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 Claims
Claims 1, 3, 7, 10, 14, 21, 25-26, 28, 30-31, 259, 333, 335-337, 339-340 and 342 are pending and under examination.
Claim Rejections - 35 USC § 112
Claims 1, 3, 7, 10, 14, 21, 25, 26, 28, 30, 31, 259, 335, 336, 337, 339, 340, and 342
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. In claim 1, “a compound of formula (1)” is not defined in the specification with reasonable clarity as to what entities the applicant is intending to reference.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the “written description” inquiry, is “whatever is now claimed” (See page 1117).
A review of the language of the claim indicates that these claims are drawn to “a compound of formula (1)”. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention”. Hence, an adequate written description of the ingredients requires more than a mere statement that it is a compound of formula (1).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984). Accordingly, reciting “a compound of formula (1)”, in the absence of knowledge as to what constitutes a compound of formula (1), is not a description. In the instant case, on page 1; line 27 to page 3; line 3, Applicant discloses “a compound of formula (1)”. However, other than the mere mention on page 1; line 27 to page 3; line 3, wherein Applicant simply states “a compound of formula (1)”, Applicant does not provide any examples of a compound of formula (1)3.
There are select species of the claimed genus disclosed that is within the scope of the claimed genus, i.e., compounds 1-476 in Table 1 of the specification (pages 78-119).
The disclosure of select disclosed species may provide an adequate written description of a genus when the species disclosed is representative of the genus. However, the present claim encompasses numerous species that are not further described. There is substantial potential for variability among the species.
One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus of what constitutes “a compound of formula (1)”. The specification does not clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed (see Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claim 336, 337, and 339 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 a method of treating a neurological disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of one of the following compounds, or a pharmaceutically acceptable salt thereof (from page 406 of the specification),
PNG
media_image1.png
415
232
media_image1.png
Greyscale
wherein the neurological disorder is Frontotemporal Lobar Degeneration associated with TDP (FTLD-TDP), Amyotrophic lateral sclerosis (ALS), or Limbic-predominant Age-related TDP-43 Encephalopathy (LATE), or Alzhiemer's disease
a method of inhibiting toxicity in a cell related to a protein, the method comprising contacting the cell with one of the following compounds, or a pharmaceutically acceptable salt thereof (from page 406 of the specification),
PNG
media_image1.png
415
232
media_image1.png
Greyscale
wherein the toxicity is TDP-43-related toxicity, or C9orf72-related toxicity,
and a method of inhibiting PIKfyve in a cell expressing PIKfyve protein, the method comprising contacting the cell with one of the following compounds, or a pharmaceutically acceptable salt thereof (from page 406 of the specification),
PNG
media_image1.png
415
232
media_image1.png
Greyscale
does not reasonably provide enablement for a method of treating any neurological disorder in a subject in need thereof, the method comprising administering to the subject the full-scope of compounds of formula (1), or a pharmaceutically acceptable salt thereof, a method of inhibiting any toxicity in a cell related to a protein, the method comprising contacting the cell with the full-scope of compounds of formula (1), or a pharmaceutically acceptable salt thereof, or a method of inhibiting PIKfyve in a cell expressing PIKfyve protein, the method comprising contacting the cell with the full-scope of compounds of formula (1).
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.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention: The nature of the invention is complex in that the claims are drawn to a method of treating any neurological disorder in a subject in need thereof, the method comprising administering to the subject the full-scope of compounds of formula (1), or a pharmaceutically acceptable salt thereof, a method of inhibiting any toxicity in a cell related to a protein, the method comprising contacting the cell with the full-scope of compounds of formula (1), or a pharmaceutically acceptable salt thereof, or a method of inhibiting PIKfyve in a cell expressing PIKfyve protein, the method comprising contacting the cell with the full-scope of compounds of formula (1).
However, Applicant has only demonstrated select species (previously shown) has having successful inhibitory activity in the PIKFYVE TDP-43 model (page 405 in specification). Further, only select disease states claimed by Applicant in a method of treatment are understood in the art to be mediated by PIKFYVE and TDP-43, such as Frontotemporal Lobar Degeneration associated with TDP (FTLD-TDP), Amyotrophic lateral sclerosis (ALS), or Limbic-predominant Age-related TDP-43 Encephalopathy (LATE).
Breadth of the Claims: The claims are broad in that the claims recite a method for treating any neurological disorder in a subject in need thereof, the method comprising administering to the subject the full-scope of compounds of formula (1), or a pharmaceutically acceptable salt thereof, a method of inhibiting any toxicity in a cell related to a protein, the method comprising contacting the cell with the full-scope of compounds of formula (1), or a pharmaceutically acceptable salt thereof, or a method of inhibiting PIKfyve in a cell expressing PIKfyve protein, the method comprising contacting the cell with the full-scope of compounds of formula (1). The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims.
