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 .
Priority
This application filed on 04/21/2023, is a national phase entry under 35 U.S.C. § 371 of International Application No. PCT/US2021/055911, filed on 10/20/2021, which claims a benefit under 35 U.S.C. § 119(e) to the U.S. Provisional Patent Application No. 63/104,357 filed on 10/22/2020.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 05/30/2023, 05/24/2024, 06/07/2024, 07/19/2024 and 07/23/2025, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
The preliminary amendment filed on 02/11/2026, that cancelled claims 2-3, 7-8, 10-20, 26-34, 44-45, 51 and 53-59, is acknowledged. Claims 1, 4-6, 9, 21-25, 35-43, 46-50, 52 and 60-64 are pending.
Election/Restriction
Applicant’s response filed on 02/11/2026 to Restriction/Election Requirement filed on 12/12/2025, is acknowledged. Applicant elected without traverse Group I drawn to a method of treating a nervous system disorder in a human patient in need thereof, comprising administering a pharmaceutical composition comprising therapeutically effective amount of an anti-purinergic agent. Claims 1, 4-6, 9, 21-25, 35-43, 47-50, 52, and 60-64 read on the elected Group. Claim 46 of Group II and III are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Pursuant to the Election of Species Requirement, Applicant respectively elected without traverse, autism spectrum disorder (ASD) as the species of nervous system disorder, suramin as the species of anti-purinergic agent, and P1 as the species of purinergic receptor for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Claims 1, 4-6, 9, 21-25, 35-43, 47-50, 52, and 60-64 read on the elected species.
Thus, claims 1, 4-6, 9, 21-25, 35-43, 46-50, 52, and 60-64 are pending with claims 46 is withdrawn from further consideration, and claims 1, 4-6, 9, 21-25, 35-43, 47-50, 52, and 60-64 are under consideration.
Claim interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III). However, specific embodiments of the specification cannot be imported into the claims, particularly where the subject claim limitation is broader than the embodiment. MPEP § 2111.01(II).
Claim interpretation for therapeutically effective amount
Claim 1 recites “a method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof”
Instant specification recites:
“The term "therapeutically effective" means an amount of the anti-purinergic agent needed to provide a meaningful or demonstrable benefit, as understood by medical practitioners, to a subject, such as a human patient in need of treatment. Conditions, intended to be treated include, for example, autistic disorder, childhood disintegrative disorder, pervasive developmental disorder-not otherwise specified (PDD-NOS), and Asperger syndrome. For example, a meaningful or demonstrable benefit can be assessed or quantified using various clinical parameters. The demonstration of a benefit can also include those benefits provided by models, including but not limited to in vitro models, in vivo models, and animal models.” [page 30, ln. 3-13].
FIG. 3 shows a plot of the total concentration, in ng/ml, of suramin in plasma versus brain tissue in mice when administered by intraperitoneal (IP) injection, 20 mg/kg, weekly to the mice [page 22, ln. 18-20]
Thus, the therapeutically effective amount is given its plain meaning as any therapeutic amount of the antipurinergic agent that produce a positive response and meaningful or demonstrable benefit. For example, 20mg/kg of suramin appears to be the therapeutically effective amount of suramin.
Claims Objection
Claims 60-64 are objected to for the following informalities:
The claims recite “…, two-fold (two times), … five-fold (five times), etc. while the parenthetical recitation in claims 60-64 is intended for the same terms, for better practice, parenthetical recitation should be avoided in the claim.
Also, the claims include typographical errors. For example, the claims recite 100-fold (ten times).
Appropriate correction is required.
Rejections 35 U.S.C. 112(b)
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 4, 21 and 36 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.
Claim 4 recites “… respiratory (inhalation), …”.
The recitation of the parentheses renders the claim indefinite because it is unclear whether the limitations in the parentheses are part of the claimed invention and further limit the route of administration or are exemplary of the respiratory administration. See MPEP § 2173.05(d). Claim 21 also include parentheses. In view of compact prosecution, for the purpose of applying prior art, the parenthetic recitations are interpreted as exemplary and are not further limiting the claim.
Claim 21 recites “… (e.g. Epstein Barr Human Herpesvirus 6 and 7, Herpes Simplex Virus, Cytomegalovirus, and others) …”, and claim 36 recites “… i.e. dosed, …”. As provided in MEMP 2173.05(d), “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a 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. The examiner should analyze whether the metes and bounds of the claim are clearly set forth. Note that the mere use of the phrase "such as" or "for example" in a claim does not by itself render the claim indefinite.
