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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed on 24 August 2026 is acknowledged. Claims 12-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed om 24 August 2026.
Benefit
The application is a National Stage entry under 35 USC 371 of PCT/US2023/066180 (4/25/2023), which claims benefit of US Provisional 63/6369,533 (4/25/2022).
Formal Matters
Claims 1-21 are pending. Claims 12-21 are withdrawn without traverse, as set forth above. Claims 1-11 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5 November 2024 has been considered by the examiner. A signed copy is attached.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shetye et al., WO 2022076795 A1 (14 April 2022, benefit to 8 October 2020).
Regarding claim 1, Shetye teaches a nasal insert (nasal molding device 100; FIG 3A) configured to be deployed over an extended period (p. 14, lines 28-29) into an airway of a person (p. 9, line 5) to modify a physical structure forming the airway (p. 13, lines 7-8), the nasal insert (100) comprising:
a nasal insert body (nasal molding stent 110) having a size and shape (p. 9, lines 9-17) matched to the airway of the person (p. 14, lines 1-2) and having a corrective surface configured to engage one or more of nasal bone and cartilage surrounding the airway (p. 14, lines 4-7) and to permanently adjust the structure of the airway (p. 14, lines 4-7) and dimensioned to be inserted into a nasal passage of the person (p. 9, lines 9-17) by the person to apply pressure via the corrective surface to the one or more of nasal bone and cartilage surrounding the airway (p. 14, lines 4-7); and
a passageway formed in the nasal insert body to allow air to enter and exit the airway when the nasal insert is inserted in the airway (FIG 1).
Regarding claim 2, Shetye teaches the nasal insert of claim 1, wherein the nasal insert is manufactured using size and shape information of the person to match the airway of the person (FIG 4, “dimensions of exemplary symmetrical individual nasal molding devices”, p. 4, lines 28-29; “3D printing or other additive manufacturing”, p. 12, lines 23-25).
Regarding claim 3, Shetye teaches the nasal insert of claim 2, where the nasal insert is manufactured using an additive manufacturing process (FIG 4, “dimensions of exemplary symmetrical individual nasal molding devices”, p. 4, lines 28-29; “3D printing or other additive manufacturing”, p. 12, lines 23-25) using size and shape information acquired from medical images of the person (“based on 3D scans or 2D images of a subject’s face”, p. 13, lines 14-17; FIG 4, “any suitable size range”, p. 13, lines 18-29).
Regarding claim 9, Shetye teaches the nasal insert of claim 1, further comprising an adjustment system that incrementally changes a geometry (FIGs 1-3C, “molding stent 110 comprising a substantially tubular shape having a length 112 comprising a superior with 114 and an inferior width 116, p. 9, lines 3-4) of the nasal insert body to be matched to the size and shape of the airway (“based on 3D scans or 2D images of a subject’s face”, p. 13, lines 14-17; FIG 4, “any suitable size range”, p. 13, lines 18-29).
Regarding claim 11, Shetye teaches the nasal insert of claim 1, wherein the nasal insert body includes one or more recesses or passages formed in a sidewall (FIGs 1-3C, “molding stent 110 comprising a substantially tubular shape having a length 112 comprising a superior with 114 and an inferior width 116, comprising a hollow interior (passage), p. 9, lines 3-9).
Claims 1, 2, 4-6, and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maryanka, US 20040059368 (25 March 2004).
Regarding claim 1, Maryanka teaches a nasal insert (nasal dilation device) configured to be deployed over an extended period (¶17) into an airway of a person (nasal cavity; ¶11) to modify a physical structure forming the airway (¶12), the nasal insert (nasal dilation device) comprising:
a nasal insert body (nasal dilation device) having a size and shape (¶¶15, 27) matched to the airway of the person (¶27) and having a corrective surface (¶20) configured to engage one or more of nasal bone and cartilage surrounding the airway (¶¶11, 23) and to permanently adjust the structure of the airway (¶15) and dimensioned to be inserted into a nasal passage of the person (¶27) by the person to apply pressure via the corrective surface to the one or more of nasal bone and cartilage surrounding the airway (¶11); and
a passageway formed in the nasal insert body to allow air to enter and exit the airway when the nasal insert is inserted in the airway (¶¶11, 27).
