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 .
Status of Claims
Claims 1-20 are currently pending and under consideration.
Claim Objections
Claims 1, 7, 9, 12, 15, 16 and 19 are objected to because of the following informalities:
In claim 1, the article “a” should be inserted before the term “proximal end” in line 3.
In claims 7, 9, 15, 16 and 19, the units used for location values are represented in two different units, cm and mm. For consistency reasons, examiner recommends the Applicant use either mm or cm.
In claim 12, the second occurrence of “implantable” in line 1 should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-17 and 20 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.
The term “generally” in claims 1, 11, 12, and 20 a relative term which renders the claims indefinite. The term “generally” 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. The relative location of the first and second plane in claims 1, 12, and 20 and the arrangement of the pre-formed distal portion in claim 11 are rendered indefinite by the use of the relative term “generally”. Further, dependent claims 2–11 and 13-17 depending from claims 1 and 12, respectively, are indefinite for the same reasons set forth for the independent claims 1 and 12.
In claim 5, the phrase “and mechanically and electrically coupled” is grammatically incomplete. It is unclear whether the second electrical conductor “is mechanically and electrically coupled” to the ring electrode or whether some other structure is intended. For the purpose of examination, the phrase has been interpreted as “wherein a second electrical conductor extends through a second lead body lumen and is mechanically and electrically coupled to the ring electrode.”
Claims 16 and 17 are indefinite because it appears that the statutory subject matter is changed from the implantable medical lead of claim 12 to the pre-formed distal portion of claims 12. Because claim 12 is directed to an implantable medical lead, it is unclear whether claims 16 and 17 are intended to further limit the implantable medical lead or instead separately claim only the pre-formed distal portion. For the purpose of examination, claims 16 and 17 has been interpreted as further limitation the implantable medical lead. Applicant is recommended to amend the preamble of claims 16 and 17 to “The implantable medical lead of claim 12” in order to overcome this rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As set forth in the rejection of claims 16 and 17 under 35 U.S.C. 112(b) above, claims 16 and 17 can be interpreted as separately claiming only the pre-formed distal portion. For this interpretation, claims 16 and 17 does not further limit their parent claim 12, which is directed to an implantable medical lead, and fails to incorporate all limitations of claim 12. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 8, 10, 12-14 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et. al (US 20090264974 A1, published 10/22/2009, hereinafter known as Zhang).
Regarding claim 1, Zhang discloses an implantable lead for use with an implantable medical device (IMD) (“lead implanted within a heart…lead is part of an implantable system” [0022] and annotated Fig. 1 below), the implantable lead comprising:
a lead body having proximal end and a distal end opposite the proximal end (“ lead includes a lead body extending from a proximal end to a distal end” [0024]);
a proximal connector at the proximal end of the lead body configured for mechanically and electrically coupling the lead to the IMD (“lead terminal pins are attached to pulse generator” [0024]);
a pre-formed distal portion comprising (“a pre-formed biased distal portion can be provided” [0030]):
a first portion extending from the distal end to a first curve (area shown between reference numbers 109 and 140 as shown in annotated Fig. 1 below, [0026]), the first portion being located in a first plane (“lead body includes a pre-formed, biased V-shape or J-shape formed in the intermediate portion of the lead body…pre-formed J-shape can be in either 2D or 3D”, the structure of the implantable lead in the prior art is the same as the structure of the implantable lead in the present invention, since both leads are placed in the same areas of the heart, it can only be assumed by one of ordinary skill in the art that the planar structure of the leads are the same [0026]);
a second portion extending from the first curve to a second curve (second portion and second curve shown below in annotated Fig. 1 below, [0026]), wherein the second portion and the second curve are located in a second plane that is generally orthogonal to the first plane (“lead body includes a pre-formed, biased V-shape or J-shape formed in the intermediate portion of the lead body…pre-formed J-shape can be in either 2D or 3D”, the structure of the implantable lead in the prior art is the same as the structure of the implantable lead in the present invention, since both leads are placed in the same areas of the heart, it can only be assumed by one of ordinary skill in the art that the planar structure of the leads are the same [0026]);
a third portion extending from the second curve to a third curve (area shown between reference number 105 and 12 as shown in annotated Fig. 1 below, [0026]);
a helical electrode extending distally from the distal end of the lead body (“lead is adapted to be actively fixated within the pulmonary artery utilizing a helix”, helix 410 in Fig. 7, [0040]); and
a ring electrode located along the first portion (“electrodes can be ring electrodes” electrodes 524 & 526 in Fig. 8, [0043]).
