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 .
Claims 5, 7, 10-12, and 15-21 are cancelled. A complete action on the merits of pending claims 1-4, 6, 8, 9, 13, 14, and 22-31 appears herein.
Response to Arguments
Applicant's arguments filed 12/27/2025 have been fully considered but they are not persuasive.
Applicant argues “Applicant respectfully submits that not all elements are disclosed by the combination of references. In particular, the Office alleges that Turi teaches incorporating a pressure sensor into a piercing element to determine when the piercing element has fully pierced through the septum. Applicant respectfully submits that this is not what Turi teaches; rather, Turi does not disclose details of the transseptal crossing catheter, except to state that the same is used prior to deployment of the Turi system, and uses a (presumably standard, as details are undisclosed) transseptal needle (again, the needle usage is disclosed without any disclosure of pressure monitoring)”
Examiner respectfully disagrees and contends that, as further discussed in the rejection to claim 1 below, Turi teaches puncturing the interatrial septum with a transseptal needle device; wherein immediately after the puncture, the presence of the tip of the transseptal needle within the left atrium is confirmed by measuring the pressure sensed through the lumen of the transseptal needle. (Col. 7, Lines 45-59)
Applicant further argues “The Turi system incorporating the pressure sensor is part of the sheath 10 which is deployed after transseptal (TS) access is successfully achieved using the needle, and is notably disclosed without any use of pressure monitoring.”
Examiner respectfully disagrees, and contends that, as further discussed in the rejection to claim 1 below, Turi teaches measuring the pressure within a lumen of a transseptal needle to confirm placement of said needle in the left atrium. (Col. 7, Lines 45-59) Sensing the pressure through the needle lumen would require the pressure sensor be within or directly coupled to said needle lumen.
Applicant further argues “To see how pressure monitoring is used in Turi, it is important to note that the key aspect of Turi is its use of retaining means 16 to "hold" a portion of the sheath in the left atrium (LA). The Background of the Invention section in Turi lays out in significant detail the dangers of not doing so, particularly due to dangers occurring when the operative device inadvertently falls back into the right atrium (RA) (or in some cases never gets into the LA): In other words, it is key for Turi to deploy the retaining means in the LA and have the retaining means remain in the LA, not accidentally falling back into the RA, because if the retaining means accidentally fell back into the RA, it could not perform any desired retaining functionality in the LA - it would lose all of its disclosed function. And this is the reason for the pressure monitoring. It is used to ensure that the tip of the sheath, and thus deployment of the retaining means, is in the LA. Accordingly, what is measured is if the detected pressure (felt as transmitted through the catheter) measures appropriately for left atrial pressure (see below):”
Examiner respectfully contends that, while ensuring the retaining means is in the left atrium may be a reason for pressure monitoring via the sheath (10) of Turi, Turi further teaches measuring the pressure through the lumen of a transseptal needle to confirm said transseptal needle has successfully punctured through an interatrial septum and into the left atrium.
Applicant further argues “Pointedly, there is no disclosure of a sensor to monitor pressure during the septal crossing, i.e., actual left atrial access. Rather, such a sensor is only disclosed and used after such access has been achieved, and only as a way to determine catheter tip position, not whether access has occurred.
Examiner respectfully disagrees. The current language of claim 1 does not require a pressure sensor configured to monitor pressure during the septal crossing. The current claim language merely requires “a measurement device to measure a parameter associated with transseptal access, to provide real time feedback to an operator to define when transseptal access is achieved.” The pressure sensor of Turi, as further discussed in the rejection to claim 1 below, is a measurement device configured to measure a parameter associated with transseptal access, (the pressure within the transseptal needle lumen) to provide real time feedback to an operator to define when transseptal access is achieved. (Col. 7, Lines 45-59; The pressure measurements are used to confirm (define) when transseptal access is achieved, and would be considered real time during pressure monitoring.)
Applicant further argues “In contrast, the amended claim requires the same piercing element to (a) include an electrode using RF to create the septal hole and (b) incorporate a measurement device for real-time transseptal access feedback. No reference teaches co-locating RF heating and parameter sensing in the piercing element, as required. Thus, due to the lack of teaching of the piercing element having an RF electrode for TS access and incorporating a measurement device to measure a parameter associated with TS access, to provide real time feedback to an operator to define when TS access is achieved, Applicant respectfully submits that as even the combination of references does not disclose all elements of the claimed invention, the rejection of independent claim 1 should be withdrawn.”
Examiner respectfully contends that, as further discussed in the rejection to claim 1 below, Saadat teaches using an RF electrode for transseptal access and Turi, as discussed above, teaches measure a parameter associated with transseptal access, to provide real time feedback to an operator to define when TS access is achieved.
