DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/31/2026 has been entered.
Status of the Applications, Amendments and/or Claims
This action is written in response to applicant's correspondence(s) submitted on 01/31/2026. In the paper of 01/31/2026, Applicant amended claims 43, 48-49, 55 and 63 and canceled claim 45 and added new claim 64. Accordingly, claims 43-44, 46, 48-50 and 52-64 are pending. Claims 1-42, 45, 47 and 51 are canceled. Claims 43-44, 46, 48-50 and 52-64 are under review.
Response to Arguments
Moot Rejection(s) and/or Withdrawn Rejection(s)
The rejection of claims 43-44, 48-50 and 52-62 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in favor a new rejection. The new rejection of the claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is provided below.
The rejection of claim 45 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is moot based on the cancellation of this claim.
The rejection of claim 45 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kudchodkar et al. (2004, Journal of virology, 78(20), pp.11030-11039) is moot based on the cancellation of this claim.
The rejection of claim 45 under pre-AIA 35 U.S.C. 102(a) as being anticipated by Adhikari et al. (March 2, 2009, Japanese journal of infectious diseases, 62(3), pp.212-214) is moot based on the cancellation of this claim.
The rejection of claim 45 under pre-AIA 35 U.S.C. 102(a) as being anticipated by Wang et al. (2000, Biotechniques, 28(2), pp.292-296) is moot based on the cancellation of this claim.
The rejection of claim 45 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,190,152 is moot based on the cancellation of this claim.
Maintained Rejection(s)
The rejection of claims 43-44, 46, 48-50, 52, 54 and 56 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kudchodkar et al. (2004, Journal of virology, 78(20), pp.11030-11039) is maintained. Applicant’s argument(s) are addressed below in section entitled “Arguments”.
The rejection of claims 43-44, 46, 48, 50, 52-54 and 56-57 under pre-AIA 35 U.S.C. 102(a) as being anticipated by Adhikari et al. (March 2, 2009, Japanese journal of infectious diseases, 62(3), pp.212-214) is maintained. Applicant’s argument(s) are addressed below in section entitled “Arguments”.
The rejection of claims 43-44, 46, 48, 50, 52, 54, 56 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Wang et al. (2000, Biotechniques, 28(2), pp.292-296) is maintained. Applicant’s argument(s) are addressed below in section entitled “Arguments”.
The rejection of claims 58-59 and 61 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nakatani et al. (2004, European Journal of Clinical Microbiology and Infectious Diseases, 23, pp.851-854: newly cited) in view of Goldenberger et al. (1995, Genome Research, 4(6), pp.368-370: previously cited) is maintained. Applicant’s argument(s) are addressed below in section entitled “Arguments”.
The rejection of claims 43-44, 46, 48-50 and 52-62 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,190,152 is maintained.
Argument(s)
Applicant's arguments filed 01/31/2026 have been fully considered but they are not persuasive as follows.
Concerning Applicant’s arguments that the specific direct chemical lysis compositions, wherein the pH of the direct chemical lysis composition is in the range of 6.6 to 10 are enabled and that Applicant was in possession of the claimed genus of direct lysis compositions of claim 43, Applicant’s arguments are not found persuasive because as Applicant points out on page 7 of the Remarks of 01/31/2026 concerning the Wands factors, the necessary experimentation required to achieve the claimed direct lysis composition with the functional limitation “of extracting nucleic acids from cells” is unreasonable and undue based on the broad limitations recited by claim 43, as claim 43 directs a functional limitation of a solution with the ability for direct extraction of nucleic acids from cells to any aqueous solution comprising a buffer component in the range of 0.2 M to 2M, a non-ionic surfactant in combination with NaCl, or KCl or CH3CO2Na2 or (NH4)2SO4, without adequate supporting written disclosure.
The current enablement rejection highlights disclosure in the specification concerning the addition of “heat” with an aqueous direct lysis solution, as providing some basis of evidence for meeting the functional limitation of extracting nucleic acids from cells, where the claim recites limitation of a buffer component with a range of 0.2 M to 2M, a non-ionic surfactant in combination with NaCl, or KCl or CH3CO2Na2 or (NH4)2SO4. Applicant arguments omit supporting evidence for the broadly drawn claimed limitations as being adequate for the genus of aqueous solutions meeting the functional limitation of extracting nucleic acids from cells, without significantly more.
