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 .
Drawings
Figure 2 is objected to because the lines A-A, B-B and C-C are grainy and difficult to see in the drawing provided. Line A-A is specific to figure 4, line B-B is specific to figure 5 and line C-C is specific to figure 6.
Figure 5 contains the figure number 10c, and this should be 10b.
Figures 4-6 are objected to because they lack detail and are grainy. Many of the figure numbers contain lines pointing to a specific area of the figure however, it cannot be determined where the lines actually go or what element they are pointing to.
Figures 4-6 are objected to because they do not seem to match figure 2. Line A-A is a cross-section line for figure 4. In the area of line A-A in figure 2 there are three contacts (15) and two contacts (17). Contacts 15 are considered to be electrodes and contacts 17 are considered to be sensors. Element 121 in figure 4 is described as “first stimulation contact conductive layer”, if this drawing is being interpreted correctly there are six “first stimulation contact conductive layers”, which appear to be traces which electrically connect the electrodes to their respective connections 16/18 (figure 2). However, figure 4 shows what appears to be two electrodes and one sensor connected to traces, however this fails to match figure 2 in any way.
Figure 5 is the intermediate layer, and in figure 2 there are no contacts or openings for contacts seen in figure 2.
Figure 6 doesn’t show the contacts. The drawings are objected to because the detail cannot be determined.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the plurality of first stimulation contact conductive layers located in the stimulation segment, plurality of second stimulation contact conductive layers located in the intermediate segment, a plurality of third stimulation contact conductive layers located connection segment, a plurality of first collection contact conductive layers located in the stimulation segment, a plurality of second collection contact layers located in the intermediate segment, a plurality of third collection contact layers located in the collection segment must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 6-7, 9 and 12-13 objected to because of the following informalities:
Claim 1, lines 9-11 recite “and each of the plurality of first connection contacts is electrically connected to at least one stimulation contact through at least one stimulation contact conductive layer”. This language lacks proper antecedent basis and should read: “and each of the plurality of the first connection contacts is electrically connected to at least one of the stimulation contact through at least one of the stimulation contact conductive layers”.
Claim 1, lines 13-14 recite: “with at least one collection contact each arranged near one of the plurality of stimulation contacts and each insulated from the plurality of stimulation contacts,”. This language should read “with at least one collection contact arranged near one of the plurality of stimulation contacts, wherein the collection contacts and the stimulation contacts are individually insulated”
Claim 1, lines 14-16 recite: “the outer surface of the connection segment of the conductive flexible circuit board is provided with at least one second connection contact each insulated from the plurality of first connection contacts,”. This language should read “the outer surface of the connection segment of the conductive flexible circuit board is provided with a second connection contact insulated from the plurality of first connection contacts,”.
Claim 1, lines 18-19 recites: “the plurality of collection contact conductive layers”. This language should read “the plurality of the collection contact conductive layers”.
Claim 1, lines 21-21 recite: “and each of the at least one second connection contact is electrically connected to at least one collection contact through at least one collection contact conductive layer.” This language should read “and the at least one second connection contact is electrically connected to the at least one collection contact through the at least one collection contact conductive layer.”
Claim 6, lines 11 and 20 recite “layers is”, this should read “layers are”.
Claim 7, line 2 recites “layers is”, this should read “layers are”.
Claim 9, line 2 recites “contacts is”, this should read “contacts are”.
Claims 12-13 each recite “layers is”, this should read “layers are”.
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 3, 6-8 and 12-15 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.
Regarding claim 3: the claim recites in lines 2-5 recites “a plurality of collection contacts, at least one collection contact is provided near each of the plurality of stimulation contacts, and each of the at least one second collection contact is electrically connected to one collection contact through one collection contact conductive layer.” The underlined language is not understood. The language appears to be claiming that the collection contacts have their own conductive layer.
Regarding claim 6: the claim appears to be directed towards figures 4-6. Figures 4-6 are difficult to discern and have been objected to. Claim 6, lines 10-12 recite “and each of the plurality of second stimulation contact conductive layers is electrically connected to at least one first stimulation contact conductive layer and at least one third stimulation contact conductive layer”. The first stimulation contact conductive layer is 121 (figure 4), the second stimulation contact conductive layer is not shown in the figures and the third stimulation contact conductive layer is element 122 (figure 5). In light of the figures as well as the claim language this is not understood. Stimulation contact conductive layers and the collection contact conductive layers are considered to be traces and will run lengthwise connecting the electrodes to the contacts via the traces. However it is unclear what this language is directed towards. Lines 19-21 are rejected on the same basis, this is not shown in the figures and it is unclear what the language is directed towards. For the purposes of examination it will be assumed that the contact conductive layers are metallic traces which run from the electrode or sensor to the contact.
