DETAILED ACTION
Applicants’ arguments, filed 7 August 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Note Regarding Claim Amendments
Claim 1 has been amended to require that at least a portion of the preservative system be encapsulated by the micelle structure of the nonionic block EO-PO copolymer. This was not required in the previously presented claims on 8 April 2026 because the claims on 8 April 2026 recited that a portion of either the preservative system or the medicinal clay be encapsulated by the micelle structure of the nonionic block EO-PO copolymer. As such, the instant claims require that the preservative system is within the hydrophobic core of the micelle structure, which was previously optional rather than required.
As such, the examiner has presented new rejections below. The new rejections are understood to have been necessitated by the above-discussed claim amendment.
Claim Rejections - 35 USC § 112(b) – 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 8-9 and 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.
Claims 8-9 and 16 further limit the chemical composition or amount of the medicinal clay. However, claim 1 has been amended to require that the medicinal clay is optional. As such, it is unclear whether claims 8-9 further limit the claimed subject matter, and it is unclear whether the limitation drawn to the amount of the medicinal clay in claim 16 is further limiting.
For the purposes of examination under prior art, the examiner will examine claims 8-9 and 16 under the assumption that the medicinal clay is present and that the additional limitations further limit the claimed subject matter.
Claim Rejections - 35 USC § 103 – Obviousness
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) 1-4, 6-7, 17 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. (European Journal of Pharmaceutics and Biopharmaceutics, Vol. 112, 2017, pages 164-176).
Alkhatib et al. (hereafter referred to as Alkhatib) is drawn to a composition comprising nanocellulose, octenidine, and poloxamer, as of Alkhatib, page 164, title. The examiner understands poloxamer to be the nonionic block EO-PO copolymer and octenidine to be the preservative. Alkhatib teaches polyacrylamide, as of page 171, right column, second line below figure 4. Alkhatib teaches that the poloxamer is in the form of a micelle, as of Alkhatib, page 164, 6th line of abstract.
As to claim 1, the claim requires that the nonionic block EO-PO copolymer (e.g. poloxamer) encapsulates at least a portion of the preservative system (e.g. octenidine) within the hydrophobic core of the micelle structure. Although Alkhatib does not specifically teach the word “encapsulated”, this would appear to be the case in view of the following teachings from page 165 of Alkhatib, which are reproduced below.
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The examiner understands the above-reproduced text to teach that art prior to this document failed to encapsulate octenidine; however, in the composition of Alkhatib, the octenidine has been encapsulated, as evidenced by slower release kinetics.
As to claim 1, Alkhatib is not anticipatory because Alkhatib teaches polyacrylamide in a list of components and does not exemplify a composition comprising polyacrylamide. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 2, Alkhatib teaches poloxamer 338 and 407 in the abstract. These are two separate nonionic block EO-PO copolymers.
As to claim 3, Alkhatib teaches the following as of page 166, Table 1, reproduced below.
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The number of repeat units of the ethylene oxide and propylene oxide blocks appear to be within the claim scope. Additionally, Alkhatib teaches the following poloxamer concentrations as of page 166, left column, top paragraph below table 1.
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Poloxamer concentrations of 20%, 22%, and 25% are within the claim scope.
As to claim 4, Alkhatib teaches both poloxamer 338 and poloxamer 407, as of the text reproduced above from page 166.
As to claim 6, Alkhatib teaches both poloxamer 338 and poloxamer 407, as of the text reproduced above from page 166. These are understood to read on the two separate preservative systems.
As to claim 7, Alkhatib teaches octenidine.
As to claim 17, Alkhatib teaches a gel in multiple locations in the reference including page 168, left column, top paragraph.
As to claim 37, Alkhatib does not teach a cationic polymer.
Claim(s) 1-4, 6-8, 16-17 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. (European Journal of Pharmaceutics and Biopharmaceutics, Vol. 112, 2017, pages 164-176) in view of Appavoo et al. (US 20220040066 A1).
Alkhatib is drawn to a composition comprising octenidine loaded into a poloxamer particle, further combined with cellulose. This is used for an antimicrobial purpose. See the rejection above over Alkhatib by itself.
Alkhatib does not teach an optional medicinal clay.
