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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/3/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
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 “through-holes” of claims 1, 3, 11 and 13 and the “balloon section” of claim 30 and the “at least two longitudinal holes” of claim 29 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 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:
“Adapting mechanism…to enable translation of vibrations from the transducer to the flexible wire”
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.
The specification does not describe the associated structure.
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.
Claim Objections
Claims 7, 9, 17, and 19 are objected to because of the following informalities:
Claims 7 and 9 are identical claims. Please amend the limitations or change the dependency of the claims to alter the identical scope.
Claims 17 and 19 are identical claims. Please amend the limitations or change the dependency of the claims to alter the identical scope.
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 2-3, 12-13, and 29 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.
In regard to claims 2 and 12, the specification does not disclose the associated structure for the adapting mechanism. Therefore, the scope of the limitation cannot be ascertained. The applicant should consider cancelling the claim as the specification cannot be amended to include new subject matter.
In regard to claims 3, 13, and 29, it is unclear if the recited holes in these claims are referencing the holes of the independent claims or a new set of holes. The specification and drawings does not help ascertain the scope because these structures are inadequately discussed. For the purposes of this action, the holes are interpreted as the same holes.
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.
Claim(s) 1-5, 11-15, 20, 24-25, and 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallace (US 2016/0270806).
In regard to claim 1 (FIRST INTERPRETATION), Wallace discloses a device comprising: an ultrasound transducer (120, Fig. 1; see par [0124]-[0125]), a probe (1001, Fig. 10; see par [0161]-[0162] comprising a flexible wire (1000, Fig. 10; see par. [0162]) that is coupled to the ultrasound transducer (120, Fig. 1; par [0124] and [0161]; and a flexible sheath (1002, Fig. 10; see par. [0161]) encapsulating the flexible wire, wherein the flexible sheath (1002, Fig. 10; see par. [0161) comprises one or more through-holes (1005 and/or the openings at the distal end of the catheter 1002; see Fig. 10).
In regard to claim 2, Wallace discloses the device of claim 1, further comprising an adapting mechanism (1101, Fig. 11; see par. [0162]) coupled to the ultrasound transducer to enable translation of vibrations from the transducer to the flexible wire (see par. [0162] – “ultrasound transmission member 1000 is attached to a sonic connector 1101 which is configured to couple the proximal end of the ultrasound transmission member 1000 to the horn of the ultrasound transducer”), causing the flexible wire to be oscillated transversely to its longitudinal axis (see par. [0163] – “propagate ultrasound energy along the proximal end 1100 and produce mostly longitudinal and surface waves along the ultrasound transmission member 1000”), thereby transmitting the vibrations produced by the ultrasound transducer (Fig. 10-11; see par. [0162]-[0163], intended use, the device of Wallace is considered capable of transmitting the vibrations produce by the transducer).
In regard to claim 3, Wallace discloses the device of claim 1, wherein the flexible sheath (1002) comprises a plurality of through-holes (1005 and/or the openings at the distal end of the catheter 1002; see Fig. 10).
In regard to claim 4, Wallace discloses the device of claim 1, wherein the flexible sheath (1002) prevents mucosal tissue in vivo from making direct contact with the flexible wire (Fig. 10-11, intended use, the device of Wallace is considered capable of having the flexible sheath prevent mucosal tissue from making contact with the flexible wire 1000).
In regard to claim 5, Wallace discloses the device of claim 1, wherein the flexible wire (1000) comprises nitinol or titanium (see par. [0161]).
