DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/04/2026 has been entered.
Response to Amendment
Applicant’s amendments of claims 24-27, 29-31, 33, and 35-42 are acknowledged by the Examiner.
Applicant’s cancelation of claims 28, 32, 34, and 43 are acknowledged by the Examiner.
Applicant’s addition of new claim 44 is acknowledged by the Examiner.
Applicant’s cancelation of claim 28, and amendment of claim 30 has overcome the previous drawing objections. Therefore, the drawing objections are withdrawn.
Applicant’s amendments of claims 24, 26, 31, and 41-42 has overcome the previous specification objections. Therefore, the specification objections are withdrawn.
Applicant’s amendment of claim 24-27, 29-30, 35-38, 41-42 and the cancelation of claims 28, 34, and 43 has overcome the previous claim objections. Therefore, the claim objections are withdrawn.
Applicant’s cancelation of the limitations of claims 35 and 39 which were interpreted under 35 U.S.C. 112(f) has rendered the previous interpretations moot.
Applicant’s amendments of claims 24, 26, 30-31, 41, and 42, the cancelation of claims 28, and the clarification that a linen material is formed from flax has overcome the previous claim rejections under 35 U.S.C. 112(a). Therefore, the claim rejections under 35 U.S.C. 112(a) are withdrawn.
Applicant’s amendments of claims 24, 29-31, 33, 35, 37, 39, 42 and the cancelation of claims 32, 34, and 43 has overcome the previous claim rejections under 35 U.S.C. 112(b). Therefore, the claim rejections under 35 U.S.C. 112(b) are withdrawn.
Currently claims 24-27, 29-31, 33, 35-42, and 44 are pending in the application.
Response to Arguments
Applicant's arguments filed 01/04/2026 with respect to the reference of Karni have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the structure of Karni does not disclose a stable natural configuration that acts as a durable intraoral separator. Examiner respectfully disagrees. Applicant has not pointed to any disclosure of Karni to show that the device of Karni is not a capable of maintaining structural integrity through repeated use. Thus, this argument is non-persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the capacity of Karni to recover or continue adapting through continued use) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally Applicant states that Karni’s device is a single use device. Examiner respectfully disagrees. Although Karni states the device is “disposable”, the disclosure of Karni does not state the device is “single use”.
In response to applicant's argument that Karni does not suggest a mouth guard that is customizable in length or shape by trimming, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the compacted cotton of Karni is more than capable of being trimmed as claimed.
In response to Applicant’s argument that Karni does not disclose or suggest a natural material structure configured to remain structurally intact through repeated intraoral use. Examiner respectfully disagrees. The disclosure of Karni does not suggest that the device would break down after any use. The Examiner argues that the compacted cotton material of Karni would maintain structural integrity through multiple uses until a user wishes to dispose of the device.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., visible bite impressions that withstand repeated intraoral use) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, as discussed above, the device of Karni being formed from the compacted cotton material would maintain structural integrity through multiple uses until a user wishes to dispose of the device, and would maintain bite impressions as described in [0010]).
In response to Applicant’s arguments regarding claim 39 and the reference of Karni. Examiner first notes that the originally filed specification does not provide support for any “intentional unfinished state” being provided in the device. Therefore, this limitation is new matter. Additionally, as discussed in the final rejection, applicant’s specification [0022] states trimming the device results in raw or unfinished edges. Thus, because the device of Karni is formed from partially compacted cotton, it is capable of being cut by scissors which would intentionally form a raw or unfinished state to permit perimeter trimming for customization.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a reinforced or sealed edge) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It can clearly be seen in figure 1a of Karni that 101 does in fact, have an edge structure. Additionally Karni does not disclose fraying is an issue of the device, or that trimming is necessary to the function of the device, thus the edge of 101 is considered to resist fraying such that trimming is not necessary.
Applicant’s arguments of claim 42 are similar to that of claim 24 and are non-persuasive for similar reasons.
