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 .
This is the First Office Action on the Merits of US18/835,427 filed on 08/02/2024 which is a 371 of PCT/US2023/012877 filed on 02/13/2023 which claims US priority benefit of US Provisional 63/310,312 filed on 02/15/2022. The Filing Receipt filed on 01/16/2025 is controlling.
Claims 12-19 are cancelled.
Claims 1-11, and 20 are under examination.
Information Disclosure Statement
The IDS statements filed on 08/02/2024 and 12/10/2025 have been considered by the examiner.
Claim Objections
Claims 2 and 3 are objected to because of the following informalities:
Claim 2 contains an abbreviated term which should be written in full-length the first time it appears in the claims. P2X7R should be written as “purinoceptor type 2 subtype 1 family member 7 receptor”. Appropriate correction is required.
Claim 3 recites …a composition or combination of claim 1. For improved clarity, amend claim 3: ..administering a composition
Claim Rejections - 35 USC § 112
Scope of enablement
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 1-11, and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the Compounds #3, #4, #5, or #6 of claim 1, does not reasonably provide enablement for functional derivatives of the Compound #3, #4, #5, or #6 of claim 1 or for methods of treating or preventing immune-related diseases, type 1 diabetes, transplant rejection, or lung fibrosis, or extending lifespan, using compounds Compound #3, #4, #5, or #6 or compounds listed in base claims 7-8. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Many factors are to be considered when determining if sufficient evidence exists to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue". These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention: The nature of the invention is drawn to methods of preventing or treating immune-related diseases, type 1 diabetes, transplant rejection and lung fibrosis. The methods are also drawn to slowing or delaying aging process or extending lifespan.
The breadth of the claims: The claims encompass derivatives of the Compound #3, #4, #5, and #6 of claim 1. The claims encompass preventing and treating immune-related diseases, type 1 diabetes, transplant rejection and lung fibrosis, and extending lifespan, in a human subject.
The state of the prior art: The state of the prior art in preventing disease, including Type 1 diabetes, is unpredictable. See Chen et al (US 2020/0062693 published 02/27/2020).
The predictability in the art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833,166 USPQ18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is highly unpredictable since one skilled in the art would recognize that preventing any/all immune-related diseases or specifically Type 1 diabetes would require experimental and statistically significant results showing such prevention. In the absence of a showing of a nexus between any and all known such conditions listed in the claims, one of ordinary skill in the art is unable to fully predict possible results from the administration of the compound of claim 1 or the compounds listed in claim 7. Those of skill in the art recognize that in vitro assays and or cell-cultured based assays are generally useful to observe basic physiological and cellular phenomenon such as screening the effects of potential drugs. However, clinical correlations are generally lacking. The greatly increased complexity of the in vivo environment as compared to the very narrowly defined and controlled conditions of an in- vitro assay does not permit a single extrapolation of in vitro assays to human diagnostic efficacy with any reasonable degree of predictability. In vitro assays cannot easily assess cell-cell interactions that may be important in a particular pathological state. Furthermore, it is well known in the art that cultured cells, over a period time, lose phenotypic characteristics associated with their normal counterpart cell type. Freshney (Culture of Animal Cells, A Manual of Basic Technique & Specialized Applications, John Wiley & Sons, Inc., 2010, New Jersey, Chapters I-II, pages 1-23) teach that it is recognized in the art that there are many differences between cultured cells and their counterparts in vivo. These differences stem from the dissociation of cells from a three-dimensional geometry and their propagation on a two-dimensional substrate. Specific cell interactions characteristic of histology of the tissue are lost. The culture environment lacks the input of the nervous and endocrine systems involved in homeostatic regulation in vivo. Without this control, cellular metabolism may be more constant in vitro but may not be truly representative of the tissue from which the cells were derived. This has often led to tissue culture being regarded in a rather skeptical light (p. 1-23, see Major Differences In Vitro). Further, contrary to predictions in the state of the art, the effects of whether a subject has rs3751143 is shown to be unpredictable in the state of the art. For example, Wang et al disclose that whether a subject has rs3751143 is not predictive of likehood of cancer.
