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
Claims 1-5 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 “ measuring the expression level of the mRNA or protein of one or more genes selected from the group consisting of Orai1, TRPC3, and TRPC6 in a biological sample isolated from a subject”, which just details measuring the information without limits to or structures doing the measurement, wherein these measurement could be performed by a reviewer looking at a chart or report, which constitutes a mental process.
Furthermore, claim 1 has no other steps as well as a preamble with no extra helpful information so no practical application. In addition, all that is being measured are gene (Orai1, TRPC3, and TRPC6) expression levels, which are natural compounds.
In addition, claim 3 recites “judging whether the candidate material increases or decreases the expression of the mRNA or protein of one or more genes selected from the group consisting of Orai1, TRPC3, and TRPC6 in skeletal muscle cells”, which constitutes an abstract idea.
This judicial exception is not integrated into a practical application, and does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements are “treating a biological sample”, which is well known in the known art (as shown below in the art rejections below).
Furthermore, in claim 3, all that is being measured are gene (Orai1, TRPC3, and TRPC6) expression levels, which are natural compounds and wherein this measurement is being viewed as mere data gathering.
Furthermore, the above described judicial exceptions (i.e. natural phenomenon/compounds and abstract ideas) are not integrated into a practical application because these limitations recite abstract ideas (i.e. invoke a judicial exception) and this judicial exception is not integrated into a practical application because the above cited limitations are both directed to an abstract idea, which could be performed by a mental step or with the use of a black box computer.
Furthermore, 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).
In addition, 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 of TRPC3, TRPC6 or Orai1) and using rules to identify options (such as providing a screening result or providing information for diagnosis of limb-girdle muscular dystrophy type 2H).
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 3 (and therefore their dependent claims as well) would be ineligible since in step 1 it is noted even if the claims are directed towards one of the statutory categories (i.e. a methods of providing information for diagnosis or screening a drug for treatment), while in step 2a it is noted that the claim is directed to a judicial exception (an abstract idea, as described above as the comparison step in claim 3) 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 step is simply a mere data gathering step.
Therefore claims 1-5 are ineligible.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 AND 2 are rejected under 35 U.S.C. 102(a)(10 as being anticipated by Choi et al (“Tripartite motif-containing protein 32 regulates Ca21 movement in skeletal Muscle”).
Regarding Claim 1, Choi et al teaches a method of providing information for the diagnosis of limb-girdle muscular dystrophy type 2H (see abstract and introduction section), comprising:
measuring the expression level of the mRNA or protein of one or more genes selected from the group consisting of Orai1, TRPC3, and TRPC6 in a biological sample isolated from a subject (see p. 1861-1863).
Regarding Claim 2, Choi et al teaches judging that the subject has developed limb-girdle muscular dystrophy type 2H or is at high risk of developing limb-girdle muscular dystrophy type 2H when the expression level of Orai1 and/or TRPC3 either increases or decreases compared to the expression level in the normal control sample (see p. 1865 and 1867).
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) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lorinthu et al (WO 2024161042 A1) in view of Choi et al (“Tripartite motif-containing protein 32 regulates Ca21 movement in skeletal Muscle”).
Regarding Claims 3-5, Lorinthu et al teaches a method of screening a drug for the treatment of a muscular disorder(see abstract and page 18, line 26 – page 19, line 10) , comprising:
treating a biological sample, which is isolated from a subject suspected of having a muscular dystrophy disorder, with a candidate material (i.e. a treatment) (see abstract and page 8, lines 11-14), and
judging whether the candidate material (the treatment) increases or decreases the expression of the mRNA or protein of one or more genes selected from the group consisting of Orai1, TRPC3, or TRPC6 in skeletal muscle cells (see page 8, lines 27-31 and pages 42-43).
However, Lorinthu et al does not explicitly disclose that the muscular disorder is limb-girdle muscular dystrophy type 2H, and that this type of muscular dystrophy is diagnosed by measuring Orai1, TRPC3, and TRPC6.
However, in the analogous art of diagnosis of LGMD2H, Choi et al teaches measuring the expression levels of Orai1, TRPC6 OR TRPC3, wherein “The expression levels of seven proteins that mediate SOCE in skeletal muscle were examined
by immunoblot assays using myotube lysates (Fig. 5B). Interestingly, there were significantly different patterns in the expression levels of the proteins between WT TRIM32 and NHL-Del. TRPC3 and TRPC6 expression was greater with WT
TRIM32 than with the vector control, and Orai1 and TRPC3 expression was significantly lower with NHL-Del than with the vector control or WT TRIM32. TRPC6 expression with
NHL-Del was significantly greater than that with the vector control but significantly lower than that with WT TRIM32”, therefore meaning that increasing or decreasing the levels of Orai1, TRPC6 OR TRPC3 may be used in order to diagnose limb-girdle muscular dystrophy type 2H (see p. 1865 of Choi et al). Therefore, it would have been obvious to one of ordinary skill in the art to utilize the Orai1, TRPC6 OR TRPC3 measurements (disclosed in both Choi et al and Lorinthu et al) for the benefit of diagnosing a patient with LGMD2H, and wherein it would further be obvious to determine the treatment of LGMD2H required based upon these measurements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ma et al (CA 3172425 A) discloses a compound that can be a therapeutic or prophylactic drug for TRPC6-related diseases, such as nephrotic syndrome, membranous nephropathy, acute renal failure, septicemia, chronic renal failure, diabetic nephropathy, pulmonary hypertension, acute lung injury, heart failure, malignant tumor, and muscular dystrophy (see abstract).
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.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
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