Regarding claim 2, Maryanka teaches the nasal insert of claim 1, as set forth above, wherein the nasal insert is manufactured using size and shape information of the person to match the airway of the person (¶27).
Regarding claim 4, Maryanka teaches the nasal insert of claim 1, as set forth above, wherein the nasal insert forms one in a set of nasal inserts (¶¶12, 18), each nasal insert in the set of nasal inserts (¶18) having a different size or geometry (¶¶12, 23-25), and wherein the set of nasal inserts are configured to provide incremental adjustments to the airway over a treatment duration (¶¶20, 23-25).
Regarding claim 5, Maryanka teaches the nasal insert of claim 1, as set forth above, wherein the nasal insert body includes a grip (expansion means of the draw-pull element, ¶37) configured to facilitate insertion, removal, and adjustment of the nasal insert in the airway by the person (¶¶38, 40; claim 15).
Regarding claim 6, Maryanka teaches the nasal insert of claim 5, as set forth above, wherein the grip (expansion means of the draw-pull element, ¶37) includes an opening dimensioned to at least partially receive a digit of the person to rotate the nasal insert in the airway (expansion means, ¶27).
Regarding claim 8, Maryanka teaches the nasal insert of claim 1, as set forth above, wherein the nasal insert body is compressible (¶52).
Regarding claim 9, Maryanka teaches the nasal insert of claim 1, as set forth above, further comprising an adjustment system (expansion means and holding means, ¶18) that incrementally changes a geometry (¶¶23-25) of the nasal insert body to be matched to the size and shape of the airway (¶27).
Regarding claim 10, Maryanka teaches the nasal insert of claim 9, as set forth above, wherein the adjustment system (¶18) includes an expandable material (¶¶44, 64).
Regarding claim 11, Maryanka teaches the nasal insert of claim 1, as set forth above, wherein the nasal insert body includes one or more recesses or passages formed in a sidewall (FIGs 1-3, spaces between ribs; claim 3).
Claims 1, 2, 7, 8, and 10 are rejected under 35 U.S.C. 102(a)(2) as being unpatentable over in view of Matheny, et al., US 20220168465 (2 June 2022, benefit to 14 April 2020).
Regarding claim 1, Matheny teaches a nasal insert (biodegradable nasal splint, ¶8) configured to be deployed over an extended period (¶¶6, 39) into an airway of a person (¶9) to modify a physical structure forming the airway (¶9), the nasal insert (biodegradable support, ¶39) comprising:
a nasal insert body (¶39) having a size and shape (¶41) matched to the airway of the person (¶¶12, 18) and having a corrective surface (¶39) configured to engage one or more of nasal bone and cartilage surrounding the airway (¶¶9, 40) and to permanently adjust the structure of the airway (¶¶9, 40) and dimensioned to be inserted into a nasal passage of the person (¶41) by the person to apply pressure via the corrective surface to the one or more of nasal bone and cartilage surrounding the airway (¶61); and
a passageway formed in the nasal insert body to allow air to enter and exit the airway when the nasal insert is inserted in the airway (¶¶10).
Regarding claim 2, Matheny teaches the nasal insert of claim 1, as set forth above, wherein the nasal insert is manufactured using size and shape information of the person to match the airway of the person (¶41).
Regarding claim 7, Matheny teaches the nasal insert of claim 1, as set forth above, wherein the nasal insert body comprises hydrogel (¶71).
Regarding claim 8, Matheny teaches the nasal insert of claim 1, as set forth above, wherein the nasal insert body is compressible (¶142).
Regarding claim 10, Matheny teaches the nasal insert of claim 9, as set forth above, wherein the adjustment system includes an expandable material (¶142).
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Maryanka, US 20060259065 (16 November 2006) teaches nasal cavity dilator.
Brennan, US 5931852 (3 August 1999) teaches nasal airway devices.
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-F 9am-6pm (CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
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