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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
The disclosure of the prior-filed application, Application No. 17/227,126, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for claims 1-18 of this application. Specifically, the prior-filed application fails to provide adequate support for the first unit, the second, unit, the gas permeable filter, the collector, and the collection tool of claims 1 and 11. Therefore, the effective filing date of the instant application is 07/12/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/12/2024 was considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
¶ [0020] of the published application recites “a chamber 213 is referred to as a second unit and an interior space of the chamber 213 referred to as a second chamber”, which conflicts with claims 1 and 11 which suggest that the chamber 213 corresponds to the first unit and the first chamber. The Examiner suggests amending the recitation in ¶ [0020] to be “a chamber 213 is referred to as a first unit and an interior space of the chamber 213 referred to as a first chamber”.
¶ [0021] recites “the cartridge 22 (sometimes referred to as a first unit and an interior space in the cartridge 22 referred to as a first chamber)”, which conflicts with claims 1 and 11 which suggest that the cartridge is the second unit. The Examiner suggests amending the recitation in ¶ [0021] to be “the cartridge 22 (sometimes referred to as a second unit and an interior space in the cartridge 22 referred to as a second chamber)”
Appropriate correction is required.
Claim Objections
Claims 1, 4, 5, 9, 11, 14, and 17 are objected to because of the following informalities:
Claim 1, line 3: –a– should be inserted before “biological”;
Claim 1, line 20: “secure a” should be replaced with –secure the–;
Claim 1, line 21: “a human” should be replaced with –the human–;
Claim 4, line 1: –configured to be– should be inserted after “is”;
Claim 5, line 3: the comma after “base” should be deleted;
Claim 5, line 9: –the cap– should be inserted before “comprising:
Claim 5, line 6: “holes is” should be replaced with –holes are–;
Claim 5, line 10: a comma should be inserted after “enclosure”;
Claim 9, line 1: –the– should be inserted before “collection”;
Claim 11, line 2: –a– should be inserted before “biological”;
Claim 11, line 6: “secure a” should be replaced with –secure the–;
Claim 11, line 7: “a human” should be replaced with –the human–;
Claim 14, line 3: the comma after “base” should be deleted;
Claim 4, line 9: –the cap– should be inserted before “comprising:
Claim 14, line 6: “holes is” should be replaced with –holes are–;
Claim 14, line 10: a comma should be inserted after “enclosure”; and
Claim 17, line 1: –the– should be inserted before “collection”.
Appropriate 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.
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 1-18 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 recites “the pump is configured, when activated, to create a negative pressure in a gas flow pathway” in lines 10-12 and “thereby allowing an ambient gas stream forcedly flows from the exterior” in lines 13-14. It is unclear how an ambient gas stream is allowed to forcedly flow due to a pump. If the pump is forcing the ambient gas stream to flow, is it being allowed to flow? The examiner suggests amending the recitation in lines 13-14 to be “therebycausing an ambient gas stream to forcedly flow[[s]]”. Claim 11 recites a similar limitation, so it is rejected on similar grounds.
Claim 1 recites “a purified gas stream is produced by suction of the ambient gas stream passing through the gas permeable filter and carries volatile compounds of the biological sample from the second chamber to the first chamber” in lines 21-25, which indicates that the purified gas stream reaches the first chamber . Claim 1 also recites “an ambient gas stream forcedly flows from the exterior through the inlet portion into the second chamber and the first chamber” in lines 14-16, which indicates that the ambient gas stream reaches the first chamber. It is unclear whether the purified gas stream is different from the ambient gas stream. The specification suggests that they are the same (i.e., there is only one flow path for the gas to reach the first chamber), but the differences in claim terminology suggest that they are different. Consistent terminology should be used. The Examiner suggests amending the recitation in lines 21-25 to be “suction of the ambient gas stream through the gas permeable filter purifies the ambient gas stream, and the ambient gas stream carries volatile compounds of the biological sample from the second chamber to the first chamber” or the like. Claim 11 recites a similar limitation, so it is rejected on similar grounds.
Claims 2-10 are rejected by virtue of their dependence from claim 1.
Claims 12-18 are rejected by virtue of their dependence from claim 11.
