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 14 September 2026 in which the specification and claim 12 was amended, no claims were canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
All previous rejections not reiterated below are withdrawn in view of the amendments.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 12-14 are under prosecution.
4. This Office Action includes new rejections necessitated by the amendments.
Claim Interpretation
5. The claims are subject to the following interpretation:
A. Claim 12 (upon which claims 13-14 depend) is amended to recite “an X-NTP.” Paragraph 0118 defines an X-NTP as having a reporter selected from four possible states, a hairpin for TCH (i.e., translation control by hybridization; paragraph 0011 ) followed by a section of PEG. The claimed “X-NTP” is therefore limited to this definition.
In addition, it is noted that while the common meaning of “NTP” is “nucleotide triphosphate,” the limiting definition discussed above makes no mention of any triphosphates. Thus, the claimed “X-NTP” does not require a triphosphate.
B. The claimed hairpin for TCH (as discussed above), clearly describes an intended use of the claimed X-NTP. Because no further structural requirements for a hairpin for TCH are present in the specification, any hairpin is interpreted as being capable of controlling translation by hybridization.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 12-14 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 12 (upon which claims 13-14 depend) is drawn to an X-NTP, which, as noted above, comprises a reporter selected from four possible states. A review of the specification yields no guidance as to what constitutes a “possible state.” Thus, the term is indefinite.
For the purposes of examination, the “four possible states” are interpreted as one of A, G, T, and C.
B. Claim 13 is indefinite in the recitation of “triethylene glycol (X),” as it is unclear of the X of claim 13 is different from the X of claim 12.
Claim Rejections - 35 USC § 102/103
8. The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 12-14 are rejected under 35 U.S.C. 102(a)(1/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Balasubramanian et al. (PCT International Patent Application Publication No. WO 01/57248 A2, published 9 August 20021).
Regarding claims 12-14, Balasubramanian et al. teach a reporter construct, in the form of a labeled DNA comprising a high impedance polymer, in the form of the 5’ portion of a 5’-Cy3 labeled DNA oligo comprising the first deoxy C (i.e., claims 12 and 14) linked to a low impedance polymer, in the form of a first hexaethylene glycol linker (i.e., claims 12 and 13; page 8, lines 10-20). Balasubramanian et al. further teach the reporter construct is operably linked to an X-NTP, in the form of the amino T (i.e., the reporter), attached to the second hexaethylene glycol linker (i.e., a section of PEG), and a hairpin, in the form of the 13 bases on each side of the glycols residues, which are complementary and can form a hairpin (page 8, lines 10-20). Any additional components of the DNA molecule of Subramanian et al. are encompassed by the open claim language “comprising” found in the instant claims.
Paragraph 0122 of the instant specification explicitly states that the impedance of hexaethylene glycol is over 0.1, and the impedance of nucleotides are less than 0.1. Thus, the claims have been given the broadest reasonable interpretation consistent with the teachings of the specification regarding “low” and “high” impedance polymers (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
Alternatively, it is 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 glycol lengths and/or the nucleotide sequence of the reporter construct 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.
Double Patenting
12. 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.
13. Claims 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,457,979 B2 in combination with Balasubramanian et al. (PCT International Patent Application Publication No. WO 01/57248 A2, published 9 August 2001).
Both sets of claims are drawn to the same impedance polymers. Any additional limitations of the ‘979 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘979 claims do not teach claimed the X-NTP.
However, Balasubramanian et al. teach the claimed X-NTP as discussed above, which has the added advantage of being a self-priming template (page 8, lines 20-30). Thus, Balasubramanian 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 ‘979 claims with the teachings of Balasubramanian et al. to arrive at the instantly claimed constructs with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in constructs having the added advantage of being self-priming templates as explicitly taught by Balasubramanian et al. (page 8, lines 10-20). In addition, it would have been obvious to the ordinary artisan that the known techniques of Balasubramanian et al. (could have been applied to the ‘979 claims with predictable results because the known techniques of Balasubramanian et al. predictably result in useful molecules for sequencing applications.
14. Claims 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,676,782 B2 in combination with Balasubramanian et al. (PCT International Patent Application Publication No. WO 01/57248 A2, published 9 August 2001).
Both sets of claims are drawn to the same reporter construct. Any additional limitations of the ‘782 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘782 claims do not teach claimed the X-NTP.
However, Balasubramanian et al. teach the claimed X-NTP, as well as the rationale for combining, as discussed above.
15. Claims 12-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 17/456,342 in combination with Balasubramanian et al. (PCT International Patent Application Publication No. WO 01/57248 A2, published 9 August 2001).
Both sets of claims are drawn to the same reporter construct. Any additional limitations of the ‘342 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘342 claims do not teach claimed the X-NTP.
However, Balasubramanian et al. teach the claimed X-NTP, as well as the rationale for combining, as discussed above.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
16. Applicant’s arguments with respect to the previous rejections of the claims have been considered but are moot in view if the withdrawn rejections (necessitated by the amendments) and because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
17. No claim is allowed.
18. 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).
19. 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.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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