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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/25/2025 has been entered.
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.
Claim 6 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 6 does not match the claim 6 is the pervious claim set. In the pervious claim set dated 1/31/2025 claim 6 was an independent claim tit is now a dependent claim to claim 1. Claim 6 claims “the elongated hollow body including a converging conical section, an angle section joined to the conical section, with the conical section having a central axis AF not parallel to a central axis AN of the angle section, and a body section joined to the angle section, with the body section having a length at least twice the length of the angle section. “ This subject matter is already in independent claim 1 and does not further limit the claim.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnon (US Pub 2011/0048430) in view of Dubrul et al. (US Pub 2007/0191876).
With respect to claim 1, Arnon discloses a surgical sheath (see fig 2A below) comprising: an elongated hollow body (fig 2A); the elongated hollow body having at least one end formed into an atraumatic rim (fig 2A, 11) adapted to prevent fraying; the elongated hollow body including a converging (see fig 2A below) conical section (Fig 2A, 14), an angle section (fig 2A, 10) joined to the conical section, with the conical section having a central axis AF not parallel to a central axis AN of the angle section (See fig 2A below), and a body section (fig 2A, 12) joined to the angle section, with the body section having a length at least twice the length of the angle section (fig 2A) wherein the conical section comprises an outer wall that, when extrapolated, converges at a point within the elongated hollow body (paragraph 42 and figure 2B discloses that the hollow body can be bulbous in the bulbous configuration shown below the conical section converges within the body).
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Arnon does not disclose the hollow body comprising a braided material having interstitial spaces filled with a filling material.
Dubrul et al. discloses a sheath (See figures 7 and 8 below) having a hollow body (fig 8, 30) comprising a braided material (fig 7, 24 and paragraph 48) having interstitial spaces (paragraph 48, spaces between the fibers) filled with a filling material (paragraph 48, “membrane”) to have sufficient strength to support a lumen in the body (paragraph 31). With respect to claim 4, Dubrul discloses with the braided material comprising a tube of braided round monofilament fibers having a diameter of 0.2 to 0.3 mm (paragraph 32, .5 to 50 mils or .0127mm-1.27mm. With respect to claim 5, Dubrul discloses wherein the interstitial spaces are square (See fig 8 below).
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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 device of Arnon to include the hollow body comprising a braided material having interstitial spaces filled with a filling material in view of Dubrul in order to have sufficient strength to support a lumen in the body.
With respect to claim 2, Arnon in view of Dubrul both disclose the sheath having a low-profile configuration that expands to an expanded configuration (fig 7 to fig 8 of Dubrul and paragraph 16 of Arnon) but does not specifical disclose the expanded configuration is at least four times the low-profile configuration. Both Dubrul and Arnon are used for nasal procedures as with the current application. With regard to claim 2, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein the expanded configuration is at least four times the low-profile configuration, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 3, Arnon in view of Dubrul discloses the claimed invention except for the maximum diameter of the low-profile configuration is 8 to 12 mm. Both Dubrul and Arnon are used for nasal procedures as with the current application. With regard to claim 3, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein the maximum diameter of the low-profile configuration is 8 to 12 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnon (US Pub 2011/0048430) in view of Dubrul et al. (US Pub 2007/0191876) and further in view of Andersen et al. (US Patent 5,876,445).
Arnon discloses the elongated hollow body including a converging (see fig 2b above) conical section (Fig 2A, 14), an angle section (fig 2A, 10) joined to the conical section, with the conical section having a central axis AF not parallel to a central axis AN of the angle section (See fig 2A above), and a body section (fig 2A, 12) joined to the angle section, with the body section having a length at least twice the length of the angle section (fig 2A).
With respect to claim 6, Arnon does not disclose the hollow body comprising a braided material having interstitial spaces filled with a filling material wherein the braided tube formed by a first set of fibers interwoven with a second set of fibers, all of the fibers in the first set of fibers extending in a first spiral pattern, uniformly parallel to each other and spaced apart from each other, all of the fibers in the second set of fibers uniformly extending in a second spiral pattern, uniformly parallel to each other and spaced apart from each other, all of the fibers in the first set of fibers perpendicular to all of the fibers in the second set of fibers the fibers having a plurality of distinct contact points providing the elongated hollow body with a non-continuous inner contact surface and does not disclose the filling material being a silicone material.
Dubrul et al. discloses a sheath (See figures 7 and 8 above) having a hollow body (fig 8, 30) comprising a braided material (fig 7, 24 and paragraph 48) having interstitial spaces (paragraph 48, spaces between the fibers) filled with a filling material (paragraph 48, “membrane”) wherein the braided tube (paragraph 48) formed by a first set of fibers (paragraph 48 and fig 8 above) interwoven with a second set of fibers (paragraph 48 and fig 8 above), all of the fibers in the first set of fibers extending in a first spiral pattern (paragraph 48 and fig 8 above), uniformly parallel to each other and spaced apart from each other (paragraph 48 and fig 8 above), all of the fibers in the second set of fibers uniformly extending in a second spiral pattern (paragraph 48 and fig 8 above), uniformly parallel (fig 7 and 8) to each other and spaced apart from each other, all of the fibers in the first set of fibers perpendicular to all of the fibers in the second set of fibers the fibers (paragraph 48 and fig 8 above) having a plurality of distinct contact (paragraph 48 and fig 8 above) points providing the elongated hollow body with a non-continuous inner contact surface to have sufficient strength to support a lumen in the body (paragraph 31).
Andersen discloses a sheath having a filling material being silicone (col. 10, ll. 59) to prevent unraveling and cover sharp points (col. 8, ll. 38-41).
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 device of Arnon to include the hollow body comprising a braided material having interstitial spaces filled with a filling material wherein the braided tube formed by a first set of fibers interwoven with a second set of fibers, all of the fibers in the first set of fibers extending in a first spiral pattern, uniformly parallel to each other and spaced apart from each other, all of the fibers in the second set of fibers uniformly extending in a second spiral pattern, uniformly parallel to each other and spaced apart from each other, all of the fibers in the first set of fibers perpendicular to all of the fibers in the second set of fibers the fibers having a plurality of distinct contact points providing the elongated hollow body with a non-continuous inner contact surface in view of Dubrul in order to have sufficient strength to support a lumen in the body and 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 device of Arnon in view of Dubrul to include the filling material being silicone in view of Andersen in order to prevent unraveling and cover sharp points.
With respect to claim 6, Arnon in view of Dubrul both disclose the sheath having a low-profile configuration that expands to an expanded configuration (fig 7 to fig 8 of Dubrul and paragraph 16 of Arnon) but does not specifical disclose the expanded configuration is at least four times the low-profile configuration. Both Dubrul and Arnon are used for nasal procedures as with the current application. With regard to claim 6, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein the expanded configuration is at least four times the low-profile configuration, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant's arguments filed 10/25/2025 have been fully considered but they are not persuasive. The applicant argues that the conical section does not converge within the body. The examiner respectfully disagrees. Paragraph 42 and figure 2B discloses that the hollow body can be bulbous in the bulbous configuration shown above the conical section converges within the body. The bulbous configuration meets the claimed limitations.
The rejection is deemed proper.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773