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 .
Status of the Claims
Claims 1-7 are pending in the application.
Information Disclosure Statement
The IDS’s dated 2/4/2025, 4/8/2025 and 6/26/2025 have been considered. Signed copies are enclosed herewith.
Claim Rejections - 35 USC § 112
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.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite “the viscoelastic composition comprising a thickening substance and water and having a shear storage modulus G’ of 0.7 or more” (claims 1 and 6), a shear storage modulus G” of 7.0 Pa of less (claim 2), a polysaccharide or a hydrophilic polymer (claim 3), a loss tangent of more than 0.6 (claim 4); and is colorless and transparent (claim 5).
The claims are drawn to any and all thickening substances (claim 1) or any and all polysaccharides or hydrophilic polymers (claim 3) and any amount thereof that when combined with water produces a viscoelastic composition having the claimed properties/characteristics.
Table 1 of the instant specification illustrates exemplary formulations comprising xanthan gum (XG) in combination with either guar gum (GG) or locust bean gum (LBG). However, the only formulations that fall within the claimed properties are composed of the particular thickening substances, xanthan gum and guar gum (in combination) in a specific weight ratio of 7:3 and in a very narrow concentration of 0.26-0.40 wt%. It is also noted that said exemplified formulations do not possess a G’ of greater than 2.18. It is further noted that other formulations are exemplified that do not fall within the scope of the claim. Thus, the Table shows evidence of unpredictability.
For these reasons, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed invention.
Dependent claim 7 does not remedy the issue and as such said dependent claim suffers from the same deficiency.
Claims 1-7 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 the compositions listed in Table 1 of the instant specification, does not reasonably provide enablement for a viscoelastic composition for securing the field of view of an endoscope, the viscoelastic composition comprising a thickening substance and water and having a shear storage modulus G’ of 0.7 Pa or more and a method of using thereof. 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 and/or use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention: The claims are drawn to a viscoelastic composition for securing the field of view of an endoscope, the viscoelastic composition comprising a thickening substance and water and having a shear storage modulus G’ of 0.7 or more, and a method of using thereof (claims 1 and 6), a shear storage modulus G” of 7.0 Pa or less (claim 2), wherein the thickening substance is a polysaccharide or a hydrophilic polymer (claim 3), a loss tangent of more than 0.6 (claim 4), and the composition is colorless and transparent (claim 5). The nature of the invention requires knowledge of thickening substances that are able to have an effect of increasing viscosity when dissolved or dispersed in water, how to measure for shear storage modulus and loss tangent, how to adjust the composition in order to obtain the claimed shear storage modulus and loss tangent values, and how ingredients effect the optical characteristics of the overall composition.
Breadth of the Claims: The claims are broad in that any and all thickening substances or any and all polysaccharides or any and hydrophilic polymers may be used to form the claimed composition that is fed to the vicinity of a distal part of an endoscope. Further, the specification at [0012] states,
The term “thickening substance” of the present invention means a substance having an effect of increasing viscosity when dissolved or dispersed in water. The thickening substance of the present invention may comprise one kind of component or may comprise a combination of two or more kinds of components.
Thus, any and all combinations of thickening substances are also permitted. The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims.
Guidance of the Specification and Existence of Working Examples: The specification describes a viscoelastic composition comprising a thickening substance and water and a method for securing the field of view of an endoscope comprising feeding the viscoelastic composition to the distal part of the endoscope [0007]). The specification further describes the viscoelastic composition having a shear storage modulus of 0.7 Pa or more, a shear storage modulus of 7.0 Pa or less, and a loss tangent of more than 0.6 ([0008]). The specification also states that the composition must not be colored or opaque to the extent that makes observation or operation in the field of view of an endoscope substantially impossible ([0039]. The specification defines a “thickening substance” to mean “a substance having an effect of increasing viscosity when dissolved or dispersed in water” ([0012]). The specification states that the thickening substance of the present invention may comprise one kind of thickening substance or may