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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/04/2026 has been entered.
Response to Arguments
Applicant's arguments filed 08/04/2026 have been fully considered but they are not persuasive.
Applicant argues “Independent claim 22 recites 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. The Examiner relies on the depth stops of Padilla. Applicant respectfully submits that Padilla teaches a different mechanism directed to a different purpose. Padilla is a transmyocardial revascularization (TMR) device in which a finger slide reciprocates an energy-delivery fiber back and forth over a set stroke to create a revascularization channel of a defined length. Padilla’s stops define the length of that repeated stroke; they do not act as a one-directional safety limit that arrests the needle before it can suddenly break through a septum and perforate the far wall of the heart chamber.”
Examiner respectfully contends that, the current claim language recites “a governor to inhibit movement of the piercing element past a pre-specified point to avoid sudden exertion of the needle through the septum and subsequent perforation.” The claimed “mechanism” appears to just be term “a governor.” Padilla, as further discussed in the rejection to claim 22 below, teaches a governor (stops (95)) configured to inhibit movement of a translating element past a pre-specified point. (Col. 10, lines 21-24) In the combination presented in the rejection to claim 22 below, the translating element would be the piercing element of Gaiser/Saadat. The recitation of “to avoid sudden exertion of the needle through the septum and subsequent perforation” is a recitation of intended use.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As further discussed in the rejection to claim 22 below, 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. Furthermore, one of ordinary skill in the art could position the depth stops (95) such that the depth stops don’t allow distal tip (18) to travel the combined distance of the average septum width and average atrium diameter.
Applicant further argues “Tellingly, the rejection itself concedes that Padilla’s depth stops would avoid the claimed perforation only ‘at least in a situation where the septum is disposed distally past the maximum translation distance allowed by the depth stop of Padilla.’ That conditional framing confirms that Padilla does not teach the claimed safety function; whether Padilla’s stroke limit happens to fall short of a far wall in some hypothetical arrangement is a fortuity, not a teaching of a governor ‘to avoid sudden exertion of the needle through the septum and subsequent perforation.’ The claimed governor is affirmatively configured to provide that safety margin—consistent with the specification’s explanation that a governor is ‘implemented to inhibit movement of the cutting element past a pre-specified point,’ adding ‘a significant safety factor.’ (Spec. [0057].)”
Examiner respectfully contends that the phrase “to avoid sudden exertion of the needle through the septum and subsequent perforation” is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As further discussed in the rejection to claim 22 below, 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. Furthermore, one of ordinary skill in the art could position the depth stops (95) such that the depth stops don’t allow distal tip (18) to travel the combined distance of the average septum width and average atrium diameter.
Applicant further argues “Claim 22 further shares with claim 1 the requirement that a single piercing element both delivers RF energy to create the septal hole and mechanically pierces the septum. For the reasons given above with respect to Gaiser and Saadat, the cited art does not teach or suggest such a co-located RF/needle piercing element, and the proposed reason to combine rests on hindsight. Dependent claims 23 and 26–28 are allowable at least by virtue of their dependence from claim 22 and for their additional features. Withdrawal of the rejection is respectfully requested.”
Examiner respectfully contends that, as best understood by examiner, Applicant hasn’t provided any reasons in the remarks dated 08/04/2026 why Gaiser and Saadat couldn’t be combined in the manner proposed in the rejection to claim 1. It appears the arguments regarding the rejection to claim 1 are directed towards prior art reference Turi and the combination of Gaiser/Saadat with Turi. More specifically, as best understood by examiner, the reasons given in Remarks dated 08/04/2026 are combining a radiofrequency piercing element AND an “access defining measurement in the same piercing element.” Claim 22 does not require any limitations directed towards an “access defining measurement in the same piercing element.” Gaiser and Saadat were not relied on to teach an “access defining measurement in the same piercing element.” The reason for combining Gaiser and Saadat, as further discussed in the rejection to claim 22 below, is to minimize the number of devices required to be inserted/removed from the target treatment site. Therefore, there would be no reason Gaiser and Saadat couldn’t be combined in the manner described in the rejection to claim 22 below, and there is no hindsight reasoning for such a combination.
