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 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 1-19 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 1 recites the limitation "mask attachment area" in line 14 and 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "mask attachment area" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claims 10-19 recite the limitation "the method as set forth in claim 1" in their first line. There is insufficient antecedent basis for this limitation in the claim. The examiner suggests modifying the claim to recite "the method as set forth in claim 9”. For the purposes of examination, claims 10-19 will be assumed to depend from claim 9.
The term “more or less” in claim 1 is a relative term which renders the claim indefinite. The term “more or less” 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. “More or less” renders the term “centered” indefinite.
The term “more or less” in claim 3 is a relative term which renders the claim indefinite. The term “more or less” 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. “More or less” renders the term “centered” indefinite.
The term “more or less” in claim 9 is a relative term which renders the claim indefinite. The term “more or less” 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. “More or less” renders the term “centered” indefinite.
The term “more or less” in claim 11 is a relative term which renders the claim indefinite. The term “more or less” 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. “More or less” renders the term “centered” indefinite.
Claims 2-8 and 10-19 are rejected due to dependency.
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 3 and 11 are 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 3 and 11 recite the limitation, “wherein the open area is more or less centered with respect to the collector attachment section.”, which does not further limit the limitation disclosed in claim 1, “wherein the collector attachment section has an open area more or less centered over the collector attachment section”. 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 § 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.
Claim(s) 1-7 and 9-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Shin (KR 20210049049 A) in view of Huang (US 20210298639 A1).
Regarding claim 1, Shin discloses a wearable collector device (title), comprising:(a) a single piece flexible substrate (Fig 15 (b) element 400), wherein the substrate distinguishes a mask attachment section (Fig 15 (b) element 700, [0087]: "include a detachable portion (700) for detachably attaching and detaching the capturing pad (200) to the mask body (100).", wherein the ends attach to the mask) and a collector attachment section situated below of the mask attachment section (Fig 15 (b) element 400, wherein the middle of element 400 holds the collector), wherein the collector attachment section has an open area more or less centered over the collector attachment section ([0089]: "a space is provided between the porous foreign matter filter part (400) and the inner surface of the mask body (100) so that a capture pad (200) can be inserted and placed there between, and an opening is formed in some of the edges so that the capture pad (200) can be inserted through the opening."); (b) a double-sided adhesive sized to fit a side of the mask attachment section ([0088]: "made of an adhesive sheet.", wherein the sheet attaches both the substrate 400 and the mask 100 per Fig 15 (b)), wherein one side of the adhesive is suited to adhere to the side of the mask attachment section (Fig 15 (b) element 700 to 400), and wherein the other side of the adhesive is suited to adhere to an inner surface of a mask ([0069]: “in which a capturing pad is arranged on the inner surface of the mask body", element 700 is attached to the inner surface of element 100) ; and (c) a porous membrane (Fig 15 (b) element 210, [0070]: “includes a porous sheet portion (210), and wherein the membrane is sized to be removably attached to the collector attachment section either the same side of the mask attachment area or the other side of the mask attachment area (Fig 15 (b) element 210 and 200, [0089]: “space is provided between the porous foreign matter filter part (400) and the inner surface of the mask body (100) so that a capture pad (200) can be inserted and placed therebetween, and an opening is formed in some of the edges so that the capture pad (200) can be inserted through the opening. With the capture pad (200) inserted, the opening can be continuously opened or closed by sewing or gluing, and further, can be made openable and closable by employing any known fastening means such as velcro, hooks, hooks, buttons, strings, pins, adhesive sheets, etc.” wherein the membrane is attached to 400), wherein the membrane has pores size in the range of 50 nm- 5pm ([0073]: “the pore size of the porous sheet is 180 to 220 nm, the target substance in the gas can be captured.”) and capable of collecting biomarkers, pathogens, or viral loads through exposure from breath-derived droplets ([0062]: “captures target substances contained in the exhaled breath of a user wearing a mask”, wherein the target substances are biomarkers per Figs 3, 4, and 5), and wherein the membrane is capable freely moving with respect to the inner surface of the mask while the mask is worn by a person ([0087]: “detachably attaching and detaching the capturing pad (200) to the mask body (100)”, and [0089], wherein the membrane may be moved).
Shin fails to disclose wherein the collector attachment section has an open area more or less centered over the collector attachment section and wherein the membrane is sized to cover at least the open area of the collector attachment section.
