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
In response to the amendment filed on 12/31/2025, Claims 2, 4, and 13 have been cancelled and Claims 1, 3, 5-12, 14-20 are pending. In response to the claim amendments, the previous 112(b) rejections of Claims 7, 10 and 16 have been obviated.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 11, and 20 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.
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, 3, 5-7, 10-12, 14-16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski (US PGPub 2022/0240979) in view of Medhkour (US PGPub 2001/0023365).
Regarding Claim 1, Urbanski teaches a perforation device for transseptal access system (Paragraph 0018 and 0022), the perforation device comprising:
an electrically conductive core (32, 34; Figure 2; Paragraph 0037) comprising a proximal portion (32) having a proximal portion length (Figure 2), and a distal portion (42) having a distal portion length (Figure 2), wherein the proximal portion (32) is formed from a first material having a first modulus of elasticity (e.g. steel or titanium; Paragraph 0037), and the distal portion is formed from a second material (nitinol; Paragraph 0037) having a second modulus of elasticity that is lower than the first modulus of elasticity (Paragraph 0037 the distal is lower than the proximal so that the proximal can push and the distal can flex and bend); and
an exposed electrically conductive functional tip (36; Paragraph 0032) at a distal end of the core (42; Figure 2), and
an insulation layer (48) over a portion of the core (32, 42) (Paragraph 0032-0033)
wherein the insulation layer (48) has a first thickness over the proximal portion (32) of the core, and the insulation layer (48) has a second thickness over the distal portion (42) of the core.
Urbanski fails to disclose:
wherein the first thickness is greater than the second thickness
wherein the greater thickness provides enhanced protection from radiofrequency energy exposure during handling.
Medhkour teaches an apparatus for delivering RF energy comprising an electrically conductive core (32; Figure 1-2; Paragraph 0031), an exposed electrically conductive functional tip (38; Figure 3) at the distal end of the core (32), and an insultation layer (34; Paragraph 0031) over a portion of the core (32; Paragraph 0031; Figures 1-4), the insulation layer (34; Figure 3) comprising a first thickness (46; Figure 3) over a proximal portion of the core (32) and a second thickness (42) over the distal portion of the core (32), wherein the first thickness (46) is greater than the second thickness (42) (Figure 3; Paragraph 0033), wherein the greater thickness (48) provides enhanced protection from radiofrequency energy exposure during handling (Paragraph 0033, wherein the Examiner notes that a thicker insulating layer would inherently have enhanced energy protection than a thinner insulating layer formed of the same material and there is nothing in Medhkour to suggest that portion 42 is formed of a different material than portion 48 in Figure 3 and Paragraphs 0031-0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the insulation layer of Urbanski to include the variable thickness teachings of Medhkour, for the advantage of providing varying degrees of flexibility or suppleness to the distal end of perforation device (Paragraph 0033).
Regarding Claim 3, the combination of references disclosed above teaches the perforation device of claim 1, wherein Urbanski teaches the proximal portion has a first diameter (when the proximal portion is element 60 in Figure 6) and the distal portion (42) has a second diameter that is greater than the first diameter (60) (see Figure 6; Paragraph 0052).
Regarding Claim 5, Urbanski teaches the perforation device of claim 1, wherein the proximal (32) and distal portions (42) of the core have substantially the same diameter (see Figure 4, 6, and 7).
Regarding Claim 6, the combination of references disclosed above teaches the perforation device of claim 1, wherein Urbanski teaches the perforation device is substantially isodiametric along substantially the entire length of the core (see Figure 4 and see Figure 7).
Regarding Claim 7, the combination of references disclosed above teaches the perforation device of claim 1, wherein Urbanski teaches the proximal (32) and distal portions (42) of the core are mechanically attached together at a joint, and wherein the proximal and distal portions of the core are attached by laser welding, friction welding, brazing, soldering, or adhesive bonding, (Paragraph 0044).
Regarding Claim 10, the combination of references disclosed above teaches the perforation device of claim 1, but fails to explicitly state wherein the proximal portion and the distal portion have substantially equal bending stiffnesses.
