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 .
Status of Claims
The claim set submitted on 24 DECEMBER 2025 is acknowledged and considered. In the claim set, Claims 1-3, 6-10 and 12 are ‘Currently Amended’; and Claims 4, 5, 11 and 13-20 are ‘Original’ or ‘Previously Presented’; Claims 21-25 are ‘Canceled’.
Current pending claims are Claims 1-20 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 22 DECEMBER 2025 was filed after the mailing date of the Non-Final Office Action on 25 JUNE 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
In the newly submitted IDS, Applicant has cited the MILTON and O’BRIEN references. The Examiner has previously cited this reference on the PTO-892 on 25 JUNE 2025.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 24 DECEMBER 2025, with respect to the objection to the specification, objection to the drawings, the claim objection and the 112(b) rejections have been fully considered and are persuasive. The objection to the specification, objection to the drawings, the claim objection and the 112(b) rejections has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot. In response to Applicant’s amendments, the grounds of rejection for the pending claims are modified and partially based of the previously used prior art.
In the REMARKS filed on 24 DECEMBER 2025, Applicant has stated:
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Therefore, the double patenting rejection has been maintained.
In response to Applicant’s assertion that the amendments to Claim 9 overcome the 101 rejection; the Examiner respectfully disagrees. The amendment to step a. is merely rewording and the amendment to step c. that defined the spectrometer test chamber that is fluid connection with said cooling chamber and the heating step is in the spectrometer chamber is something that is already taught by the prior art to O’BRIEN and therefore is not ‘significantly more’ than the abstract idea.
The amendment to Claim 9 and 10 does not change the 101 analysis below.
The rejection of the pending claim under 101 has been maintained.
Applicant asserts the references do not now teach "said spectrometer test chamber configured for detection of proteins in the air sample". This is newly added and the rejection below has been modified to reflect this limitation.
Applicant asserts that the combination of references “fail to discloses a system that provide to the spectrometer test chamber two separate fluids, an air sample and an inert gas to be mixed inside the spectrometer test chamber.” In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., spectrometer test chamber two separate fluids, an air sample and an inert gas to be mixed inside the spectrometer test chamber) are not recited in the rejected Claim 1. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 11-17 of U.S. Patent No. 12,276,586 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant invention and the ‘586 patent are both directed to a system and method of using the system with all of the same structural elements and method steps. The instant invention is more broadly claim as compared to ‘586 patent which has more specific structural elements and more specific method steps. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the ‘586 patent to more generally claim the system and method of the instant invention to a compound of interest.
Each of the dependent claims are claimed exactly the same such that they are indistinguishable or are slightly different which would be obvious to one having ordinary skill in the art (i.e. instant invention Claim 2, temperature of 30 to 55 degrees Celsius; ‘586 patent about 30 to about 60 degrees Celsius).
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 9-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract ideas without significantly more. The claim(s) recite(s) a method of preparing an air sample with steps (a) – (c), in Claim 9, and step (d) and (e ), which comprise (d) preparing the air sample for detection and (e) in Claim 10, which comprises a comparing and determining spectral profiles from FTIR mass spectrometry to indicate the presence of proteins in said air sample, which is judicial exception (an abstract idea that falls within the mathematical concept and mental process groupings in the 2019 PEG) .
This judicial exception is not integrated into a practical application because after the determining step by comparing nothing else is done. There does not appear to have any additional steps which are significantly more than the abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no steps that are significantly more. The steps recited in Claims 9-10, 16 are well-understood routine and convention as taught by MILTON (see rejection below).
The techniques claimed in Claims 11-12, 17 are well understood routine and convention and does not add any additional steps which are significantly more than the abstract idea.
Claims 13-15 are well known in the art and WURC to be optimizable and/or are a result effective variable and does not add any additional steps which are significantly more than the abstract idea.
