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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/20/2026 has been entered.
Applicants' arguments, filed 05/20/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-7, 13-15, and 17-21, are pending and under examination.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract refers to the purported merits of the invention and is 41 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 13, and 15, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Levitt (WO 2003000299 A1, cited on IDS dated 12/11/2025).
Levitt teaches a laxative preparation comprising dehydrated magnesium sulphate, wherein in a particular embodiment comprised dehydrated magnesium sulphate in 40 hard gelatine capsules with a total capsule mass of 13.46 g (example 2). The compositions can be used prior to colonoscopy for complete bowel preparation and cleansing the bowel (abs, example 4).
Regarding claim 1, Levitt discloses an oral solid formulation comprising sulfate, wherein each unit solid formulation has a total weight of about 0.33 g (13.46 g/ 40 capsules), thereby appearing meet the limitation of “about 0.3 g or less.” The examiner notes that the term “about” is not defined by the instant specification, and the examiner is interpreting “about” to include anything reasonable, including about 0.33 g.
Regarding the limitation of a colon cleansing agent, the limitation is intended use, and where the composition as claimed is anticipated above, and can be used to cleanse the bowel, the limitation is met.
Regarding claim 3, the embodiment disclosed by Levitt comprises magnesium sulfate.
Regarding claim 13, each unit solid formulation has a total weight of about 0.33 g, thereby meeting the claimed limitation, for the same reasons discussed above.
Regarding claim 15, the formulation of Levitt is in the form of capsules.
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.
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.
Claims 2-5, 7, 14, and 17-19, are rejected under 35 U.S.C. 103 as being unpatentable over Levitt (WO 2003000299 A1, cited on IDS dated 12/11/2025), in view of Crockett et al (US 20130189377 A1, cited on IDS dated 01/16/2025).
Levitt is discussed above and further teaches the formulations may be in the form of capsules, tablets, etc. (pg 3 ln 20-23). The magnesium sulfate can be placed in 60-80 capsules, even allowing the need to take 100 capsules (ex 4). In embodiments, sodium sulfate is included at 32 g (ex 4).
Levitt does not appear to teach an embodiment comprising sodium sulfate, potassium sulfate, and magnesium sulfate, their amounts as instantly claimed, nor a further pharmaceutically acceptable additive.
Crockett et al teach solid oral pharmaceutical compositions that can be used for colon cleansing, with embodiments comprising 20.24 g sodium sulfate, 3.48 g potassium sulfate, 17.1 g magnesium sulfate, and 34 g PEG 3500, where typically 40-120 tablets are required to administer this dosage (¶ 68, composition 5). For example at 120 tablets, the resulting unit solid formulation has a weight of about 0.62 g. The dosage forms may be less than 5 g, preferably more than 0.1 g, etc. (¶ 50). The optimal number of tablets required to deliver the required dose will depend upon the intended usage (¶ 63). The formulations may further include additives including excipients, sweeteners, flavoring agents., etc. (¶ 12). Excipients include binders, disintegrants, glidants, fillers, etc. (¶ 39). Magnesium sulfate may range from 0.02 to 80 g, for example 0.2 to 20 g, for example about 3 g (¶ 20).
Regarding claim 2, it would have been obvious to modify the amount of sulfate to known amounts suitable for colon cleaning formulations, including 40.82 g, as taught by Crockett et al, falling within the claimed range.
Regarding claim 3, claim 3 is discussed above, and purely arguendo, if somehow the dehydrated sodium sulfate of Levitt does not meet the limitation of sodium sulfate, it would have been obvious to modify Levitt by including known forms of sodium sulfate suitable for colon cleaning formulations, including sodium sulfate, as taught by Crockett et al.
Regarding claims 4 and 5, it would have been obvious to modify Levitt by including known combinations of sulfates suitable for colon cleansing formulations, including sodium sulfate, potassium sulfate, and magnesium sulfate, where the combination was known by Crockett et al to have improved tablet characteristics.
Regarding claim 7, it would have been obvious to formulate the dosage with 80 to 100 capsules, as taught by Levitt, depending on the desired dosage while keeping the total tablet weights the same.
Regarding claim 14, it would have been obvious to further include excipients, sweeteners, etc., including binders, disintegrants, glidants, fillers, as taught by Crockett et al, which are evidenced by the instant specification as pharmaceutically acceptable additives (see pg 21 of the instant specification), depending on the desired formulation characteristics.
