DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1 and 8-9 are pending and represent all claims currently under consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/05/2026 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claims 1 and 8-9 are considered to have an effective filing date of 07/23/2021.
Response to Arguments
Applicant's arguments filed 06/05/2026 have been fully considered but they are not persuasive.
Applicant argues that Park does not teach or suggest the specific, synergistically optimized combination of features recited in the amended claim 1. Applicant further states that Park explicitly teaches that the stability of the formulation is highest at a pH of 6.0, which does not render the pH of 5.8 obvious (Remarks, pages 3-4). This argument is not persuasive, because as previously stated, Park states it would be apparent for a person skilled in the art that the specific description is merely a preferred embodiment, and the scope of the present invention is not limited thereto (Park, column 13, lines 13-16). Park teaches a pH ranging from 5.7 to 6.2 (Park, claim 3). Therefore, it would be prima facie obvious to a person skilled in the art to optimize the pH of the claimed formulation within the pH range taught by Park, which includes the claimed pH of 5.8. Regarding Park’s teaching that the stability is highest at a pH of 6.0, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP § 2123(II).
Applicant argues that Park does not provide experimental data sufficient to ensure actual long-term stability, and that an extended period of 8 weeks as disclosed in the present application is generally recognized as accelerated conditions that can reliably predict long-term storage stability. Applicant states that long-term storage stability would not be readily predictable from the mere 7-day data on physical degradation disclosed in Park (Remarks, page 4). This argument is not persuasive, because Park specifically says the invention stably maintains a fusion protein under the storing condition for a long period of time (Park, column 2, lines 38-43), and that stability for long-term storage may be enhanced (Park, column 4, lines 5-7). Therefore, long-term storage stability would be reasonably expected absent evidence to the contrary.
Applicant argues that the specific combination of features in claim 1 or formulation 8 of table 1 of the specification results in unexpectedly improved properties (Remarks, pages 4-7). This argument is not persuasive, because as stated below, Park exemplifies a formulation comprising a histidine, polysorbate 20, and sucrose in the claimed amounts with no sodium. While the example from Park comprises a pH of 6.0 instead of 5.8 as claimed, Park teaches it would be apparent for a person skilled in the art that the specific description is merely a preferred embodiment, and the scope of the present invention is not limited thereto (Park, column 13, lines 13-16). Therefore, it would be obvious to a person skilled in the art to optimize the pH of each formulation within the pH range taught by Park, which includes the claimed pH of 5.8. In the data cited from the specification by the Applicant, Formulations 8 and 10 differ only in pH, having a pH of 5.8 and 6.0, respectively (instant specification, page 9, table 1). Formulations 8 and 10 appear to result in no significant difference in any of the properties measured by the Applicant (instant specification, pages 10-21; figures 6-9). The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." See MPEP 716.02(b). Therefore, based on the evidence provided by the Applicant, the example of Park cited below, which matches all elements of the claimed composition with the exception of a pH of 6.0, would be reasonably expected to have the same properties as the claimed composition.
Maintained/Modified 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.
Claims 1 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Park (US 9982032 B2) and as evidenced by PubChem (Sucrose, 2025). Park was cited previously by the Examiner. The references were cited previously by the Examiner.
Regarding claim 1, Park teaches a liquid formulation (i.e., composition) comprising 10 to 100 mg/ml of aflibercept, a sugar which can be sucrose, a surfactant which can be polysorbate 20, and a buffer consisting of a histidine salt having a pH ranging from 5.7 to 6.2 (Park, claim 3). Park exemplifies a formulation comprising the histidine salt buffer in 10 mM, which would contain histidine in the same molar amount and which lies within the claimed range; polysorbate 20 in 0.01%; sucrose in 5%; and no sodium chloride (Park, column 12, lines 11-13, formulation 4). Park teaches an amount of polysorbate 20 defined as a % w/v (Park, column 9, line 19), and therefore the 0.01% of polysorbate 20 exemplified by Park matches the claimed amount. Park defines the sugar (i.e., sucrose) concentration as a percent v/v (Park, column 6, lines 11-12). As evidenced by PubChem, the density of sucrose is 1.6 g/mL (PubChem, 4.2.8 Density), resulting in a percent w/v of 8% which lies within the claimed range.
Park further teaches that the liquid formulation may be used for ophthalmic drug delivery (Park, column 6, lines 24-25), and that the amount of administration is determined by doctors and is an amount effective for the desired therapy (i.e., a therapeutically effective amount; Park, column 8, lines 49-51).
Park teaches an evaluation to find the optimal pH condition (Park, columns 8-9, example 1) and salt concentration (Park, column 11, example 5, formulation 3) for an exemplary formulation. Park teaches a formulation without an additional salt as a preferred alternative to a composition comprising sodium chloride (Park, column 11, example 5, formulation 3). Park further states it would be apparent for a person skilled in the art that the specific description is merely a preferred embodiment, and the scope of the present invention is not limited thereto (Park, column 13, lines 13-16). Therefore, it would be obvious to a person skilled in the art to optimize the pH of each formulation within the pH range taught by Park, which includes the claimed pH of 5.8.
Park is considered to be analogous to the claimed invention, because both Park and the instant invention are in the same field of ophthalmic liquid compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed invention based on the teachings of Park under the meaning of 35 U.S.C. 103.
Regarding claim 8, Park teaches all the elements of the current invention as applied to claim 1. Park teaches the liquid formulation is suitable for intravitreal injection (Park, claim 4).
Regarding claim 9, Park teaches a liquid formulation (i.e., composition) comprising 10 to 100 mg/ml of aflibercept, a sugar which can be sucrose, a surfactant which can be polysorbate 20, and a buffer consisting of a histidine salt having a pH ranging from 5.7 to 6.2 (Park, claim 3). Park exemplifies a formulation comprising the histidine salt buffer in 10 mM, which would contain histidine in the same molar amount and which lies within the claimed range; polysorbate 20 in 0.01%; sucrose in 5%; and no sodium chloride (Park, column 12, lines 11-13, formulation 4). Park teaches an amount of polysorbate 20 defined as a % w/v (Park, column 9, line 19), and therefore the 0.01% of polysorbate 20 exemplified by Park matches the claimed amount. Park defines the sugar (i.e., sucrose) concentration as a percent v/v (Park, column 6, lines 11-12). As evidenced by PubChem, the density of sucrose is 1.6 g/mL (PubChem, 4.2.8 Density), resulting in a percent w/v of 8% which lies within the claimed range.
Park further teaches the liquid formulation show enhanced aflibercept stability (Park, column 6, lines 13-16). Park teaches an evaluation to find the optimal pH condition (Park, columns 8-9, example 1) and salt concentration (Park, column 11, example 5, formulation 3) for an exemplary formulation. Park teaches a formulation without an additional salt as a preferred alternative to a composition comprising sodium chloride (Park, column 11, example 5, formulation 3). Park further states it would be apparent for a person skilled in the art that the specific description is merely a preferred embodiment, and the scope of the present invention is not limited thereto (Park, column 13, lines 13-16). Therefore, it would be obvious to a person skilled in the art to optimize the pH of each formulation within the pH range taught by Park, which includes the claimed pH of 5.8.
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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