DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 04/08/2026 is acknowledged. Regarding the Office action mailed 12/08/2025:
The rejection of claim 16 under 35 USC 112(b) is withdrawn in view of the amendment.
The rejection of claims 7 and 11 under 35 USC 112(b) is moot for claim 7 and withdrawn in view of the amendment for claim 11.
The rejection under 35 USC 102(a)(2) over Wu is withdrawn, as Wu did not disclose a composition with a zwitterionic surfactant.
The rejection under 35 USC 102(a)(2) over De Wet is withdrawn, as the composition cited in De Wet did not comprise a zwitterionic surfactant.
The rejection under 35 USC 102(a)(2) over Bartolome is withdrawn, as Bartolome did not disclose a composition with a zwitterionic surfactant.
The rejection under 35 USC 102(a)(1) over Yue is withdrawn, as Yue did not disclose a composition with a zwitterionic surfactant.
The rejection under 35 USC 102(a)(1) over Mendez is withdrawn, as Mendez did not disclose a composition with a zwitterionic surfactant.
The rejection under 35 USC 102(a)(1) over Donohue is withdrawn, as Donohue did not disclose a composition with a zwitterionic surfactant.
The rejection under 35 USC 103 over Donohue and Cardinal is maintained and applied to amended claim 1.
New rejections are also set forth as necessitated by the amendment.
Claim Rejections - 35 USC § 103
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1, 11 and 132 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donohue (US 2020/0017891, previously cited) in view of Cardinal (US 2021/0355454, previously cited).
Donohue disclosed a lysis buffer comprising a surfactant (cetyltrimethylammonium bromide, which is a cationic surfactant), a protease component (proteinase K), a chelating agent (EDTA), and a buffering salt (trisaminomethane, i.e., Tris). See paragraph [0253]. Donohue’s lysis solution happened to have CTAB (cetyltrimethylammonium bromide) as a surfactant. Donohue did not use a zwitterionic detergent as recited in claim 1, or more particularly the zwitterionic detergents of claim 11.
Cardinal taught that zwitterionic agents, including all those recited in claim 11, could be used for cell lysis (paragraph [0352]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to substitute cetyltrimethylammonium bromide used by Donohue with the alternative cell lysis surfactants disclosed by Cardinal, since all were known in the art to include in lysis buffers for the purpose of lysing cells. MPEP 2144.06. Regarding the limitation “wherein the composition is configured to lyse cells while the protease component remains active, and wherein the composition lyses cells at ambient conditions”, and regarding the limitations of claim 132, as the rejection arrives at a composition indistinguishable from claim 1, the properties of the composition are presumed inherent. MPEP 2112(III, V): “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”
If there is something not recited in the claim that is required for these properties, grounds for rejection under 35 USC 112(a) and (b) could be appropriate; see MPEP 2172.01.
Claim(s) 1-5, 16, 17 and 132 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yue (US 2012/0041175, previously cited) in view of Kuslich (US 2014/0162888, previously cited) and Seligson (US 4,935,342).
Yue disclosed a lysis buffer comprising a surfactant (SDS, an anionic detergent), a protease component (proteinase K), a chelating agent (EDTA), a buffering salt (1X SSC), and a disaccharide (sucrose, 27%). See paragraph [0331].
SSC is a buffer and stands for saline sodium citrate; see Kuslich paragraph [0218].
27% sucrose is 27 grams of sucrose per 100 mL of solution. Based on a molecular weight of 342.30 g/mol for sucrose, a 27% solution equates to approximately 789 mM, which is “about” 600 mM:
27g X 1mol X 1000mL X 1000mmol = 788.78mmol/L
100mL 342.30g L mol
Seligson disclosed (column 8, lines 22-25): “A lysing enzyme, such as Proteinase K may be employed in conjunction with an anionic, nonionic, or zwitterionic detergent.”
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to substitute SDS used by Yue with a zwitterionic detergent as disclosed by Seligson, since Seligson taught that zwitterionic detergent and anionic detergents could both be used in conjunction with Proteinase K in lysis buffers. MPEP 2144.06.
