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 .
Election/Restrictions
Applicant’s election without traverse of a method of using a SRC inhibitor in the reply filed on 2026 May 24 is acknowledged. Claims 3, 4, 7, 11, 13, 15, 17, 20, 21, 24, 30, 33-35, 39, 43, 46-48, and 50 are pending in the examined application. As a result of the election of an SRC inhibitor, claims 3, 4, 7, 15, 20, 21, 24, and 50 are examined on the merits with respect to a SRC as the active agent. A search of claim 3 has been extended to the following scope: a SRC inhibitor of bosutinib and dasatinib; and a lung inflammation as the disorder.
Claims 30, 33-35, 39, 43, and 46-48 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2926 May 24.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2024 September 18 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3, 4, 7, 15, 20, 21, 24, and 50 are objected to because of the following informalities: the language “inhibiting neutrophil production of reactive oxygen species” is not related to the method that is practiced, treating neutrophil-mediated inflammation in a subject. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim(s) 3, 4, 7, 15, 20, 21, and 24 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of written description.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims 3, 4, 7, 15, 20, 21, and 24 are drawn to a method of treating neutrophil-mediated inflammation with a SRC inhibitor.
(1) Level of skill and knowledge in the art:
PULS (The Oncologist, 2011, 16, 566-578) describes different SRC inhibitors: bosutinib, saracatininb, dasatinib, ponitnib, KXR-391, XL-228, TG100435/TG100853, and DCC2036 (page 569, table 1).
(2) Partial structure:
Different SRC inhibitors are discussed (pages 17-18, paragraph [092] and [093]): bosutinib, saracatininb, KXR-392, PP!, PP2, and dasatinib.
(3) Physical and/or chemical properties and (4) Functional characteristics:
Tables 1 and 2 describe that bosutininib in concentration of 200 nM or 150 nM can inhibit reactive oxygen species.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim(s) 3, 4, 7, 15, 20, 21, and 24 is/are broad and generic, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless to the method using any SRC inhibitor. Although the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond those compounds specifically disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus. While having written description of SRC inhibitors bosutinib, saracatininb, KXR-392, PP!, PP2, and dasatinib and compounds identified in the specification tables and/or examples, the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
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) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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)(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.
Claim(s) 1, 7, 15, and 50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CARNEIRO (Frontiers in Physiology, 2017, 3 (159), 1-15, cited in IDS) describes that bosutinib ameliorates lung inflammation (abstract; page 10, column 1, last paragraph to column 2, paragraph 1; page 12, column 1, second paragraph and column 2, second paragraph).
Claim(s) 1, 7, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CRUZ (PLOS One, 2016, 0147005, 1-17) describes that dasatinib reduces lung inflammation (abstract).
Claim(s) 1, 7, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MACFARLANE (Journal of Inflammation, 2020, 1&:34, 1-12), cited in IDS describes that dasatinib reduces lung inflammation (abstract; page 5, figure 4; page 5, column 2 to page 7, column 2).
Conclusion
Claims 3, 4, 7, 15, 20, 21, 24, and 50 are not allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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