with contact and intraocular lenses ([0203]). The antifouling polymers comprise antimicrobial properties attributed to the third monomer (c) comprising a structure capable of bacterial kill-on-contact ([0207]). While Murphy teaches coating the surface of a polyurethane device with the above polymer, the antifouling coatings can also be used to prevent bacterial attachment to other types of implantable devices ([0210]).
The teachings of Murphy differ from that of the instant invention in that Murphy does not explicitly teach an embodiment comprising the instantly elected structure of compound a1 nor the instantly elected silicone hydrogel material, as recited in claim 1. Murphy also fails to explicitly teach the materials of claim 6.
Yamashita discloses a method for producing various medical devices including ophthalmic lenses with improved surface characteristics (abstract). A medical device that is in direct contact with a part of the human body needs to be biocompatible on its surface. For the expression of biocompatibility, it is important that the adhesion of substances such as water, protein and lipid is controlled (p. 1, para. 3). Yamashita teaches medical polymers which are bound to and/or infiltrated inside the device surface. A coating having an interpenetrating network structure may be 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, and has features such as compatibility, reversible attraction of biomolecules (eg, mucins) from physiological fluids, prevention of irreversible deposition of proteins, lipids and salts, and inhibition of microbial adhesion (p. 7-8, bridging para.). 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, and balafilcon A, (description, para. 28), which read on the silicone hydrogels of claims 1 and 6. The contact/ophthalmic lens reads on a medical device of claim 8. The medical polymer of Yamashita is a chain structure having a structural unit derived from an unsaturated group-containing monomer. The polymer may also be a copolymer of the above structural unit and a another monomer (i.e., comonomer) (description, para. 8). The monomer containing an unsaturated group is selected from various methoxypolyethylene glycol methacrylates (Examples; description, para. 13). 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).
First, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention to use the (3-acrylamido-propyl)trimethyl-ammonium monomer of Murphy:
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, in the antifouling polymer coating since such a cationic monomer is known and routine in the art as taught by Murphy. One of ordinary skill in the art could have performed simple substitution of one known cationic monomer for another to predictably yield a polymer of the instant invention. Such a substitution results in a hydrophilic polymer comprising a monomer unit reading on the instantly elected structure for compound a1 (i.e., Formula (I) wherein R1 is a propylene group, R2-R4 are methyl groups).
It would have also been prima facie obvious to one of ordinary skill in the art use the ophthalmic lens of Yamashita comprising a hydrogel lens material such as comfilcon, lotrafilcon, or balafilcon, as the medical device of Murphy since such a medical device/material is known and routine in the art for undergoing antifouling polymer treatment. Murphy teaches its antifouling polymers can be used to prevent bacterial attachment to various types of implantable devices and that contact lenses are known to suffer from the non-specific absorption of proteins and other unwanted materials. Yamashita specifically teaches surface modifying ophthalmic lenses with polymers that provide reversible attraction of biomolecules (eg, mucins) from physiological fluids, prevent the deposition of proteins, lipids and salts, and inhibit microbial adhesion. As such, one of ordinary skill in the art would recognize that the antifouling polymer of Murphy could be applied to the ophthalmic lens of Yamashita, comprising a hydrogel material such as comfilcon, lotrafilcon, or balafilcon, to improve the lens in the same way as the other medical devices taught by Murphy. One of ordinary skill in the art would have been motivated to select the ophthalmic lenses of Yamashita for antifouling treatment according to Murphy, since ophthalmic lenses suffer from non-specific absorption of proteins and would therefore benefit from such an antifouling coating. Such a modification would result a coated medical device as claimed, wherein the medical device comprises a silicone hydrogel material, as elected by Applicant and recited in claim 1, such as comfilcon, lotrafilcon, or balafilcon, as recited in claim 6, wherein the medical device is an ophthalmic lens as recited in claim 8.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since both Murphy and Yamashita teach hydrophilic antifouling coatings for medical devices. Additionally, the medical polymers used to coat the ophthalmic lenses of Yamashita are polyethylene glycol antifouling polymers ideally comprises quaternary salt monomers which are similar to the polyethylene glycol antifouling polymers of Murphy also comprises quaternary ammonium monomers.
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, 6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5 of U.S. Patent No. 12,360,397 in view of Hyuugaji, S., et al. (US 20180217294 A1, 08/02/2018, IDS dated 08/24/2023), hereinafter 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. Conflicting claim 5 recites wherein said medical device comprises a material selected from a hydrogel, a silicone hydrogel, a low water content soft material, and a low water content hard material, which reads on the materials of instant claim 1. Conflicting claim 3 recites wherein said hydrophilic polymer A comprises an amide group. 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 50% 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, 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 Yamashita. 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 Yamashita.
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 medical device comprises a material selected form a hydrogel, a silicone hydrogel, and a low water content material (copending claim 3), which reads on the materials of claim 1.
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.
It would have been prima facie obvious to adopt a ternary system copolymer by adding an the DMAPAA Q of Yamashita, into the copolymer of the conflicting claims since it is a known and routine monomer in the art. Yamashita teaches that DMAPAA Q is a known and effective monomer to coat a medical device in combination with methoxy polyethylene glycol (meth)acrylate, preferably a silicone hydrogel contact lens. Thus, one of ordinary skill in the art could have added DMAPAA Q as taught by Yamashita 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, 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 with respect to the rejections under 35 USC 103 in view of Yamashita and Hyuugaji have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to the rejections under 35 USC 103 in view of Hyuugaji have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 9-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
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