Given that bending stiffness is a result effective variable dependent on the thickness of the conductive core at either the proximal and distal portions and given that Urbanski teaches that “the thickness of the material can be caried to adjust the rigidity of the shaft”, it would have been obvious to one of ordinary skill in the art to optimize the thickness of the materials forming the core through routine experimentation in order to achieve a desirable bending stiffness for the proximal and distal portions of the core, such that the bending stiffness are substantially equal. This configuration would result in the distal portion having the higher modulus of elasticity being thicker than the proximal portion material which has a lower modulus of elasticity. Alternatively one can modify the proximal portion to be thinner than the distal portion. The Examiner notes “[W]here 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 the perforation device with the proximal and distal portion having a substantially equal bending stiffness as recited in claim 10 is merely an obvious variant of the prior art.
-Regarding Claim 11, Urbanski teaches a perforation device for transseptal access system (Paragraph 0018 and 0022), the perforation device comprising:
an electrically conductive core (32, 34; Figure 2; Paragraph 0037) comprising a proximal portion (32) having a proximal portion length (Figure 2), and a distal portion (42) having a distal portion length (Figure 2), wherein the proximal portion (32) is formed from a first material having a first modulus of elasticity (e.g. steel or titanium; Paragraph 0037), and the distal portion is formed from a second material (nitinol; Paragraph 0037) having a second modulus of elasticity that is lower than the first modulus of elasticity (Paragraph 0037 the distal is lower than the proximal so that the proximal can push and the distal can flex and bend); and
an exposed electrically conductive functional tip (36; Paragraph 0032) at a distal end of the core (42; Figure 2).
an insulation layer (48) over a portion of the core (32, 42) (Paragraph 0032-0033; Figure 2)
wherein the insulation layer (48) has a first thickness over the proximal portion (32) of the core, and the insulation layer (48) has a second thickness over the distal portion (42) of the core.
Urbanski fails to disclose:
wherein the first thickness is greater than the second thickness
wherein the greater thickness provides enhanced protection from radiofrequency energy exposure during handling.
Medhkour teaches an apparatus for delivering RF energy comprising an electrically conductive core (32; Figure 1-2; Paragraph 0031), an exposed electrically conductive functional tip (38; Figure 3) at the distal end of the core (32), and an insultation layer (34; Paragraph 0031) over a portion of the core (32; Paragraph 0031; Figures 1-4), the insulation layer (34; Figure 3) comprising a first thickness (46; Figure 3) over a proximal portion of the core (32) and a second thickness (42) over the distal portion of the core (32), wherein the first thickness (46) is greater than the second thickness (42) (Figure 3; Paragraph 0033), wherein the greater thickness (48) provides enhanced protection from radiofrequency energy exposure during handling (Paragraph 0033, wherein the Examiner notes that a thicker insulating layer would inherently have enhanced energy protection than a thinner insulating layer formed of the same material and there is nothing in Medhkour to suggest that portion 42 is formed of a different material than portion 48 in Figure 3 and Paragraphs 0031-0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the insulation layer of Urbanski to include the variable thickness teachings of Medhkour, for the advantage of providing varying degrees of flexibility or suppleness to the distal end of perforation device (Paragraph 0033; Medhkour).
Regarding Claim 12, the combination of references disclosed above teaches the perforation device of claim 11, wherein Urbanski teaches the proximal portion has a first diameter (when the proximal portion is element 60 in Figure 6) and the distal portion (42) has a second diameter that is greater than the first diameter (60) (see Figure 6; Paragraph 0052).
Regarding Claim 14, the combination of references disclosed above teaches the perforation device of claim 11, wherein Urbanski teaches the proximal (32) and distal portions (42) of the core have substantially the same diameter (see Figure 4, 6, and 7).
Regarding Claim 15, the combination of references disclosed above teaches the perforation device of claim 11, wherein Urbanski teaches the perforation device is substantially isodiametric along substantially the entire length of the core (see Figure 4 and see Figure 7).
