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 .
1. Formal Matters
A. In the response submitted 11/24/25, Applicants elect the species of Ab1902 and gastric cancer. However, upon further review, all species have been examined.
B. Claims 1-20 are pending and are the subject of this Office Action.
2. Specification
The use of at least the terms DyLightTM (paragraph [0213]), CantoTM (paragraph 0213), Bright-GloTM (paragraph [0217]) and CellTiter-Glo® (paragraph [0219] which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The Examiner performed a cursory review, but Applicants are urged to perform a more thorough review of the specification.
3. Claim Objections
A. C3, 12 and 19 are objected to since it is unclear how “n” can be a decimal, since it refers to an entire compound subunit.
B. Claim 4 is objected to since it only recited “selected from” a single compound, as opposed to a group.
4. Claim Rejections - 35 USC § 112(a) – scope of enablement
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 18 and 20 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating the solid cancers recited in the claims, does not reasonably provide enablement for (1) treating any blood-borne tumors (leukemia, lymphoma and myeloma), nor for (2) treating any cancer with regard to prevention.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
It is noted that the term “treatment” encompasses the definition “preventive or prophylactic measures” (paragraph [0207] of the published application. See also [0208]). In absence of the definition of prevention, the Examiner is interpreting this term to mean that the pharmaceutical compositions of the claims will keep cancer from occurring in 100% of the subjects.
Applicants do not provide guidance or working examples that any cancer is able to be prevented, nor is it predictable to one ordinary skill in the art how to prevent cancer from occurring in 100% of the subjects administered the pharmaceutical composition of the claims.
In addition, regarding “treating” insofar as it reads on reducing the signs and symptoms of cancer, the breadth of the claims is excessive since it includes the blood-borne cancers leukemia, lymphoma or myeloma.
Salvador teaches that tight junctions are specialized differentiations of epithelial cell membranes which regulate selective transport across the epithelium (last paragraph of page 135) and that claudins are one such member and which are altered in cancer cells (page 136, right column under “Claudins”).
Though Salvador does not teach claudin18.2, Coati does and teaches that this protein is a highly specific tight junction protein of the gastric mucosa and that claudin 18.2 is a drug target for metastatic gastric cancer (Background). This is supported by Sahin et al. (e.g. Abstract), who teach this tight junction protein is also activated in numerous malignancies (page 7625, left column, second full paragraph; Table 2) and is a pan-cancer target.
Given this, the art supports treating cancers with claudin18.2 in tissue involving epithelial tight junctions. However, the specification does not provide guidance or working examples of treating blood-borne tumors, which are not solid and, therefore, do not have tight junctions. Additionally, no link in the prior art could be found between blood-borne cancers and claudin. Given this, it is not predictable to one of ordinary skill in the art how to use claudin18.2 antibodies to treat these cancers.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
5. Prior Art of Interest Not Relied Upon
A. WO2020/063676 (cited in paragraph [0180] of the specification and disclosed on the IDS submitted 3/28/23) teaches the compound of instant claims 12 and 19, which has the core structure, known as exatecan, as recited in instant claim 3.
B. Both Nakada et al. and Iwata et al. teach an ADC using a derivative (claims 12 and 19) of exatecan (claim 3) for the treatment of cancer. This compound was later marketed as EnhertuTM by AstraZeneca.
C. U.S. Patent No. 8,613,919 (e.g. column 4, lines 9-50) and U.S. Patent No. 11,603,407 (column 2, line 56 – column 3, line 16; column 3, lines 39-56; column 5, line 27 – column 7, line 18) teach the general antibody formulation conditions recited in instant claims 4-12.
6. Conclusion
A. Claims 18 and 20 are not allowable.
B. Claims 3, 4, 12 and 19 are objected to, but are otherwise allowable.
C. Claims 1-17 and 19 are allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647