Applicant further argues “While the depth stops of Pedilla can be used to locate the position or depth of the optical fiber to ensure access through the endocardium, they differ from that claimed as amended, which is for a governor that inhibits movement of the piercing element past a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation.
Examiner respectfully disagrees and contends that, as further discussed in the rejection to claim 16 below, the depth stops of Padilla limit/inhibit movement of a translating member past a pre-specified point, (Col. 10, Lines 21-24) and would therefore avoid sudden exertion of the needle through the septum and subsequent perforation at least in a situation where the septum is disposed distally past the maximum translation distance allowed by the depth stop of Padilla.
Applicant further argues “In the Padilla case, there is relatively constant pressure or push-back against the movement of the optical fiber as it creates its revascularization channel, and all that is necessary is to ensure access is made to the blood pool, i.e., through the endocardium. The physician performing the procedure need only push against the finger slide, which is pre-set by knob 128 to only allow a certain channel of movement, from one point to another point. There is no change in pressure as the optical fiber moves under influence of the finger slide – simply a release once the blood pool is entered. In the present case, by contrast, the physician performing the procedure feels a rising pressure as the septum tents, and thus has to exert a greater pressure until access is made, at which point resistance goes to zero and continued momentum, heightened by the greater pressure, causes the danger of perforation and tamponade. That is why the governor is of importance in this embodiment, and is in part why the same differs between from Padilla. Padilla’s system limits movement to a particular back-and-forth range to create a channel of a given length, to ensure the endocardium is passed through. This contrasts with the present system, which as claimed provides a governor that only inhibits movement past a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation.
Examiner respectfully contends that the current claim language does not require a push-back or pressure change caused by movement of the needle. Regarding the governor, the current claim language of claim 16 merely requires “a governor that only inhibits movement past a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation.” As discussed above, the depth stops of Padilla limit/inhibit movement of a translating member past a pre-specified point, (Col. 10, Lines 21-24) and would therefore avoid sudden exertion of the needle through the septum and subsequent perforation at least in a situation where the septum is disposed distally past the maximum translation distance allowed by the depth stop of Padilla.
Applicant further argues “The stated reason to combine these references is that the combination would minimize the number of instruments that needed to be introduced/removed from the treatment zone. But Applicant submits that it is not clear how this would occur. The Gaiser system includes, as noted above, a standard needle TS access device, followed by use of the "main" Gaiser system with the electrodes for left atrial ablation. Even if the standard needle TS access system employed RF electrodes at the tip for septal access purposes, there would still be the need for the ablation electrode system which creates an “elongate, continuous, therapeutically effective ablated lesion without the need to move tip 18 along the target site.”
Examiner respectfully contends that, as further discussed in the rejection to claim 16 below, Rf electrodes were not placed on the TS access system of Gaiser in the rejection of claim 16 in the non-final rejection dated 08/25/2025. Instead, the RF electrodes in the “main” Gaiser system were configured to be able to apply RF energy to the septum a hole is created in said septum in addition to said electrode’s other functions. Therefore, the TS system of Gaiser would not be needed, and only the “main” Gaiser system need be introduced into the target treatment zone.
Applicant further argues “Critically, having the electrode at the tip would require the need to move the tip along the target site, negating the benefits, advantages, and very point of Gaiser. And neither reference provides any guidance on how to modify tip-based electrodes to affect tissue in the catheter axial direction (to access the septum) to provide multiple transverse ablation directions (i.e., a lesion) as required by Gaiser. There is no indication or even suggestion that the Gaiser system could be modified for anything beyond (RF ablation) lesion creation, and there is still further no indication that a TS needle system with RF electrodes could be modified to be enabled to create lesions via ablation. And thus two catheters would remain needed, with no benefit or predictability of success for the proposed combination.”
Examiner respectfully contends that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, as further discussed in the rejection to claim 16 below, Gasier teaches forming a transseptal access hole in a septum and a catheter configured to deliver RF energy to a target tissue. Saadat teaches using RF energy to pierce through a septal wall, thereby creating a hole in the septum.
Applicant further argues “Applicant initially notes that each reference solves a narrow, distinct issue in cardiac procedures, with no suggestion to integrate elements across them for an RF-piercing element with co-located measurement feedback (claim 1, or a combined RF/needle/governor element per claim 16) during transseptal access.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gasier teaches forming a transseptal access hole in a septum and a catheter configured to deliver RF energy to a target tissue. Saadat teaches using RF energy to pierce through a septal wall, thereby creating a hole in the septum. Turi teaches confirming the presence of a transseptal needle within the left atrium using a pressure sensor disposed within the lumen of the transseptal needle.