Claims 17-20 are well known in the art and WURC and does not add any additional steps which are significantly more than the abstract idea
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over MILTON, US Publication No. 2017/0299477 A1, now cited on the Information Disclosure Statement on 22 DECEMBER 2025, and further in view of O’BRIEN, US Publication No. 2003/0015019 A1, now cited on the Information Disclosure Statement on 22 DECEMBER 2025.
Applicant’s invention is directed towards a device, a system.
Regarding Claim 1, the MILTON reference disclose a system, Figure 1, S1, [0042, 0043], comprising:
a pump configured to pump an air sample, [0043, 0083], from a container to a cooling chamber, [0014], said cooling chamber is configured to cool the exhaled air sample to a sub-zero temperature, [0049], and is in fluid connection to a spectrometer test chamber, [0073], said spectrometer test chamber configured for detection of proteins, [0034, 0035, 0040], detection of protein biomarker in exhaled breath aerosol (EBA) particles; a gas source, [0044], configured to supply a gas to the spectrometer test chamber at a pressure higher than the atmospheric pressure, [0016]; and one or more heating elements for heating said air sample, [0022, 0054, 0055].
The MILTON reference discloses the claimed invention, but is silent in regards to the specific rate at which the pump is configured to pump an air sample into a container.
MILTON teaches that a subject breath is pulled through the device with a pump that keeps the flow within the device moving at an extremely constant rate, [0083].
Since the objection of the EBA collection device is to keep flow within the device moving at an extremely constant rate and this could is interpreted to be a particular parameter to be a result-effective variable, it would be obvious to one having ordinary skill in the art before the effective filing date to have the pump configured to pump an air sample at a capacity of at least 0.5 liter/sec to keep the flow within the device moving, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In addition, it would be obvious to one having ordinary skill in the art before the effective filing date to have the pump configured to pump an air sample at a capacity of at least 0.5 liter/sec out of routine optimization to keep flow within the device moving, In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017).
The MILTON reference suggests the claimed invention, but is silent in regards to an inert gas source.
O’BRIEN discloses a system, Figure 1, [0002, 0044, 0140], system 10, comprising:
a pump configured to pump an air sample, pump 18 and sample inlet 14, [0042, 0140, 0145], from a container to a cooling chamber, sample chamber 62 and coil 66 (interpreted to be a cooling chamber), [0038, 0177, 0178, 0191],
said cooling chamber is configured to cool the exhaled air sample to a sub-zero temperature, and is in fluid connection to a spectrometer test chamber, said spectrometer test chamber configured for detection of analytes in the air sample, [0027, 0038, 0127, 0199], Claim 21, analytes in an air sample such as air-pollution analysis, clinical breath analysis, metabolic studies, process streams, clean rooms, etc., [0022];
an inert gas source, [0160, 0161], configured to supply an inert gas to the spectrometer test chamber at a pressure higher than the atmospheric pressure, [0027], starting at atmospheric pressure to about 100 psi to 15,000 psi, Claim 22; and
one or more heating elements for heating said air sample, [0015, 0027, 0311], Claim 22.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the MILTON reference with the inert gas as taught by O’BRIEN so that a baseline for mass spectrometry only detects the analyte of interest and aid in pneumatic focusing providing higher sensitivity for sample determination, O’BRIEN [0094-0099].
