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 of Group I, claims 1-8, in the reply filed on 8/7/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election under (i-b) of
(i-b-1) atropine sulfate;
(i-b-2) boric acid;
(i-b-3) eye drop;
(i-b-4) Hypromellose (a.k.a., hydroxypropyl methylcellulose, or HPMC) thickener;
Sodium chloride osmotic pressure regulator;
A benzalkonium chloride preservative;
A disodium edetate stabilizer, and
Water;
Claims 1-8 reading thereon, in the reply filed on 8/7/2024 remains acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13, 20-21 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 8/7/2024.
Claims 2-3, 5-6, 20-21, 24-26, 29-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/7/2024. Examiner notes that amended claim 1 uses consisting of transition language. However, the claim 1 pharmaceutical composition is missing sodium chloride and benzlkonium chloride, each of which was elected under (i-b-4). Accordingly, the subject matter under examination is shifted to the components currently recited in amended claim 1.
Response to Arguments
Applicants' arguments, filed 9/26/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicant’s arguments, see pp. 5-6, filed 9/26/2025, with respect to the rejections under 35 USC 112(a) and 112(b) have been fully considered and are persuasive, in view of the claim amendments. The rejections of claim 1 has been withdrawn.
Applicant's arguments regarding the obviousness rejection have been fully considered but they are not persuasive.
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.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as obvious over Tan et al. (WO 2017/204262 A1; 2017 Nov 30; filed 2017 May 27; priority 2016; cited in a prior Office action), in view of Lanigan et al. (“Final Report on the Safety Assessment of EDTA, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA”; 2002; International Journal of Toxicology; 21(Suppl. 2):95-142; DOI: 10.1080/1091581029009652 2).
Tan teaches aqueous composition comprising 0.001 – 0.1 % (w/v) atropine or a salt thereof, a water soluble polymer and buffer (I) which is at a pH range of 6 or lower, wherein the buffer (I) is at least one selected from the group that includes a borate buffer (abstract; Claim 1).
The aqueous composition wherein the atropine or salt thereof is Applicant elected atropine sulfate [0044] (reading on amended claim 1). The concentration used in Examples 18-22 is 0.01 g/100 mL (0.01% (w/v)) (Table 6; see also [0135]), reading on concentrations of claims 1.
Regarding pH, example pH values of Table 6 are 5 (pH 5.0 is also among preferable and more preferable pH values at [0091]), reading on the amended range of claim 1.
The borate buffer is derived from at least one selected from the group consisting of, inter alia, Applicant elected boric acid [0013], 4th section; [0077]; claim 5, reading on claim 1. The concentration of 1.9 g/100 mL (1.9 % (w/v)) was used in Table 6, Example 20, reads on the concentration range of claim 1.
The aqueous composition wherein the aqueous composition is Applicant elected eyedrop [0046].
Regarding Applicant elected Hypromellose (HPMC, per [0098] of Tan), the water soluble polymer as hydroxypropyl methylcellulose, with concentration ranges of 0.1 to 1.0 (w/v) and more preferably 0.1 to 0.6 % (w/v) are taught at [0069], claim 10; Table 7 uses concentrations of 0.6 g/100 ml (0.6 % w/v), reading on claim 1; the range 0.1 to 1.0% taught also reads on the range of claim 1.
Regarding Applicant elected disodium edetate, this component is taught as a stabilizer at [0086], reading on this component of claim 1. However, the concentration range recited by claim 1, line 7 is not taught.
Regarding Applicant elected water, compositions are aqueous (abstract, claim 1), indicating water as solvent (see also water component at [0141]), in an amount to reach 100 parts by weight; i.e., water, q.s.
Accordingly, each of the elected components, recited pH and eye drop limitations of claim 1 are taught, but the amount of disodium edetate is not taught.
Regarding the alternative obviousness rejection, amended claim 1 recites an intended use, “for treating and/or preventing NITM”. Examiner takes the position that the examined pharmaceutical composition, containing most of the elected components, in the recited amounts, in the elected form of an eye drop, would be suitable for the intended use recited, absent evidence to the contrary. Alternatively, the intended use would have been obvious, based on the same field of use, which includes teaching that atropine is known to inhibit or prevent myopia [0003] of Tan; as NITM (Nearwork-Induced Transient Myopia) is a specific type of myopia. Thus, a formulation to treat eyes, in the form of eye drops, is construed to be suitable for the recited intended use of claim 1.
