DETAILED ACTION
The present Office Action is responsive to the Amendment received on December 10, 2025.
Preliminary Remark
Claims 7 and 8 are canceled.
Claims 9-15 and 26-28 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected invention without traverse, there being no allowable generic or linking claim.
Amendment Not Fully Marked:
The amendment received on December 10, 2025 contains an amendment that is not marked. The phrase, “groups (i), (ii), (iii), or (iv), or a combination thereof:.” now contains a period after the colon which was not previously present but not properly marked. For the purpose of compact prosecution, failure to mark the amendment has been treated as a typographical error instead of the entire amendment being held non-responsive.
Claim Objections
Claim 2 is objected to because of the following informalities: the phrase, “ligating the first and second probe, thereby generated a ligation product” should be corrected to “ligating the first and second probe, thereby generating a ligation product” for grammatical reasons. Appropriate correction is required.
Drawings
The replacement drawings received on December 10, 2025 are acceptable.
Claim Rejections - 35 USC § 112
The rejection of claims 7 and 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter, made in the Office Action mailed on August 20, 2025 is withdrawn in view of the Amendment received on December 10, 2025, by way of their cancellation.
Rejection – Maintained & New Grounds, Necessitated by Amendment
Preliminarily, some of the rejection rationality for the below claims have been withdrawn. Only the rejections based on the below-reiterated rationale are maintained as discussed.
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.
The rejection of claims 1-6 and 16-25 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter, made in the Office Action mailed on August 20, 2025 is maintained for the reasons of record.
Applicants’ claim amendment and arguments presented in the Amendment received on December 10, 2025 have been considered but they have not been found persuasive for the reasons discussed below.
The Rejection & Response:
Re: Claim 1:
Claim 1 is indefinite for the following reasons:
Claim 1 is also missing a conjunction between step (a)(iii) and (a)(iv). For the purpose of prosecution, the conjunction “and” is assumed.
Response:
Applicants’ attention is directed to the sets (i)-(iv) which actually recite the group of captured analytes, wherein a conjunction is missing between group (iii) and (iv).
Re: Claims 5 & 6:
With this interpretation, claim 5 is also indefinite because the claim recites analytes which are not recited in the parent claim (claim 1), thereby appearing to broaden the scope of the parent claim.
Claim 5 is also indefinite because step (b) of the claim appears to make the determination of prostate cancer based on markers which are not required in the parent claims, thereby being disjointed from the parent claim.
Claim 6 is also indefinite for the same reasons as claim 5.
Response:
Applicants’ amendment does not rectify this issue nor argue this point.
To reiterate, claims 5 and 6 recite capture analytes, CD24, KRT8, KRT18, CD3E, CD4, CD8A, CD247, CD79A, CD79B, IGHA1, IGHG1, etc. are recited as being “the two or more analytes,” but none of these analytes are part of the groups recited in claim 1.
Claims 2-8 and 16-25 are also indefinite by way of their dependency on claim 1.
Rejection – New Grounds, Necessitated by Amendment:
Claim 1 contains a period after the recitation of the phrase, “one of groups (i), (ii), (iii), or (iv) or a combination thereof:.” while containing additional limitations.
As already discussed above in the “Preliminary Remark” section, the period has been construed to be a typographical error and treated as such for the purpose of prosecution.
Claim Rejections - 35 USC § 101
The rejection of claims 1-8 and 16-25 under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception (i.e., abstract idea) without significantly more, as discussed in the Office Action mailed on August 20, 2025 is withdrawn in view of the Amendment received on December 10, 2025.
Claim Rejections - 35 USC § 103
The rejection of claims 1-4, 7, 17-22, 24, and 25 under 35 U.S.C. 103 as being obvious over Chell et al. (WO 2021/133849 A1, published July 2021) in view of Erho et al. (Journal of Oncology, 2012, pages 1-11) and Shaheduzzaman et al. (Cancer Biology & Therapy, 2007, vol. 7, pages e1-e8), made in the Office Action mailed on August 20, 2025 is withdrawn in view of the Amendment received on December 10, 2025.
The rejection of claim 5 under 35 U.S.C. 103 as being unpatentable over Chell et al. (WO 2021/133849 A1, published July 2021) in view of Erho et al. (Journal of Oncology, 2012, pages 1-11) and Shaheduzzaman et al. (Cancer Biology & Therapy, 2007, vol. 7, pages e1-e8), as applied to claims 1-4, 7, 17-22, 24, and 25 above, and further in view of Pascal et al. (BMC Cancer, 2009, vol. 9, pages 1-15) made in the Office Action mailed on August 20, 2025 is withdrawn in view of the Amendment received on December 10, 2025.
The rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Chell et al. (WO 2021/133849 A1, published July 2021) in view of Erho et al. (Journal of Oncology, 2012, pages 1-11) and Shaheduzzaman et al. (Cancer Biology & Therapy, 2007, vol. 7, pages e1-e8), as applied to claims 1-4, 7, 17-22, 24, and 25 above, and further in view of Bankaitis-Davis et al. (WO 2008/121132 A2, published October 2008) made in the Office Action mailed on August 20, 2025 is withdrawn in view of the Amendment received on December 10, 2025.
The rejection of claims 16 and 23 under 35 U.S.C. 103 as being unpatentable over Chell et al. (WO 2021/133849 A1, published July 2021) in view of Erho et al. (Journal of Oncology, 2012, pages 1-11) and Shaheduzzaman et al. (Cancer Biology & Therapy, 2007, vol. 7, pages e1-e8), as applied to claims 1-4, 7, 17-22, 24, and 25 above, and further in view of Magbanua et al. (Journal of Clinical Oncology: Meeting Abstract, May 20, 2010, pages ) made in the Office Action mailed on August 20, 2025 is withdrawn in view of the Amendment received on December 10, 2025.
Rejection – New Grounds, Necessitated by Amendment
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.
Claims 1-4, 17-22, 24, and 25 are rejected under 35 U.S.C. 103 as being obvious over Chell et al. (WO 2021/133849 A1, published July 2021) in view of Larkin et al. (British Journal of Cancer, 2012, vol. 106, pages 157-165) and Shaheduzzaman et al. (Cancer Biology & Therapy, 2007, vol. 7, pages e1-e8).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The present rejection is made in pursuit of compact prosecution, based on an interpretation that the means of obtaining the expression data of the two or more markers are actively/positively required in the claims.
With regard to claims 1 and 7, Chell et al. teach a method of assaying for gene expression of markers from a sample applied on a spatial gene expression array, wherein the artisans teach the steps of:
determining the expression of two or more captured analytes or complements thereof from a biological sample from a subject, wherein the captured analytes or complements thereof are hybridized to capture probes on a spatial gene expression array, wherein the spatial gene expression array comprises a plurality of captured probes, a capture probe of the plurality comprising a spatial barcode and a capture domain (see mRNA capture in order to interrogate spatial gene expression in a sample”, page 1, lines 31-33; also Figure 1, “contact sample with array of spatially-barcoded capture probes”; also “a capture probe of the plurality includes: (i) a spatial barcode and (ii) a capture domain”); and
identifying the presence or absence of the two or more captured analytes (“[t]arged RNA capture can be used to capture a defined set of RNA molecules of interest …”, page 2, lines 5-6).
With regard to claim 2, the capture analytes or complements thereof are obtained by:
providing two or more sets of target analyte probes, wherein a first probe for the set comprises a capture probe binding domain and a second probe of the set comprises a functional sequence (“contacting a first and a second probe with the biological sample, where the first probe and the second probe each include one or more sequences that are substantially complementary to sequences of the analyte, and where the second probe includes a capture probe capture domain [“first” or “second” does not matter so long as one of the probes contains the capture domain], see page 2, lines 12-15; also “capture probe of the plurality includes: (i) a spatial barcode; and (ii) a capture domain”, page 2, lines 11-12), and wherein the first and second probes hybridize adjacent to each other on the target analyte from the biological sample (“hybridizing the first probe and the second probe to the analyte”, page 2, line 16);
ligating the first and second probe, thereby generated a ligation product (“(d) generating a ligation product by ligating the first probe and the second probe to the analyte”, page 2, lines 16-17); and
releasing the ligation product from the target analyte (“releasing the ligated product from the analyte”, page 2, lines 17-18), thereby allowing the capture probe binding domain of the ligation product to hybridize to the capture domain of the capture probe on the spatial gene expression array (“hybridizing the ligation product to the capture domain”, page 2, lines 17-18).
With regard to claims 1, 3 and 4, the artisans also teach extending the capture probe and the ligation product against each other (see Figure 7), releasing, amplifying and sequencing the released product (“ligation product can then be captured by capture probes … on an array, optionally amplified, and sequenced, thus determining the location and optionally the abundance of the analyte in the biological sample”, page 20, lines 18-20).
With regard to claim 22, the sample is biopsy, or fixed and/or stained biological sample (“subject for analysis using any of a variety of techniques including, but not limited to biopsy, surgery … tissue section …”, page 11, lines 23-26).
With regard to claims 24 and 25, the analytes are mRNA (see above).
