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 .
Information Disclosure Statement
Acknowledgement is made to Applicant’s lack of an Information Disclosure Statement submission.
Claim Objections
Claims 1-19 are objected to because of the following informalities:
Claim 1 recites “the top end of the first molar spacer” in line 7 and “the top end of the second molar spacer”. There is poor antecedent basis for the “top end” in both limitations, as a top end has not been previously recited. It is suggested to amend both limitations to “a top end”. Claim 17 is objected to for the same issue. Claims 2-16 and 18-19 are objected to as depending upon objected-to base claims.
Appropriate correction is required.
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 and 12 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 4 recites “The bite block of claim 3 wherein the center portion dips downwardly and further extends at an upward angle”. However, it is unclear how a center portion of the bridge may both dip downwardly and also further extend at an upward angle while also connecting the first molar spacer to the second molar spacer, as required by parent claim 1. It is also not clear the relative direction from which the center portion dips down or extends upward. It appears that this claim may apply to the support tab (fig. 2, 90 and [0069]) which details the claimed configuration above, except that the limitation appears to be part of the support tab connected to the center portion, and is not the center portion. The center portion in claim 1 is required to connect the first molar spacer to the second molar spacer, and the support tab does not include this function. The configuration of the center portion dipping downwardly and further extending upwardly is not described in the specification and is not clear from the drawings. It has been interpreted by the examiner that claim 4 intends to refer to the support tab connected to the center portion. It is suggested to amend claim 4 to recite: “The bite block of claim 3 wherein the center portion further comprises a support tab which dips downwardly and further extends at an upward angle from the bridge” to ensure clarity.
Claim 12 recites the limitation " the first and second posterior teeth ". There is insufficient antecedent basis for this limitation in the claim. There has been no previous recitation of first and second posterior teeth; however, claim 1 recites left and right mandibular and maxillary posterior teeth. It is not clear if “first and second posterior teeth” refers to any of these previously recited teeth, or if something else is intended by the claim. It has been interpreted by the examiner that the first and second posterior teeth are the left and right posterior maxillary or mandibular teeth. Claim 12 is interpreted to mean that the “at least 40 mm” length is the length of the first and second molar spacers that extends between the front and rear of the jaw, as detailed in original specification [0056].
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.
Claims 1-3, 6, 10, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Lane (US 2007/0197876 A1), hereafter Lane.
Regarding Claim 1, Lane discloses a bite block device for inhibiting a biting force on an endotracheal tube extending through a human patient's mouth (fig. 4, abstract), the bite block device comprising: a first molar spacer (figs. 2, left side 20, see annotated fig. [0038]) configured to contact left maxillary posterior teeth on a top surface (figs. 2 and 4, left side 20 contacts the left upper molars on the top surface [0043]) and left mandibular posterior teeth on a bottom surface (figs. 2 and 4, the bottom surface of 20 contacts the lower molars on the left side); a second molar spacer configured to contact right maxillary posterior teeth on a top surface (see annotated fig. 2, the right side trapezoidal block 20 [0040]) and right mandibular posterior teeth on a bottom surface (figs. 2 and 4, the device is symmetrical and the right trapezoidal block is positioned between the upper and lower molars on the right side [0043]); and a bridge (fig. 2, mouthguard 10 [0038]) connecting the top end of the first molar spacer at a first end (see annotated fig. 2 below) to the top end of the second molar spacer at a second end (see annotated figure 2 below) and extending forwardly to a center portion (see annotated figure) configured to extend along a lingual surface of maxillary incisors (fig. 2, the mouthguard extends along the lingual surface of the upper incisors, see alternate view in fig. 1 [0044]).
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Regarding Claim 2, Lane discloses a bite block of claim 1 wherein the first molar spacer and second molar spacer are fixedly attached to the bridge ([0040] the bite blocks 20 are integral with the mouthguard 10).
Regarding Claim 3, Lane discloses a bite block of claim 1 wherein the first end and second end of the bridge extend upwardly from the top end of the first molar spacer and the top end of the second molar spacer, respectively (this configuration is shown in fig. 1, the mouthguard 10 is positioned extend upwardly along the inclined angle of the bite blocks 20).
