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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/5/2026 has been entered.
Response to Amendment
The Amendment filed on 2/5/2026 has been entered. Claims 1-16 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejection previously set forth in the final Office Action mailed 12/15/2025.
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 3 and 4 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 1 recites “at least one sample well” and claim 3 recites “an array of sample wells.” Claim 3 is therefore unclear if the at least one sample well is part of the array of sample wells or is separate from the array of sample wells. For examination purposes, they are interpreted to be part of the same. Claim 4 is rejected by virtue of their dependence on a rejected base claim.
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(s) 1-3, 5, 6 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent No. 6,159,368, hereinafter Moring.
Regarding claim 1, Moring teaches a perfusion-enabled bioreactor (figure 2), comprising: a lid (item 20); a frame (item 38); at least one recess (the opening formed within item 38), wherein the at least one recess is attached to the frame (figure 3); at least one sample well (item 18), wherein the at least one sample well is attached to the frame (figure 3), wherein the at least one sample well is located within the at least one recess (figure 3); at least one fill port (the top opening of item 12), wherein the at least one fill port is attached to the frame (figure 3), wherein the at least one fill port is located within the at least one recess (figure 3); a membrane (items 8a and 8b) located beneath the frame (figure 3), wherein the membrane is adhered to a bottom of the at least one sample well (figure 3); a base (items 24 and 29) comprising at least one reservoir (item 26), wherein the base is wider than the frame and lid (figure 2); and a locking mechanism (items 37 and 39) that seals the frame to the base (figure 3); wherein at least the frame and base are injection molded (column 12, lines 6-30).
Regarding claim 2, Moring teaches further comprising a skirt (item 14) adhered to a bottom of the frame (figure 3), such that the membrane is located between the frame and the skirt (figure 3), the skirt comprising a channel (item 16c) leading from each sample well to the reservoir (figure 3).
Regarding claim 3, Moring teaches wherein the frame comprises an array of sample wells (figure 2), wherein the base is divided into multiple reservoirs (figure 2), and wherein each of the channels directs fluid from a sample well into a specific reservoir (figure 3).
Regarding claim 5, Moring teaches wherein the locking mechanism comprises a pair of gaskets (items 21, 42 and 44) that clamp the frame to the base at each end of the bioreactor (figure 2).
Regarding claim 6, Moring teaches wherein the base includes a channel around a top edge (item 49) to receive a bottom edge of the frame such that the base and the frame are sealably mated (figure 3).
Regarding claim 9, Moring teaches wherein the membrane is comprised of polycarbonate, cellulose, nylon, PEEK, polypropylene, or combinations thereof (column 14, lines 47-50).
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.
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) 4, 7, 10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moring.
Regarding claim 4, Moring teaches a media collection port (item 51) form which fluid can be collected from each reservoir (intended use MPEP § 2114 (II)).
Moring fails to teach the media collection port is within the frame.
However, it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art. MPEP §2144.04 (VI)(C). The rearrangement in this case does not modify the operation of the device because the media collection port would still be able to pull a vacuum on the device. The benefits of this modification include an easier connection as the port would be on the upper side of the device instead of the bottom.
Regarding claim 7, Moring teaches wherein a bottom of the lid sits flush with the frame (figure 3), and wherein the lid comprises a raised center portion (figure 3).
Moring fails to specifically disclose the clearance between the raised center portion and the frame.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum clearance between the raised center portion and the frame to at least 1-2 mm which would allow required airflow around the frame and into the sample wells (MPEP § 2144.05 (II)).
Regarding claim 10, Moring teaches all limitations of claim 1; however, Moring fails to specifically disclose that one or more of the lid, the frame, the base, and the skirt are transparent.
Moring further teaches making portions of the device out of a transparent material so that real time monitoring of the device can occur (columns, 32-33, lines 65-3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made one or more of the lid, the frame, the base, and the skirt transparent because it would allow for real time monitoring of the device to occur (columns, 32-33, lines 65-3).
