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 .
DETAILED ACTION
Priority
Acknowledgment is made of applicant's claim for foreign priority based on a European application 23220053.5 filed on December 22, 2023.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings do not show the essential element of an orientation transmitter and therefore are objected to. The drawings must show every feature of the invention specified in the claims. Therefore, the orientation transmitter 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 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.
Claims 1 - 19 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims discloses an orientation transmitter 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 at the time the application was filed, had possession of the claimed invention. The written description must clearly allow persons skilled in the art to recognize that the applicant(s) invented what is claimed. The specification describes the orientation transmitter on what it does rather than what the orientation transmitter is. The written description requirement is sometimes satisfied by disclosure of descriptive means by way of formulas, structures, figures, and diagrams. In this case the disclose does not contain any of these means and does not disclose figures or diagrams showing an orientation transmitter. The most descriptive paragraph in the specification for the orientation transmitter is paragraph 0097 and 0098 which states: “…Creating a 3D model of an orientation transmitter, [0098] Manufacturing of the prosthetic socket and the orientation transmitter based on the 3D models wherein the orientation transmitter is created such that the manufactured socket can be directly or indirectly connected to a component adapter by means of the orientation transmitter so that the position and orientation of the inner surface of the prosthetic socket relative to the position and orientation of the component adapter corresponds to the position and orientation of the prior inner surface of the prior socket to the component adapter.” But as stated above, this describes what the orientation transmitter does rather than the physical structure for the orientation transmitter. The orientation transmitter could be a metal guide to help position the prosthetic to the component adapter; or the orientation transmitter might be a hollow tube that holds the prosthetic and the socket, or some apparatus that creates markings such as a laser. The specification (Par. 0067) and claims (claim 7) describe the orientation transmitter as having markings, but this is far short of describing the physical structure for the orientation transmitter. The orientation transmitter is a critical feature of the invention and without a proper disclosure, the claimed invention is rejected under 35 USC 112(a).
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.
Claim 1 is rejected under 35 USC 112(b). Claim 1 recites the limitation: “the manufactured socket.” There is insufficient antecedent basis for this limitation in the claim. The claim describes a prosthetic socket, but not a “manufactured socket.”
Claim 1 is rejected under 35 USC 112(b). Claim 1 recites the limitation: “determining information about an orientation transmitter.” One having ordinary skill in the art would not understand how to “determine information about an orientation transmitter.” See also 35 USC 112(a) rejection.
Claim 1 is rejected under 35 USC 112(b). Claim 1 recites the limitation: “providing the orientation transmitter based on…” One having ordinary skill in the art would not understand the meaning of “providing” for an orientation transmitter in the context of the claim. Appropriate action is required.
Claim 17 is rejected under 35 USC 112(b). Claim 17 recites the limitation: “the orienter of claim 14.” There is insufficient antecedent basis for this limitation in the claim as claim 14 does not disclose “an orienter.”
Claims 17 and 18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. Regarding claims 17 and 18 it is unclear if the claim encompasses a system, device, or a method. More specifically, the limitations of method claims 1, 4 and 14 and the system claim of 17 embrace or overlap two different statutory classes of invention of an system or apparatus, and a method. Claim 7 is a “A system comprising: the orienter of claim 14…” and claim 14 is a method claim. The court determined in IPXL Holdings LLC v. Amazon.com, Inc., 77 UDPQ2d 1140 (Fed. Cir. 2005) that claims with a device structure and a method step therein are indefinite under 112(b) because it cannot be determined when the claim is infringed. Additionally, combining two separate statutory classes of invention in a single claim raises a serious question for a manufacturer or seller regarding infringement. Therefore, a claim directed to more than one different statutory class of invention is not sufficiently precise to provide competitors with an accurate determination of the "metes and bounds" of protection involved so that an evaluation of the possibility of infringement may be ascertained with a reasonable degree of certainty, as discussed by the court in In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970), stated at 166 USPQ 208. See MPEP 2173.05(p)(II): “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b).” Claim 18 depends from claim 17 and therefore also rejected under 35 USC 112(b). Appropriate action is required.