Pursuant to 35 U.S.C. 112(b), the claim must apprise one of ordinary skill in the art of its scope so as to provide clear warning to others as to what constitutes infringement. MPEP 2173.02(II); Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000).
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1, 4-6, 9, 21-25, 35-43, 47-50, 52, and 60-64 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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.
The instant claim 1 is directed to “method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous system disorder”. The recitation of prodrug of compounds of formula I is not adequately defined in the instant specification.
The MPEP states that for a generic claim can be adequately described if the disclosure presents a sufficient number of representative species in examples that encompass the genus. (MPEP § 2163). A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole cover, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing. Each of these factors has been considered, with the most relevant factors discussed below. For each claim drawn to a genus, each of these factors is to be considered to determine whether there is disclosure of a representative number of species that would lead one skilled in the art to conclude that applicant was in possession of the claimed invention.
With respect to the scope of the claims, the full scope includes “a method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, ....”
J. Zawilska et al. (Prodrugs: a challenge for the drug development. Pharmacol. Rep. 2013; 65(1):1-14, “Zawilska” cited in the PTO-892), teaches that “Prodrugs, which have no or poor biological activity, are chemically modified versions of a pharmacologically active agent, which must undergo transformation in vivo to release the active drug.” [Abstract]. Zawilska teaches the major groups of prodrugs:
PNG
media_image1.png
634
658
media_image1.png
Greyscale
Zawilska teaches that “the rationale behind the use of prodrugs is to optimize the absorption, distribution, metabolism, excretion, and unwanted toxicity of the parent drug.” [Pg. 2, col. 1]. Zawilska teaches that there are two main classes of prodrugs, carrier-linked prodrugs (the drug is temporary linked to a carrier that undergoes biotransformation, releasing the parent drug and the carrier), and bioprecursor prodrugs (result from a molecular modification of the drug and transformed metabolically or chemically by hydration or reduction. [Pg. 2, col. 2].
Zawilska teaches that “some esters are not suitable substrates for endogenous esterases, sulfatases or phosphatases, which, in turn, impose unfavorable, too slow kinetics of the prodrug hydrolysis.” [Pg. 4, col. 1, 1st para.]. Zawilska teaches that the prodrug should be easily dissolved in water, and marginally taken up by cells, the drug should be efficiently and rapidly transported, the enzyme should have high intrinsic activity, and enzyme cannot be inactivated by a prodrug or drug. Zawilska teaches that “Despite the remarkable progress made in the field of prodrug design, more studies are clearly needed, especially at early stages of the drug discovery, for prodrugs to achieve the desired state of art and take their place in modern pharmacotherapy.” Pg. 11, col. 21st para.].
The instant claims are directed to antipurinergic agents. These antipurinergic agents may comprises multiple groups of prodrugs precursor. For example, the specification recites suramin as one of the antipurinergic agents. Suramin includes multiple NH and OH groups (suramin chemical structure is shown below) with multiple sites to which a prodrug moiety could bind. As discussed above by Zawilska, these functional group leads to multiples prodrugs. The description does not provide adequate description on the binding moiety, the type of prodrugs (carrier linked prodrugs or bioprecursor prodrugs), kinetics of the prodrug hydrolysis, or the enzyme-prodrug interaction. See Zawilska above. The specification does not provide answer to question regarding prodrug of compound of all antipurinergic agents, for example, does the metabolism of all antipurinergic agents are well understood, does the prodrug will be active, does the prodrug will introduce any unfavorable interaction, etc. Zawilska teaches that “more studies are clearly needed, especially at early stages of the drug discovery, for prodrugs to achieve the desired state of art”
The description does not include a definition of the prodrug that satisfies the functional definition of all antipurinergic agents. "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention."). Problems satisfying the written description requirement for original claims often occur when claim language is generic or functional, or both. Ariad, 593 F.3d at 1349, 94 USPQ2d at 1171 ("The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus."
Comparison of the scope of the claims and the scope of the specification reveals that the scope of the claims is broader than that supported by the specification. There is no guidance in the specification regarding prodrugs. The specification only recites:
A prodrug is a medication or compound that, after administration, is metabolized (i.e., converted within the body) into a pharmacologically active drug. Prodrugs can be designed to improve bioavailability when a drug itself is poorly absorbed from the gastrointestinal tract. Prodrugs are intended to include covalently bonded carriers that release an active parent drug of the present invention in vivo when such prodrug is administered. In some classifications, esters are viewed as prodrugs. The prodrugs of emodin can be prepared using convention chemical methods, depending on the prodrug chosen. [Page 37-38].