Huang discloses a wearable collector (title) including a single piece flexible substrate (Fig 9 element 62), wherein the substrate distinguishes a mask attachment section ([0040-0041]: “The ring-shaped frame 62 may be a hook side of Velcro… The assembled breath sample collector 60 may be attached on the inside of the breath sample collecting mask 70 with the hook side Velcro frame 62 sticking to the loop side Velcro 71” ) and a collector attachment section situated below of the mask attachment section (Fig 9, element 62 facing inside the mask, behind the side attaching to 71 per Fig 10), wherein the collector attachment section has an open area more or less centered over the collector attachment section (Fig 9, the open area of element 62) and wherein the membrane is sized to cover at least the open area of the collector attachment section (Fig 9 element 61 covering the open area of element 62).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify Shin to include an open area as disclosed by Huang in order to improve the quantity of sample collected by increasing exposure to the patient’s air flow (Huang [0049]).
Regarding claim 2, Shin as modified by Huang discloses 5he wearable collector device as set forth in claim 1, but fails to disclose wherein the substrate is made of paper, plastic, or composite material.
Huang discloses the substrate is made of paper, plastic, or composite material ( [0007]: “a plastic frame”)
As Shin does not specify a material for the substrate, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the material of the substrate disclosed by Shin to the material of the substrate disclosed by Huang in order to provide structural integrity for the collection device.
Regarding claim 3, Huang discloses wherein the open area is more or less centered with respect to the collector attachment section (Fig 9).
Regarding claim 4, Shin discloses wherein the collector attachment section has a rectangular shape or an angled shape (Fig 15 (b) wherein element 400 is rectangular).
Regarding claim 5, Shin discloses wherein the mask has pleats and wherein the other side of the adhesive is suited to adhere to a single pleat (Fig 9, Fig 15 (b) element 700).
Regarding claim 6, Shin discloses sensors to detect collected levels of the biomarkers, pathogens. or viral loads ([0064]: “and includes a sensor unit (900)”, [0067]: “The above sensor unit (900) changes color depending on target substances, microorganisms, viruses, or fungi contained in the user's breath.”).
Regarding claim 7, Shin discloses visual indicators to visualize detection of collected levels of the biomarkers, pathogens, or viral loads ([0067]: “The above sensor unit (900) changes color depending on target substances, microorganisms, viruses, or fungi contained in the user's breath.”).
Regarding claim 9, Shin discloses a method of collecting biomarkers, pathogens, or viral loads through exposure from breath- derived droplets, comprising (title), comprising: (a) adhering a wearable collector device to an inner surface of a face mask (Fig 15 (b) element 700 attaching the collector (element 200 and 400 to face mask 100), wherein the wearable collector device comprises: (i) a single piece flexible substrate (Fig 15 (b) element 400), wherein the substrate distinguishes a mask attachment section (Fig 15 (b) element 700, [0087]: "include a detachable portion (700) for detachably attaching and detaching the capturing pad (200) to the mask body (100).", wherein the ends attach to the mask) and a collector attachment section situated below of the mask attachment section (Fig 15 (b) elements 400 and 700 together, [0089]: "the detachable portion (700) may be implemented as a unique structure of the porous foreign matter filter portion (400)”, wherein the middle of element 400 holds the collector); and (iii) a porous membrane (Fig 15 (b) element 210, [0070]: “includes a porous sheet portion (210)”), and wherein the membrane is sized to be removably attached to the collector attachment section either the same side of the mask attachment area or the other side of the mask attachment area (Fig 15 (b) element 210 and 200, [0089]: “a capture pad (200) can be inserted and placed there… [0089]: “In the state in which the collecting pad 200 is inserted, the opening may be continuously opened, or may be closed”, wherein the collecting pad may be removed or inserted into the collection attachment section formed by element 400), wherein the membrane has pores size in the range of 50 nm- 5pm ([0073]: “the pore size of the porous sheet is 180 to 220 nm, the target substance in the gas can be captured.”) and capable of collecting biomarkers, pathogens, or viral loads through exposure from breath-derived droplets ([0062]: “captures target substances contained in the exhaled breath of a user wearing a mask”, wherein the target substances are biomarkers per Figs 3, 4, and 5), and wherein the membrane is capable freely moving with respect to the inner surface of the mask while the mask is worn by a person ([0087]: “detachably attaching and detaching the capturing pad (200) to the mask body (100)”, and [0089], wherein the membrane may be moved); and (b) removing the membrane from the wearable collector device for analysis of collected biomarkers, pathogens, or viral loads ([0087]: "include a detachable portion (700) for detachably attaching and detaching the capturing pad (200) to the mask body (100).", Fig 15 element 700 and 200).
Shin fails to disclose wherein the collector attachment section has an open area more or less centered over the collector attachment section and wherein the membrane is sized to cover at least the open area of the collector attachment section.