In regard to claim 11, Wallace discloses a method for delivering a drug to an in vivo target tissue, the method comprising: introducing into a body orifice of a subject a device comprising an ultrasound transducer (120, Fig. 1; see par. [0124]) capable of vibrating at an ultrasonic frequency (see par. [0125]), a probe (1001, Fig. 10; see par. [0161]) comprising a flexible wire (1000, Fig. 10; see par. [0162]) that is coupled to the ultrasound transducer (120, Fig. 1; see par. [0124] and [0161]); and a flexible sheath (1002, see Fig. 10; see par. [0161]) encapsulating the flexible wire, wherein the flexible sheath (1002) comprises one or more through-holes (1005 and/or the openings at the distal end of the catheter 1002; see Fig. 10), wherein a liquid comprising a drug is present in the body orifice (see par. [0177] – “therapeutic drug may be delivery either before delivery of ultrasound energy to the treatment area”); and vibrating the flexible wire such that energy produced by the vibrations from the flexible wire exits the through-holes (see par. [0165] – “ultrasound transmission member 1000 is configured to propagate ultrasound energy in form of surface waves along the length of the ultrasound transmission member 1000 that is exposed to the treatment area”) and interacts with the drug to thereby deliver the drug into a target tissue within the body orifice (see par. [0174] – “incorporates delivery of ultrasound delivery of ultrasound energy to the vessel wall before, during and after delivery of the therapeutic agent”).
In regard to claim 12, Wallace discloses the method of claim 11, further comprising an adapting mechanism (1101, Fig. 11; see par. [0162]) coupled to the ultrasound transducer (120, Fig. 1; see par. [0124]) to enable translation of vibrations from the transducer to the flexible wire (see par. [0162]), causing the flexible wire to be oscillated transversely to its longitudinal axis (see par. [0163]), thereby transmitting the vibrations produced by the ultrasound transducer (see par. [0165]).
In regard to claim 13, Wallace discloses the method of claim 11, wherein the flexible sheath (1002) comprises a plurality of through-holes (1005 and/or the openings at the distal end of the catheter 1002; see Fig. 10).
In regard to claim 14, Wallace discloses the method of claim 11, wherein the flexible sheath (1002) prevents mucosal tissue in vivo from making direct contact with the flexible wire (see par. [0161] – “extending longitudinally through the lumen of the catheter body 1002 is the elongate ultrasound transmission member 1000”).
In regard to claim 15, Wallace discloses the method of claim 11, wherein the flexible wire (1000) comprises nitinol or titanium (see par. [0161]).
In regard to claim 20, Wallace discloses the method of claim 11, wherein the flexible sheath (1002) comprises silicone rubber (see par. [0161]).
In regard to claim 24, Wallace discloses the device of claim 1, wherein the flexible sheath (1002) is configured to fit within an endoscope (Fig. 15; see par. [0168], intended use, the device of Wallace is considered capable of fitting within an endoscope).
In regard to claim 25, Wallace discloses the device of claim 1, wherein the flexible sheath (1002) comprises a plurality of lumens that extend along a length of the sheath and are physically separated from each other (see Fig. 10; see par. [0161]-“flexible catheter body 1002 is preferably an elongate tube having one or more lumens extending longitudinally”- see lumens extending along length of sheath 1002 and are separated from each other).
In regard to claim 29, Wallace discloses the device of claim 1, wherein the sheath (1002) comprises at least two longitudinal holes (Fig. 10; see par. [0161] – “flexible catheter body 1002 is preferably an elongate tube having one or more lumens extending longitudinally” - see lumens extending along length of sheath 1002 holes are distal end of sheath 1002).
In regard to claim 1 (SECOND INTEPRETATION), Wallace discloses a device comprising: an ultrasound transducer (120, Fig. 1; see par. [0124]) capable of vibrating at an ultrasonic frequency (see par. [0125]); a probe (104, Fig. 6; see par. [0124]) comprising a flexible wire (110, Fig. 2C; par. [0124]) that is coupled to the ultrasound transducer (120, Fig. 1; par. [0124); and a flexible sheath (602, Fig. 6; par. [0149]) encapsulating the flexible wire (110, Fig. 2C; par. [0124]), wherein the flexible sheath (602, Fig. 6; par. [0149]) comprises one or more through holes (604, Fig. 6 - see through holes between sheath and catheter 100).
In regard to claim 27, Wallace discloses the device of claim 1, wherein the flexible sheath (602) comprises a hole at its distal end (604, Fig. 6 - see through holes between sheath and catheter 100).
In regard to claim 28, Wallace discloses the device of claim 27, wherein the flexible sheath (602) is retractable (Fig. 6, intended use, the device of Wallace is considered capable of having the sheath retractable) and wherein a distal portion of the flexible wire (110) extends through the hole (604, Fig. 6 - see through holes between sheath and catheter 100) at the distal end of the flexible sheath the flexible sheath is retracted (Fig. 2C, 6, intended use, the device of Wallace is considered capable of having the wire extend through the hold at the distal end of the sheath when retracted).
