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 .
Priority
Acknowledgment is made of Applicant' s claim for priority under 35 U.S.C. § 119(e) with reference to Application Number: 63/039,567 filed on 6/16/2020.
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 8 is 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. Claim 8 recites that the bite block is made from material that comprises “ethylene” and “urethane.” Ethylene as a monomer is a flammable gas. The original specification failed to provide any guidance on how a monomeric ethylene is suitable for making a bite block, and how one could effectively make a bite block from it. Likewise, urethane as a monomer is a crystalline compound used as a solvent. The original specification failed to provide any guidance on a monomeric urethane is suitable for making a bite block, and one could effectively make a bite block from it. In other words, Applicant’s original specification failed to describe how ethylene nor urethane can be used as a material in a bite block in a way the conveys that applicant has possession of this feature.
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, 2, 6, and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crosbie (US 5069206).
Regarding claim 1, Crosbie teaches a bite block (see fig. 6, bite block 10; see col. 2, lines 25-37, the user bites on the block) comprising a complementary first half component and second half component (see annotated figs. 1 and 4 below),
each half component having a front portion configured to be inserted in the oral cavity of a subject during use (see annotated fig. 1 below and fig. 6, the front portions 22 and 34 are inserted into the mouth during use),
a back portion configured to be external to the subject during use (see fig. 6, the half components each have a back portion that remains external during use),
a hinge side with a hinge side interface surface (see annotated fig. 4 below, the inner side of the hinge sides are the interface surface as the two surfaces interface with one another when the bite block is closed),
a lock side with a lock side interface surface (see annotated fig. 4 below, the lock sides have outer surfaces that interface with one another),
a concave interior surface positioned between the hinge side interface surface and the lock side interface surface (see annotated fig. 4 below), and
an external surface (see annotated fig. 4 below);
the first half component and the second half component being connected by a hinge positioned on the hinge side of each component (see fig. 4, hinge 36 connects the components and is located on the hinge sides, see col. 2, lines 35-38),
the lock side of each half component comprising a portion of a complementary lock (see annotated fig. 2, the lock sides have complementary lock portions 40n and 40a), wherein the complementary half components can be pivoted at the hinge to bring lock components in contact and the interior surfaces in apposition forming a closed bite block having an elliptical lumen from front to back (see figs. 2 and 4 and col. 2, lines 26-45, the hinge allows the two components to pivot to come together. The lock components contact one another and the interior surfaces come into position side by side to form a closed bite block. As seen in figs. 1 and 3, an elliptical lumen is formed in hole 22, this lumen extending from the front to the back as shown in fig. 6. A circle is a form of an ellipse where both foci are at the center.).
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Regarding claim 2, Crosbie further teaches wherein the bite block is a one-piece construction (see figs. 2 and 4, and col. 2, lines 36-38, the block is formed of one piece, connected by living hinge 36).
Regarding claim 6, Crosbie further teaches wherein the back portion forms an external lip having a larger diameter relative to the front portion (see figs. 2 and 6, the back portion of the bite block has a larger diameter than the front portion that is inserted into the mouth).
Regarding claim 9, Crosbie further teaches the bite block of claim 1 (see above rejection of claim 1) configured to be closed by manual approximation of the lock sides of each half of the bite block (see col. 3, lines 3-5, the bite block is squeezed shut to engage the locking sides of each half).
Regarding claim 10, Crosbie further teaches the bite block of claim 1 (see above rejection of claim 1) configured to be opened by manual separation of the lock sides of each half of the bite block (see col. 3, lines 18-22, the locking mechanism is manually separated to allow the bite block to hinge open and remove the bite block).
Regarding claim 11, Crosbie further teaches the bite block of claim 1 (see above rejection of claim 1) configured to provide an audible click or snap sound when the device is appropriately engaged in the closed position (see figs. 2 and 3 and col. 2, lines 37-39, when the device is closed, the serrated teeth 38a-n of the locking mechanism come into contact with the serrated grooves 40a-n. The serrated teeth are configured to making an audible click as they pass through the grooves when closing the bite block. “audible click” and “snap sound” only require some sound be made when it is closed and these two pieces contacting one another make some sound.).
