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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 24, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 13-14 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 claim has been amended to include that the hydrogel “consists essentially of water, glycerin, chlorhexidine digluconate (CHG), and polyvinyl alcohol, such that the water is in an amount of about 40% to about 84% by weight, the CHG is in an amount of about 0.005% by weight and the PVA is in an amount of about 15% by weight based on a total weight of the hydrogel.”. Support for the claimed hydrogel “consisting essentially of” the claimed components and the specific percentages of the claimed components are not supported in the originally filed specification. Applicant points to pars 90 and 130 for support. While it is noted that par. 90 provide support for hydrogels being able to contain “over 99% water”, the cited paragraph does not provide support for the claimed hydrogel “consisting essentially of” the claimed components. It is noted that while par. 130 mentions glycerin, it is discussed relative to a prior art oral rinse that contains “2.5 mg of chlorhexidine gluconate in a glycerin and gelatin matrix”. It is noted that the cited paragraph does not provide support for a hydrogel “consisting essentially of” water, chlorhexidine digluconate and PVA as claimed. It is noted that support for the claimed range of CHG and PVA is provided, specific support for the claimed ranges in a hydrogel “consisting essentially of” water, glycerin, chlorhexidine digluconate, and polyvinyl alcohol is not provided.
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 and 13-14 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.
With respect to claim 1, the applicant claims “the antimicrobial disposed in a hydrogel” and then further claims the hydrogel consists essentially of several elements including CHG. It is noted that CHG is a known antimicrobial and therefore, it is unclear if the claimed antimicrobial disposed in the hydrogel is the claimed CHG or another antimicrobial. It is noted that for examination purposes, since the claim limitations the hydrogel to “consist essentially of” the claimed elements, the limitation is being interpreted as the claimed antimicrobial being the claimed CHG, however, the applicant should amend the claim to clarify what is being claimed.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (2014/0011162) in view of Cozean et al (2015/0290102) in view of Caldwell et al. (2005/0129744).
Zegarelli teaches a system including an oral appliance containing an antimicrobial for delivering the antimicrobial to an oral cavity, the system comprising the oral appliance, the oral appliance having an exterior surface 44 and an interior surface 46, the interior surface of the oral appliance configured to contour at least a portion of teeth and/or soft tissue areas of the oral cavity (see fig. 4, par. 47), and the antimicrobial disposed in a hydrogel at discreate regions of the interior surface (par. 46, “medicament infused polymer gel or hydrogel”, par. 96, regarding the medicament is an antimicrobial), the exterior surface or both the interior surface and the exterior surface of the oral appliance for delivering the antimicrobial to the oral cavity (see abstract, pars. 60, 96 regarding an antimicrobial, pars. 42, 44 regarding the antimicrobial being in a carrier, i.e. the hydrogel and on the interior and/or exterior surface), wherein the hydrogel consists essentially of water (par. 78, such that a hydrogel inherently has water), chlorhexidine (par. 107) and polyvinyl alcohol (PVA) (pars. 42, 78). It is noted that pars. 78, 85, and 92 and claim 4 provide support for the hydrogel being a polymer hydrogel, specifically a synthetic hydrogel including PVA and that the hydrogel consists essentially of only the PVA hydrogel, which includes water, and the medicant, which is chlorhexidine. Zegarelli further teaches wherein the chlorhexidine is in an amount of about 0.05% by weight ( see pars. 11, 117, such that the antimicrobial is the medicament) and the PVA is in an amount of about 15% by weight based on a total weight of the hydrogel (see pars. 42, 78, 84, the polymer comprises 20-90% weight of the formation, such that 20% is about 15%). Zegarelli teaches the invention as substantially claimed and discussed above, however, does not specifically teach the chlorhexidine is digluconate, the hydrogel further has glycerin and the water is in an amount of about 40 to 80% by weight.
Cozean teaches an antimicrobial composition which can be a gel (par. 32, 88) for use in an oral cavity (par. 71) wherein the antimicrobial is chlorhexidine digluconate (par. 73). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the chlorhexidine phosphanilate taught by Zegarelli to be chlorhexidine digluconate as taught by Cozean as an obvious matter of design choice. It is noted that Cozean teaches the two are known equivalents used for the same purpose of providing antimicrobial effects (see par. 73), therefore, it would have been an obvious matter of design choice to select the desired chlorhexidine desired. Zegarelli/Cozean teaches the invention as substantially claimed and discussed above, however, does not specifically teach the hydrogel further has glycerin and the water is in an amount of about 40 to 80% by weight.
