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 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 60, 61 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 60 recites the limitation "the liner" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim. Dependent claim carries the same issue as its independent.
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) 1,2,15,24,25,27,28 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Phillips (7655049) or, in the alternative, under 35 U.S.C. 103 as obvious over Lohmann (5728167). Phillips disclose (Fig. 2B) an adjustable overlaying interface for adjusting a prosthesis to a liner worn over a residual limb of a user, the adjustable overlaying interface comprising: a sleeve 218, the sleeve is fully capable of being pulled on an outer surface of the liner since it has an open volume pocket to receive a liner on a residual limb and is separate thereof, the sleeve being thereby adapted to be worn over the liner and at least partially inside a socket of the prosthesis. It can also be seen (Fig. 2B) there is an inflatable bladder 206, the inflatable bladder being attached to or integrally formed with the sleeve. Fig. 2A of Phillips also shows a fluid-providing device 216, and discloses (col. 7, lines 14-16) the fluid-providing device being fluidly connected to the inflatable bladder. Additionally Phillips discloses (col. 8, lines 35-40) the fluid-providing device being operative to inflate the inflatable bladder with a fluid. Further Phillips discloses that the system accommodates (col. 2, lines 37-42,50-52) variations in volume of the residual limb are compensatable by using the fluid-providing device to inflate and/or deflate the inflatable bladder. However, in the alternative Phillips did not explicitly state the sleeve is pullable on an outer surface of the liner. Lohmann teaches (Fig. 1) a sleeve 32 which is pullable (col. 4, lines 44-49) on a liner 16 of a residual limb 12. It would have been obvious to one of ordinary skill in the art to use a pullable sleeve as taught by Lohmann with the prosthetic system of Phillips such that the sleeve conforms to the shape of the residual limb, see Lohmann col. 3, lines 55-59. Regarding claim 2, Phillips discloses (col. 8, lines 32-34) a valve, the valve being fluidly connected to the inflatable bladder to selectively let the fluid out of the inflatable bladder. With respect to claim 15, Phillips discloses (Figs. 2A,B) the inflatable bladder 206, part of a system 202 being secured to the outer surface of the sleeve. Further Phillips disclosing (col. 6, lines 24-26) at least a portion of the outer surface of the sleeve being adapted to face an inner surface of the socket. Regarding claim 24, Phillips discloses (col. 8, lines 58,59,64-66) the inflatable bladder comprises a film made of bladder material impervious to fluid and the material of the bladder can be made from elastomers. Regarding claim 25, Phillips discloses (col. 11, lines 28-30,34-40) a thickness of the adjustable overlaying interface along substantially an entirety of a periphery thereof is less than 3 mm when the inflatable bladder is fully deflated. With respect to claim 27, it can be seen (Fig. 3) Phillips shows the fluid-providing device 316 is longitudinally spaced apart from the inflatable bladder since it is located at a distance above and away from the bladder(s) 302. Regarding claim 28, Phillips also disclose (col. 9, lines 22-30) the fluid-providing device is a pump.
Claim(s) 29,30,58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phillips (7655049). Fig. 2B shows a prosthetic liner-recovering sheath 218 for use with a prosthetic socket and an associated liner, the prosthetic liner-recovering sheath comprising: a sheath body being substantially tubular along at least a longitudinal portion thereof and having a liner-superposing inner surface at least partially defining a liner-receiving cavity; and a thickness-adjusting system 202 secured to or formed integral with the sheath body and comprising at least one variable-volume pad 206 arranged to be pressurized so as to adjust a thickness of the sheath along at least a portion of a periphery thereof. Regarding claim 30, Phillips also discloses (col. 8, lines 18-22) the thickness-adjusting system further comprises a fluid-providing device in fluid communication with the at least one variable-volume pad to respectively inflate and deflate the at least one variable-volume pad. Regarding claim 58, Phillips also discloses (col. 6, lines 15-26) there can be a kit of components that includes an inner member having a limb-facing surface at least partially delimiting a limb-receiving cavity and being superposable onto the residual limb of the user, and an opposed outer surface, and the prosthetic a prosthetic liner-recovering sheath overlaying at least partially the outer surface of the inner member.
Claim(s) 60 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Love (5405405). Love discloses (col. 4, lines 1-9) a method for mounting a prosthesis to a residual limb of a user, the method comprising: providing (see Fig. 1) an adjustable overlaying interface having: a sleeve 30, the sleeve being pullable (since they are separate) on an outer surface of the liner 40, the sleeve being thereby adapted to be worn over the liner. Fig. 5 shows the sleeve 30 at least partially inside a socket 20 of the prosthesis and defines an inflatable bladder 30, the inflatable bladder being attached to or integrally formed with the sleeve (col. 3, lines 58-68). Fig. 1 shows a fluid-providing device 38, the fluid-providing device being fluidly connected via tube 39 to the inflatable bladder, the fluid-providing device being operative to inflate the inflatable bladder with a fluid. Love also discloses (col. 6, lines 37,40,41,52-58) variations in volume of the residual limb are compensatable by using the fluid-providing device to inflate and/or deflate the inflatable bladder. Fig. 1 shows the sequence of using the prosthetic components by installing the adjustable overlaying interface 30 over a liner 40 donned over the residual limb of the user; at least partially inserting the residual limb wearing the liner and the adjustable overlaying interface within a socket 20 of the prosthesis. Love also states (col. 3, lines 12,13) the system allows a patient to at least either inflate or deflate the inflatable bladder of the adjustable overlay interface to compensate variations in volume of the residual limb.
