DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
This application is a continuation of 17/609069. The instant claims are similar to the claims filed on 9/11/24 with the parent case, before the case was abandoned. While each case is treated separately and the instant case is treated on its own merits, it is considered that it would be helpful to reply to, without incorporating, Applicant’s arguments, in order to move prosecution forward and reduce issues. Applicant's arguments filed on 9/11/24 with the parent case are not persuasive.
Smaill already teaches expanding and locking the basket at multiple dimensions for placing the electrodes in mathematically closed surfaces. Thus, Smaill already teaches an expanding and locking mechanism to perform this functionality. The claim does not require any particular locking mechanism either. It only requires an arm to move the splines. Smail implicitly teaches a structure that would move the splines from outside the body, given that the basket is used and expanded inside the heart, and any such structure would have a length, thus meeting the “arm”. Nevertheless, even if an arm to move the splines is somehow determined not to be inherent, Harlev most certainly teaches an arm to move the splines. This teaching is all that is required to meet the claim. Applicant arguing that Harlev teaches two locking positions is not persuasive, as it considers the references in isolation. Neither the claims, nor the specification require that the arm is the locking mechanism. The claims do not require the particulars of the locking mechanism. Neither does the original disclosure provide such details. If they did, these mechanisms are well-known in the art, and provided in multiple reference with the attached PTO-892. It is possibly the reason that Smaill does not provide the particulars of the inherently present mechanism, as these are details that are non-essential and need not be specified in detail. Nevertheless, it is noted that given the disclosure of Smaill for multiple locking positions, phosita would readily understand, appreciate and find obvious to use any known locking mechanism to arrive at multiple locking positions.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show a first electrode at a proximal pole and a second electrode at a distal pole, as well as said two pole electrodes in combination with a 66-electrode catheter where the 66 electrodes are distributed uniformly, as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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. No new matter should be entered. Note here, that if the above were meant to be conveyed with Fig. 18, that Fig. 18 is blurry and should be corrected without introducing new matter.
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 1-23 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.
1) Regarding Claim 1, which is not an original claim, a person having ordinary skill in the art would not have reasonably concluded from the original disclosure that Applicant was in possession of the full scope of a catheter, wherein “the array of splines form a respective mathematically closed virtual surfaces(sic) each with different dimensions”. Mathematically closed surfaces in the context of a three-dimensional basket of a catheter are understood as closed ellipsoids, or spheres that can be expressed analytically. The original disclosure makes no mention of the splines forming completer fully closed spheres or ellipses that are mathematically closed surfaces, which is not precluded by the claims. That would require perfect spheres or ellipsoids that are continuous at every point. This is never disclosed. In each and every instance, it is the electrodes (ie. discrete points) that are evenly spaced and placed on the splines so as to form points on a “mathematically closed virtual surface” (e.g. ¶¶ 22,46,92-93,104). The claims do not preclude that the splines form some analytically fully closed surface (e.g. a complete sphere, or a complete ellipsoid), which is not supported. Thus, Claims 1-23 fail the written description requirement. See MPEP 2163 and 2163.05. None of the dependent claims correct the above.
2) Claims 8-14 are not original claims, nevertheless it is noted that written description issues may arise even for original claims (see MPEP 2163.I.A.). A person having ordinary skill in the art would not have reasonably concluded from the original disclosure that Applicant was in possession of an embodiment that combines 66 electrodes, two of which located at poles, all being “spaced evenly” along the mathematical closed virtual surfaces of the basket, something not precluded by Claim 8. The limitations appear to be combining two different embodiments. First, it is noted that it is not possible to distribute evenly more than 20 points on a sphere [see NPL by Gonzalez, on record 6/12/24 in parent 17/609069, page 2: "On the sphere, it is impossible to arrange regularly more than 20 points (the vertices of a dodecahedron), and the optimum configuration of a large number of points is problem-specific"]. The only virtual surface that Applicant describes in the specification is a sphere (e.g. Fig. 9, page 7, lines 16-22). The only "uniform" distribution described involves 64 electrodes on the splines and is not actually uniform, it is "approximately equally spaced" (page 7, lines 16-22). The addition of the two pole electrodes occurs in a separate embodiment, that of Fig. 18 (e.g. 17:29 -18:9). However, there is nothing in the disclosure to suggest that the embodiment of Fig. 18 is combined with the embodiment of Fig. 9, leading to a uniform distribution of all 66 electrodes, something which is not precluded by the claims. There is nothing in the original disclosure to suggest that Applicant has solved the problem of uniformly distributing all 66 electrodes on the closed virtual surface. Thus, Claims 8-14 fail the written description requirement.
