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 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 3, 4, 6, 27, 29 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 “wherein the infectious agent is a virus, a bacterium and/or a fungus”. The use of “and/or” is unclear. Is applicant suggesting a single agent can be a virus, bacterium AND a fungus?
Regarding claims 4, 6, 27, 29, the phrase "optionally" along with the use of “and/or” renders the claim indefinite because it is unclear whether the limitations following the phrase(s) are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 3, 4, 5, 9, 20, 21, 24 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2, 3, 4, 5, 24 recites limitations related to the exhalant – which is not part of the claimed device and does not further structurally limit the claim.
Claim 9 recites limitations related to the detection assay. Examiner notes that the detection assay is not part of the claimed device and thus the device is not further structurally limited.
Claims 20 and 21 recite limitations related to methods of manufacturing and do not further structurally limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-6, 15, 16, 18-22, 24-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sislian et al. (US 2016/0022946 A1), hereinafter Sislian.
Regarding Claim 1, Sislian teaches: A device for capturing exhaled breath of an individual (figure 2A; paragraph 0044), the device comprising: a mouthpiece (figure 2A);
a mixing chamber, to which the mouthpiece is connected (figure 2A – dark portion; paragraph 0080-0092 and 0104);
an exhaust tube connected to the mixing chamber, the exhaust tube comprising an outlet (figure 2) towards collector); and
a container having a capture material disposed therein (figure 2A; 2B; paragraph 0059-0060);
wherein the mixing chamber is configured to cause exhaled breath from the individual introduced therein via the mouthpiece to contact the capture material and trap an exhalant in and/or on the capture material (paragraph 0059-0060; 0080-0092).
Regarding Claim 2, Sislian teaches: The device of claim 1, wherein the exhalant comprises an infectious agent and/or a particle thereof (paragraph 0044-0045).
Regarding Claim 3, Sislian teaches: The device of claim 2, wherein the infectious agent is a virus, a bacterium and/or a fungus (paragraph 0044-0045).
Regarding Claim 4, Sislian teaches: The device of claim 1, wherein the exhalant comprises a protein, polynucleotide, lipid, carbohydrate, and/or chemical biomarker indicating a presence of a disease (paragraph 0044-0045), optionally the disease comprising a cancer or a metabolic disorder.
Regarding Claim 5, Sislian teaches: The device of claim 1, wherein the exhalant comprises an analyte indicating a presence of alcohol, tobacco, and/or other drugs (paragraph 0008; 0044-0045; 0059-0060).
Regarding Claim 6, Sislian teaches: The device of claim 1, wherein the container is mechanically and/or adhesively connected to the mixing chamber, optionally in a removable manner (figures 2A-2C; paragraph 0056).
Regarding Claim 15, Sislian teaches: The device of claim 1, wherein the capture material comprises a gel or a hydrogel (paragraph 0062).
Regarding Claim 16, Sislian teaches: The device of claim 1, wherein the capture material is configured to release the exhalant captured therein for further diagnostic testing and/or wherein the capture material is configured for release from the container (paragraph 0058-0059).
Regarding Claim 18, Sislian teaches: The device of claim 1, wherein the capture material is a viscous fluid (paragraph 0062; examiner notes any fluid/gel has some viscosity).
Regarding Claim 19, Sislian teaches: The device of claim 1, wherein the capture material is fixed onto an interior surface of the container in a manner of a coating on the interior surface of the container (figure 2A-2C)).
Regarding Claim 20, Sislian teaches: The device of claim 1, wherein the device is made via an additive manufacturing technique (Official notice is being taken that the device shown in figure 2A is capable of being manufactured via additive manufacturing – which is well known in the art).
Regarding Claim 21, Sislian teaches: The device of claim 1, wherein the mouthpiece, mixing chamber, and exhaust tube are manufactured as a unitary structure via an injection molding technique (Official notice is being taken that the device shown in figure 2A is capable of being manufactured via injection molding – which is well known in the art).
Regarding Claim 22, Sislian teaches: The device of claim 1, wherein:
the capture material comprises an electric charge to increase capture of the exhalant by the capture material, relative to a non-electrically charged capture material;
the capture material is hydrophobic or hydrophilic to modify capture properties of the capture material (paragraph 0062; PEG is hydrophilic which implies a charge portions that attract and allow strong hydrogen bonding with water)
the capture material is molded to increase a surface area of the capture material that is exposed to the exhalant within the device (this limitation represents intended use and lacks patentable weight; figure 2A-2C – PEG is ‘molded’ to the shape of the reservoir); and/or the capture material is in a form of a ball inside the device (paragraph 0062).
Regarding Claim 24, Sislian teaches: The device of claims 1, wherein the exhalant comprises SARS-COV-2 virus and/or particles thereof, an infectious agent or particles thereof associated with a Streptococcal infection, and/or an infectious agent or particles thereof associated with mononucleosis (paragraph 0044-0045; 0060).
