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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,29,60 and dependents have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 4, 8, 10-13, 15, 19, 24-25, 27, 28, 61,66 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.
The term “proximate” in claim 1 is a relative term which renders the claim indefinite. The term “proximate” 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. Claim 1 recites “the inflatable bladder being permanently attached to the pullable sleeve……a thickness-adjusting system which is permanently secured to the pullable sleeve…….both the fluid-providing device and the valve are located proximate a longitudinal extremity of the sleeve so as to be outside the socket….” of which define multiple features that suggest elements are connected to the sleeve but there is no reference frames to establish where or how these components are arranged. For example as best understood, if one is providing a fair reading of the claim, it might be understood that the location has to be exterior to the surface of the sleeve, however, how far away is the structure from the sleeve implied by the clause “located proximate a longitudinal extremity of the sleeve” because it suggests possibly an interpretation that is transverse to the axis based on a fair reading of the claim by reciting the elements are permanently connected. However, one could also incorporate holes through a wall of the sleeve to extend a connection outside the sleeve to provide the locating of the fluid-providing device and valve outside the socket, thus, no limitations or description are read into claims and it must be indicated that the claim is not clear as to what is the exact arrangement or location of the inflatable bladder or any orientation of the fluid-providing device and valve because it is not clear how far or what direction a longitudinal extremity is “proximate” some arbitrary location that has some features permanently secured.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 61 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 61 particularly recites “pulling the sleeve of the adjustable overlaying interface over the residual limb” of which depends on claim 60 that recited a “liner was donned over the residual limb” to thus not define any new location. In fact it would seem to possibly contradict claim 60 that said a liner was on the limb and now claim 61 could imply the interface is on the limb first, but is not evident what the further scope is to be intended. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,15,27,29,58,60,61,66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernhardt (9017420). Fig. 1 shows a prosthetic liner-recovering sheath for use with a prosthetic socket 16 and an associated liner 12, the prosthetic liner-recovering sheath 22 comprising: a sheath body 24 being substantially tubular along at least a longitudinal portion thereof. Fig. 2 shows the body of the sheath has a liner-superposing inner surface 26 at least partially defining a liner-receiving cavity. Bernhardt discloses (col. 5, lines 8,9) that the sheath body is capable of being pulled on an outer surface of the liner. Bernhardt discloses (col. 4, lines 52-64) a thickness-adjusting system mounted to or formed integral with the sheath body and comprising at least one variable-volume pad arranged to be pressurized so as to adjust a thickness of the sheath along at least a portion of a periphery thereof. Bernhardt additionally discloses (col. 5, lines 13-43) a fluid-providing device 46 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, Fig. 1 shows a kit for adjusting a prosthesis to a residual limb of a user, the kit comprising: an inner member 12 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, of which sheath 22 at least partially covers the outer surface of the inner member. With respect to claims 1 (as best understood) and 60, Bernhardt discloses (col. 4, lines 11-15) a method for mounting a prosthesis to a residual limb of a user. Bernhardt also disclose (col. 5, lines 32-43) the method comprising: providing an adjustable overlaying interface shown (Fig. 1) with a sleeve 22, the sleeve being pullable (col. 5, lines 8,9) on an outer surface of a liner 12, the pullable sleeve being thereby adapted to be worn over the liner and at least partially inside a socket 16 of the prosthesis 18. Fig. 2 shows an inflatable bladder 42, the inflatable bladder wall 28 being permanently attached (col 4, lines 45-47) to the pullable sleeve inner wall 26, Fig. 5 shows a fluid-providing device 52, the fluid-providing device being fluidly connected to the inflatable bladder, (col. 5, lines 49-54) the fluid-providing device being operative to inflate the inflatable bladder with a fluid (air). It can be construed the inflatable bladder and the fluid-providing device at least partially forming together a thickness-adjusting system which is permanently secured to the pullable sleeve 50 as seen in Fig. 5 and the thickness-adjusting system further comprising a valve 46, the valve being fluidly connected to the inflatable bladder to selectively let the fluid out of