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 in response to the amendments filed on 9/22/2025. Claims 1, 7, 11, 12, 13, 15, 18, 20, 24 and 25 are amended. Claims 8-10, 16-17 and 23 are canceled. Claims 26-31 are newly added. Claims 1-7, 11-15, 18-22 and 24-31 are pending and addressed below.
Response to Arguments
Applicant’s arguments regarding claim 1, filed on 9/22/2025, have been fully considered but are not persuasive.
Regarding arguments on page 1, the applicant states that “Applicant respectfully submits that the device of Jaffe does not comprise a "nasal molding device" with "molding stents" because nowhere in Jaffe does it teach, expressly or inherently, that the device may be used for, or might be effective for, nasal molding therapy. Rather, Jaffe discloses "a patient interface for communicating fluids to and/or from a patient's nasal cavity" (see Abstract, Jaffe). Simply applying the device of Jaffe, which is a generically sized-and-shaped patient interface, to the nostrils of a subject does not make it a nasal molding device, nor does it constitute nasal molding therapy, as it will it not have the effect of providing nasal molding therapy including positioning and molding a subject's nostrils for a corrective non-surgical intervention. Because of this, Applicant respectfully submits that Jaffe does not anticipate amended claim 1, because Jaffe does not teach, expressly or inherently, a nasal molding device with molding stents”. The examiner disagrees with the applicant because since Jaffe discloses all of the structural elements in the same arrangement as claimed, then Jaffe’s device is fully capable in being used as a nasal molding device. Also, the examiner wants to note that claim 1 is an apparatus claims and not a method claim therefore, the recitation of specific method steps does not provide substantial weight to the claims since the patentability of an apparatus does not depend on its method of use. Also, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the rejection is proper.
Applicant’s arguments are only directed to the amended claims, therefore the arguments are addressed in the body of the rejection below.
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 of this title, 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 1-7, 11-15, 18-22 and 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (US Pub No. 2008/0190436).
Regarding claim 1, Jaffe discloses (Figures 20-21) a nasal molding device (170) comprising a pair of nasal molding stents (174, 175) comprising a first (174) and a second (175) molding stent, each molding stent having a substantially tubular shape comprising a superior end extending for a length to an inferior end (Figure 21); a columella bridge (see annotated figure below) laterally attached to the inferior end of each molding stent, the columella bridge having a width; and a lip band (172) attached to the columella bridge and the inferior end of each molding stent (Figure 21), the lip band having a substantially planar shape comprising a length extending between opposing lateral ends (Figure 21), a height extending from a superior to an inferior direction (Figure 21), and a thickness (Figure 21); wherein each molding stent comprises a molding stent axis (see annotated figure below) aligned in parallel with the length of each molding stent, and the lip band comprises a lip band axis (see annotated figure below) aligned in parallel with the width of the lip band (Paragraphs 0159-0163).
Jaffe fails to disclose wherein the molding stent axis and the lip band axis form an angulation between about 125 degrees and 145 degrees, such that each molding stent is angled in a posterior direction.
Since Jaffe discloses in Paragraph 0106 that the nostril interfaces can be angled relative to the body portion so as to substantially conform with the nostril which may make interface more comfortable for the patient to wear, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jaffe to have the molding stent axis and the lip band axis to form an angulation between about 125 degrees and 145 degrees, such that each molding stent is angled in a posterior direction since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (MPEP 2144.05).
Regarding claim 2, wherein each molding stent comprises a superior width and an inferior width (Figure 21).
Regarding claim 3, Jaffe discloses the invention of claim 2 above but fails to disclose wherein the superior width and the inferior width are each between about 1 and 15 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jaffe to have the superior width and the inferior width to be each between about 1 and 15 mm since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 4, wherein the inferior width of the first molding stent is equal to the inferior width of the second stent (see annotated figure below).
PNG
media_image1.png
514
545
media_image1.png
Greyscale
Regarding claim 5, wherein the inferior width of the first molding stent is not equal to the inferior width of the second stent (see annotated figure below).
PNG
media_image2.png
513
521
media_image2.png
Greyscale
Regarding claim 6, Jaffe discloses the invention of claim 1 above but fails to disclose wherein the length of each molding stent is between about 5 and 20 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jaffe to have the length of each molding stent to be between about 5 and 20 mm since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 7, Jaffe discloses the invention of claim 1 above but fails to disclose wherein the superior end of each molding stent has a Shore hardness that is less than the inferior end of each molding stent, wherein the Shore hardness of the superior end is between about 0 Shore OO and 100 Shore OO and wherein the Shore hardness of the inferior end is between about 0 Shore OO and 100 Shore OO.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jaffe to have the superior end of each molding stent to have a Shore hardness that is less than the inferior end of each molding stent, wherein the Shore hardness of the superior end is between about 0 Shore OO and 100 Shore OO and wherein the Shore hardness of the inferior end is between about 0 Shore OO and 100 Shore OO since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 11, Jaffe discloses the invention of claim 1 above but fails to disclose wherein the angulation is about 135 degrees.
