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 .
Response to Amendment
This office action is responsive to the amendment filed on February 17, 2026. As directed by the amendment: claims 1, 4, 5, 7-9, and 11-15 have been amended, claims 2-3 have been canceled, and claim 21 have been added. Thus, claims 1, and 4-21 are presently pending in the application.
Response to Arguments
Applicant argues on page 10 of the remarks that the objection made on claim 7, 11, and 15 should be withdrawn. Applicant response is persuasive and the previous claim objections has been hereby withdrawn.
Applicant argues on page 10-11 of the remarks that the 101 human organism rejections on claim 2-4 and 11-19. Previously, examiner states that “configured to” language must be amended in to overcome the rejection. Applicant canceled claims 2-3 but has amended that claim to advance prosecution. Applicant response is persuasive, the previous 101 rejections has been hereby withdrawn.
Applicant argues on pages 11-14 of the remarks that none of the cited references disclose or suggest that " a dental arch mold configured to receive a plurality of teeth of a user, configured to extend past the rear molars of the user to reach a back of a jaw of the user, and configured to fully occlude a mouth of the user when worn to form an airtight seal with an oral cavity of the user, the dental arch mold being form-fit to the user, molded to the jaw of the user, and having a dental arch opening that extends at least through a front face of the dental arch mold to an interior side of the dental arch mold, wherein the dental arch opening defines a first airflow path to the oral cavity; a first nasal pillow configured to be received by a first nostril of the user and to form an airtight seal with a first nasal passage of the user, wherein the first nasal pillow defines a second airflow path to the first nasal passage; and a second nasal pillow configured to be received by a second nostril of the user and to form an airtight seal with a second nasal passage of the user, wherein the second nasal pillow defines a third airflow path to the second nasal passage; and wherein the first airflow path, the second airflow path, and the third airflow path are configured to be pressurized independently from each other," in claims 1, 11, and 20. However, the applicant has amended the rejections and the new 103 rejection stated below addresses the new limitation of the claim. The BRI of “dental arch mold configured to receive a plurality of teeth of a user” is any mold that is can be put in the mouth and hold teeth. In the prior art of Anderson, the limitation of “dental arch mold configured to receive a plurality of teeth and extend past the rear molars of the user to reach a back of jaw of a user and fully occlude a mouth of the user when worn to form airtight seal with the oral cavity of the user. ” is interpreted as functional; Examiner is reading this as any mold that goes into the patient mouth, Since Anderson does not specifically teach the extending past the molars one would be motivated to change the dental mold itself to be able to “extend” to the jaw and past the molars and form a “airtight” fit for gap distribution (para. 0028; Koslov) and improving the amount of air that can pass through the airway (Col. 4 lines 1-9; Feld). Since the oral applicant (100) is “configured to” receive the plurality of teeth. In terms of the different flow paths to the mouth and the two nostrils, Aylsworth teaches you are able to independently change the different flow/pressure to the different parts of the mask. One would be motivated to allow for the different flow paths to be independent so the individual could control the flow/pressure to each nostril or mouth of the patient.
Claim Objections
Claim 7, 20, 21 objected to because of the following informalities:
Regarding Claim 7, “based on a pressure of gas to the different airflow paths” should read – based on a pressure of gas each of the first airflow path, the second airflow path, and the third airflow path— for consistency.
Regarding Claim 20, “and configured to fully occlude a mouth of the user when worn to form an airtight seal within an oral cavity of the user, fully occluding a mouth of the user when worn” should read –and configured to fully occlude a mouth of the user when worn to form an airtight seal within an oral cavity of the user— the limitation is redundant.
Regarding Claim 21, “each other-and-the-” should read –each other and the—
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 and 11, and their dependencies 4-10, 12-19, and 21 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 and 11 positively recites “the dental arch mold being form-fit to the user”. It is suggested that the language be amended to read –wherein the dental arch mold is configured to being a form-fit to the user—to overcome the rejection.
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1, 5-10, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singer et al. (WO 2018067563 A1), hereafter as Singer, Urban et al. (US 20190175388 A1), hereafter as Urban and Aylsworth et al. (US 20050011523 A1), hereafter Aylsworth.
