Prosecution Insights
Last updated: July 17, 2026
Application No. 19/264,527

SPATIALLY ENCODED BIOLOGICAL ASSAYS

Final Rejection §103§112
Filed
Jul 09, 2025
Priority
Apr 05, 2010 — provisional 61/321,124 +14 more
Examiner
CROW, ROBERT THOMAS
Art Unit
1683
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Prognosys Biosciences Inc.
OA Round
2 (Final)
42%
Grant Probability
Moderate
3-4
OA Rounds
2y 11m
Est. Remaining
73%
With Interview

Examiner Intelligence

Grants 42% of resolved cases
42%
Career Allowance Rate
296 granted / 712 resolved
-18.4% vs TC avg
Strong +32% interview lift
Without
With
+31.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
50 currently pending
Career history
758
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
57.0%
+17.0% vs TC avg
§102
1.5%
-38.5% vs TC avg
§112
11.5%
-28.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 712 resolved cases

Office Action

§103 §112
FINAL ACTION Notice of Pre-AIA or AIA Status 1. The present application is being examined under the pre-AIA first to invent provisions. Amendments and Status of the Claims 2. This action is in response to papers filed 27 March 2026 in which the specification and claims 21, 25-26, 33-35, and 37-40 were amended, claims 32 and 36 were canceled, and no new claims were added. All of the amendments to the claims have been thoroughly reviewed and entered. Any previous rejections not reiterated below are withdrawn in view of the amendments and/or the Terminal Disclaimer discussed below. Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections necessitated by the amendments. 3. Claims 21-31, 33-35,and 37-40 are under prosecution. 4. This Office Action includes new rejections necessitated by the amendments. Terminal Disclaimer 5. The terminal disclaimer filed on 27 March 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patents 10,662,468, 11,001,879, 11,549,138, and 11,761,030, and U.S. Patent Application Nos. 19/264,491, 18/516,576, 19/021,568, and 19/021,991 has been reviewed and is accepted. The terminal disclaimer has been recorded. Interview Summary 6. The interview summary is acknowledged and the interview record is complete. Information Disclosure Statement 7. The Information Disclosure Statement filed 27 March 2026 is acknowledged and has been considered. Specification 8. The substitute specification filed 27 March 2026 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: the marked up Specification is not properly labeled as such nor is the clean copy properly labeled. Claim Rejections - 35 USC § 112 9. The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 10. Claims 21-31, 33-35, and 37-40 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection necessitated by the amendments. A. Claim 21 (upon which clams 22-31, 33-35,and 37-40 depend) recites each of the following: I. The claimed first oligonucleotide (complementary to a target) and the second oligonucleotide (having a location sequence). The claim encompasses each capture area having the first and second nucleic acids only comprising the target region and the locations region, respectively. A review of at least parent Application 15/187,667 (which is the oldest application in the continuity chain; henceforth the “598 Patent) does not yield teachings of this embodiment. It is noted that while Figures 3 and 4 of the ‘598 Patent each teach pairs of probes, they do not support the presently claimed embodiments. II. Capture areas comprising a second sequence that identifies a location. A review of the “598 Patent only yields teachings where the location probe is delivered to the substate after parent analytes/biological samples have been delivered (e.g., Figures 1 and 2), and does not support location sequences prior to fixing the sample to a support. B. Claim 38 recites tissue section that are “fresh frozen.” While the ‘598 Patent recites fresh samples and frozen samples, the ‘598 Patent does not teach sections that are “fresh frozen.” Thus, because the cited limitations are missing from at least the ‘598 patent, the limitations constitute new matter. Claim Rejections - 35 USC § 103 11. 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. 12. Claims 21, 24-26, 33-35, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) and Baidya et al. (U.S. Patent No. US 6,716,579 B1, issued 6 April 2004). Regarding claim 21, Kincaid teaches a composition comprising a substrate having a plurality of capture areas (i.e., features of a microarray; Abstract), each comprising an oligomer test probe 112 (Abstract, Figure 5, and paragraphs 0083-0084), which is complementary to a nucleic acid analyte (i.e., a polynucleotide analyte; paragraphs 0052-0053) and a second oligonucleotide that identifies a location of the substrate, in the form of control probe 101 that generates a control signal that is unique to the feature on the microarray (Abstract, Figure 5, and paragraphs 0083-0084t). Each capture area of the microarray comprises the claimed pair of oligonucleotides (Figure 5 and paragraph 0084). Kincaid also teaches the second (i.e., control) probe is labeled (Abstract), that the label is a primer for amplification or ligation (paragraph 0064). Kincaid further teaches: At least one feature