FINAL 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 .
Amendments and Status of the Claims
2. This action is in response to papers filed 10 July 2026 in which the specification and claims 92 and 103-105 were amended, claim 111 was canceled, and new claim 112 were added. All of the amendments have been thoroughly reviewed and entered.
Any previous rejections not reiterated below are withdrawn in view of the amendments.
Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections necessitated by the amendments.
3. Claims 92-110 and 112 are under prosecution.
4. This Office Action includes new rejections necessitated by the amendments.
Claim Interpretation
5. As noted in the previous Office Action, the claims are drawn to a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claims recite structural limitations of the “system.” Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. Claims 92-93, 102-103, 106-107, 110, and 112 are rejected under 35 U.S.C. 103 as being unpatentable over Kain et al. (U.S. Patent Application Publication No. US 2014/0274747 A1, published 18 September 2014).
Regarding claims 92-93 Kain et al. teach system (paragraph 0002) comprising an array of features, in the form of an array of pads on a substrate surface, wherein each pad has a different subset of nucleic acids with different sequences, and an optical detector, in the form of a pixel array (paragraph 0012), wherein each pixel has 3 or more pads (paragraph 0042); thus, the area of at least three features (i.e., pads) are in an area less than the optical resolution (i.e., each pixel). Kain et al. also teach a space between first and second features that does not comprise a probe (i.e., the gap between 3a and 3b in Figure 3) and that pixel 13 overlaps the two features (Figure 3B and paragraph 0073). Kain et al. further teach the signals from two features are integrated into a single resolution element; i.e., the signals from two features are detected and displayed in one pixel (paragraph 0042).
Regarding claim 102, the system of claim 92 is discussed above. Kain et al. teach the probes are nucleic acid probes (paragraph 0029).
Regarding claim 103, the system of claim 92 is discussed above. Kain et al. teach a third feature comprising a third plurality of probes (paragraph 0042), wherein the probes are different nucleic acid sequences (paragraph 0058).
Regarding claim 106, the system of claim 92 is discussed above. Kain et al. teach each pad has the capture probes immobilized (i.e.. attached) therein (paragraph 0026).
Regarding claim 107, the system of claim 106 is discussed above. Kain et al. teach the nucleic acids are attached to beads immobilized (i.e., held) on the pads (paragraph 0112).
Regarding claim 110, the system of claim 92 is discussed above. Kain et al. teach the detector (i.e., pixel array) is a CMOS sensor (paragraph 0050).
Regarding claim 112, the system of claim 92 is discussed above. Kain et al. teach optical resolutions of 2 microns (paragraph 0052).
It is also noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is advised that 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, Applicant should not merely rely upon counsel’s arguments in 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.
9. Claims 94-99, 104-105, and 108-109 are rejected under 35 U.S.C. 103 as being unpatentable over Kain et al. (U.S. Patent Application Publication No. US 2014/0274747 A1, published 18 September 2014) as applied to claims 92 and 103 above, and further in combination with Penn et al. (U.S. Patent Application Publication No. US 2002/0081590 A1, published 27 June 2002).
Regarding claims 94-99, 104-105, and 108-109, the system of claim 92 is discussed above in Section 8.
Kain et al. also teach the systems have the added advantage of reducing the required optics hardware (paragraph 0022). Thus, Kain et al. teach the known techniques discussed above.
While Kain et al. teach the probes are different nucleic acid sequences (i.e., claims 95-96; paragraph 0058) and that each feature (i.e., pad) is individually addressable (i.e., claim 105; paragraph 0074), Kain et al. do not explicitly teach the different features target different subject-specific feature (i.e., claim 94).
However, Penn et al. teach systems (paragraph 0327) comprising microarrays, wherein the microarrays comprise spots of discrete probes derived from a subject, in the form the human genome (i.e., claim 94) and each representing a single exon (Examples 1-2). Thus, each spot represents a different feature (i.e., exon) of the human genome (i.e., claim 94).
It is noted that paragraph 0032 defines a “subject” as encompassing “a representation of a kinds of specific source of genetic materials.” Thus, the spots representing the human genome are a “subject,” and the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding a “subject” (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
Penn et al. also the immobilized probes include any of the following:
Sequences from cell types (i.e., claim 97; paragraph 0285):
Sequences of E. coli genes, which are indicative of both an organism type and species (i.e., claims 98-99; paragraph 0136);
Sequences from humans, which are indicative of a species (i.e. claim 99; paragraph 0075);
Sequences complementary to a gene, in the form of genome-derived exons (i.e., claim 108; paragraph 0355); or
Non-coding regions (i.e., claim 109; paragraph 0162).
