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 .
Response to Amendment
The amendment filed on May 28, 2026 has been entered. Claims 1 and 3-17 remain pending in the application. Applicant’s amendments to the specification and claim objections, and 112(b) rejection previously set forth in the Non-Final Office Action mailed May 28, 2026 have overcome each and every rejection.
Response to Arguments
Specification Objections
Applicant amended the specification to eliminate informalities and typographical errors from originally filed specification. This successfully overcomes the previous specification objections and the objections are withdrawn.
Claim Objections
Applicant amended claims 1 and 16 to eliminate informalities from originally filed claims 1 and 16. This successfully overcomes the previous claim objections and the objections are withdrawn.
35 U.S.C. § 112(b)
Applicant amended claim 12 to eliminate indefinite language from originally filed claim 12. This successfully overcomes the previous rejection under 35 U.S.C. 112(b) and the rejection is withdrawn.
35 U.S.C. § 102 and 103
Applicant’s amendments and arguments, see pg. 8-16, filed May 28, 2026, with respect to the rejection(s) under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sumaily (US 10299670 B1, published 05/28/2019).
Sumaily teaches a self-retaining nasal septum retractor includes two pivotally attached arms having handles on one end and speculum blades on the opposing end (Abstract). The speculum joints are pivoted up so the handles and arms are positioned above the patient's head, giving the user an unobstructed working area to maneuver the handles of the tools inserted in the nostril (Col. 4, lines 61-65). Handles having finger loops are located at the proximal end of the arms for a user to engage with the fingers and thumb to operate the instrument; the distal ends of the arms are attached in series to joints which pivotally attach speculum blades to the arms (Col. 2, lines 40-45). The speculum blades are adjustably connected to the arms through pivoting joints (Col. 1, lines 57-58). The self-retaining mechanism allows a user to lock the arms (Col. 5, lines 54-55). Other locking mechanisms known in the art are contemplated for use with this device, such mechanism may include a threaded bolt that adjusts the width through twisting the bolt or an electrically powered locking mechanism that the user operates through a user interface (Col. 5, lines 19-23).
Applicant’s arguments filed May 28, 2026 with respect to claims 1 and 3-17 have been considered but are not persuasive as they are confined to whether the Krespi reference teaches newly added claim features by amendment. As noted above, these features are taught by the Sumaily reference, see the rejection below for additional details.
Claim Objections
Claim 1 objected to because of the following informalities: “self-retracting nasal valve retractor”. This appears to be a typographical error as page 7, paragraph [0034] and page 12, paragraph [0043] of the specification discuss a “self-retaining nasal valve retractor”. Thus, examiner will interpret the limitation of claim 1 as “self-retaining nasal valve retractor”. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Krespi et al. (US 2022/0395327 A1, published 12/15/2022, hereinafter referred to as Krespi) in view of Sumaily (US 10299670 B1, published 05/28/2019).
Regarding claim 1, Krespi discloses a method for treatment of nasal valve obstruction comprising ([0038]):
inserting a handheld laser device into a nostril of a patient (Fig. 1, and [0038]);
said handheld laser device having a handpiece section (13 in Fig. 3, and [0043]) and connected to a diode laser at a proximal end of said handheld laser device (19 in Fig. 2, and [0042]), with laser energy delivered along fiber optic internal to the handheld laser device inside said handpiece section (32 in Fig. 1, and [0053]); said fiber optic extending from a distal end of said handpiece section and contained within a malleable sheath (32 in Fig. 1, and [0041]); said fiber optic culminating in a laser fiber optic tip at the distal end of said handheld laser device (34 in Fig. 1, and [0042]);
delivering laser energy by said laser fiber optic tip (34 in Fig. 1) to a selected treatment location within a nasal valve of said nostril ([0047]); ablating obstructing tissue at said selected treatment location with said laser energy ([0094]).
Krespi does not disclose the method comprising:
retracting a nostril of a patient with a non-obstructing and self-retaining nasal valve retractor to expose a nasal valve, said nasal valve retractor having a distal end with a pair of distal end retracting prongs with said distal end retracting prongs controlled at a proximal end of said nasal valve retractor by an adjustment knob, said adjustment knob altering distance between said distal end retracting prongs by turning said adjustment knob.
However, Sumaily teaches a self-retaining nasal septum retractor that includes two pivotally attached arms having handles on one end and speculum blades on the opposing end (Abstract). The speculum joints are pivoted up so the handles and arms are positioned above the patient's head, giving the user an unobstructed working area to maneuver the handles of the tools inserted in the nostril (Col. 4, lines 61-65). Handles having finger loops are located at the proximal end of the arms for a user to engage with the fingers and thumb to operate the instrument; the distal ends of the arms are attached in series to joints which pivotally attach speculum blades to the arms (Col. 2, lines 40-45). The speculum blades are adjustably connected to the arms through pivoting joints (Col. 1, lines 57-58). The self-retaining mechanism allows a user to lock the arms (Col. 5, lines 54-55). Other locking mechanisms known in the art are contemplated for use with this device, such mechanism may include a threaded bolt that adjusts the width through twisting the bolt or an electrically powered locking mechanism that the user operates through a user interface (Col. 5, lines 19-23).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the self-retaining nasal septum retractor of Sumaily with the method of treatment of a nasal valve obstruction of Krespi because this instrument provides minimally invasive visual and physical access to the inner nose (Sumaily Col 1, lines 15-16).
