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 .
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:
“dissolution barrier is configured to selectively allow movement of conducting ions” in claim 3.
“dissolution barrier is configured to inhibit movement of metal ions from a surface of the one or more electrode contacts” in claim 9.
“dissolution barrier is configured to permit conduction of electrical current therethrough” in claim 10.
“dissolution barrier is configured to inhibit movement of metal ions from a surface of the one or more electrode contacts” in claim 14.
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.
Regarding this interpretation of the claim limitations invoking 35 USC § 112 (f): the specification states that the dissolution barrier can be
paragraph 0035 “The dissolution barrier is formed from a material that permits the conduction of electrical current, which predominantly flows in tissue by the movement of small ions such as chlorine (e.g., Cl-) and sodium (e.g., Na+ ), but inhibits the movement of metal ions from the surface of the electrode contacts.”
paragraph 0057 “A dissolution barrier in accordance with embodiments presented herein may be formed from a number of different material types that fulfil many of the above characteristics. For example, in certain embodiments, the dissolution barrier may be formed from biocompatible conducting polymers or biocompatible conducting hydrogels. In further embodiments, the dissolution barrier may be formed from dissolution resistant nanoparticles such as carbon nanotubes suspended in biocompatible polymers, plastics, silicones or other insulating solids. In further embodiments, the dissolution barrier may be formed from woven biocompatible material, such as insulating polymers or plastics. For example, it may be that finely woven mats of insulating materials can be made with sufficient porosity to allow the passage of charge carrying ions while reducing the flow of larger metal ions, such as platinum ions.”
paragraph 0058 “In certain embodiments, the dissolution barrier may be formed from self-assembled monolayers. As shown in FIG. 4, a self-assembled monolayer 462 is formed from carbon chain molecules 462 with thiol or “head” groups 464 that promote adhesion to conductors and with functional groups 466, such as proteins, at the other end thereof. The thiol groups 464 can be used to firmly attach the carbon chain molecules 462 to surfaces that may not attach as easily without the self-assembled monolayer 462. If the carbon chains 462 are made short, then the self-assembled monolayer 462 can present a low impedance to the passage of current and, depending on the functional group, may also be effective in inhibiting metal ions from diffusion from the surface.”
paragraph 0059 “In certain examples, the dissolution barrier may be formed from ion permeable membranes. Ion permeable membranes are materials that allow the movement of conducting ions through drift, but which block the diffusion of platinum ions. This selectivity (to conducting ions through drift but not to the diffusion of platinum ions) can be based on several factors. For example, the selectivity may be based on the size of the ion, where platinum ions (e.g., [PtCl4]2-) are large, but the main current carrying ions (e.g., Cl-, Na+, K+) are small. The selectivity may also or alternatively be based on the valency of the ions (i.e., platinum ions are divalent whereas the current carrying ions are monovalent). The selectivity may also or alternatively be based on the actual drift versus diffusion properties, where current carrying ions move under the influence of electric fields, but diffused ions do not. The selectivity may also or alternatively be based on frequency, where charge carrying ions move rapidly in a tissue-stimulating prosthesis, but platinum ions move much more slowly under the influence of diffusion and other transport mechanisms in the body.”
paragraph 0060 “ In certain examples, the dissolution barrier may be formed from doped crystalline materials, such a nitrogen doped diamond and titanium nitride. These materials can provide low impedance interfaces and are usually applied using sputter, vapour or other deposition techniques.”
Therefore for the purpose of examination the dissolution barrier will be considered to be one of:
biocompatible conducting polymers,
biocompatible conducting hydrogels
dissolution resistant nanoparticles such as carbon nanotubes suspended in biocompatible polymers, plastics, silicones or other insulating solids
woven biocompatible material, such as insulating polymers or plastics
self-assembled monolayers
ion permeable membranes, or
doped crystalline materials, such a nitrogen doped diamond and titanium nitride
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 1-8 and 11-12 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.
Claim 1 recites “one or more electrode contacts configured to at least one of source or sink current signals”. As is known in the art electrodes are passive electrically conductive elements. In order to source current then current is delivered to the electrode and in order to sink current the signal at the electrode-tissue-interface is sunk/received. Therefore any electrode can be a source or a sink and therefore the claim language is indefinite in that it is unclear what, if any, configuration the electrodes actually have to establish the electrode as a source or sink. It would be the signal processor which sources current or sinks current and not the electrode itself. For the purpose of examination it will be assumed that any electrode can source or sink current. Claims 2-8 are also rejected in that they depend from claim 1.
