Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
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.
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 antimicrobial is chlorhexidine (par. 107), 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 further teaches wherein when the oral appliance is worn, the hydrogel is compressed against an entrance of a gingival crevice to from a seal that prevents oral fluids from entering the gingival crevice, to release the chlorhexidine into the gingival crevice, and to absorb oral fluid from the gingival crevice (see pars. 42, 44-46, 84, 114). Such that it is noted that the limitation if function as to how the claimed appliance is worn. It is noted that the applicant is capable of functioning as claimed as Zegarelli teaches the appliance providing a tight fit that compresses the hydrogel and delivers the medicament, i.e. the chlorhexidine, to the gingival sulcus and into the periodontal pockets, i.e. a gingival crevice. Zegarelli further teaches the hydrogel absorbs fluid from the gingival crevice since it teaches it can hold a sample of saliva, blood, cells, etc, and when the appliance is removed, it can be sent to the lab for testing. It is further noted that since the prior art of Zegarelli teaches the hydrogel functioning as claimed, it would also be capable of creating a seal, such that it absorbs the fluid and does not let it enter the crevice. Since the prior art of Zegarelli teaches the hydrogel as claimed, it is capable of functioning as claimed when in use as evidence above, and therefore, the claimed limitations are taught by Zegarelli. 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 2144.05). 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 filed August 26, 2026 have been fully considered but they are not persuasive.
The applicant argues that the prior art does not teach the new limitations directed towards how the oral appliance functions when worn. However, it is noted that the limitation is functional, and therefore, the appliance taught by the prior art only has to be capable of functioning as claimed. It is noted that Zegarelli teaches the hydrogel is located on the appliance so that it delivers the medicament, i.e. the chlorhexidine to the gingival pocket and periodontal pockets, i.e. a gingival crevice (see pars. 42, 44-46, 84, 114) and it is configured to provide a tight fit so that the hydrogel is compressed against an entrance of a gingival crescive to form a seal that prevents oral fluids form entering the gingival crevice, to release the CHG into the gingival crevice, and to absorb oral fluid from the gingival crevice (see pars. 42, 44-46, 84, 114). It is noted that the applicant is capable of functioning as claimed as Zegarelli teaches the appliance providing a tight fit that compresses the hydrogel and delivers the medicament, i.e. the chlorhexidine, to the gingival sulcus and into the periodontal pockets, i.e. a gingival crevice. Zegarelli further teaches the hydrogel absorbs fluid from the gingival crevice since it teaches it can hold a sample of saliva, blood, cells, etc, and when the appliance is removed, it can be sent to the lab for testing. Such that it creates a seal in that it absorbs the fluids and does not let them enter the crevice. Since the prior art of Zegarelli teaches the hydrogel as claimed, it is capable of functioning as claimed when in use as evidenced above, and therefore, the claimed limitations are taught by Zegarelli. Therefore, the applicant’s arguments regarding Zegarelli not teach the limitations directed towards how the oral appliance would function when used are not persuasive.
The applicant argues that support for 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” is provided in the originally filed application. Applicant points to paragraph 48 teaching that the embodiments are not limited and further to par. 10 which teaches the antimicrobial composition having chlorhexidine in amount from .01-20% in a carrier of PVA in amounts from 99.5-80%, par. 130 which teaches the chlorhexidine includes 0.05%, par. 88 which teaches water within the hydrogel, par. 76 for teaching a polymer in an amount of 15% and par. 128 which teaches chlorhexidine gluconate with glycerin in the periodontal treatment context. It is noted that support for the hydrogel comprising the claimed water, PVA, and CHG. However, specific support for the water in amounts of 40-84% is not found. The applicant teaches that the hydrogel can comprise over 99% water, however, does not teach the claimed hydrogel “consisting essentially of” water, glycerin, chlorhexidine digluconate (CHG), and polyvinyl alcohol, with the water in the claimed range. It is further noted that support for the hydrogel comprising the claimed PVA in an amount of 15% and the CHG in an amount of 0.05% along with water is supported by the originally filed specification. However, the specification does not provide enough support for the claimed hydrogel “consisting essentially of” the PVA, CHG, and the specific range of water. It is further noted that the applicant does not have support for the hydrogel having glycerin. The applicant mentions glycerin once in the entire specification in par. 128. It is noted that in that paragraph, the applicant is discussing a prior art oral rinse which includes chlorhexidine in a glycerin and gelatin matrix. The applicant does not disclose the claimed hydrogel comprising a glycerin in combination with the other claimed elements. It is noted that the applicant would have support for the hydrogel “comprising” water, CHG, and PVA but NOT “consisting essentially of” water, CHG, and PVA. It is noted that the applicant does not have support for a hydrogel comprising glycerin. Therefore, in view of the above arguments, the applicant’s arguments regarding support are not persuasive and the rejection is maintained.
The applicant argues that the office action argues that the claimed ranges are moot since the applicant discloses a very wide range. However, it is noted that the cited prior art teaches the claimed ranges as discussed above in detail. The rejection does not argue that they are moot but rather references the disclosure to support the motivation. Such that the rejection is referencing the disclosure to show that the applicant has not disclosed that the claimed range provides an advantage or unexpected result but rather is a result effective variable and it would have been obvious to one having ordinary skill in the art to select the claimed range as discussed by the prior art (see rejection above), in order to achieve the desired effect.
The applicant argues that the prior art, specifically Zegarelli, does not teach the claimed 4 component formulation. However, as discussed above, in detail support for the claimed 4 component formulation is not specifically provided, and the combination of the prior art teaches the claimed 4 component formulation). Further, 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.
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 Cozean does not provide a reason for one of ordinary skill in the art to select CHG at about 0.05%. However, it is noted that Zegarelli teaches the amount of antimicrobial, which is a chlorhexidine, to be in the claimed range and that Zegarelli is only be modified to teach the specific claimed chlorhexidine digluconate and the range of chlorhexidine is not being modified by Cozean. The modification of Zegarelli with Cozean 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.
The applicant further argues that the prior art of Caldwell does not teach the hydrogel “consisting essentially of” the claimed components and that it lists a wide ranges of components in several different paragraphs and that selective reconstruction does not provide a prima facie case of obviousness. However, it is noted that Caldwell is only being used to introduce glycerin to the claimed hydrogel and to further teach the claimed ranges of the other components taught by the prior art. It is noted that “selective reconstruction” is NOT being used, as Caldwell provide motivation for adding glycerin to a hydrogel (see detailed rejection above) and further analysis is provided for modifying the prior art of Zegarelli/Cozean to teach the claimed ranges of the other components taught by Zegarelli/Cozean.
The applicant further argues that the rational of a result effective variable only applies where the prior art recognized that the variable at issue is a result effective variable. However, it is noted that only the rejection of claim 13 with Maier to teaches the claimed elastic modulus uses the motivation of a result effective variable and the prior art of Maier recognizes the variable as a result effective variable (see par. 40 of Maier and rejection).
It is noted that the motivation to combine Zegarelli and Cozean with Caldwell to teach the claimed ranges of water and PVA is provided for in MPEP 2144.05 and includes discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05). 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. It is noted that burden is shifted to the applicant to establish that the claimed ranges are significant and unexpected (see MPEP 716.02(b)) if the applicant wants to argue that the claimed ranges are a result effective variable that provides an unexpected result.
In response to applicant's arguments against the references 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art of Houle has been cited to teach that a hydrogel can be a seal.
The prior art of Binner has been cited to teach that a hydrogel forms a seal (see par. 232).
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.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 9/18/2026
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