Regarding claim 6: lines 4-6 recite: “a plurality of first stimulation contact conductive layers, a plurality of second stimulation contact conductive layers, and a plurality of third stimulation contact conductive layers”. Claim 6 depends from claim 1, claim 1 recites “a plurality of stimulation contact conductive layers”. It is unclear if these are the same layers or different layers.
Regarding claim 6: lines 13-15 recite: “a plurality of first collection contact conductive layers, a plurality of second collection contact conductive layers, and a plurality of third collection contact conductive layers”. Claim 6 depends from claim 1, claim 1 recites “a plurality of collection contact conductive layers”. It is unclear if these are the same layers or different layers.
Regarding claim 6: lines 27-37 recite first, second, third and forth openings. The language found in lines 27-37 is not understood and is indefinite. It is assumed that each opening connects one of the three electrodes to a proximal connector and the remaining opening connects a collection contact to a proximal connector.
Claims 8 and 14-15 recite “and at least a portion of at least two stimulation contact conductive layers overlaps in the thickness direction of the conductive flexible circuit board.” This language is not understood and is indefinite.
Claim 13 is 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. Claim 13 is a duplicate of claim 12 and therefore does not further limit the claim. 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.
The remainder of the claims are also rejected in that they depend from previously rejected claims.
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, 3 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Young et al. US 10,589,085.
PNG
media_image1.png
492
637
media_image1.png
Greyscale
Regarding claim 1: Young discloses an implantable medical lead comprising a conductive flexible circuit board (“thin film”, figure 2), wherein the conductive flexible circuit board is divided into a stimulation segment, connection segment with an intermediate segment between the stimulation and connection segments (figure 2);
an outer surface of the stimulation segment 304 (figure 2) includes electrodes/stimulation contacts 132 (figure 2), an outer surface of the connection segment 310 (figure 2) includes a plurality of contacts/connectors 305 (figure 2), each electrode/stimulation contact 132 (figure 2) is connected to a contact 305 (figure 2) through metal traces within the cable 303 (figure 2 each metal trace within the cable is considered to be a contact conductive layer; the traces extend lengthwise and are embedded in the thin film, figure 9);
the outer surface of the stimulation segment 304 (figure 2) includes collection contacts 132 (the collection contacts are considered to be sensors, each electrode 132 on the stimulation segment 304 can act as a stimulation electrode or sense current, column 5, lines 45-50) which are near other electrodes 132 (figure 2); each of the collection contacts/sensors 132 (figure 2) is connected to a connection contact 305 (figure 2) in the connection segment 310 (figure 2) via the cable 303 which includes individual traces, the sensors/collection contacts are connected via wire traces 137 (figure 6), each trace is insulated from every other trace (figure 9). In figure 9 the first traces 135 connect the electrodes 132 (figure 2) and the second traces 137 (figure 9) connect the sensors 132 (figure 2).
Regarding claim 3: Young disclose that the outer surface of the stimulation segment 304 (figure 2) includes collection contacts/sensors 132 (figure 2, column 5, lines 45-50 discloses how each electrode can be a stimulation or sense electrode). Young further discloses that each collection contacts/sensors 132 (figure 2) is connected individually to a contact 305 on the proximal end 310 (figure 2) via the cable with metallic traces (figure 2), each metal trace is embedded in the structure as is shown in figure 9.
Regarding claim 14-15 as understood: Young discloses that the stimulation contact conductive layers are distributed on two layers L1/L2 (figure 9) which have different thicknesses. The layers are considered to overlap in that they overlay each other.
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.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Young et al. US 10,589,085 in view of Mercanzini et al. US 2013/0085361.
Regarding claim 2: Young discloses that the implant 130 is cylindrical (figures 1-2), cylindrical shapes are disclosed in column 1, line 47. Also note that the thin film is wrapped around a core creating a cylindrical shape (figure 2). However, it is unclear if the proximal end carrying the connection contacts is also cylindrical. Mercanzini however teaches of a deep brain electrode/lead 200 (figure 7, paragraph 0159) which includes a cylindrical proximal section 218 (figure 7) with multiple contacts 208 (figure 7). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Young to include a cylindrical proximal structure with contacts, as taught by Mercanzini, in order to communicate with the distal portion of the microelectronics.