Regarding claims 3 and 6: the term “approximately” in claims 3 and 6 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the word approximately cannot be determined from the specification or the claim language.
Regarding claim 6: the claim recites “conductivity that is greater than approximately 1 kiloohm (kΩ).” Conductivity is measured in S/m and not KΩ, KΩ is a measure of resistance, therefore this language is objected to.
Claim 11 recites “sufficiently low”, the use of the word “sufficiently” is objected to in that it is a relative term and it is unclear what “sufficiently low” is or could be.
Claim 12 recites “sufficient porosity”, the use of the word “sufficient” is objected to in that it is a relative term and it is unclear what “sufficiently low” is or could be.
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 1-2, 9-10 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boling et al. US 2008/0195227 as evidenced by the journal article to Zhang, C., Driver, N., Tian, Q., Jiang, W., & Liu, H. (2018). Electrochemical deposition of conductive polymers onto magnesium microwires for neural electrode applications. Journal of Biomedical Materials Research Part A, 106(7), 1887–1895. https://doi.org/10.1002/jbm.a.36385herein Zhang
Regarding claim 1: Boling disclose a tissue-stimulating prosthesis (“Medical electrical lead”, abstract), comprising:
a stimulating assembly 300 (figures 3B-3D) with electrode contacts 304/306/308/310 (figures 3B-3D) configured to at least one of source or sink current signals (paragraph 0025, “Furthermore, the lead systems may be connected to one or more implantable medical devices, such as electrostimulation and/or recording devices, which allow the lead systems to provide other treatments in addition to the bioactive agent treatment.” If the electrode is utilized to stimulate it is a source if it is utilized to record it is a sink); and
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a dissolution barrier 322 (figures 3B-3D) encapsulating the stimulating assembly (the barrier completely covers the electrodes along the lead which is considered to be encapsulating), wherein the dissolution barrier is configured to inhibit movement of metal ions from a surface of the one or more electrode contacts (paragraph 0036, the barrier is comprised of a conductive polymer, specifically poly(3,4-ethylenedioxythiopene) which is known as PEDOT. As discussed in the claim interpretation section, the barrier is considered to be a biocompatible conductive polymer, in this case PEDOT. The use of PEDOT is clarified by Zhang’s journal article which states in the abstract “Specifically, pure magnesium (Mg) microwire with a diameter of 127 µm was used as the electrode substrate and the conductive polymer, that is, poly(3,4-ethylenedioxythiophene) (PEDOT), was electrochemically deposited onto Mg microwires to decrease corrosion rate and improve biocompatibility of the electrodes for potential neural electrode applications.” As is known in the art corrosion is the process which degrades the electrode material.i).
Regarding claim 2: Boling disclose that the dissolution barrier 322 (figures 3A-3D) is composed of PEDOT, PEDOT is a conductive polymer (paragraph 0036), therefore the dissolution barrier is composed of PEDOT which is a conductive polymer and is considered to selectively allow movement of conductive ions in that the stimulation from the electrodes works as expected.
Regarding claim 9: Boling disclose an apparatus (“Medical electrical lead”, abstract), comprising:
an implant carrier member 302 (“lead body”, figures 3B-3D),
electrode contacts 304/306/308/310 (figures 3B-3D) distributed on the implant carrier member 302 (figures 3B-3D) for applying electrical stimulation to adjacent tissue (paragraph 0034); and
a dissolution barrier 322 (figures 3B-3D) encapsulating the stimulating assembly (the barrier completely covers the electrodes along the lead which is considered to be encapsulating), wherein the dissolution barrier is configured to inhibit movement of metal ions from a surface of the one or more electrode contacts (paragraph 0036, the barrier is comprised of a conductive polymer, specifically poly(3,4-ethylenedioxythiopene) which is known as PEDOT. As discussed in the claim interpretation section, the barrier is considered to be a biocompatible conductive polymer, in this case PEDOT. The use of PEDOT is clarified by Zhang’s journal article which states in the abstract “Specifically, pure magnesium (Mg) microwire with a diameter of 127 µm was used as the electrode substrate and the conductive polymer, that is, poly(3,4-ethylenedioxythiophene) (PEDOT), was electrochemically deposited onto Mg microwires to decrease corrosion rate and improve biocompatibility of the electrodes for potential neural electrode applications.” As is known in the art corrosion is the process which degrades the electrode material.).
