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 3/29/24. Claims 1-12 are pending and considered on the merits.
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 1-12 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 Applicant uses several phrases that are not common terms of art and not clearly defined in the Specification. These include:
CRS plate: This is not a common term in the art. [48] in the Specification indicates that CRS could stand for Cell Ratio-Sensitivity plate, however it is unclear what structural components are required for a CRS plate. In particular it is unclear if components #1042, #141, #1041a-c) are required to be considered a CRS plate or if another plate, such as a microtiter plate, that can also meet this limitation. If the Applicant wishes to claim a plate similar to Figs 3-7, they should
Claims 7 and 8 include the limitation “new data, which is the cell experiment-based data of the individual”. This is confusing because all prior claims are drawn to cell experiment-based data from cancer cells separated from an individual. So it is unclear what is the origin of the new data and now to integrate that into the method.
In the interest of compact prosecution, CRS plate will read on any plate that can culture organoids and be exposed to radiation to accomplish the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4-6, and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pasch et al. (Clinical Cancer Research, 2019).
Due to the indefiniteness of CRF plate, the 24-well culture plate will read on this limitation.
Pausch et al. teach a method of determining radiation sensitivity in cancer organoids comprising the following steps:
Dispensing a patent-derived cancer organoid (at least one cancer cells) of either colorectal cancer (DP) or pancreatic adenocarcinoma (DP) from patient biopsies were plated in 24-well culture plates (Pasch, pg. 5377, col 2);
The plate and the organoids were filled with feeding medium and were allowed to grow for 1-7 days;
The plate and spheroids were exposed to several different controlled dose of ionizing radiation from one of two sources, those doses were 0, 2 and 5 Gy (See Figs 4 and 5);
Cell viability was measured;
Cell viability was measured using multiphoton imaging (Pasch Fig 4);
The results of the cell viability from the multiphoton imaging was compilated into a treatment response to radiation dose graphs (Pasch, Fig 4 A-F and Fig 5A, 5C, 5E-G);
These results showed the growth response and median growth of various cancer cells (e.g. a cell growth factor, including cell size increase rate and degree of cell viability) to radiation treatment alone (e.g. a radiation response factor) and combined with 5-FU (5-fluorouracil), a chemotherapeutic agent, to determine their cells sensitivity to radiation treatment at different doses and combined with a 5-FU.
Since these experiments are performed by a laboratory technician(s) then they are considered the control unit who can graph and examine the results to diagnose radiation sensitivity of a particular cancer cell to determine if the cancer has one of two sensitivity features including i) responsive or ii) non-responsive when compared to a control. As seen in Pausch et al., these graphs can include curve fitting and comparison to a control (Pausch, Fig 4 A-E, Fig 5F and E) as reference data. The graphs on Fig 4A-E and Fig 5F and 5E show an index between the control and the radiation dose both by % Growth as well as the amount of spheroids for other individuals. This index is base on the difference between the distance of the control or radiation dose on the X or Y axis.
Also while Pasch et al. teach measuring the growth response only once after culturing and irradiation, they do not teach continuing to culture for 5-7 days and re-measuring the cell viability. However this would be an obvious to one of ordinary skill in the art since it is simply repeating a step already executed. In this instance the one of ordinary skill would simply retake the cell viability measurement at a later time to check for a change of viability over a longer period of time.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 3 is/are 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).
Pasch et al. teach the method of claim 1 and plotting the results of irradiation to cancer spheroid growth in a dose-response type curve. However they do not teach calculating RT50 or %RT50. However this would be obvious over Adamus-Górka et al. who teach plotting a dose-response curve from the irradiation results of cancer tissues that is then fitted with several statistical models (Adamus-Górka, see Abstract and Fig 1). They teach how to calculate D50 based on each models (Adamus-Górka, Table 1). They define D50 as:
D50, which is the dose that is associated with the 50% response probability and γ50, which is the gradient of the dose-response curve at the level of the 50% response probability (Adamus-Górka, pg. 2424, above Fig 1).
It appears that D50 reads on RT50 or %RT50 as limited in claim 3. It would be obvious to calculate D50 from the experiments of Pasch et al. since this is a common method to analyze dose-response curves for irradiated cancer cells. One of ordinary skill would recognize this as simply applying a known technique to analyze cancer cells exposed to a controlled dose of radiation (MPEP 2141 III (D)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 12 is/are 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.
Pasch et al. teach the method of claim 1, but they do not teach using a slit type radiation dose modulator as limited in claim 12. This would be obvious in view of JP’208, who teach that cancer tissue has various sizes and complicated shapes of varying density (JP’208, 0006). They teach that a slit collimator can be used to distribute the radiation on an arbitrary shape to obtain a necessary three-dimensional dose distribution (JP’208 0026, 0033). Therefore it would be obvious to use the slit collimator of JP’208 to irradiate the spheroids of Pasch et al. since this would provide an accurate dose to produce more accurate cell viability data. One of ordinary skill would recognize this as simply applying a known technique to provide a controlled dose of radiation to cancer cells (MPEP 2141 III (D)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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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