DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to implantable device comprising a frame member; and a tension member, classified in A61B 2018/00482.
II. Claims 16-20, drawn to method of using the implantable device by placing the implantable device within a body of a patient such that the implantable device is disposed adjacent at least a portion of a urethra of a patient, classified in A61F 2/0036.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product such as bariatric gastric banding or banding to treat gastroesophageal reflux disease (GERD).
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions have acquired a separate status in the art in view of their different classification; and/or the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). Further, the searches for products and processes are not coextensive. Art anticipating or rendering obvious a product will not necessarily anticipate or render obvious a method of use. Further, the considerations under 35 USC 101 and/or 35 USC 112 are different for products and processes, thus in addition to a search burden, there is an examination burden (see at least MPEP 803).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention (Group I or Group II) to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
After a telephone conversation with Timothy Ford on July 08, 2026 at contact number on record 202-470-6456, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Currently Claims 1-15 are being examined on the merits as drawn to elected Invention.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "333" (see instant application specification as-filed [0052]) and "323" (see instant application specification as-filed [0052]) have both been used to designate “opening” .
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: figures do not include “333” mentioned in instant application specification as-filed [0052].
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 “the first pivot” and “the second pivot” 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. 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.
Specification
The disclosure is objected to because of the following informalities:
“…the tension member is configured to be disposed the rigid state when an electrical current is applied to the tension member …” in para.[0015] needs to be corrected. A suggested correction is -- the tension member is configured to be disposed in the rigid state when an electrical current is applied to the tension member --.
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 4 line 4 “its rigid state” needs to be corrected. A suggested correction is –[[ its]] the rigid state – in light of its antecedent in claim 1 line 6 “a rigid state”.
Claim 1 in lines 6-7 “the tension member being configured to be disposed in the rigid state when an electrical current is applied to the tension member” needs to be corrected. A suggested correction is -- the tension member being configured to be disposed in the rigid state [[when]] upon an electrical current [[is]] being applied to the tension member -- to avoid conditional limitation recitation which would raise question as to what occurs when the condition is not met.
Claim 11 line 4-5 “the tension member being slidable coupled to the first pivot and being slidably coupled to the second pivot” needs to be corrected. A suggested correction is -- the tension member being [[slidable]] slidably coupled to the first pivot and being slidably coupled to the second pivot--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for the following reasons:
Claims 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention for the following reasons.
Please note, USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Consequently, when claim 1 is broadly yet reasonably interpreted, the implantable device as explicitly, positively, specifically claimed encompass other implantable device, for example heart-lung bypass pumps that are driven by electrical actuators. However, the specification discloses implantable device species configured to be disposed within the body of the patient in a manner that the frame member is configured to surround or partially surrounds a portion of bodily passageway such as the urethra. Thus, claim 1 contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Dependent claims 2-15 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112 (a) because the additional recited limitations fail to cure the 35 U.S.C. 112 (a) issue in their respective base claims. Consequently, dependent claims 2-15 are also rejected under 35 U.S.C. 112 (a) based in their direct/indirect dependency on their respective base claims.
Claim Rejections - 35 USC § 112 (b)
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.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph for the following reasons:
Claim 11 recites “the tension member being slidable coupled to the first pivot and being slidably coupled to the second pivot” which renders this claim as recited unclear. More specifically, as recited it is unclear as to what recited structure actually slidably couples the tension member to the first pivot and the second pivot. Additionally, claim 11 is also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: a structure that actually slidably couples the tension member to the first pivot and the second pivot.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed para.[0025-0026], [0060].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-13 and 15 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Severson; Gregg (Pub. No.: US 20170231738 A1, hereinafter referred to as “Severson”).