Applicant’s arguments, see remarks, filed 08/04/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gaiser (US 6,241,728 B1) in view of Saadat (US 2007/0293724 A1) in view of Wittkampf (US 2011/0087261 A1).
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 measurement device of claim 1 and the push-retract mechanism of claim 23 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.
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 presently filed specification does not disclose or support the piercing element being “advanced and retracted by a push-retract mechanism of the type used to extend and retract the point of a ball point pen,” as described in claim 23. As best understood by examiner, the only discussion of a ball point pen is in par. [0057] which 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).” Said recitation does not provide enough support for the push-retract mechanism being “of the type used to extend and retract the point of a ball point pen.” The “type” of mechanism used in ball point pens is not discussed, shown, or otherwise described anywhere in the specification. As such, the amended claim limitation “wherein the piercing element is advanced and retracted by a push-retract mechanism of the type used to extend and retract the point of a ball point pen” is considered new matter.
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.
Claims 1-4, 6, 8, 9, 13, 14, and 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.
Regarding claim 1, the claim recites the limitation “a measurement device to measure a parameter associated with transseptal access during advancement of the piercing element through the septum, to provide real time feedback to an operator to define, as the piercing element crosses the septum, when transseptal access is achieved.” Claim 1 does not provide sufficient structure to the “measurement device” to explain/support how the measurement of the parameter is taken or how the real-time feedback is provided. Furthermore, looking to applicant’s specification, the presently filed specification does not provide any further structure/support for the “measurement device” or how said device performs the claimed functions described above. As best understood by examiner, the “measurement device” is only referenced in Par. [0047] in the recitation “Where a reduction in the negative pressure is used, a measurement device may be employed to measure the pressure during the drawing step.” For the purpose of examination, any sensor, circuit, component, or instrument configured to take a measurement and is capable of performing the claimed functions is interpreted as reading on the limitation “a measurement device to measure a parameter associated with transseptal access during advancement of the piercing element through the septum, to provide real time feedback to an operator to define, as the piercing element crosses the septum, when transseptal access is achieved.” Claims 2-4, 6, 8, 9, 13, and 14 are rejected due to their respective dependencies on claim 1.
Regarding claim 23, the claim recites the limitation “a push-retract mechanism of the type used to extends and retract the point of a ball point pen.” This limitation renders the claim indefinite and unclear as to what the “type” of mechanism used to retract the point of a ball point pen refers to. (e.g. any mechanism that translates a rod or shaft, any mechanism configured to be depressed by a user’s finger, any mechanism that makes an auditory click when actuated, etc.)
The term “type” in claim 23 is a relative term which renders the claim indefinite. The term “type” 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. This limitation renders the claim indefinite and unclear as to what the “type” of mechanism used to retract the point of a ball point pen refers to. (e.g. any mechanism that translates a rod or shaft, any mechanism configured to be depressed by a user’s finger, any mechanism that makes an auditory click when actuated, etc.) For the purpose of examination, the limitation “a push-retract mechanism of the type used to extend and retract the point of a ball point pen” is interpreted as referring to any mechanism that translates a rod or shaft.
Examiner respectfully suggests applicant refrain from directly comparing any aspect of their device to that of a ball point pen in the claims.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the claim limitation “the piercing element” in claims 1, 2, 3, and 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. For the purpose of examination, any structure having a sharp distal point or a needle-like shape is interpreted as reading on said limitation. (Par. [0037] and Fig. 1-3 and 40A-J of the presently filed specification/drawings)
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 Wittkampf (US 2011/0087261 A1).