Chell et al. explicitly teach that their method is can be utilized for assaying analytes of cancer (“targeted RNA capture can detect genes that are overexpressed or underexpressed in cancer”, page 27, lines 2-3), such as prostate cancer (“cancer is … prostate cancer”, page 70, lines 17-22).
Chell et al., however, do not explicitly teach the marker analytes presently recited in claim 1.
Chell et al. do not teach that that the gene expressions of the markers are compared against reference sample (claim 17) or that the prostate cancer is adenocarcinoma (claim 18).
Chell et al. do not explicitly teach staining and imaging of the sample (claim 19), said stain being hematoxylin and eosin (claim 20), or optical labels (claim 21).
Larkin et al. teach a well-known knowledge of ANPEP and PSCA being useful as an expression marker for prostate cancer:
“The aim of our study was to identify putative PCa [Prostate Cancer] progression markers by using a panel of 91 genes and assessing levels in PCa tissue” (page 158, 1st column)
“The six genes that were best used to model PCa progression included: ANPEP, EFNA1, INMT, HSPB1, and PSCA” (page 161, 2nd column)
Shaheduzzman et al. also teach a well-known means of staining the sample tissue with H&E (page e2, 1st column, bottom paragraph) and optical labels (IHC).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Chell et al. with the teaching of Larkin et al. and Shaheduzzaman et al., thereby arriving at the invention as claimed for the following reasons.
The rationale to combine known elements for the same known endeavor has long been recognized by the courts:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
With an explicit suggestion made by Chell et al. who suggest that the disclosed method could be adopted to assay for markers and their expression levels associated with prostate cancer, and the prior art knowledge of the ANPEP and PSCA being useful prostate cancer markers, one of ordinary skill in the art would have been motivated to include such prior art known genes in a method of assaying for markers and their levels which are associated with prostate cancer for the purpose of determining a subject’s status, yielding no more than a predictable outcome.
Lastly with regard to the prostate cancer being adenocarcinoma, one of ordinary skill in the art would have recognized well-enough that the prostate cancer was typically adenocarcinoma in nature (more prevalent case) and thus would have had a reasonable expectation of success at determining such a type of cancer in the prostate cancer sample.
In KSR, the Supreme Court particularly emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art,” Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chell et al. (WO 2021/133849 A1, published July 2021) in view of Larkin et al. (British Journal of Cancer, 2012, vol. 106, pages 157-165) and Shaheduzzaman et al. (Cancer Biology & Therapy, 2007, vol. 7, pages e1-e8), as applied to claims 1-4, 17-22, 24, and 25 above, and further in view of Pascal et al. (BMC Cancer, 2009, vol. 9, pages 1-15).
The teachings of Chell et al., Larkin et al., and Shaheduzzaman et al. have already been discussed above.
Chell et al., Larkin et al. and Shaheduzzaman et al. do not explicitly disclose all possible sample types and markers associated with prostate cancer.
Consequently, Chell et al., Larkin et al. and Shaheduzzaman et al. do not teach that the sample is a luminal cell and that the markers associated with the prostate cancer are CD24, KRT8, or KRT18.
Pascal et al. teach that gene markers CD24 is differentially expressed (i.e., increased) between prostate tumor when compared against normal luminal cell (“increased CD24 … compared to luminal cells”, page 5, 1st column, 2nd para; see also Figure 3), as well as KRT 8 and KRT18 (“KRT … relative expression levels of luminal cells KRT8 and KRT18 were increased in G3 and G4 …”, page 11, 1st column).
Pascal et al. teach that differentiation of G3 and G4 are indicative of prostate tumor differentiation:
“Gleason grade is a pathology characterization of prostate tumors. Tumor glands can appear from well-differentiated to poorly differentiated. The degree of differentiation is scaled from 3 to 5 (grade 1 and 2 are no longer in wide use), with 3 to indicate tumors with glandular differentiation, 4 to indicate tumors with aglandular differentiation, and 5 to indicate no differentiation with cancer cells not organized into recognizable structure” (page 2, 1st column)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Chell et al., Larkin et al. and Shaheduzzaman et al. with the teachings of Pascal et al., thereby arriving at the invention as claimed for the following reasons.
The rationale to combine known elements for the same known endeavor has long been recognized by the courts:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
With an explicit suggestion made by Chell et al. who suggest that the disclosed method could be adopted to assay for markers and their expression levels associated with prostate cancer, and the prior art knowledge of the CD24, KRT8, and KRT18 being differentially expressed in prostate cancer, one of ordinary skill in the art would have been motivated to include such prior art known genes in a method of assaying for markers and their levels which are associated with prostate cancer for the purpose of determining a subject’s status, yielding no more than a predictable outcome.
