DETAILED ACTION
The following is a Final Office Action on the merits.
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 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.
Response to Amendment
Acknowledgment is made to the amendment received 3/30/2026.
Specification
The specification amendments of 2/12/2025 and 3/23/2025 are not entered as they do not accurately reflect the preliminary amendment of 12/27/2021.
The preliminary amendment filed 12/27/2021 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of PCT/US2020/041248. The Examiner notes that the application may claim priority to the PCT, but cannot incorporate by reference the PCT since the application filing date is the PCT filing date not the national state entry date on which the preliminary amendment was made.
Applicant is required to cancel the new matter in the reply to this Office Action.
The Examiner notes that while the originally filed disclosure states in various places the proximal portion has greater flexibility than the distal portion, the originally filed disclosure also provides support for “a flexibility of the distal portion of the probe shaft is greater than a flexibility of the proximal portion of the probe shaft” in Par. [0063]: “In one example, the distal portion 112 of the probe shaft 102 can have a flexibility that is approximately two times to approximately four times greater than a flexibility of the proximal portion 118 of the probe shaft 102.”
Claim Objections
Claim 18 is objected to because of the following informalities: amend “cryogenic fluid” to -cryogenic fluid from the cryogenic fluid source- in ll. 3. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-8, 12-14, 16, 18-19 & 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat (2015/0164571) in view of Lin et al. (2018/0078327) and Berg et al. (6,858,024).
Concerning claim 1, as illustrated in at least Figs. 2, 6E-F, 7-8 & 16A, Saadat disclose a device (surgical probe 29; [0147]) comprising:
a probe shaft having a distal end and a proximal end (probe shaft 20 has a shaft distal end 21 and a shaft proximal end 27; [0147] // or // shaft 265 has a distal and proximal end; [0180]), the probe shaft has a curved portion such that a longitudinal axis of a distal portion of the probe shaft has a non-zero angle with respect to a longitudinal axis of a proximal portion of the probe shaft (angle of shaft 265 is between approximately 30 and 60 degrees, and the point of bend is between 1 cm and 3 cm from the distal end of ablation element 263; [0180]), wherein the distal portion extends from the distal end of the probe shaft to the curved portion and the proximal portion extends from the proximal end of the probe shaft to the curved portion (distal portion of shaft extends from bend to distal end of probe and proximal portion of shaft extends form proximal end to bend; Fig. 16A);
a housing coupled to the proximal end of the probe shaft; a handle coupled to the housing; (handpiece 23 couples to proximal end 27 of shaft 20 and has pistol grip 24 or finger grips 25; [0147], [0163]);
an end effector coupled to the distal end of the probe shaft (distal end effector 30 couples to shaft distal end 21 at end effector proximal end 31 and has multiple variations that may be optionally interchanged depending upon which particular embodiment is utilized by a practitioner: where ablation element 263 couples to the proximal end of shaft 265; [0180]), wherein the end effector defines an atraumatic surface when the distal end of the probe shaft is advanced through a nasal cavity of a patient and is positioned proximate to a nasal tissue region having at least one nasal nerve (end effector member 30 in each embodiment has contained within expandable structure presents an atraumatic surface; [0017], [0158]), and wherein the end effector is configured to transmit lateral pressure against the nasal tissue region (end effector member 30 can be pressed against the lateral nasal wall; [0149], [0151]); and
a trigger positioned in the handle, wherein activation of the trigger causes the end effector to ablate the at least one nasal nerve when the end effector is in contact against the nasal tissue region (pistol trigger liquid cryogen flow control actuator 26, which may be used to control the flow of liquid cryogen to ablate nasal tissue when the surgeon holds surgical device 29 using pistol grip 24; [0149], [0164]).
Saadat fails to specifically disclose wherein a flexibility of the distal portion of the probe shaft is greater than a flexibility of the proximal portion of the probe shaft. However, Lin et al. disclose a device (15/35) comprising a probe shaft (16/36) having a more rigid proximal section (23/43) and a more flexible distal section (22/42). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Saadat such that a flexibility of the distal portion of the probe shaft is greater than a flexibility of the proximal portion of the probe shaft in order to provide the benefit of being flexible enough to follow the surgical plane defined by the bone of the lateral nasal wall and the mucosa as the end effector is advanced towards the target nasal nerve as taught by Lin et al. ([0054-0055]; Fig. 2A-B).
