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 .
Claim Rejections - 35 USC § 112 – Written Description
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 1-20 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.
While the instant specification provides examples of disinfecting liquid environments, it provides no examples for disinfecting solid of gaseous environments. Additionally, the specification provides minimal guidance for the treatment methods of solid environment and no guidance for the treatment of a gaseous environment. Where it does provide guidance, the specification only discloses very generic method steps. The guidance can be found at:
Page 11, lines 7-13: “preventing infection of a solid surface by producing said solid surface comprising the composition. Thus the composition may comprise thickener, pigments (such as titanium dioxide or iron oxides) and/or extender pigments (such as talc, mica or diatomaceous earth), ultra-violet light absorbers (such as benzophenone) or scatterers (such as micronized titanium dioxide), buffers, sequestrants, and anti-microbial agents.” Here, the specification discloses one method of treating a solid surface, wherein the solid surface is produced with cucurbituril isomers, derivatives or variants thereof. There is not, however, an explanation of how to produce such a surface and what steps need to be taken. Furthermore, this treatment method appears to be directed to a method of preventing infection, not a method of disinfecting.
Page 11, lines 15-17: “The composition is optionally in the form of a solution or liquid suspension, optionally suitable for dispensing as an aerosol or spray, or in the form of a liquid coating and the step of treating the solid surface is coating the solid surface with the liquid composition.” Here the specification discloses a solid surface may be coated with a liquid composition of the cucurbituril isomers, derivatives or variants thereof, but there is not guidance as to how to carry out such a method.
Page 11, lines 19-24: “The solid surface may be part of an air filter cartridge, part of an item of medical personal protective equipment such as a mask or a pair of gloves, a wipe, or a human mucous membrane such as found in nasal passages or eyes. The composition may be applied to the surface of the solid surface or incorporated into the solid surface. Knowledge of how to incorporate the composition into the solid surface of, for example, a part of an air filter cartridge, mask, gloves or a wipe, is within the ambit of the skilled person.” While the specification asserts including the instant composition in a solid surface is within the ambit of a skilled person, there is no guidance as to how to incorporate such a composition such that it is still able to disinfect the solid environment.
Page 11, lines 24-27: “The non-toxic or cytotoxic nature of the composition is particularly useful for application to human mucous membrane as use of the composition is less likely to result in unpleasant or dangerous side effects.” The specification suggests treating human mucous membrane, but does not disclose how carry out this method.
MPEP 2163 states that an applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997).
MPEP 2163 also states that to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
In the present case, while the instant specification provides generic methods for treating a solid surface, it does not provide a detailed description of how to carry out those methods. The instant specification also lacks guidance for methods of treating a gaseous environment. Additionally, the instant specification lacks examples for treating a gaseous environment and a solid surface. On the other hand, the scope of the claims are very broad, encompassing any treatment method of a liquid, gas and solid. Accordingly, considering the breadth of the claims and the guidance in the specification, a skilled artisan would not have reasonably concluded the inventors possessed the full scope of the claimed invention. Therefore, the specification provides insufficient written description to support the breadth of the claimed method.
Claim Rejections - 35 USC § 112 – New Matter
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 1-20 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.
To satisfy the written description requirement, “the missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.” Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998).
Even if the recitation were obvious over the disclosure of the Specification, that is not the standard for satisfaction of the written description requirement. See In re Huston, 308 F.3d 1267, 1277 (Fed. Cir. 2002) (‘“Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.’”).
In the present case, the term “infected” is not supported by the application as originally filed. The examiner appreciates the instant specification discloses “disinfecting or preventing infection of a gaseous environment by, a liquid of, or a solid surface of one of an enveloped virus, a non-enveloped virus, or a mixture thereof” (emphasis added) [ p. 1, lines 3-5]. However, an “infected” environment is not necessarily present in the application as originally filed.
Claim Rejections - 35 USC § 112 – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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.
The term “infected” in claim 1 is a relative term which renders the claim indefinite. The term “infected” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear to what degree an environment may comprise viruses and still meet the requirements of the claim. For the purposes of examination the infected will be interpreted as an environment with one of an enveloped virus, a non-enveloped virus, or a mixture thereof. Support for this can be found at page 1 lines 1-5.
