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, 5, 7, 15, 23, 25, 32, 39, 44, 48, 52, 57, 58, 62, 64, 72, 80, 82, 89, 101, 102, 105, 109, 115, 117, 120, 128-130, 133, 135, 137, 138, 142, and 143 are pending.
Claims 2-4, 6, 8-14, 16-22, 24, 26-31, 33-38, 40-43, 45-47, 49-51, 53-56, 59-61, 63, 65-71, 73-79, 81, 83-88, 90-100, 103, 104, 106-108, 110-114, 116, 118, 119, 121-127, 131, 132, 134, 136, 139-141, and 144-148 are cancelled.
Examiner previously required a restriction (dated April 21, 2026). In response, Applicant elected, without traverse, Group I which encompasses claims 1, 5, 7, 15, 23, 25, 32, 39, 44, 48, 52, 57, 58, 62, 64, 72, 80, 82, 89, 101, 102, 105, 109, 115, 117, 120, 128-130, and 133.
Accordingly, claims 135, 137, 138, 142, and 143 are withdrawn.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/US2022/075684, filed on August 30, 2022. This application also claims the benefits of priority to U.S. Provisional Application No.:
63/238,691, filed on August 30, 2021,
63/238,694, filed on August 30, 2021,
63/282,906, filed on November 24, 2021,
63/283,132, filed on November 24, 2021,
63/393,206, filed on July 28, 2022, and
63/393,205, filed on July 28, 2022.
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group (I) which encompasses claims 1, 5, 7, 15, 23, 25, 32, 39, 44, 48, 52, 57, 58, 62, 64, 72, 80, 82, 89, 101, 102, 105, 109, 115, 117, 120, 128-130, and 133. Applicant also elected 4-(4-(ethylamino)piperidin-1-yl)-N-(8-fluoro-7-methoxy-2-methylimidazo[1,2-a]pyridin-6-yl)-2-methyl-2H-indazole-7-carboxamide, which is Compound 459 found within Table 1 of the instant specification:
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and indicated claims 1, 5, 7, 15, 23, 25, 32, 39, 44, 48, 52, and 57 read on said species. The elected species was not found in the prior art and, thus, the search was expanded.
Applicant did not explicitly state that the species was elected with or without traverse. Therefore, Examiner interprets that Applicant elected the species without traverse as well.
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.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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 52 is objected to because of the following informalities:
To ensure that all variables in Formula (I-b) is addressed in the claim, claim 52 should read:
“…wherein A, B, L1, L2, R2, R3c, m, and subvariables thereof are as defined in claim 1.”
Appropriate correction is required.
Claim Rejections – Improper Markush Grouping
Claims 1, 5, 7, 15, 23, 25, 32, 39, 44, 48, 52, 57, 58, 62, 64, 72, 80, 82, 89, 101, 102, 105, 109, 115, 117, 120, 128-130, and 133 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the Specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
The claimed Markush group encompasses compounds having substantially different core structures and having substantially different uses. Some examples are depicted below:
Prior art: Renold et al. (Renold) (WO2010084067A2; published July 29, 2010)
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See Renold, pg. 61, Table C, compound C3 (herein, referred to as Renold-compound-C3).
Renold-compound-C3 is a compound encompassed by the instant claims as explained in “Rejection Part 1” of the “Claim Rejections - 35 USC § 102” section below.
Renold-compound-C3 is one of the many compounds disclosed by Renold that is useful as an insecticide (see Renold, abstract).
Prior art: Dai et al. (Dai) (US20170174688A1; published June 22, 2017)
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See Dai, pg. 36, right col., Example 68 (herein, referred to as Dai-example-68).
Dai-example-68 is a compound encompassed by the instant claims as explained in “Rejection Part 2” of the “Claim Rejections - 35 USC § 102” section below.
Dai-example-68 is one of the many compounds disclosed by Dai that is useful as an agent in the treatment of diseases and conditions mediated and modulated by SUV420H1 (see Dai, abstract).
