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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 06/15/2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim.
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: “fixation mechanism” in claim 1.
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.
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.
The specification of the present invention discloses in [0022] “Fixation mechanism 126 may include, for example, one or more elongated tines such as fixation tines configured to4
substantially maintain an orientation of lead 102 with respect to a target site. Fixation mechanism 126 may include any shape, including a helically-shaped fixation element, as shown in FIGS. 1-2”. Therefore, a tine, helix, or equivalent structure capable of securing the position of the device at a target site will be interpreted as meeting the limitation.
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.
Claim(s) 1, 2, 4, 5, and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gerber (US 2008/0103575).
Regarding claim 1, Gerber discloses an implant tool system (FIG 1A-2) comprising: an implantable medical device (14, FIG 2, [0022-0034]) sized to be inserted through a lumen of an introducer from a proximal end of the introducer to a distal end of the introducer (such an introducer needle 38, [0029-0031]), wherein the implantable medical device comprises: a device body extending from a proximal end of the implantable medical device to a distal end of the implantable medical device (elongate body 48, FIG 2; or alternatively lead body 62, 72, 82, 92 of the embodiments of FIG 3A-4C); a balloon mechanically supported by the device body (66B or 76C or 86E-G or 96B, FIGs 3-4C; a fixation mechanism (66A or 76A-B or 86A-C or 96B, FIGs 3-4C) configured to affix the distal end of the implantable medical device to a target site within a body of a patient (0066-0076] disclose the use of various inflatable members to fix the positioning of the lead); and a zone visual marker (45, [0037]), positioned on an exterior surface of the device body (FIG 2, [0037]), comprising: a distal end of the zone visual marker (leading distal edge of marker 45), wherein the distal end of the zone visual marker aligning with the proximal end of the introducer indicates when to move the introducer relative to the implantable medical device (examiner notes the introducer is not a positively recited element of the claim. However, the position of the distal edge of 45 relative to an introducer such as needle 38 can be used to determine the relative location of the distal end of the implantable medical device and therefore can be used to “indicate” when to move i.e. further advance the device relative to the introducer); and a proximal end of the zone visual marker (trailing proximal edge of 45), wherein the proximal end of the zone visual marker aligning with the proximal end of the introducer indicates when to: inflate the balloon and affix the distal end of the implantable medical device to the target site via the fixation mechanism, or deflate the balloon such that the balloon can be withdrawn through the introducer (The proximal trailing edge of the marker being aligned with the introducer is at least configured such that it could indicate that the device has been inserted to the desired depth and that the device is properly positioned for the next step of the treatment to be performed such as inflate the balloon to fix the position of the device at the target site).
Regarding claim 2, Gerber discloses the proximal end of the zone visual marker aligning with or being distal to the proximal end of the introducer indicates when to deflate the balloon and withdraw the implantable medical device through the lumen (Examiner notes the introducer is not a positively recited element of the claim. The device is at least configured such that the location of the proximal end of the zone visual marker can be used to indicate when to deflate the balloon and withdraw the device because it was determined that the procedure has been completed).
Regarding claims 4-5, Gerber discloses the implantable medical device comprises a rotation visual marker ([0037] discloses that lead 14 “may include one or more orientation markers 45”. Therefore, there is contemplated to be at least an additional marker 45) can positioned on the exterior surface of the device body ([0037]), wherein an angular rotation of the rotation visual marker corresponds to an angular rotation of the fixation mechanism ([0037] discloses orientation marker 45 may also extend around the same portion of the circumference of lead body 48 or along the side of the paddle lead as electrodes 50. In this way, orientation marker 45 faces the same direction as electrodes, thus indicating the orientation of electrodes 50 to the clinician. Because the position of the electrodes is also fixed relative to the fixation mechanism, the marker 45 therefore corresponds to an angular position of the fixation mechanism as well as the electrode) wherein the rotation visual marker is a longitudinal visual marker that extends around only a portion of a circumference of the device body ([0037] ”orientation marker 45 may also extend around the same portion of the circumference of lead body 48 or along the side of the paddle lead” which is understood to mean only along a portion of the circumference of the device body).
