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 .
Benefit
The application claims benefit to US Provisional 63/536,791 (6 September 2023).
Formal Matters
Claims 1-24 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5 September 2024 and 15 January 2025 have been considered by the examiner. Signed copies are attached.
Drawings - Objections
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “FIG 18” has been used to designate both embodiment 200 and embodiment 300. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(b)
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 2, 4, 12, 15, 20, and 22 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claim 1 recites the limitation "a first dilating force" in line 16 and the limitation “a second dilating force” in line 23. However, dependent claim 2 recites “the first dilation force” in line 2 and “the second dilation force” in line 3. Similarly, dependent claim 4 recites “the second dilation force” in line 1 and “the first dilation force” in line 2. Dependent claims 2 and 4 lack antecedent basis, but they claims appear to refer back to the recitation in claim 1 to “a first dilating force” and “a second dilating force”. For the purpose of compact prosecution, the examiner will interpret the dependent claims to mean “first dilating force” and “second dilating force”.
Independent claim 10 recites the limitation the limitation "a first dilating force" in line 11 and the limitation “a second dilating force” in line 15. However, dependent claim 12 recites “the first dilation force” in lines 13-14 and “the second dilation force” in line 14. Similarly, dependent claim 15 recites “the second dilation force” in line 6 and “the first dilation force” in line 6. Dependent claims 12 and 15 lack antecedent basis, but they claims appear to refer back to the recitation in claim 10 to “a first dilating force” and “a second dilating force”. For the purpose of compact prosecution, the examiner will interpret the dependent claims to mean “first dilating force” and “second dilating force”.
Independent claim 19 recites the limitation "a first dilating force" in line 16 and the limitation “a second dilating force” in line 21. However, dependent claim 20 recites “the first dilation force” in line 2 and “the second dilation force” in line 3. Similarly, dependent claim 22 recites “the second dilation force” in line 1 and “the first dilation force” in line 2. Dependent claims 20 and 22 lack antecedent basis, but they claims appear to refer back to the recitation in claim 19 to “a first dilating force” and “a second dilating force”. For the purpose of compact prosecution, the examiner interprets the dependent claims to mean “first dilating force” and “second dilating force”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 8, 10, 12, 16-20, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guyuron et al., US 20120022582 (26 January 2012).
Regarding independent claim 8, 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 (¶89), the external nasal dilator (90) 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 having a top edge, bottom edge, a left edge, and a right edge collectively defining an outer perimeter of the external nasal dilator (FIG 10);
an upper section (22) of the flexible substrate (20) carrying an upper resilient member (12) extending laterally across the upper section (FIG 10);
wherein, when the external nasal dilator is adhered to the nose, the upper resilient member (12) applies a first dilating force to the internal nasal valves (¶¶53, 89);
a lower section of the flexible substrate (24) carrying a lower resilient member (14) that is distinct from the upper resilient member (12) and extends laterally across the lower section (FIGs 9, 10);
wherein, when the external nasal dilator (90) is adhered to the nose, the lower resilient member applies a second dilating force to the external nasal valves (¶54);
an intermediate section of the flexible substrate (15) extending laterally between, and longitudinally separating (FIGs 9-11), the upper resilient member (12) and the lower resilient member (14); and
a plurality of discrete slits (FIG 11, slots 98a, 98b; ¶92) through the intermediate section, the discrete slits being laterally spaced apart and longitudinally elongated (FIG 11, ¶93).
Regarding claim 10, Guyuron teaches the external nasal dilator of claim 8, as set forth above, wherein the slits are longitudinally elongated towards a longitudinal midline of the external nasal dilator (perforations, ¶64; FIGs 9-11).
Regarding claim 12, Guyuron teaches the external nasal dilator of claim 8, as set forth above, wherein: the left edge and the right edge converge inwardly toward each other to form a left recess along the left edge and a right recess along the right edge (FIGs 9-11; ¶80),
the left recess and right recess dividing the flexible substrate into two laterally opposed upper lobes and two laterally opposed lower lobes (FIGs 9-11; ¶80);
the upper section (22) includes the two laterally opposed upper lobes and the upper resilient member (12) extends laterally from one upper lobe to the other upper lobe (FIGs 9-11; ¶89);
the lower section (24) includes the two laterally opposed lower lobes and the lower resilient (14) member extends laterally from one lower lobe to the other lower lobe (FIGs 9-11; ¶89);
the left recess and the right recess are in the intermediate section (FIGs 9-11; ¶80); and
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; ¶89, 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).
