DETAILED ACTION
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
Claims 1, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, 142-147, 149, and 159 are pending. Claims 2-30, 32-42, 44-50, 52-69, 71, 72, 74-90, 92-95, 97, 98, 100, 101, 103-111, 113-132, 134-141, 148, and 150-158 are cancelled.
Examiner previously required a restriction (dated September 19, 2025). In response, Applicant elected, without traverse, Group I which encompasses claims 1, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 142-146. Accordingly, claims 147, 149, and 159 are withdrawn.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/US2021/063761, filed on December 16, 2021. This application also claims priority to U.S. Provisional Application No. 63/126,505, filed on December 16, 2020.
In this office action, Examiner used the effective filing date of the International patent application PCT/US2021/063761 (i.e., December 16, 2021) as the effective filing date of the instant application. This is because claim 1 of the provisional application does not provide written description support for the full scope of claim 1 of the instant application, for at least the following reasons amongst potential others:
The provisional application does not disclose embodiments in which R7 is H and does not state R7 has the option to be H in claim 1, whereas claim 1 of the instant application explicitly recites that R7 can be H,
The provisional application does not disclose embodiments in which Cy2 is cyclohexane and does not state Cy2 has the option to be a cyclohexane in claim 1, whereas claim 1 of the instant application explicitly recites that Cy2 can be a cyclohexane, and
The provisional application does not disclose compound 41A in claim 1 or in its corresponding specification. The provisional specification only discloses how to synthesize compound 41 (on pg. 176 of provisional specification), not 41A. However, instant claim 1 does include compound 41A.
Since claims 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 143-146 are all dependent on claim 1, these claims are also subjected to the effective filing date of December 16, 2021.
Claim 142 is also subjected to the effective filing date of December 16, 2021 since it encompasses compounds that were not previously disclosed in the provisional application.
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group I which corresponds to claims 1, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 142-146. Applicant also elected the following species without traverse:
PNG
media_image1.png
237
652
media_image1.png
Greyscale
and indicated that at least claims 1, 31, 51, 73, 96, 99, 102, 112, 133, 142, 145, and 146 encompass said species. The elected species was not found in the prior art and, thus, the search was expanded.
Information Disclosure Statement
The information disclosure statement filed on October 18, 2023 lists the following references:
WO2017214367A1
Butler Thomas et al: “Oral Long-Acting Menin Inhibitor, BMF-219, Normalizes Type 2
Diabetes Mellitus in Two Rat Models,” ADA 2022, 1 June 2022 (2022-06-01), XP093001069, Retrieved from the Internet: URL: https://biomeafusion.com/wp-content/uploads/2022/06/ADA-Poster-2022_Regular-Abstract_052622_Final2.pdf
Extended European Search Report for EP Application No. 19906970.9, dated September 15, 2022, 56 pages.
Examiner could not locate the above references within the file wrapper of the instant application. Thus, the above references were not considered. All remaining references cited by Applicant were considered.
Specification - Abstract
The abstract of the disclosure is objected to because it is not in compliance with 37 C.F.R. 1.72 (b). Specifically, the sheet presenting the abstract includes other parts of the application or other material. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, compounds 20, 36-41, 41A, 42, 44, and 45 have different compound identification numbers when discussed in the specification.
For example, compound 20 is “B0700-320” and compound 44 is “B0700-516.” For consistency, please re-number compounds 20, 36-41, 41A, 42, 44, and 45 in claim 1 to the identification numbers used in the instant specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 143-146 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 compound according to formula (L-I):
Cy1 – Cy2 – X – W – Y – Cy3 – L – Cy4 – R1
wherein Cy1, Cy2, X, W, Y, Cy3, L, Cy4, R1, R8a, R3a, R3b, R3c, R6a, R6b, and R6c are as recited in claim 1
R6e and R6f is H
R7 is as recited in claim 1 without the inclusion of phenyl, an 8-10 membered bicyclic aryl ring, and a 5-6 membered heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur
or the compound is compound 20, 36, 37, 38, 39, 40, 41, 41A, 42, 44, or 45 as recited in claim 1”
does not reasonably provide enablement for elements that are outside the scope of the enabling elements listed above. 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 the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01(a), “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.”
In evaluating the enablement question, several factors are to be considered. According to In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), these factors include:
1) The nature of the invention,
2) the state of the prior art,
3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present,
5) the presence or absence of working examples,
6) the breadth of the claims, and
7) the quantity of experimentation needed, and
8) the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention
The nature of the invention claims heterocyclic compounds that inhibit the binding of menin and MLL or MLL fusion proteins. Also described are specific irreversible inhibitors of menin-MLL interaction. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the menin-MLL irreversible inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, leukemia and other diseases or conditions dependent on menin-MLL interaction.
State of the prior art
See “Claim Rejections - 35 USC § 102” and “Claim Rejections - 35 USC § 103” sections below.
