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.
Claim 19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim comprises a limitation directed to obtaining “the stock colloidal suspension”. It’s unclear what components are present in the “stock colloidal suspension”.
Claim 19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claim comprises the term “medicated colloidal suspension”. The limitations imposed on the claims by the word “medicated” is unclear.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friton et al (US 2005/0288280) in view of Jain et al (International Journal of Pharma Professional Research, 2010, 1(1), 34-45; submitted with IDS on 11/29/23) and Rawat et al (Indian Drugs, 2006, 43(7), 565-573; submitted with IDS on 3/12/25).
Scope of prior art
Friton teaches compositions comprising Meloxicam for treatment of inflammatory diseases in animals (abstract, paragraphs [0003] – [0023]) comprising administration of meloxicam. Friton describes aqueous compositions comprising meloxicam (paragraph [0065]). Friton also teaches addition of solubilizers to the aqueous solution and adding NaOH to provide a pH above 7 (paragraphs [0048]. [0049], [0054], [0067]-[0070]. In paragraph [0048], arginine is listed as a solubilizer for meloxicam. In paragraph [0054], Art teaches addition of buffer systems to achieve the desired pH.
Ascertaining the difference
Friton teaches aqueous compositions comprising meloxicam and addition of solubilizer such as arginine, but fails to teach hydrotrope or colloidal suspension. Friton also does not teach piroxicam (Claim 20).
Secondary references
Jain teaches Hydrotropy as a method of solubilizing insoluble substrates. Jain teaches that one of the advantages of hydrotropy is the ease of practice. On page 39, column 1 Jain teaches that it only requires mixing the drug with the hydrotrope in water. On page 39, column 2 Jain teaches commonly used hydrotropes which includes the currently claimed agents. In column 41, right column Kain teaches hydrotropes used to solubilize meloxicam. In column 43, left column Jian teaches hydrotropes used to solubilize piroxicam.
Rawat teaches hydrotropic solubilization of COX-2 inhibitors including meloxicam. Om page 567, Figure 4 Rawat demonstrates that solubility of meloxicam significantly increases at the pH of the solution rises above 7. On page 568, Table II, Rawat teaches meloxicam solubilized using sodium salicylate, sodium bicarbonate or Nicotinamide as hydrotropes.
Obviousness
A person of ordinary skill in the art, prior to the earliest effective filing date of the current application, would have found it obvious to solubilize meloxicam or piroxicam in water by mixing the agents with a hydrotrope, adding water and adjusting pH to above 7. Friton teaches preparing meloxicam solutions by adding arginine as solubilize. Since arginine acts as a hydrotrope, addition of arginine, meloxicam and water would result in preparation of the currently claimed colloidal composition.
In view of the cited art, it was known prior to filing of the instant application that meloxicam and piroxicam can be solubilized in water by employing hydrotropes. It was also known that solubility increases in alkaline pH and that pH can be adjusted by adding NaOH to the solution. Since the steps in the current claims require addition of hydrotrope and the active agent to water and subsequently adjusting pH, following suggestions of the art would result in the currently claimed product which can be used for treatment of inflammatory conditions in an animal.
Conclusion
Claims 1-20 are pending
Claims 1-20 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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