DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Receipt of Remarks/Amendments filed on 06/05/2026 is acknowledged. Claims 1 and 10 are amended and claims 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 Claims 10-15 remain withdrawn as being drawn to a non-elected invention.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.
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Withdrawn Rejections
Claims 1-2, 4, 6, and 8-9 were rejected under 35 U.S.C. 112(a) as new matter. Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
The following grounds of rejection are maintained:
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, on record), 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 10,000 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 and moisture absorption) 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) covalently ([0019]; [0058]; [0099]). 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, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use a PEG derivative having the molecular weight of Gravett (i.e., 10,000 Da) in the method of Nho since such a molecular weight is known and routine in the art and would have achieved the same technical effect sought out by Nho. The technical effect sought out by Nho is to increase oral moisture persistency by forming a covalent bond of an oral mucous membrane with the polyethylene glycol derivative ([0012]). The same PEG derivative, but with a 10 kDa molecular weight, is taught by Gravett to increase lubricity on tissue surfaces via covalent bonding. Thus, one of ordinary skill in the art would have been specifically motivated to select a PEG derivative having a molecular weight of 10k, as taught by Gravett, since this molecular weight is known to increase tissue lubricity via covalent bonding and would have achieved the desired technical effect in the method 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 70% mean epithelial 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.
Regarding the ability of the reconstituted oral rinse to improve moisture absorption as recited in claim 1, the composition made obvious by the prior art is identical to the composition claimed. As such, 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.
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 06/05/2026 have been fully considered but they are not persuasive:
(1) Applicant argues against the claim rejection under 35 USC 103, stating that a broad disclosure such as that of Nho does not render obvious the selection of a narrow, critical range. Applicant further argues that Gravett does not remedy the teachings of Nho since Gravett teaches its composition to adhere to a tissue by reacting the synthetic polymer with the tissue so as to covalently adhere the synthetic polymer to tissue. According to Applicant, administering such a composition would cause adhesion to the internal tissues of the mouth and cause suffocation.
In response to applicant's arguments against Nho individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Nho discloses a broad range and Gravett teaches the specifically claimed molecular weight of 10 kDa, which is made obvious for the reasons above. Regarding Applicants arguments that the polymer of Gravett is not applicable to the oral rinse of Nho, it is first noted that the synthetic polymer of Gravett is identical to the polymer which is instantly claimed and that taught by Nho. As such, there is no reason why one of ordinary skill in the art could not apply it to an oral rinse since Applicant’s disclosure and Nho indicate its use in an oral rinse. Secondly, the formation of covalent bonds between the PEG derivative and epithelial cells in the oral cavity is explicitly taught and encouraged by Nho (see abstract). Additionally, the instant specification teaches that the technical effect of the instant invention is obtained by “modifying the terminal reactive group of polyethylene glycol to allow covalent bonding with oral mucosa epithelial cells, thereby allowing the polyethylene glycol derivative to adhere to oral mucosa epithelial cells for a long time” (see p. 4, lines 11-15). It is therefore unclear how the polymer of Gravett would lead to suffocation when it is identical to the instantly claimed polymer and that of Nho and it achieves the exact same technical effect of the instant invention (i.e., covalent bonding). Lastly, Gravett is not relied on for its specific reaction and administration methods, rather Gravett is relied on for teaching a specific molecular weight of a PEG derivative to be used in the method of Nho. Regardless of how the PEG derivative of Gravett is administered in the Gravett disclosure, transferring the molecular weight teaching into the method of Nho would not change the operation of the Nho method.
(2) Applicant asserts that a person skilled in the art would never consider a polymer used in a composition for restenosis as an option for oral rinse compositions to alleviate xerostomia, arguing that the obviousness conclusion is gleaned only through hindsight.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Nho and Gravett teach PEG derivatives having the same structure. In Nho the polymer is used to treat xerostomia, which is a condition causing dryness of the mouth. The technical effect sought out by Nho is to provide a PEG derivative which forms covalent bonds to the oral mucosa to improve moisturizing properties (see [0012] of Nho). Gravett teaches the same polymer to increase the lubricity of tissue via covalent bonding of the polymer to the tissue. Such teachings are directly related and one of ordinary skill in the art would have immediately recognized the disclosure of Gravett as relevant to the technical effect sought out by Nho.