Regarding Claim 6, Lane discloses a bite block of claim 1 wherein a distance between the first end and the second end of the bridge is approximately equal to a width of an upper jaw of the patient (since the mouthguard 10 covers the maxillary teeth from the incisors to the molars [0038], the distance between the first end and the second end of the bridge are approximately equal to the width of the upper jaw).
Regarding Claim 10, Lane discloses a bite block of claim 1 wherein the first and second molar spacers are wedge shaped blocks tapering from a broad front end to a narrow rear end (fig. 2, the bite blocks 20 are trapezoidal in shape and tapered toward the back as seen in fig. 4 [0039]).
Regarding Claim 17, Lane discloses a method of inhibiting a biting force on an endotracheal tube extending through a human patient's mouth (abstract, fig. 4), comprising: providing a bite block having a first molar spacer (figs. 2, left side 20, see annotated fig. [0038]) configured to contact left maxillary posterior teeth on a top surface (figs. 2 and 4, left side 20 contacts the left upper molars on the top surface [0043]) and left mandibular posterior teeth on a bottom surface (figs. 2 and 4, the bottom surface of 20 contacts the lower molars on the left side); a second molar spacer configured to contact right maxillary posterior teeth on a top surface (see annotated fig. 2, the right side trapezoidal block 20 [0040]) and right mandibular posterior teeth on a bottom surface (figs. 2 and 4, the device is symmetrical and the right trapezoidal block is positioned between the upper and lower molars on the right side [0043]); and a bridge (fig. 2, mouthguard 10 [0038]) connecting the top end of the first molar spacer at a first end (see annotated fig. 2 below) to the top end of the second molar spacer at a second end (see annotated figure 2 below) and extending forwardly to a center portion (see annotated figure) configured to extend along a lingual surface of maxillary incisors (fig. 2, the mouthguard extends along the lingual surface of the upper incisors, see alternate view in fig. 1 [0044]); positioning the first molar spacer between the left maxillary posterior teeth and the left mandibular posterior teeth (fig. 4 [0043]); positioning the second molar spacer between the right maxillary posterior teeth and right mandibular posterior teeth (fig. 4 [0043]); and positioning the bridge along the lingual surface of the maxillary incisors (fig. 4 [0044]).
Regarding Claim 18, Lane discloses a method of claim 17 further comprising distributing a biting force of the patient onto the first molar spacer and the second molar spacer ([0026] and fig. 4, the contacting surfaces are the molars and the bite blocks 20).
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 5 is rejected under 35 U.S.C. 103 as unpatentable over Lane in view of Roettger et al. (US 8567408), hereafter Roettger.
Regarding Claim 5, Lane discloses a bite block of claim 1, but is silent on wherein the bridge does not contact the patient's buccal mucosa or lips (based on fig. 2, it appears that the front part of the bridge contacts the patient’s buccal mucosa in front of the incisors).
Roettger teaches an oral appliance for spacing apart occlusal surface of the molars (fig. 1, abstract) having a connector band (fig. 1, 20, col. 6 line 7) which may be positioned against lingual, palatal, buccal, or labial surfaces of the gums or teeth (col. 6 lines 61-64) in addition to alternatively being a channel (fig. 6A, 18, col. 6 line 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bridge of Lane’s device to not contact the patient’s buccal mucosa or lips by connecting the first molar spacer to the second molar spacer using one of the alternative constructions taught by Roettger, such as the lingual embodiment of fig. 3A (col. 3 lines 42-45), as this construction would predictably be able to connect two bite surface for posterior molars while retaining the device within the mouth.
Claims 7-9, 11-12, 14, and 19 are rejected under 35 U.S.C. 103 as unpatentable over Lane in view of Bertoch et al. (US 2002/0095119 A1), hereafter Bertoch.
Regarding Claim 7, Lane discloses a bite block of claim 6 but is silent on wherein the distance between the first end and the second end of the bridge is at least 25 mm.
Bertoch teaches a bite block (fig. 1, 20, [0045]) for an endotracheal tube ([0003]) that has posterior molar contacting areas (fig. 1, 30 [0047]) and a bridge (the portion of the guard 20 that connects the wedges 30).