Applicant further argues “First, Applicant notes that a PHOSITA would not be motivated to selectively combine Saadat's optional RF electrode to modify Gaiser's mechanical puncture (which works fine for its ablation purpose) or add Turi's post-puncture sensor to a piercing element. The reason for this is that the references do not recognize the problem the current claim solves: unreliable real-time confirmation during RF-assisted puncture. Instead, they optimize separate stages (pre-puncture visualization in Saadat, puncture in Gaiser/Turi mechanically, post-puncture retention in Turi). Combining them would require recognizing a need for RF with integrated feedback, which is absent—making the rationale for combining only possible through impermissible hindsight (In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, as further discussed in the rejection to claim 1 below, Gasier teaches forming a transseptal access hole in a septum and a catheter configured to deliver RF energy to a target tissue. Saadat teaches using RF energy to pierce through a septal wall, thereby creating a hole in the septum. One of ordinary skill in the art would recognize that configuring the RF energy catheter of Gaiser to create the transseptal access hole would minimize the number of instruments required to be inserted into the patient. Turi teaches confirming the presence of a transseptal needle within the left atrium using a pressure sensor disposed within the lumen of the transseptal needle. Including the pressure sensor of Turi would allow for a user to easily confirm that the transseptal needle has reached the target tissue zone, as suggested in Turi. (Col. 5, Lines 47-59)
Applicant further argues “Second, Applicant respectfully submits that there must be evidence that the combination would yield a predictable result without undue experimentation. Here, modifying the Gaiser/Saadat system by adding Turi's sensor ignores that Turi's balloon (used for retention) is incompatible with Saadat's hood (which expands orthogonally and would clearly obstruct sheath advancement). In more detail, Saadat's visualization relies on an expandable hood (¶ [0180]) that deploys at the catheter tip for blood displacement, which would physically obstruct Gaiser's electrode catheter (10) extension or Turi's balloon inflation (Col. 3:15-25). Modifying Gaiser's sheath (8) to incorporate the hood would further requires "substantial redesign" (In re Ratti, 270 F.2d 810 (CCPA 1959)), as the hood's fluid infusion (¶ [0182]) conflicts with the dry (non-external-fluid-flowing) mechanical environments in Gaiser/Turi. Saadat teaches away from non-visualized modifications by emphasizing hood-centric feedback, not embedded piercing sensors. Therefore, a PHOSITA, reading these at the time of the invention, would see no reason to combine these together, as each works independently for its own purpose and would be highly difficult if not impossible to combine together in a single unit. Put another way, combining these would not just combine together elements that individually are performing their unique roles, but combining them together would eviscerate each’s reason for being, thus destroying their functionality, and thus the combination would not be obvious to the PHOSITA.
Examiner respectfully contends that neither the balloon of Turi or the hood of Saadat were relied on or discussed in the rejections to claims 1 and 16. Saadat was merely used to teach using RF energy to create a transseptal access hole. Turi was merely relied on to teach a pressure sensor disposed within a transseptal needle lumen and used to confirm placement of said needle in the left atrium of a patient.
Applicant further argues “Third, Applicant notes that the reasoning given to combine is “that the user can monitor and confirm when the distal tip (18) of Gaiser has fully pierced through the septum. Doing so would minimize the risk of only partially passing through the septum, providing a safer procedure.” Page 7 of Office Action, 3rd complete paragraph. However, Applicant reiterates that such cannot be a proper articulated reasoning as no reference has disclosed monitoring during passing through the septum – the only monitoring is in Turi, and it is post-crossing, for determining if the distal tip of the sheath is located in the LA, not for monitoring when the prior deployed Brockenbrough needle has passed through the septum.
Examiner respectfully contends that the current claim language of claim 1 merely requires real-time feedback to define when transseptal access is achieved, and does not require continuous pressure monitoring during passing through the septum. As further discussed in the rejection to claim 1 below, Turi teaches measuring pressure to confirm needle disposed in left atrium. (Col. 7, Lines 47-59) The determination of the needle being located within the left atrium would be considered real-time at least when pressure monitoring is occurring.
Applicant further argues “Moreover, even assuming, arguendo, monitoring was disclosed, it would not minimize the risk of only passing partially through the septum. As noted above, the user can feel the effects of the device as it is, e.g., tenting the septum – the pressure is generally rising. The risk is not that only partial access is present; rather, the risk is present when the device is all the way through the septum and may potentially perforate tissue that it should not. Applicant has added claim language to make this distinction even more clear.”
Examiner respectfully contends that, as further discussed in the rejection to claim 16 below, incorporating the pressure sensor of Turi would allow for confirmation that the needle is located in the target heart chamber, as suggested in Turi, (Col. 7, Lines 47-59) and would thereby minimize the risk of only passing partially through the septum. Furthermore, the depth stops of Padilla limit/inhibit movement of a translating member past a pre-specified point, (Col. 10, Lines 21-24) and would therefore avoid perforation of a nontarget tissue at least in a situation where the nontarget tissue is disposed distally past the maximum translation distance allowed by the depth stop of Padilla.
