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 with traverse of Group I, claims 1-17, in the reply filed on May 22nd, 2026 is acknowledged. The traversal is on the ground(s) that “it would not be unduly burdensome for the Examiner to search and examine all of the claims present”. This is not found persuasive because Group I, claims 1-17, is directed toward an apparatus classified in A61B18/02, and Group II, claims 18-20, is directed toward a method of manufacturing, classified in A61B17/00. Further Group II, Claims 18-20, does not require all of the limitations of the apparatus claim (e.g. a vacuum circuit; an insulated portion, wherein the vacuum circuit runs through the insulated portion between the return tube and an insulating shaft), therefore the process as claimed can be used to make another and materially different product (e.g. a cryoablation probe that does not comprise a vacuum circuit for insulation).
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 6-7, 10-12, 14, & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Milder (US 5423807 A), hereinafter “Milder”, in view of Ramadhyani et al. (US 20210045794 A1), and hereinafter “Ramadhyani”.
Regarding claim 1, Milder discloses a cryoablation probe comprising: a working fluid circuit ([Col. 8, lines 24-50]; Figure 15—element 136); and a shaft ([Col. 8, lines 24-50]; Figures 15 & 16—element 130), the shaft comprising: a supply tube ([Col. 8, line 38-50] & [Col. 9, lines 20-36]; Figure 16—element 140); a return tube surrounding the supply tube ([Col. 8, line 38-50] & [Col. 9, lines 20-36]; Figure 16—element 142); and an expansion chamber, wherein fluid from the working fluid circuit travels through the supply tube and expands in the expansion chamber ([Col. 8, line 38-68] & [Col. 9, lines 20-36]; Figure 16—element 144; the examiner is considering the expansion chamber to be the interior lumen of the boiling chamber 144); a distal tip configured to seal a distal end of the return tube ([Col. 8, line 38-68] & [Col. 9, lines 20-36]; Figure 16—element 144; the examiner is considering the distal tip to be the boiling chamber 144), the distal tip comprising: a tip portion extending distally from the distal end of the return tube ([Col. 8, line 38-68] & [Col. 9, lines 20-36]; Figure 16—element 144); a plug portion configured to be inserted inside of the return tube ([Col. 8, lines 50-68]; Figure 16—elements 146/148); and a compressive element surrounding the return tube and the plug portion of the distal tip, configured to seal the distal tip to the return tube ([Col. 8, lines 50-68]; Figure 16—element 150).
Milder does not disclose a vacuum circuit; an insulated portion, wherein the vacuum circuit runs through the insulated portion between the return tube and an insulating shaft; the expansion chamber extending distally to the insulated portion.
Ramadhyani teaches a cryoablation probe comprising a supply tube ([0030] & [0032]; Figure 1—element 152), a return tube surrounding the supply tube ([0019], [0020], & [0032]; Figure 1—element 201), an expansion chamber ([0036]; Figure 1—element 156), a vacuum circuit ([0049]; Figure 4—element 182), and an insulated portion ([0019] & [0041]; Figure 1—elements 170/180), wherein the vacuum circuit runs through the insulated portion between the return tube and an insulating shaft ([0019], [0020], [0041], & [0049]; Figure 1—elements 180, 201, & 202); the expansion chamber extending distally to the insulated portion ([0036], [0041], & [0049]; Figure 1—elements 156 & 180).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the cryoablation probe, as disclosed by Milder, to include a vacuum circuit, an insulated portion, wherein the vacuum circuit runs through the insulated portion between the return tube and an insulating shaft, and the expansion chamber extending distally to the insulated portion, as disclosed by Ramadhyani, as both references and the claimed invention are directed toward cryoablation probes comprising distal expansion chambers. As disclosed by Milder, it is important to contain the cryogenic liquid while it boils only at the tip in order to prevent chilling of the return tube which can freeze unintended vasculature ([Col. 9, lines 20-36]). As disclosed by Ramadhyani, a vacuum can be actively drawn into a chamber defined by the return tube and an insulating shaft so as to define a thermally insulated region, such that the region is thermally insulated from the cryogen in the return tube in order to insulate portions of the patients other than a target site where a cryoablation procedure is performed ([0019], [0020], [0041]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cryoablation probe, as disclosed by Milder, to include a vacuum circuit, an insulated portion, wherein the vacuum circuit runs through the insulated portion between the return tube and an insulating shaft, and the expansion chamber extending distally to the insulated portion, as disclosed by Ramadhyani, as such a modification would aid in insulating portions of the patients other than a target site where a cryoablation procedure is performed.
