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 .
Response to Arguments
Applicant's arguments filed 8/7/2025 have been fully considered but they are not persuasive.
All rejections of cancelled claims 7 and 14 are withdrawn.
112: Applicant amendments were sufficient to overcome rejections of claims 2-4, 11-13, and 15-18. Claim 5 remains rejected as the issues were not fully resolved. New 112 rejections have been issued for claims 1-4, 6, 8-13, 16, and 19.
102: The rejection of claim 1 is maintained.
103: The rejections of claims 1-8, 11-13, and 16-18 are maintained. New 103 rejections of claims 9-10, 15, and 19 have been issued.
102(a)(1) Rejection over Ingram
Applicant argues that Ingram is solely directed to the use of solid films for the treatment of bloating, discomfort and/or pain, and does not teach a liquid composition. Applicant’s arguments are not persuasive as Ingram teaches the film is soluble in an aqueous solution and is intended to quickly dissolve in the oral cavity [page 5], i.e. the ingredients of the film become dispersed in a liquid solution, which is then swallowed. Ingram’s discussion of the dissolution time of the film [see page 5 line 6] and strip thickness [page 6 line 21] also demonstrates that the film is not intended to be ingested in solid form (i.e. not swallowed while still in solid film form. Thus, Ingram meets the instantly claimed limitation of a liquid composition of claim 1 as amended.
103 Rejections over Ingram
Applicant’s arguments regarding Ingram not teaching a liquid composition for administration are not persuasive for the same reasons discussed above. Applicant also argues that modifying Ingram to administer a liquid composition would remove the advantages conferred by a film product. This is not persuasive as Ingram, without modification, may be relied on for teaching the liquid composition comprising of simethicone and sucrose stearate (a sucrose fatty acid ester). The film is intended to dissolve in saliva (i.e. be ingested as a liquid) in the oral cavity [page 5]. Thus, the dissolution of the film in an aqueous liquid does not negate any of the advantages conferred by the film as taught by Ingram.
103 Rejections over Ingram in view of Scetta
In response to applicant's argument that the proposed modifications would render the prior art inventions inoperable, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, applicant argues that modifying Ingram’s film to include an oily medium or modifying Scetta’s composition to comprise an aqueous medium would render the prior art inventions inoperable or unsatisfactory. This is not persuasive as Ingram is relied on for teaching the oral administration of a liquid composition comprising simethicone and sucrose esters of fatty acids for treatment of gas-related gastrointestinal symptoms [claim 27], and Scetta is relied on for teaching the use of the composition for intestinal colic in children/infants [claim 10] and the combination of simethicone products with milk [page 4, line 9; page 12]. Nothing in the disclosure of Ingram indicates that the film may not be dissolved in another water-containing liquid (such as milk) prior to administration. To the contrary, Ingram states that the film is soluble in an “aqueous water solution such as saliva” [page 5 line 23], suggesting that the film may be dissolved in other aqueous water solutions.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New Rejections – 35 USC 112(a)
Claims 1-4, 6, 8-13, and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treatment for disorders of the gastrointestinal tract such as intestinal colic, abdominal cramps and flatulence, does not reasonably provide enablement for a method of treatment for all disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: 1) scope or breadth of the claims; 2) nature of the invention; 3) relative level of skill possessed by one of ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or direction provided by the inventor; 7) presence or absence of working examples; and 8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. When the above factors are weighed, it is the Examiner's position that one skilled in the art could not practice the invention without undue experimentation. While all of the factors have been considered, only those required for a prima facie case are set forth below.
1) Scope or breadth of the claims: The claims are broader in scope than the enabling disclosure. Under BRI, the recitation, “a method of treatment” in claim 1 may be construed as the treatment for any disease or condition.
2) Nature of the invention: The nature of the invention is drawn to the pharmaceutical art. This claim cover diseases/conditions that are known to exist and those that may be discovered in the future, for which there is no enablement provided.
