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 action is in response to the amendment filed on 07/16/2025 and RCE filed on 08/13/2025. Claims 1-22 are pending. Claims 1, 5, and 11 are independent. Claims 4-10, 15, 19, and 20 are withdrawn. Claims 21 and 22 are newly added.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/16/2025 has been entered.
Claim Objections
Claims 1, 2, and 11 are objected to because of the following informalities:
Claim 1, line 9, “a length of lead” should be amended to --a length of the implantable medical lead--.
Claim 1, line 9, “the length of lead” should be amended to --the length of the implantable medical lead--.
Claim 1, line 12, “the lead” should be amended to --the implantable medical lead--.
Claim 2, line 2, “the length of lead” should be amended to --the length of the implantable medical lead--.
Claim 11, line 9, “length of lead” should be amended to --length of the implantable medical lead--.
Claim 11, line 11, “length of lead” should be amended to --length of the implantable medical lead--.
Claim 11, line 13, “the lead” should be amended to --the implantable medical lead--.
Claim 11, line 18, “lead” should be amended to --the implantable medical lead--.
Claim 11, line 20, “lead” should be amended to --the implantable medical lead--.
Claim 11, line 22, “lead” should be amended to --the implantable medical lead--.
Claim 11, line 23, “the lead” should be amended to --the implantable medical lead--.
Claim 11, line 24, “lead” should be amended to --the implantable medical lead--.
Appropriate correction is required.
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.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
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 1-3, 11-14, 16-18, 21 and 22 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.
Claim 1 recites the limitation “wherein the length of lead to introduce into the body of the patient varies by 10 centimeters (cm) to 50 cm based on one or more of a path of the lead to a heart of the patient or a heart size of the patient.” The limitation is indefinite because it recites a range varies on various or different condition (or a variable based on another variable), such that the length of lead to introduce into the body of the patient varies by 10 centimeters (cm) to 50 cm based on one or more of a path of the lead to a heart of the patient or a heart size of the patient. Secondly, the limitation “the length of lead to introduce into the body of the patient varies by 10 centimeters (cm) to 50 cm” is unclear whether it means that the length of lead to introduce into the body of the patient changes by 10 centimeters (cm) to 50 cm in a reference length or the length of lead to introduce into the body of the patient has a range of 10 centimeters (cm) to 50 cm. Therefore, it is unclear what the metes and bounds is for claim 1. For the purpose of examination, the limitation “wherein the length of lead to introduce into the body of the patient varies by 10 centimeters (cm) to 50 cm based on one or more of a path of the lead to a heart of the patient or a heart size of the patient” is interpreted to be “wherein the length of the implantable medical lead to introduce into the body of the patient has a range of 10 centimeters (cm) to 50 cm.”
Claim 11 recites the limitation “wherein the minimum length of lead to introduce into the body of the patient varies by 10 centimeters (cm) to 50 cm based on one or more of a path of the lead to a heart of the patient or a heart size of the patient.” The limitation is indefinite because it recites a range varies on various or different condition (or a variable based on another variable), such that the minimum length of lead to introduce into the body of the patient varies by 10 centimeters (cm) to 50 cm based on one or more of a path of the lead to a heart of the patient or a heart size of the patient. Secondly, the limitation “the length of lead to introduce into the body of the patient varies by 10 centimeters (cm) to 50 cm” is unclear whether it means that the minimum length of lead to introduce into the body of the patient changes by 10 centimeters (cm) to 50 cm in a reference length or the length of lead to introduce into the body of the patient has a range of 10 centimeters (cm) to 50 cm. Therefore, it is unclear what the metes and bounds is for claim 11. For the purpose of examination, the limitation “wherein the minimum length of lead to introduce into the body of the patient varies by 10 centimeters (cm) to 50 cm based on one or more of a path of the lead to a heart of the patient or a heart size of the patient” is interpreted to be “wherein the minimum length of the implantable medical lead to introduce into the body of the patient has a range of 10 centimeters (cm) to 50 cm.”