Prior art: Suzuki et al. (Suzuki) (Suzuki, T. et al. 4,7-Bis(dimethylamino)benzimidazoles and twin-type derivatives: reversible two-stage redox system modulated by proton-transfer. Tetrahedron Letters 2003, 44, 7881-7884.)
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See Suzuki, pg. 7884, compound 5 in scheme 5 and Figure 3. This compound was also described on pg. 7883, right col., last paragraph, 3rd-to-last sentence (herein, referred to as Suzuki-compound-5).
Suzuki-compound-5 is a compound encompassed by the instant claims as explained in “Rejection Part 3” of the “Claim Rejections - 35 USC § 102” section below.
Suzuki-compound-5 is a compound disclosed by Suzuki that can undergo reversible two-stage one-electron oxidation (pg. 7883, right col., last paragraph, 3rd-to-last sentence).
This property is useful in electroluminescent devices (see Suzuki, pg. 7881, left col., 2nd sentence).
Prior art: Koltun et al. (Koltun) (WO2019118909A1; published June 20, 2019)
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See Koltun, pg. 141, Example 38 (herein, referred to as Koltun-example-38).
Koltun-example-38 is a compound encompassed by the instant claims as explained in “Rejection Part 7” in the “Claim Rejections - 35 USC § 102” section below.
Koltun-example-38 is one of the many compounds disclosed by Koltun that is useful as an inhibitor of SHP2 (see Koltun, abstract).
Clearly no ‘‘single structural similarity’’ can be seen amongst the different core structures described above. Furthermore, even though each of the above compounds are encompassed by the instant claims, they all have substantially different uses.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR41.31 (a) (1) (emphasis provided).
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, 5, 7, 15, 23, 25, 32, 39, 44, 48, 52, 57, 58, 62, 64, 72, 80, 82, 89, 101, 102, 105, 109, 115, 117, 120, 128-130, and 133 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.
In claim 1, one of the alternatives for R1, R6, and R8 is “-SRE.” However, claim 1 does not define RE. Consequently, it is unclear which substituents are encompassed by “-SRE,” and the scope of claim 1 cannot be ascertained. Therefore, claim 1 is rendered indefinite.
Claims 5, 7, 15, 23, 25, 32, 39, 44, 48, 52, 57, 129, 130, and 133, which are dependent on claim 1, are also rejected for further requiring and/or reciting the indefinite limitation of claim 1.
Claim 57 recites “…wherein the compound is selected from a compound listed in Table 1…” There is a lack of antecedent basis for the limitation, “Table 1” as claim 1 (in which claim 57 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).”
In the instant case, instead of having claim 57 refer to Table 1 of the instant specification, it would be clearer if Applicant pastes the compounds from Table 1 of the instant specification into claim 57.
According to claim 58, when R3c is alkyl, alkylene, alkenyl, alkynyl, heteroalkyl, haloalkyl, cycloalkyl, heterocyclyl, aryl, or heteroaryl, R3c is optionally substituted with one or more R8. However, claim 58 does not define R8. Consequently, it is unclear which substituents are encompassed by R8 and the scope of claim 58 cannot be ascertained. Therefore, claim 58 is rendered indefinite.
Claims 62, 64, 72, 80, 82, 89, 101, 102, 105, 109, 115, 117, 120, and 128, which are dependent on claim 58, are also rejected for further requiring and/or reciting the indefinite limitation of claim 58.
Regarding claims 102 and 133, the phrase "e.g.," renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 128 recites “…wherein the compound is selected from any one of the compounds shown in Table 2…” There is a lack of antecedent basis for the limitation, “Table 2” as claim 58 (in which claim 128 is dependent on) does not disclose a “Table 2.”
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).”
In the instant case, instead of having claim 128 refer to Table 2 of the instant specification, it would be clearer if Applicant pastes the compounds from Table 2 of the instant specification into claim 128.