It has been held that where the general conditions of the claims are disclosed in the prior art, finding the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05.II.A). Optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over prior art (MPEP 2144.05). As taught by Bertoch, the dimensions and shape of the guard 20 can be varied in accordance with the shape of the mouth of the patient for whom the securing device is used ([0050]).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to dimension Lane’s first and second molar spacers to be at least 40 mm long as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 8, Lane discloses a bite block of claim 1 but is silent on further comprising a tab extending forwardly from the bridge.
Bertoch teaches a bite block (fig. 1, 20, [0045]) for an endotracheal tube ([0003]) that has a tab extending forward (fig. 1, 50 [0048]) from a bridge (center portion of bite block 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a tab extending forward from Lane’s bridge of the bite block in order to provide a structure to secure an endotracheal tube so that it is not unintentionally advanced too far or retracted from the patient’s mouth (Bertoch [0004]).
Regarding Claim 9, the modified Lane discloses a bite block of claim 8 further comprising a medical tubing attached to the tab (Bertoch fig. 2 shows tab 50 securing medical tubing 60 to the bite block 20 using a latch 40 [0048]).
Regarding Claim 11, Lane discloses a bite block of claim 10, but is silent on wherein a height of the broad front end of the first and second molar spacers is at least 10 mm.
Bertoch teaches a bite block (fig. 1, 20, [0045]) for an endotracheal tube ([0003]) also having wedge-shaped tapered posterior molar contacting areas (fig. 1, 30 [0047]) that can be dimensioned so that the incisors are sufficiently separated to be larger than the outer diameter of a catheter (which may be an endotracheal tube [0003]) so as to prevent occlusion of the catheter by the patient’s teeth ([0047]).
It has been held that where the general conditions of the claims are disclosed in the prior art, finding the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05.II.A). Optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over prior art (MPEP 2144.05). As taught by Bertoch, the height of the molar spacers (fig. 1, 30 [0047]) is selected to both contact the upper molars and the lower molars while providing sufficient distance between the incisors for an endotracheal tube to pass through ([0047]).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the height of the broad front end of Lane’s first and second molar spacers to be at least 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 12, Lane discloses a bite block of claim 1, but is silent on wherein a length of the first and second molar spacers extending across the first and second posterior teeth of the patient is at least 40 mm.
Bertoch teaches a bite block (fig. 1, 20, [0045]) for an endotracheal tube ([0003]) also having posterior molar contacting areas (fig. 1, 30 [0047]).
It has been held that where the general conditions of the claims are disclosed in the prior art, finding the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05.II.A). Optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over prior art (MPEP 2144.05). As taught by Bertoch, the dimensions and shape of the guard 20 can be varied in accordance with the shape of the mouth of the patient for whom the securing device is used ([0050]).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to dimension Lane’s first and second molar spacers to be at least 40 mm long as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 14, Lane discloses a bite block of claim 1 wherein the first and second molar spacer are configured to create an interincisal distance between an incisal edge of maxillary central incisors of an upper jaw of the patient and an incisal edge of mandibular central incisors of a lower jaw of the patient (fig. 4 [0022] the bite blocks 20 keep the jaw open, thus creating an interincisal distance between the mandible and maxilla), but is silent on the distance being at least 10 mm.
Bertoch teaches a bite block (fig. 1, 20, [0045]) for an endotracheal tube ([0003]) also having wedge-shaped tapered posterior molar contacting areas (fig. 1, 30 [0047]) that can be dimensioned so that the incisors are sufficiently separated to be larger than the outer diameter of a catheter (which may be an endotracheal tube [0003]) so as to prevent occlusion of the catheter by the patient’s teeth ([0047]).
It has been held that where the general conditions of the claims are disclosed in the prior art, finding the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05.II.A). Optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over prior art (MPEP 2144.05). As taught by Bertoch, the height of the molar spacers (fig. 1, 30 [0047]) is selected to both contact the upper molars and the lower molars while providing sufficient distance between the incisors for an endotracheal tube to pass through ([0047]).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the height of the broad front end of Lane’s first and second molar spacers to be at least 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 19, Lane discloses a method of claim 17 but is silent on further comprising attaching an endotracheal tube to the bite block.