Regarding the limitation “wherein the composition is configured to lyse cells while the protease component remains active, and wherein the composition lyses cells at ambient conditions”, and regarding the limitations of claim 132, as the rejection arrives at a composition indistinguishable from claim 1, the properties of the composition are presumed inherent. MPEP 2112(III, V): “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”
If there is something not recited in the claim that is required for these properties, grounds for rejection under 35 USC 112(a) and (b) could be appropriate; see MPEP 2172.01.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donohue (US 2020/0017891, previously cited) in view of Cardinal (US 2021/0355454, previously cited) as applied to claims 1, 11 and 132 above, and further in view of Mendez (US 2009/0269816, previously cited).
The disclosures of Donohue and Cardinal have been discussed. Donohue used Proteinase K in the lysis buffer. Donohue did not disclose a mixture of proteases as disclosed in claims 13-15.
Mendez disclosed a lysis buffer comprising a surfactant (SDS, Sarkosyl), a protease component (pronase, which is a mixture of proteinases, which are produced by Streptomyces griseus), a chelating agent (EDTA), and a buffering salt (Tris). See paragraph [0150].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to combine the Proteinase K used by Donohue with pronase as used by Mendez when making the lysis buffer suggested by the combined teachings of Donohue and Cardinal, since both types of protease were known in the art to include in lysis buffers for the purpose of lysing cells. MPEP 2144.06.
Claim(s) 1, 11, 16, 18, 19 and 132 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanno (US 2005/0037351).
Kanno disclosed a procedure in which cell were lysed (paragraph [0270], emphasis provided):
To 0.25 ml of cryopreserved blood there was added 0.25 ml of 2× Digestion Buffer (20 mM Tris, pH 8; 200 mM NaCl; 50 mM EDTA; 1% surfactant) heated to 37° C. The surfactant was one selected from among the following surfactants. Specifically, the surfactant used was the anionic surfactant Sodium dodecyl sulfate (SDS), the amphoteric surfactant 3-[(3-Cholamidopropyl) dimethylammonio]-1-propa- nesulfonate (CHAPS) or 3-[(3-Cholamidopropyl) dimethylammonio]-2-hydroxy-1- -propanesulfonate (CHAPSO), the non-ionic surfactants Polyethyleneglycol tert-octylphenyl ether (Triton X-114), Polyethyleneglycol tert-octylphenyl ether (Triton X-100), Polyoxyethylene alkyl ether (Nissan Dispanol TOC), (Octylphenoxy)polyethoxyethanol (Igepal CA630) or Nonoxynol-8.5 (Nissan Nonion NS-208.5), or the cationic surfactants Hexadecylpyridinium Chloride (HPC), Hexadecylpyridinium Bromide (HPB), Hexadecyltrimethylammonium Chloride (HTAC) or Hexadecyltrimethylammonium Bromide (HTAB). After adding 2× Digestion Buffer and further adding 0.05 µg of Proteinase K (PCR-Grade, Roche), the mixture was stirred in a vortex while periodically heating it in a 37°C. water bath, to complete dissolution.
The difference between the claimed composition and Kanno is that Kanno added the components to the cells to be lysed in two steps: 1) adding the zwitterionic surfactant, EDTA, and buffering salt (Tris, NaCl) and 2) Proteinase. It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to combine these components into one mixture, then add to the sample. One would have been motivated to do this in situations where one was processing a plurality of samples, as this would have saved time and effort. By combining the components into a single solution, one could have cut the number of additions of reagent to sample by 50%, by requiring only a single dispensing of reagent to each sample, instead of dispensing the components separately.
Regarding the limitation “wherein the composition is configured to lyse cells while the protease component remains active, and wherein the composition lyses cells at ambient conditions”, and regarding the limitations of claim 132, as the rejection arrives at a composition indistinguishable from claim 1, the properties of the composition are presumed inherent. MPEP 2112(III, V): “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”
If there is something not recited in the claim that is required for these properties, grounds for rejection under 35 USC 112(a) and (b) could be appropriate; see MPEP 2172.01.
Response to Arguments
The only remarks that would be germane to any of the rejections above would be the remarks addressing the 35 USC 103 rejection of claims 9-11, which have been applied to amended claim 1. On this, Applicant simply indicates: “Applicant has cancelled claims 9 and 10. As claim 11 depends on amended claim 1, Applicant believes that claim 11 is in condition for allowance.”
For the reasons discussed above, the claims are not in condition for allowance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
Prosecution Insights