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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/18/26 has been entered. ‘Paragraphs 0018 and 0021 of Nakamura et al. teach that the composition of Nakamura et al. is designed to be a gel formation injected into a surgical site by means of a syringe or applied by means of a sustained release polymer, i.e., an implant, inserted into the surgical site. Thus, the composition of Nakamura et al. is not designed to be applied directly to the eye in the form of eye-drops as required by the pending claims.”
Applicant's arguments filed have been fully considered but they are not persuasive. The claims remain rejected for the reasons of record. Applicant again argues that the composition of Nakamura should not be considered “eye drops” but as previously argued, there is o clear structural requirement that would preclude the Nakamura composition from being considered “drops.”
The examiner has also presented an obviousness rejection so that even if one would not accept that the Nakamura composition could be deemed “eye drops” the claimed composition would still have to be considered obvious.
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 1-8 are rejected under 35 U.S.C. 102(a)(1)(2)as being anticipated by NAKAMURA et al (2010/0087486).
Nakamura et al is drawn to medicant compositions in liquid form to be applied directly to the eye (eye drops) with the TGF-Beta inhibitor 4-[4-(1,3-benzodioxole-5-yl)-5- pyridinyl)-1 H-imidazole-2-yl]benzamide (also known was SB-431542 – applicant’s exemplified as in claim 5) [006][0019] and combined with other active ingredients, excipients etc.
The reference anticipates the claim subject matter as the intended use “medicant for…” does not impart a structural difference from the compound disclosed in the prior art (or the myriad of other known TGF-Beta signal inhibiting agents).
Nakamura indicates that the formulation can be applied directly to the eye with a syringe making the formulation functionally “eye drop” absent any added structural limitation to the composition.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
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 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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura (above) and Quay 6444791 & Galardy 5189178.
Nakamura et al is drawn to medicant compositions in liquid form to be applied directly to the eye with the TGF-Beta inhibitor 4-[4-(1,3-benzodioxole-5-yl)-5- pyridinyl)-1 H-imidazole-2-yl]benzamide (also known was SB-431542 – applicant’s exemplified as in claim 5) [006][0019] and combined with other active ingredients, excipients etc.
The reference anticipates the claim subject matter as the intended use “medicant for…” does not impart a structural difference from the compound disclosed in the prior art (or the myriad of other known TGF-Beta signal inhibiting agents). Nakamura indicates that the formulation can be applied directly to the eye with a syringe making the formulation functionally “eye drop” absent any added structural limitation to the composition, however even if one would not consider the composition of Nakamura to be “eye drops” it would have been obvious at the time the invention was filed to formulate the gel of Nakamura into a conventional eye drop because Quay and Galardy both teach that it would have been obvious to formulate the corneal effecticting composition in either a gel or eye drops. Specifically, Quay teaches “A variety of topical antiprotease formulations are useful within the methods of the invention, including solutions, gels, creams, particulate suspensions, and the like. For example, eyedrops comprising an aqueous protease inhibitor solution isotonic with tears are particularly useful for repeated instillation during periods of reflex tear production. However, poor bioavailability of drugs and other therapeutic agents in topical ophthalmic preparations limits therapeutic drug delivery and efficacy from aqueous solutions and other topical formulations. Poor bioavailability is attributable to a variety of factors, including rapid clearance of therapeutic agents by tear flow, neutralization or degradation of therapeutic agents by proteases and other mechanisms, barriers to diffusion and penetration of therapeutic agents… also enhance drug transport to intraocular target sites. In addition, the delivery systems are safe and non-irritating and provide other advantages that promote patient compliance.”
Galardy teaches “For localized conditions, topical administration is preferred. For example, to treat ulcerated cornea, direct application to the affected eye may employ a formulation as eyedrops…the compounds of the invention can also be formulated as gels or ointments, or can be incorporated into collagen or a hydrophilic polymer shield. The materials can also be inserted as a contact lens or reservoir or as a subconjunctival formulation.”
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
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