DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Group II, claims 7-9, in the reply filed on 07 April 2026 is acknowledged. Claims 1-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07 April 2026.
Claim Status
3. Claims 1-6 are withdrawn.
Claims 7-9 are under consideration.
Priority
4. The instant application is a National Stage (371) of PCT/JP2022/009368, filed 04 March 2022, which claims priority to JP2021-053010, filed 26 March 2021.
Receipt is acknowledged of certified copies of papers required by 35 CFR 1.55. Should Applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CRF 41.154(b) and 41.202(e). Until a certified English translation has been filed, the effective filing date for purposes of applying prior art is 04 March 2022.
Failure to provide a certified translation may result in no benefit being accorded for the non-English translation.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on 09 July 2025, 28 January 2025, and 26 September 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
6. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
7. The abstract of the disclosure is objected to because “An object is” is incorrect grammar. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
8. Claim 7 is objected to because of the following informalities:
“a test region in which a well formation area, which is an area of the substrate in a region where the wells are formed, is 5 mm2 or more” is unclear. Examiner suggests rewording this phrase to “a test region comprising a well formation area, wherein the well formation area is an area of the substrate where the wells are formed and is 5 mm2 or more”.
“a total volume of the wells obtained by integrating individual volumes of the wells is 17 nL or more” is unclear. Examiner suggests rewording this phrase to “the total volume of the wells is 17 nL or more”.
“a depth”, “a volume” and “a thickness” is improper grammar and should all be changed to “the”.
“each” should be added after “6,000” fL to make it clear that the volume is per well.
Appropriate correction is required.
9. Claim 8 is objected to because of the following informalities:
“a detection chip in which the well array as claimed in Claim 7 is placed” should read “a detection chip comprising the well array of claim 7”.
“a detection unit in which an observation visual field can be fixed with a size” should read “a detection unit comprising an observation visual field that can be fixed to a size”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
10. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
11. Claim 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Revzin (The Royal Society of Chemistry, 2005, 5: 30-37) (See IDS filed 28 January 2025).
Regarding claim 7, Revzin teaches a microwell array for characterization and sorting of leukocytes that is fabricated using poly(ethylene glycol) (PEG) photolithography on a glass slide (Abstract).
Revzin further teaches "The height of the resultant hydrogel microstructures varied from 2 to 10 µm […] The second microwell format contained 150 X 150 array elements with individual wells comprised of 10 µm wide PEG walls and 225 µm² glass attachment pads." (Experimental, ¶ 3). These “glass attachment pads” correspond to the opening area of each well, which is later made clear by the discussion of “15 µm × 15 µm PEG wells” (Page 35, ¶ 2) and 15 µm × 15 µm = 225 µm². This is further supported by Figure 2(A), wherein the scale (see the line that indicates 20 µm) can be seen. Figure 2 also demonstrates that the wells are adjacent to each other:
PNG
media_image1.png
458
395
media_image1.png
Greyscale
To find the total area of the wells in the 150 x 150 array:
(150 x 150 array elements)*(225 µm²) = 5,062,500 µm² = 5.0625 mm2
This does not account for the side wall thickness, which would make the actual area of the array larger.
In summary, Revzin teaches a well array with adjacent wells and side walls on a substrate (glass slide) with the substrate area being more than 5 mm², the depth of the wells being 2 to 10 µm, an opening area of 225 µm², and 10 µm wide walls. The calculation for the individual well volume is 225 µm² x 10 µm (using a 10 µm depth) = 2250 fL and thus the total volume would be 2250 fL x 150² array elements = 50.625 nL.
Claim Rejections - 35 USC § 103
12. 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.
13. 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.
14. Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Revzin (The Royal Society of Chemistry, 2005, 5: 30-37) (See IDS filed 28 January 2025) in view of Halverson
(WO 2011063332 A2; Published 26 May 2011).
Regarding claims 7-9, Revzin teaches a microwell array for characterization and sorting of leukocytes that is fabricated using poly(ethylene glycol) (PEG) photolithography on a glass slide (Abstract).
Revzin further teaches "The height of the resultant hydrogel microstructures varied from 2 to 10 µm […] The second microwell format contained 150 X 150 array elements with individual wells comprised of 10 µm wide PEG walls and 225 µm² glass attachment pads." (Experimental, ¶ 3). These “glass attachment pads” correspond to the opening area of each well, which is later made clear by the discussion of “15 µm × 15 µm PEG wells” (Page 35, ¶ 2) and 15 µm × 15 µm = 225 µm². This is further supported by Figure 2(A), wherein the scale (see the line that indicates 20 µm) can be seen. Figure 2 also demonstrates that the wells are adjacent to each other:
PNG
media_image1.png
458
395
media_image1.png
Greyscale
To find the total area of the wells in the 150 x 150 array:
(150 x 150 array elements)*(225 µm²) = 5,062,500 µm² = 5.0625 mm2
This does not account for the side wall thickness, which would make the actual area of the array larger.
In summary, Revzin teaches a well array with adjacent wells and side walls on a substrate (glass slide) with the substrate area being more than 5 mm², the depth of the wells being 2 to 10 µm, an opening area of 225 µm², and 10 µm wide walls. The calculation for the individual well volume is 225 µm² x 10 µm (using a 10 µm depth) = 2250 fL and thus the total volume would be 2250 fL x 150² array elements = 50.625 nL.