Applicant argues that the limitation “consisting essentially” as recited by claim 43, obviates each of the rejections under 35 U.S.C 102(a) because MPEP provides that “the transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim." MPEP 2111.03 (II) (emphasis added). (Remarks of 01/31/2026, pg 10, 2nd para) and the cited references teach additional components in addition to the claimed ones.
The argument is not persuasive as all of the claims recite “consisting essentially of”, a limitation that differs from the MPEP’s “consisting of”. The claims (e.g. claim 43) require components are recited so broadly drawn that it is unknown how essential each component is to the functional ability of extracting nucleic acids from cells. The rejections are maintained. Applicant is invited to amend the claims or to point to disclosure in the specification that satisfy the genus encompassed by the claims and that are commensurate in scope with the limitations recited.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/26/2026 was filed after the mailing date of the Final Office action of 10/31/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 43-44, 46, 48-50 and 52-63 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 43-44, 46, 48-50 and 52-63 are directed to a direct chemical lysis composition for extracting nucleic acids from cells consisting essentially of an aqueous solution comprising
a) a buffer component,
b) a salt component, wherein the salt component is selected from the group consisting of sodium chloride (NaCl), potassium chloride (KCl), sodium acetate (C2H3NaO2) and ammonium sulfate ((NH4)2SO4),
c) a non-ionic surfactant;
wherein the concentration of the buffer component in the direct chemical lysis composition is in the range of 0.2 M to 2 M and wherein the pH of the direct chemical lysis is in the range of 6.6 to 10.
Concerning the functional language corresponding to “direct chemical lysis”, the specification discloses that the instant direct chemical lysis composition “permits direct nucleic acid extraction from cells in a biological sample without the need to decant off a transport media or otherwise exchange the transport media with assay compatible buffers. There is no need to combine the sample with proteinase K or another enzyme to extract nucleic acids from the cells” (page 5, para [0012]).
In contrast to para [0012] however, the specification discloses only predictability when specific compositions are used with heat incubation at 120 ⁰C for 20 min.
Claims 43-44, 46, 48-50 and 52-63 are now rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for being too broadly drawn encompassing a vast genus of compositions, including compositions that do NOT permit direct nucleic acid extraction from the cells of a biological sample.
The specification fails to satisfy the written description requirement of 35 U.S.C. 112 first paragraphs with respect to the full scope of claim 43-44, 46, 48-50 and 52-63 since the specification fails to teach a complete structure for the members of the genus of instant direct chemical lysis compositions that are enabled for direct extraction of nucleic acids from every biological sample, without either the need for heat incubation and/or proteinase K enzyme”.
As already noted, the following specific direct chemical lysis compositions are enabled with use of heat incubation at 120 ⁰C for 20 min, to promote the release nucleic acids from HPV 16, 18, 45 and HBB samples.
The compositions disclosed by the specification include:
1 M Tris-HCl, 0.5 M NaCl, 1% Triton X-100, pH of 9.0;
330 mM Tris-HCl, 16.67 mM NaCl, pH of 7.8;
0.77M Tris-HCl, 0.386 M NaCl, 0.77% Triton X-100, pH 9.0;
0.255M Tris-HCl, 0.0129 M NaCl, pH 7.8;
0.75 M Tris HCl, 0.193 M NaCl and 0.75% Triton X-100, pH 7.9;
1.5M Tris, 0.386 M NaCl and 1.5% Triton X-100 (v/v), pH 7.9.
1 M Tris-HCl, 0.257 M NaCl, 1% Triton X-100, pH of 7.9.
Claims 43-44, 46, 48-50 and 52-63 are broadly drawn and are not limited to the compositions (1)-(7) above. The specification EVEN shows a high variability/unpredictability concerning whether these compositions can promote direct nucleic acid extraction from any sample without the addition of heat incubation at 120 ⁰C for 20 min.
Working Examples
The specification (pages 14-15, para [0043]) particularly teach two diluent solutions that are embodiments of the direct chemical lysis composition of the present invention.
Diluent 1 contained 1 M Tris-HCl, 0.5 M NaCl, 1% Triton X-100, pH of 9.0.
Diluent 2 contained 330 mM Tris-HCl, 16.67 mM NaCl, pH of 7.8.
The specification further notes the testing of additional diluent solutions that are modification of diluents 1 and 2 from above (see pg 15, para [0044]) to working buffers i.e.