Saadat in view of Lin et al. fail to specifically disclose wherein the flexibility of the distal portion of the probe shaft has the flexibility that is approximately two times to approximately four times greater than the flexibility of the proximal portion of the probe shaft. However, Berg et al. teach a device a medical device shaft comprising discrete shaft sections, including a more flexible distal section to allow for better placement and less traumatic section on the target tissue, where the discrete shaft sections are of selected flexibility or durometer to selectively vary the flexural modulus of the shaft to match identified functions of the particular segment of the catheter shaft in specific procedures, and specifically wherein the flexibility of the distal portion of the probe shaft has the flexibility that is approximately two times to approximately four times greater than the flexibility of the proximal portion of the probe shaft. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Saadat in view of Lin et al. such that the flexibility of the distal portion of the probe shaft has the flexibility that is approximately two times to approximately four times greater than the flexibility of the proximal portion of the probe shaft in order to provide the benefit of matching identified functions of the particular segment of the catheter shaft in specific procedures as taught by Berg et al. (Col. 1-2, ll. 63-10, Col. 2-3, ll. 47-16)
The modified invention of Saadat in view of Lin et al. and Berg et al. results in a difference in flexibility between the proximal portion and the distal portion provides a flexing location at the curved portion.
Concerning claim 2, Saadat discloses the non-zero angle between the longitudinal axis of the distal portion of the probe shaft and the longitudinal axis of the proximal portion of the probe shaft is between about 30 and 60 degrees ([0180]), and thus fails to disclose the angle is between about 15 degrees and about 25 degrees. It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the angle of Saadat to be between about 15 degrees and about 25 degrees as a matter of routine optimization since Applicant places no criticality on the angle (merely stating the angle “can be between about 15 degrees and about 25 degrees, and preferably about 20 degrees”) 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).
Concerning claim 3, Saadat discloses the curved portion (bend) of the probe shaft is positioned about 4 cm from the distal end of the end effector (264) and the curved portion of the probe shaft causes a lateral deviation of the distal end (264) of the end effector (263) with respect to the longitudinal axis of the proximal portion (262) of the probe shaft ([0180]). Saadat in view of Lin et al. and Berg et al. fail to disclose the curved portion of the probe shaft causes a lateral deviation of the distal end of the end effector with respect to the longitudinal axis of the proximal portion of the probe shaft of about 1 cm. However, in the embodiment of Fig. 16B, Saadat teaches deflection of the shaft between 60-120 degrees in one or two directions, thus spanning an angle range of -120 to +120, which would include a lateral deviation of the distal end of the end effector with respect to the longitudinal axis of the proximal portion of the probe shaft of about 1 cm ([0180]; Fig. 16B). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Saadat in view of Lin et al. and Berg et al. such that the lateral deviation of the distal end of the end effector with respect to the longitudinal axis of the proximal portion of the probe shaft of about 1 cm in order to provide the benefit of obtaining a desired position of the end effector, and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Concerning claim 5, Saadat discloses the probe shaft (20/265) is rotatable relative to the housing (23) to facilitate positioning of the end effector without having to rotate the device excessively ([0149]). Saadat in view of Lin et al. and Berg et al. fail to specifically disclose the shaft rotatable 180 degrees. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Saadat in view of Lin et al. and Berg et al. such that the probe shaft is rotatable 180 degrees relative to the housing in order to facilitate positioning of the end effector as taught by Saadat, and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Concerning claims 6-7, Saadat discloses shaft (20) can be made from various biocompatible materials such as a surgical grade stainless steel hypodermic tube, or may alternatively be fabricated from a polymeric extrusion ([0147]), but fails to disclose the distal portion of the probe shaft comprises a first material (polymer), and wherein the proximal portion of the probe shaft comprises a second material (stainless steel) that is different than the first material. However, Berg et al. further disclose using various materials (Nitinol, hypotube, articulated stainless steel or fiber filled polymer to create shaft segments of varying flexibility (Col. 15, ll. 8-27; Fig. 19). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Saadat in view of Lin et al. and Berg et al. such that the distal portion of the probe shaft comprises a first material (polymer), and wherein the proximal portion of the probe shaft comprises a second material (stainless steel) that is different than the first material in order to provide the benefit of creating the desired flexibility via materials as taught by Berg et al., and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Concerning claim 8, Saadat discloses the proximal portion of the probe shaft comprising a first tube (91/inlet) having a first diameter and a second tube (90/outlet) having a second diameter that is greater than the first diameter such that an air gap (98) separates the tubes (91, 90) ([0172]; Fig. 8).