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.
(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 - 5, 10 – 12, 14, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Dignam et al. (US PG Pub. No. 9283660), herein “Dignam.”
Regarding claim 1,
Dignam teaches a method for manufacturing a new prosthesis for a lower limb, the method comprising the following steps: (Abstract: “The present invention relates to standardizing the manufacture above-the-knee (AK) and below-the-knee (BK) prosthetic sockets…”)
- a) Providing 3D-data of a prior inner surface of a prior socket and of its position and its orientation relative to a component adapter, (Col. 2, lines 31 – 33: “…some fabrication facilities create a digitized solid model computer file by scanning the inside of the patient's plaster wrap with a mechanical sensor or laser scanner.”)
- b) Creating a 3D model of a prosthetic socket with an attachment area for a socket adapter, wherein the prosthetic socket has an inner surface based on the scanned prior inner surface and an outer surface, (Col. 2, lines 33 – 49: “This digitized image can then be modified by computer software designed for this purpose to dimensionally add or subtract “material” from the digitized image in a manner similar to that of a prosthetist adding or shaving material off the plaster cast to adjust or fine tune the cast to better replicate the truncated limb. Once the Computer Aided Design (CAD) file is generated, it can then be loaded into computer controlled CNC machine tool often referred to as a “carver”, which cuts out a replica of the residual limb in a rigid but malleable material like a high density polymeric foam or wax. At this point, like the process described above for a plaster cast, a thermoforming material is drawn over the positive mold making a negative replica of the limb. This thermoform or thermoset material can be used as a preliminary “check socket” to assess how the well the socket fits the patient.”)
- c) Determining information about an orientation transmitter, (alignment jig) (Col. 3, lines 22 – 28: “All of these settings, beyond the CAD file of the truncated limb, become key parameters in determining the final configuration of the prosthesis from socket to ankle. The object of this invention is to use an alignment jig, instrumented with linear and angular micro-encoders, to produce a fully digitized representation of the complete prosthesis, which can be used as a "prescription…” Col. 5, lines 17 – 31: “The Digital Alignment Jig— This is an alignment jig where the principle degrees of freedom used by the prosthetist to manually align the socket to the pylon through extension and rotation of clamps and fixtures, to be instrumented with linear and rotary micro-encoders that fully characterize the linear and angular measurements “locked down” by the prosthetist after the “best fit.” These parameters are simultaneously recorded on a PDA or other device which, along with the CAD file, constitute the Complete Digital Record. Once recorded, the jig could be used for other alignments, with the jig reset later, manually, with the technician resetting the clamps and fixtures manually, but with the aid of the digital readout of linear and rotational settings on the PDA.” See also Abstract.)
- d) Manufacturing of the prosthetic socket based on the 3D model and providing the orientation transmitter (alignment jig) based on the information, (Col. 1, lines 47 – 51: “Conventional production of above-the-knee (AK) and below-the-knee (BK) prosthetic sockets and attached hardware entails mounting various components on an apparatus like the Hosmer VFJ-100 Vertical Fabricating Jig, to provide proper alignment of the various parts that make up a prosthetic device.” Col. 1, lines 63 – 65: “The alignment jig plays an important role in physically securing all of the parts, with proper orientation, during the manufacturing process.”)