Guidance of the Specification and Existence of Working Examples: The specification describes the following compounds
PNG
media_image1.png
415
232
media_image1.png
Greyscale
as having successful inhibitory activity against PIKFYVE TDP-43 models, and other compounds of the Applicant’s formula as not being active. Further, the specification describes TDP-43 as a driver of diseases such as ALS and FTLD-TDP.
However, no working examples are given for the compounds of formula (1) affecting other mechanisms outside of PIKFYVE and TDP-43. Enabled disease states would need to be understood to be involved with PIKFYVE inhibition and the subsequent decrease in TDP-43 aggregation.
Predictability and State of the Art: The state of the art at the time the invention was made was unpredictable and underdeveloped. It is known in the art that TDP-43 is a protein that can aggregate and cause ALS and FTLD-TDP, that Inhibiting PIKFYVE kinase increases exocytosis of aggregation prone proteins such as TDP-43 (See Page 791, PIKFYVE inhibition clears pTDP-43 through amphisome and multivesicular body exocytosis) and that this mechanism of PIKFYVE inhibition has been show across a multitude of ALS types, including C9orf72, as taught by Hung, S. (PIKFYVE inhibition mitigates disease in models of diverse forms of ALS), Cell Press, Vol. 186, pp. 786-802 (Year: 2023).
It is understood in the art that diseases such as FTLD-TDP, ALS, LATE, and Alzhiemer's disease are all shown to have involvement with TDP-43, such that inhibition of PIKFYVE kinase would lower TDP-43 in these disease states as well. The nexus between FTLD-TDP, ALS, and TDP-43 has been elucidated by Applicant so far.
Zhou, X. (TDP-43 in Alzheimer’s disease: Pathophysiology and therapeutic strategies), Pharmacological Research, Vol. 221, pp. 1-18 (Year: 2025) teaches that TDP-43 is a relevant protein in Alzheimer’s Disease progression, and that this is a potential target of novel therapeutic treatments (See Page 1; Abstract).
NIH. What Is Limbic-Predominant Age-Related TDP-43 Encephalopathy (LATE)?, [online], [retrieved on 05/22/2026]. https://www.nia.nih.gov/health/alzheimers-and-dementia/what-limbic-predominant-age-related-tdp-43-encephalopathy-late (Year:2023) teaches that TDP-43 is a relevant protein in Limbic-Predominant Age-Related TDP-43 Encephalopathy (LATE) (See Page 1; Paragraph 3).
However, it is not understood that all neurological diseases would be treated by targeting TDP-43, such as chronic traumatic encephalopathy, or any frontotemporal lobar degeneration.
Mayo Clinic. Chronic traumatic encephalopathy, [online], [retrieved on 05/22/2026]. https://www.mayoclinic.org/diseases-conditions/chronic-traumatic-encephalopathy/symptoms-causes/syc-20370921 (Year:2025) teaches that the primary cause of Chronic traumatic encephalopathy is repeated physical trauma to the head (See page 1; Paragraph 1). Based on this teaching, one would not expect this disease to be affected by addressing TDP-43.
Sobue, G. (Pathogenesis of Frontotemporal Lobar Degeneration: Insights From Loss of Function Theory and Early Involvement of the Caudate Nucleus), Frontiers in Neuroscience, Vol. 12, No. 473 pp. 1-9 (Year: 2018) teaches that there are three pathogenic proteins in Frontotemporal Lobar Degeneration, TDP-43, FUS, and tau (See Page 1; Abstract). Based on this teaching, one would not expect that addressing TDP-43 would affect Frontotemporal Lobar Degeneration that is caused by either FUS or tau.
Amount of Experimentation Necessary: The quantity of experimentation necessary to carry out the claimed invention is high, as the skilled artisan could not rely on the prior art or instant specification to teach a method of treating any neurological disorder in a subject in need thereof, the method comprising administering to the subject the full-scope of compounds of formula (1), or a pharmaceutically acceptable salt thereof, a method of inhibiting any toxicity in a cell related to a protein, the method comprising contacting the cell with the full-scope of compounds of formula (1), or a pharmaceutically acceptable salt thereof, or a method of inhibiting PIKfyve in a cell expressing PIKfyve protein, the method comprising contacting the cell with the full-scope of compounds of formula (1).
In order to carry out the claimed invention, one of ordinary skill in the art would have to determine that the full-scope of compounds of formula (1) have inhibitory activity against PIKFYVE TDP-43 models, and that TDP-43 is a toxic protein involved in all neurological disorders.
