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
Applicant’s amendment of 29 October 2025, in which claim 1 has been amended, is acknowledged.
Claims 1-5, 12, 14-18 and 23-26 are pending in the instant application.
Claims 1-5, 12, 14-18 and 23-26 are being examined on their merits herein.
Response to arguments of 29 October 2025
On 14 March 2025, Applicant has amended independent claim 1 to recite that “the formulation is not re-administered during the dosing interval if the subject has a bowel movement after the administration of the formulation.” On 29 October 2025, Applicant has added to claim 1 the limitation “and the formulation is administered independently of the bowel movement”. A new rejection is made below, based on Applicant’s amendment of 29 October 2025.
Applicant’s arguments (Remarks of 29 October 2025, pages 4-9) against the rejection of claims 1-5, 12, 14-18 and 23-26 under 35 U.S.C. 103 over Sinha et al. (US 2018/0140619) and Sinha et al. (Gastroenterology 2015, 149, 52-55), in view of NCT02290665 (submitted 14 August 2018), have been considered.
Applicant argues (page 5, last two paragraphs, Remarks of 29 October 2025) that Sinha 2018 and Sinha 2015, or NCT’665 do not teach a method that does not require re-administration of the formulation after a bowel movement.
The examiner has previously noted that Sinha 2018 teaches the very same formulation (based on poloxamer, thus sustained release formulation) as in the instant claims, administered locally to the colon, to treat the very same disease, IBD; the patient population in Sinha 2018 includes human patients. Sinha 2018 teaches [0005] that the recommended dosing time frame for enemas is once or twice a day, which overlaps with a dosing interval greater than 12 hours in the instant claims.
The examiner has previously stated that Sinha 2018 teaches a thermosensitive gel enema formulation of 5-aminosalicylic acid [0006]-[0017], which is the very formulation in the instant claims, administered topically to the colon of a patient to treat IBD, such formulation being more tolerable and providing greater comfort and a less frequent dosing schedule [0032] compared to conventional liquid enema formulations. The examiner has previously stated that Sinha implies that the gel enema formulations of the invention will provide a less frequent dosing than the recommended once or twice a day for liquid enemas, and greater comfort/better retention (allowing for no re-administration after a bowel movement, or for less urgency/spasm that leads to a bowel movement) than with liquid enemas.
Applicant argues (page 6, second paragraph) that “there is no basis” in the teachings of Sinha 2018 to make an assertion that a greater comfort/retention which is taught in Sinha 2018 would lead a POSITA to conclude that there would be a therapeutic concentration of the agent remaining in the colon of the subject after a bowel movement. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., therapeutic concentration of the agent remaining in the colon of the subject after a bowel movement) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Rather, the instant claims recite treating IBD with a thermosensitive gel enema formulation of 5-aminosalicylic acid, with a dosing interval that is greater than 12 hours, whether or not the patient has had a bowel movement.
Sinha teaches the very same gel enema formulations as in the instant claims. Sinha 2018 does not teach whether the patients treated with the gel enema have a bowel movement during treatment, yet the ability to provide comfort/retention is inherent to the formulation. As such, said gel enema formulations, upon administration to the same patient population, patients suffering from IBD, will have the same effect on comfort/retention in the colon. By teaching better retention with the gel enema formulations compared to liquid enema formulations, Sinha 2018 provides the motivation to administer the gel enemas less frequently than twice or once a day, which overlaps with the dosing interval in the instant claims.
Applicant argues (page 7, last two paragraphs) that the dosing regimen of once or twice a day is provided in the Background section of Sinha 2018, when discussing issues with previous therapies. Applicant argues that the Background section in Sinha suggest re-administration of the claimed formulation because the immediate urge to have a bowel movement occurs in 5-10 minutes.
Applicant argues (page 7, last paragraph, page 8) that the instant claims are drawn to a method of treatment, and the cited references, individually or in combination (page 8) do not provide a reasonable expectation of success to administer the claimed formulation at dosing intervals of greater than 12 hours to IBD patients, wherein the formulation does not need to be re-administered after a bowel movement.