has a different control probe sequence (paragraph 0081); The labels for the various control signals are different from one another and different from the labels associates with the test probe and target signals (paragraph 0076); The signal emitted from the control label is unique to the control probe and is distinguishable from any other signals emitted from the microarray (paragraph 0075); Labeled control targets hybridize to the control probes, resulting in at least two signals for each feature (paragraph 0020) Thus, at least one capture area comprises a second (control) oligonucleotide that corresponds to a location of the pair of nucleic acids in the at least one capture area on the substrate. Because the sequence of the second oligonucleotide is different (paragraph 0081), the signal therefrom corresponds specifically to that capture area. It is noted that the claim does not necessarily require each capture area to have more than one pair of probes. Thus, because there is at least a pair of oligonucleotides at each feature, two (i.e., at least one) capture areas comprise more than one pair of first and second oligonucleotides, in particular since one feature has a different second probe as discussed above. Kincaid also teaches the compositions have the added advantage of allowing normalization of signal trends across the array of capture areas (Abstract). Thus, Kincaid teaches the known techniques discussed above. Kincaid does not teach tissues. However, Baidya et al. teach arrays comprising a plurality polynucleotide probes (column 11, lines 1-30) and contacting the array with a test subject (column 12, lines 25-40), wherein the test subject is a tissue section (column 12, lines 50-65). Baidya et al. also teach the compositions have the added advantage of detecting differential expression of multiple gene transcripts (Abstract). Thus, Baidya et al. teach the known techniques discussed above. It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the cited prior art to arrive at the instantly claimed composition with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a composition having the added advantage of allowing normalization of signal trends across the array of capture areas as explicitly taught by Kincaid (Abstract) and allowing detection of differential expression of multiple gene transcripts as explicitly taught by Baidya et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in compositions useful for nucleic acid detection. Regarding claim 24, the composition of claim 21 is discussed above. Kincaid also teaches the compositions further includes a fiducial marker (paragraph 0006). Thus, it would have been obvious to include a fiducial marker. Regarding claims 25-26, 33-35, and 38, the composition of claim 21 is discussed above. The instant claims refer to the target nucleic acid and the tissue, which are not actually part of the claimed composition, and thus do not further limit the composition. In addition, Baidya et al. teaches the immobilized probes are generated from genomic DNA (Example 1). Thus, it would have been obvious to have genomic DNA targets (i.e., claims 25 and 34). Baidya et al. also teach RNA transcripts (i.e., claims 26 and 34; column 5, lines 35-40). Because Baidya et al also teach the sample is from a tissue section as discussed above, it would have been obvious to have the target RNA from a tissue section (i.e., claim 35). Baidya et al also teach including sequences common to RNA transcripts; i.e., the targets are selected using oligo-dT primers (column 13, lines 1-15). Thus it would have been obvious to have RNA transcripts having poly-A tails, which are common to RNA transcripts (i.e., claim 33). Further, with respect to claims 25-26, Kincaid teaches the nucleic acid analyte is a mRNA (paragraph 0043), and with respect to claim 34, Kincaid teaches gene specific targets (paragraph 0043). Thus, it would have been obvious to have the first oligonucleotide be complementary to any of the instantly claimed target nucleic acids. 13. Claims 22, 27, 29, 31, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) and Baidya et al. (U.S. Patent No. US 6,716,579 B1, issued 6 April 2004) as applied to claim 21 above, and further in combination with Ahmadian et al. (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006). Regarding claims 22, 27, 29, 32, and 40, the composition of claim 21 is discussed above in Section 12. Kincaid teaches mRNA targets (i.e., the RNA transcripts of claim 40; paragraph 0043), the second oligonucleotide (i.e., a control probe) is labeled (Abstract) and that the label is a primer (i.e., claims 29 and 40; paragraph 0064). The previously cited prior art does not teach slides (i.e., claims 22 and 40) or primers in the first oligonucleotide (i.e., claims 27 and 40). However, Ahmadian et al. teach compositions (i.e., microarrays; Abstract) comprising each of the following: Substrates that are slides (i.e., claims 22 and 40; paragraph 0078); and First oligonucleotides (i.e., target probes) having a primer binding site (i.e., claims 27 and 40; paragraph 0028); Ahmadian et al. also teach the compositions allow for multiplex extension of variant target bases (paragraph 0083). Thus, Ahmadian et