Revzin does not teach a detection device with a detection chip and detection unit with an observation visual field set equal in size to the test region. However, Halverson teaches a microwell array for detecting analytes in a sample (Abstract). Halverson further teaches using an optical system to detect an analyte in a microwell array article, which can include an optical device (Page 45, ¶ 4). The optical device can include microscopes, more specifically a confocal microscope (Page 46, ¶ 2). The “detection chip” in this case would be the glass slide in which the array is placed on the microscope. The “detection unit” is the microscope itself, which has an observation visual field that can be zoomed in/out to fit the entirety of the test region. This microscope will allow the user to see and take pictures of the results of the array. Therefore, it would have been obvious to one of ordinary skill before the filing date to take the microwell array of Revzin and further place it on a microscope in order to analyze the array results, as discussed in Halverson. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Furthermore, the well formation area, the total volume of the wells, the well depth, the well area, the individual volumes of the well, the thickness of the walls, and the visual field size are all result-effective variables that are routinely optimized in the art. The size of the wells as well as the size of the array can be optimized to fit the needs of the user, as discussed in Revzin wherein there were two different microarray sizes (Experimental, ¶ 2) and “Presently, the photomask is designed to cover only small regions of 75 × 25 mm glass slide with the microwell pattern. By simply redesigning the photomask, microwell array may be expanded to completely cover a glass slide.” (Experimental, ¶ 3). The visual field size can simply be changed by zooming in or out with the microscope as deemed fit or by using a lens with different magnification power. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
Double Patenting
15. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
16. Claims 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-8 of copending Application No. 18/552,371 in view of Revzin (The Royal Society of Chemistry, 2005, 5: 30-37) (See IDS filed 28 January 2025) and Halverson (WO 2011063332 A2; Published 26 May 2011).
Regarding claim 7 of the Instant Application, claim 7 of ‘371 recites a well array for use in the biological substance detection method of claim 1. Claim 1 of ‘371 recites the well array is formed by defining a plurality of wells adjacent to each other with a side wall stood on a substrate. Claim 4 of ‘371 recites that the wells each have a volume between 2 fL and 100 pL, which overlaps with the range in claim 7 of the Instant Application (74 fL to 6,000 fL). ‘371 does not mention the rest of the measurements for the array.
However, Revzin teaches a microwell array for characterization and sorting of leukocytes that is fabricated using poly(ethylene glycol) (PEG) photolithography on a glass slide (Abstract).
Revzin further teaches "The height of the resultant hydrogel microstructures varied from 2 to 10 µm […] The second microwell format contained 150 X 150 array elements with individual wells comprised of 10 µm wide PEG walls and 225 µm² glass attachment pads." (Experimental, ¶ 3). These “glass attachment pads” correspond to the opening area of each well, which is later made clear by the discussion of “15 µm × 15 µm PEG wells” (Page 35, ¶ 2) and 15 µm × 15 µm = 225 µm². This is further supported by Figure 2(A), wherein the scale (see the line that indicates 20 µm) can be seen. Figure 2 also demonstrates that the wells are adjacent to each other:
PNG
media_image1.png
458
395
media_image1.png
Greyscale
To find the total area of the wells in the 150 x 150 array:
(150 x 150 array elements)*(225 µm²) = 5,062,500 µm² = 5.0625 mm2
This does not account for the side wall thickness, which would make the actual area of the array larger.
In summary, Revzin teaches a well array with adjacent wells and side walls on a substrate (glass slide) with the substrate area being more than 5 mm², the depth of the wells being 2 to 10 µm, an opening area of 225 µm², and 10 µm wide walls. The calculation for the individual well volume is 225 µm² x 10 µm (using a 10 µm depth) = 2250 fL and thus the total volume would be 2250 fL x 150² array elements = 50.625 nL.
Therefore, it would have been obvious to one of ordinary skill before the filing date to take the microwell array of ‘371 and further apply the measurements used in Revzin to arrive at the well array of claim 7 of the Instant Application. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding claims 8-9 of the Instant Application, claim 8 of ‘371 recites a detection device with a detection chip having the well array of claim 7 of ‘371 and a detection unit. ‘371 does not teach the observation visual field that can be set equal to the size of the test region. However, Halverson teaches a microwell array for detecting analytes in a sample (Abstract). Halverson further teaches using an optical system to detect an analyte in a microwell array article, which can include an optical device (Page 45, ¶ 4). The optical device can include microscopes, more specifically a confocal microscope (Page 46,
¶ 2). The “detection chip” in this case would be the glass slide in which the array is placed on the microscope. The “detection unit” is the microscope itself, which has an observation visual field that can be zoomed in/out to fit the entirety of the test region. This microscope will allow the user to see and take pictures of the results of the array. Therefore, it would have been obvious to one of ordinary skill before the filing date to take the microwell array made obvious by ‘371 and Revzin and further place it on a microscope in order to analyze the array results, as discussed in Halverson. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Furthermore, the well formation area, the total volume of the wells, the well depth, the well area, the individual volumes of the well, the thickness of the walls, and the visual field size are all result-effective variables that are routinely optimized in the art. The size of the wells as well as the size of the array can be optimized to fit the needs of the user, as discussed in Revzin wherein there were two different microarray sizes (Experimental, ¶ 2) and “Presently, the photomask is designed to cover only small regions of 75 × 25 mm glass slide with the microwell pattern. By simply redesigning the photomask, microwell array may be expanded to completely cover a glass slide.” (Experimental, ¶ 3). The visual field size can simply be changed by zooming in or out with the microscope as deemed fit or by using a lens with different magnification power. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
17. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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