DETAILED ACTION
Notice of Pre-AIA or AIA Status and New Examiner
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Please note that the examiner for this application has changed. Please address future correspondence to Robert T. Crow (Art Unit 1683) whose telephone number is (571) 272-1113.
Preliminary Amendment
3. The preliminary Amendment filed 6 February 2023, in which the specification and claim 15 was amended, claims 1-9 and 16-17 were cancelled, and new claims 18-21 were added, is acknowledged and entered.
Election/Restrictions
4. Applicant’s response filed 13 April 2026 is acknowledged. The previous Requirement for Species Election with withdrawn.
5. Claims 10-15 and 18-21 are under prosecution.
Information Disclosure Statement
6. The Information Disclosure Statement filed 6 February2023 is acknowledged and has 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
7. The use of trade names or marks used in commerce (including but not necessarily limited to Tween 20), 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 Interpretation
8. The claims are subject to the following interpretation:
A. It is noted that the courts have held that when a claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated (In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978)). See MPEP § 2112.02.
The courts have also 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). See MPEP § 2114.
Therefore, the various uses recited in the claims (e.g., “for use with a sequencing apparatus,” “reagents for incorporates…” and “ reagents for chemically removing…”) fail to define additional structural elements of the claimed kits and cartridges and clearly define uses of the compositions contained therein. Theus, any prior art that teaches the structural elements of the claims either anticipate, or render obvious, the claims.
B. The preambles of claims 13-15 and 18-19 each recite a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
Claim Rejections - 35 USC § 103
9. 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.
10. 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.
11. Claims 10-11 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) and Zenhausern et al. (U.S. Patent Application Publication No. US 2014/0186841 A1, published 3 July 2014) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019).
Regarding claims 10-11 and 20, Gordon et al. teach sequencing devices (Title) comprising a plurality of chambers (i.e., reservoirs; paragraph 0007), wherein one at least one reservoir comprises sequencing reagents (paragraph 0007), in the form of a polymerase for incorporating labeled nucleotides (paragraph 0014), wherein the analogues comprise a cleavable blocking group (paragraph 0007). Gordon et al. further teach the device comprises a reservoir comprising a wash buffer (paragraph 0007), and a reservoir comprising reagents for removing the label and blocking moiety (i.e., a “cleave solution;” paragraph 0304).
Gordon et al. also teach a buffer comprising a combination of two different cleaving agent scavengers, in the form of an azide compound (i.e., claim 20) and cystamine (paragraph 0149), which comprises a disulfide moiety (i.e., claim 11). Paul et al. teach cystamine is an antioxidant (page 2, column 1, first full paragraph). Gordon et al. also teach the device comprises a (fifth) reservoir for the cleavage agent scavenging step (paragraph 0009).
Gordon et al. also teach the devices have the added advantage of allowing reduced cost (paragraph 0005). Thus, Gordon et al. teach the known techniques discussed above.
Gordon et al. do not explicitly teach the chambers are part of a cartridge.
However, Zenhausern et al. teach cartridges (paragraph 0013) comprising multiple chambers (i.e., reservoirs) for different reagents (paragraph 0041), and that the cartridges have the added advantage of eliminating the potential for sample contamination (paragraph 0013). Thus, Zenhausern 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 Gordon et al. and Zenhausern et al. as evidenced by Paul et al. to arrive at the instantly claimed cartridges with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in cartridges having the added advantages of allowing reduced cost as explicitly taught by Gordon et al (paragraph 0005) and eliminating the potential for sample contamination as explicitly taught by Zenhausern 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 components useful for nucleic acid detection.
Regarding claim 21, the cartridge of claim 10 is discussed above. In an alternative embodiment, Gordon et al. teach an imaging buffer comprising a combination of scavengers including ascorbate, which is an antioxidant, and the scavenger Trolox (paragraph 0194), which is the claimed carboxylic acid compound.
Zenhausern et al. teach cartridges (paragraph 0013) comprising multiple chambers (i.e., reservoirs) for different reagents (paragraph 0041); Thus, it would have been obvious to have the imaging solution in its own chamber (i.e., reservoir).
12. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) and Zenhausern et al. (U.S. Patent Application Publication No. US 2014/0186841 A1, published 3 July 2014) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019) as applied to claim 10 above, and further in combination with Johnson (U.S. Patent Application Publication No. US 2009/0191287 A1, published 30 July 2009).
