FINAL ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Amendments and Status of the Claims
2. This action is in response to papers filed 26 August 2026 in which no claims were amended, no claims were canceled, and no new claims were added.
Any previous rejections not reiterated below are withdrawn in view Applicant’s arguments, which are discussed below.
Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections.
3. Claims 58-77 are under prosecution.
Claim Rejections - 35 USC § 103
4. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
5. Claims 58-77 are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Regarding claim 58, Matthiesen teaches methods of hybridizing a nucleic acid comprising providing a first nucleic acid, a second nucleic acid, and a hybridization composition comprising a solvent which denatures double-stranded nucleic acids sequences, and allowing the hybridization of the first and second nucleic acid sequences in the presence of the composition for a period of time (page 8). Matthiesen also teaches butadiene dioxide and 2-pyrrolidone (claim 15 of Matthiesen), and the effective amounts range from 0.1 to 95% (pages 5-6).
With respect to tetramethylene sulfoxide, the final structure listed on pages 7-8 of Matthiesen teaches a compound where Y is S, Z is not present, and X is O, and A and B are part of the alkyldiyl. Matthiesen does not explicitly teach the length of the alkyldiyl group, but does teach it is an unsaturated hydrocarbon (page 12).
In addition, Matthiesen also teach tetrahydrothiapyran oxide, which is a one carbon homolog (i.e., six membered ring) of the instantly claimed (five membered ring) compound, and thus is an obvious variant based on the citation above.
The courts have also stated:
[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious) (see MPEP 2144.09).
Thus, the claimed compound has a five carbon ring, which is an obvious variant of the prior art.
In addition, Matthiesen also teach tetrahydrothiapyran oxide, which is a one carbon homolog (i.e., six membered ring) of the instantly claimed (five membered ring) compound, and thus is an obvious variant based on the citation above.
It is further noted that the courts have stated:
similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
Thus, the substitution of the claimed five membered sulfoxide for the six membered sulfoxide is an obvious variation of the prior art.
The courts have also held that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). See MPEP 2144.04 IV.C. Thus, any order of combining the first and second nucleic acids with the hybridization composition is obvious.
In addition, 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.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
Alternatively, with respect to tetrahydrothiophene-1-oxide (tetramethylene sulfoxide), Westberry et al. teach hybridization of nucleic acids during amplification (paragraph 0039), wherein sulfoxides are added and denaturants (i.e., melting/disruptive agents, paragraph 0070), wherein the sulfoxide is tetramethylene sulfoxide at 0.5% (paragraph 0095), which overlaps the range discussed page 6 of Matthiesen, and which has the added advantage of reducing non-specific amplification (paragraph 0070).
Lee et al. similarly teach tetramethylene sulfoxide as an additive for amplification of nucleic acids that facilitates denaturation, as well as percentages that overlap those on page 6 of Matthiesen (paragraph 0050), which is necessary for amplification (paragraph 0055).
With respect to 2-pyrrolidone, Bloch teaches it is a preferred denaturant (column 6, lines 1-10). Van Ness et al. also teach the use of 2-pyrrlione in hybridization assays, in percentages that overlap those taught by Matthiesen, which allows release of nucleic acids during hybridization in a complex sample (Abstract). Demorest et al. teach hybridization assays using 2-pyrrolidone in percentages that overlap Matthiesen, which as the added advantage of allowing use in in situ spotted arrays (paragraph 0093).
With respect to butadiene sulfone and 2-pyrrolidone, Chakrabarti et al. teach methods using adjuvants in hybridization and denaturation (paragraph 0064), including 2-pyrrolidone (paragraph 0024) and butadiene sulfone (paragraph 0114), as well as percentages that overlap Matthiesen, and that the reagents are used to enhance amplification reactions (paragraphs 0015).
Thus, the cited prior art teaches 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 combined the teachings of Matthiesen with any of the other cited prior art references to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in methods having the added advantages of reducing and/or eliminating the use of formamide as explicitly taught by Matthiesen (Abstract) and any of:
Reducing non-specific amplification as explicitly taught by Westberry et al. (paragraph 0070);
Providing reagents necessary for amplification as explicitly taught by Lee et al. (paragraph 0055);
Using a preferred denaturant as explicitly taught by Bloch (column 6, lines 1-10);
Allowing release of nucleic acids during hybridization in a complex sample and explicitly taught by Van Ness et al. (Abstract);
Allowing use in in situ spotted arrays as explicitly taught by Demorest et al. (paragraph 0093); and
Enhancing amplification reactions as explicitly taught by Chakrabarti et al. (paragraph 0015).