In response, [0005] Sinha, under Background, describes liquid solution enemas, dosing once or twice a day, retained for 1-3 hours (and the fact that patients with distal colitis are often unable to tolerate such enemas due to urgency/spasm); but Sinha 2018 further teaches a thermosensitive gel enema formulation of 5-aminosalicylic acid [0006]-[0017], which is the very formulation in the instant claims, administered topically to the colon of a patient to treat IBD, such formulation being more tolerable and providing greater comfort and a less frequent dosing schedule [0032] compared to conventional liquid enema formulations. Thus, the examiner maintains that Sinha implies that the gel enema formulations of the invention will provide a less frequent dosing than the recommended once or twice a day for liquid enemas, and greater comfort/better retention (allowing for no re-administration after a bowel movement, or for less urgency/spasm that leads to a bowel movement) than with liquid enemas.
Thus, the prior art cited in the rejection on record teach the very same formulation of 5-ASA, containing a block copolymer comprising PEG and PG (poloxamers have the structure
PNG
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154
527
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Greyscale
and are block copolymers comprising polyethylene glycol and polypropylene glycol), as the one administered in the instant method. Formulations containing block copolymers are sustained release formulations which ensure that the therapeutic agent is absorbed and retained for longer time than non-gelling immediate release formulations (such as the liquid formulations in the Background section of Sinha 2018).
Further, regarding the instantly claimed dosing interval, Sinha 2015 and Sinha 2018 teach a dosing interval of 48 hours when administering the thermosensitive gel enema formulation containing 5-aminosalicylic acid to mice to treat IBD.
Furthermore, Sinha 2015 teaches that the mesalazine polymer enema formulation MPL demonstrated improvement over mesalazine liquid ML enema formulation in mice suffering from IBD; and Sinha 2015 teaches that TDDP allows for less frequent administration and has enormous potential to improve the care in patients with IBD.
The person of ordinary skill in the art would have administered an enema formulation TDDP of 5-aminosalicylic acid to human patients suffering from IBD in a method of treating IBD taught by Sinha, and would have determined the dosing interval in the method of treatment, with the expectation that said administration will be tolerable to human patients, will be less frequent than the dosing interval (once or twice a day) for liquid enemas, will be better tolerated/better retained (allowing for no-re-administration after a bowel movement and/or less urgency/spasm that leads to a bowel movement) than a liquid enema, and will result in therapeutic effect. Determining the dosing interval of a known drug, 5-aminosalicylic acid, in a known formulation, enema comprising block copolymer of polyethylene glycol and polypropylene glycol, administered by a known route of administration, locally to the colon, in a known method of treating IBD in human patients is well within the skill of the artisan.
Applicant’s arguments (Remarks, page 9) related to the Pamnani Declaration of May 2, 2022, have been addressed in the office action mailed on 6 October 2022, pages 2-8.
For all the reasons above, the rejection of claims 1-5, 12, 14-18 and 23-26 under 35 U.S.C. 103 over Sinha (US 2018/0140619) and Sinha (Gastroenterology 2015, 149, 52-55, cited in IDS of 7 January 2021), in view of NCT02290665, is herein maintained and is reproduced below.
Applicant has presented no arguments (Remarks of 29 October 2025, page 10, first paragraph) against the provisional rejection of instant claims 1-5, 12, 14-18, and 23-26 on the ground of nonstatutory double patenting over claims 19, 22-26 of co-pending Appl. No. 17/332,431. As a result, this provisional rejection is herein maintained and is reproduced below.
The following rejections below are made based on Applicant’s amendment of 29 October 2025.
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.
Claims 1-5, 12, 14-18 and 23-26 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, as amended on 29 October 2025, recites “the formulation is not re-administered during the dosing interval if the subject has a bowel movement after the administration of the formulation and the formulation is administered independently of the bowel movement.”
The Specification teaches (page 18, last paragraph, page 19, first paragraph): “In methods that do not require re-administration of an agent following a bowel movement, the agent may nonetheless be re-administered at an interval that is independently defined and not dependent on the subject's bowel movements. For example, the agent may be re-administered after one of the intervals described above or according to a dosing regimen.” Thus, the Specification seems to teach that administration of the formulation is done according to a dosing regimen comprising a dosing interval, whether or not the subject has a bowel movement at any time after administration of the formulation.