- e) Directly or indirectly connecting the manufactured socket to a component adapter by means of the orientation transmitter so that the position and orientation of the inner surface of the prosthetic socket relative to the position and orientation of the component adapter corresponds to the position and orientation of the prior inner surface of the prior socket to the component adapter. (Col. 1, lines 50 – 58: “…the Hosmer VFJ-100 Vertical Fabricating Jig, to provide proper alignment of the various parts that make up a prosthetic device. A prosthetic device may include the socket which fits the amputee's truncated limb, the attachment plate rigidly fixed to the socket, a pylon which connects the socket's attachment plate to an articulating or fixed ankle and/or the artificial foot. The pylon is essentially a linear structure, often a cylindrical pipe, with associate hardware for connecting the socket to the ankle or foot.” Col. 9, line 59 – Col. 10, line 2: (33) However this plastic replica is formed, it can be used to create a “check socket” with the addition of a socket attachment plate, pylon, and foot, formed on an alignment jig. The prosthetist uses this temporary check socket to work with the patient and assure a proper fit 6. By using the Digital Alignment Jig (DAJ), the prosthetist is able to record all of the alignment settings digitally. This data together with the CAD file forms the complete digital record or prescription of the prosthesis 7. This prescription can then be sent electronically 8 directly to the Central Fab 3 or to the Central Records Facility 3 where it is accessible by the Central Fab.” Col. 10, lines 14 – 21: “Using the Automated Alignment Jig (AAJ), technicians at the Central Fab can assemble the socket, pylon, and ankle attachment on the Automated Alignment Jig 10. The Central Fab now sends the aligned prosthesis back to Patient Care Facility for final fitting of the patient. The prosthetist is able to slightly modify the angles of the various prosthesis components within a very limited range using pyramid adaptors described above.”)
Regarding claim 2,
The previously cited reference(s) teach the limitations of claim 1 which claim 2 depends. Dignam also teaches that in method step c) a 3D model of the orientation transmitter is created and in method step d) the orientation transmitter is manufactured. (Col. 4, lines 45 – 54: “Once the technician has assembled the various components on the jig, aligned them, and locked down all of the setting, the jig itself stores the settings while the technician continues on to the production of the prosthesis. The jig now unable to be used for other production until the technician has finished the original prosthesis. Furthermore, once the jig is used for production of a different prosthesis, the original settings are essentially lost. If another duplicate socket is required at a later date, the process must be repeated from scratch, requiring new settings to be generated.” See also Col. 3, lines 22 – 30.)
Regarding claim 3,
The previously cited reference(s) teach the limitations of claim 1 which claim 3 depends. Dignam also teaches that wherein method step a) comprises a1) Providing a prior prosthesis for the lower limb, (Col. 9, line 59 – Col. 10, line 2) the prior prosthesis comprising the prior socket and a prior connector for connecting to a component adapter of a prosthetic component in a predetermined prior orientation, (See figure 2A that shows the lower limb. Col. 1, lines 52 – 58.) a2) Scanning the prior inner surface of the prior socket and detecting its position and orientation relative to the position of the component adapter. (Col. 2, lines 31 – 39: “…some fabrication facilities create a digitized solid model computer file by scanning the inside of the patient's plaster wrap with a mechanical sensor or laser scanner. This digitized image can then be modified by computer software designed for this purpose to dimensionally add or subtract “material” from the digitized image in a manner similar to that of a prosthetist adding or shaving material off the plaster cast to adjust or fine tune the cast to better replicate the truncated limb.” See also Col. 1, line 66 – Col. 2, line 8; Col. 9, lines 43 – 53; and Col. 9, line 59 – Col. 10, line 2.)
Regarding claim 4,
The previously cited reference(s) teach the limitations of claim 3 which claim 4 depends. Dignam also teaches that the prior connector comprises four screws and the component adapter is a pyramid adapter, wherein method step al) comprises the following steps: a1 i) Unscrewing two neighboring screws of the prior connector, a1 ii) Removing the prior connector from the component adapter, a1 iii)Positioning the prior prosthesis with the prior connector on a holding pyramid adapter, a1 iv)Tightening the two unscrewed screws. (Col. 4, lines 34 – 44: “Beyond the extensions and rotations described above, there are other minor angular adjustments that can be made at specific sites using what are known as single and dual pyramid adaptors. In these adaptors, the relative angles of male and female adaptor plates, within a few degrees of rotation, can be adjusted with four screws in the female component tightened against sloping sides of the male pyramid component. These pyramid adaptors can be found at the socket and ankle ends of the pylon as well as at the end of the Upper Clamp Assembly shaft when coupled with a rotatable joint affixed to the Mandrel Bushing.” See also Col. 10, lines 37 – 45. Examiner’s Note – Dignam teaches 8 instances of “screws” and 15 instances of screw wherein the procedures listed in elements i) – iv) above would be obvious to one having ordinary skill in the art.)