comprise a combination of two or more thickening substances and provides examples of thickening substances including, but not limited to, alcohols such as methanol, ethanol, 2-propanol, 1,4- butanediol, 1,3-butylene glycol, propylene glycol, glycerin catechin, glucose, fructose, galactose, sucrose, lactose, maltose, trehalose, xylitol, sorbitol, mannitol, glucosamine, and galactosamine; polysaccharides such as Aureobasidium culture solution, flaxseed gum, gum Arabic, arabinogalactan, alginic acid and salts thereof, propylene glycol alginate ester, welan gum, Cassia gum, gum ghatti, curdlan, carrageenan, karaya gum, xanthan gum, guar gum, guar gum enzymolysis products, psyllium seed gum, Artemisia sphaerocephala seed gum, gellan gum, succinoglycan, tamarind gum, tara gum, tragacanth gum, furcellaran, funoran, pullulan, pectin, macrophomopsis gum, Rhamsan gum, locust bean gum, starch grafted acrylate, acetylated distarch adipate, acetylated oxidized starch, acetylated distarch phosphate, starch sodium octenylsuccinate, carboxymethyl cellulose and salts thereof, carboxymethyl ethyl cellulose, starch acetate, oxidized starch, sodium starch glycolate, hydroxypropyl distarch phosphate, hydroxypropyl cellulose, hydroxypropyl starch, hydroxypropyl methyl cellulose, hydroxymethyl cellulose, hydroxyethyl methyl cellulose, hydroxyethyl cellulose, ethyl cellulose, methyl cellulose, cellulose, distarch phosphate, monostarch phosphate, phosphated distarch phosphate, fucoidan, diutan gum, glucomannan, hyaluronic acid and salts thereof, keratan sulfate, heparin, chondroitin sulfate, dermatan sulfate, scleroglucan, schizophyllan, okra extracts, Krantz aloe extracts, sesbania gum, agarose, agaropectin, amylose, amylopectin, pregelatinized starch, inulin, levan, graminan, agar, hydroxypropyl methylcellulose stearoxy ether, dextran, dextrin, croscarmellose sodium, glucuronoxylan, and arabinoxylan; proteins such as gelatin, hydrolyzed gelatin, and collagen; polyamino acids such as polyglutamic acid, polylysine, and polyaspartic acid; hydrophilic polymers such as a carboxyvinyl polymer, polyacrylic acid and salts thereof, a partially neutralized polyacrylic acid, polyvinyl alcohol, a polyvinyl alcohol- polyethylene glycol graft copolymer, polyethylene glycol, polypropylene glycol, and polybutylene glycol; and metal salts such as calcium chloride, aluminum hydroxide, magnesium chloride, and copper sulfate ([0012]).
Table 1 of the instant specification illustrates working examples. However, the only formulations that are exemplified with the claimed properties are composed of the particular thickening substances, xanthan gum in combination with either guar gum or locust bean gum in specific weight ratios and specific concentrations. When taking the limitations of claim 4 into consideration (i.e., a loss tangent of more than 0.6), the only formulations that fall within the claimed properties are composed of the particular combination of thickening substances, xanthan gum and guar gum in a specific weight ratio of 7:3 and in a very narrow concentration of 0.26-0.40 wt%. It is further noted that other formulations are exemplified that do not fall within the scope of the claim 4 including other xanthan gum/guar gum compositions and xanthan gum/locust bean gum compositions. In fact, there are more formulations in Table 1 that do not fall within the scope of the claimed invention than there are formulations that do fall within the scope of the claimed invention. Thus, the Table shows evidence of unpredictability.
Predictability and State of the Art: The state of the art at the time the invention was made was unpredictable and underdeveloped. For example, Yano et al. (WO 2017/057504 A1, Apr. 6, 2017) teaches transparent viscoelastic compositions comprising a thickening substance and water and having a loss tangent of 0.6 or less; and a method for securing the field of view of an endoscope comprising feeding said composition into the distal part of the endoscope (abstract; [0011] and [0044]) and Yano et al. (Gastrointestinal Endoscopy, 2016, see PTO-892) teaches a clear gel composition comprising OS-1 Jelly (Otsuka Pharmaceuticals) for securing the visual field of an endoscope (abstract; pg. 809). However, neither reference discusses shear storage modulus or a loss tangent of more than 0.6.
Additionally, Seo et al. (Dysphagia, 2013, see PTO-892), in the food art, teaches two commercial food thickeners: sample A comprises xanthan gum and dextrin and sample B comprises xanthan gum, guar gum and dextrin (pg. 206). Each sample is mixed with water in concentrations of 1%, 1.5%, 2%, 2.5% and 3% (pg. 206) and storage modulus G’, loss modulus G” and loss tangent (tan δ) values were obtained (Table 3). None of the G’ or the loss tangent values are within the claimed ranges of claims 2 or 3 and the reference does not speak to the color or degree of transparency of the compositions.
Thus, the state of the prior art does not provide the necessary guidance to obtain viscoelastic compositions having the claimed properties to be used in the intended/claimed method.
