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.
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: “dilution module” in claim 9.
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.
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 the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The claims disclose “a fluid intake module with a changeable container” and “a dilution module”. No where in the specification is a fluid intake module or a dilution module described and no container is described. The specification seems to describe the invention in different terms than those supplied in the claims. This is problematic because it causes confusion over the meaning and scope of the claims if the claims are not supported and described in the specification. Correction is required.
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.
Claims 1-18 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, 9, 10, 11, and 18 discloses “a fluid intake module,” “a container,” and “a dilution module” which were not described in the specification or claims in such a way that that one of ordinary skill in the art would understand the metes and bounds of the claim. It is unclear what is included in “a fluid intake module” or “a dilution module” and how the terms in the claims relate to the descriptions in the specification. Correction is required.
With respect to claim 13, the limitation “a third reciprocating pump” is confusing since there is no first or second reciprocating pump disclosed. It causes confusion as to whether a first and second pump are intended but not claimed. Clarification is required.
With respect to claim 14, “a second valve” and “a third valve” are disclosed, however no “first valve” is claimed. This causes confusion as to how many valves are actually part of the system. Clarification is required.
With respect to claim 14, the limitation “an ambient” is indefinite. “Ambient” is an adjective. There appears to be no noun associated with it such that the meaning is unclear. Correction is required.
With respect to claim 15, the limitation that the valves are “selected from the group consisting of ball, butterfly, diaphragm, globe, needle, pinch, plug, electric, and optical valves”. However, the specification only discloses “pinch valves.” The other types of valves are obvious variants (ball, butterfly, diaphragm, globe, needle, pinch, and plug) and would have been known to those of ordinary skill in the art as art equivalents for controlling fluid flow. However, an electric valve and an optical valve are not definite. It isn’t clear exactly what the electric or optical valve entails, whether electric implies any of the above valves controlled electrically instead of manually or if electric is the means by which the flow is stopped or started. Also, optical valve has no obvious meaning in the art and although optics are sometimes used for stopping single particles, there is no valve that uses only optical power to stop fluid flow. Clarification is required.
With respect to claim 18, the limitation “configured to storing air” lacks antecedent basis. It is unclear if the “air” that is stored in the reservoir is the same “ambient air or gas” received by the inhalation exposure chamber. Clarification is required.
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)(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, 2, 3, 4, 5, 13, 14, 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by Purves U.S. Patent #11,957,450.
With respect to claim 1, Purves discloses:
A first reservoir for storing a fluid with fluid-borne matters (Figure 4F, reservoir = piston chamber 100, Col.13, l 62-67)
A fluid intake module coupled to the first reservoir by a fluidical conduit, the fluid intake module having a container with a changeable volume, wherein when the volume increases, the fluid intake module receives fluid, and when the volume decreases, the fluid intake module expels fluid (Figure 4F, fluid intake module = human lungs of person 180, fluidical conduit = breath intake conduit 44, volume increase = fluid intake and volume decrease = fluid expelled is inherently how lungs work)
A sensor disposed in the fluidical conduit between the first reservoir and the fluid intake module for detecting fluid-borne matters in the fluidical conduit (Figure 4F, sensors 52, 56, 60, Col.13, l 17-10, fluid born matters = carbon dioxide)
With respect to claim 2, 3, 4, 5, 13, 14, 15, Purves discloses all of the limitations as applied to claim 1. In addition, Purves discloses:
2- The fluid is air and the fluid intake module is configured to emulate breathing (abstract)
3- An inhalation exposure chamber fluidically coupled to the first reservoir (Figure 4F, inhalation exposure chamber = chamber that holds filter 96, Col.13, l 50-61)
3- A pressure regulated pump fluidically coupled to the first reservoir for creating a negative pressure in the first reservoir (Figure 4F, pressure regulated pump = piston108 + piston pump 112, Col.14, l 8-17)
4- The inhalation exposure chamber receives ambient air (Col.13, l 50-61)
5- The inhalation exposure chamber includes a filter for filtering ambient air (Col.13, l 50-61)
13- the fluid intake module includes a third reciprocating pump for controllably changing the volume of the container (third reciprocating pump = human diaphragm)
14- a second valve and a third valve, the second valve disposed in the fluidical conduit for controlling fluid flow in the fluidical conduit, the third valve configured to control fluidical connection between the sensor and an ambient, wherein when the second valve is closed the third valve is open and vice versa ( Figure 4F, second valve = pump 80, third valve = 88, Col.15, l 49-60)
15- the second and third valves are regulation valves selected as butterfly valves (Figures 4F)
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) 9, 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Purves U.S. Patent #11,957,450.
With respect to claim 9, Purves discloses all of the limitations as applied to claim 1 above. However, Purves fails to disclose a dilution module for diluting a concentration of the fluid-borne matters in the first reservoir to a level detectable by the sensor.
