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 .
Applicant’s preliminary amendments filed on 03/06/2024 are acknowledged.
Claims 40-58 are pending for examination. Claims 1-39 are cancelled.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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. Such claim limitation(s) is/are: “engagement means configured for releasably engaging…” in claims 40 and 58.
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. Supports can at least be found at paragraph [0105] of the PGPUB.
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 40-54 and 58 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. Claims that depend directly or indirectly from claims 40 and 58 is/are also rejected due to said dependency.
In regard to claims 40 and 58, the claims recite “an aqueous solution may be introduced into the housing”. The claims contain conditional/ optional languages, “may be”, which do not positively claim the limitations (“Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation”, see MPEP 2103 C and 2111.04). The conditional/ optional limitations are not given patentable weight. It is unclear whether the function/ step recited after “may be” is performed or not. It is suggested that “configured to be” or similar languages should be set forth in order to positively claim the limitations.
In regard to claim 41, the claim recites “the polymer membrane is dissolvable in aqueous solution”. It is unclear whether “aqueous solution” refers to the “aqueous solution” recited in claim 40 or a different aqueous solution, Clarification is requested y amendments. If the first, it is suggested that “the aqueous solution” should be set forth.
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.
Claims 40-42, 45, 47, and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable Beck et al. (USPGPUB 2014/0366609) and further in view of Paz et al. (USPGPUB 2005/0137491). In regard to claim 40, Beck discloses a sampling device (Figs. 2-4 and associated descriptions) for the collection of aerosol particles contained in a breath sample of a human or animal for the purpose of sampling a non-volatile respiratory pathogen present in the breath sample (It is noted that the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02; [0016-0016]; [0037-0039]; [0048]; [0050]), the sampling device comprising: a housing (elements 204/301/406, Figs. 2-4 and associated descriptions) having a flow inlet for the inflow of a breath sample into the housing (elements 203/305/407, Figs. 2-4 and associated descriptions; at least one inlet, [0011] and claim 1) and a flow outlet for the outflow of the breath sample out of the housing (elements 206/306/408, Figs. 2-4 and associated descriptions; at least one outlet, [0011] and claim 1), the flow of the breath sample from the flow inlet to the flow outlet defining a flow path of the breath sample (Figs. 2-4 and associated descriptions); a polymer membrane arranged inside the housing, between the flow inlet and the flow outlet, and in the flow path of the breath sample (elements 205/302/the membrane housing in element 406, Figs. 2-4 and associated descriptions; abstract; [0031-0032]; [0098-0100]; [0119]), the polymer membrane configured to collect aerosol particles contained in the breath sample (abstract; [0013]; [0048-0050]; [0088]) and the collected particles can be analyzed by dissolving the collected particles from the exhaled breath in a solvent. The solvent could then be analyzed by the senor unit ([0042]).
Beck does not specifically disclose an engagement means configured for releasably engaging an elution device to the housing such that an aqueous solution may be introduced into the housing from the elution device to elute the aerosol particles from the polymer membrane upon contact with the aqueous solution.
Paz teaches a breath aerosol collection and analysis system (Figs. 1-7 and associated descriptions) comprises a collection device configured to capture aerosol analytes (elements 40/44, Figs. 6-7 and associated descriptions); a breath inlet (element 14, Fig. 5 and associated descriptions); a breath outlet (element 21, Fig. 5 and associated descriptions); an engagement means (structures for receiving elements 51/62, 66/68 and/or 67/69, Figs. 6-7 and associated descriptions) configured for releasably engaging an elution device to the housing such that an aqueous solution may be introduced into the housing from the elution device to elute the aerosol particles from the collection device upon contact with the aqueous solution (rejected as best understood, see the 35 USC 112(b) rejection above; elements 60 and/or 68/69, Figs. 6-7 and associated descriptions; liquid solvent flows in or out the housing, [0060-0061]).
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 (Beck) to incorporate the engagement structure(s) and associated elution device/ elements/ functions as taught by Paz in the any side/ portion of the housing, since both devices are breath aerosol collection and analysis systems and one of ordinary skill in the art would have recognized that the engagement structures as taught by Paz facilitate connecting elution devices and providing the solvent to the housing for analyzing the removed dissolving aerosols (see Paz). The rationale would have been to better connecting to the elution device and using the solvent to collect dissolved aerosol particles.
In regard to claim 41, Beck as modified by Paz discloses the polymer membrane is dissolvable in aqueous solution (rejected as best understood, see the 35 USC 112(b) rejected above; the polymer membrane may be dissolvable in a certain type of acid solutions, [0099] of Beck ).
In regard to claim 42, Beck as modified by Paz discloses the engagement means includes a screw thread (element 62, Fig. 6 and associated descriptions; for hollow gland is screwed, [0060] of Paz).
In regard to claim 45, Beck as modified by Paz discloses the polymer membrane includes at least one layer ([0099-0102] of Beck ) and different thicknesses of filter membrane can be used ([0121] and Table 3 of Beck ) but does not specifically discloses the polymer membrane has a thickness in a range between 0.5 μm to 50 μm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try different thickness of filter membrane including a range between 0.5 μm to 50 μm through experiments/ investigations in order to find the optimal thickness(es) of the filter membrane. The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007).
In regard to claim 47, Beck as modified by Paz discloses the polymer membrane comprises fibers ([0097-0099] of Beck ) but does not specifically discloses the fibers each have a diameter in the range between 20 nm to 1 μm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try different diameters of fibers including range between 20 nm to 1 μm through experiments/ investigations in order to find the optimal diameter(s) of the fibers. The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007).
