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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 9/26/2025 is acknowledged. Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “a custom-made cap with inlet and outlet,” “a cotton swab,” “nitrocellulose,” “Dynabeads,” “unit 1 can be permanently attached to unit 2 or provided separately” are not recited in the specification.
Claim Objections
Claim 2 is objected to because of the following informalities: before the first recitation of “NA,” there should be a “(NA)” after nucleic acid to improve clarity of the claims. Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “unit 1” and “unit 2” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 3, 4 and 6 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.
Claim 3 recites the limitation "the sample" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 4 is rejected by virtue of their dependence on a rejected base claim.
Claim 4 contains the trademark/trade name “whatman # 1 paper”. 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 “whatman # 1 paper” and, accordingly, the identification/description is indefinite.
Claim 4 contains the trademark/trade name “Dynabeads”. 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 “Dynabeads” and, accordingly, the identification/description is indefinite.
Claim 6 recites the limitation "the lysis buffer" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-4, 6 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/195594, hereinafter Mason.
Regarding claim 1, Mason teaches a kit (figure 8), comprising: an all-inclusive, low complexity, portable, disposable, easy to use, and rapid nucleic acid detection device (intended use MPEP § 2114 (II)) with two complementary units (figure 8): unit 1 (figure 8B, the container to “Shake to lyse tissue” and “Dip (3x) to bind nucleic acids”) for nucleic acid, extraction, and purification (intended use MPEP § 2114 (II)), unit 2 (figure 8B, the container to “Dip (3x) into amplification reaction) for rapid isothermal amplification, labeling, and detection of target nucleic acids (intended use MPEP § 2114 (II)); an optional sample collection tool (optional and not required, but still taught as item 10) wherein results can be obtained rapidly to provide real time information for decision makers in any setting (intended use MPEP § 2114 (II)).
Regarding the limitations of an instruction manual for use by a person thirteen years or older, the information being printed on the instruction sheet is considered to be nonfunctional descriptive material and therefore is given minimal patentable weight and therefore Mason teaches all of the limitations (MPEP § 2111.05 and 2112.01 (III)).
Regarding claim 2, Mason teaches wherein unit 1 is a standalone device for nucleic acid extraction comprising a tube that contains reagents for cell lysis and NA extraction (pages 41-42, lines 30-7).
Regarding claim 3, Mason teaches further comprising a tube (figure 8B, the container to “Shake to lyse tissue” and “Dip (3x) to bind nucleic acids”) that has a custom-made cap with inlet (the right half of the opening of the tube) and outlet (the left half of the opening of the tube) for sample introduction into the device and removal of extracted nucleic acids (intended use MPEP § 2114 (II)), wherein the sample is introduced using a cotton swab (intended use MPEP § 2114 (II)), wherein a dipstick is introduced in the outlet to capture extracted nucleic acids (intended use MPEP § 2114 (II)).
Regarding claim 4, the dipstick is not positively claimed and therefore any limitation on the dipstick has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Mason. Further, Mason teaches this limitation on page 30, lines 14-18).
Regarding claim 6, Mason teaches wherein the lysis buffer comprise a mechanical disruption buffer with ball bearings (pages 41-42, lines 30-7).
Regarding claim 21, Mason teaches wherein unit 2 comprises a microfluidic device (page 30, lines 24-28).
Claim(s) 1, 2, 5, 6 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2014/0057210, hereinafter Malik.
Regarding claim 1, Malik teaches a kit (figures 1 and 7), comprising: an all-inclusive, low complexity, portable, disposable, easy to use, and rapid nucleic acid detection device (intended use MPEP § 2114 (II)) with two complementary units (figure 1 and 7): unit 1 (figure 1) for nucleic acid, extraction, and purification (intended use MPEP § 2114 (II)), unit 2 (item 710) for rapid isothermal amplification, labeling, and detection of target nucleic acids (intended use MPEP § 2114 (II)); an optional sample collection tool (optional and not required and is taught in paragraph [0074]); and wherein results can be obtained rapidly to provide real time information for decision makers in any setting (intended use MPEP § 2114 (II)).
Regarding the limitations of an instruction manual for use by a person thirteen years or older, the information being printed on the instruction sheet is considered to be nonfunctional descriptive material and therefore is given minimal patentable weight and therefore Malik teaches all of the limitations (MPEP § 2111.05 and 2112.01 (III)).
Regarding claim 2, Malik teaches wherein unit 1 is a standalone device for nucleic acid extraction comprising a tube that contains reagents for cell lysis and NA extraction (paragraph [0075]).
Regarding claim 5, Malik teaches wherein unit 1 is a cartridge containing reagents for cell lysis and NA extraction (paragraph [0075]) with an inlet for sample introduction (paragraph [0075]) and an outlet (paragraph [0092]) retrofitted with a nucleic acid binding membrane (item 150 and paragraph [0076])) which docks directly into the sample inlet of the unit 2 (figure 7), wherein unit 1 can be permanently attached to unit 2 or provided separately (paragraph [0092]).
Regarding claim 6, Malik teaches wherein the lysis buffer comprises mechanical disruption buffer with ball bearings, alkaline lysis buffer, or combinations thereof (paragraph [0159]).
Regarding claim 20, Malik teaches wherein unit 2 comprises a microfluidic device (paragraph [0092]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796