DETAILED ACTION
The following is a Non-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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/6/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 1/6/2026.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
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 1-10 & 12-15 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.
Claim 1 recites the limitation “at least one radiopaque flag…comprising a sinusoidal shape converging to a point when the balloon is fully inflated”. The originally filed disclosure fails to provide support for “fully” inflated.
Claims 2-10 & 12-15 depend from claim 1 and are thus also rejected.
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) 1-2, 4, 10 & 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (2017/0042615, previously cited) in view of Schaer (EP1790304) and Maguire et al. (2003/0195496).
The Examiner notes that Salahieh et al. Par. [0278] teaches that “various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination”.
Concerning claims 1 & 10, as illustrated in at least Fig. 3A, 18J, 18P-R & 39C, Salahieh et al. disclose a balloon catheter (an inflatable and flexible spherically shaped balloon; Abstract), comprising:
a shaft configured for insertion into a heart of a patient (catheter/shaft 57; [0148], [0151]);
an inflatable balloon coupled to a distal end of the shaft, the balloon extending from a proximal balloon portion to a distal balloon portion to define an equator of the balloon about an axis extending from the proximal balloon portion to the distal balloon portion (spherical expandable membrane 34, such as a balloon; [0097], [0148], [0153], [0163], [0172]);
ten flexible substrates, which are disposed on the balloon radially about a center of the balloon, the ten flexible substrates extending from a distal end of the distal balloon portion of the balloon to a proximal end of the proximal balloon portion, each of the ten flexible substrates having its maximum width disposed proximate the equator of the balloon (ten flex circuits 89/branches 87, disposed radially around membrane 34, extend from a distal end of a distal balloon portion to a proximal end of a proximal end portion of membrane 34, flex circuits 89 having base substrates 52 and conductive pads 59 having maximum/wider surface areas of the flex circuits 89 that connect to electrodes 6 located proximate, or near, the equator of the membrane 34; [0097], [0154]); and
ten radiopaque flags, each radiopaque flag of the ten radiopaque flags being disposed on a respective flexible substrate of the ten flexible substrates adjacent to the equator of the balloon (radiopaque markers 58 can be added to conductive pads 59 that connect to electrodes 6, located equatorially on membrane 34, for visualization // or // radiopaque markers 58 can be in the shape of an “x” across electrodes 6, located equatorially on membrane 34, allowing for the center and edges of the electrodes to be pinpointed; [0227-0228]).
Salahieh et al. fail to disclose at least one radiopaque flag of the ten radiopaque flags comprising a sinusoidal shape when the balloon is inflated or each of the radiopaque flags to comprise a sinusoidal shape configured to fold in conformance with a corresponding flexible substrate of the ten flexible substrates as the inflatable balloon collapses into a sheath. However, Salahieh et al. disclose various embodiments of radiopaque shapes and patterns that can be used with balloon (34) for the visualization and orientation of the placement of the electrodes (6) onto the tissue as well as the overall shape of the expandable membrane structure (34) ([0227-0229]; Fig. 39A-E). Further, Schaer discloses a balloon comprising electrodes having a sinusoidal/serpentine shape when the balloon is inflated that provide the the electrode with a desired flexibility ([0089]). Maguire et al. further teach that materials of electrode and radiopaque marker materials used on an inflatable medical balloon can be the same ([0212]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the radiopaque markings of Salahieh et al. such that at least one radiopaque flag of the ten radiopaque flags comprises a sinusoidal shape or each of the radiopaque flags comprises a sinusoidal shape when the balloon is fully inflated and configured to fold in conformance with a corresponding flexible substrate of the ten flexible substrates as the inflatable balloon collapses into a sheath in order to provide the benefit of radiopaque markers with a desired flexibility as taught by Schaer in view of the teachings of Maguire et al. that materials of electrodes and radiopaque markers can be the same and since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Salahieh et al. in view of Schaer and Maguire et al. fail to disclose the sinusoidal shape converging to a point. However, Saab discloses a catheter comprising a radiopaque marking (96) that comprises a shape (triangle) that converges to a point such that the shape/point is configured to be a directional feature. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the radiopaque markings of Salahieh et al. in view of Schaer and Maguire et al. such that the sinusoidal shape converges to a point in order to provide the benefit of a directional feature as taught by Saab ([0037]; Fig. 5) and since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Concerning claim 2¸Salahieh et al. disclose ten electrodes (6), which are disposed over each of the respective ten flexible substrates (89); and irrigation pores (7) disposed over the balloon (34) and some of the irrigation pores (7) are distributed over areas covered with the electrodes (6), and others of the irrigation pores (7) are distributed between the areas covered with the electrodes (6) ([0097], [0210]; Fig. 18J & 37A-D)
Concerning claim 4¸Salahieh et al. disclose each of the electrodes (6) has its largest width proximate, or near, the equator of the balloon (39) and its smallest width proximate the distal balloon portion ([0227]; Fig. 5D).
Concerning claim 12, Salahieh et al. in view of Schaer, Maguire et al. and Saab disclose at least one radiopaque flag of the ten radiopaque flags comprises a portion having a rectangular shape, a longitudinal length of the rectangular shape being oriented perpendicular to the equator of the inflatable balloon ([0230]; Fig. 40A).
Concerning claim 13, Salahieh et al. disclose the inflatable balloon (34) comprises either a spherical shape or an oblong shape ([0163]).
