DETAILED ACTION
It is noted that this application has been transferred to Examiner Joseph G. Dauner of Art Unit 1682. Please direct all future correspondences to Examiner Dauner. Contact information for Examiner Dauner is provided at the end of this Office 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 .
The amended claims dated 5/14/2026 are under consideration.
The amendments and arguments presented in the papers filed 7/15/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 1/16/226 listed below have been reconsidered as indicated.
a) The rejections of claims 1, 5, 7, 9, 21, 24, 29, 34, 58, 116, and 220-227 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn upon further consideration of the claims.
b) The rejections of claims 1, 5, 7, 9, 21, 24, 29, 34, 58, 116, and 220-227 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement are withdrawn upon further consideration of the claims.
c) The rejections of claims 1, 5, 7, 9, 21, 24, 29, 34, 58, 116, and 220-227 under 35 U.S.C. 101 because the claimed invention is not supported by either a specific, substantial, and credible asserted utility or a well-established utility are withdrawn upon further consideration of the claims.
d) The rejections of claims 1, 5, 7, 9, 21, 24, 29, 34, 58, 116, and 220-227 under 35 U.S.C. 112, first paragraph because one skilled in the art clearly would not know how to use the claimed invention are withdrawn upon further consideration of the claims.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New grounds of rejection necessitated by amendment are detailed below.
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) 1, 5, 7, 9, 58, 116, 220, 221, 222, 223, 224, 225, 226 and 227 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chee (WO 2017/192633 A1; cited on the 1/22/2024 IDS) and Frisen (WO 2016/162309 A1).
Regarding claims 1, 9, 58, 224 and 226, Chee teaches providing a sample comprising a polypeptide associated with a recording tag at a location in a sample (Fig. 23B; p. 188, lines 23-28; and Example 3). See also, Fig. 41
Chee further teaches providing a plurality of barcoded probes spatially arranged on an array (Fig. 23; p. 74, lines 25-30; p. 106, lines 16-18; and p. 188). Chee further teaches that beads having immobilized molecules and a diameter of between 100 nm and 1mm were known (p. 75, lines 15-21).
Chee teaches a step of decoding barcodes was known (p. 69, lines 25-30; and p. 125, lines 25-30).
Chee teaches adding sequence information to the recording tag that is derived from a spatial barcode (p. 42, lines 7-22; Fig. 23).
Chee teaches adding sequence information for a molecular probe, such as an antibody, that binds with the polypeptide (Fig. 26, 32, 33, 35, 42, 43).
Chee teaches sequencing extended recording tags to obtain the information from the spatial barcodes which are complementary to the recording tags and molecular probes that were added to the original recording tag (p. 81, lines 1-7; p. 90, lines 22-28). The extending is by way of a polymerase and nucleotides.
Chee teaches using the sequencing information to identify the spatial position of a protein within cellular tissue mounted on the array surface (p. 188, lines 15-30).
While Chee teaches the above aspects of a method, Chee does not teach the spatial barcodes are on a bead (claim 1) and decoded (claim 1) via imaging (claim 24) and the use of labeled probes (claim 29) as opposed to on an array as noted above.
However, Frisen demonstrates that a bead array is spatially encoded and decoded to determine where in the bead array the individual spatial barcodes are located (p. 3, lines 11-24; p. 25, lines 20-35; p. 48). One would recognize that labeled probes attached via hybridization may be detected via imaging.
It would have been prima facie obvious to the ordinary artisan at the time of filing to have modified the method of Chee by simply substituting the array of Chee with the known bead array of Frisen. The two arrays are functionally equivalent as each have barcodes spatially oriented and are used to capture analytes in tissue sections.
Regarding claim 5, Chee teaches the molecular probes include a tag or barcode that may be decoded as a detectable tag (p. 69, 125-126 and 171). One would recognize that the decoding may be done via imaging hybridized probes.
Regarding claim 7, Chee teaches using multiple molecular probe antibodies sequentially, such that the nucleic acid tag sequence information of each is added to the recording tag (Fig. 7).
Regarding claim 116, Chee teaches providing a sample comprising a polypeptide associated with a recording tag at a location in a sample (Fig. 23B; p. 188, lines 23-28; and Example 3). See also, Fig. 41.
Chee teaches adding sequence information for a molecular probe, such as an antibody, that binds with the polypeptide (Fig. 26, 32, 33, 35, 42, 43).
Chee teaches the molecular probes include a tag or barcode that may be decoded as a detectable tag (p. 69, 125-126 and 171). One would recognize that the decoding may be done via imaging hybridized probes.
Chee teaches using multiple molecular probe antibodies sequentially, such that the nucleic acid tag sequence information of each is added to the recording tag (Fig. 7). It would have been prima facie obvious to have decoded each of the tags/barcodes attached to the polypeptide.
Chee teaches sequencing extended recording tags to obtain the information form the barcodes which are complementary to the recording tags and molecular probes that were added to the original recording tag (p. 81, lines 1-7; p. 90, lines 22-28). The extending is by way of a polymerase and nucleotides.
Chee teaches using the sequencing information to identify the spatial position of a protein with cellular tissue mounted on the array surface (p. 188, lines 15-30).
While Chee teaches the above aspects of a method, Chee does not teach the performing the decoding in situ.
However, Frisen demonstrates that a bead array is spatially encoded and decoded in situ to determine where in the bead array the individual spatial barcodes are located (p. 3, lines 11-24; p. 25, lines 20-35; p. 48). One would recognize that labeled probes attached via hybridization may be detected via imaging.
It would have been prima facie obvious to the ordinary artisan at the time of filing to have modified the method of Chee by simply substituting the array of Chee with the known bead array of Frisen. The two arrays are functionally equivalent as each have barcodes spatially oriented and are used to capture analytes in tissue sections.
Regarding claim 220, the claim is an obvious variant of the method suggested by Chee and Frisen as described above. The claim is the result of rearranging the order of steps with a predictable result. The results are predictable as once the bead and the polypeptide interact, the spatial barcode of the bead may be determined at any point.
Regarding claim 221, Frisen teaches beads with the probes are randomly distributed (p. 42).
Regarding claims 222 and 225, the antibody molecular probes of Chee are specific for an epitope that identifies the polypeptide. Using the sequence of the probe tag associated with the antibody one is readily able to identify the polypeptide and the antibody located at a particular position.
Regarding claim 223, Chee teaches using multiple molecular probe antibodies sequentially, such that the nucleic acid tag sequence information of each is added to the recording tag (Fig. 7).
Regarding claim 227, as noted above, Chee teaches the molecular probes are antibodies.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682
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