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 .
Detailed Action
Claim Rejections - 35 USC § 112, indefiniteness
The following is a quotation 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 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 2, 6, 12 and 19-20 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. Claim 2 recites the limitation “such as” which makes the claim indefinite. Regarding claims 2, 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 6 also recites the limitation “preferably” which makes the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 12 recites the limitation “substantially” which makes the claim indefinite. The term “substantially” in claim 12 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 19 recites limitation within parenthesis which is not required as the claim also recites two to five. Claim 20 recites “comprise or consist” which makes the claim indefinite because it is not clear whether the claim is “open-ended” or does not permit any other component. Appropriate correction is requested.
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.
Claims 1-2, 4, 6-7, 10, 12, 17-24 and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Chandrashekhar et al. (USPG Pub. 2020/0188368A1).
Chandrashekhar et al. teaches an aqueous solution (para [0074]. Example 3, ready to use formulation water for injection; this is an aqueous solution) suitable for parenteral injection (para [0017], parenteral formulation) comprising: (1) fosaprepitant (para (0074), Example 3, fosaprepitant dimegiumine) or a pharmaceutically acceptable salt thereof; (2) palonosetron (para [0074], Example 3, palonosetron hydrochloride), or a pharmaceutically acceptable salt thereof; (3) a cyclodextrin (para (0074), Example 3. Hydroxy propyl Beta cyclodextrin): (4) a water-soluble antioxidant (para [0056], contain anti-oxidants monothioglycerol: See instant claim 2, monothioglycerol is a valid antioxidant); and (5) water (para [0074], Example 3, water for injection); wherein the concentration of fosaprepitant in the aqueous solution ranges from about 1.6 mg/ml. to about 16.4 mg/mL (para [0063], concentration of fosaprepitant from about 0.5 mg/ml to 10 mg/ml); the concentration of palonosetron in the aqueous solution ranges from about 1 g/mL. to about ranges 16.7 g/mL (para [0063], concentration of Palonosetron ranges from about 0.0005 mg/ml to 5 mg/ml; equivalent to 5 g/mL to 5000 g/mL); the weight ratio of fosaprepitant to the cyclodextrin ranges from about 1:10 to about 1:255 (para [0073], Example 3, fosaprepitant dimeglumine 1.0 mg/ml Hydroxy propyl beta cyclodextrin 49 06 mg/mL; This is a weight ratio of 1:49); and the pH of the aqueous solution ranges from about 9 to about 12 (para [0051], parenteral formulation having a pH in the range of 4-12), wherein the concentration of fosaprepitant or weight ratio of fosaprepitant to the cyclodextrin is calculated based on equivalent weight to fosaprepitant dimeglumine salt (para [0074]. Example 3, fosaprepitant dimeglumine); and the concentration of palonosetron is calculated based on equivalent weight to palonosetron hydrochloride salt (para [0074], Example 3, palonosetron hydrochloride).
Chandrashekhar et al. does not teach these specific concentrations or ingredients in the same instance nor wherein the aqueous solution comprises water in an amount of greater than 50% by weight, or any ranges.
It would have been obvious to one skilled in art to arrive at this concentration of water in the aqueous solution through routine experimentation. Chandrashekhar et al. teaches wherein the water-soluble antioxidant is a sulfur containing antioxidant, such as an amino acid, such as methionine, or monothioglycerol (pare [0056], contain anti-oxidants monothioglycerol) or sodium metabisulfite, etc. Chandrashekhar et al. teaches wherein the water-soluble, antioxidant (para [0056] antioxidant. citric acid) is present in the aqueous solution at 3 concentration ranging from about 0.1 mg/ml to about 30 mg/ml (para [0064], Example 6, citric acid monohydrate 3.33 mg/mL), such 42 as about 0.5 mg/ml, about 1 mg/ml, about 1.5 mg/ml, about 2 mg/ml, about 2.5 mg/ml. about 5 mg/ml, about 10 mg/ml, about 15 mg/ml, about 20 mg/ml, about 30 mg/ml, or any ranges or values between the recited values, such BS about 1.5-2.5 mg/ml, about 2-5 mg/ml, etc. Thus, art teaches use an aqueous solution comprising fosaprepitant, palonosetron, a cyclodextrin, antioxidant and water. This combination is not in a single embodiment. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results of making an aqueous solution suitable for parenteral injection, see MPEP 2143 part (I)(A). It would have been further obvious to one skilled in art to arrive at the claimed concentration of water in the aqueous solution through routine experimentation.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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