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 .
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
Claim Rejections - 35 USC § 112
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 4, 5, 6, 9, 12, 13, and 16 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.
Claims 4, 5, and 12 recites the limitation "the dental channel", “the U-shaped horizontal channel”, and “the dentition anchoring site” (or simply “dentition anchoring site” in claim 12). There is insufficient antecedent basis for these limitations in the claims.
The term “substantial masseter muscle” in claims 6 and 13 is a relative term which renders the claim indefinite. The term “substantial” 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. It is furthermore noted that the phrase should recite “substantial masseter muscle pressure” (emphasis added). However, even with such amendment, it is unclear what pressure would qualify as “substantial” pressure.
Regarding claims 9 and 16, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim Objections
Claims 11 and 14 are objected to because of the following informalities: “a dental channel is a depression area on the bite guard” should read “a dental area that is a depression area on the bite guard”, and “incisor’s teeth” should read “incisors” in claim 11; “a… medical grade materials” should simply read “medical grade materials” in claim 14. Appropriate correction is required.
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) 1 – 3, 6, 8, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cha (KR 20080006151).
1. Cha discloses an oropharyngeal airway integrated bite guard device (see Figs. 1, 3, and 6), comprising: a pharyngeal body (see Fig. 3, 10) having a buccal end and a pharyngeal end (respective left and right ends of body 10, as illustrated in Fig. 3), the pharyngeal body is sized such that when the pharyngeal body is inserted into a user's mouth until the buccal end is disposed outside of the user's mouth and the pharyngeal end is disposed within the pharynx above an epiglottis inside the user's mouth (Fig. 1 illustrates the oropharyngeal airway once it has been inserted into the patient’s oral airway; see also p. 4, para 1 of the provided translation); a bite block body (generally corresponding to area 13, see Figs. 3 and 4) forming a sturdy section at the buccal end of the pharyngeal body configured to isolate one or more incisor teeth to prevent dentition from occluding an airway during mastication (see p. 4, para 2, p. 5, last para, p. 2, para 8); and a bite guard encloses the entire bite block body (20, see Figs. 3 and 4) to protect one or more incisor teeth and a gum line from dental damage during masseter muscle clenching downward force (p. 4, para 5, p. 5, last para, p. 2, paras 8 and 9).
2. Cha discloses the device of claim 1, wherein the device further comprises an internal conduit channel, which is a hollow inner tubular void enclosed within the pharyngeal body of the device configured to communicate air passage from the pharyngeal end to the buccal end (Figs. 3 and 4, p. 4, para 2).
3. Cha discloses the device of claim 1, wherein the device further comprises a dental channel of designated depression area on the bite guard, which is an anchoring point of contact where the incisors can be seated for one or more teeth or the gum line (see Fig. 4, channel formed between 21 and 40, where the incisors are seated on the bite block, and which helps in locking or latching the device to the jaw, see p. 5, para 1).
6. Cha discloses the device of claim 1, wherein the bite guard is made of soft material to provide dental protection from substantial masseter muscle (see p. 4, para 5, p. 5, last para, p. 2, paras 8 – 9).
8. Cha discloses the device of claim 1, wherein the bite guard is made from any one of plastic, synthetic plastic, synthetic rubber, or elastomer material (p. 4, para 5).
9. Cha discloses the device of claim 1, wherein the bite guard is further made of a thermoplastic elastomers (TPE) material like Silicone (p. 4, para. 5).
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4, 5, 11 – 13, 15, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Cha or, in the alternative, under 35 U.S.C. 103 as obvious over Cha in view of Carpenter (US 2669988).
4. Cha discloses the device of claim 1, wherein the device further comprises a plurality of dental ridges (ridges 21 and 40, respectively) forming a U-shaped horizontal channel (examiner considers the channel as U-shaped as illustrated, insofar as that it generally includes an upper left ridge, a bottom, and upper right ridge; applicant may overcome the interpretation by further claiming the U-shaped ridge as having curved surfaces where the dental ridges meet the dental channel) combined with the dental channel providing a designated depression or a trough area for the teeth (see Fig. 4, channel formed between 21 and 40, where the incisors are seated on the bite block, and which helps in locking or latching the device to the jaw, see p. 5, para 1).
Without admitting otherwise, it additionally would have been obvious to modify Cha so that the U-shaped horizontal channel has curved surfaces where the dental ridges meet the dental channel. Cha discloses a number of different bite block embodiments, see Figs. 5 – 7, and that the present invention is not limited to the embodiments described, see p. 5, para 7. Carpenter discloses a bite guard device comprising: a dental channel that is a depression area on the bite guard (see Fig. 8, dental depression holding incisors 10), wherein the dental channel is an anchoring point of contact where the incisors can be seated for one or more teeth or the gum line (see Fig. 8, c. 1: 50 - 55); and a plurality of dental ridges (24 and 20, see c. 2: 10 – 20) forming a U-shaped horizontal channel (see c. 1: 50 and Fig. 8) combined with the dental channel providing a designated depression or a trough area for the incisor's teeth (see c. 2: 10 – 20, Fig. 8), the U-shaped horizontal channel having curved surfaces where the dental ridges meet the dental channel (see Fig. 8, ridges 24 and 20 are curved toward the dental channel with an expanding thickness). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify Cha according to the U-shaped horizontal channel having curved surfaces of Carpenter for the benefit of appropriately latching and comfortably fitting the anatomy of the patient’s teeth, without sharp corners that may damage the teeth or gums.