As set forth above, for the purpose of compact prosecution, the examiner interprets the dependent claims to mean “first dilating force” and “second dilating force”.
Regarding claim 16, Guyuron teaches the external nasal dilator of claim 8, as set forth above, wherein: the left edge and the right edge converge inwardly toward each other to form a left recess along the left edge and a right recess along the right edge (FIGs 9-11; ¶80),
the left recess and right recess dividing the flexible substrate into two laterally opposed upper lobes and two laterally opposed lower lobes (FIGs 9-11);
the upper section (22) includes the two laterally opposed upper lobes and the upper resilient member (12) extends laterally from one upper lobe to the other upper lobe (FIGs 9-11; ¶89);
the lower section (24) includes the two laterally opposed lower lobes and the lower resilient member (14) extends laterally from one lower lobe to the other lower lobe (FIGs 9-11; ¶89);
the left recess and the right recess are in the intermediate section (FIGs 9-11; ¶80); and
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 are closer to the upper resilient member than the lower resilient member (FIGs 9-11; the figures show the innermost point of the recesses adjacent separating line 28 to be closer to element 12 than element 97).
Regarding claim 17, Guyuron teaches the external nasal dilator of claim 8, as set forth above, further comprising:
a pair of opposed cuts (FIGs 10-11, slots 98a, 98b) extending longitudinally through the flexible substrate (20) at respective laterally opposed ends of the lower resilient member (14),
the opposed cuts defining a pair of opposed flaps (FIGs 10-11, 98a, 98b) of the lower resilient member (14) that direct the second dilating force (FIGs 10-11; ¶90-92, bendable support members 97, hooks 92) and
wherein the upper resilient member (12) has a lateral length from a left terminal end thereof to a right terminal end thereof and a distance between the opposed cuts is less than the lateral length (FIGs 9-11).
Regarding claim 18, Guyuron teaches the external nasal dilator of claim 8, as set forth above, further comprising:
a pair of opposed cuts (FIGs 10-11, slots 98a, 98b) extending longitudinally through the flexible substrate (20), respectively, at laterally opposed ends of the lower resilient member (14),
the opposed cuts defining a pair of opposed flaps (FIGs 10-11, 98a, 98b) of the lower resilient member (14) that direct the second dilating force (FIGs 10-11; ¶90-92, bendable support members 97, hooks 92) and
wherein the upper resilient member (12) has a lateral length from a left terminal end thereof to a right terminal end thereof and a distance between the opposed cuts is less than the lateral length (FIGs 9-11).
Regarding independent claim 19, 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 (¶89), the external nasal dilator (90) 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 having a top edge, bottom edge, a left edge, and a right edge collectively defining an outer perimeter of the external nasal dilator (FIG 10);
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 (FIGs 9-11), the left recess and right recess dividing the flexible substrate into two laterally opposed upper lobes and two laterally opposed lower lobes (FIGs 9-11);
an upper section (22) of the flexible substrate (20) including the two laterally opposed upper lobes (FIGs 9-11) and carrying an upper resilient member (12) extending laterally from one upper lobe to the other upper lobe (FIG 10);
wherein, when the external nasal dilator (90) is adhered to the nose, the upper resilient member (12) applies a first dilating force to the internal nasal valves (¶¶53, 89);
a lower section of the flexible substrate (24) including the two laterally opposed lower lobes (FIGs 9-11) and carrying a lower resilient member (14) that is distinct from the upper resilient member (12) and extends laterally from one lower lobe to the other lower lobe (FIGs 9-11);
wherein, when the external nasal dilator (90) is adhered to the nose, the lower resilient member applies a second dilating force to the external nasal valves (¶54);
an intermediate section of the flexible substrate (15) extending laterally between, and longitudinally separating, the upper resilient member (12) and the lower resilient member (14),
the left recess and the right recess being in the intermediate section (FIGs 9-11); and
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 (FIGs 9-11), the left convergence point and the right convergence point being closer to the upper resilient member than the lower resilient member (FIGs 9-11).
Regarding claim 20, Guyuron teaches the external nasal dilator of claim 19, as set forth above, wherein the intermediate section (28), 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, ¶89; 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).
As set forth above, for the purpose of compact prosecution, the examiner interprets the dependent claims to mean “first dilating force” and “second dilating force”.
