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 .
DETAILED ACTION
Claims 14-17, 20, 24-32, 43, 44, 47 and 51-53 are pending in the application. Claims 14, 15 and 24-29 are rejected. Claims 16, 17, 20, 30-32, 43, 44, 47 and 51-53 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election of the species “a generic small molecule Gα12 inhibitor” to prosecute the invention of Group I, claims 14-17, 20, 24-31 and 51-53 in the reply filed on January 14th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s elected species is not allowable and therefore examination has been limited to the elected species and claims embracing the species as elected by Application, which are claims 14, 15 and 24-29.
Claims 16, 17, 20, 30-32, 43, 44, 47 and 51-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 14th, 2026.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on November 12th, 2024 and January 14th, 2026.
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 14, 15 and 24-29 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.
Claim Scope (MPEP 2163(II)(A)(1)
MPEP 2163 outlines the methodology for determining adequacy of written description. MPEP 2163(II)(A)(1) instructs “For Each Claim, Determine What the Claim as a Whole Covers”.
The instant claims are directed to methods of treating bronchoconstriction in a subject in need thereof by administering “a therapeutically effective amount of a Gα12 inhibitor.” The scope of subject matter under examination is limited to Applicant’s elected species where the Gα12 inhibitor is a small molecule. Applicant provides the following definition of a “small molecule” (as recited in instant claim 15) on pages 16 and 17 as follows:
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Applicant provides the following definition for “Gα12 inhibitor” on page 11:
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Dependent claims 24-29 recite additional disease states, identity of the subject or modes of administration.
Disclosed Support (MPEP 2163(II)(A)(2))
MPEP 2163(II)(A)(2) instructs “Review the Entire Application to Understand How Applicant Provides Support for the Claimed Invention Including Each Element and/or Step”. Regarding the application of compounds that can inhibit Gα12, the specification states the following on page 2:
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The specification further notes on page 7 (paragraph [0031]): “In the context of HASMC function, however, Gα12/13 signaling remains poorly understood.” The specification uses co-immunoprecipitation to demonstrate (in paragraph [00122]) that Gα12 couples to the M3R and uses siRNA to demonstrate (in paragraph [00123]) that “Gα12 mediates M3R-induced activation of PI3K/ROCK activation.” These demonstrations appear to be the basis for Applicant’s assertion that Gα12 inhibitors can be used to inhibit bronchoconstriction, i.e. that the Gα12 inhibitors can disrupt the interaction between Gα12 and the M3R. The specification further indicates that this discovery was previously unknown as follows on page 34:
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Regarding using the compounds in practice, the specification only discusses generalities including the following statement for determining a “therapeutically effective amount” on page 18 (paragraph [0070]): “The effectiveness of a therapy can be determined by suitable methods known by those of skill in the art including those described herein.” In the following paragraph ([0045] as cited above), the specification only refers to properties of the Gα12 inhibitor rather than any structural features. Paragraph [0062] on pages 16 and 17 similarly provides generic descriptions and the only examples of “small molecules” do not appear to specifically be Gα12 inhibitors.
As further noted in MPEP 2163(II)(A)(2), “Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art.” According to Applicant’s specification, an interaction intended to be inhibited, i.e. Gα12 with the M3R, was not known to persons of ordinary skill in the art at the time the application was filed.
Determination of Sufficient Support (MPEP 2163(II)(A)(3))
MPEP 2163(II)(A)(3) instructs “Determine Whether There is Sufficient Written Description to Inform a Skilled Artisan That Inventor was in Possession of the Claimed Invention as a Whole at the Time the Application Was Filed”. This section of the MPEP further provides the following guidance:
Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
In this situation, Applicant has not disclosed examples of small molecule Gα12 inhibitors embraced by the instant claims. While the lack of any examples does not necessarily result in a lack of written description, MPEP 2163 (II)(A)(3)(a)(ii) discusses support for a generic claim as follows:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above).
The same section notes the following:
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 this situation, Applicant provides no description of structures embraced by the instant claims. Furthermore, given that Applicant asserts that the interaction between Gα12 and the M3R is previously unknown, there is no knowledge or basis in the art for determining which structural features would be expected to yield useful inhibitors. Accordingly, Applicant has not demonstrated the structural attributes that would be expected to result in useful embodiments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626