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 .
This office action is in response to applicant’s communication of 11/03/2025. Currently claims 1-28 are pending and rejected below.
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 28 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. It is unclear how the claim language of “…the stylet is self-orienting such that manual rotation of a proximal portion of the stylet does not transmit an amount of torque to the distal tip to cause a rotation thereof…”. It is unclear to the examiner how a manual rotation of the proximal stylet portion would not transmit an amount of torque to the tip of the stylet. Examiner believes the applicant’s stylet to be of one solid material from proximal to distal tip and therefore any rotation of one end would transmit some amount of torque to the tip or other end. Appropriate correction is required.
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 1-27 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. It is unclear how the term “non-steerable” is to be used in the claim and what it’s metes, bounds, and definition is. Further it is unclear how the term “automatic” is to be used in the claim and what it’s metes, bounds, and definition is. Is this claim attempting to say that the catheter is flexible or has a stiffness that will flex when passing through a tortious passage, is this a certain amount of elasticity or resliance, or does the term “non-steerable” or “automatic” referencing some other property. It is unclear and appropriate correction is required.
Claims 1-27 (particularly claim 1) are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the first pre formed bend, and the second preformed bend, and how the stylet is “non-steerable”. It is unclear how the device is “non-steerable” but has pre-formed bends (first and second). The functional limitations of “such that an orientation of the distal tip is automatic based on the vasculature of the patient…” does not clarify the structural cooperative relationship of how the first and second bends are also “non-steeable”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowe et al. (US 2003/0144657 A1) in view of Reynolds et al. (US 2004/0167436 A1) in further view of Niazi (US 2005/0010237 A1).
Bowe discloses a stylet (2) (as in figures 1-19) comprising: a core wire (24/23) including: a first pre-formed bend of a first angle (50); a second pre-formed bend of a second angle (48 or 46), the second pre-formed bend being distal of the first pre-formed bend, and the first angle being greater than the second angle (figure 16); and a narrow segment (figure 12) being distal of the second pre-formed bend and having a reduced width or diameter that increases deflection of a distal tip.
Bowe discloses the claimed invention except for the narrow segment. Reynolds teaches that it is known to use a distal segment (Reynolds 26-44 area as in figure 5 for example) between the narrow segment (24-26) and the distal tip (28-30), the distal segment having a width or diameter greater than the respective width or diameter of the narrow segment (figure 5 for example) as set forth in para [0077]-[0084] to provide providing and facilitating navigation and treatment within the anatomy of a patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Bowe with a distal segment (Reynolds 26-44 area as in figure 5 for example) between the narrow segment (24-26) and the distal tip (28-30), the distal segment having a width or diameter greater than the respective width or diameter of the narrow segment as taught by Reynolds, since such a modification would provide the system with a distal segment (Reynolds 26-44 area as in figure 5 for example) between the narrow segment (24-26) and the distal tip (28-30), the distal segment having a width or diameter greater than the respective width or diameter of the narrow segment for providing and facilitating navigation and treatment within the anatomy of a patient (see para [0002]-[0011].
Bowe in view of Reynolds discloses the claimed invention except for the core wire has a pre-formed shape including the first pre- formed bend and the second pre-formed bend. Niazi teaches that it is known to use a core wire has a pre-formed shape including the first pre- formed bend and the second pre-formed bend as set forth in paragraphs at columns [0038-0040] discussing the obturator for example as in figure 2a and 40a to provide a means to guide and cannulate a catheter to a coronary sinus or anatomical location in the heart.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Bowe in view of Reynolds with the core wire has a pre-formed shape including the first pre- formed bend and the second pre-formed bend as taught by Niazi, since such a modification would provide the system with the core wire has a pre-formed shape including the first pre- formed bend and the second pre-formed bend for providing a means to guide and cannulate a catheter to a coronary sinus or anatomical location in the heart.
Examiner is of the position that one would form the guide ribbon of Bowe or wire of Reynolds with the preformed bends similar to the guiding obturator in Niazi figure 2a (first second and multiple bends 42/44/46) to perform the guidance to the heart.