Regarding claim 23, Guyuron teaches the external nasal dilator of claim 19, as set forth above, further comprising a plurality of discrete slits (perforations) through the intermediate section (28), the discrete slits being laterally spaced apart and longitudinally elongated (¶64).
Regarding claim 24, Guyuron teaches the external nasal dilator of claim 19, as set forth above, further comprising:
a pair of opposed cuts (FIGs 10-11, slots 98a, 98b) extending longitudinally through the flexible substrate, respectively, at laterally opposed ends of the lower resilient member,
the opposed cuts (FIGs 10-11, slots 98a, 98b) defining a pair of opposed flaps FIGs 10-11) of the lower resilient member that direct the second dilating force (bendable support members 97, configurable hooks 92; ¶¶91-92); and
wherein the upper resilient member (12) 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 9-11).
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 1-7, 9, 11, 13-15, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Guyuron et al., US 20120022582 (26 January 2012).
Regarding claim 1, 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 (¶89), the external nasal dilator (90) 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 having a top edge, bottom edge, a left edge, and a right edge collectively defining an outer perimeter of the external nasal dilator (FIG 10),
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 (FIGs 9-11), the left recess and right recess dividing the flexible substrate into two laterally opposed upper lobes and two laterally opposed lower lobes (FIGs 9-11);
an upper section (22) of the flexible substrate (20) including the two laterally opposed upper lobes and carrying an upper resilient member (12) extending laterally from one upper lobe to the other upper lobe (FIG 10);
wherein, when the external nasal dilator is adhered to the nose, the upper resilient member (12) applies a first dilating force to the internal nasal valves (¶¶53, 89);
a lower section of the flexible substrate (24) including the two laterally opposed lower lobes (FIGs 9-11) and carrying a lower resilient member (14) that is distinct from the upper resilient member (12) and extends laterally from one lower lobe to the other lower lobe (FIGs 9-11),
wherein, when the external nasal dilator is adhered to the nose, the upper resilient member (12) applies a first dilating force to the internal nasal valves (¶¶53, 89); and
an intermediate section of the flexible substrate (15) extending laterally between and longitudinally separating (FIGs 9-11) the upper resilient member (12) and the lower resilient member (14), the left recess and the right recess being in the intermediate section (FIGs 9-11).
Guyuron does not teach the lower resilient member and the lower section being laterally elongated relative to the upper resilient member and the upper section, respectively.
Applicant’s disclosure states that the lower resilient member and section may be elongated relative to the upper resilient member and section, but provides no details of criticality or unexpected results that would occur from this specific arrangement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to elongate the shape of the lower resilient member and section relative to the upper resilient member and section, since a change in shape of an element involves only routine skill in the art. The motivation to do so would be to identify a shape that allows the device to apply dilation force to both internal and external valves.
Regarding claim 2, Guyuron teaches the external nasal dilator of claim 1, as set forth above, 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; ¶89, 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).
As set forth above, for the purpose of compact prosecution, the examiner interprets the dependent claims to mean “first dilating force” and “second dilating force”.
Regarding claim 3, Guyuron teaches the external nasal dilator of claim 1, as set forth above.
Guyuron does not explicitly teach that the adhesive back surface has greater surface area on the lower section than the upper section.
Instead, Guyuron 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; ¶71, adhesion and peel strengths will have a range based on the thickness of the adhesive, amount of surface area in contact with the bonding substrate and the condition of the substrate). The impact of surface area and shape on the adhesive is a results effective variable that is disclosed in the art. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to identify a shape of the adhesion surface area, since a change in shape of an element involves only routine skill in the art. The motivation for identifying a change of shape that allows the device to apply dilation force to both internal and external regions while maintaining the desired adhesion. This would amount to nothing more than routine experimentation.
Regarding claim 4, Guyuron teaches the external nasal dilator of claim 1, as set forth above.
Guyuron does not expressly teach wherein the second dilation force is greater than the first dilation force.
Guyuron teaches that a first dilating force and a second dilating force are applied by upper resilient member (12) and lower resilient member (14) (¶84). Guyuron also teaches that it may be desirable to use a material with greater resiliency to dilate the nasal valve and lower resiliency to dilate the nostrils or vice versa (¶69).
The relative force between the resilient members is a results effective variable that is disclosed in the art. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to increase the second dilating force relative to the first dilating force because it was known in the art that different levels of resilience can achieve different dilation results on the nasal valve and nostrils. The motivation for the modification would have been to identify the appropriate dilation force for the internal nasal valve while reenforcing the nostrils to reduce nostril collapse.