In view of the breadth of the claims and the lack of guidance provided by the specification as well as the unpredictability of the art, the skilled artisan would have required an undue amount of experimentation to make and/or use the claimed invention. Therefore, claims 336, 337, and 339 are not considered to be fully enabled by the instant specification.
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)(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.
Claim(s) 1, 3, 7, 10, 14, 21, 25, 26, 28, 30, 31, 259, and 333 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ichida, J. K., et. al. (US Patent Publication No. US 2021/0338683 A1; Published 11/4/2021).
Ichida teaches the following formula.
PNG
media_image2.png
129
191
media_image2.png
Greyscale
Applicant discloses the following formula.
PNG
media_image3.png
108
162
media_image3.png
Greyscale
The formula of Ichida teaches the Applicant’s formula at least when:
The ring A of Ichida corresponds to the five-membered ring of the Applicant’s formula, including Y and X. Ichida teaches that ring A is a 5 membered heteroaryl having at least one nitrogen, teaching the Applicant's core ring structure as well as X and Y.
R2 of Ichida is a substituted or unsubstituted heterocycle or heteroaryl, and
corresponds to R2 of applicant, wherein it is defined as an optionally substituted heterocycle or heteroaryl.
R3 of Ichida is defined to include a substituted or unsubstituted oxygen-containing heterocyclyl, and corresponds to R3 of applicant, wherein it is defined as one of many oxygen-containing heterocycles, including
PNG
media_image4.png
104
51
media_image4.png
Greyscale
.
L2 and R1 of Ichida cumulatively correspond to R1 of the Applicant. L2 of Ichida can be defined as absent. R1 of Ichida can be defined as substituted or unsubstituted heterocycle or heteroaryl, which teaches the Applicant's R1, wherein it is an optionally substituted C2-C9 heterocycle or heteroaryl. Thus, the formula taught by Ichida anticipates that of the Applicant.
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.
Claim(s) 335, 336, 337, 339, 340, and 342 are rejected under 35 U.S.C. 103 as being unpatentable over Ichida, J. K., et. al. (US Patent Publication No.US 2018/0161335 A1; Published 6/14/2018) in view of Ichida, J. K., et. al. (US Patent Publication No.US 2021/0338683 A1; Published 11/4/2021).
Ichida teaches in US 2018/0161335A1 that PIKFYVE kinase inhibition can be used to treat a subject with C9orf72-mutated amyotrophic lateral sclerosis (See Page 3; paragraph 0014) (reading on claims 336 and 337). Ichida teaches that C9ORF72 mutations are the most common cause of ALS (See Page 5; Paragraph 0028), and that they cause glutamate induced excitotoxicity in motor neurons (See Page 5; paragraph 0028) (reading on claim 339 and 340).
Thus far, Ichida provides a nexus between PIKFYVE kinase inhibition, treatment of C9orf72-mutated amyotrophic lateral sclerosis, and inhibiting C9orf72 related toxicity in motor neurons, such that one having ordinary skill in the art, before the Applicant’s effective filing date, would have had sufficient teaching, suggestion, and motivation to pursue a method of treating C9orf72-mutated amyotrophic lateral sclerosis and a method of inhibiting C9orf72 related neuron toxicity using a PIKFYVE inhibitor.
Ichida does not teach the Applicant’s compounds.
However, Ichida ( 2021/0338683 A1) teaches Applicant’s formula 1 (see previous 35 USC § 102 rejection). Ichida teaches that the Applicant’s claimed compounds are known to be PIKFYVE inhibitors (See Page 5; paragraph 0064 – Page 8; paragraph 0103; formula II). Ichida also teaches that these compounds can be in pharmaceutical compositions suitable for use in a subject, such as a human, and may comprise one or more pharmaceutically acceptable excipients or carriers (See Page 23; Paragraph 0166) (reading on claim 335).
Thus far, Ichida provides a nexus between PIKFYVE inhibition, treatment of C9orf72-mutated amyotrophic lateral sclerosis, inhibiting toxicity in motor neurons, and the Applicant’s claimed compounds, such that one having ordinary skill in the art, before the Applicant’s effective filing date, would have had sufficient teaching, suggestion, and motivation to pursue a method of treating C9orf72-mutated amyotrophic lateral sclerosis and a method of inhibiting C9orf72 related neuron toxicity using the Applicant’s claimed compounds of formula (1).
Ichida elucidates the nexus between the Applicant’s compounds of formula (1), as well as their mechanism of PIKFYVE inhibition, and its relevance in treating ALS and inhibiting neuronal toxicity related to a C9orf72 mutation. Further Ichida, provides motivation to formulate the Applicant’s compounds in a composition with pharmaceutically acceptable excipients.