Applicant's arguments filed 01/04/2026 with respect to the reference of Williams have been fully considered but they are not persuasive.
In response to Applicant’s arguments that Williams does not disclose the claimed configuration formed from the now-recited class of materials. Examiner respectfully disagrees. Applicant’s deletion of the recited materials does not limit the “natural, non-synthetic materials” as Applicant suggests. Contrarily, the list of materials is expanded to include any and all natural, non-synthetic materials. Therefore, Williams still reads on independent claim 24. Additionally there is no distinctive method of conformance found in claim 24 as applicant would suggest.
In response to Applicant’s arguments of claim 25-27 and 30. Williams is no longer relied upon to disclose these features. Therefore, the arguments are moot.
In response to Applicant’s argument of claim 38, Examiner respectfully disagrees. Williams does disclose multiple natural layers formed from natural rubber. Thus, Williams does teach a freely layered configuration as claimed. With respect to “non-rubber”, Applicant has not claimed non-rubber, and if it was claimed, it would fall under 35 U.S.C. 112(a) new matter for directly contradicting their originally filed specification which discloses the use of latex or natural rubber.
Applicant's arguments filed 01/04/2026 with respect to the reference of Heck have been fully considered but they are not persuasive.
In response to Applicant’s arguments that Heck does not disclose the claimed configuration formed from the now-recited class of materials. Examiner respectfully disagrees. Applicant’s deletion of the recited materials does not limit the “natural, non-synthetic materials” as Applicant suggests. Contrarily, the list of materials is expanded to include any and all natural, non-synthetic materials. Therefore, Heck still reads on independent claim 24. Additionally there is no distinctive method of conformance found in claim 24 as applicant would suggest.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a gradual conformance) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant’s arguments regarding claim 33, Examiner respectfully disagrees. Gauze is an interlaced structure formed from long natural fivers of cotton, and are more than cable of functioning as claimed. Thus, the rejection of claim 33 is maintained.
Applicant's arguments filed 01/04/2026 with respect to the combination of Karni in view of Wiesel have been fully considered but they are not persuasive.
The combination of Karni in view of Wiesel discloses the claimed invention as Karni discloses the structure of claim 24, and Wiesel teaches the use of hemp in an analogous oral device for multiple benefits which would improve the device of Karni.
Applicant alleges that the combination relies on impermissible hindsight, but fails to identify said hindsight (i.e. non-analogous art, no teaching for use of the material, etc.). Nonetheless, 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).
Applicant's arguments filed 01/04/2026 with respect to the reference of Karni in view of Wooding have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the teaching provided by Wooding of creating a water-repellant top coat (see [col 6 ln 15-20]) provides a benefit to the device of Karni in that the combination would have provided an improved configuration that would add the benefit of creating a water-repellant top coat (see [col 6 ln 15-20]) thereby increasing the device’s ability to refrain from absorbing excess saliva which could render the device inoperable. Thus, the combination improves the intraoral structural performance of the device of Karni.
Applicant's arguments filed 01/04/2026 with respect to the reference of Heck in view of Dills have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the use of stitching materials) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally the amended claim does not limit the stitching to only intra-oral applications. Nonetheless, the Examiner notes that the stitching of Dills when included into the device of Heck would be for intraoral applications.
Thus, the rejections are maintained and updated in view of Applicant’s amendments.
Double Patenting
Claims 24-27, 29-31, 33, 35-37, and 41-42 of this application is patentably indistinct from claims 34, 36, 38, 40, 50, 55, 59, 61, and 63 of Application No. 19/203,464. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Claim 24-27, 29-31, 33, 35-37, and 41-42 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 34, 36, 38, 40, 42, 55, 59, 61, and 63 of co-pending Application No. 19/203,464 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Instant Application
19/203,464
24. A mouth guard comprising:
a configuration formed entirely of natural, non-synthetic materials configured to maintain structural integrity through repeated intraoral use, provide protective separation between upper and lower teeth during use, and exclude all synthetic thermoplastic or synthetic polymer components.