Regarding claim 17, it would have been obvious to modify the composition made obvious above by including known amount of sodium sulfate suitable for laxative or colon cleansing action, such as 20.24 g, as taught by Crockett et al, thereby meeting the claimed limitation.
Regarding claim 18, where magnesium sulfate is made obvious above, it would have been obvious to include known amount of magnesium sulfate, including from 0.02 to 80 g, for example 0.2 to 20 g, for example about 3 g, as taught by Crockett et al. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 19, where potassium sulfate is made obvious above, it would have been obvious to include known amount of potassium sulfate, including 3.48 g, as taught by Crockett et al.
Claims 6 and 20, are rejected under 35 U.S.C. 103 as being unpatentable over Levitt (WO 2003000299 A1, cited on IDS dated 12/11/2025), in view of Nam et al (KR 20190041233 A, cited on IDS dated 06/29/2023).
Levitt is discussed above but does not appear to teach simethicone.
Nam et al are discussed above.
Regarding claim 6, it would have been obvious to further include where simethicone was known to have synergistic colon cleansing effects when combined with magnesium sulfate, potassium sulfate, and sodium sulfate, as taught by Nam et al above.
Regarding claim 20, simethicone is made obvious above, and it would have been obvious to include known amount of simethicone that was known to have synergy in colon cleansing formulations comprising sodium sulfate, potassium sulfate, and magnesium sulfate, including from 80-800 mg, as taught by Nam et al.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Levitt (WO 2003000299 A1, cited on IDS dated 12/11/2025) and Crockett et al (US 20130189377 A1, cited on IDS dated 01/16/2025), and further in view of Nam et al (KR 20190041233 A, cited on IDS dated 06/29/2023).
Levitt and Crockett et al are discussed above but do not appear to teach simethicone.
Nam et al are discussed above.
Regarding claim 21, it would have been obvious to formulate the oral solid formulation comprising those amounts of sodium sulfate, magnesium sulfate, potassium sulfate, and simethicone, as made obvious above and for the same reasons.
Claims 1-5, 7, 13-15, and 17-19, are rejected under 35 U.S.C. 103 as being unpatentable over Levitt (WO 2003000299 A1, cited on IDS dated 12/11/2025), in view of Crockett et al (US 20130189377 A1, cited on IDS dated 01/16/2025), and Ilhan et al (Peertechz J Med Chem Res, 2017, 3.1, pp. 012-022, cited on IDS dated 01/16/2025).
Levitt is discussed above, and purely arguendo, if somehow the total weight of each unit solid formulation is not about 0.3 g or less, the following applies.
Crockett et al is discussed above.
Ilhan et al teach multi-unit dosage forms, including mini tablets, where the dose is divided into subunits, were known to spread to the entire gastrointestinal tract resulting in a reduced risk of local irritation as a result of an equal drug release (pg 12 2nd col, table 1). Multi-unit dosage forms show a more reliable dissolution profile than single units, which means better bioavailability (pg 12 2nd col). Smaller tablets are advantageous for use in patients suffering from swallowing difficulty (abs, pg 12 1st col). Mini tablets were known to be used for colon treatments (pg 18 2nd col). Tables, capsules, and granules with an average weight less than 300 mg are disclosed (table 3).
It would have been obvious to formulate the solid oral formulation of Levitt in smaller unit formulations, where Crockett et al teach unit solid formulations of less than 5 g, preferably more than 0.1 g, were known to be suitable for colon cleansing formulations, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Additional motivation for reducing tablet size and weight is provided by Ilhan et al, where it was known that multi-unit dosage forms, including small tablets with a weight of 300 mg or less, reduce local side effects, have improved dissolution profile, and are advantageous for use in patients suffering from swallowing difficulty. As such, it would have been within the relative skills of the skilled artisan to split the dosage form over a larger number of tablets, thereby reducing the size and weight of each tablet for the above mentioned benefits.
The additional limitations of claims 1-5, 7, 13-15, and 17-19, are rejected for the same reasons above as applied to each and every claimed limitation.
Claims 6, 20, and 21, are rejected under 35 U.S.C. 103 as being unpatentable over Levitt (WO 2003000299 A1, cited on IDS dated 12/11/2025), Crockett et al (US 20130189377 A1, cited on IDS dated 01/16/2025), and Ilhan et al (Peertechz J Med Chem Res, 2017, 3.1, pp. 012-022, cited on IDS dated 01/16/2025), and further in view of Nam et al (KR 20190041233 A, cited on IDS dated 06/29/2023).