Regarding claim 12, the cartridge of claim 10 is discussed above in Section 11.
In an alternative embodiment, Gordon et al. teach an imaging buffer comprising a combination of oxygen scavengers including ascorbate, which is an antioxidant (paragraph 0194).
Neither Gordon et al. nor Zenhausern et al. teach the functionally equivalent antioxidant lipoic acid.
However, Johnson teaches lipoic acid is a particularly effected reactive oxygen species (i.e., ROS) scavenger (paragraphs 0012 and 0038). Thus, Johnson teaches 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 functionally equivalent scavenger of Johnson with Gordon et al. and Zenhausern et al. as evidenced by Paul et al. to arrive at the instantly claimed cartridge 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 cartridge having the added advantage of using a particularly effective oxygen scavenger as explicitly taught by Johnson (paragraph 0038). In addition, it would have been obvious to the ordinary artisan that the known techniques Johnson could have been combined with the cited prior art with predictable results because the known techniques of Johnson predictably result in a reliable, functionally equivalent oxygen scavenger.
13. Claims 13-14 and 18 is are rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019).
Regarding claims 13-14 and 18, Gordon et al. teach kits (paragraph 0001) comprising a sequencing device (Title) comprising a plurality of chambers (i.e., reservoirs; paragraph 0007), wherein one at least one reservoir comprises sequencing reagents (paragraph 0007), in the form of a polymerase for incorporating labeled nucleotides (paragraph 0014), wherein the analogues comprise a cleavable blocking group (paragraph 0007). Gordon et al. further teach the device comprises a reservoir comprising a wash buffer (paragraph 0007), and a reservoir comprising reagents for removing the label and blocking moiety (i.e., a “cleave solution;” paragraph 0304).
Gordon et al. also teach a buffer comprising a combination of two different cleaving agent scavengers, in the form of an azide compound (i.e., claim 18) and cystamine (paragraph 0149), which comprises a disulfide moiety (i.e., claim 14). Paul et al. teach cystamine is an antioxidant (page 2, column 1, first full paragraph). Gordon et al. also teach the device comprises a (fifth) reservoir for the cleavage agent scavenging step (paragraph 0009).
14. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019) as applied to claim 13 above, and further in combination with Johnson (U.S. Patent Application Publication No. US 2009/0191287 A1, published 30 July 2009).
Regarding claim 15, the kit of claim 13 is discussed above in Section 13.
In an alternative embodiment, Gordon et al. teach an imaging buffer comprising a combination of oxygen scavengers including ascorbate, which is an antioxidant (paragraph 0194).
Gordon et al. do not teach the functionally equivalent antioxidant lipoic acid.
However, Johnson teaches lipoic acid is a particularly effected reactive oxygen species (i.e., ROS) scavenger (paragraphs 0012 and 0038). Thus, Johnson teaches 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 functionally equivalent scavenger of Johnson with Gordon et al. as evidenced by Paul et al. to arrive at the instantly claimed kit 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 kit having the added advantage of using a particularly effective oxygen scavenger as explicitly taught by Johnson (paragraph 0038). In addition, it would have been obvious to the ordinary artisan that the known techniques Johnson could have been combined with Gordon et al. with predictable results because the known techniques of Johnson predictably result in a reliable, functionally equivalent oxygen scavenger.
15. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019) as applied to claim 13 above, and further in combination with Zenhausern et al. (U.S. Patent Application Publication No. US 2014/0186841 A1, published 3 July 2014).
Regarding claim 19, the kit of claim 13 is discussed above in Section 13.
In an alternative embodiment, Gordon et al. teach an imaging buffer comprising a combination of scavengers including ascorbate, which is an antioxidant, and the scavenger Trolox, which is the claimed carboxylic acid compound.
Gordon et al. also teach the kits have the added advantage of allowing reduced cost (paragraph 0005). Thus, Gordon et al. teach the known techniques discussed above.
Gordon do not explicitly teach the imaging buffer is in its own chamber (i.e., reservoir).