Regarding claim 12, Crosbie further teaches a method for protecting teeth and gums from clenching damage in a person (see fig. 6, the bite block is inserted into the mouth and covers the teeth and gums, protecting them from damage) requiring endotracheal tube administration, comprising the steps of inserting an endotracheal tube into a patient (Fig. 6 and col. 2, line 66 - col. 3, line 2, “after intubating has been performed and the tube is established,” thus, the endotracheal tube has been inserted into the patient), once the endotracheal tube is appropriately inserted, surrounding a segment of the endotracheal tube using a bite block of claim 1 in an open configuration (see above rejection of claim 1; see col. 3, lines 1-3, the bite block is slide down the tube to the patient’s mouth and past the teeth, placing it around this point on the tube) and locking the bite block in position such that the endotracheal tube passes through the bite block (see col. 6, lines 3-7, the block is locked into position); and deploying the bite block to the interior of the patient's mouth (see col. 3, lines 1-3 and fig. 6, the block is deployed within the mouth).
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.
Claims 13 is rejected under 35 U.S.C. 102 as being anticipated by Crosbie (US 5069206), or alternatively under 35 U.S.C. 103 as unpatentable over Crosbie in view of Freed (US 5398679).
Regarding claim 13, Crosbie further teaches the step of unlocking the bite block during a procedure (see col. 2, line 65-68, the bite block is unlocked and loosely placed on the endotracheal tube prior to intubation. “During a procedure” here is interpreted as meaning any time after the intubation procedure has begun, so initiating the intubation is during a procedure), adjusting or altering the endotracheal tube, and locking the bite block in position after adjusting or altering the endotracheal tube (see col. 2, line 68 - col. 3, line 5, after the tube has been adjusted to the proper position within the trachea, the bit block is slid down the tube to be placed within the mouth and locked in that position).
However, without admitting otherwise, if applicant is not fully convinced Crosbie discloses all the limitations of claim 13 in an interpretation under 35 USC 102, Crosbie in view of Freed discloses all the limitations of claim 13 in an interpretation under 35 USC 103.
Crosbie teaches all previous elements of the claim above but does not explicitly teach the step of unlocking the bite block during a procedure, adjusting or altering the endotracheal tube, and locking the bite block in position after adjusting or altering the endotracheal tube.
However, Freed teaches an analogous bite block and method of using (see abstract and fig. 1; see col. 5, lines 329-56) wherein the method includes unlocking the bite block during a procedure (see col. 5, lines 52-56, Freed teaches unlocking the bite block “during a procedure” at a point after the initial placement of the endotracheal tube), adjusting or altering the endotracheal tube, and locking the bite block in position after adjusting or altering the endotracheal tube (see col. 5, lines 52-56, Freed teaches the step of unfastening the bite block, adjusting the tube, and refastening during a procedure).
Crosbie teaches that the bite block is easily operated and easily applied to the tube to allow the tube to be adjusted and the bite block placed (see col. 1, lines 56-30 and col. 3, lines 1-6), but is silent as to specifically doing so during a procedure (in a narrower interpretation where “during a procedure” means after initial tube placement).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to use the device of Crosbie to perform the steps as taught by Freed to include unlocking the bite block during a procedure, adjusting or altering the endotracheal tube, and locking the bite block in position after adjusting or altering the endotracheal tube, as taught by Freed. Freed teaches this is a known method step for using a bite block during an endotracheal procedure.
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.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Crosbie (US 5069206) in view of Wells (US 5862801).
Regarding claim 3, Crosbie teaches all previous elements of the claim above but does not explicitly teach wherein the bite block is a plastic material.
However, Wells teaches an analogous bite block (col. 1, lines 17-21 and col. 2, lines 19-24, see fig. 1, the protector 10 protects the tube as the user bites it) wherein the bite block is a plastic material (see col. 2, lines 32-36, “the first endotracheal tube protector portion and the second endotracheal tube protector portion are formed of a single unitary piece of material, for example, plastic”).