34. A mouth guard comprising:(a) two strips made entirely of natural, non-synthetic materials each strip formed from a structure having sufficient pliability and structural integrity to conform to the left and right sides of a wearer's mouth (structural integrity through repeated use and separation between upper and lower teeth as seen in figure 9)…(b) a flexible connector composed of natural, non-synthetic materials…and wherein no synthetic polymers, thermoplastics, or synthetic adhesives are used in any component of the mouth guard.
25. The mouth guard of claim 24, wherein the configuration comprises a first strip and a second strip, each formed entirely of the natural, non-synthetic materials.
34. A mouth guard comprising:(a) two strips made entirely of natural, non-synthetic materials
26. The mouth guard of claim 25, wherein the configuration further comprises a flexible connector formed of the natural, non-synthetic materials, the flexible connector joining the first and second strips.
34. …(b) a flexible connector composed of natural, non-synthetic materials integrated into each strip by sewing, weaving, or other natural methods that exclude synthetic adhesives or synthetic bonding agents
27. The mouth guard of claim 26, wherein the flexible connector allows angular variation and width adaptability between the first and second strips.
34… wherein the connector is flexible and non-rigid, permitting independent movement of the two strips and, in some embodiments, allowing adaptation to angular or width variations in a wearer's mouth
29. The mouth guard of claim 24, wherein the natural, non- synthetic materials comprise long natural fibers selected from hemp, jute, flax, or silk.
36. The mouth guard of claim 34, wherein the natural, non-synthetic materials include, but are not limited to, hemp, flax, … jute, …silk …
30. The mouth guard of claim 24, wherein the natural, non- synthetic materials are selected from straw, bamboo, or miswak
36. The mouth guard of claim 34, wherein the natural, non-synthetic materials include, but are not limited to …bamboo…straw…
31. The mouth guard of claim 24, wherein the configuration is coated with beeswax.
59. The mouth guard of claim 34, wherein one or more portions are treated, coated, or infused with natural substances including, but not limited to, beeswax….
33. The mouth guard of claim 24, wherein the configuration comprises an interlaced structure formed of long natural fibers, the interlaced structure being sufficient to independently function as a durable intraoral barrier between upper and lower teeth while maintaining structural integrity through repeated intraoral use.
61. The mouth guard of claim 34, wherein each strip (formed of a natural material including hemp which are long natural fibers) is formed into a dense structure using natural techniques including but not limited to interlacing.
34. each strip formed from a structure having structural integrity to conform to the left and right sides of a wearer's mouth (thereby functioning as a durable intraoral barrier between teeth)
35. The mouth guard of claim 24, wherein the configuration is customizable by trimming an edge or perimeter such as with scissors.
42. The mouth guard of claim 34, wherein the structure includes a perimeter that is manually adjustable by a wearer using non-synthetic techniques, including but not limited to trimming with a scissors
36. The mouth guard of claim 24, wherein the natural, non-synthetic materials are configured to conform passively to the upper and lower teeth of the wearer through applied pressure, while maintaining structural integrity through repeated intraoral use, without reliance on thermoplastic molding.
40. The mouth guard of claim 34, wherein the structure is sufficiently pliable to gradually conform to a wearer's bite pattern (including upper and lower teeth) through repeated wear.
34. each strip formed from a structure having structural integrity (thereby maintaining integrity through repeated use)
37. The mouth guard of claim 24, wherein repeated intraoral use results in visible bite impressions in the natural, non-synthetic materials of the mouth guard, while the mouth guard remains structurally and functionally intact.
40. The mouth guard of claim 34, wherein the structure is sufficiently pliable to gradually conform to a wearer's bite pattern (including upper and lower teeth) through repeated wear.
34. each strip formed from a structure having structural integrity (thereby remaining structurally and functionally intact in use)
41. The mouth guard of claim 24, wherein the configuration comprises stitching used for assembly of one or more intraoral structural components, securing said components for intraoral use without the use of synthetic adhesives.