It would have been obvious to one of ordinary skill in the art at the time of the invention to dilute a sample based on expected concentrations and ability of the sensors. Diluting samples is well known in the art and used to ensure samples are within the range of the sensor abilities.
With respect to claims 16 and 17, Purves discloses all of the limitations as applied to claim 1 above. However, Purves fails to disclose the sensor is a particulate matter sensor or configured to quantify oxygen levels or detect virus or allergens.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use a particulate matter sensor or to quantify oxygen levels since Purves discloses a carbon dioxide sensor (capnometer, Col.17, l 19-30) and uses that to determine if breath collection criteria are met. An oxygen level measurement or particulate matter sensor would be alternatives to qualify the quality of the breath collection in order to determine if target ranges are satisfied. Purves even discloses that the point of the cardon dioxide measurement is to compare to the oxygen levels (Col.17, l 39-42).
With respect to claim 18, Purves discloses a system for analyzing airborne particles comprising:
The inhalation exposure chamber receives ambient air (Col.13, l 50-61)
An airborne particle generator configured to create airborne particles (Figure 4F, mouthpiece 36, wherein breath from user 180 inherently contains airborne particles)
A reservoir fluidically connected to the inhalation exposure chamber during a first time period and fluidically coupled to the airborne particle generator during a second time period, not overlapping the first time period, the reservoir configured for storing air mixed with airborne particles (Figure 4F, reservoir = piston chamber 100, Col.13, l 62-67, Col.16, l 29-60, Col.18, 6-20, Col.15, l 49-60)
A pressure regulated pump fluidically coupled to the first reservoir for creating a negative pressure in the first reservoir (Figure 4F, pressure regulated pump = piston108 + piston pump 112, Col.14, l 8-17)
A breath-emulating module coupled to the first reservoir by a fluidical conduit, the breath-emulating module having a container with a changeable volume, wherein when the volume increases, the breath-emulating module receives fluid, and when the volume decreases, the breath-emulating module expels fluid (Figure 4F, fluid intake module = human lungs of person 180, fluidical conduit = breath intake conduit 44, volume increase = fluid intake and volume decrease = fluid expelled is inherently how lungs work)
A sensor disposed in the fluidical conduit between the first reservoir and the fluid intake module for detecting fluid-borne matters in the fluidical conduit (Figure 4F, sensors 52, 56, 60, Col.13, l 17-10, fluid born matters = carbon dioxide)
However, Purves fails to disclose a dilution module and a particulate matter sensor.
It would have been obvious to one of ordinary skill in the art at the time of the invention to dilute a sample based on expected concentrations and ability of the sensors. Diluting samples is well known in the art and used to ensure samples are within the range of the sensor abilities.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use a particulate matter sensor or to quantify oxygen levels since Purves discloses a carbon dioxide sensor (capnometer, Col.17, l 19-30) and uses that to determine if breath collection criteria are met. An oxygen level measurement or particulate matter sensor would be alternatives to qualify the quality of the breath collection in order to determine if target ranges are satisfied. Purves even discloses that the point of the cardon dioxide measurement is to compare to the oxygen levels (Col.17, l 39-42).
Allowable Subject Matter
Claims 6, 7, 8, 10, 11, and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if any deficiencies under 35 USC 112 are corrected.
The following is a statement of reasons for the indication of allowable subject matter: With respect to claims 6, 7, and 8, the prior art alone or in combination fail to disclose or suggest the inhalation exposure chamber includes temperature, humidity, and gas level controls to emulate physiologically or clinically relevant exposure in combination with the rest of the claimed limitations.
With respect to claims 10, 11, and 12, the prior art alone or in combination fail to disclose or suggest the dilution module details in combination with the rest of the claimed limitations.
Claims 19-25 are allowed.
With respect to claims 19-25, the prior art alone or in combination fail to disclose or suggest filling a reservoir with clean fluid, sucking fluid-born particles into the reservoir to mix with the clean fluid, detecting fluid-borne particles by a particulate matter sensor during the volume increase of a container and detecting fluid-born particles by the PM sensor during the volume decrease, in combination with the rest of the claimed limitations.
Citation
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ahmed U.S. Patent #10,226,201 and Ahmed U.S. Patent #10,694,978 disclose a breath measuring unit to measure specific particles in a fluid comprising a disposable cartridge configured for collecting the sample.
Baghdassarian U.S. Patent #6,582,376 discloses a hollow body device for collecting breath and measuring concentration for specific components with a collection reservoir connected to a hollow body with a sensor in between.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA CAROLE BRYANT whose telephone number is (571)272-9787. The examiner can normally be reached M-F, 12-4 pm.
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/REBECCA C BRYANT/ Primary Examiner, Art Unit 2877