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 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: “a detector to detect” in claims 12 and 16.
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.
“a detector” in claims 12 and 16 will be interpreted as a sensor and processor per para [0014]: “a detecting system that comprises (a) a sensor for collecting information regarding the strength of the breath and/or the loudness of the voice by the subject, and providing the information to a processor” of applicant’s specification and claim 14.
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 3-5, 24, and 26 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.
The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” 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.
The term “about” in claim 3 is a relative term which renders the claim indefinite. The term “about” 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.
The term “about” in claim 4 is a relative term which renders the claim indefinite. The term “about” 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.
The term “about” in claim 5 is a relative term which renders the claim indefinite. The term “about” 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.
The term “about” in claim 24 is a relative term which renders the claim indefinite. The term “about” 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.
The term “about” in claim 26 is a relative term which renders the claim indefinite. The term “about” 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.
Claims
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 22-28 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 22-28 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 22 meets the first prong of the step 2A analysis because it is directed to the organization of human activity, as evidenced by the claim language of “receiving exhaled air from the subject, wherein the exhaled air is provided from the subject speaking”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that relates to managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions), which are types of activities that have been found by the courts to represents judicial exceptions (see MPEP 2106.04 (a)(2) II methods of organizing human activity).
The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a filter for collecting the aerosol sample from the subject” in claim 22. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0060]: “a mechanism for collecting aerosol particles by using a conventional filter” of Ikeda et al. (US 20140137523 A1). Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 22 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 23-28 fail to cure the deficiencies of independent claim 22 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 22-28 is/are rejected under 35 U.S.C. 101.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3,5, 7-8, 17, 22, and 25-28 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Beck et al. (US 20180306775 A1), hereinafter Beck.
Regarding claim 1, Beck discloses a device for collecting an aerosol sample from a subject (title), the device comprising:(a) a conduit defining an inner space for passage of exhaled air (Fig 3 element 301), wherein the conduit comprises: (i) a first opening for receiving the exhaled air from the subject (Fig 3 element 305, [0078]: “The mouthpiece section 308 and tubular element 303 is detachable and in fluid communication with the housing 301 via the inlet 305.”); (ii) a second opening for expelling at least a portion of the exhaled air (Fig 3 element 306, [0077]: “at least one outlet 306.”); and (iii) a long axis (Fig 3, the horizontal axis stretching from 305 to 306); and (b) a filter for collecting the aerosol sample from the exhaled air ([0094]: “the sampling element 302 is a filter membrane”), wherein the filter is positioned between the first opening and the second opening and is substantially perpendicular to the long axis (Fig 3 element 302, wherein the filter is perpendicular to the horizontal long axis), and wherein the filter: iv) is an electrostatically charged filter ([0098]: "filter membrane is an electrostatic filter");(v) exhibits a low airflow resistance; or (vi) both (iv) and (v).
Regarding claim 3, Beck discloses wherein the filter exhibits an airflow resistance of less than about 5 cm H20/L/sec at flow rates of about 14 L/sec ( [0101]: "air flow resistance of about 36 Pa at 9.5 m/min media velocity.").
Regarding claim 5, Beck discloses a diameter of the conduit is about 10 to about 20 millimeters ([0120]).
Regarding claim 7, Beck discloses wherein the filter comprises a non-woven synthetic fiber or a nanofiber ([0098]: " a non-woven filter membrane comprising a blend of acrylic fibers and polypropylene fibers.”).
Regarding claim 8, Beck discloses wherein the filter comprises a material that is non-chemically reactive with the aerosol sample ([0098]: " a non-woven filter membrane comprising a blend of acrylic fibers and polypropylene fibers.”).
Regarding claim 9, Beck discloses wherein the filter comprises a sensor configured to detect a molecule or a pathogen ([0135]: "biomarkers which may be used for diagnosis of diseases or illnesses, such as cancer, inflammation, infection and/or oxidative stress.").
Regarding claim 15, Beck discloses wherein the device is configured to capture speech-generated droplets provided by the subject while speaking ([0038]: "are carried by liquid droplets (aerosol)").
