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 .
DETAILED ACTION
The Response of 11 March 2026 has been entered.
Claims 1-4, 7, 9-20, 23 and 25-33 are currently pending.
Claims 3, 4, 7, 11-13, 15, 19, 20, 23 and 25-33 stand withdrawn as being drawn to a nonelected species (claims 3, 4, 7, 11, 12, 15) or invention (claims 19, 20, 23 and 25-33). Claims 1, 2, 9, 10, 14 and 16-18 have been found free of the prior art with respect to the elected combination of species. The examination has thus been expanded to an additional species of administered agent, namely an IPMK therapeutic agent which is chlorogenic acid.
Claims 1, 2, 9, 10, 14 and 16-18 are considered herein with respect to the elected combination of species of: uveitis as the condition, an IPMK therapeutic agent which is chlorogenic acid as the administered agent, anterior uveitis as the type of uveitis, prednisone as the uveitis therapeutic agent, an IDO2 variant as the variant nucleic acid, a hetero/homozygous variant and IDO2 8:40015454 as the IDO2 variant.
Any rejection not reiterated herein has been withdrawn.
Response to Arguments
Applicant's arguments filed 11 March 2026 have been fully considered but they are not persuasive.
Applicant argues that the term "standard dosage amount" is not indefinite since one of ordinary skill in the art would understand the meaning of the term. This is not persuasive because the dosage amount for any uveitis therapeutic agent (e.g., a steroid) would be expected to vary depending on a range of patient-specific criteria, such as age, medical history, symptoms, etc., and as such one of ordinary skill would not be capable of reasonably ascertaining what a “standard dosage amount” is in order to determine whether a dosage falls within the range of the amount required by claim 14. Moreover, the claims comprise administering the uveitis therapeutic agent in combination with the IDO2 protein/IPMK therapeutic agent, and there is no evidence that such combinations are well known in the art such that a standard dosage amount would be readily ascertainable.
Applicant's remaining arguments have been fully considered but are moot in view of the new grounds of rejection herein.
Claim Rejections - 35 USC § 112(a) (written description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 2, 9, 10, 14 and 16-18 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites administering an IPMK therapeutic agent. The specification states that the IPMK therapeutic agent can be an agonist, an antagonist or IPMK protein (Published Spec. US20240238384, [0035]). The terms “agonist” and "antagonist" are generally used in the art to refer to substances which bind to a receptor and cause or inhibit the same response as an endogenous substance that normally binds to the receptor (see e.g. definition at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/agonist). IPMK is not a receptor but rather an enzyme (a kinase). While the metes and bounds of the term “IPMK therapeutic agent” are unclear a (see indefiniteness rejection, below), the term is construed herein to include any substance capable of producing similar physiological effect(s) as IPMK or opposing such effects. As evidenced by Lee et al., Molecules and Cells 44.4 (2021): 187-194, IPMK is a key enzymatic mediator of inositol phosphate (IP) metabolism, which produces a wide range of IP second messengers that mediate diverse cellular events (Lee, under ACTION MODES OF THE IPMK SIGNALING). Thus, the term "IPMK therapeutic agent" encompasses a large and diverse genus of potential compounds that stimulate or inhibit a diverse range of cellular effects.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species sufficient to show the applicant was in possession of the claimed genus (MPEP 2163). A “representative number of species” means that the species which are adequately described are representative of the entire genus (Id.). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus (Id.).
The specification states that the IPMK therapeutic agent can be IPMK protein or a flavonoid such as myricetin, quercetin, luteolin, kaempferol, isorhamnetin, diosmetin, rhamnetin, and apigenin; vilazodone; aurintricarboxylic acid; or chlorogenic acid (Published Spec. US20240238384, [0035]). Each of the above-listed compounds, other than IPMK protein, is an IPMK inhibitor (see Gu et al., Journal of medicinal chemistry 62.3 (2019): 1443-1454, Table 1 for myricetin, quercetin, luteolin, kaempferol, isorhamnetin, diosmetin, rhamnetin, and apigenin; Mayr et al., Journal of Biological Chemistry 280.14 (2005): 13229-13240, Table V for aurintricarboxylic acid and chlorogenic acid; Lee et al., Molecules and cells 43.3 (2020): 222-227, Abstract for vilazodone). The specification further discloses that IPMK loss-of-function and missense mutations are significantly associated with uveitis risk (Spec., [0108]) (suggesting replacement of IPMK as being therapeutic), but discloses only IPMK protein as an IPMK "agonist". The specification also fails to disclose any compounds capable of indirectly producing similar physiological effect(s) as IPMK, which fall within the scope of the claims. The specification also does not provide any teachings or guidance that would allow one of ordinary skill in the art to identify other members of the genus. For example, the specification does not identify any specific mechanism of action through which IPMK is capable of treating uveitis that would allow one to identify other compounds capable of mimicking such effects.