Applicant further argues “Finally, Applicant submits that the combination has no reasonable expectation of success because the devices are in several ways incompatible. In particular, integrating Saadat's RF into a piercing element with Turi's pressure sensor (on Gaiser's base) is inherently incompatible, as RF heating inherently clashes with sensor patency, rendering the device unpredictable or inoperable. In more detail, Saadat's RF "energizable probe" causes tissue "ablation or modification" via heat (¶ [0227]), leading to charring (carbonized tissue) and coagulation (clotting). Turi's pressure sensor requires fluid patency through the needle lumen (Col. 7:47-59: "monitoring the pressure sensed through the transseptal needle lumen"). Turi’s pressure confirmation depends on unobstructed fluid communication through the needle lumen to detect a left atrial waveform; colocating RF perforation at that tip introduces localized heating and coagulum that risks occluding the pressure opening. A tip-mounted pressure sensing port (as proposed) would clog with char/clots during RF puncture, invalidating real-time feedback (i.e., no accurate pressure reading would be achieved to indicate presence of the tip in the left atrium). No reference resolves this—Gaiser's RF is non-piercing (Col. 6:21-26), Turi's sensor is mechanical-only, Saadat's sensors are hood-based (¶ [0183]). That the cited art does not recognize or resolve this conflict undermines any reasonable expectation of success in the proposed combination. A PHOSITA would not only be unable to predict success, but in fact would expect failure, as RF heat (typically 50-100°C) denatures proteins, occluding ports. Absent teaching to resolve this incompatibility, the modification would degrade or defeat the intended sensing function, undermining a “reasonable expectation of success. Because the cited art does not disclose or suggest a single component that combines RF perforation with co-located parameter sensing for real time access determination—and because the proposed combination would be inoperable or at least unpredictable in the absence of guidance to resolve sensing/occlusion conflicts and other issues noted above, —the §103 rejection should be withdrawn for claims reciting the integrated RF piercing/pressure feedback limitation, namely claim 1 and its dependents.”
Examiner respectfully contends that one of ordinary skill in the art would be able to combine the teachings of Gaiser, Saadat, and Turi, as discussed in the rejection to claim 16 below, in such a way as to overcome the potential issue of a clogged needle port. For example, providing a component to determine a clog is present and/or unclog said needle port if necessary, or providing a secondary lumen for suction/evacuation to draw debris away from the needle lumen during RF puncture.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the metallic band of claims 4, and 31 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 22, 29, and 30 are objected to because of the following informalities:
The term “radioopaque” should read --radiopaque--
Appropriate correction is required.
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.
Claim 23 is 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 claim current recites therein “wherein the governor that inhibits movement of the piercing element past a pre-specified pint is similar to that used to extend the point of a ball point pen.” It is the Examiner’s position that this limitation as not described in the specification in such a way as to reasonably convey to one skill in the relevant art that the inventor or joint inventor, or for applications subject to pre-AIA 35.U.S.C. 112, the inventor(s), at the time the application as filed, had possession of the claimed invention.
Looking to the filed Specification, the limitation of “a governor” is only discussed in paragraph [0057], which merely recites “In some implementations, a governor 81 or other means may be implemented to inhibit movement of the cutting element past a pre-specified point. In this way, a significant safety factor is added.” Examiner notes that the same paragraph ([0057]) of the filed Specification further recites “The mechanism that pushes the needle may be similar to those used to extend the point of a ball point pen (and to retract the same as well).” However, as best understood by examiner, there is no discussion/recitation in the Specification that the governor pushes/retracts the needle. It appears that the component supported by the filed Specification to be “similar to those used to extend the point of a ball point pen (and to retract the same as well)” is “the mechanism” and not the governor. There is no teaching that the mechanism is a component of the governor, or that the governor is a component of the mechanism. Neither the Specification nor Drawings provide sufficient disclosure to show that Applicant was in possession of the invention set forth in claim 23. The disclosure appears to be simply making a blanket statement that a movement mechanism, separate from the governor, is similar to a structure in a ball point pen without describing/disclosing how the two structures are alike.
As such, it is for at least the reasoning set forth above that claim 23 fails to comply with the written description requirement.
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 23 is 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.
The term “similar” in claim 23 is a relative term which renders the claim indefinite. The term “similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, any governor comprising a structural element, function, mode of use, or result that would have any overlap with that of a governor used to extend the point of a ball point pen is interpreted as reading on the claim.
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) 1-3, 8, 9, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Turi (US 5,312,341).
