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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/2025 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 12/23/2025 is acknowledged. Claim 1 amended and claims is 3, 5, and 7 are canceled. Claims 10-15 remain withdrawn as being drawn to a non-elected invention. Claims 1-2, 4, 6, and 8-9 are examined on the merits herein.
Oath/Declaration
The Declaration under Rule 132, filed 12/23/2025, is acknowledged. Examiner’s response is detailed at the end of the action.
Priority
The instant application filed 05/11/2022 is a National Stage entry of PCT/KR2022/003921, with an international filing date: 03/21/2022; PCT/KR2022/003921 is a Continuation of application No. 17/208075, filed 03/22/2021, now abandoned.
Withdrawn Objections and Rejections
Claim 5 was rejected under 35 U.S.C. 112(d). Applicant’s cancellation of claim 5 has rendered the rejection moot and the rejection is withdrawn.
Claims 1-2, 4-6, and 8-9 were rejected under 35 U.S.C. 103 as being unpatentable over Nho in view of Sehl and Shah. Upon further consideration, the rejection is withdrawn.
Claim Rejections - 35 USC § 112(a) – 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.
Claim 1-2, 4, 6, and 8-9 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 following limitation has been added as part of the amendment filed on 12/23/2025: “wherein after application the oral rinse composition maintains at least 70% pharynx epithelial cell viability under dry conditions”. However, the instant specification and claims as originally filed do not disclose 70% to 100% pharynx epithelial cell viability under dry conditions, as instantly claimed. The only mention of cell viability in the specification is in regards to Experimental Example 6 (p. 29-32 of Spec.). Experimental Example 6 and Table 10 show that “the mean value of the cell viability of Example 6 of the present invention based on the cell viability (%) of the positive control was 71.9% (median: 81.5%)” (p. 31-32 of specification). Cell viability (%) is only reported by its mean and median value with no data showing the full range of the results. The newly added limitation recites “epithelial cell viability”, not “mean” or “median” epithelial cell viability. Additionally, since only one value is reported, there is no support for the fully claimed range of “at least 70%”, which includes values all the way up to 100%. Experimental Example 6, nor any other passage of the originally filed disclosure, describes maintaining cell viability throughout the entire range of 70-100% as instantly claimed. Furthermore, Experimental Example 6 does not appear to indicate what molecular weight of the PEG compound is tested. If Applicant believes this rejection is in error, applicant must disclose where in the specification support for the entire scope of the amendment(s) and/or new claims can be found. As a result, Claim 1 represents new matter. The remaining claims are rejected by virtue of their dependency on claim 1.
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.
Claims 1-2, 4, 6, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nho, K., et al. (US 2014/0155457 A1, 06/05/2014, on record), hereinafter Nho in view of Gravett, D., et al. (US 20040219214 A1, 11/04/2004, PTO-892), hereinafter Gravett, and Shah, P., et al. (US 2019/0083366 A1, 03/21/2019, on record), hereinafter Shah.
Nho teaches a method of relieving, improving, preventing or treating xerostomia including applying an oral cavity composition including a polyethylene glycol (PEG) derivative whose reactor is modified to form a covalent bond with an epithelial cell of the oral cavity (abstract). Nho teaches Formula 1 and 2, wherein the L1 and L2 are linkers, containing a carbonyl, an ester etc.; with n from 10-2000, m from 0-3, p from 0-1, and q is 3-8 (¶ [0022]-[0029]; claim 4):
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R1 and R2 are selected from the group including:
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,
and the core from the group including:
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.
Nho further defines the PEG derivative to have the following structure (Example 19; claim 5):
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, which reads on the active ingredient (i.e., chemical formula 1) of claim 1. Nho defines n as an integer from 10 to 2,000 ([0026]; claim 4). By the Examiner’s calculations this gives a total MW of between ~2,700 and ~353,000 Da for the PEG derivative above.