The prodrugs of suramin can be prepared using convention chemical methods, depending on the prodrug chosen includes esters, sulfonamide derivatives and anhydrides, and the various esters and prodrugs can include further derivatization to make polyethylene glycol (PEG) and polypropylene glycol (PPG) derivatives and mixed derivatives. [page 41].
The prodrugs of tangeretin can be prepared using convention chemical methods, depending on the prodrug chosen. [page 42].
The prodrugs of A-804598 can be prepared using convention chemical methods, depending on the prodrug chosen. [page 46].
The generic definition provided in the instant specification do little in describing a prodrug for the claimed antipurinergic agents because antipurinergic agents encompass hundreds/thousands of species each of which encompasses multiple sites for prodrug binding. The instant specification does provide example for the prodrug of the antipurinergic agents, let alone, its activity, metabolism, enzymatic interaction, toxicity, etc. BOC Sciences (https://www.bocsci.com/blog/prodrug-activation-strategies-in-drug-discovery/?srsltid=AfmBOor0dyaRkHg4KY8ggdEj09mix1fTx8ZGgnvoIJzT5gtvjX5jYSHE, 2023), teaches that “the design of prodrugs must ensure their ability to degrade and release the parent drug at the appropriate time and site. This requires that the designed prodrugs have suitable chemical stability and enzymatic stability. They should neither degrade before reaching the target site nor remain undegraded for an extended period after entering the target site, as this would hinder their pharmacological effect. Additionally, prodrugs often have distinct chemical structures from the parent drug, which may introduce new toxicities. On one hand, this could result from unexpected metabolism of the prodrug, leading to the formation of unforeseen metabolites. On the other hand, it may occur because inert carriers generated from prodrug cleavage can transform into toxic metabolites, such as formaldehyde and acetaldehyde. Therefore, the comprehensive evaluation of prodrugs should include their physicochemical properties, pharmacological effects, pharmacokinetic properties, and potential toxic reactions.” [Pg. 8]. Thus, in view of BOC Science, claiming prodrug of the antipurinergic agents required more than what provided by instant specification. One skilled in the art cannot, as one can do with a fully described prodrugs, visualize or recognize the identity of the prodrugs of the genus of antipurinergic agents. Having analyzed the claims with regard to the written description guidelines, the specification does not disclose a representative number of prodrugs or relate the functional language of “a prodrug that provides for anti-bacterial activity” to sufficiently to describe said prodrugs. Thus, one of ordinary skill in the art would be led to conclude that applicants were not in possession of the invention commensurate with the scope of the claims, at the time the application was filed.
§ 112(a)- Written Description for claims 60-64- antipurinergic agent selectivity
Claims 60-64 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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.
The instant claims 64-66 recite “… wherein the antipurinergic agent has a selectivity of at least about two-fold (two times), or at least about five-fold (five times), or at least about ten- fold (ten times), or at least about 100-fold (ten times), or at least about 1000-fold (1000 times), or at least about 10,000-fold (10,000 times) for a P2X receptor over a P1 receptor or over a P2Y receptor; for a P2Y receptor over a P1 receptor or over a P2X receptor; for a P2X or a P2Y receptor over a P1 receptor; for a P2X3 receptor subtype over a P1 receptor or over a PY receptor; or for a P2X7 receptor subtype over a P1 receptor or over a PY receptor.” The recitation of antipurinergic agent is not adequately defined in the instant specification.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. MPEP § 2163(II)(A)(3)(a)(ii). A "representative number of species" means that the species which are adequately described are representative of the entire genus. MPEP § 2163(II)(A)(3)(a)(ii). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. MPEP § 2163(II)(A)(3)(a)(ii) (citing AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Claims 64-66 failing to comply with the written description requirement because neither the application as filed nor the art of record disclose.
What is conventional or well known to one of ordinary skill in the art need not be disclosed in detail. MPEP § (II)(A)(3)(a). Thus, the state of and predictability in the art is a relevant consideration in determining compliance with § 112(a), written description. MPEP § (II)(A)(3)(a) (citing Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1085 (Fed. Cir. 2005) ("The ‘written description’ requirement must be applied in the context of the particular invention and the state of the knowledge…. As each field evolves, the balance also evolves between what is known and what is added by each inventive contribution”).