Regrading Claim 1, Singer disclose an apparatus (Figs. 1-6) for pressurizing one or more airways of a user, comprising:
a dental arch mold (Fig. 1-6; 30) configured to receive a plurality of teeth of a user (Examiner notes: this limitation is functional; claim 2, 3; Pg. 4 lines 2-10), configured to form an airtight seal with an oral cavity of the user (Examiner notes: the mandible portion is impression of a patient’s teeth and forms an airtight seal with the oral passageway; Pg. 4 lines 17-24), the dental arch mold being form-fit to the user, molded to the jaw of the user (Pg. 15 lines 29-Pg. 16 line 4; Examiner notes: it is customized to fit the user’s mouth), and having a dental arch opening (Fig. 2-4; 60) that extends at least through a front face of the dental arch mold (Fig. 2) to an interior side of the dental arch mold (Fig. 3-4; Examiner notes: opening 60 extends from 104 to inside), wherein the dental arch opening defines a first airflow path to the oral cavity (Pg. 14 lines 18-27);
a first nasal pillow (Fig. 3-4; 46a) configured to be received by a first nostril of the user and to form an airtight seal with a first nasal passage of the user (Claim 29; Pg. 6 lines 6-12), wherein the first nasal pillow defines a second airflow path to the first nasal passage (Fig. 2; 44a); and
a second nasal pillow (Fig. 3-4; 46b) configured to be received by a second nostril of the user and to form an airtight seal with a second nasal passage of the user (Claim 29; Pg. 6 lines 6-12), wherein the second nasal pillow defines a third airflow path to the second nasal passage (Fig. 2; 44b);
wherein the first airflow path and/or the second airflow path with the third airflow path are configured to be pressurized independently from each other and the apparatus is adapted to independently deliver different air pressures and/or air flow rates to the different components each of the first airflow path and/or the second airflow path and the third airflow path (Fig. 1-7d; Pg. 11 lines 10-17; Examiner notes: Singer teaches that you could separately or simultaneously give flow to the nose component or the mouth component or both).
Singer does not specifically disclose or show that the dental arch mold extends past the rear molars of the user to reach a back of a jaw of the user, and configured to fully occlude a mouth of the user when worn.
However, Urban teaches the dental arch mold (10) extends past the rear molars (Fig. 9-10; 26 to 36, 52 to 58) of the user to reach a back of a jaw of the user (Fig. 11), and configured to fully occlude a mouth of the user when worn (Fig. 11; para. 0024).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dental mold arch that is customizable of Singer to be able to extends past the rear molars of the user to reach a back of a jaw of the user, and configured to fully occlude a mouth of the user when worn as taught by Urban for the purpose of support and maintain a patient's mandible relative to the maxilla in a substantially centric occlusion position without producing orthodontic movement (para. 0023) and provide more stable and predictable mandible support (para. 0021).
Modified Singer does not specifically teach that wherein the first airflow path, the second airflow path, AND the third airflow path (Examiner notes: Singer just teaches you could separately deliver to either the nose, mouth, or both but is silent on the different nostrils in the nose component that the two nasal components are independently given air at different flows/pressures) are configured to be pressurized independently from each other and the apparatus is adapted to independently deliver different air pressures and/or air flow rates to the different air tubes each of the first airflow path, the second airflow path, and the third airflow path.
However, Aylsworth teaches wherein the first airflow path (Fig 2; from 41), the second airflow path (Fig. 2; 38), and the third airflow path (Fig. 2; 46) are configured to be pressurized independently from each other and the apparatus is adapted to independently deliver different air pressures (depending sensors 36, 44, 45) and/or air flow rates (depending on 34, 42, 43) to the different air tubes (Fig. 2; with valves 48,50,51; para. para. 0040-0041, 0052) each of the first airflow path, the second airflow path, and the third airflow path (Fig. 2; para. 0039-0040, 0052; this limitation is functional).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus Singer to include wherein the first airflow path, the second airflow path, AND the third airflow path are configured to be pressurized independently from each other and the apparatus is adapted to independently deliver different air pressures and/or air flow rates to the different air tubes each of the first airflow path, the second airflow path, and the third airflow path by Aylsworth for the purpose of ensuring that each naris is carrying at least part of the therapeutic gas flow (para. 0040) and if medical doctors prescribe a different flow or pressure for each of the airflow paths (para. 0048). Also, having the capability of individually controlling pressure and/or therapeutic gas flow to each nostril or naris of the patient, and to the patient's mouth depending on different situations (para. 0053).