The mouth guard of claim 34, wherein the components are assembled using only natural, non-synthetic materials and natural assembly techniques, including but not limited to stitching,
42. A method of forming a mouth guard, comprising:
(a) selecting one or more natural, non-synthetic materials;
(b) constructing the mouth guard entirely of the selected natural, non-synthetic materials without synthetic adhesives or thermoplastic processing; and
(c) allowing the mouth guard to adapt in fit through natural use and pressure over time while retaining structural integrity through repeated intraoral use.
63. (New) A method of manufacturing a mouth guard comprising:
constructing a structure entirely from natural, non-synthetic materials, the structure being created using one or more techniques including, but not limited to: (a) forming long natural fibers into structural components using a natural technique such as interlacing, weaving, knitting, braiding, wrapping, binding, or other natural techniques; …and assembling the mouth guard using only natural, non-synthetic materials and natural, non- synthetic attachment methods that exclude synthetic adhesives, synthetic bonding agents, or synthetic processing techniques; wherein the resulting mouth guard is configured … adapt to a wearer's mouth through passive, manual, integrated, or other non-synthetic fitting techniques (such a manufacturing technique allows the mouth guard to retain structural integrity through repeated intraoral use).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not provide antecedent support for the limitation of “the configuration is intentionally provided in a raw or unfinished state” as recited in claim 39. However, this limitation of “intentionally providing” is considered new matter, and thus should not be amended into the specification.
Claim Objections
Claims 24-25, 33, 36-38, 40-42, and 44 are objected to because of the following informalities:
Claim 24 recites the limitation “between upper and lower teeth”. This limitation should be amended to recite “a plurality of upper teeth and a plurality of lower teeth” to properly present the limitations.
Claim 24 recites the limitation “maintain structural integrity”. This limitation should be amended to recite “a structural integrity” to properly present the limitation.
Claim 24 recites the limitation “through repeated intraoral use”. This limitation should be amended to recite “through a repeated intraoral use” to properly present the limitation.
Claim 24 recites the limitation “during use”. This limitation should be amended to recite “during the repeated intraoral use” to maintain consistency and clarity in the claims.
Claim 25 recites the limitation “each formed entirely of the natural, non-synthetic materials”. This limitation should be amended to recite “the first strip and second strip formed entirely” to maintain consistency and clarity in the claims.
Claim 33 recites the limitation “between upper and lower teeth”. This limitation should be amended to recite “the plurality of upper teeth and the plurality of lower teeth” to maintain consistency with the suggested amendment of claim 24.
Claim 33 recites the limitation “while maintaining structural integrity”. This limitation should be amended to recite “the structural integrity” as this limitation was previously presented in claim 24.
Claim 33 recites the limitation “through repeated intraoral use”. This limitation should be amended to recite “the repeated intraoral use” as this limitation was previously presented in claim 24.
Claim 36 recites the limitation “the upper and lower teeth”. This limitation should be amended to recite “the plurality of upper teeth and the plurality of lower teeth” to maintain consistency with the suggested amendment of claim 24.
Claim 36 recites the limitation “through applied pressure”. This limitation should be amended to recite “an applied pressure” to properly present the limitation.
Claim 36 recites the limitation “while maintaining structural integrity”. This limitation should be amended to recite “the structural integrity” as this limitation was previously presented in claim 24.
Claim 36 recites the limitation “through repeated intraoral use”. This limitation should be amended to recite “the repeated intraoral use” as this limitation was previously presented in claim 24.
Claim 36 recites the limitation “without reliance on thermoplastic molding”. This limitation should be amended to recite “reliance on a thermoplastic molding” to properly present the limitation, or should be removed from the claim as this limitation is inherent to the recitation of claim 24 excluding all synthetic thermoplastic (and consequently all thermoplastic formation techniques).
Claim 37 recites the limitation “repeated intraoral use”. This limitation should be amended to recite “the repeated intraoral use” as this limitation was previously presented in claim 24.