The art rejection(s) below is/are made as best understood by the examiner because of the 35 U.S.C. 112(b) issue(s) stated above.
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.
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) 1-3, 11-14, 16-18, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tronnes (US Pub. No.: 2010/0228328) in view of Williams et al. (US Pub. No.: 2007/0112405).
Regarding claims 1-3, 21, and 22, Tronnes discloses [claim 1] an implant tool system (200, Fig. 2) comprising: an implantable medical lead (201, Fig. 2 and Para. [0024) configured to be delivered through an access point on a body of a patient; a delivery catheter (220, Fig. 2) configured to deliver the implantable medical lead along an implantation path in the body of the patient; and a visual marker (marker 215/216, Fig. 2) positioned: on a body of the implantable medical lead, and proximal a distal end of the implantable medical lead by a distance indicative of a length of the implantable medical lead to introduce into the body of the patient (Fig. 2 and Para. [0029]); [claim 2] wherein the visual marker (Fig. 2, e.g. marker 216 is positioned such that introduction of the length of the implantable medical lead into the body of the patient provides lead slack that reduces the likelihood of one or more of dislodgment of the implantable medical lead from an implant point or damage to a tissue of the patient) is positioned such that introduction of the length of the implantable medical lead into the body of the patient provides lead slack that reduces the likelihood of one or more of dislodgment of the implantable medical lead from an implant point or damage to a tissue of the patient; [claim 3] wherein the visual marker is configured to be integrated into the body of the implantable medical lead or reversibly secured to the body of the implantable medical lead (Para. [0031]); [claims 21 and 22] wherein, the implant tool system is fully capable that, in a first instance, the visual marker on the body of the implantable medical lead is not aligned with a reference point and the implantable medical lead is not in contact with an implant point of the heart of the patient, and wherein, in a second instance, the visual marker on the body of the implantable medical lead is aligned with the reference point and the implantable medical lead is in contact with the implant point of the patient; wherein the reference point comprises the access point or a proximal end of the delivery catheter (Fig. 2, the implant tool system200 is fully capable that, in a first instance, the visual marker on the body of the implantable medical lead is not aligned with a reference point and the implantable medical lead is not in contact with an implant point of the heart of the patient, and wherein, in a second instance, the visual marker on the body of the implantable medical lead is aligned with the reference point and the implantable medical lead is in contact with the implant point of the patient; wherein the reference point comprises the access point or a proximal end of the delivery catheter). Tronnes further discloses that each distal end electrode is spaced apart from its corresponding marker by a distance corresponding to the length of the introducer (Para. [0029] and Fig. 2). However, Tronnes does not specifically disclose that the length of the implantable medical lead to introduce into the body of the patient has a range of 10 centimeters (cm) to 50 cm.
Williams teaches, in the same field of endeavor (medical lead introduction system), a catheter (300, Figs. 3 and 4) for introducing a medical lead to a heart; wherein the length of the catheter has a range of about 30 cm to 60 cm, such as 30 cm (Para. [0030]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the length of the catheter of Tronnes to be from 10 cm to 50 cm, such as 30 cm as taught by Williams, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art. See MPEP 2144.05. In modified invention, the length of the implantable medical lead to introduce into the body of the patient has a range of 10 centimeters (cm) to 50 cm because Tronnes discloses that each distal end electrode is spaced apart from its corresponding marker by a distance corresponding to the length of the introducer (Tronnes, Para. [0029] and Fig. 2). In addition, the range of the length of the lead to be 10 centimeters (cm) to 50 cm is fully capable to be based on one or more of a path of the lead to a heart of the patient or a heart size of the patient.
