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 .
Response to Amendment
Rejection of Claim(s) 1-8 and 10-14 under 35 U.S.C. 102(a)(1) as being anticipated by Cox (US 2024/0035937) have been modified in light of applicant’s amendments.
Rejection of Claim(s) 9 under 35 U.S.C. 103 as being unpatentable over Cox has been modified in light of applicant’s amendments.
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, 10-14 and 21-25 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 (662) connected to the base (605); a mold frame (577) defining a cavity configured to form a polymeric support within the cavity (refer to figure 5B); wherein an inner wall of the mold frame (577) comprises a rib (588) (refer to Figure 17B) that extends into the cavity and the rib (588) is configured to retain the polymeric support (580) within the cavity; and a lid (207) removably coupled to the mold frame (577). (Refer to Figures 3A-6)
Regarding claim 2, the mold frame (577) 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 (577) can be seated into the aperture. (Refer to Figure 6)
Regarding claim 4, the base (605) has at least one clip or tab (608) that releasably secures the mold frame (577) to the base (605).
Regarding claim 5, a substrate (610) removably positioned on a bottom region of the mold frame (577) wherein the substrate forms a surface.
Regarding claim 6, the substrate (610) 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 (577) and the base (605) and is configured to collect liquid during capture of a tissue section. (Refer to paragraph [0105]) (Refer to Figure 6)
Regarding claim 21, the rib (588) extends around an inner perimeter of the cavity. (Refer to Figure 5B)
Regarding claim 22, a peripheral trough surrounds the cavity and is configured to collect excess liquid. (Refer to Figures 5A and 5B)
Regarding claim 23, the handle (662) comprises a planar structure that extends outwardly from a side of the carrier device. (Refer to Figure 6)
Regarding claim 24, a cover film (610) removably positionable on a bottom of the mold frame such that the cover film encloses a lower end of the cavity.
Regarding claim 25, the hydrogel comprises a polymer selected from the group consisting of agarose, amylose, amylopectin, alginate, gelatin, cellulose, polyethylene glycol, polyvinyl alcohol, and acrylate polymers and copolymers thereof. (Refer to paragraph [0130])
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 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Lafond (US 6446807).
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.
Cox fails to teach a storage assembly configured to retain a plurality of carrier devices.
Lafond teaches a stacked modular assembly of containers. (Refer to Figures 1-3)
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.
It would have been obvious to one having ordinary skill in the art to provide the device of Cox with a storage assembly to retain a plurality of carrier devices during transporting and handling.
Response to Arguments
Applicant's arguments filed 3/24/2026 have been fully considered but they are not persuasive. Applicants argue that Cox does not teach “a mold frame defining a cavity configured to form a polymeric support within the cavity; wherein an inner wall of the mold frame comprises a rib that extends into the cavity and the rib is configured to retain the polymeric support within the cavity”. Examiner respectfully disagrees. Refer to modified rejection above. With respect to the recited “rib” applicant’s disclosure teaches an extending wall which is equivalent to Cox’s recess in the insert that retains the gasket. Applicants further argue that Cox does not teach sealing to a hydrogel. Examiner respectfully disagrees. Cox teaches collagen, Matrigel ® and Proteogycan which are all considered hydrogels.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/JYOTI Mutreja/ Primary Examiner, Art Unit 1798