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 .
Notice of Priority
This applications claims priority for Chinese Patent Application No. CN202210550653.1 filed 18 May 2022. Certified copy of foreign priority has not been received in its entirety.
DETAILED ACTION
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 15 November 2024 and 25 June 2026 have been considered by the Examiner.
Claim Status
Claim(s) 1-10 are examined on the merits herein.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 8-10 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 3-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
MPEP 2173.05(a)(I) states:
The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). Applicants need not confine themselves to the terminology used in the prior art, but are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained. During patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997); In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969). See also MPEP § 2111 - § 2111.01. When the specification states the meaning that a term in the claim is intended to have, the claim is examined using that meaning, in order to achieve a complete exploration of the applicant’s invention and its relation to the prior art. In re Zletz, 893 F.2d 319, 13 USPQ2d 1320 (Fed. Cir. 1989).
MPEP 2173.05(a)(III) states:
Consistent with the well-established axiom in patent law that a patentee or applicant is free to be his or her own lexicographer, a patentee or applicant may use terms in a manner contrary to or inconsistent with one or more of their ordinary meanings if the written description clearly redefines the terms. See, e.g., Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999) ("While we have held many times that a patentee can act as his own lexicographer to specifically define terms of a claim contrary to their ordinary meaning," in such a situation the written description must clearly redefine a claim term "so as to put a reasonable competitor or one reasonably skilled in the art on notice that the patentee intended to so redefine that claim term."); Hormone Research Foundation Inc. v. Genentech Inc., 904 F.2d 1558, 15 USPQ2d 1039 (Fed. Cir. 1990). Accordingly, when there is more than one meaning for a term, it is incumbent upon applicant to make clear which meaning is being relied upon to claim the invention. Until the meaning of a term or phrase used in a claim is clear, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate. It is appropriate to compare the meaning of terms given in technical dictionaries in order to ascertain the accepted meaning of a term in the art. In re Barr, 444 F.2d 588, 170 USPQ 330 (CCPA 1971).
Claim(s) 3-6 detail the compositions of at least Claim(s) 1 or 2 , with or without a prostaglandin analog. The mentioned claims cite reference in multiple instances to the term(s)/phrase(s) “free alkali” and “is dimesylate”, for example in Claim 3:
“wherein the timolol is in a form of free alkali or any pharmaceutically acceptable salt (except maleate) thereof in a case that the netarsudil is dimesylate”
First, it is unclear what is meant by the term “free alkali”. The term, in its own right, is oxymoronic (i.e. how can an organic compound be both “free” and “alkali” simultaneously), and if given its broadest reasonable interpretation, may even mean a free alkali metal ion (i.e. K+). The term “free”, for example in regards to timolol, below:
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may mean the free base form of timolol that is non-ionic. The term “alkali” may mean “bound to an alkali metal ion” without clarification as to the structural arrangement of the binding (i.e. N1-N4); multiple interpretations are consistently present for instances of the term “free alkali”. The vagueness of the claim language gives rise to these multiple interpretations and lends undue broadness to the metes and bounds of the claimed invention. Similarly, Claim 4 shares this form description when reading, below:
“netarsudil is in a form of free alkali”
As do Claim(s) 5-6, below:
“timolol free alkali” and “netarsudil free alkali”
Additionally, the phrase “is dimesylate” is unclear in its reference, for example, in Claim 3:
“in a case that the netarsudil is dimesylate”
The claim may be interpreted as “in a case that the netarsudil compound is a dimesylate salt”, but may also be interpretated as “in a case that the netarsudil is replaced with a compound called dimesylate” or even “in a case that the netarsudil is in a covalent dimesylate form”. From the claim language alone, it is unclear what is meant by the term because it carries multiple interpretations, which similarly lend undue broadness to the metes and bounds of the claimed invention.
Furthermore, the two phrases (above) appear in combination presented as “… wherein timolol is in a form of free alkali or any pharmaceutically acceptable salt (except maleate) thereof in a case that the netarsudil is dimesylate, preferably timolol mesylate.” The positional choice of the phraseology renders the claim language unclear, and therefore the metes and bounds of the limitation as unclear. For example, the “netarsudil is dimesylate” may be interpreted as related to “preferably timolol mesylate” because of the statement’s structure. It also unclear whether this statement appears to be a defined limitation at all, as the limitation for timolol is, or maybe is not, related to the condition of “netarsudil is dimesylate”; it is uncertain whether the form of timolol in the composition is clearly stated. For at least these reasons, the metes and bounds of claims citing this language are unclear and too broad.
