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 .
Formal Matters
Applicant’s Response and Amendments filed 5/8/2026 is acknowledged. Claim 17 is cancelled. Claims 2, 4, 7, 12, 15, 18, 20, 22, and 24 are amended. Claims 1-17 and 18-24 are pending and under examination.
Objections/Rejections Withdrawn
The objection to the drawings is withdrawn in light of Applicant’s clarification in the Response filed 8 May 2026.
The rejection of claims 2, 4, 12, 15, 20, and 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of Applicant’s amendments.
The rejection of claims 8, 10, 12, 16-20, 23, and 24 under 35 U.S.C. 102(a)(1) as being anticipated by Guyuron et al., US 20120022582 (26 January 2012), is withdrawn in light of Applicant’s arguments and amendments filed 5/8/2026.
The rejection of claims 1-7, 9, 11, 13-15, 21, and 22 under 35 U.S.C. 103 as being unpatentable over Guyuron et al., US 20120022582 (26 January 2012) is withdrawn in light of Applicant’s arguments and amendments filed 5/8/2026.
Response to Arguments
Applicant’s arguments have been fully considered and they are persuasive. However, upon further search and consideration additional rejections are required as set forth below. Accordingly this Office Action is Non-Final.
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.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Fenton et al., US 9,642,995 (9 May 2017) in view of Guyuron et al., US 20120022582 (26 January 2012).
Regarding claim 1, Fenton teaches an external nasal dilator (FIGs 1, 2, nasal dilator 10; claim 1) configured to dilate laterally opposed internal nasal valves and external nasal valves of a human nose (claim 1), the external nasal dilator (10) comprising:
a flexible substrate (¶¶60, 89) having an adhesive back surface (34) for adhering the external nasal dilator to a human nose (¶89),
the flexible substrate (FIG 2, flexible strip 14; col 4, lines 7-8) having a top edge (FIG 2), bottom edge (FIG 2), a left edge (FIG 2), and a right edge (FIG 2) collectively defining an outer perimeter of the external nasal dilator (FIG 2),
the left edge and the right edge converging inwardly toward each other to form a left recess along the left edge and a right recess along the right edge (FIG 2), the left recess and right recess dividing the flexible substrate into two laterally opposed upper lobes and two laterally opposed lower lobes (FIG 2);
an upper section (FIG 2) of the flexible substrate (14) including the two laterally opposed upper lobes and carrying an upper resilient member (FIG 2, upper portion of resilient band 22, above recesses 36a/c; col 4, line 13) extending laterally from one upper lobe to the other upper lobe (FIG 2);
wherein, when the external nasal dilator is adhered to the nose (FIG 5), the upper resilient member (FIG 2, col 4, lines 17-18) applies a first dilating force to the internal nasal valves (FIG 6);
a lower section of the flexible substrate (FIG 2, flexible strip 14; col 4, lines 7-8) including the two laterally opposed lower lobes (FIG 2) and carrying a lower resilient member (FIG 2, lower portion of resilient band 22, below recesses 36b,d; col 4, line 13) that is distinct from (FIG 2, separated by 26a/b; col 4, lines 14-16) the upper resilient member (FIG 2, upper portion of resilient band 22, above recesses 36a/c; col 4, line 13) and extends laterally from one lower lobe to the other lower lobe (FIG 2),
wherein, when the external nasal dilator is adhered to the nose (FIG 5), the upper resilient member (FIG 2, upper portion of resilient band 22, above recesses 36a/c; col 4, line 13) applies a first dilating force to the internal nasal valves (FIG 6); and
an intermediate section (FIG 2, intermediate segment 20; col 4, line 10) of the flexible substrate (14) extending laterally between and longitudinally separating (FIG 2) the upper resilient member (FIG 2, upper portion of resilient band 22, above recesses 36a/c; col 4, line 13) and the lower resilient member (FIG 2, lower portion of resilient band 22, below recesses 36b,d; col 4, line 13), the left recess and the right recess being in the intermediate section (FIG 2). Fenton does not expressly teach wherein the lower resilient member applies a second dilating force to the external nasal valves.
Guyuron teaches an external nasal dilator (FIGs 9-11, 90) configured to dilate laterally opposed internal nasal valves and external nasal valves of a human nose (FIG 9, ¶89; claim 1), the external nasal dilator (90) comprising: a flexible substrate (FIG 9, substrate 20; ¶89) having an adhesive back surface (FIG 9, adhesive layer 34; ¶89) for adhering the external nasal dilator to a human nose (¶89), an upper resilient member (FIGs 9, 10, upper resilient member 12; ¶89) applies a dilating force to an internal nasal valve of the user (claim 1) and the lower resilient member (FIGs 9, 10, lower resilient member 14; ¶89) independently applies a dilating force to an external nasal valve of the user (claim 1). Guyuron also teaches that it is the relative rigidity and flexibility of the material used in the nasal dilator combined the upper and lower resilient members (12, 14) that supplies dilating force to the nasal valve and/or nostrils, including the spring force (¶69) and that it may be desirable to use a material with greater resiliency to dilate the nasal valve and a lower resiliency to dilate the nostrils or vice versa (¶69).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Fenton and Guyuron, given that the prior art included each element claimed, although not necessarily in a single reference. Fenton and Guyuron teach in the same field of endeavor, external nasal dilators.
