DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 11/26/24.
The examiner acknowledges the amendments to the claims.
Claims 1-3, 5-7, 9-11, 13, 15-18, 20-22, 24-26, 28 are pending in this application.
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 .
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 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ivanov (RU 2477088 C1), and see English Translation of Ivanov.
Regarding claim 1, Ivanov discloses anatomical nasal conformer device, the device comprising:
a first stent 1 and a second stent 2 (Figures 1, 4, 7, 9-11) each being configured to be inserted into a different nostril of a user, each of the first stent and the second stent defining an opening extending along a centerline x (Figures 2, 5) from an anterior end (lower side 9) of the stent to a posterior end (rear 7) of the stent, wherein the centerline includes a posterior portion adjacent the posterior end 7, an anterior portion adjacent the anterior end 9, and a middle portion (including middle 6) disposed between the posterior portion and the anterior portion, wherein the anterior portion of the centerline and the posterior portion of the centerline form an angle (the first and second stents are curved downwards due to bend 8; Figures 2, 5).
However, Ivanov does not expressly teach the angle being in the range of 90 to 65 degrees, but sets forth that the angle is a result effective variable which could be optimized to create maximal comfort for the patient in conforming to curves of the nasal passages of the patient and to accelerate clinical recovery after surgery (see Abstract of English Translation of Ivanov, and paragraph [52] of English Translation of Description of Ivanov: ”The shape of the endonasal activator corresponds to the normal anatomical structure of the inner surface of the nasal passages” which is “comfortable to wear, does not require additional fixation, and is securely held in the nasal cavity”).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the angle to be in the range of 90 to 65 degrees for the purpose of optimizing comfort and recovery for the patient, and 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 2, Ivanov as modified teaches the claimed invention, as discussed above, except for the angle being in the range of 80 to 75 degrees.
However, Ivanov sets forth that the angle is a result effective variable which could be optimized to create maximal comfort for the patient in conforming to curves of the nasal passages of the patient and to accelerate clinical recovery after surgery (see Abstract of English Translation of Ivanov, and paragraph [52] of English Translation of Description of Ivanov: ”The shape of the endonasal activator corresponds to the normal anatomical structure of the inner surface of the nasal passages” which is “comfortable to wear, does not require additional fixation, and is securely held in the nasal cavity”).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the angle to be in the range of 80 to 75 degrees for the purpose of optimizing comfort and recovery for the patient, and 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 3, Ivanov as modified teaches the claimed invention, as discussed above, including the angle is a first angle, wherein the middle portion of the centerline and the posterior portion of the centerline form a second angle (see annotated Figure 5 below), however does not expressly teach wherein the second angle is in the range of 35 to 55 degrees.
FIGURE 5 OF IVANOV
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However, Ivanov sets forth that the angle is a result effective variable which could be optimized to create maximal comfort for the patient in conforming to curves of the nasal passages of the patient and to accelerate clinical recovery after surgery (see Abstract of English Translation of Ivanov) as well as to stabilize the device in the middle position of the nasal septum (see paragraph [7] of English Translation of Description of Ivanov: “patients need to achieve stabilization of the median position of the nasal septum for a long postoperative recovery period, to prevent cicatricial deformities after the above operations” and it is “necessary to provide patients with maximum comfort for a long time, to prevent the possibility of injury to the nasal mucosa”).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the second angle to be in the range of 35 to 55 degrees for the purpose of optimizing comfort and recovery for the patient, and 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 5, Ivanov as modified teaches the first stent 1 and the second stent 2 each include a nostril dome supporting protrusion (tubercle or protuberance 10; Figures 2, 5, 10) extending anteriorly from an outer surface of the stent adjacent the intersection of the anterior portion of the centerline and the middle portion of the centerline (Id.; protrusions 10 extend towards front of device).
Regarding claim 6, Ivanov as modified teaches the nostril dome supporting protrusion 10 of each of the first stent and the second stent further extend medially (Id. protrusions 10 also extend towards each other or inwards towards a medial axis of the device).
Regarding claim 7, Ivanov as modified teaches the nostril dome supporting protrusion 10 is configured to be disposed posteriorly to a nasal aperture margin (away from front face of lower side 9) and to apply pressure to a deep margin of the lower lateral cartilage when the first stent and the second stent are inserted into the nostrils of a user (Id.; due to the protrusions extending medially as seen in Figure 10, the protrusions can apply pressure to deep, inner margins of lower lateral cartilage).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ivanov (RU 2477088 C1), and see English Translation of Ivanov, in view of Duran Von Arx (U.S. Pub. No. 2008/0009897).