al. teach the known techniques discussed above. It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Ahmadian et al. with Kincaid and Baidya et al. to arrive at the instantly claimed compositions with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in compositions having the added advantage of allowing for multiplex extension of variant target bases as explicitly taught by Ahmadian et al. (paragraph 0083). In addition, it would have been obvious to the ordinary artisan that Kincaid in combination with Baidya et al. could have been modified with the known techniques of Ahmadian et al. with predictable results because the known techniques of Ahmadian et al. predictably result in microarray probes useful for nucleic acid detection. Regarding claim 31, the composition of claim 29 is discussed above. Kincaid teaches the second oligonucleotide (i.e., a control probe) is labeled (Abstract), that the label is a primer (paragraph 0064), and that the signal provided by the label in unique (paragraph 0075). Kincaid also teach the control probes do not interfere with target hybridization (paragraph 0016). Thus, it would have been obvious to have a unique primer sequence on the second oligonucleotide. Ahmadian et al. teach the first oligonucleotides (i.e., probes having target primers) have unique sequence tags (paragraph 0092). Thus, it would have been obvious to have each target binding region have a different primer. 14. Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) and Baidya et al. (U.S. Patent No. US 6,716,579 B1, issued 6 April 2004) as applied to claim 21 above, and further in combination with Gumbrecht et al. (U.S. Patent Application US 2004/0029203 A1, published 12 February 2004). Regarding claim 23, the composition of claim 21 is discussed above in Section 12. The previously cited prior art does not teach flow cells. However, Gumbrecht et al. teach compositions (i.e., arrays) of DNA probes (paragraph 0005), wherein the arrays are within a flow cell, which has the added advantage of allowing supply volumes for detection to be jointly accessible (paragraph 0013). Thus, Gumbrecht et al. teach the known techniques discussed above. It would therefore have alternatively been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kincaid and Baidya et al. with the teachings of Gumbrecht et al. to arrive at the instantly claimed composition with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a composition having the added advantage of allowing supply volumes for detection to be jointly accessible to the array as explicitly taught by Gumbrecht et al. (paragraph 0013). In addition, it would have been obvious to the ordinary artisan that Kincaid and Baidya et al. could have been modified with the known techniques of Gumbrecht et al. with predictable results because the known techniques of Gumbrecht et al. predictably result in arrays useful for nucleic acid detection. 15. Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003), Baidya et al. (U.S. Patent No. US 6,716,579 B1, issued 6 April 2004), and Ahmadian et al. (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006) as applied to claims 27 and 29 above, and further in view of Willis et al. (U.S. Patent Application Publication No. US 2004/0101835 A1, published 27 May 2004). Regarding claims 28 and 30, the compositions of claims 27 and 29 discussed above in Section 13. None of the previously cited art teaches universal primers. However, Willis et al. teach compositions, in the form of barcoded probe arrays (paragraph 0094), wherein the probes comprise universal priming sites (i.e., claim 28; paragraph 0022), which have the added advantage of allowing multiplex amplification (paragraph 0128). Willis et al. also teach constant regions (i.e., claim 30), which have the added advantage of prohibiting self-hybridization or hairpin formation (paragraph 0159). Thus, Willis et al. teach the known techniques discussed above. It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cited prior art with the teachings of Willis et al. to arrive at the instantly claimed compositions with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in compositions having the added advantage of allowing multiplex amplification and prohibition of self-hybridization and hairpin formation as explicitly taught by Willis et al. (paragraphs 0128 and 0159, respectively). In addition, it would have been obvious to the ordinary artisan that the cited prior art could have been modified with the known techniques of Willis et al. with predictable results because the known techniques of Willis et al. predictably result in probe regions useful for nucleic acid manipulation. 