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 .
Claims 1-20, filed 07/06/2023, are under consideration.
Claim Rejections - 35 USC § 112
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 1-20 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 order of steps in claim 1 is confusing. Step a recites obtaining a sample of peripheral blood mononuclear cells from said patient; and step b recites exposing said cells to conditioned media from a regenerative cell population. Then step c recites generating said conditioned media of “b” through activating said regenerative cell population. It does not seem possible that step c could follow step b. The medium in “b” is already in contact with the cells from “a”; it is a “conditioned medium” and is presumed to have already been removed from a culture of regenerative cells. If “conditioned medium” does not refer to medium that has been removed from a culture of regenerative cells, it would have been clearer to recite that a co-culture of regenerative cells and cells from the patient sample should be established. Step d recites obtaining the cells that were already obtained in step a and continuously present through step b. Step e recites optionally expanding “said cells’. Step f can be interpreted as indicating that only cells that have been expanded should be administered to the patient.
The term “activating” in claim 1 c) is vague. It does not clearly instruct the practitioner of the method as to what treatment the regenerative cells should receive.
Claims 2-20 are unclear as they depend from claim 1.
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 1-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
A method of overcoming resistance to TNF-alpha blockade in a patient. Although the method is not clearly recited, as noted above, the simplest interpretation of the method is that peripheral blood mononuclear cells obtained from a patient should be exposed to a medium conditioned by regenerative cells. After this exposure, the patient cells are then administered back to the patient. Claims 16 and 17 recite that the regenerative cells used to condition the medium are pluripotent stem cells. The specification contemplates that regenerative cell can be a mesenchymal stem cell. Thus, the claims are based on the premise that peripheral blood mononuclear cells, specifically T cells Th2 cells, Th9 cells, and regulatory T cells, acquire ability to overcome TNF-alpha blockade upon exposure to medium conditioned by pluripotent stem cells or mesenchymal stem cells. No evidence in favor of this premise can be found in the instant disclosure or in the prior art.
The courts have stated that patent protection is granted in return for an enabling disclosure, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute an enabling disclosure. Reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. See Genentech v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 (1997).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. 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 on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL C GAMETT/Primary Examiner
Art Unit 1647