However, Zenhausern et al. teach kits (paragraph 0031) cand multiple chambers (i.e., reservoirs) for different reagents (paragraph 0041), and which has the added advantage of eliminating the potential for sample contamination (paragraph 0013). Thus, Zenhausern 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 Gordon et al. and Zenhausern et al. as evidenced by Paul et al. to arrive at the instantly claimed kit 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 kit having the added advantages of allowing reduced cost as explicitly taught by Gordon et al (paragraph 0005) and eliminating the potential for sample contamination as explicitly taught by Zenhausern 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 components useful for nucleic acid detection.
Double Patenting
16. 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.
17. Claims 10-11 and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,597,969 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) and Zenhausern et al. (U.S. Patent Application Publication No. US 2014/0186841 A1, published 3 July 2014) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019).
Both sets of claims are drawn to the same compositions each within their own chamber. Any additional limitations of the ‘696 claims are encompassed by the open claim language “comprising” found on the instant claims.
The ‘969 claims do not require the claimed scavenger or the claimed cartridge.
However, these limitations along with the other claimed limitations and the rationale for combining are taught by the cited references as discussed above.
18. Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,597,969 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) and Zenhausern et al. (U.S. Patent Application Publication No. US 2014/0186841 A1, published 3 July 2014) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019) as applied to claim 10 above, and further in combination with Johnson (U.S. Patent Application Publication No. US 2009/0191287 A1, published 30 July 2009) based on the citations and rationale provided above.
19. Claims 13-14 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,597,969 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019).
Both sets of claims are drawn to the same compositions each within their own chamber. Any additional limitations of the ‘696 claims are encompassed by the open claim language “comprising” found on the instant claims.
The ‘969 claims do not require the claimed scavenger.
However, these limitations along with the other claimed limitations and the rationale for combining are taught by the cited references as discussed above.
20. Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,597,969 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019) as applied to claim 13 above, and further in combination with Johnson (U.S. Patent Application Publication No. US 2009/0191287 A1, published 30 July 2009) based on the citations and rationale provided above.
21. Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,597,969 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019) as applied to claim 13 above, and further in combination with Zenhausern et al. (U.S. Patent Application Publication No. US 2014/0186841 A1, published 3 July 2014) based on the citations and rationale provided above.
22. Claims 10-11 and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24 of U.S. Patent No. 12,195,796 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) and Zenhausern et al. (U.S. Patent Application Publication No. US 2014/0186841 A1, published 3 July 2014) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019).
Both sets of claims are drawn to the same compositions each within their own chamber. Any additional limitations of the ‘796 claims are encompassed by the open claim language “comprising” found on the instant claims.
The ‘796 claims do not require the claimed scavenger or the claimed cartridge.
However, these limitations along with the other claimed limitations and the rationale for combining are taught by the cited references as discussed above.
23. Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24 of U.S. Patent No. 12,195,796 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) and Zenhausern et al. (U.S. Patent Application Publication No. US 2014/0186841 A1, published 3 July 2014) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019) as applied to claim 10 above, and further in combination with Johnson (U.S. Patent Application Publication No. US 2009/0191287 A1, published 30 July 2009) based on the citations and rationale provided above.
24. Claims 13-14 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24 of U.S. Patent No. 12,195,796 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019).
Both sets of claims are drawn to the same compositions each within their own chamber. Any additional limitations of the ‘696 claims are encompassed by the open claim language “comprising” found on the instant claims.
The ‘796 claims do not require the claimed scavenger.
However, these limitations along with the other claimed limitations and the rationale for combining are taught by the cited references as discussed above.
25. Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24 of U.S. Patent No. 12,195,796 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019) as applied to claim 13 above, and further in combination with Johnson (U.S. Patent Application Publication No. US 2009/0191287 A1, published 30 July 2009) based on the citations and rationale provided above.
26. Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24 of U.S. Patent No. 12,195,796 B2 in combination with Gordon et al. (U.S. Patent Application Publication No. US 2010/0323350 A1, published 23 December 2010) as evidenced by Paul et al. (Frontiers in Neurology, vol. 10, Article 1315, pages 1-9, published December 2019) as applied to claim 13 above, and further in combination with Zenhausern et al. (U.S. Patent Application Publication No. US 2014/0186841 A1, published 3 July 2014) based on the citations and rationale provided above.
Conclusion
27. No claim is allowed.
28. 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
Prosecution Insights