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 .
Priority
This application is a continuation of US Application no. 17/357,991, now US Patent no. 12,232,802 filed 25 June 2021, which is a continuation of US Application no. 16/466,934, now US Patent no. 11,071,584 filed 5 June 2019, which is a national stage entry of PCT/US2017/064225 filed 1 December 2017, which claims the benefit of domestic priority from US Provisional Application no. 62/432,045 filed 9 December 2016.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite that the balloon is comprised of a compliant material. However, the originally filed disclosure describes the balloon as being formed from a non-compliant material (para 56) which directly contradicts the requirement of the claims. Accordingly, the disclosure fails to provide adequate written description for the subject matter of claims 6 and 16.
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, 4-7, 11, and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham et al. (US Publication no. 2016/0374754 – disclosed by Applicant), in view of McDaniel (US Patent no. 8,728,073 – disclosed by Applicant), further in view of Paul et al. (US Patent no. 9,289,606 – disclosed by Applicant).
In regard to claim 1, Asirvatham et al. discloses an ablation balloon comprising (referencing figure 3c): a bulbous shaped proximal portion 371 (para 93); a longitudinally extending distal portion 375 (para 94) coupled to the bulbous shaped 371 proximal portion; and at least one ablation element 376 configured to deliver ablation energy to target tissue in contact with at least a portion of the ablation balloon (para 96).
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Asirvatham et al. is considered to demonstrate an ablation balloon with the same function of the claimed invention and generally shaped in the manner as claimed, however the proximal portion is bulbous and not “semi-spherical” as claimed.
McDaniel teaches an ablation balloon having a spherical balloon section 1223 as described in relation to figures 12A,B (col 34 lines 35-64).
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It would have been obvious to one of ordinary skill in the art to modify the bulbous proximal section of Asirvatham et al. with a spherical/semi-spherical configuration taught by McDaniel, since McDaniel demonstrates that such a configuration was a known balloon geometry for providing an enlarged proximal balloon surface for engaging an ablation balloon to an anatomical ostium while permitting the reduced diameter intermediate section to extend within the target vessel. Such modification would have involved the use of an known suitable alternative balloon geometry to expand and abut the pulmonary vein ostium and atrial back wall in a predictable manner.
Asirvatham et al. in view of McDaniel are considered to suggest the invention as claimed, however neither disclose that the ablation energy is laser energy. Paul et al. describe an ablation catheter with an expandable section, wherein Paul et al. teach that ablative energy can be in the form of radiofrequency energy, cryoablation, lasers, chemicals, or high-intensity ultrasound (col 1 lines 31-36). This demonstrates that laser ablation is a suitable alternative equivalent modality for delivering ablation energy as in Asirvatham et al. and McDaniel. Further, Paul et al. teach that the laser ablation is applied from a laser diode source (col 20 lines 38-40). It would have been obvious to one of ordinary skill in the art to modify the ablation element of Asirvatham et al. to employ laser energy technique as suggested by as a known alternative energy modality for producing tissue ablation. It is further considered to have been obvious to one of ordinary skill in the art to modify the electrodes of Asirvatham et al. into laser diodes as taught by Paul et al. as it would comprise the substitution of a known element for another.
In regard to claim 4, figure 3C of Asirvatham et al. as modified by McDaniel shows the semi-spherical proximal portion 371 has a first circumference and the longitudinally extending distal portion has a second circumference, and wherein the first circumference is larger than the second circumference.
In regard to claim 5, Asrivatham et al. explicitly teaches longitudinally extending distal portion 375 is configured to engage with an ostium of the pulmonary vein 118 (para 90, 93, 94).
In regard to claim 6, Asirvtham et al. is silent with respect the material of the balloon. McDaniel teaches that the balloon comprises a compliant material (col 14 lines 38-42). It is considered to have been obvious to one of ordinary skill in the art to modify the balloon of Asirvatham et al. to comprise compliant material since it is explicitly taught by the McDaniel as being a suitable material, wherein it has been held as obvious to one of ordinary skill to select a known material based on its suitability for the intended use as a matter of obvious design choice.
In regard to claim 7, figure 3C of Asirvatham et al. comprises a catheter shaft 373 coupled to a proximal end of the proximal portion.
In regard to claim 8, Asrivatham et al. teaches that the longitudinally extending distal portion is configured to overcome a biasing force exerted upon the ablation balloon by the catheter shaft by engaging with an ostium of the pulmonary vein to overcome the biasing force (the inflated state of the balloon in Asirvatham et al. is considered to provide a biasing force between the balloon and wall of the pulmonary vein).
In regard to claim 11, Asirvatham et al. discloses an ablation balloon comprising (referencing figure 3c): a catheter shaft 373; and ablation balloon 370 comprising a bulbous shaped proximal portion 371 (para 93); a longitudinally extending distal portion 375 (para 94) coupled to the bulbous shaped 371 proximal portion; and at least one ablation element 376 configured to deliver ablation energy to target tissue in contact with at least a portion of the ablation balloon (para 96).
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Asirvatham et al. is considered to demonstrate an ablation balloon with the same function of the claimed invention and generally shaped in the manner as claimed, however the proximal portion is bulbous and not “semi-spherical” as claimed.
McDaniel teaches an ablation balloon having a spherical balloon section 1223 as described in relation to figures 12A,B (col 34 lines 35-64).
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It would have been obvious to one of ordinary skill in the art to modify the bulbous proximal section of Asirvatham et al. with a spherical/semi-spherical configuration taught by McDaniel, since McDaniel demonstrates that such a configuration was a known balloon geometry for providing an enlarged proximal balloon surface for engaging an ablation balloon to an anatomical ostium while permitting the reduced diameter intermediate section to extend within the target vessel. Such modification would have involved the use of an known suitable alternative balloon geometry to expand and abut the pulmonary vein ostium and atrial back wall in a predictable manner.