Claim(s) 3-6 also cite the term “preferably”, which renders the claim indefinite as the metes and bounds are left ambiguous, for example as to whether the “preferable” species in the ingredients list are to be included in the claim, or whether they are to be optional. In regards to this assertion, MPEP 2173.05 (c)(I) states:
If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.
In the present instance, the mentioned claims recite the broad recitation of a β-adrenergic receptor blocker, while also reciting “preferable” species (i.e. timolol mesylate, timolol sulfate, timolol hydrobromide, timolol phosphate, timolol nitrate, etc.) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Furthermore, Claim(s) 3-4 also cite reference to parenthetical exceptions (i.e. “except maleate”, “except hydrochloride”, “except mesylate”, etc.). For similar reasons as above, it is unclear whether this exception is a required limitation of the claim or merely an optional example, and is therefore rendered indefinite.
Claim 7 details a composition according to Claim 1, wherein the medicine composition does not comprise precipitate after being stored at 5, 25, and 40 °C for 24 months, 6 weeks, and 14 days, respectively. The mentioned limitation is an example of “future claiming”, where future states of a composition are being claimed in the Instant invention. Herein, “future claiming” invokes broadness into the interpretation of the claim, pending uncertainty between the Instant composition (i.e. Claim 1) and that of the composition of the future state, which may or may not be different compositionally because components may degrade into soluble forms that do not appear as precipitates below the amounts of “significant change compared with zero day”; “significant change” may be variably-interpreted. Additionally, it is unclear from the claim language how other storage parameters are addressed (i.e. container material, headspace gas, vibration) beyond time and temperature which could interfere with the mentioned limitation if the Instantly claimed invention were to be practiced.
Claim(s) 8-10 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.The mentioned claims provide for the use of the compound medicine composition according to Claim 1 for the preparation of medicine for treating eye disease or reducing intra-ocular pressure, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. For the purposes of the instant office action, the mentioned claims are being interpreted as drawn to a method of treating ocular diseases with the composition of Claim 1.
Therefore, Claim 3-10 are rejected under 35 U.S.C. 112(b). For the sake of compact prosecution, Claim(s) 3-6 that reference “{species} in a form of free alkali” will be interpreted as the name of the species (i.e. timolol) alone, in regards to its concurrent presence with “netarsudil dimesylate” in a composition.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim(s) 3-6, citing reference to the term “preferably” and a parenthetical “except”, will be interpreted inasmuch as the “preferable” and “excepted” species are suggested teachings and not claim limitations (as discussed below). Therefore, species proceeding “preferably” or found within the parenthetical “except” will not be regarded as claim limitations, nor examined for prior art purposes. Additionally, as also mentioned above, Claim(s) 3-6 that reference “{species} in a form of free alkali” will be interpreted inasmuch as they pertain to the named {species} alone (i.e. timolol, netarsudil) alone, in regards to its concurrent presence with “netarsudil dimesylate” in a composition.
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 non-obviousness.
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) 1-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Pepose et al [Priority Filing: 23 April 2021; US 2024/0216334 Al; henceforth Pepose].
Pepose teaches the formulation of ophthalmic solutions for treating glaucoma, containing an alpha-adrenergic antagonist and timolol/netarsudil. In doing so, Pepose addresses several limitations of the instant invention.
Claim 1 details a composition that comprises seven components – (1) a listed β-adrenergic receptor blocker (2) (netarsudil) or pharmaceutically acceptable salts thereof (3) a listed preservative (4) a listed buffering agent (5) a listed tonicity agent (6) a listed pH regulator (7) water. In regards to Claim 1, Pepose teaches similar compositions for administering one or more additional therapeutic agents to the patient [pg. 12; [0186]], and addresses several component limitations. Pepose teaches the incorporation of (1) a beta blocker, such as timolol or a pharmaceutically acceptable salt thereof [pg. 12; [0188]]. Pepose also teaches the incorporation of (2) a Rho kinase inhibitor, such as netarsudil or a pharmaceutically acceptable salt thereof [pg. 12; [0191]]. Furthermore, Pepose teaches the administration of (2) to the patient in the form of an ophthalmic solution, such as a sterile, isotonic, buffered aqueous solution containing netarsudil dimesylate alongside, (3) benzalkonium chloride (e.g., 0.015% w/w), (4) boric acid, and (5) mannitol [pg. 12; [0195]]. Pepose also teaches the use of (6) sodium carbonate/bicarbonate citing exemplary buffers include ... a carbonate salt ... specifying the salt form of a buffer may comprise any suitable counterion. For example, the salt form of an acid may comprise an alkali or alkaline earth metal counterion [pg. 15; [0224]]. Pepose further teaches the Netarsudil dimesylate may be administered to the patient once per day as one eye drop of the sterile, isotonic, buffered (7) aqueous solution [pgs. 12-13; [0195]]. The above teachings also meet the limitations of the Claim 3.