Claim 3 recites “wherein the second unit is… fluidly connected to the second unit through the valve” in lines 8-9. It is unclear how the second unit is fluidly connected to itself. The specification does not provide clarification. For the purposes of examination, the recitation will be interpreted to be “wherein the second unit is… fluidly connected to the first unit through the valve”. Claim 13 recites a similar limitation, so it is rejected on similar grounds.
Claim 5 recites “a base” in line 3, and claim 1 recites “an output portion” in line 7. It is unclear whether the base and the outlet portion are different from each other. Paragraph [0021] of the published application recites “a base 221 (sometimes referred to as an outlet portion)”, which indicates that they are the same. However, the claim indicates that they are different (e.g., “the second unit further comprises: a base”). The Examiner suggests amending claim 5 to clarify that that the output portion and the base are the same. Claim 14 recites a similar limitation, so it is rejected on similar grounds.
Claim 5 recites “a cap” in line 8, and claim 1 recites “an inlet portion” in line 9. It is unclear whether the cap and the inlet portion are different from each other. Paragraph [0021] of the published application recites “a cap 222 (sometimes referred to as an inlet portion)”, which indicates that they are the same. However, the claim language indicates that they are different (e.g., “the second unit further comprises:… a cap”). The Examiner suggests amending claim 5 to clarify that that the inlet portion and the cap are the same. Claim 14 recites a similar limitation, so it is rejected on similar grounds.
Claim 5 recites “the gas permeable filter is disposed in the upstream region and closes off the aperture” in lines 13-14. The recitation of “closes off the aperture” indicates that the aperture does not allow elements to pass through it. However, claim 1 recites “a purified gas stream is produced by suction of the ambient gas stream passing through the gas permeable filter” in lines 22-23, which suggests that the gas stream passes through the filter and the aperture. Therefore, it is unclear whether the aperture is closed off or not. The Examiner suggests replacing the recitation in claim 5 with “the gas permeable filter is disposed in the upstream region and partially closes off the aperture”. Claim 14 recites a similar limitation, so it is rejected on similar grounds.
Claim 8 recites “the collection tool” in line 1 and “the absorbent portion” in line 2. There are insufficient antecedent bases for these limitations in the claim. The Examiner suggests clarifying how these elements are related to the “collector” of line 19 of claim 1.
Claim 8 recites “the collection tool is inserted such that the absorbent portion is passed through the axial bore and a section of the collection tool stays adjacent to the blade structure”, which include method steps. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). The Examiner suggests amending the recitation to be “the collection tool is configured to be inserted…”
Claim 9 recites “a remaining section” in line 3. Claim 1 recites “a collector” in line 9. It is unclear how the remaining section is related to the collector of claim 1. The specification suggests that the collector is the same as the remaining section (¶ [0027] recites “a remaining section 10b (sometimes referred to as collector)”), but the difference in terminology suggests that they are different. The Examiner suggests amending the claim to use consistent language.
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.
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.
Claims 1, 3, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0321904 A1 (Miller) in view of JP 2021/092557 A (Yamashita) and US 2019/0195899 A1 (Hill Jr.).
With regards to claims 1 and 11, Miller teaches a portable device and kit for detecting or identifying diseases or disorders in a human subject by collecting biological sample from the human subject (Fig. 1A and ¶ [0038] depict a breath collection device 100), comprising: a pump unit (¶ [0016] discloses a housing of the breath collection device including an intake pump); a first unit comprising a first chamber fluidly connecting to the pump unit and a gas sensor unit disposed in the first chamber (Fig. 2A and ¶ [0043] depict a chamber 31 (i.e., a first unit) including an internal bladder 16 (i.e., a first chamber); ¶ [0016] discloses an intake pump fluidically for guiding aerosols from a mask to a collection element, wherein the aerosols are then sent to a gas sensor; ¶ [0045] discloses the gas sensors 6A-C are mounted on an inner wall surface of the internal bladder 16); a second unit comprising a second chamber (Fig. 2A and ¶ [0043] depict a sample vessel 32 which has a chamber), an outlet portion fluidly connecting between the second chamber and the first chamber (Fig. 2A depicts an outlet (upper opening) of the sample vessel 32 fluidly connected to the internal bladder 16), and an inlet portion fluidly connecting between the second chamber and an exterior of the second chamber (Fig. 2A depicts an inlet (lower opening) connected to an outside of the chamber), wherein a gas flow pathway is provided between the first chamber and the second chamber through the outlet portion (Fig. 2A depicts the flows 22, 23 through the sample vessel 32, its outlet, and the internal bladder 16).
