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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Nishishita et al. (WO/2023/140302) in view of Watakabe et al. (US 2015/0315537 A1)
Regarding claims 1 and 7: Nishishita teaches an automated method of using a discharge solution to detach cells in culture. (Abstract) This method may include use of automated shaking. (0014) Specifically, Nishishita teaches that a drawback of using only shaking to dislodge cells, even automated, requires a length of time of continuous shaking which damages the cells in culture. (0009) To remedy this drawback, Nishishita specifies a method of shaking the culture container during the cell dissociation step to encourage detachment. (0014) Furthermore, Nishishita defines “physical exfoliation” of the culture vessel to mean applying shaking, vibration, or ultrasonic treatment to the culture vessel. (0022) Nishishita fails to explicitly disclose use of tapping of the culture vessel or tapping/shaking in multiple directions.
Watakabe teaches a cell detachment device including a base, vessel holder, guide mechanism, collided member, urging member, and power imparting mechanism. (57) Specifically, Watakabe seeks to automate the cell detachment process and fully automate tapping (0007) of the cell culture vessel. Watakabe further teaches that the configuration of the device allows for the vessel holder (containing the cell culture vessel) to be moved in a direction both away from the collided member (0014) and towards the collided member (0015). This reads on a cell detachment method using a cell detachment system comprising tapping said culture vessel in first and second directions different from each other as viewed in a direction perpendicular to the culture surface. Watakabe further discloses that the configuration of the device further allows for the vessel to continue vibrating after colliding with the collided member. (0022)
Regarding claims 2 and 3: Nishishita teaches that the discharge angle may be anywhere between 0-90 degrees and defines the discharge angle to mean the angle at which the cells are discharged relative to the surface of the culture vessel adhered to them. (0070) This reads on both claim 2 of use of an angle of more than 30 degrees to less than 150 degrees and claim 3 of use of an angle of more than 45 degrees and less than 135 degrees.
Regarding claim 4 and 5: Nishishita fails to explicitly teach the tapping of the culture vessel, however Watakabe states use of automated tapping within the configuration of the device, allowing for a vibration and impact shock to be applied regularly to the culture vessel. (0013)
As discussed above, Nishishita teaches use of shaking of the culture vessel and Watakabe teaches tapping of the culture vessel. Neither Nishishita nor Watakabe teach specific rates of tapping or shaking, as this is something typically optimized by a person skilled in the art and may vary greatly based on cell type, culture conditions, and stage of growth. Furthermore, as discussed above, Nishishita teaches that rapid and sustained shaking of the culture vessel will damage the cells. (0009) As such, it would be obvious to a person of ordinary skill in the art to have a rate of tapping which is greater than the rate of shaking so as to avoid damage to the cells in culture.
Regarding claim 6: Nishishita teaches use of physical exfoliation to stimulate the entire culture vessel during the process of cell detachment and details use of an ultrasonic treatment as a method of exfoliation. (0022)
It would have been obvious to one skilled in the art to combine the teachings of tapping of the culture vessel in an automated fashion by Watakabe with the protocol for mechanical cell detachment taught by Nishishita. One skilled in the art would have motive to combine and a reasonable expectation of success based on the teachings of Watakabe, who states that the automation of tapping allows for agitation in the form of tapping to apply impact shock throughout the dissociation process.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 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.
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/HANNA MARIE THUESON/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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