DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment and Status of the Claims
2. The preliminary amendment filed 15 August 2025, in which claim 1 was cancelled and new claims 2-20 were added, is acknowledged and entered.
The preliminary amendment filed 25 August 2025, in which claims 2-20 were cancelled and new claims 21-40 were added, is acknowledged and entered
Claims 21-40 are under prosecution.
Terminal Disclaimer
3. The terminal disclaimer filed on 2 October 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patents 12391980, 12297488, 12234505, 11560587, 11401545, 11208684, 11384386, 10961566, 10787701, 10472669, 10480022, 10308982, and 9371598
has been reviewed and is accepted. The terminal disclaimer has been recorded.
Information Disclosure Statement
4. The Information Disclosure Statements filed 31 July 2025 and 20 November 2025 are acknowledged and have been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
5. The use of trade names or marks used in commerce (including but not necessarily limited to those on page 9 of the instant specification), has been noted in this application. Any trade names or marks should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 21-40 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 22-40 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 tech 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. Claims 26, 33, and 40 each recite mRNA. A review of the ‘598 Patent yields no teaching of mRNA.
C. Claims 32 and 40 each recite oligonucleotides comprising a cleavage site. The ‘598 Patent only teaches peptide cleavage sites (column 9, lines 45-67).
D. Claim 34 recites a “gene-specific” target nucleic acid. A review of the ‘598 Patent yields no teaching of any “gene-specific” element.
E. Claim 36 (upon which claims 37-39 depend) recites contacting a tissue section with the substrate. The ‘598 Patent only teaches tissue sections that themselves form an array (e.g., column 8, lines 30-45), but not teach oligonucleotide arrays contacted with tissue sections.
F. 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.”
For the purposes of examination, the limitation is interpreted as encompassing fresh or frozen sections.
G. Claim 17 recites enzymatic release of cDNA. The ‘598 patent does not teach enzymatic release.
Thus, because the cited limitations are missing from at least the ‘598 patent, the limitations constitute new matter.
In addition, because the instant claims are new claims filed after the original filing date of this instant Application, the cited limitations constitute new matter with respect to the instant specification.
8. 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.
9. Claims 21-40 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.
A. Claim 21 (upon which claims 22-40 depend), claims 25-26, and claims 33-35 are each indefinite as they refer to the sequence of the target nucleic acid, which is not part of the claimed composition. The metes and bounds of the claim are therefore unclear, as the same composition simultaneously infringes if the first oligonucleotide sequence is complementary to one target nucleic acid, but does not infringe with a different target nucleic acid not complementary to the first oligonucleotide sequence.
B. Claim 36 (upon which claims 38-39 depend) is indefinite as it lists an active method step; thus, it is unclear if the claim is describing a use of the claimed composition.
In addition, claim 38 contains the active method step “is positioned;” thus, it is unclear if the claim is describing a use of the claimed composition.
Claim Rejections - 35 USC § 102
10. The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
11. Claims 21, 25-26, 33-36, and 38 and are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003).
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).
Regarding claims 25-26, 33-36, and 38, Kincaid teaches the composition of claim 21. The instant claims refer to the target nucleic acid, which is not actually part of the claimed composition, and thus do not further limit the composition.
Claim Rejections - 35 USC § 103
12. 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.
13. Claims 21, 24-26, and 34 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).
It is noted that while claims 25-26 and 34 have been rejected as described above, the claims are also obvious using the interpretation outlined below.
It is also noted that this rejection applies to claim 21 to the extent that it is drawn to the embodiments of dependent claims 24-26 and 34.
Regarding claims 24-26 and 34, Kincaid teaches the composition of claim 21, which comprises 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 compositions further includes a fiducial marker (i.e., claim 24; paragraph 0006). Thus, it would have been obvious to include a fiducial marker.
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.
14. Claims 22, 27, 29, 31-32, 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) as applied to claim 21 above, and further in view of 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 Sections 11 and 13.
Kincaid teaches cleavage (i.e., claim 32; paragraph 0045), mRNA targets (i.e., 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).
Kincaid does not teach slides (i.e., claims 22 and 40), primers in the first oligonucleotide (i.e., claims 27 and 40), or cleavage sites in the probes (i.e., claim 32).
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);
First oligonucleotides (i.e., target probes) having a primer binding site (i.e., claims 27 and 40; paragraph 0028);
Oligonucleotides comprising cleavage sites (i.e., claim 32; paragraph 0072).
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 Kincaid with the teachings of Ahmadian 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 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.
15. 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) as applied to claim 21 above, and further in view of 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 Sections 11 and 13.
Kincaid 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 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 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.
16. 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) in view of 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 14.
Neither Kincaid nor Ahmadian et al. teach 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.
17. Claim 32 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) as applied to claim 21 above, and further in view of Willis et al. (U.S. Patent Application Publication No. US 2004/0101835 A1, published 27 May 2004).
It is noted that while claim 32 has been rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claim 32, the composition of claim 21 is discussed above in Sections 11 and 13.