Regarding claim 1, Gaiser teaches
an ablation element (Fig. 1, Char. 18: tip; Col. 6, Lines 21-26) attached to a distal tip of a tubular member (Fig. 1, Char. 10: electrode catheter) configured to move within an elongated member, (Col. 4, Lines 35-37: electrode catheter (10) slides within sheath (8)), ablation element is configured to be advanced distally or proximally, (Col. 4, Lines 35-37) wherein the ablation element incorporates radiofrequency energy to create a hole in the septum or to reduce an amount of force necessary to create a hole in the septum, (Col. 6, Lines 21-26: The ablative energy delivered by RF electrode (24) can be used to create a hole in any tissue if desired by a user, including a septum).
Gaiser further teaches a piercing element configured to pierce the septum of the heart, wherein the piercing element further incorporates a needle configured to mechanically pierce the septum; (Col. 3, Lines 8-15) wherein the electrode catheter (10) and distal tip (18) are passed through a punctured hole in the septal wall. (Col. 2, Lines 37-41)
Gaiser, as applied to claim 1 above, is silent regarding the ablation element comprising the piercing element; and wherein the piercing element further incorporates a measurement device to measure a parameter associated with transseptal access, to provide real time feedback to an operator to define when transseptal access is achieved, and wherein the distal tip includes a radiopaque marker to allow visualization of the distal tip under fluoroscopy.
Saadat, in a similar field of endeavor, teaches a needle configured to deliver RF energy to ablate a target tissue. (Par. [0187])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gaiser, as applied to claim 1 above, to incorporate the teachings of Saadat, and configure the tip (18) of Gaiser to comprise a needle at the distal most end of said tip (18), such that said needle is configured to mechanically pierce the septum. Doing so would be a simple substitution of one septal hole creation mechanism for another for the predictable result of creating a hole in a septum through which the catheter (10) of Gaiser can be passed through, and would minimize the number of devices that need to be inserted/removed from the target treatment site.
The combination of Gaiser/Saadat, as applied to claim 1 above, is silent regarding wherein the piercing element further incorporates a measurement device to measure a parameter associated with transseptal access, to provide real time feedback to an operator to define when transseptal access is achieved, and wherein the distal tip includes a radiopaque marker to allow visualization of the distal tip under fluoroscopy.
Turi, in a similar field of endeavor, teaches incorporating a pressure sensor into a piercing element to determine when the piercing element has fully pierced through the septum; (Col. 7, Lines 47-59) and providing a distal tip of a transeptal device with a radiopaque marker to allow visualization of the distal tip under fluoroscopy. (Col. 7, Lines 38-46)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat, as applied to claim 1 above, to incorporate the teachings of Turi, and configure the distal tip (18) of Gaiser to incorporate the pressure sensor of Turi, such that the user can monitor and confirm when the distal tip (18) of Gaiser has fully pierced through the septum; and to configure the distal tip (18) and catheter (10) of Gaiser to comprise a radiopaque marker. Configuring the distal tip (18) of Gasier to incorporate the pressure sensor of Turi would minimize the risk of only partially piercing through the septum, providing a safer procedure. Configuring the distal tip (18) of Gasier and catheter (10) of Gaiser to incorporate a radiopaque marker would allow for distal tip (18) and catheter (10) to be easily visualized and positioned by a user, as suggested in Turi. (Col. 7, Lines 38-46)
Regarding claim 2, the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, teaches the parameter is pressure. (Turi: Col. 7, Lines 47-59 – it is implicit that this feature be present in the Gaiser/Saadat/Turi combination based on the rejection to claim 1 above.)
Regarding claim 3, the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, teaches the piercing element incorporates various shapes. (Gaiser: Fig. 3: the tip (18) of electrode catheter (10) is configured to be maneuvered into a state comprising a curved portion and a straight portion.)
Regarding claim 8, the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, teaches a dilator. (Gaiser: Col. 6, Lines 1-7)
Regarding claim 9, the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, teaches a steerable sheath. (Gaiser: Fig. 6, Char. 42: outer sheath; Col. 5, Lines 63-67)
Regarding claim 13, the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, teaches the elongated member has further defined a guidewire lumen therein, the guidewire lumen extending from the proximal end to the distal end. (Gaiser: Col. 6, Lines 1-9: The guidewire would be positioned within sheath (8) as sheath 8 is navigated to the target area)
Regarding claim 14, the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, teaches the distal end of the device incorporates a fixed curve. (Gaiser: Col. 4, Lines 5-9)
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Turi (US 5,312,341), as applied to claim 1 above, and further in view of St. Goar (US 5,695,457).