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Regarding claim 2, Zhang discloses the second portion and the third portion share the second plane (“lead body includes a pre-formed, biased V-shape or J-shape formed in the intermediate portion of the lead body…pre-formed J-shape can be in either 2D or 3D”, the structure of the implantable lead in the prior art is the same as the structure of the implantable lead in the present invention, since both leads are placed in the same areas of the heart, it can only be assumed by one of ordinary skill in the art that the planar structure of the leads are the same [0026]).
Regarding claim 3, Zhang discloses the third portion is located in a third plane that intersects the second plane (“lead body includes a pre-formed, biased V-shape or J-shape formed in the intermediate portion of the lead body…pre-formed J-shape can be in either 2D or 3D”, the structure of the implantable lead in the prior art is the same as the structure of the implantable lead in the present invention, since both leads are placed in the same areas of the heart, it can only be assumed by one of ordinary skill in the art that the planar structure of the leads are the same [0026]).
Regarding claim 4, Zhang discloses a first conductor extends through a first lead body lumen and is mechanically and electrically coupled to the helical electrode (“lead includes one or more conductors…the conductors are coupled to one or more electrodes… lead is adapted to be actively fixated within the pulmonary artery utilizing a helix” [0024] & [0040]).
Regarding claim 5, Zhang discloses a second electrical conductor extends through a second lead body lumen and mechanically and electrically coupled to the ring electrode (“lead includes one or more conductors…the conductors are coupled to one or more electrodes…electrodes can be ring electrodes” 524 & 526 in Fig. 8, [0024] & [0043]).
Regarding claim 6, Zhang discloses the second portion includes a shocking coil (“electrode can include a shocking coil electrode” [0025]).
Regarding claim 8 and 14, Zhang discloses the first portion is configured to be directed towards a ventricular septum and the second portion or the second curve are configured to be positioned adjacent a posterior right ventricular septal groove (“lead includes electrodes which are located so as to be proximate to or abut the septum (reference number 18 in Fig. 1) or be within the outflow tract when the lead is implanted…lead can be implanted as discussed above such that electrodes are located at the outflow tract or adjacent the RV septum” [0049]).
Regarding claim 10, Zhang discloses a stylet lumen configured for removably receiving a stylet (“lead can be configured to allow both a stylet or catheter delivery…an opening can be left through the middle of the lead to allow a stylet to be used” [0029]).
Regarding claim 12, Zhang discloses an implantable medical implantable lead (“lead implanted within a heart…lead is part of an implantable system” [0022]) comprising:
an elongate body defining a proximal portion and a pre-formed distal portion of the implantable lead (“lead includes a lead body extending from a proximal end to a distal end” [0024]), the pre-formed distal portion (“a pre-formed biased distal portion can be provided” [0030]) comprising:
a first portion extending from a distal end to a first curve (area shown between reference numbers 109 and 140 as shown in annotated Fig. 1 above, [0026]), the first portion being located in a first plane (“lead body includes a pre-formed, biased V-shape or J-shape formed in the intermediate portion of the lead body…pre-formed J-shape can be in either 2D or 3D”, the structure of the implantable lead in the prior art is the same as the structure of the implantable lead in the present invention, since both leads are placed in the same areas of the heart, it can only be assumed by one of ordinary skill in the art that the planar structure of the leads are the same [0026]); and
a second portion extending from the first curve to a second curve, (second portion and second curve shown below in annotated Fig. 1 above, [0026]), wherein the second portion and the second curve are located in a second plane that is generally orthogonal to the first plane (“lead body includes a pre-formed, biased V-shape or J-shape formed in the intermediate portion of the lead body…pre-formed J-shape can be in either 2D or 3D”, the structure of the implantable lead in the prior art is the same as the structure of the implantable lead in the present invention, since both leads are placed in the same areas of the heart, it can only be assumed by one of ordinary skill in the art that the planar structure of the leads are the same [0026]);
a helical electrode extending distally from the distal end (“lead is adapted to be actively fixated within the pulmonary artery utilizing a helix”, helix 410 in Fig. 7, [0040]); and
a ring electrode located along the first portion (“electrodes can be ring electrodes” electrodes 524 & 526 in Fig. 8, [0043]).
