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 .
Claim Rejections - 35 USC § 112
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.
Claim 16 is 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.
Regarding claim 16, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 7 and 11 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.
Claims 7 and 11 contains the trademark/trade names TERGITOL 15-S-9, TRITON X-100, TWEEN 20, EMPIGEN BB and ZWITTERGENT 3-14. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe surfactants and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6, 7, 12, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wu (US 2024/0263194).
Wu disclosed a lysis buffer comprising a surfactant (NP-40), a protease component (proteinase K), a chelating agent (EDTA), and a buffering salt (Tris). See paragraph [0254].
Claim(s) 1-7, 12, 13, 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by De Wet (US 2023/0133281).
De Wet disclosed a lysis buffer comprising a surfactant (Triton X-100), a protease component (proteinase K and trypsin), a chelating agent (EDTA), a buffering salt (Tris-HCL), and a disaccharide (sucrose, 100 mM, which is “about” 200 mM). See paragraph [0181].
Claim(s) 1, 12, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bartolome (US 2021/0095313).
Bartolome disclosed a lysis buffer comprising a surfactant (sodium dodecyl sulfate, i.e. SDS), a protease component (proteinase K), a chelating agent (EDTA), and a buffering salt (Tris-HCL). See paragraph [0278].
Claim(s) 1-5, 12, 16, 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yue (US 2012/0041175) as evidenced by Kuslich (US 2014/0162888).
Yue disclosed a lysis buffer comprising a surfactant (SDS), 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
Claim(s) 1, 13-15 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mendez (US 2009/0269816).
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].
Claim(s) 1, 8, 12 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donohue (US 2020/0017891).
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].
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) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donohue (US 2020/0017891) in view of Cardinal (US 2021/0355454).
The teachings of Donohue have been discussed. Donohue’s lysis solution happened to have CTAB (cetyltrimethylammonium bromide) as a surfactant. Donohue did not use benzalkonium chloride as recited in claim 9, a zwitterionic detergent as recited in claim 10, or more particularly the zwitterionic detergents of claim 11.
Cardinal taught that cetyltrimethylammonium bromide and benzalkonium chloride were both cationic agents used for cell lysis (paragraph [0350]). Similarly, 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 or combine the 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 and 2144.07.
Conclusion
No claims are free of the prior art.
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