Appavoo et al. (hereafter referred to as Appavoo) is drawn to antimicrobial compositions comprising modified clay and non-ionic triblock copolymers, as of Appavoo, title and abstract. The composition of Appavoo may comprise the polymer known by the trade name “Pluronic” along with clay, as of Appavoo, page 5, right column, Table 1, reproduced below.
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The polymer known as Pluronic has the following chemical structure, as of Appavoo, page 3, relevant structure reproduced below.
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The composition of Appavoo is antimicrobial, as of Appavoo, title.
Appavoo does not teach a polyacrylamide.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the clay of Appavoo with the composition of Alkhatib. Alkhatib is drawn to an antimicrobial composition, and suggests oral uses as of page 165, left column, second paragraph. Appavoo is drawn to antimicrobial compositions, as of Appavoo, title, and teaches their use for oral care, as of the abstract of Appavoo. As such, the skilled artisan would have been motivated to have combined the clay of Appavoo with the composition of Alkhatib in order to have predictably achieved an antimicrobial effect with a reasonable expectation of success. Combining prior art elements (e.g. the poloxamer/octenidine of Alkhatib and the clay of Appavoo) according to known methods to yield predictable results (e.g. an antimicrobial effect, including for oral use) is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 1, Alkhatib teaches poloxamer, which reads on the required nonionic block EO-PO copolymer, octenidine, which reads on the required preservative, and polyacrylamide. Appavoo teaches a clay which is understood to read on the optional medicinal clay. The reason that the clay of Appavoo reads on the optional medicinal clay is because Appavoo indicates that the clay has antimicrobial components, as of at least Appavoo, paragraph 0012, and an antimicrobial effect is medicinal.
As to claim 2, Alkhatib teaches poloxamer 338 and 407 in the abstract. These are two separate nonionic block EO-PO copolymers.
As to claim 3, Alkhatib teaches the following as of page 166, Table 1, reproduced in the rejection above. The number of repeat units of the ethylene oxide and propylene oxide blocks appear to be within the claim scope. Additionally, Alkhatib teaches the following poloxamer concentrations as of page 166, left column, top paragraph below table 1, reproduced in the rejection above. Poloxamer concentrations of 20%, 22%, and 25% are within the claim scope.
As to claim 4, Alkhatib teaches both poloxamer 338 and poloxamer 407, as of the text reproduced above from page 166.
As to claim 6, Alkhatib teaches both poloxamer 338 and poloxamer 407, as of the text reproduced above from page 166. These are understood to read on the two separate preservative systems.
As to claim 7, Alkhatib teaches octenidine.
As to claim 8, Appavoo teaches modified clay in the title. The examiner understands this to be synthetic clay due to the synthetic modification step of the clay.
As to claim 16, Alkhatib and Appavoo teach poloxamer (i.e. nonionic block EO-PO copolymer), octenidine (a preservative), clay, as of Appavoo, and polyacrylamide. As best understood by the examiner, the amount of antimicrobial ingredients in the composition of the prior art appears to differ from what is required by the instant claims. Nevertheless, generally, differences in concentration between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a poly(EO-PO) copolymer in combination with clay and preservatives used for antimicrobial purposes has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of the amounts of this component via routine experimentation.
As to claim 17, Alkhatib teaches a gel in multiple locations in the reference including page 168, left column, top paragraph.
As to claim 37, Alkhatib does not teach a cationic polymer.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. (European Journal of Pharmaceutics and Biopharmaceutics, Vol. 112, 2017, pages 164-176) in view of Appavoo et al. (US 20220040066 A1), the combination further in view of Kostjukovs et al. (US 2019/0357540 A1) and Hagen et al. (US 2017/0095508 A1).
Alkhatib is drawn to a composition comprising poloxamer and octenidine. Appavoo teaches antibacterial clay. See the rejection above over Alkhatib and Appavoo by themselves.
Neither Alkhatib nor Appavoo teach the required illite-smectite combination.
Kostjukovs et al. (hereafter referred to as Kostjukovs) is drawn to a composition comprising 40% to 70% illite-smectite as an antimicrobial, as of Kostjukovs, abstract.
