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 .
Summary
Receipt of Applicant’s disclosure documents filed on 06/29/2024 is acknowledged. Claims 1-15 are pending.
Priority
The current application is a continuation of International Application No. PCT/KR2023/010399 filed on July 19, 2023, which claims priority to Korean Patent Application No. 10-2022-0089764 filed on July 18, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/26/2024 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. Signed copies have been attached to this office action.
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.
Claims 4 and 13 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.
Regarding Claim 4 (Improper Mixed Claim Type): Claim 1 is directed to a product ("A bowel cleansing composition..."). Dependent Claim 4 further limits the composition by reciting method steps: "...administered in a mode by taking the preparation solution, followed by taking the water-soluble solvent separately, wherein the mode is repeated a total of two to four times the day before and on the day of the examination." A claim that recites both a product and a method of using that product is indefinite under 35 U.S.C. 112(b) because it is unclear whether infringement occurs upon the manufacture/sale of the physical composition or only when a user actually performs the recited administration steps (see IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 77 USPQ2d 1140 (Fed. Cir. 2005)).
Regarding Claim 13 (Chemical Identity in Solution): Claim 13 recites that the composition comprises "sodium picosulfate... magnesium oxide... and citric acid..." in a water-soluble solvent. Claim 13 depends from Claim 1, which broadly recites a "bowel cleansing composition" without restriction to a dry solid form, and Kang discloses formulating such compositions as solutions (¶ [0050]- ¶ [0052]). When magnesium oxide (MgO) and citric acid are introduced into an aqueous solvent, they inherently undergo an acid-base neutralization reaction to form magnesium citrate, leaving free magnesium and citrate ions in the solvent. Because the starting chemical species (magnesium oxide) ceases to exist as a distinct entity upon dissolution, it is unclear whether the claim boundaries encompass the unreacted starting dry materials or the resulting ionic reaction products in solution.
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.
Claim(s) 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MoviPrep® (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution), NDA 021881, originally approved in 2010 and publicly available (via FDA.gov and DailyMed) well before the effective filing date of the present application (the "MoviPrep Label").
Regarding Claim 9: The MoviPrep Label discloses a bowel cleansing composition comprising polyethylene glycol as a first effective ingredient and ascorbic acid together with sodium ascorbate as a second effective ingredient, dissolved in a water-soluble solvent. The label instructs that the entire reconstituted dose is prepared by dissolving 200 g of polyethylene glycol 3350, 9.4 g of ascorbic acid, and 11.8 g of sodium ascorbate (21.2 g total ascorbate species) in 2 L of water. Based on this 2 L total volume, the composition yields 100 g/L of polyethylene glycol and 10.6 g/L of ascorbate species, both of which fall squarely within Claim 9's ranges of 10 g/L to 500 g/L for the first effective ingredient and 1 g/L to 300 g/L for the second effective ingredient, and the 2 L preparation volume falls within Claim 9's claimed 1.0 L to 3.0 L range for the water-soluble solvent.
Regarding Claim 10: The MoviPrep Label discloses that the entire reconstituted dose contains 200 grams of polyethylene glycol 3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate, dissolved in 2 L of water. These figures are identical, to the precision reported on the label, to the amounts recited in Claim 10 (200 g polyethylene glycol 3350; 9.4 g ascorbic acid; 11.8 g sodium ascorbate; 15 g anhydrous sodium sulfate; 5.382 g sodium chloride; 2.030 g potassium chloride; 1.0 L to 3.0 L of water). The MoviPrep Label therefore anticipates Claim 10 in its entirety.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Rose et al. (US 2008/0260682 A1) hereinafter the reference is referred as “Rose” in view of Kang et al. (US 2015/0342937 A1) hereinafter the reference is referred as “Kang”, and further in view of EP 3,015,102 A1(hereinafter the reference is referred as "EP'102") and US 2016/0220492 A1 (hereinafter the reference is referred as "Appavu").
Prima Facie Obviousness: The combination of Rose and Kang establishes a prima facie case of obviousness. The prior art references reside in the identical field of endeavor (purgative bowel preparations), address the identical clinical problem (improving patient compliance while maintaining colon cleansing efficacy), and disclose overlapping component concentrations and physical parameters. Where the parameters of a desired product are explicitly taught by the prior art, or where a claimed range overlaps with disclosures in the prior art, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Peterson, 315 F.3d 1325, 65 USPQ2d 1379 (Fed. Cir. 2003)).
