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, 3, 8, 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. Support for the hydrogel comprising “about 10% weight to about 15% by weight polyvinyl alcohol (PVA)” is not found in the originally filed specification. The applicant points to paragraphs 72 and 77 for providing support. However, paragraph 72 is related to the thickness of the appliance and not the specific of the hydrogel. Further paragraph 77 is related to a polymer and the molecular weight of the polymer. Support for the hydrogel comprising 15-20% by weight of PVA can be found in paragraph 99, however, does not provide support for the claimed range of 10-15% by weight.
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, 3 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (2014/0011162) as evidenced by the definition of a hydrogel further in view of Kim (2010/0136027).
Zegarelli discloses with respect to claim 1, a system comprising 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 (par. 46, “a medicament infused polymer gel or hydrogel”, par. 96 regarding the medicament is an antimicrobial) at discreate regions of the interior surface, 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, such anti-fungal or antibacterial, pars. 42, 44 regarding the antimicrobial (i.e., medicament) being in a carrier (i.e., the hydrogel)) and on the interior and/or exterior surface), wherein the antimicrobial is chlorhexidine phosphanilate (par. 107) present in the hydrogel (par. 46) in an amount of about 0.05% by weight based on a total weight of the hydrogel (see pars. 11, 117, such that the antimicrobial is the medicament), and wherein the hydrogel comprises water, and about 10% by weight to about 15% by weight of polyvinyl alcohol (PVA)) (see par. 42 that the polymer can be in a hydrogel form, par. 78, that the polymer comprises 20-90% weight of the formation and par. 84 which teaches the hydrogel can be from polyvinyl alcohol. It is noted that 20% is about 15%). Therefore, Zegarelli teaches the hydrogel comprising about 15% PVA (such that it is the polymer which is disclosed to be 20-90% weight of the formulation in par. 78), which is within the claimed range, and water as a hydrogel inherently has water (see cited definition of a hydrogel). Zegarelli teaches the invention as substantially claimed and discussed above including the antimicrobial is chlorhexidine phosphanilate, however, does not specifically teach the antimicrobial is chlorhexidine gluconate.
Kim teaches a composition for treating a bacterial infection including a hydrogel (par. 149) comprising an antimicrobial which is chlorhexidine gluconate (see par. 165).
It is noted that Kim teaches the use of chlorhexidine phosphanilate along with several of the same antimicrobial agents disclosed by Zegarelli (see par. 107 of Zegarelli). It is further noted that Zegarelli also teaches in par. 107 that “Other exemplary antibacterial agent include, by way of illustration and no limitation,”, therefore, it is noted that selection of a well-known antimicrobial would have been obvious to one having ordinary skill in the art before the effective filling date of the invention based on the user’s preference and desired outcome. It is noted that Zegarelli discloses the claimed invention except that chlorhexidine phosphanilate is used instead of chlorhexidine gluconate. Kim shows that the two antimicrobials are known equivalents. Therefore, because these two antimicrobials were art recognized equivalents at the time the invention was made, one of ordinary skill in the art before the effective filling date of the invention would have found it obvious to substitute chlorhexidine gluconate for chlorhexidine phosphanilate. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the antimicrobial of Zegarelli with the chlorhexidine gluconate taught by Kim as a matter of obvious design choice based on the desired out come and user’s preference.
With respect to claim 8, Zegarelli/Kim teaches the invention as substantially claimed and discussed above including Zegarelli further teaching the hydrogel further comprises hydroxypropyl cellulose (see par. 83).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable Zegarelli (2014/0011162) as evidenced by the definition of a hydrogel further in view of Kim (2010/0136027) further in view of Maier (US 2013/0098797).
Zegarelli/Kim 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/Kim, 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 rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (2014/0011162) as evidenced by the definition of a hydrogel further in view of Kim (2010/0136027) further in view of Sawhney (US 2001/0046518).
With respect to claim 14, Zegarelli/Kim 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(Il). 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/Kim, 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.
Claim(s) 1, 3 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (2014/0011162) as evidenced by the definition of a hydrogel further in view of Kim (2010/0136027) in view of KR 100550065 (KR).
