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 11/26/25, Applicants elected the species of GVH. However, upon further review, all species have been examined.
B. Claims 26-28, 32-41 and 43-51 are pending and are the subject of this Office Action.
2. Specification
The use of at least the terms CytofixTM (page 119, line 23) and FlowJoTM (page 122, line 21), 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
Claims 27, 32-34, 44 and 45 are objected to since the phrase “graft versus host” should be hyphenated (i.e. “graft-versus-host”).
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 26-28, 32-41 and 51 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating interleukin-2 receptor gamma-mediated diseases or conditions, does not reasonably provide enablement for preventing these diseases or conditions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
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.
The breadth of the claims is excessive with regard to claiming preventing interleukin-2 receptor gamma-mediated diseases or conditions. As discussed on pages 1-2 of the specification, the IL2R gamma chain is also known as the “common cytokine receptor gamma chain”, which is also part of the IL-4, 7, 9, 15 and 21 complexes and these interleukins were well-known at the time of the instant invention to be involved in the claimed disease processes (see, for example, the references cited on these pages of the specification). Furthermore, page 1 of R&D SystemsTM teaches –
Multiple studies have now demonstrated that cytokines belonging to the gamma-chain family serve as critical regulators of the development, survival, proliferation, differentiation, and/or function of cells of both the innate and adaptive immune systems.
However, while it is clear that antibodies against the gamma chain of these interleukins would be expected to be useful in treating the diseases/conditions recited in claim 27 (which includes claims 32-35), Applicants provide no guidance or working examples of preventing any disease or condition. Given the lack of a definition in the specification, the Examiner is interpreting prevention as the condition will not occur in 100% of the subjects administered the antibody and Applicants have not provided any guidance or working examples of such.
Given this lack of guidance and working examples, it is not predictable to one of ordinary skill in the art how to prevent cancer in a subject, let alone all subjects administered the antibody of the claims.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
4. Conclusion
A. Claims 43-50 are allowable
B. Claims 44 and 45 are objected to, but are otherwise allowable.
C. Claims 26-28, 32-41 and 51 are not 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