The specification describes only IPMK protein and a series of IPMK inhibitors, and therefore fails to describe species reflective of the scope and variation within the genus (there is no description of "agonists" other than IPMK protein itself, and no description of compounds having indirect effects). As such, the specification as filed does not evidence possession of the full scope of the claimed genus of IPMK therapeutic agents.
Claim Rejections - 35 USC § 112(b) (indefiniteness)
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.
Claims 1, 2, 8-10, 14 and 16-18 rejected under 35 U.S.C. 112(b) 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.
Claim 1 recites administering an IPMK therapeutic agent. The specification states that the IPMK therapeutic agent can be an agonist, an antagonist or IPMK protein (Published Spec. US20240238384, [0035]). The terms “agonist” and "antagonist" are generally used in the art to refer to substances which bind to a receptor and cause or inhibit the same response as an endogenous substance that normally binds to the receptor (see e.g. definition at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/agonist). IPMK is not a receptor but rather an enzyme (a kinase), so the meaning of the terms agonist/antagonist are unclear in the context of the claimed IPMK therapeutic agent. The term "IPMK therapeutic agent" is construed herein to include any substance capable of producing similar physiological effect(s) as IPMK or opposing such effects. As evidenced by Lee et al., Molecules and Cells 44.4 (2021): 187-194, IPMK is a key enzymatic mediator of inositol phosphate (IP) metabolism, which produces a wide range of IP second messengers that mediate diverse cellular events (Lee, under ACTION MODES OF THE IPMK SIGNALING). Since the term "IPMK therapeutic agent" is not standardly used in the art, the metes and bounds of what would qualify as an "IPMK therapeutic agent" are undefined and indefinite (e.g., it is unclear what range of effects and/or what degree of relatedness to IPMK would be required to be considered an "IPMK therapeutic agent").
Claim 14 recites “administering a uveitis therapeutic agent in a dosage amount that is the same or less than a standard dosage amount”. The term “standard dosage amount” is a relative term which renders the claim indefinite. The term “standard” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The particular dosage amount for any uveitis therapeutic agent (e.g., a steroid) would be expected to vary depending on a range of patient-specific criteria, such as age, medical history, symptoms, etc., and as such one of ordinary skill would not be capable of reasonably ascertaining what a “standard dosage amount” is in order to determine whether a dosage falls within the range of the amount required by claim 14.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as obvious over US20220184019 to Zhang et al., as evidenced Chen et al., PloS one 8.8 (2013): e72161 and Juanola et al., Ophthalmology 123.8 (2016): 1632-1636 (previously cited).
Zhang teaches a method of treating uveitis, comprising administering chlorogenic acid ([0004]-[0024]; Experimental Example 1). Chang exemplifies treatment of uveitis in an experimental autoimmune uveitis (EAU) animal model wherein uveitis is induced via interphotoreceptor retinoid-binding protein (IRBP) (Experimental Example 1). Chen evidences that IRBP-induced uveitis comprises anterior uveitis (Chen, Table 1; p. 9, last ¶), and thus it would have been obvious to treat anterior uveitis using the method of Zhang.
Regarding the recitation in claim 1 that the subject is HLA-B27 negative, Juanola evidences that approximately 50% of cases of anterior uveitis are (HLA)-B27-negative (p. 1632, 1st ¶). Zhang teaches a general method of treating uveitis, and it would have been obvious in view of such teaching to treat any uveitis patient including both HLA-B27 positive and HLA-B27 negative patients (see also, MPEP 2144.08, noting that the size of the genus is a relevant consideration in whether a teaching related to a genus (in this case, treating uveitis generally) renders a species within the genus (HLA-B27-negative uveitis) obvious; the instant genus comprises only two species and it would have been obvious that both would be encompassed by the teachings of Zhang).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zhang as evidenced by Chen and Juanola, as applied to claims 1 and 2, in view of Burkholder et al., Bmj 372 (2021).
Claim 9 differs from Zhang as evidenced by Chen and Juanola, as applied to claims 1 and 2, in that: the method further comprises administering a uveitis therapeutic agent which is prednisone (prednisone = elected species of uveitis therapeutic agent).
Burkholder teaches that steroids are the first line treatment for uveitis (including anterior uveitis), and that in severe cases of inflammation systemic prednisone is recommended (p. 8, under Corticosteroid treatment; p. 10, under Systemic corticosteroids).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the method of Zhang to treat uveitis by administering chlorogenic acid wherein the treatment further comprises administering prednisone as taught by Burkholder because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to administer prednisone in the method of Zhang because Burkholder recommends such treatment in the case of severe uveitis inflammation and it would have been prima facie obvious to combine therapeutic agents known to be useful for treating the same condition. Administering prednisone in the method of Zhang would have led to predictable results with a reasonable expectation of success because Burkholder teaches that prednisone is a common first-line treatment for uveitis, including anterior uveitis.
Conclusion
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 ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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