Nho teaches granulation of the PEG derivatives in which a powdery polyethylene glycol derivative is granulized to easily use and package (¶ [0088]), thereby reading on the granule formulation of claim 1. The final dosage form comprises the granulized polyethylene glycol derivative (48 parts by weight), erythritol (25 parts by weight), xylitol (16 parts by weight), malic acid (3 parts by weight), lemon flavoring (i.e., flavoring agent of claim 1) (3 parts by weight), and sodium hydrogen carbonate (5 parts by weight) (¶ [0089]). The sodium hydrogen carbonate is used as an acid regulator (i.e., acidity adjusting agent of claim 1) to maintain a neutral pH in the oral cavity (¶ [0061]). The amount of sodium hydrogen carbonate present in the final dosage form of Nho (i.e., 5 parts by weight) also reads on claim 4. Nho further teaches that the powder or granules according to the present invention have no muco adhesive property in a dry state, but as the powders or granules are rapidly gelated by moisture, a mucoadhesive property is recovered. Accordingly, the oral cavity composition of the present invention is a product put in the oral cavity in a suitable amount whenever patients (i.e., a subject in need thereof) feel dryness of the mouth. The composition is mixed with saliva in the oral cavity or a small amount of water, kept in the oral cavity for approximately 10 to 30 seconds, and spit out (¶ [0063]), which reads on applying the oral rinse to the subject as recited in claim 1.
The teachings of Nho differ from that of the instantly claimed invention in that Nho does not explicitly teach the molecular weight of the PEG derivative to be between 8,000 and 15,000 Da nor wherein the oral rinse composition is dissolved in water and reconstituted in the form of a solution as recited in claim 1. Nho also does not explicitly teach the properties of the oral rinse composition (i.e., cell viability, storage stability, moisture absorption, and static electricity) as recited in claim 1. Lastly, Nho does not explicitly teach every limitation of claims 2, 6, and 8-9.
Gravett discloses a composition comprising a synthetic polymer comprising multiple activated groups. The multiple activated groups are reactive with functionality present on animal tissue, so that upon administration of the polymer to the tissue, the polymer binds to the tissue (abstract). The compounds of Gravett are reacted with tissue in instances where enhanced lubricity is desired ([0082]). Specifically, the composition of Gravett is used to enhanced lubricity on the surface of tissue or a medical device. A preferred activated polymer is as follows: the activated functional group-containing compound is the tetrafunctional PEG, pentaerythritol poly(ethylene glycol) ether tetra-succinimidyl glutarate (10,000 mol. wt.) ([0083]). Figure 1 illustrates the structure of a tetrafunctionally activated PEG succinimidyl glutarate (SG-PEG):
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(Fig. 1). Such a compound reads on the polyethylene glycol derivative having Formula I and molecular weight of claim 1. The multifunctional hydroxysuccinimidyl PEG derivative (e.g., tetra functional poly(ethylene glycol) succinimidyl glutarate) may be in the form of a solution ([0035]).
Shah teaches a dry mouthwash comprising granules that reconstitute in an aqueous solution such as water, to produce a solution that tastes and functions as a typical mouthwash (abstract; claim 1). The granules of Shah provide a convenient and effective mouthwash for travel and use outside the home (¶ [0002]), which dissolve better than tablets and powders (¶ [0004]). The dry mouthwash granule comprises an active component, an organic acid component and a carbonate salt component, wherein said granule has a particle size between 53 microns and 1190 microns (claim 1). The mouthwash granule substantially dissolves when placed in water of 60-150° F in less than 30 seconds (claim 6). The dry mouthwash granule is also non-hygroscopic (claim 23). The granules of examples I-III may be non-hygroscopic and/or generally resistant to moisture uptake ((¶ [0020]).
Regarding the molecular weight of the PEG derivative in claim 1, Nho teaches a broad range of MW as discussed above (~2,700 and ~353,000 Da). While this range is broad compared to the instantly claimed range, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Additionally, it would have been prima facie obvious to combine the teachings of Nho and Gravett before the effective filing date of the claimed invention by using a PEG derivative having the molecular weight of Gravett (i.e., 10,000 Da) in the method of Nho to yield the instant invention. It would have been prima facie obvious to do so since Nho and Gravett teach the same PEG derivative and a molecular weight of 10k is known and effective for enhancing lubricity on the surface of tissue as taught by Gravett. Xerostomia is a disease in which the oral mucosa (i.e., tissue) becomes dry due to a decrease in saliva secretion, which may cause a burning feeling of the oral mucosa or the ulceration of oral mucosa (p. 1 of instant spec.). Thus, one of ordinary skill in the art would have been specifically motivated to select a molecular weight of 10k, as taught by Gravett, to increase lubricity on tissue surfaces, for the method of alleviating xerostomia of Nho. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Nho and Gravett teach the same PEG derivatives, specifically as they relate to improving wettability and lubricity of tissue. Furthermore, the 10k molecular weight of Gravett falls within the broader range taught by Nho, and one of ordinary skill in the art could have adjusted the molecular weight through known and routine methods.