The presence or absence of working examples: The specification provides a working example of screening small molecules capable of selectively binding eATP. (See Figs 1-2). Fig 3A-3B show results of treatment with a P2X7R inhibitor (oATP) that prolongs allograft survival in P2X7R-/- mice. Fig 3B shows results using oATP or CE224,535. Fig4 shows increased survival of B6 mice using oATP. No other working Examples are described.
The amount of direction or guidance present: The guidance present in the specification is mostly prophetic. No guidance is provided for preventing the conditions recited in the claims. No guidance is provided for treating immune-related diseases, type 1 diabetes, or lung fibrosis.
The level of the skill in the art: The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
The quantity of experimentation needed: The quantity of experimentation needed is undue. One skilled in the art would need to determine what diseases out of all known immune-related diseases would be benefited by the administration of compounds of claim 1.
Thus, the specification fails to provide sufficient support of the broad use of the compounds of claim 1 for the treatment and prevention of claimed conditions. Therefore, one of ordinary skill in the art would require performing an undue amount of experimentation with no guarantee of success in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable". Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, one of ordinary skill in the art would have to engage in undue experimentation to test which diseases can be prevented and treated by the compounds of the instant claims, with no assurance of success.
Written Description
Claims 1-6, 10-11, and 20 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.
Claims are drawn to methods of treating and preventing human disease conditions including preventing Type 1 diabetes by administering compositions comprising the compounds of instant claim 1. Specifically, claim 1 recites the Compounds #3, #4, #5, or #6 including derivatives thereof. While having possession of the Compounds #3, #4, #5, or #6, the applicants do not show possession of a representative set of functional derivatives of such compounds, specifically for methods of treating or preventing immune-related diseases, type 1 diabetes, transplant rejection, or lung fibrosis, or extending lifespan, using such derivative compounds.
Claims require the critically essential element of a functional derivative of such compounds, specifically for methods of treating or preventing immune-related diseases, type 1 diabetes, transplant rejection, or lung fibrosis, or extending lifespan, using such derivative compounds.
The state of the art shows unpredictability in whether a derivative of such compounds of claim 1 would possess the therapeutic properties require of the claims. Chen et al, (US 2020/0062693 published 02/27/2020).
The Court of Appeals for the Federal Circuit has recently held that a "written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as be structure, formula [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 1997 U.S. App. LEXlS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original).
To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these.
While having written description of the claims drawn to the pharmaceutical comprising the compounds of claim 1, the specification does not provide sufficient descriptive support for the myriad of embodiments embraced by the claims regarding functional derivatives of such compounds. When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Given this lack of description of representative species encompassed by the genus of the claim, the specification does not sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the entire scope of the claimed invention.
For inventions in an unpredictable art, adequate written description of a genus, which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, first paragraph. In the instant case, the unpredictability of the art is evidenced by the cited references, above. Adequate written description requires more than a mere statement that a compound is part of the invention and reference to a potential method of isolating a compound. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al ( US 2020/0062693 published 02/27/2020).
Regarding claim 1, Chen et al discloses a composition comprising a compound of the present disclosure may be administered to individuals in a formulation comprising instant Compound #3. (See para. 0136; 0123), See the eighth recited compound in Para. 0123). Note that Compound #3 is 1-Benzylamino-3-[4-(3-benzylamino-2-hydroxy-propoxy)- phenoxy]-propan-2-ol having the molecular formula C26H32O4N2.
PNG
media_image1.png
378
264
media_image1.png
Greyscale
Regarding claim 3, Chen et al teach a method of treating or preventing immune-related diseases, type 1 diabetes, transplant rejection, or lung fibrosis in a subject in need thereof, the method comprising administering a composition of claim 1 to the subject. Chen et al disclose a method of treating or preventing immune-related diseases, type I diabetes, transplant rejection, or lung fibrosis in a subject in need thereof, the method comprising administering a composition or combination of claim 1. (See para. 0137.) Chen et al teach methods to treat inflammatory disorders in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a compound of Formula I or II; Para. [0127] for treating inflammatory disorders including acute and chronic inflammation disorders such as asthma, chronic obstructive lung disease, pulmonary fibrosis. See para 0135.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2020/0062693 published 02/27/2020) in view of Alcaraz et al (US2003/0013704 published 01/16/2003).