As set forth above, for the purpose of compact prosecution, the examiner interprets the dependent claims to mean “first dilating force” and “second dilating force”.
Regarding claim 5, Guyuron teaches the external nasal dilator of claim 1, as set forth above, wherein 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 are closer to the upper resilient member than the lower resilient member (FIGs 9-11; the figures show the innermost point of the recesses adjacent separating line 28 to be closer to element 12 than element 97).
Regarding claim 6, Guyuron teaches the external nasal dilator of claim 1, as set forth above, further comprising a plurality of discrete slits (perforations) through the intermediate section (28), the discrete slits being laterally spaced apart and longitudinally elongated (¶64).
Regarding claim 7, Guyuron teaches the external nasal dilator of claim 1, as set forth above, further comprising:
a pair of opposed cuts (FIGs 10-11, slots 98a, 98b) extending longitudinally through the flexible substrate, respectively, at laterally opposed ends of the lower resilient member,
the opposed cuts (FIGs 10-11, slots 98a, 98b) defining a pair of opposed flaps FIGs 10-11) of the lower resilient member that direct the second dilating force (bendable support members 97, configurable hooks 92; ¶¶91-92); and
wherein the upper resilient member (12) 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 9-11).
Regarding claim 9, Guyuron teaches the external nasal dilator of claim 8, as set forth above, wherein:
the left edge and the right edge converge inwardly toward each other to form a left recess along the left edge and a right recess along the right edge (FIGs 9-11; ¶80),
the left recess and right recess dividing the flexible substrate (20) into two laterally opposed upper lobes and two laterally opposed lower lobes (FIGs 9-11; ¶80);
the upper section (22) includes the two laterally opposed upper lobes and the upper resilient member (12) extends laterally from one upper lobe to the other upper lobe (FIGs 9-11);
the lower section (24) includes the two laterally opposed lower lobes and the lower resilient member (14) extends laterally from one lower lobe to the other lower lobe (FIGs 9-11); and
the left recess and the right recess are in the intermediate section (FIGs 9-11).
Guyuron does not teach the lower resilient member and the lower section are laterally elongated relative to the upper resilient member and the upper section, respectively. Applicant’s disclosure states that the lower resilient member and section may be elongated relative to the upper resilient member and section, but provides no details of criticality or unexpected results that would occur from this specific arrangement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to elongate the shape of the lower resilient member and section relative to the upper resilient member and section, since a change in shape of an element involves only routine skill in the art. The motivation to do so would be to identify a shape that allows the device to apply dilation force to both internal and external valves.
Regarding claim 11, Guyuron teaches the external nasal dilator of claim 8, as set forth above.
Guyuron does not teach wherein the slits are longitudinally elongated towards a longitudinal midline of the external nasal dilator at an angle of 15˚ to 75˚ relative to the lateral direction.
Guyuron at FIGs 9-11 show that perforations exist at straight angles relative to the lateral direction.
Applicant’s disclosure lists several ranges for angles for the slits relative to the lateral direction, but does not disclose the criticality or unexpected results that would occur from using this specific range. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to identify a range of angles for the slits relative to the lateral direction because the general conditions are disclosed in the prior art. Discovering optimum or workable ranges involve only routine skill in the art. Motivation for doing so would have been to provide a mechanical weakness (frangible or separable, ¶64 of Guyuron) between the upper and lower sections enabling the two parts to be separated easily.
Regarding claim 13, Guyuron teaches the external nasal dilator of claim 8, as set forth above.
Guyuron does not explicitly teach that the adhesive back surface has greater surface area on the lower section than the upper section.
Instead, Guyuron 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; ¶71, adhesion and peel strengths will have a range based on the thickness of the adhesive, amount of surface area in contact with the bonding substrate and the condition of the substrate). The impact of surface area and shape on the adhesive is a results effective variable that is disclosed in the art. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to identify a shape of the adhesion surface area, since a change in shape of an element involves only routine skill in the art. The motivation for identifying a change of shape that allows the device to apply dilation force to both internal and external regions while maintaining the desired adhesion. This would amount to nothing more than routine experimentation.
Regarding claim 14, Guyuron teaches the external nasal dilator of claim 8, as set forth above.
