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 § 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.
Claims 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The definition in Claim 1 of "for use in increasing glutathione levels in the brain” is vague and unclear since this merely seems to define an inherent suitability of the composition to achieve a vague mode of action.
Claim 1 recites "a compound that is a substrate or substrate precursor for glutathione synthesis", but it is unclear what kind of compound it is. The same applies to "a compound that targets the regulation of the antioxidant expression level of glutathione by targeting the regulation of Nrf2 dependence" and "a compound that further enhances the antioxidant effect of glutathione".
The definition of "functional derivatives" in Claim 3 and 5 is considered to be vague and unclear. This definition fails to define a commonly agreed group of therapeutic compounds known to one of skill in this art. There is also no indication of which function having to be maintained and no test with test criteria to enable of skill in the art to identify further compounds for the claimed function. There is also no clear disclosure in the application as a whole of any functional derivatives such as glycine/N-acetylcysteine/taurine/ergothioneine. The definition of a "derivative" seems to imply that the products of an undefined chemical modification process is encompassed within the scope of the claims. Without, however any definition of the nature of the chemical modification process and no further characterization of the nature of the derivatives, the identity of the derivatives cannot be determined.
With regard to the definition in Claim 12 of "dietary recommendations ... etc.", it is considered that this feature relates only to the presentation of information and is considered to be vague and unclear.
With regard to the definition in Claim 13 of "lifestyle recommendations ... etc.", it is considered that this feature relates only to the presentation of information and is considered to be vague and unclear.
The definition in Claims 14 to 16 of use of the composition "in healthy individuals in need of increasing ... etc." also appears inconsistent and unclear. In this regard, the definition of healthy individuals is not regarded as wholly consistent with the definition that they are in need of for example increasing motor performance. This would suggest that these claims also encompass therapeutic treatment because in general individuals in need of increasing, for example motor performance (or cognitive/motivation/mental energy) would at least include individuals with motor impairment.
The definition in Claims 6 to 10, 12-13, 18 and 19 of compositions for use in a method of treatment "to decrease performance anxiety'' and to decrease "stress" appear unclear because these claims again appear to be drafted in the format of medical indication claims but do not seem to be limited to the treatment of medical disorders since ''performance anxiety" and "stress" may be included within the spectrum of normal (non-pathological) reactions in healthy patients and are not limited to therapeutic treatments wherein disorders are identified. Treatment of "stress" (see Claim 19) also appears particularly vague in so far as any condition adverse to the functioning/well-being of an organism may be regarded as stress.
In so far as particular medical indications are defined in the claim 20 such as increasing motivational performance and/or mental energy and/or motor performance/performance anxiety/decreasing stress, it is noted that these definitions do not seem to define particular well-defined disorders but merely vague desiderata (e.g. increasing motivational performance/metal energy) which have no objective determination or clinical parameters that may be diagnostic of further disorders (e.g. cognitive/motor performance). These desiderata/parameters have not apparently been experimentally demonstrated in the application and it is not clear how far these definitions would overlap with previous treatment of psychological disorders such as for example treatment of depression, schizophrenia or neurodegenerative disorders which would generally, be expected to have symptoms largely overlapping with the claimed indications.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The present invention is to provide a composition and a method for enhancing glutathione concentration in the brain (paragraph [0008]). Here, in the examples of the description of the present application, it is specifically shown that the above-mentioned problem can be solved only when a small part of the compounds is used with respect to the compounds (I) - (iii), and it is not shown at all whether or not the above-mentioned problem can be solved when the compounds (I) - (iii) other than the compounds are used.
Then, it is common knowledge at the time of filing the present application that if the structure of the compound is different, the activity shown by the compound is also
different, and considering that the description of the present application describes
only the activity when some compounds are used, it is recognized that it is necessary
to use a specific compound for enhancing glutathione concentration in the brain.
Thus, even if the activity when a small part of the compound is used is shown, it is not recognized that it can be generalized to the scope of the invention according to the
claim 1-13, 18-19, and it cannot be said that a person skilled in the art can recognize that the invention of the present application can solve the above-mentioned problem.
Therefore, the invention according to the claims 1-13, 18 and 19 is not described in the detailed description of the invention.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by Sahley (US Pat. 5,681,578 (hereafter US’578) or Tech (US Pub. 2009/0017047, hereafter USPub’047) or Handelmann et al. or Chigurupati et al. (US Pub. 2016/0191468, hereafter USPub’478) or WO 2016/191468 (hereafter WO’468) or Landes et al (US Pub. 2012/0141611, hereafter USPub’611) or Bennett et al. (US Pub. 2014/0170211, hereafter USPub’211) or Wyzisk et al. (US Pub. 2014/0348795, hereafter USPub’795).
Claims 1-3,7-20
US’578/ USPub’047 disclose glycine in the context of treating stress (see abstract
and §0001 in 01 and abstract, column 1 line 58 to column 2 line 2 in 02).
Handelmann et al. discloses that a glycine prodrug (milacemide) improved cognition in an animal model (see abstract) and improved attention (see discussion)
which could be considered as equating to mental energy. Milacemide could apparently be considered as a "functional derivative" within the vague definition of Claim 3.
USPub’478 discloses a beverage composition for treating stress and
cognitive deficits which may contain substances such as glutathione, taurine
and glycine (see §0002, §0054, §0061, §0123, §0213).
USPub’211 discloses glycine/N-acetyl cysteine/taurine to treat traumatic brain
injury and in particular cognitive impairment/anxiety/motivation by limiting oxidative stress (see abstract, §0008, §0009, §0030, §0056, §0046, §0067, §0081, §0096, §0117, §0123, §0141). N-acetyl cysteine is disclosed as an antioxidant precursor to glutathione (see §0045).
USPub’795 discloses a nutraceutical composition comprising glycine for treating cognitive dysfunction and anxiety by increasing glutathione levels (see abstract, §0009, §0010, §0013, Claims 1, 11).
As far as can presently be determined it appears that glycine for use in treating the therapeutic conditions or having the defined non-therapeutic effects defined in the claims is known in view of the each of the disclosures listed supra.
Claim 5
USPub’611 discloses a composition containing L-ergothioneine as an antioxidant for brain health in particular in reducing oxidative stress (see §0003, §0008)
Claim 6
WO’468 discloses compositions comprising glycine and n-acetylcysteine for improving cognition and treating stress via an improvement in glutathione levels (see §0007, §0010, §0018, §0021, Example 10).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH D CARR whose telephone number is (571)272-0637. The examiner can normally be reached Monday-Friday (10:30 am -7:00 pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 572-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEBORAH D CARR/Primary Examiner, Art Unit 1691