Regarding Claim 16, the combination of references disclosed above teaches the perforation device of claim 11, wherein Urbanski teaches the proximal (32) and distal portions (42) of the core are mechanically attached together at a joint, and wherein the proximal and distal portions of the core are attached by laser welding, friction welding, brazing, soldering, or adhesive bonding (Paragraph 0044).
Regarding Claim 19, the combination of references disclosed above teaches the perforation device of claim 11, wherein Urbanski teaches the perforation device is configured to be operatively coupled to a radiofrequency generator for delivery of radiofrequency energy to the functional tip 36; Figure 32).
Regarding Claim 20, Urbanski teaches a method of making a perforation device for transseptal access system, the method comprising:
providing an electrically conductive core (32, 34; Figure 2; Paragraph 0037) comprising a proximal portion (32) having a proximal portion length (Figure 2), and a distal portion (42) having a distal portion length (Figure 2), wherein the proximal portion (32) is formed from a first material having a first modulus of elasticity (e.g. steel or titanium; Paragraph 0037), and the distal portion is formed from a second material (nitinol; Paragraph 0037) having a second modulus of elasticity that is lower than the first modulus of elasticity (Paragraph 0037 the distal is lower than the proximal so that the proximal can push and the distal can flex and bend);
securing an exposed electrically conductive functional tip (36; Paragraph 0032) at a distal end of the core (42; Figure 2); and
securing an insulation layer (48) over a portion of the core (32, 42, Paragraph 0032).
wherein the insulation layer (48) has a first thickness over the proximal portion (32) of the core, and the insulation layer (48) has a second thickness over the distal portion (42) of the core.
Urbanski fails to disclose:
wherein the first thickness is greater than the second thickness
wherein the greater thickness provides enhanced protection from radiofrequency energy exposure during handling.
Medhkour teaches an apparatus for delivering RF energy comprising an electrically conductive core (32; Figure 1-2; Paragraph 0031), an exposed electrically conductive functional tip (38; Figure 3) at the distal end of the core (32), and an insultation layer (34; Paragraph 0031) over a portion of the core (32; Paragraph 0031; Figures 1-4), the insulation layer (34; Figure 3) comprising a first thickness (46; Figure 3) over a proximal portion of the core (32) and a second thickness (42) over the distal portion of the core (32), wherein the first thickness (46) is greater than the second thickness (42) (Figure 3; Paragraph 0033), wherein the greater thickness (48) provides enhanced protection from radiofrequency energy exposure during handling (Paragraph 0033, wherein the Examiner notes that a thicker insulating layer would inherently have enhanced energy protection than a thinner insulating layer formed of the same material and there is nothing in Medhkour to suggest that portion 42 is formed of a different material than portion 48 in Figure 3 and Paragraphs 0031-0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the insulation layer of Urbanski to include the variable thickness teachings of Medhkour, for the advantage of providing varying degrees of flexibility or suppleness to the distal end of perforation device (Paragraph 0033; Medhkour).
Claim(s) 8, 9, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski and Medhkour, as applied to claim 1 and 11 above, and further in view of Ogata (US PGPub 2016/0235463)
Regarding Claim 8, 9, 17, and 18, Urbanski teaches the perforation device of claim 1/11, wherein but fails to explicitly teach the first material is a tungsten copper alloy or a molybdenum copper alloy (Claims 8 and 17), and the second material is a copper cladded stainless steel or a platinum core stainless steel (Claim 9 and 18).
Urbanski does teach that the first and second material can be different (Paragraph 0037; Urbanski) but fails to teach the specific alloys claimed.
Ogata teaches a core wire configured to be coupled to a radiofrequency generator (abstract) wherein “the core wire 12(1) is constructed of a conductive material, such as stainless steel, copper, Nitinol, Elgiloy, platinum, MP35N silver, tantalum, titanium, tungsten, or any combination thereof, although other conductive materials in other combinations may be utilized.” (Paragraph 0025).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the materials of the core portions taught by Urbanski with the materials as taught by Ogata, 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, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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