As per independent Claim 1, Severson discloses an implantable device (Severson in at least abstract, fig. 1, fig. 6, fig. 8, [0002], [0004-0010], [0028], [0035], [0043], [0047-0051], [0054-0058] for example discloses relevant subject-matter. More specifically, Severson in at least fig. 6B, abstract, [0002], [0028], for example discloses implantable device. See at least Severson [0002] “implantable medical devices”; [0028] “systems…for treating medical conditions, such as urinary incontinence…or other medical conditions… implantable electronic control system is powered by an implantable battery and optional capacitor that control an implantable actuator, such as a clamshell or cuff disposed around a person's urethra”) comprising:
a frame member (Severson, [0004], [0008], [0028-0029], [0047-0048] fig. 6B, 6G, 6H, [0047-0048] for example discloses frame member 600G. See at least [0029] “actuator 104 may be a clamshell, cuff, bladder tube actuator… or any other similar type of actuator”; [0048] “actuator 600G includes straight EAP fibers 610G and circular rings 612G …orientations of EAP fibers… may be useful as well with respect to the urethral … actuators disclosed herein”) and
a tension member (Severson, [0004], [0008], [0028-0029], fig. 6B, 6G, 6H, [0047-0048] for example discloses a tension member 612G, 610G. See Severson [0048] “actuator 600G includes straight EAP fibers 610G and circular rings 612G …orientations of EAP fibers… may be useful as well with respect to the urethral … actuators disclosed herein”),
the tension member having a first portion coupled to the frame member at a first location of the frame member and a second portion coupled to the frame member at a second location of the frame member (Severson, fig. 6B, fig. 6G, [0047-0048] for example discloses tension member 612G, 610G having a first portion coupled to the frame member at a first location of the frame member (see 612G, 610G in fig. 6G left end portion) and a second portion coupled to the frame member at a second location of the frame member (see 612G, 610G in fig. 6G right end portion)),
the tension member being configured to be disposed in a flexible state and a rigid state (Severson, [0004], [0028], [0047-0048] for example discloses tension member being configured to be disposed in a flexible state and a rigid state. See at least Severson [0004] “actuator may be a cuff or clamshell configured to be disposed around the urethra …actuator changes shape in response to signals from the electronic control system…signal is a current, voltage, or field that changes the shape of the actuator”;[0028] “implantable electronic control system is powered by an implantable battery and optional capacitor that control an implantable actuator, such as a clamshell or cuff disposed around a person's urethra … Upon receiving a signal … electronic control system causes the actuator to change shape by, for example, contracting, bending, expanding, deflating, etc. The clamshell or cuff actuator may change shape to allow, restrict, prevent or otherwise control flow of urine through a urethra”; [0048] “actuator 600G includes … EAP fibers …When power is not applied to the EAP fibers, the … actuators … may be soft and flexible; when power is applied to the EAP fibers, the … actuators … may be stiff and rigid…orientations of EAP fibers … may be useful as well with respect to the urethral … actuators disclosed herein.”;),
the tension member being configured to be disposed in the rigid state when an electrical current is applied to the tension member (see Severson at least fig. fig. 6G, fig. 6B, 6H, [0004] [0028], [0029], [0036], [0047-0048] for example discloses tension member being configured to be disposed in the rigid state when an electrical current is applied to the tension member. See at least Severson [0004] “actuator changes shape in response to signals from the electronic control system. … the signal is a current, voltage, or field that changes the shape of the actuator”; [0028] “Upon receiving a signal … electronic control system causes the actuator to change shape by, for example, contracting, bending, expanding, deflating, etc. The clamshell or cuff actuator may change shape to allow, restrict, prevent or otherwise control flow of urine through a urethra… actuator is “open” or “on” when an electrical signal is applied to it and “closed” or “off” when the electrical signal is unapplied.”; [0048] “actuator 600G includes … EAP fibers …When power is not applied to the EAP fibers, the … actuators … may be soft and flexible; when power is applied to the EAP fibers, the … actuators … may be stiff and rigid…orientations of EAP fibers … may be useful as well with respect to the urethral … actuators disclosed herein.”; [0056] “The system 800 may further include an EAP controller 810 for supplying electrical signals to an EAP-based actuator”).