One skilled in the art would have been motivated and have had reasonable expectation of success to combine the teachings of Ichida in these references prior to the applicant’s effective filling date, to arrive at the Applicant’s claimed invention.
Therefore, it would have been obvious to one having ordinary skill in the art, before Applicant’s effective filing date, to combine these teachings and arrive at a pharmaceutical composition comprising the compound of claim 1, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, as well as a method of treating a neurological disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of the compound of claim 1, wherein the neurological disorder is ALS, as well as a method of inhibiting toxicity in a cell related to a protein, the method comprising contacting the cell with the compound claim 1 or a pharmaceutically acceptable salt thereof, wherein the toxicity is a C9orf72-related toxicity.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
(Of Note: The following double patenting rejections are PROVISIONAL)
Claims 1, 3, 7, 10, 14, 21, 25, 26, 28, 30, 31, 259, 333, and 335 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 18/007,983: 1, 6, 7, 18-21, and 23-25 (for present claims 1, 3, 7, 10, 14, 21, 25, 26, 28, 30, 31, 259, 333, and 335).
(Of Note: This rejection will support the rejections that follow below where applicable.)
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compounds of the instant application. The co-pending claims 1, 6, 7, 18-21, and 23-25 are all drawn to the same compounds of the Applicant’s formula.
Claim 1 of the Applicant is taught by claim 1 of the co-pending, wherein the co-pending formula (Ia) only differs from the Applicant’s formula by specifying: R-3 as
PNG
media_image5.png
52
54
media_image5.png
Greyscale
and Applicant’s Y as N. Applicant’s X is already exclusively defined as NRA, as taught by the formula (Ia) of the co-pending.
Claim 3 of the Applicant further defines Y as N, as taught by the Applicant’s formula (Ia) in claim 1, previously explained.
R
Claim 7 of the Applicant further defines RA as at least H and C1-C2 alkyl optionally substituted with hydroxyl or -S(O)CH3, C3 alkyl, and C4-C5 alkyl substituted with hydroxyl, as taught by the formula (Ia) in claim 1, and claim 6 and 7 of the co-pending, wherein R--A is defined as optionally substituted C1-6 alkyl, or H, respectively.
Claim 10 of the Applicant further defines R1 as at least pyrazol-1-yl, as taught by the formula (Ia) in claim 1 of the co-pending.
Claim 14 of the Applicant further defines R1 as substituted pyrazol-1-yl, as taught by the formula (Ia) in claim 1 of the co-pending.
Claim 21 of the Applicant further defines R1 as substituted pyrimidin-6-yl, as taught by the formula (Ia) in claim 1 of the co-pending, as well, as claim 18.
Claim 25 of the Applicant further defines R2 as optionally substituted C2-C9 heteroaryl, as taught by the formula (Ia) in claim 1 of the co-pending wherein R2 is defined as optionally substituted C1-9 heteroaryl, as well, as claim 19 and claim 20.
Claim 26 of the Applicant further defines R2 as optionally substituted pyridyl, as taught by claim 20 of the co-pending.
Claim 28 of the Applicant further defines R2 as optionally substituted tetrahydropyranyl, optionally substituted dihydropyranyl, optionally substituted piperidinyl, or optionally substituted azetidinyl, as taught by claim 21 of the co-pending.
Claim 30 of the Applicant further defines R1A of R1 as substituted by oxo, as taught by the formula (Ia) in claim 1 of the co-pending, wherein the optional substitution can be oxo.
Claim 31 pf the Applicant includes the same formula previously explained to have been taught by the co-pending.
Claim 259 of the Applicant includes the formulas taught by the co-pending, wherein the only difference is further defining the formula with limitations from the dependent claims previously explained as taught by the co-pending. For example, formula 41 in Applicant’s claim 259, wherein R2 of the Applicant’s formula is defined to be
PNG
media_image6.png
55
77
media_image6.png
Greyscale
, which is taught by the co-pending formula (Ia).
Claim 333 of the Applicant is drawn to compounds of the formula previously explained to be taught by the co-pending, and further taught by co-pending claim 23, compound 8 (reading on compound 1 from Table 1 of Applicant’s specification), as well as claim 24, compound 120 (reading on compound 468 from Table 1 of Applicant’s specification).
Claim 335 of the Applicant is drawn to the compounds of the Applicant’s formula previously explained to be taught by the co-pending, in a composition as pharmaceutically acceptable salts, with pharmaceutically acceptable excipients, further taught by co-pending claim 25.
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 18/007,983. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OROD MOTEVALLI whose telephone number is (571)272-6026. The examiner can normally be reached Monday - Friday 10:00AM - 6:00PM.
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, Amy L Clark can be reached at (571) 272-1310. 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.
/OROD MOTEVALLI/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
Prosecution Insights