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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Claims 2-5 are pending in the application.
Claim Rejections - 35 USC § 112
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 2-5 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 nature of the instant invention has claims which are an oral composition comprising histidine betaine. The oral compositions of the instant invention additionally comprise a preservative in additional to the active ingredient histidine betaine. Preservative is not defined within the specification with respect to the oral composition claimed herein. Preservative in pharmaceuticals is defined as a “natural or synthetic chemical that is added to products such as foods, pharmaceuticals, paints, biological samples, wood, etc. to prevent decomposition by microbial growth or by undesirable chemical changes” and as “substances that are commonly added to various foods and pharmaceutical products in order to prolong their shelf life” Shitole et al. Millipore Sigma states that “a variety of preservatives can be used in therapeutic applications such as topical, oral, transmucosal, inhalation, and otic, as well as injectables” and that they “help to increase the shelf life of products and prevent microbial growth”. The applicant’s specification states that benzalkonium chloride, benzyl alcohol, phenol, urea, parabens, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), tocopherol, thimerosal, chlorobutanol, or the like can be used in topical formulations, however, there is no indication what preservatives are employed in oral formulations. Millipore Sigma attached herewith compares several preservatives, i.e. benzalkonium chloride, benzyl alcohol, parabens, benzoic acid and sodium benzoate and their use in different types of application. For example, benzalkonium chloride can be used in inhalations, nasal, ophthalmic, otic, parenteral, topical and transdermal but is not considered in oral formulations. Millipore Sigma further states that it is incompatible with histidine unless the API is acidic. Benzyl alcohol can be used in nasal, oral, otic, parenteral, rectal, topical & transdermal and vaginal. Methylparaben and propylparaben can be used in inhalation, injection, nasal, ophthalmic, oral, oromucosal, otic, rectal, topical & transdermal and vaginal. Benzoic acid can be used in oral, oromucosal, parenteral, rectal, topical & transdermal and vaginal. Sodium benzoate can be used in oral, oromucosal, parenteral, rectal, topical & transdermal. The most common preservatives known for use in oral compositions are methylparaben, propylparaben, sodium benzoate and potassium sorbate. Each of which are neither supported nor contemplated by the instant application.
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 3-5 are 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. The following reasons apply:
Claims 3-5 are substantial duplicates of claim 2, as the only difference is a statement of intended use, which does not limit the scope of the claim under the broadest reasonable interpretation and therefore is not given material weight. Note In re Tuominen 671 F.2d 1359, 1360, 213 USPQ 89, 90 (C.C.P.A. 1982).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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