Regarding claim 13, Zhang discloses the pre-formed distal portion includes a third portion extending from the second curve to a third curve (area shown between reference number 105 and 12 as shown in annotated Fig. 1, [0026]).
Regarding claim 18, Zhang discloses a medical method (“method comprising: providing a lead having a lead body” [claim 18]) comprising:
implanting an implantable medical lead within a right ventricle of a patient’s heart (“lead is inserted through the right ventricle and into the pulmonary artery using a guiding catheter or a stylet” [0039]), including:
securing a helical electrode extending from a distal end of the implantable medical lead (“lead is adapted to be actively fixated within the pulmonary artery utilizing a helix”, helix 410 is located on the distal end of the lead in Fig. 7, [0040]) at a mid- or upper septal location on a right ventricular septum (“lead includes electrodes which are located so as to be proximate to or abut the septum” ventricular septum 18 in Fig. 1, [0049]) such that the helical electrode is capable of stimulating a left bundle branch or a right bundle branch of the patient’s heart (it is well known in the art that stimulation of the right ventricular septum also stimulates the left or right bundle branches); and
positioning a shocking coil located on a pre-formed portion of the implantable medical lead at a location adjacent a posterior right ventricular septal groove of the patient’s heart (“electrode can include a shocking coil electrode…lead can be implanted as discussed above such that electrodes are located at the outflow tract or adjacent the RV septum” [0024] & [0049]) and
coupling the implantable medical lead to an implantable pulse generator (“lead terminal pins are attached to pulse generator” [0024]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 7, 9, 11, 15-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of TzeTze et. al, (US 20230381501 A1, published 11/30/2023, hereinafter known as Tze).
Regarding claims 7, 15, and 19, Zhang does not disclose wherein a distal end of the shocking coil is located 30 – 40 mm from the distal end of the lead body.
However, Tze teaches a lead for a cardiac conduction system, including a distal end including a first electrode configured to be inserted into a portion of a ventricular septum; a second electrode coupled to the lead body; a fixation element configured to fix the lead to the portion of the ventricular septum; and a proximal end (Abstract). The shocking coil is provided at a distance between at or about 10 mm to at or about 50 mm from the second electrode or the distal end [0043].
The specification discloses the appropriate ranges that apply to the claimed invention on page 11 as 30-40 millimeters (mm). However, the specification does not disclose that the specifically claimed ranges of distance values of the shocking coil from the distal end is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Zhang in view of Tze teaches that the implantable lead can have a distance value of 30-40 mm, the prior art therefore provides teaching that the distance value is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Because Applicants fail to disclose that the claimed ranges of distance values provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that a relatively high distance absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable ranges of distance values by normal optimization procedures known in the cardiac stimulation arts.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the distance of the shocking coil from the distal end of the lead of Tze with the implantable lead of Zhang because at this distance, when a portion of the lead is implanted in the IVS through the right ventricle, the lead body can have a curvature, e.g., due to the flexibility of the lead body and length of the slack or portion between the shocking coil (Tze, [0043]).
Regarding claims 9 and 16, Zhang does not disclose wherein the ring electrode is located 1.0 -1.2 cm from the distal end.
However, Tze teaches that the lead body includes a non-conductive spacer proximal to the helix electrode, an outer electrode (e.g., a ring electrode) proximal to the spacer [0029]. The spacer and the first electrode extends through a cavity inside the housing, through a space inside the outer coil, and through a space inside the second electrode…the spacer has a length that ranges from at or about 4 mm to at or about 12 mm (0.4-1.2 cm) [0038].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the distance of the ring electrode from the distal end of the lead of Tze with the implantable lead of Zhang because the spacer can be integral to the first electrode as an electrode (Tze, [0037]).
