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
Applicant's arguments filed 9/2/26 have been found persuasive. All previous rejections have been overcome by Applicant’s amendments and arguments.
In the previous Non-Final Rejection mailed on 6/16/26, the limitations in question “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”, were rejected on the basis of Smaill. Smaill presents the same disclosure (e.g. 25:7-11: “It will be possible to lock the dimensions of the electrode array in multiple dimensions between fully open and fully closed states. Electrodes will be uniformly spaced as far as is possible in open and closed states and distributed evenly across the mathematically closed virtual surface that bounds them”) as that of the instant application, which respectively provides support for these claimed limitations.
Applicant’s argument includes the following rationale:
“ Applicant's amended claim 1 recites, in part, "an arm connected to the array of splines... wherein the array of splines can be locked into any one of multiple positions between the closed position and the open position" where "in each of the open position, closed position, and the multiple positions between the closed position and the open position, the plurality of electrodes forms points on a respective mathematically closed virtual surface, each with different dimensions." That is, the claim affirmatively requires a relationship between each physical position of the array of splines and a corresponding mathematically closed virtual surface. The open position has a respective mathematically closed virtual surface; the closed position has a respective mathematically closed virtual surface; and each of the multiple intermediate positions likewise has a respective mathematically closed virtual surface. Further, the respective mathematically closed virtual surfaces have different dimensions.
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Smaill is generally directed to a heart mapping system and method of determining physiological information using an open catheter. See e.g., Smaill at Abstract and claim 1. Smaill discloses the catheter being used only "in the open state... and in the closed state" (See e.g., Smaill at para. 164) and describes that "[e]lectrodes will be uniformly spaced as far as is possible in open and closed states and distributed evenly across the mathematically closed virtual surface that bounds them." See e.g., Smaill at para. 222. Smaill states that an adjustable catheter can have its dimensions altered by withdrawing or advancing splines into or out of the catheter and that it can be locked in multiple dimensions between fully open and fully closed states. See, e.g., Smaill at paras. 221-222. However, Smaill does not state that the electrodes, in each such intermediate locked position, form points on a respective mathematically closed virtual surface, as recited in claim 1.
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Smaill's general discussion of interpolating measured electrode potentials across a closed surface is insufficient to cure this deficiency. Such disclosure establishes that Smaill employs a mathematically defined surface for its mapping calculations. It does not disclose the structural relationship now required by claim 1-namely, that in each mechanical position throughout the claimed expansion range, the electrodes themselves form points on a respective mathematically closed virtual surface having dimensions corresponding to that position.
The Office Action therefore appears to derive the claimed arrangement by combining separate teachings within Smaill: Smaill's disclosure of lockable intermediate dimensions, its disclosure of a mathematically closed virtual surface, and its disclosure concerning electrode distribution.
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To the extent that the Office Action is understood as asserting that every intermediate position of Smaill necessarily forms a respective mathematically closed virtual surface, the rejection also fails as a matter of inherency. MPEP §2112 explains that a characteristic that merely might result from the teachings of a prior-art reference is not inherently disclosed. Rather, the Examiner must provide factual evidence or technical reasoning establishing that the asserted characteristic necessarily flows from the prior-art disclosure. See, In re Oelrich, 666 F.2d 578, 581- 82 (CCPA 1981); In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993). No such showing has been made here.
As noted, Smaill states that the dimensions of its array can be changed by withdrawing or advancing splines into or out of the catheter. However, Smaill does not describe the positions of the individual electrodes during every degree of such withdrawal or advancement, much less establish that the electrodes necessarily remain positioned as points on the boundary of a mathematically closed virtual surface at every intermediate position. The mere ability to mechanically stop or lock an array at different dimensions does not establish the claimed mathematical relationship. Stated differently, a "known catheter dimension," an "intermediate expansion position," and a "mathematically closed virtual surface defined by the electrode points" are not interchangeable concepts. The Office Action has not provided evidence or technical reasoning establishing that the third necessarily follows from either of the first two. Accordingly, inherency cannot supply the missing limitation.