Although Miller teaches the use of a flowmeter to adjust the flow of a gas stream through the device (¶ [0044] of Miller), Miller is silent regarding whether the pump unit is configured, when activated, to create a negative pressure in a gas flow pathway provided between the first chamber and second chamber through the outlet portion, thereby allowing an ambient gas stream forcedly flows from the exterior through the inlet portion into the second chamber and the first chamber.
In a system relevant to the problem of causing flow of a gas stream, Yamashita teaches a pump unit configured, when activated, to create a negative pressure in a gas flow pathway provided between chambers, thereby causing an ambient gas stream to forced flow from the exterior through the chambers (First paragraph of page 4 of the translation of Yamashita discloses sample atmosphere is sucked from the intake unit 12 by a suction pump arranged on the downstream side of the sampler 10; Figs. 1-3 depicts the sampler 10 having the intake unit 12 and a plurality of chambers through which the gas passes). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified gas flow pathway of Miller, based on the teachings of Yamashita, to incorporate that the pump unit is configured, when activated, to create a negative pressure in a gas flow pathway provided between the first chamber and second chamber through the outlet portion, thereby allowing an ambient gas stream forcedly flows from the exterior through the inlet portion into the second chamber and the first chamber. It would have been the simple substitution of one known configuration for transporting fluid for another to obtain predictable results.
The above combination is silent regarding a collector or a collection tool comprising an absorbent portion and an elongate portion adjoining to the absorbent portion, wherein the absorbent portion is configured to temporarily secure a biological sample of a human subject
In the same field of endeavor of analyzing gaseous biological samples, Hill Jr. teaches a collector and a collection tool comprising an absorbent portion and an elongate portion adjoining to the absorbent portion, wherein the absorbent portion is configured to temporarily secure a biological sample of a human subject (¶¶ [0008], [0054] discloses a swab capable of collecting a particle sample from the subject, wherein the swab necessarily includes an absorbent portion and an elongate portion adjoining to the absorbent portion, ¶¶ [0051], [0064] discloses obtaining a particle sample by either isolating a breath sample or obtaining a swab sample from a subject and subjecting the sample to heat using thermal desorption for volatilizing the sample). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the breath sample collected within the sample vessel of Miller with a swab along with elements for thermal desorption as taught by Hill Jr. Because both the elements of Miller and Hill Jr. have or produce volatilized samples (see ¶ [0008] of Miller; ¶ [0006] of Hill Jr.), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent regarding a gas permeable filter disposed in an upstream region of the second chamber; and a collector disposed in a downstream region of the second chamber, wherein a purified gas stream is produced by suction of the ambient gas stream passing through the gas permeable filter and carries volatile compounds of the biological sample from the second chamber to the first chamber.
In a system relevant to the problem of collecting and storing samples, Yamashita teaches a gas permeable filter disposed in an upstream region of a chamber; and a collector disposed in a downstream region of the chamber (Fig. 5 and Paragraphs 2-3 of page 5 of the translation of Yamashita depict an upstream portion of a chamber including a urethane foam filter unit 31 and a downstream portion of the chamber including a filter unit 41 for collecting volatile pels and compounds). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second chamber and the swab of the above combination to incorporate, based on the teachings of Yamashita, to incorporate that a gas permeable filter is disposed in an upstream region of the chamber and the swab is disposed in a downstream region of the chamber. The motivation would have been to ensure that gas that transports the volatilized sample is not contaminated. The Examiner notes that the above combination results in a purified gas stream is produced by suction of the ambient gas stream passing through the gas permeable filter (Fig. 5 and Paragraphs 2-3 of page 5 of the translation of Yamashita depicts the gas that passes through 31 being purified; First paragraph of page 4 of the translation of Yamashita discloses sample atmosphere is sucked from the intake unit 12 by a suction pump arranged on the downstream side of the sampler 10) and carries volatile compounds of the biological sample from the from the second chamber to the first chamber (the above gas stream would carry the volatilized samples from the swab of Hill Jr. to the internal bladder of Miller).
