Detailed Action
► The applicant's Preliminary Amendment filed 21 OCT 2022 has been entered. Following the entry of the Preliminary Amendment, Claim(s) 2-27 is/are pending.
► The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
35 U.S.C. 112(b)/ 112 (pre-AIA ), second paragraph
► The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim Rejection(s) under 35 U.S.C. 112(b)/ 112 (pre-AIA ), second paragraph
► Claim(s) 19, 22, 24 and 27 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language.
Claim 19 for example, is drawn to an embodiment of “a method of Claim 18”. However, Claim 18 is drawn to a composition”. As such Claim 19 is indefinite. Claim(s) 22, 24 and 27 follow the same pattern and as such are indefinite For the evaluation of the prior art, the examiner has assumed Claims 19, 22, 24 and 27 recite “The composition of Claim…” rather has “The method of Claim…”
Non-Statutory Obviousness-type Double Patenting
► 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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b). It is noted that the doctrine of double patenting is also designed to protect third parties from harassment by multiple patent owners in connection with the same invention.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
NSODP REJECTION(S)
► Instant Claim(s) 2-13 and 15-27 is/are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over Claims 1-30 of U.S. Patent No. 11,434,524 hereinafter US-524’] in view of Russel et al. [US 2020/0040376 - hereinafter “Russel”]
Claim(s) 2 is drawn to a method for reducing capture of a proxy of an analyte in an area of an array not covered by a biological sample, the method comprising: (a) disposing a biological sample onto an array at a first area, wherein the array comprises a plurality of capture probes and the biological sample is a non-permeabilized biological sample, wherein: the first area comprises a capture probe of the plurality of capture probes comprising (i) a spatial barcode and (ii) a capture domain; and a second area of the array comprises a capture probe of the plurality of capture probes comprising (i) a spatial barcode and (ii) a capture domain, and the second area is an area of the array not covered by the biological sample disposed on the array; (b) contacting the second area of the array with a solution comprising a blocking probe, wherein the blocking probe comprises a sequence that binds specifically to the capture domain of the capture probe in the second area of the array; (c) removing residual solution comprising the blocking probe from at least the second area of the array prior to permeabilizing the biological sample; and (d) permeabilizing the biological sample, such that the capture domain of the capture probe of the first area of the array binds specifically to the proxy of the analyte; thereby reducing capture of the proxy of the analyte in the second area of the array not covered by the biological sample.
Claim(s) 1-30 of US -524’ reasonably suggest the method of Claim 2 and the composition of Claim 18. Although the conflicting claims are not identical, they are not
patentably distinct from each other.
The Claim(s) 1-30 teach a method which comprises most the limitations recited except the Claim(s) 1-30 do not teach the use of analyte/target proxies. However, the use of “analyte/target proxies” in biomedical assays was routine, consider for example para 7 in Russel. Accordingly, absent an unexpected result it would have been prima facie obvious to the PHOSITA at the time of the invention to modify the method of US-524’ wherein target proxies are utilized in substitution for and/or in combination with actual target molecules. Absent an unexpected result, this limitation is considered to be a simple design choice well within the knowledge, skill, ability and common sense of the PHOSITA at the time of the invention. The substitution of one known second method/reagent with known properties for a first known method/reagent with known properties would have been prima facie obvious to the ordinary artisan at the time of the invention in the absence of an unexpected result. As regards the motivation to make the substitution recited above, the motivation to combine arises from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. Support for making this obviousness rejection comes from the M.P.E.P. at 2144.07 and 2144.09, as well as, the SCOTUS decision in KSR International. Co. v. Teleflex, Inc., et al., 550 U.S.398 (2007).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
As regards Instant Claim(s) 3-13, see at least Claims 2-10 in US-524’.
As regards Instant Claim(s) 15-17, see especially Claims 28-30 in US 524’.
As regards Instant Claim(s) 18-27, see especially Claims 20-27 in US 524’.
► Instant Claim(s) 14 is/are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over Claims 1-30 of US-524’ in view of Russel as applied above against Claim 2 and further in view of Chee et al. [WO 2019/089851 – hereinafter “Chee”].
Claim 14 is drawn to an embodiment of Claim 2 wherein the target analyte is a protein.
Claim(s) 1-30 in view of Russel reasonably suggest a method as recited by Claim 14, but fail to teach an embodiment wherein the target analyte is a protein/peptide. However, the use of spatial proteomics, in manner similar to the spatial transcriptomics approach first disclosed by Stahl et al. [Science 353 :78-82 -hereinafter “Stahl”], to detect the presence and location of proteins was known, consider for example para 925 in Chee Accordingly, absent an unexpected result it would have been prima facie obvious to the PHOSITA at the time of the invention to modify the method of US-524’ wherein target analytes are proteins rather than or in addition to, the nucleic acids disclosed by the claims of USA-524’
Conclusion
C. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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/ETHAN C WHISENANT/Primary Examiner, Art Unit 1683 ethan.whisenant@uspto.gov
EXAMINER SEARCH NOTES
05 FEB 2026 - ECW
Databases searched: All available via PE2E SEARCH
CAplus, Medline and BIOSIS via STNext; and Google Scholar (note the search terms used below)
Performed Similarity searches as appropriate
Reviewed the parent(s), if any, and any search(es) performed therein : see the BIB data sheet
Reviewed, the search(es), if any, performed by prior examiners including any international examiners.
Planned Search
Search terms:
All Inventor(s) e.g. Iyer E?/au
Spatial (transcriptomic$ or proteomic$)
Array$ or microarray
Prox$
Capture probe$
Spatial barcode
blocking probe$
RNA or mRNA or miRNA or rRNA or DNA
Sequenc$
► See the Examiner’s PE2E SEARCH notes/strategy in IFW