Regarding claim 4, Krespi as modified discloses the method for treatment of nasal valve obstruction recited in claim 1 as set forth above, wherein said handheld laser device operates in non-contact mode at 60 to 70 degrees Celsius ([0009]).
The specification discloses the appropriate ranges that apply to the claimed invention on page(s) 4, paragraph [009] as a temperature range from 60 to 90 degrees Celsius. However, the specification does not disclose that the specifically claimed range(s) of temperature is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Krespi further discloses that the temperature range of the skin for treatment is 60 to 70 degrees Celsius, and the therefore provides teaching that the temperature range is known in the art, and are variable that achieve a recognized result without crusting the surface of the tissue, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization [0039].
Because Applicants fail to disclose that the claimed range(s) of temperature provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that an acceptable range for laser treatment in a non-contact mode absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of temperature by normal optimization procedures known in the diode laser treatment arts.
Regarding claim 10, Krespi as modified discloses the method for treatment of nasal valve obstruction recited in claim 1 as set forth above, wherein said selected treatment location is a turbinate ([0016], [0038]).
Regarding claim 11, Krespi as modified discloses the method for treatment of nasal valve obstruction recited in claim 1 as set forth above, wherein said selected treatment location is swell bodies ([0109]).
Regarding claim 12, Krespi as modified discloses the method for treatment of nasal valve obstruction recited in claim 1 as set forth above, wherein said selected treatment location is herniated soft tissue of a nasal floor ([0115]).
Regarding claim 13, Krespi as modified discloses the method for treatment of nasal valve obstruction recited in claim 1 as set forth above, wherein said laser fiber optic tip is a 400 micron tip ([0097]).
Regarding claim 14, Krespi as modified discloses the method for treatment of nasal valve obstruction recited in claim 1 as set forth above, wherein said laser fiber optic tip is a 400 micron malleable tip ([0097]).
Regarding claim 15, Krespi as modified discloses the method for treatment of nasal valve obstruction recited in claim 1 as set forth above, wherein said treatment of nasal valve obstruction includes a pulse mode of laser treatment ([0116]).
Regarding claim 16, Krespi as modified discloses the method for treatment of nasal valve obstruction recited in claim 1 as set forth above, wherein said treatment of nasal valve obstruction includes a continuous mode of laser treatment ([0101]).
Regarding claim 17, Krespi as modified discloses the method for treatment of nasal valve obstruction as recited in claim 12 as set forth above, wherein said herniated soft tissue of a nasal floor is vestibular swell body ([0109]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Krespi in view of Sumaily (hereinafter known as modified Krespi), as applied to claim 1 above, and further in view of Wolf et al. (US 10335221 B2, published 07/02/2019, hereinafter referred to as Wolf).
Regarding claim 6, modified Krespi discloses the method for treatment of nasal valve obstruction recited in claim 1, as set forth above.
However, modified Krespi does not disclose wherein said selected treatment location is upper lateral cartilage.
Wolf teaches various submucosal tissues that may be treated include upper lateral cartilage (33). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the treatment location of the upper lateral cartilage as taught by Wolf with the method for treatment of nasal valve obstruction of modified Krespi because treatments may be targeted at strengthening cartilage in the area of the upper lateral cartilage (Wolf (108)).
Regarding claim 7, modified Krespi discloses the method for treatment of nasal valve obstruction recited in claim 1, as set forth above.
However, modified Krespi does not disclose wherein said selected treatment is lower lateral cartilage.
Wolf teaches various submucosal tissues that may be treated include lower lateral cartilage (33). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the treatment location of the lower lateral cartilage as taught by Wolf with the method for treatment of nasal valve obstruction of modified Krespi because treatments may be targeted at strengthening cartilage in the area of the lower lateral cartilage (Wolf (108)).
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Krespi in view of Sumaily (hereinafter known as modified Krespi), as applied to claim 1 above, and further in view of Slatkine et al. (US 20170281256 A1, published 10/05/2017, hereinafter referred to as Slatkine).
Regarding claim 3, modified Krespi discloses the method for treatment of nasal valve obstruction recited in claim 1, as set forth above. Furthermore, Krespi teaches wherein said handheld laser device operates in contact mode ([0047]).
However, modified Krespi does not disclose wherein said handheld laser device operates in contact mode at more than 100 degrees Celsius.
Slatkine teaches a device for thermal incision of tissue including a tissue heating element, a detector that detects when the tissue heating element contacts the tissue, and a heat controller that controls heating of the tissue heating element, wherein the heat controller for the tissue heating element controls heating the tissue heating element based on detecting when the tissue heating element contacts tissue (Abstract). In some embodiments, heated temperatures of the tip are between 100 and 850 degrees Celsius ([0136]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the temperature range of more than 100 degrees Celsius as taught by Slatkine with the device operation in contact mode of modified Krespi because high temperatures in contact mode help to deliver most of the energy to the tissue within a short time duration (Slatkine [0152]).