Crosbie teaches any suitable polymer can be used to form the bite block (col. 2, lines 44-45), but is silent as to the specific polymer that is used. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to use plastic as the suitable polymer for the bite block of Crosbie because Wells teaches this is a suitable polymer used to form bite blocks.
Regarding claim 5, Crosbie teaches all previous elements of the claim above but does not teach a rubberized external surface configured to cushion and protect dentition from pressure damage during use.
However, Wells teaches an analogous bite block (col. 1, lines 17-21 and col. 2, lines 19-24, see fig. 1, the protector 10 protects the tube as the user bites it) wherein the bite block comprises a rubberized external surface (Fig. 3, external surface 20; see col. 2, lines 44-46, the cover is made of rubber) configured to cushion and protect dentition from pressure damage during use (see col. 2, lines 40-46 “This cover material assists in cushioning any age patient's teeth and/or gums when the patient bites down on the protector. The cover material itself may be made of any suitable material, for example, rubber, polyurethane, silicone gel or the like.”).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Crosbie (US 5069206) in view of Ciccone et al. (US PGPub 20120136314).
Regarding claim 4, Crosbie teaches all previous elements of the claim above but does not teach complementary interlocks positioned on the hinge side interface.
However, Ciccone teaches an analogous medical tube holder (abstract and fig. 1) comprising complementary interlocks (see fig. 4, interlocks 220 and 222; see paragraph 136) positioned on the hinge side interface (see fig. 4, the interlocks are on inner hinge side interfaces of the complementary halves. The hinge is element 42).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the hinge side interfaces of Crosbie to have complementary interlocks, as taught by Ciccone, for the purpose of interlocking the halves in the longitudinal and lateral directions and providing some force to help open the block when desired (see paragraph 136 of Ciccone “thus, the internal spring force stored in the interengaging elements can also provide the suitable transverse force to assist in opening the cover 24. The interengaging elements also serve to interlock the base 22 and the cover 24 in the longitudinal and lateral directions, similar to that of the projection 81 and receptacle 79 of the previous embodiment”).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Crosbie (US 5069206) in view of Haider et al. (US PGPub 20160095995).
Regarding claim 7 Crosbie teaches all previous elements of the claim above but does not teach wherein the bite block made from a material having a durometer measurement of from 10 to 80.
However, Haider teaches an analogous bite block (abstract and fig. 1) wherein the bite block made from a material having a durometer measurement of from 10 to 80 (see paragraph 8 “the posterior aspect distributes clenching force to the person's palate when properly deployed. In some aspects, the posterior aspect comprises a material having a durometer measurement of from 10 to 80.”).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the material of the bite block of Crosbie to be made of material having a durometer from 10 to 80, as taught by Haider, for the purpose of using a material known in the art that distributes clenching force in bite blocks (paragraph 8 of Haider).
Regarding claim 8 Crosbie teaches all previous elements of the claim above but does not teach wherein the material comprises at least one material selected from urethane, polyurethane, ethylene, polyethylene, thermoplastic elastomer, and/or silicone.
However, Haider teaches an analogous bite block (abstract and fig. 1) wherein the bite block made from a material comprises at least one material selected from urethane, polyurethane, ethylene, polyethylene, thermoplastic elastomer, and/or silicone (see paragraph 8, “at least one material selected from the list consisting of urethane foam, polyurethane foam, ethylene foam, polyethylene foam, thermoplastic elastomer and silicone.”).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the material of the bite block of Crosbie to be made of material selected from urethane, polyurethane, ethylene, polyethylene, thermoplastic elastomer, and/or silicone, as taught by Haider, for the purpose of using a material known in the art that distributes clenching force in bite blocks (paragraph 8 of Haider).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Crosbie (US 5069206) in view of Bierman et al. (US 6572588) and further in view of Cushner et al. (US PGPub 20140275803).