Regarding claim 2, Milder in view of Ramadhyani disclose all of the limitations of claim 1, as described above.
Milder further discloses wherein at least a portion of the plug portion has a first portion that has a diameter that is larger than an inner diameter of the return tube and wherein the compressive element is a ring ([Col. 8, lines 50-68]; Figure 16—elements 146/148 & 150; the plug 146 having an outer diameter greater than the inner diameter of return tube 142 provides a seal around the neck; the compressive element 150 may be a solid, flat, metal ring).
Regarding claim 3, Milder in view of Ramadhyani disclose all of the limitations of claim 2, as described above.
Milder further discloses the plug portion comprising a neck section having a minimum neck diameter and a base section having a minimum base diameter, wherein the base section is located proximally to the neck section along the return tube, wherein the minimum neck diameter is smaller than the inner diameter of the return tube, and wherein the base section includes the first portion having a diameter larger than the inner diameter of the return tube ([Col. 8, lines 50-68]; Figure 16—elements 146/148; see figure below; the plug 146 having an outer diameter greater than the inner diameter of return tube 142 provides a seal around the plug; the examiner is considering the base section comprising the first portion to be the proximal portion of the plug 146 comprising the proximal most barb 148 (which is shown as comprising a diameter that is larger than the inner diameter of the return tube 142), and the neck section to be the distal portion of the plug 146 without barbs 148 (which is shown as comprising a diameter that is smaller than the inner diameter of the return tube 142); see figure below).
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Regarding claim 4, Milder in view of Ramadhyani disclose all of the limitations of claim 3, as described above.
Milder further discloses the plug portion comprising a first shoulder between the neck section and the base section ([Col. 8, lines 50-68]; Figure 16—elements 146/148; see figure below; the examiner is considering the first shoulder to be defined by a shoulder of a barb 148 that is located distally relative to the base barb).
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Regarding claim 6, Milder in view of Ramadhyani disclose all of the limitations of claim 3, as described above.
Milder further discloses the base section comprising a barb configured to form an interference fit with the return tube, wherein the first portion of the plug portion is the barb ([Col. 8, lines 50-68]; Figure 16—elements 146/148; see figure in above rejection of claim 3; the plug 146 having an outer diameter greater than the inner diameter of return tube 142 provides a compressive seal around the plug; the examiner is considering the base section comprising the first portion to be the proximal portion of the plug 146 comprising the proximal most barb 148 (which is shown as comprising a diameter that is larger than the inner diameter of the return tube 142).
Regarding claim 7, Milder in view of Ramadhyani disclose all of the limitations of claim 1, as described above.
Milder further discloses wherein a proximal end of the tip portion has a larger diameter than a distal end of the plug portion, and wherein the distal tip comprises a tip shoulder between the tip portion and the plug portion, wherein a distal end of the return tube abuts the distal tip at the tip shoulder ([Col. 8, lines 37-68]; Figure 16—elements 142, 144, & 146; see figure below the examiner is considering the proximal end of the distal tip to be the proximal end of the boiling chamber 144 that extends just distal to the return tube 142 (and is portrayed as having a larger diameter than the return tube 142), and the tip shoulder to be the shoulder between the proximal end of the boiling chamber 144 and the plug 146 (which is portrayed as abutting the return tube 142)).
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Regarding claim 10, Milder in view of Ramadhyani disclose all of the limitations of claim 2, as described above.
Milder further discloses wherein the ring comprises a metal ring ([Col. 8, lines 50-68]; Figure 16—element 150; the compressive element 150 may be a solid, flat, metal ring).
Regarding claim 11, Milder in view of Ramadhyani disclose all of the limitations of claim 1, as described above.
Milder further discloses wherein the compressive element is a compressive wrap surrounding the return tube and the plug portion of the distal tip, configured to seal the distal tip to the return tube ([Col. 8, lines 50-68]; Figure 16—element 150; the compressive element 150 may be a conductive wire wrapped one or more times around return tube 142).
Regarding claim 12, Milder in view of Ramadhyani disclose all of the limitations of claim 11, as described above.
