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 .
This communication is responsive to amended application filed on 03/26/2026.
Claims 4-10, and 13-26 have been canceled.
Claim 28 has been added.
Claims 1-3, 11-12, and 27-28 are presented for examination.
Response to Arguments
Applicant’s arguments/amendments with respect to claim 1 have been fully considered and are persuasive. The rejection of 35 USC 101 has been withdrawn.
Applicant’s arguments/amendments with respect to claim 1 have been fully considered and are persuasive. The rejection of 35 USC 112 has been withdrawn.
Applicant’s arguments/amendments with respect to claim 1 have been fully considered and are persuasive. The rejection of 35 USC 103 has been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: “sockett” (line 25) is misspelled. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3, 11-12, and 27-28 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites an outer socket, a first inner socket, a data processor, which were not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
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.
The term “optionally” in claim 1 is a relative term which renders the claim indefinite. The term “optionally” 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.
Allowable Subject Matter
Claims 1-3, 11-12, and 27-28 are allowable over prior art.
The following is a statement of reasons for the indication of allowable subject matter:
RADSPIELER et al (US Publication No. 2018/0036144 A1) discloses Abstract, The present invention relates to a medical apparatus (100) for use in manufacturing a plaster impression of limb stump, in particular of a lower stump, wherein the apparatus (100) comprises a pressure vessel (1) with a fluid chamber of pressure chamber (DK) for receiving or storing a fluid (F) being under pressure, wherein the pressure vessel (1) is limited against an exterior (Ä), wherein the pressure vessel (1) comprises an insertion opening (9) for the insertion of a limb stump (KS) into the interior (I) of the pressure vessel (1) and a fluid-tight membrane (5) made of two materials, which are arranged to form or limit the fluid chamber or the pressure chamber (DK). In addition, the present invention relates to a system (300) having a medical apparatus (100) and at least one contact surface (111); [0014] The wall of the pressure vessel limits its interior. According to the present invention, the interior of the pressure vessel is understood to be the space or volume defined by the geometry of the pressure vessel or encompassed or circumscribed by an outer wall of the pressure vessel; [0025] A method according to the present invention, serves for adjusting a plaster impression to a limb stump of a patient or measuring the dimensions of the limb stump, e.g. its volume, its geometry, its surface and/or a combination thereof; [0009] An object of the present invention may be to provide an apparatus, a system and a method for use in making a plaster impression for a prosthesis shaft, or at least for an outer shaft thereof, in particular for the lower extremity; [0020] The adapter according to the present invention is provided and/or prepared for use in the production of a plaster impression or a data model of a limb stump, in particular a lower leg stump; [0205] the apparatus comprises at least one device for measuring or scanning the limb stump, which device is configured to prepare or calculate a data model of the limb stump or a data model of the shaft to be produced; [0207] In some exemplary embodiments according to the present invention, the apparatus comprises a shaping device or is connected thereto in signal communication. The shaping device is arranged and/or configured to manufacture the prosthesis shaft based on the data model of the limb stump or on the data model of the shaft to be produced for the limb stump; [0445] The device 73 may be configured to store and/or output the data model in a known file format. A corresponding output device may be provided, as well as a suitable display device for displaying the data model or representation based thereon, in particular of the limb stump KS or the shaft to be produced. The data model thus created may be used elsewhere to create a shaft. For this purpose, the file which contains the data model may be sent, e.g., to a remote workshop for prosthesis shafts, which is likewise encompassed by the present invention; [0446] However, the data model may also be connected in signal communication with a shaping device 75 adapted to manufacture the prosthesis shaft on the basis of the data model of the limb stump KS or the shaft to be manufactured for the limb stump KS. The signal connection may be wired or “wireless”; [0232] In some exemplary embodiments according to the present invention, the medical apparatus comprises a detection device or is connected thereto and/or is used therewith. The detection device is configured to determine, based on, or considering a pressure value detected or determined by a pressure measuring device, e.g. the pressure sensor, the weight with which the patient, whose limb stump is inserted into the medical apparatus, should be weighted with so that the measured pressure detected by the pressure measuring device lies in a predetermined target range or moves within said range; [0058] As shown in FIGS. 26 and 27, such profile data may be represented in the form of a digital representation 14 as stored in a computerized design tool, depicted in FIG. 26 as a laptop CAD system 16. In addition to the BK by Measurement process described above, there are also several other known methods for obtaining the digital representation 14 of the patient's residual limb as depicted in FIG. 2. For example, such methods include the use of wand-based CAD systems such as the TracerCAD system, commercially available from Tracer Corporation of Miami, Fla., or by a digitizing system such as the Benz CAD/CAM and Digitizing systems, available through Benz Group Limited, Horns Cross, Greenhithe, Kent U.K. Such CAD systems are also capable of making the modifications to the digital representation of the limb.
Slemker et al (US Publication No. 2007/0021858 A1) discloses [0058] As shown in FIGS. 26 and 27, such profile data may be represented in the form of a digital representation 14 as stored in a computerized design tool, depicted in FIG. 26 as a laptop CAD system 16. In addition to the BK by Measurement process described above, there are also several other known methods for obtaining the digital representation 14 of the patient's residual limb as depicted in FIG. 2. For example, such methods include the use of wand-based CAD systems such as the TracerCAD system, commercially available from Tracer Corporation of Miami, Fla., or by a digitizing system such as the Benz CAD/CAM and Digitizing systems, available through Benz Group Limited, Horns Cross, Greenhithe, Kent U.K. Such CAD systems are also capable of making the modifications to the digital representation of the limb.