Amended claim 1 lacks clarity for a number of reasons. The claim presents a scenario “if the subject has a bowel movement after administration of the formulation”- namely, in this scenario, the formulation is not re-administered during the dosing interval, where the dosing interval is defined as greater than 12 hours. It is noted that “a bowel movement after administration” in claim 1 does not specify a specific time after administration of the formulation; rather, claim 1 encompasses any bowel movement, no matter when it occurs, as long as it occurs after administration of the formulation.
It is unclear what happens in an alternative scenario, namely if the subject does not have a bowel movement after administration of the formulation. Can the formulation be re-administered in this scenario during the dosing interval?
The claim language “is not re-administered during the dosing interval” is unclear, because a dosing interval is the period of time between consecutive doses of a medication. Re-administration during a dosing interval seems consistent with more frequent administration/shorter dosing interval.
Further confusion comes from the newly added limitation to claim 1 “and the formulation is administered independently of the bowel movement.” It is unclear what the term “the bowel movement” in claim 1 refers to, because the claim does not recite that the subject necessarily has a bowel movement, and the claim fails to explain how the administration is related to any bowel movement that the subject may have during the treatment.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5, 12, 14-18 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha et al. (US 2018/0140619, published 24 May 2018, priority from U.S. Provisional Patent Application 62/156,682, filed on 4 May 2015, cited in PTO-892 of 10 December 2020) and Sinha et al. (Gastroenterology 2015, 149, 52-55, cited in IDS of 7 January 2021), in view of NCT02290665 (submitted 14 August 2018, https://clinicaltrials.gov/ct2/history/NCT02290665?A=1&B=3&C=merged,
accessed 20 February 2021, cited in PTO-892 of 24 February 2021).
Sinha (US 2018/0140619) teaches (claims 16, 19) a method of treating inflammatory bowel disease comprising administering locally to a colon to a patient in need thereof an enema composition comprising a salicylic acid derivative such as 5-aminosalicylic acid, in a formulation containing a non-ionic block copolymer consisting of polyethylene glycol and polypropylene glycol, and a phospholipid.
Sinha teaches [0003]-[0005] that 1.5 million Americans suffer from IBD; patients with active distal colitis are often unable to tolerate enemas due to urgency/spasm associated with inability to retain a liquid solution for the recommended dosing and time frame; current treatments for patients with IBD leave significant opportunities for improvement. Thus, Sinha implicitly teaches that the goal of his work is to treat human patients suffering from IBD with formulations of the invention.
Sinha teaches [0005] that patients with active distal colitis are often unable to tolerate liquid enemas due to urgency/spasm and the associated inability to retain a liquid solution for the recommended dosing and time frame once or twice a day retained for 1-3 hours. Sinha teaches [0005] that the recommended dosing for liquid enemas is once or twice a day, which corresponds to a dosing interval of 12 hours or 24 hours, which overlaps with the instant rage of greater than 12 hours in claim 1.
Sinha teaches [0017] that a thermosensitive enema was developed that has the advantages of the liquid enema, namely proximal delivery, but without retention issues associated with liquids. Sinha teaches that the invention provides topical therapies for IBD that are more tolerable ([0005], last two lines). Sinha also teaches [0032] that the greater comfort with the formulation of the invention may provide for a less frequent dosing schedule. Thus, Sinha 2018 clearly teaches that the instant gel formulation was developed to provide improvement in tolerability compared to conventional liquid enema formulations. Sinha implies that the gel enema formulations of the invention will provide a less frequent dosing than the recommended once or twice a day for liquid enemas, and greater comfort/better retention (allowing for no re-administration after a bowel movement, or for less urgency/spasm that leads to a bowel movement) than with liquid enemas.
Sinha teaches ([0041], [0039], [0040]) a method of treating ulcerative colitis (DSS-induced colitis mouse animal model) by providing locally to the colon of a subject suffering from ulcerative colitis (C57BL/6 mouse) an enema formulation comprising 5-aminosalicylic acid, with a dosing interval of 48 hours (enema treatments on day 4 and day 6, [0039], lines 5-6).
Sinha teaches that mice were given enema treatments on day 4 and day 6, which is consistent with a dosing interval of 48 hours, which satisfies the limitations of instant claims 1, 2, 3.
By teaching enema administration, Sinha teaches that the drug formulation was provided topically, as in instant claim 4, rectally, as in instant claim 5.