Asirvatham et al. in view of McDaniel are considered to suggest the invention as claimed, however neither disclose that the ablation energy is laser energy. Paul et al. describe an ablation catheter with an expandable section, wherein Paul et al. teach that ablative energy can be in the form of radiofrequency energy, cryoablation, lasers, chemicals, or high-intensity ultrasound (col 1 lines 31-36). This demonstrates that laser ablation is a suitable alternative equivalent modality for delivering ablation energy as in Asirvatham et al. and McDaniel. Further, Paul et al. teach that the laser ablation is applied from a laser diode source (col 20 lines 38-40). It would have been obvious to one of ordinary skill in the art to modify the ablation element of Asirvatham et al. to employ laser energy technique as suggested by as a known alternative energy modality for producing tissue ablation. It is further considered to have been obvious to one of ordinary skill in the art to modify the electrodes of Asirvatham et al. into laser diodes as taught by Paul et al. as it would comprise the substitution of a known element for another.
In regard to claim 14, figure 3C of Asirvatham et al. as modified by McDaniel shows the semi-spherical proximal portion 371 has a first circumference and the longitudinally extending distal portion has a second circumference, and wherein the first circumference is larger than the second circumference.
In regard to claim 15, Asrivatham et al. explicitly teaches longitudinally extending distal portion 375 is configured to engage with an ostium of the pulmonary vein 118 (para 90, 93, 94).
In regard to claim 16, Asirvtham et al. is silent with respect the material of the balloon. McDaniel teaches that the balloon comprises a compliant material (col 14 lines 38-42). It is considered to have been obvious to one of ordinary skill in the art to modify the balloon of Asirvatham et al. to comprise compliant material since it is explicitly taught by the McDaniel as being a suitable material, wherein it has been held as obvious to one of ordinary skill to select a known material based on its suitability for the intended use as a matter of obvious design choice.
In regard to claim 17, figure 3C of Asirvatham et al. comprises a catheter shaft 373 coupled to a proximal end of the proximal portion.
In regard to claim 18, Asrivatham et al. teaches that the longitudinally extending distal portion is configured to overcome a biasing force exerted upon the ablation balloon by the catheter shaft by engaging with an ostium of the pulmonary vein to overcome the biasing force (the inflated state of the balloon in Asirvatham et al. is considered to provide a biasing force between the balloon and wall of the pulmonary vein).
Claim(s) 2, 3, 9, 10, 12, 13, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham et al. (US Publication no. 2016/0374754 – disclosed by Applicant), in view of McDaniel (US Patent no. 8,728,073 – disclosed by Applicant) and Paul et al. (US Patent no. 9,289,606 – disclosed by Applicant), further in view of Warnking et al. (US Patent no. 8,974,445 – disclosed by Applicant).
In regard to claims 2 and 12, Asirvatham et al. in view of McDaniel and Paul et al. suggest the invention as claimed, however none teach that the balloon further comprising an intermediate portion located between the semi-spherical proximal portion and the longitudinally extending distal portion, the intermediate portion having a varying diameter. Warnking et al. discloses an expandable balloon on the end of a catheter 30 that is capable for use to ablate tissue in or near the pulmonary artery (col 12 lines 32-45). The balloon 50 of Warnking et al. depicted in figure 3 with a semi-spherical portion 54 comprising a first diameter, and a semi-spherical proximal portion 52 comprising a second diameter greater than the first diameter. Figure 3 of Warnking et al. also shows intermediate section 60 coupled between the proximal 52 and distal 54 portions, wherein the diameter varies along the longitudinal axis of the medical device balloon.
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It would have been obvious to one of ordinary skill in the art to modify the balloon structure described by Asirvatham et al. in view of McDaniel and Paul et al. to include a varying diameter intermediate portion as taught by Warnking et al. in order to provide a gradual transition between the larger proximal portion and reduced diameter distal portion to provide a smooth transition between balloon sections to enhance conformity of the balloon to surrounding tissue.
In regard to claims 3 and 13, Asirvatham et al. alone or as modified includes an enlarged proximal portion 371 that extends circumferentially around the vein opening and is configured to contact surrounding antral/atrial tissue thereby providing continuous circumferential engagement with tissue around the vein.
In regard to claims 9 and 19, the structural configuration of Asirvatham et al. as shown in figure 3C and as modified by McDaniel is capable of the intended use for at least one of the semi-spherical proximal portion 371 and/or the intermediate portion 375 is configured to engage with an uninterrupted length and circumference of an antrum of a pulmonary vein, and the longitudinally extending distal portion 375 is configured to engage with an ostium of the pulmonary vein as enlarged proximal portion 371 that extends circumferentially around the vein opening and is configured to contact surrounding antral/atrial tissue thereby providing continuous circumferential engagement with tissue around the vein. The longitudinally extending distal portion 375 is also shown to extend through the vein into the vein ostium.
In regard to claims 10 and 20, the structural configuration of Asirvatham et al. as shown in figure 3C and as modified by McDaniel is considered configured to minimize and unify wall stress along a circumference of pulmonary vein tissue. the limitations recited here are considered functional language descriptive merely of the intended use of the invention without further limiting structure. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The structures of both McDaniel and Warnking et al. are also considered capable of achieving this result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rizq et al. (US 2011/0270238 – disclosed by Applicant) presents a balloon shape with a semi-spherical proximal end and is depicted in figures 5A,B. However, the balloon structure lacks ablation elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 21 August 2026
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