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.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 June 2026 has been entered.
Amendments and Status of the Claims
3. This action is in response to papers filed 18 June 2026 in which claims 1, 11, and 21 were 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All previous rejections not reiterated below are withdrawn in view of the amendments.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.
4. Claims 1-6, 8-11, 16-18, and 21 are under prosecution.
Claim Interpretation
5. 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.
It is also noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in the claims (e.g., hybridization) fail to define additional structural elements of the claimed composition/kit/system. See MPEP § 2114.
The phrase “for use in hybridization” clearly defines a use of the composition, and thus does not further distinguish the composition/kit/system over the prior art. Therefore, any prior art teaching the structural elements of the claim either anticipates, or renders obvious, the instant claims.
B. “Component (b)” is interpreted as requiring a cyclic molecule structure for the at least one polar protic solvent as well as the at least one polar aprotic solvent.
C. Claim 21 recites 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.
C. Claim 21 also recites 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 § 112
5. 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.
6. Claims 1-6, 8-11, 16-18, and 21 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 1 (upon which claims 2-6, 8-11, 16-18, and 21 depend) is indefinite because the claim lists the entire composition as “the improvement;” thus, it is unclear what specific component of the claim results in the improvement.
See MPEP § 2129 III for the proper format of a Jepson claim.
B. Claim 1 (upon which claims 2-6, 8-11, 16-18, and 21 depend) is also indefinite in the recitations “10 vol %” and “5% wt to 30% wt,” and the percentages do not state what they are relative to (e.g., wt/vol, vol/vol, etc.).
Applicant is strongly cautioned against the introduction of new matter in response to this rejection.
C. Claim 5 is indefinite in the recitation of an amount of solvent that does not result in the denaturing of nucleic acids. As noted in the instant specification, denaturation is dependent upon not only the solvent concentration, but temperature as well (pages 2-3), and on the presence of other denaturing agents (page 12). Thus, the metes and bounds of the claim are unclear as the same composition will both infringe upon the claim when used at one temperature, but not infringe at a different temperature.
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. Claims 1-6, 8-11, 16-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Matthiesen (U.S. Patent Application Publication No. US 2013/0040294 A1, published 14 February 2013).
Regarding claim 1, Matthiesen teaches compositions comprising a DNA hybridization probe having a concentration of 0.75 ng/mL (i.e., 0.1 to 100 ng/mL ; paragraph 0096), a polar aprotic solvent having a cyclic structure (paragraphs 0022-0025), and a carboxylic acid amide, in the form of formamide, present at 15% (i.e., less than 25%; paragraph 0020). The polar aprotic solvent is present in a 15% volume to volume ratio (paragraph 0019), and the compositions further comprise dextran sulfate at 10 % (paragraph 0083).
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph).
With respect to the claimed volume based ratio, Matthiesen teaches the polar aprotic solvent is present in a 15% volume to volume ratio (paragraph 0019), and that formamide, present at 15% (i.e., less than 25%; paragraph 0020). Because formamide is a liquid, it is believed that the 15% formamide also refers to volume. Thus, the ratio volume to volume is 1:1
With respect to the claimed 10 % dextran sulfate percentage, because dextran sulfate is a solid, the 10% amount (paragraph 0083) is believe to be a wt %.
Alternatively, it is noted that 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.
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).
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.
Regarding claims 2-4, the composition of claim 1 is discussed above. Matthiesen teaches the polar aprotic solvent is a heterocycle comprising a ring-forming nitrogen and an amide functionality; e.g., Formula 9 of paragraph 0024.
Regarding claim 5, the composition of claim 1 is discussed above. While Matthiesen teaches the compositions utilize the polar aprotic solvent to denature the nucleic acids (paragraph 0094), Matthiesen also teach formamide causes denaturation (paragraph 0008), and that the composition comprises both as discussed above. Thus, it would have been obvious that the total amount of the polar protic/aprotic solvent necessary for denaturation would not need to be present, since the formamide is also included so as to aid denaturation.
Alternatively, it is reiterated that 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, and that 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.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claims 6, 8, and 10, the composition of claim 1 is discussed above. Matthiesen teaches formamide is present at 15% (i.e., less than 25%; paragraph 0020).
It is reiterated that the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed, and that the burden is shifted to the applicants to prove that subject matter shown to be in the prior art does not possess the characteristic relied on.
As noted above, Matthiesen teaches formamide is present at 15% (i.e., less than 25%; paragraph 0020). Because formamide is a liquid, it is believed that the 15% formamide also refers to volume.
Alternatively, it is reiterated that 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, and that 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.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 9, the composition of claim 1 is discussed above. Matthiesen teaches the composition comprises a detergent (paragraph 0057).
