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 with traverse of Group I in the reply filed on 03/27/2026 is acknowledged. The traversal is on the ground(s) that the previous Office Action did not establish an undue search burden of the claims as specified by MPEP 803. This is not found persuasive because the instant application is a national stage entry filed under 35 U.S.C. 371 and is therefore not subject to US restriction practice but rather subject to lack of unity practice, see MPEP 1893.03(d). It is noted that undue search burden is not a criterion in lack of unity analysis. The test is whether or not special technical features can be established. It is noted that inventions listed as Groups I-III do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features as set forth on page 4 of the previous Office Action.
Claims 22-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/27/2026.
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: driving device in claim 12.
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.
Applicant’s specification, page 6, paragraph 2, describes the driving device as a driving pump.
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 1 and 10-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being and 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 1 recites “a fourth valve” and “a fifth valve” in line 9. It is unclear how there is a fourth and fifth valve when there is no limitation to a third valve. Further explanation is requested and correction required. For examination purposes, this is being treated as a third and fourth valve, respectively.
Claims 10-21 are further rejected as they depend from Claim 1.
Claim 12, line 2, states “a first valve” and line 3 states “a second valve”. It is unclear if this is the same first valve and second valve as stated in Claim 1 or different valves altogether, further clarification is requested and correction required. For examination purposes, it is interpreted as the first valve and second valve of Claim 1.
Claims 13-17 are further rejected as they depend from Claim 12.
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.
Claims 1, 11, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones et al. (CA3032193A1).
Regarding Claim 1, Jones teaches the following:
A device used in the rapid extraction and analysis of a nucleic acid (para 245)(a device for nucleic acid extraction)
Which includes a pouch 510 (first container), a fitment 590 (second container)(para 252) and a cannulated transfer vessel such as a cannulated syringe (gas storage device)(para 443).
The fitment 590 serves as a loading attachment for introducing sample and reagents into the closed pouch 510 (the first container is configured to accommodate or contain a reagent for nucleic acid extraction)(para 252) and a seal 1860c (first valve) which controls the directionality of fluid movement in the pouch (para 383 and Fig. 20A, below)
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Seal 1860a (second valve) which is configured to allow fluid to be injected from the fitment (second container)(the first and second container are in fluid communication, and a second valve is arranged between them)(para 383)
The injection port 541 receives the cannulated syringe (gas storage device) through the first surface of fitment 590 (second container)(the second container and gas storage device are in fluid communication)(para 443)
The injection port 541 (sample inlet) is for receiving the sample to be tested and not opened until the transfer vessel (syringe) is placed into the sample injection opening (para 443)(the second container has a sample inlet provided with a third valve) and a second injection port 588 (sample outlet) configured similarly to the sample injection opening (a sample outlet provided with a fourth valve)(para 443)
Note: the sample outlet port being used as an outlet is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The second injection port of Jones would be capable of being used as a sample outlet port and therefore meets the claim.
Regarding Claim 11, Jones teaches all of the limitations of Claim 1 (see above). Jones further teaches a cannulated transfer vessel such as a cannulated syringe (the gas storage device is a syringe)(para 443).
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Regarding Claim 18, Jones teaches all of the limitations of Claim 1 (see above). Jones further teaches the first container to have a first chamber, second chamber, and third chamber separated from each other (see Fig. 2, below), where the lysis solution is injected into blister 522 (first chamber), the wash solution is injection into blister 544 (second chamber)(para 307), and the eluting solution is added to blister 546 (third chamber)(para 367) and the seals 1860a-1860e (second valve) are used to selectively plunge liquid out of the selected blisters and to control the directionality of the fluid movement (para 383).
Regarding Claim 19, Jones teaches all of the limitations of Claim 18 (see above). Jones further teaches the use of cell lysate (para 359)(the lysing solution is a cell lysing solution).
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 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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (CA3032193A1) in view of Jang (WO2018155764).
Jones teaches all of the limitations of Claim 1 (see above). Jones does not explicitly teach the device being airtight.
Jang teaches a close-type extract separation apparatus (para 14). Jang further teaches a sealing member between the cover and the chamber cartridge which keeps the device airtight (para 14). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jones with seals where needed to maintain an airtight device as taught by Jang. One would have been motivated to make this modification as it would allow the extraction process to be performed without exposure to air, thereby preventing infection from the air entering the sample (para 48).
Claims 12-17 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (CA3032193A1) in view of Koh et al. (WO2020213930A1).
Regarding Claim 12, Jones teaches all of the limitations of Claim 1 (see above). Jones further teaches seal 1860a (second valve) which is configured to allow fluid to be injected from the fitment (second container)(para 383) and a seal 1860c (first valve) which controls the directionality of fluid movement in the pouch (para 383). Jones does not explicitly teach a driving device connected to the first valve or the first container being tubular.
Koh teaches an analyte collection device for the purification of samples using magnetic particles (para 8). Koh further teaches a transfer line 70 (toward the end of the tubular device) to be equipped with a pump and valve (para 103 and Fig. 6, below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jones with the pump and valve as taught by Koh. One would have been motivated to make this modification as it would allow for the control of the transfer of fluid (para 103). Further the change of shape to a tubular device would be obvious as a change in shape has been held prima facie obvious. See MPEP 2144.04(IV)(B).
Regarding Claim 13, Jones in view of Koh teaches all of the limitations of Claim 12 (see above). Jones further teaches compression of plungers can inject (into the first container) a reagent, like a lysis buffer and a wash buffer (lysing solution for nucleic acid extraction and a washing solution for nucleic acid extraction)(para 307), and an elution buffer can be injected from the fitment into blister 548 (part of the first container)(an eluting solution for nucleic acid extraction)(para 367).
Regarding Claim 14, Jones in view of Koh teaches all of the limitations of Claim 13 (see above). Jones further teaches the lysis solution is injected into blister 522, the wash solution is injection into blister 544 (para 307), and the eluting solution is added to blister 546 (para 367)(the lysing solution, the washing solution, and the eluting solution are separated from each other).
Regarding Claim 15, Jones in view of Koh teaches all of the limitations of Claim 14 (see above). Jones further teaches the use of cell lysate (para 359)(the lysing solution is a cell lysing solution).
Regarding Claim 16, Jones in view of Koh teaches all of the limitations of Claim 13 (see above). Jones further teaches the wash solution is injection into blister 544 (para 307) and the eluting solution is added to blister 546 (para 367)(the washing solution and the eluting solution are separated from each other).
Regarding Claim 17, Jones in view of Koh teaches all of the limitations of Claim 16 (see above). Jones further teaches the use of cell lysate (para 359)(the lysing solution is a cell lysing solution).
Regarding Claims 20 and 21, Jones teaches all of the limitations of Claim 1 (see above). Jones further teaches a seal 1860c (first valve) which controls the directionality of fluid movement in the pouch (first container)(para 383). Jones does not explicitly teach a driving device in fluid communication to the first valve or the driving device being a driving pump.
Koh teaches a transfer line 70 to be equipped with a pump and valve (para 103 and Fig. 6, below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jones with the pump as taught by Koh. One would have been motivated to make this modification as it would allow for the control of the transfer of fluid (para 103).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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