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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/30/2025 has been entered.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP19218170.9, filed on December 19, 2019.
Status of Claims
This Office Action is responsive to the claims filed on October 21, 2024. Claim 1 has been amended. Claims 11-15 have been cancelled. Claims 2, 5, 6, and 16 were previously cancelled. Claims 1, 3, 4, and 7-10 are presently pending in this application.
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.
Claims 1, 3, 4, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Erhardt (Non-Patent Literature: Erhardt, JB. Et al. 2017. Precise Localization of Silicone-based Intercranial Planar Electrodes in Magnetic Resonance Imaging. 2017 39th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC)) in view of Grinstaff (US 20150297316).
Regarding claim 1, Erhardt teaches an implantable electrode array (Pg. 514, left col.; metal foil electrodes; Fig. 2) suitable for being placed in anatomic tissue of a human or animal body (Pg. 514, left col.; The result was an approximately 420 μm thick implant sample with electrode sites; Pg. 515, left col.; electrode samples implanted on the preserved sheep brain), comprising;
a structure (Pg. 514; The picosecond laser was used to structure the approximately 420 μm thick silicone rubber in geometries easily visible in MRI; reference structures shown in Fig. 2 and 3) for referencing electrode contacts (Pg. 514, right col.; The electrode location is determined by drawing connecting lines between the side edges of diagonally opposing reference structures) of the implantable electrode array in magnetic resonance images (Pg. 515, C. MRI examination in clinical setting; The electrode samples implanted on the preserved sheep brain could be clearly identified; Fig. 3 and 4 shows referencing electrode contacts of the implantable electrode array in magnetic resonance images), the structure being arranged in a predefined portion of the implantable electrode array (Abstract; Simple silicone reference structures were strategically placed on the implant surface to visualize the electrodes position in MRI; Fig. 2 Each sample consists of a 3 mm in diameter MP35N metal disc in the center and four surrounding elevated silicone structures as reference), the structure comprising:
a plurality of patterns (Fig. 2 shows there are 4 patterns), each pattern having a predefined form (Pg. 514; The picosecond laser was used to structure the approximately 420 μm thick silicone rubber in geometries easily visible in MRI) and comprising a material having a magnetic susceptibility which is different from the magnetic susceptibility of the anatomic tissue surrounding the array when placed in the human or animal body (Pg. 515, left col.; electrode samples implanted on the preserved sheep brain could be clearly identified (Fig. 4). The silicone substrate is rapidly found in a sagittal view and the reference structures unambiguously identify the location of the metal disc; Figs. 3 and 4 show the structure is different from the surrounding tissue), each pattern being in a predefined spatial relationship with one of the electrode contacts (Pg. 514, right col.; electrode location is determined by drawing connecting lines between the side edges of diagonally opposing reference structures (Fig. 3B). These lines coincide with the rim of the electrode structure, which allows for fitting a circle with the diameter of the metal disc in the center of the lines),
wherein the electrode contacts form a first regular two-dimensional grid with a first grid constant (Fig. 2 shows the four electrode contacts form 2D grid with a regular spacing), and the patterns form a second regular two-dimensional grid (Fig. 2 shows the four reference structures form a second regular 2D grid) with a second grid constant identical to the first grid constant (Fig. 2 shows the first grid of the electrodes and the second grid of the reference structures overlap and thus have identical grid constants), and wherein the predefined form is a cross (Pg. 514, right col.; electrode location is determined by drawing connecting lines between the side edges of diagonally opposing reference structures (Fig. 3B). These lines coincide with the rim of the electrode structure, which allows for fitting a circle with the diameter of the metal disc in the center of the lines; Fig. 2 and Fig. 3 show the reference structure pattern is a cross).
Erhardt does not explicitly teach the material comprises particles with a material selected from the group consisting of iron, iron oxide, oxides of rare earths, and pyrolytic carbon material.