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Claim 1 requires more than the existence of (i) multiple expansion positions and (ii) a mathematically closed virtual surface somewhere in the operation of the catheter. It requires that the plurality of electrodes form points on a respective mathematically closed virtual surface in each of the recited positions. The cited portions of Smaill do not disclose that arrangement. Accordingly, Smaill does not anticipate claim 1.”
Applicant’s position is found convincing, thus Smaill:
does not “affirmatively require(s) a relationship between each physical position of the array of splines and a corresponding mathematically closed virtual surface.”
does not disclose “each of the multiple intermediate positions likewise has a respective mathematically closed virtual surface”.
does not disclose that “the respective mathematically closed virtual surfaces have different dimensions”.
general discussion of interpolating measured electrode potentials across a closed surface is insufficient to cure this deficiency. Such disclosure establishes that Smaill employs a mathematically defined surface for its mapping calculations. It does not disclose the structural relationship now required by claim 1-namely, that in each mechanical position throughout the claimed expansion range, the electrodes themselves form points on a respective mathematically closed virtual surface having dimensions corresponding to that position.
does not describe the positions of the individual electrodes during every degree of such withdrawal or advancement, much less establish that the electrodes necessarily remain positioned as points on the boundary of a mathematically closed virtual surface at every intermediate position. The mere ability to mechanically stop or lock an array at different dimensions does not establish the claimed mathematical relationship. Stated differently, a "known catheter dimension," an "intermediate expansion position," and a "mathematically closed virtual surface defined by the electrode points" are not interchangeable concepts.
does not explicitly or implicitly disclose “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”, in the absence of further evidence.
Similarly, the instant application fails to support these limitations:
The instant application discloses:
“[0021] Preferably the electrode array and thus splines can be locked into any one of a multitude of dimensions between fully open and fully closed states.”
“[0022] Preferably the electrodes are uniformly spaced as far as is possible in open and closed states and distributed evenly across the mathematically closed virtual surface that bounds them. “
“[0045] Preferably the electrode array and thus splines can be locked into any one of a multitude of dimensions between fully open and fully closed states.”
“[0046] Preferably the electrodes are uniformly spaced as far as is possible in open and closed states and distributed evenly across the mathematically closed virtual surface that bounds them.”
“[0104] The mapping approach above could be carried out using combinations of catheters with different dimensions. However, in preferred forms of the invention, a single adjustable catheter may be used. With such a single adjustable catheter, the dimensions of the electrode array may be altered by withdrawing or advancing the splines into or out of the catheter. Preferably the catheter is steerable. Preferably it will be possible to lock the dimensions of the electrode array into any one of a multitude of dimensions between fully open and fully closed states. Preferably the electrodes are uniformly spaced as far as is possible in open and closed states and distributed evenly across the mathematically closed virtual surface that bounds them. Preferably inter-electrode spacing will be sufficient to characterize electrical activity appropriately within endocardial regions on the order of 10 mm in diameter.”
There is nothing else disclosed in the specification to support the claimed “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”.
Phosita would not have reasonably concluded that this disclosure supports the claimed limitations in question. The instant specification:
does not affirmatively require a relationship between each physical position of the array of splines and a corresponding mathematically closed virtual surface,
does not disclose “each of the multiple intermediate positions likewise has a respective mathematically closed virtual surface”,
does not disclose that “the respective mathematically closed virtual surfaces have different dimensions”
only provides general discussion of interpolating measured electrode potentials across a closed surface is insufficient to cure this deficiency. Such disclosure establishes that the instant disclosure employs a mathematically defined surface for its mapping calculations. It does not disclose the structural relationship now required by claim 1-namely, that in each mechanical position throughout the claimed expansion range, the electrodes themselves form points on a respective mathematically closed virtual surface having dimensions corresponding to that position,
does not describe the positions of the individual electrodes during every degree of such withdrawal or advancement, much less establish that the electrodes necessarily remain positioned as points on the boundary of a mathematically closed virtual surface at every intermediate position. The mere ability to mechanically stop or lock an array at different dimensions does not establish the claimed mathematical relationship. Stated differently, a "known catheter dimension," an "intermediate expansion position," and a "mathematically closed virtual surface defined by the electrode points" are not interchangeable concepts, and vi) does not explicitly or implicitly disclose “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”, in the absence of further evidence. Applicant must provide factual evidence or technical reasoning establishing that the asserted characteristic necessarily flows from the prior-art disclosure. See, In re Oelrich, 666 F.2d 578, 581- 82 (CCPA 1981); In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993). No such showing has been made here.
