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 .
Application Status
Claims 1, 7-8, and 26-39 are pending and examined on the merits herein.
Grounds of Rejection Withdrawn
All previous rejections and objections of claims 3 are rendered moot by claim cancellation.
Previous objection to claims 1, 8, and 34 are withdrawn in view of claim amendments.
Previous rejection of claims 1, 7-8, and 26-39 under 35 U.S.C. 112(b) are withdrawn in view of claim amendments.
Claim Objections
Claims 1 and 27 are objected to because of the following informalities:
Claim 1, line 9 recites “interferon gamma (INFγ)” it should read “interferon gamma (IFNγ)”.
Claim 27, line 2 recites “IFN-g” but claim 1 refers to “IFNγ”
Claims 7-8, 26, 28-30 and 34-39 depend from claim 1 and therefore include all of the limitations recited therein, and are thus included in this objection.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 27 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.
Claim 27 is drawn to the method of claim 1 that further comprises one or more of IFN-g, CD30 and/or IL-2, but the method as recited in claim 1 already requires measurement of IFNγ and IL-2, therefore it is unclear how the method can further comprise measurement of cytokines that have already been required.
Claim Rejections - 35 USC § 102
Rejection Maintained
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 31-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonanno (BMC Immunol, 2009, 10:46; cited in OA 09/25/2025).
Bonanno teaches a kit that comprises a stimulation agent (PHA) and a buffer appropriate for NK cells (culture media) with instructions for use (the cited methods section is an equivalent to instructions; page 13, col 1, para 3).
Further printed instructions do not distinguish the claimed product (MPEP 2112.01 (III)).
Regarding claim 31, the limitations as to the length of time of contact with the stimulating agent, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. MPEP2121 states that all prior art teachings are presumed to be operable/enabling unless there is evidence showing otherwise.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMBER K FAUST/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
Prosecution Insights