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 03/17/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1-10 are objected to because of the following informalities: “Claim” followed by the claim number in each claim does not need to be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 1 is 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. More specifically, the claim limitation “a percentage of an area…” is not clear, nor is it defined by the 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.
Claims 1-2, 6-7, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2004/0209352 A1-Ozaki et al. (hereinafter Ozaki).
Regarding claim 1, Ozaki discloses a cell culture substrate used to prepare a cell culture scaffold (activity of an isolated cell and/or a cultured cell, and a cell immbolization device, para. [0002]), the cell culture substrate (cell immobilization device 19, para. [0047], line 6, Fig. 1) comprising: a base (substrate 1, para. [0048], line 6, Fig. 1); a first segment disposed on the base (sensor part 16, para. [0048], line 2, Fig. 1) and occupying a part of one surface of the cell culture substrate (where senor part 16 is shown occupying a first part of device 19, shown in Fig. 1); and a second segment disposed on the base (solution retaining part 17, para. [0048], line 5, Fig. 1) and occupying another part of the one surface (where part 17 occupies another part of one surface of device 19, shown in Fig. 1), wherein the second segment has a relatively higher surface free energy than the first segment (Fig. 1 shows part 17—the second segment, has a higher surface than that of the first segment—part 16, also shown in Fig. 1) and is disposed such that a percentage of an area of the second segment in a total area of the first segment and the second segment increases in a first direction along the one surface.
Regarding claim 2, Ozaki discloses wherein the first segment (part 16, shown in Fig. 1) is formed of at least one of an organic material (examples of substrate 1, from which part 16 is included maybe formed from polyethylene, para. [0053], lines 10-11) containing no biological materials and an inorganic material (alumina, para. [0053], line 8), and the second segment Part 17, shown in Fig. 1) is formed of at least one of an inorganic material (silicon carbide, Silicon dioxide, and silicon nitride, para. [0053], lines 7-9) and a metal material (an electrode 11 is disposed on part 17, shown in Fig. 1, Ozaki discloses the electrode 11 may be a metal, para. [0054], lines 2-3).
Regarding claim 6, wherein the second segment has a contact angle with water of 45° or less (Ozaki discloses substrate 1 may be formed a polymide (para. [0053], line 16), which includes hydrophilic properties, and where the second segment is disposed on substrate 1. Also, Ozaki discloses the substrate 1 may have a predetermined angle (para. [0067], lines 12-13).
Regarding claim 7, Ozaki discloses wherein the second segment has a surface on which a hydrophilic functional group is introduced (Ozaki discloses substrate 1 may be formed a polymide (para. [0053], line 16), which includes hydrophilic properties, and where the second segment is disposed on substrate 1).
Regarding claim 9, Ozaki discloses wherein the base is formed of a transparent material having insulating properties (substrate 1 may be formed from material typified by single crystal silicon, amorphous silicon, silicon carbide, para. [0053], lines 2-4), where the latter materials are known to be transparent.
Regarding claim 10, Ozaki discloses a cell culture scaffold kit comprising: the cell culture substrate according to Claim 1 (the culture substrate is discussed above in claim 1); and a reagent containing a coating agent for forming a medium disposed on the cell culture substrate (a cell culture medium 5 is charged to fill in the solution retaining part 17, and media containing any of a variety of nutrients, growth factors, antibiotics and the like; buffer solutions including a predetermined chemical substance, compound, drug or the like dissolved therein, para. [0072], lines 5-9), where the culture medium 5 containing a chemical substance, compound or drug is disposed on substrate 1 via solution retaining part 17, as shown in Fig. 1).
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.
Claims 3-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0209352 A1-Ozaki et al. (hereinafter Ozaki) as applied to claim 1 above, and further in view of a different embodiments of Ozaki.
Regarding claim 3, Ozaki teaches a conductive layer (coating layer 21 has a conductive material, para. [0048], lines 12-13, Fig. 1, cover a main surface of base 1, Fig. 1) covering a main surface which is one surface of the base; and an insulating layer (insulating layer 3, para. [0048], line 9, Fig. 1) covering the main surface of the base with the conductive layer interposed between the insulating layer and the main surface. However, Ozaki does not explicitly teach an opening at a position corresponding to the second segment.
