DETAILED ACTION
This is the initial Office action for non-provisional application 18/909,478 filed October 8, 2024, which claims priority from provisional application 63/588,840. Claims 1-20, as originally filed, are currently pending.
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Invention I and Species B in the reply filed on February 4, 2026 is acknowledged.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Species A and claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Invention II, there being no allowable generic or linking claim.
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 12 and 13 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.
Claim 12 recites the limitation “a bridge length extending between the first end and the first end … between 1 cm and 10 cm”; however, a distance between the first end and the first end would be zero. For examination purposes, the above limitation of claim 12 has been interpreted as “a bridge length extending between the first end and the second end … between 1 cm and 10 cm”.
Claim 13 recites the limitation “a bridge width extending between the first side and the first side … between 0.3 cm and 3 cm”; however, a distance between the first side and the first side would be zero. For examination purposes, the above limitation of claim 13 has been interpreted as “a bridge width extending between the first side and the second side … between 0.3 cm and 3 cm”.
Claim Rejections - 35 USC § 102
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 10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kehiaian (US 2009/0205640).
Regarding claim 10, Kehiaian discloses a nasal strip (nose strip 40) capable of treating obstructive sleep apnea (Figs. 4a-4b; ¶ 0001-0003 & 0023), the nasal strip (40) comprising:
a substrate (upper layer 47) formed of a flexible, elastic material and having a skin-facing surface and a non-skin-facing surface opposite the skin-facing surface (Fig. 4c; ¶ 0024 & 0026), the substrate (47) having:
a bridge portion (median portion 46) having a first end (upper end portion 45), a second end (lower end portion 44) opposite the first end (45), a first side, a second side opposite the first side, and a longitudinal axis extending between the first end (45) and the second end (44), the bridge portion (46) being sized and dimensioned to extend between a first nasal sidewall of a user’s nose and second nasal sidewall of the user’s nose opposite the first nasal sidewall and across a bridge of the user’s nose and capable of being positionable over at least a portion of an infratrochlear nerve of the user’s nose thereby capable of providing an epidermal tractional force parallel to a surface of application on the user’s nose and in a direction toward the bridge of the user’s nose to stimulate the infratrochlear nerves of the user’s nose (Figs. 4a-4b; ¶ 0024 & 0030); and
a plurality of lateral portion pairs (each of the upper end portion 45 and lower end portion 44 includes a lateral portion pair A, see annotated Fig. 4a below), each of the plurality of lateral portion pairs (A) including a first lateral portion (B, see annotated Fig. 4a below) extending from the first side of the bridge portion (46) and a second lateral portion (C, see annotated Fig. 4a below) extending from the second side of the bridge portion (46) (Fig. 4a); and
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an adhesive layer (adhesive layer 48) disposed on the skin-facing surface of the substrate (47), the adhesive layer (48) being operable to attach the substrate to an epidermal surface of the user’s nose (Figs. 4c; ¶ 0024 & 0027);
wherein the first lateral portion (B) of each of the plurality of lateral portion pairs (A) is sized and dimensioned to be capable of being positionable over a portion of an anterior ethmoidal nerve on the first nasal sidewall of the user’s nose when the bridge portion (46) is positioned across the bridge of the user’s nose thereby capable of providing an epidermal tractional force parallel to the surface of application of the user’s nose and in a direction toward the bridge portion (46) to stimulate the anterior ethmoidal nerve on the first nasal sidewall of the user’s nose (Fig. 4a); and
wherein the second lateral portion (C) of each of the plurality of lateral portion pairs (A) is sized and dimensioned to be capable of being positionable over a portion of an anterior ethmoidal nerve on the second nasal sidewall of the user’s nose when the bridge portion (46) is positioned across the bridge of the user’s nose thereby capable of providing an epidermal tractional force parallel to the surface of application of the user’s nose and in a direction toward the bridge portion (46) to stimulate the anterior ethmoidal nerve on the second nasal sidewall of the user’s nose (Fig. 4a).
With respect to the limitations regarding the positioning of the portions of the nasal strip on a user’s nose and the resulting effect on the underlying nerves are recitation of the intended use of the claimed invention which 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. In the instant case, Kehiaian discloses the structure of the claimed nasal strip, as discussed above, and would be capable of being positioned in the recited manner on a user’s nose.
Regarding claim 11, Kehiaian discloses that the first lateral portion (B) of each of the lateral portion pairs (A) is spaced a distance from the first lateral portion (B) of at least one other lateral portion pair (A) of the plurality of lateral portion pairs (A) and the second lateral portion (C) of each of the lateral portion pairs (A) is spaced a distance from the second lateral portion (C) of at least one other lateral portion pair (A) of the plurality of lateral portion pairs (A) (Fig. 4a).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kehiaian as applied to claim 10 above, in view of Altaher (US 2024/0252340).
Kehiaian discloses the invention substantially as claimed, as described above, and further discloses that the bridge portion (46) has a bridge length extending between the first end (45) and the second end (44) and a bridge width extending between the first side and the second side (Fig. 4a).
However, Kehiaian fails to teach that the bridge length is in a range between 1 cm and 10 cm and the bridge width is in a range between 0.3 cm and 3 cm.