Concerning claim 14, Salahieh et al. disclose a balloon advancer rod (46/134) disposed within an interior of the inflatable balloon (34), the balloon advancer rod (46/134) configured to switch the inflatable balloon (34) between the spherical shape and the oblong shape ([0015], [0167-169], [0263]; Fig. 61A-63C).
Concerning claim 15, Salahieh et al. disclose each flexible substrate (52) of the ten flexible substrates comprises a plurality of perforations (7) along an edge of each flexible substrate of the ten flexible substrates, the plurality of perforations configured to increase adhesion of each flexible substrate to the inflatable balloon (Fig. 37B & E). In the alternative, Salahieh et al. disclose each flexible substrate (52) of the ten flexible substrates comprises a plurality of perforations (53), the plurality of perforations configured to increase adhesion of each flexible substrate to the inflatable balloon ([0107]; Fig. 1D). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Salahieh et al. in view of Schaer, Maguire et al. and Saab such that the plurality of perforations are along an edge of each flexible substrate of the ten flexible substrates, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (2017/0042615, previously cited) in view of Schaer (EP1790304) and Maguire et al. (2003/0195496), as applied to claim 1, in further view of Harlev et al. (2017/0319172, previously cited).
Concerning claim 3¸ Salahieh et al. in view of Schaer, Maguire et al. and Saab fail to disclose a magnetic position sensor disposed on the shaft proximally to the balloon. However, Harlev et al. disclose a balloon catheter (104) comprising a shaft (122), a tip section (124), and a position sensor (130) disposed on the shaft (122) proximally to the tip section (124). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Salahieh et al. in view of Schaer, Maguire et al. and Saab to further comprise a magnetic position sensor disposed on the shaft proximally to the balloon in order to provide the benefit of determining the position of the distal portion of the catheter shaft as taught by Harlev et al. ([0074]; Fig. 2).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (2017/0042615, previously cited) in view of Schaer (EP1790304) and Maguire et al. (2003/0195496), as applied to claim 1, in further view of Hanson et al. (2015/0190195, previously cited).
Concerning claim 5¸ Salahieh et al. in view of Schaer, Maguire et al. and Saab fail to disclose a yarn disposed between the balloon and the flexible substrate. However, Hanson et al. disclose a balloon catheter (120) comprising a balloon (130), a flexible substrate (200) and a yarn (additional layer 400) disposed between the balloon (120) and the flexible substrate (130). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Salahieh et al. in view of Schaer, Maguire et al. and Saab to further comprise a yarn disposed between the balloon and the flexible substrate in order to provide the benefit of tear resistance as taught by Hanson et al. (Abstract, [0039], [0063-0064], [0078]; Fig. 4-6 & 8)
Concerning claim 6¸ Hanson et al. further disclose the yarn is selected from one of an ultra-high molecular weight fiber or a liquid crystal polymer fiber ([0063]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (2017/0042615, previously cited) in view of Schaer (EP1790304) and Maguire et al. (2003/0195496), as applied to claim 1, in further view of Lindquist et al. (2015/0005799, previously cited).
Concerning claim 7¸ Salahieh et al. in view of Schaer, Maguire et al. and Saab fail to disclose the flexible substrate comprises a patterned topography that is configured to increase adhesion of the flexible substrate to the balloon. However, Lindquist et al. disclose a balloon catheter (10) comprising a balloon (20), a flexible substrate (22), the flexible substrate (22) comprises a patterned topography that is configured to increase adhesion of the flexible substrate (22) to the balloon (20). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Salahieh et al. in view of Schaer, Maguire et al. and Saab such that the flexible substrate comprises a patterned topography that is configured to increase adhesion of the flexible substrate to the balloon in order to provide the benefit of improving adhesive adhesion of the flex circuit to the balloon as taught by Lindquist et al. ([0057]; Fig. 1).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (2017/0042615, previously cited) in view of Schaer (EP1790304) and Maguire et al. (2003/0195496), as applied to claim 2, in further view of Mathur et al. (2014/0266235, previously cited).
Concerning claim 8¸ Salahieh et al. in view of Schaer, Maguire et al. and Saab fail to specifically disclose each flexible substrate extends from the distal balloon portion to the proximal balloon portion and a width of the substrate, as measured parallel to the equator of the balloon, increases gradually from the distal balloon portion to the maximum width and decreases gradually near the proximal portion of the balloon. However, Mathur et al. disclose a balloon catheter (10) comprising a balloon (130) and a plurality of flexible substates (140/500), each flexible substrate (140/500) extends from a distal balloon portion to a proximal balloon portion and a width of the substrate (140/500), as measured parallel to an equator of the balloon (130), increases gradually from the distal balloon portion to the maximum width and decreases gradually near the proximal portion of the balloon. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Salahieh et al. in view of Schaer, Maguire et al. and Saab such that each flexible substrate extends from the distal balloon portion to the proximal balloon portion and a width of the substrate, as measured parallel to the equator of the balloon, increases gradually from the distal balloon portion to the maximum width and decreases gradually near the proximal portion of the balloon in order to provide the benefit of having an elongated portion on each of the proximal and distal ends for attachment to the balloon as taught by Mathur et al. ([0117]; Fig. 1 & 5A-B) and since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. The modified invention of Salahieh et al. in view of Schaer, Maguire et al., Saab and Mathur et al. teach each flexible substrate width gradually increasing from the distal balloon portion to its greatest width near the equator and gradually decreasing near the proximal portion of the balloon.
Claim 9 is rejected upon the same rationale as provided for claim 4.
Response to Arguments
Applicant’s arguments 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
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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