Regarding Claim 25, Sislian teaches: The device of claim 1, wherein the device is configured for diagnosis, monitoring, and/or study of conditions and/or diseases (abstract).
Regarding Claim 26, Sislian teaches: A system for detecting an exhalant contained within exhaled breath of an individual, the system comprising at least one device according to claims 1 (abstract; figure 1).
Regarding Claim 27, Sislian teaches: The system of claim 26, comprising a device, container, and reagent for recovering and/or analyzing the capture material and/or for recovering and/or analyzing the exhalant from the capture material and, optionally, a plurality of single-use containers, mouthpieces, and/or exhaust tubes (abstract; figure 1; paragraph 0045-0062).
Regarding Claim 28, Sislian teaches: A diagnostic test kit for detecting an exhalant contained within exhaled breath of an individual, the diagnostic test kit comprising at least one device according to claim 1 (abstract; claim 1).
Regarding Claim 29, Sislian teaches: The diagnostic test kit of claim 28, comprising a device, container, and reagent for recovering and/or analyzing the capture material and/or for recovering and/or analyzing the exhalant from the capture material and, optionally, a plurality of single-use containers, mouthpieces, and/or exhaust tubes (abstract; figure 1; paragraph 0045-0062).
Regarding Claim 30, Sislian teaches: A method for detecting an exhalant contained within exhaled breath of an individual, the method comprising:
providing at least one device according to claim 1;
flowing exhaled breath from the individual through the device for a predetermined period of time; and
capturing the exhalant in the capture material (abstract; figure 1; paragraph 0045-0062).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sislian, in view of Kvasnik et al. (US 2009/0044597 A1), hereinafter Kvasnik.
Regarding 7, Sislian teaches: The device of claim 1, but fails to mention wherein the container is connected to the mixing chamber via a hinge.
Kvasnik teaches the use of a hinge to connect a mixing chamber to the container (hinge arrangement 76; paragraph 0046). It would haven obvious to one of ordinary skill in the art, before the effective filing date to have modified the device to include wherein the container is connected to the mixing chamber via a hinge for an easier/convenient connection.
Claim(s) 8, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sislian, in view of Gaston et al. (US 6033368), hereinafter Gaston.
Regarding Claim 8, Sislian teaches: The device of claim 1, but does not mention wherein the capture material is directly linked to a detection assay.
Gaston teaches: wherein the capture material is directly linked to a detection assay (col 4, lines 50-55; claim 1). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the device wherein the capture material is directly linked to a detection assay for a more efficient analysis.
Regarding Claim 9, Sislian in view of Gaston teaches: The device of claim 8 wherein the detection assay comprises a colorimetric assay or a lateral flow assay (Gaston - col 2 lines 10-15).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sislian, in view of Reardon et al. (US 2015/0232913 A1), hereinafter Reardon.
Regarding Claim 17, Sislian teaches: The device of claim 1, wherein the capture material comprises a gel. Sislian does not mention wherein the gel is of one or more of agarose, carbomers, Polyvinylalcohol (PVA), and polyacrylic acid (PAA).
Reardon teaches wherein the gel is of one or more of agarose, carbomers, Polyvinylalcohol (PVA), and polyacrylic acid (PAA) (paragraph 0249). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the device wherein the gel is of one or more of agarose, carbomers, Polyvinylalcohol (PVA), and polyacrylic acid (PAA) as the substitution of one capture material for another would have yielded predictable results to one of ordinary skill.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sislian, in view of Meka et al. (US 2007/0173731 A1), hereinafter Meka.
Regarding Claim 23, Sislian teaches: The device of claim 1, but doesn’t mention wherein the mixing chamber comprises an inner surface that is hydrophobic and/or negatively charged to inhibit the exhalant from adhering to the inner surface of the mixing chamber and to increase an amount of the exhalant that is captured by the capture material.
Meka teaches: wherein the mixing chamber comprises an inner surface that is hydrophobic and/or negatively charged to inhibit the exhalant from adhering to the inner surface of the mixing chamber and to increase an amount of the exhalant that is captured by the capture material (paragraph 0068, 0072). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the device wherein the mixing chamber comprises an inner surface that is hydrophobic and/or negatively charged to inhibit the exhalant from adhering to the inner surface of the mixing chamber and to increase an amount of the exhalant that is captured by the capture material to avoid interaction of the sample with the surface of the chamber.
Allowable Subject Matter
Claim 10-14, 31-35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 closest prior art of record (Sislian, Kvasnik; Gaston) fail to teach a flow restrictor and also fails to teach a resonator such that the device produces an audible tone when a predetermined volumetric flow rate is emitted.
None of the prior art considered, alone or in combination, teaches that particular feature combined with the other limitations of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791