Zegarelli discloses with respect to claim 1, a system comprising 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 (par. 46, “a medicament infused polymer gel or hydrogel”, par. 96 regarding the medicament is an antimicrobial) at discreate regions of the interior surface, 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, such anti-fungal or antibacterial, pars. 42, 44 regarding the antimicrobial (i.e., medicament) being in a carrier (i.e., the hydrogel)) and on the interior and/or exterior surface), wherein the antimicrobial is chlorhexidine phosphanilate (par. 107) present in the hydrogel (par. 46) in an amount of about 0.05% by weight based on a total weight of the hydrogel (see pars. 11, 117, such that the antimicrobial is the medicament), and wherein the hydrogel comprises water, and about 20% by weight of polyvinyl alcohol (PVA)) (see par. 42 that the polymer can be in a hydrogel form, par. 78, that the polymer comprises 20-90% weight of the formation and par. 84 which teaches the hydrogel can be from polyvinyl alcohol. It is noted that 20% is about 15%). Therefore, Zegarelli teaches the hydrogel comprising about 20% PVA (such that it is the polymer which is disclosed to be 20-90% weight of the formulation in par. 78), which is close to the claimed range, and water as a hydrogel inherently has water (see cited definition of a hydrogel). Zegarelli teaches the invention as substantially claimed and discussed above including the antimicrobial is chlorhexidine phosphanilate, however, does not specifically teach the antimicrobial is chlorhexidine gluconate and does not specifically teach the hydrogel comprises about 10% weight to about 15% weight of PVA.
Kim teaches a composition for treating a bacterial infection including a hydrogel (par. 149) comprising an antimicrobial which is chlorhexidine gluconate (see par. 165).
It is noted that Kim teaches the use of chlorhexidine phosphanilate along with several of the same antimicrobial agents disclosed by Zegarelli (see par. 107 of Zegarelli). It is further noted that Zegarelli also teaches in par. 107 that “Other exemplary antibacterial agent include, by way of illustration and no limitation,”, therefore, it is noted that selection of a well-known antimicrobial would have been obvious to one having ordinary skill in the art before the effective filling date of the invention based on the user’s preference and desired outcome. It is noted that Zegarelli discloses the claimed invention except that chlorhexidine phosphanilate is used instead of chlorhexidine gluconate. Kim shows that the two antimicrobials are known equivalents. Therefore, because these two antimicrobials were art recognized equivalents at the time the invention was made, one of ordinary skill in the art before the effective filling date of the invention would have found it obvious to substitute chlorhexidine gluconate for chlorhexidine phosphanilate. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the antimicrobial of Zegarelli with the chlorhexidine gluconate taught by Kim as a matter of obvious design choice based on the desired out come and user’s preference. Zegarelli/Kim teaches the invention as substantially claimed and discussed above,
however, does not specifically teach the hydrogel comprises about 10% weight to about 15% weight of PVA.
KR teaches a hydrogel for delivering a medicament to the oral cavity (a whitening agent), comprising a hydrogel comprising water and about 10% weight to about 15% weight of PVA (see last paragraph on page 3 continuing on to page 4 regarding the water soluble adhesive of the hydrogel which is PVA and can be provided in the hydrogel from the range of 0.1-70%). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the amount of PVA in the hydrogel as taught by Zegarelli/Kim with the range taught by KR in order to provide the desired properties to the hydrogel in order to deliver the medicament to the teeth.
With respect to claim 8, Zegarelli/Kim/KR teaches the invention as substantially claimed and discussed above including Zegarelli further teaching the hydrogel further comprises hydroxypropyl cellulose (see par. 83).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable Zegarelli (2014/0011162) as evidenced by the definition of a hydrogel further in view of Kim (2010/0136027) in view of KR 100550065 (KR).further in view of Maier (US 2013/0098797).
Zegarelli/Kim/KR 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/Kim/KR, 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 rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (2014/0011162) as evidenced by the definition of a hydrogel further in view of Kim (2010/0136027) in view of KR 100550065 (KR) further in view of Sawhney (US 2001/0046518).
With respect to claim 14, Zegarelli/Kim/KR 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(Il). 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/Kim/KR, 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.
Applicant's arguments filed October 10, 2025 have been fully considered but they are not persuasive.
The applicant argues that one having ordinary skill in the art would not have motivation to modify Zegarelli with the claimed range of antimicrobial (chlorhexidine) to be 0.05% and the hydrogel to have about 10-15% by weight of PVA. However, it is noted that Zegarelli teaches the claimed range of the antimicrobial (chlorhexidine ) as disclosed in par. 11. Specifically “the medicament comprises, consists essentially of or consists of an amount from about 0.01% to about 50%, from about 0.1% to about 20% by weight, from about 0.5% to about 10%, from about 1% to about 7% by weight.”. Further Zegarelli further teaches the amount of PVA in the hydrogel is about 10-15% by weight as claimed. As discussed in the previous office action and above in detail, par. 42 of Zegarelli the hydrogel comprises a polymer (“the medicament is released from the polymer (e.g., gel or hydrogel)” ) and that the polymer “the polymer comprises 20 wt % to 90 wt % of the formulation” and further in par. 85 that the polymer can be PVA. It is noted that 20% is considered to be “about 15%”. It is noted that Zegarelli teaches the claimed ranges of the antimicrobial chlorhexidine and also the PVA as it is “about” 15% as claimed, therefore, Zegarelli is NOT being modified to teach the claimed ranges of an antimicrobial and PVA within the hydrogel and therefore, the applicant’s arguments are moot.