Although, Fenton discloses the claimed external nasal dilator (flexible substrate, upper section, lower section, opposing lobes, and intermediate section), Fenton does not expressly disclose a that the lower resilient member applies a second dilating force to the external nasal valves. Guyuron specifically addresses a device comprising an upper resilient member applies a dilating force to an internal nasal valve of the user and the lower resilient member independently applies a dilating force to an external nasal valve of the user (claim 1). Guyuron teaches that it is the relative rigidity and flexibility of the material used in the nasal dilator combined the upper and lower resilient members (12, 14) that supplies dilating force to the nasal valve and/or nostrils, including the spring force (¶69). Guyuron expresses these differential spring forces as being independent to the upper or lower resilient member (¶69). The performance of the spring force is also echoed by Fenton at Table 2 (col 7), which shows the distance “a” required to achieve the optimal 10% force in the X axis direction using different lengths of spring (resilient) material.
Because Fenton’s device includes a lobed nasal device comprising an intermediate recess and different lengths of resilient bands 22, as well as an explanation of the force vectors in X, Y, Z axes (Table 2, col 7) and Guyuron expresses differential spring forces as being independent to the upper or lower resilient member depending on material composition and spring force (¶69), a person of ordinary skill in the art seeking to further control or optimize nasal dilator force distribution across Fenton’s device architecture, would reasonably consult Guyuron’s applied anatomical force solution (material and spring force ¶69) and apply both the material selection properties of rigidity and flexibility along with the length component providing a secondary force (spring force) in the X axis direction (Fenton, Table 2). A person of ordinary skill in the art attempting to optimize nasal dilation would look for established structures, materials, and designs to avoid creating a novel interface. Guyuron’s separate internal nasal valve and external nasal valve force structures comprising relative rigidity and flexibility of material can be incorporated alongside Fenton’s X, Y, Z force parameters and differential spring force lengths (same general location and interaction with the nasal anatomy) using known assembly methods without redesigning Fenton’s primary device architecture.
Because the references address the same engineering problem (optimization of external nasal dilators) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (optimizing the structures, materials, and length resilient members to provide an improvement in more than one dilating force or dilating force vector (X, Y, Z), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Fenton modified by Guyuron teaches the external nasal dilator of claim 1, as set forth above, for the reasons set forth above.
Guyuron teaches wherein the intermediate section, right recess, and left recess separate the first dilation force at the upper lobes from the second dilation force at the lower lobes (FIGs 9-11; upper resilient member 12 applies the dilating force at the upper lobe and lower resilient member 14 applies the dilating force at the lower lobe; ¶89).
Regarding claim 3, Fenton modified by Guyuron teaches the external nasal dilator of claim 1, as set forth above, for the reasons set forth.
Fenton teaches wherein the adhesive back surface has greater surface area on the lower section than the upper section (FIGs 1, 2; col 4, lines 25-34).
Guyuron also teaches that the adhesive back surface has greater surface area on the lower section than the upper section (FIG 3, ¶62, adhesive may be applied across the entire user-side surface or may be applied to a portion of the surface).
Regarding claim 4, Fenton modified by Guyuron teaches the external nasal dilator of claim 1, as set forth above, for the reasons set forth above.
Guyuron teaches wherein the second dilation force is greater than the first dilation force (¶69).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fenton et al., US 9,642,995 (9 May 2017), in view of Guyuron et al., US 20120022582 (26 January 2012), and further in view of Ierulli, US 20120209313 (16 August 2012).
Regarding claim 7, Fenton modified by Guyuron teaches the external nasal dilator of claim 1, as set forth above, for the reasons set forth above.
Fenton modified by Guyuron do not teach the external nasal dilator (further comprising: a pair of opposed cuts extending longitudinally through the flexible substrate, respectively, at laterally opposed ends of the lower resilient member, the opposed cuts defining a pair of opposed flaps of the lower resilient member that direct the second dilating force; and wherein the upper resilient member has a lateral length from a left end thereof to a right end thereof and a distance between the opposed cuts is less than the lateral length.