In regard to claim 52, Beck as modified by Paz discloses the sampling device is configured as a hand-held sampling device for the collection of aerosol particles present in a human breath bioaerosol (Figs. 2-4 and associated descriptions of Beck ; abstract).
In regard to claim 53, Beck as modified by Paz discloses a system (referring to claim 40 above) for the collection and elution of aerosol particles contained in a breath sample of a human or animal for the purpose of sampling a non-volatile respiratory pathogen present in the breath sample (It is noted that the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02; [0016-0016]; [0037-0039]; [0048]; [0050]), the system comprising: a sampling device according to claim 40 (referring to claim 40 above); and an elution device releasably connected to the housing by the engagement means (referring to claim 40 above); the elution device configured for introducing an aqueous solution into the housing such that aerosol particles are eluted from the polymer membrane upon contact with the aqueous solution, and upon elution of the polymer membrane, for receiving the eluate (referring to claim 40 above; Figs. 6-7 and associated descriptions of Paz).
Claims 55-58 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Beck and Paz as applied to claims 40-42, 45, 47, and 52-53 above, and further in view of Lampropoulos et al. (USPGPUB 2022/0178922). In regard to claim 55, Beck as modified by Paz discloses a method for collecting, and eluting aerosol particles present in a breath sample of a human or animal (referring to claim 40 above), the method comprising: a) creating a flow of a breath sample of a human or animal through a flow inlet of a sampling device (referring to claim 40 above); b) sorbing of aerosol particles contained in the breath sample with a polymer membrane arranged inside the sampling device (referring to claim 40 above); c) connecting the sampling device to an elution device that contains an aqueous solution (referring to claim 40 above; Figs. 6-7 and associated descriptions of Paz); d) eluting the polymer membrane by bringing the aqueous solution into contact with the polymer membrane (referring to claim 40 above); and e) detecting a drug or biomarker in an assay of the eluate (sensor unit, [0136]; sensor, [0046] and [0048]; abstract; drug, abstract; biomarker, [0048-0051] of Beck).
Beck as modified by Paz does not specifically disclose detecting a non-volatile respiratory pathogen.
Lampropoulos teaches a pathogen sampling and testing system (Figs. 1-6 and associated descriptions) comprising an assay strip (Figs. 6A-6C and associated descriptions) for detecting a pathogen in a breath sample (detecting respiratory pathogens such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Exhalation, and particularly coughing, by an infected individual can produce infectious aerosols, [0026]; proteins, [0042]; antibody binds specifically with a protein of the pathogen of interest for the assay, [0046]).
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 (Beck as modified by Paz) to incorporate the assay strip and associated functions/ elements as taught by Lampropoulos since both systems are for detecting breath aerosol particles and one of ordinary skill in the art would have recognized that the system as taught Beck as modified by Paz discloses proteins in the breath can be collected (see at least [0050] of Beck) and Lampropoulos teaches SARS-CoV-2 can be detected based on the assay strip (see at least [0026], [0042] and [0046]). The rationale would have been to detect more pathogen related information of the breath.
In regard to claim 56, Beck as modified by Paz and Lampropoulos discloses turning the sampling device, together with the elution device, upside down between step c) and step d) (Fig. 7 and associated descriptions of Paz; it is noted that flipping or upside down operation can be performed by connecting one of the tube on one side of the housing and then flipping the housing for connecting the other tube before starting the flow of solvent).
In regard to claim 57, Beck as modified by Paz and Lampropoulos discloses wherein the assay for detecting the pathogen is an assay selected from the group consisting of a nucleic acid amplification test (NAAT), a PCR assay, an isothermal amplification assay, a DNA hybridization assay, a CRISPR-based assay, a sequencing assay, and an immunoassay ([0026], [0042] and [0046] of Lampropoulos).
In regard to claim 58, Beck as modified by Paz and Lampropoulos discloses the sampling device comprises: a housing having a flow inlet for the inflow of a breath sample into the housing (referring to claim 40 above) and a flow outlet for the outflow of the breath sample out of the housing (referring to claim 40 above), the flow of the breath sample from the flow inlet to the flow outlet defining a flow path of the breath sample (referring to claim 40 above); a polymer membrane arranged inside the housing, between the flow inlet and the flow outlet (referring to claim 40 above), and in the flow path of the breath sample, the polymer membrane configured to collect aerosol particles contained in the breath sample (referring to claim 40 above); and an engagement means configured for releasably engaging an elution device to the housing such that an aqueous solution may be introduced into the housing from the elution device to elute the aerosol particles from the polymer membrane upon contact with the aqueous solution (rejected as best understood, see the 35 USC 112(b) rejected above; referring to claim 40 above).
Allowable Subject Matter
Claims 43-44, 46, 48-51, and 54 are objected to as being dependent upon a rejected base claim, but would be allowable if overcome the 35 USC 112(b) rejections and rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not teach or suggest each and every limitations recited in claims 43-44, 46, 48-51, and 54.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Beck et al. (USPGPUB 2015/0226726) teaches a similar breath aerosol particle collecting system comprises at least one breath inlet, at least one breath outlet, a filter membrane (elements 203/206/205, Fig. 1) and a sensor (element 603, Fig. 4) and a solvent is utilized to wash the filter with the solvent to form an eluate for analysis (abstract; claims 1-3; [0009]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791