Concerning claim 12, Saadat discloses a cryogenic fluid source (reservoir/liquid cryogen cartridge) positioned at least partially in the handle (24); and a lumen (91) disposed in the probe shaft and in fluid communication with the cryogenic fluid source ([0148], [0169]; Fig. 2 & 7).
Concerning claim 13, while Saadat teaches housing (23) may accommodate liquid cryogen cartridges ([0148]), Saadat in view of Lin et al. and Berg et al. fail to disclose a height of the cryogenic fluid source in relation to the longitudinal axis of the proximal portion of the probe shaft, and thus fail to specifically disclose a height of the cryogenic fluid source is less than about 2 cm above the longitudinal axis of the proximal portion of the probe shaft. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Saadat in view of Lin et al. and Berg et al. such that a height of the cryogenic fluid source is less than about 2 cm above the longitudinal axis of the proximal portion of the probe shaft since Applicant places no criticality on the height (merely stating: “In one example, the height 128 is less than approximately 2 cm. In another example, the height 128 can be approximately 0.5 inches (e.g., approximately 1.27 cm”) and since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Concerning claim 14, Saadat discloses the cryogenic fluid source (cartridge) comprises a canister that is removably positioned at least partially in the handle (23) ([0148]; Fig. 2 & 15A).
Concerning claim 16, Saadat discloses the end effector (30) comprises: a planar member (83) defining a flattened shape disposed at the distal end (146) of the probe shaft (145), the planar member (83) having an elongate structure with arcuate edges to define the atraumatic surface; and an expandable structure (81) surrounding the planar member (83) and coupled to the distal end (146) of the probe shaft (145), wherein the expandable structure (81) is inflatable from a deflated configuration to an expanded configuration, and wherein an interior of the expandable structure is in fluid communication with the cryogenic fluid source ([0158-0160], [0172]; Fig. 6E & 7-8).
Concerning claim 18, Saadat discloses the expandable structure (81/109) is configured to transition from the deflated configuration to the expanded configuration upon evaporation of cryogenic fluid within the interior of the expandable structure (81/109) ([0158-0160], [0172]; Fig. 6E & 7-8).
Concerning claim 19, Saadat discloses the planar member (83) comprises an elongate loop structure formed by a rigid wire that is configured to manipulate tissue in the nasal cavity ([0158]; Fig. 6E & 7-8).
Concerning claim 21, Saadat discloses the planar member (83) extends within the expandable structure (91) such that it is unattached to an interior of the expandable structure (81) ([0158-0160]; Fig. 6E).
Concerning claim 22, Saadat discloses the device is configured to cool an external surface of the expandable structure (81) to between -20 degrees Celsius to -90 degrees Celsius for less than 120 seconds so as to controllably freeze the at least one nasal nerve at a depth less than 4 mm from a surface of the nasal tissue region so as to reduce at least one symptom of rhinitis of the patient ([0177-0179]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat (2015/0164571) in view of Lin et al. (2018/0078327) and Berg et al. (6,858,024), as applied to claim 12, in further view of Saadat et al. (2017/0231474).
Concerning claim 15, Saadat in view of Lin et al. and Berg et al. fail to specifically disclose the location with respect to the handle and/or housing, and probe shaft, and thus fail to disclose an angle between a longitudinal axis of the cryogenic fluid source and the longitudinal axis of the proximal portion of the probe shaft is between about 60 degrees and about 90 degrees. However, Saadat et al. teach a medical device (Fig. 1) comprising a cryogenic fluid source (9) positioned at least partially in a handle (2) coupled to housing (19), wherein an angle between a longitudinal axis of the cryogenic fluid source (9) and the longitudinal axis of the proximal portion of a probe shaft (3) is between about 60 degrees and about 90 degrees ([0066]; Fig. 1). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Saadat in view of Lin et al. and Berg et al. such that an angle between a longitudinal axis of the cryogenic fluid source and the longitudinal axis of the proximal portion of the probe shaft is between about 60 degrees and about 90 degrees as taught by Saadat et al., since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fahey et al. (2018/0344411) teach a proximal and distal shaft section and an intermediate curve (Fig. 9A-C).
Palushi et al. (2020/0315697) teach a proximal and distal shaft section and an intermediate curve (Fig. 5).
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 JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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