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 .
Election/Restrictions
Applicant’s election without traverse of invention group I, claims 1-3, 5-7 and 16-28, in the reply filed on 10/09/2025 is acknowledged.
Claims 8-12 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/09/2025.
Claims 1-3, 5-12 and 15-28 are pending, claims 1-3, 5-7 and 16-28 are under examination.
Priority
Acknowledge is made that this application is national stage of international patent application PCT/JP2021/09837, filed on 10/28/2021; which claims priority from Japan Patent application JP2020-181848, filed on 10/29/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/21/2023 is being considered by the examiner.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 5-7 and 16-28 are rejected under 35 U.S.C. 103 as being unpatentable over Peters (US20200397697).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Peters teaches A pharmaceutical composition comprising, in a unit dosage form: a Tie-2 activator; and a micelle, wherein the micelle comprises a mucoadhesive component; wherein the pharmaceutical composition is formulated for administration to an eye; wherein the micelle further comprises a degradable hydrophobic polymer and a degradable synthetic hydrophilic polymer. wherein the degradable synthetic hydrophilic polymer is selected from the group consisting of methacrylic acid, acrylic acid, hydroxyethyl methacrylate, hydroxypropylmethacrylamide, hydroxyethyl acrylate, poly(ethylene glycol) methacrylate, poly(N-isopropylacrylamide) (PNIPAM), poly(vinyl alcohol) (PVA), poly(2-oxazoline), polyethylene glycol, polyvinylpyrollidone, and copolymers thereof (claims 128, 133, 135 and 138). Pharmaceutical compositions can be administered in therapeutically-effective amounts as pharmaceutical compositions by various forms and routes including, for example, intravenous, intravitreal, subcutaneous, intramuscular, intraocular ([0071]). A pharmaceutical composition can be administered in a local or systemic manner, for example, via injection of the compound directly into an organ, optionally in a depot or sustained release formulation, or via direct administration to the posterior or anterior portion of the eye of a subject ([0072]). Non-limiting examples of ocular conditions that can be treated by a compound disclosed herein include increased intraocular pressure in the eye and ocular hypertension ([0154, 0156]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Peters is that Peters is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Regarding claims 1-3, 6, 18-19, Peters teaches a method of treating ocular condition such as increased intraocular pressure in the eye and ocular hypertension by administering a composition comprising hydrophilic polymer poly(2-oxazoline) to anterior portion of the eye or intraocular. The anterior portion of the eye or intraocular includes anterior chamber of eyeball as one of few choices. The properties of poly(2-oxazoline) are regarded as inherency of prior art poly(2-oxazoline). Since prior art teaches the same polymer, this polymer must have the same properties.
Peters is silent about “increase the ocular tension of the subject, and cooling the eyeball that has received the temperature responsive polymer to decrease the ocular tension”, which is regarded as inherency of prior art steps. In summary, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same composition comprising the same poly(2-oxazoline) by the same mode of administration in the same amount to the same anterior chamber of eyeball in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, prior art teaches, either expressly or inherently implied, each and every limitation of the instant claims. it remains the Examiner's position that the instantly claimed method is obvious.
Regarding claims 5,7, 16-17 and 20-28, Peters teaches hydrophilic polymer is selected from the group consisting of methacrylic acid, acrylic acid, hydroxyethyl methacrylate, hydroxypropylmethacrylamide, hydroxyethyl acrylate, poly(ethylene glycol) methacrylate, poly(N-isopropylacrylamide) (PNIPAM), poly(vinyl alcohol) (PVA), poly(2-oxazoline), polyethylene glycol, polyvinylpyrollidone, and copolymers thereof, thus, it is obvious to have copolymer of poly(2-oxazoline) and polyethylene glycol as hydrophilic polymer. Since both poly(2-oxazoline) and copolymer of poly(2-oxazoline) and polyethylene glycol are recognized as hydrophilic polymer, it is obvious to have the mixture of poly(2-oxazoline) and the copolymer of poly(2-oxazoline) and polyethylene glycol as hydrophilic polymer in the composition, because "It 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). MPEP 2144.06.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613