Claim(s) 1 and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nita (US 5,380,274).
In regard to claim 1, Nita discloses a device comprising: an ultrasound transducer (18, Fig. 1; Col 3, In 40-41) capable of vibrating at an ultrasonic frequency (Col 3, In 42-43 – “operable to convert the electrical signal into ultrasonic vibration”); a probe (Fig. 1; Col 3, In 56-57 – “distal end of the catheter 10”) comprising a flexible wire (22, Fig. 2; Col 3, In 53) that is coupled to the ultrasound transducer (Col 3, In 54-57); and a flexible sheath (20, Fig. 2; Col 3, In 46) encapsulating the flexible wire (Fig. 2 - see sheath 20 around wire 22), wherein the flexible sheath (20, Fig. 2; Col 3, In 46) comprises one or more through-holes (Fig. 2 - see multiple through-holes in sheath 20).
In regard to claim 21, Nita discloses the device of claim 1, wherein the flexible wire (22) is at least 100 cm in length (Col 5, In 18-19 - ‘ultrasound transmission member 22 having an overall length of 63 inches’).
In regard to claim 22, Nita discloses the device of claim 21, wherein the flexible wire (22, Fig. 2; Col 3, In 53 - 'transmission member 22’) is about 150 cm in length (Col 5, in 18-19 - ‘ultrasound transmission member 22 having an overall length of 63 inches’).
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(s) 6-9, 16-19, 23, 26, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace.
In regard to claim 6, Wallace is silent wherein the flexible wire has a diameter of .635 mm. In a separate embodiment Wallace discloses wherein the flexible wire (903, Fig. 9; see par. [0158]) has a diameter of .635 mm (903, Fig. 9; para [0158] – “flexible member 902...has a circular shape having a diameter anywhere between 0.1 mm to 5 mm”). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the flexible member in Wallace's separate embodiment with the previously disclosed embodiment to optimize the diameter of the flexible member to optimize the ability to transmit ultrasound energy through the member.
In regard to claim 7, Wallace is silent wherein the flexible wire has a length of about 10 cm to about 30 cm. In a separate embodiment Wallace discloses wherein the flexible wire (903, Fig. 9; par. [0158]) has a length of about 10 cm to about 30 cm (see par. [0158]- “length that can vary anywhere between 0.1 mm and 500 mm”). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the flexible member in Wallace's separate embodiment with the previously disclosed embodiment to optimize the diameter of the flexible member to optimize the ability to transmit ultrasound energy through the member.
In regard to claim 8, Wallace is silent wherein the flexible sheath has a diameter of about 2 mm to about 4 mm, it is well known in the art that optimizing diameter and size is within the ordinary skill of one in the art. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for an optimized sheath size to allow for ample space within the sheath while also maintain an small cross-sectional size for use within the body.
In regard to claim 9, Wallace is silent wherein the flexible sheath has a length of about 10 cm to about 30 cm. In a separate embodiment Wallace discloses wherein the flexible wire (903, Fig. 9; para [0158]) has a length of about 10 cm to about 30 cm (see par. [0158] – “length that can vary anywhere between 0.1 mm and 500 mm”). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the flexible member in Wallace's separate embodiment with the previously disclosed embodiment to optimize the diameter of the flexible member to optimize the ability to transmit ultrasound energy through the member.
In regard to claim 16, Wallace is silent wherein the flexible wire has a diameter of .635 mm. In a separate embodiment Wallace discloses wherein the flexible wire (903, Fig. 9; par. [0158]) has a diameter of .635 mm (903, Fig. 9; para [0158] – “flexible member 902 has a circular shape having a diameter anywhere between 0.1 mm to 5 mm”). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the flexible member in Wallace's separate embodiment with the previously disclosed embodiment to optimize the diameter of the flexible member to optimize the diameter of the flexible member to optimize the ability to transmit ultrasound energy through the member.
