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 .
This application is the national stage entry of PCT/JP2022/023483, filed 10 June 2022; and claims benefit of foreign priority document JAPAN 2021-101297, filed 18 June 2021. This foreign priority document is not in English.
Claims 1-8 are pending in the current application and are examined on the merits herein.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Herbrechtsmeier et al. (US 5,391,592, issued 21 Feb 1995, provided by Applicant in IDS filed 15 Dec 2023).
Herbrechtsmeier et al. teaches a contact lens comprising a crosslinked lipophilized cyclodextrin derivative, wherein each repeating cyclodextrin unit includes at least one polysiloxane group. The process for producing the contact lens includes the reaction of a cyclodextrin with a polysiloxane (abstract). The invention relates to a contact lens comprising a crosslinked lipophilized cyclodextrin derivative which is obtainable by reacting a compound of formula I
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with a compound of formula II
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, where the radicals R1 are each, independently of the others, hydrogen, R2 or R3 wherein, of the (3 times n) radicals R, at least one radical R1 has the meaning of R3 and the remaining radicals R1 are hydrogen or have the meaning of R2, R2 being unsubstituted or halogen-substituted alkyl or alkyl-substituted aryl and R3 being unsubstituted or halogen-substituted alkenyl (column 2, lines 5-40). Preferably from 50% to 100% of a third of the R1 radicals have the meaning of R3, whilst the other radicals R1 have the meaning of R2 (column 3, lines 30-35). The invention relates most especially to a contact lens compri3sing a crosslinked lipophilized cyclodextrin derivative which has repeating subunits of formula VII
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wherein R2 is unsubstituted alkyl, and R7 is a divalent radical of formula VIII
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, x is an integer of from 1 to 500, R4 and R5 are each, independently of the other, alkyl or phenyl, and R8 is alkylene. The index n in a compound of formula VII is preferably 6, 7 or 8 (column 9, line 40 to column 10, line 5). In an embodiment R2 is lower alkyl having from 4 to 7 carbon atoms, x is an integer of from 1 to 200, R4 and R5 are each, independently of the other, lower alkyl or phenyl, and R8 is lower alkylene having from 3 to 6 carbon atoms (column 10, lines 20-25). Herbrechtsmeier et al. teaches working example 8, in which a cyclodextrin/siloxane network was obtained by reacting compounds of formula I with compounds of formula IV, the variables of formula I having the following meanings: n is 7, the two radicals R1 in positions 2 and 6 are pentyl, 40% of the radicals R1 in position 3 are pentyl and 60% of the radicals R1 in position 3 are pentenyl, and the for the variables of formula IV R4 and R5 are methyl, and x is the integer 5, 11, 17, 37, 82 or 100 (column 15, line 60 to column 16, line 15), corresponding to the claimed compound where the group R is pentyl or the claimed formula (3), m is 0, R2 is methyl, b is 5, c is 5, 11, 17, 37, 82 or 100, the another sugar unit is another cyclodextrin unit, and NH:NA:NE:NS:NLS=0:2.4:0:0:0.6. These compound were produced according to the method of example 1, comprising etherifying a β-cyclodextrin with sodium hydride (an alkali metal) and 1-bromopent-4-ene (an unsaturated group-containing halide), and in a subsequent step heptakis-(2,6-di-O-n-pentyl-3-O-(a)-pentenyl)-3-cyclodextrin was reacted with an equivalent amount of α,ω-dihydrogen-polydimethylsiloxane (an organohydrogenpolysiloxane) in the presence of cis-bis-(styrolo)dichloro-platinum as catalyst (a curing catalyst) (column 13, line 5-35), addressing limitations of claim 2 and 4.
Herbrechtsmeier et al. does not specifically disclose the compound wherein the ratio of molar numbers is NH:NA:NE:NS:NLS=(0 to 2.85):(0 to 2.85):(0 to 2.9):(0 to 2.9):(0.15 to 0.5) (claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select from within the teachings of Herbrechtsmeier et al. to arrive at the claimed molar numbers of the substituents. One of ordinary skill in the art would have been motivated to modify the teachings of Herbrechtsmeier et al. with a reasonable expectation of success because Herbrechtsmeier et al. provides guidance in the form of the working example 8 which is the claimed compound where NH:NA:NE:NS:NLS=0:2.4:0:0:0.6; Herbrechtsmeier et al. teaches preferably from 50% to 100% of a third of the R1 radicals have the meaning of R3, where in working example 8 60% of a third of the R1 radicals have the meaning of R3, providing guidance for selecting lower end of the preferred range; suggesting it would have been obvious to select the value of 50% which would make obvious the claimed compound where NH:NA:NE:NS:NLS=0:2.5:0:0:0.5.
Regarding claim 3, this claim further limits the formula (2), however the scope of this claim encompasses the compound taught by Herbrechtsmeier et al. contains which contains no groups of formula (2).
Regarding claim 4, the method makes optional the step 2, in this case the method taught by Herbrechtsmeier et al. is not required to perform this optional step. See MPEP 2111.04 at I. providing “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” Further, step 3 explicitly allows for reaction of the compound resulting from step 1, such as in the method taught by Herbrechtsmeier et al. detailed above.
Allowable Subject Matter
Claims 5-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Herbrechtsmeier et al. (US 5,391,592, issued 21 Feb 1995, provided by Applicant in IDS filed 15 Dec 2023).
Herbrechtsmeier et al. teaches a contact lens comprising the compound as detailed above.
It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Herbrechtsmeier et al. to formulate the compound as cosmetic composition. MPEP 2143.01 at V. provides “If a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, there may be no suggestion or motivation to make the proposed modification. In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984)” In this case, formulating the compound taught by Herbrechtsmeier et al. as a cosmetic composition would render the invention being modified unsatisfactory for its intended purpose as a contact lens.
Other relevant art is Abbehausen et al. (J. Braz. Chem. Soc., 2010, 21(10), p1867-1876, cited in PTO-892).
Abbehausen et al. discloses a hybrid polymer derived from siloxane and β-cyclodextrin (β-CD) was obtained by reaction of β-CD with γ-isocyanatopropyltriethoxysilane (IPTS), followed by hydrolysis/condensation reactions, generating a β-CD-modified polysilsesquioxane resin (PSS-β-CD) (page 1867, abstract). Abbehausen et al. discloses the schematic reaction of β-CD with IPTS to give the intermediate compound
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(page 1869, figure 1). The compound taught by Abbehausen et al. differs from the claimed compound for at least the reason that formula (2) of the claimed compound does not encompass the group R1 to be an alkoxy group. Therefore Abbehausen et al. does not teach or fairly suggest each and every limitation of the invention as claimed.
Copending Application No. 18/567,067 (reference application), now allowed, has been fully considered herein.
The Reference claims are patentably distinct from the claims at issue because the claims of the reference application require a molar ratio of NH:NS:NL=(0.5 to 2.5):(0.3 to 2.0):(0.1 to 0.5) and NH+NS+NL=3.0, which includes a molar ratio of 0.1 to 0.5 for the group having reference formula (3). In contrast the examined claims requires a molar ratio of NH:NA:NE:NS:NLS=(0 to 2.85):(0 to 2.85):(0 to 2.9):(0 to 2.9):(0.15 to 0.5) and NH+NA+NE+NS+NLS=3.0, which does not allow for the presence of a group having reference formula (3).
Conclusion
No claim is currently in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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