Claim 37 recites the limitation “in visible bite impressions”. This limitation should be amended to recite “a plurality of visible bite impressions” to properly present the limitation.
Claim 37 recites the limitation “while the mouth guard remains structurally and functionally intact”. This limitation can be removed as it is redundant in view of the recitation of “maintain structural integrity through repeated intraoral use” recited in claim 24 which inherently claims the mouth guard configuration will remain structurally and functionally intact through use.
Claim 38 recites the limitation “while maintaining structural integrity through repeated intraoral use”. This limitation can be removed as it is redundant in view of the recitation of “maintain structural integrity through repeated intraoral use” recited in claim 24.
Claim 38 recites the limitation “through repeated intraoral use”. This limitation should be amended to recite “the repeated intraoral use” as this limitation was previously presented in claim 24.
Claim 40 recites the limitation “a finished edge that resist fraying”. This limitation should be amended to recite “resists” to be grammatically correct.
Claim 41 recites the limitation “said components”. This limitation should be amended to recite “said one or more intraoral structural components” to maintain consistency in the claims.
Claim 41 recites the limitation “for intraoral use”. This limitation should be amended to recite “the repeated intraoral use” as this limitation was previously presented in claim 24.
Claim 42 recites the limitation “the selected natural, non-synthetic materials”. This limitation should be amended to recite “the selected one or more natural, non-synthetic materials” to maintain consistency in the claims.
Claim 42 recites the limitation “through natural use and pressure over time”. This limitation should be amended to recite “through a natural use and a pressure over a time” to properly present the limitations.
Claim 42 recites the limitation “maintain structural integrity”. This limitation should be amended to recite “a structural integrity” to properly present the limitation.
Claim 42 recites the limitation “through repeated intraoral use”. This limitation should be amended to recite “through a repeated intraoral use” to properly present the limitation.
Claim 44 recites the limitation “The method of claim 42,”. This limitation should be amended to recite “The method of forming a mouth guard of claim 42” to maintain consistency in the claims.
Appropriate correction is required.
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.
Claim 39 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 subject matter of “the configuration is intentionally provided in a raw or unfinished state” was not described in the originally filed specification, and thus is new matter.
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 24-27, 29-31, 33, 35-41, and 44 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.
Claim 24 recites the limitation “a configuration formed entirely of natural, non-synthetic materials configured to maintain structural integrity through repeated intraoral use”. This limitation renders the claim indefinite as it is unclear if applicant is claiming the configuration maintains structural integrity through repeated intraoral use, or if Applicant is claiming the natural, non-synthetic materials maintains structural integrity through repeated intraoral use. For the purpose of examination, Examiner will interpret this limitation as best understood.
The term “sufficient” in claim 33 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, Examiner will interpret this limitation as best understood.
Regarding claim 35, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 36 recites the limitation "the wearer" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a wearer”.
Claim 38 recites the limitation "the thickness" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a thickness”.
Claim 41 recites the limitation "one or more intraoral structural components " in line 2. This limitation renders the claim indefinite as it is unclear if applicant is claiming one or more structural components of the user’s mouth, or one or more components of the configuration. For the purpose of examination, Examiner will interpret this limitation as “one or more intraoral structural components of the configuration”.
Claim 44 recites the limitation "the size or fit" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a size or fit”.
Claims 25-27, 29-31, 37, and 39-40 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim, and therefore containing the same offending limitations.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 24-27, 35-37, 39-40, and 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karni (US 2016/0175137 A1).
In regards to claim 24, Karni discloses a mouth guard (101; see [0030]; see figure 1a) comprising:
a configuration (configuration as seen in figure 1a) formed entirely of natural, non-synthetic materials (compacted cotton; see [0009]) configured to maintain structural integrity through repeated intraoral use (compacted cotton is capable of maintaining structural integrity through repeated use; thus, the configuration is configured as claimed), provide protective separation between upper and lower teeth during use (the device is between the user’s upper and lower jaws, and thus provides the claimed separation; see [0010]), and exclude all synthetic thermoplastic or synthetic polymer components (the device is formed from compacted cotton and thus, exclude all synthetic thermoplastic or synthetic polymer components).