Claim 2 details a separate composition with similar limitations to that of Claim 1, with the additional limitation for the comprisal of a listed prostaglandin analog. In regards to Claim 2, Pepose meets this limitation by teaching the incorporation of a prostaglandin analog, such as latanoprost, bimatoprost, travoprost, tafluprost, latanoprostene bunod, or a pharmaceutically acceptable salt thereof [pg. 12; [0187]].
Claim 4 details a further limitation to Claim 3 wherein the composition of netarsudil must co-occur with timolol maleate. In regards to Claim 4, Pepose meets this limitation by teaching timolol in their compositions to be administered as timolol maleate in the form of an ophthalmic solution [pg. 12; [0194]].
Claim 5 details further limitations to Claim 1 for compositional amounts of (1) through (6). In regards to Claim 5, Pepose meets the limitation for the compositional abundance of (1) by teaching that 3.4 mg/mL (~0.147 w/v) timolol maleate may be administered to the eye of the patient [pg. 12; [0194]]. Pepose also meets the limitation for the compositional abundance of (2) by teaching netarsudil dimesylate (0.02% w/w) [pg. 12; [0195]]. Pepose also meets the limitation for the compositional abundance of (3) by teaching that the netarsudil aqueous solution may contain benzalkonium chloride (e.g., 0.015% w/w) [pg. 12; [0195]]. Pepose also meets the limitation for the compositional abundance of (4) by teaching that the buffer may be present at a concentration of from about 1 mM to about 10 mM [pg. 16; [0227]]. Pepose also meets the limitation for the compositional abundance of (5) by teaching the tonicity modifier being present in an amount ranging from about 0.01 % (w/v) to about 7% (w/v) [pg. 16; [0232]]. Pepose also meets the limitation for the compositional abundance of (6) by teaching am optimal buffering capacity in a pH range near the pKa of the buffer, e.g., within about 1 pH unit or within about 2 pH units of the pKa the buffer [pg. 16; [0225]], where the buffer can have a pKa of from about 4.0 to about 6.0; more preferably, from about 4.5 to about 5.5 [pg. 16; [0226]]. More specifically, Pepose teaches a single embodiment [pg. 12; [0195]], below:
“an ophthalmic solution, such as a sterile, isotonic, buffered aqueous solution containing netarsudil dimesylate (0.02% w/w) having a pH of approximately 5 and an osmolality of approximately 295 mOsmol/kg”
Claim 6 details similar limitations to Claim 5, with an additional limitation for the compositional abundance of the prostaglandin analog. In regards to Claim 6, Pepose meets this limitation by teaching a sterile, isotonic, buffered aqueous solution ... where each 1 mL of the solution contains 50 micrograms (.005 w/w) of latanoprost [pg. 12; [0192]]. In regards to ranges, It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 8 details a method of using the composition of Claim 1 to prepare medicines for preventing/treating eye disease. In regards to Claim 8, Pepose meets the limitations of this method by first teaching the preparation of ophthalmic solutions of timolol maleate [pg. 12; [0194]] and netarsudil dimesylate [pg. 13; [0195]], which may be administered together [pg. 13; [0196]] as additional therapeutic agents [pg. 12; [0186]]. Pepose further teaches their invention to provide methods for treating patients suffering from mydriasis, glaucoma, and other ocular conditions by using a liquid aqueous ophthalmic formulations [pg. 3; [0033]] bearing mutual components to Claim 1 (herein discussed), as also required by Claim 9. Claim 10 also details the method of using the composition of Claim 1 to prepare medicines for reducing intra-ocular pressure, and in regards to Claim 10, Pepose meets these limitations by characterizing their invention by the reduction in intraocular pressure in the eye as the result of applying their prepared compositions [pg. 11; [0171]].
A prima facie case of obviousness can be made for one of ordinary skill in the art to combine formulations taught by Pepose to arrive at the Instant invention before the effective filing date the Instant application. With Pepose teaching embodiments of their invention to comprise administration of one or more additional therapeutic agents to the patient [pg. 12; [0186]], one of ordinary skill in the art would be motivated to start with the netarsudil dimesylate formulation (discussed above) and add into it timolol maleate and latanoprost at the disclosed ranges with some minor, routine optimization, to reproduce the Instant invention with a high expectation of success for treating glaucoma, glaucoma-symptoms, and potentially other eye diseases with the formulation.
Therefore, Claim(s) 1-6 and 8-10 are rejected under 35 USC § 103.
Conclusion
No claims are allowed in this action.
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/STANLEY BRAM/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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