Kostjukovs is deficient because Kostjukovs does not actually teach that illite-smectite is a form of clay.
Hagen et al. (hereafter referred to as Hagen) is drawn to antimicrobial clay, as of Hagen, title and abstract. Hagen teaches that illite-smectite is an antimicrobial clay.
Hagen does not teach the percentage of illite-smectite.
It would have been prima facie obvious for one of ordinary skill in the art to have used the illite-smectite of Kostjukovs as the clay in the composition of Appavoo. Appavoo is drawn to a composition comprising clay, Pluronic, and other preservatives for antimicrobial purposes. Hagen teaches that illite-smectite is a form of antimicrobial clay, and Kostjukovs teaches 40-70% illite-smectite. As such, the skilled artisan would have been motivated to have used the clay of Kostjukovs in the composition of Appavoo in order to have predictably provided an antimicrobial effect with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (the illite-smectite of Kostjukovs) for incorporation into a composition (that of Appavoo), based on its recognized suitability for its intended use (as a clay with antimicrobial properties, as taught by Hagen). See MPEP 2144.07.
In the alternative, the skilled artisan would have been motivated to have substituted the clay of Kostjukovs in place of the clay of Appavoo to have predictably formed an antimicrobial composition with a reasonable expectation of success. The simple substitution of one known ingredient (the illite-smectite of Kostjukovs) in place of another (the clay of Appavoo) in order to achieve predictable results (formation of a composition comprising clay, Pluronic, and preservatives for antimicrobial use, as taught by Appavoo) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. (European Journal of Pharmaceutics and Biopharmaceutics, Vol. 112, 2017, pages 164-176) in view of Kolzunova et al. (“Features of microbiological behavior and biocide properties of electrosynthesized polymethylolacrylamide films” accessed at https://pubs.aip.org/aip/acp/article-abstract/1736/1/020083/840663/Features-of-microbiologicalbehavior-and-biocide on 23 April 2026, originally published 18 May 2016).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. (European Journal of Pharmaceutics and Biopharmaceutics, Vol. 112, 2017, pages 164-176) in view of Appavoo et al. (US 20220040066 A1), the combination further in view of Kolzunova et al. (“Features of microbiological behavior and biocide properties of electrosynthesized polymethylolacrylamide films” accessed at https://pubs.aip.org/aip/acp/article-abstract/1736/1/020083/840663/Features-of-microbiologicalbehavior-and-biocide on 23 April 2026, originally published 18 May 2016)
Alkhatib is drawn to a composition comprising poloxamer and octenidine. Appavoo teaches antibacterial clay. See the rejection above over Alkhatib and Appavoo by themselves.
Neither Alkhatib nor Appavoo teach that the polyacrylamide is crosslinked with N,N-methylenebisacrylamide.
Kolzunova teaches that polyacrylamide crosslinked with N,N-methylene-bis-acrylamide has sufficient antimicrobial properties to provide protection from biofouling and bio-corrosion, as of Kolzunova. The examiner understands this as a teaching that polyacrylamide crosslinked with N,N-methylene-bis-acrylamide has antimicrobial properties.
Kolzunova does not teach clay or a poly(EO-PO) copolymer.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the crosslinked polyacrylamide of Kolzunova with the composition of Alkhatib by itself or in view of Appavoo. The composition of Alkhatib is drawn to antimicrobial materials, and may be used for oral care embodiments. Appavoo is also drawn to antimicrobials for oral care embodiments. Kolzunova teaches that polyacrylamide crosslinked with N,N-methylene-bis-acrylamide has antimicrobial properties. As such, the skilled artisan would have been motivated to have combined the crosslinked polyacrylamide of Kolzunova with the composition of Alkhatib by itself or in view of Appavoo to have predictably imparted an antimicrobial effect to the composition of Alkhatib or the oral composition of Alkhatib in view of Appavoo with a reasonable expectation of success.
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
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.
Claim 18 is 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 nonionic block EO-PO copolymer having a viscosity of about 3 times higher at 37°C than at 20°C, does not reasonably provide enablement for nonionic block EO-PO copolymer in combination with a preservative having a viscosity of about 3 times higher at 37°C than at 20°C. 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 use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. See MPEP 2164.01(a). The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by MPEP 2164.01(a) and are set forth below.