In regards to claim 25, Karni discloses the invention as discussed above.
Karni further discloses wherein the configuration comprises a first strip (left 102) and a second strip (right 102; see [0031]; see figure 1a), each formed entirely of the natural, non-synthetic materials (the device is formed from compacted cotton (see [0009]); thus, left and right 102 are formed from compacted cotton).
In regards to claim 26, Karni discloses the invention as discussed above.
Karni further discloses wherein the configuration further comprises a flexible connector (103; see [0030]; see figure 1a) formed of the natural, non-synthetic materials (the device is formed from compacted cotton (see [0009]); thus, 103 is formed from compacted cotton), the flexible connector joining the first and second strips (see figure 1a).
In regards to claim 27, Karni discloses the invention as discussed above.
Karni further discloses, wherein the flexible connector (103) allows angular variation and width adaptability between the first and second strips (left and right 102; see [0030] the mouth guard has the ability to conform, and can take the shape of its surrounding, thus 103 is able to conform to allow angular variation and width adaptability of the first and second strips as claimed).
In regards to claim 35, Karni discloses the invention as discussed above.
Karni further discloses wherein the configuration is customizable by trimming an edge or perimeter such as with scissors (the configuration is made from compacted cotton which is capable of being customized by trimming the edge with scissors).
In regards to claim 36, Karni discloses the invention as discussed above.
Karni further discloses wherein the natural, non-synthetic materials are configured to conform passively to the upper and lower teeth of the wearer through applied pressure (see [0009-0010] and [0030] in reference to further compaction by the user applying pressure through their teeth), while maintaining structural integrity through repeated intraoral use (as discussed above: compacted cotton is capable of maintaining structural integrity through repeated use; thus, the configuration, even after passive conformation is capable of maintaining structural integrity through repeated use), without reliance on thermoplastic molding (the passive conformation does not use thermoplastic molding).
In regards to claim 37, Karni discloses the invention as discussed above.
Karni further discloses wherein repeated intraoral use results in visible bite impressions in the natural, non-synthetic materials (compacted cotton) of the mouth guard (101; see [0009-0010] and [0030]; the passive conformation of the mouth guard to the user’s teeth results in visible bite impressions), while the mouth guard remains structurally and functionally intact (the mouth guard can still be used after the passive conformation, and thus remains structurally and functionally intact after passive conformation to the user’s teeth).
In regards to claim 39, Karni discloses the invention as discussed above.
Karni further discloses wherein an edge portion of the configuration is intentionally provided in a raw or unfinished state (the mouth guard (and thus the edge portion) is intentionally provided in a partially compacted, non-conformed state (i.e. a raw, or unfinished state); see [0009-0010]) to permit perimeter trimming for customization (the partially compacted state is made from cotton which permits trimming the edge with scissors).
In regards to claim 40, Karni discloses the invention as discussed above.
Karni further discloses wherein the configuration comprises a finished edge that resist fraying such that trimming is not required (see figure 1a that the configuration has a formed or finished edge; see [0010] that the device can be adjusted without using trimming and thus, trimming of the formed or finished edge is not required).
In regards to claim 42, Karni discloses. A method of forming a mouth guard (101; see [0030]; see figure 1a), comprising:
(a) selecting one or more natural, non-synthetic materials (cotton; see [0009]);
(b) constructing the mouth guard (101) entirely of the selected natural, non-synthetic materials without synthetic adhesives or thermoplastic processing (see [0009] that the mouth guard is formed from compacted cotton; thus, 101 is entirely formed from compacted cotton without synthetic adhesives or thermoplastic processing); and
(c) allowing the mouth guard to adapt in fit through natural use and pressure over time (see [0009-0010] and [0030] in reference to the mouth guard conforming by a user applying pressure with their teeth, thus allowing the mouth guard to adapt in fit through natural use and pressure over time) while retaining structural integrity through repeated intraoral use (compacted cotton is capable of maintaining structural integrity through repeated use).