Regarding the dissolution step of claim 1, it would have been further obvious to modify the combined method of Nho and Gravett according to the teachings of Shah by dissolving the combined granules in water to form a solution as taught by Shah thereby rendering the instantly claimed invention. One of ordinary skill in the art would have been motivated to implement the method of Shah in which granules are reconstituted in the form of a solution at the time of use, since granules are more convenient to travel with and use outside the home as compared to liquid mouthwash as taught by Shah. One of ordinary skill in the art would have had a reasonable expectation of success in dissolving the granules from the combined method of Nho and Gravett in water to form a solution since Nho teaches that granules comprising the PEG derivative of the invention must be mixed with saliva or a small amount of water in order to activate it’s muco-adhesive properties and Gravett teaches that the PEG derivative may be in the form of a solution.
Regarding the pH of claim 1, Nho teaches that sodium hydrogen carbonate is used as an acid regulator to maintain a neutral pH in the oral cavity, as discussed above. Thus, it would have been prima facie obvious to one of ordinary skill in the art to ensure that the reconstituted solution also exhibits a neutral pH (i.e., pH 7) prior to using it in the oral cavity since a neutral pH is desired in the oral cavity, as taught by Nho.
Regarding the ability of the oral rinse to maintain at least 70% cell viability as recited in claim 1, the instant specification evidences that such a property would be inherent to the combined composition of Nho, Gravett, and Shah. Example 6 of the specification discloses that a 4arm-PEG-SG (i.e., succinimidyl glutarate) derivative, such as that of Nho and Gravett, maintains a mean cell viability of 71.9% (p. 31, Table 10 and final para.). Additionally, because the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
The recitation of “wherein the oral rinse composition is prepared in the granule formulation to improve […]” in claim 1 is simply a recitation of an intended result. A “‘whereby [or wherein] clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). As discussed above, Nho teaches preparing the oral rinse composition in a granule formulation. Thus, the structural limitation of a granule formulation is met and the improvement in storage stability, moisture absorption, and static electricity would be inherent to the granule formulation. Further support can be found in Examples 7-8 of the instant specification which demonstrate an improvement in the claimed properties when the composition is formulated as a granule as compared to a powder (p. 35-36 of spec; p. 34, lines 1-6 of spec.). As such, these properties appear to be inherent to the morphology of the composition when it is a granule. The granules of the combined method of Nho, Gravett, and Shah would inherently possess improved properties as compared to a powder formulation of the same composition as evidenced by applicant’s own specification. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claim 2, it would have been prima facie obvious to use granules with a particle size between 53 microns and 1190 microns as taught by Shah since this is a known and effective particle size for mouthwash (i.e., oral rinse) granules. One of ordinary skill in the art could have performed the combined method above using granules of this size to predictably yield the instant invention. 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.
Regarding claim 6, because the solution made obvious by the prior art is identical to the solution claimed, the solution must necessarily have the characteristics claimed (i.e., viscosity) as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claim 8, Nho teaches administering and spitting out (i.e., rinsing) the granules for alleviating xerostomia as discussed above. Shah teaches dissolving dry mouthwash granules in water to reconstitute it in solution form as discussed above. Thus, it would have been obvious to one of ordinary skill in the art that the combined method of Nho, Gravett, and Shah would entail administering and rinsing the solution in which the granules for alleviating xerostomia have been dissolved.
Regarding claim 9, Nho teaches that the composition for alleviating xerostomia may be put in the oral cavity in a suitable amount whenever patients feel dryness of the mouth as discussed above. Thus, one of ordinary skill in the art would have been motivated to apply the oral rinse composition using the combined method of Nho, Gravett, and Shah however many times a day is necessary to reduce dryness of the mouth. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive:
Applicant argues that the broad molecular weight disclosure of Nho does not render obvious the selection of a narrow, critical range, and Sehl does not remedy such deficiency because Sehl merely provides a recipe of adhesive materials for hernia repair. Applicant cites Experimental Examples 1 and 2 of the instant specification and a new example of the Declaration as showings for the criticality of the instantly claimed molecular weight.