However, in the instant case, neither the instant specification not the state of the prior art described the structure relationship between the antipurinergic agents and the selectivity toward P2X, P1, or P2Y. The instant specification describes only very few representatives of the antipurinergic agents, and there is no description of the selectivity for even a single antipurinergic agent. And while instant specification describes A-804598 as a selective P2X7, Tangeretin as a selective P2Y2 antagonist, and Emodin as a selective P2X7 antagonist, [page 83], there is no comparison between the selectivity of these antipurinergic agents with respect to P2X, P1, or P2Y.
However, neither the art nor the specification teaches any structure-function relationship between the “antipurinergic agents” and the “selectivity over P2X, P1, or P2Y”, such that one of skill can recognize which species of “antipurinergic agents” perform the function of “selectivity on P2X over P1 and P2Y or P2Y over P2X and P1”. Indeed, one of skill cannot glean from the disclosure or the art of record which other substances (aside from the disclosed substances) are even “selective antipurinergic agents” in the first place.
Claim breath is relevant to the instant § 112(a) written description rejection. The written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. MPEP § 2163(II)(A)(3)(a)(ii) (citing Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021)). Applicant is not in possession of the full claim scope because neither the specification nor the art of record provides sufficient guidance (representative species or a structure-function relationship) allowing one of skill to correctly predict these species, aside from those disclosed. A "representative number of species" means that the species which are adequately described are representative of the entire genus. MPEP § 2163(II)(A)(3)(a)(ii); see also, Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1164 (Fed. Cir. 2019) (“[a]s a result, a POSA is deprived of any meaningful guidance into what compounds beyond the examples and formulas, if any, would provide the same result”).
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-6, 21-25, 35-42, 47-50, 52, and 60-64 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by R. Pakbaz (US PG-Pub 2020/0030265A1, 01/30/2020, “Pakbaz” cited in the IDS dated 05/30/2023).
Pakbaz discloses a method of treating neurodevelopmental disorders and improving behavioral and social interaction in subjects diagnosed with neurodevelopmental disorders comprises administering composition includes an antipurinergic compound and a carrier, wherein the neurodevelopmental disorder is autism spectral disorders, and wherein the antipurinergic compound is suramin, [0007], [0008], [0121]:
PNG
media_image2.png
314
356
media_image2.png
Greyscale
Pakbaz discloses a method of administering suramin to males between the ages of 4 to 17 years diagnosed with autism (ADOS) [0125], Example 1, wherein the study participants were given 20 mg/kg of suramin intravenously [0126], wherein suramin administered in a single dose, and wherein the study outcome is measure by ADOS reciprocal social interaction domain scores; Peabody picture vocabulary test (PPVT); social interaction; cortical connectivity as measured by EEG power and coherence analysis; autonomic nervous system balance as measured by EKG analysis of heart rate variability; praxia and motor coordination as measured by fine motor and gross motor digital balance board and dynamic gait analysis; aberrant behaviors as measured by aberrant behavior checklist (ABC); clinical global impression—improvement scale (CGI-I) as measured by the 7-point scale reflecting the change in core autism behaviors; global assessment of child development behaviors as measured by child behavior checklist (CBCL); and repetitive behaviors as measure by the repetitive behavior questionnaire (RBQ). [0127]
Therefore, Pakbaz’s method anticipates claim 1 and meets each and every structural/method step limitation of claim 1. Note that the respective claim 1 and claim 47 recitations of:
“… wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous system disorder …”
are inherently met by the administration of the effective amount of suramin because they necessarily flow from the administration. MPEP § 2112. Furthermore, claim scope is not limited by claim language that does not limit a claim to a particular structure. MPEP § 2111.04 (citing In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) (whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited). The above claim 1 limitations do not limit the method steps in any fashion, but merely reflect the intended result of the claimed administration.
Claim 4 is met because suramin is administered intravenously, [0126].
Claim 5 is met because the antipurinergic agent is suramin.
Claim 6 is met because Pakbaz teaches that a method of administering a single dose of suramin intranasally, [0128].
Claims 21-23 is met because Pakbaz discloses that the disorder is autism spectral disorders, [0008], and the subject of Example 1 above are diagnosed with autism.
Claim 24 is met because Pakbaz discloses that the autism spectral disorders encompass autism, Asperger syndrome, pervasive development disorder not otherwise specified (PDD-NOS), and childhood disintegrative disorder. [0004], [0008], [0121], claim 4.