In addition, it would have been obvious to the ordinary artisan that the known techniques of Matthiesen and the cited prior art could have combined with predictable results because the known techniques of Matthiesen and the cited prior art predictably result in use of functionally equivalent solvents for hybridization.
Regarding claim 59, Matthiesen teaches methods of hybridizing a nucleic acid comprising providing a first nucleic acid in an in situ biological sample (page 10), including FISH (page 4) and providing a second nucleic acid, and a hybridization composition comprising a solvent which denatures double-stranded nucleic acids sequences, and allowing the hybridization of the first and second nucleic acid sequences in the presence of the composition for a period of time (page 9). Matthiesen also teaches the methods have the added advantage of less toxic hybridization solvents (page 3). Matthiesen also teaches butadiene dioxide and 2-pyrrolidone (claim 15 of Matthiesen), and the effective amounts range from 0.1 to 95% (pages 5-6).
With respect to tetramethylene sulfoxide, the final structure listed on pages 7-8 of Matthiesen teaches a compound where Y is S, Z is not present, and X is O, and A and B are part of the alkyldiyl. Matthiesen does not explicitly teach the length of the alkyldiyl group, but does teach it is an unsaturated hydrocarbon (page 12).
In addition, Matthiesen also teach tetrahydrothiapyran oxide, which is a one carbon homolog (i.e., six membered ring) of the instantly claimed (five membered ring) compound,
It is reiterated that the courts have stated that:
A. Similar properties may normally be presumed when compounds are very close in structure;
B. Compounds which are homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties; and
C. Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results.
Thus, the claimed compound has a five carbon ring, which is an obvious variant of the prior art structure on page 7 of Matthiesen, and/or the substitution of the claimed five membered sulfoxide for the six membered sulfoxide is an obvious variation of the prior art, and any order of combining the first and second nucleic acids with the hybridization composition is obvious.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Alternatively, with respect to tetrahydrothiophene-1-oxide (tetramethylene sulfoxide), Westberry et al. teach hybridization of nucleic acids during amplification (paragraph 0039), wherein sulfoxides are added as denaturants (i.e., melting/disruptive agents, paragraph 0070), wherein the sulfoxide is tetramethylene sulfoxide at 0.5% (paragraph 0095), which overlaps the range discussed page 6 of Matthiesen, and which has the added advantage of reducing non-specific amplification (paragraph 0070).
Lee et al. similarly teach tetramethylene sulfoxide as an additive for amplification of nucleic acids that facilitates denaturation, as well as percentages that overlap those on page 6 of Matthiesen (paragraph 0050), which is necessary for amplification (paragraph 0055).
With respect to 2-pyrrolidone, Bloch teaches it is a preferred denaturant (column 6, lines 1-10). Van Ness et al. also teach the use of 2-pyrrlione in hybridization assays, in percentages that overlap those taught by Matthiesen, which allows release of nucleic acids during hybridization in a complex sample (Abstract). Demorest et al. teach hybridization assays using 2-pyrrolidone in percentages that overlap Matthiesen, which as the added advantage of allowing use in in situ spotted arrays (paragraph 0093).
With respect to butadiene sulfone and 2-pyrrolidone, Chakrabarti et al. teach methods using adjuvants in hybridization and denaturation (paragraph 0064), including 2-pyrrolidone (paragraph 0024) and butadiene sulfone (paragraph 0114), as well as percentages that overlap Matthiesen, and that the reagents are used to enhance amplification reactions (paragraphs 0015).
Thus, the cited prior art teaches 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 combined the teachings of Matthiesen with any of the other cited prior art references to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in methods having the added advantages of reducing and/or eliminating the use of formamide as explicitly taught by Matthiesen (Abstract) and any of:
Reducing non-specific amplification as explicitly taught by Westberry et al. (paragraph 0070);
Providing reagents necessary for amplification as explicitly taught by Lee et al. (paragraph 0055);
Using a preferred denaturant as explicitly taught by Bloch (column 6, lines 1-10);
Allowing release of nucleic acids during hybridization in a complex sample and explicitly taught by Van Ness et al. (Abstract);
Allowing use in in situ spotted arrays as explicitly taught by Demorest et al. (paragraph 0093);
Enhancing amplification reactions as explicitly taught by Chakrabarti et al. (paragraph 0015).
In addition, it would have been obvious to the ordinary artisan that the known techniques of Matthiesen and the cited prior art could have combined with predictable results because the known techniques of Matthiesen and the cited prior art predictably result in use of functionally equivalent solvents for hybridization.
Regarding claims 60-62, the method of claim 58 is discussed above. Matthiesen also teaches supplying heat energy, using a heat wire, to hybridize the nucleic acids (page 9).