Claim(s) 24 and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams (US 5,636,379 A).
In regards to claim 24, Williams discloses a mouth guard (jaw joint protector; see [col 2 ln 35-40]; see figure 1) comprising:
a configuration (configuration of the jaw joint protector; see figure 1) formed entirely of natural, non-synthetic materials (see [col 6 ln 5-20] in reference to the jaw joint protector being formed from natural rubber, a natural and non-synthetic material) configured to maintain structural integrity through repeated intraoral use (natural rubber maintains structural integrity through repeated intraoral use through the elastic property of natural rubber), provide protective separation between upper and lower teeth during use (see figure 1), and exclude all synthetic thermoplastic or synthetic polymer components (the jaw joint protector being formed from natural rubber excludes synthetic thermoplastic and synthetic polymer components).
In regards to claim 38, Williams discloses the invention as discussed above.
Williams further discloses wherein the configuration comprises multiple layers of the natural, non-synthetic materials to increase the thickness of the mouth guard (see figure 4 that the configuration of the jaw joint protector includes upper, middle, and lower layers which increases the thickness of the jaw joint protector as claimed), while maintaining structural integrity through repeated intraoral use (as discussed above natural rubber maintains structural integrity through repeated intraoral use through the elastic property of natural rubber; thus, three layers of natural rubber also maintains structural integrity through repeated intraoral use).
Claim(s) 24 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heck (US 2003/0170590 A1).
In regards to claim 24, Heck discloses a mouth guard (3; see [0016]; see figure 3) comprising:
a configuration (21; see [0016]; see figure 3) formed entirely of natural, non-synthetic materials (cotton gauze; see [0016]) configured to maintain structural integrity through repeated intraoral use (cotton gauze is capable of maintaining structural integrity through repeated intraoral use and thus, is configured as claimed), provide protective separation between upper and lower teeth during use (see figure 2), and exclude all synthetic thermoplastic or synthetic polymer components (21 is formed from cotton gauze and thus, excludes all synthetic thermoplastic or synthetic polymer components).
In regards to claim 33, Heck discloses the invention as discussed above.
Heck further discloses wherein the configuration (21) comprises an interlaced structure formed of long natural fibers (cotton gauze is formed from long natural fibers of cotton spun into a yarn, then interwoven (i.e. interlaced) into gauze), the interlaced structure being sufficient to independently function as a durable intraoral barrier between upper and lower teeth while maintaining structural integrity through repeated intraoral use (see figure 2 that 21 is sufficient to independently function as a durable intraoral barrier between upper and lower teeth, and as discussed above cotton gauze is capable of maintaining structural integrity through repeated intraoral use).
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.
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.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karni in view of Wiesel (US 6,155,832 A).
In regards to claim 29, Karni discloses the invention as discussed above.
Karni does not disclose wherein the natural, non- synthetic materials comprise long natural fibers selected from hemp, jute, flax, or silk.
However, Wiesel teaches an analogous oral device (10; see [col 5 ln 35-45]; see figure 7) which conforms to a user’s teeth through use (see figure 7) the device being formed from natural, non-synthetic materials (hemp; see [Col 5 ln 15-20]); the natural, non-synthetic materials comprise long natural fibers selected from hemp (see [Col 5 ln 15-20]; Wiesel disclosing the device being formed from hemp thereby discloses long natural fibers as claimed) for the benefits of providing a high strength, lightweight, highly porous material (see [Col 5 ln 15-20]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the natural, non-synthetic materials (cotton) as disclosed by Karni and to have used the natural, non-synthetic materials (hemp) as taught by Wiesel in order to have provided an improved oral device that would add the benefit of providing a material which is high strength, lightweight, and highly porous (see [Col 5 ln 15-20]).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karni in view of Teller et al. (US 2017/0319806 A1) (hereinafter Teller).
In regards to claim 30, Karni discloses the invention as discussed above.