The references are discussed above but do not appear to teach simethicone.
Nam et al teach colonic purgative compositions comprising magnesium sulfate, potassium sulfate, sodium sulfate, and simethicone (¶¶ 15, 36). When simethicone was combined with magnesium sulfate, potassium sulfate, and simethicone, a synergistic effect was observed and the dosage could be reduced by 20% and exhibit an equivalent colon cleansing effect (¶ 40). Simethicone is recognized as a drug that suppresses the formation of intestinal gas bubbles, which improves the field of view of the endoscope during a colonoscopy (¶ 41). Simethicone was known to be included in an amount ranging from 80-800 mg (¶ 50).
Regarding claim 6, it would have been obvious to further include where simethicone was known to have synergistic colon cleansing effects when combined with magnesium sulfate, potassium sulfate, and sodium sulfate, as taught by Nam et al above.
Regarding claim 20, simethicone is made obvious above, and it would have been obvious to include known amount of simethicone that was known to have synergy in colon cleansing formulations comprising sodium sulfate, potassium sulfate, and magnesium sulfate, including from 80-800 mg, as taught by Nam et al.
Regarding claim 21, it would have been obvious to formulate the oral solid formulation comprising those amounts of sodium sulfate, magnesium sulfate, potassium sulfate, and simethicone, as made obvious above and for the same reasons.
Claims 1-5, 7, 13-15, and 17-19, are rejected under 35 U.S.C. 103 as being unpatentable over Crockett et al (US 20130189377 A1, cited on IDS dated 01/16/2025), in view of Ilhan et al (Peertechz J Med Chem Res, 2017, 3.1, pp. 012-022, cited on IDS dated 01/16/2025).
Crockett et al teach solid oral pharmaceutical compositions that can be used for colon cleansing, with embodiments comprising 20.24 g sodium sulfate, 3.48 g potassium sulfate, 17.1 g magnesium sulfate, and 34 g PEG 3500, where typically 40-120 tablets are required to administer this dosage (¶ 68, composition 5). For example at 120 tablets, the resulting unit solid formulation has a weight of about 0.62 g. The dosage forms may be less than 5 g, preferably more than 0.1 g, etc. (¶ 50). The optimal number of tablets required to deliver the required dose will depend upon the intended usage (¶ 63). The formulations may further include additives including excipients, sweeteners, flavoring agents., etc. (¶ 12). Excipients include binders, disintegrants, glidants, fillers, etc. (¶ 39). Magnesium sulfate may range from 0.02 to 80 g, for example 0.2 to 20 g, for example about 3 g (¶ 20).
Crockett et al do not specifically teach an embodiment with a unit solid formulation having a weight as instantly claimed.
Ilhan et al teach multi-unit dosage forms, including mini tablets, where the dose is divided into subunits, were known to spread to the entire gastrointestinal tract resulting in a reduced risk of local irritation as a result of an equal drug release (pg 12 2nd col, table 1). Multi-unit dosage forms show a more reliable dissolution profile than single units, which means better bioavailability (pg 12 2nd col). Smaller tablets are advantageous for use in patients suffering from swallowing difficulty (abs, pg 12 1st col). Mini tablets were known to be used for colon treatments (pg 18 2nd col). Tables, capsules, and granules with an average weight less than 300 mg are disclosed (table 3).
Regarding claim 1, it would have been obvious to formulate the solid oral formulation of Crockett et al in smaller unit formulations, where Crockett et al teach the unit solid formulations may be less than 5 g, preferably more than 0.1 g, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Additional motivation for reducing tablet size and weight is provided by Ilhan et al, where it was known that multi-unit dosage forms, including small tablets with a weight of 300 mg or less, reduce local side effects, have improved dissolution profile, and are advantageous for use in patients suffering from swallowing difficulty. As such, it would have been within the relative skills of the skilled artisan to split the dosage form over a larger number of tablets, thereby reducing the size and weight of each tablet for the above mentioned benefits.
Regarding claims 2, the embodiment of Crockett et al recited above comprises sulfate at 40.82 g, falling within the claimed range.
Regarding claims 3-5, the embodiment of Crockett et al recited above comprises sodium sulfate, potassium sulfate, magnesium sulfate, and polyethylene glycol.