In addition, Penn et al. teach the arrays comprise more than two human exon probe spots (i.e., from a first subject), and control spots of E. coli genes, which are the claimed third spot from a second subject (i.e., claim 104; paragraph 0277). Penn et al. also teach the spots are spatially addressable (i.e., claim 105; claim 55 of Penn et al.), and that the systems have the added advantage of confirming expression of genes (Abstract) Thus, Penn 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 teachings of the cited prior art to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of reducing the required optics hardware as explicitly taught by Kain et al. (paragraph 0022) and confirming the expression of genes as explicitly taught by Penn 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 systems useful for assaying nucleic acids.
10. Claims 94-101, 104-105, and 108 are rejected under 35 U.S.C. 103 as being unpatentable over Kain et al. (U.S. Patent Application Publication No. US 2014/0274747 A1, published 18 September 2014) as applied to claims 92 and 103 above, and further in view of combination with Kim et al. (U.S. Patent Application Publication No. US 2004/0038233 A1, published 26 February 2004).
It is noted that while claims 94-100, 104-105, and 108 have been rejected as described above, the claims are also obvious using the interpretation outlined below.
Regarding claims 94-100, 104-105, and 108, the system of claim 92 is discussed above in Section 8.
Kain et al. also teach the systems have the added advantage of reducing the required optics hardware (paragraph 0022). Thus, Kain et al. teach the known techniques discussed above.
While Kain et al. teach the probes are different nucleic acid sequences (i.e., claims 95-96; paragraph 0058) and that each feature (i.e., pad) is individually addressable (i.e., claim 105; paragraph 0074), Kain et al. do not explicitly teach the different features target different subject-specific feature (i.e., claim 94).
However, Kim et al. teach microarrays having different features (i.e., spots) each having pluralities of probes that are different from one another, in the form of spots of different probes (Figure 5) each of which is dedicated to a different subject-specific feature of a subject; namely the probes are to different species (i.e., M. kansassi and M fortuitum) of Mycobacterium (i.e., claims 94-95; paragraph 0057). The probes comprise nucleic acid sequences (i.e., claim 96; Table 2), and are indicative of a cell type, in the form of different types of Mycobacterium (i.e., claim 97; Figure 3), which are different specific species (i.e., claims 99 and 100) of specific organisms (i.e., claim 98). Kim et al. further teach the probes identify drug resistance (i.e., claim 101), in the form of probes to the rpoB gene (i.e., claim 108; paragraph 0017). Kim et al. teach the array includes an individually addressable third feature (i.e., claim 105; Figure 5), in the form of the probes to the different subject M. scrofalaceum (i.e., claim 104 Figure 5), and that the arrays have the added advantage of allowing speedy and accurate detection in large quantities (paragraph 0013). Thus, Kim 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 teachings of the cited prior art to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of reducing the required optics hardware as explicitly taught by Kain et al. (paragraph 0022) and allowing speedy and accurate detection in large quantities as explicitly taught by Kim et al. (paragraph 0013). 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 systems useful for assaying nucleic acids.
Double Patenting
11. 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.
12. Claims 92-95, 102-103, 106-108, 110, and 112 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,725,233 in view of Kain et al. (U.S. Patent Application Publication No. US 2014/0274747 A1, published 18 September 2014).
Both sets of claims are drawn to biochips having first and second features, subject-specific features, genes, etc. Any additional limitations of the ‘233 claims are encompassed by the open claim language “comprising” found in that instant claims.
The ‘233 claims do not require the instantly claimed optical detector..
However, the optical detector, as well as the additional limitations of the claims and the rationale for combining are taught by Kain et al. as discussed above.
13. Claims 94-99, 104-105, and 108-109 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,725,233 in view of Kain et al. (U.S. Patent Application Publication No. US 2014/0274747 A1, published 18 September 2014) as applied to claims 92 and 103 above, and further in combination with Penn et al. (U.S. Patent Application Publication No. US 2002/0081590 A1, published 27 June 2002) based on the citations and rationale presented above.
14. Claims 94-101, 104-105, and 108 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,725,233 in view of Kain et al. (U.S. Patent Application Publication No. US 2014/0274747 A1, published 18 September 2014) as applied to claims 92 and 103 above, and further in combination with Kim et al. (U.S. Patent Application Publication No. US 2004/0038233 A1, published 26 February 2004) based on the citations and rationale presented above.
Response to Arguments
15. Applicant's arguments filed 10 July 226 (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 argue that Kain et al. do not teach the limitations of claim 92.
However, the limitations of claim 92 are taught by Kain et al., as discussed above.
B. Applicant argues on pages 7-8 of the Remarks that paragraph 0024 of Kain et al. teaches away from the claimed invention.
However, paragraph 0024 of Kain et al. describes “a particularly useful application” and “[i]n particular embodiments,” and thus is non-limiting with respect to the teachings of the reference as a whole.
C. Applicant’s remaining arguments 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.
Conclusion
16. No claim is allowed.
17. 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).
18. 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.
19. 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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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.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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