Regarding Claim 1: Rose teaches a bowel cleansing composition administered via a split-dose regimen (evening before and morning of the examination) (¶ [0003], ¶ [0060]). Rose further teaches that the volume administered for a split-dose can be minimized to a range of 480 to 500 mL (¶ [0063]).
Kang similarly discloses low-volume bowel cleansing formulations designed to maximize patient compliance (¶ [0003], ¶ [0012]). Kang teaches preparing a total preparation solution volume of 0.1 L to 1.0 L (100 to 1000 mL) to be taken prior to examination (¶ [0021]). In paragraph ¶ [0080], Kang explicitly teaches administering this low-volume preparation on the day of the examination. Kang's Example 1 dosing regimen confirms this in practice, disclosing ingestion of a total of 500 mL of the bowel cleansing solution starting 5 hours before the scheduled examination (¶ [0119]).
Motivation to Combine: A person having ordinary skill in the art (PHOSITA) would have been motivated to modify the split-dose administration volumes of Rose by integrating the precise, low-volume targets (e.g., 500 mL) explicitly taught by Kang. The configuration of a day-of dosage to be 700 mL or less is explicitly driven by a known clinical desire to decrease the overall fluid ingestion burden on the patient, thereby reducing adverse gastrointestinal side effects (e.g., taste aversion, nausea, vomiting) and increasing compliance, as explicitly detailed by Kang (¶ [0012]).
Reasonable Expectation of Success: A PHOSITA would have possessed a reasonable expectation of success in executing this combination. Both Rose and Kang utilize standard, biocompatible osmotic laxative mechanisms that operate effectively regardless of total carrier fluid reduction. Because the underlying active ingredients act predictably within the human gastrointestinal tract to draw water into the bowel lumen, optimizing the liquid volume to 700 mL or less represents the predictable application of known low-volume formulation methods to achieve a highly expected clinical result.
Regarding Claim 2: Rose discloses a day-of administration volume of 480 to 500 mL (¶ [0063]), and Kang teaches a volume range spanning 0.1 L to 1.0 L (inclusive of 500 mL or less) (¶ [0021]). It represents a matter of routine optimization for a PHOSITA to select a value of "500 mL or less" from these overlapping prior art ranges to optimize palatability and efficacy.
Regarding Claim 3: Rose explicitly teaches that the total fluid volume necessary for a complete colonic purge ranges from 0.5 to 5 L, 0.75 to 4 L, or 1.5 to 2 L (¶ [0062]). The claimed range of "1.0 L to 4.0 L" is directly encompassed by and broadly overlaps with the ranges disclosed by Rose (0.5 to 5 L; 0.75 to 4 L), establishing a prima facie case of obviousness that the applicant has not rebutted.
Regarding Claim 4: Rose teaches providing the purgative composition as a dry powder, tablet, or concentrated solution (¶ [0013]). Rose further details an administration method where the active composition is first dissolved in a small, concentrated amount of liquid, followed by the separate consumption of the remaining required hydration vehicle/solvent (¶ [0063]). Kang likewise describes a two-part regimen in paragraph ¶ [0074], wherein active ingredients are dissolved in a minimal aqueous solvent volume (0.05 L to 0.2 L) and taken repeatedly alongside a separate beverage vehicle. A PHOSITA would have combined these techniques with a reasonable expectation of success to accommodate patients who experience taste aversion to highly concentrated active ingredients.
Regarding Claim 5: Rose discloses dry powder compositions reconstituted into solutions (¶ [0013], ¶ [0062]). Kang explicitly discloses formulating the bowel cleansing components into solutions, liquid suspensions, or emulsions (e.g., incorporating simethicone suspensions for gas relief) (¶ [0050], ¶ [0051]).