Regarding claim 8, Gerber discloses the implantable medical device comprises at least one radiopaque marker ([0037] discloses that lead 14 “may include one or more orientation markers 45”. Therefore, there is contemplated to be at least an additional marker 45. [0037] further discloses that 45 can be a radiographic marker) that indicates when to move the introducer relative to the implantable medical device ([0037] marker 45 “thus indicating the orientation of electrodes 50 to the clinician. When the clinician implants lead 14 in patient 16, orientation marker 45 may remain visible to the clinician”, therefore indicating when to move the relative positioning of the device such as rotationally).
Regarding claim 9, Gerber discloses the zone visual marker is integrated into the device body ([0037] discloses 45 can be printed on to body 48 or an indentation thereon, which is interpreted as being integrated into the body).
Regarding claim 10, Gerber discloses the implantable medical device comprises an implantable medical lead configured to deliver therapy to the patient (the device is disclosed as being a lead, [0021-0024]).
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.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber (US 2008/0103575) in view of Thai et al. (US 2022/0039833).
Regarding claim 3, Gerber discloses the invention substantially as claimed, as set forth above for claim 1. Gerber further discloses the fixation mechanism “may define protrusions of any suitable shape and size that are capable of engaging with surrounding tissue when implanted in patient 16. In other embodiments, balloons 66 may define tines or flange-like structures when expanded” ([0061]), therefore contemplating alternative shapes of the fixation mechanism.
Gerber is silent regarding the fixation mechanism being a helix.
However, Thai et al. disclose a fixation mechanism (140, FIG 4) for affixing the distal end of an implantable medical device (110) to a target site within the body of a patient ([0075-0080]; anchor 140 engages directly with the target site within a body) wherein the fixation mechanism is a helix ([0077] discloses the use of a helical rib anchor is interchangeable with a circumferential balloon anchor).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the balloon fixation mechanism of Gerber to be formed as a helix, as taught by Thai et al., for the purpose of being formed in a shape commonly known in the art and performing equally as well at attaching a distal end of an implantable medical device within a target tissue. Furthermore, the substitution of one shape known in the art for another would have resulted in the predictable result of securely anchoring the device body in place. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber (US 2008/0103575) in view of Bajema et al. (US 2017/0021139).
Regarding claims 6-7, Gerber discloses the invention substantially as claimed, as set forth above for claim 1.
Gerber further discloses the use of a plurality of markers 45 ([0037]) but fails to explicitly disclose the implantable medical device comprises one or more depth visual markers, positioned on the exterior surface of the device body, indicative of a depth of insertion of the implantable medical device through the lumen, wherein the one or more depth visual markers are circumferential visual markers that completely extends around a circumference of the device body.
However, Bajema et al. teaches in the same field of endeavor a medical device for insertion into a target site of the body (10, FIG 3-4) having a device body (see elongate shaft in FIGs 5-7) comprising one or more depth visual markers (32, [[0054-58] disclose the markers are used to determine a depth. [0057] discloses “the marking 30 is provided on the catheter 10 in the form of spaced marks 32, each of which represents a known distance from a pre-determined, fixed location on the catheter 10.”), positioned on the exterior surface of the device body 9[0054-0055]), indicative of a depth of insertion of the medical device ([0054 and 0057]), wherein the one or more depth visual markers are circumferential visual markers that completely extends around a circumference of the device body ([0054] “marking 30 may comprise a plurality of spaced marks 32, such as circular or partially circular (e.g., 1-359 degrees) bands surrounding the shaft 14 and positioned at pre-determined intervals”).
Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device body of Gerber to further comprise one or more depth visual markers, positioned on the exterior surface of the device body, indicative of a depth of insertion of the implantable medical device through the lumen, wherein the one or more depth visual markers are circumferential visual markers that completely extends around a circumference of the device body, as taught by Bajema et al., for the purpose of providing an enhanced trackability during an interventional procedure while minimizing the use of fluoroscopy ([0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
Prosecution Insights