Regarding claim 1, Gaiser teaches a device for transseptal access, (Fig. 1) comprising:
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 during advancement of the piercing element through the septum, to provide real time feedback to an operator to define, as the piercing element crosses the septum, 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 the piercing element further incorporates a measurement device to measure a parameter associated with transseptal access during advancement of the piercing element through the septum, to provide real time feedback to an operator to define, as the piercing element crosses the septum, when transseptal access is achieved, and wherein the distal tip includes a radiopaque marker to allow visualization of the distal tip under fluoroscopy.
Wittkampf, in a similar field of endeavor, teaches a transseptal puncturing device (Fig. 3-4) comprising a measurement device (Fig. 1B, Char. 43: pressure sensor) located at a tip of the piercing element (Fig. 1B, Char. 4: puncture section) to measure a parameter associated with transseptal access, (Par. [0056]: Pressure sensor (43) senses pressure) wherein the measurement device is configured to monitor the parameter during advancement of the piercing element through the septum and to detect a change in the parameter indicating the piercing element has crossed the septum, to provide real time feedback to an operator to define in real time when transseptal access is achieved; (Par. [0042]: Multiple pressure measurements are taken, including during advancement into the septum, and the measured pressures provide a practitioner with feedback/confirmation that a puncture is made from the right atrium to the left atrium) and wherein a portion of the transeptal puncturing device is provided with a radiopaque marker (Par. [0039]: The distal end of the dilator is provided with a radiopaque marker allowing the practitioner to image said distal end) to allow visualization of the distal tip under fluoroscopy. (The radiopaque marker would be visible under fluoroscopy)
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 Wittkampf, and configure the distal tip (18) and catheter (10) of Gaiser to comprise a radiopaque marker, and to include the pressure sensor (43) of Wittkampf in the tip of the piercing element of Gaiser, such that the pressure can be monitored/measured throughout the piercing of the septum, and a user can receive real time feedback based on said pressure measurements when transseptal access is achieved. Configuring the distal tip (18) and catheter (10) of Gaiser to include a radiopaque marker would allow for both the distal tip (18) and catheter (10) to be easily viewed and positioned by auser, as suggested in Wittkampf. (Par. [0039]) Including the pressure sensor (43) of Wittkampf in the tip of the piercing element of Gaiser would minimize the risk of only partially piercing through the septum, providing a safer procedure.
Regarding claim 2, the combination of Gaiser/Saadat/Wittkampf, as applied to claim 1 above, teaches the parameter is pressure. (Wittkampf: Par. [0042] – it is implicit that this feature be present in the Gaiser/Saadat/Wittkampf combination based on the rejection to claim 1 above.)
Regarding claim 3, the combination of Gaiser/Saadat/Wittkampf, 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/Wittkampf, as applied to claim 1 above, teaches a dilator. (Gaiser: Col. 6, Lines 1-7)
Regarding claim 9, the combination of Gaiser/Saadat/Wittkampf, 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/Wittkampf, 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/Wittkampf, 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 Wittkampf (US 2011/0087261 A1), 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/Wittkampf, 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/Wittkampf, 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 Wittkampf (US 2011/0087261 A1), as applied to claim 1 above, and further in view of Wang (US 5,441,516).
Regarding Claim 6, the combination of Gaiser/Saadat/Wittkampf, 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/Wittkampf, 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 (Fig. 10C, Char. 95: depth stops) 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 piercing element is advanced and retracted by a push-retract mechanism of the type used to extend and retract the point of a ball point pen. (Padilla: Col. 10, Lines 21-24: slider (106) of Padilla would translate the shaft of catheter (10) – it is implicit that this feature be present in the Gaiser/Saadat/Padilla/Wang combination based on the rejection to claim 22 above; In light of the rejection of claim 23 under 112(b) above, the slider (106) of Padilla is considered a mechanism “of the type used to extend and retract the point of a ball point pen” due to slider (106) being used to translate a shaft.)
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 (Fig. 10C, Char. 95: depth stops) 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
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
