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 .
Response to Amendment
This Action is in response to the Amendment filed April 2, 2026.
Claims 1-2, 5-6, 9-13, 15-16, 19-20 are amended.
No claims are canceled.
Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed April 2, 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., an identifier material directly deposited onto, incorporated into, or encapsulated as part of the surface of the assembly by printing, laser marking, or overmolding becomes a component of the assembly and is expressly excluded from the separate from category) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is unclear why applicant argues that encapsulation/overmolding disqualifies a label as being separate from the lead port assembly as paragraph [0043] of applicant’s specification states that the header can be epoxied and overmolded over the pre-printed label so that the typed of label materials and inks are not an issue.
Applicant appears to be arguing that the instant claims require a pre-printed label that is affixed with adhesive to the lead port assembly. However, the claimed invention simply states “an identifier material, separate from the lead port assembly, affixed to the lead port assembly” in claim 1; or “affixing an identifier material to a lead port assembly for placement in a header … the identifier material separate from the lead port assembly” in claim 10. The identification material of the claims 1-2, 5-12, and15-20 is not required to be on a pre-printed label, or on a sticker or other marker, which is affixed to the lead port assembly as described in paragraph [0043] of Applicant’s specification. It is the Examiner’s position that Edgell discloses an identifier material/labels that is/are separate from the lead port assembly as its identifiers are of a different material than that used for the lead port assembly, and the labels of Edgell are affixed (Meriam Webster definition of affix: to attach physically or to attach in any way) to the lead port assembly.
Several paragraphs of Edgell support the Examiner’s position. Since the claim recites “the identifier material is … affixed to the lead port assembly”, the identifier can be attached physically or attached in any way. Edgell discloses a color-coded background printed onto the surface of the core assembly or the lead port assembly, which is printed with indicia as shown in Fig. 4B and described in paragraph [0058] of Edgell. The labels 84, 96, 88 of Edgell are not part of the lead port assembly as they are printed with pigment onto, and are not etched into the lead port assembly. That is, the labels of Edgell that may “include multiple sections, regions or features having different characteristics” (paragraph [0059] of Edgell) are separate from the core assembly or lead port assembly. Paragraph [0060] of Edgell discloses an embodiment where the label is printed (attached in any way) to define first and second portions 90 and 92 as shown in Fig. 5, and thus Edgell discloses a label with a first layer/background and a second layer printed on top of the background to provide the indicia. See also “label 62 can be printed by printing the first and second portions separately onto a different background or no background at all” of paragraph [0060] which implies that the label is separate from a background/carrier material or no background.
It appears that Applicant has misconstrued paragraph [0052] of Edgell. The entirety of that paragraph was cited in the Office Action and is printed below:
[0052] FIG. 3 is a side view of the core assembly 38 according to an exemplary embodiment. In the illustrated embodiment, the labels 62, 64, and 66 are disposed on an outer surface 68 of the core assembly 38, proximate the respective lead bore cavities 42, 44, and 46. In one embodiment, the labels 62, 64, 66 are disposed on the outer surface 68 via a printing process. Printing the labels 62, 64, and 66 onto the core assembly 38 can simplify the manufacturing process as opposed to using separately printed labels and can allow the labels 62, 64, and 66 to be encapsulated when the header body 40 (shown in FIGS. 1 and 2) is molded over the core assembly 38. In alternative embodiments, the labels 62, 64, and 66 can be encapsulated via another layer instead of, or in addition to, the header body 40.
In this paragraph, Edgell discloses an illustrated embodiment in which the labels “are disposed on an outer surface of the core assembly”, and another embodiment in which the labels “are disposed on the outer surface 68 via a printing process.” Contrary to Applicant’s assertion, Edgell discloses two embodiments where the illustrated embodiment shows labels disposed on an outer core assembly, not using a printing process. That is, Edgell does not “teach away” from using the illustrated embodiment of a separate label disposed on the outer core assembly as a separate element.
The full sentence of Edgell concerning the printing the labels is as follows:
Printing the labels 62, 64, and 66 onto the core assembly 38 can simplify the manufacturing process as opposed to using separately printed labels and can allow the labels 62, 64, and 66 to be encapsulated when the header body 40 (shown in FIGS. 1 and 2) is molded over the core assembly 38.
That is, printing the labels simplifies the manufacturing process … and can allow the labels to be encapsulated when the header body is molded over the core assembly.
In response to applicant’s arguments concerning claim 2, page 7, lines 6-15 of the Office Action dated 01/09/2026 addresses the motivation for placing an identifier material on a strain relief. Edgell discloses labels are disposed proximate to the respective bore cavities, and Alves teaches that the strain reliever would be inserted proximal to the electrical contact segment. It would have been obvious to place the identifier material on the strain reliever as it is proximate to the bore cavities and the strain reliever would cover the label of Edgell. Thus, in order to see the label, one of ordinary skill in the art would have modified the system of Edgell in view of Genehr Alves to have identification material/label affixed to an outer surface of the strain reliever/strain relief segment.