Regarding claim 7, where unit solid formulations having a total weight of about 0.3 g or less are made obvious above, it would have been obvious for the skilled artisan to adjust the number of tablets in order to achieve desired unit formulation weights, as discussed above, by starting with the exemplified 120 tablets of Crockett et al, and adjusting up from there, where it is taught that the number of tablets can be optimized and unit solid formulations can be adjusted to unit solid formulations with a weight overlapping the claimed range. Further, it would have been obvious to split up the dosage into a larger number of tablets having less weight where it was known that smaller tablets (i.e., lower weight tablets) provide improved dissolution, are easier to swallow, and reduce side effects such local irritation, etc., as discussed above by Ilhan et al.
Regarding claim 13, it would have been obvious to formulate the oral solid formulation of Crockett et al in smaller unit formulations, where Crockett et al teach the unit solid formulations may be less than 5 g, preferably more than 0.1 g, such as from about 0.05 g to about 0.5 g and from about 0.05 to about 0.3 g, overlapping the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Additional motivation for reducing tablet size and weight is provided by Ilhan et al above and for the same reasons.
Regarding claim 14, it would have been obvious to further include excipients, sweeteners, etc., including binders, disintegrants, glidants, fillers, as taught by Crockett et al, which are evidenced by the instant specification as pharmaceutically acceptable additives (see pg 21 of the instant specification).
Regarding claim 15, the formulation made obvious above is in the form of tablets, as taught by Crockett et al.
Regarding claim 17, the formulation made obvious above comprises sodium sulfate at 20.24 g, as taught by Crockett et al, thereby meeting the claimed limitation.
Regarding claim 18, it would have been obvious to modify the composition above by adjusting the amount of magnesium sulfate within the disclosed ranges, including 0.02 to 80 g, for example 0.2 to 20 g, for example about 3 g, as motived by Crockett et al above. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 19, the formulation made obvious above comprises potassium sulfate at 3.48 g, as taught by Crockett et al, thereby meeting the claimed limitation.
Response to Arguments
First, Applicants assert in response to the experimental design examples, each tablet (tablets 1-3) were administered to three beagles (three beagles per group). Applicants assert that the global trend in animal experimentation is to reduce the number of animal subjects as far as possible and asserts that three beagles per group is not a small sample size in the relevant technical field.
Second, Applicants assert visual observations and evaluations by scoring GI side effects in subjects is standard in the art and should be regarded as objective results. Applicants assert the present application demonstrates that tablets weighing 0.3 g or less reduced GI side effects to a greater extend compared to other tablet weights and provides additional experimental data. Applicants again assert that a reduction in side effects occurs only at the claimed tablet weights.
Third, Applicants assert Crockett et al do not suggest a tablet weight of 0.3 g or less, and does not disclose any critical significance within a specific range, and asserts the skilled artisan would expect tablet weights of 0.1-1 g to have similar effects.
Fourth, Applicants assert Illhan et al does not disclose the significance of tablet weight of 0.3 g or less, and the skilled artisan would not be able to identify what effects would be exhibit in any particular weight range. Applicants assert Crockett et al in view of Illhan et al does not identify any effects from the colon cleansing formulation comprising sulfate as an active ingredient in the claimed weight range, and the skilled artisan would not be able to identify which tablet weights would lead to any improvement.
Fifth, Applicants again assert that when sulfates are provided, heat is generated, and it is “technically plausible” to predict that the area of gastric mucosa where adverse effects occur due to heat generation will increase, and asserts it is reasonable to conclude that it is difficult to predict that GI side effects would be reduced by applying Illhan et al to Crockett et al.
Sixth, Applicants assert Belsey et al does not explicitly disclose small tablets, but dividing doses can reduce side effects. Applicants assert Belsey et al refers to reducing the amount of active agent per dose and splitting the administration into separate doses, and the skilled artisan would only consider splitting dose frequency not dividing unit dosage forms.
Seventh, Applicants assert that the previous Office Action noted that the 150 mg tablet showed a higher score than the 300 mg tablet, however, Applicants assert the conclusion should be made based on the overall scores across tablet weights, not based on a separate comparison of individual scores for each tablet. Applicants assert the overall tendency is that tablets weighing 300 mg or less significantly reduce GI side effects compared to other tablet weights.
