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 .
Applicant’s amendment, filed 01/19/2023, has been entered.
Claims 2-8 have been canceled.
Claims 1, 9-20 are pending.
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 07/21/2025 is acknowledged. The traversal is on the ground(s) that the burden necessary to sustain the conclusion that the groups lack of unity of invention has not been met. This is not found persuasive for reasons stated in the Restriction Requirement.
Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of drug compound bound to a podocalyxin targeting molecule, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of JP 2019-512548 A (corresponding to US 2017/0328907) (cited in IDS) that disclosed an antibody-drug conjugate formed by an antibody that specifically binds podocalyxin (see, e.g., claims 1-12). Therefore, unity does not exist.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 9-16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 17-20 are currently under examination as they read on a method for transmucosal administration comprising administering a drug compound bound to a podocalyxin targeting molecule.
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.
Claims 17-20 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.
There is insufficient written description of the genus encompassed by the recitation of “a podocalyxin targeting molecule”.
The specification discloses the term “podocalyxin targeting molecule” as used herein, refers to any molecule having an ability to bind to podocalyxin. Further, the specification discloses that the chemical species of the target molecule is not particularly limited and can include various chemical species such as low molecular compounds, high molecular compounds, biological substances. Specifically, examples include saccharides, lipids, oligopeptides, proteins, and nucleic acids. Examples of the function of target molecule include a podocalyxin- recognizing antibodies, lectins, and interacting proteins. Examples of the podocalyxin targeting molecule include preferably anti-podocalyxin antibodies or antigen binding fragments thereof, and lectins (for example, rBC2LCN) (paragraph bridging pages 7-8). However, given the absence of a precise definition for said targeting molecule, the possible targeting molecules are not limited to the above disclosed examples.
Moreover, the specification does not describe an actual reduction to practice or a partial structures, or physical properties, or chemical properties of any targeting molecule has podocalyxin binding ability. For example, there is no information regarding what structural features would likely be associated with such binding of the targeting molecule. Thus, the specification does not disclose a correlation between selective binding and the critical structure of a putative targeting molecule.
The level of the skill and knowledge in the art is that there is no known correlation between any structural component and the ability to selectively bind podocalyxin for the genus of targeting molecules encompassed by the claims. Thus, the disclosure does not allow one of skill in the art to visualize or recognize the structure of any targeting molecule required to practice the claimed invention. Accordingly, one of skill in the art would conclude that Applicant would not have been in possession of the claimed genus of “podocalyxin targeting molecule” because the genus of said molecule possessing the desired function and activity are not adequately described in the instant disclosure as-filed.
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.
(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 17-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by McNagny et al. (US Patent 7,833,733; see entire document).
McNagny et al. taught antibodies to podocalyxin conjugated to enzyme or radio label (column 13, second paragraph; column 14, third paragraph). McNagny also taught various routes of administration including rectal which would be absorbed via mucous membrane and inhalant which reads on the routes recited in claim 18 (column 22, last paragraph). Given that the antibody specifically binds podocalyxin, the mucous membrane would express podocalyxin. Taken together, MacNagny anticipate the present claims.
Conclusion
No claim is allowed.
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/SHARON X WEN/Primary Examiner, Art Unit 1641