Sinha teaches administration of 5-aminosalicylic acid (synonyms mesalazine, mesalamine, 5-ASA, [0026]) as therapeutic agent, as in the instant claims.
Sinha teaches that 5-aminosalicylic acid is provided in a formulation that exists as a liquid as 23 °C and transitions to a viscous gel at 37 °C [0017], as in the instant claims.
Sinha teaches that the enema formulation ([0027]-[0031]) comprises 5-aminosalicylic acid [0030] active ingredient, as in instant claim 1, in a mixture with a polymer, which is a block copolymer of polyethylene glycol and polypropylene glycol [0028], as in the instant claims, and the formulation also contains phosphatidylcholine [0029] as a lipid, as in instant claim 12.
Sinha teaches [0041] that the mesalazine polymer formulation MPL demonstrated improvement over mesalazine liquid ML formulation. Mice treated with MPL had larger colons compared to ML treatment; histopathology of sections of explanted mice colons showed healthier mucosa in MPL mice compared to other groups; further, healthier colon mucosa correlates with better tolerability/ better retention in the colon/ less urgency of bowel evacuation. By teaching healthier colon mucosa in mice treated with MPL vs. liquid ML formulation, Sinha teaches better tolerability with the mesalazine polymer formulation MPL over mesalazine liquid ML formulation. Further, Sinha implicitly teaches that the therapeutic effect is maintained during the dosing regimen.
Sinha teaches [0040] that 3-D imaging software was utilized to assess the volume of enema retained at predetermined intervals; the volume of enema retained measured by substantially greater in mice with colitis treated with polymer-based formulation versus liquid formulation. Sinha explains [0005] that retention of fluid is important in order to maximize the time for the therapeutic agent to diffuse from the carrier enema fluid to the mucosal wall of the digestive tract.
The patient population in Sinha includes human patients, as in the instant claims.
Sinha does not teach that 5-ASA induces remission of ulcerative colitis, as in instant claim 14, or maintains remission of said disease, as in instant claim 15.
Sinha does not teach that 5-ASA is retained in the colon for greater than 12 hours, as in instant claim 16, for at least 15 hours, as in instant claim 25, or for at least 24 hours, as in instant claim 26.
Sinha does not teach that the method further comprises systemic administration to the subject, as in instant claim 18, or that the method does not comprise systemic administration of 5-ASA to the subject, as in instant claim 17.
Sinha et al. (Gastroenterology 2015, 149, 52-55) teaches (Supplementary Figure 6) a method of treating ulcerative colitis (DSS-induced colitis mouse animal model) by providing locally to the colon of a subject suffering from ulcerative colitis (C57BL/6 mouse) an enema formulation comprising 5-aminosalicylic acid, with a dosing interval of 48 hours (enema treatments on day 4 and day 6, Supplementary Figure 6A).
Sinha teaches that mice were given enema treatments on day 4 and day 6, which is consistent with a dosing interval of 48 hours, which satisfies the limitations of instant claims 1, 2, 3.
By teaching enema administration, Sinha teaches that the drug formulation was provided topically, as in instant claim 4, rectally, as in instant claim 5.
Sinha teaches administration of 5-aminosalicylic acid (synonyms mesalazine, mesalamine, 5-ASA) as therapeutic agent, as in the instant claims.
Sinha teaches that 5-aminosalicylic acid is provided in a formulation that exists as a liquid as 23 °C and transitions to a viscous gel at 37 °C (page 52, right column, second paragraph), as in the instant claims.
Sinha teaches that the enema formulation comprises 5-aminosalicylic acid (mesalamine, see Budenoside and mesalamine formulations, page 55.e1) active ingredient, as in instant claim 1, in a mixture with a polymer, which is a block copolymer of polyethylene glycol and polypropylene glycol (Supplementary Figure 1a and 2), as in the instant claims, and the formulation also contains phosphatidylcholine (Supplementary 55.e1, left column, second paragraph) as a lipid, as in instant claim 12.