While Kincaid teaches cleavage (paragraph 0045), Kincaid does not teach the first or second nucleic acid (i.e., the probes) have a cleavage site.
However, Willis et al. teach compositions, in the form of barcoded probe arrays (paragraph 0094), wherein a probe comprising a cleavage site, a barcode sequence and a target recognition region (e.g., Figure 2b), and that the cleavage (i.e., restriction) site has the added advantage of allowing ligation into amplification vectors (paragraph 0289-0290). 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 Kincaid with the teachings of Willis 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 ligation into amplification vectors as explicitly taught by Willis et al. (paragraphs 0289-0290). In addition, it would have been obvious to the ordinary artisan that Kincaid 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.
18. Claims 22 and 36-37 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) 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 claims 22 and 36 have been rejected as described above, the claims are also obvious using the interpretation outlined below.
Regarding claims 22 and 36, the composition of claim 21 is discussed above in Sections 11 and 13.
Kincaid does not teach tissues.
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), thereby having a substrate with tissue sections contacting the substrate and nucleic acids thereon (i.e. claim 36). 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.
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 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 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.
19. 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) in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007) as applied to claim 36 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 36 is discussed above in Section 18.
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.
20. 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) in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007) as applied to claim 36 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 36 is discussed above in Section 18.
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.
Double Patenting
21. 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.
22. Claims 21-26 and 32-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 19/264,491.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same probes, capture areas, substrates, slides, flow cells, mRNA, etc. Any additional limitations of the ‘491 claims are encompassed by the open claim language “comprising” found in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
23. Claims 27, 29, 31, 38, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 19/264,491 as applied to claims 21 and 36 above, and further in view of Ahmadian et al. (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
24. Claims 28 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 19/264,491 in view of 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) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
25. Claim 37 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 19/264,491 as applied to claim 36 above, and further in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
26. Claim 39 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 19/264,491 as applied to claim 36 above, and further in view of Barth et al. (U.S. Patent Application Publication No. 2003/0040011 a1, published 27 February 2003) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
27. Claims 21-27, 29, 33-35, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-31 of copending Application No. 18/516,576.
Both sets of claims are drawn to the same probes, capture areas, substrates, slides, flow cells, mRNA, etc. Any additional limitations of the ‘576 claims are encompassed by the open claim language “comprising” found in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
28. Claims 28, 30, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-31 of copending Application No. 18/516,576 as applied to claims 21, 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) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
29. Claim 31 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-31 of copending Application No. 18/516,576 as applied to claim 29 above, and further in view of Ahmadian et al. (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
30. Claims 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-31 of copending Application No. 18/516,576 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) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
31. Claim 38 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-31 of copending Application No. 18/516,576 in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007) as applied to claim 36 above, and further in view of Erlander et al (U.S. Patent Application Publication No. US 2005/0239079 A1, published 27 October 2005) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
32. Claim 39 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-31 of copending Application No. 18/516,576 in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007) as applied to claim 36 above, and further in view of Barth et al. (U.S. Patent Application Publication No. 2003/0040011 A1, published 27 February 2003) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
33. Claims 21, 24-26, 33-36, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/021,568 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003).
Both sets of claims are drawn to the same capture areas, probes, substrates, etc. Any additional limitations of the ‘568 claim is encompassed by the open claim language “comprising” found in the instant claims.
The ‘568 claim does not include pluralities of probes at each location.
However, Kincaid teaches this limitation, as well as the additional limitations described above and the rationale for combining. The claims are therefore obvious based on the citations and rational discussed above.
This is a provisional nonstatutory double patenting rejection.
34. Claims 22, 27, 29, 31-32, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/021,568 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003 as applied to claim 21 above, and further in view of Ahmadian et al (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
35. Claim 23 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/021,568 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003 as applied to claim 21 above, and further in view of Gumbrecht et al. (U.S. Patent Application US 2004/0029203 A1, published 12 February 2004) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
36. Claims 28 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/021,568 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003 in view of 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) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
37. Claims 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/021,568 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) 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) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
38. Claim 38 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/021,568 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007) as applied to claim 36 above, and further in view of Erlander et al (U.S. Patent Application Publication No. US 2005/0239079 A1, published 27 October 2005) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
39. Claim 39 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/021,568 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007) as applied to claim 36 above, and further in view of Barth et al. (U.S. Patent Application Publication No. 2003/0040011 a1, published 27 February 2003) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
40. Claims 21, 23-26, and 33-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 19/021,991 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003).
Both sets of claims are drawn to the same probes, substrates, etc. Any additional limitations of the ‘991 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘991 claims do not include the plurality of pairs.
However, Kincaid teaches this limitation, as well as the additional limitations described above and the rationale for combining. The claims are therefore obvious based on the citations and rational discussed above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
41. Claims 22, 27, 29, 31-32, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 19/021,991 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 21 above, and further in view of Ahmadian et al. (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
42. Claims 28 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 19/021,991 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) in view of 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) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
43. Claim 39 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 19/021,991 in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 36 above, and further in view of Barth et al. (U.S. Patent Application Publication No. 2003/0040011 a1, published 27 February 2003) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
44. Claims 21, 24-26, 33-36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,662,468 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003).
