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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-18 and Fig. 3 in the reply filed on 08/04/2027 is acknowledged. Claim 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 1-18 are presently pending in this application.
Claim Rejections - 35 USC § 102
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 1-7 and 11-15 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Ide et al. (2010/0057093) “Ide”.
Regarding claim 1, Ide discloses a graft injector assembly (Fig. 1; abstract) comprising an elongated injector body 11 (Fig. 3) formed from at least a first material (par. 0176), the body comprising a proximal end portion 11b, a distal end portion 11a, and an interior surface 11c extending between the proximal end portion and the distal end portion (as shown in Fig. 3); and a coating formed from at least a second material disposed on the interior surface of the body (par. 0217 discloses the interior surface 11c is coated), wherein a lumen is defined by the interior surface and the coating (lumen created by inner surface 11c; Fig. 3), the lumen structured to store a graft 7 comprising corneal tissue (par. 0032 discloses the graft includes corneal endothelial cells) and to allow the graft to exit distally through the distal end portion (Figs. 13a-d).
Regarding claims 2-3 and 5, Ide discloses wherein adhesion of the second material to corneal tissue is less than adhesion of the first material to corneal tissue (par. 0176 discloses the first material is glass and par. 0208 discloses polyethylene glycol for coating or second material); wherein the second material is more hydrophilic than the first material (par. 0217 discloses the coating is hydrophilic) and wherein the first material comprises a glass material (par. 0176).
Regarding claim 4, Ide discloses further comprising the corneal graft, the corneal graft comprising a Descemet membrane and endothelial cells (par. 0032).
Regarding claim 6, Ide discloses wherein the coating is disposed on the entire interior surface of the body (par. 0217 discloses the coating all of the interior space 11c is coated).
Regarding claim 7, the claimed phrase “the coating is covalently bonded to the body” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Regarding claims 11-15, Ide discloses wherein the second material comprises a functional bioactive moiety compatible with the graft that lubricates the interior surface; wherein the functional bioactive moiety is selected from amine, carboxylic acid, hydroxyl, sugar, polysaccharide, glycosaminoglycan, peptide, protein, polymer, or any combination of these; wherein the polymer is selected from a polyethylene glycol, a polyvinyl alcohol, a polyhydroxy ethyl methacrylate, a poly(meth)acrylic acid, a polyvinylpyrrolidone, or any combination of these and wherein the second material comprises a polymer comprising amine, polyethylene glycol, or both; wherein the second material comprises polymers of various chain lengths (par. 0208 discloses the coating comprises polyethylene glycol).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ide et al. (2010/0057093) “Ide” in view of Grinstaff et al. (2018/0043066).
Ide discloses the claimed invention of claim 1; except for wherein the second material comprises a positively charged functional group, a charge-neutral functional group, or both. However, Grinstaff teaches a similar coating comprising a positively charged functional group, a charge-neutral functional group, or both (par. 0299 discloses charged functional groups). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second material in Ide to include a positively charged functional group, a charge-neutral functional group, or both, as taught and suggested by Grinstaff, for providing a hydrophilic coating with low friction (par. 0299).
Claims 9 and 10 rejected under 35 U.S.C. 103 as being unpatentable over Ide et al. (2010/0057093) “Ide” in view of Guo (2022/0280699).
Ide discloses the claimed invention of claim 1; except for wherein the second material comprises an organosilane material and wherein the second material comprises a nanoparticulate material. However, Guo teaches a similar coating comprising nanoparticulate organosilane material (par. 0049). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second material in Ide to include organosilane material and wherein the second material comprises a nanoparticulate material, as taught and suggested by Guo, for providing a lubricious coating (par. 0049).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ide et al. (2010/0057093) “Ide” in view of Hunter et al. (2004/0043052).
Ide discloses the claimed invention of claim 1; except for wherein the coating further comprises an antifungal agent, wherein the antifungal agent is non- covalently bonded to the second material and wherein the antifungal agent is coupled to the second material using physical entrapment, chemical conjugation, immobilization, or any combination of these. However, Hunter teaches a similar coating comprising an antifungal agent, wherein the antifungal agent is non- covalently bonded to the second material (par. 0096) and wherein the antifungal agent is coupled to the second material using physical entrapment, chemical conjugation, immobilization, or any combination of these (par. 0110). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating in Ide to include wherein the coating further comprises an antifungal agent, wherein the antifungal agent is non- covalently bonded to the second material and wherein the antifungal agent is coupled to the second material using physical entrapment, chemical conjugation, immobilization, or any combination of these, as taught and suggested by Hunter, for providing antimicrobial coating to minimize infections.
Furthermore, regarding claims 17-18, the claimed phrases “non- covalently bonded to the second material” and “is coupled to the second material using physical entrapment, chemical conjugation, immobilization, or any combination of these” are being treated as a product-by-process limitations and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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