With regards to claim 3 and 13, the above combination teaches or suggests a casing (Fig. 2A and ¶ [0039] of Miller depict a housing 11), having a head portion and a socket formed on the head portion (Figs. 1A, 2A of Miller depicts a top of the housing 11 having a socket through which the first check valve 13 enters the housing 11); a valve, disposed in the socket of the casing (Figs. 1A, 2A of Miller depicts a first check valve 13 in the socket); and a controller (Fig. 2A and ¶ [0048] of Miller depict circuitry 18 comprising a microcontroller); wherein the first unit, the pump unit and the controller are disposed inside the casing (¶ [0016] of Miller discloses a housing of the breath collection device including an intake pump; Fig. 2A and ¶ [0043] of Miller depict the circuitry 18 and internal bladder 16 within the housing 11); and wherein the second unit is releasably engaged to the socket of the casing and fluidly connected to the second unit through the valve (Fig. 1A of Miller depicts the valve being rotatably screwed into the socket, which indicates that the sample vessel is also releasably engaged with the socket; Fig. 2A of Miller depicts the sample vessel fluidly connected to the housing 11).
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0321904 A1 (Miller) in view of JP 2021/092557 A (Yamashita) and US 2019/0195899 A1 (Hill Jr.), as applied to respective claims 1 and 11 above, and further in view of US 2003/0234366 A1 (Basch).
With regards to claims 2 and 12, the above combination is silent regarding whether the gas permeable filter is a carbon filter cartridge.
In the same field of endeavor of gas samplers, Basch teaches a gas permeable filter being a carbon filter cartridge (¶ [0002] teaches conventional gas samples for collecting particulates include drawing gas past a collector such as an activated carbon cartridge). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the gas permeable filter of the above combination with the carbon filter cartridge of Basch. Because both elements are configured to filter a gas, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0321904 A1 (Miller) in view of JP 2021/092557 A (Yamashita) and US 2019/0195899 A1 (Hill Jr.), as applied to claim 3 above, and further in view of US 2017/0014826 A1 (Engel)
With regards to claim 4, the above combination is silent regarding a removable cover is disposed on the socket when the second unit is disengaged with the socket of the casing.
In a system relevant to the problem of protecting elements, Engel teaches a removable cover is disposed on a socket when an element is disengaged with the socket of the casing (¶ [0041] discloses a bottom lid 210 is used to seal second opening 214 up until container 104 is about to be connected with a cartridge 102; ¶ [0037] discloses the bottom lid 210 is a removable lid). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination, based on the teachings of Engel, to incorporate a removable cover is disposed on the socket when the second unit is disengaged with the socket of the casing. The motivation would have been to protect the internal elements when the device is not assembled.
No Prior Art Rejections of claims 5-10 and 14-18.
With regards to claims 5 and 14, the prior art does not teach or suggest the second unit further comprises: a base, comprising a bottom baffle, one or more venting holes penetrating the bottom baffle, a tubular wall extended upright from the bottom baffle and defining a cavity therein and a top opening above the cavity, wherein the venting holes is fluidly connected with the first chamber; and a cap mounted on the base to form the second chamber therein, comprising an enclosure defining an interior space, an aperture formed on a top portion of the enclosure and a bottom opening; wherein the upstream region of the second chamber is adjacent to the aperture and the downstream region of the second chamber is adjacent to the upstream region, the gas permeable filter is disposed in the upstream region and closes off the aperture, the tubular wall is positioned within the downstream region; wherein the cavity of the base is covered by the gas permeable filter from above and enclosed circumferentially by the enclosure, along with the other features of claims 5 and 14. There are no prior art rejections of claims 6-10 and 15-18 by virtue of their dependence from respective claims 5 and 14.
The closest prior art is JP 2021092557 A (Yamashita) which, in Fig. 5, teaches a volatile compound collection area 40 (i.e., a base) comprising a lower wall with an opening 13, a semi-volatile compound collection area 30 (i.e., a cap) mounted on 40. However, Yamashita does not teach or suggest the above features.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2020/0309753 A1 (Mamerow)
US 2024/0225478 A1 (Neuner)
US 2018/0372599 A1 (Cardin)
US 2005/0065446 A1 (Talton).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PUYA AGAHI/ Primary Examiner, Art Unit 3791
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