Regarding claims 11 and 16-18, the composition of claim 1 is discussed above. Matthiesen teaches formamide is present (paragraph 0020). Because the remaining claim limitations of claim 11 are optional, they are not actually required by the claim.
In addition, Matthiesen also teach buffering agents (i.e., claim 16) and blocking agents (i.e., claim 17; paragraph 0035), as well as NaCl (i.e., the inorganic salt of claim 18; paragraph 0090).
Regarding claim 21, the composition of claim 1 is discussed above. As noted above, the claimed kit and system ae merely describing a collection (i.e., the composition) comprising the claimed limitations.
In addition, Matthiesen teaches kits have the added advantage of providing all key reagents (paragraph 0156). Thus, tit would have been obvious to provide all key reagents of the composition described above (which includes the probe).
Matthiesen also teaches compositions used with systems (paragraph 0149). Thus, it would have been obvious to have a system comprising the claimed composition.
Double Patenting
10. 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.
11. Claims 1-6, 8-11, 16-18, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-112 of copending Application No. 19/682,934 in combination with Matthiesen (U.S. Patent Application Publication No. US 2013/0040294 A1, published 14 February 2013).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising the same limitations (e.g., a probe, dextran sulfate, formamide, a cyclic polar aprotic solvent, probes, blockers, buffers, etc.). Any additional limitations of the ‘934 claims are encompassed by the open claim language “comprising” found in the instant claims.
While the ‘934 claims do not require the specific probe concentration, this is taught by Matthiesen as discussed above. Matthiesen also teach the compositions and methods described therein have the added advantage of easier automation (paragraph 0011). Thus, Matthiesen 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 ‘934 claims with the teachings of Matthiesen to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in methods having the added advantage of easier automation as explicitly taught by Matthiesen (paragraph 0011). In addition, it would have been obvious to the ordinary artisan that the known techniques of Matthiesen could have been applied to the ‘934 claims with predictable results because the known techniques of Matthiesen predictably result in useful hybridization compositions.
This is a provisional nonstatutory double patenting rejection.
12. Claims 1-6, 8-11, 16-18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,662,698 in combination with Matthiesen (U.S. Patent Application Publication No. US 2013/0040294 A1, published 14 February 2013).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising the same limitations (e.g., a probe, dextran sulfate, formamide, a cyclic polar aprotic solvent, probes, blockers, buffers, etc.). Any additional limitations of the ‘698 claims are encompassed by the open claim language “comprising” found in the instant claims.
While the ‘698 claims do not require the specific probe concentration, this is taught by Matthiesen as discussed above. Matthiesen also teach the compositions comprise 2-pyrrolidone or 2-piperidone (paragraph 0080), and that the compositions and methods described therein have the added advantage of easier automation (paragraph 0011). Thus, Matthiesen 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 ‘698 claims with the teachings of Matthiesen to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in methods having the added advantage of easier automation as explicitly taught by Matthiesen (paragraph 0011). In addition, it would have been obvious to the ordinary artisan that the known techniques of Matthiesen could have been applied to the ‘698 claims with predictable results because the known techniques of Matthiesen predictably result in useful hybridization compositions.
Response to Arguments
13. Applicant’s arguments with respect to the previous rejections of the claims have been considered but are moot because the new grounds of rejection necessitated by the amendments.
14. However, it is noted that the Declaration under 37 CFR 1.132 filed 28 October 2025 (hereafter the “Declaration”) is insufficient to overcome the instant rejections for the reasons discussed below.
A. Paragraph 1 merely summarizes the distinguished background of Dr. Sven Hauke.
B. The remainder of the Declaration presents data from various experiments related to the instant claims.
However, Applicant argues on pages 15-18 of the Remarks that the claimed invention displays unexpected results, as presented in Figures 5-8.
However, the data presented in the Declaration is not commensurate in scope with the instant claims for the following reasons:
The various solutions describe therein are limited to the use of “carbonic acid amide,” which appears to be formamide, at a concentration of 25.5 vol 5, and thus does not represent the full scope of the claimed “at least 10 vol %.”
The examples are limited to 2-pyrrolidone, and thus do not represent the full scope of the claimed the polar protic/aprotic solvent having a cyclic molecule structure, which encompasses a vast array of other compounds.
The probe concentration is not within the claimed range.
The compositions are limited to a specific buffer (i.e., 1.3X SSC) and a specific salt and concentration (i.e., 575 mM NaCl), neither of which are required by any of the claims.
The examples are derived from methods requiring limitations (e.g., temperature, time, labeled targets, etc.), that are not required by the claimed compositions.
Therefore, the alleged unexpected results are not commensurate in scope with the instant claims. See MPEP 716.02(d).
Conclusion
15. No claim is allowed.
16. 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