Claims 25 and 40-42 are met because Pakbaz discloses that autism spectral disorders feature includes social deficits and communication difficulties, stereotyped or repetitive behaviors and interests, sensory issues, and in some cases, cognitive delays. [0004]. The autism spectral disorders symptoms were assessed after the administration of suramin by primary and secondary outcome measures including ABC, ADOS, CGI, etc., [0127].
Claims 35 and 36 are met because Pakbaz’s Example 1 method include a single dose daily of suramin.
Claims 37-39 are met for the following reasons: Pakbaz discloses a method of treating autism spectral disorders by administering effective amount of suramin, 20mg/kg. The claimed effective amount of suramin is interpreted as 20mg/kg according to the instant specification (see claim interpretation above). Pakbaz is silent on level of suramin in the brain tissue and the blood plasma partitioning ratio but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting brain tissue level of suramin is inherently 1-1000 ng/mL and the blood plasma partitioning ratio is inherently 0.05-0.50. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
The above Pakbaz teachings meet each and every limitation of claims 47-50 and 51 because Pakbaz discloses that “suramin has been shown to inhibit excess purinergic signaling by acting as a competitive inhibitor of nucleotide signaling at both ionotropic purinergic (P2X) receptors, and G-protein coupled, metabotropic purinergic (P2Y) receptors. Pakbaz discloses that the purinergic associates with autism spectral disorders includes P2Y2 and P2X7 purinergic receptor expression, [0016], [0017].
Claims 60-64 are met for the following reasons: Pakbaz discloses a method of treating autism spectral disorders and inhibiting purinergic receptor by administering effective amount of suramin. Pakbaz while recites the same antipurinergic agent, suramin, and teaches that suramin is effective in inhibiting P2X and P2Y, Pakbaz is silent on selectivity of suramin for P2X over P1 or P2Y but otherwise teaches a substantially identical method as claimed using identical antipurinergic at the same effective amount. As such, it is reasonable to presume that the resulting selectivity is inherently the same. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
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 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.
Claims 9 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over R. Pakbaz (US PG-Pub 2020/0030265A1, 01/30/2020, “Pakbaz” cited in the IDS dated 05/30/2023) (as applied above to claims 1, 4-6, 21-25, 35-42, 47-50, 52, and 60-64) in view of Naviaux JC, et al. Mol Autism. 2015 Jan 13; 6:1 “Naviaux” cited in the IDS dated 07/19/2024).
The disclosures set forth above in the 102 rejection over the same Pakbaz reference are herein incorporated by reference.
Pakbaz discloses “a method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous system disorder.”
Pakbaz discloses that:
The term “salt” as used herein is a broad term and includes without limitation pharmaceutically acceptable salts such as a salt of a compound that does not cause significant harm to an organism to which it is administered and does not abrogate the biological activity and properties of the compound. In some embodiments, the salt is an acid addition salt of the compound. Pharmaceutical salts can be obtained by reacting a compound with an inorganic acid, an organic acid, or a base. Suitable pharmaceutically acceptable salts include metallic salts, organic salts, salts of free acids and bases, inorganic salts, and other salts which are currently in widespread pharmaceutical use and are listed in sources well known to those of skill in the art, such as, for example, The Merck Index. [0037].
Pakbaz discloses that the antipurinergic agent is suramin, and discloses that suramin improves social behaviors in ASDs and correct multisystem abnormalities that defined the ASD-like phenotype in an ASDs mouse model. [0017].
However, Palbaz does not teach that the salt is hexa-sodium salt, or the mouse model is FMR mouse model.
In the same field of endeavor, Naviaux teaches a method of treating autism spectrum disorders (ASDs) in the Fragile X (Fmr1) knockout mouse model by administering purinergic antagonist suramin (20 mg/kg intraperitoneally), wherein suramin restored normal social behavior, and improved metabolism, brain synaptosomal structure and ASD-like features of both the environmental MIA, and the genetic Fragile X models. [Abstract].
Naviaux teaches that suramin is administered as suramin hexa-sodium salt. [page 2, col. 2, 2nd para.].
