I. ACKNOWLEDGEMENT
This Office Action addresses U.S. Application No. 18/947117 (“’117 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is November 14, 2024.
II. STATUS OF CLAIMS
Claims 1-18 were filed with the application. Therefore, as of the date of this Office Action, the status of the claims is:
a. Claims 1-18 (“Pending Claims”).
b. Claims 1-18 (“Examined Claims”)
III. PRIORITY AND CONTINUING DATA
The ‘117 application claims priority under 35 USC 119 to KR 10-2024-0061124, filed May 9, 2024. As such, the AIA first to file provisions of 35 USC apply to this proceeding.
IV. CLAIM OBJECTIONS
Claim 12 is objected to in that the word “is” in line 2 should be “are.”
V. REJECTIONS UNDER 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.
As to claim 1, the claim is rejected as being indefinite in that it recites a first valve and a third valve in valve in line 10, but no second valve. Therefore, it is unclear whether there are two or three valves. Second, the phrase “analyzes a biomarker in pulmonary diseases in indefinite in that the biomarker is indicative of pulmonary diseases, not in the pulmonary disease. Third, the claim recites that the analysis line analyzes a biomarker, but it does not include any structure to analyze the biomarker. Therefore, it is unclear how a line does any analysis. Fourth, the claim recites a first and second branch flow path and an alveolar gas extraction line and an analysis line. The disclosure only has two lines, i.e. the alveolar gas extraction line is part of the first branch and the analysis line is part of the second branch. However, the claim makes it seem that these are separate entities. Therefore, it is unclear what the relationship between the lines and the flow path branch is.
Similarly, claim 2 is indefinite in that a second valve is recited, but there are already two valves recited in claim 1.
Claim 8 is also rejected in that the phrase biomarker in pulmonary disease is indefinite, as discussed above.
Claim 11 is indefinite in that the first flow sensor measures flow rate, not the amount of the expired air. Therefore, it is unclear what measures the amount of the expired air.
As to claim 13, the claim is rejected as being indefinite in that the phrase “analyzes a biomarker in pulmonary diseases in indefinite in that the biomarker is indicative of pulmonary diseases, not in the pulmonary disease.
Claims 16 and 18 are rejected as being indefinite in that the phrase “analyzes a biomarker in pulmonary diseases in indefinite in that the biomarker is indicative of pulmonary diseases, not in the pulmonary disease.
Claim 17 is rejected in that it is unclear what exactly each step does, as the steps are not related back to the method.
Claims 3-7, 9, 10, 12, 14, and 15 are rejected as being dependent upon a rejected base claim.
VI. ART REJECTIONS
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.
Claims 1, 5-7, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Purves US PG PUB 2021/0267483 in view of Wright et al US Patent 4,297,821 and Phillips US Patent 6,726,637.
Purves shows a system for breath collection including a lung function measurement line forming a flow path for exhaled air to flow through (line 48 in figure 7a) having a capnometer to identify alveolar air, a first branch flow path 84 branched from the lung function measuring line, , that includes an alveolar extraction line that leads to receptacle 308, where the alveolar collection line has a valve 80. Purves has a second branch that has a line that leads to tubes 152 for collecting the sample and later providing the tube to analyze the sample. The pump is a two way pump for providing suction for collecting the sample and for driving the sample to the collection tube 152 through the valves 120. As such, it functions as two pumps, one in each line. Purves is deficient in two ways. First, Purvis does not have a flow sensor in the lung function measurement line. Rather, it has a capnometer to measure carbon dioxide and identify alveolar air based on the carbon dioxide. However, Wright teaches that flow rate of exhaled air can be used to identify the start of alveolar air column 1, line 63) . As such, it would have been obvious to modify Purves to use a flow meter instead of a capnometer, as it is merely the substitution of one alveolar identification technique for another. Second, the Examiner notes that after the rise discussed in column 1, if the flow rate falls to zero, the sample collection will be triggered. Second, the analysis line does not analyze the sample. However, Phillips has a alveolar collection that device that includes the analyzer 130 in the device to analyze the sample. Such an arrangement makes measurement time quicker and avoids the need to carry the tube 152 to a different device. As such, it would have been obvious to include analyzer with the tube 152, to improve measurement time.
As to claim 5, there is an outside air inflow path 92.
As to claim 6, there is a bypass flow path through valve 88.
As to claim 7, the combination has an analysis unit 130.
Claim 16 is rejected for the reasons given above.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Purves in view of Wright et al and Phillips, as applied to claims xxx above, further in view of Daniels US PG PUB 2021/0325279.
The combination measures VOCs but does not mention nitric oxide. However, in paragraph ]0247], Daniels teaches that nitric oxide is a known VOC to be measured. As such, it would have been obvious to modify the combination to measure nitric oxide, as it is a known indicator of respiratory disease and therefore the known use of the device of the combination.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Purves in view of Wright et al and Phillips, as applied to claims xxx above, further in view of Colman et al US PG PUB 2009/0312662.
The combination does not have a Nafion tube. However, Colman teaches a breath sampling device that use Nafion tubing to reduce humidity in the sampling tube (paragraph [0006]). As such, it would have been obvious to modify the combination to use a Nafion tube in the analyzer line, to reduce humidity and increase the accuracy of measurement.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wright et al US Patent 4,297,871 in view of Purves US PG PUB 2021/0267483.
Wright teaches measuring alcohol in alveolar air (see column 1, line 63) , wherein when the flow rate falls after initially rising, the sample is collected and the measurement is made. The Examiner notes that after the rise discussed in column 1, if the flow rate falls to zero, the sample collection will be triggered. Wright measures alcohol concentration, which does not perform pulmonary disease screening. However, Purves teaches that it is also desirable to measure VOCs indicative of disease, in alveolar air (see paragraph [0003], for example). As such, it would have been obvious to modify Wright to as a disease screening device, as it is merely using a measurement device for a known purpose in the art.
VII. ART REJECTIONS
Claims 2-4, 10, 12, 17 and 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 13-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 2-4, 10, and 12 define over the art in that none of the art has the second valve between the first valve and the analysis line, and the third valve recite in claim 1.
Claim 11 defines over the art of record in that the valves do not function as described in the claim.
Claims 13-15 and 17-18 define over the art in that none of the art has the sampling loop.
VIII. CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Kosowski can be reached at (571) 272-3744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT L NASSER/ Primary Examiner, Art Unit 3992
Prosecution Insights