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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/17/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 8-10, 12, 13, 30 and 35 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.
Claim 8 recites the limitation "the one or more features" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 9 and 10 are rejected under 35 U.S.C. 112b since the claims incorporate all the limitations of and depend upon claim 8.
Claim 12 recites the limitation "the one or more microfluidic channels" in line 2. There is insufficient antecedent basis for this limitation in the claim. While there is antecedent basis for one or more microfluidic channels, the claim does not have antecedent basis for the claims that pass through the membrane.
Claim 13 is rejected under 35 U.S.C. 112b since the claim incorporates all the limitations of and depend upon claim 12.
Claim 30 recites the limitation "the one or more microfluidic channels" in lines 2 to 3. There is insufficient antecedent basis for this limitation in the claim. While there is antecedent basis for one or more microfluidic channels, the claim does not have antecedent basis for the claims that pass through the membrane.
Claim 35 is indefinite since the claim attempts to claim a process without setting forth any steps involved in the process. The claim merely cites an intent without any active, positive steps as to how the membrane is manufactured. See also MPEPO §2173.05(q).
Appropriate corrective action is required.
Claim Rejections - 35 USC § 102
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 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.
Claim 35 is rejected under 35 U.S.C. 102a1 as being anticipated by Manina et al. (WO 2020/229629 A1 – hereafter ‘629).
For claim 35, ‘629 discloses a process for manufacturing a membrane (page 23, sixth paragraph) where the microchannels for the pressure chamber of ‘629 and the cell culture chamber (Fig. 1A; page 36, last paragraph; page 37; second paragraph) and passes by the membrane. Moreover, the claim language does not limit the microchannels form a fluid connection between the two sides of the membrane.
Therefore, ‘629 meets the limitations of claim 35.
Allowable Subject Matter
Claims 1, 2, 4, 5, 7, 11, 24, 25, 27-29, 31 and 34 are allowed.
The following is an examiner’s statement of reasons for allowance: For claim 1, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a microfluidic cell culture device that includes two or more reservoirs, a first microfluidic chamber having a non-planar surface, a second microfluidic chamber that functions as a pressure chamber, a flexible non-porous membrane that separates the two chambers and one or more microfluidic channels connected the first microfluidic chamber to the two or more media reservoirs.
The closest prior art is Manina et al. (WO 2020/229629 A1 – hereafter ‘629) which discloses a microfluidic device that can manipulate different cell types that includes a lower chamber for culturing cells, an upper chamber that functions as a pressure chamber separated by a membrane (last paragraph on page 36; page 37, second paragraph; Fig. 1A; lower chamber 10; upper chamber 14; membrane 16). Manina does not teach or fairly suggest where the culture chamber has a non-planar surface that is opposite a surface of the membrane. Specifically, Manina discloses that the surface opposite the membrane is planar and all of the embodiments require that this surface is planar in order to have the membrane contact the cells when the membrane is actuated. The prior art further does not provide a teaching, suggestion or motivation for changing the shape of the lower surface of Manina and it appears that changing this surface shape would render Manina inoperable for its intended purpose.
For claim 24, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a method for cultivating cells that includes using a microfluidic cell culture device that includes two or more reservoirs, a first microfluidic chamber having a non-planar surface, a second microfluidic chamber that functions as a pressure chamber, a flexible non-porous membrane that separates the two chambers and one or more microfluidic channels connected the first microfluidic chamber to the two or more media reservoirs. This also include using the step of cultivating a biological material on the non-planar surface.
The closest prior art is Manina et al. (WO 2020/229629 A1 – hereafter ‘629) which discloses a microfluidic device that can manipulate different cell types that includes a lower chamber for culturing cells, an upper chamber that functions as a pressure chamber separated by a membrane (last paragraph on page 36; page 37, second paragraph; Fig. 1A; lower chamber 10; upper chamber 14; membrane 16). Manina does not teach or fairly suggest where the culture chamber has a non-planar surface that is opposite a surface of the membrane. Specifically, Manina discloses that the surface opposite the membrane is planar and all of the embodiments require that this surface is planar in order to have the membrane contact the cells when the membrane is actuated. The prior art further does not provide a teaching, suggestion or motivation for changing the shape of the lower surface of Manina and it appears that changing this surface shape would render Manina inoperable for its intended purpose.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 8-10, 12, 13 and 30 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 8-10, 12, 13 and 30 would be allowable for the same reasons as claims 1 and 24 respectively.
The closest prior art is Manina et al. (WO 2020/229629 A1 – hereafter ‘629) which discloses a microfluidic device that can manipulate different cell types that includes a lower chamber for culturing cells, an upper chamber that functions as a pressure chamber separated by a membrane (last paragraph on page 36; page 37, second paragraph; Fig. 1A; lower chamber 10; upper chamber 14; membrane 16). Manina does not teach or fairly suggest where the culture chamber has a non-planar surface that is opposite a surface of the membrane. Specifically, Manina discloses that the surface opposite the membrane is planar and all of the embodiments require that this surface is planar in order to have the membrane contact the cells when the membrane is actuated. The prior art further does not provide a teaching, suggestion or motivation for changing the shape of the lower surface of Manina and it appears that changing this surface shape would render Manina inoperable for its intended purpose.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ingber et al. (US 10,472,612 B2) discloses a cell culture system for culturing cells on a membrane.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799