Naviaux teaches that the antipurinergic therapy with suramin was tested in social approach, T-maze, locomotor activity, marble burying, acoustic startle, prepulse inhibition paradigms, Social Preference and Social Novelty, [page 2, col. 2, 3rd para, Figure 1]. See page 4, col. 2, Results.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to evaluate Pakbaz method of administering suramin for treating ADSs in a FMR mouse model. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Naviaux teaches the importance of Fmr1 protein in ADSs and intellectual disability; teaches that the Fmr1 knockout is the oldest, and one of the most studied genetic mouse models used in autism research; and that the FMR mouse model is the most suitable model to study the genetic causes of autism, the abnormalities in purinergic signaling and in purine and pyrimidine metabolism, and to test the connection between abnormalities in purinergic signaling and the environmental MIA and genetic Fragile X models.
One of ordinary skill in the art would have been motivated to use suramin hexa-sodium salt in the Pakbaz’s method of administering suramin salt for treating ADSs with reasonable expectation of success because injection of suramin hexa-sodium is known in the art, is approved salt of suramin and is administered by Naviaux.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Double Patenting Rejection over copending Application No. 18/435,069
Claims 1, 4-6, 9, 21-25, 35-42, 47-50, 52, and 60-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/435,069 (US PG PUB 2024/0277641A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims recite “a method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous system disorder: a) anxiety or anxiety-like behavior, b) willingness to explore the environment, c) social interaction, etc.; wherein said composition is administered by a route selected from oral, transdermal, parenteral, intravenous, intranasally, etc.; wherein said antipurinergic agent is selected from the group consisting of berberine, emodin, suramin, etc.; wherein said antipurinergic agent is suramin, or hexa-sodium salt; wherein the nervous system disorder is selected from autism spectrum disorder (ASD), fragile X syndrome (FXS), etc.; wherein said composition is administered at least once daily, or at least twice daily, etc.; wherein the brain tissue level of the antipurinergic agent in the patient is from about 1 ng/ml to about 1000 ng/ml and blood plasma partitioning ratio for the antipurinergic agent is at least about 0.05-0.50; wherein the assessment score is selected from ABC, ADOS, ATEC, CARS CGI, and SRS; wherein the method includes inhibiting or modulating a purinergic receptor in a human patient in need thereof; wherein said purinergic receptor is selected from the group consisting of a P1 receptor, a P2X receptor, and a P2Y receptor, selected from P2X7, P2Y2, etc.; and wherein the antipurinergic agent has a selectivity for a P2X receptor over a P1 receptor or over a P2Y receptor, for a P2Y receptor over a P1 receptor or over a P2X receptor, for a P2X or a P2Y receptor over a P1 receptor, for a P2X3 receptor subtype over a P1 receptor or over a PY receptor or for a P2X7 receptor subtype over a P1 receptor or over a PY receptor.”
Copending Application No. 18/435,069 recites a method of treating a nervous system disorder in a mammal in need thereof, comprising administering to said mammal a pharmaceutical composition comprising an effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, according to a dosing regimen comprising administering a loading dose once daily about 1 mg/kg to about 15 mg/kg of the antipurinergic agent; wherein the method is used to adjust the loading and maintenance doses according to efficacy and/or safety/tolerability endpoints selected from: a) anxiety or anxiety-like behavior, b) willingness to explore the environment, c) social interaction, d) spatial learning and memory, e) learning and memory, f) irritability, agitation and or crying, g) lethargy and/or social withdrawal, h) stereotypic behavior, i) hyperactivity and/or noncompliance, and j) restrictive and/or repetitive behaviors; wherein said nervous system, disorder is selected from autism spectrum disorder (ASD), fragile X syndrome (FXS), etc.; wherein the method includes inhibiting or modulating a purinergic receptor in a mammal; wherein said antipurinergic agent is selected from berberine, emodin, suramin, etc.; wherein said salt is the hexa-sodium salt; wherein said composition is administered nasally or intranasally or intravenously.
Therefore, copending Application No. 18/435,069 meets claims 1, 4-6, 9, 21-25, 35-36, 40-42, 47-50 and 52.
Claims 37-39 and 60-64 are met for the following reasons: copending Application No. 18/435,069 recites a method of treating autism spectral disorders by administering effective amount of suramin. copending Application No. 18/435,069 is silent on level of suramin in the brain tissue and the blood plasma partitioning ratio and on selectivity of suramin for P2X over P1 or P2Y but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting brain tissue level of suramin is inherently 1-1000 ng/mL and the blood plasma partitioning ratio is inherently 0.05-0.50, and that the resulting selectivity is inherently the same. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
Claim 43 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/435,069 (US PG PUB 2024/0277641A1) (as applied above to claims 1, 4-6, 9, 21-25, 35-42, 47-50, 52, and 60-64) in view of Naviaux JC, et al. Mol Autism. 2015 Jan 13; 6:1 “Naviaux” cited in the IDS dated 07/19/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Copending Application No. 18/435,069 recites “a method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous system disorder.”