Since Jaffe discloses in Paragraph 0106 that the nostril interfaces can be angled relative to the body portion so as to substantially conform with the nostril which may make interface more comfortable for the patient to wear, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jaffe to have the angulation to be about 135 degrees since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (MPEP 2144.05).
Regarding claim 12, wherein the molding stent axis of the first molding stent is not aligned in parallel with the molding stent axis of the second molding stent (see annotated figure for claim 1 above).
Regarding claim 13, wherein a distance between the superior ends of the molding stents is less than a distance between the inferior ends of the molding stents (clearly shown in Figure 21).
Regarding claim 14, Jaffe discloses the invention of claim 1 above but fails to disclose wherein the width of the columella bridge is between about 1 and 15 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jaffe to have the width of the columella bridge to be between about 1 and 15 mm since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 15, Jaffe discloses the invention of claim 1 above but fails to disclose wherein the length of the lip band is between about 20 and 100 mm, wherein the height of the lip band is between about 1 and 15 mm and wherein the thickness of the lip band is between about 0.5 and 5 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jaffe to have the length of the lip band to be between about 20 and 100 mm, wherein the height of the lip band is between about 1 and 15 mm and wherein the thickness of the lip band is between about 0.5 and 5 mm since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 18, wherein each lateral end comprises a connector (177, 178) configured to receive an elastic band [Fully configured in doing this since Jaffe discloses all of the structural elements in the same arrangement as claimed. The examiner wants to note that the elastic band is not positively recited in the claim], the connector being a hook connector [Connectors 177, 178 are shaped to receive hooks which will be considered a hook connector].
Regarding claim 19, wherein the height of the lip band curves in a superior direction at a position directly inferior to an attachment between the lip band and the columella bridge (clearly shown in Figures 20-21).
Regarding claim 20, wherein the length of the lip band comprises a curvature, such that each lateral end curves in an anterior direction (clearly shown in Figures 20-21).
Regarding claim 21, further comprising one or more retainers (177, 178), each retainer comprising a planar shape having a top surface comprising a connector [Outer edge forming a loop at top surface of 177 and 178 is considered a connector] and a bottom surface [Surface where the adhesive 179 is attached as shown in Figure 21] configured to adhere to a subject’s face or head (Paragraph 0161).
Regarding claim 22, wherein the connector is configured to receive an elastic band [Fully configured in doing this since Jaffe discloses all of the structural elements in the same arrangement as claimed. The examiner wants to note that the elastic band is not positively recited in the claim], the connector being a loop connector [Outer edge of top surface of 177 and 178 is looped shape as shown in Figure 21 which are considered loop connectors].
Regarding claim 26, wherein each molding stent comprises a wall thickness, wherein the wall thickness of the inferior end is different from the wall thickness of the superior end of each molding stent (clearly shown in Figure 21).
Regarding claim 27, wherein each molding stent comprises a wall thickness, wherein the wall thickness decreases from the inferior end to the superior end of each molding stent (clearly shown in Figure 21).
Regarding claim 28, wherein the columella bridge comprises a substantially planar surface that curves along a length between each molding stent (clearly shown in Figure 21).
Regarding claim 29, wherein the surface is convex in the superior direction (clearly shown in Figure 21).
Regarding claim 30, wherein the surface curves below the inferior ends of each molding stent (clearly shown in Figure 21).
Regarding claim 31, wherein the lip band comprises a medial thickness that is greater than the thicknesses of the lateral ends (clearly shown in Figure 21).
Allowable Subject Matter
Claims 24 and 25 are allowed.
The prior art of record of Jaffe fails to disclose the method of providing a second nasal molding device comprising a pair of nasal molding stents comprising a first and a second molding stent, each molding stent having a substantially tubular shape comprising a superior end extending for a length to an inferior end; a columella bridge laterally attached to the inferior end of each molding stent, the columella bridge having a width; and a lip band attached to the columella bridge and the inferior end of each molding stent, the lip band having a substantially planar shape comprising a length extending between opposing lateral ends, a height extending from a superior to an inferior direction, and a thickness; wherein each molding stent comprises a molding stent axis aligned in parallel with the length of each molding stent, and the lip band comprises a lip band axis aligned in parallel with the width of the lip band; affixing the second device to the subject; wherein the columella bridge width of the second device is less than the columella bridge width of the first device; the distance between the superior ends of the molding stents of the second device is less than the distance between the superior ends of the molding stents of the first device; or the wall thicknesses of the pair of nasal molding stents of the second device is greater than the wall thicknesses of the pair of nasal molding stents of the first device (claim 24) and providing one or more retainers, each retainer comprising a planar shape having a top surface comprising one or more connectors and a bottom surface configured to adhere to the subject’s face or head; adhering the one or more retainers to the skin of the subject; and attaching one or more elastic bands from the one or more connectors of the retainers to the nasal molding device (claim 25).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771