Prosecution Insights
Last updated: October 02, 2026
Application No. 17/822,332

TARGETED MEASURE OF TRANSCRIPTIONAL ACTIVITY RELATED TO HORMONE RECEPTORS

Final Rejection §103§112§DP
Filed
Aug 25, 2022
Priority
Apr 29, 2016 — provisional 62/329,774 +2 more
Examiner
JOHANNSEN, DIANA B
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Yale University
OA Round
4 (Final)
53%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 53% of resolved cases
53%
Career Allowance Rate
269 granted / 506 resolved
-6.8% vs TC avg
Strong +43% interview lift
Without
With
+42.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
32 currently pending
Career history
549
Total Applications
across all art units

Statute-Specific Performance

§101
18.0%
-22.0% vs TC avg
§103
25.3%
-14.7% vs TC avg
§102
12.2%
-27.8% vs TC avg
§112
37.6%
-2.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 506 resolved cases

Office Action

§103 §112 §DP
FINAL ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the Amendment and Response filed 11 May 2026. Claims 1, 6, and 12-25 have been amended, (non-elected) claims 2-5 and 7-8 have been canceled, and claims 26-31 have been added. Claim 6 remains withdrawn (see paragraphs 5-7 below), and claims 1 and 12-31 are now under consideration. Applicant’s amendments and arguments have been thoroughly reviewed, and have overcome the following objections/rejections set forth in the prior Office action: The rejections of claims under 35 USC 112(b) in view of Applicant’s clarifying amendments (although it is noted that the amended/new claims remain indefinite for the reasons given below); and The rejection of claims under 35 USC 103 as being unpatentable over Reeve et al in view of Nilsson et al, in view of Applicant’s amendments to the claims (and particularly the amendment adding several additional genes to the recited group of target genes [see (b) of independent claims 1 and 17], and the requirement that each probe of the “set” of the claims “specifically hybridize to” one of the recited target genes (as a result of which amendments different closest prior art now applies against the claimed invention, as set forth below). Claims 1 and 12-31 are rejected for the reasons given below, which include new grounds of rejection necessitated by Applicant’s amendments. Any rejections and/or objections not reiterated in this action have been withdrawn. This action is FINAL. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Election/Restrictions Applicant’s election without traverse of MAPT, CD2, and QDPR (currently recited in (b) of each of independent claims 1 and 17) and LDHA (currently recited in (c) of independent claim 17) in the reply filed on 18 February 2025 is acknowledged. It is noted that MAPT, CD2, and QDPR are now recited in each of the independent claims as members of an 18 gene group (as compared to the 10 gene group recited in the version of the claims addressed in the prior Office action mailed 10 February 2026). The prior art continues to apply against the elected species (with the claim language requiring that MAPT, CD2, and QDPR be among a group of genes selected from the noted larger grouping of 18 genes). Claim 6 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 February 2025. Claims 1 and 12-31 are now under consideration herein as directed to the elected species identified above. Claim Rejections - 35 USC § 112(b)/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. THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS: Claims 1 and 12-31 are rejected 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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 1, 12-16, and 19-25 are indefinite over the recitation in claim 1 of the limitation “composition comprising…..(b) a set of nucleic acid probes consisting of”, while claims 17-18 and 26-31 are indefinite over the recitation in independent claim 17 of the same language (“composition comprising….(b) a set of nucleic acid probes consisting of….”). Initially, it is noted that claim 1 was previously directed to a “mixture comprising” the nucleic acids of (a) and “nucleic acid probes….for detecting mRNA expression levels of at least ten” of a recited group of genes (as set forth in (b)); thus, the nucleic acids of the claim and the probes of the claim were required to be present together in a “mixture”, and the term “set” was not used in reference to the probes. However, the claims now under consideration more broadly recite a “composition comprising” nucleic acids and probes – i.e., the claims are no longer limited to a “mixture”, but encompass any “composition” - but subsequently recite at (b) a “set of nucleic acid probes consisting of….” 