The term "about" in claim 133 is a relative term which renders the claim indefinite. The term "about" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification only provides the following guidance (page 21): "The term "about" is used herein to mean within the typical ranges of tolerances in the art. For example, "about" can be understood as about 2 standard deviations from the mean. In certain embodiments, about means ±10%. In certain embodiments, about means +5%. When about is present before a series of numbers or a range, it is understood that "about" can modify each of the numbers in the series or range." While the specification provides examples, the only definition given is "typical ranges of tolerances" which does not provide one of ordinary skill in the art a clear scope for the range covered by the term 'about' as typical ranges of tolerances could vary depending on what one considers typical.
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.
Rejection Part 1:
Claims 1, 23, 39, 44, 48, 58, 80, 101, 102, 105, 109, 117, 120, 129 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Renold et al. (Renold) (WO2010084067A2; published July 29, 2010).
Renold discloses compounds useful as an insecticide (see abstract). One of those compounds is shown below:
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(see Renold, pg. 61, Table C, compound C3; referred to as Renold-compound-C3).
Renold-compound-C3 is a compound encompassed by the instant claims wherein:
A = heterocyclyl (i.e.,
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) substituted with 2 R1
one R1 is aryl (i.e., phenyl) substituted with 2 R6 (wherein R6 = Cl) and
the other R1 is C1 haloalkyl (i.e., -CF3)
L1 = absent
L2 = -C(O)N(R4)-
R4 = H
X = Z = N
Y = N(R3c)
R3c = C1 alkyl (i.e., Me)
m = 0 (i.e., R2 is absent)
or with respect to instant claim 58:M = P = C(R2)
R2 = H
W = U = C
B = heterocyclyl (i.e.,
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).
To analyze the above compound by HPLC-MS, a solvent system comprising water is used (see pg. 60, lines 18-25 and pg. 61, lines 1-5). Therefore, Renold also discloses a composition comprising Renold-compound-C3 (i.e., a compound encompassed by instant claim 1) and water (a known pharmaceutically acceptable excipient; see Baldrick, P. Pharmaceutical Excipient Development: The Need for Preclinical Guidance. Regulatory Toxicology and Pharmacology 2000, 32, 210-218 – pg. 210, right col., lines 11-13).
Therefore, Renold-compound-C3 anticipates instant claims 1, 23, 39, 44, 48, 58, 80, 101, 102, 105, 109, 117, 120, and 129.
Rejection Part 2:
Claims 1, 5, 7, 39, 44, 58, 62, 102, 105, 120, and 129 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Dai et al. (Dai) (US20170174688A1; published June 22, 2017).
Dai discloses compounds useful as an agent for the treatment of diseases and conditions mediated and modulated by SUV420H1 (see abstract). One of those compounds is shown below:
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(see Dai, pg. 36, right col., Example 68; referred to as Dai-example-68).
Dai-example-68 is a compound encompassed by the instant claims wherein:
A = heteroaryl (i.e.,
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) substituted with 1 R1
R1 = -NRBRC
RB = RC = H
L1 = C1-alkylene
L2 = absent
X = N
Y = C(R3a)
R3a = C1 alkyl substituted with NH2
Note: according to the definition of “alkyl” in the instant specification, “[e]ach instance of an alkyl group may be independently optionally substituted… with one or more substituents” (see pg. 8, 2nd to last paragraph, 3rd-to-last sentence).
Z = C(R3a)
R3a = H
m = 0 (i.e., R2 is absent)
or with respect to instant claim 58:M = P = C(R2)
R2 = H
W = U = C
B = heteroaryl (i.e.,
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) substituted with 1 R1
R1 = C1 alkyl.
To obtain an 1H NMR spectrum for the above compound, DMSO-d6 was used to dissolve the compound (see pg. 36, right col., example 68, last sentence). Therefore, Dai also discloses a composition comprising Dai-example-68 (i.e., a compound encompassed by instant claim 1) and DMSO (a known pharmaceutically acceptable excipient; see McKim et al. Dimethyl Sulfoxide USP, PhEur in Approved Pharmaceutical Products and Medical Devices. Pharmaceutical Technology. 2008, 32. – 1st sentence of article).