Both sets of claims are drawn to the same probes, mapping, mRNA, etc. Any additional limitations of the ‘468 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘468 claims do not include the plurality of pairs.
However, Kincaid teaches this limitation, as well as the additional limitations described above and the rationale for combining. The claims are therefore obvious based on the citations and rational discussed above.
45. Claims 22, 27, 29, 31-32, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,662,468 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 21 above, and further in view of Ahmadian et al. (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006) based on the citations and rationale provided above.
46. Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,662,468 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 21 above, and further in view of Gumbrecht et al. (U.S. Patent Application US 2004/0029203 A1, published 12 February 2004) based on the citations and rationale provided above.
47. Claims 28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,662,468 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) in view of 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)based on the citations and rationale provided above.
48. Claim 38 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,662,468 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 36 above, and further in view of Erlander et al (U.S. Patent Application Publication No. US 2005/0239079 A1, published 27 October 2005) based on the citations and rationale provided above.
49. Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,662,468 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 36 above, and further in view of Barth et al. (U.S. Patent Application Publication No. 2003/0040011 a1, published 27 February 2003) based on the citations and rationale provided above.
50. Claims 21, 24-26, and 33-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,001,879 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003).
Both sets of claims are drawn to the same probes, tissue sections,, mRNA, etc. Any additional limitations of the ‘879 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘879 claims do not include generating the nucleic acid.
The ‘468 claims do not include the plurality of pairs.
However, Kincaid teaches this limitation, as well as the additional limitations described above and the rationale for combining. The claims are therefore obvious based on the citations and rational discussed above.
51. Claims 22, 27, 29, 31-32, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,001,879 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 21 above, and further in view of Ahmadian et al. (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006) based on the citations and rationale provided above.
52. Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,001,879 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 21 above, and further in view of Gumbrecht et al. (U.S. Patent Application US 2004/0029203 A1, published 12 February 2004) based on the citations and rationale provided above.
53. Claims 28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,001,879 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) in view of 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) based on the citations and rationale provided above.
54. Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,001,879 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 37 above, and further in view of Barth et al. (U.S. Patent Application Publication No. 2003/0040011 a1, published 27 February 2003) based on the citations and rationale provided above.
55. Claims 21-26, 33-36, and 38-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,549,138 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003).
Both sets of claims are drawn to the same probes, substrates, flow cells, mRNA, protection (i.e., in wells), etc. Any additional limitations of the ‘138 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘138 claims do not include the claimed pairs.
However, Kincaid teaches this limitation, as well as the additional limitations described above and the rationale for combining. The claims are therefore obvious based on the citations and rational discussed above.
56. Claims 27, 29, 31-32, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,549,138 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 21 above, and further in view of Ahmadian et al. (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006) based on the citations and rationale provided above.
57. Claims 28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,549,138 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) in view of 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) based on the citations and rationale provided above.
58. Claim 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,549,138 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 36 above, and further in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007) based on the citations and rationale provided above.
59. Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,549,138 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 36 above, and further in view of Barth et al. (U.S. Patent Application Publication No. 2003/0040011 a1, published 27 February 2003) based on the citations and rationale provided above.
60. Claims 21, 24-26, 33-36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,761,030 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003).
Both sets of claims are drawn to the same probes, substrates, fiducials, mRNA, etc. Any additional limitations of the ‘030 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘030 claims do not include the pairs of nucleic acids.
However, Kincaid teaches this limitation, as well as the additional limitations described above and the rationale for combining. The claims are therefore obvious based on the citations and rational discussed above.
61. Claims 22, 27, 29, 31-32, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,761,030 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 21 above, and further in view of Ahmadian et al. (U.S. Patent Application Publication No. US 2006/0088872 A1, published 27 April 2006) based on the citations and rationale provided above.
62. Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,761,030 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 21 above, and further in view of Gumbrecht et al. (U.S. Patent Application US 2004/0029203 A1, published 12 February 2004) based on the citations and rationale provided above.
63. Claims 28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,761,030 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) in view of 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) based on the citations and rationale provided above.
64. Claim 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,761,030 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 36 above, and further in view of Stanchfield et al. (U.S. Patent Application Publication No. US 2007/0269347 A1, published 22 November 2007) based on the citations and rationale provided above.
65. Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,761,030 B2 in view of in view of Kincaid (U.S. Patent Application Publication No. US 2003/0186310 A1, published 2 October 2003) as applied to claim 36 above, and further in view of Barth et al. (U.S. Patent Application Publication No. 2003/0040011 a1, published 27 February 2003) based on the citations and rationale provided above.
Conclusion
66. No claim is allowed.
67. 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.
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/Robert T. Crow/Primary Examiner, Art Unit 1683
Robert T. Crow
Primary Examiner
Art Unit 1683