Claims 1 and 3 are anticipated by Chen et al for reasons applied above.
Regarding claims 2, 4, Chen et al discloses a composition or combination comprising a compound of the present disclosure which may be administered to individuals in a formulation. (See para 0135-0136). Chen et al disclose compounds represented by Formula I or Formula II, or pharmaceutically acceptable salts or solvates thereof, or a composition comprising such a compound or a pharmaceutically acceptable salt or solvate thereof, can be administered to a patient or subject in need. of treatment either individually, or in combination with other therapeutic agents that have similar or synergistic biological activities). Chen et al disclose the composition of claim 1 para 0123, specifically eighth recited compound in para. 0123).
However, Chen et al fails to explicitly disclose b) one or more of a population of transplantation cells, rapamycin, oATP, CE-224535, AZD9056, GSK1482160, a polypeptide comprising the ectodomain of P2X7R, a P2X7R soluble protein, a steroid, teplizumab, rituximab, antithymocyte globulin (ATG), and mycophenolate mofetil (MMF).
Alcaraz is in the field of treating inflammation (see para 0003) and teaches AZD9056. (See para 0212.) See especially Example 7 showing 2-Chloro-5-[3-[(3-hydroxpropyl)aninojpopyl]-N-(tcyco3.3.1.13.7ldec-1-ymehy)-benzande which is AZD9056.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition or combination of Chen et al to include AZD9056 as taught by Alcaraz.
The motivation for doing so would have been to provide a combination therapy useful in the treatment of inflammatory and immune-related disorders (Alcaraz Para. [0003]; Chen et al Paras. [0037], [0135]).
Given the high skill level of one of ordinary skill in the art before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art having the cited references would have had a reasonable expectation of success to add AZD9056 to the composition of Chen et al to arrive at the presently claimed invention.
Claims 1-6, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al, (US 2020/0062693 published 02/27/2020) in view of Alcaraz et al (US2003/0013704 published 01/16/2003), in view of D’Addio et al (J Clin Invest Vol128(8): 3490-3503; 2018; IDS ref).
Claims 1-4, are rendered obvious over Chen et al in view of Alcaraz et al for reasons provided above.
However, regarding claims 5, 6, and 20 Chen et al in view of Alcaraz does not teach the subject has rs3751143 (claims 5 and 20) or hyper-Th17 syndrome (claim 6).
Regarding claims 5 and 20, D'Addio is in the field of improving transplant outcomes (D'Addio Abstract) and teaches wherein the subject has or has been determined to have rs3751143 (Pg. 3490, second column, first partial paragraph, a single-nucleotide polymorphism (SNP), rs3751143 located in exon 13 of P2X7R, targets the intracellular C-terminal portion of P2X7R. This mutation is relatively frequent and results in loss of function of P2X7R).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Fiorina et al to include wherein the subject has or has been determined to have rs3751143 as taught by D'Addio.
The motivation for doing so would have been to provide a method of determining a patient population comprising rs3751143 that would benefit from treatment with a P2X7R protein (D'Addio Abstract, Introduction).
Regarding claim 6, Fiorina et al fails to explicitly disclose wherein the subject has Hyper-Th17 syndrome.
D'Addio is in the field of improving transplant outcomes. (See Abstract.) D'Addio teaches wherein the subject has Hyper-Th17 syndrome (Pg. 3498, second column, first full paragraph, data suggest that carriers of the mutant P2X7R allele may represent a population of patients with a fragile immune system at risk of developing a hyper-Th17 syndrome in response to various immune stimulations (e.g., infections, inflammation, or tissue damage)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Fiorina et al to include wherein the subject has Hyper-Th17 syndrome as taught by D'Addio.
The motivation for doing so would have been to provide a method of determining a patient population comprising Hyper-Th17 syndrome that would benefit from treatment with a P2X7R protein (D'Addio second column, first full paragraph).