16. Claims 22 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) and Baidya et al. (U.S. Patent No. US 6,716,579 B1, issued 6 April 2004) as applied to claim 21 above, and further in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007). It is noted that while claim 22 is rejected as described above, the claim is also obvious using the interpretation outlined below. Regarding claims 22 and 37, the composition of claim 21 is discussed above in Section 12. The previously cited prior art does not teach gaskets. However, Stanchfield et al. teach compositions comprising microarrays where tissue sections are attached to a slide (i.e., claim 22), and the nucleic acids are then deposited (paragraphs 0003 and 0049. Stanchfield et al. also teach a chamber holding the slide (paragraph 0015), wherein the chamber comprises gasket (paragraph 0035); thus, the tissue section is positioned in the open area of the gasket because it is on the slide, which is surrounded by the gasket (i.e., claim 37). Alternatively, the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04. Thus, any placement of the arrays and the gasket is obvious. MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel’s mere arguments cannot take the place of evidence in the record. It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09. Stanchfield et al. also teach the compositions have the added advantage of maintaining an air-tight seal (paragraph 0035). Thus, Stanchfield et al. teach the known techniques discussed above. It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kincaid and Baidya et al. with the teachings of Stanchfield et al. to arrive at the instantly claimed compositions with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in compositions having the added advantage of maintaining an air-tight seal as explicitly taught by Stanchfield et al. (paragraph 0035). In addition, it would have been obvious to the ordinary artisan that Kincaid and Baidya et al. could have been modified with the known techniques of Stanchfield et al. with predictable results because the known techniques of Stanchfield et al. predictably result in arrays useful for nucleic acid detection. 17. Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) and Baidya et al. (U.S. Patent No. US 6,716,579 B1, issued 6 April 2004) as applied to claim 21 above, and further in view of Erlander et al (U.S. Patent Application Publication No. US 2005/0239079 A1, published 27 October 2005). It is noted that while claim 38 has been rejected as described above, the claim is also obvious using the interpretation outlined below. Regarding claim 38, the composition of claim 21 is discussed above in Section 12. The previously cited prior art does not teach the tissues are formalin-fixed paraffin-embedded tissues. However, Erlander et al teach compositions where tissue sections are screened using an oligonucleotide microarray (paragraphs 0163 and 0170), wherein the tissue samples are formalin-fixed paraffin-embedded tissues (paragraph 0044). Erlander et al. also teach the compositions have the added advantage of allowing comparison of expression profiling between those who respond to a treatment (i.e., TAM) and those who do not (paragraph 0170). Thus, Erlander et al. teach the known techniques discussed above. It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cited prior art with the teachings of Erlander et al. to arrive at the instantly claimed composition with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a composition having the added advantage of allowing comparison of gene expression of responders and non-responders to a drug treatment as explicitly taught by Erlander et al. (paragraph 0170). In addition, it would have been obvious to the ordinary artisan that the cited prior art could have been modified with the known techniques of Erlander et al. art with predictable results because the known techniques of Erlander et al. predictably result in useful sample sources for analyzing gene expression. 18. Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) and Baidya et al. (U.S. Patent No. US 6,716,579 B1, issued 6 April 2004) as applied to claim 21 above, and further in view of Barth et al. (U.S. Patent Application Publication No. 2003/0040011 A1, published 27 February 2003). Regarding claim 39, the composition of claim 21 is discussed above in Section 12. The cited prior art does not teach protection of a portion of the substrate. However, Barth et al. teach array compositions (paragraph 0010), having gaskets thereon, wherein the gaskets surround each location of the microarray (paragraph 0065 and Figure 2), thereby protecting at least a portion of the substrate (i.e., plate 102). Bart et al. also teach the compositions have the added advantage of creating a plurality of sealed reaction cells (paragraph 0058). Thus, Barth et al. teach the known techniques discussed above. It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified gasket of the cited prior art with the teachings of Barth et al. to arrive at the instantly claimed composition with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in composition having the added advantage of creating a plurality of sealed reaction cells as explicitly taught by Barth et al. (paragraph 0058). In addition, it would have been obvious to the ordinary artisan that the cited prior art could have been modified with the known techniques of Barth et al. with predictable results because the known techniques of Barth et al. predictably result in useful microarrays. Response to Arguments 19. Applicant's arguments filed 27 March 2026 (hereafter the “Remarks”) have been fully considered but they are not persuasive for the reasons discussed below. A. Pages 6-7 of the Remarks discuss the amendments and include