Regarding claims 11-14 and 16-18, Tronnes discloses [claim 11] an implant tool system (200, Fig. 2) comprising: an implantable medical lead (201, Fig. 2 and Para. [0024) configured to be delivered through an access point on a body of a patient; a delivery catheter (220, Fig. 2) configured to deliver the implantable medical lead along an implantation path in the body of the patient; a first visual marker (215, Fig. 2) positioned: on a body of the implantable medical lead, and proximal a distal end of the implantable medical lead by a first distance (Fig. 2 and Para. [0029], the distance is fully capable of indicating a minimum length of lead to introduce into the body of the patient such that the distal end of the implantable medical lead abuts an implant point) indicative of a minimum length of lead to introduce into the body of the patient such that the distal end of the implantable medical lead abuts an implant point (Fig. 2 and Para. [0029]); and a second visual marker (216, Fig. 2) positioned: on the body of the implantable medical lead and proximal the distal end of the implantable medical lead by a second lead distance indicative of an additional length (E1+d or M1-2+d1) of lead to introduce into the body of the patient (Fig. 2), wherein the additional length of lead to introduce into the body of the patient is based on one or more of the path of the lead into the heart of the patient or the heart size of the patient, wherein the additional length of lead ranges from 1 cm to 5 cm (Para. [0026], E1+d is a between 1 cm and 5 cm); [claim 12] a third visual marker (217, Fig. 2) positioned: on the body of the implantable medical lead and proximal the distal end of the implantable medical lead by a third lead distance (the lead distance from distal end of the marker 217 to the distal end of the lead is fully capable of indicating a length to withdraw the delivery catheter from the body of the patient after fixation of the implantable medical lead to a tissue of the patient and before slitting the delivery catheter because the position of the markers are fixed/known or the distances between the markers and the distal end of the lead are fixed/known) indicative of a length to withdraw the delivery catheter from the body of the patient after fixation of the implantable medical lead to a tissue of the patient and before slitting the delivery catheter; [claim 13] wherein the second visual marker is positioned such that introduction of the length of lead into the body of the patient provides lead slack that reduces the likelihood of one or more of dislodgment of the implantable medical lead from an implant point or damage to a tissue of the patient; [claim 14] wherein the second visual marker is configured to be integrated into the body of the implantable medical lead or reversibly secured to the body of the implantable medical lead (Para. [0031]); [claim 17] wherein the position of the first visual marker is based on one or more of a body mass index of the patient, height of the patient, vasculature tortuosity of the patient, an access vessel of the patient, a location along the access vessel of the patient, the heart size of the patient, or the implant point (Fig. 2, the position of the first visual marker is fully capable to be based on one of vasculature tortuosity of the patient, an access vessel of the patient, a location along the access vessel of the patient, the heart size of the patient, or the implant point); [claim 18] wherein the position of the first visual marker is based on a length of the delivery catheter from a proximal end of the delivery catheter to a distal end of the delivery catheter (Para. [0029] and Fig. 2). However, Tronnes does not disclose that the minimum length of lead to introduce into the body of the patient ranges from 10 centimeters (cm) to 50cm.
Williams teaches, in the same field of endeavor (medical lead introduction system), a catheter (300, Figs. 3 and 4) for introducing a medical lead to a heart; wherein the length of the catheter has a range of about 30 cm to 60 cm, such as 30 cm (Para. [0030]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the length of the catheter of Tronnes to be from 10 cm to 50 cm, such as 30 cm as taught by Williams, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art. See MPEP 2144.05. In modified invention, the length of the implantable medical lead to introduce into the body of the patient has a range of 10 centimeters (cm) to 50 cm because Tronnes discloses that each distal end electrode is spaced apart from its corresponding marker by a distance corresponding to the length of the introducer (Tronnes, Para. [0029] and Fig. 2). In addition, the range of the minimum length of the lead to be 10 centimeters (cm) to 50 cm is fully capable to be based on one or more of a path of the lead to a heart of the patient or a heart size of the patient.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 11-14, 16-18, 21 and 22 have been considered but are moot in view of new ground(s) of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/Primary Examiner, Art Unit 3771