Milder further discloses the plug portion comprising a neck section having a neck diameter and a base section having a base diameter, wherein the base section is located proximally to the neck section along the return tube, wherein the neck diameter is smaller than an inner diameter of the return tube, and wherein the base diameter is equal to or larger than the inner diameter of the return tube ([Col. 8, lines 50-68]; Figure 16—elements 146/148; see figure below; the plug 146 having an outer diameter greater than the inner diameter of return tube 142 provides a seal around the plug; the examiner is considering the base section to be the proximal portion of the plug 146 comprising the proximal most barb 148 (which is shown as comprising a diameter that is larger than the inner diameter of the return tube 142), and the neck section to be the distal portion of the plug 146 without barbs 148 (which is shown as comprising a diameter that is smaller than the inner diameter of the return tube 142); see figure below).
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Regarding claim 14, Milder in view of Ramadhyani disclose all of the limitations of claim 12, as described above.
Milder further discloses the compressive wrap comprising a filament wrapped around the return tube and plug portion of the distal tip with a wrap threshold tension ([Col. 8, lines 50-68]; Figure 16—element 150; the compressive element 150 may be a conductive wire wrapped one or more times around return tube 142; the examiner is considering “a wrap threshold tension” to be the tension required to tightly squeeze the return tube 142 against plug 146).
Regarding claim 16, Milder in view of Ramadhyani disclose all of the limitations of claim 1, as described above.
Milder further discloses the tip portion comprising an atraumatic surface ([Col. 8, lines 37-68]; Figure 16—element 144; the tip portion 144 is shown as comprising a rounded distal surface).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Milder in view of Ramadhyani and Rosenblum et al. (US 9052045 B2), hereinafter “Rosenblum”.
Regarding claim 5, Milder in view of Ramadhyani disclose all of the limitations of claim 3, as described above.
Milder does not disclose the neck section comprising a protrusion configured to form a seal with the return tube, wherein the ring surrounds the protrusion.
Rosenblum teaches a plug portion ([Col. 3, lines 20-37]; Figures 1, 4A, & 4B—element 18) configured to be inserted inside of a tube ([Col. 3, lines 8-37]; Figures 1, 4A, & 4B—element 14), a compressive element comprising a ring configured to seal the plug portion and the tube ([Col. 3, lines 20-37]; Figures 1, 4A, & 4B—element 20), wherein the plug portion comprising a base section comprising a diameter that is larger than the inner diameter of the tube ([Col. 3, lines 49-67]; Figures 4A & 4B—element 24/30) and a neck section that comprises a minimum neck diameter that is smaller than the inner diameter of the tube ([Col. 3, lines 49-67]; Figures 4A & 4B—element 28); the neck section comprising a protrusion configured to form a seal with the return tube, wherein the ring surrounds the protrusion ([Col. 3, lines 49-67], [Col. 4, lines 25-65]; Figures 4A & 4B—elements 20 & 32; the neck section 28 comprises a raised peripheral seal 32).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the neck section of the plug portion, as disclosed by Milder, to include the neck section comprising a protrusion configured to form a seal with the return tube, wherein the ring surrounds the protrusion, as taught by Rosenblum, as both references and the claimed invention are directed toward sealed connections between a plug portion and tube portion to prevent leakage of fluid. As disclosed by Rosenblum, the neck section may comprise a raised peripheral seal that is adapted to engage the inner surface of the tube in order to aid in sealing the tube where it is fitted over the plug against egress of fluid from the tube that may be present in the tube under pressure ([Col. 4, lines 25-37]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the neck section of the plug portion, as disclosed by Milder, to include the neck section comprising a protrusion configured to form a seal with the return tube, wherein the ring surrounds the protrusion, as taught by Rosenblum, as such a modification would further aid in sealing the tube where it is fitted over the plug against egress of fluid from the tube that may be present in the tube under pressure.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Milder in view of Ramadhyani and Blake et al. (US 20210080043 A1), hereinafter “Blake”.
Regarding claim 8, Milder in view of Ramadhyani disclose all of the limitations of claim 7, as described above.
Milder does not disclose wherein a distal end of the compressive element surrounds the distal tip at the tip shoulder or distally to the tip shoulder.