4) State of, or the amount of knowledge in, the prior art: The art teaches that compositions comprising simethicone are well-known for use in methods of treating GI symptoms such as bloating, gas, and abdominal pain, see e.g., Meier et al. (2007). However, the simple recitation of the administration of a composition comprising simethicone and sucrose esters as described in the instant claims does not mean that the method is enabled for treatment of all diseases or conditions. The art does not recite this method for the treatment of other diseases/conditions.
7) Presence or absence of working examples: The specification fails to provide scientific data and working embodiments with respect to administration to a human subject and the efficacy of the method in treating any disease or condition. Since the specification fails to disclose working examples of the claimed method being administered to treat any disease, the state of the art must be relied upon to determine the scope of enablement. Therefore, as the state of the art discloses use of the method in GI disorders, the instant claimed method is not enabled for the treatment of all diseases/conditions.
MPEP 2103(I)(A): “The purpose of this requirement is to limit patent protection to inventions that possess a certain level of “real world” value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research (Brenner v. Manson, 383 U.S. 519, 528-36, 148 USPQ 689, 693-96 (1966); In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197, 1200-03, 26 USPQ2d 1600, 1603-06 (Fed. Cir. 1993)).”
MPEP 2164.03: "Thus, the public' s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.” This has not been done and consequently the enablement requirement is not satisfied for the full scope of the claims as written.
Claim Rejections - 35 USC § 112(b)
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.
Maintained Rejections – 35 USC 112(b)
Claim 5 is 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 5, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For purposes of compact prosecution, the limitations following the phrase will be interpreted as optional.
New Rejections – 35 USC 112(b)
Claims 1, 8, 16 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 1, this claim recites the limitation of administering "to the subject". There is insufficient antecedent basis for this limitation in the claim. Additionally, claim 1 recites “sucrose esters of fatty acids (or sucrester)”. The instant specification refers to “sucrester” as sucrose esters, which embraces compounds that are not sucrose esters of fatty acids, such as sucrose esters of glycerides. This renders the scope of the claim indefinite, since it is unclear whether the term in parentheses is essential to the claimed invention.
Regarding claim 8, this claim depends from cancelled claim 7, therefore the scope of the claim is unclear. For purposes of compact prosecution, claim 8 is being interpreted as depending from claim 1.
Regarding claim 16, the phrase “comprising or, alternatively, consisting of” renders the claim indefinite because it is unclear whether the claim is open or closed to other unrecited elements. Additionally, claim 16 recites “sucrose esters of fatty acids (or sucrester)”. This renders the claim indefinite since it is unclear whether the term in parentheses is essential to the claimed invention. (See 112 rejection of claim 1 above.)
Claim Rejections - 35 USC § 102
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.
Maintained Rejections - 35 USC § 102
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ingram et al. (WO2012025730A2, published 03/01/2012).
Regarding claim 1, Ingram teaches a method of treating bloating, discomfort and/or pain caused by excess gas in the stomach and/or intestinal tract using a film [claim 27] comprising simethicone [claim 1] and sucrose stearate [claim 4], which is a sucrose ester of stearic acid (reads on sucrose ester of fatty acid). Ingram further teaches the dissolution of the water-soluble film in the oral cavity (i.e. dissolving the film into a liquid in saliva) [claim 2] of a human subject [page 5 lines 1-4]. Thus, the invention of claim 1 is anticipated by Ingram.
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.
Maintained Rejections – 35 USC § 103
Claims 1-4, 6, 8, 11-13, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ingram et al. (WO2012025730A2, published 03/01/2012) as evidenced by Hu et al. (2019) and LGC Standards (downloaded May 2025).