Grinstaff, however, teaches an implantable array (Abstract, Paragraph [0007]; flexible polymeric tissue markers) suitable for being placed in anatomic tissue of a human or animal body (Paragraphs [0023]; generally be applicable to mark any tissue in a subject; and [0215]; As used herein, a “subject” means a human or animal), comprising a structure (Paragraphs [0124] and Fig. 1; Placement of the iron oxide nanoparticles making up a pattern) for referencing predefined distinct points (Paragraphs [0124]; deposited on the tissue markers in any desirable pattern; a pattern that can act as an identification tag) of the implantable electrode array in magnetic resonance images (Paragraph [0120]; at least one contrast agent detectable by at least magnetic resonance imaging (MRI)), the structure being arranged in a predefined portion of the implantable array (Paragraphs [0134]; or more contrast agents can be… placed atop a surface), the structure comprising:
a plurality of patterns (Paragraphs [0124]; The contrast agent(s) can be deposited on the tissue markers in any desirable pattern; the shape of the contrast agent placed on the matrix is a pattern. Fig. 1 shows the nanoparticles are placed in dots across the polymer matrix), each pattern having a predefined form (Paragraph [0124]; the contrast agent(s) can be deposited on the tissue markers… one alphabet, or at least one numerical digit, or at least one symbol, or any combinations thereof; Fig. 1) and comprising a material (Paragraph [0120]; Examples of MRI contrast agent(s) suitable for use in the tissue markers described herein can include, but are not limited to, metal oxide particles (e.g., iron oxide nanoparticles)) having a magnetic susceptibility which is different from the magnetic susceptibility of the anatomic tissue surrounding the array when placed in the human or animal body (Paragraph [0120]; Such MRI-detectable contrast agent(s) can have a magnetic susceptibility… or it can comprise a paramagnetic material that can induce T1 relaxivity yielding an increased signal on T1-weighted MRI or a decreased signal on T2-weighted MRI; Examiner notes the contrast agent selected induces relaxivity and decease T2-weighted MRI signals, which is understood to have the property of having a magnetic susceptibility which is different from the magnetic susceptibility of the anatomic tissue surrounding the array when placed in the human or animal body based on Applicant’s Specification, Paragraph [0039], which states “This difference in magnetic susceptibility is linked with a difference in the respective effective transverse relaxation times (T2*), e.g., a very short T2* for the material with a high magnetic susceptibility… such that the MRI signal in and near the pattern is lost”);
wherein the material comprises particles with a material of iron oxide (Paragraph [0120]; Examples of MRI-detectable contrast agent(s) include iron oxide particles; Fig. 1, iron oxide nanoparticles).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the implantable electrode array of Erhardt to have included material comprises particles with a material selected from the group consisting of iron, iron oxide as taught by Grinstaff because it is a well understood material for visualizing markers in MRI and would further allow controlling the visibility of the markers depending on the type of MRI contrast imaging being performed (Grinstaff, Paragraph [0120]).
Regarding claim 3, together Erhardt and Grinstaff teach all of the limitations of claim 1 as noted above.
Grinstaff further teaches the magnetic susceptibility of the material is than the magnetic susceptibility of the anatomic tissue surrounding the array when placed in the human or animal body (Paragraph [0120]; Such MRI-detectable contrast agent(s) can have a magnetic susceptibility… or it can comprise a paramagnetic material that can induce T1 relaxivity yielding an increased signal on T1-weighted MRI or a decreased signal on T2-weighted MRI; As noted in the rejection of claim 1, the contrast agent is understood to have the property of the magnetic susceptibility being higher than the magnetic susceptibility of the anatomic tissue surrounding the array when placed in the human or animal body based on Applicant’s Specification, Paragraph [0039], which states “This difference in magnetic susceptibility is linked with a difference in the respective effective transverse relaxation times (T2*), e.g., a very short T2* for the material with a high magnetic susceptibility… such that the MRI signal in and near the pattern is lost”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the implantable electrode array of Erhardt in view of Grinstaff such that the magnetic susceptibility of the material is than the magnetic susceptibility of the anatomic tissue surrounding the array when placed in the human or animal body because it allow controlling the visibility of the markers depending on the type of MRI contrast imaging being performed (Grinstaff, Paragraph [0120]).