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved; see MPEP 2164.03. Keeping that in mind, the factors set forth in MPEP 2164.01 are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative skill level (B)-(E)
The invention relates to a composition comprising a nonionic block EO-PO copolymer. The relative skill of those in the art is high, that of an MD or PhD. That factor is outweighed, however, by the unpredictable nature of the art.
As an initial matter, claim 1 recites a nonionic block EO-PO copolymer. These copolymers are triblock copolymers of ethylene oxide block propylene oxide block ethylene oxide. These polymers are commonly known as poloxamers, or also under the trade name “Pluronic.”
As illustrative of the state of the art, the examiner cites Alkhatib et al. (European Journal of Pharmaceutics and Biopharmaceutics, Vol. 112, 2017, pages 164-176), which was discussed in greater detail in the obviousness rejections above. Alkhatib is drawn to a poloxamer hybrid system, as of Alkhatib, page 164, title and abstract.
It is the examiner’s position that the increase in viscosity with an increase of temperature from about 20°C to about 37°C is a well-known property of poloxamers. However, data in Alkhatib indicates that this change in viscosity is negated by incorporation of a preservative. See Alkhatib, page 169, left column, figures 2a and 2b, reproduced below.
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The above-reproduced figures indicate a significant increase in viscosity with an increase of temperature from about 20°C to about 37°C for poloxamer in water. However, this property appears to have been negated by the loading of preservative.
Consequently, there would have been no reasonable expectation that the skilled artisan would have been able to have made and used a composition comprising poloxamer loaded with preservative that would have had an increase in viscosity of at least three times with an increase of temperature from about 20°C to about 37°C in the absence of undue experimentation. The reason that such experimentation would have been undue is because Alkhatib attempted this experiment and failed to achieve an increase in viscosity of at least three times with an increase of temperature from about 20°C to about 37°C in the case of preservative-loaded poloxamer. As such, there would have been no reasonable expectation of success in the case where the prior art teaches failure, resulting in a prima facie case of undue experimentation.
The breadth of the claims (A)
The instant claims are broad in that they do not limit the preservative and do not exclude a wide variety of ingredients that may have negated the increase in viscosity of at least three times with an increase of temperature from about 20°C to about 37°C that would have occurred in the case of poloxamers.
3. The amount of direction or guidance provided and the presence or absence of working examples (F)-(G)
The instant application provides the following in figure 1.
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This figure does indeed show a multiple order of magnitude increase in viscosity with a temperature increase from 20°C to 37°C. However, looking towards the instant specification, there is a lack of clarity as to whether the above-reproduced data was obtained on poloxamer loaded with preservative of poloxamer in the absence of preservative. In the absence of such clarity, the examiner takes the position that the specification provides no direction or guidance for practicing the claimed invention in its “full scope” because it is unclear as to whether the specification provides data showing that poloxamer loaded with preservative still experiences the required viscosity change with increasing temperature or whether the presence of preservative negates such a viscosity change.
4. The quantity of experimentation necessary (H)
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to have formed a composition that achieves an increase of viscosity of at least three-fold with a temperature increase of from 20°C to 37°C, as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
Response to Arguments Regarding Obviousness Rejection
Applicant presented arguments regarding the previously applied obviousness rejection, as of applicant’s response on 7 August 2026 (hereafter referred to as applicant’s response). These arguments relate to the previously applied rejection that has been withdrawn. As such, applicant’s arguments appear to be moot and will not be addressed substantively in this office action.
Withdrawn Double Patenting Rejections
The examiner previously rejected the instant claims over the claims of US Patent 12,213,993 on the grounds of non-statutory double patenting. This rejection has been withdrawn because the claims of the ‘993 patent fail to recite the required preservative.
The examiner previously rejected the instant claims over the claims of copending application 18/984,413 on the grounds of provisional non-statutory double patenting. This rejection has been withdrawn because the claims of the ‘413 application fail to recite the required preservative.
Consequently, the arguments presented by applicant in applicant’s response regarding the previously applied double patenting rejections are understood to be moot in view of the withdrawal of those rejections and will not be addressed substantively by the examiner.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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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.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
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