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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/19/2024 has been entered.
The Amendment filed 09/19/2024, amended claims 1, 4-6, 9 and 13-14.
Claims 1-15 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 USC § 103
Applicant’s amendment to independent claims 1 and 9 that limits the active ingredient to indomethacin, is sufficient to overcome these rejections since Geraci, the primary reference, teaches administration of diclofenac.
REJECTIONS
In view of the amendment to the independent claims that limits the active ingredient to indomethacin, the below rejections are new. However, DeBoer and Karabog continue to be relied upon as secondary and tertiary references, respectively.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(New) Claims 1-6, 8-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Loza (Original and Translation of Effect of the administration of rectal indomethacin on amylase serum levels after endoscopic retrograde cholangiopancreatography, and its impact on the development of secondary pancreatitis episodes, Rev Esp Enferm Dig, published 2007, PTO-892) in view of DeBoer (Drug Absorption By Sublingual and Rectal Routes, Br. J. Anaesth., published 1994, PTO-892 of 01/30/2025).
Loza teaches the effect of the administration of rectal indomethacin on amylase serum levels after endoscopic retrograde cholangiopancreatography, and its impact on the development of secondary pancreatitis episodes (title, original).
Loza specifically teaches a method of treating ERCP pancreatitis by administering 100mg of rectal indomethacin prior to performing ERCP (Original-abstract; Translation-pg. 1, Col. 2; Translation-pg. 3, Col. 1, paragraph prior to “Discussion”; Translation-pg. 4, Col. 1, last paragraph; Translation-pg. 5, last paragraph).
Regarding claims 1 and 9, while Loza teaches a method of prophylactically treating post-endoscopic retrograde cholangiopancreatography (ERCP) acute pancreatitis by administering 100 mg indomethacin rectally, it differs from that of the instantly claimed invention in that it does not teach sublingual or buccal administration.
DeBoer teaches drug absorption by sublingual and rectal routes (title). DeBoer teaches that though there are benefits of rectal administration, there are also disadvantages such as interruption of absorption by defecation, degradation of drugs by microorganisms in the rectum, and patient acceptability. DeBoer teaches that while there are also disadvantages to sublingual and buccal administration, these modes of administration result in rapid absorption of drugs, resulting in rapid systemic action. Since drugs administered sublingually or buccally pass directly into the systemic circulation, there is no hepatic high-clearance or metabolism/decomposition of the drug in the gastrointestinal tract, allowing for higher systemic availability (pg. 74, Col. 2, “Buccal and Sublingual administration of Drugs”).
In summary, DeBoer teaches that both rectal and sublingual routes serve as alternatives to oral and parenteral administration. DeBoer teaches that sublingual and buccal routes are useful over rectal administration when fast action is desired with potent drugs (pg. 79, final three paragraphs).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the rectal administration of Loza with sublingual or buccal administration, to arrive at instant claims 1 and 9. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
- DeBoer teaches that though there are benefits of rectal administration, there are also disadvantages such as interruption of absorption by defecation, degradation of drugs by microorganisms in the rectum, and patient acceptability, and
-DeBoer teaches that sublingual and buccal administration result in rapid absorption of drugs, resulting in rapid systemic action, and further teaches that since drugs administered sublingually or buccally pass directly into the systemic circulation, there is no hepatic high-clearance or metabolism/decomposition of the drug in the gastrointestinal tract, allowing for higher systemic availability
As such, an artisan of ordinary skill would have been motivated to sublingually or buccally administer the indomethacin of Loza, to predictably arrive at a method wherein indomethacin is rapidly absorbed, resulting in its rapid systemic action, and thus, the rapid prophylactic treatment of post-endoscopic retrograde cholangiopancreatography acute pancreatitis.
Though Lopez does not explicitly teach the indomethacin in a composition comprising a carrier, Lopez teaches the 100 mg rectally administered indomethacin in a form that delivers a dose (Translation-pg. 5, 1st paragraph). As such, the teaching of the rectal administration of 100 mg indomethacin in a dose, meets the limitation of a pharmaceutical composition comprising indomethacin and a pharmaceutically acceptable carrier since rectal administration as a dose, necessitates a carrier for the indomethacin.
Regarding the recitation “wherein said pharmaceutical composition is administered before any cannulation procedures,” in claim 9, since Loza teaches administration of indomethacin prior to ERCP, and since Lopez does not teach any cannulation procedure prior to the indomethacin administration, this limitation is met.
Regarding claims 2-3 and 10-11, the combination of Loza and DeBoer teaches sublingual or buccal administration.
Regarding claims 4-6 and 13-14, Loza teaches 100 mg indomethacin.
In the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05. Moreover, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 8 and 15, Loza teaches administration to men and women (Translation-pg. 2, Col. 1, “Results”).
Claims 1-6, 8-11, and 13-15 are rendered obvious.
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Loza (Original and Translation of Effect of the administration of rectal indomethacin on amylase serum levels after endoscopic retrograde cholangiopancreatography, and its impact on the development of secondary pancreatitis episodes, Rev Esp Enferm Dig, published 2007, PTO-892) and DeBoer (Drug Absorption By Sublingual and Rectal Routes, Br. J. Anaesth., published 1994, PTO-892 of 01/30/2025), as applied to claims 1-6, 8-11, and 13-15 above, and further in view of US PG-Pub 2019/0117555 to Karaboga (published 2019, PTO-892 of 01/30/2025).
Loza and DeBoer are applied as discussed above and incorporated herein.
While the combination of Loza and DeBoer teaches a method of prophylactically treating post-endoscopic retrograde cholangiopancreatography acute pancreatitis by sublingually or buccally administering a composition comprising 100mg indomethacin and carrier, followed by administering ERCP, it differs from that of the instantly claimed invention in that it does not teach the carriers of instant claims 7 or 12.
Karaboga teaches sublingual formulations containing water, polyethylene glycol, colloidal silica and others as carriers, excipients, and/or diluents, wherein water is a diluent, polyethylene glycol is a binding agent, and colloidal silica is a flow agent ([0051]-[0052]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select water, polyethylene glycol, or colloidal silica as a carrier/excipient/diluent, in the sublingual formulation of indomethacin in the combined method of Loza and DeBoer, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Loza teaches pharmaceutical formulations comprising indomethacin and pharmaceutical carriers, and
-Karaboga teaches water, polyethylene glycol, and colloidal silica as suitable carriers, excipients and/or diluents, in sublingual formulations.
As such, an artisan of ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a formulation that is suitable for sublingual administration and that is optimized for dilution, binding, and/or flow.
Claims 1-15 are rendered obvious.
Response to Arguments
In view of the above new rejections, the arguments filed 09/19/2024, are not pertinent since they are primarily directed toward the teachings of Geraci, which is no longer relied upon as a reference.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622