First, the examiner thanks Applicants for explaining the experimental design. As best understood by the examiner, tablets 1-3 were administered to each beagle (three beagles per group), for a total of 9 beagles tested. The examiner also acknowledges that the state of the art with regard to animal testing is to reduce the number of animal subjects and that the number of tested beagles are of similar sample size in the relevant technical field. However, it is not clear, where three distinct groups were tested, which group the data presented by Applicants comes from, or if the data is an average of the three groups, as there appears to be only one point of data in the figure for each tablet weight. The instant specification does not appear to disclose how a single data point for each tablet was achieved, making the interpretation of the results unclear.
Second, it appears that the numbers associated with the scoring system where based on a standard objective measurement, as asserted by Applicants. Applicants assert that the data presented demonstrates that tablets weighing 0.3 g or less reduced GI side effects to a greater extend compared to other tablet weights, however, where there are no data showing the statistical significance of the results (e.g., error bars, t-test ANOVA, p-value, etc.), the statistical differences cannot be determined. Purely arguendo, if the results were statistically significant, it is unclear why Applicants are asserting that a reduction in side effects only occurred at the claimed tablet weights, where the results show that various tablet weights lower than others, and where the 150 mg tablet appears to be worse than the 300 mg tablet for one test, and the opposite for another, a trend in the data cannot be established for the full scope of the instant claims. It is noted that while about 300 g had the lowest side effect score, side effects were still present, and the about 150 mg tablet had a side effect score falling between the about 600 mg and about 300 mg. Additionally, all test results appear to be based on tablet formulations, and it is not clear what effect a different dosage type (i.e., capsule, pellet, etc.), would have on the results, where they would be expected to have different release rates, degradation, disintegration times, etc.
Third, respectfully, this argument is not persuasive. Contrary to Applicants’ assertion, Crockett et al do appear teach a tablet weight ranging from 0.1-5 g, which includes tablets weight about 0.3 g or less. The examiner notes that Illhan et al was relied upon for motivation to select a tablet weight of about 0.3 g or less, with the reasonable expectation that less GI side effects would occur, as discussed above. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Fourth, respectfully, this argument is not persuasive. Illhan et al were relied upon for teaching that tablet weights of 0.3 g or less specifically increase the spread of tablet dosage forms thought the entire GI tract resulting in a reduced risk of local irrational as a result of an equal drug release, among other benefits. While Illhan et al may be directed to a different active agent, the skilled artisan would reasonably recognize the general teaching that smaller dosage forms spread more evenly throughout the GI tract, reducing increased concentration in any single area, thereby reducing the risk of local irritation, as the active agent causing the irritation is spread out, resulting in less concentration in any given area. Accordingly, when formulating the oral dosage form of Crockett et al, the skilled artisan would have reasonably looked to the teachings of Illhan et al, thereby formulating the dosage forms with a weight of about 0.3 g or less, with the reasonable expectation that splitting the dosage over a larger number of smaller tablets, would increase the spread of the active agents throughout the GI tract, resulting in the above mentioned benefits.
Fifth, respectfully, this argument is not persuasive. The examiner again notes that attorney argument does not replace evidence where evidence is required. An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness. See MPEP 2145(I). Purely arguendo, even if evidence where provided, the same rationale above would apply, where the skilled artisan would reasonably expect that by spreading out the active agent throughout the GI tract, and avoiding a high local concentration, the total heat generated would be spread over a larger area, reducing the intensity of heat in any particular area that may cause local side effects.
Sixth, this argument is persuasive. Upon further review, it does appear that Belsey et al is referring to splitting dose frequency rather than reducing the size of tablets, as shown from the excerpts from references 69 and 70 referred to by Belsey et al in Applicants’ response. The examiner notes that Belsey et al are no longer relied upon in the prior art rejection above.
Seventh, respectfully, this argument is not persuasive. Applicants assert the overall tendency is that the tablets weighting 300 mg or less significantly reduce GI side effects compared to other tablet weights, but as discussed above, the statistical significance of the results cannot be determined. Purely arguendo, even if the results were determined to be statistically significant, each individual result must be evaluated to determine a trend in the data, and whether or not that data can be reasonably extended to the full scope of the instant claims. For example, in one result, the 150 mg tablet performed worse than the 300 mg tablet, and in another, the opposite was true, and because of this, it does not appear that a trend in the data can be established for the tablet weights as they approach the lower limits.