Regarding claim 9, Ivanov as modified teaches the claimed invention, as discussed above, except for the first stent and the second stent each include a lateral ala vestibule protrusion extending laterally from an outer surface of the stent adjacent the anterior portion of the centerline, wherein the first stent and the second stent each include an infradome recessed portion disposed between the nostril dome supporting protrusion 10 and the lateral ala vestibule protrusion.
Duran Von Arx teaches an anatomical nasal conformer device including a first stent and a second stent 1 (Figures 5, 7) each defining an opening extending along a centerline from an anterior end to a posterior end of the stent (Figure 4), wherein each of the first and second stents includes a lateral ala vestibule protrusion (widened part 2; Figure 7, [0006], [0018]) extending laterally from an outer surface of the stent adjacent the anterior portion of the centerline.
It would have been obvious to one of ordinary skill before the effective filing date to modify Ivanov as modified with each stent including a lateral ala vestibule protrusion as claimed, as taught by Duran Von Arx, since the widened lateral parts stimulate the alar of the nose for ease of breathing (Duran Von Arx; [0001], [0004]).
FIGURES 10-11 OF IVANOV
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Furthermore, once the combination is made, an infradome recessed portion would be formed between the nostril dome supporting protrusion and the lateral ala vestibule protrusion on each of the first and second stents, since Ivanov teaches a curved recessed surface adjacent to and extending laterally from the nostril dome supporting protrusion (see annotated Figures 10-11 above showing infradome recessed portion on first stent between nostril dome supporting protrusion 10 and where lateral ala vestibule protrusion 2 would be placed once Ivanov is combined with Duran Von Arx).
Regarding claim 10, Ivanov as modified teaches the claimed invention, as discussed above, except for the first stent and the second stent each include a lateral ala vestibule protrusion extending laterally from an outer surface of the stent adjacent the anterior portion of the centerline.
Duran Von Arx teaches an anatomical nasal conformer device including a first stent and a second stent 1 (Figures 5, 7) each defining an opening extending along a centerline from an anterior end to a posterior end of the stent (Figure 4), wherein each of the first and second stents includes a lateral ala vestibule protrusion (widened part 2; Figure 7, [0006], [0018]) extending laterally from an outer surface of the stent adjacent the anterior portion of the centerline.
It would have been obvious to one of ordinary skill before the effective filing date to modify Ivanov as modified with each stent including a lateral ala vestibule protrusion as claimed, as taught by Duran Von Arx, since the widened lateral parts stimulate the alar of the nose for ease of breathing (Duran Von Arx; [0001], [0004]).
Regarding claim 11, Ivanov as modified teaches the lateral ala vestibule protrusion 2 (Duran Von Arx; Figure 7) is configured to be disposed posteriorly to a nasal aperture margin (away from front face of the device) and to apply pressure to a lateral aspect of the nasal vestibule when the first stent and the second stent are inserted into the nostrils of a user (Duran Von Arx; [0001], [0004]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ivanov (RU 2477088 C1), and see English Translation of Ivanov, in view of Santelli, Jr. (U.S. Pub. No. 2014/0261459).
Regarding claim 13, Ivanov as modified teaches a central bridge 3 (Figure 1) extending between and coupling together the anterior end of the first stent 1 and the anterior end of the second stent 2. However, Ivanov as modified does not teach a handle protrusion extending from the central bridge.
Santelli, Jr. teaches a nasal device including a central bridge 14 (Figures 1A-1C) and a handle protrusion 20 extending from the central bridge.
It would have been obvious to one of ordinary skill before the effective filing date to modify Ivanov as modified with a handle protrusion as claimed, as taught by Santelli, Jr., to provide a surface for facilitating handling by a user and insertion of the nasal device into a patient’s nostril’s ([0031]; Santelli, Jr.).
Claims 15-18 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ivanov (RU 2477088 C1), and see English Translation of Ivanov in view of Sheyte et al. (U.S. Pub. No. 2023/0355420).
Regarding claim 15, Ivanov discloses a first anatomical nasal conformer device, the device comprising:
a first stent 1 and a second stent 2 (Figures 1, 4, 7, 9-11) each being configured to be inserted into a different nostril of a user, each of the first stent and the second stent defining an opening extending along a centerline x (Figures 2, 5) from an anterior end (lower side 9) of the stent to a posterior end (rear 7) of the stent, wherein the centerline includes a posterior portion adjacent the posterior end 7, an anterior portion adjacent the anterior end 9, and a middle portion (including middle 6) disposed between the posterior portion and the anterior portion, wherein the anterior portion of the centerline and the posterior portion of the centerline form an angle (the first and second stents are curved downwards due to bend 8; Figures 2, 5),
wherein the first stent and the second stent each include a nostril dome supporting protrusion (tubercle or protuberance 10; Figures 2, 5, 10) extending anteriorly from an outer surface of the stent adjacent the intersection of the anterior portion of the centerline and the middle portion of the centerline (Id.; protrusions 10 extend towards front of device), wherein the nostril dome supporting protrusion extends from the outer surface by a length, and wherein the anterior portion includes a nasal aperture portion configured to abut the nasal aperture margin (at front face of lower side 9) when the first stent and the second stent are inserted into the nostrils of the user, wherein the nasal aperture portion has a longest width as measured perpendicular to the centerline (see elongate cross-section of nasal aperture portion in Figures 3-5).