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.
Claim(s) 61 is rejected under 35 U.S.C. 103 as being unpatentable over Love (5405405) in view of Birgisdottir et al. (2017/0209290). Love is explained supra. However, Love did not disclose installing the adjustable overlaying interface comprises “pulling” the sleeve of the adjustable overlaying interface over the residual limb. Birgisdottir et al. teach (paragraph 181) that a sleeve interface is pulled over the residual limb. It would have been obvious to one of ordinary skill to provide the sleeve interface to be pulled over the residual limb as taught by Birgisdottir et al. with the method of using the socket and interface of Love in order to firmly secure the interface and couple the residual limb into the socket by assuring the interface is sufficiently on the limb, see Birgisdottir paragraph 16.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Phillips (7655049) in view of Love (5405405). Phillips is explained supra. However, Phillips did not disclose both the fluid-providing device and the valve are located proximate a longitudinal extremity of the sleeve so as to be outside the socket when in use. Love teaches (Fig. 5) that both the fluid-providing device 38 (Fig. 1) and the valve 37 are located proximate a longitudinal extremity of the sleeve 30 so as to be outside the socket 20 when in use. It would have been obvious to one of ordinary skill in the art to provide both the fluid-providing device and the valve are located proximate a longitudinal extremity of the sleeve so as to be outside the socket when in use as taught by Love with the prosthetic assembly of Phillips such that one has access to connect and add or remove fluid in an easy manner.
Claim(s) 4,8 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (7655049) in view of Lohmann (5728167). Phillips is explained supra. However, Phillips did not disclose the sleeve is at least partially made of a stretchable sleeve material so as to snugly fit over the liner or the sleeve is at least partially made of a material selected from the list consisting of: nylon, polyester, elastane, aramid fibers, cotton, wool, silk, thermoplastic polyurethane, polyurethane, polyvinyl chloride or a combination thereof. Lohmann teaches (col. 3, lines 55-60) the material for the sleeve is at least partially made of a stretchable sleeve material so as to snugly fit over the liner and can be cotton or wool. It would have been obvious to one of ordinary skill in the art to select an appropriate material such as cotton or wool that is stretchable as taught by Lohmann for the sleeve of Phillips such that it provides the necessary stretchability needed to pull onto the liner and residual limb of the patient or user in order to restrict movement.
Claim(s) 10,11 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (7655049) alternatively in view of Lohmann (5728167) and in view of Beldzisky (FR 2521001). Phillips is explained supra. However, Phillips did not disclose at least a portion of an inner surface of the sleeve has a sleeve friction coefficient against human skin of less than substantially 1. Beldzisky teaches (see translation i.e. pages 3,5,6) the material for the sleeve is provided with a low coefficient of friction. Please note the recitation of “substantially 1” is relative terminology and is broadened range. Thus since Beldzisky is concerned with the same issue of reducing friction on the patient’s limb and movement it can be considered within the scope of “less than substantially 1” by the suggestion to have low coefficient of friction. It would have been obvious to one of ordinary skill in the art to select provide a sleeve friction coefficient against human skin of less than substantially 1 as taught by Beldzisky for the sleeve of Phillips such that it provides the necessary compatibility with the patient or user and improve wearing of the sleeve, page 3 of Beldzisky. Regarding claim 11, Phillips also did not explicitly detail the inner surface of the sleeve having a first zone with a coefficient against human skin less than 0.5. As mentioned above Beldzisky teaches low coefficient of friction which one of ordinary skill in the art would know and consider to be less than 1. Thus it would have been obvious to find the optimal reduced or low coefficient of friction against human skin to be a very low value such that it is less than 0.5 since finding the optimal value only involves routine skill in the art and Beldzisky stated it is important to have a low coefficient of friction against human skin to reduce inflammation.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Phillips (7655049) in view of Redkar et al. (2022/0071783). Phillips is explained supra. It is noted Phillips does disclose (col. 6, lines 24-26) the outer surface being adapted to at least partially face the socket. However, Phillips did not disclose the inflatable bladder comprises two walls sealed together on a periphery thereof, the two walls being further attached together locally and within their periphery so as to define relief zones where the inflatable bladder is uninflatable and a plurality of inflatable cells where the inflatable bladder is inflatable. Redkar et al. teach (Figs. 1A,B,2) the inflatable bladder 115 comprises two walls sealed together on a periphery thereof, the two walls being further attached together locally and within their periphery so as to define relief zones where the inflatable bladder is uninflatable and a plurality of inflatable cells where the inflatable bladder is inflatable, see paragraph 45. It would have been obvious to one of ordinary skill in the art to provide the inflatable bladder as two walls sealed together on a periphery thereof, the two walls being further attached together locally and within their periphery so as to define relief zones where the inflatable bladder is uninflatable and a plurality of inflatable cells where the inflatable bladder is inflatable as taught by Redkar et al. with the sleeve of Phillips such that it provides the necessary distribution of force provided by the bladders and balance pressure about the residual limb.
Allowable Subject Matter
Claims 12,13 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.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799