10, 11, 12, 13, 14, 15, 16, 17, or 18 nucleic acid probes…” Given the use of the open transitional language “comprising”, as well as the fact that the claims – particularly given the explicit inclusion of “at least one” additional probe(s) as recited in c) of independent claim 17 – may include additional probes (as well as any other additional materials, again given the recitation of a “composition comprising” the recited components), it is unclear how the requirement for a “set of nucleic acid probes consisting of….” actually limits what is claimed. More particularly, it is not clear what characteristics might characterize a “set of probes…consisting of” a particular grouping of probes in the context of a “composition” that is claimed as “comprising” the set, and which composition also may include additional probes (again, as is apparent from the language of independent claim 17). Accordingly, further clarification is needed to ensure that the boundaries of the claims are clear. Claims 21-23 are each indefinite over the recitation of the language “wherein the marker is….” (followed by a recitation of a further more specific type of “marker”) because claim 1, from which the claim depend, recites a “set of nucleic acid probes…..each labeled with a marker”, such that multiple markers are required by the language of claim 1. There is no single particular marker in claim 1 that clearly meets the requirements of being “the marker”, and claims 21-23 may thus reasonably be interpreted in multiple ways, such as requiring that any one marker be of the recited further type, that all markers (or some markers) be of the recited further type, etc. Clarification is therefore required to ensure that the manner in which claims 21-23 further limit independent claim 1 is clear. Claims 27-29 are indefinite over the recitation of the limitations “wherein the marker in (b) and/or (c) is” in claims 27-28 and the similar language “wherein the marker in (b) or (c) is” in claim 29. As was the case with claims 21-23 relative to independent claim 1(see above), claim 17 (from which claims 27-29 depend) encompasses multiple probes – in this case at least 10 probes referenced in (b), and one or more in (c) – each of which is labeled with a “marker”. Thus, there is no single particular marker referenced in either (b) or (c) that is clearly “the marker” of (b)/“the marker” of (c), and it is not clear whether the further recitations of claim 27-29 apply to any marker of (b) and any marker of (c), all/each or some such markers, etc. Further clarification is therefore needed. Claim Rejections - 35 USC § 103 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. 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. THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS: Claim(s) 1, 12-16, and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gehrmann et al (WO 2010/003773 A1 [14 Jan 2010]; cited herein) in view of Abba et al (Mol Cancer Res 5(9):881 [2007]; cited herein). Gehrmann et al teach methods “for predicting an outcome of cancer in a patient suffering from cancer”, which method particularly apply to node-positive, previously treated breast cancer (see entire reference, particularly the Abstract and pages 17-18). Gehrmann et al’s methods comprising determining in a biological sample from a patient expression levels of plurality of genes selected from preferred gene groupings (again, see the entire reference, particularly the Abstract and pages 17-18). Gehrmann et al teach that quantitative reverse transcriptase PCR “is currently the accepted standard for quantifying gene expression” (page 5), and further teach that their methods typically employ isolated nucleic acids from samples and quantitative RT-PCR of their preferred genes normalized relative to housekeeping genes (or “microarray-based technologies”), with primer and probe mixes being employed in RT-PCR (see, e.g., pages 23-24, and the Examples at pages 28-29). Gehrmann et al disclose employing in their methods an “RT-PCR Assay set up for 1 well” that includes sample RNA and a primer/probe mix – thus disclosing a composition contained in a well that includes sample nucleic acids and primers/probes, and inherently disclosing a larger structure/plate including such wells (another type of “composition” including the recited reagents/materials) - such that Gehrmann et al both disclose and exemplify compositions including sample nucleic acids and primers/probes targeting their disclosed genes for hybridization and amplification in a manner that requires “specific” hybridization to achieve successful detection. Among the most preferred groups of genes from which target genes are to be selected for use in the methods of Gehrmann et al are several genes of the 18 gene group of instant claim 1, including MAPT (one of Applicant’s elected genes), ESR1, CA12, NAT1, SLC39A6, and SCUBE2 (see, e.g., pages 17-18 and 27). Gehrmann et al also disclose several groups of additional genes that may be targeted via their methods, which additional gene groupings include CD2 (another gene of Applicant’s elected species), CD3D, STC2, ABAT, ADCY1, and MRPS30 (see pages 48-53). As Gehrmann et al teach that all of their disclosed genes function as targets that are informative with regard to breast cancer (and particularly node-positive breast cancer), and the detection of their genes via method employing compositions