Regarding claim 4, the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, is silent regarding the piercing element has, at a distal end, a metallic band encircling a polymer tip
St. Goar, in a similar field of endeavor, teaches providing a catheter with a metallic radiopaque marker ring and forming said catheter from a polymer compounded with a radiopaque material to increase the radiopacity. (Col. 14, Lines 40-47)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, to incorporate the teachings of St. Goar, and to configure the distal tip (18) of Gaiser to comprise a polymer compounded with a radiopaque material and have radiopaque metallic band encircling said distal tip (18). Doing so would provide distal tip (18) with increased radiopacity, allowing said distal tip to be easily viewed by a user during manipulation and placement in contact with a target tissue, as suggested in St. Goar. (Col. 14, Lines 40-47)
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Turi (US 5,312,341), as applied to claim 1 above, and further in view of Wang (US 5,441,516).
Regarding Claim 6, the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, is silent regarding polymer tubing surrounding the piercing element.
Wang, in a similar field of endeavor, teaches using a polymer tube as a protective sheath for surgical devices. (Fig. 11 and Col. 9, Lines 56-57)
It has been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination”- MPEP 2144.07 It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Gaiser/Saadat/Turi, as applied to claim 1 above, to incorporate the teachings of Wang and have the sheath (8) of Gaiser be/include the polymeric materials taught by Wang since these materials are recognized by Wang as being suitable for the intended purpose of serving as a protective sheath for surgical instruments.
Claim(s) 22, 23, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Padilla (US 6,152,918) in view of Wang (US 5,441,516).
Regarding claim 22, Gaiser teaches
an elongated member having a proximal end and a distal end, configured to be delivered to a septal location; (Fig. 1 and 3, Char. 8: sheath)
an ablation element (Fig. 1, Char. 18: tip; Col. 6, Lines 21-26) attached to a tubular member (Fig. 1, Char. 10: electrode catheter) that moves within the elongated member, (Col. 4, Lines 35-37) wherein the ablation element is configured to be advanced distally or proximally, (Col. 4, Lines 35-37) wherein the ablation element includes an RF electrode and incorporates radiofrequency energy to create a hole in the septum, (Col. 6, Lines 21-26: The ablative energy delivered by RF electrode (24) can be used to create a hole in any tissue if desired by a user, including a septum).
Gaiser further teaches a piercing element configured to pierce the septum of the heart, wherein the piercing element further incorporates a needle configured to mechanically pierce the septum (Col. 3, Lines 8-15)
Gaiser, as applied to claim 22 above, is silent regarding the ablation element comprising the piercing element; and wherein the piercing element further includes a governor to inhibit movement of the piercing element pass a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation, and wherein the distal tip includes a radiopaque marker to allow visualization of the distal tip under fluoroscopy.
Saadat, in a similar field of endeavor, teaches a needle configured to deliver RF energy to ablate a target tissue. (Par. [0187])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gaiser, as applied to claim 22 above, to incorporate the teachings of Saadat, and configure the tip (18) of Gaiser to comprise a needle at the distal most end of said tip (18), such that said needle is configured to mechanically pierce the septum. Doing so would be a simple substitution of one septal hole creation mechanism for another for the predictable result of creating a hole in a septum through which the catheter (10) of Gaiser can be passed through, and would minimize the number of devices that need to be inserted/removed from the target treatment site.
The combination of Gaiser/Saadat, as applied to claim 22 above, is silent regarding the piercing element further includes a governor to inhibit movement of the piercing element pass a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation, and wherein the distal tip includes a radiopaque marker to allow visualization of the distal tip under fluoroscopy.
Padilla, in a similar field of endeavor, teaches actuating translation of an energy delivery device via a mechanical slide (Fig. 10A, Char. 106: finger slide) located at a handle of an instrument, the mechanical slide attached at least in part to the energy delivery device; (Col. 9, Line 63 – Col. 10, Line 13) and a governor coupled to the energy delivery device, and configured to inhibit movement of energy delivery device past a pre-specified point to avoid sudden exertion of the energy delivery device. (Col. 10, Lines 21-24)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Graiser/Saadat, as applied to claim 16 above, to incorporate the teachings of Padilla, and configure the handle (14) of Graiser to include a mechanical slide of Padilla configured to control translation of catheter (10) of Gaiser, and the depth stops (95) of Padilla, such that depth stops (95) inhibit movement of the distal tip (18) of Gaiser past a pre-specified point. Doing so would be a simple substitution of one translation control mechanism for another for the predictable result of translating catheter (10) within sheath (8) of Gaiser to a degree desired by a user.
In this combination, the depth stops (95) of Padilla would avoid sudden exertion of the needle through the septum and subsequent perforation by limiting the distance distal tip (18) of Gaiser can translate, at least in a situation where the next tissue structure past the septum is located at a distance past what the depth stops (95) would allow distal tip (18) to travel.
The combination of Gaiser/Saadat/Padilla, as applied to claim 22 above, is silent regarding the distal tip includes a radiopaque marker to allow visualization of the distal tip under fluoroscopy.