It is noted that 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.
Regarding the concentration of disodium edetate, the skilled artisan would have consulted similar formulations to evaluate workable concentrations. Such a reference is Lanigan, which teaches EDTA and its salts, which function as chelating agents in cosmetic formulations. Typical concentration of use of EDTA is less than 2%, with the other salts in current use at even lower concentrations (abstract). Regarding disodium EDTA (Figure 1), synonyms include disodium Edetate (96, right, 5th paragraph). In Table 3, the concentration of disodium EDTA in eye lotion is 0.1-0.2%. Similar amounts, ranging from 0.1 up to 0.6% are used in other eye products (p. 101). Thus, either of these ranges would have been obvious to use in the Tan eye drop pharmaceutical compositions, rendering obvious the concentrations of disodium edetate concentration range. Additionally, workable ranges would have been obvious as a result of routine optimization.
Applicant argues that Tan does not teach a pharmaceutical composition of the amended claims; thus, Tan cannot anticipate the claims. Applicant further argues that Example 20 of Tan demonstrates that the incorporation of boric acid had a negative effect on the stability of formulation, [0125] of Tan discloses the undesirable decrease in viscosity over time; [0126] indicates more tropic acid was produced from the formulation comprising boric acid than from other compositions studied therein; that Tan teaches ([0126]) it is not preferable to add boric acid, due to negative effects.
Applicant wrongly cites Tan. [0126] states that more tropic acid was produced from the aqueous composition comprising atropine and hydroxyethyl cellulose, and further comprising mannitol or boric acid as a tonicity agent than from other aqueous compositions. The result suggested that it is not preferable to add mannitol or boric acid as a tonicity agent to an aqueous composition comprising atropine and hydroxyethyl cellulose from the viewpoint of the stability of atropine. While this is a teaching away from boric acid, it only applies to formulations also containing hydroxyethyl cellulose. The current rejection is based on Hypromellose as thickening agent. Thus, the teaching away does not apply to the alternate formulation with Hypromellose (HPMC), a different material; see HEC vs. HPMC [0098].
Applicant argues at length that hydroxyethyl cellulose and Hypromellose are equivalent. The examiner acknowledges that these two components are taught as alternative “water-soluble polymers, capable of dissolving in water”. The word “equivalent” does not appear in Tan.
The skilled artisan would understand that HPMC is a mixed ether containing both methyl and hydroxypropyl groups. HEC is composed of alkaline cellulose and ethylene oxide. While both dissolve in cold water, HPMC is generally insoluble in hot water. A review of the art regarding properties of these two compounds rapidly identifies similarities and differences. These two compounds are chemically distinct, and have unique chemical and physical properties. While both have some functional similarity, no chemist would take the position adopted by Applicant that a teaching away from HEC in combination with boric acid has decreased viscosity over time. The cited locations of HCE and HPMC do not rely on water soluble polymers having any equivalence in terms of atropine stability with or without boric acid.
While the skilled artisan of ordinary skill in the art would have been led away from the combination of HEC and boric acid being combined with atropine (“The result suggested that it is not preferable to add mannitol or boric acid as a tonicity agent to an aqueous composition comprising atropine and hydroxyethyl cellulose from the viewpoint of the stability of atropine”. Per [0126]), the Examiner fails to see any parallel teaching applicant argues for, i.e., that boric acid + HPMC +atropine is not recommended does not appear. Examiner relies on what is taught.
Applicant alleges in argument (2) of consequences that somehow would occur if the Examiner’s logic were followed. The Examiner does not follow how this allegation would somehow render the rejection unsuitable. Concentrations taught are utilized as exemplary. The skilled artisan is able to identify exemplary amounts, and use these, or similar amounts as a result of routine optimization.
Applicant argues, at (3) that Tan and Lanigan would have no motivation for combining. Lanigan is relied on for suitable concentrations of disodium edetate for eye applications. The ranges taught overlap with the 0.1% amount in claim 1, rendering the claimed amount prima facie obvious.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614