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 .
Claim Status
The preliminary amendment filed 5/16/24 is acknowledged. Claims 1-14 are pending and under examination.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 6 and 12 are objected to because of the following informalities: The claims recite the term “comprise” but refers to nouns that are singular. As such, the verb “comprise” should be “comprises.” Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The claim recites the acronym “NK cell” without having made clear the full meaning of the term in its first use. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The claim ends in a comma. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: The claim recites wherein the disease is “cancer or tumor.” Grammatically, the phrase should be “cancer or a tumor.” Appropriate correction is required.
Claim Rejections - 35 USC § 112b
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 1-14 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 claim’s use of “and” appears to require the presence of all three recited antibody configurations. If “antibody” is interpreted according to the specification’s guidance to encompass multispecific formats, the claim could be understood to require a single multispecific construct comprising all three configurations. However, each of the three configurations is itself introduced as “an antibody or antigen-binding fragment,” leaving unclear whether the three recited “antibodies or antigen-binding fragments” are intended to represent separate antibody molecules, antigen-binding domains within a multispecific construct, or some other structural components. This ambiguity is further highlighted by claim 3, which recites that the antibody comprises a “bivalent bispecific molecule,” raising uncertainty as to how the three antibody configurations recited in claim 1 are structurally related within the claimed molecule. Moreover, in view of the specification, the application does not appear to be directed to a single multispecific/multivalent construct, but rather three distinct antibodies [see tables 1 and 18]. The claim therefore does not clearly identify the relationship between the three recited antibody entities and how they comprise the isolated antibody. Claims 2-14 are included in this rejection because they implicitly or explicitly require the composition of claim 1 without resolving the indefiniteness discussed above, and consequently, it is unclear what antibody or antigen-binding fragment is being further limited by these dependent claims.
To advance compact prosecution, claim 1 is interpreted as a binding protein which binds specifically to mesothelin (MSLN) and comprises 1), 2), or 3). Furthermore, dependent claims referencing the antibody or antigen binding fragment of claim 1 will be understood, for the purposes of examination, as being directed to the binding protein of claim 1, as this appears consistent with the claims. Appropriate correction is required.
Therefore, claims 1-14 are rejected under 35 U.S.C. 112(b) as indefinite.
Claim 3 contains the trademark/trade name “Unibody.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an antibody format and, accordingly, the identification/description is indefinite.
Therefore, claim 3 is rejected under 35 U.S.C. 112(b) as indefinite.
Claim Rejections - 35 USC § 112a
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 3 is 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 3 recites “wherein the antibody comprises a human antibody.” However, the specification does not reasonably convey that the inventors were in possession of an antibody that is a human antibody. The specification describes and exemplifies only a humanized MSLN antibody (antibody #19-1) and does not disclose any fully human MSLN antibodies, representative species of human antibodies, or other identifying characteristics sufficient to demonstrate possession of the claimed antibody genus. Although a humanized antibody is described, a humanized antibody is structurally and compositionally distinct from a fully human antibody. Accordingly, the specification does not demonstrate possession of a human antibody.
Therefore, claim 3 is rejected under 35 U.S.C. 112(a) for lack of written description.
Subject Matter Free of the Art
Although anti-MSLN antibodies and binding proteins are known in the art, the prior art fails to teach or suggest any of the binding proteins of claim 1. In particular, SEQ ID NOs: 7, 32, and 21 are novel CDR sequences. Accordingly, the claimed binding protein is considered novel and nonobvious. The dependent claims directed to alternative formats and additional components, pharmaceutical compositions comprising said protein, cells expressing said protein, and methods of use are allowable because they require the binding protein defined by the allowable claims.
The closest prior art is O’Hara et al., published March 14, 2016, which teaches mesothelin antibodies and CAR-T cells and their use in the treatment of various cancers. However, it has been determined that the prior art does not teach the claimed binding protein comprised of the distinct combination of CDRs of instant claim 1.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tirone D Johnson whose telephone number is (571)272-1256. The examiner can normally be reached M-F, 9-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIRONE D. JOHNSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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