Given the high skill level of one of ordinary skill in the art before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art having the cited references would have had a reasonable expectation of success to add combine the elements of the cited references to arrive at the presently claimed invention.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fiorina et al (US 2019/0184027 published 06/20/2019) of in view of D’Addio.
Regarding base claim 7, Fiorina et al discloses a method of treating or preventing immune-related diseases, type 1 diabetes, transplant rejection, or lung fibrosis in a subject in need thereof (Para. [0035], a method of delaying rejection of a transplanted organ in an individual), the method comprising administering a composition comprising one or more of oATP, CE-224535, AZD9056, GSK1482160, a polypeptide comprising the ectodomain of P2X7R, and a P2X7R soluble protein to the subject (Para. [0035], comprising providing an inhibitor of ATP signaling, and administering a therapeutically effective dosage of the inhibitor to the subject the inhibitor is a P2X7R-lg fusion the inhibitor is CE-224535, AZD9056, GSK1482160, or oATP).
Fiorina et al fails to explicitly disclose wherein the subject has or has been determined to have rs3751143.
D'Addio is in the field of improving transplant outcomes (D'Addio Abstract) and teaches wherein the subject has or has been determined to have rs3751143 (Pg. 3490, second column, first partial paragraph, a single-nucleotide polymorphism (SNP), s3751143 located in exon 13 of P2X7R, targets the intracellular C-terminal portion of P2X7R. This mutation is relatively frequent and results in loss of function of P2X7R).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Fiorina et al to include wherein the subject has or has been determined to have rs3751143 as taught by D'Addio.
The motivation for doing so would have been to provide a method of determining a patient population comprising rs3751143 that would benefit from treatment with a P2X7R protein (D'Addio Abstract, Introduction).
Regarding base claim 8, Fiorina et al discloses a method of slowing or delaying aging processes or extending lifespan in a subject (Para. [0037], a method of preventing and/or decreasing the extent of rejection and/or treating rejection of a graft in a subject, wherein treating rejection of a graft in a subject would extend lifespan of said subject), the method comprising: administering a composition comprising one or more of oATP, CE224535, AZD9056, GSK1482160, a polypeptide comprising the ectodomain of P2X7R, and a P2X7R soluble protein to the subject (Para. [0037], comprising providing an inhibitor of ATP signaling, and administering a therapeutically effective dosage of the inhibitor to the subject the inhibitor of ATP signaling is a P2X7R fusion protein; Para. [0038], the inhibitor of ATP signaling is a soluble P2XR fusion protein).
Fiorina et al fails to explicitly disclose wherein the subject has or has been determined to have rs3751143.
D'Addio is in the field of improving transplant outcomes. (See Abstract.) D'Addio teaches wherein the subject has or has been determined to have rs3751143 (Pg. 3490, second column, first partial paragraph, a single-nucleotide polymorphism (SNP), rs3751143 located in exon 13 of P2X7R, targets the intracellular C-terminal portion of P2X7R. This mutation is relatively frequent and results in loss of function of P2X7R).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Fiorina et al to include wherein the subject has or has been determined to have rs3751143 as taught by D'Addio.
The motivation for doing so would have been to provide a method of determining a patient population comprising rs3751143 that would benefit from treatment with a P2X7R protein (D'Addio Abstract, Introduction).
Regarding claim 9, Fiorina et al fails to explicitly disclose wherein the subject has Hyper-Th17 syndrome.
D'Addio is in the field of improving transplant outcomes. (See Abstract.) D'Addio teaches wherein the subject has Hyper-Th17 syndrome (Pg. 3498, second column, first full paragraph, data suggest that carriers of the mutant P2X7R allele may represent a population of patients with a fragile immune system at risk of developing a hyper-Th17 syndrome in response to various immune stimulations (e.g., infections, inflammation, or tissue damage)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Fiorina et al to include wherein the subject has Hyper-Th17 syndrome as taught by D'Addio.
The motivation for doing so would have been to provide a method of determining a patient population comprising Hyper-Th17 syndrome that would benefit from treatment with a P2X7R protein (D'Addio second column, first full paragraph).