Blake teaches a tip configured to seal a tube ([0047]; Figures 3B, & 6A-6B—elements 2 & 3),the tip comprising a plug portion configured to be inserted inside of the tube ([0054] & [0058]; Figures 3B, & 6A-6B—element 4), wherein the tube abuts a tip shoulder ([0072]; Figures 3B, & 6A-6B—element 22), a compressive element surrounding the tube and plug portion ([0047], [0050], & [0082]-[0085]; Figures 6A-6B—element 1) and wherein a distal end of the compressive element surrounds the tip at the tip shoulder or distally to the tip shoulder ([0091]; Figures 6A-6B—element 1 & 22).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the placement of the compressive element, as disclosed by Milder, to include wherein a distal end of the compressive element surrounds the tip at the tip shoulder or distally to the tip shoulder, as taught by Blake, as both references and the claimed invention are directed toward medical devices comprising sealed connections between a tube and a plug portion using a compressive element. As disclosed by Blake, the shoulder serves as a stop for insertion of the tube onto the plug, the compressive element may be positioned between the shoulder and the proximal end of the plug in order to retain the tube on the plug or alternatively the compressive element may enclose and grip the shoulder in order to better encapsulate the assembly ([0072]-[0076], [0089], & [0091]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the placement of the compressive element, as disclosed by Milder, to include wherein a distal end of the compressive element surrounds the tip at the tip shoulder or distally to the tip shoulder, as taught by Blake, as providing the compressive element with a distal end that surrounds the tip shoulder or distally to the tip shoulder is a known and suitable alternative to providing the compressive element with a distal end that is located between the tip shoulder and the proximal end of the plug, and further such a modification would better encapsulate the assembly.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Milder in view of Ramadhyani and McKay (US 20060284415 A1), hereinafter “McKay”.
Regarding claim 9, Milder in view of Ramadhyani disclose all of the limitations of claim 2, as described above.
Milder does not disclose wherein the ring comprises a swage ring.
McKay teaches a compressive element comprising a ring ([0023]; Figures 5 & 6—element 52) configured to seal a first tubular element ([0023]; Figures 5 & 6—element 50) to a second tubular element ([0023]; Figures 5 & 6—element 34a); wherein the ring comprises a swage ring ([0023]; Figures 5 & 6—element 52).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the compressive element comprising a ring, as disclosed by Milder, to include wherein the ring comprises a swage ring, as taught by McKay, as both references and the claimed invention are directed toward medical devices comprising sealed connections between two components. As disclosed by Milder, the plug portion and the return tube are connected in a sealed relationship via a compressive element comprising a solid, flat, metal ring ([Col. 8, lines 50-68]). As disclosed by McKay, the first tubular element and the second tubular element are mechanically coupled and sealed together via a swage ring ([0023]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the compressive element comprising a ring, as disclosed by Milder, to include wherein the ring comprises a swage ring, as taught by McKay, as such a modification would provide for a suitable and known compressive element ring that produces the predictable result of providing a sealed connection.
4. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Milder in view of Ramadhyani and Prescott et al. (US 2937892 A), hereinafter “Prescott”.
Regarding claim 13, Milder in view of Ramadhyani disclose all of the limitations of claim 12, as described above.
Milder does not disclose the plug portion comprising a ramp between the neck section and the base section, wherein a diameter of the plug portion increases over a length of the ramp moving in a proximal direction from the neck section to the base section.