For claim 3, a different embodiment of Ozaki teaches an opening (through-hole 14b) at a position corresponding to the second segment (solution retaining part 17, shown in Fig. 5), which reads on the instant claim limitation of an opening at a position corresponding to the second segment.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Ozaki and further include an opening of the second segment as taught by a different embodiment of Ozaki. Further, a different embodiment of Ozaki teaches opening 14b allows for a cell to be retained in order to make contact with a sensor (para. [0087], lines 1-5).
Regarding claim 4, Ozaki teaches a first conductive layer (coating layer 21 has a conductive material, para. [0048], lines 12-13, Fig. 1, cover a main surface of base 1, Fig. 1) covering a main surface which is one surface of the base; an insulating layer (insulating layer 3, para. [0048], line 9, Fig. 1) covering the main surface of the base with the first conductive layer interposed between the insulating layer and the main surface (shown in Fig. 1). Further, Ozaki teaches the electrode 11 may be formed using one material selected from these materials, or multiple kinds of materials may be deposited into e.g., layers, para. [0054], lines 7-9), where the latter corresponds to additional layers, or a second conductive layer. However, Ozaki does not explicitly teach an opening at a position corresponding to the second segment.
For claim 4, a different embodiment of Ozaki teaches an opening (through-hole 14b) at a position corresponding to the second segment (solution retaining part 17, shown in Fig. 5), which reads on the instant claim limitation of an opening at a position corresponding to the second segment.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Ozaki and further include an opening of the second segment as taught by a different embodiment of Ozaki. Further, a different embodiment of Ozaki teaches opening 14b allows for a cell to be retained in order to make contact with a sensor (para. [0087], lines 1-5).
Regarding claim 5, Ozaki teaches the invention discussed above in claim 3. Further, a second segment (solution retaining part 17, para. [0048], line 5, Fig. 1), and a conductive layer, also discussed above. Additionally, the cell immobilization device 19a is constituted such that electrodes 11a are arranged at each intersecting point of a lattice having 6 rows and 6 columns (para. [0080], lines 3-5). However, Ozaki does not explicitly teach a plurality of underlying wires extending along the cross direction and spaced in the first direction.
For claim 5, a different embodiment of Ozaki teaches the cell immobilization device 19a has multiple electrodes 11a and corresponding lead wires 9a (para. [0080], lines 6-10), and the different embodiment of Ozaki teaches although the solution retaining part omitted, the divider member that constitutes the solution retaining part may be provided either per every one electrode 11a, or per a set of multiple electrodes 11a (para. [0081], lines 1-6), which reads on the instant claim limitation of the conductive layer includes a plurality of underlying wires extending along the cross direction and spaced in the first direction.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Ozaki and further include a plurality of underlying wires extending along the cross direction and spaced in the first direction as taught by a different embodiment of Ozaki. Further, the different embodiment of Ozaki teaches the multiple electrodes are useful for example, in carrying out the analysis of a network because of network can be formed among cells immobilized on each electrode (para. [0081], lines 7-13).
Regarding claim 8, Ozaki teaches the invention discussed above in claim 1. Further, Ozaki teaches a segment, also discussed above. However, Ozaki does not explicitly teach wherein a minimum circumscribed circle of the second segment has a radius of 2 µm or more and 100 µm or less.
For claim 8, a different embodiment of Ozaki teaches an opening (through-hole 14b) at a position corresponding to the second segment (solution retaining part 17, shown in Fig. 5), where the different embodiment of Ozaki teaches any shape and size of the opening 14b (para. [0087], lines 7-11), and Ozaki teaches the diameter of the opening on the upper face of the sensor part 16b is in the range of 10 Lim or greater and 500 um or less, and usually, the diameter is in the range of 10 um or greater and 100 um or less (para. [0087], lines 12-16), which reads on the instant claim limitation wherein a minimum circumscribed circle of the second segment has a radius of 2 µm or more and 100 µm or less.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Ozaki and further include wherein a minimum circumscribed circle of the second segment has a radius of 2 µm or more and 100 µm or less as taught by a different embodiment of Ozaki. Further, a different embodiment of Ozaki teaches opening 14b allows for a cell to be retained in order to make contact with a sensor (para. [0087], lines 1-5) and the different embodiment of Ozaki teaches the size of the through-hole 14b can be employed may be an arbitrary size depending on the subject cell to be captured (para. [0087], lines 12-16).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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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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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799