Cadwall teaches an antimicrobial disposed in a hydrogel (see pars. 6, 11, 47-48), wherein they hydrogel comprises water (par. 36), glycerin (par. 56), chlorhexidine (par. 48) and polyvinyl alcohol (par. 54), wherein the water is in an amount of 40% to about 84% (par. 55, “about 20% to 90%”) and the PVA is in an amount of about 15% by weight based on the total weight of the hydrogel (par. 54). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the hydrogel taught by Zegarelli/Cozean to include glycerin in order to allow for the hydrogel to retain more water (see par. 56). It is noted that the combination teaches the hydrogel “consists essentially of” the claimed water, glycerin, chlorhexidine and PVA as claimed such that Zegarelli which teaches the hydrogel consisting of water, PVA, and a chlorhexidine is modified to include glycerin. Further it is noted that it would have been obvious to one having ordinary skill in the art to modify Zegarelli/Cozean to have the claimed ranges of water and PVA since it has been held that where the general condition of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.07). It is further noted that the applicant has not disclosed that the claimed range provides an advantage or any unexpected results. The applicant discloses a wide range of weight percentages of the different claimed elements. For example par. 10 of the specification teaches that the chlorhexidine can be in the range from 0.01 to 20% weight, par. 76 teaches the polymer (specifically the claimed PVA) can be in an amount from 5 to 100% of the hydrogel, par. 0001 teaches the chlorhexidine can be in the range from 0.00001 to 5% weight of the hydrogel, and par. 88 teaches that the hydrogel can contain “over 99% water”. Therefore, it is noted that the claimed ranges are determined to be design choice since a wide range is disclosed by the applicant and there is no evidence or disclosure of the claimed ranges providing an advantage or unexpected result.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (2014/0011162) in view of Cozean et al (2015/0290102) in view of Caldwell et al. (2005/0129744) as applied to claim 1 above, and further in view of Maier (2013/0098797).
Zegarelli/Cozean/Caldwell teaches the claimed invention substantially as claimed and discussed above, however, does not specifically teach wherein the hydrogel has an elastic modulus from about 0.27% kPa to about 1.5 +/-0.3 % kPa.
Maier teaches a hydrogel capable of delivering medicaments which can be made of polyvinyl alcohol (par. 41) that states the elastic modulus is a result effective variable (par. 40, "The elastic modulus E' of a gel increases with the increase of the dry polymer concentration as a portion of the hydrogel") and is in a range of 0.05 Kpa to 500kpa (par. 40). It is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Zegarelli/Cozean/Caldwell, by requiring wherein the hydrogel has an elastic modulus from about 0.27% kPa to about 1.5 +/-0.3 % kPa, as taught by Maier, for the purpose of adjusting the percentage of amount of dry polymer concentration to arrive at an optimal elastic modulus for a desired rate of dispersing a medicament in a particular application. See MPEP 2144.05(II). It is further noted that the applicant has not disclosed that the claimed elastic modulus provides an unexpected result or provides advantages.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (2014/0011162) in view of Cozean et al (2015/0290102) in view of Caldwell et al. (2005/0129744) as applied to claim 1 above, and further in view of Sawhney (2001/0046518).
With respect to claim 14, Zegarelli/Cozean/Caldwell teaches the claimed invention substantially as claimed and discussed above, however, does not specifically teach wherein the hydrogel has a tensile strength from about 4.0 to about 131 kPa.
Sawhney teaches a hydrogel which can be used in dental/oral applications (par. 64) which can have a tensile strength from about 4 to about 131 kPa (par. 51, "Hydrogels having a tensile strength in excess of 10 KPa are preferred, and hydrogels having a tensile strength greater than 50 KPa are more preferred"). It is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Zegarelli/Cozean/Caldwell, by requiring wherein the hydrogel has a tensile strength from about 4.0 to about 131 kpa, for the purpose of requiring a high enough tensile strength to withstand forces of the mouth. See MPEP 2144.05(II). It is further noted that the applicant does not disclose that the claimed tensile strength provides an unexpected result or provides advantages and claims a wide range.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The applicant argues that it would not have been obvious to one having ordinary skill in the art to modify the chlorhexidine taught by Zegarelli to be the specific claimed chlorhexidine digluconate (CHG). However, it is noted that the applicant does not disclose that the specific CHG provides an advantage or any unexpected result versus the chlorhexidine used by Zegarelli. The prior art of Cozean teaches that a variety of chlorhexidines are known in the art and are all known to provide antimicrobial effects. The applicant’s own specification uses the term “chlorhexidine” throughout the specification. It is further noted that par. 102-103 and 106 of the applicant’s own specification lists several different antimicrobial agents that can be used including several different chlorhexidines (see specifically par. 106). Therefore, the applicant’s argument that it would not have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the chlorhexidine taught by Zegarelli to be the claimed chlorhexidine are not persuasive.
The applicant further argues that the range of chlorhexidine cannot be substituted, however, it is noted that the Zegarelli teaches the claimed range of chlorhexidine as discussed above and in the previous office action. The modification of Zegarelli is only substituting one known antimicrobial for another and therefore, the disclosed range of the chlorhexidine would be the same, such that only the specific antimicrobial is being modified. It is noted that this is also evidenced by the applicant’s own specification which discloses a laundry list of antimicrobial agents and a wide range of ranges. Therefore, the applicant’s arguments are moot.
Further applicant argues that limitations of the hydrogel “consisting essentially of”, however it is noted that as discussed above in detail, the applicant does not seem to show support for the claimed hydrogel and specific ranges combined together to be limited to the claimed water, glycerin, CHG and PVA. Further it is noted that the combination above teaches the claimed limitations.
The applicant further argues that the prior art discloses a wide range of weights for the different claimed elements, however, it is noted that the applicant also discloses a wide range as discussed above in detail and therefore, the applicants’ arguments with respect to the prior art teaching wide ranges is moot.
Conclusion
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 5/21/2026
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