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 .
Status of the Application
Claims 1-31 are pending. During a telephone conversation with Mr. Eric Balicky on 9/16/25 a provisional election was made without traverse to prosecute the invention of Group II, drawn to a method of treating depression by administering a dopamine D4 and 5-HT2A receptor antagonist, reverse agonist, or partial agonist, and the species, pipamperone. Affirmation of this election must be made by applicant in replying to this Office action. Claims 5-6, 22 have withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 1-4, 7-21, 23-31 are examined herein insofar as it reads on the elected invention and species.
Claim Objections
Claim 19 is objected to because of the following informalities: In the phrase “with a an effective amount of a dopamine D4 and 5-HT2A receptor antagonist” please delete the unnecessary “a”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112(b):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 8-10, 30-31 are rejected under 35 U.S.C. 112(b) or 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Regarding claims 3, 8-10, 30-31, the phrases "preferably" and “e.g.” renders the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 1-4, 7-12, 15-19, 23-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buntinx (EP 1 541 197, of record).
Buntinx teaches the use of the D4 and 5-HT2A receptor antagonist, pipamperone, (paragraphs 0010-0011) for treating a mood or anxiety disorder, wherein 5-15 mg of pipamperone is administered simultaneously, separate, or sequentially to augment the therapeutic effect with a second active agent selected from an SNDRI, SNRI, or SSRI (paragraph 0012), for example the SSRI, citalopram or escitalopram (paragraphs 0031-0034). For example, pipamperone can be administered 1-12 months before administration of the second active agent (paragraph 0085). An example of a mood disorder is depression, which are commonly treated with SSRIs. However, these compounds can give rise to side effects. Moreover, a substantial problem is the non-response to SSRIs or delayed therapeutic effect (paragraph 0048). It was found that this non-response to SSRIs in depression may be declared by partial inhibition of the 5-HT2A stimulation, therefore 5-HT2A antagonism appears to be the answer (paragraph 0050). Examples 2-3, 6 and Figures 3-11 shows the effect of pipamperon as an add-on treatment in comparison to using SSRIs or SNRI in treating major depression for 8 weeks. Some side effects include central and peripheral nervous system, gastrointestinal, musculoskeletal, psychiatric, respiratory, skin and appendages, vascular, and urinary in nature (paragraph 0157). Specifically, Figures 3 and 6 show remission rates form the combo treatment for major depression (paragraph 0129). The term “treatment” or “treating” encompasses prevention or recurrence or relapse-prevention of the disease or symptoms associated therewith (paragraph 0074). In Example 6, the Hamilton Depression Rating Scale score was reduced by at least 20% more than reached with conventional known antidepressants as well as preventing significantly more relapses during 48 weeks following treatment (paragraphs 0184). Tables 3 and 4 show an active controlled randomized relapse prevention study for 36 weeks, where the active mono and combo therapy was continued (paragraph 0185).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 13-14, 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Buntinx (EP 1 541 197, of record), as applied to claims 1-4, 7-12, 15-19, 23-31, in view of Papaetropoulos et al. (“The effect of depression on motor function and disease severity of Parkinson’s disease,” Clinical Neurology and Neurosurgery, 2006, 108, 465-469) and Pan et al. (“Bidirectional Association Between Depression and Metabolic Syndrome,” Diabetes Care, 2012, 35, 1171-1180).
The instant claims are directed to a method for treating a subject with depression by administering a dopamine D4 and 5HT2A receptor antagonist, reverse agonist, or partial agonist, wherein the subject is partially responsive to antidepressant therapy.
Buntinx teaches as discussed above, however, fail to disclose wherein the side effects comprise motor symptoms or metabolic syndrome.
Papaetropoulos et al. teach that depression can have a profound negative impact on a patient’s motor functioning (abstract).
Pan et al. teach the bidirectional association between depression and metabolic syndrome (abstract).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have selected a subject with the side effects, motor symptoms and metabolic syndrome, as taught by Papaetropoulos and Pan et al., in the method of treating depression by administering pipamperone, as taught by Buntinx.
A person of ordinary skill in the art would have been motivated to select a subject having the side effects, motor symptoms and metabolic syndrome, because Papaetropoulos and Pan et al. teach that subjects suffering from depression have a high likelihood of also having motor symptoms and metabolic syndrome. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating depression in a subject with motor symptoms and metabolic syndrome by administering pipamperone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623