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 .
Election/Restrictions
Regarding the restriction requirement, Applicant's election, without traverse, of the invention of Group II in the reply filed on 21 April 2026 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Regarding the election of species requirement, Applicants elected, without traverse, the
following species for examination:
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Applicant is reminded that, upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional corresponding species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following elected claims are generic with respect to the elected species: claims 1 and 6. However, no generic claim has been found allowable. See rejections below.
The election species requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-11 are pending. Claim 4 is withdrawn as being drawn to a non-elected species. Claim 10-11 are withdrawn as being drawn to a non-elected invention.
Priority
The instant application claims priority as follows:
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Information Disclosure Statement
All references from the IDS(s) received 20 Feb 2024 have been considered unless marked with a strikethrough.
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 framework for the objective analysis for determining obviousness under 35 U.S.C. 103 is stated in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Obviousness is a question of law based on underlying factual inquiries. The factual inquiries enunciated by the Supreme Court in Graham are summarized as follows:
(A) Determining the scope and content of the prior art;
(B) Ascertaining the differences between the claimed invention and the prior art; and
(C) Resolving the level of ordinary skill in the pertinent art.
Objective evidence relevant to the issue of obviousness must be evaluated by Office personnel. Id. at 17-18, 148 USPQ at 467. The evidence may be included in the specification as filed, accompany the application on filing, or be provided in a timely manner at some other point during the prosecution. The weight to be given any objective evidence is determined on a case-by-case basis. The mere fact that an applicant has presented evidence does not mean that the evidence is dispositive of the issue of obviousness.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation (TSM) in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
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.
Rejections under 35 USC § 103
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Becker et al. (Neuropsychopharmacol 39, 2049-2060; published 9 April 2014) and Roux et al. (WO-2018096184-A1; published 31 May 2018).
Brief Discussion of the Cited References
Becker et al.
Becker et al. teach: “[w]e reasoned that restoring mGluR4 activity in mutant mice using a positive allosteric modulator (PAM) may relieve behavioral deficits in these animals. We compared efficiency of a chronic treatment (7–17 days; Supplementary Figure S5a) with VU0155041, a mGluR4 PAM (5 mg/kg), or risperidone (0.2 mg/kg) in improving autistic symptoms. Chronic treatment was chosen for better translational value and to match published conditions of risperidone administration in mice (Penagarikano et al, 2011).” See Becker et al. page 2055, column 1. Becker et al. teach that “mGluR4 PAM treatment, when administered to mutant mice, restored neuronal reactivity induced by social exposure in specific brain regions associated with reward and social behavior.” See Becker et al. page 2055, column 1. Becker et al. teach that they “found that chronic treatment with the PAM VU0155041 was more efficient than the antipsychotic risperidone in improving autistic-like symptoms in Oprm1_/_ mice, especially regarding social behavior, without sedative side effects” … “[r]emarkably, VU0155041 treatment in Oprm1_/_ mice normalized immediate early gene expression induced by social exposure in several brain regions processing reward and social recognition, suggesting that facilitation of mGluR4 signaling was able to restore social reward in these animals.” See Becker et al. page 2058, column 1. Becker et al. conclude that “this study substantiates the notion that ASDs could be considered an extreme case of early-onset deficient reward processes and proposes facilitation of mGluR4 receptor activity as a promising novel therapeutic strategy.” See Becker et al. page 2058, column 1.
Roux et al.