Amount of Experimentation Necessary: The quantity of experimentation necessary to carry out the claimed invention is undue, as the skilled artisan could not rely on the prior art or the instant specification to teach how to make and use any compositions comprising a thickening substance and water that has a shear storage modulus of 0.7 Pa or more, a shear modulus of 7.0 Pa or less, wherein the thickening substance is a polysaccharide or a hydrophilic polymer, has a loss tangent of more than 0.6, or is colorless and transparent outside of the particular xanthan gum/guar gum or xanthan gum/locust bean gum compositions disclosed in Table 1. In order to carry out the claimed invention, one of ordinary skill in the art would have to identify compositions comprising one or more thickening substances and water that have a shear storage modulus of 0.7 or more, a shear storage modulus of 7.0 Pa or less, a loss tangent of more than 0.6, and/or is colorless and transparent. Applicant has provided a partial showing of compositions possessing the claimed properties, however said showing is not sufficient for the enablement of the full scope of the claimed viscoelastic composition required by the claimed composition and method of using thereof.
In view of the breadth of the claims, the lack of guidance provided by the specification, and the unpredictability shown in the specification and in the art, the skilled artisan would have required an undue amount of experimentation to make and/or use the claimed invention. Therefore, claims 1-7 are not considered to be enabled by the instant specification.
Claim Rejections - 35 USC § 102/103
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 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.
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 1-3 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yano et al. (WO 2017/057504 A1, Apr. 6, 2017, hereafter as “Yano”). The foreign reference is not in the English language. As such, US 2018/0280587 A1 is being used as the English equivalent of said foreign reference. Please note that the citations referenced in the rejection are from the US pre-grant publication.
The instant invention is drawn to a viscoelastic composition for securing the field of view of an endoscope, the viscoelastic composition comprising a thickening substance and water and has a shear storage modulus G’ of 0.7 Pa or more; and a method using thereof.
Regarding instant claims 1-3, 5 and 6, Yano teaches a method for securing the field of view of an endoscope comprising feeding a viscoelastic composition from a proximal part of the endoscope, through a channel, into a distant part of the endoscope (abstract; [0014]). Yano teaches that the viscoelastic composition comprises a thickening substance and water ([0011]). Yano teaches thickening substances including polysaccharides (e.g., guar gum, locust bean gum) and hydrophilic polymers ([0039]). Yano teaches that the viscoelastic composition is transparent ([0044]).
Yano is silent to the limitation “a shear storage modulus G’ of 0.7 Pa or more” (instant claim 1), “a shear storage modulus G’ of 7.0 Pa or less” (instant claim 2) and “colorless” (instant claim 5).
However, Yano teaches the same thickening substances ([0039]) as disclosed in the instant specification at [0012] as well as the same viscosity range of 200 to 2,000 mPa·s (abstract) as disclosed in the instant specification at [0032]. Yano further teaches a particular viscoelastic composition containing xanthan gum and locust bean gum in a concentration of 0.08%, the ratio of xanthan gum to locust bean gum being 4:6, a viscosity of 1012 mPa·s, and a loss tangent of 0.11 (Table 2) which is nearly identical to the first composition in Table 2 of the instant specification (i.e., xanthan gum and locust bean gum in a concentration of 0.08%, ratio of xanthan gum to locust bean gum being 5:5, loss tangent of 0.11) and has a G’ value of 3.26 Pa which falls within the claimed G’ range of 0.7 Pa or more and 7.0 Pa or less.
MPEP 2112.01(I) states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. MPEP 2112.01(II) also states that a chemical composition and its properties are inseparable.
Thus, a skilled artisan would have reasonably expected a similar composition such as the one advanced by Yano to possess similar properties including shear storage modulus and colorless as that of the instant composition.
Alternatively, it is noted that tan δ = G” / G’ where tan δ is loss tangent, G” is shear loss modulus and G’ is shear storage modulus as evidenced by the instant specification at [0025]. Yano teaches that viscoelastic compositions having a loss tangent of about 0.6 or less were “acceptable” in securing the field of view ([0065]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the composition of Yano in order to produce ratio of G” to G’ or, a loss tangent, of about 0.6 or less by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Yano teaches that viscoelastic compositions having a loss tangent of about 0.6 or less are effective in securing the field of view. One of ordinary skill in the art would have reasonably expected that modifying the composition in order to produce optimal loss tangent values would have also modified the G” and/or G’ values because of the known correlation of tan δ = G” / G’.
Regarding instant claim 7, Yano further teaches that the endoscope is a medical endoscope ([0015]).
Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ viscoelastic composition differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Thus, the teachings of Yano render the instant claims anticipated or, in the alternative, prima facie obvious.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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