The level of the skill in the art
The level of ordinary skill in the art is relatively high. A person of ordinary skill would typically have formal training in medicinal chemistry and organic synthesis and would be familiar with standard methods for evaluating therapeutic efficacy of compounds.
The presence or absence of working examples
While the instant application does provide some working examples of inhibitors of menin-MLL interaction having a structure represented by Formula (L-I) (specific structures provided on pg. 335-358; data on the instant compounds’ menin-MLL in vitro inhibitory activity provided on pg. 361-363), there are no working examples of menin-MLL inhibitors with structural elements that are outside the scope of the enabling elements listed above.
According to MPEP § 2163:
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. 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, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’ See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
In the instant case, even though the specification provides data on the menin-MLL in vitro inhibitory activity of compounds of diverse structures, it does not include any data on the menin-MLL in vitro inhibitory activity of compounds of Formula (L-I) with structural elements that are outside the scope of the enabling elements listed above. For example, there are no working examples of a compound of Formula (L-I) wherein R7 is phenyl, an 8-10 membered bicyclic aryl ring, and a 5-6 membered heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur. Thus, the specification is not adequately reflecting the structural diversity of the claimed genus
The amount of direction or guidance present and quantity of experimentation necessary
As stated previously, the instant specification does not provide any working examples of a compound of Formula (L-I) wherein R7 is phenyl, an 8-10 membered bicyclic aryl ring, and a 5-6 membered heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur. In the absence of clear guidance, a person of ordinary skill in the art would require undue experimentation to:
make all compounds comprising structural elements that are outside the scope of the enabling elements listed above and
determine which of those compounds are inhibitors of menin-MLL interaction in vitro.
The breadth of the claims
The claims are broad insofar as the instant claims recite a compound according to formula (L-I) wherein the compound can possess a structurally diverse range of chemical groups.
Claims 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 143-146, which are dependent on claim 1, are also rejected for further requiring and/or reciting elements that are outside the scope of the enabling elements listed above.
Claim Rejections - 35 USC § 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 142-146 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.
The term “substituted” and the phrase “optionally substituted” in claims 1, 43, and 112 with regard to Cy1, Cy2, Cy3, L, Cy4, R3a, R3b, R3c, R6c, and/or R7, is a relative phrase which renders the claims indefinite. The term “substituted” and/or the phrase “optionally substituted” are not defined by the claims, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. Although the instant specification, on pgs. 25-28 (para. 00123-00129), provide examples of “suitable substituents” which include halogen, R*, etc., and further discloses that the substituents themselves may be further “substituted,” neither the specification, nor the claims, explicitly limits the invention to any specifically disclosed or recited embodiments. Hence, claims 1, 43, and 112 are rendered indefinite.
Claim 31 recites the limitation “-C(H)2-N(H)2-” wherein X = -C(H)2, W = -N(H)2, and Y = absent. Claim 31 is dependent on claim 1 which does not recite that W can be -N(H)2. Thus, there is insufficient antecedent basis for this limitation in claim 31.
Claim 70 recites the limitation “R7-Cy1-Cy2-X-W-Y-Cy3” which is not disclosed in claim 1, the claim in which claim 70 is dependent upon. Claim 1 discloses a compound according to formula (L-1) which comprises the following fragment: Cy1-Cy2-X-W-Y-Cy3-. Thus, there is insufficient antecedent basis for this limitation in claim 70.
Claim 142 recites “A compound which is selected from any one of compounds listed in Table 1.” There is a lack of antecedent basis for the limitation, “Table 1,” as claim 1 (in which claim 142 is dependent on) does not disclose a Table 1.
Further, according to MPEP 2173.05(s):
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
Therefore, instead of having claim 142 refer to Table 1 of the instant specification, Applicant should incorporate the compounds into claim 142 instead.
Claims 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 143-146, which are dependent on claim 1, are also rejected for further requiring and/or reciting the indefinite limitations of claim 1.
Note on 35 USC § 102 and § 103 Rejections
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.
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.
(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, 31, 43, 51, 70, 73, 96, 99, 102, 112, 133, 142, 145, and 146 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by:
Butler et al. (Butler) (WO2020142557A1; International filing date: December 31, 2019; published July 9, 2020)
Butler discloses the following compound:
PNG
media_image2.png
305
904
media_image2.png
Greyscale
(i.e., compound 10 as disclosed on pg. 158, Example 9; same as compound of formula XVI in claim 102) which corresponds to a compound of instant formula (L-I) wherein:
Cy1 is
PNG
media_image3.png
97
128
media_image3.png
Greyscale
; R7 is a morpholine group (i.e., a 6-membered heterocycloalkyl ring having 2 heteroatoms independently selected from nitrogen and oxygen),
Cy2 is a phenyl ring,
X is -NR3a -; R3a is H,
W is -C(O)-,
Y is absent,
Cy3 is pyridylene,
L is -CH2- (i.e., C1 alkylene),
Cy4 is piperidinylene,
R1 is -N(R3c)-C(O)-C(R6a)=C(R6b)(R6c); R3c = R6a = R6b = R6c = H
This compound reads on instant claims 1, 31, 43, 51, 70, 73, 96, 99, 102, 112, and 133.