Ierulli teaches the external nasal dilator (FIGs 6, 7, nasal dilator 10; ¶62) further comprising:
a pair of opposed cuts (FIGs 6, 7) extending longitudinally through the flexible substrate, respectively, at laterally opposed ends of the lower resilient member (FIGs 6, 7),
the opposed cuts (FIGs 6, 7) defining a pair of opposed flaps (FIGs 6, 7, flap 25; ¶86) of the lower resilient member (FIG 7) that direct the second dilating force (¶81); and
wherein the upper resilient member (FIGs 6, 7) has a lateral length from a left end thereof to a right end thereof and a distance between the opposed cuts is less than the lateral length (FIGs 6, 7; ¶81).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Fenton, Guyuron, and Ierulli, given that the prior art included each element claimed, although not necessarily in a single reference. Fenton, Guyuron, and Ierulli teach in the same field of endeavor of external nasal dilators.
Although, Fenton discloses the claimed external nasal dilator (flexible substrate, upper section, lower section, opposing lobes, and intermediate section) and Guyuron specifically addresses a device comprising an upper resilient member applies a dilating force to an internal nasal valve of the user and the lower resilient member independently applies a dilating force to an external nasal valve of the user (claim 1), neither Fenton nor Guyuron teaches the external nasal dilator further comprising a pair of opposed cuts extending longitudinally through the flexible substrate, respectively, at laterally opposed ends of the lower resilient member, the opposed cuts defining a pair of opposed flaps of the lower resilient member that direct the second dilating force; and wherein the upper resilient member has a lateral length from a left end thereof to a right end thereof and a distance between the opposed cuts is less than the lateral length. Ierulli teaches the external nasal dilator further comprising a pair of opposed cuts extending longitudinally through the flexible substrate, respectively, at laterally opposed ends of the lower resilient member, the opposed cuts defining a pair of opposed flaps (FIGs 6, 7, flap 25; ¶86) of the lower resilient member (FIG 7) that direct the second dilating force (¶81); and wherein the upper resilient member (FIGs 6, 7) has a lateral length from a left end thereof to a right end thereof and a distance between the opposed cuts is less than the lateral length (FIGs 6, 7; ¶81). Ierulli explains that these cuts transfer focused spring biasing forces from primarily peel forces and tensile forces into primarily shear forces and that the transformed spring biasing forces are redistributed or imparted to tissue engaging surfaces of dilator 10 (¶81).
Because Fenton’s device includes a lobed nasal device comprising an intermediate recess and different lengths of resilient band 22, as well as an explanation of the force vectors in an X, Y, Z axis (Table 2, col 7) and Guyuron expresses these differential spring forces as being independent to the upper or lower resilient member (¶69), a person of ordinary skill in the art seeking to further control or optimize nasal dilator force distribution across Fenton’s device architecture, would reasonably consult Guyuron’s applied anatomical force solution (spring force ¶69) and apply both the material selection properties of rigidity and flexibility along with the length component providing a secondary force in the X axis direction (Table 2). Additionally, a person of ordinary skill in the art attempting to optimize nasal dilation spring biasing forces would look to Ierulli’s transfer spring force solution (¶81) to avoid creating a novel interface.
Because the references address the same engineering problem (optimization of external nasal dilators and their spring forces) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (optimizing the structures, materials, and length that resilient members to provide, along with known modifications to affect the transfer of spring forces), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Allowable Subject Matter
Claims 5, 6, 8-16, and 18-24 are allowable.
The following is a statement of reasons for the indication of allowable subject matter: Applicant’s arguments filed 5/8/2026 are persuasive. Guyuron et al., US 20120022582 (26 January 2012) is the closest prior art.
Regarding independent claim 8, Guyuron does not teach “an intermediate section of the flexible substrate extending laterally between, and longitudinally separating, the upper resilient member and the lower resilient member; and a plurality of discrete slits through the intermediate section, the discrete slits being laterally spaced apart and longitudinally elongated.” Claims 9-16 and 18 are dependent on claim 8.
Claim 6 also recites “a plurality of discrete slits through the intermediate section, the discrete slits being laterally spaced apart and longitudinally elongated.” Guyuron is the closest prior art, but does not teach longitudinally elongated slits through the intermediate section.
Regarding independent claim 19, Guyuron does not teach “a left convergence point defining an innermost edge of the left recess and a right convergence point defining an innermost edge of the right recess, the left convergence point and the right convergence point being closer to the upper resilient member than the lower resilient member.” Claims 20-24 are dependent on claim 19.
Claims 5, 16, 19 each recite “a left convergence point defining an innermost edge of the left recess and a right convergence point defining an innermost edge of the right recess, the left convergence point and the right convergence point being closer to the upper resilient member than the lower resilient member.” Guyuron does not teach “a left convergence point defining an innermost edge of the left recess and a right convergence point defining an innermost edge of the right recess, the left convergence point and the right convergence point being closer to the upper resilient member than the lower resilient member.”
Conclusion
Claims 1-4 and 7 are rejected. Claims 5, 6, 8-16, and 18-24 are allowable.
This office action is NON-FINAL.
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/CHERIE M POLAND/Examiner, Art Unit 3771
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