Claims 6, 20, and 21, are rejected under 35 U.S.C. 103 as being unpatentable over Crockett et al (US 20130189377 A1, cited on IDS dated 01/16/2025) and Ilhan et al (Peertechz J Med Chem Res, 2017, 3.1, pp. 012-022, cited on IDS dated 01/16/2025), and further in view of Nam et al (KR 20190041233 A, cited on IDS dated 06/29/2023).
Crockett et al and Ilhan et al are discussed above but do not appear to teach simethicone.
Nam et al teach colonic purgative compositions comprising magnesium sulfate, potassium sulfate, sodium sulfate, and simethicone (¶¶ 15, 36). When simethicone was combined with magnesium sulfate, potassium sulfate, and simethicone, a synergistic effect was observed and the dosage could be reduced by 20% and exhibit an equivalent colon cleansing effect (¶ 40). Simethicone is recognized as a drug that suppresses the formation of intestinal gas bubbles, which improves the field of view of the endoscope during a colonoscopy (¶ 41). Simethicone was known to be included in an amount ranging from 80-800 mg (¶ 50).
Regarding claim 6, it would have been obvious to further include simethicone to the solid oral formulation made obvious above, where simethicone was known to have synergistic colon cleansing effects when combined with magnesium sulfate, potassium sulfate, and sodium sulfate, as taught by Nam et al above, and where simethicone was known to improve visibility of the colon as taught by Nam et al.
Regarding claim 20, where simethicone is made obvious above, it would have been obvious to include known amounts suitable for colon cleansing formulations, including from 80-800 mg (i.e., 0.08-0.8 g), as taught by Nam et al, falling within the claimed range.
Regarding claim 21, it would have been obvious to formulate the tablet made obvious above comprising 20.24 g sodium sulfate, 0.02 to 80 g, for example 0.2 to 20 g, for example about 3 g magnesium sulfate, 3.48 g potassium sulfate, and 80-800 mg (i.e., 0.08-0.8 g) simethicone, for the same reasons discussed above. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
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 1-7, 13-15, and 17-21, are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,510,884, hereinafter ‘884, in view of Crockett et al (US 20130189377 A1), Ilhan et al (Peertechz J Med Chem Res, 2017, 3.1, pp. 012-022), and Nam et al (KR 20190041233 A).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘884 disclose a bowel cleansing composition comprising polyethylene glycol (PEG) from 140-180 g and ascorbate ingredients (claim 1). The composition is in the form of a tablet, granule, powder, capsule or liquid (claim 1). The cleansing compositions further comprise sodium sulfate at a weight ratio of PEG to sodium sulfate of 7:1 to 12:1, with embodiments comprising 16-20 g of sodium sulfate (claims 3 and 22).
The claims of ‘884 do not disclose the unit solid formulation weight as instantly claimed, sulfate in an amount of about 25 g to about 60 g, embodiments comprising sodium sulfate, magnesium sulfate, and potassium sulfate, simethicone, nor wherein the solid formulation comprises the number of solid unit forms as instantly claimed.
It would have been obvious to modify the claims of ‘884 to include the formulation as unit solid forms in known weights suitable for colon cleansing formulations, such as those taught by Crockett et al above and for the same reasons. Additional motivation is provided by Ilhan et al for the same reasons discussed above.
It would have been obvious to adjust the amount of sodium sulfate of ‘884 to known amounts suitable for sulfates in colon cleansing formulations, such as 20.24 g as taught by Crockett et al above, falling within the claimed range.
Where ‘884 discloses the combination of PEG and sodium sulfate, it would have been obvious to modify the formulation of ‘884 by using known combinations of sulfates suitable for colon cleansing formulations used combination with PEG, such as sodium sulfate, magnesium sulfate and potassium sulfate, and within the known amounts, as taught by Crockett et al above.
It would have been obvious to further include simethicone, an in known amounts, as taught by Nam et al above and for the same reasons.
It would have been obvious to formulate the bowel cleansing composition in the form of multi-dose tablets, such as 120 tablet doses, which are taught by Crockett et al to be suitable for colon cleaning formulations. Further, it was known that multi-dose formulations of mini tablets were known to reduce the risk of local side effects, be easier to swallow, etc., as taught by Ilhan et al above.
Response to Arguments
Applicants have not provided arguments with respect to the nonstatutory double patenting rejection in their response. Accordingly, the claims are rejected for the same reasons above and of record.
Conclusion
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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