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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 2/2/26. Claims 1, 3, and 5-13 are pending and are considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 103 (a) rejections are withdrawn:
Claim(s) 1, 2, 4-6, and 9-11 were rejected under 35 U.S.C. 103 as being unpatentable over Pasch et al. (Clinical Cancer Research, 2019).
Claim(s) 3 were rejected under 35 U.S.C. 103 as being unpatentable over Pasch et al. (Clinical Cancer Research, 2019) as applied to claims 1, 2, 4-6, and 9-11 above, and further in view of Adamus-Górka et al. (Cancers 2011).
Claim(s) 12 were rejected under 35 U.S.C. 103 as being unpatentable over Pasch et al. (Clinical Cancer Research, 2019) as applied to claims 1, 2, 4-6, and 9-11 above, and further in view of JP 4203208 B2 (published 2008-12-24). Since JP’208 is in Japanese, an English translation is provided. For convenience, all citations to JP’208 will be to this translation.
The following 35 U.S.C. 112 rejections are withdrawn:
Claims 1-12 were 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 Applicant’s substantial amendments to claim 1 step (e) and (f) necessitated the above withdrawals. All arguments drawn to these rejections are now considered moot.
New Rejections Necessitated by Amendment
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, 3, and 5-13 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 amendments to claim 1 step (e) is confusing because it is unclear how the cell viability measured in claim 1 is used in "obtaining cell experiment-based data including:
i) cell growth factor which is selected from cell viability increase rate, a cell growth rate, and a cell size increase rate: and
ii) a radiation response factor.
The Specification indicates "cell viability" is measured by strength or size of a fluorescent signal from living or dying cells, or counting dead cells, or transduction of MTT or APT of cells [98].
Cell Growth Factor is the measurement of cell viability over time (Specification [104]). The claim does not indicate that multiple cell viability measurements were taken over time. It appears there is a step missing between measuring cell viability and how that data is manipulated to produce the values for cell growth factor.
Since cell viability is the measurement of living or dead cells, it is unclear how this measurement is interpreted into cell growth rate without including time in the measurement. Also the means recited to collect cell viability does not include a measurement of the size of the cell. Without size, it is unclear how one of ordinary skill would obtain "a cell size increase rate".
The step of diagnosing based on both the cell growth factor and radiation response factor is not clearly described in the claims. It is unclear how these two variables are combined and what is the criteria for the results of the diagnosis. The claims do not clearly show steps for integrating the data to achieve a result and how that result is interpreted in the diagnosis. For example, the claims do not provide a scale or other threshold to conclude if the patient is sensitive to radiation.
In summary, it is unclear from the claims how measurement of cell viability in claim 1(d) is converted into one of the i) cell growth factors and ii) radiation response factors in claim 1(e). Furthermore it is unclear in the claims how factors i) and ii) are combined to formulate a diagnosis and how the results of that diagnosis are interpreted or a conclusion made.
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.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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