Karni does not disclose wherein the natural, non- synthetic materials are selected from straw, bamboo, or miswak.
However, Teller teaches an analogous oral device (10; see [0017]; see figure 1; see figure 3 that 20 of 10 is intended to be placed in a user’s oral cavity) formed from natural, non-synthetic materials (see [0018]); wherein the natural, non-synthetic materials are selected from bamboo (see [0018]) for the purpose of providing an oral device which is healthful, clean, and safe (See [0018]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the natural, non-synthetic materials (cotton) as disclosed by Karni and to have used the natural, non-synthetic materials (bamboo) as taught by Teller in order to have provided an improved oral device that would add the benefit of being healthful, clean, and safe (See [0018]).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karni in view of Wooding (US 2,796,362 A).
In regards to claim 31, Karni discloses the invention as discussed above.
Karni does not disclose wherein the configuration is coated with beeswax.
However, Wooding teaches an analogous base material (base material; see [col 1 ln 15-20]) formed from a natural, non-synthetic substance (untreated regenerated cellulose; see [Col 1 ln 30-40]) wherein the base material (untreated regenerated cellulose) is coated with a beeswax (see [Col 6 ln 17-30]) for the purpose of creating a water-repellant top coat (see [col 6 ln 15-20]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the configuration as disclosed by Karni by including beeswax coating as taught by Wooding in order to have provided an improved configuration that would add the benefit of creating a water-repellant top coat (see [col 6 ln 15-20]) thereby increasing the device’s ability to refrain from absorbing excess saliva which could render the device inoperable.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heck in view of Dills (US 2,512,489 A).
In regards to claim 41, Heck discloses the invention as discussed above.
Heck does not disclose wherein the configuration comprises stitching used for assembly of one or more intraoral structural components, securing said components for intraoral use without the use of synthetic adhesives. Heck does teach the presence of a seam (seam of 32 overlapping 33) but teaches the seam is to be closed using adhesive (see [0019]).
However, Dills teaches a fabric configuration which comprises an analogous seam (12; see [col 2 ln 13-25]; see figure 1); wherein the configuration comprises stitching used for assembly (see [col 2 ln 13-25]) without the use of synthetic adhesive (stitching not including synthetic adhesive)
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the means for closing the seam as disclosed by Heck and to have sealed the seam using stitching as taught by Dills in order to have provided an improved configuration which would remove the necessity of adhesive and provide a sterile, non-synthetic cotton or silk means for closing the seam (see [Col 2 ln 30-40]), thereby making the configuration of Heck safer to insert into the user’s mouth.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karni in view of Roettger et al. (US 2010/0269836 A1) (hereinafter Roettger).
In regards to claim 44, Karni discloses the invention as discussed above.
Karni further discloses that the mouth guard is adjustable to an individual's dental system shape (see [0010]), that a length of the mouth guard is determined by the need of the patient (See [0011]), and discloses a material of the mouth guard (compacted cotton; see [0009]) which is capable of being trimmed at an edge portion of the mouth guard by use of scissors to adjust a length of the mouth guard. Karni does not disclose further comprising trimming an edge portion of the mouth guard to adjust the size or fit of the mouth guard.
However, Roettger teaches an analogous mouth guard (10; see [0041]; see figure 1) and a method of forming said mouth guard (see [0041]); wherein the method comprises trimming an edge portion of the mouth guard to adjust the size or fit of the mouth guard (see [0081]) for the purpose of removing excess material from the mouth guard (see [0081]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of forming the mouth guard as disclosed by Karni and to have included the step of trimming an edge portion of the mouth guard to adjust the size or fit of the mouth guard as taught by Roettger in order to have provided an improved method of forming the mouth guard that would add the benefit of removing excess material from the mouth guard (see [0081]), thereby ensuring the mouth guard was properly sized to the user’s dentition and needs of the user as contemplated by [0011] of Karni.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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/DANIEL A MILLER/ Primary Examiner, Art Unit 3786