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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Examiner notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112(b)
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(s) 1-10 is/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 pre-AIA the applicant regards as the invention.
The term “firmly” in claim 1 is a relative term which renders the claim indefinite. The term “firmly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The same issue arises mutatis mutandis with the term ‘approximately’ in claim(s) 3. Particular to claim(s) 3, the scope of the claim(s) cannot be wholly determined as the claim encompasses an ‘approximate’ range.
Claim(s) 2-10 is/are rejected due to its/their dependence on claim(s) 1.
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Birnboim (US 20130116596 A1).
For claim 1, Birnboim teaches A method of collecting DNA from a human
subject, [entire disclosure see esp. ¶77] the method comprising:
obtaining a collection device comprising an elongate arm and a swab head disposed at a distal end of the elongate arm, the swab head comprising a plurality of bristles disposed on a surface of the swab head; [Fig(s). 1]
exposing the swab head of the collection device by removing the collection device from a first sealed container; [Fig(s). 36 steps 1-2]
inserting the swab head within an orifice of the human subject, [Fig(s). 36 steps 8-9 in view of ¶77]
wherein the plurality of bristles is oriented toward a collection site within the orifice; [¶¶82-83]
firmly moving the swab head over the collection site; [Fig(s). 36 steps 8-9 ¶112]
removing the swab head from the orifice; [Fig(s). 36 steps 9-10]
and placing the collection device in a second sealed container. [Fig(s). 36 steps 11-12]
For claim 2, Birnboim teaches The method of claim 1,
wherein the orifice is a mouth, the collection site is an internal surface of a cheek. [Fig(s). 36 steps 9-10 ¶¶82-83]
For claim 3, Birnboim teaches The method of claim 1, further comprising the step of aerating the swab for approximately 30 seconds prior to inserting in the second sealed container. [see § 112b rejection — consider at least aeration that occurs as part of steps 9-11 in Fig(s). 36]
For claim 4, Birnboim teaches A method of extracting DNA from a collection device, the method comprising:
obtaining a test sample from a subject, [Fig(s). 36 steps 8-9 in view of ¶77]
wherein the test sample is disposed on a collection device comprising an elongate arm and a swab head disposed at a distal end of the elongate arm, the swab head comprising a plurality of bristles for extracting and holding the test sample; [Fig(s). 1]
exposing the test sample; [Fig(s). 36 steps 9-10]
positioning the collection device relative to a collection receptacle; and transferring the test sample to the collection receptacle. [Fig(s). 36 steps 9-11]
For claim 5, Birnboim teaches The method of claim 4,
wherein the collection receptacle is a well plate comprising at least one or more wells. [¶119]
For claim 6, Birnboim teaches The method of claim 5,
wherein positioning the collection device comprises positioning the collection device relative to the well plate, such that at least a portion of the plurality of bristles holding the test sample are aligned with the at least one or more wells of the well plate. [Fig(s). 36 steps 9-12 in view of ¶119]
For claim 7, Birnboim teaches The method of claim 6,
wherein transferring the test sample comprises inserting at least a portion of the plurality of bristles into the at least one or more wells of the well plate. [Fig(s). 36 steps 9-12 in view of ¶119]
For claim 8, Birnboim teaches The method of claim 4,
wherein exposing the test sample comprises removing the collection device from a sealed container. [Fig(s). 36 steps 1-2]
For claim 9, Birnboim teaches The method of claim 4, further comprising a step of assaying the test sample. [¶88 ¶116]
For claim 10, Birnboim teaches The method of claim 9,
wherein the step of assaying the test samples comprises performing one or more genetic test measurements to generate genotyping data. [¶88 ¶116]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791
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