Regarding claim 17, Beck discloses a device for speech-generated droplets from a subject (title), the device comprising:(a) a conduit defining an inner space for passage of exhaled air comprising the speech-generated droplets (Fig 3 element 301, [0038]: "are carried by liquid droplets (aerosol)"), wherein the conduit comprises: (i) a first opening for receiving the exhaled air from the subject (Fig 3 element 305, [0078]: “The mouthpiece section 308 and tubular element 303 is detachable and in fluid communication with the housing 301 via the inlet 305.”); a filter for collecting the speech-generated droplets from the exhaled air ([0094]: “the sampling element 302 is a filter membrane”), wherein the filter is positioned in the inner space, (Fig 3 element 302), and wherein the speech-generated droplets are produced from speaking by the subject ([0038]: "are carried by liquid droplets (aerosol)", wherein the subject may speak to the same effect).
Regarding claim 22, Beck discloses a method for collecting an aerosol sample from a subject (title), comprising providing a device comprising a filter for collecting the aerosol sample from the subject ([0094]: “the sampling element 302 is a filter membrane”); and receiving exhaled air from the subject (title), wherein the exhaled air is provided by speaking by the subject ([0038]: "are carried by liquid droplets (aerosol)", wherein the active step of receiving liquid droplets is provided by exhaled air from the subject, and exhaled breath may be obtained via speaking to generate the same droplets).
Regarding claim 25, Beck discloses wherein the aerosol sample comprises speech-generated droplets ([0038]: "are carried by liquid droplets (aerosol)").
Regarding claim 26, Beck discloses wherein the speech-generated droplets have a size from about 1 pm to about 150 pm ([0038]: "are carried by liquid droplets (aerosol)", wherein droplet sizes are known to be between 1-150 pm, see Stadnytski et al (“The airborne lifetime of small speech droplets and their potential importance in SARS-CoV-2 transmission”). page 1 para 1; “known that normal speaking also produces thousands of oral fluid droplets with a broad size distribution (ca. 1 μm to 500 μm)”).
Regarding claim 27, Beck discloses further comprising detecting a molecule or pathogen from the filter ([0135]: "biomarkers which may be used for diagnosis of diseases or illnesses, such as cancer, inflammation, infection and/or oxidative stress”).
Regarding claim 28, Beck discloses wherein the molecule or pathogen is detected by a color signal, an optical signal, an electronic signal, a chemical signal, or by artificial intelligence ([0014]: “analysis is performed using a suitable analyzing method like spectroscopy or preferably mass-spectroscopy or Surface enhanced Raman spectroscopy (SERS”)).
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.
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(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Ku et al. (US 20140180156, as cited by Applicant’s IDS filed 04/10/2025), hereinafter Ku.
Regarding claim 4, Beck discloses the device of claim 1 but does not disclose the length of the conduit between the first opening and the second opening is about 100 to about 150 millimeters. However, Beck discloses that the size of the device may be variable ([0070]: " The mouthpiece and tubular element 202 may be of same size or type as a conventional used for alcohol-test.").
Ku discloses a device for collecting an aerosol sample from a subject wherein the length of the conduit between the first opening and the second opening is about 100 to about 150 millimeters. ([0008]: “The distance between the notch and the first opening measured along the body's outer surface is optionally about 1.0 cm or greater.”).
As Beck discloses that the dimensions of the device may be similar to other devices in the field, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the length of the conduit disclosed by Beck to the length disclosed by Ku in order to clarify the dimensions of the device. It would have further been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the conduit of Beck to between 100 mm to 150 mm as applicant appears to have placed no criticality on the claimed range ([0055]: “the length of the conduit 100 between the first opening 104 and the second opening 106 is about 50 to about 300 millimeters. In some embodiments, the length of the conduit 100 between the first opening 104 and the second opening 106 is about 80 to about 250 millimeters. In some embodiments, the length of the conduit 110 between the first opening 104 and the second opening 106 is about 100 to about 200 millimeters.”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Tao et al. (US 20130150746 A1), hereinafter Tao.
Regarding claim 9, Beck discloses the device of claim 1 but fails to disclose wherein the filter comprises a sensor configured to detect a molecule or a pathogen.
Tao discloses a device for collecting an aerosol sample from a subject (abstract), the device comprising a sensor configured to detect a molecule or a pathogen ([0023]: “and detecting changing colors of the plurality of integrated sensors that include a porous membrane coated with sensing materials, which change color upon interactions with target analytes.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the filter disclosed by Beck with the sensor disclosed by Tao in order to improve the efficiency of the device by allowing for immediate detection without the need for external sensors (Tao [0009]).