Wang, in a similar field of endeavor, teaches placing bands of radiopaque markers on a surgical device inserted into a patient’s body in order to better locate said device. (Col. 6, Lines 3-10)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat/Padilla, as applied to claim 22 above, to incorporate the teachings of Wang, and configure the distal tip (18) of Gaiser to comprise the radiopaque markers of Wang. Doing so would allow for a user to easily determine the location/position of the distal tip (18) of Gaiser within the patient, as suggested in Wang. (Col. 6, Lines 3-10)
Regarding claim 23, the combination of Gaiser/Saadat/Padilla/Wang, as applied to claim 22 above, teaches the governor that inhibits movement of the piercing element past a pre-specified point (Padilla: Col. 10, Lines 21-24 – it is implicit that this feature be present in the Gaiser/Saadat/Padilla/Wang combination based on the rejection to claim 22 above.) is similar to that used to extend the point of a ball point pen. (The depth stops (95) of Padilla would be considered “similar” to a governor used to extend the point of a ball point pen at least in that both depth stops (95) and the ball point pen governor allow a translating shaft to translate a limited distance.)
Regarding claim 26, the combination of Gaiser/Saadat/Padilla/Wang, as applied to claim 22 above, teaches a guidewire. (Gaiser: Col. 6, Lines 1-7: Introduction into the right atrium can be accomplished with the aid of a conventional needle guidewire)
Regarding claim 27, the combination of Gaiser/Saadat/Padilla/Wang, as applied to claim 22 above, teaches a sheath. (Gaiser: Fig. 6, Char. 42: outer sheath)
Regarding claim 28, the combination of Gaiser/Saadat/Padilla/Wang, as applied to claim 22 above, teaches the sheath is steerable or incorporates a fixed curve. (Gaiser: Col. 5, Lines 63-67)
Claim(s) 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Padilla (US 6,152,918) in view of Wang (US 5,441,516), as applied to claim 22 above, and further in view of Khairkhahan (US 2002/0169377 A1).
Regarding claim 24, the combination of Gaiser/Saadat/Padilla/Wang, as applied to claim 22 above, teaches a dilator. (Gaiser: Col. 6, Lines 1-7)
The combination of Gaiser/Saadat/Padilla/Wang, as applied to claim 22 above, is silent regarding the elongated member is the dilator.
Khairkhahan, in a similar field of endeavor, teaches a dilator (Fig. 1, Char. 20: dilator) comprising a tapered conical surface (Fig. 1-3, Char. 27: tapered surface and Par. [0060]) an inner sheath structure (Fig. 1, Char. 26: tubular body) configured to house a translating needle; (Par. [0048]: Needle (44) is axially moveable through aperture (45) in the distal end (24) of tubular body (26)) and
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat/Padilla/Wang, as applied to claim 22 above, to incorporate the teachings of Khairkhahan, and configure sheath (8) of Gaiser to comprise the tapered conical surface (27) of Khairkhahan such that tapered surface (27) can dilate the transseptal hole created by the piercing element. Doing so would be a simple substitution of one dilator structure for another for the predictable result of dilating the transseptal hole.
Regarding claim 25, the combination of Gaiser/Saadat/Padilla/Wang/Khairkhahan, as applied to claim 24 above, teaches the piercing element is embedded into the dilator. (Khairkhahan: Fig. 3 – it is implicit that this feature be present in the Gasier/Saadat/Padilla/Wang/Khairkhahan combination based on the rejection to claim 24 above.)
Claim(s) 29 is rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1), in view of Padilla (6,152,918), in view of Khairkhahan (US 2002/0169377 A1).
Regarding claims 29, Gaiser teaches
an elongated member (Fig. 1 and 3, Char. 8: sheath) having a shape of a dilator (Sheath (8) has a circular cross section) and a proximal end and a distal end, (Fig. 1 and 3) wherein the elongated member is configured to be delivered to a septal location; (Fig. 1 and 3)
an ablation element attached to a tubular member (Fig. 1, Char. 10: electrode catheter) that is embedded within the elongated member, (Col. 4, Lines 35-37) wherein the ablation element is configured to be advanced distally or proximally, (Col. 4, Lines 35-37) wherein the ablation element includes an RF electrode and incorporates radiofrequency energy to create a hole in the septum, (Col. 6, Lines 21-26; The ablative energy delivered by RF electrode (24) can be used to create a hole in any tissue if desired by a user, including the septum).
