DETAILED ACTION
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 Claims
Claims 1-8 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 7, line 1, recites the limitation “the supplement composition”. There is insufficient antecedent basis for this limitation in the claim. Applicant is required to amend the claim so as to provide proper antecedent basis for this language in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of U.S. Patent No 11,344,585 B2 (referred to as the ‘585 patent).
Claims 1-10 of the ‘585 patent recite a method for treating Autism Spectrum Disorder (ASD) or for reducing the likelihood of a subject developing ASD in a subject in need thereof, the method comprising: a) diagnosing the subject with ASD, or, if the subject is a fetus of a pregnant woman, testing the pregnant woman for ASD, b) if ASD is diagnosed, treating the subject and/or the pregnant woman with an antibiotic agent or an antiviral agent, and c) further treating the subject and/or the pregnant woman with a supplement composition comprising therapeutically effective amounts of: (i) L-lysine, (ii) Elderberry extract (an antioxidant and an anti-inflammatory), (iii) olive leaf extract (an antioxidant), (iv) Astragalus root extract, and (v) Bacillus coagulans GBI-30 probiotic (BC30) (an anti-inflammatory). The subject is a child aged 16 years or younger. The subject or the pregnant woman is infected with a herpes family virus (testing the subject for risk markers of ASD, and one or more of the risk markers is detected). The antiviral agent is valacyclovir or ganciclovir. The supplement composition is delivered orally to the subject or the pregnant woman in the form of a chocolate bar, a gummy candy or a jelly candy. The subject is diagnosed with ASD. The subject was diagnosed with ASD and the method further comprises, after administering the antiviral or antibacterial agent, and the supplement composition, assessing the subject for improvement of the ASD.
Claims 1-8 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No 12,150,966 B2 (referred to as the ‘966 patent) in view of Cai et al (N A J Med Sci. 2015;8(1):20-30.) and Zhang (Journal of Traditional Chinese Medicine. 2010;30(1):53-59.).
Claims 1-8 of the ‘966 patent recite a method for reducing the likelihood of a subject developing Autism Spectrum Disorder (ASD), the method comprising: a) testing the subject for risk markers of ASD, or, if the subject is a fetus of a pregnant woman, testing the pregnant woman for the risk markers; b) if one or more of the risk markers is detected, treating the subject and/or the pregnant woman with a therapeutically-effective amount of a composition comprising an antibiotic, an antiviral, an anti-inflammatory compound, an anti-oxidant, a probiotic, an immunomodulatory compound and/or folate; c) further treating the subject, or the pregnant woman, by administering to the subject or pregnant woman, a therapeutically-effective amount of a composition comprising Bacillus coagulans GBI-30 probiotic (BC30) (an anti-inflammatory); and (d) further treating the subject, or the pregnant woman, by administering to the subject or pregnant woman, a therapeutically-effective amount of a composition comprising one or more components from the group consisting of: (i) Elderberry extract (an antioxidant and an anti-inflammatory), (ii) olive leaf extract (an antioxidant), and (iii) L-lysine; wherein the method further comprises testing the subject to assess behavioral performance following treatment steps (b), (c) and (d). The risk marker is selected from genetic markers, family history, pathogenic infections, immune system responses to a pathogenic infection, and signs of poor immune health. The subject is a child aged 16 years or younger. The subject or the pregnant woman has previously contracted an infection, currently has an infection, or is known to have been exposed to one or more infectious agents. The subject or the pregnant woman is infected with one or more of cytomegalovirus, Epstein-Barr virus, rubella virus, measles virus, herpes simplex type 1 or 2, herpes zoster, other herpes family viruses, or any other chronic, congenital, persistent, latent, dormant, acute and/or subacute viral infection. The antiviral agent is valacyclovir or ganciclovir. The supplement composition is delivered orally to the subject or the pregnant woman in the form of a chocolate bar, a gummy candy or a jelly candy. The method further comprising, prior to treating the subject, diagnosing the subject with ASD.
The ‘966 patent does not teach the method for treating a subject with ASD comprises Astragalus root extract (claim 1).
However, it was well-known in the art that Astragalus root extract is used for the treatment of ASD. In support, Cai teaches Radix astragali is frequently used to treat ASD symptoms (Table 1), and Zhang teaches Radix Astragali Mongolici is included in treatments for ASD (p.55 col right – para 5, p.56 col left – para 5).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate Astragalus root extract, since the ‘966 patent discloses a method for treating a subject with ASD, and Cai and Zhang both disclose that Astragalus root extract is used to treat ASD. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references and routine practice to incorporate Astragalus root extract with a reasonable expectation for successfully treating a subject with ASD.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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