Regrading Claim 4, Modified Singer disclose the apparatus of Claim 1, wherein the first and second nasal pillows (Fig. 3-4; 46a-46b; Examiner notes: nasal components can be inserted into the nose) and are
Singer does not specifically disclose that nasal pillows are configured to fully occlude a respective nostril of the user.
However, Singer does teach nasal components are comprise an impression of a subject's nose (Pg. 15 lines 12-28).
Therefore, Modified Singer is considered to be in field of dental arch and nasal components. Due to an absence of the limitations of the it being able to occlude the nostrils of the user, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that “nasal pillow” would reasonably will reasoning encompass the absent limitation of fully occluding the nostril of the user. One would be motivated to use the nasal pillows to ensure accurate breathing and comfort to the patient and form the airtight seal to administer therapy.
Regrading Claim 5, Modified Singer disclose the apparatus of Claim 1,
Aylsworth further comprising a plurality of air pressure sensors (Fig 2; 36, 44, 45) and air flow meters (flow sensors 34, 42, 43; Fig. 2; para. 0039, 0043; Aylsworth), wherein at least two of the plurality of air pressure sensors and air flow meters are located in a different air flow path from each other (Fig. 2; para. 0039-0040; Aylsworth; Examiner notes: 36 and 44 are on different flow paths and 42 and 43 are one different flow paths from each other Fig. 2).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus Modified Singer to include a plurality of air pressure sensors and air flow meters wherein at least two of the plurality of air pressure sensors and air flow meters are located in a different air flow path from each other by Aylsworth for the purpose of having the capability of individually controlling pressure and/or therapeutic gas flow to each nostril or naris of the patient, and/or to the patient's mouth depending on different situations (para. 0039, 0053).
Regrading Claim 6, Modified Singer disclose the apparatus of Claim 5,
Modified Singer does not disclose further comprising a multi-output air regulator capable of producing a plurality of different outputs having air pressures or air flow rates which are different from one another, the air regulator in independent fluid communication with at least two of the opening of the dental arch mold, the first nasal pillow, and the second nasal pillow.
However, Aylsworth teaches a multi-output air regulator (device 30; Fig. 2; para. 0039-0041, 0052) capable of producing a plurality of different outputs (Fig. 2; para. 0039) having air pressures or air flow rates which are different from one another (Fig. 2; Examiner notes: each flow path has a pressure transducer and flow sensor), the air regulator (device 30; flow sensors 34, 42, 43; pressure transducers 36, 44, 45; pressure control valves 48, 50, 51; Fig. 2; para. 0039, 0043, 0052) in independent fluid communication with at least two of the opening of the dental arch mold, the first nasal pillow, and the second nasal pillow (Shown in Fig. 2; tube 38 and tube 46 & tube to the mouth of the patient).
Further, Aylsworth teaches wherein the multi-output air regulator (device 30; Fig. 2; para. 0039-0041, 0052; Aylsworth) is in communication with the plurality of sensors (flow sensors 34, 42, 43; Fig. 2; para. 0039, 0043; Aylsworth) and dynamically adjusts air flow or air pressure at the different outputs based on information from the plurality of sensors (para. 0039-0040, 0052; Aylsworth).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus Singer to include the a multi-output air regulator capable of producing a plurality of different outputs having air pressures or air flow rates which are different from one another as taught by Aylsworth for the purpose of having the capability of individually controlling pressure and/or therapeutic gas flow to each nostril or naris of the patient, and/or to the patient's mouth depending on different situations (para. 0039, 0053).
Regrading Claim 7, Modified Singer disclose the apparatus of claim 1, further comprising: at least one valve (control valves 48, 50, 51; Fig. 2; para. 0040-0041, 0052; Aylsworth), wherein opening and closing of the at least one valve (control valves 48, 50, 51; Fig. 2; para. 0040-0041, 0052; Aylsworth) is based on a pressure of gas to different airflow paths (38, 46; Fig. 2; para. 0039-0041, 0052; Aylsworth).