(3) Applicant points to experimental examples 1 and 2 of the instant specification, arguing that the 4-arm PEG-OH having a molecular weight of 10,000 unexpectedly shows high moisture absorption. Applicant also points to the new experimental example in the Declaration of 12/23/2025, which is provided as evidence for the surprising superiority of the 10 kDa 4arm PEG-SG on cell viability. Applicant states that the results presented in the Declaration are significant because they show that the branched 4arm PEG of this application remains in the cells even after cell washing by covalent bonding and it provides a moisturizing effect for an extended time under dry conditions (since covalent bonding prevents it from being washed away). According to Applicant these results were not foreseen or disclosed by the cited prior art.
Regarding experimental example 1, the data compares a 4-arm PEG-OH to a Di-PEG-OH and a 6arm PEG-OH. The comparative examples are not representative of the closest prior art since Nho explicitly teaches a 4-arm PEG-OH. Additionally, no conclusions can be drawn regarding molecular weight since the comparison between comparative example 1 and example 1 is not a single-variable comparison since both structure and molecular weight vary. Regarding both experimental examples 1 and 2, the 4-arm PEG-OH (i.e., the inventive example) is different than the structure which is instantly claimed, which is a 4-arm PEG-SG (succinimidyl glutarate). Thus, neither of these examples are commensurate in scope with the PEG derivative as instantly claimed. Furthermore, it is not unexpected that a 4arm PEG having a molecular weight of 10 kDa would have good moisture absorption, since such a molecular weight is preferred in the PEG derivatives of Gravett for providing increased lubricity (i.e., moisturizing properties). Regarding the final example, which does utilize a 4arm PEG-SG, the improved cell viability in the declaration is not unexpected in view of the prior art teachings. The 4arm PEGs of Nho and Gravett achieve the exact same technical effect disclosed by the Applicant. Both Nho and Gravett teach their respective 4arm PEG-SG derivatives to covalently bond to tissue for increasing moisture/lubricity of the tissue. As such, the results presented by the Applicant are not “unexpected” since one of ordinary skill in the art would have expected the 4arm PEG-SG derivative of Nho or Gravett, specifically the 10k one of Gravett, to covalently bond to epithelial cells and remain in the cells after washing to provide an improved moisturizing effect (i.e., lubricity) thereby maintaining cell viability.
Evidence pertaining to secondary considerations must be taken into account whenever it has been properly presented; however, it does not necessarily control the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (Fed. Cir. 2007) ("the record establish[ed] such a strong case of obviousness" that allegedly unexpectedly superior results were ultimately insufficient to overcome obviousness conclusion); Leapfrog Enterprises Inc. v. Fisher-Price Inc., 485 F.3d 1157, 1162, 82 USPQ2d 1687, 1692 (Fed. Cir. 2007) ("given the strength of the prima facie obviousness showing, the evidence on secondary considerations was inadequate to overcome a final conclusion" of obviousness); and Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988). Office personnel should not evaluate rebuttal evidence for its "knockdown" value against the prima facie case, Piasecki, 745 F.2d at 1473, 223 USPQ at 788, or summarily dismiss it as not compelling or insufficient. Office personnel should weigh all relevant evidence of record in order to determine whether the claims would have been obvious based on a preponderance (more likely than not) standard, and then explain their conclusions. See MPEP § 716 - § 716.10 for additional information pertaining to the evaluation of rebuttal evidence submitted under 37 CFR 1.132. As discussed above, the instant prima facie case for using a PEG derivative having the molecular weight of 10 kDa is very strong and the secondary considerations are not enough to overcome it.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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 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
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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