In addition, with respect to claim 60, it is noted that the subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. “Wherein” clauses are examples of language that may raise a question as to the limiting effect of the language in a claim. See MPEP 2103 I.C. and MPEP § 2111.04.
It is further noted that the courts have held that optimization through routine experimentation, and in particular, when related to differences in temperature, do not support patentability (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Thus, the claimed manipulations of temperature are obvious variants merely representing routine optimization of the teachings of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claim 63, the method of claim 58 is discussed above. Matthiesen teaches the first nucleic acid (i.e., probe) is double stranded (pages 35-36) and the second nucleic acid is the sample nucleic acid and is single stranded (page 11).
Regarding claim 64, the method of claim 58 is discussed above. Matthiesen teaches a step of denaturing followed by a step of combining (i.e., hybridization; page 9).
Regarding claim 65, the method of claim 58 is discussed above. Matthiesen teaches steps of heating and cooling the combined (i.e., hybridization) composition and nucleic acid sequences (page 9).
In addition, with respect to claims 64 and 65, it is reiterated that the courts have held that any order of steps of the prior art is obvious.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claims 66-70, the method of claim 58 is discussed above. Matthiesen teaches hybridization times of 4 minutes (page 39).
Regarding claims 71-74, the method of claim 58 is discussed above. Matthiesen teaches the “step of method of the invention includes the steps of heating and cooling (page 9), and that the denaturing of binding and hybridization occurs in less than 5 minutes (page 9). Thus, it would have been obvious for the binding reaction, which includes steps of cooling and heating, to occur in less than five minutes, thus resulting in a cooling step of less than 5 minutes.
Further, with respect to claims 66-74, 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).
It is also 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.
Therefore, the claimed ranges alternatively represent routine optimization and/or an obvious variant of the values taught by the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claim 75, the method of claim 58 is discussed above. Matthiesen teaches the claimed temperature values for denaturation (page 39).
In addition, it is reiterated 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, and that the courts have 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 particular when related to temperature.
Therefore, the claimed temperature merely represents routine optimization and/or an obvious variant of the values taught by the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claims 76-77, the method of claim 58 is discussed above. Matthiesen teaches the first nucleic acid is in a sample in the form of a histology sample (page 30).
Double Patenting
6. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
7. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-52 of U.S. Patent No. 9,297,035 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to methods of hybridizing nucleic acids using hybridization compositions and additional nucleic acids. Any additional limitations of the ‘035 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘035 claims do not require the claimed functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
8. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of U.S. Patent No. 9,303,287 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to methods of hybridizing nucleic acids using hybridization compositions and additional nucleic acids. Any additional limitations of the ‘287 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘287 claims do not require the claimed functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
9. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-61 of U.S. Patent No. 9,309,562 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to methods of hybridizing nucleic acids using hybridization compositions and additional nucleic acids. Any additional limitations of the ‘562 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘562 claims do not require the claimed functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
10. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,388,456 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to methods of hybridizing nucleic acids using hybridization compositions and additional nucleic acids. Any additional limitations of the ‘456 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘456 claims do not require the claimed functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
11. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,202,638 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to methods of hybridizing nucleic acids using hybridization compositions and additional nucleic acids. Any additional limitations of the ‘638 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘638 claims do not require the claimed functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
12. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10,662,465 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to methods of hybridizing nucleic acids using hybridization compositions and additional nucleic acids. Any additional limitations of the ‘465 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘465 claims do not require the claimed functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
13. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,118,214 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to hybridization compositions and additional nucleic acids. Any additional limitations of the ‘214 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘214 claims do not require the claimed method steps or functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
14. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,118,226 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to hybridization compositions and additional nucleic acids. Any additional limitations of the ‘226 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘226 claims do not require the claimed method steps or functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
It is noted that the instant Application is not a divisional of the parent application of the ‘226 parent; therefore, the nonstatutory double patenting rejections are proper.
15. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,795,499 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to methods of hybridizing nucleic acids using hybridization compositions and additional nucleic acids. Any additional limitations of the ‘499 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘499 claims do not require the claimed functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
16. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,834,703 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to hybridization compositions and additional nucleic acids. Any additional limitations of the ‘703 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘703 claims do not require the claimed method steps or functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
17. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,209,276 B2 in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to hybridization compositions and additional nucleic acids. Any additional limitations of the ‘276 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘276 claims do not require the claimed method steps or functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
18. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,534,755 B2 (formerly Application No. 17/588,023) in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn methods of hybridizing nucleic acids using hybridization compositions and additional nucleic acids. Any additional limitations of the ‘755 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘755 claims do not require the claimed functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
19. Claims 58-77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61-74 of copending Application No. 19/035,623 in view of in view of Matthiesen (PCT International Publication No. WO 2010/097655 A1, published 2 September 2010) alternatively further in view of Westberry (U.S. Patent Application Publication No. US 2007/0264633 A1, published 15 November 2007), Lee et al (U.S. Patent Application Publication No. US 2010/0136542 A1, published 3 June 2010), Bloch (U.S. Patent No. 5,972,618, issued 26 October 1999), Van Ness et al (U.S. Patent No. 5,106,730, issued 21 April 1992), Demorest et al. (U.S. Patent Application Publication No. US 2005/0191657 A12, published 1 September 2005), or Chakrabarti et al (U.S. Patent Application Publication No. US 2003/0039992 A1, published 27 February 2003).
Both sets of claims are drawn to hybridization compositions and additional nucleic acids. Any additional limitations of the ‘623 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘623 claims do not require the claimed functionally equivalent solvents.
However, the claimed solvents, the additional claimed limitations, and the rationale for combining are taught by the prior art as discussed above.
This is a provisional nonstatutory double patenting rejection
Information Disclosure Statement
20. The Information Disclosure Statements filed 2 July 2026, 26 August 2026, and 1 September 2026 are acknowledged and have been considered.
Response to Arguments
21. Applicant's arguments filed 26 August 2026 (hereafter the “Remarks”) have been fully considered but they are not fully persuasive as discussed below.
A. Applicant’s arguments on pages 5-8 of the Remarks refer to the previous rejections based on WO 2010/097656.
The Declaration under 37 CFR 1.132 filed 26 August 2026 (originally filed with U.S. Application No. 14/352,815) is sufficient to overcome the previous rejection of the claims based upon WO 2010/097656, and the rejections are therefore withdrawn.
B. Applicant argues on pages 8-11 of the Remarks that the WO 2010/097655 (hereafter the “‘655 publication”) that not all polar solvents are suitable, that a skilled artisan would not be able to predict functional denaturing performance, there is no reason to pick the claimed compounds, and that the cited references comprise additional reagents.
As noted above, counsel’s arguments cannot take place of evidence in the record. Because Applicant has provided no evidence to support the assertions regarding what a skilled artisan would or would not pick, the argument is not persuasive.
The Response above should not be construed as an invitation to file an after final declaration.
In addition, as noted in the rejections above, each of the cited references provides a specific motivation to choose each of the instantly claimed solvents.
Specifically:
Tetramethylene-1-oxide is used for reducing non-specific amplification as explicitly taught by Westberry et al. (paragraph 0070);
Tetramethylene-1-oxide is provided as a reagent necessary for denaturation during amplification as explicitly taught by Lee et al. (paragraph 0055);
2-Pyrrolidone is specifically cited as a preferred denaturant by Bloch (column 6, lines 1-10);
2-Pyrrolidone is specifically cited by Van Ness et al. for Allowing release of nucleic acids during hybridization in a complex sample (Abstract);
2-Pyrrolidone is specifically cited by Demorest et al. as allowing use in in situ spotted arrays(paragraph 0093); and
Butadiene sulfone and 2-pyrrolidone cited for enhancing amplification reactions as explicitly taught by Chakrabarti et al. (paragraph 0015).
It is also reiterated that the courts have stated that:
Similar properties may normally be presumed when compounds are very close in structure; and
Compounds which are homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
With respect to any additional reagents, the secondary references are not relied upon for these reagents; rather, only for providing a rationale for choosing the specifically claimed compounds.
In addition, even if additional regents were to be required, the inclusion of any additional reagent is encompassed by the open claim language “comprising” found in the instant claims.
It is also noted the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. (No 04-1350 (US 30 April 2007) clearly establishes that it is obvious to try when choosing from a finite list of identified, predictable solutions with a reasonable expectation of success See MPEP 2143 I. Since the cited art has indicated the claimed compounds are used in conditions requiring denaturation, there is a reasonable expectation of success.
C. Applicant argues on page 11 that the routine optimization and other dependent claim rationales do not establish the use of the claimed compounds in the claimed context.
However, it is reiterated that the prior art specifically provides a reason for using each and every one of the claimed compounds during conditions that require denaturation.
D. Pages 11-13 of the Remarks refer to the double patenting rejections, and rely upon arguments already addressed above. The double patenting rejection based on the ‘655 publication are therefore maintained.
Conclusion
22. No claim is allowed.
23. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
24. 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.
25. 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