Regrading Claim 8, Modified Singer disclose the apparatus of Claim 1, wherein a flow of gas to each of the first airflow path (Fig. 3-4; 60; Singer), the second airflow path, and the third airflow path (Fig. 3-4; 46a-4b; Singer; and tube 38 and tube 46; Fig. 2; para. 0038; Aylsworth) is controlled individually by a valve (control valves 48, 50, 51; Fig. 2; para. 0039-0041, 0052; Aylsworth).
Regrading Claim 9, Modified Singer disclose the apparatus of Claim 1, further comprising a plurality of valves (control valves 48, 50, 51; Fig. 2; para. 0039-0041, 0052; Aylsworth) each valve controlling a flow of gas to an individual one of the first airflow path (Fig. 3-4; 60; Singer), the second airflow path, and third airflow path (Fig. 3-4; 46a-4b; Singer; and tube 38 and tube 46; Fig. 2; para. 0038; Aylsworth).
Regrading Claim 10, Modified Singer disclose the apparatus of Claim 1, further comprising a face shield (Fig. 1-2; 40) attached to each of the dental mold arch (Fig. 1-4; 30; Examiner notes: it is attached indirectly to the mouth component), the first nasal pillow (Fig. 3-4; 46a) , and the second nasal pillow (Fig. 3-4; 46b).
Regrading Claim 20, Singer discloses an apparatus for pressurizing one or more airways of a user, comprising:
a dental arch mold (Fig. 1-6; 30) configured to receive a plurality of teeth of a user (Examiner notes: this limitation is functional; claim 2, 3; Pg. 4 lines 2-10), configured to form an airtight seal with an oral cavity of the user (Examiner notes: the mandible portion is impression of a patient’s teeth and forms an airtight seal with the oral passageway; Pg. 4 lines 17-24),
the dental arch mold having a dental arch opening (Fig. 3-4; 60) that extends at least through a front face of the dental arch mold to an interior side of the dental arch mold (Fig. 3-4; Examiner notes: opening 60 extends from 104 to inside), wherein the dental arch opening defines a first airflow path to the oral cavity(Pg. 14 lines 18-27);
a first nasal pillow (Fig. 3-4; 46a) configured to be received by and occluding a first nostril of the user (Claim 29; Pg. 6 lines 6-12; Examiner notes: this limitation is functional, Singer teaches the nasal component comprised to fit the patient exactly), wherein the first nasal pillow defines a second airflow path to the first nostril (Fig. 2; 44a);
a second nasal pillow (Fig. 3-4; 46b) configured to be received by and occluding a second nostril of the user(Claim 29; Pg. 6 lines 6-12; Examiner notes: this limitation is functional, Singer teaches the nasal component comprised to fit the patient exactly), wherein the second nasal pillow defines a third airflow path to the second nostril (Fig. 2; 44b);
Singer does not specifically teach that the dental arch mold is configured to extend past the rear molars of the user to reach a back of a jaw of the user, and configured to fully occlude a mouth of the user when worn.
However, Urban teaches the dental arch mold (10) extends past the rear molars (Fig. 9-10; 26 to 36, 52 to 58) of the user to reach a back of a jaw of the user (Fig. 11), and configured to fully occlude a mouth of the user when worn (Fig. 11; para. 0024).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dental mold arch that is customizable of Singer to be able to extends past the rear molars of the user to reach a back of a jaw of the user, and configured to fully occlude a mouth of the user when worn as taught by Urban for the purpose of support and maintain a patient's mandible relative to the maxilla in a substantially centric occlusion position without producing orthodontic movement (para. 0023) and provide more stable and predictable mandible support (para. 0021).
Singer does not specifically disclose that nasal pillows are configured to fully occlude a respective nostril of the user.
However, Singer does teach nasal components are comprise an impression of a subject's nose (Pg. 15 lines 12-28).
Therefore, Modified Singer is considered to be in field of dental arch and nasal components. Due to an absence of the limitations of the it being able to occlude the nostrils of the user, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that “nasal pillow” would reasonably will reasoning encompass the absent limitation of fully occluding the nostril of the user. One would be motivated to use the nasal pillows to ensure accurate breathing and comfort to the patient and form the airtight seal to administer therapy.
Modified Singer does not disclose a plurality of air pressure sensors and air flow meters, wherein at least two of the plurality of air pressure sensors and air flow meters are located in a different air flow path from each other; and a multi-output air regulator in communication with the plurality of sensors and capable of producing a plurality of different outputs having air pressures or air flow rates which are different from one another wherein the first airflow path, the second airflow path, and the third airflow path are configured to be pressurized independently from each other.
