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 .
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.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Specifically, claim 1 recites “characterizing the patient as having an increased risk of having or developing pulmonary exacerbations if the level of one or more metabolites associated with pulmonary exacerbation are significantly different from a control value” and claim 7 recites “ comparing the level of one or more metabolites associated with pulmonary exacerbations to a control value, and characterizing the patient as responding well to treatment if the level of one or more metabolites associated with pulmonary exacerbations has a value closer to the control value”. Both of these recitations have been interpreted as an abstract idea.
This judicial exception is not integrated into a practical application because each of these recitations simply compare a measured biomarker value (i.e. a metabolite value) to a control value in order to characterize the patient as having an increased risk of developing pulmonary exacerbation.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because besides the above recitations, since claims 1 and 7 just recite “determining the level of one or more metabolites..” which is interpreted as mere data gathering and it is noted that data gathering to be used in the abstract idea is insignificant extrasolution activity, and not a particular practical application. See MPEP 2106.05(g).
Furthermore, the examiner notes that office policy (per the July 2015 Interim Eligibility Guidance with regards to USC 101 rejections) states that abstracts ideas may be ideas themselves and that one specific example of an abstract idea is the idea of comparing new and stored information (such comparing the measured levels at least one biomarker, like IL-18, IL-18BP, CD161+, etc.) and using rules to identify whether or not the level of the at least biomarkers indicative of a patient/subject having a toxic and/or dysfunctional response to an immunomodulatory treatment.
In addition, the examiner notes that following the procedure outlined in Mayo
Collab. Svcs. v. Prometheus Labs (SCOTUS) 101 USPQ2d 1961, 132 S. Ct. 1289 (2012) that claims 1 and 7 (and therefore their dependent claims as well) would be ineligible since in step 1 it is noted that the claims are directed towards one of the statutory categories (i.e. “ a method of determining if a patient having cystic fibrosis has an increased risk…” in claim 1 and “a method of evaluating the response of a patient with cystic fibrosis having pulmonary exacerbation” in claim 7), while in step 2a it is noted that the claim is directed to a judicial exception (an abstract idea, as described above as the comparing/characterizing step) and in step 2b it is noted that the claims do not recite additional elements that amount to significantly more than the judicial exception since the additional measuring (i.e. determining levels) steps are simply mere data gathering steps.
Therefore claims 1-13 are ineligible.
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.
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.
Claim(s) 1-4 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Britz-McKibbin et al (US PGPub 2017/0199203) in view of Sin et al (US PGPub 2019/0383830).
Regarding Claim 1, Britz-McKibbin et al teaches a method of determining if a patient having cystic fibrosis has disease progression (see [0012] and [0053]), comprising:
determining the level of one or more metabolites associated with cystic fibrosis disease progression in a sweat sample from the patient (see [0049] and [0057]), and characterizing the patient as having an increased risk of cystic fibrosis progression if the level of one or more metabolites associated with disease progression are significantly different from a control value (see [0035], [0043]-[0045], [0049] and [0053]).
Britz-McKibbin et al does not explicitly disclose that cystic fibrosis disease progression incorporates pulmonary exacerbations.
However, in the analogous art of compositions and methods for diagnosing acute exacerbations of chronic obstructive pulmonary disease (AECOPD), Sin et al teaches the use of metabolite biomarker panels to diagnose pulmonary exacerbations associated with cystic fibrosis (see [0131], [0271] and [0291]). Accordingly, it would have been obvious to one of ordinary skill in the art that pulmonary exacerbation could be used as indicators of cystic fibrosis disease progression since its known that periodic worsening of cystic fibrosis systems include pulmonary exacerbations (see [0003] and [0270]).
Regarding Claims 2 and 8, the combination of Britz-McKibbin et al and Sin et al teaches obtaining a sweat sample from the patient (see [0049] and [0057] of Britz-McKibbin et al).
Regarding Claims 3 and 9, the combination of Britz-McKibbin et al and Sin et al teaches that the sweat sample is obtained using a skin patch (see [0057], [0069] and [0092] of Britz-McKibbin et al).