(i) 0.77M Tris-HCl, 0.386 M NaCl, 0.77% Triton X-100 (with a pH of approximately 9.0: diluent 1a); and
(ii) 0.255M Tris-HCl, 0.0129 M NaCl (with a pH of approximately 7.8): diluent 2a.
Based on para [0046] on page 18, nucleic acid extraction did NOT occur using diluent 1a or diluent 2a at low incubation temperatures for HPV 16 and HBB samples, as indicated by Table 1a on page 17 and Table 1c on page18, respectively.
However, diluent 1a or diluent 2a promote nucleic acid extraction at low incubation temperatures for HPV 45 and HPV 18 samples, respectively as indicated by Table 1b on page 17 and Table 1d on page18 respectively.
Other compositions for direct nucleic acid extraction as indicated below were tested on para [0048] on page 18, with a 20 min, 120 ⁰C incubation then cool to 25 min:
0.77 M Tris HCl;
0.386 M NaCl;
0.77% Triton X-100;
0.77M Tris-HCl, 0.386 M NaCl, 0.77% Triton X-100.
Nucleic acids of HPV 16, 18 and 45 are detected using compositions (a) through (d) after incubation at 120 ⁰C, but not for the HBB sample (see Tables 2a-2d on pages 20-21 and page 21, para [0049]).
Further, Table 4 on page 25 and para [0053] disclose that DNA extraction from sample combined with Surepath and ThinPrep preservCyt and heat was most predictive.
Table 5 on pages 29-30, and para [0057]-[0059] on pages 30-31 showed that for heat-incubated samples at pH 6.6, pH 7.3, pH 7.8, pH 8.0, pH 9.0, or pH 10.0, nucleic acid extraction were enabled with diluent 1a and/or diluent 2a.
Finally on pages 40-41, para [0072], the chemical lysis composition consisting 0.75 M Tris HCl, 0.193 M NaCl and 0.75% Triton X-100, pH 7.9 with heat incubation at 120 ⁰C for 20 min tested and the Tables on pages 42-43 show enablement for nucleic acid extraction.
The compositions (1)-(7) above do not form a representative number of species to cover the breadth of the claimed genus of compositions claimed by claims 43-44, 46, 48-50 and 52-63. The ordinary skilled artisan would not have believed that the Applicant was in possession of the entire breadth of the claimed genus of compositions.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 43-44, 46, 48-50, 52, 54 and 56 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kudchodkar et al. (2004, Journal of virology, 78(20), pp.11030-11039).
Regarding claims 43-44, 46, 48-50, 54 and 56-57, Kudchodkar et al. teach a cell lysis composition consisting of 200 mM Tris HCl (pH 7.5), 140 mM NaCl, 1% NP-40, 10 mM NaF, 1 mM EDTA, 200 µM NaVO4, 2 mM phenylmethylsulfonyl fluoride (PMSF), 1.5 µg of aprotinin per ml, and 1 µg of leupeptin per ml (see pg 11031, right col., section entitled “Time course viral infections”).
Accordingly, the composition of Kudchodkar et al. meets all of the limitations of the instant claims 43, 46 and 50 since it comprises a buffer component with a concentration in the range of 0.2 M to 2 M and a pH in the range of 6.6 to 10 or 7 to 9 (i.e. 200 mM Tris HCl (pH 7.5).
Regarding claims 43 and 48-49, the composition of Kudchodkar et al. comprises a metal salt component, that has a concentration in the range 0.01 M to 1 M and is at least 0.01 M (i.e. 140 mM NaCl).
Regarding claim 44, the composition of Kudchodkar et al. does not comprise proteinase K.
Regarding claims 43, 52 and 54, the composition of Kudchodkar et al. comprises a non-ionic surfactant (i.e. 1% NP-40, Non-idet 40 also known as polyethylene glycol nonylphenyl ether).
Regarding claim 56, the composition of Kudchodkar et al. does not comprise a fixative agent.
Accordingly, the instant claims 43-44, 46, 48-50, 52, 54 and 56 are anticipated by Kudchodkar et al.
Claims 43-44, 46, 48, 50, 52-54, 56-59 and 61-62 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Adhikari et al. (March 2, 2009, Japanese journal of infectious diseases, 62(3), pp.212-214).
Regarding claim 43, Adhikari et al. teach a 10X composition for LAMP (i.e. 10X LAMP consisting 200 mM Tris-HCl (pH 8.8), 100 mM KCl, 100 mM NH4SO4 and 1% Triton X-100) (see pg 212, right col., 2nd para).