comprising target nucleic acids from a sample and primers/probes that must hybridize specifically to a corresponding target gene to function in detection thereof, Gehrmann et al’s teachings thus suggest compositions meeting the requirements of claim 1 as directed to the group of genes identified above (meeting the requirement for 10/11/12 of the 18 gene grouping recited in claim 1). However, Gehrmann et al do not teach inclusion in such compositions of a probe and/or primer(s) targeting the elected gene QDPR (and thus do not suggest all limitations of the claims as directed to the elected species presently under consideration). Abba et al, like Gehrmann et al, teach groups of genes whose expression is informative with regard to breast cancer prognosis, with Abba et al focusing in particular on lymph node metastasis (see entire reference). Like Gehrmann et al, Abba et al teach that real-time RT-PCR may successfully be employed in measuring gene expression levels using nucleic acids from breast cancer samples (see, e.g., page 883, right column, first full paragraph and page 888, right column, first full paragraph), and among the informative genes taught by Abba et al is QDPR (i.e., the third gene of Applicant’s elected species that is recited in independent claim 1), with Abba et al teaching that altered QDPR expression is associated with poor breast cancer prognosis (see e.g., Table 2 on page 884). Abba et al also more generally teach that identification of gene expression profiles (as well as individual biomarkers) for the development of lymph node metastasis “will be of significant benefit to improve tumor classification and may, in the future, influence clinical decision making and the development of targeted therapies” (page 881, right column bridging to page 882, left column), and that gene expression profiling “will likely add substantial information that may help in better defining breast cancer outcome classes” (page 887, left column, first full paragraph). In view of the teachings of Gehrmann et al and Abba et al, 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 have prepared a composition comprising nucleic acids from a biological sample of a subject and a “set”/combination of 10/11/12/13 probes including probes specifically hybridizing to 10/11/12/13 of the genes of independent claim 1, including the elected genes MAPT and CD2 (as taught by Gehrmann et al) and QDPR (as taught by Abba et al). It is reiterated that claim 1 is indefinite and not clearly limited with regard to the number of probes that may be present in the claimed “composition comprising” the recited elements of the claim. As each of these genes is disclosed as exhibiting altered expression in breast cancer (and particularly with both references focusing on analysis of node-positive breast cancer), and given Abba et al’s teaching regarding the benefits of performing gene expression profiling with regard to such genes, an ordinary artisan would have been motivated to have studied all of these genes – and thus to have prepared a composition meeting the requirements of the claims - for any of the benefits of profiling such genes in a particular subject with breast cancer, assisting in forming a diagnosis/prognosis for such a subject, evaluating therapy response in such a subject, etc. Further (and particularly given that the claims merely require a composition having the features specified in the claims, i.e., no particular method or use of the claimed compositions is required), an ordinary artisan would have had a reasonable expectation of success in preparing compositions meeting the requirements of the claims. Regarding dependent claims 12-14, as well as dependent claims 24-25, it is reiterated that both Gehrmann et al and Abba et al teach testing samples from a breast cancer/samples from humans with breast cancer (as set forth above). With further regard to hormone receptor positive (HR+), and specifically estrogen receptor positive (ER+) breast cancer (as recited in claims 13-14), Gehrmann et al further teach classifying tested samples with respect to HR status, including a disclosure of having tested ER+ samples (see, e.g., page 23), and Abba et al also disclose knowledge of ER status (see, e.g., page 882, right column); thus, the teachings of Gehrmann et al and Abba et al suggest samples meeting the requirements of claims 13-14. Regarding dependent claims 15-16 and 19, these claims recite more particular intended uses for the claimed compositions. As Gehrmann et al and Abba et al both teach quantitative real-time PCR, the compositions suggested by Gehrmann et al in view of Abba et al are capable of being used in the manner set forth in the claims. Regarding dependent claim 20, it is reiterated that Gehrmann et al in view of Abba et al teach the use of primers (as well as probes), as discussed above. Regarding claims 21-23, Gehrmann et al further teach that their probes may be labeled in a variety of ways, including via the use of biotin, a fluorophore, or other well-known labels (which labels