Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
OBJECTION
2. Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
NON-PRIOR ART REJECTIONS
3. 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 74 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. This claim is indefinite because it is redundant in that the first two alternatives recited for transporting and/or storing the composition are identical. Correction is required.
4. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24, 28, 35, 37, 42, and 46-47 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
These claims are drawn to a formulation which is a type of product, and it is well settled in U.S. patent practice that product claims are examined only based upon the required product or product components, and ‘intended use’ language is not afforded patentable weight. Thus, the claims are drawn to a formulation comprising detergent, metal chelating agent, and buffer. The further limitations of the noted claims relate not to the formulation components themselves, but to an ‘intended use’ of the formulation; thus, the claims are not further limiting.
PRIOR ART REJECTION
5. 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.
6. 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.
Claims 1, 7, 9, 12, 15, 24, 28, 35, 37, 42, 46-47, 52, 64, and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischer et al. (US 2014/0193804).
Regarding independent claim 1, Fischer discloses a formulation comprising detergent in the range of about 0.1% to about 3%, metal chelating agent in the range of about 0.1 mM to about 5.0 mM, and buffer in the range of about 20 mM to about 40 mM. See paragraphs 0012-0045, 0048-0054, 0059-0061, 0086-0099, 0101, 0105, and 0121, and Table 1.
Regarding claim 7, Fischer discloses sodium lauryl sulfate (SDS) as the detergent (see paragraph 0020).
Regarding claim 9, Fischer discloses EGTA as the metal chelating agent (see paragraph 0022).
Regarding claim 12, Fischer discloses phosphate as the buffer (see paragraph 0024).
Regarding claim 15, Fischer discloses a pH of the formulation in the range of about 6.5 to about 7.5 (see paragraph 0025).
Regarding claims 24, 28, 35, 37, 42, 46, and 47, as noted above the recited ‘intended use’ further limitations do not carry patentable weight, and thus cannot distinguish from the disclosure of Fischer.
Regarding claim 52, Fischer further discloses sample collection systems. See paragraphs 0086-0095, 0101, and 0105.
Regarding claim 64, Fischer further discloses methods for purifying a nucleic acid from a biological sample comprising collecting a sample from a subject, contacting the sample with the formulation of claim 1, and purifying nucleic acid. See paragraphs 0039-0047.
Regarding claim 74, Fischer further discloses methods wherein transporting and/or storing the composition is at room temperature for at least about 1 day. See paragraph 0048.
The claimed formulations, sample collection system, and methods of purifying a nucleic acid cannot be distinguished from those disclosed by Fischer.
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al. (US 2014/0193804) in view of Vos (US 5,275,942).
The formulations of Fischer are discussed above.
Fischer does not explicitly disclose a formulation comprising ‘about 3%’ SDS or both EDTA and EGTA, and which excludes guanidinium thiocyanate.
Vos discloses the use of 3% SDS to lyse cells in order to isolate nucleic acids (see column 6, lines 37-40).
One of ordinary skill in the art would have been motivated to combine the teachings within Fischer, or of Fischer and Vos, to achieve the invention as claimed for the following reasons. As far as the limitation ‘about 3%’ SDS, this reasonably reads on the ‘about 1%’ SDS disclosed by Fischer. However, for the sake of completeness, the Office also cites Vos as explicitly disclosing the use of 3% SDS as appropriate for lysing cells for isolation of nucleic acids. As far as inclusion of both EDTA and EGTA, this is suggested by Fischer by the use of the language ‘one or more chelators’ in paragraph 0018 and ‘or any combination thereof’ in paragraph 0022. Although the formulations of Fischer include a chaotrope, several chaotropes other than guanidinium thiocyanate are disclosed (see paragraph 0019), so Fischer clearly suggests formulations which do not comprise guanidinium thiocyanate. In conclusion, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make and use the claimed formulation.
CONCLUSION
8. No claims are free of the prior art.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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.
10/30/25
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681