However, Aylsworth teaches a plurality of air pressure sensors (Fig 2; 36, 44, 45) and air flow meters (flow sensors 34, 42, 43; Fig. 2; para. 0039, 0043; Aylsworth), wherein at least two of the plurality of air pressure sensors and air flow meters are located in a different air flow path from each other (Fig. 2; para. 0039-0040; Aylsworth; Examiner notes: 36 and 44 are on different flow paths and 42 and 43 are one different flow paths from each other Fig. 2), and a multi-output air regulator (device 30; Fig. 2; para. 0039-0041, 0052) capable of producing a plurality of different outputs (Fig. 2; para. 0039) having air pressures or air flow rates which are different from one another (Fig. 2; Examiner notes: each flow path has a pressure transducer and flow sensor), wherein the first airflow path (Fig 2; from 41), the second airflow path (Fig. 2; 38), and the third airflow path (Fig. 2; 46) are configured to be pressurized independently from each other.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus Modified Singer to include a plurality of air pressure sensors and air flow meters wherein at least two of the plurality of air pressure sensors and air flow meters are located in a different air flow path from each other and a multi-output air regulator in communication with the plurality of sensors and capable of producing a plurality of different outputs having air pressures or air flow rates which are different from one another wherein the first airflow path, the second airflow path, and the third airflow path are configured to be pressurized independently from each other by Aylsworth for the purpose of ensuring that each naris is carrying at least part of the therapeutic gas flow (para. 0040) and if medical doctors prescribe a different flow or pressure for each of the airflow paths (para. 0048). Also, having the capability of individually controlling pressure and/or therapeutic gas flow to each nostril or naris of the patient, and to the patient's mouth depending on different situations (para. 0053).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singer in view of Urban.
Regrading Claim 11, Singer discloses an apparatus for pressurizing one or more airways of a user, comprising:
a dental arch mold (Fig. 1-6; 30) configured to receive a plurality of teeth of a user (Examiner notes: this limitation is functional; claim 2, 3; Pg. 4 lines 2-10), configured to form an airtight seal with an oral cavity of the user (Examiner notes: the mandible portion is impression of a patient’s teeth and forms an airtight seal with the oral passageway; Pg. 4 lines 17-24), the dental arch mold being form-fit to the user, molded to the jaw of the user (Pg. 15 lines 29-Pg. 16 line 4; Examiner notes: it is customized to fit the user’s mouth), and having a dental arch mold port (Fig. 2-4; 60) that extends at least through a front face of the dental arch mold to an interior side of the dental arch mold (Fig. 3-4; Examiner notes: opening 60 extends from 104 to inside), wherein the dental arch mold port defines a first airflow path to the oral cavity (Pg. 14 lines 18-27);
a first nasal pillow (Fig. 3-4; 46a) configured to be received by a first nostril of the user and to form an airtight seal with a first nasal passage of the user (Claim 29; Pg. 6 lines 6-12), the first nasal pillow having a first nasal pillow port (out of 46a), wherein the first nasal port defines a second airflow path to the first nasal passage (Fig. 2; 44a);
a second nasal pillow (Fig. 3-4; 46b) configured to be received by a second nostril of the user and to form an airtight seal with a second nasal passage of the user (Claim 29; Pg. 6 lines 6-12), the second nasal pillow having a second nasal pillow port (out of 46b), wherein the second nasal port defines a third airflow path to the second nasal passage(Fig. 2; 44b); and
wherein at least two of the: dental arch mold port, the first nasal pillow port, and the second nasal pillow port are connected to different air tubes and configured to be pressurized independently from each other (Fig. 1-7d; Pg. 11 lines 10-17; Examiner notes: Singer teaches that you could separately or simultaneously give flow to the nose component or the mouth component or both; this limitation is functional).
Singer does not specifically teach that the dental arch mold is configured to extend past the rear molars of the user to reach a back of a jaw of the user, and configured to fully occlude a mouth of the user when worn.