also meet the requirements for “a tag” (see page 14 bridging to page 15); thus, the teachings of Gehrmann et al in view of Abba et al also suggest compositions comprising probes labeled as specified in claims 21-23. Claim(s) 17-18 and 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Gehrmann et al in view of Abba et al, as applied to claims 1, 12-16, and 19-25, above, and further in view of Oyolu et al (Stem Cells 30:580-584 [2012]; cited herein). The relevant teachings of Gehrmann et al and Abba et al are set forth above. While Gehrmann et al teach several possible housekeeping genes that may be employed as reference genes in RT-PCR (see page 29), neither Gehrmann et al nor Abba et al teach the elected reference gene LDHA (as is set forth in c) of independent claim 17). Oyolu et al teach that LDHA is among a small group of housekeeping genes whose expression can also be “leveraged to distinguish between human cell types” (see entire reference, particularly the Abstract). In view of the teachings of Oyolu et al, 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 have prepared a composition further comprising a probe (and or primer(s)) targeting LDHA (in addition to nucleic acids from a biological sample of a subject and a “set”/combination of 10/11/12/13 probes including probes specifically hybridizing to 10/11/12/13 of the genes of b) of independent claim 17, as are suggested by Gehrmann et al in view of Abba et al). An ordinary artisan would have been motivated to have made such a modification by the teaching of Oyolu et al that LDHA is a housekeeping gene that provides an additional benefit of aiding in cell type differentiation (such that probes/primers targeting LDHA could be employed in multiple different ways, thus providing an extra benefit to practitioners). Again, it is noted that the present claims are draw to a “composition comprising” the recited components (and are not limited with regard to how a practitioner may choose to use those materials). Given the teachings of the cited art, an ordinary artisan also would have clearly had a reasonable expectation of success in preparing such compositions (as all that is required is adding an additional probe/primer to the composition). Regarding dependent claim 18, this claim recites more particular intended uses for the claimed compositions. As Gehrmann et al and Abba et al both teach quantitative real-time PCR, the compositions suggested by Gehrmann et al in view of Abba et al and Oyolu et al are capable of being used in the manner set forth in the claims. Regarding dependent claim 26, it is reiterated that Gehrmann et al in view of Abba et al and Oyolu et al teach the use of primers (as well as probes), as discussed above. Regarding claims 27-29, Gehrmann et al further teach that their probes may be labeled in a variety of ways, including via the use of biotin, a fluorophore, or other well-known labels (which labels also meet the requirements for “a tag” (see page 14 bridging to page 15); thus, the teachings of Gehrmann et al in view of Abba et al and Oyolu et al also suggest compositions comprising probes labeled as specified in claims 21-23. Regarding dependent claims 30-31, it is reiterated that both Gehrmann et al and Abba et al teach testing samples from a breast cancer/samples from humans with breast cancer (as set forth above), such that the combined teachings of Gehrmann et al, Abba et al, and Oyolu et al suggest compositions as claimed. 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 FOLLOWING ARE NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS: Claims 1 and 12-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-83 of copending Application No. 19/473,231 (not yet published; projected publication date 10 September 2026) in view of Gehrmann et al (WO 2010/003773 A1 [14 Jan 2010]; cited herein). The ‘231 claims recite methods comprising extracting molecules from a biological sample, and quantitating expression levels therein of a group of hormone receptor genes and at least one reference gene, wherein the quantitating employs RNA transcripts (see, e.g., text of claim 1). Preferred samples set forth in the ‘231 claims are breast cancer samples, including ER+ samples (see, e.g., claims 6-8), and preferred embodiments of the methods of the ‘231 claims employ RT-qPCR (see, e.g., claim 37). Instant independent claims 1 and 17 are directed compositions including “nucleic acids from a biological sample of a subject” and a “set of nucleic acid probes….for detecting mRNA expression levels”, said probe set including probes targeting the identical group of genes of the ‘231 claims; instant claim 17 further recites inclusion of “at least one nucleic acid probe or probes” for detecting mRNA of at least one reference gene selected from the same group of reference genes set forth in the ‘231 claims. The ‘231 claims thus set forth methods in which biological sample nucleic acids are necessarily contacted with reagents so as to quantitate those nucleic acids, preferably via RT-PCR; however, the ‘231 claims