However, Ivanov does not expressly teach the angle formed by the anterior portion of the centerline and the posterior portion of the centerline being oblique.
Ivanov sets forth that the angle is a result effective variable which could be optimized to create maximal comfort for the patient in conforming to curves of the nasal passages of the patient and to accelerate clinical recovery after surgery (see Abstract of English Translation of Ivanov, and paragraph [52] of English Translation of Description of Ivanov: ”The shape of the endonasal activator corresponds to the normal anatomical structure of the inner surface of the nasal passages” which is “comfortable to wear, does not require additional fixation, and is securely held in the nasal cavity”).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the angle to be oblique for the purpose of optimizing comfort and recovery for the patient and accelerating clinical recovery, and 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).
Furthermore, Ivanov does not teach a system further comprising a second anatomical nasal conformer device including the elements of the first anatomical conformer device, and wherein one of the length of the nostril dome supporting protrusion or the longest width of the nasal aperture portion is larger for the second anatomical nasal conformer device than the one of the first anatomical nasal conformer device.
In Figures 1, 3A-3B, Sheyte et al. teaches a first anatomical nasal conformer device including a first stent 110a and a second stent 110b each having a nasal aperture portion (Id.). In [0050], [0066] Sheyte et al. further teaches that a patient may switch from the first anatomical nasal conformer to a second anatomical nasal conformer device (a larger sized device) after they get older for further treatment. One of ordinary skill in the art would recognize that it would have been obvious before the effective filing date to modify Ivanov as modified with a larger second anatomical nasal conformer device, as taught by Sheyte et al., wherein one of the length of the nostril dome supporting protrusion or the longest width of the nasal aperture portion being larger for the second nasal conformer device than the one of the first anatomical nasal conformer device to further treat a patient as they get older and require a larger nasal aperture portion or nostril dome supporting protrusion to maintain maximal comfort for the patient and to continue accelerating clinical recovery as they get older.
Regarding claims 16-17, Ivanov as modified teaches the claimed invention, as discussed above, except for the oblique angle being in the range of 90 to 65 degrees, or in the range of 80 to 75 degrees.
Ivanov sets forth that the angle is a result effective variable which could be optimized to create maximal comfort for the patient in conforming to curves of the nasal passages of the patient and to accelerate clinical recovery after surgery (see Abstract of English Translation of Ivanov, and paragraph [52] of English Translation of Description of Ivanov: ”The shape of the endonasal activator corresponds to the normal anatomical structure of the inner surface of the nasal passages” which is “comfortable to wear, does not require additional fixation, and is securely held in the nasal cavity”).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the oblique angle to be in the range of 90 to 65 degrees, or in the range of 80 to 75 degrees for the purpose of optimizing comfort and recovery for the patient, and 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 18, Ivanov as modified teaches the claimed invention, as discussed above, including the oblique angle is a first angle, wherein the middle portion of the centerline and the posterior portion of the centerline form a second angle (see annotated Figure 5 above), however does not expressly teach wherein the second angle is in the range of 35 to 55 degrees.
However, Ivanov sets forth that the angle is a result effective variable which could be optimized to create maximal comfort for the patient in conforming to curves of the nasal passages of the patient and to accelerate clinical recovery (see Abstract of English Translation of Ivanov) as well as to stabilize the device in the middle position of the nasal septum (see paragraph [7] of English Translation of Description of Ivanov: “patients need to achieve stabilization of the median position of the nasal septum for a long postoperative recovery period, to prevent cicatricial deformities after the above operations” and it is “necessary to provide patients with maximum comfort for a long time, to prevent the possibility of injury to the nasal mucosa”).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the second angle to be in the range of 35 to 55 degrees for the purpose of optimizing comfort and recovery for the patient, and 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 20, Ivanov as modified teaches the first stent 1 and the second stent 2 each include a nostril dome supporting protrusion (tubercle or protuberance 10; Figures 2, 5, 10) extending anteriorly from an outer surface of the stent adjacent the intersection of the anterior portion of the centerline and the middle portion of the centerline (Id.; protrusions 10 extend towards front of device).