Applicant’s arguments concerning the dependent claims address features that are not positively recited in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). With respect to the claims 2-7 and 12-15, Edgell discloses labels are disposed proximate to the respective bore cavities, and Alves teaches that the strain reliever would be inserted proximal to the electrical contact segment. It is commonsense that the label of Edgell would be placed on the side of the strain reliever in order for the label to be seen.
The rejections are maintained.
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.
Claims 1, 9-10, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2017/0354829 to Edgell et al. (hereinafter referred to as “Edgell”).
Regarding claim 1, Edgell discloses a system, comprising: a lead port assembly for placement in a header of an implantable medical device (e.g., abstract, paragraph [0042], and Fig. 2, core assembly 38), the lead port assembly comprising: proximal and distal ends, the proximal end comprising a bore configured to receive a proximal end of a lead (e.g., paragraph [0044]: core assembly 38 includes multiple interconnected cores, each defining a different one of the lead bore cavities 42, 44, 46 where they are received on the left-hand or proximal end); and an electrical contact configured to couple to an electrical contact of the lead when the lead is inserted into the lead port assembly (e.g., paragraph [0043]: electrical contacts 58 connect leads 14, 15, 16 shown in Fig. 1 to the pulse generator; and Fig. 2, 58); and an identifier material, separate from the lead port assembly, affixed to the lead port assembly, comprising a marking to identify a type of the lead port assembly (e.g., paragraphs [0052]: labels 62, 64, 66 are printed onto -or attached to- the core assembly 38; or, another embodiment uses separately printed labels disposed on the core assembly, Fig. 3 labels/identifiers 62, 64, 66; and [0058]-[0065]: Figs. 5-7).
With respect to claim 9, Edgell discloses the system of claim 1, comprising the header and a housing of the implantable medical device (e.g., paragraph [0036] and Fig. 1, housing 20 and header 22), wherein the lead port assembly is a generic lead port assembly for placement in the header (prior to the core assembly being labeled), wherein the identifier material is affixed to the lead port assembly to identify the type of the lead port assembly (e.g., paragraph [0052]) after the lead port assembly is coupled to a housing of the implantable medical device before incorporation in the header (the product of Edgell is substantially identical to the claimed invention – this clause introduces a product by process limitation and patentability is based on the product see MPEP 2113), wherein the type of the lead port assembly depends at least in part on electrical connections between the lead port assembly and the implantable medical device (this limitation is necessarily the case for any implantable medical device including the one disclosed by Edgell).
Referring to claim 10, Edgell discloses a method, comprising: affixing an identifier material to the identifier material on a lead port assembly for placement in a header of an implantable medical device (e.g., paragraphs [0052]: labels 62, 64, 66 are printed onto -or attached to- the core assembly 38; or, another embodiment uses separately printed labels disposed on the core assembly, Fig. 3 labels/identifiers 62, 64, 66, and labels 62, 64, 66 can be encapsulated when the header body 40 is molded over the core assembly 38; and [0058]-[0065]: Figs. 5-7), wherein the lead port assembly comprises: proximal and distal ends (e.g., Figs. 2-3 core assembly 38 has two ends: proximal end adjacent the bore openings where the labels 62, 64, 66 are located and a distal end on the other side of the core assembly 38), the proximal end comprising a bore configured to receive a proximal end of a lead (e.g., paragraph [0044]: core assembly 38 includes multiple interconnected cores, each defining a different one of the lead bore cavities 42, 44, 46 where they are received on the left-hand or proximal end); and an electrical contact configured to couple to an electrical contact of the lead when the lead is inserted into the lead port assembly (e.g., paragraph [0043]: electrical contacts 58 connect leads 14, 15, 16 shown in Fig. 1 to the pulse generator; and Fig. 2, 58), wherein the identifier material comprises a marking to identify a type of the lead port assembly (e.g., paragraph [0052]: in one embodiment, labels 62, 64, 66 are printed onto the core assembly 38 – another embodiment separately printed labels can be used; and Fig. 3, labels/identifiers 62, 64, 66).