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.
1) Claims 1-11, 15, 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coulston et al. (WO 2018/037209 A1, publication date 03/01/2018; hereinafter Coulston ‘209), as evidenced by HMSC (A World of Viruses, Harvard Museums of Science and Culture, 2026 [retrieved 1/27/2026], https://hmsc.harvard.edu/online-exhibits/world-viruses/).
Coulston ‘209 discloses a suspension composition comprising cucurbiturils [abstract]. In one example, a suspension comprising 1 wt. % CB[n] [p. 28, lines 1-4] was sprayed onto jars [p. 28, lines 10-13]. “The CB[n] mixture was made up of 15 % by weight of CB[5], 48 % by weight of CB[6], 25 % by weight of CB[7] and 12 % by weight of CB[8], based on the total amount of cucurbituril” (i.e., cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril; instant claims 8-11) [ p. 25, lines 2-4].
HMSC discloses that viruses “are, in fact, ever present in our world, occupying nearly all organisms, and found in virtually every type of habitat, even in the air we breathe and the deepest depths of the ocean” [p. 2, last paragraph]. In other words, the application of the prior art reads on treat an infected environment, as instantly claimed, because viruses are expected to be in virtually every type of habitat.
The prior art anticipates claims 1-7 and 18 because it discloses treating (spraying) a suspension comprising 1 wt.% cucurbituril isomers, which according to instant claim 15 is an effective amount, to a solids surface (jar). The prior art anticipates claims 8-10, and 15 because those cucurbituril isomers in composition comprise cucurbit[6]-, [7]- and [8]uril, wherein 10 to 30% w/w of the total cucurbituril isomers is cucurbit[8]uril. Since the prior art composition contains substantially the same components, i.e., cucurbituril isomers, in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties and be capable of satisfying the same applications, i.e., disinfect or prevent infection of a gaseous environment, liquid or solid surface of an enveloped and non-enveloped virus, such as those disclosed in instant claims 2-7.
2) Claims 1-11, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coulston et al. (US 2019/0046426 A1, publication date 02/14/2019; hereinafter Coulston ‘426), as evidenced by HMSC (A World of Viruses, Harvard Museums of Science and Culture, 2026 [retrieved 1/27/2026], https://hmsc.harvard.edu/online-exhibits/world-viruses/).
Coulston ‘426 discloses coating (i.e., instant claim 19) a glass slide with an aqueous solution (i.e., instant claim 18) of CB[n] and allowing it to dry [0138]. According to Coulston ‘426, compositions of CB[n] comprise CB[6], CB[7], and CB[8] (i.e., cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril; instant claims 8-11, 15) [0138].
HMSC discloses that viruses “are, in fact, ever present in our world, occupying nearly all organisms, and found in virtually every type of habitat, even in the air we breathe and the deepest depths of the ocean” [p. 2, last paragraph]. In other words, the application of the prior art reads on treat an infected environment, as instantly claimed, because viruses are expected to be in virtually every type of habitat.
The prior art anticipates instant claims 1-11, 13, 14, 18 and 19 because it discloses coating a solid surface with a solution comprising cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril. Because the prior art contains the same steps of applying substantially the same composition as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e., disinfect or prevent infection of a gaseous environment, liquid or solid surface of an enveloped and non-enveloped virus, such as those disclosed in instant claims 2-7.
3) Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coulston et al. (WO 2017/141029 A1, publication date 08/24/20217; hereinafter Coulston ‘029; cited in IDS 01/23/2023), as evidenced by HMSC (A World of Viruses, Harvard Museums of Science and Culture, 2026 [retrieved 1/27/2026], https://hmsc.harvard.edu/online-exhibits/world-viruses/).
Coulston ‘029 discloses “a method for counteracting malodour in a moist environment, comprising application of a composition comprising a mixture of two or more cucurbiturils selected from CB[5], CB[6], CB[7] and CB[8]” [abstract].
