DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 101
3. 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.
4. Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 1-10 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04):
Claim(s) 1-11, recite the following mental process:
A diagnostic method to diagnose infection with infectious diseases…
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
The abstract idea is not integrated into a practical application because the additional limitation of “using sulfur metabolite as a biomarker” in claim 1 add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process is “using sulfur metabolite as a biomarker”. Such feature add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
The additional limitations of dependent claims 2-10 are merely directed to and further narrow the scope of the mental process or further narrow the scope of the additional limitations that do not integrate the mental process into a practical application or are not significantly more than the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Claim Rejections - 35 USC § 102
5. 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.
6. 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
7. Claims 1-5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lewis et al., U.S. Patent Application No. 2002/0017125 A1 (“Lewis”).
As to Claim 1, Lewis teaches the following:
A diagnostic method to diagnose infection with infectious diseases using sulfur metabolite as a biomarker (see “In yet another aspect, the present invention provides methods for detecting or diagnosing, for example, infections, lung cancer, oral infections and halitosis using a breath sample of a mammal. Preferably, the mammal is a human being. In other embodiments, the present invention provides methods for other medical applications, such as those involving the detection of marker gas(es) in mammalian breath as well as odors from potentially infected areas of the skin.” in para. [0018]; see “Under certain conditions, mammalian breath contains marker gases indicative of certain infections, disorders and medical conditions and the devices of the present invention can be used to detect such marker gases.” in para. [0034]; and see “As explained above, volatile sulfur compounds (e.g., H.sub.2S, CH.sub.3--SH, CH.sub.3--S--CH.sub.3) are the marker gases implicated in halitosis and periodontal diseases (see, Tonzetich, Arch. Oral Biol., 16:587-597 (1971); Rizzo, Periodontics, 5:233-236 (1967)).” in para. [0082]).
As to Claim 2, Lewis teaches the following:
wherein the sulfur metabolite is collected from an exhaled air (see “dimethyl sulfide” in list of “METABOLIC PRODUCTS OR OFF-GASSES” in Table 3).
As to Claim 3, Lewis teaches the following:
wherein the sulfur metabolite is produced by metabolism of an active sulfur compound in vivo (see “dimethyl sulfide” in list of “METABOLIC PRODUCTS OR OFF-GASSES” in Table 3).
As to Claim 4, Lewis teaches the following:
wherein the sulfur metabolite is at least one type of sulfite ions (HSO₃ ), thiosulfate ions (HS2O₃ ), and hydrogen disulfide ions (HS2⁻) (see “dimethyl sulfide” in list of “METABOLIC PRODUCTS OR OFF-GASSES” in Table 3)
As to Claim 5, Lewis teaches the following:
wherein the infectious diseases is viral infection (see “wherein said analyte is a member selected from the group consisting of … viruses …” in claim 18).
As to Claim 7, Lewis teaches the following:
wherein the infectious diseases is pneumonia due to the infection (see “Thus, the present invention provides a method for the detection of pneumonia, the method comprising: contacting an array of sensors with mammalian breath suspected of containing a marker gases indicative of pneumonia; and detecting the marker gas to determine the presence of pneumonia.” in para. [0069]; and see “wherein said analyte is a member selected from the group consisting of … viruses …” in claim 18).
Claim Rejections - 35 USC § 103
8. 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.
9. 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.
10. Claims 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis, as applied to claim 5 above, and further in view of Indani et al., U.S. Patent Application Publication No. 2023/0064209 A1 (“Indani”).
As to Claims 6 and 9, Lewis teaches the subject matter of claim 5 above. Lewis does not teach the following:
wherein the infectious diseases is new coronavirus infection; and
wherein diagnosing a risk of exacerbation of the new coronavirus infection.
However, Indani teaches the following:
wherein the sulfur metabolite is at least one type of sulfite ions (HSO₃ ), thiosulfate ions (HS2O₃ ), and hydrogen disulfide ions (HS2⁻) (see “Breath analyzers are dependent on the chemical signature of the material, for instance, alcohol, ammonia, hydrogen sulphide, etc. and are therefore gas chromatography based and not antibody-antigen based as is the case with the present disclosure.” in para. [0072])
wherein the infectious diseases is new coronavirus infection (see “In an exemplary embodiment, the sensor may be activated by the antigen-antibody reaction to detect breath pathogen and display information associated with say corona virus indicative of Severe Acute Respiratory Syndrome (SARS), Middle East respiratory syndrome (MERS), Corona Virus Disease 2019 (COVID-19), virus indicative of Ebola, Zica, influenza, Anthrax, or bacteria indicative of Tuberculosis, Pneumococcus, and the like.” in para. [0042]); and
wherein diagnosing a risk of exacerbation of the new coronavirus infection (see “In an embodiment of the present disclosure, the one or more hardware processors 104, are configured to determine, at step 202, one or more viable sensors to detect a pathogen corresponding to a condition or a disease under observation. The disease under observation may be COVID-19, SARS, MERS, and the like.” in para. [0044]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Lewis’s diagnosing the infection with infectious disease to diagnosing the infection with infectious disease that is new coronavirus infection and diagnosing a risk of exacerbation of the new coronavirus infection, as taught by Indani, in order to allow for the detection of an additional pathogen. Furthermore, Lewis and Indani are in the same field of endeavor and are analogous art (see “In yet another aspect, the present invention provides methods for detecting or diagnosing, for example, infections, lung cancer, oral infections and halitosis using a breath sample of a mammal. Preferably, the mammal is a human being. In other embodiments, the present invention provides methods for other medical applications, such as those involving the detection of marker gas(es) in mammalian breath as well as odors from potentially infected areas of the skin.” in para. [0018]; and see “The disclosure herein generally relates to detecting pathogens, and, more particularly, to detecting pathogens from a gaseous mixture associated with secretions.” in Indani, para. [0002]).
As to Claim 8, Lewis teaches the following:
wherein the infectious diseases is pneumonia due to the infection (see “wherein said analyte is a member selected from the group consisting of … viruses …” in claim 18; and see “Thus, the present invention provides a method for the detection of pneumonia, the method comprising: contacting an array of sensors with mammalian breath suspected of containing a marker gases indicative of pneumonia; and detecting the marker gas to determine the presence of pneumonia.” in para. [0069]).
As to Claim 10, Lewis teaches the following:
The diagnostic method according to claim 8,
wherein the sulfur metabolite is sulfite ions (HSO₃) (see “dimethyl sulfide” in list of “METABOLIC PRODUCTS OR OFF-GASSES” in Table 3).
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 01/16/2026