3) Claims 10 and 12 are not original claims, nevertheless it is noted that written description issues may arise even for original claims (see MPEP 2163.I.A.). A person having ordinary skill in the art would not have reasonably concluded from the original disclosure that Applicant was in possession of an embodiment where the electrodes are distributed both evenly and non-evenly on the basket, something which is not precluded by Claims 10 and 12. Claim 8 requires that the electrodes are distributed evenly on the basket. However, dependent claims 10 and 12, all require a non-even distribution of electrodes (by reciting a different number or spacing of electrodes on each spline). This arises from different embodiments in the specification (e.g. Fig. 10 and Table 1 denote the non-even electrode distribution embodiments, to which the even embodiment is presented as an improvement, see 14:1-2), which are combined in these dependent claims, resulting in an embodiment that clearly fails the enablement requirement.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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, 5-7, 15-23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by WO 2016/133409 by Smaill or, in the alternative, under 35 U.S.C. 103 as obvious over Smaill in view of US 20090171274 by Harlev.
Regarding Claim 1, Smaill teaches a catheter (e.g. abstract, Figure 1: catheter 1) comprising:
an array of splines (e.g. ¶¶ 158, 170, Fig. 1: splines 2);
a plurality of electrodes formed at least by electrodes located on each of the splines (e.g. ¶170, Fig. 1: electrodes 3 arranged on the splines); and
wherein the splines are configured to move from a closed position to an open position forming an open basket, wherein the array of splines can be locked into any one of multiple positions between the closed position and the open position, wherein in each of the open position, closed position, and the multiple positions between the closed position and the open position, the array of splines form a respective mathematically closed virtual surfaces each with different dimensions (e.g. ¶¶120,130,166-167,170,221-222: splines are expanded in multiple dimensions which form mathematically closed surfaces for the electrodes, for their use to specify potentials and potential gradients at measurement points via modeling; Note that this disclosure is identical to Applicant’s ¶¶45,104, which are the sole support for the instant limitations), and
wherein in each of the mathematically closed virtual surfaces the plurality of electrodes are distributed across the respective closed virtual surface (e.g. ¶222, Fig. 1: electrodes 3 are distributed on the splines 2).
As phosita would readily understand and appreciate, the disclosure of expanding and locking the splines in multiple dimensions clearly necessitates and implicitly discloses a spline expansion and locking mechanism connected to the array of splines. It is noted here, in the interest of moving prosecution forward, and as it relates to the arguments of the parent case for similar claims (9/11/24), the claims do not require any particular locking mechanism, the claims do not require that the arm itself does anything other than move the splines (neither does the specification, ie. there is no disclosure of the arm itself locking the splines), and Smaill already teaches an expansion and locking mechanism that locks the splines at different dimensions.
As it relates to an “arm” being part of the implicit expansion mechanism, and being connected to move the splines: while Smail is silent in the detailed description regarding the exact non-essential details of the inherently present mechanism that expands the splines of the expandable basket catheter (e.g. Fig. 7, 16:1-6,15-20), given the structure and use of catheter 1 to reach into the chambers of the heart (1:7-10) from the exterior of the body and expand the basket 2 at the distal end of the catheter, any mechanism used to expand the basket splines must be connected to the splines and any mechanism must involve an intermediary element having a length, thus an arm.
Alternatively, in the interest of advancing prosecution and in the event that it is determined that Smaill does not implicitly disclose an arm connected to the splines as part of the inherent expansion mechanism, wherein the arm is configured to move the splines.
However, Harlev teaches an analogous expandable basket electrode catheter which utilizes a wire to expand the splines of the basket (e.g. par. 57, Fig. 15: wire 52 or screw 153 moves the splines to an open position). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a spline expansion mechanism with an arm in a device according to the teachings of Smaill, as taught by Harlev, as this would only amount to an equivalent mechanism to predictably expand the splines, as intended by both Smaill and Harlev.
Regarding Claim 5, Smaill and Smaill as modified in Claim 1 teaches the catheter of claim 1, wherein in the open position, the plurality of electrodes are distributed across the array of splines with an inter-electrode spacing, across the respective mathematically closed virtual surface, that is configured to characterize electrical activity within endocardial regions on the order of 10 mm in diameter (e.g. 25:12-13: “Inter-electrode spacing will be sufficient to characterize electrical activity appropriately within endocardial regions on the order of 10 mm diameter”).
Regarding Claim 6, Smaill and Smaill as modified in Claim teaches the catheter of claim 1, wherein the plurality of electrodes are distributed across the array of splines with the least linear distance between neighboring electrodes (e.g. Fig. 1, 16:15-20, 25:9-11: electrodes 3 are evenly distributed across the mathematically closed virtual surface, and by definition a uniform distribution requires equal inter electrode spacing, thus minimum distance).
Regarding Claim 7, Smaill and Smaill as modified in Claim 1, the catheter of claim 1, wherein a first electrode of the plurality of electrodes is located at a proximal pole of the basket, and a second electrode of the plurality of electrodes is located adjacent a distal pole of the basket (in the absence of a limiting definition of “proximal” and “distal”, any pair of electrodes at opposite ends of the spherical basket satisfy the claim).