Sinha teaches (Supplementary Figure 6A-E) that the mesalazine polymer formulation MPL demonstrated improvement over mesalazine liquid ML formulation. Mice treated with MPL had larger colons compared to ML treatment; histopathology of sections of explanted mice colons showed healthier mucosa in MPL mice compared to ML formulation; further, healthier colon mucosa correlates with better tolerability/ better retention in the colon/ less urgency of bowel evacuation. By teaching healthier colon mucosa in mice treated with MPL vs. liquid ML formulation, Sinha teaches better tolerability with the mesalazine polymer formulation MPL over mesalazine liquid ML formulation. Further, Sinha implicitly teaches that the therapeutic effect is maintained during the dosing regimen.
Sinha teaches (page 51, left column, last paragraph, right column, first paragraph) a thermo-sensitive drug delivery platform (TDDP) that is a liquid near room temperature and transitions to a viscous gel at 37 °C (page 52, right column, second paragraph); the platform is a nonionic surfactant copolymer consisting of hydrophilic polyethylene glycol and hydrophobic polypropylene glycol blocks. Sinha teaches that TDDP has the advantages of a liquid enema (more proximal delivery) and addresses retention issues associated with liquids.
Sinha teaches (page 53, right column, second paragraph) that the thermo-sensitive delivery platform (TDDP) for topical administration to the colon of mesalamine, is superior to standard treatments. Sinha teaches (page 54, left column, first paragraph) that because of its greater proximal reach and retention, the TDDP could allow for less frequent administration, which is likely to improve patient compliance. Sinha teaches (page 53, left column, last paragraph) that TDDP has enormous potential to improve the care of patients with IBD.
Sinha does not specifically teach the method in human patients, as in the instant claims.
Sinha does not teach that 5-ASA induces remission of ulcerative colitis, as in instant claim 14, or maintains remission of said disease, as in instant claim 15.
Sinha does not teach that 5-ASA is retained in the colon for greater than 12 hours, as in instant claim 16, for at least 15 hours, as in instant claim 25, or for at least 24 hours, as in instant claim 26.
Sinha does not teach that the method further comprises systemic administration to the subject, as in instant claim 18, or that the method does not comprise systemic administration of 5-ASA to the subject, as in instant claim 17.
NCT02290665 teaches local therapeutics for the treatment of gastrointestinal disorders. NCT02290665 teaches (page 4, under Arms and Interventions) thermosensitive gel rectal formulation administered to human patients. NCT02290665 teaches (page 3, under Study Description) that a study was performed to determine patient preference for a biocompatible thermosensitive solution-gel comprised of poloxamer, an inactive compound designed as GRAS by FDA. NCT02290665 teaches that the gel could subsequently be used as medium for drug delivery; the poloxamer gel is administered to study participants (18 patients) in order to assess preference and proximal distribution.
It would have been obvious to a person of ordinary skill in the art to combine the teachings of Sinha, Sinha and NCT02290665 to arrive at the instant method. The person of ordinary skill in the art would have been motivated to administer the poloxamer-based enema formulation (TDDP) comprising 5-aminosalicylic acid, taught by Sinha and Sinha, to human patients suffering from ulcerative colitis/IBD, with the expectation that said administration will result in therapeutic effect.
The person of ordinary skill in the art would have been motivated to determine the dosing interval in human patients in the method of treating IBD with 5-aminosalicylic acid, formulated as poloxamer based enema (TDDP) taught by Sinha and Sinha, because
Sinha 2018 teaches a thermosensitive gel enema formulation of 5-aminosalicylic acid, which is the very formulation in the instant claims, administered topically to the colon of a patient to treat IBD, such formulation being more tolerable and providing greater comfort/better retention and a less frequent dosing schedule compared to conventional liquid enema formulations (for which the recommended dosing schedule is once or twice a day);
Sinha 2015 and Sinha 2018 teach a dosing interval of 48 hours when administering the thermosensitive gel enema formulation containing 5-aminosalicylic acid to mice to treat IBD;
Sinha 2015 teaches that the mesalazine polymer enema formulation MPL demonstrated improvement over mesalazine liquid ML enema formulation in mice suffering from IBD;
Sinha 2015 teaches that TDDP allows for less frequent administration and has enormous potential to improve the care in patients with IBD; and
NCT02290665 teaches evaluation of the very poloxamer based enema (TDDP) formulation in human patients to assess preference and proximal distribution.