“The present invention relates to a novel pharmaceutical use of bromide, i.e. the treatment of autism spectral disorder (ASD).” See Roux et al. at the abstract. Roux et al. that “In particular, bromide will provide improvement in cognitive flexibility, relieving social deficit and or exacerbated anxiety associated with autism.” See Roux et al. at page 7, starting at line 4. Roux et al. teach chronic bromide administration at, for example, each of Figures 1-16 and the legends thereto. Figures 1 and 12 discuss, in particular, sodium bromide injections. Roux et al. teach that “these data indicate that bromide administration was a more efficient treatment than bumetanide in relieving social deficits in our mouse model, suggesting a highly promising therapeutic potential to restore social abilities in patients with ASD.” See Roux et al. at page 30, starting at line 16. Regarding the dosage of bromide to be administered, Roux et al. that “The amount of active ingredients required for use in treatment will vary with the nature of the condition being treated and the age and condition of the patient, and will ultimately be at the discretion of the attendant physician or veterinarian. In general however, doses employed for adult human treatment will typically be in the range of 0.02 to 5000 mg per day, preferably 1 to 1500 mg per day.” See Roux et al. et Page 12, starting at line 5. Roux et al. that “The amount of bromide to be administered to bring about the desired effect must be calculated on the basis of the bromide ion content of the source of bromide e.g. if sodium bromide is being used, the bromide content of the product must be determined. Preferably, the amount of bromide to be administered will typically be from 3.0mg/kg to 100mg/kg, preferably from 6.0mg/kg to 50mg/kg” and that “When calculating an appropriate dosage of bromide, the physician may take into account the patients diet and other drug/supplement therapy.” See Roux et al. at page 12, starting at line 11.
Comparison Between the Claimed Invention and the Prior Art
Relevant to independent claims 1 and 6:
Becker et al. teach, among other aspects of the claimed invention, a method for the treating ASD comprising administering a PAM of mGlu4 receptor.
Roux et al. teach, among other aspects of the claimed invention, a method for the treating ASD comprising administering a bromide salt.
Relevant to claim 2, Roux et al. teach that administration of bromide will provide improvement in cognitive flexibility, relieving social deficit and or exacerbated anxiety associated with autism. See Roux et al. at page 7, starting at line 4. Similarly, Becker et al. teach the treatment with VU0155041 as improving autistic-like symptoms, especially regarding social behavior, without sedative side effects. See Becker et al. page 2058, column 1.
Relevant to claim 3, Roux et al. teach sodium bromide injections. See Roux et al. at, for example, Figures 1 and 12.
Relevant to claims 5 and 7, Becker et al. teach VU0155041, a mGluR4 PAM (5 mg/kg), for treatment in improving autistic symptoms. See Becker et al. page 2055, column 1.
Relevant to claims 8, Roux et al. teach chronic bromide administration at, for example, each of Figures 1-16 and the legends thereto.
Relevant to claims 9, Roux et al. teach that the amount of bromide to be administered will typically be from 3.0mg/kg to 100mg/kg, preferably from 6.0mg/kg to 50mg/kg.” See Roux et al. at page 12, starting at line 11. A claimed numerical range that overlaps with, or is close to, a range disclosed in the prior art is presumed to be prima facie obvious through routine experimentation. MPEP § 2144.05. In the instant case, recited amount (at least 10 mg/kg) either overlaps with, or are close to, ranges disclosed in the prior art.
Differences Between the Claimed Invention and the Prior Art
Becker et al. do not teach administering bromide salts.
Roux et al. do not teach administering a PAM of mGlu4 receptor, such as VU0155041.
Conclusion of Obviousness
At the time of filing, with regard to treating autism spectrum disorder (ASD), it would have been obvious to combine administering sodium bromide and administering VU0155041, as encompassed by claims 1-3 and 5-9.
Under KSR Int'l Co. v. Teleflex Inc., combining known elements (such as a combined treatment with two working medications) is "obvious to try" when there is a reasonable expectation of success. Moreover, combining two known drugs to treat a disease is prima facie obvious if each drug was already known to treat the condition and a person of ordinary skill in the art would expect an additive or predictable result. In re Couvaras, Case No. 22-1489 (Fed. Cir. June 14, 2023). Here, as discussed above, Becker et al. teach the administering VU0155041 in the treatment of ASD, and Roux et al. teach sodium bromide VU0155041 in the treatment of ASD. One of ordinary skill in the art would have had a reasonable expectation of success that combing the treatment taught by Becker et al. with the treatment taught by Roux et al. would result in a treatment effective for treating ASD. Therefore, the claimed invention was obvious at the time of filing.
Conclusion
No claim is currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY S MAYHEW whose telephone number is
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/BSM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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