HMSC discloses that viruses “are, in fact, ever present in our world, occupying nearly all organisms, and found in virtually every type of habitat, even in the air we breathe and the deepest depths of the ocean” [p. 2, last paragraph]. In other words, the application of the prior art reads on treat an infected environment, as instantly claimed, because viruses are expected to be in virtually every type of habitat.
The prior art anticipates claims 1-8, 13 and 14 because it discloses treating (application) a gaseous environment, a liquid or a solid (moist environment) with a composition comprising cucurbituril isomers. Specifically, those isomers must include, at least, cucurbit[6]uril, cucurbit[7]uril or cucurbit[8]uril. Th Additionally, because the prior art contains the same steps of applying substantially the same composition as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e., disinfect or prevent infection of a gaseous environment, liquid or solid surface of an enveloped and non-enveloped virus, such as those disclosed in instant claims 2-7.
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.
1) Claims 12, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Coulston et al. (WO 2018/037209 A1, publication date 03/01/2018; herein after Coulston ‘209), as evidenced by HMSC (A World of Viruses, Harvard Museums of Science and Culture, 2026 [retrieved 1/27/2026], https://hmsc.harvard.edu/online-exhibits/world-viruses/) as applied to claims 1-11, 15, 16 and 18 above.
Coulston ‘209 does not anticipate claims 12, 17, 19 and 20 because Coulston ‘209 does not disclose applying a suspension of cucurbituril comprising a virucide, or only cucurbit[6]-, [7]- and [8]uril isomers, or a liquid coating, or the specific solid surface in one example or embodiment.
Regarding instant claims 12 and 17, Coulston ‘209 discloses a suspension composition which may comprise cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril (i.e., no other cucurbituril isomers; instant claim 17) [p. 30 claim 1 and p. 31, claim 8] and where the liquid medium of the suspension may be hydroalcoholic (i.e., alcohols are viricides according to instant claim 12) [p. 30, claim 2]. The cucurbituril comprises 0.1-5 wt.% of the total composition (i.e., an effective amount according to instant claim 15) [p. 18, line 28]. Coulston ‘209 discloses a method comprising applying the composition by spray to inanimate surfaces [p. 33, claim 16].
Coulston ‘209 teaches the steps and components of the method of disinfecting recited in instant claims 12 and 17 and uses each for their established function in the art, but does not explicitly combine all the components and steps together into a single embodiment. However, given the disclosure of each component individually, it would have been prima facie obvious to combine them. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have treated a solid surface (inanimate surfaces) with a composition comprising an effective amount of cucurbituril isomers, specifically cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril, and a viricide (alcohol). Since the prior art composition contains substantially the same components, i.e., cucurbituril isomers, in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties and be capable of satisfying the same applications, i.e., disinfect or prevent infection of a gaseous environment, liquid or solid surface of an enveloped and non-enveloped virus.
Regarding instant claim 19, Coulston ‘209 discloses the composition be used to for pray coating granules (i.e., instant claim 19) [p. 22, lines 1-2].
Regarding instant claim 20, Coulston ‘209 discloses applying to composition to filter material [p. 20, line 27] and air filtration devices [p. 34, line 7]. Given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Coulston ‘209 to have selected and combined known components for their established functions with predictable results. MPEP 2143 and 2144.06(I). Therefore it, would have been obvious for one of ordinary skill in the art, at the time of filling, to have applied to cucurbituril composition taught by Coulston ‘209 to an air filter cartridge.
2) Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Coulston et al. (WO 2018/037209 A1, publication date 03/01/2018; herein after Coulston ‘209), as evidenced by HMSC (A World of Viruses, Harvard Museums of Science and Culture, 2026 [retrieved 1/27/2026], https://hmsc.harvard.edu/online-exhibits/world-viruses/) as applied to claims 1-12, 15 and 17-20 above, an further in view of Scognamiglio et al. (Food and Chemical Toxicology, 2012, vol. 50, p. S244-S255).