Regarding claim 4, together Erhardt and Grinstaff teach all of the limitations of claim 1 as noted above.
Erhardt further teaches each pattern is isolated and spaced apart from each other pattern (Fig. 2 shows that the patterns are isolated and spaced apart from each other).
Regarding claim 7, together Erhardt and Grinstaff teach all of the limitations of claim 1 as noted above.
Erhardt further teaches the predefined portion comprises at least one of a top surface or a rear surface (Pg. 514, left col.; fabrication process to produce elevated structures on the implant… aligning both ceramic substrates against a corned stop and then pressing the two silicone surfaces on to each other; The patterns are pressed onto the implant which is considered to be a top or rear surface); or an edge or a corner (Fig. 2 shows the patterns are in each corner of the implant).
Regarding claim 8, together Erhardt and Grinstaff teach all of the limitations of claim 1 as noted above.
Erhardt further teaches two patterns are aligned along a straight first line (Fig. 2 shows 2 patterns along a first straight line; See below Fig. B, element L1), and two patterns are aligned along a straight second line (Fig. 2 shows 2 patterns along a second straight line; See below Fig. B, element L2), the second line being perpendicular to the first line (Fig. 2 shows the lines are perpendicular. See below Fig. B).
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Figure B: Adapted from Erhardt, Fig. 2
Erhardt does not explicitly teach at least three patterns aligned along the straight first line; and at least three patterns aligned along the straight second line.
One of ordinary skill in the art would have realized the only difference between the claimed invention and the implantable electrode array of Erhardt in view of Grinstaff is that the claimed array includes a larger grid of patterns such that there is at least three patterns aligned along the straight first line and there is at least three patterns aligned along the straight second line. One of ordinary skill in the art would have realized extending the patterns and electrodes of the implantable electrode array of Erhardt in view of Grinstaff to include at least three patterns aligned along the straight first line and at least three patterns aligned along the straight second line would have been a simple duplication of parts that would have had the predictable result of forming a larger electrode array with more points to receive signals and send activation signals to the implant while maintaining the ability to localize each electrode using the patterns.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have duplicated the patterns and electrodes of the implantable electrode array of Erhardt in view of Grinstaff to include at least three patterns aligned along the straight first line and at least three patterns aligned along the straight second line as because it would have allowed forming a larger electrode array with more points to receive signals and send activation signals to the implant while maintaining the ability to localize each electrode using the patterns, thereby improving sensing and therapy when implanted within the tissue.
Regarding claim 9, together Erhardt and Grinstaff teach all of the limitations of claim 1 as noted above.
Grinstaff further teaches the material is a polymer (Paragraph [0137]; polymer pellets or powder (e.g., polyethylene pellets or powder) and solid iron oxide nanoparticle powder can be homogenized, mixed, and then fed into the hopper of a twin-screw extruder).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the implantable electrode array of Erhardt in view of Grinstaff such that material is a polymer as taught by Grinstaff because it would have been a well understood method fabricating the markers and further ensured the size, dimension, and amount of contrast agent used in the marker is a desired amount (Grinstaff, Paragraph [0137]).
Regarding claim 10, together Erhardt and Grinstaff teach all of the limitations of claim 1 as noted above.
Erhardt further teaches the implantable electrode array comprises at least one layer of a polymer (Pg. 514, left col.; Once the homogenous silicone rubber layer had dried for a few minutes, two more layers were added in the same way; The cleaned surface was then covered with another layer of silicone rubber; Silicone rubber is a known polymer).
Response to Arguments
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to the claims and withdraws all previous rejections under 35 USC 112(b).
Claim Rejections under – 35 U.S.C. § 102
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
10/20/2025