Copending Application No. 18/435,069 does not teach that the composition of suramin is evaluated in FMR mouse model.
Naviaux teaches as discussed above.
The obviousness rationale is similar to the obviousness rationale of the 103 Rejection above, page 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting Rejection over copending Application No. 18/033,167
Claims 1, 4-6, 9, 21-25, 35-42, 47-50, 52, and 60-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-11, 21-26 and 28-35 of copending Application No. 18/033,167 (US PG PUB 2023/0390226A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims recite “a method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous system disorder: a) anxiety or anxiety-like behavior, b) willingness to explore the environment, c) social interaction, etc.; wherein said composition is administered by a route selected from oral, transdermal, parenteral, intravenous, intranasally, etc.; wherein said antipurinergic agent is selected from the group consisting of berberine, emodin, suramin, etc.; wherein said antipurinergic agent is suramin, or hexa-sodium salt; wherein the nervous system disorder is selected from autism spectrum disorder (ASD), fragile X syndrome (FXS), etc.; wherein said composition is administered at least once daily, or at least twice daily, etc.; wherein the brain tissue level of the antipurinergic agent in the patient is from about 1 ng/ml to about 1000 ng/ml and blood plasma partitioning ratio for the antipurinergic agent is at least about 0.05-0.50; wherein the assessment score is selected from ABC, ADOS, ATEC, CARS CGI, and SRS; wherein the method includes inhibiting or modulating a purinergic receptor in a human patient in need thereof; wherein said purinergic receptor is selected from the group consisting of a P1 receptor, a P2X receptor, and a P2Y receptor, selected from P2X7, P2Y2, etc.; and wherein the antipurinergic agent has a selectivity for a P2X receptor over a P1 receptor or over a P2Y receptor, for a P2Y receptor over a P1 receptor or over a P2X receptor, for a P2X or a P2Y receptor over a P1 receptor, for a P2X3 receptor subtype over a P1 receptor or over a PY receptor or for a P2X7 receptor subtype over a P1 receptor or over a PY receptor.”
Copending Application No. 18/033,167 recites method of treating a nervous system disorder in a human patient in need thereof, comprising intranasally administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of suramin, or a pharmaceutically acceptable salt, ester, or solvate, or prodrug thereof, wherein said salt is the hexa-sodium salt; wherein the brain tissue level of the suramin in the patient is from 1 ng/ml to 1000 ng/ml, and wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous disorder: a) anxiety or anxiety-like behavior, b) willingness to explore the environment, c) social interaction, d) spatial learning and memory, e) learning and memory, f) irritability, agitation and or crying, g) lethargy and/or social withdrawal, h) stereotypic behavior, i) hyperactivity and/or noncompliance, or j) restrictive and/or repetitive behaviors; wherein said nervous system, disorder is selected from autism spectrum disorder (ASD), fragile X syndrome (FXS), etc.; wherein said autism spectrum disorder manifests one or more symptoms selected from difficulty communicating, difficulty interacting with others, and repetitive behaviors; wherein suramin administered once or twice daily; wherein said composition is administered, at least once per a time interval based on the average half-life of suramin.
Therefore, copending Application No. 18/033,167 meets claims 1, 4-6, 9, 21-25 and 35-42
Claims 47-50, 52 and 60-64 are met for the following reasons: copending Application No. 18/033,167 recites a method of treating autism spectral disorders by administering effective amount of suramin. Copending Application No. 18/033,167 is silent on inhibiting purinergic receptor and on the selectivity of suramin for P2X over P1 or P2Y but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that inhibiting purinergic receptor and the selectivity of suramin is inherently the same. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
Claim 43 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-11, 21-26 and 28-35 of copending Application No. 18/033,167 (US PG PUB 2023/0390226A1) (as applied above to claims 1, 4-6, 9, 21-25, 35-42, 47-50, 52, and 60-64) in view of Naviaux JC, et al. Mol Autism. 2015 Jan 13; 6:1 “Naviaux” cited in the IDS dated 07/19/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Copending Application No. 18/033,167 recites “a method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous system disorder.”
Copending Application No. 18/033,167 does not teach that the composition of suramin is evaluated in FMR mouse model.
Naviaux teaches as discussed above.