Given the high skill level of one of ordinary skill in the art before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art having the cited references would have had a reasonable expectation of success to add combine the elements of the cited references to arrive at the presently claimed invention.
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.
Claims 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. US 11,452,781 B2 in view of D'Addio (see above). Although the patented claims are not identical to the instant claims, they are not patentably distinct because they are rendered obvious over the combination of patented claims and D’Addio.
Regarding claims 7-9, patented claims are essentially the same as present claims except that patented claims fail to recite that the subject has or has been determined to have rs3751143 or Hyper-Th17 syndrome.
D'Addio is in the field of improving transplant outcomes. (See Abstract.) D'Addio teaches wherein the subject has or has been determined to have rs3751143 (Pg. 3490, second column, first partial paragraph, a single-nucleotide polymorphism (SNP), rs3751143 located in exon 13 of P2X7R, targets the intracellular C-terminal portion of P2X7R. This mutation is relatively frequent and results in loss of function of P2X7R).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Fiorina et al to include wherein the subject has or has been determined to have rs3751143 as taught by D'Addio.
The motivation for doing so would have been to provide a method of determining a patient population comprising rs3751143 that would benefit from treatment with a P2X7R protein (D'Addio Abstract, Introduction).
Further, D'Addio is in the field of improving transplant outcomes. (See Abstract.) D'Addio teaches wherein the subject has Hyper-Th17 syndrome (Pg. 3498, second column, first full paragraph, data suggest that carriers of the mutant P2X7R allele may represent a population of patients with a fragile immune system at risk of developing a hyper-Th17 syndrome in response to various immune stimulations (e.g., infections, inflammation, or tissue damage)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patented claims to include wherein the subject has Hyper-Th17 syndrome as taught by D'Addio.
The motivation for doing so would have been to provide a method of determining a patient population comprising Hyper-Th17 syndrome that would benefit from treatment with a P2X7R protein (D'Addio second column, first full paragraph).
Given the high skill level of one of ordinary skill in the art before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art having the patented claims and cited reference would have had a reasonable expectation of success to add combine the elements to arrive at the presently claimed invention.
Claims 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. US 10,071167 B2 in view of D'Addio (see above). Although the patented claims are not identical to the instant claims, they are not patentably distinct because they are rendered obvious over the combination of patented claims and D’Addio.
Regarding claims 7-9, patented claims are essentially the same as present claims except that patented claims fail to recite that the subject has or has been determined to have rs3751143 or Hyper-Th17 syndrome.
D'Addio is in the field of improving transplant outcomes. (See Abstract.) D'Addio teaches wherein the subject has or has been determined to have rs3751143 (Pg. 3490, second column, first partial paragraph, a single-nucleotide polymorphism (SNP), rs3751143 located in exon 13 of P2X7R, targets the intracellular C-terminal portion of P2X7R. This mutation is relatively frequent and results in loss of function of P2X7R).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Fiorina et al to include wherein the subject has or has been determined to have rs3751143 as taught by D'Addio.
The motivation for doing so would have been to provide a method of determining a patient population comprising rs3751143 that would benefit from treatment with a P2X7R protein (D'Addio Abstract, Introduction).
Further, D'Addio is in the field of improving transplant outcomes. (See Abstract.) D'Addio teaches wherein the subject has Hyper-Th17 syndrome (Pg. 3498, second column, first full paragraph, data suggest that carriers of the mutant P2X7R allele may represent a population of patients with a fragile immune system at risk of developing a hyper-Th17 syndrome in response to various immune stimulations (e.g., infections, inflammation, or tissue damage)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patented claims to include wherein the subject has Hyper-Th17 syndrome as taught by D'Addio.
The motivation for doing so would have been to provide a method of determining a patient population comprising Hyper-Th17 syndrome that would benefit from treatment with a P2X7R protein (D'Addio second column, first full paragraph).
Given the high skill level of one of ordinary skill in the art before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art having the patented claims and cited reference would have had a reasonable expectation of success to add combine the elements to arrive at the presently claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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, Melissa Fisher can be reached at 571-270-7430. 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.
CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
Prosecution Insights