Regarding claims 44 and 56-57, the 10X composition for LAMP taught by Adhikari et al. does not comprise an enzyme, or the enzyme proteinase K and also does not comprise a fixative agent (claim 56), or any one or more selected from formaldehyde, formic acid, methanol, ethanol, buffered formalin, and EDTA.
Accordingly, the composition of Adhikari et al. meets all the limitations of claim 43-44 and 56-57 by comprising:
a) a buffer component (i.e. 200 mM Tris-HCl: with a concentration in the range of 0.2 M to 2M),
b) a metal salt component (i.e. 100 mM KCl), and
c) a non-ionic surfactant (i.e. 1% Triton X-100).
Regarding claims 43, 46 and 50, the 10X composition for LAMP taught by Adhikari et al. comprises 200 mM Tris-HCl (pH 8.8), thereby meeting the limitations of claims 43 and 46 i.e. having pH falling between 6.6 to 10, or pH between 7 to 9.
Regarding claims 43 and 48, the 10X composition for LAMP taught by Adhikari et al. comprises metal salt with concentration 100 mM KCl, thereby meeting the limitations of claim 47 (is KCl) and claim 48 (is at least 0.01 M).
Regarding claims 43 and 52-54, the 10X composition for LAMP taught by Adhikari et al. comprises the non-ionic surfactant is a polyethylene glycol-based or a polysorbate-based non-ionic surfactant (i.e. 1% Triton X-100 also known as polyoxyethylene octyl phenyl ether).
Regarding claim 58, Adhikari et al. teach a composition, comprising the direct chemical lysis composition of claim 43 and a specimen storage composition (see pg 212, right col., 2nd para wherein Adhikari et al. teach 25 µl reaction mixture comprising the 10X LAMP buffer and a 4 µl DNA storage medium).
Regarding claim 59, Adhikari et al. teach specimen storage composition comprises at least EDTA (see pg 212, right col., 2nd para, wherein Adhikari et al. cite direct-LAMP assay in TE buffer).
Regarding claim 61, Adhikari et al. teach the specimen storage composition comprises a sample comprising cells (see pg 212, right col., 2nd para).
Regarding claim 62, Adhikari et al. teach sputum smear cells (i.e. exfoliated cells, oral cells or throat cells: abstract).
The instant claims 43-44, 46, 48, 50, 52-54, 56-59 and 61-62 are anticipated by Adhikari et al.
Claims 43-44, 46, 48, 50, 52, 54, 56 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Wang et al. (2000, Biotechniques, 28(2), pp.292-296).
Regarding claim 43, Wang et al. teach a homogenization composition consisting 200 mM Tris-HCl (pH 8.5), 1.5% (wt/vol) lithium dodecylsulfate, 300 mM LiCl, 10 mmol/L Na2 EDTA, 1% (wt/vol) sodium deoxycholate and 1% (vol/vol) NP-40 (see pg 292, rightmost col., 1st para).
Regarding claims 43-44 and 56, the composition taught by Wang et al. does not comprise an enzyme (claim 43), or the enzyme proteinase K (claim 44) and also does not comprise a fixative agent (claim 56).
Accordingly, the composition of Wang et al. meets all the limitations of claim 43-44, 50 and 56 by comprising:
a) a buffer component (i.e. 200 mM Tris-HCl: with a concentration in the range of 0.2 M to 2M),
b) a metal salt component (i.e. 300 mM LiCl), and
c) a non-ionic surfactant (i.e. 1% NP-40).
Regarding claims 43, 46 and 50, the composition taught by Wang et al. comprises 200 mM Tris-HCl (pH 8.8), thereby meeting the limitations of claim 46 i.e. having pH falling between 6.6 to 10, or pH between 7 to 9.
Regarding claims 43 and 48, the composition taught by Wang et al. comprises metal salt with concentration 300 mM LiCl, thereby meeting the limitations of claim 48 (is at least 0.01 M).
Regarding claims 43, 52 and 54, the composition taught by Wang et al. comprises the non-ionic surfactant is a polyethylene glycol-based or a polysorbate-based non-ionic surfactant (i.e. 1% NP-40 also known as polyethylene glycol nonylphenyl ether).