Regarding claim 5, modified Krespi discloses the method for treatment of nasal valve obstruction recited in claim 1, as set forth above. Furthermore, Krespi teaches wherein said handheld laser device operates in interstitial mode ([0047]).
However, modified Krespi does not disclose wherein said handheld laser device operates in interstitial mode at more than 100 degrees Celsius.
Slatkine teaches a device for thermal incision of tissue including a tissue heating element, a detector that detects when the tissue heating element contacts the tissue, and a heat controller that controls heating of the tissue heating element, wherein the heating tissue element can be used for evaporating a desired volume of tissue (Abstract, [0043]). In some embodiments, heated temperatures of the tip are between 100 and 850 degrees Celsius ([0136]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the temperature range of more than 100 degrees Celsius as taught by Slatkine with the device operation in interstitial mode of modified Krespi because high temperatures in contact mode help to deliver most of the energy to the tissue within a short time duration (Slatkine [0152]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Krespi in view of Sumaily (hereinafter known as modified Krespi), as applied to claim 1 above, and further in view of Alliger (US 20130108714 A1, published 05/02/2013).
Regarding claim 8, modified Krespi discloses the method for treatment of nasal valve obstruction recited in claim 1 as set forth above, wherein said laser fiber optic tip (“fiber optic is attached to the laser delivery device” [0014]) is used in contact mode with said ablating step (“ablating blood vessels with a blue laser in a non-contact or contact coagulation mode” [0013]).
However, modified Krespi does not disclose wherein said selected treatment location is cartilaginous septal spurs.
Alliger teaches a method for treating acute and chronic sinusitis, exposing affected tissue of the sinus to effective amounts of chlorine dioxide as a bioactive agent (Abstract). A deviated nasal septum, nasal bone spur, or nasal polyps may block the opening of the sinuses (9). Nasal, or septal, spurs can significantly block the nasal valves.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the treatment location of nasal spurs as taught by Alliger with the method for treatment of nasal valve obstruction of modified Krespi because surgical repair of a deviated septum or nasal polyps is believed to prevent the condition (sinusitis) from returning (Alliger (11)).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Krespi in view of Sumaily (hereinafter known as modified Krespi), as applied to claim 1 above, further in view of Saadat et al., (US 11602260 B2, published 03/14/2023, hereinafter referred to as Saadat), and further in view of Saadat et. al, (US 10939965 B1, published 03/09/2021, hereinafter referred to as Saadat 2).
Regarding claim 9, modified Krespi discloses wherein said laser fiber optic tip is used in interstitial mode with said ablating step (“fiber tip can deliver the laser energy in at least three different modes of tissue interaction, including…(iii) interstitial, by puncturing through the tissue and delivering the energy into the tissue” [0047]).
However, modified Krespi does not disclose wherein said selected treatment location is fibro-fatty tissue, with two passes made by said fiber optic tip towards piriform aperture.
Saadat teaches cryosurgical probes which are configured to be advanced into a nasal cavity for treating conditions such as rhinitis (Abstract). Wherein the surface of the ablation element may include an absorbent structure such as a fibrous structure, which is what makes up fibro-fatty tissue (Col. 4, lines 35-38).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the treatment location of fibrous structures as taught by Saadat with the method for treatment of nasal valve obstruction of modified Krespi because chronic severe nasal obstruction resulting from remodeling of submucosal tissues of the inferior turbinates due to dilation of the venous sinuses or fibrosis can interfere with the quality of life (Saadat Col. 1, lines 22-25).
Further, modified Krespi in view of Saadat does not disclose two passes made by said fiber optic tip towards piriform aperture.
However, Saadat 2 teaches devices used to identify the location of a nerve in order to modify a property of the nerve, specifically, pre-operative scans of a patient's nasal cavity (Abstract). The target treatment location may be determined by identifying anatomical landmarks in the image of the nasal cavity and using predetermined relations of nerves locations relative to the anatomical landmarks (Col. 9, liens 30-33). The anatomical landmark may be one or more of…the piriform aperture (Col. 9, lines 40 & 45). Based on simple logic, it would be obvious to try a variation of passes made by the fiber optic tip towards the piriform aperture based on the strength of treatment necessitated, see MPEP 2143(I)(E).
Regarding claim 9, the specification discloses the appropriate ranges that apply to the claimed invention on page 12 of the applicant’s printed publication. However, the specification does not disclose that the specifically claimed range(s) of passes of the fiber optic tip is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Because Applicants fail to disclose that the claimed range(s) of passes of the fiber optic tip provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art recognizes stimulation duration is a result effective variable, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of passes of the fiber optic tip by normal optimization procedures known in the tissue ablation arts.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the identification and treatment of the piriform aperture as taught by Saadat 2 with the method for treatment of nasal valve obstruction of modified Krespi because treatments including physically damaging (comprising, cutting, or removing), thermal ablating, or chemically altering of these nerves have shown to provide relief to patients that suffer from the nasal ailments (Saadat 2 Col. 2, lines 58-62).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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