The obviousness rationale is similar to the obviousness rationale of the 103 Rejection above, page 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting Rejection over copending Application No. 17/615,673
Claims 1, 4-6, 9, 21-25, 35-43, 47-50, 52, and 60-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, 14, 18, 22-23, 26-27, 29-30, 38-40, 48 and 50 of copending Application No. 17/615,673 (US PG PUB 2022/0226268A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims recite “a method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous system disorder: a) anxiety or anxiety-like behavior, b) willingness to explore the environment, c) social interaction, etc.; wherein said composition is administered by a route selected from oral, transdermal, parenteral, intravenous, intranasally, etc.; wherein said antipurinergic agent is selected from the group consisting of berberine, emodin, suramin, etc.; wherein said antipurinergic agent is suramin, or hexa-sodium salt; wherein the nervous system disorder is selected from autism spectrum disorder (ASD), fragile X syndrome (FXS), etc.; wherein said composition is administered at least once daily, or at least twice daily, etc.; wherein the brain tissue level of the antipurinergic agent in the patient is from about 1 ng/ml to about 1000 ng/ml and blood plasma partitioning ratio for the antipurinergic agent is at least about 0.05-0.50; wherein the assessment score is selected from ABC, ADOS, ATEC, CARS CGI, and SRS; wherein the method includes inhibiting or modulating a purinergic receptor in a human patient in need thereof; wherein said purinergic receptor is selected from the group consisting of a P1 receptor, a P2X receptor, and a P2Y receptor, selected from P2X7, P2Y2, etc.; and wherein the antipurinergic agent has a selectivity for a P2X receptor over a P1 receptor or over a P2Y receptor, for a P2Y receptor over a P1 receptor or over a P2X receptor, for a P2X or a P2Y receptor over a P1 receptor, for a P2X3 receptor subtype over a P1 receptor or over a PY receptor or for a P2X7 receptor subtype over a P1 receptor or over a PY receptor.”
Copending Application No. 17/615,673 recites method for treating cognitive, social, or behavioral disabilities and neurodevelopmental disorders, comprising intranasally administering a therapeutically effective amount of a pharmaceutical composition comprising a therapeutically effective amount of suramin, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, and a penetration enhancer comprising from about 10% to about 75% by weight of the pharmaceutical composition to a patient in need thereof; wherein said salt is the hexa-sodium salt; wherein the brain tissue level of the suramin in the patient is from 1 ng/ml to 1000 ng/ml; wherein said nervous system, disorder is selected from autism spectrum disorder (ASD), fragile X syndrome (FXS), etc.; wherein said autism spectrum disorder manifests one or more symptoms selected from difficulty communicating, difficulty interacting with others, and repetitive behaviors; wherein suramin administered once or twice daily; wherein the brain tissue to blood plasma partitioning ratio for the suramin is at least about 0.05-0.50; and wherein the assessment score is selected from ABC, ADOS, ATEC, CARS CGI, and SRS.
Therefore, copending Application No. 17/615,673 meets claims 1, 4-6, 9, 21-25, 35-42, 47-50, 52.
Claims and 60-64 are met for the following reasons: copending Application No. 18/033,167 recites a method of treating autism spectral disorders by administering effective amount of suramin. Copending Application No. 17/615,673 is silent on selectivity of suramin for P2X over P1 or P2Y but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting selectivity is inherently the same. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
Claim 43 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, 14, 18, 22-23, 26-27, 29-30, 38-40, 48 and 50 of copending Application No. 17/615,673 (US PG PUB 2022/0226268A1) (as applied above to claims 1, 4-6, 9, 21-25, 35-42, 47-50, 52, and 60-64) in view of Naviaux JC, et al. Mol Autism. 2015 Jan 13; 6:1 “Naviaux” cited in the IDS dated 07/19/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Copending Application No. 17/615,673 recites “a method of treating a nervous system disorder in a human patient in need thereof, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof, wherein said composition provides an improvement in said patient in at least one of the following disorders, symptoms, or behavioral manifestations of the nervous system disorder.”
Copending Application No. 17/615,673 does not teach that the composition of suramin is evaluated in FMR mouse model.
Naviaux teaches as discussed above.
The obviousness rationale is similar to the obviousness rationale of the 103 Rejection above, page 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 4-6, 9, 21-25, 35-43, 47-50, 52, and 60-64 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANAHIL MIRGHANI ALI ABDALHAMEED whose telephone number is (571)272-1242. The examiner can normally be reached M-F 7:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights