DETAILED ACTION
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.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al U.S 2014/0046389.
Claim 1: Anderson et al disclose a pacemaker lead comprising: a lead body (see paragraph 11,” introducing into a coronary sinus of a heart a distal portion of a lead body component that comprises a proximal end and a distal end, wherein a first electrode, a second electrode, a third electrode and a fourth electrode are coupled to the lead body component, wherein the first through fourth electrodes are located on the lead body component from most distal to most proximal” comprising a body fixing part that has a straight configuration (straight configuration at fig. 5) and a self-bending spiral or wave form configuration (bent configuration at fig. 3); a lead fixing part having a plurality of electrodes 24/26, fig. 2 (the pacing lead includes three electrodes, see abstract, paragraph 29) thereon; a stylet channel; a stylet inserted through the stylet channel (it is noted that the pacing lead 16 has a hollow center for guidewire or stylet delivery (see fig. 2, paragraph 47); wherein the body fixing part has the straight configuration when the stylet is inserted through the stylet channel (see fig. 5), and has the spiral or wave form configuration when the stylet is withdrawn from the stylet channel (it is noted that the stylet may also be used to help the helix fixation member engage with the myocardium. This may be done by pre-bending the stylet wire, see fig. 3, paragraph 47).
Claims 2-4: Anderson et al disclose wherein the stylet 16 is stiffer at a proximal part (see paragraph 47, line 2) than at a distal part., further comprising a guidewire channel (lead 16 has a hollow center for a guidewire or stylet delivery to pass over the guidewire, see paragraph 47); and wherein an entrance for the guidewire channel is located between a distal end of the lead body and the electrodes (it is noted that a window appears via a scope during rotation to allow a surgeon to confirm that the rotation at the proximal end of the lead is turning the helix member 32, see paragraph 47).
Claims 5-6: Anderson et al disclose wherein an entrance for the guidewire
channel is located between the distal end of the stylet channel and the electrodes., wherein the guidewire channel is separate from the stylet channel (see fig. 7, paragraph 47, lines 9-12).
Claims 7, 9: Anderson et al disclose wherein the guidewire channel does not
extend or extends only partially through the lead body (see paragraph 11), wherein the guidewire channel (it is noted that lead 16 has a hollow center for a guidewire or stylet delivery to pass over the guidewire, see paragraph 47, fig. 7) extends only partially through the lead body and does not extend through the entire lead body.
Claims 8, 10: Anderson et al disclose the guidewire channel (it is noted that lead 16 has a hollow center for a guidewire or stylet delivery to pass over the guidewire, see paragraph 47, fig. 7) extends only partially through the lead body at a distal end of the lead body; wherein the guidewire channel extends only through the lead fixing part (see paragraph 29).
Claim Rejections - 35 USC § 103
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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al in view of Cross, Jr et al U.S 2006/0089692.
Claim 11 : Anderson et al disclose the invention substantially as claimed but is silent regarding further comprising reinforcing wires embedded in a wall of the lead body. Cross, Jr discloses similar device (a medical lead for use with an implantable medical device comprising a lead body having a distal end and a proximal end, an electrode formed at the distal end, an electrical contact formed at the proximal end, and a conductor electrically coupling the electrode and the electrical contact. The medical lead also comprises a stylet guide tube within the lead body, wherein the stylet guide tube comprises a coiled wire defining a lumen to removably receive a stylet, see paragraph 9) with reinforcing wires embedded in a wall of the lead body (see fig. 3, paragraph 59 that teaches conductor 55 comprises straight wires that extend axially along the length of lead 50). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson’s device to include reinforcing wires embedded in a wall of the lead body as taught by Cross, Jr in order to reduce the overall length of the conductor relative to coiled conductors, and thereby reduces conductor impedance (see paragraph 59).
Claim 12: Anderson et al disclose the invention substantially as claimed but is silent regarding the spiral or wave form consists of three bends. It would have been to one ordinary skilled in the art at the time the invention was made to construct the device that consists of three bends, since the applicant has not disclosed that doing so solves any stated problem or is anything more than selecting one of numerous shapes or configurations a person ordinary skill in the art would find available to substitute with the device that consists of three bends that is know in the surgical art (it is noted that applicant’ disclosure in paragraph 91 only stated that the body fixing part is formed after bending one side of the lead body part 120).
Conclusion
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/VI X NGUYEN/Primary Examiner, Art Unit 3771