Regarding claims 1, 6, and 8, Ingram teaches a method of treating bloating, discomfort and/or pain caused by excess gas in the stomach and/or intestinal tract using a film [claim 27] comprising simethicone [claim 1] and sucrose stearate [claim 4] which is a sucrose ester of stearic acid (a fatty acid). Ingram also teaches its composition to be suitable for oral consumption for humans [page 5 lines 1-5] (reads on oral administration to a subject). Ingram further teaches the dissolution of the water-soluble film in the oral cavity [claim 2] of a human subject [page 5 lines 1-4], i.e. dissolving the film into a liquid in saliva (reads on liquid composition). Additionally, Ingram teaches “[o]ther excipients include: Glycerol as plasticiser, artificial sweetener (select from acesulfame K, sodium saccharin and sucralose), flavouring (peppermint or cranberry), and preservative (potassium sorbate)” [page 13 lines 5-8] which reads on the optional limitation of at least one food or pharmaceutical grade additive and/or excipient.
Regarding claims 2-3 and 18, Ingram teaches the composition to include “gums (e.g. xanthan gum, tragacanth gum, guar gum, acacia gum, Arabic gum)” [page 22 lines 28-29]. Evidentiary reference Hu teaches that xanthan gum has a molecular weight range of 2.0 × 106 to 2.0 × 107 Da [page 1, Introduction] which is 2000-20000 kDa, which overlaps with the instantly claimed 500 kDa to 10000 kDa 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 4, Ingram teaches treating “bloating, discomfort and/or pain caused by excess gas in the stomach and/or intestinal tract” which reads on “intestinal colics, abdominal cramps, flatulence” [claim 27].
Regarding claims 11 and 16-17, Ingram teaches the simethicone weight percentage range of about 10 to 50% [page 5 lines 13-16] which overlaps with the recitation of 1 to 10% in instant claims 11 and 16. Ingram also teaches sucrose stearate to be between about 0.1 to 10% by weight [claims 4, 5] which overlaps with the recitation of 0.05 to 1.5% in instant claims 11 and 16-17. Instant claim 17 recites simethicone in the amount of 1-7% which is close to the range taught in the prior art. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, the ranges taught in Ingram make obvious the instant limitations.
Regarding claim 12, the aforementioned concentration ranges taught by Ingram overlap with the instantly claimed 15:1 and 1:1 ratio range for simethicone to sucrose esters of fatty acids.
Regarding claim 13, as discussed above, Ingram teaches stearic acid which is a C18 fatty acid. While Ingram does not explicitly disclose the C18 monoester percentage within sucrose stearate, evidentiary reference LGC provides the evidence that sucrose stearate comprises 70% monostearate which is within the instant claimed range of 50 to 90%. Thus, absent evidence of the contrary, Ingram makes obvious the instant claimed limitations.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ingram et al. (WO2012025730A2, published 03/01/2012) as applied to claim 1 above, and further in view of Scetta (WO2013/121354A1, published 08/22/2013).
Regarding claim 5, Ingram does not explicitly teach the method of claim 1 for treatment of intestinal colics and/or abdominal cramps in pediatric subjects or neonates. Scetta teaches an orally administered liquid simethicone composition [claim 1] for the treatment of gas, bloating, and flatulence [claim 10]. Scetta further teaches the treatment to be used in treating intestinal colics, “especially in children and infants” [claim 10]. Thus, Ingram and Scetta teach overlapping treatments that address the same symptoms. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Ingram to treat the same symptoms with a composition comprising the same active ingredient, in a specific patient population such as children and infants.
New Claim Rejections - 35 USC § 103
Claims 9, 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ingram as applied to claims 1 and 6 above, and further in view of Yazdani-Brojeni (2014) and Scetta (WO2013/121354A1, published 08/22/2013).