do not specify the use of probes (or primers) as set forth in the instant claims, and thus do recite all limitations of the present claims. However, Gehrmann et al teach methods “for predicting an outcome of cancer in a patient suffering from cancer”, which method particularly apply to node-positive, previously treated breast cancer (see entire reference, particularly the Abstract and pages 17-18). Gehrmann et al’s methods comprising determining in a biological sample from a patient expression levels of plurality of genes selected from preferred gene groupings (again, see the entire reference, particularly the Abstract and pages 17-18). Gehrmann et al teach that quantitative reverse transcriptase PCR “is currently the accepted standard for quantifying gene expression” (page 5), and further teach that their methods typically employ isolated nucleic acids from samples and quantitative RT-PCR of their preferred genes normalized relative to housekeeping genes (or “microarray-based technologies”), with primer and probe mixes being employed in RT-PCR (see, e.g., pages 23-24, and the Examples at pages 28-29). Gehrmann et al disclose employing in their methods an “RT-PCR Assay set up for 1 well” that includes sample RNA and a primer/probe mix – thus disclosing a composition contained in a well that includes sample nucleic acids and primers/probes - such that Gehrmann et al both disclose and exemplify compositions including sample nucleic acids and primers/probes targeting their disclosed genes for hybridization and amplification in a manner that requires “specific” hybridization to achieve successful detection. (It is also noted that Gehrmann et al teach several of the genes set forth in both the instant claims and the ’231 claims, including MAPT, ESR1, CA12, NAT1, SLC39A6, and SCUBE2 (see, e.g., pages 17-18 and 27), and CD2, CD3D, STC2, ABAT, ADCY1, and MRPS30 (see pages 48-53). In view of the teachings of the ‘231 claims and Gehrmann et al, it would have been prima facie obvious to one of ordinary skill in the art to have prepared compositions meeting the requirements of the present claims, simply by employing the probes (and/or primers) necessary to practice the method steps of the ‘231 claims (as taught by Gehrmann et al) in such methods (resulting in formation of a “composition” meeting the requirements of the claims). Accordingly, the compositions of the instant claims are not patentably distinct from the ‘231 claims. Regarding dependent claims 12-14, as well as dependent claims 24-25 and 30-31, it is reiterated that the ‘231 claims recite breast cancer samples (as well as ER+ breast cancer) (and it is also noted that Gehrmann et al further teach classifying tested samples with respect to HR status, including a disclosure of having tested ER+ samples (see, e.g., page 23). Regarding dependent claims 15-16 and 18-19, these claims recite more particular intended uses for the claimed compositions, which preferred intended use corresponds to the technique recited in the ‘231 claims (see again, e.g., claim 37-38), such that the ‘231 claims suggest an intended use as set forth in the instant claims. Regarding dependent claims 20 and 26, it is reiterated that Gehrmann et al teaches the use of primers (as well as probes), as discussed above. Regarding claims 21-23 and 27-29, Gehrmann et al further teach that their probes may be labeled in a variety of ways, including via the use of biotin, a fluorophore, or other well-known labels (which labels also meet the requirements for “a tag” (see page 14 bridging to page 15); thus, these claimed inventions also would have been obvious to one of ordinary skill in the art over the ‘231 claims in view of the teachings of Gehrmann et al. Accordingly, instant claims 1 and 12-31 are not patentable distinct from the ‘231 claims. This is a provisional nonstatutory double patenting rejection. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA B JOHANNSEN whose telephone number is (571)272-0744. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm 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, Wu-Cheng Winston Shen can be reached at (571) 272-3157. 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. /DIANA B JOHANNSEN/Primary Examiner, Art Unit 1682
Read full office action

Prosecution Timeline

Show 4 earlier events
Oct 02, 2025
Examiner Interview Summary
Dec 09, 2025
Final Rejection mailed — §103, §112, §DP
Jan 15, 2026
Request for Continued Examination
Jan 18, 2026
Response after Non-Final Action
Feb 10, 2026
Non-Final Rejection mailed — §103, §112, §DP
Apr 28, 2026
Examiner Interview Summary
May 11, 2026
Response Filed
Aug 04, 2026
Final Rejection mailed — §103, §112, §DP (current)

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Prosecution Projections

5-6
Expected OA Rounds
53%
Grant Probability
96%
With Interview (+42.8%)
4y 0m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 506 resolved cases by this examiner. Grant probability derived from career allowance rate.

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