Regarding Claims 4 and 10, the combination of Britz-McKibbin et al and Sin et al teaches the level of the one or more metabolites is determined using high performance liquid chromatography (see [0038] of Britz-McKibbin et al).
Regarding Claim 7, Britz-McKibbin et al teaches a method of evaluating the response of a patient with cystic fibrosis having disease progressions to treatment (see [0012] and [0053]), comprising:
determining the level of one or more metabolites associated with cystic fibrosis disease progression in a sweat sample from the patient (see [0049] and [0057]), and characterizing the patient as having as responding well to treatment if the level of one or more metabolites associated with disease progression has a value closer to the control value. (see [0035], [0043]-[0045], [0049] and [0053]).
Britz-McKibbin et al does not explicitly disclose that cystic fibrosis disease progression incorporates pulmonary exacerbations.
However, in the analogous art of compositions and methods for diagnosing acute exacerbations of chronic obstructive pulmonary disease (AECOPD), Sin et al teaches the use of metabolite biomarker panels to diagnose pulmonary exacerbations associated with cystic fibrosis (see [0131], [0271] and [0291]). Accordingly, it would have been obvious to one of ordinary skill in the art that pulmonary exacerbation could be used as indicators of cystic fibrosis disease progression since its known that periodic worsening of cystic fibrosis systems include pulmonary exacerbations (see [0003] and [0270]).
Claim(s) 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Britz-McKibbin et al and Sin et al as applied to claims 1 and 7 above, and further in view of Phan et al (“"Capturing actively produced microbial volatile organic compounds from human associated samples with vacuum assisted sorbent extraction" ).
Regarding Claims 5 and 11, the combination of Britz-McKibbin et al and Sin et al does not explicitly disclose that the metabolites associated with pulmonary exacerbations are selected from the group consisting of thymidine, N-acetyl tyrosine, 2- piperidinone, and adipate C6-DC.
However, in the analogous art of measuring volatile organic compounds as biomarkers related to pulmonary exacerbations, Phan teaches that patients having cystic fibrosis also have the volatile metabolite 2- piperidinone in sputum samples (pg 4, para 2, In 138-140 "We implemented the strategy for identifying actively produced volatiles with sputum samples from seven human subjects with cystic fibrosis. We compared the volatiles in the sample with those that emerged from samples cultured with a stable isotope label.", pg 4, para 3, In 171-172 "there were volatiles also detected as unlabeled from the same cultured sputum (Figure S4). Volatiles 2-piperidinone; benzaldehyde quantification of the seven subjects is shown in Fig. S4). Therefore, since Phan teaches that 2-piperidinone is a volatile metabolite associated with pulmonary secretions in cystic fibrosis patients, it would have been obvious to an artisan of ordinary skill in the art to experiment with detecting the volatile metabolite in sweat, to provide another pulmonary biomarker to the method of McMaster, thus improving the predictive power of the method.
Claim(s) 6, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Britz-McKibbin et al and Sin et al as applied to claims 1 and 7 above, and further in view of Barash et al (US PGPub 2003/0036505).
Regarding Claims 6 and 12, the combination of Britz-McKibbin et al and Sin et al does not explicitly disclose that the metabolites associated with pulmonary exacerbations comprise thymidine.
However, in the analogous art of gene sequencing relating to treatment of genetic disease (such as cystic fibrosis), Barash et al teaches a method of screening compounds to identify those which modulate the action of the polypeptide of the present invention. For example, a control assay may be performed in the absence of the compound to be screened and compared to the amount of fibroblast proliferation in the presence of the compound to determine if the compound stimulates proliferation by determining the uptake of .sup.3[H] thymidine in each case. The amount of fibroblast cell proliferation is measured by liquid scintillation chromatography which measures the incorporation of .sup.3[H] thymidine (see [0705]). It would have been obvious to one of ordinary skill in the art to utilize thymidine as the metabolite screened (as taught by Barash et al) for the benefit of enabling determination of fibroblast proliferation.
Regarding Claim 13, the combination of Britz-McKibbin et al, Sin et al and Barash et al teaches that the treatment is antibiotic treatment (see [0035] and [0051] of Britz-McKibbin et al).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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, 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.
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.
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
Prosecution Insights