Coulston, which is taught above, differs from instant claims 13 and 14 insofar as it does not disclose phenoxyethanol. Coulston does, however, disclose the composition may further comprise fragrances [p. 20, line 16]. Coulston also discloses that the composition may be formulated in “a detergent, a cleansing composition, a shampoo …. a personal deodorant, an antiperspirant, a cosmetic product, a fine fragrance …. a hard surface cleaner … chemical toilets” [p. 21, lines 15-18]. Coulston also discloses that “[i]n one embodiment, the cucurbituril is a CB[8] compound” (i.e., excluding other analogues, derivatives and isomers) [p. 6, line 21] and that the composition may comprise 0.1-60% by weight of cucurbituril based on the total weight of the composition [p. 32, claim 10 (lines 4-9)].
Scognamiglio discloses “2-Phenoxyethanol is a fragrance ingredient used in many fragrance mixtures (compounds). It may be found in fragrances used in decorative cosmetics, fine fragrances, shampoos, toilet soaps and other toiletries as well as in non-cosmetic products such as household cleaners and detergents” [p. S245, Section 4, first two sentences]. Scognamiglio also discloses 2-phenoxyethanol resulted in zero cases of irritation when applied to human skin in the amounts from 1-15% [p. S247, Table 3 & section 5.2.1].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
In the present case it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected 2-phenoxyethanol as the fragrance desired by Coulston because Scognamiglio discloses it for use as a fragrance in the same context. Additionally, Scognamiglio discloses 2-phenoxyethanol has the desirable property of not irritating human skin. Similarly, one would have been motivated to include the 2-phenoxyethanol in amounts from 1% to 15% w/w because Scognamiglio discloses that is a suitable range for 2-phenoxyethanol. One would have been further motivated to select this range because Scognamiglio discloses it does not irritate skin in these amounts.
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). In the present case, the claimed weight ratio of phenoxy ethanol to cucurbit[8]uril (less than 9:1; instant claims 13) overlaps with the weight ratio taught in the prior art (15:0.1 to 1:60) and so prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising cucurbit[8]uril and 2-phenoxyethanol within the claimed mass ratios. Wherein the composition does not comprise any other cucurbituril isomers.
Regarding instant claim 14, Coulston ‘209 discloses a suspension composition which may comprise cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril (i.e., no other cucurbituril isomers; instant claim 17) [p. 30 claim 1 and p. 31, claim 8]. Coulston also disclose the composition may further comprise fragrances [p. 20, line 16] and that the composition may be formulated in “a detergent, a cleansing composition, a shampoo …. a personal deodorant, an antiperspirant, a cosmetic product, a fine fragrance …. a hard surface cleaner … chemical toilets” [p. 21, lines 15-18]. Finally, Coulston discloses that the composition may comprise 0.1-60% by weight of cucurbituril based on the total weight of the composition [p. 32, claim 10 (lines 4-9)].
Scognamiglio discloses “2-Phenoxyethanol is a fragrance ingredient used in many fragrance mixtures (compounds). It may be found in fragrances used in decorative cosmetics, fine fragrances, shampoos, toilet soaps and other toiletries as well as in non-cosmetic products such as household cleaners and detergents” [p. S245, Section 4, first two sentences]. Scognamiglio also discloses 2-phenoxyethanol resulted in zero cases of irritation when applied to human skin in the amounts from 1-15% [p. S247, Table 3 & section 5.2.1].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
In the present case it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected 2-phenoxyethanol as the fragrance desired by Coulston because Scognamiglio discloses it for use as a fragrance in the same context. Additionally, Scognamiglio discloses 2-phenoxyethanol has the desirable property of not irritating human skin. Similarly, one would have been motivated to include the 2-phenoxyethanol in amounts from 1% to 15% w/w because Scognamiglio discloses that is a suitable range for 2-phenoxyethanol. One would have been further motivated to select this range because Scognamiglio discloses it does not irritate skin in these amounts.
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). In the present case, the claimed weight ratio of phenoxy ethanol to cucurbit[8]uril (more than 5:1; instant claims 14) overlaps with the weight ratio taught in the prior art (about 15:0.1 to about 1:60) and so prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising cucurbit[6, 7, 8]uril and 2-phenoxyethanol within the claimed mass ratios. Wherein the composition does not comprise any other cucurbituril isomers.
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.
1) Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 9,926,404 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim producing a solid surface from a composition comprising an effective amount of one or more cucurbituril isomers (claim 1). Additionally, the claims of ‘404 disclose the isomers of cucurbituril present in composition are cucurbit[6]uril, cucurbit[7]uril, and cucurbit[8]uril (claim 3).