This Application is a CON of 17/609,069. The original claims can be found in the parent case. Here are the claims that relate to the claimed “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”. The only claims relevant to this are Claims 5, 29 and 30 (which include improper multiple dependencies):
“1. An open catheter comprising: at least eight splines making up a basket, each of the splines includes at least six electrodes, an arm connected to and capable of moving the splines from a closed position to an open position, and multiple positions therebetween.
2. The open catheter of claim 1 wherein the electrodes on the splines provide an array of electrodes.
3. The open catheter of claim 2 wherein the electrode array may be altered by withdrawing or advancing the splines into or out of the arm of the catheter.
4. The open catheter of any one of claims 1 to 3 wherein the basket is steerable.
5. The open catheter of any one of claims 2 to 4 wherein the electrode array and thus splines can be locked into any one of a multitude of dimensions between a fully open and a fully closed state.”
24. An open catheter comprising: an array of splines making up a basket, each of the splines including a multitude of electrodes and each of said multitude of electrodes are evenly distributed along each of said splines. an arm connected to and capable of moving the splines from a closed position to an open position, and multiple positions therebetween.
25. An open catheter of claim 24 wherein the array of splines is made up of eight splines.
26. An open catheter of claim 24 or 25 wherein each of the splines includes at least six electrodes creating an electrode array.
27. The open catheter of claim 26 wherein the electrode array may be altered by withdrawing or advancing the splines into or out of the arm of the catheter.
28. The open catheter of any one of claims 24 to 27 wherein the basket is steerable.
29. The open catheter of any one of claims 24 to 28 wherein the electrode array and thus splines can be locked into any one of a multitude of dimensions between a fully open state and a fully closed state.
30. The open catheter of any one of claims 24 to 29 wherein the electrodes are uniformly spaced as far as is possible in open and closed states and distributed evenly across the mathematically closed virtual surface that bounds them.”
The exact same logic that applies to the specification (see above), applies to original claims 5, 29-30. In short, these claims do not add anything to the specification, and do not affirmatively support a relationship between each physical position of the array of splines and a corresponding mathematically closed virtual surface, either explicitly or implicitly.
Thus, phosita would not have reasonably concluded from the original disclosure that Applicant was in possession of “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”.
None of the drawings remedy the above. No figure depicts or identifies a series of intermediate locked catheter configurations each associated with its own respective mathematically closed virtual surface. No figure adds anything specific to the disclosure in terms of “wherein in each of the open position, closed position, and the multiple positions between the closed position and the open position, the plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”.
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 feature of “in each of … the multiple positions between the closed position and the open position, the plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions” 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 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.
Regarding Claim 1, a person having ordinary skill in the art would not have reasonably concluded from the original disclosure that Applicant was in possession of a catheter as claimed in Claim 1, particularly in terms of “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”, before the effective filing date of the claimed invention.