Applicant’s arguments against Sehl are rendered moot since Sehl is no longer relied on in the rejection above. Regarding Applicant’s assertion and evidence for the criticality of the instantly claimed molecular weight, such evidence is not found persuasive in view of the reasons belows.
Response to the Declaration under Rule 132
Dr. Kwang Nho provided a Declaration under Rule 132 that is dated 12/23/2025. The Declaration meets the formal requirements. In the most relevant part, the Declaration details that the 4-arm PEG-OH derivative having a molecular weight of 10 kDa provides improved moisture absorption and epithelial cell viability as compared to 4-arm PEGs having molecular weights of 20, 30, and 4 kDa.
A Declaration is due full consideration and weight for all that it discloses. Declarations are reviewed for the following considerations: 1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison (In re Huang, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996)), 2) whether the Declaration presents a comparison to the closest art, 3) whether the Declaration is commensurate in scope with the scope of the claims (In re Kulling, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)), 4) whether the Declaration shows a difference in kind rather than merely a difference in degree (In re Waymouth, 182 USPQ 290, 293 (C.C.P.A. 1974)), and 5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness (Pfizer Inc. v. Apotex, Inc., 82 USPQ2d 1321, 1339 (Fed. Cir. 2007)).
The relevant criterion here are Nos 1), 2), 3), and 5) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison; whether the Declaration presents a comparison to the closest art; whether the Declaration is commensurate in scope with the scope of the claims; and whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness.
The examiner has carefully reviewed the Declaration, including the data presented in the Declaration. Regarding Experimental Example 1 (p. 2-3), the comparative examples 1-3 have a Di-PEG and 6-arm PEG structure. As discussed in the prior art rejection above, the Nho reference discloses the inventive 4-arm PEG derivative, meaning the comparative examples of Experimental Example 1 do not provide a comparison to the closest prior art, nor a single variable comparison for analyzing molecular weight, since the molecular structures are different. Regarding Experimental Example 2 (p. 4), the comparative examples 4-5 have a 4-arm PEG structure and molecular weights of 20 kDa and 30 kDa, which fall outside of the instantly claimed range but within the broader range of the Nho reference. However, the instantly claimed molecular weight range is 8 kDa to 15 kDa. A value of 15 kDa falls exactly between the inventive 10 kDa example and the comparative 20 kDa example, meaning the Examiner cannot easily assume how a 15 kDa example would perform. Additionally, there is no absorption data for molecular weights below or around the instantly claimed minimum of 8 kDa. Thus, the data does not reasonably convey that 4-arm PEGs across the entire scope of the claimed molecular weight range, would result in significantly improved rates of absorption. These examples cannot be considered commensurate in scope with the claimed molecular weight range. Regarding the New Experimental Example (p. 5-7), the two comparative examples define 4-arm PEGs having a molecular weight of 4k and 20k. First, without numerical data in the form of a table, it is unclear if the 20k comparative example actually provides a cell viability of less than 70%, which is the cutoff as instantly claimed. From the provided graph it appears that the 20k comparative example actually does achieve 70% cell viability. Second, the instantly claimed minimum and maximum of 8k and 15k fall between the inventive 10k and comparative examples, meaning the Examiner cannot easily assume how an 8k or 15k example would perform. Thus, the data does not reasonably convey that 4-arm PEGs across the entire scope of the claimed molecular weight range, would result in a cell viability of at least 70% while those outside the range would not. These examples cannot be considered commensurate in scope with the claimed molecular weight range nor the cell viability range. Given the entirety of the data presented in the Declaration, the Examiner has not been convinced that a 4-arm PEG of the invention comprising a molecular weight of 8,000 to 15,000 Daltons would provide a significant and unexpected improvement over the same 4-arm PEGs of Nho with a broader molecular weight. Additionally, Gravett above teaches that 4-arm PEG derivatives with a 10 kDa molecular weight are preferred for increasing the lubricity of tissue surfaces in the body. Thus, it is reasonable that one or ordinary skill in the art would select such a molecular weight with the expectation or hope of it providing high moisture absorption and cell viability. Since Applicant has not proven a significant or unexpected improvement, the prima facie case for altering the molecular weight still stands.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616