However, Urban teaches the dental arch mold (10) extends past the rear molars (Fig. 9-10; 26 to 36, 52 to 58) of the user to reach a back of a jaw of the user (Fig. 11), and configured to fully occlude a mouth of the user when worn (Fig. 11; para. 0024).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dental mold arch that is customizable of Singer to be able to extends past the rear molars of the user to reach a back of a jaw of the user, and configured to fully occlude a mouth of the user when worn as taught by Urban for the purpose of support and maintain a patient's mandible relative to the maxilla in a substantially centric occlusion position without producing orthodontic movement (para. 0023) and provide more stable and predictable mandible support (para. 0021).
Regrading Claim 12, Modified Singer disclose the apparatus of Claim 11, wherein the first and second nasal pillows (Fig. 3-4; 46a-46b; Examiner notes: nasal components can be inserted into the nose)
Singer does not specifically disclose that nasal pillows are configured to fully occlude a respective nostril of the user.
However, Singer does teach nasal components are comprise an impression of a subject's nose (Pg. 15 lines 12-28).
Therefore, Modified Singer is considered to be in field of dental arch and nasal components. Due to an absence of the limitations of the it being able to occlude the nostrils of the user, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that “nasal pillow” would reasonably will reasoning encompass the absent limitation of fully occluding the nostril of the user. One would be motivated to use the nasal pillows to ensure accurate breathing and comfort to the patient and form the airtight seal to administer therapy.
Claim(s) 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singer and Urban, as applied to claim 12, in view of Aylsworth.
Regrading Claim 13, Modified Singer disclose the apparatus of Claim 12,
Singer does not specifically disclose further comprising a plurality of air pressure sensors and air flow meters wherein at least two of the plurality of air pressure sensors and air flow meters are located in a different air flow path from each other.
Aylsworth further comprising a plurality of air pressure sensors (Fig 2; 36, 44, 45) and air flow meters (flow sensors 34, 42, 43; Fig. 2; para. 0039, 0043; Aylsworth), wherein at least two of the plurality of air pressure sensors and air flow meters are located in a different air flow path from each other (Fig. 2; para. 0039-0040; Aylsworth; Examiner notes: 36 and 44 are on different flow paths and 42 and 43 are one different flow paths from each other Fig. 2).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus Modified Singer to include a plurality of air pressure sensors and air flow meters wherein at least two of the plurality of air pressure sensors and air flow meters are located in a different air flow path from each other by Aylsworth for the purpose of having the capability of individually controlling pressure and/or therapeutic gas flow to each nostril or naris of the patient, and/or to the patient's mouth depending on different situations (para. 0039, 0053).
Regrading Claim 14, Modified Singer disclose the apparatus of Claim 13,
Modified Singer does not disclose further comprising a multi-output air regulator capable of producing a plurality of different outputs having air pressures or air flow rates which are different from one another, the air regulator in independent fluid communication with at least two of the opening of the dental arch mold, the first nasal pillow, and the second nasal pillow.
However, Aylsworth teaches a multi-output air regulator (device 30; Fig. 2; para. 0039-0041, 0052) capable of producing a plurality of different outputs (Fig. 2; para. 0039) having air pressures or air flow rates which are different from one another (Fig. 2; Examiner notes: each flow path has a pressure transducer and flow sensor), the air regulator (device 30; flow sensors 34, 42, 43; pressure transducers 36, 44, 45; pressure control valves 48, 50, 51; Fig. 2; para. 0039, 0043, 0052) in independent fluid communication with at least two of the opening of the dental arch mold, the first nasal pillow, and the second nasal pillow (Shown in Fig. 2; tube 38 and tube 46 & tube to the mouth of the patient).
Further, Aylsworth teaches wherein the multi-output air regulator (device 30; Fig. 2; para. 0039-0041, 0052; Aylsworth) is in communication with the plurality of sensors (flow sensors 34, 42, 43; Fig. 2; para. 0039, 0043; Aylsworth) and dynamically adjusts air flow or air pressure at the different outputs based on information from the plurality of sensors (para. 0039-0040, 0052; Aylsworth).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus Singer to include the a multi-output air regulator capable of producing a plurality of different outputs having air pressures or air flow rates which are different from one another as taught by Aylsworth for the purpose of having the capability of individually controlling pressure and/or therapeutic gas flow to each nostril or naris of the patient, and/or to the patient's mouth depending on different situations (para. 0039, 0053).