2) Claims 1-11, 16, 18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,484,615 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘615 claims a composition comprising cucurbituril formulated as an aerosol (claim 1 and 13) which is applied to an air filtration device (air filter cartridge; claim 14). The claims of ‘615 disclose the isomers of cucurbituril present in the composition are cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril, wherein cucurbit[8]uril makes up 10-30% by weight of the total cucurbituril isomers (claim 1 and 13). Because the compositions of ‘615 and the composition of the instantly claimed methods contain substantially the same components one would have expected them to have the same capabilities, i.e., disinfect of prevent infection of a solid surface.
3) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,881,592 B2 in view of Scognamiglio et al. (Food and Chemical Toxicology, 2012, vol. 50, p. S244-S255). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘592 claims a suspension of cucurbituril isomers (claim 1) comprising cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril or mixtures thereof (claim 8) and ethanol (claim 3). The claims at issue also discloses “wherein the composition comprises from 0.1 to 60% by weight of cucurbituril based on the total weight of the composition” (claim 10) and that the composition may comprise a fragrance (claim 13). Wherein breads are coated with the composition (claim 22).
The claims at issue do not disclose phenoxyethanol.
Scognamiglio discloses “2-Phenoxyethanol is a fragrance ingredient used in many fragrance mixtures (compounds). It may be found in fragrances used in decorative cosmetics, fine fragrances, shampoos, toilet soaps and other toiletries as well as in non-cosmetic products such as household cleaners and detergents” [p. S245, Section 4, first two sentences]. Scognamiglio also discloses 2-phenoxyethanol resulted in zero cases of irritation when applied to human skin in the amounts from 1-15% [p. S247, Table 3 & section 5.2.1].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
In the present case it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected 2-phenoxyethanol as the fragrance desired by Coulston because Scognamiglio discloses it for use as a fragrance in the same context. Additionally, Scognamiglio discloses 2-phenoxyethanol has the desirable property of not irritating human skin. Similarly, one would have been motivated to include the 2-phenoxyethanol in amounts from 1% to 15% w/w because Scognamiglio discloses that is a suitable range for 2-phenoxyethanol. One would have been further motivated to select this range because Scognamiglio discloses it does not irritate skin in these amounts.
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). In the present case, the claimed weight ratio of phenoxy ethanol to cucurbit[8]uril overlaps with the weight ratio taught in the prior art (15:0.1 to 1:60) and so prima facie case of obviousness exists.
Because the compositions of ‘592 the composition of the instantly claimed methods contain substantially the same components one would have expected them to have the same capabilities, i.e., disinfect of prevent infection of a solid surface.
4) Claims 1-11 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/633,367 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim producing a solid surface comprising cucurbituril or derivatives thereof. The claims of ‘367 discloses a solid composition comprising one or more cucurbituril and derivatives and/or analogues thereof (claim 1). The one or more cucurbituril consist of cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril (claim 2), wherein cucurbit[8]uril makes up 1-30% by weight of the cucurbituril in composition (claim 7). Because the compositions contain substantially the same components one would have expected them to have the same capabilities, i.e., disinfect of prevent infection of a solid surface.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5) Claim 1, 8-11 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/784,839 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘839 claims a composition comprising 0.1 to 5% w/w of cucurbituril isomers such as cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril (claims 1, 2 and 6). Because the compositions of ‘839 and the composition of the instantly claimed methods contain substantially the same components one would have expected them to have the same capabilities, i.e., disinfect of prevent infection of a solid surface.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
1) On page 8 of their remarks, Applicant argues none of Coulston ‘209, Coulston ‘426 or Coulston ‘029 anticipated the instant claims because none apply the composition to an infected surface.
This argument is not persuasive. Each Coulston disclosure recites the instantly claimed method steps of treating a surface with the instantly claimed compositions. Additionally, considering the ubiquity of viruses, as evidenced by HMSC above, the compositions of the prior art would have been expected to have been applied to an infected environment, as instantly claimed. Therefore, considering both the method steps and composition are disclosed in one example, each of the Coulston disclosures anticipate the instant claims.
