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 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.
Claim 29 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The term “next-generation sequencing” is not described or supported in the disclosure.
Claim 29 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for sequencing of a DNA sample, does not reasonably provide enablement for all uses of next-generation sequencing. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims. The disclosure does not recite all possible acts for next-generation sequencing, which is the breadth of a general claim to the use of next-generation sequencing as claimed. Nor does the disclosure define “next-generation sequencing”. Therefore, the scope of the claim exceeds the disclosure.
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 29 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.
Claim 29 includes the term “next-generation sequencing” which is not defined in the disclosure. It is not clear what the term includes and excludes.
Allowable Subject Matter
Claims 23-28 and 30-42 are allowed.
The following is an examiner’s statement of reasons for allowance:
The prior art fails to teach or suggest A method for determining an abundance characterization of a biological sample, the method comprising: generating a set of target-associated molecules comprising: target-associated regions with sequence similarity to a target sequence region of a biological target; and target variation regions with sequence dissimilarity to a sequence region of the biological target; forming a mixture including the target-associated molecules and DNA from the biological sample; dividing the mixture into a first portion and a second portion; amplifying the first portion of the mixture; amplifying the second portion of the mixture; and determining the abundance characterization of the biological target based on amplicons of the first portion of the mixture and amplicons of the second portion of the mixture as recited in claim 23. Claims 24-28 and 30-42 are allowable by virtue of their dependency.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A VANORE whose telephone number is (571)272-2483. The examiner can normally be reached Monday to Friday 7AM to 6 PM.
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/DAVID A VANORE/Primary Examiner, Art Unit 2878
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