Regrading Claim 15, Modified Singer discloses the apparatus of claim 14, further comprising; at least one valve (Figs. 7a-7d; 90; Pg. 16 line 27- Pg. 17 line 28).
Modified Singer does not specifically disclose wherein opening and closing of the at least one valve is based on a pressure of gas to the different air tubes.
However, Aylsworth teaches wherein opening and closing of at least one valve (control valves 48, 50, 51; Fig. 2; para. 0040-0041, 0052; Aylsworth) is based on a pressure of gas to different air tubes (38, 46; Fig. 2; para. 0039-0041, 0052; Aylsworth).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the valve system of Modified Singer to include the opening and closing of the at least one valve is based on a pressure of gas to the different air tubes as taught by Aylsworth for the purpose of having the capability of individually controlling pressure and/or therapeutic gas flow to each nostril or naris of the patient, and/or to the patient's mouth depending on different situations (para. 0039, 0053).
Regrading Claim 16, Modified Singer disclose the apparatus of claim 15, wherein a flow of gas to each of the different air tubes (tube 38 and tube 46; Fig. 2; para. 0038; Aylsworth) is controlled individually by a valve (control valves 48, 50, 51; Fig. 2; para. 0039-0041, 0052; Aylsworth).
Regrading Claim 17, Modified Singer the apparatus of claim 16, further comprising a plurality of valves (control valves 48, 50, 51; Fig. 2; para. 0039-0041, 0052; Aylsworth) each valve controlling a flow of gas to one of the different air tubes(38, 46; Fig. 2; para. 0039-0041, 0052; Aylsworth).
Regrading Claim 18, Modified Singer disclose the apparatus of Claim 17, further comprising a face shield (Fig. 1-2; 40) attached to each of the dental mold arch (Fig. 1-4; 30; Examiner notes: it is attached indirectly to the mouth component), the first nasal pillow (Fig. 3-4; 46a) , and the second nasal pillow (Fig. 3-4; 46b).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singer, Urban, and Aylsworth, as applied to claim 18, in view of Daly (US 20070240718 A1).
Regrading Claim 19, Modified Singer disclose the apparatus of Claim 18,
Modified Singer does not disclose a protective conduit attached.
However, Daly teaches a protective conduit (volume 111, 113, 115; Fig. 1B) attached to each of the face shield (mask 104; Fig. 1B; para. 0063) and the multi-output air regulator (CPAP device 130; Fig. 1B; para. 0058).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device Modified Singer to a protective conduit (volume 111, 113, 115; Fig. 1B) as taught by Daly for the purpose of preventing damage to said respiratory conduit (claim 16).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singer and Urban, as applied to claim 11, in view of Aylsworth.
Regarding Claim 21, Modified Singer disclose the apparatus of Claim 11, the first airflow path (Fig. 3-4; 60), the second airflow path (Fig. 3-4; 44a) and the third airflow path (Fig. 2-4; 44b).
Modified Singer does not specifically teach that the different flow paths are configured to be pressurized independently from each other-and-the apparatus is adapted to independently deliver different air pressures and/or air flow rates to each of the first airflow path, the second airflow path, and the third airflow path.
However, Aylsworth teaches wherein the first airflow path (Fig 2; from 41), the second airflow path (Fig. 2; 38), and the third airflow path (Fig. 2; 46) are configured to be pressurized independently from each other and the apparatus is adapted to independently deliver different air pressures (depending sensors 36, 44, 45) and/or air flow rates (depending on 34, 42, 43) to the different air tubes (Fig. 2; with valves 48,50,51; para. para. 0040-0041, 0052) each of the first airflow path, the second airflow path, and the third airflow path (Fig. 2; para. 0039-0040, 0052; this limitation is functional).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus Singer to include wherein the first airflow path, the second airflow path, AND the third airflow path are configured to be pressurized independently from each other and the apparatus is adapted to independently deliver different air pressures and/or air flow rates to the different air tubes each of the first airflow path, the second airflow path, and the third airflow path by Aylsworth for the purpose of ensuring that each naris is carrying at least part of the therapeutic gas flow (para. 0040) and if medical doctors prescribe a different flow or pressure for each of the airflow paths (para. 0048). Also, having the capability of individually controlling pressure and/or therapeutic gas flow to each nostril or naris of the patient, and to the patient's mouth depending on different situations (para. 0053).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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/MAAP AHMED ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785