Prescott teaches a plug portion configured to be inserted into a tube ([Col. 1, lines 46-51]; Figure 3—elements 10 & 22), the plug portion comprising a neck with a diameter that is smaller than an inner diameter of the tube ([Col. 1, line 52 – Col. 2, line 32]; Figure 3—element 16; the examiner is considering the neck to be the smallest diameter portion of tapered portion 16) and a base with a diameter that is equal to or larger than the inner diameter or the tube ([Col. 1, line 52 – Col. 2, line 32]; Figure 3—element 14; the examiner is considering the base to be the cylindrical portion 14 that comprises a diameter that is equal to the inner diameter of the tube 22); the plug portion comprising a ramp between the neck section and the base section, wherein a diameter of the plug portion increases over a length of the ramp moving in a proximal direction from the neck section to the base section ([Col. 1, line 52 – Col. 2, line 32]; Figure 3—element 16; the examiner is considering the ramp to be the tapered portion 16 extending from the smallest diameter portion (e.g. the neck) to the cylindrical portion 14 (e.g. the base)).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the plug portion including the base and the neck, as disclosed by Milder, to include the plug portion comprising a ramp between the neck section and the base section, wherein a diameter of the plug portion increases over a length of the ramp moving in a proximal direction from the neck section to the base section, as taught by Prescott, as both references and the claimed invention are directed toward devices comprising plug portions for sealing a tube. As disclosed by Milder, the plug portion is configured to make a fluid tight coupling with the tube ([Col. 8, lines 50-68]). As disclosed by Prescott, the plug portion may comprise a portion that is equal to the diameter of the tube and a reversely tapered portion this plug portion makes a fluid tight coupling that does not injure the tube so that the coupling can be removed and replaced and indefinite number of times ([Col. 1, line 52 – Col. 2, line 32]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the plug portion including the base and the neck, as disclosed by Milder, to include the plug portion comprising a ramp between the neck section and the base section, wherein a diameter of the plug portion increases over a length of the ramp moving in a proximal direction from the neck section to the base section, as taught by Prescott, as such a modification would provide for a suitable and know plug configuration that produces the predictable result of creating a fluid tight seal with a tube, and further would provide for a coupling that does not injure the tube so that the coupling can be removed and replaced and indefinite number of times.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Milder in view of Ramadhyani and Werner (US 7581762 B1), hereinafter “Werner”.
Regarding claim 15, Milder in view of Ramadhyani disclose all of the limitations of claim 14, as described above.
Milder does not disclose an adhesive configured to encapsulate the compressive wrap, wherein the adhesive is configured to maintain the wrap threshold tension of the filament.
Werner teaches a plug portion configured to seal a tube ([Col. 2, lines 35-50]; Figure 3—elements 11 & 12), a compressive wrap ([Col. 1, line 60 – Col. 2, line 7] & [Col. 2, lines 35-50]; Figure 3—element 13), and an adhesive configured to encapsulate the compressive wrap, wherein the adhesive is configured to maintain the wrap threshold tension of the filament ([Col. 2, lines 30-35] & [Col. 4, lines 19-25]; Figures 2-3—element 6; a layer of material 6, such as tape or other protective covering, may be placed over windings of wrap in order to protect the compressive wrap from abrasion, as the tape protects the wrap from abrasion it is the examiners position that the tape would aid in maintaining the wrap threshold tension of the filament).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the compressive wrap, as disclosed by Milder, to include an adhesive configured to encapsulate the compressive wrap, as taught by Werner, as both references and the claimed invention are directed toward devices comprising a plug configured to be received within a tube and a compressive wrap configured to seal the plug and the tube. As disclosed by Werner, a layer, such as tap may be placed over the compressive wrap in order to protect the compressive wrap from abrasion ([Col. 2, lines 30-35] & [Col. 4, lines 19-25]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the compressive wrap, as disclosed by Milder, to include an adhesive configured to encapsulate the compressive wrap, as taught by Werner, as such a modification would protect the compressive wrap from abrasion.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Milder in view of Ramadhyani and Oetiker (US 5031301 A), hereinafter “Oetiker”.
Regarding claim 17, Milder in view of Ramadhyani disclose all of the limitations of claim 1, as described above.
Milder does not disclose wherein a proximal end of the distal tip comprises one or more curved edges.
Oetiker teaches a tip comprising a plug portion configured to be inserted inside of a tube and configured to seal the tube ([Col. 3, line 40 -Col. 4, line 20] & [Col. 6, lines 7-30]; Figures 1 & 6—element 10), wherein a proximal end of the tip comprises one or more curved edges ([Col. 3, line 40 -Col. 4, line 20]; Figure 1—elements 25/26; the end 25 of the tip/plug 10 is rounded off at 26 in order to minimize damage to the tube).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the distal tip, as disclosed by Milder, to include wherein the proximal end of the tip comprises one or more curved edges, as taught by Oetiker, as both references and the claimed invention are directed toward devices comprising a sealed connection between a plug portion and tube. As disclosed by Oetiker the end of the plug portion may be rounded off in order to minimize damage to the tube ([Col. 3, line 40 -Col. 4, line 20]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the proximal end of the distal tip, as disclosed by Milder, to include wherein the proximal end of the tip comprises one or more curved edges, as taught by Oetiker, as such a modification would minimize damage to the tube when the plug is inserted therein.
Conclusion
Accordingly, claims 1-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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