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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on 2/6/2026 is acknowledged.
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) 1-8 and 10-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cox (US 2024/0035937).
Regarding claim 1, Cox teaches a modular assay support device comprising a base (605) comprising a planar body that defines an aperture; a handle (260) connected to the base; a mold frame (672) defining a cavity configured to form a polymeric support within the cavity; and a lid (636) removably coupled to the mold frame. (Refer to Figure 6)
Regarding claim 2, the mold frame (672) is removably seated in or on the base (605). (Refer to Figure 6)
Regarding claim 3, the base (605) forms an aperture and wherein the mold frame (672) can be seated into the aperture. (Refer to Figure 6)
Regarding claim 4, the base (605) has at least one clip or tab (662) that releasably secures the mold frame (672) to the base (605).
Regarding claim 5, a substrate (gasket) removably positioned on a bottom region of the mold frame (672) wherein the substrate forms a surface.
Regarding claim 6, the substrate (gasket) comprises a polyester (PE) film, polypropylene (PP) film, polyvinyl chloride (PVC) film, or a low-density polyethylene (LDPE) film.
Regarding claim 7, the polymeric support is a hydrogel. (Refer to paragraph [0115])
Regarding claim 8, the hydrogel comprises agarose, gelatin, polyacrylamide, or combinations thereof. (Refer to paragraph [0125])
Regarding claim 10, a tissue section attached to a surface of the polymeric support. (Refer to paragraph [0114])
Regarding claim 11, the tissue section is a fixed-formalin paraffin-embedded (FFPE) tissue section. (Refer to paragraph [0243])
Regarding claim 12, the tissue section is a fresh-frozen tissue section. (Refer to paragraph [0243])
Regarding claim 13, the lid comprises a polyester (PE) film, polypropylene (PP) film, polyvinyl chloride (PVC) film, or a low-density polyethylene (LDPE) film. (Refer to paragraph [0226-0227])
Regarding claim 14, a peripheral recess is defined between the mold frame and the base and is configured to collect liquid during capture of a tissue section. (Refer to paragraph [0105])
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox.
Refer above for the teachings of Cox.
Cox fails to teach the hydrogel has a compression or Young's modulus between about 5 kPa and about 2.5 MPa.
It would have been obvious to one having ordinary skill in the art to provide the device of Cox such that the hydrogel has a compression or Young's modulus between about 5 kPa and about 2.5 MPa in order to ensure a tight seal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI NAGPAUL whose telephone number is (571)272-1273. The examiner can normally be reached M-F 9am to 5pm, EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JYOTI Mutreja/Primary Examiner, Art Unit 1798