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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/31/2026 has been entered.
Response to Amendment
This office action is in response to the amendments filed on 7/31/2026. Claims 1, 7, 19 and 28 amended. Claims 1-7, 11-15, 18-22 and 24-31 are pending and addressed below.
Response to Arguments
Applicant’s arguments, filed on 7/31/2026, with respect to claim 1 have been considered but are moot because the arguments do not apply to the new reference being used in the current rejection. 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 11-15, 18-22 and 24-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 1, 24 and 25, the claims each recite the limitation “wherein each molding stent comprises a molding stent axis aligned in parallel with the length of each molding stent”. Since the limitation uses “each molding stent” twice without tying the second instance back to the first instance, then it is not clear if this limitation is referring that every molding stent’s axis is parallel to the length of every molding stent (first and second molding stents) or that each individual molding stent, that stent’s own axis is parallel to that same stent’s own length. Therefore, the scope of the claims is unclear. Appropriate correction is required.
Claims 2-7, 11-15, 18-22 and 26-31 are rejected due to being dependent on claim 1.
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 Ronayne (US Pub No. 2022/0370747).
Regarding claim 1 as best understood, Ronayne discloses (Figures 3-12) a nasal molding device (300) comprising a pair of nasal molding stents (305) comprising a first (right 305) and a second (left 305) molding stent, each molding stent having a substantially tubular shape comprising a superior end extending for a length to an inferior end (Figure 3); a columella bridge (307) laterally attached to the inferior end of each molding stent (Figure 5), the columella bridge having a width and comprising a projection (clearly shown in Figures 5 and 11 where element 307 is projecting inward); and a lip band (313) attached to the columella bridge and the inferior end of each molding stent (Figure 3), the lip band having a substantially planar shape comprising a length extending between opposing lateral ends (Figures 3-4), a height extending from a superior to an inferior direction (Figures 3-4), and a thickness (Figures 3-4); wherein the columella bridge projection extends away from the lip band in an anterior direction (clearly shown in Figures 3 and 6), 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 (see annotated figure below) and wherein each molding stent is angled in a posterior direction (Figure 3).
Ronayne 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 Ronayne discloses that the each molding stent is angled in a posterior direction as shown in Figure 3, 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 Ronayne to have the molding stent axis and the lip band axis to form an angulation between about 125 degrees and 145 degrees 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)).
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Regarding claim 2, wherein each molding stent comprises a superior width and an inferior width (Figure 4).
Regarding claim 3, Ronayne 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 Ronayne 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).
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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).
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Regarding claim 6, Ronayne 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 Ronayne 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, Ronayne 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 a Shore hardness of 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 Ronayne to have the superior end of each molding stent to have a Shore hardness that is less than the a Shore hardness of 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, Ronayne discloses the invention of claim 1 above but fails to disclose wherein the angulation is about 135 degrees.
Since Ronayne discloses that the each molding stent is angled in a posterior direction as shown in Figure 3, 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 Ronayne to have the angulation to be about 135 degrees 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 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).
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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 annotated figure below).
Regarding claim 14, Ronayne 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 Ronayne 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, Ronayne 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 Ronayne 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 (339) (Figure 5) configured to receive an elastic band [Fully configured in doing this since Ronayne 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 and is only functionally recited], the connector being a hook connector [Connectors 339 are shaped to receive hooks within openings 341 which will be considered a hook connector].
Regarding claim 19, wherein the lip band comprises a medial concave portion aligned with the columella bridge (clearly shown in Figure 3), and lateral convex portions extending to the lateral ends (clearly shown in Figure 3).
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 Figure 3).
Regarding claim 21, further comprising one or more retainers (339), each retainer comprising a planar shape having a top surface (surface at the front of the device which is opposite from surface 342) comprising a connector (341) and a bottom surface (342) configured to adhere to a subject’s face or head (Paragraph 0133).
Regarding claim 22, wherein the connector is configured to receive an elastic band [Fully configured in doing this since Ronayne 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 and is only functionally recited], the connector being a loop connector [Opening 341 is loop shaped as shown in Figures 3-4 which is considered a loop connector].
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 Figures 4-6).
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 Figures 4-6).
Regarding claim 28, wherein the columella bridge projection comprises a substantially planar surface that curves along a length between each molding stent (clearly shown in Figure 5).
Regarding claim 29, wherein the surface is convex in the superior direction (clearly shown in Figures 4-5).
Regarding claim 30, wherein the surface curves below the inferior ends of each molding stent (clearly shown in Figure 5).
Regarding claim 31, wherein the lip band (313) comprises a medial thickness that is greater than the thicknesses of the lateral ends (clearly shown in Figure 11).
Allowable Subject Matter
Claims 24 and 25 would be allowable if they overcome the 112 rejection set forth in this Office Action.
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
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.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
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