The instant claims 43-44, 46, 48, 50, 52, 54, 56 are anticipated by Wang et al.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 58-59 and 61 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nakatani et al. (2004, European Journal of Clinical Microbiology and Infectious Diseases, 23, pp.851-854: newly cited) in view of Goldenberger et al. (1995, Genome Research, 4(6), pp.368-370: previously cited).
Regarding claims 58-59, Nakatani et al. teach a composition, comprising a direct chemical lysis composition and a specimen storage composition (see pg 852, right col., 2nd para: wherein Nakatani et al. teach mix of 10 µl, 10X lysis composition comprising 200 mM Tris pH 8.4 and 500 mM KCl and 10 µl sample in specimen storage buffer to a final volume of 100 µl, sample in EDTA: see pg 852, left col., 1st para).
Regarding claim 61, Nakatani et al. teach the specimen storage composition comprises a sample comprising cells, blood, or a combination thereof (see pg 852, left col., 1st para).
Omitted from Nakatani et al. (claim 58)
Nakatani et al. do not teach the direct chemical lysis composition comprising a non-ionic surfactant.
Goldenmeyer et al. (claim 58)
Regarding claim 58, Goldenmeyer et al. teach a direct chemical lysis composition called Triton X-100 buffer (see pg 368, right col., section of “DNA Extraction”, entitled “Procedure B”) for lysing various bacterial species e.g. S. aureus (see also pg 369, rightmost column and last seven lines before Fig. 1 and pg 370, left col., first para).
comprising:
a) a buffer component,
b) a metal salt component (1 mM EDTA: Ethylenediaminetetraacetic acid having the formula [CH2N(CH2CO2H)2]2 is also called sodium calcium edetate and is a salt that binds metal ions),
and
c) a non-ionic surfactant (1% Triton X, polyethylene glycol octylphenyl ether or a polyethylene glycol-based surfactant);
wherein the direct chemical lysis composition does not comprise an enzyme.
It would have been prima facie obvious to an ordinary skilled artisan to modify the composition as taught by Nakatani et al., said composition comprising a direct chemical lysis composition and a specimen storage composition, before the effective filing date of the instant invention, by further including a non-ionic surfactant as the prior art of Goldenmeyer et al. already teach the well-known utility of non-ionic surfactant in direct lysis compositions.
In view of the combined teachings of all of the cited reference(s), the instant claims 58-59 and 61 are prima facie obvious.
Double Patenting
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.
Claims 43-44, 46, 48-50 and 52-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,190,152.
The instant claim 43 is directed to a direct chemical lysis composition for extracting nucleic acids from cells, consisting essentially an aqueous solution comprising:
a) a buffer component,
b) a salt component selected from NaCl, KCl, Ch3Co2Na2 and (NH4)2SO4, and
c) a non-ionic surfactant;
wherein the concentration of the buffer component in the direct chemical lysis composition is in the range of 0.2 M to 2 M, wherein the pH of the direct chemical lysis is in the range of 6.6 to 10, wherein the direct chemical lysis composition does not comprise an enzyme.
The instant claim 60 is directed to the direct chemical lysis composition of claim 43, and a specimen storage composition, wherein the specimen storage composition comprises at least one constituent selected from the group consisting of formaldehyde, formic acid, methanol, ethanol, buffered formalin, and EDTA, wherein the specimen storage composition comprises a liquid-based cytology composition or paraffin media.
While claim 1 of U.S. Patent No. 10,190,152 recites:
A composition consisting of a direct chemical lysis composition in combination with a liquid-based cytology sample or a formalin-fixed, paraffin embedded sample,
the direct chemical lysis composition consisting of:
a) a buffer composition comprising a buffer component and a metal salt component,
wherein the metal salt component is selected from the group consisting of sodium chloride (NaCl), potassium chloride (KCl), sodium acetate and ammonium sulfate,
wherein a concentration of the buffer component is in a range of 0.2 M to 2 M and a concentration of the metal salt component is in a range of 0.01 M to 1 M; and b) a non-ionic surfactant wherein a concentration of the non-ionic surfactant is in a range of 0.01 to 2 percent (v/v).
Although the claims at issue are not identical, they are not patentably distinct from each other
instant claims 1-7 of U.S. Patent No. 10,190,152 anticipate the direct chemical lysis composition of claim 43 and the direct chemical lysis composition in combination with a liquid-based cytology sample or a formalin-fixed, paraffin embedded sample of the instant claim 60.
Conclusion
Claim 64 is allowable. No other claims are currently allowed in the view of the rejections above.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681