Regarding claim 10: Boling disclose that the dissolution barrier 322 (figures 3A-3D) is composed of PEDOT, PEDOT is a conductive polymer (paragraph 0036), therefore the dissolution barrier is composed of PEDOT which is a conductive polymer and is considered to selectively allow movement of conductive ions in that the stimulation from the electrodes works as expected.
Regarding claim 14: : Boling disclose a method, comprising:
providing electrode contacts 304/306/308/310 (figures 3B-3D);
layering a dissolution barrier (paragraphs 0011, 0013, 0035, 0036 and 0039), wherein the dissolution barrier is configured to inhibit movement of metal ions from a surface of the electrode contacts (paragraph 0036, the barrier is comprised of a conductive polymer, specifically poly(3,4-ethylenedioxythiopene) which is known as PEDOT. As discussed in the claim interpretation section, the barrier is considered to be a biocompatible conductive polymer, in this case PEDOT. The use of PEDOT is clarified by Zhang’s journal article which states in the abstract “Specifically, pure magnesium (Mg) microwire with a diameter of 127 µm was used as the electrode substrate and the conductive polymer, that is, poly(3,4-ethylenedioxythiophene) (PEDOT), was electrochemically deposited onto Mg microwires to decrease corrosion rate and improve biocompatibility of the electrodes for potential neural electrode applications.” As is known in the art corrosion is the process which degrades the electrode material.).
positioning the electrode contacts to apply electrical stimulation to tissue (paragraphs 0032, 0059).
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boling et al. US 2008/0195227 as evidenced by the journal article to Zhang, C., Driver, N., Tian, Q., Jiang, W., & Liu, H. (2018). Electrochemical deposition of conductive polymers onto magnesium microwires for neural electrode applications. Journal of Biomedical Materials Research Part A, 106(7), 1887–1895. https://doi.org/10.1002/jbm.a.36385herein Zhang and further in view of Richardson-Burns et al. US 2011/0087315.
Regarding claim 15: Boling/Zhang discloses the claimed invention however Boling/Zhang does not specifically disclose the use of dip coating the polymer onto the electrodes. Richardson-Burns however teaches the use of dip coating an electrode with a hydrogel solution (claim 1) and that a PEDOT-hydrogel can be used (paragraph 0027). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Boling/Zhang to include the use of dip coating electrodes with a conductive polymer such as a PEDOT-hydrogel, in order to use multiple coatings.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18 and 20 of U.S. Patent No. 12,138,448. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below in underline in the adjoining chart.
18/911,990
12,138,448
Claim 1. A tissue-stimulating prosthesis, comprising: a stimulating assembly comprising one or more electrode contacts configured to at least one of source or sink current signals; and a dissolution barrier encapsulating the stimulating assembly, wherein the dissolution barrier is configured to inhibit movement of metal ions from a surface of the one or more electrode contacts.
Claim 1. A tissue-stimulating prosthesis, comprising: a stimulating assembly comprising an elongate carrier member and a plurality of electrode contacts disposed along the elongate carrier member configured to at least one of source or sink current signals; and a dissolution barrier encapsulating the stimulating assembly, wherein the dissolution barrier is configured to inhibit movement of metal ions from a surface of the plurality of electrode contacts to inhibit in situ dissolution of the plurality of electrode contacts.
Claim 9. An apparatus, comprising: an implantable carrier member; one or more electrode contacts distributed on the implantable carrier member for applying electrical stimulation signals to adjacent tissue; and a dissolution barrier on the one or more electrode contacts, wherein the dissolution barrier is configured to inhibit movement of metal ions from a surface of the one or more electrode contacts.
Claim 18. An apparatus, comprising: an implantable carrier member formed from an insulating material and having a center longitudinal axis and an outer surface; a plurality of electrode contacts distributed on the outer surface of the implantable carrier member along the center longitudinal axis for applying electrical stimulation signals to adjacent neural tissue; and a continuous dissolution barrier layered on each of the plurality of electrode contacts and the implantable carrier member, wherein the continuous dissolution barrier is configured to inhibit movement of metal ions from a surface of the plurality of electrode contacts.
Claim 10. The apparatus of claim 9, wherein the dissolution barrier is configured to permit conduction of electrical current therethrough.
Claim 20. The apparatus of claim 18, wherein the continuous dissolution barrier is configured to permit conduction of electrical current.
Allowable Subject Matter
Claims 3-8, 11-13 and 16-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Due to the multiple allowable claims a detailed reasons for allowance will be provided upon allowance.
Conclusion
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i Corrosion Definition https://www.britannica.com/science/corrosion
Prosecution Insights