Huang discloses a wearable collector (title) including a single piece flexible substrate (Fig 9 element 62), wherein the substrate distinguishes a mask attachment section ([0040-0041]: “The ring-shaped frame 62 may be a hook side of Velcro… The assembled breath sample collector 60 may be attached on the inside of the breath sample collecting mask 70 with the hook side Velcro frame 62 sticking to the loop side Velcro 71” ) and a collector attachment section situated below of the mask attachment section (Fig 9, element 62 facing inside the mask, behind the side attaching to 71 per Fig 10), wherein the collector attachment section has an open area more or less centered over the collector attachment section (Fig 9, the open area of element 62) and wherein the membrane is sized to cover at least the open area of the collector attachment section (Fig 9 element 61 covering the open area of element 62).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify Shin to include an open area as disclosed by Huang in order to improve the quantity of sample collected by increasing exposure to the patient’s air flow (Huang [0049]).
Regarding claim 10, Shin as modified by Huang discloses the method of claim 9, but fails to disclose wherein the substrate is made of paper, plastic, or composite material.
Huang discloses the substrate is made of paper, plastic, or composite material ( [0007]: “a plastic frame”)
As Shin does not specify a material for the substrate, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the material of the substrate disclosed by Shin to the material of the substrate disclosed by Huang in order to provide structural integrity for the collection device.
Regarding claim 11, Huang discloses wherein the open area is more or less centered with respect to the collector attachment section (Fig 9).
Regarding claim 12, Shin discloses wherein the collector attachment section has a rectangular shape or an angled shape (Fig 15 (b) wherein element 400 is rectangular).
Regarding claim 13, Shin discloses wherein the mask has pleats and wherein the other side of the adhesive is suited to adhere to a single pleat (Fig 9, Fig 15 (b) element 700).
Regarding claim 14, Shin discloses sensors to detect collected levels of the biomarkers, pathogens. or viral loads ([0064]: “and includes a sensor unit (900)”, [0067]: “The above sensor unit (900) changes color depending on target substances, microorganisms, viruses, or fungi contained in the user's breath.”).
Regarding claim 15, Shin discloses sensing collected levels of biomarkers, pathogens, or viral loads. ([0064]: “and includes a sensor unit (900)”, [0067]: “The above sensor unit (900) changes color depending on target substances, microorganisms, viruses, or fungi contained in the user's breath.”).
Regarding claim 16, Shin discloses visual indicators to visualize detection of collected levels of the biomarkers, pathogens, or viral loads ([0067]: “The above sensor unit (900) changes color depending on target substances, microorganisms, viruses, or fungi contained in the user's breath.”).
Regarding claim 17, Shin visualizing collected levels of the biomarkers, pathogens, or viral loads. ([0067]: “The above sensor unit (900) changes color depending on target substances, microorganisms, viruses, or fungi contained in the user's breath.”).
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin in view of Huang in view of Daniels (US 20230200678 A1).
Regarding claim 8, Shin as modified by Huang discloses the wearable collector device as set forth in claim 1, but fails to disclose wherein the membrane is made out of polycarbonate, nitrocellulose or aluminum oxide.
Daniels discloses a wearable collector device (title) wherein the membrane is made out of polycarbonate, nitrocellulose or aluminum oxide ([0221[: “The detection zone is typically a nitrocellulose porous membrane”).
As Shin discloses that the membrane is made of a fiber ([0073]: “one or more fiber materials”) but does not further specify a material, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the membrane disclosed by Shin to the membrane disclosed by Daniels in order to clarify the material used and to allow for the disposal of biological components on the membrane (Daniels [0221]).
Regarding claim 18, Shin as modified by Huang discloses the method of claim 9, but fails to disclose wherein the membrane is made out of polycarbonate, nitrocellulose or aluminum oxide.
Daniels discloses a wearable collector device (title) wherein the membrane is made out of polycarbonate, nitrocellulose or aluminum oxide ([0221[: “The detection zone is typically a nitrocellulose porous membrane”).
As Shin discloses that the membrane is made of a fiber ([0073]: “one or more fiber materials”) but does not further specify a material, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the membrane disclosed by Shin to the membrane disclosed by Daniels in order to clarify the material used and to allow for the disposal of biological components on the membrane (Daniels [0221]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin in view of Huang in further view of Frenz et al. (US 20220049293 A1), hereinafter Frenz.
Shin discloses the method of claim 9, but fails to disclose wherein the substrate is made from die-cutting, molding, hot embossing, or laser-cutting.
Frenz discloses a substrate made from die-cutting, molding, hot embossing, or laser-cutting ([0480]: “the surface of a substrate is modified to contain one or more wells, using techniques such as (but not limited to) stamping, micro etching, or molding techniques”).
As Shin fails to specify a method of producing the substrate, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Shin with the method of making a substrate as disclosed by Frenz in order to clarify the method of obtaining the substrate and additionally allowing for specificity in the shape of the substrate (Frenz ([0480]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alburty ( US 20220125333 A1) – discloses a wearable collector device
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791