Paterno et al (L. Paterno, M. Ibrahimi, E. Gruppioni, A. Menciassi, L. Ricotti, “Sockets for Limb Prostheses: A review of Existing Technologies and Open Challenges”, IEEE, pgs. 1996-2010, 2018) discloses Abstract—In the prosthetics field, one of the most important bottlenecks is still the human-machine interface, namely the socket. Indeed, a large number of amputees still rejects prostheses or points out a low satisfaction level, due to a sub-optimal interaction between the socket and the residual limb tissues. The aim of this paper is to describe the main parameters (displacements, stress, volume fluctuations and temperature) affecting the stump-socket inter face and reducing the comfort/stability of limb prostheses. In this review, a classification of the different socket types proposed in the literature is reported, together with an analysis of advantages and disadvantages of the different solutions, from multiple viewpoints. The paper then describes the technological solutions available to face an altered distribution of stresses on the residual limb tissues, volume fluctuations affecting the stump overtime and temperature variations affecting the residual tissues within the socket. The open challenges in this research field are highlighted and the possible future routes are discussed, towards the ambitious objective of achieving an advanced socket able to self-adapt in real-time to the complex interplay of factors affecting the stump, during both static and dynamic tasks.
Kuiken et al (US Patent No. 7, 922, 773 B1) discloses Thus, an inner socket 80 is fit intimately to the residual limb. Then an outer socket 84 is mechanically attached to the inner socket by conventional attachment means such as bolts 86. A permanent magnet 88 with a fixed magnetic field is mounted adjacent the distal tip 90 of radius 72 (Col. 6 lines 61-64).
Erenstone et al (US Patent No. 10,905,568 B2) discloses there is seen in FIG. 1, a prosthetic socket design system 10 comprising a patient data acquisition module 12 that is configured to acquire the specific anthropomorphic data of a patient having a residual limb 14 to be outfitted with a prosthetic device, as seen in FIG. 2. Data acquisition module 12 may comprise a digital scanner 16 that acquires patient anthropomorphic data via 3D digital scanning that acquires the coordinates of the bones, fatty tissues, and muscles of the residual limb to be outfitted with the socket and prosthetic device, as seen in FIG. 3. Data acquisition module 12 is configured to digitize the coordinates into a shapefile (digital mold) through use of conventional scanning software. Data acquisition module 12 may alternatively or additionally be configured to acquire patient anthropomorphic data through the digitization of a physical mold. For example, a user may acquire the exact coordinates of a residual limb from a plaster cast of that residual limb using the same 3D scanning process described above and then digitize those coordinates into a shapefile. Data acquisition module 12 may alternatively or additionally be configured to acquire patient anthropomorphic data that is obtained by a user manually measuring predetermined set of coordinates and then entering the coordinates into data acquisition module 12 so that the digital shapefile can be generated (Col. 2 line 55 through Col. 3 line 12).
However, none of the cited prior art references of record fully anticipate or render
obvious the independent claims in particular the limitation of: “using the measured circumferential measurements to manufacture a prosthetic socket to be worn by one of the one or more patients at a first time or wear point, wherein the circumferential measurements used to manufacture the prosthetic socket correspond to those measured for the one of the one or more patients, wherein the prosthetic socket comprises an outer socket, a first inner socket that fits within the outer socket, wherein the first inner socket has dimensions which correspond to the measured circumferential measurements of the limb stump of the one of the one or more patients, and optionally one or more extensions useable in conjunction with the first inner socket to be used at the first time or wear point using a data processor or computer to calculate calculated circumferential measurements for either a second inner socket that fits within the outer socket, or one or more extensions that fit between the outer socket and the first inner socket, wherein the calculated circumferential measurements are based on the measured circumferential measurement used for the first inner socket and optionally the one or more extensions useable in conjunction with the first inner socket to be used at the first time or wear point, and optionally, data for one or a plurality of other patients that corresponds to the patient specific data for the one of the one or more patients that will wear the prosthetic socket at the first time or wear point, and wherein the calculated circumferential measurements are for a second time or wear point for the one of the one or more patients that will wear the prosthetic socket at the first time or wear point, wherein the calculated circumferential measurements are different from the measured circumferential measurements and are based on the patient specific data and the data for one or a plurality of other patients; and using the calculated circumferential measurements to manufacture either a second inner socket that fits within the outer socket, wherein the second inner socket has dimensions which correspond to the calculated circumferential measurements for the limb stump of the one of the one or more patients at the second time or wear point, or one or more extensions useable in conjunction with the first inner socket to be used at the second time or wear point” as recited in claim 1.
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 KIBROM K GEBRESILASSIE whose telephone number is (571)272-8571. The examiner can normally be reached M-F 9:00 AM-5:30 PM.
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KIBROM K. GEBRESILASSIE
Primary Examiner
Art Unit 2189
/KIBROM K GEBRESILASSIE/ Primary Examiner, Art Unit 2189 05/05/2026
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