Regarding claim 20, Edgell discloses a method, comprising: identifying a type of a lead port assembly for placement in a header of an implantable medical device (e.g., paragraph [0052]: labels 62, 64, 66 can be encapsulated when the header body 40 is molded over the core assembly 38) using a marking on an identifier material affixed to the lead port assembly (e.g., paragraphs [0052]: in one embodiment, labels 62, 64, 66 are printed onto the core assembly 38 – another embodiment separately printed labels can be used; and Fig. 3, labels/identifiers 62, 64, 66; [0058]-[0065]: Figs. 5-7), wherein the lead port assembly comprises: proximal and distal ends (e.g., Figs. 2-3 core assembly 38 has two ends: proximal end adjacent the bore openings where the labels 62, 64, 66 are located and a distal end on the other side of the core assembly 38), the proximal end comprising a bore configured to receive a proximal end of a lead (e.g., paragraph [0044]: core assembly 38 includes multiple interconnected cores, each defining a different one of the lead bore cavities 42, 44, 46 where they are received on the left-hand or proximal end); and an electrical contact configured to couple to an electrical contact of the lead when the lead is inserted into the lead port assembly (e.g., paragraph [0043]: electrical contacts 58 connect leads 14, 15, 16 shown in Fig. 1 to the pulse generator; and Fig. 2, 58).
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.
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.
Claims 2-7 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Edgell as applied to claims 1 and 10 above, and further in view of US Patent Application Publication No. 2024/0082588 to Genehr Alves (EFD: 03/17/2022).
With respect to claims 2 and 11, Edgell discloses the system of claim 1 and the method of claim 10, but does not expressly disclose that the lead port assembly comprises a strain relief segment at the proximal end of the bore having a first length, wherein the electrical contact is located distal to the strain relief segment on the lead port assembly, wherein the identifier material is separate from the strain relief segment and the lead port assembly, and affixed to the strain relief segment of the lead port assembly to identify the type of the lead port assembly. However, Genehr Alves, in a related art: self-sealing relief mechanism for implantable pulse generators, teaches that a strain relief segment positioned at the proximal end of the bore was well-known to those skilled in the art (e.g., paragraphs [0020]: Fig. 1 is a sectional view of a prior art strain relief for an electrode lead of an implantable pulse generator; and [0023]-[0024]: medical implant with a housing 2 and a socket for inserting an end portion 3 of an electrode lead 30; strain relief 21 surrounds the through-opening for receiving the end portion of the lead). Accordingly, one of ordinary skill in the art would have recognized the benefits of lead port assembly of an implantable medical device having a strain relief proximal to the electrical contact segment of the lead port assembly in view of the teachings of Genehr Alves. Consequently, one of ordinary skill in the art would have modified the system and method of Edgell so that its core assembly/lead port assembly comprise a strain relief segment at the proximal end of the bore in view of the teachings of Genehr Alves, and because the combination would have yielded a predictable result: an IMD with strain relief at the lead connection area.
With respect to the identifier material being affixed to the strain relief segment, the strain reliever of Edgell in view of Genehr Alves would be inserted proximal to the electrical contact segment of the core assembly in order to surround the through-openings of bore cavities 42, 44, 46 as shown in Fig. 4A of Edgell. Edgell discloses, in Fig. 3, that the labels 62, 64, 66 are disposed on the outer surface 68 of the core assembly 38 proximate to the respective lead bore cavities and are shown in Fig. 3 labeling the area where the strain relief of the core assembly combination would be placed. Accordingly, it would have been obvious to one of ordinary skill in the art to place the label/identifier of Edgell in view of Genehr Alves on the strain relief segment using an affixed label or printing the label on the strain relief segment.
With respect to claims 3 and 12-13, Edgell in view of Genehr Alves teaches the system of claim 2 and the method of claim 11, wherein the affixing of the identifier material to the strain relief segment occurs prior to forming the header of the implantable medical device, and the identifier material includes a carrier material comprising the marking (e.g., paragraphs [0052]: in one embodiment, labels 62, 64, 66 are printed onto the core assembly 38 – another embodiment separately printed labels can be used and then the labels are encapsulated when the header body is molded over the core assembly; and [0058]-[0060]: Figs. 4B-5), wherein the carrier material is separate from the strain relief segment and the lead port assembly and is affixed to the strain relief segment to identify the type of the lead port assembly (e.g., paragraph [0052]: label identifies the type of lead port assembly and is separate from the strain relief segment and the lead port assembly).
As to claims 4 and 14, Edgell in view of Genehr Alves teaches the system of claim 3 and the method of claim 11, wherein the carrier material is affixed to an outer surface of the strain relief segment with an adhesive (e.g., paragraphs [0052]-[0053]: printed/affixed labels can be encapsulated via another layer in addition to the header body 40; and [0066] of Edgell: the label may be entirely sealed so that no part of the label is exposed on an exterior of the pulse generator and that no part of the label may come into contact with tissue or fluids of the patient where the label may be sealed with an adhesive material).
With respect to claims 5 and 15, Edgell in view of Genehr Alves teaches the system of claim 2 and the method of claim 12, wherein the identifier material is affixed to a side portion of the strain relief segment viewable, through material of the header, from a side of the header (e.g., paragraph [0042]: header body 40 is transparent – thus, the identifier material printed on the side of the strain relief segment would be viewable through the material of the header).