As per dependent Claim 2, Severson further discloses the implantable device wherein the frame member is configured to be placed in an open configuration and a closed configuration (Severson in fig. 6B, 6G, [0028] for example discloses frame member is configured to be placed in an open configuration and a closed configuration. Severson [0028] “Upon receiving a signal … the electronic control system causes the actuator to change shape by, for example, contracting, bending, expanding, deflating, etc. The clamshell or cuff actuator may change shape to allow, restrict, prevent or otherwise control flow of urine through a urethra…the actuator “closed” or “off” when the electrical signal is unapplied.”).
As per dependent Claim 3, Severson further discloses the implantable device wherein the frame member is configured to be placed in an open configuration and a closed configuration (Severson [0028]), the frame member being biased to the closed configuration (Severson [0028] “the actuator “closed” or “off” when the electrical signal is unapplied.”).
As per dependent Claim 4, Severson further discloses the implantable device wherein the frame member is configured to be placed in an open configuration and a closed configuration, the frame member being biased to the closed configuration (Severson [0028] ), the frame member being configured to be placed in the open configuration in response to the tension member being placed in its rigid state (Severson [0028] “the actuator is “open” or “on” when an electrical signal is applied to it”).
As per dependent Claim 5, Severson further discloses the implantable device further comprising: a control member operatively coupled to the tension member (Severson fig. 6B, [0047] for example discloses a control member 602b operatively coupled to the tension member 612G, 610G. See Severson [0047] “connector 606B connects a urethral cuff 604B to the electronic control unit 602B” ), the control member being configured to provide an electrical current to the tension member (Severson fig. 6B, [0028] for example discloses the control member 602b being configured to provide an electrical current to the tension member 612G, 610G. See at least Severson [0028] “implantable electronic control system is powered by an implantable battery … that control an implantable actuator, such as a clamshell or cuff disposed around a person's urethra …Upon receiving a signal …electronic control system causes the actuator to change shape by, for example, contracting, bending, expanding, deflating…the actuator includes a material that changes shape in response to an electric current and/or voltage, electric, magnetic, and/or electromagnetic field, or other such effect or force, such as electroactive polymer (“EAP”), a shape-memory alloy, a piezoelectric material, or any other combination or composite of different materials… the actuator is “open” or “on” when an electrical signal is applied to it”; [0047] “actuators 604A, 604B, 604C, 604L may be made of a material that changes shape in response to an electrical current, voltage, or field, such as EAP”).
As per dependent Claim 6, Severson further discloses the implantable device further comprising: a control member operatively coupled to the tension member(Severson fig. 6B, [0047]), the control member being configured to provide an electrical current to the tension member (Severson fig. 6B, [0028]), the control member including a battery (Severson in at least [0028], [0043], [0056] for example discloses control member/electronic control system including a battery. [0028] “implantable electronic control system is powered by an implantable battery and optional capacitor that control an implantable actuator, such as a clamshell or cuff disposed around a person's urethra”; [0043] “battery may be any battery, including non-rechargeable and rechargeable batteries. The battery may be disposed within the electronic control system, within the actuator, or disposed elsewhere in the patient's body”; [0056] “non-rechargeable or rechargeable battery 818 may supply power to the components described herein. The system 800 may further include an EAP controller 810 for supplying electrical signals to an EAP-based actuator”).
As per dependent Claim 7, Severson further discloses the implantable device further comprising: a control member, the control member being operatively coupled to the tension member via a wire (Severson in at least fig. 6B, fig. 6H, [0049] for example discloses a control member 602B, the control member being operatively coupled to the tension member 612G, 610G via a wire/conductors 616H. see Severson [0029] “connection 106 connects the electronic control system 102 and actuator 104; the connection may include one or more of tubing for carrying … electrical conductors for carrying analog and/or digital electronic signals, strengthening wires, or any other such material”; [0049] “Conductors 614H supply power to the actuator via wires 616H.”).
