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
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Italy on 04/29/20. It is noted, however, that applicant has not filed a certified copy of the IT 102020000009442 application as required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/25/25 is acknowledged. Claims 21-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 14-20 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 14 recites “along their vertical axis” in lines 10-11. The Examiner submits this the limitation “their vertical axis” is unclear - as it is unclear as to which element is being referred to by the term “their”.
Claims 15-20 are rejected on the basis of being dependent upon claim 14.
Claim 20 contains the trademark/trade name “Matrigel ®”.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
In the present case, the trademark/trade name is used to identify/describe a “basal membrane preparation in solution extracted from mouse sarcoma” (see Spec., Pg. 11, lines 33-34 through Pg. 12, line 1) and, accordingly, the identification/description is indefinite.
Inventorship
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 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.
Claims 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kane (US 2004/0149659) in view of Domansky et al. (US 2005/0260754). Kane teaches a well or plurality of wells for processing a fluid. The embodiments of the device most relevant to the instant claims are shown in Figures 1-5B and described in Paragraphs 0056-0076.
Regarding claim 14, 16, and 17 – As shown in Figures 1-3 and 5a-5b, Kane teaches a microplate (100) comprising: at least one fixed element (base 101) which is a rigid flat support which has an upper face and a lower face (bottom end 3), having, on said upper face, wells (50), said wells (50) being delimited by a hydrophobic (Kane teaches hydrophobic materials for the wells in Para 0094) rim and crossed by a hole (rim of well 50 opening), and moving elements (bottom wall 4), received in said wells (50) through said holes (well opening), which are cylinders (cylindrical disc bottom wall 4) having an upper base and a lower base, wherein said moving elements (4) move, even independently of each other, along their vertical axis, and the upper base of said moving elements (4) includes a hydrophilic surface (Kane teaches a hydrophilic sieve filter material in Paragraphs 0100-0102) with relief items (grid 80 with spacers 81a-d, 83a-d, and 84a-d). See Paragraphs 0056-0064. The Examiner considers the grid (80), spacers (81a-d, 83a-d, and 84a-d) and upper surface of the bottom wall (4) covered by the sieve filter to meet the limitation of an “upper base of said moving element including a hydrophilic surface (filter) with relief items (grid 80). With respect to the bottom wall disc (4) being movable, Kane teaches providing the bottom wall (4) as a separate insert in Paragraphs 0048 and 0076. Kane does not teach microchannels connecting the wells to define a microfluidic circuit. Kane also does not teach a sol polymer comprising a biologically active matrix.
Domansky teaches a bioreactor device for growing and/or examining a matrix of biological material within a system that includes a multiwell plate attached to a microchannel network for processing the biological material. The device is best shown in Figures 1-4 and described in Paragraphs 0033-0039. As shown in the cited Figures, Domansky teaches a bioreactor device that includes a microplate element (fluidic manifold 24) having a plurality of bioreactor wells (4) and reservoir wells (6) connected to a lower control manifold (control manifold 11). The bioreactor wells (4) include a matrix of biological material. The upper fluidic manifold (24) has openings on the bottom surface which connect to the lower control manifold (22). See Figures 4 and 9 of Domansky. The lower control manifold includes a plurality of chambers (13, 18, 19) connected to each other by a plurality of microchannels (20) for processing fluids through the control manifold. The Examiner submits one of ordinary skill in the art at the time of the effective date of the invention to combine the microfluidic network from Domansky with the device of Kane. One of ordinary skill in the art would add the microfluidic network to Kane in order to further collect and process material from the wells as taught by Domansky.
Regarding claim 15 – Kane shows an access channel (port 7) in the bottom end (3) of each well (50) which extends through the lower face of the fixed element (base 101) in Figure 5A. Domansky also teaches an exit port (29) that exits the bottom of the microplate (24) in Figure 4.
Regarding claim 18 – Figure 3 and 5A of Kane show the relief items (spacers 81a-d, 83a-d, and 84a-d of grid 80) distributed in a controlled manner such that they occupy between 10 and 70% of the overall hydrophilic surface.
Regarding claims 19 and 20 – Kane teaches every element of claims 19 and 20 except for the sol material. Kane recites a filter comprised of a biologically active material in a polymeric formulation in Paragraph 0054 and 0100-0102, but does not recite a sol polymeric material. Domansky in Paragraphs 0030 teaches numerous polymeric materials which may be used to form a matrix for holding biological material including sol materials such as collagen. The polymeric material for the matrix includes the ability to provide an appropriate response from cells or biological material such as attachment, proliferation and/or gene expression while held in the matrix. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the sol polymeric material from Domansky with the device of Kane. One of ordinary skill in the art at the time would add the collagen material to Kane in order to provide a matrix material that allows for attachment, proliferation and/or gene expression while held in the matrix.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 May 21, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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