Regarding claim 14, Crosbie teaches a one-piece bite block (see fig. 6, bite block 10; see col. 2, lines 25-37, the user bites on the block; see figs. 2 and 4, and col. 2, lines 36-38, the block is formed of one piece, connected by living hinge 36) comprising a complementary first half component and second half component (see annotated figs. 1 and 4 above),
each half component having a front portion configured to be inserted in the oral cavity of a subject during use (see annotated fig. 1 above and fig. 6, the front portions 22 and 34 are inserted into the mouth during use),
a lipped back portion configured to be external to the subject during use (see annotated fig. 6 below, the half components each have a back portion that remains external during use, the rim of component 12 forms a lip),
a hinge side with a hinge side interface surface (see annotated fig. 4 above, the inner side of the hinge sides are the interface surface as the two surfaces interface with one another when the bite block is closed) and a lock side with a lock side interface surface (see annotated fig. 4 above, the lock sides have outer surfaces that interface with one another),
a concave interior surface positioned between the hinge side interface surface and the lock side interface surface (see annotated fig. 4 above), and an external surface (see annotated fig. 4 above);
the first and second half component being connected by a hinge positioned on the hinge side of each component (see fig. 4, hinge 36 connects the components and is located on the hinge sides, see col. 2, lines 35-38),
the lock side of each half component comprising a portion of a complementary lock (see annotated fig. 2, the lock sides have complementary lock portions 40n and 40a) configured to provide an audible click or snap sound when the device is appropriately engaged in the closed position (see figs. 2 and 3 and col. 2, lines 37-39, when the device is closed, the serrated teeth 38a-n of the locking mechanism come into contact with the serrated grooves 40a-n. The serrated teeth are configured to making an audible click as they pass through the grooves when closing the bite block)., wherein the complementary half components can be pivoted at the hinge to bring lock components in contact and the interior surfaces in apposition forming a closed bite block having an elliptical lumen from front to back (see figs. 2 and 4 and col. 2, lines 26-45, the hinge allows the two components to pivot to come together. The lock components contact one another and the interior surfaces come into position side by side to form a closed bite block. As seen in figs. 1 and 3, an elliptical lumen is formed in hole 22, this lumen extending from the front to the back as shown in fig. 6. A circle is a form of an ellipse where both foci are at the center.).
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Annotated fig. 6 showing the lip
Crosbie does not teach both the hinge side interface and the lock side interface having complementary interlocks configured to minimize translation of the first half component and the second half component with respect to each other during use.
However, Bierman teaches an analogous medical tube holder (abstract and fig. 1) comprising wherein both the hinge side interface and the lock side interface (see annotated fig. 4 below) having complementary interlocks (interlocks 390 and 392, one pair on the lock side interfaces and one pair on the hinge side interfaces) configured to minimize translation of the first half component and the second half component with respect to each other during use (see col. 17, line 64 - col. 18, line 13, “The interengaging elements also serve to interlock the base 150 and the cover 200 in the longitudinal and lateral directions”).
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Annotated fig. 11 of Bierman
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the lock side and hinge side interfaces of Crosbie to have complementary interlocks, as taught by Bierman, for the purpose of interlocking the halves in the longitudinal and lateral directions and providing some force to help open the block when desired (see col. 17, line 64 - col. 18, line 13 of Bierman).
Crosbie further does not teach wherein each half component comprises a lipped front portion.
However, Cushner teaches an analogous bit block (abstract and fig. 1) wherein each half component (see fig. 3, there can be considered two “halves” of the device) comprises a lipped front portion (Fig. 3, 80; see paragraphs 42-43).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the half components of Cushner to have a lip at the front portion inserted into the oral cavity, for the purpose of hugging the person’s teeth to maintain it’s position in the mouth (see paragraph 42 of Cushner).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Herrick (US PGPub 20050092328); Rogers (US 5555881); Thompson (US 5699787).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVANNAH GABRIEL whose telephone number is (571)272-6462. The examiner can normally be reached 7:30 - 4:30 M-F.
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/S.G./Examiner, Art Unit 3785
/SAMCHUAN C YAO/Supervisory Patent Examiner, Art Unit 3785