In the alternative, where the range of PVA taught by Zegarelli is not considered to be “about 15%”, it is noted that the applicant does not disclose that the specific range provided any unexpected advantage or unexpected results and also discloses wide ranges of the PVA (see for example pars. 87 and 99). Since the prior art of KR teaches overlapping ranges with that of Zegarelli. It is noted that the hydrogel of Zegarelli is used for the same purpose of the current invention which is for delivering a medicament and the amount of a polymer in hydrogel characterizes the swelling in the hydrogel. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the range of the PVA within the hydrogel in order to provide the hydrogel with the desired swelling and medicament delivery properties.
While it is noted that Zegarelli teaches the claimed range of the antimicrobial, it appears that the applicant is arguing the specific claimed ranges provides an unexcepted results, however, it is noted that no evidence has been provided to support this. It is noted that specifically in par. 103 of the applicant’s disclosure that Chlorhexidine can be useful in ranges from about 0.01-20% by weight. It is noted that it is not specific to chlorhexidine gluconate. Further par. 104 of the applicant’s disclosure, the similar laundry list of antimicrobial agents as taught by Zegarelli and Kim are provided which includes chlorhexidine phosphanilate which is the same chlorhexidine as taught by Zegarelli (see detailed rejection above). Therefore, it is noted that there is no evidence that the specific claimed ranges and specific antimicrobial agent provides any unexpected results or advantages. Therefore, it is noted that the claims are rejected under the prior art as applied above.
The applicant further argues that the prior art of Zegarelli does not teach chlorhexidine gluconate. It is agreed that Zegarelli does not teach the use of chlorhexidine gluconate specifically, however, does teach chlorhexidine phosphanilate (see par. 107) which is also a long list of alternative antimicrobials. As discussed above, the applicant also includes a long list of alternative antimicrobials (see par. 104 of the applicant’s own disclosure) that includes the antimicrobial chlorhexidine gluconate as taught by Zegarelli. Therefore, it is noted that the applicant discloses that the two different antimicrobials are known equivalents. Further while it is agreed that Kim is not for delivering an antimicrobial to the oral cavity, it is analogous art as it is directed towards a hydrogel with an antimicrobial for treating an infection in a person. Therefore, it is considered analogous art since it is solving the same problem of delivering an antimicrobial to a patient in a hydrogel. It is noted that Kim is only be used to teach the specific antimicrobial claimed. Par. 165 of Kim teaches a long list of antimicrobial agents that are known equivalents including the claimed chlorhexidine gluconate and chlorhexidine phosphanilate as taught by Zegarelli. Therefore, Kim clearly teaches the two are known equivalents and could be substituted for each other depending on user preference. It is noted that the applicant does not disclose that the claimed chlorhexidine gluconate provide an advantage or unexpected result of the other disclosed antimicrobials disclosed and therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the specific antimicrobial of chlorhexidine phosphanilate as taught by Zegarelli with the claimed chlorhexidine gluconate as taught by Kim as a matter of obvious design choice as the modification requires substituting one specific antimicrobial with another well known antimicrobial which are known equivalents.
The applicant further argues unexpected results with respect to the claimed hydrogel composition. However, it is noted that the range of PVA claimed is 10-15% and the range of PVA used in the experiment is 15.44%. Further the “unexpected results” are in comparison to a control group in which no hydrogel was used. It is noted that unexpected results cannot be shown without a comparison of the closest prior art. In order to show unexpected results, the claimed invention would need to be compared with the hydrogel of Zegarelli which includes the claimed range of the antimicrobial and a similar range of the PVA in the hydrogel. Since the applicant only compared the current hydrogel in a method to a control group that did not use a hydrogel and only used periodontal debridement, unexpected results are not shown and the applicants’ arguments are moot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art of Rahikkala have been cited to teach that varying the amount of PVA, the release rate of the medicament can be varied.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEIDI MARIE EIDE whose telephone number is (571)270-3081. The examiner can normally be reached Mon-Fri 9:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on 571-270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HEIDI M EIDE/Primary Examiner, Art Unit 3772 10/22/2025