As to claims 6 and 16, Edgell in view of Genehr Alves teaches the system of claim 2 and the method of claim 11, wherein the identifier material is affixed to a top portion of the strain relief segment (as shown in Fig. 4A of Edgell modified to have a strain relief segment at the bore openings – the labels/identifier material would
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be printed on a top portion), wherein the top portion of the strain relief segment is opposite a top of a housing of the implantable medical device, between a top of the header and the top of the housing.
With respect to claims 7 and 17, Edgell in view of Genehr Alves teaches the system of claim 2 and the method of claim 16, wherein the strain relief segment comprises a tube shape at the proximal end of the bore having an opening commensurate to a diameter of the lead at the strain relief segment when the lead is fully inserted into the lead port assembly to relieve strain on electrical connections of or associated with the lead port assembly, wherein the first length is along the lead port assembly from the proximal end of the bore (e.g., Abstract and paragraph [0024] of Genehr Alves: strain relief 21 is a sleeve which surrounds the through-opening 22 for receiving the end of the lead which would relieve strain on the electrical connections of the lead port assembly/core assembly). Accordingly, one of ordinary skill in the art would have modified the system and method of Edgell in view of Genehr Alves so that the strain relief segment is tube shaped at the proximal end of the bore and has an opening commensurate to a diameter of the lead at the strain relief segment when the lead is fully inserted into the lead port assembly to relieve strain on electrical connections of the lead port assembly in view of the teachings of Genehr Alves that such a strain relief structure was known to those skilled in the art to provide strain relief to the inserted lead, and because the combination would have yielded a predictable result.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Edgell as applied to claims 1 and 10 above, and further in view of US Patent Application Publication No. 2021/0104853 to Deininger et al. (hereinafter referred to as “Deininger”).
Edgell discloses the system of claim 1 and the method of claim 10, but does not expressly teach that the lead port assembly comprises a distal end to contact the proximal end of the lead when the lead is fully inserted into the lead port assembly, wherein the distal end comprises a mechanical retention feature to engage and retain the proximal end of the lead when the lead is fully inserted into the lead port assembly. However, Deininger, in a related art: apparatus and method for electrically coupling a stimulation lead with an implantable pulse generator, teaches a lead port assembly having a distal end (stop 119) to contact the proximal end of the lead thereby aligning the electrical connections of the fully inserted lead with corresponding electrical connector elements of the IMD (e.g., paragraph [0044] of Deininger); and a mechanical retention feature (set screw 132) that tightens against the proximal end 114 of stimulation lead 104 and secures the lead’s position when the lead is fully inserted (e.g., paragraph [0045] of Deininger). Accordingly, one of ordinary skill in the art would have recognized the benefits of a distal end that stops the inserted lead in the position so that the electrical connections of the lead correspond with the electrical connector elements of the IMD, and a mechanical retention feature (set screw) in view of the teachings of Deininger. Consequently, one of ordinary skill in the art would have modified the system and method of Edgell so that the bores of its core assembly have a distal end and a mechanical retention feature in order to position the inserted lead correcting within the IMD bore as taught by Deininger, and because the combination would have yielded a predictable result.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Edgell.
Edgell discloses the method of claim 10, wherein the lead port assembly is a generic lead port assembly for placement in the header (e.g., paragraph [0066]: the header body may be molded or otherwise formed as described above but without the labels), wherein affixing the identifier material to the lead port assembly comprises affixing the identifier material to the identifier material on the lead port assembly (e.g., paragraphs [0052] and [0066]), but does not expressly disclose that the identification occurs after the lead port assembly is coupled to a housing of the implantable medical device. However, paragraph [0066] of Edgell discloses a generic lead port assembly can be provided with labels after the header body/lead port assembly is made by forming a recess within the material of the header body and then inserting the label within the recess such that the label fits entirely within the recess and then fully encapsulating the label within the recess thereby incorporating the identifier material in the header). Thus, one of ordinary skill in the art would have recognized that generic (unlabeled) lead port assemblies, even those coupled to a housing of an implantable medical device, could be labeled with such identification in view of the teachings of Edgell, and because the combination would have yielded a predictable result.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2021/078853 to Biotronik is directed to an implantable medical device that also anticipates claim 1 where the identification material is separate from the core assembly and affixed to the lead port assembly via the header/material (see Figs all of the figures).
US Patent No. 8,200,335 to Donofrio et al. is directed to an implantable medical device lead connection assembly that teaches an identification material, separate from the lead port assembly, and affixed to the lead port assembly (e.g., column 14, lines 28-53: In addition to or instead of using different geometrical sizes for the leads, a visible identifier such as alphanumeric identifies, symbolic identifiers or other types of visible identifies may be used to associate leads with their respective connectors).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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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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/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792
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