Regarding Claim 6: Kang discloses a primary bowel cleansing composition containing at least one sugar alcohol (such as sorbitol, xylitol, or erythritol) at a concentration of 10 g/L to 500 g/L and a second cleansing component consisting of ascorbic acid or its salt at a concentration of 15 g/L to 500 g/L (¶ [0021], ¶ [0033]). These components and concentrations directly overlap the claimed sugar alcohol (10 to 500 g/L) and ascorbic acid (1 to 300 g/L) ranges. While Kang specifies a primary preparation volume of 0.1 to 1.0 L (¶ [0021]), Rose teaches complete-purge solvent volumes of 0.5 to 5 L and 0.75 to 4 L (¶ [0062]), both of which fully encompass the claimed 1.0 L to 3.0 L range. Diluting a known chemical purgative mixture to fit conventional volumetric guidelines is a matter of routine clinical optimization, which a PHOSITA would perform with a high expectation of success to meet established physiological hydration protocols.
Regarding Claim 7: Kang explicitly discloses adding alkali metal bicarbonates to neutralize the high acidity of the ascorbic acid component (¶ [0065]). Specifically, Kang teaches adding sodium bicarbonate at 0.1 g/L to 10 g/L and potassium bicarbonate at 0.1 g/L to 20 g/L. The claimed range of 0.5 g/L to 5 g/L falls squarely within the concentration boundaries taught by Kang, rendering the specific narrow range prima facie obvious.
Regarding Claim 8: Kang discloses every single chemical component and its broad operational concentration range (10–500 g/L sorbitol, 15–500 g/L ascorbic acid, 0.1–10 g/L sodium bicarbonate, and 0.1–20 g/L potassium bicarbonate) (¶ [0033], ¶ [0065]). Arriving at the exact parameters of Claim 8 (110 g D-sorbitol, 15 g ascorbic acid, 2.1 g sodium bicarbonate, 0.9 g potassium bicarbonate dissolved in 1.0–3.0 L of water) represents nothing more than the routine optimization of overlapping ranges to achieve proper solution osmolarity and flavor palatability. A PHOSITA would reasonably expect that selecting values within these known ranges would successfully yield an effective, palatable formulation.
Regarding Claim 9: To the extent Claim 9 is not deemed fully anticipated by the MoviPrep Label (see 35 U.S.C. 102(a)(1) rejection, supra), Rose teaches standard colonic purgative formulations utilizing polyethylene glycol (PEG 3350 or PEG 8000) at total dosages of 100 g to 1000 g (¶ [0059]), dissolved in solvent volumes of 0.5 to 5 L or 0.75 to 4 L (¶ [0062]), which encompass the claimed 1.0 to 3.0 L range. Kang further identifies the state of the art in paragraphs ¶ [0012] and ¶ [0045] as combining 200 g of PEG with 10.6 g of ascorbic acid in a 2 L liquid formulation (yielding 100 g/L PEG and 10.6 g/L ascorbic acid). This established commercial formulation, independently confirmed by the MoviPrep Label, falls directly within the claimed concentration criteria.
Regarding Claims 10, 11, and 12: As to Claim 10, see the 35 U.S.C. 102(a)(1) rejection above; the MoviPrep Label alone anticipates this claim and independently renders it obvious in view of Rose and Kang. As to Claims 11 and 12, these claims recite the same classes of ingredients as Claim 10 and the MoviPrep Label (PEG, ascorbic acid, sodium ascorbate, sodium sulfate, sodium chloride, and potassium chloride, in a water-soluble solvent), but in different relative proportions. The MoviPrep Label's exact, FDA-approved formulation (200 g PEG; 15 g sodium sulfate; 5.38 g sodium chloride; 2.03 g potassium chloride; 9.4 g ascorbic acid; 11.8 g sodium ascorbate per 2 L) provides a known starting formulation from which a PHOSITA would have been motivated to vary the relative proportions of PEG, ascorbate species, and electrolytes, while remaining within the same recognized ingredient classes, in order to optimize osmolarity, palatability, and patient electrolyte retention, consistent with Rose's and Kang's shared emphasis on reducing total ingestion volume while maintaining cleansing efficacy (Rose ¶ [0005]; Kang ¶ [0012]). Adjusting the relative proportions of the ingredients of a known, commercially marketed formulation is a recognized result-effective variable and the product of routine experimentation (see In re Aller, 220 F.2d 454, 105 USPQ 233 (CCPA 1955); In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)). Rose itself confirms that formulation amounts may be adjusted according to the knowledge of a person of ordinary skill in the art to optimize the composition (¶ [0051]). Absent a showing of unexpected results tied to the specific claimed gram-weight values in Claims 11 and 12, a PHOSITA would execute these structural formulations with a reasonable expectation of success based on the predictable chemical behavior of this known PEG/ascorbate/electrolyte osmotic laxative system.