Regarding claim 12, Moring teaches a system for 3D cell culture (figure 2), comprising: an injection molded (column 12, lines 6-30) perfusion-enabled bioreactor (figure 2), the perfusion-enabled bioreactor comprising: a lid (item 20); a frame (item 38); at least one recess (the opening formed within item 38), wherein the at least one recess is attached to the frame (figure 3); an array of sample wells (each of item 18), wherein the array of sample wells is attached to the frame (figure 3), wherein the array of sample wells is located within the at least one recess (figures 2 and 3); and at least one fill port (the top opening of item 12), wherein the at least one fill port is attached to the frame (figure 3), wherein the at least one fill port is located within the at least one recess (figure 3); a membrane (items 8a and 8b) adhered to a bottom of the frame beneath the array of sample wells (figure 3); a skirt (item 14) adhered to a bottom of the frame (figure 3), such that the membrane is located between the frame and the skirt (figure 3), the skirt comprising a plurality of channels (item 16c); a base (items 24 and 29) comprising at least one reservoir (item 26), wherein the base is wider than the frame and lid (figure 3); and a locking mechanism (items 37 and 39) that seals the frame to the base (figure 3); wherein the base of the well plate is configured to be sealably mated with the frame so that when mated the sample wells are in fluidic communication with the reservoirs via the channels of the skirt (figure 3); wherein a media collection port (item 51) through which media can be collected from each reservoir in the base (intended use MPEP § 2114 (II)); and wherein when the sample wells are filled with a 3D cell culture support matrix (intended use MPEP § 2114 (II)), the system is configured so that a pressure above the 3D cell culture support matrix is atmospheric pressure (intended use MPEP § 2114 (II)) and a pressure below the membrane is a negative pressure (intended use MPEP § 2114 (II)), wherein the negative pressure perfuses a fluid along a vertical fluid flow path from the sample wells through the 3D cell culture support matrix, through the membrane, and along the channels to the reservoir (intended use MPEP § 2114 (II)).
Moring fails to teach the media collection port is within the frame.
However, it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art. MPEP §2144.04 (VI)(C). The rearrangement in this case does not modify the operation of the device because the media collection port would still be able to pull a vacuum on the device. The benefits of this modification include an easier connection as the port would be on the upper side of the device instead of the bottom
Regarding claim 13, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Moring and the apparatus of Moring is capable of having the media collection port allow a sample to collected from the reservoir with a syringe. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Moring (see MPEP §2114).
Regarding claim 14, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Moring and the apparatus of Moring is capable of having the negative pressure drawn by a tube connected to the media collection port. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Moring (see MPEP §2114).
Regarding claim 15, Moring teaches wherein the at least one reservoir comprises at least four reservoirs (figure 2).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moring in view of United States Application Publication No. 2002/0195386, hereinafter Young.
Regarding claim 8, Moring teaches all limitations of claim 1; however, Moring fail to teach the membrane is adhered to the bottom of the at least one sample well by heat sealing.
Young teaches a device with the filter medium is heat-sealed to the bottom surface of the upper plate to enhance the quality of the seal (Young, paragraph [0007]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have heat sealed the membrane to the bottom of the plurality of wells because it would enhance the quality of the seal (Young, paragraph [0007]).
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 16 is allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record is Moring which teaches a lid, a frame, at least one recess, at least one sample well, at least one fill port, a membrane, a base and a locking mechanism. However, the prior art does not disclose, teach or suggest the claimed combination of the recess comprises at least two/four recess with at least two/six sample wells within each recess.
Response to Arguments
Applicant's arguments filed 2/5/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Moring fails to teach …” at least one sample well, wherein the at least one sample well is attached to the frame, wherein the at least one sample well is located within the at least one recess,” is not found persuasive. As shown above, the claim mapping to Moring has been changed and the recess is considered to be the opening formed within item 38 as a recess is an area which is set back or indented and the opening within item 38 is considered to be set back/intended. The at least one sample well is considered to be item 18 and as can be seen from figure 3 item 18 is attached to the frame and it is posited within the opening of item 38 and therefore located within the at least one recess. Therefore, Moring anticipates the instant claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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