Regarding claim 21, Ivanov as modified teaches the nostril dome supporting protrusion 10 of each of the first stent and the second stent further extend medially (Id. protrusions 10 also extend towards each other or inwards towards a medial axis of the device).
Regarding claim 22, Ivanov as modified teaches the nostril dome supporting protrusion 10 is configured to extend beyond the nasal aperture margin (away from front face of lower side 9) and to apply pressure to a deep margin of the lower lateral cartilage when the first stent and the second stent are inserted into the nostrils of a user (Id.; due to the protrusions extending medially as seen in Figure 10, the protrusions can apply pressure to deep, inner margins of lower lateral cartilage).
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Ivanov (RU 2477088 C1), and see English Translation of Ivanov in view of Sheyte et al. (U.S. Pub. No. 2023/0355420, as applied to claim 20 above, and further in view of Duran Von Arx (U.S. Pub. No. 2008/0009897).
Regarding claim 24, Ivanov as modified teaches the claimed invention, as discussed above, except for the first stent and the second stent each include a lateral ala vestibule protrusion extending laterally from an outer surface of the stent adjacent the anterior portion of the centerline, wherein the first stent and the second stent each include an infradome recessed portion disposed between the nostril dome supporting protrusion and the lateral ala vestibule protrusion.
Duran Von Arx teaches an anatomical nasal conformer device including a first stent and a second stent 1 (Figures 5, 7) each defining an opening extending along a centerline from an anterior end to a posterior end of the stent (Figure 4), wherein each of the first and second stents includes a lateral ala vestibule protrusion (widened part 2; Figure 7, [0006], [0018]) extending laterally from an outer surface of the stent adjacent the anterior portion of the centerline.
It would have been obvious to one of ordinary skill before the effective filing date to modify Ivanov as modified with each stent including a lateral ala vestibule protrusion as claimed, as taught by Duran Von Arx, since the widened lateral parts stimulate the alar of the nose for ease of breathing (Duran Von Arx; [0001], [0004]).
Furthermore, once the combination is made, an infradome recessed portion would be formed between the nostril dome supporting protrusion and the lateral ala vestibule protrusion on each of the first and second stents, since Ivanov teaches a curved recessed surface adjacent to and extending laterally from the nostril dome supporting protrusion (see annotated Figures 10-11 above showing infradome recessed portion on first stent between nostril dome supporting protrusion 10 and where lateral ala vestibule protrusion 2 would be placed once Ivanov is combined with Duran Von Arx).
Regarding claim 25, Ivanov as modified teaches the claimed invention, as discussed above, except for the first stent and the second stent each include a lateral ala vestibule protrusion extending laterally from an outer surface of the stent adjacent the anterior portion of the centerline.
Duran Von Arx teaches an anatomical nasal conformer device including a first stent and a second stent 1 (Figures 5, 7) each defining an opening extending along a centerline from an anterior end to a posterior end of the stent (Figure 4), wherein each of the first and second stents includes a lateral ala vestibule protrusion (widened part 2; Figure 7, [0006], [0018]) extending laterally from an outer surface of the stent adjacent the the anterior portion of the centerline.
It would have been obvious to one of ordinary skill before the effective filing date to modify Ivanov as modified with each stent including a lateral ala vestibule protrusion as claimed, as taught by Duran Von Arx, since the widened lateral parts stimulate the alar of the nose for ease of breathing (Duran Von Arx; [0001], [0004]).
Regarding claim 26, Ivanov as modified teaches the lateral ala vestibule protrusion 2 (Duran Von Arx; Figure 7) is configured to be disposed posteriorly to a nasal aperture margin (away from front face of the device) and to apply pressure to a lateral aspect of the nasal vestibule when the first stent and the second stent are inserted into the nostrils of a user (Duran Von Arx; [0001], [0004]).
Claim 28 are rejected under 35 U.S.C. 103 as being unpatentable over Ivanov (RU 2477088 C1), and see English Translation of Ivanov in view of Sheyte et al. (U.S. Pub. No. 2023/0355420, as applied to claim 15 above, and further in view of Santelli, Jr. (U.S. Pub. No. 2014/0261459).
Regarding claim 28, Ivanov as modified teaches a central bridge 3 (Figure 1) extending between and coupling together the anterior end of the first stent 1 and the anterior end of the second stent 2. However, Ivanov as modified does not teach a handle protrusion extending from the central bridge.
Santelli, Jr. teaches a nasal device including a central bridge 14 (Figures 1A-1C) and a handle protrusion 20 extending from the central bridge.
It would have been obvious to one of ordinary skill before the effective filing date to modify Ivanov as modified with a handle protrusion as claimed, as taught by Santelli, Jr., to provide a surface for facilitating handling by a user and insertion of the nasal device into a patient’s nostril’s ([0031]; Santelli, Jr.).
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771