Regarding Claim 13: Claim 13 is further rejected under 35 U.S.C. 103 as being unpatentable over Kang in view of EP 3,015,102 A1 (Kang et al., "Intestine Cleansing Composition," published May 4, 2016) ("EP'102"), and further in view of US 2016/0220492 A1 (Appavu et al., "Pharmaceutical Composition of Sodium Picosulfate," published August 4, 2016) ("Appavu"). EP'102, a related family member sharing common inventorship with Kang, discloses a bowel cleansing composition comprising the same first cleansing ingredient (sugar alcohol, 10 g/L to 500 g/L), second cleansing ingredient (ascorbic acid or a mixture of ascorbic acid and a salt of ascorbic acid, 15 g/L to 500 g/L), and aqueous solvent (0.1 L to 1.0 L) as Kang, further comprising picosulfate as a third cleansing ingredient at a concentration of 1 mg/L to 100 mg/L (i.e., 0.001 g/L to 0.1 g/L) (EP'102, claims and Summary). This disclosed picosulfate range is identical to the range recited in Claim 13 (0.001 g/L to 0.1 g/L of sodium picosulfate). Appavu independently confirms that sodium picosulfate, citric acid, and magnesium oxide (together with sodium bicarbonate) form a known, art-recognized combination for bowel cleansing prior to colonoscopy (Appavu, Abstract). A PHOSITA, starting from Kang's sugar-alcohol/ascorbic-acid formulation and its own disclosed magnesium oxide and citric acid adjuncts (¶ [0057]- ¶ [0058]), would have been motivated by EP'102 to add sodium picosulfate at the specific, art-recognized concentration of 1 mg/L to 100 mg/L to obtain the combined osmotic (sugar alcohol) and stimulant (picosulfate) laxative effect that EP'102 itself teaches achieves superior cleansing efficacy and improved taste relative to conventional formulations, and would have been further motivated by Appavu to pair the added picosulfate with magnesium oxide and citric acid, consistent with this well-established, art-recognized combination. A PHOSITA would have had a reasonable expectation of success given the well-documented, independent mechanisms of action and established safety profiles of these known laxative agents, as evidenced by their combined commercial use prior to the effective filing date.
Regarding Claim 14: Claim 14 is further rejected under 35 U.S.C. 103 as being unpatentable over Kang in view of EP'102. Kang explicitly suggests this precise multi-action hybrid approach in paragraph ¶ [0084]. Kang teaches that the sugar alcohol composition of the invention (e.g., sorbitol) can be mixed directly with, or used as a vehicle for, alternative commercial PEG formulations (such as COLYTE) or picosulfate formulations (such as PICOLIGHT) to obtain an optimized purgative effect while minimizing total ingestion volumes. EP'102 confirms that picosulfate is effectively incorporated into a sugar-alcohol-based bowel cleansing composition at a concentration of 1 mg/L to 100 mg/L (0.001 g/L to 0.1 g/L), which falls entirely within Claim 14's broader claimed range of 0.001 g/L to 1 g/L of sodium picosulfate. A PHOSITA would be motivated to combine Kang's PEG and sorbitol-containing embodiments (¶ [0021], ¶ [0056]) with the picosulfate teaching of EP'102 and the hybrid-formulation suggestion of Kang ¶ [0084] to arrive at the claimed PEG/sorbitol/picosulfate combination, and would reasonably expect success given the well-established, independent and complementary mechanisms of action of osmotic (PEG, sorbitol) and stimulant (picosulfate) laxative agents.
Regarding Claim 15: Rose teaches an osmotic electrolyte composition containing calcium, phosphate, potassium, magnesium, bicarbonate, chloride, sodium, and sulfate salts, individually or as salts thereof (¶ [0028]), and specifically identifies the use of sodium sulfate within its active electrolyte combinations (¶ [0033], ¶ [0042]). Because Rose already discloses potassium and magnesium as suitable electrolyte cations and sulfate as a suitable anion, selecting potassium sulfate and magnesium sulfate therefrom involves nothing more than choosing from a finite number of identified, predictable electrolyte combinations to generate an osmotic gradient, representing an obvious-to-try design choice within the routine capability of a PHOSITA (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)), executed with an entirely predictable expectation of success.
Conclusion
No claims are allowed.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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