Regarding claim 10, Beck discloses the device of claim 1 but fails to disclose wherein the filter comprises a sensor to detect a bacterium, a virus, or a viral particle. However, Beck discloses an external sensor to detect a bacterium, a virus, or a viral particle ([0135]: "biomarkers which may be used for diagnosis of diseases or illnesses, such as cancer, inflammation, infection and/or oxidative stress.").
Tao discloses a device for collecting an aerosol sample from a subject (abstract), the device comprising a sensor ([0116]: “a sensor unit 603 for analyzing the collected compounds in the testing device 602”)configured to detect a molecule or a pathogen ([0023]: “and detecting changing colors of the plurality of integrated sensors that include a porous membrane coated with sensing materials, which change color upon interactions with target analytes.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the filter disclosed by Beck with the sensor disclosed by Tao in order to improve the efficiency and reduce the cost of the device by allowing for immediate detection without the need for external sensors (Tao [0009]).
Claim(s) 12-14, 16, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of of Luxon et al. (US 20230320660 A1), hereinafter Luxon.
Regarding claim 12, Beck discloses the device of claim 1 but fails to disclose a detector to detect strength of breath of the subject, loudness of voice of the subject, or both.
Luxon discloses a device for collecting an aerosol sample from a subject (abstract), further comprising a detector to detect strength of breath of the subject, loudness of voice of the subject, or both ([0082]: “Sensors 224 in the exhalation airway lumen may measure parameters associated with exhaled air, including pressure, flow, sounds”, [0123]: “microprocessors 1103”, consisted with the 112f interpretation above).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Beck to include the detector as disclosed by Luxon in order to allow for detection of parameters associated with pulmonary diseases (Luxon [0215]).
Regarding claim 13, Beck as modified by Luxon discloses the device of claim 12. Luxon further discloses wherein the detector is attached to an outside wall of the conduit (Fig 2 element 222, [0082]: “Sensors 222, 224, and 226 may sense any of the parameters listed herewithin”).
Regarding claim 14, Beck as modified by Luxon discloses the device of claim 12. Luxon further discloses wherein the detector is a detecting system that comprises (a) a sensor for collecting information regarding the strength of the breath of the subject, the loudness of the voice of the subject ([0082]: “Sensors 224 in the exhalation airway lumen may measure parameters associated with exhaled air, including pressure, flow, sounds”), or both, and providing the information to a processor ([0123]: “microprocessors 1103”);(b) the processor for processing the information provided by the sensor ([0123]); and (c) a structure configured to allow the sensor to attach to the conduit (Fig 2, wherein the sensors are attached to the conduit).
Regarding claim 16, Beck discloses a device for collecting an aerosol sample from a subject (title), comprising:(a) a conduit defining an inner space for passage of exhaled air (Fig 3 element 301), wherein the conduit has a first opening for receiving the exhaled air from the subject (Fig 3 element 305, [0078]: “The mouthpiece section 308 and tubular element 303 is detachable and in fluid communication with the housing 301 via the inlet 305.”); and (b) a filter positioned in the inner space (Fig 3 element 302).
Beck fails to disclose a detector to detect strength of breath, loudness of voice, or both, wherein the detector is positioned in the inner space.
Luxon discloses a device for collecting an aerosol sample from a subject (abstract), further comprising a detector to detect strength of breath of the subject, loudness of voice of the subject, or both ([0082]: “Sensors 224 in the exhalation airway lumen may measure parameters associated with exhaled air, including pressure, flow, sounds”, [0123]: “microprocessors 1103”, consisted with the 112f interpretation above), wherein the detector is positioned in the inner space (Fig 2 element 224).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Beck to include the detector as disclosed by Luxon in order to allow for detection of parameters associated with pulmonary diseases (Luxon [0215]).
Regarding claim 23, Beck discloses the device of claim 22 but fails to disclose further comprising detecting loudness of the speaking.
Luxon discloses a method for collecting an aerosol sample from a subject (abstract), further comprising detecting loudness of the speaking. ([0082]: “Sensors 224 in the exhalation airway lumen may measure parameters associated with exhaled air, including pressure, flow, sounds”, [0123]: “microprocessors 1103”, consisted with the 112f interpretation above).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Beck to include the detector as disclosed by Luxon in order to allow for detection of parameters associated with pulmonary diseases (Luxon [0215]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Call et al. (US 20220236147 A1)
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791