Examiner is of the position that the device of Niazi would carry out the function of “elastically change from the pre-formed shape to a second shape during insertion of the stylet into a vasculature of the patient due to an anatomical insertion pathway of the vasculature” as it guides the catheter during canulation to the specific anatomical heart site however it is not so stiff as to be unbendable and tear through the patients vasculature.
Examiner is of the position that the prior art specifically Reynolds teaches forming the core wire of an elastic and resilient material that would have a second shape with greater potential energy than the preformed shape. Reynolds discloses that the material to form the core wire may be an elastic material that would be resilient. See para [0045].
Examiner is of the position that the prior art of Reynolds would have a preformed shape and would flex to traverse tortious body anatomy and then return to the preformed shape when not in the tortious body anatomy. This would be evidence of the second shape greater than the potential energy of the core wire in the preformed shape.
Concerning the claim language of “…wherein the stylet is non-steerable such that an orientation of the distal tip is automatic based on the vasculature of the patient...”. Examiner if of the position that this claim language is a functional type of limitation that requires the stylet to flex or conform in shape to pass through a vasculature of the patient in the shape/direction of the vasculature’s interior path. Examiner is of the position that the prior art of Bowe, Reynolds, and Nizai are flexible and of an elastic enough property to move through a patents vasculature in in an automatic fashion and would conform in shape to the tortious pathway of the vasculature and not steer without some form of steerage by the operatior. Bowe contemplates that the “steerage” feature is an alternative or optional feature and the pull ribbon may not be included. (see para [0010-0014] embodiment without the steering mechanism) or (device in figures 3-6).
Further Examiner references (Worley US 2006/0276868 A1) which shows a similar multiple bend guiding wire 32 or 44 for examples.
Concerning claim 2 and the first angle is about 15-90° with respect to a longitudinal axis of the stylet, and an arc length of the first pre-formed bend is about 3-7 inches (see para [0085]).
Concerning claim 3 and the second angle is about 8-15° with respect to a longitudinal axis of the stylet, and an arc length of the second pre-formed bend is about 0.2- 0.5 inches (see para [0085]).
Concerning claim 4 and the first pre-formed bend and the second pre-formed bend are entirely within 10 inches from an end of the distal tip of the core wire (again see para [0085]).
Concerning claim 5 and the first angle is about 60° with respect to a longitudinal axis of the stylet, and the second angle is about 10° with respect to the longitudinal axis of the stylet (see para [0013]).
Concerning claim 6 and the first pre-formed bend is longer than the second pre- formed bend (see figure 1).
Concerning claim 7 and the first pre-formed bend has an arc length of at least 4 inches longer than the second pre-formed bend (see para [0084]-[0085]).
Concerning claim 8 and the first pre-formed bend and the second pre-formed bend are in the same plane (see figure 17).
Concerning claim 9 and the narrow segment includes a rounded and/or flattened cross-section (see Reynolds figures 1-17 for example).
Concerning claim 10 and the core wire comprises a distal segment between the narrow segment and the distal tip, the distal segment having a width or diameter greater than the narrow segment (see figure 1 of Reynolds for one example).
Concerning claim 11 and the distal tip has a width or diameter greater than the distal segment (Reynolds figure 1 near 28 for example).
Concerning claim 12 and the core wire includes a proximal taper proximal of the narrow segment and distal taper distal of the narrow segment (see near 26).
Concerning claim 13 and the proximal taper is longer than the distal taper (compare 20 to 26).
Concerning claim 14 and the proximal taper includes a first tapered portion and a second tapered portion, the first tapered portion being tapered at a greater angle than the second tapered portion (see 18 and 22).
Concerning claim 15 and a tubular body disposed over the core wire (see 46 or 54 of Reynolds for example).
Concerning claim 16 and the distal tip of the core wire extends distally of the tubular body and the distal tip is conductive of an electrocardiogram (ECG) signal (see figure 9 and tubular body 9 for example).
Concerning claim 17 and the tubular body has an opening in a sidewall to allow fluid contact with the core wire (see figure 7 or para [0081]-[0084]).
Concerning claim 18 and comprising a navigation device disposed over the core wire and within the tubular body (80 for one example as in figure 7).
Concerning claim 19 and the navigation device comprises a conductive coil (46).