In regard to claim 17, Wallace is silent wherein the flexible wire has a length of about 10 cm to about 30 cm. In a separate embodiment Wallace discloses wherein the flexible wire (903, Fig. 9; para [0158]) has a length of about 10 cm to about 30 cm (see par. [0158] – “length that can vary anywhere between 0.1 mm and 500 mm”). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the flexible member in Wallace's separate embodiment with the previously disclosed embodiment to optimize the diameter of the flexible member to optimize the ability to transmit ultrasound energy through the member.
In regard to claim 18, Wallace discloses the method of claim 11, wherein the flexible sheath (1002, Fig. 10; par. [0161]). Wallace is silent wherein the flexible sheath has a diameter of about 2 mm to about 4 mm, it is well known in the art that optimizing diameter and size is within the ordinary skill of one in the art. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the diameter as claimed in order to allow for an optimized sheath size to allow for ample space within the sheath while also maintain an small cross-sectional size for use within the body.
In regard to claim 19, Wallace is silent wherein the flexible wire has a length of about 10 cm to about 30 cm. In a separate embodiment Wallace discloses wherein the flexible wire (903, Fig. 9; para [0158]) has a length of about 10 cm to about 30 cm (see par. [0158] – “length that can vary anywhere between 0.1 mm and 500 mm”). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the flexible member in Wallace's separate embodiment with the previously disclosed embodiment to optimize the diameter of the flexible member to optimize the ability to transmit ultrasound energy through the member.
In regard to claim 23, Wallace is silent wherein the flexible wire is about 1 mm in diameter. In a separate embodiment Wallace discloses wherein the flexible wire (903, Fig. 9; para [0158]) has a diameter of 1 mm (903, Fig. 9; par. [0158]). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the flexible member in Wallace's separate embodiment with the previously disclosed embodiment to optimize the diameter of the flexible member to optimize the ability to transmit ultrasound energy through the member.
In regard to claim 26, Wallace discloses the device of claim 25, wherein comprising a plurality of lumens (Fig. 10; para [0161] - ‘flexible catheter body 1002 is preferably an elongate tube having one or more lumens extending longitudinally’ - see lumens extending along length of sheath 1002 and are separated from each other). Wallace is silent wherein each of the plurality of lumens comprises a different therapeutic composition. In a separate embodiment Wallace teaches wherein the lumen comprises a different therapeutic composition (Fig. 6; see par. [0045] – “therapeutic agent(s) maybe delivered to the treatment area in variety of different forms and mixtures”). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the lumen comprising different therapeutic compositions with the previously disclosed embodiment to allow for different drug delivery during the usage of the device.
In regard to claim 30, Wallace is silent wherein the sheath comprises a least of a balloon section proximal to a distal tip of the flexible wire and a balloon section distal to the distal tip of the wire, each balloon section serving as a barrier to longitudinal diffusion of contents within the flexible sheath. In a separate embodiment Wallace discloses wherein the sheath comprises at least one of a balloon section (502, Fig. 5; par. [0146]) proximal to a distal tip of the flexible wire and a balloon section distal to the distal tip of the wire (Fig. 5 - see balloon distal to distal tip of the wire), each balloon section serving as a barrier to longitudinal diffusion of contents within the flexible sheath (par. [0146] – “prevent downstream flow of blood and therapeutic drug”). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the balloon in Wallace's separate embodiment with the previously discloses embodiment to maximize the effectiveness of the vibration and drug absorption.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Coury et al. (US 4,820,289; hereafter Coury).
In regard to claim 10, Wallace discloses the device of claim 1, wherein the flexible sheath (1002, Fig. 10; para [0161) comprises silicone rubber (par. [0161] – “catheter body 1002 can be formed of any polymeric material”). Wallace is silent wherein the sheath is specifically a silicone rubber.
Coury teaches wherein the sheath is specifically a silicone rubber (Col 2, In 51-54 – “sheath of the present external catheter can be of any thin, flexible, elastomeric, moisture-impermeable material such as latex rubber or silicone rubber”).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized Coury's silicone rubber sheath with Wallace's device to allow for the flexible sheath to allow for a material that is compliant enough while also reducing the irritation when used in the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783