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, 2, 4-10, 18, 30, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a method of detecting inhibitors of cytochrome P450 (CYP450). This judicial exception is not integrated into a practical application because the claims provide for an abstract idea, and do not provide for any steps that tell the artisan how to apply the abstract idea in a meaningful manner.
The independent claim is drawn to a method of detecting inhibitors of the enzyme class CYP450, by exposing the enzyme to a potential inhibitor, providing a substrate for the enzyme, and detecting a signal provided by measurement of the enzymatic substrate or product. There are no claims drawn to methods of instructing the artisan what to do with the acquired data. Based upon the claims, there are several active steps, followed by a mental process of observing. See MPEP 2106.04(a). In order to fully analyze the claims under 35 USC 101, the Applicant is directed to MPEP 2106, especially the flow chart provided in section III.
The first step of the flow chart asks if the claims are drawn to a statutory category. Since the claims are drawn to a method, the claims disclose one of the described statutory categories. Step 2A asks if the claims are directed to an abstract idea. Based upon an analysis of this step, there are 2 active steps of applying inhibitor, and a substrate to the claimed enzyme, and there are 2 “mental steps” of observing the resultant reaction. Since the 2 mental steps are considered abstract ideas (see MPEP 2106.04(a)) the 2 active steps must be analyzed to determine if they comprise steps that the artisan would consider well-understood, routine, and conventional activities. See MPEP 2106.05(d). Given a broad analysis, the active steps are merely applying a test compound to an enzyme, applying a known substrate for the described enzyme, and observing if the substrate is consumed or the product is formed; based upon the rate of substrate consumption, and/or product production, the ordinary artisan can calculate whether the test compound provides inhibitory activity to the enzyme. Given this broad analysis, the claimed method is a routine method for determining if a compound acts as an inhibitor to a compound. See, for example, Matsui, et al (PGPub 2004/0106216) who provides for these broadly described steps in the first claim of the application. Additionally, Matsui shows that the claimed method, using the claimed enzyme should also be considered routine. See paragraph [0002] [0087] and claim 1. Notably, Matsui explicitly shows using the same substrates to the CYP450 enzymes. See paragraph [0089]. When considering other prior art, it was found that Tureinen, et al (European Journal of Pharmaceutical Sciences, 29, 130-138, 2006) provides for 3 independent CYP450 inhibition screening tests, wherein each test generally provides for overlapping steps as those claimed; this further suggests that the claimed active steps should be considered well-understood, routine, and conventional. See page 130, “Abstract” section; page 132 and 133, “Materials and Methods” section.
Since it is established that the claims comprise well-understood, routine, and conventional steps, followed by an abstract idea, step 2B asks if there are additional elements that provide for significantly more than the judicial exception. Since there are no steps that follow the determination step, the claims cannot be considered eligible under 35 USC 101. The listed dependent claims list specific CYP450 enzymes, specific substrates, and specific detection means; none of these dependent claims provide for significantly more than the judicial exception.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claim(s) 1, 2, 4-10, 18, 30, 31, 36, 38, 41-44 and 47 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Matsui, et al (PGPub 2004/0106216). Matsui provides an applied example that reads upon the claimed method. Specifically, Matsui contacts a CYP450 with the potential inhibitor α-naphthoflavone, and the substrate testosterone. Matsui incubates the reaction mixture, then uses optical methods to detect the level of inhibition. See paragraph [0122]. Although it does not appear as though α-naphthoflavone is a “drug,” it is unclear if this compound fulfills the claimed group of chemical compounds. If this compound fulfills the claimed classifications, then the claims are anticipated. However, if there is evidence to suggest that the α-naphthoflavone of Matsui is not one of the claimed compounds, there is nothing non-obvious about applying other test compounds to CYP450, in order to determine their respective inhibitor power. As such, the claims can either be considered anticipated by Matsui, or obvious over Matsui, based upon the fact that this would be a simple substitution, and obvious to try. See MPEP 2143(I).
With respect to claim 1, as discussed above, Matsui teaches the claimed method. If α-naphthoflavone is one of the claimed chemical compound classes, then the claims must be anticipated. If it is shown that α-naphthoflavone is not one of the claimed classes, it would be reasonable to suggest that the ordinary artisan would find it obvious to try any compound that could possibly inhibit CYP450, since there is no limitation on what types of compounds can be tested as possible inhibitors.
With respect to claim 2, α-naphthoflavone does not appear to be a pesticide.
With respect to claim 4, as discussed above, Matsui uses optical methods in the applied example, but also teaches other methods of detection. See paragraph [0093] [0122].
With respect to claim 5, Matsui indicates that products can be determined using known methods of detection and determination. See paragraph [0093].
With respect to claim 6, Matsui teaches many of the claimed substrates, including fluorescein, coumarin, testosterone and progesterone. See paragraph [0104].
With respect to claims 7 and 31, Matsui teaches the same fluorescein and coumarin derivatives. See paragraph [0104].
With respect to claims 8-10 and 30, Matsui teaches all of the same CYP450 enzymes. See paragraph [0087]. Even if Matsui does not list all of the claimed enzymes, there is nothing non-obvious about applying Matsui’s method to any known cytochrome enzyme.
With respect to claim 18, it is unclear if α-naphthoflavone is a “marine toxin.” However, Matsui provides no limitation of the type of chemical substance used, and as such, there is nothing non-obvious about determining the inhibitory action of “marine toxins” on CYP450 activity. This is highlighted by the fact that Matsui notes that CYP450 is used, biologically, to metabolize toxins, and as such, it would be obvious to determine any toxins activity. See paragraph [0005].
With respect to claim 36, Matsui provides no limitations on the location from where the test sample is acquired.
With respect to claim 38, in the above-cited applied example, Matsui teaches all of the claimed components, including the enzyme, a substrate, a buffer within the claimed pH range, and a signal detector. See paragraph [0122].
With respect to claim 41, as discussed above, Matsui uses testosterone in the applied example, but also teaches all of the other substrates. See paragraph [0104].
With respect to claims 42-44, Matsui teaches all of the same CYP450 enzymes. See paragraph [0087].
With respect to claim 48, Matsui explicitly teaches the inclusion of a NADPH regeneration system. See paragraph [0107].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651