the Interview Summary. B. Pages 7-11 of the Remarks discuss the previous new matter rejections. I. With respect to the arguments regarding the rejection of claim 21, Applicant cites paragraphs 0092, 0103, and 0115 of the instant specification. However, none of these paragraph appear in the ‘598 Patent. Therefore, because the subject matter is not present in an application to which the instant Application claims priority, the subject matter constitutes new matter. II. With respect to the citations of provisional Application 61/321,124, it is noted that claimed subject matter is considered essential subject matter. In order to incorporate essential material in the specification by reference to an unpublished U.S. Application, foreign application or patent, or publication, Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g). III. Regarding Applicant’s citation of paragraphs 0047-0049 of the instant specification, it is reiterated that the claim encompasses each feature having the first and second nucleic acids separate from one another in a capture area; thus amplification to include both sequences (i.e., “generating a nucleic acid (emphasis added by the examiner) comprising (i)…and (ii)…” as claimed would be amplification to form a bridged structure between the two separate probes. The ‘598 patent does not yield teachings of this embodiment. Thus, because the full scope of the claim is not supported by the ‘598 patent, the claim includes new matter. IV. The remaining new matter rejections are withdrawn in view of the amendments and/or arguments. C. Page 11 of the Remarks discusses the previous indefiniteness rejections, with are withdrawn in view of amendments and/or arguments. D. Applicant argues on pages 11-13 of the Remarks that Kincaid does not teach the second (control) probe corresponds to a location on the substrate because all control probes are allegedly the same sequence. While these arguments are directed to the previous anticipation rejection, which is withdrawn in view of the amendments, Kincaid is still part of the rejections necessitated by the amendments, and the arguments are addressed below. As noted in the rejections above, Kincaid teaches: The second (i.e., control) probe is labeled (Abstract), that the label is a primer for amplification or ligation (paragraph 0064); At least one feature has a different control probe sequence (paragraph 0081); The labels for the various control signals are different from one another and different from the labels associates with the test probe and target signals (paragraph 0076); The signal emitted from the control label is unique to the control probe and is distinguishable from any other signals emitted from the microarray (paragraph 0075); and Labeled control targets hybridize to the control probes, resulting in at least two signals for each feature (paragraph 0020) Thus, at least one capture area (i.e., the claimed “a capture area) comprise a second (control) oligonucleotide that corresponds to a location of the capture area on the substrate. Because the sequence of the second oligonucleotide is different (paragraph 0081), the signal therefrom corresponds specifically to that capture area. In addition, with respect to the alleged use of the control probes by Kincaid for quality control purposes, the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in the claims (e.g., having a sequence that corresponds to a location) fail to define additional structural elements of the claimed composition/apparatus. Because the prior art teaches the structural elements of the claim, the claim is obvious. See MPEP § 2114. Further, the fact that the inventor has allegedly recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). E. Applicant’s remaining arguments regarding the previous obviousness rejections rely on alleged deficiencies previously addressed, which are unpersuasive for the reasons discussed above. Therefore, the claims remained rejected based on the prior art citations presented in the rejections. F. Applicant’s arguments regarding the previous double patenting ejections have been considered, and the rejections are withdraw in view of the Terminal Disclaimer discussed above. Conclusion 20. No claim is allowed. 21. 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). 22. 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. 23. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30. 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, Anne Gussow can be reached at 571-272-6047. 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. Robert T. Crow Primary Examiner Art Unit 1683 /Robert T. Crow/Primary Examiner, Art Unit 1683
Read full office action

Prosecution Timeline

Jul 09, 2025
Application Filed
Aug 15, 2025
Response after Non-Final Action
Aug 25, 2025
Response after Non-Final Action
Aug 27, 2025
Response after Non-Final Action
Feb 12, 2026
Non-Final Rejection mailed — §103, §112
Mar 04, 2026
Examiner Interview Summary
Mar 27, 2026
Response Filed
Apr 21, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
42%
Grant Probability
73%
With Interview (+31.7%)
3y 11m (~2y 11m remaining)
Median Time to Grant
Moderate
PTA Risk
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