Regarding claim 11, Zhang does not disclose wherein the pre-formed distal portion is configured to have a generally linear arrangement when constrained by a stylet or delivery catheter.
However, Tze teaches the first electrode can be a linear electrode…the distal end of the lead can be placed to the desired location using the catheter or stylet [0034] & [0050]. The lead visually has a linear configuration as shown in Figs. 1A and 1B.
Paragraph [0059] of the specification of the instant application recites “lead 114 in FIG. 2 is shown in a generally linear configuration, such as when a stylet is inserted into the stylet lumen”, indicating that a visual confirmation of a linear configuration is sufficient for examination purposes.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the use of a generally linear configuration of the lead using a stylet of Tze with the implantable lead of Zhang because this allows for a smooth insertion of the lead into the tissue.
Regarding claim 17, Zhang does not disclose wherein the pre-formed distal portion includes an outer diameter that tapers towards the distal end.
However, Tze teaches the first electrode extends from the lead body and can include a tapered tip and a rod integral to the tapered tip, as shown in Fig. 1C [0034].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the tapered distal portion of the lead of Tze with the implantable lead of Zhang because this structure allows for a smooth insertion of the lead into the tissue.
Regarding claim 20, Zhang discloses the pre-formed distal portion (“a pre-formed biased distal portion can be provided” [0030]) of the implantable medical lead (“lead implanted within a heart…lead is part of an implantable system” [0022]) includes:
a first portion extending from the distal end to a first curve (area shown between reference numbers 109 and 140 as shown in annotated Fig. 1 above, [0026]), the first portion being located in a first plane (“lead body includes a pre-formed, biased V-shape or J-shape formed in the intermediate portion of the lead body…pre-formed J-shape can be in either 2D or 3D”, the structure of the implantable lead in the prior art is the same as the structure of the implantable lead in the present invention, since both leads are placed in the same areas of the heart, it can only be assumed by one of ordinary skill in the art that the planar structure of the leads are the same [0026]); and
a second portion extending from the first curve to a second curve (second portion and second curve shown below in annotated Fig. 1 below, [0026]), wherein the second portion and the second curve are located in a second plane that is generally orthogonal to the first plane (“lead body includes a pre-formed, biased V-shape or J-shape formed in the intermediate portion of the lead body…pre-formed J-shape can be in either 2D or 3D”, the structure of the implantable lead in the prior art is the same as the structure of the implantable lead in the present invention, since both leads are placed in the same areas of the heart, it can only be assumed by one of ordinary skill in the art that the planar structure of the leads are the same [0026]).
Zhang does not disclose wherein the shocking coil is located along the second curve and is spaced 30 – 40 mm from the distal end of the implantable medical lead.
However, Tze teaches a lead for a cardiac conduction system, including a distal end including a first electrode configured to be inserted into a portion of a ventricular septum; a second electrode coupled to the lead body; a fixation element configured to fix the lead to the portion of the ventricular septum; and a proximal end (Abstract). The shocking coil is provided at a distance between at or about 10 mm to at or about 50 mm from the second electrode or the distal end [0043].
The specification discloses the appropriate ranges that apply to the claimed invention on page 11 as 30-40 millimeters (mm). However, the specification does not disclose that the specifically claimed ranges of distance values of the shocking coil from the distal end is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Zhang in view of Tze teaches that the implantable lead can have a distance value of 30-40 mm, the prior art therefore provides teaching that the distance value is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Because Applicants fail to disclose that the claimed ranges of distance values provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that a relatively high distance absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable ranges of distance values by normal optimization procedures known in the cardiac stimulation arts.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the distance of the shocking coil from the distal end of the lead of Tze with the implantable lead of Zhang because at this distance, when a portion of the lead is implanted in the IVS through the right ventricle, the lead body can have a curvature, e.g., due to the flexibility of the lead body and length of the slack or portion between the shocking coil (Tze, [0043]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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