In KSR, the Supreme Court particularly emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art,” Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chell et al. (WO 2021/133849 A1, published July 2021) in view of Larkin et al. (British Journal of Cancer, 2012, vol. 106, pages 157-165) and Shaheduzzaman et al. (Cancer Biology & Therapy, 2007, vol. 7, pages e1-e8), as applied to claims 1-4, 17-22, 24, and 25 above, and further in view of Bankaitis-Davis et al. (WO 2008/121132 A2, published October 2008).
The teachings of Chell et all., Larkin et al., and Shaheduzzaman et al. have already been discussed above.
Chell et al., Larkin et al. and Shaheduzzaman et al. do not explicitly disclose all possible sample types and markers associated with prostate cancer.
Consequently, Chell et al., Larkin et al. and Shaheduzzaman et al. do not teach that the sample is a immune cell and that the markers associated with the prostate cancer recited in claim 6.
Bankaitis-Davis et al. teach that gene markers that are differentially expressed in prostate cancer in cells (“invention is based in part upon the identification of gene expression profiles … associated with prostate cancer”, page 3, lines 9-10), wherein the artisans teach that “constituents are selected to distinguish from a normal reference subject and a prostate-cancer diagnosed subject” (page 9, lines 23-24). The constituents are those gene markers are CD4 and CD8A (see claims 1 and 6(b)(ii)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Chell et al., Larkin et al. and Shaheduzzaman et al. with the teachings of Bankaitis-Davis et al., thereby arriving at the invention as claimed for the following reasons.
The rationale to combine known elements for the same known endeavor has long been recognized by the courts:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
With an explicit suggestion made by Chell et al. who suggest that the disclosed method could be adopted to assay for markers and their expression levels associated with prostate cancer, and the prior art knowledge of the CD4 and CD8A being differentially expressed in prostate cancer, one of ordinary skill in the art would have been motivated to include such prior art known genes in a method of assaying for markers and their levels which are associated with prostate cancer for the purpose of determining a subject’s status, yielding no more than a predictable outcome.
In KSR, the Supreme Court particularly emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art,” Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Claims 16 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Chell et al. (WO 2021/133849 A1, published July 2021) in view of Larkin et al. (British Journal of Cancer, 2012, vol. 106, pages 157-165) and Shaheduzzaman et al. (Cancer Biology & Therapy, 2007, vol. 7, pages e1-e8), as applied to claims 1-4, 17-22, 24, and 25 above, and further in view of Magbanua et al. (Journal of Clinical Oncology: Meeting Abstract, May 20, 2010, pages ).
The teachings of Chell et al., Larkin et al. and Shaheduzzaman et al. have already been discussed above.
None of the artisans explicitly state that their sample was from serially obtained biological sample and different time points (claim 16), or that the sample comprises serial tissue sections of serial biopsies (claim 23).
Magbanua et al. demonstrate a well-known practice of taking serial sections of tissues when analyzing patient specimen, such as for cancers:
“cDNA microarray expression profiles from pretreatment biopsy (T1) were compared to those biopsy specimen obtained 24-72 hours after initiation of treatment (T2) or in tumors surgically removed after chemotherapy (TS)” (page 1, Methods)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Chell et al., Larkin et al. and Shaheduzzaman et al. with the teachings of Magbanua et al., thereby arriving at the invention as claimed for the following reasons.
The rationale of obviousness is based on the combination of practice known in the art which is routine and convention, yielding no more than a predictable outcome as discussed in KSR.
In KSR, the Supreme Court particularly emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art,” Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
One of ordinary skill in the art would have had no more than a predictable outcome of analyzing for the prostate markers observed from samples which have been serially obtained so as to monitor the progression of the disease, or the effectiveness of a treatment, a practice which have been routinely performed in the art of molecular diagnostics.
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
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. 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.
The rejection of claims 1-6 and 16-251 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,505,828, made in the Office Action mailed on August 20, 2025 is maintained for the reasons of record.
Applicants did not present any arguments for this rejection. Therefore, the rejection is maintained for the reasons already of record.
The Rejection:
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘828 patent is directed to a method of using a spatial gene expression array as presently claimed, for the purpose of assaying samples such as tissue samples. While the claims of the ‘828 patent did not explicitly claim a method of detecting prostate cancers as presently recited in the instant application, the application of such a method for the analysis of prior art known gene marker levels which are correlated with cancers, such as prostate cancer, would have been an obvious application as detailed above, for such prostate cancer gene markers have been characterized in the prior art.
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Conclusion
No claims are allowed.
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.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 February 25, 2026
/YJK/
1 Claim preamble contained a typographical error in reciting that claims 1-25 were rejected, however, the record as a whole is clear that claims 9-15 are withdrawn from further consideration for being directed to non-elected invention.