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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on January 21, 2026. Claim(s) 1-5, 7, 10-12, 14, 17, 23, 26, 27, 29, 36-39, and 43-46 are pending. Claim(s) 36-39, and 43-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a method of treating a disorder associated with PINK1 and election of species of component 41088 (compound) and kidney disorder (disease) without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim(s) 1-5, 7, 10-12, 14, 17, 23, 26-27, and 29 are examined herein insofar as they read on the elected invention and species. The elected species was found free of the art, therefore the search was expanded to a genus encompassing the elected specie.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7, 10-12, 14, 17, 23, 26-27, and 29 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6, 26-32, 43, 51, 55, 57, 58, and 60-62 of copending Application No. 18/684,942. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method of treating PINK1 associated disorders, including kidney disease, fibrosis, and reperfusion disorder with the administration of a compound as depicted in claim 1. The copending claims are drawn to a compound of formula as depicted in claim 1 (claims 1-6, 26-32, 43) and methods of treating a fibrosis, cardiomyopathy, a kidney disease, a fibrotic disorder, or a reperfusion injury (claims 51, 55, 57, 58, and 60-62) administering said compounds.
While copending claims 1-6, 26-32, 43 are product claims, they must have utility. In order to understand the utility of the compounds, Examiner went to the specification for guidance as well as method claims 51, 55, 57, 58, and 60-62. Since the scope of the composition of the instant invention encompasses the compounds/compositions of the copending application and their utilities are overlapping, then the instant application is obvious over said patent.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-5, 7, 10-12, 14, 17, 23, 26-27, and 29 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 9, 13, 14, 23, 25, 27, 32, 33, 36, 38, 43, 44, 52, 54, 56, 61, 64, 69 of copending Application No. 18/684,939. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method of treating PINK1 associated disorders, including kidney disease, fibrosis, and reperfusion disorder with the administration of a compound as depicted in claim 1. The copending claims are drawn to a compound of formula as depicted in claim 1 (claims 1-2, 9, 13, 14, 23, 25, 27, 32, 33, 36, 38, 43, 44) and methods of treating a fibrosis, cardiomyopathy, a kidney disease, a fibrotic disorder, or a reperfusion injury (claims 52, 54, 56, 61, 64, 69) administering said compounds. While copending claims 1-2, 9, 13, 14, 23, 25, 27, 32, 33, 36, 38, 43, 44 are product claims, they must have utility. In order to understand the utility of the compounds, Examiner went to the specification for guidance as well as method claims 52, 54, 56, 61, 64, 69. Since the scope of the composition of the instant invention encompasses the compounds/compositions of the copending application and their utilities are overlapping, then the instant application is obvious over said patent.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim Rejections - 35 USC § 112, first paragraph
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 1-5, 7, 10-12, 14, 17, 23, 26-27, and 29 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while enabling for disorders associated with PINK1, wherein the disorder is a chronic kidney disorder selected from those of claim 27 and a fibrotic disorder selected from those of claim 29 comprising administering formula I as recited in claim 7, does not reasonably provide enablement for the treatment of any PINK1 associated disorder with formula I of claim 1 as recited in the instant claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The specification does not provide sufficient information that all PINK1 associated disorders in the instant claims are treatable by compounds of formula I as described in the methods claimed.
The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims and nature of the invention
The breadth of the instant claims is seen to encompass methods for treating of any PINK1 associated disorder with formula I of claim 1.
The claims are extremely broad. Currently, there are no known agents that treat these diseases all inclusively.
The state of the prior art and level of predictability in the art
Leites (Cell, 2021) teaches when PINK1 is mutated, it triggers dysfunction and chronic neuroinflammation not just in neurons, but also in astrocytes and microglia (page 4). Therefore, a successful treatment must address the complex chemical “cross-talk” and inflammation happening between these different cells. It is evident that even after the priority date of the instant application, the molecular mechanism regulated by PINK1 has yet to be completely understood.
Vizziello (Cells, 2021) establishes that mutations in PINK1 typically cause early onset symptoms and distinct non-motor complications like severe anxiety, depression, and executive cognitive function. However, individual genetic background variations mean that therapeutic trials tailored strictly to a patient’s genotype have historically yielded uneven clinical outcomes, showing that PINK1 disorders still unfold against a complex and unpredictable polygenic background (page 5-6).
The treatment of these disorders is highly unpredictable. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The amount of direction provided by the inventor and existence of working examples
The specification does not provide guidance for the treatment of the scope of disorders embraced by umbrella term PINK1 associated disorder as recited with the formula of claim 1. Applicant demonstrates with three compounds (35985, 40180, and 40270) the restoration of kidney function ([0460], [0461], [0471]) including kidney fibrosis ([00464]), ischemia reperfusion injury of kidney ([0466]-[0467]) and of heart ([0468]-[0469]).
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 27 USPQ2d 1510 (CAFC). The disclosure does not demonstrate sufficient evidence to support the Applicant's claim to the treatment. There are not sufficient working examples or data from references of the prior art to provide a nexus between those examples and a method of treating the embraced disorders with the broad scope of claimed compounds.
The level of one of ordinary skill
The level of skill in the art is high (MD’s, PhD’s, or those with advanced degrees). As discussed above, 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
Considering the state of the art as discussed by the references above, particularly with regards to the alleviation of the scope of disorders recited claimed with the formula of claim 1, the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Genentech, 108 F.3d at 1366 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, methods of treating any PINK1 associated disorder by administering a formula of claim1 is not considered to be enabled by the instant specification.
Claim Rejections - 35 USC § 102
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.
Claims 1, 11-12, 14, 17, 23, 26-27, and 29 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Roulet (WO 2018/237145) of record.
Roulet teaches modulators of PINK1 and their implications in the treatment of related conditions such as neurodegenerative disease, mitochondrial disease, fibrosis, and cardiomyopathy [0007].
Roulet teaches the fibrosis is liver fibrosis, kidney fibrosis or pulmonary fibrosis [0182].
Roulet teaches a compound of formula IX (claim 47):
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Roulet teaches the patient to be mammals, including human [080].
Roulet teaches administration can be in the form of oral administration, administration as a suppository, topical contact, intravenous, parenteral, intraperitoneal, intramuscular, intralesional, intrathecal, intracranial, intranasal or subcutaneous administration, or the implantation of a slow-release device, e.g., a mini-osmotic pump, to a subject [087].
Roulet teaches the compound may be administered simultaneously or sequentially [088].
Roulet teaches diabetic nephropathy as an ailment that can benefit from said treatment [0102].
Based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
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.
Claims 2-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Roulet (WO2018237145) of record as applied to claims 1, 11-12, 14, 17, 23, 26-27, and 29 in the 102(a)(1) rejection above.
Roulet is discussed above.
Formula IX as taught by Roulet embraces the instant claims, however, the difference between Roulet and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831,15 USPQ2d 1566 (Fed. Cir. 1990)).
However, based on the above, Roulet teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Therefore, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Conclusion
Claims 1-5, 7, 10-12, 14, 17, 23, 26-27, and 29 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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