5. Cha, or alternatively Cha in view of Carpenter, discloses the device of claim 1, wherein the device further comprises the U-shaped horizontal channel combining with the dental channel providing the dentition anchoring site to limit movement of the oropharyngeal airway bite guard device within the specified area (see claim 4 above, Cha discloses a U-shaped horizontal channel, and Carpenter alternatively renders obvious curved surfaces within said channel; Cha limits movement via stop 21 and latch 40; Carpenter furthermore renders obvious limitation of the movement as described in c. 2: 10 – 20, for the benefit of appropriately latching and comfortably fitting the anatomy of the patient’s teeth).
11. Cha discloses a bite guard device (see Figs. 1, 3, and 6) comprising: a dental channel that is a depression area on the bite guard, wherein the dental channel is an anchoring point of contact where the incisors can be seated for one or more teeth or the gum line (see Fig. 4, channel formed between 21 and 40, where the incisors are seated on the bite block, and which helps in locking or latching the device to the jaw, see p. 5, para 1; see also p. 2, paras 4 - 5); and a plurality of dental ridges (ridges 21 and 40, respectively) forming a U-shaped horizontal channel (examiner considers the channel as U-shaped as illustrated, insofar as that it generally includes an upper left ridge, a bottom, and upper right ridge; applicant may overcome the interpretation by further claiming the U-shaped ridge as having curved surfaces where the dental ridges meet the dental channel) combined with the dental channel providing a designated depression or a trough area for the incisor's teeth (see Fig. 4, channel formed between 21 and 40, where the incisors are seated on the bite block, and which helps in locking or latching the device to the jaw, see p. 5, para 1).
Without admitting otherwise, it additionally would have been obvious to modify Cha so that the U-shaped horizontal channel has curved surfaces where the dental ridges meet the dental channel. Cha discloses a number of different bite block embodiments, see Figs. 5 – 7, and that the present invention is not limited to the embodiments described, see p. 5, para 7. Carpenter discloses a bite guard device comprising: a dental channel that is a depression area on the bite guard (see Fig. 8, dental depression holding incisors 10), wherein the dental channel is an anchoring point of contact where the incisors can be seated for one or more teeth or the gum line (see Fig. 8, c. 1: 50 - 55); and a plurality of dental ridges (24 and 20, see c. 2: 10 – 20) forming a U-shaped horizontal channel (see c. 1: 50 and Fig. 8) combined with the dental channel providing a designated depression or a trough area for the incisor's teeth (see c. 2: 10 – 20, Fig. 8), the U-shaped horizontal channel having curved surfaces where the dental ridges meet the dental channel (see Fig. 8, ridges 24 and 20 are curved toward the dental channel with an expanding thickness). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify Cha according to the U-shaped horizontal channel having curved surfaces of Carpenter for the benefit of appropriately latching and comfortably fitting the anatomy of the patient’s teeth, without sharp corners that may damage the teeth or gums.
12. The device of claim 11, wherein the U-shaped horizontal channel combining with the dental channel provide dentition anchoring site to limit the movement of the oropharyngeal airway bite guard device within the specified area (see claim 11 above, Cha discloses a U-shaped horizontal channel, and Carpenter alternatively renders obvious curved surfaces within said channel; Cha limits movement via stop 21 and latch 40; Carpenter furthermore renders obvious limitation of the movement as described in c. 2: 10 – 20, for the benefit of appropriately latching and comfortably fitting the anatomy of the patient’s teeth).
13. Cha discloses the device of claim 11, wherein the bite guard is made of soft material to provide dental protection from substantial masseter muscle (see p. 4, para 5, p. 5, last para, p. 2, paras 8 – 9).
15. Cha discloses the device of claim 11, wherein the bite guard is made from any one of plastic, synthetic plastic, synthetic rubber, or elastomer material (p. 4, para 5).
16. Cha discloses the device of claim 11, wherein the bite guard is made of a thermoplastic elastomers (TPE) material like Silicone (p. 4, para 5).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cha in view of Fillyaw (US 20040040556).
7. Cha discloses the device of claim 1, wherein the bite guard is made of non-brittle material medical-grade (see p. 4, para 5, p. 5, last para, p. 2, paras 8 – 9). However, Cha does not disclose non-toxic and latex-free medical-grade materials. Nonetheless, Fillyaw discloses a mouthpiece comprising non-brittle, non-toxic and latex-free medical-grade materials [0029]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the bite guard of Cha according to the latex-free material of Fillyaw for the benefit of patient safety.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cha, or alternatively Cha in view of Carpenter, further in view of Fillyaw (US 20040040556).
14. Cha discloses the device of claim 11, wherein the bite guard is made of non-brittle material medical-grade (see p. 4, para 5, p. 5, last para, p. 2, paras 8 – 9). However, Cha does not disclose non-toxic and latex-free medical-grade materials. Nonetheless, Fillyaw discloses a mouthpiece comprising non-brittle, non-toxic and latex-free medical-grade materials [0029]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the bite guard of Cha according to the latex-free material of Fillyaw for the benefit of patient safety.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cha in view of Bertram (US 20020010417).
10. Cha discloses the device of claim 1, wherein the bite guard is made of a soft material, but does not explicitly disclose having Shore A Hardness between 15 to 35. Nonetheless, Betram discloses a respiratory passage contacting soft silicone having Shore A Hardness between 15 to 35, see [0009]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the bite guard of Cha with the Shore A Hardness of Bertram for the benefit of preventing injury or strain to the patient despite contact of the patient.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cha, or alternatively Cha in view of Carpenter, further in view of Bertram (US 20020010417).
17. Cha discloses the device of claim 11, wherein the bite guard is made of a soft material, but does not explicitly disclose having Shore A Hardness between 15 to 35. Nonetheless, Betram discloses a respiratory passage contacting soft silicone having Shore A Hardness between 15 to 35, see [0009]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the bite guard of Cha with the Shore A Hardness of Bertram for the benefit of preventing injury or strain to the patient despite contact of the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Please see the provided PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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