Altaher discloses a nasal strip (breathing assist assembly 10) comprising a substrate (panel 12) having a bridge portion (vertical portion 26), wherein the bridge portion (26) has a bridge length extending between a first end (distal end 30) and a second end (proximal end 28), the bridge length being in a range between 2 inches (5.1 cm) and 5 inches (12.7 cm), and a bridge width extending between a first side and a second side, the bridge width being in a range less than 0.5 inches (1.27 cm) (Figs. 1 & 6; ¶ 0028).
In the case where the claimed ranges (1 cm to 10 cm, 0.3 cm to 3 cm) “overlap or lie inside ranges disclosed by the prior art” (5.1 cm to 12.7 cm, less and 1.27 cm), a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Further, it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to construct the bridge portion of the nasal device taught by Kehiaian to have a bridge length in the range between 5.1 cm and 12.7 cm and a bridge width less than 1.27 cm as taught by Altaher, which overlaps with the claimed length range between 1 cm and 10 cm and width range between .3 cm and 3 cm, for the purpose of sizing the nasal strip to be suitably positioned on a user’s nose bridge.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kehiaian as applied to claim 10 above, in view of Fenton et al. (US 2012/0172923).
Kehiaian discloses the invention substantially as claimed, as described above, and further discloses that the first lateral portion (B) of each of the plurality of lateral portion pairs (A) has a first proximal end, a first distal end opposite the first proximal end, a first lateral length extending between the first proximal end and the first distal end, a first exterior side, a first interior side opposite the first exterior side, and a first lateral width extending between the first interior side and the first exterior side, and the second lateral portion (C) of each of the plurality of lateral portion pairs (A) has a second proximal end, a second distal end opposite the second proximal end, a second lateral length extending between the second proximal end and the second distal end, a second exterior side, a second interior side opposite the second exterior side, and a second lateral width extending between the second interior side and the second exterior side (Fig. 4a).
However, Kehiaian fails to teach that at least one of the first lateral length and the second lateral length being in a range between 0.4 cm and 4 cm, and at least one of the first lateral width and the second lateral width being in a range between 0.2 cm and 2 cm.
Fenton discloses a nasal strip (nasal dilator 10) comprising a substrate (resilient band 22) having a bridge portion and a plurality of lateral portion pairs (branches), each of the plurality of lateral portion pairs including a first lateral portion extending from a first side of the bridge portion and a second lateral portion extending from a second side of the bridge portion, wherein the first lateral portion of each of the plurality of lateral portion pairs has a first proximal end, a first distal end opposite the first proximal end, a first lateral length (approximately equal to length of the slot between two adjacent branches) extending between the first proximal end and the first distal end, a first exterior side, a first interior side opposite the first exterior side, and a first lateral width extending between the first interior side and the first exterior side, and the second lateral portion of each of the plurality of lateral portion pairs has a second proximal end, a second distal end opposite the second proximal end, a second lateral length (approximately equal to length of the slot between two adjacent branches) extending between the second proximal end and the second distal end, a second exterior side, a second interior side opposite the second exterior side, and a second lateral width extending between the second interior side and the second exterior side, wherein at least one of the first lateral length and the second lateral length being typically .631 inches (1.6 cm), and wherein at least one of the first lateral width and the second lateral width being typically 0.196 inches (0.5 cm) (Figs. 1-2; ¶ 0020 & 0025).
In the case where the claimed ranges (0.4 cm to 4 cm, 0.2 cm to 2 cm) “overlap or lie inside ranges disclosed by the prior art” (1.6 cm, 0.5 cm), a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Further, it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to construct the nasal device taught by Kehiaian such that at least one of the first and second lateral portions have a length of typically 1.6 cm and a width of typically 0.5 cm as taught by Fenton, which lies inside the claimed length range between 0.4 cm and 4 cm and width range between .2 cm and 2 cm, for the purpose of sizing the nasal strip to be suitably positioned on sides of a user’s nose.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kehiaian as applied to claim 10 above, in view of Bentivegna et al. (US 2015/0359654).
Kehiaian discloses the invention substantially as claimed, as described above, and further discloses that the substrate (47) is a woven fabric configured to stretch (¶ 0026).
However, Kehiaian fails to teach that the woven fabric is configured to stretch in a first direction by an amount in a range between 35% and 55% and in a second direction perpendicular to the first direction by an amount in a range between 35% and 55%.
Bentivegna discloses a strip (truss member 10) comprising a substrate (base layer material 200), wherein the substrate (200) is configured to stretch is a first direction and a second direction perpendicular to the first direction by an amount in a range between 35% and 55% (the tape material can stretch to about 140% of its original length, equivalent to an increase of about 40% which lies within the claimed range of 35% and 55%) (¶ 0012-0015).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the substrate of the nasal strip taught by Kehiaian to stretch in a first direction by an amount in a range between 35% and 55% and in a second direction perpendicular to the first direction by an amount in a range between 35% and 55% as taught by Bentivegna for the purpose of creating a suitable pulling force on the skin on which the nasal strip is being applied.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 2/13/2026