As per dependent Claim 8, Severson further discloses the implantable device further comprising: a control member (Severson fig. 1, fig. 6B 102/602B), a first wire extending from a first end portion of the tension member to the control member, a second wire extending from a second end portion of the tension member to the control member (Severson, fig. 6B, fig. 6H, [0047-0049] for example discloses a first wire 616H top left extending from a first end portion of the tension member to the control member, a second wire 616H bottom left extending from a second end portion of the tension member to the control member. See at least [0029] “connection 106 connects the electronic control system 102 and actuator 104; the connection may include one or more of tubing for carrying … electrical conductors for carrying analog and/or digital electronic signals, strengthening wires, or any other such material”; [0049] “Conductors 614H supply power to the actuator via wires 616H”).
As per dependent Claim 9, Severson further discloses the implantable device wherein the frame member includes a first end portion and a second end portion, the first location of the frame member being disposed proximate the first end portion, the second location of the frame member being disposed proximate the second end portion (Severson in at least fig. 6B, fig. 6G discloses frame member 600G includes a first end portion at left end in fig. 6G and a second end portion at right end in fig. 6G, the first location of the frame member (see 612G, 610G in fig. 6G left end portion) being disposed proximate the first end portion, the second location of the frame member (see 612G, 610G in fig. 6G right end portion) being disposed proximate the second end portion).
As per dependent Claim 10, Severson further discloses the implantable device wherein the frame member includes a first pivot and a second pivot, the frame member being configured to bend at the first pivot and bend at the second pivot (Severson in at least [0028], fig. 6B, 6G, [0047-0048] for example discloses the frame member 600G includes a first pivot 602G and a second pivot 604G, the frame member being configured to bend at the first pivot and bend at the second pivot to encircle the urethra as illustrated in fig. 6B at 604B. See at least Severson [0028] “implantable electronic control system is powered by an implantable battery and optional capacitor that control an implantable actuator, such as a clamshell or cuff disposed around a person's urethra … Upon receiving a signal … electronic control system causes the actuator to change shape by, for example, contracting, bending, expanding, deflating, etc. The clamshell or cuff actuator may change shape to allow, restrict, prevent or otherwise control flow of urine through a urethra”).
As per dependent Claim 11, Severson further discloses the implantable device wherein the frame member includes a first pivot and a second pivot, the frame member being configured to bend at the first pivot and bend at the second pivot (Severson in at least [0028], fig. 6B, 6G, [0047-0048]), the tension member being slidable coupled to the first pivot and being slidably coupled to the second pivot (as seen in fig. 6G tension member 612G and 610G are slidable over first pivot 602G and second pivot 604G and thus, prior can be broadly yet reasonably interpreted as disclosing subject-matter as now explicitly, positively and specifically recited (i.e. tension member being slidable coupled to the first pivot and being slidably coupled to the second pivot) by the Applicants ).
As per dependent Claim 12, Severson further discloses the implantable device further comprising: a housing, the housing containing the frame member and the tension member (Severson fig. 6B, 6G, 6H, [0048-0049] cuff appears to have a housing as seen in fig. 6B, 6G, 6H).
As per dependent Claim 13, Severson further discloses the implantable device wherein the tension member is a first tension member, the device further comprising: a second tension member operatively coupled to the frame member (Severson in at least fig. 6B, fig. 6G, fig. 6H, [0047-0048] for example discloses the tension member is a first tension member 612G, the device further comprising: a second tension member 610G operatively coupled to the frame member 600G. See at least Severson [0048] “actuator 600G includes straight EAP fibers 610G and circular rings 612G”).
As per dependent Claim 15, Severson further discloses the implantable device wherein the frame member includes a non-conductive material (Severson in at least fig. 6G, fig. 6H, [0048-0049] for example discloses frame member 600G includes a non-conductive material/silicone rubber coating 602H, 612H. [0048] “EAP fibers may be molded within silicone”; [0049] “a silicon rubber coating… fabric layer under the silicon rubber layers 602H, 612H may be added to give the EAP material strength and/or protect the EAP material”).
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Severson in view of Li; Jamie (Pub. No.: US 20130041207 A1, hereinafter referred to as “Li”).