2) On page 9 of their remarks, Applicant argues that the instantly claimed methods are not obvious over Coulston ‘209 because are directed to treating an infected surface and Coulston ‘209 does not disclose an infected surface.
This argument is not persuasive. Coulston ‘209 recites the instantly claimed method steps of treating a surface with the instantly claimed compositions. Therefore, Coulston ‘209 reads on the instant claims. Furthermore, Coulston ‘209 suggests applying the composition to a filter material [p. 20, line 27] and air filtration devices [p. 34, line 7] which is an infected surface according to instant claim 20.
3) On page 9 of their remarks, Applicant argues the claimed composition unexpectedly inactivated multiple enveloped and non-enveloped viruses.
This argument is not persuasive. To begin, the Examiner respectfully notes that example 3 discloses a solution comprising cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril (sold as AqFreshRTM by Aqdot) and phenoxyethanol. Therefore, it is unclear if the results shown in Table 4a-8b are the result of only the cucurbituril compounds or the action of the phenoxyethanol.
Additionally, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). The Examiner respectfully notes that the claims are much broader than the showing of objective evidence and there is no explanation as to why these narrow examples reasonably represent the broad scope that is claimed. The Examiner found the claims to not be commensurate in scope with the evidence for the following reasons:
Virus contact time. The evidence demonstrates that virus contact time (i.e., the amount of time the cucurbituril compounds contact the virus) effects what may be considered the ‘effective amount’. The solutions of cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril (sold as AqFreshRTM by Aqdot) in at an amount of 0.10% v/v and 50% v/v of the suspension concentrate (i.e., about 0.0005% w/w and 0.25% w/w cucurbituril) does not show consistent reduction in relative activity across all virus contact times. See page 17, Table 4b, rows 2 and 7; page 17-18, Table 5a, rows 2 and 7; page 18, Table 5b rows 2 and 7; page 19, Table 6b, rows 2 and 7; page 20, Table 7a, rows 2, 3, 7 and 8; page 20, Table 7b, rows 2, 3, 7, and 8; page 21, Table 8a, rows 2 and 7, pages 21-22, Table 8b, rows 2 and 7. This is important because the claims define an effective amount as from 0.000005-5%w/v cucurbituril. This range encompasses amounts which the objective evidence demonstrated were not effective for all contact times and the claims do not recite a virus contact time.
Cucurbituril isomers. The evidence provided in the specification only discloses results for three cucurbituril isomers; cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril. The specification does not disclose any objective evidence for additional cucurbituril isomers, derivatives or variants thereof. Furthermore, the specification states that samples of cucurbit[7]uril (i.e., C2) “were shown to be ineffective at preventing cell infection” [p. 13, lines 17-18]. The specification also states “Figure 3b shows the effects of AqFreshRTM and cucurbit[7]uril on respiratory syncytial virus (RSV). TCID5o assays confirm that both were also antiviral against RSV, with a 2-3 log reduction in viral titre at the highest concentrations. As previously, cucurbit[6]uril and cucurbit[8]uril were ineffective” [p. 25, lines 24-27].
Phenoxyethanol. Tables 4a-8b all use the composition comprising cucurbit[6]uril, cucurbit[7]uril and cucurbit[8]uril (sold as AqFreshRTM by Aqdot) and phenoxyethanol, discussed above. These Tables appear to be the only demonstration using non-enveloped viruses. Therefore, the claims are not commensurate in scope because they do not require phenoxyethanol, yet claim disinfection of non-enveloped viruses.
Environment. Finally, the evidence discloses aqueous solutions of the cucurbituril composition added to an aqueous solution comprising a virus. This is materially different than, for example, treating a solid surface with a solid powder. Yet the claims read on both. Accordingly, the claims are not commensurate in scope because they encompass treatment methods with have not been supported by objective evidence.
5) On page 10 of their remarks, Applicant argues the double patenting rejections should be withdrawn because they do not disclose administering a composition comprising a cucurbituril compound to an infected environment.
This argument is not persuasive. The claims stand rejected for the reasons above and of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612