However, Bertoch teaches a bite block (fig. 1, 20, [0045]) for an endotracheal tube ([0003]) that has a tab extending forward (fig. 1, 50 [0048]) from a bridge (center portion of bite block 20) to attach an endotracheal tube (fig. 2, 60 is connected to the tab 50 via latch 40 [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attach an endotracheal tube to Lane’s bite block so that it is not unintentionally advanced too far or retracted from the patient’s mouth (Bertoch [0004]).
Claims 4, 13 and 16 are rejected under 35 U.S.C. 103 as unpatentable over Lane in view of Zacco (US 7004172 B1), hereafter Zacco.
Regarding Claim 4, as best understood based on the 112(b) rejection above, Lane discloses a bite block of claim 3, but is silent on wherein the center portion dips downwardly and further extends at an upward angle.
Zacco teaches a bite block that includes an anterior end open for breathing (fig. 7, bite block 22, airway opening 31, col. 3 lines 11-17) which has a center portion connecting posterior molar bearing surfaces (see annotated fig. below). Connected to the center portion is a tubular airway opening (fig. 7, 31, col. 4 line 3) extending away from the center portion, which dips down and further extends as the same upward angle of the entire device (fig. 8). The tubular airway opening, as connected to the center portion, is used keep large, heavy lips from occluding the airway (col. 4 lines 4-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lane’s device to include a center portion that dips downwardly and further extends at an upward angle as taught by Zacco for the benefit of supporting large or protruding lips from obstructing the breathing pathway (Zacco col. lines 4-12).
Regarding Claim 13, Lane discloses a bite block of claim 1 but is silent on wherein an angle of mouth opening with respect to a patient's temporomandibular joint is at least 20 degrees.
Zacco teaches a bite block that includes an anterior end open for breathing (fig. 4, bite block 22, airway opening 30, col. 3 lines 11-17) that has an angle of inclination between the upper and lower surfaces of the mouthpiece body from 10-20 degrees, though this may be adjusted based on the size of the mouthpiece (col. 3 lines 53-63).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define the angle of the mouth opening of Lane’s bite block from Zacco’s 10-20 degrees to at least 20 degrees, as the applicant appears to have placed no criticality on the claimed range (see par. 0071) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 16, Lane discloses a bite block of claim 1, but is silent on further comprising a second bridge connecting the bottom end of the first molar spacer and the bottom end of the second molar spacer and extending forwardly to a front end configured to extend along a lingual surface of mandibular incisors.
However, Zacco teaches a bite block that includes an anterior end open for breathing (fig. 4, bite block 22, airway opening 30, col. 3 lines 11-17) that includes a second bridge connecting the bottom end of a first molar spacer and the bottom end of a second molar spacer (fig. 6C, 32, col. 3 lines 23-24) in order to additionally protect the lower surfaces of the bite guard (col. 3 lines 26-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a second bridge in Lane’s invention in order to protect the lower surface of the lower teeth as taught by Zacco.
Claim 15 is rejected under 35 U.S.C. 103 as unpatentable over Lane in view of Hervey (US 2015/0223968), hereafter Hervey.
Regarding Claim 15, Lane discloses a bite block of claim 1, but is silent on wherein the first and second molar spacer do not contact buccal surfaces of the posterior teeth of the patient.
Hervey teaches a bite block (fig. 2, [0120]) in which a first and second molar spacer (fig. 2, the distal end of device 1 having an upper cooperating surface 2 and lower cooperating surface 3 [0103]) optionally do not contact the buccal surface of the teeth ([0134]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lane’s device from the tray-shaped mouthguard to Hervey’s device (fig. 2) in which the first and second molar spacer do not contact the buccal surfaces of the posterior teeth, since these alternatives are known in the art (Hervey [0134]) and would function equally well at retaining the device within the mouth of the patient as taught by Hervey ([0134]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2013/0146068 A1 discloses a intubation oral appliance (fig. 9, abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. 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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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785