Therefore, Dai-example-68 anticipates instant claims 1, 5, 7, 39, 44, 58, 62, 102, 105, 120, and 129.
Rejection Part 3:
Claims 1, 5, 23, 25, 32, 39, 44, 58, 62, 80, 82, 102, 105, 109, and 120 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Suzuki et al. (Suzuki) (Suzuki, T. et al. 4,7-Bis(dimethylamino)benzimidazoles and twin-type derivatives: reversible two-stage redox system modulated by proton-transfer. Tetrahedron Letters 2003, 44, 7881-7884.).
Suzuki discloses a compound 5 which can undergo reversible two-stage one-electron oxidation (pg. 7883, right col., last paragraph, 3rd-to-last sentence). This property is useful in electroluminescent devices (see Suzuki, pg. 7881, left col., 2nd sentence). The structure of compound 5 is shown below:
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(see Suzuki, pg. 7884, compound 5 in scheme 5 and Figure 3; also described on pg. 7883, right col., last paragraph, 3rd-to-last sentence; referred to as Suzuki-compound-5).
Suzuki-compound-5 is a compound encompassed by the instant claims wherein:
A = heterocyclyl (i.e.,
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)
L1 = L2 = absent
X = N
Y = C(R3a)
R3a = C1 alkyl (i.e., Me)
Z = N(R3c)
R3c = H
m = 0 (i.e., R2 is absent)
or with respect to instant claim 58:M = P = C(R2)
R2 = H
W = U = C
B = heteroaryl (i.e.,
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) substituted with 2 R1
One R1 is heterocyclyl (i.e.,
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)
The other R1 is C1 alkyl (i.e., Me)
Therefore, Suzuki-compound-5 anticipates instant claims 1, 5, 23, 25, 32, 39, 44, 58, 62, 80, 82, 102, 105, 109, and 120.
Rejection Part 4:
Claims 1, 5, 23, 25, 32, 39, 44, 58, 62, 80, 82, 89, 102, 105, 109, and 120 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Li et al. (Li) (WO2020103896A1; published May 28, 2020).
Li discloses compounds useful as an inhibitor of HPK1 (see abstract). One of those compounds is shown below:
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(see Li, pg. 102, compound 73; herein, referred to as Li-compound-73).
Li-compound-73 is a compound encompassed by the instant claims wherein:
A = heteroaryl (i.e.,
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) substituted with 1 R1
R1 = aryl substituted with 1 R6
R6 = -C(O)NRBRC
RB = RC = C1 alkyl (i.e., Me)
L1 = L2 = absent
X = N(R3c)
R3c = H
Y = C(R3a)
R3a = C1 haloalkyl (i.e., -CHF2)
Z = N
m = 0 (i.e., R2 is absent)
or with respect to instant claim 58:M = P = C(R2)
R2 = H
W = U = C
B = heterocyclyl (i.e., piperazinyl) substituted with 1 R1
R1 = C1 alkyl (i.e., Me).
Therefore, Li-compound-73 anticipates instant claims 1, 5, 23, 25, 32, 39, 44, 58, 62, 80, 82, 89, 102, 105, 109, and 120.
Rejection Part 5:
Claims 1, 39, 44, and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Potts et al. (Potts) (Potts, K. T. et al. Synthesis of stable tetravalent sulfur heterocycles. Journal of the American Chemical Society 1972, 94, 6215-6216.)
Potts discloses the following compound:
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(see Potts, pg. 6216, compound 5, wherein R = COPh – see pg. 6216, right col., 2nd line; herein, referred to as Potts-compound-5).
Potts-compound-5 is a compound encompassed by the instant claims wherein:
A = B = aryl (i.e., phenyl)
L1 = L2 = absent
X = C(R3a)
R3a = H
Y = N(R3c)
R3c = aryl (i.e., phenyl)
Z = N
m = 2
R2 = -C(O)RD
RD = aryl (i.e., phenyl)
Therefore, Potts-compound-5 anticipates instant claims 1, 39, 44, and 52.