Regarding Claim 15, Smaill and Smaill as modified in Claim 1 teaches the catheter of claim 1, wherein the array of splines form an open basket when the catheter is advanced to the open position (Fig. 1, 16:1-6,15-20), yet does not explicitly disclose wherein the catheter comprises: two additional electrodes, wherein a first electrode of the two additional electrodes is located at the bottom of the open basket, a second electrode of the two additional electrodes is located at the top of the open basket. However, Harlev teaches an analogous expandable basket electrode catheter for non-contact mapping utilizing electrodes at the tip and base of the basket (e.g. Fig. 3B, par. 55: tip electrode 53 and ring electrode 57). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate two additional electrodes, wherein a first electrode of the two additional electrodes is located at the bottom of the open basket, and a second electrode of the two additional electrodes is located at the top of the open basket, in a device according to the teachings of Smaill, as taught by Harlev, in order to predictably serve as current sourcing or sinking for the locator electrodes, and/or as ablation or stimulation electrodes, as suggested by Harlev (par. 55).
Regarding Claim 16, Smaill as modified in Claim 15 teaches the catheter of claim 15, wherein the array of splines are joined at the bottom of the open basket and at the top of the open basket (as shown in Fig. 1).
Regarding Claim 17, Smaill as modified in Claim 15 teaches the catheter of claim 15, wherein the catheter has sixty-six electrodes in total, and there are eight splines that comprise the array of splines [with the additional two electrodes, the 64-electrode catheter of Smaill (see 20:17-30), becomes a 66-electrode catheter].
Regarding Claim 18, Smaill as modified in Claim 15 teaches the catheter of claim 15, wherein the open basket is configured to substantially fill an atrial chamber of the heart without making contact with the endocardial surface (e.g. as shown in Fig. 2, see 25: 17-22).
Regarding Claim 19, Smaill as modified in Claim 15 teaches the catheter of claim 18, wherein at least some of the plurality of electrodes are located where they will not contact the endocardial surface of the atrial chamber (e.g. 25: 17-22).
Regarding Claim 20, Smaill as modified in Claim 15 teaches the catheter of claim 15, wherein the catheter is configured to control the resolution of data recorded by the electrodes via expanding and/or contracting the open basket to change the distribution of the plurality of electrodes (e.g. 24:25-36; In addition, contracting the splines would bring neighboring splines closer, thus increasing resolution).
Regarding Claim 21, Samill and Smaill as modified in Claim 1 teaches the catheter of claim 1, wherein an arrangement of the plurality of electrodes may be altered by withdrawing or advancing the splines into or out of the arm of the catheter (e.g. 25:3-4: the dimensions of the electrode array are altered by withdrawing or advancing the splines into or out of the catheter).
Regarding Claim 22, Samill and Smaill as modified in Claim 1 teaches the catheter of claim 1, wherein each spline of the array of splines are adjustable by being withdrawn or advanced out of the arm of the catheter (e.g. 25:3-4: the dimensions of the electrode array are altered by withdrawing or advancing the splines into or out of the catheter).
Regarding Claim 23, Samill and Smaill as modified in Claim 1 teaches the catheter of claim 1, wherein the basket is steerable (e.g. 25:6: steerable).
Claims 2-4 are rejected under 35 U.S.C. 103 as obvious over Smaill/Harlev, as applied to Claim 1, and further in view of US 2018/0116539 by Olson and US 20170042449 by Deno.
Regarding Claims 2-4, Smaill as modified in claim 1 teaches the catheter of claim 1, wherein some of the splines of the array of splines have more electrodes distributed thereon than other splines of the array of splines (as it relates to Claim 2), or wherein the electrodes on each spline of the array of splines are spaced along the spline, and the electrode spacing over the array of splines results in some of the splines being different from other splines (as it relates to Claim 3), or wherein the catheter is configured with different electrode spacing on neighboring splines of the array of splines (as it relates to Claim 4).
However, it is well known in the art to vary the number and/or spacing of electrodes on each spline in electrophysiological applications. As one example, Olson teaches an analogous electrophysiology catheter which includes different numbers of electrodes in adjacent splines (e.g. ¶46). Another example is offered by Goedeke which teaches an analogous EP catheter having variable spacing and number of electrodes on each spline (e.g. ¶¶ 24, 56-57). Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate adjacent splines with different numbers of electrodes and/or different spacing of electrodes, as these would only amount to selections among known and limited options that would have been obvious to try, and absent any disclosed criticality, would only be a matter of routine optimization.
Conclusion/ Examiner’s Notes
Claims 8-14 are only rejected under 112. However, this is due to the 112a issues. Thus, it is suggested that Applicant first rephrases the claims to meet what is actually supported by the original disclosure.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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