The instant specification:
i) does not affirmatively require a relationship between each physical position of the array of splines and a corresponding mathematically closed virtual surface,
ii) does not disclose “each of the multiple intermediate positions likewise has a respective mathematically closed virtual surface”,
iii) does not disclose that “the respective mathematically closed virtual surfaces have different dimensions”
iv) only provides general discussion of interpolating measured electrode potentials across a closed surface is insufficient to cure this deficiency. Such disclosure establishes that the instant disclosure employs a mathematically defined surface for its mapping calculations. It does not disclose the structural relationship now required by claim 1-namely, that in each mechanical position throughout the claimed expansion range, the electrodes themselves form points on a respective mathematically closed virtual surface having dimensions corresponding to that position,
v) does not describe the positions of the individual electrodes during every degree of such withdrawal or advancement, much less establish that the electrodes necessarily remain positioned as points on the boundary of a mathematically closed virtual surface at every intermediate position. The mere ability to mechanically stop or lock an array at different dimensions does not establish the claimed mathematical relationship. Stated differently, a "known catheter dimension," an "intermediate expansion position," and a "mathematically closed virtual surface defined by the electrode points" are not interchangeable concepts, and vi) does not explicitly or implicitly disclose “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”, in the absence of further evidence. Applicant must provide factual evidence or technical reasoning establishing that the asserted characteristic necessarily flows from the prior-art disclosure. See, In re Oelrich, 666 F.2d 578, 581- 82 (CCPA 1981); In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993). No such showing has been made here.
b) This Application is a CON of 17/609,069. The original claims can be found in the parent case. Here are the claims that relate to the claimed “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”. The only claims relevant to this are Claims 5, 29 and 30 (which include improper multiple dependencies):
“1. An open catheter comprising: at least eight splines making up a basket, each of the splines includes at least six electrodes, an arm connected to and capable of moving the splines from a closed position to an open position, and multiple positions therebetween.
2. The open catheter of claim 1 wherein the electrodes on the splines provide an array of electrodes.
3. The open catheter of claim 2 wherein the electrode array may be altered by withdrawing or advancing the splines into or out of the arm of the catheter.
4. The open catheter of any one of claims 1 to 3 wherein the basket is steerable.
5. The open catheter of any one of claims 2 to 4 wherein the electrode array and thus splines can be locked into any one of a multitude of dimensions between a fully open and a fully closed state.”
24. An open catheter comprising: an array of splines making up a basket, each of the splines including a multitude of electrodes and each of said multitude of electrodes are evenly distributed along each of said splines. an arm connected to and capable of moving the splines from a closed position to an open position, and multiple positions therebetween.
25. An open catheter of claim 24 wherein the array of splines is made up of eight splines.
26. An open catheter of claim 24 or 25 wherein each of the splines includes at least six electrodes creating an electrode array.
27. The open catheter of claim 26 wherein the electrode array may be altered by withdrawing or advancing the splines into or out of the arm of the catheter.
28. The open catheter of any one of claims 24 to 27 wherein the basket is steerable.
29. The open catheter of any one of claims 24 to 28 wherein the electrode array and thus splines can be locked into any one of a multitude of dimensions between a fully open state and a fully closed state.
30. The open catheter of any one of claims 24 to 29 wherein the electrodes are uniformly spaced as far as is possible in open and closed states and distributed evenly across the mathematically closed virtual surface that bounds them.”
The exact same logic that applies to the specification (see above), applies to original claims 5, 29-30. In short, these claims do not add anything to the specification, and do not affirmatively support a relationship between each physical position of the array of splines and a corresponding mathematically closed virtual surface, either explicitly or implicitly.
Thus, phosita would not have reasonably concluded from the original disclosure that Applicant was in possession of “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 plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”.
None of the drawings remedy the above. No figure depicts or identifies a series of intermediate locked catheter configurations each associated with its own respective mathematically closed virtual surface. No figure adds anything specific to the disclosure in terms of “wherein in each of the open position, closed position, and the multiple positions between the closed position and the open position, the plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”.
Thus, Claim 1 fails the written description requirement. None of the dependent claims remedy this. See MPEP 2163 and MPEP 2163.05.
Claims 1-23 are 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.
In Claim 1, in the phrase “the plurality of electrodes forms points on a respective mathematically closed virtual surface each with different dimensions”, the term “each” is unclear as to what it refers back to. “Each” implies there are multiple elements being referred to. The “surfaces” were amended to “surface” (singular). Thus, it is unclear whether this refers to the electrodes, the point, the surface, the positions or some other limitation recited before “each”.
In Claim 21, the terms “may be” are relevant and subjective, rendering the scope of the claim unclear.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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