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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/22/2026 has been entered.
The amendment filed 07/22/2026 amended claims 1 and 9, and deleted claim 4.
Claims 1-3 and 5-15 are pending and examined on the merits herein.
Note: Claim 9 is identified as “(Previous Presented).” However, line 3 of claim 9 is amended. As such, claim 9 is interpreted as “(Amended).” See MPEP 714, 37 CFR 1.121(c).
Note: After reviewing the file wrapper, it appears that the instant Application does not contain a “Power of attorney.” See MPEP 410.02(a).
Priority
This application claims the following priority:
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REJECTIONS MAINTAINED
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.
(Maintained/Slightly Modified) Claims 1-3, 5-6, 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 of 12/17/2005) 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, “Conclusion”).
Moreover, DeBoer specifically teaches that “Absorption of indomethacin rectally seems to be comparable to that following oral administration. Baker and colleagues (1979) found no differences in clinical effects, plasma concentrations and AUC following oral and rectal administration” (pg. 72, Col. 2).
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,
-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, and
-DeBoer teaches that absorption of indomethacin rectally and orally is comparable.
As such, an ordinary skilled artisan 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 “100 mg of rectal indomethacin were administered” (Original-pg. 1, Abstract; Translation-pg. 1, Col. 2, line 4th 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 5-6 and 13-14, Loza teaches 100 mg indomethacin. See MPEP 2131.03.
Regarding claims 8 and 15, Loza teaches administration to men and women (Translation-pg. 2, Col. 1, “Results”).
Claims 1-3, 5-6, 8-11, and 13-15 are rendered obvious.
(Maintained) 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 of 12/17/2025) and DeBoer (Drug Absorption By Sublingual and Rectal Routes, Br. J. Anaesth., published 1994, PTO-892 of 01/30/2025), as applied to claims 1-3, 5-6, 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 1-3 and 5-15 are rendered obvious.
Response to Arguments
On pg. 5, Remarks, Applicant argues that “DeBoer discloses drug absorption by sublingual and rectal administration routes of various drugs. . .However indomethacin is not disclosed, suggested, or even hinted, much less in the 1-500 mg dosage range.”
This argument has been fully considered, but is not found persuasive. As a whole, the De Boer publication compares and contrasts drug absorption by sublingual/buccal administration and drug absorption by rectal administration. The conclusion of De Boer states the following:
“Although the rectal and sublingual routes are not used frequently for administration of drugs, both routes may serves as alternatives to oral and parenteral administration. Each route has different limitations which decrease general applicability for drug administration.
The disadvantages of the rectal route include interruption of absorption by defecation and lack of patient acceptability. The mechanism of drug absorption from the rectum is probably similar to that from the small intestine, despite considerable differences in physiological condition (e.g. pH, fluid content). Absorption may be extremely fast with solutions. The rectal route is suitable for short-and long-term drug delivery and it is possible partly to avoid hepatic first-pass elimination.
The sublingual and buccal routes of administration are useful when fast action is desired with potent drugs. In addition, first-pass elimination (gut-lumen, gut-wall and hepatic) is avoided. Prolonged residence in the mouth can limit usefulness because of patient intolerance, and for long-term drug administration this route is not convenient when conventional formulations are used” (pg. 79, final three paragraphs, “Conclusion”).
Thus, the teachings of De Boer are not directed to the mode of administration of specific drugs, but, as a whole, are directed toward the differences between rectal administration and buccal/subcutaneous administration, and the advantages of buccal/subcutaneous administration.
Regarding Applicant’s arguments toward indomethacin not being disclosed by DeBoer, it is respectfully pointed out that DeBoer does teach indomethacin on pg. 72:
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On pg. 6, Remarks, Applicant argues “Applicant submits that the specifically disclosed and claimed sublingual and buccal routes of administration [of] indomethacin and the claimed dosage range offer advantages and ease of use for the patient that are not disclosed.”
This argument has been fully considered, but is not found persuasive. If unexpected results have been achieved, see MPEP 716.02, which states that unexpected results a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property. MPEP 716.02 additionally states that unexpected results must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art.
It is respectfully pointed out that a careful review of the instant disclosure does not appear to provide data substantiating unexpected results according to MPEP 716.02, in regard to sublingual/buccal administration in comparison to rectal administration.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
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