As per dependent Claim 14, Severson discloses implantable device wherein the tension member includes a nitinol shape memory material (Severson, in at least [0028] discloses tension member includes a shape-memory material. [0028] “the actuator includes a material that changes shape in response to an electric current and/or voltage, electric, magnetic, and/or electromagnetic field, or other such effect or force, such as electroactive polymer (“EAP”), a shape-memory alloy, a piezoelectric material, or any other combination or composite of different materials”).
Severson does not explicitly disclose nitinol material feature.
However, in an analogous implantable device field of endeavor, Li discloses implantable device (Li in at least abstract, fig. 1-3, [0011], [0028-0041], [0043-0049], [0078], [0085], [0087], [0089-0090], [0092-0093], [0095], [0102-0103] for example discloses relevant subject-matter. More specifically, Li in at least abstract, fig. 1-3, [0011] for example discloses implantable device (fig. 1-2) . See at least Li [0011] “apparatus includes an elongate member and a shape memory element. The elongate member is configured to at least partially surround a body lumen and defines a lumen. The shape memory element is disposed of adjacent to the lumen defined by the elongate member. Further, the shape memory element is adapted to change its configuration based on a change in temperature. This change in configuration of the shape memory element causes the apparatus to move between a first configuration and a second configuration”) wherein the tension member includes a nitinol material (Li in at least fig. 1-3, [0011], [0034-0035], [0093] for example discloses tension member 104/204 includes a nitinol material. See at least [0034] “shape memory element 204 is made of Nitinol (Nickel-Titanium alloy.)”; [0093] “apparatus includes a temperature control device for changing the temperature of the shape memory element… the shape memory element is made of Nitinol” ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tension member shape-memory material used in the implantable device as taught by Severson, such that the shape-memory material includes nitinol material, as taught by Li. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, to take advantage of the known fact that a memory configuration can be set for Nitinol above a transition temperature, the temperature at which the configuration of the shape memory element changes and thus, owing to this characteristic of the Nitinol the shape memory element can be repeatedly deformed and recovered by alteration of temperature (Li, [0034-0035]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20130245365 A1 to Intoccia JR et al. discloses a medical device including a portion that includes shape-memory material such as nitinol configured to be placed within a body of a patient such that the device is disposed adjacent to a portion of a bodily passageway such as the urethra with the device portion is configured to move from a first length to a second length in response to a predetermined pressure or in response to being exposed to a predetermined pressure developed within the bodily passageway similar to that disclosed.
Prior art US 20090259315 A1 to Banik discloses medical devices such as artificial sphincters that are based on electroactive polymers that change shape in response to application of current similar to that disclosed.
Prior art US 20140163315 A1 to Forsell for disclosing apparatus that comprises an adjustable restriction device implanted in a patient that directly engages a portion of the biological passageway tissue of the patient and via an adjustment device mechanically adjusts the restriction device to temporarily restrict the fluid flow through the biological passageway similar to that disclosed.
Prior art US 20060142636 A1 to Meretei discloses systems and methods for supplementing control of an anatomical sphincter similar to that disclosed. More specifically, systems and methods for supplementing control of an anatomical sphincter via collar containing variable viscosity fluid surrounds a portion of an anatomical conduit. The flow of bodily fluids through the anatomical conduit occurs according to the viscosity level of the variable viscosity fluid. Electro-rheologic fluid in the collar liquefies in the absence of an electrical potential difference to render the collar pliable, permitting the anatomical conduit to expand and fluid to flow through the anatomical conduit. Electro-rheologic fluid in the collar solidifies in the presence of an electrical potential difference to render the collar firm, restricting the anatomical conduit from expanding and restricting fluid from passing through the anatomical conduit. A control unit, or battery, operable in response to sensed pressure data or according to an external control unit manipulated by a patient, determines when an electrical potential difference is generated to change the state of the electro-rheologic fluid in the collar. Magneto-rheologic fluids can instead be used in the collar. An implanted or external control unit, or other magnetic source, determines when a magnetic field is generated to change the state of the magneto-rheologic fluid in the collar based on sensed pressure data or according to an external control unit operated by the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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