Claims 6-8 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Young et al. US 10,589,085 in view of Mercanzini et al. US 2017/0028191.
Regarding claim 6 as understood: Young disclose a flexible substrate 301 (“thin film”, figure 2);
a plurality of first stimulation contact conductive layers at the stimulation contact segment (considered to be the wire traces from the electrodes 132 to the connectors 305, each individual electrode will have an individual trace or two individual traces, column 5, lines 35-40), a plurality of second stimulation contact conductive layers at the intermediate contact segment (considered to be the wire traces from the electrodes 132 to the connectors 305, each individual electrode will have an individual trace or two individual traces, column 5, lines 35-40), and a plurality of third stimulation contact conductive layers at the connection segment (considered to be the wire traces from the electrodes 132 to the connectors 305, each individual electrode will have an individual trace or two individual traces, column 5, lines 35-40). In the Young design, the traces run from the stimulation segment, through the intermediate segment to the connection segment thus creating electrical contact between the segments.
a plurality of first collection contact conductive layers at the stimulation contact segment (considered to be the wire traces from the electrodes 132 to the connectors 305, each individual electrode will have an individual trace or two individual traces, column 5, lines 35-40), a plurality of second collection contact conductive layers at the intermediate contact segment (considered to be the wire traces from the electrodes 132 to the connectors 305, each individual electrode will have an individual trace or two individual traces, column 5, lines 35-40), and a plurality of third collection contact conductive layers at the connection segment (considered to be the wire traces from the electrodes 132 to the connectors 305, each individual electrode will have an individual trace or two individual traces, column 5, lines 35-40). In the Young design, the traces run from the stimulation segment, through the intermediate segment to the connection segment thus creating electrical contact between the segments. To connect the stimulation electrodes traces 135 (figure 6) are used and to connect the collection/sensors traces 137 (figure 6) are used.
Young further discloses a insulating layer L1/L2 (figure 9, this is a polymer column 7, lines 16-17), the insulation L1/L2 (figure 9) encases/covers the plurality of first second and third stimulation contact conductive layers, covers the plurality of first second and third collection contact conductive layers (trace 135 is for the electrodes and trace 137 is for sensing).
In the Young disclosure each electrode 132 (figure 2) can act as a sensor or a stimulation electrode (column 5, lines 35-40), the electrodes are formed on a thin film with the traces 135/137 within the film, each trace will operably connect to an electrode distally and a contact proximally.
However, Young does not specifically disclose a plurality of first, second, third and fourth openings to connect the stimulation contacts and the collection contacts to proximal connectors. Mercanzini however teaches of a similar thin film device (figures 13a/13b which includes through holes 310 (figure 13a) and holes proximally but unlabeled, each hole 310 allows for an electrode to contact tissue and a connector to connect to an IPG while insulating the traces. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Young to include holes for electrodes/sensors to contact tissue while insulating the traces, as taught by Mercanzini, in order to stimulate and sense tissue.
Regarding claim 7: Young discloses that the electrical traces run from the distal end which connects the electrodes to the proximal end which then connects to a contact. This would have the stimulation contact conductive layers (considered to be the traces) constantly in contact. Stated another way, the first stimulation contact conductive layer is in the distal region (i.e. stimulation segment), the second stimulation contact conductive layer is in the intermediate region and the third stimulation contact conductive layer is proximal or the connection segment.
Regarding claim 8 as understood: Young discloses that the stimulation contact conductive layers are distributed on two layers L1/L2 (figure 9) which have different thicknesses. The layers are considered to overlap in that they overlay each other.
Regarding claims 12-13: Young discloses that the second collection contacts 132 (figure 2) conductive layers (traces) are electrically connected to and integrally formed with the first collection contact conductive layer and one third contact conductive layer (the traces run from the stimulation segment, through the intermediate segment to the collection segment, the first, second and third conductive layers are the traces
Claims 9 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Young et al. US 10,589,085 in view of McLaughlin et al. US 2020/02153335.
Regarding claims 9 and 16-17: Young discloses the claimed invention including multiple contacts 305 on the connection layer, however Young does not disclose that the connection segment has contacts that are annular and at intervals. McLaughlin however teaches of an implantable device, which can include microfabricated thin films (paragraph 0068). The lead 14 includes a proximal end plug 20 which as multiple ring contacts 22 (paragraph 42 and figure 2). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Young to include a proximal plug with multiple contact rings spaced apart at the proximal end, as taught by McLaughlin, in order to connect the lead to a conventional IPG.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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, Carl H Layno can be reached at 571-272-4949. 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.
PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796