Additional Disclosures Included by the combination are: Claim 2: wherein the system of claim 1, wherein one or more heating elements are configured to heat the test chamber to a temperature of 30 to 55 0C, MILTON [0036, 0054].; Claim 3: wherein the system of claim 1, wherein one or more heating elements are adopted to heat the inert gas prior to the provision of the gas to the spectrometer test chamber, MILTON [0054, 0055], O’BRIEN [0015, 0027].; Claim 4: wherein the system of claim1, wherein said air sample is an exhaled air sample, MILTON [0014], O’BRIEN [0022] .; Claim 5: wherein the system of claim l, wherein said capacity is between 0.5 liters/sec to 2 liters/sec, MILTON [0083]. Since the objection of the EBA collection device is to keep flow within the device moving at an extremely constant rate and this could is interpreted to be a particular parameter to be a result-effective variable, it would be obvious to one having ordinary skill in the art before the effective filing date to have the pump configured to pump an air sample at a capacity is between 0.5 liters/sec to 2 liters/sec to keep the flow within the device moving, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In addition, it would be obvious to one having ordinary skill in the art before the effective filing date to have the pump configured to pump an air sample at a capacity is between 0.5 liters/sec to 2 liters/sec out of routine optimization to keep flow within the device moving, In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017). ; Claim 6: wherein the system of claim 1, wherein said inert gas is characterized by being undetectable by Fourier-transform infrared (FTIR) mass spectrometry, O’BREIN [0145, 0160, 0161, 0330]. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the MILTON reference with the inert gas that is characterized by being undetectable by a Fourier-transform infrared (FTIR) mass spectrometry as taught by O’BRIEN so that a baseline for mass spectrometry only detects the analyte of interest and aid in pneumatic focusing.; Claim 7: wherein the system of claim l, wherein said supply of the inert gas is at a pressure of between 1.1 atm. to 2.5 atm, O’BRIEN Claim 20, [0103], 15 psi. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the MILTON reference with the supply pressure at a pressure of between 1.1 atm. to 2.5 atm as taught by O’BRIEN so that it is supplied at atmospheric pressure so no other adjustments or instruments are need for supplying a sample, [0103]. ; Claim 8: wherein the system of claim l, further comprising a controller configured to control at least one of: the capacity of said pump, the temperature of said cooling chamber, and the pressure of said inert gas provided by said inert gas source and the power provided to said heating unit, O’BRIEN, abstract, [0023, 0026, 0234], Claims 36 and 65. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the MILTON reference with a controller to optimize the most important parameters, O’BRIEN [0023], and can be automated, O’BRIEN [0042].
Applicant’s invention is directed towards a method.
Regarding Claim 9, the MILTON reference discloses a method for preparing an air sample for detection of a mixture of proteins in said air sample, abstract, comprising the steps:
a. pumping said air sample from a container to a cooling chamber, [0083], Claim 18;
b. cooling said sample from step (a) to a subzero temperature in said cooling chamber, [0049, 0073], Claim 18; and
c. mixing said sample from step (b) with a gas at a pressure higher than the atmospheric pressure inside a spectrometer test chamber that is in fluid communication with said cooling chamber, [0016, 0044], Claim 18, and heating said mixed sample to a temperature ranging from 30 to 55 0C, [0022, 0036, 0054, 0055], thereby, preparing an air sample for the detection of a mixture of proteins in said air sample, Claim 18.
16. The MILTON reference discloses the claimed invention, but is silent in regards to wherein the heating step , heating said mixed sample to a temperature range in said spectrometer test chamber.
17. The O’BRIEN reference disclose a method for preparing an air sample for detection of a mixture of proteins in said air sample, abstract, [0140], comprising the steps:
a. pumping said air sample from a container to a cooling chamber, [0027, 0103], pump 18 and sample inlet 14, [0140, 0145], sample chamber 62 and coil 66 (interpreted to be a cooling chamber), [0177, 0178], Claim 1;
b. cooling said sample from step (a) to a subzero temperature in said cooling chamber, [0027, 0038, 0199]; and
c. mixing said sample from step (b) with an inert gas at a pressure higher than the atmospheric pressure inside a spectrometer test chamber that is in fluid connection with said cooling chamber, [0027, 0291], and heating said mixed sample in said spectrometer test chamber thereby, [0027, 0038, 0101, 0201].
18. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the invention of MILTON with the step of and heating said mixed sample in said spectrometer test chamber as taught by O’BRIEN to prevent condensation of condensable vapors, O’BRIEN [0101, 0124].