Regarding claim 9, claim 9 recites the limitation wherein the liquid composition of claim 1 is administered via dropper, as an oral spray or syrup. As discussed previously, Ingram teaches the administration of a liquid composition wherein a soluble film dissolves into a liquid in the oral cavity. Ingram does not explicitly teach the solubilization of the film prior to oral administration such that the composition is capable of being administered via dropper, as an oral spray or syrup. Yazdani-Brojeni teaches that solid formulations of drugs have the benefit of easier transport and storage compared to liquid formulations, despite liquid formulations being easier to administer to children [pg. 258]. Yazdani-Brojeni further teaches that dissolving medication in breast milk may be an option for infants due to palatability and sanitary reasons [pg. 258]. Furthermore, Scetta teaches that the presence of water in the simethicone composition generates the possibility of bacterial and fungal proliferation [pg. 3, line 31]. Thus, it would be advantageous to store the composition in film form and dissolve the film in milk only immediately prior to administration in order to minimize risk of bacterial/fungal contamination. It would be obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Ingram with that of Yazdani-Brojeni and Scetta to solubilize the film of Ingram in breast milk prior to administration, resulting in a liquid composition capable of being administered via a dropper. A skilled artisan would recognize the benefits of formulating a solid film that could be dissolved in breast milk prior to administration, as the film allows for improved storage of the simethicone composition, and the dissolution in milk allows for ease of administration, reduced risk of bacterial/fungal proliferation, and improved palatability.
Regarding claim 10, claim 10 recites the limitation wherein the simethicone composition in water-based liquid form is administered to a pediatric subject in a mixture with an artificial milk, wherein said artificial milk comprises water and powdered milk. As discussed in the rejection above of claim 9, Ingram in view of Yazdani-Brojeni makes obvious the dissolution of a soluble film comprising simethicone and sucrose esters in breast milk for administration to a child subject. However, Yazdani-Brojeni does not teach the dissolution of solid medication in an artificial milk comprising powdered milk and water. Scetta teaches that breast milk and prepared industrial (i.e. powdered) milk are functionally equivalent as they both serve as the main food for an infant [pg. 11 line 14]. Substituting equivalents known for the same purpose is prima facie obvious. See MPEP 2144.06.
Regarding claim 15, claim 15 recites a kit. As discussed above, the rejection of claim 10 makes obvious a method wherein the composition of claim 1 is dissolved in artificial milk prior to administration. Since the only claimed structure in the kit of claim 15 is a product comprising milk proteins for pediatric subjects or neonates and the composition according to claim 1, the kit is made obvious by the prior art.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ingram as applied to claim 1 above, and further in view of Drugs.com (published 5/29/2016).
Regarding claim 19, claim 19 depends from claim 1 and recites the limitation wherein the total amount of the liquid composition administered to the subject in a day comprises 66.7 to 200.1 mg of simethicone and 5 to 10 mg of sucrose esters of fatty acids. As discussed above, Ingram makes obvious the method of claim 1 and further teaches simethicone in the range of about 10 to 50% by weight (pg. 5 lines 13-16) and sucrose stearate in the range of about 0.1 to 10% by weight (claims 4-5). Ingram does not explicitly teach a total amount of simethicone and sucrose esters of fatty acids to be administered to a subject daily. It is medically accepted that for children under 2 years old, the usual dose is 80 mg/day (20 mg x 4 times a day), and for children between the ages of 2 and 12, the daily dose should not exceed 240 mg a day without physician supervision (6 strips x 40 mg/strips = 240 mg) [Drugs.com]. It would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the dose of simethicone according to the age and/or weight of the subject (as is customary for many medications generally), using the taught amounts as guidelines. If the taught doses are interpreted as a range of 80 mg to 240 mg/day, based on the age and weight of the subject, this overlaps with the instant claimed range of 66.7 mg to 100.1 mg of simethicone daily. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
As stated earlier, Ingram teaches a composition comprising about 10 to 50% simethicone by weight (pg. 5 lines 13-16) and about 0.1 to 10% sucrose stearate by weight (claims 4-5). This equates to a ratio of simethicone/sucrose stearate ranging from 100 to 5 (10%/0.1% to 50%/10%). Thus, based on the doses taught by Drugs.com, 80 mg of simethicone would correspond with 0.8 to 16 mg of sucrose esters (80/100 to 80/5) and the upper daily limit of 240 mg of simethicone would correspond with 2.4 to 48 mg of sucrose esters of fatty acids (240/100 to 240/5). These amounts overlap with, and make obvious, the instant claimed amounts of 5 to 15 mg of sucrose esters of fatty acids.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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