the inflatable bladder (col. 5, lines 54,55), wherein both the fluid-providing device and the valve are located at a proximal portion of the adjustable overlaying interface; installing the adjustable overlaying interface over the liner donned over the residual limb of the user; at least partially inserting the residual limb wearing the liner and the adjustable overlaying interface within the socket of the prosthesis. It can be seen (fig. 2) that the fluid-providing device 52 and the valve 46 being located outside the socket with the proximal portion of the adjustable overlaying interface 50 (since it is just an alternative for sleeve 22) extending beyond an upper edge of the socket; and inflating and deflating the inflatable bladder of the adjustable overlay interface to compensate variations in volume of the residual limb (col. 5, lines 32-43). Regarding claim 61, Bernhardt discloses (col. 5, lines 8,9) that installing the adjustable overlaying interface comprises pulling the sleeve of the adjustable overlaying interface over the residual limb. With respect to claim 15, Fig. 2 shows the inflatable bladder 42 with wall 28 is secured to an outer surface of the inner sleeve wall 26, at least a portion of the outer surface 28 of the sleeve being adapted to face an inner surface of the socket 18. With respect to claim 27, it can be seen (Fig. 5) Bernhardt shows the fluid-providing device 52 is longitudinally spaced apart from the inflatable bladder since it is located at a distance above and away from the bladder(s) 42 space.
Regarding claim 66, Fig. 5 shows an adjustable overlaying interface 50 a proximal portion extending beyond an upper edge of the socket when in use (see Fig 2 for such a placement of the interface alternatively for interface 22), the valve 46 and the fluid-providing device 52 being located at the proximal portion of the adjustable overlaying interface.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Bernhardt (9017420). Bernhardt is explained supra. It is noted that Bernhardt did disclose (Col. 5, lines 53,64,65) a pump can be provided as the fluid-providing device and such systems and apparatus are known in the art. However, Bernhardt did not explicitly disclose a cartridge of pressurized compressible fluid. The examiner takes official notice based on Bernhardt stating common apparatus to deliver fluid to a bladder is known and thus one can utilize a cartridge of pressurized compressible fluid. It would have been obvious to one of ordinary skill in the art to incorporate a cartridge of pressurized compressible fluid with the pump of Bernhardt in order to provide a self-maintained adjustable sleeve for the amputee and ease of operation with it being pressurized to limit the effort for the patient.
Claim(s) 4,8 are rejected under 35 U.S.C. 103 as being unpatentable over Bernhardt (9017420) in view of Lohmann (5728167). Bernhardt is explained supra. However, Bernhardt did not disclose the specific material sleeve type to be 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 Bernhardt 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
Bernhardt (9017420) in view of Beldzisky (FR 2521001). Bernhardt is explained supra. However, Bernhardt 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, Bernhardt 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 Bernhardt (9017420) in view of Redkar et al. (2022/0071783). Bernhardt is explained supra. It is noted Bernhardt does disclose (col. 5, lines 20-21) the outer surface being adapted to at least partially face the socket. However, Bernhardt 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 Bernhardt such that it provides the necessary distribution of force provided by the bladders and balance pressure about the residual limb.
Claim(s) 24,25 are rejected under 35 U.S.C. 103 as being unpatentable over Bernhardt (9017420) in view of Phillips (7655049). Bernhardt is explained supra. However regarding claim 24, Bernhardt did not disclose the inflatable bladder comprises a film made of a bladder material impervious to the fluid, the bladder material being selected from the list consisting of: thermoplastic polyurethane, thermoplastic elastomer, polyurethane, polyvinyl chloride or a combination thereof. Phillips teaches (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. It would have been obvious to one of ordinary skill in the art to select an appropriate material such as an elastomer as taught by Phillips for the inflatable bladder film layer of Bernhardt 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. With respect to claim 25 Bernhardt did not explicitly disclose 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. Phillips teaches (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. It would have been obvious to select the appropriate dimensions for the interface and provide a low profile compressed sleeve with inflatable bladder to be less than 3mm when deflated as taught by Phillips with the sleeve and bladder of Bernhardt such that it minimizes any bunching up.
Allowable Subject Matter
Claims 12, 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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