19. Additional Disclosures Included are: Claim 10: wherein the method of claim 9, further comprising a step (d) comprising determining a spectral profile of said sample from step (c), and comparing said spectral profile to a reference profile, wherein a correlation of at least 80% between said spectral profile and said reference profile is indicative of the presence of said mixture of proteins in said air sample, [0076, 0077]. ; Claim 11: wherein the method of claim 10, wherein said determining is by using a spectrometer, [0073]. ; Claim 13: wherein the method of claim 9, wherein said inert gas is undetectable in FTIR mass spectrometry, , O’BRIEN [0145, 0160, 0161, 0330]. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the MILTON reference with the inert gas that is characterized by being undetectable by a Fourier-transform infrared (FTIR) mass spectrometry as taught by O’BRIEN so that a baseline for mass spectrometry only detects the analyte of interest and aid in pneumatic focusing.; Claim 14: wherein the method of claim 9, wherein said pumping is at a capacity of between 0.5 liters/sec to 10 liters/sec, MILTON [0083]. Since the objection of the EBA collection device is to keep flow within the device moving at an extremely constant rate and this could is interpreted to be a particular parameter to be a result-effective variable, it would be obvious to one having ordinary skill in the art before the effective filing date to have the pump configured to pump an air sample at a capacity is between 0.5 liters/sec to 2 liters/sec to keep the flow within the device moving, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In addition, it would be obvious to one having ordinary skill in the art before the effective filing date to have the pump configured to pump an air sample at a capacity is between 0.5 liters/sec to 2 liters/sec out of routine optimization to keep flow within the device moving, In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017).; Claim 15: wherein the method of claim 9, wherein said pressure higher than the atmospheric pressure comprises a pressure of between 1.1 atm. to 2.5 atm, O’BRIEN Claim 20, [0103], 15 psi. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the MILTON reference with the supply pressure at a pressure of between 1.1 atm. to 2.5 atm as taught by O’BRIEN so that it is supplied at atmospheric pressure so no other adjustments or instruments are need for supplying a sample, [0103]. ; Claim 16: wherein the method of claim10, wherein said reference profile represents or is derived from a sample comprising said mixture of proteins, [0034, 0035, 0040]. ; Claim 17: wherein the method of claim 9, wherein said air sample comprises air exhaled from a subject, [0014]. ; Claim 18: wherein the method of claim 17, wherein said subject is suspected of being infected with a pathogen, [0040]. ; Claim 19: wherein the method of claim 18, wherein said reference profile represents or is derived from a subject being positive to said pathogen, [0040]. ; and Claim 20: wherein the method of claim 18, wherein said pathogen is characterized by being capable of inducing a respiratory infectious disease, [0040].
20. Regarding Claim 12, the MILTON reference discloses the claimed invention, but is silent in regards to wherein the spectrometer comprises a FTIR mass spectrometer.
The O’BRIEN reference disclose a method for preparing an air sample for detection of a mixture of proteins in said air sample, abstract, [0140], comprising the steps:
a. pumping said air sample from a container to a cooling chamber, [0027, 0103], pump 18 and sample inlet 14, [0140, 0145], sample chamber 62 and coil 66 (interpreted to be a cooling chamber), [0177, 0178], Claim 1;
b. cooling said sample from step (a) to a subzero temperature in said cooling chamber, [0027, 0038, 0199]; and
c. mixing said sample from step (b) with an inert gas at a pressure higher than the atmospheric pressure inside a spectrometer test chamber that is in fluid connection with said cooling chamber, [0027, 0291], and heating said mixed sample in said spectrometer test chamber thereby, [0027], preparing an air sample for the detection of a mixture of proteins in said air sample, [0015, 0027, 0311]; wherein spectrometer comprises an FTIR mass spectrometer, O’BRIEN, [0021, 0117, 0208, 0211].
21. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the MILTON reference with the spectroscopy technique being with a FTIR mass spectrometer to have a better signal to noise ratio giving the most accurate results.
Conclusion
22. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
23. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797