Concerning claim 20 and the stylet has minimal or no torquability (see Reynolds para [0040]).
Concerning claim 21 and the core wire further comprises an intermediate portion of about 1-3 inches extending between the first pre-formed bend and the second pre-formed bend (see para [0055]).
Concerning claim 22 and the core wire further comprises a distal portion including the narrow segment, the distal portion extending about 1-2 inches from the second pre-formed bend to an end of the distal tip (see para [0055]).
Concerning claim 23 and a housing member at a proximal end of the core wire (see Bowe near 5).
Concerning claim 24 and the core wire comprises a nickel titanium alloy (see para [0045]).
Concerning claim 25 and the distal tip is formed of one of a J-shape, a basket, or a mesh see figure 16-18 of Bowe or Reynolds figure 7-11).
Concerning claim 26 and a second stylet that is conductive of an ECG signal (note multiples of the prior art device).
Concerning claim 27 and catheter disposed over the stylet (see 54 for example).
Concernign claim 28 and a low or non-torqueable stylet comprising: a core wire including: a first pre-formed bend of a first angle of about 15-90°; a second pre-formed bend of a second angle of about 8-15°, the second pre- formed bend being distal of the first pre-formed bend, and the first pre-formed bend being longer than the second pre-formed bend; an intermediate portion of about 1-3 inches extending between the first pre- formed bend and the second pre-formed bend; and a distal portion of about 1-2 inches between the second pre-formed bend and an end of a distal tip, the distal portion having a narrow segment with a reduced width or diameter that increases deflection of the distal tip, wherein the first pre-formed bend and the second pre-formed bend are entirely within 10 inches from an end the distal tip of the core wire; a navigation device disposed around the core wire; a tubular body disposed around the core wire and the navigation device; and. , (see rejection above with the previously identified and claimed structural elements). Further see the rejection regarding claim 1 and the Reynolds and Niazi prior art combination concerning the amended claim language
Concerning the claim language of “…wherein the stylet is self-orienting such that manual rotation of a proximal portion of the stylet does not transmit an amount of torque to the distal tip to cause a rotation thereof…”. Examiner is of the position to interpret this as meaning the stylet is very flexible and conforms to whatever the stylet is incased in (interior of the pateints vasculature). Examiner is of the positon that each of the devices of the prior art are flexible enough to move in the same direction and scope of the patients vasculature that they reside in in order to be placed into the vasculature of the patient and not cause injury.
Response to Arguments
Applicant’s arguments with respect to the rejections of claim(s) 1-28 under 35 U.S.C. 103 have been considered but are not persuasive.
Applicant argues that the prior art combination fails to teach the newly amended claim language. Examiner disagrees.
As stated in the rejection of claim 1 above concerning the claim language of “…wherein the stylet is non-steerable such that an orientation of the distal tip is automatic based on the vasculature of the patient...”. Examiner if of the position that this claim language is a functional type of limitation that requires the stylet to flex or conform in shape to pass through a vasculature of the patient in the shape/direction of the vasculature’s interior path. Examiner is of the position that the prior art of Bowe, Reynolds, and Nizai are flexible and of an elastic enough property to move through a patents vasculature in in an automatic fashion and would conform in shape to the tortious pathway of the vasculature and not steer without some form of steerage by the operatior. Bowe contemplates that the “steerage” feature is an alternative or optional feature and the pull ribbon may not be included. (see para [0010-0014] embodiment without the steering mechanism) or (device in figures 3-6).
Concerning the claim 28 language of “…wherein the stylet is self-orienting such that manual rotation of a proximal portion of the stylet does not transmit an amount of torque to the distal tip to cause a rotation thereof…”. Examiner is of the position to interpret this as meaning the stylet is very flexible and conforms to whatever the stylet is incased in (interior of the pateints vasculature). Examiner is of the positon that each of the devices of the prior art are flexible enough to move in the same direction and scope of the patients vasculature that they reside in in order to be placed into the vasculature of the patient and not cause injury.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
It is recommended applicant amend the claims to greater distinguish over the prior art of record and any obvious modification thereof
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILLIP A GRAY/Primary Examiner, Art Unit 3783