Rejection Part 6:
Claims 58, 80, 101, 102, 105, 109, 115, 117, and 120 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Cassayre et al. (Cassayre) (WO2010020522A1; published February 25, 2010).
Cassayre discloses compounds useful as an insecticide (see abstract). One of those compounds is shown below:
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(see Cassayre, pg. 74, compound A23; herein, referred to as Cassayre-compound-A23).
Cassayre-compound-A23 is a compound encompassed by the instant claims wherein:
B = heterocyclyl (i.e.,
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) substituted with 2 R1
one R1 is aryl (i.e., phenyl) substituted with 2 R6 (wherein R6 = Cl) and
the other R1 is C1 haloalkyl (i.e., CF3)
L2 = absent
L1 = -C(O)N(R4)-
R4 = H
X = Z = N
Y = S
M = P = C(R2)
R2 = H
W = U = C
A = heterocyclyl (i.e.,
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) substituted with 1 R1
R1 = C1 alkyl (i.e., Me)
Therefore, Cassayre-compound-A23 anticipates instant claims 58, 80, 101, 102, 105, 109, 115, 117, and 120.
Rejection Part 7:
Claims 58, 62, 64, 80, 82, 102, and 105 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Koltun et al. (Koltun) (WO2019118909A1; published June 20, 2019).
Koltun discloses compounds useful as an inhibitor of SHP2 (see abstract). One of those compounds is shown below:
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(see Koltun, pg. 141, Example 38; referred to as Koltun-example-38).
Koltun-example-38 is a compound encompassed by the instant claims wherein:
A = heteroaryl (i.e.,
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) substituted with 1 R1
R1 = halo (i.e., Cl)
L1 = L2 = absent
X = N
Y = Z = C(R3a)
R3a = H
M = C(R2)
R2 = C1 alkyl (i.e., Me)
P = N
W = C
U = N
B = heterocyclyl (i.e.,
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) substituted with 2 R1
Two R1 groups, together with the atoms to which they are attached, form a heterocyclyl (i.e.,
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) substituted with two R6
One R6 is C1 alkyl (i.e., Me)
And the other R6 is -NRBRC
RB = RC = H
Therefore, Koltun-example-38 anticipates instant claims 58, 62, 64, 80, 82, 102, and 105.
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, 5, 7, 15, 23, 25, 32, 39, 44, 48, 52, 57, 58, 62, 64, 72, 80, 82, 89, 101, 102, 105, 109, 115, 117, 120, 128-130, and 133 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1, 2, 4, 5, 7, 8, 13-15, 18-26, 29, and 38-40 of U.S. Patent Application No. 17/802,719,
claims 1, 5, 7, 13, 20, 22, 28, 35, 44, 46, 51, 56, 58, 65, 173, 174, 177, 181, 186, and 187 of U.S. Patent Application No. 18/688,098,
claims 1, 4, 7, 11, 13, 14, 17, 20, 27, 28, 31, 42, 44, 47, 51, 54, 57, 60, 61, 64, 67, 70, 75, 76, 81-83, 86, 88, 90, 91, 95, and 96 of U.S. Patent Application No. 19/160,796, and
claims 1, 3-5, 7, 8, 10, 13, 18-20, 24-26, 29, 31, 33, 38, and 39 of U.S. Patent Application No. 19/724,800.
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap between the instant claims and the claim sets from the co-pending applications listed above.
Specifically, the compounds claimed in the co-pending applications are also encompassed by the instant claims. Furthermore, the co-pending applications also claim certain methods and/or compositions that require the possession of compounds that are encompassed by the instant claims and the claims of the co-pending applications.
Therefore, a POSITA would have found the instant claims to not be patentably distinct from the claims of the co-pending applications (listed above).
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
