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 .
Election/Restrictions
Claims 34 – 41 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2024.
Response to Arguments
Applicant’s arguments, filed 4/9/2026, with respect to the rejection of claims 28 – 33 under 35 U.S.C. 103 as being unpatentable over Domansky et al. (US 2005/0260745 A1) in view of Pralong et al. (WO 2012/107436 A1), have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hinojosa et al. (US 2017/0121663 A1).
Applicant canceled claims 1 – 27. Claims 34 – 41 remain withdrawn.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 28 – 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Domansky et al. (US 2005/0260745 A1; hereinafter “Domansky”) and Pralong et al. (WO 2012/107436 A1; hereinafter “Pralong”), and further in view of Hinojosa et al. (US 2017/0121663 A1; hereinafter “Hinojosa”).
Regarding claim 28, Domansky teaches a method (Abstract; paragraphs 36 – 42; figures 1 – 3) comprising:
a) providing a perfusion manifold assembly (e.g., fluidic manifold 24 and control manifold 22) comprising:
i) one or more fluid reservoirs comprising fluid (e.g., reservoir well 6 can contain a fluid such as cell culture medium; paragraph 39),
ii) a fluidic backplane (e.g., membrane 23) under, and in fluidic communication with, said fluid reservoir(s), and
iii) a microfluidic culture chamber (e.g., bioreactor well 4) attached directly to the assembly; and
b) applying gas pressure to the fluid in said one or more fluid reservoirs so as to generate pressure driven flow of fluid to said microfluidic culture device (e.g., paragraphs 37 and 38) comprising a culture area (bioreactor well 4). Domansky teaches that the valves and pumps of all bioreactors are actuated via common hydraulic or pneumatic control channels (e.g., paragraphs 25 and 39). Thus, Domansky clearly indicates that gas pressure is applied either directly or indirectly to the fluids within the apparatus to enable fluid transport within the apparatus.
Domansky does not specifically teach applying gas pressure in the one or more fluid reservoirs directly, such as by utilizing gas flow controllers.
However, Pralong teaches the use of gas flow controllers for facilitating effective gas pressure applications for enabling flow in cell membrane apparatus (see Description). Utilizing gas flow controllers as taught by Pralong with the Domanksy apparatus and method would merely augment and enhance the operation of the Domansky apparatus. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the same mechanism to facilitate fluid flow utilizing gas flow controllers within the Domansky apparatus.
Modified Domansky does not specifically teach that the fluidic backplane comprises a resistor.
However, the use of fluidic resistors for flow control within a microfluidic apparatus to effectively control perfusion flow rates is well known in the art as evidenced by Hinojosa (e.g., paragraphs 4, 52, 54, 55, 59, 72, 99 and 109). Fluidic resistors enable the benefit of fine fluid flow control within microfluidic apparatus as indicated by Hinojosa. The use of fluidic resistors as taught by Hinojosa with the perfusion apparatus of Domansky would have been considered to be suitable and predictable to a person of ordinary skill in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the same fluidic resistor apparatus and methodology to facilitate effective fluid flow control within the Domansky apparatus.
Regarding claim 29, Domansky teaches the method of claim 28, wherein said fluid contacts living cells in said culture area (e.g., paragraphs 25, 26, 36 – 39, 54 and 60).
Regarding claim 30, Domansky teaches the method of claim 29, wherein said fluid comprises culture media (e.g., paragraphs 25, 26, 36 – 39, 54 and 60).
Regarding claim 31, Domansky teaches the method of claim 28, wherein said pressure is positive pressure (e.g., the pumping cycle can be activated in a forward or reverse direction; paragraphs 37 and 38).
Regarding claim 32, Domansky teaches the method of claim 28, wherein said pressure is negative pressure (e.g., the pumping cycle can be activated in a forward or reverse direction; paragraphs 37 and 38).
Regarding claim 33, Domansky teaches the use of living cells with the disclosed apparatus (paragraphs 3 – 9, 33 and 35 – 41).
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 BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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