Gaiser further teaches a piercing element configured to pierce the septum of the heart, wherein the piercing element further incorporates a needle configured to mechanically pierce the septum; (Col. 3, Lines 8-15) wherein the electrode catheter (10) and distal tip (18) are passed through the punctured hole in the septal wall; (Col. 2, Lines 37-41)
Gaiser, as applied to claim 29 above, is silent regarding the distal end of the elongated member has a bullet shape and is radiopaque so as to allow visualization of the distal end under fluoroscopy; the ablation element comprising the piercing element; wherein the piercing element further includes a governor to inhibit movement of the piercing element pass a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation.
Saadat, in a similar field of endeavor, teaches a needle configured to deliver RF energy to ablate a target tissue. (Par. [0187])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gaiser, as applied to claim 29 above, to incorporate the teachings of Saadat, and configure the tip (18) of Gaiser to comprise a needle at the distal most end of said tip (18), such that said needle is configured to mechanically pierce the septum. Doing so would be a simple substitution of one septal hole creation mechanism for another for the predictable result of creating a hole in a septum through which the catheter (10) of Gaiser can be passed through, and would minimize the number of instruments needed to be introduced/removed from the treatment zone.
The combination of Gaiser/Saadat, as applied to claim 29 above, is silent regarding the distal end of the elongated member has a bullet shape and is radiopaque so as to allow visualization of the distal end under fluoroscopy; wherein the piercing element further includes a governor to inhibit movement of the piercing element pass a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation.
Padilla, in a similar field of endeavor, teaches actuating translation of an energy delivery device via a mechanical slide (Fig. 10A, Char. 106: finger slide) located at a handle of an instrument, the mechanical slide attached at least in part to the energy delivery device; (Col. 9, Line 63 – Col. 10, Line 13) and a governor coupled to the energy delivery device, and configured to inhibit movement of energy delivery device past a pre-specified point to avoid sudden exertion of the energy delivery device. (Col. 10, Lines 21-24)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Graiser/Saadat, as applied to claim 29 above, to incorporate the teachings of Padilla, and configure the handle (14) of Graiser to include a mechanical slide of Padilla configured to control translation of catheter (10) of Gaiser, and the depth stops (95) of Padilla, such that depth stops (95) inhibit movement of the distal tip (18) of Gaiser past a pre-specified point. Doing so would be a simple substitution of one translation control mechanism for another for the predictable result of translating catheter (10) within sheath (8) of Gaiser to a degree desired by a user.
In this combination, the depth stops (95) of Padilla would avoid sudden exertion of the needle through the septum and subsequent perforation by limiting the distance distal tip (18) of Gaiser can translate, at least in a situation where the next tissue structure past the septum is located at a distance past what the depth stops (95) would allow distal tip (18) to travel.
The combination of Gaiser/Saadat/Padilla, as applied to claim 29 above, is silent regarding the distal end of the elongated member has a bullet shape and is radiopaque so as to allow visualization of the distal end under fluoroscopy.
Khairkhahan, in a similar field of endeavor, teaches a dilator (Fig. 1, Char. 20: dilator) comprising a tapered conical surface (Fig. 1-3, Char. 27: tapered surface and Par. [0060]) an inner sheath structure (Fig. 1, Char. 26: tubular body) configured to house a translating needle; (Par. [0048]: Needle (44) is axially moveable through aperture (45) in the distal end (24) of tubular body (26)) wherein the tapered conical surface comprises a radiopaque marker. (Par. [0087])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat/Padilla, as applied to claim 29 above, to incorporate the teachings of Khairkhahan, and configure the sheath (8) of Gaiser to comprise the tapered surface (27) of Khairkhahan, such that tapered surface (27) can dilate the transseptal hole created by the piercing element. Doing so would be a simple substitution of one dilator structure for another for the predictable result of dilating the transseptal hole.
Claim(s) 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Padilla (6,152,918), in view of Khairkhahan (US 2002/0169377 A1), as applied to claim 29 above, and further in view of St. Goar (US 5,695,457).
Regarding claim 30 and 31, the combination of Gaiser/Saadat/Padilla/Khairkhahan, as applied to claim 29 above, is silent regarding the piercing element is formed at least in part from a radiopaque compounded polymer; and wherein the piercing element includes a metallic band encircling a polymer tip.
St. Goar, in a similar field of endeavor, teaches providing a catheter with a metallic radiopaque marker ring and forming said catheter from a polymer compounded with a radiopaque material to increase the radiopacity. (Col. 14, Lines 40-47)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Gaiser/Saadat/Padilla/Khairkhahan, as applied to claim 29 above, to incorporate the teachings of St. Goar, and to configure the distal tip (18) of Gaiser to comprise a polymer compounded with a radiopaque material and have radiopaque metallic band encircling said distal tip (18). Doing so would provide distal tip (18) with increased radiopacity, allowing said distal tip to be easily viewed by a user during manipulation and placement in contact with a target tissue, as suggested in St. Goar. (Col. 14, Lines 40-47)
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.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794
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