Butler also discloses pharmaceutical compositions formulated for a route of administration which includes oral administration, parenteral administration, nasal administration, topical administration, and rectal administration (see Example 6 on pg. 225-226). These pharmaceutical compositions comprise of any compound of formula (I)-(XLIIIc) which includes compound 10 (i.e., compound of formula XVI) as discussed above. Thus, these pharmaceutical compositions disclosed by Butler read on instant claims 145 and 146.
Butler discloses the following compound in claim 107:
PNG
media_image4.png
212
515
media_image4.png
Greyscale
. This compound is the same as instant compound B0700-314 in Table 1 of the instant specification (pg. 339). Hence, the compound of formula XLa in Butler reads on instant claim 142.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, 142, 145, and 146 are rejected under 35 U.S.C. 103 as being unpatentable over:
Butler et al. (Butler) (WO2020142557A1; International filing date: December 31, 2019; published July 9, 2020).
The teachings of Butler as they apply to claims 1, 31, 43, 51, 70, 73, 96, 99, 102, 112, 133, 142, 145, and 146 are as discussed in “Claim Rejections - 35 USC § 102” and incorporated herein.
Butler does not teach the following compounds:
PNG
media_image5.png
154
497
media_image5.png
Greyscale
(i.e., instant compound B0700-301 from Table 1 on pg. 337 of the instant specification) or
PNG
media_image6.png
114
404
media_image6.png
Greyscale
(i.e., instant compound B0700-341 from Table 1 on pg. 344 of the instant specification), for example. The difference between compound 10 of Butler and instant compound B0700-301 is that in compound 10, the N bonded to the piperidine ring is also bonded to H instead of a methyl group (as is the case in instant compound B0700-301). The difference between compound 10 of Butler and instant compound B0700-341 is that the morpholinyl ring in compound 10 does not have a methyl group.
According to MPEP 2144.09:
I. REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE EXPECTATION THAT COMPOUNDS SIMILAR IN STRUCTURE WILL HAVE SIMILAR PROPERTIES
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).
II. HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
Since methyl is considered a homolog of H, compound 10 of Butler and instant compound B0700-301 are presumed to possess similar properties and a person of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to make instant compound B0700-301 given the disclosure of compound 10 from Butler. Thus, instant compounds B0700-301 and B0700-341, which read on instant claims 1, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 142, are rendered obvious to make.
Furthermore, Butler does not teach a pharmaceutical composition formulated for a route of administration (which includes oral administration, parenteral administration, nasal administration, topical administration, and rectal administration) wherein these pharmaceutical compositions comprise instant compound B0700-301 or B0700-341. However, given that Butler teaches how to make the different types of pharmaceutical compositions using compound 10 (which was previously established above to presume to have properties similar to instant compound B0700-301 and B0700-341), one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to follow the pharmaceutical composition formulation procedure as outlined in Butler and to replace compound 10 with instant compound B0700-301 or B0700-341. Thus, instant claims 145 and 146 are also rendered obvious.
Furthermore, given that the claimed invention is anticipated by the prior art (as explained above in the “Claim Rejections - 35 USC § 102” section), a POSITA would have found it obvious to reproduce the subject matter disclosed.
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 1, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 142-146 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-26 of U.S. Patent No. 11084825B2 (‘825B2)
claims 1-19 of U.S. Patent No. 12018032B2 (‘032B2)
claims 1-17 of U.S. Patent No. 12251385B2 (‘385B2)
claims 1-35 of U.S. Patent No. 12215113B2 (‘113B2)
claims 1-21, 23-29, 31-33, 35-39, 41, 43, 44, 46, 48, 56-62, 65-83 of U.S. Patent Application No. 19/489,148 (‘148)
claims 1-134 of U.S. Patent Application No. 19/149,041 (‘041)
claims 127-132 of U.S. Patent Application No. 18/768,954 (‘954)
claims 1-3, 10, 12, 13, 23, 25, 29, 38, 41, 43, 44, 47, 55, 67, 70-73 of U.S. Patent Application No. 18/865,235 (‘235)
claims 1 and 45-50 of U.S. Patent Application No. 18/871,252 (‘252)
Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the claim sets from the patents and patent applications listed above. Specifically, the combination of the claim sets from the patents and patent applications listed above disclose compounds and pharmaceutical compositions encompassed by instant claims 1, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, 142-146.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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, JEFFREY H. MURRAY can be reached at (571) 272-9023. 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.
/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624