Thus, the person of ordinary skill in the art would have administered an enema formulation TDDP of 5-aminosalicylic acid to human patients suffering from IBD in a method of treating IBD taught by Sinha, and would have determined the dosing interval in the method of treatment, with the expectation that said administration will be tolerable to human patients, will be less frequent than the dosing interval (once or twice a day) for liquid enemas, will be better tolerated/better retained (allowing for no-re-administration after a bowel movement and/or less urgency/spasm that leads to a bowel movement) than a liquid enema, and will result in therapeutic effect. Determining the dosing interval of a known drug, 5-aminosalicylic acid, in a known formulation, enema comprising block copolymer of polyethylene glycol and polypropylene glycol, administered by a known route of administration, locally to the colon, in a method of treating IBD in human patients is well within the skill of the artisan.
With respect to claims 14, 15, the person of ordinary skill in the art would have been motivated to practice the method taught by Sinha in patients with active disease, or to patients in remission, and monitor the therapeutic effect achieved with the 5-aminosalicylic acid enema formulation, with the expectation that 5-aminosalicyclic acid, known to treat ulcerative colitis, will maintain the remission of ulcerative colitis in patients in remission, and will induce remission of ulcerative colitis in patients with active disease.
With respect to claims 16, 25, 26, the person of ordinary skill in the art would have been motivated to determine the time of retention of enema in the colon of the patients in the method taught by Sinha, because Sinha teaches that retention of enema is important to maximize the time for the therapeutic agent to diffuse from the carrier enema fluid to the wall of the digestive tract, and Sinha further teaches that the poloxamer formulations of the invention are better retained in the colon than liquid enemas.
With respect to claims 17, 18, it would have been obvious to adjust the dose of the active agent 5-aminosalicylic acid administered locally to the colon in the method taught by Sinha so that said administration is topical rather than systemic (as in instant claim 17), or use topical therapy in conjunction with systemic therapy (as in instant claim 18) for additive effects in treating ulcerative colitis, with the expectation of achieving therapeutic effect.
As such, claims 1-5, 12, 14-18 and 23-26 are rejected as prima facie obvious.
Double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 12, 14-18 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 19, 22-28, 36, 37 of copending Application No. 17/332,431 (published as US 2021/0283148, cited in PTO-892 of 6 October 2022).
Claims 19, 22-28, 36, 37 of copending Application No. 17/332,431 are drawn to a method of treating inflammatory bowel disease (IBD), the method comprising: treating IBD in a patient in need of such treatment with an enema composition that exhibits a gel transition temperature between 32 °C and 38 °C, wherein the enema composition is produced by combining an active agent mesalazine in a dry, non-aqueous form with water, a thermo-active polymer (which is a non-ionic block copolymer consisting of polyethylene glycol and polypropylene glycol blocks, in claims 22-25), and one or more lipids to produce a lipidic suspension into which the active agent is dispersed; and the enema composition is at a temperature of less than 30 °C when administered.
The claims of copending Application No. 17/332,431 are drawn to a method of treating IBD, which is a gastrointestinal condition of instant claim 1, such as ulcerative colitis or Crohn’s disease (claims 36, 37 of Application No. 17/332,431), as in instant claims 23, 24, using an enema composition that has the same constituents and the same gel transition properties as the composition of the instant claims by the same route of administration (enema administered locally to the colon) as in the instant claims. Further, the patient population in claims 19, 22-28, 36, 37 of copending Application No. 17/332,431 encompasses human subjects.
It would have been obvious to a person of ordinary skill in the art to use the teachings of claims 19, 22-28, 36, 37 of copending Application 17/332,431 to arrive at the instant method. The person of ordinary skill in the art would have been motivated to administer the enema composition of claims of copending Application 17/332,431 to treat human subjects suffering from a gastrointestinal condition such as IBD, because claims 19, 22-28, 36, 37 of copending Application 17/332,431 teach that said formulation is effective to treat IBD in a patient in need thereof. Determining the dosing interval in a known method of treatment, using a known formulation of a known therapeutic agent, is well within the skill of the artisan. A person of ordinary skill in the art would have practiced the method of claims 19, 22-28, 36, 37 of copending Application 17/332,431 in human patients suffering from IBD, with the expectation that said administration will result in therapeutic effect.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-5, 12, 14-18 and 23-26 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629