Guyuron does not teach the lower resilient member and the lower section are laterally elongated relative to the upper resilient member and the upper section, respectively. Applicant’s disclosure states that the lower resilient member and section may be elongated relative to the upper resilient member and section, but provides no details of criticality or unexpected results that would occur from this specific arrangement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to elongate the shape of the lower resilient member and section relative to the upper resilient member and section, since a change in shape of an element involves only routine skill in the art. The motivation to do so would be to identify a shape that allows the device to apply dilation force to both internal and external valves.
Regarding claim 15, Guyuron teaches the external nasal dilator of claim 8, as set forth above.
Guyuron does not teach wherein the adhesive back surface has greater surface area on the lower section than the upper section.
Instead, Guyuron 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; ¶71, adhesion and peel strengths will have a range based on the thickness of the adhesive, amount of surface area in contact with the bonding substrate and the condition of the substrate). The impact of surface area and shape on the adhesive is a results effective variable that is disclosed in the art. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to identify a shape of the adhesion surface area, since a change in shape of an element involves only routine skill in the art. The motivation for identifying a change of shape that allows the device to apply dilation force to both internal and external regions while maintaining the desired adhesion. This would amount to nothing more than routine experimentation.
Guyuron does not teach the lower resilient member and the lower section are laterally elongated relative to the upper resilient member and the upper section. Regarding the Applicant’s disclosure states that the lower resilient member and section may be elongated relative to the upper resilient member and section, but provides no details of criticality or unexpected results that would occur from this specific arrangement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to elongate the shape of the lower resilient member and section relative to the upper resilient member and section, since a change in shape of an element involves only routine skill in the art. The motivation to do so would be to identify a shape that allows the device to apply dilation force to both internal and external valves.
Guyuron does not teach and that the second dilation force is greater than the first dilation force.
Guyuron teaches that a first dilating force and a second dilating force are applied by upper resilient member (12) and lower resilient member (14) (¶84). Guyuron also teaches that it may be desirable to use a material with greater resiliency to dilate the nasal valve and lower resiliency to dilate the nostrils or vice versa (¶69).
The relative force between the resilient members is a results effective variable that is disclosed in the art. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to increase the second dilating force relative to the first dilating force because it was known in the art that different levels of resilience can achieve different dilation results on the nasal valve and nostrils. The motivation for the modification would have been to identify the appropriate dilation force for the internal nasal valve while reenforcing the nostrils to reduce nostril collapse.
As set forth above, for the purpose of compact prosecution, the examiner interprets the dependent claims to mean “first dilating force” and “second dilating force”.
Regarding claim 21, Guyuron teaches the external nasal dilator of claim 19, as set forth above.
Guyuron does not teach wherein the adhesive back surface has greater surface area on the lower section than the upper section.
Instead, Guyuron 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; ¶71, adhesion and peel strengths will have a range based on the thickness of the adhesive, amount of surface area in contact with the bonding substrate and the condition of the substrate). The impact of surface area and shape on the adhesive is a results effective variable that is disclosed in the art. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to identify a shape of the adhesion surface area, since a change in shape of an element involves only routine skill in the art. The motivation for identifying a change of shape that allows the device to apply dilation force to both internal and external regions while maintaining the desired adhesion. This would amount to nothing more than routine experimentation.
Regarding claim 22, Guyuron teaches the external nasal dilator of claim 19, as set forth above.
Guyuron does not teach and that the second dilation force is greater than the first dilation force.
Guyuron teaches that a first dilating force and a second dilating force are applied by upper resilient member (12) and lower resilient member (14) (¶84). Guyuron also teaches that it may be desirable to use a material with greater resiliency to dilate the nasal valve and lower resiliency to dilate the nostrils or vice versa (¶69).
The relative force between the resilient members is a results effective variable that is disclosed in the art. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to increase the second dilating force relative to the first dilating force because it was known in the art that different levels of resilience can achieve different dilation results on the nasal valve and nostrils. The motivation for the modification would have been to identify the appropriate dilation force for the internal nasal valve while reenforcing the nostrils to reduce nostril collapse.
As set forth above, for the purpose of compact prosecution, the examiner interprets the dependent claims to mean “first dilating force” and “second dilating force”.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Ierulli US 20120209313 (16 August 2012) teaches nasal dilator with means to direct resilient properties.
Fenton et al., US 20120172923 (5 July 2012) teaches an improved external nasal dilator.
Guyuron US 8,084,201 (1 November 2011) teaches a nasal dilator. Patent is the same subject matter as the instantly cited prior art.
Guyuron US 20070255309 (1 November 2007) teaches a nasal dilator. Patent application publication is the same subject matter as the instantly cited prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771