Regarding claim 5,
The previously cited reference(s) teach the limitations of claim 1 which claim 5 depends. Dignam also teaches that method step e) comprises connecting a tube having a connector at each end to a socket adapter disposed on the manufactured prosthetic socket and/or to the component adapter. (Col. 3, lines 10 – 21: “This adjustable link, the so called pyramid adapter, was patented by Otto Bock in 1969 and is used worldwide. The adapter consists of two pairs of set screws surrounding a pyramid, allowing adjustment, within a limited swing angle, in two planes. Double, eccentric and sliding adapters offer even more options. Tube adapters and tube clamps add the option of varying lengths and diameters and create an easy-to-adjust connection. The various lamination anchors, socket adapters and socket attachment blocks and provide the transition to the distal component unit. The pyramid adapters are relatively limited in the range of angles they are able to secure.”)
Regarding claim 10,
The previously cited reference(s) teach the limitations of claim 1 which claim 10 depends. Dignam also teaches that the orientation transmitter comprises a socket orienter and/or a component orienter, each of which has a contact edge and an inverted pyramid, the contact edge being annular, preferably circular, and the inverted pyramid being tilted relative to the plane defined by the contact edge by a predetermined angle in a predetermined direction. (Col. 4, lines 34 – 44: “Beyond the extensions and rotations described above, there are other minor angular adjustments that can be made at specific sites using what are known as single and dual pyramid adaptors. In these adaptors, the relative angles of male and female adaptor plates, within a few degrees of rotation, can be adjusted with four screws in the female component tightened against sloping sides of the male pyramid component. These pyramid adaptors can be found at the socket and ankle ends of the pylon as well as at the end of the Upper Clamp Assembly shaft when coupled with a rotatable joint affixed to the Mandrel Bushing.” See also Col. 1, lines 59 – 65.)
Regarding claim 11,
The previously cited reference(s) teach the limitations of claim 10 which claim 11 depends. Dignam also teaches that wherein connecting the tube with the socket adapter comprises the following steps:- Positioning the tube so that the connector at one end of the tube rests against the contact edge of the socket orienter and the inverse pyramid of the socket orienter protrudes into the connector,- Tightening the four screws of the connector at the end of the tube,- Unscrewing two neighboring screws of the connector,- Removing the tube from the socket orienter and positioning the end of the tube on the socket adapter,- Tightening the two unscrewed screws. (Col. 3, lines 33 – 55: “(19) 1. Vertical Column Assembly— This is a stout cylindrical pipe with a plate or pipe grip at the bottom which allows it to be bolted or otherwise secured to the surface of a workbench. The vertical column can be aligned with a plumb bob attachment that allows the technician to precisely orient the column in the vertical or “z” direction. This vertical column can support clamp assemblies that contain horizontal shafts with fixtures at the end of each shaft that hold and align components of the prosthesis being integrated on the jig. At the back of the vertical column is a slot running the full length of the column into which a slot key on each clamp can be inserted to align the clamp on the column in a fixed position. All of the clamp assemblies can be raised and lowered on the vertical column, with a rotatable knob on each clamp that that can be tightened to “lock down” and secure the clamp to the column. A slide able collar can be positioned under the clamp assembly and tightened to allow the knob on the clamp assembly to be loosened so the assembly can be rotated in the horizontal plane and maintain a constant level in the “Z” or vertical direction.” Col. 4, lines 8 – 16: “4. Middle Clamp Assembly— This is a fixture referred to in the Hosmer literature as the Knee Holding Assembly. This assembly can have yoke-shaped fixture at the end of the horizontal shaft which allows the technician to clamp and hold larger objects like a check socket which is a thermoplastic replicas of the truncated limb. This yoke apparatus has four bolts in the semicircular yoke frame that can be tightened down to secure the object in the yoke.” See complete assembly instructions for the tube, jig, connectors, pylon, and pyramid adapters in Col. 3, line 34 – Col. 4, line 44.)
Regarding claim 12,
The previously cited reference(s) teach the limitations of claim 10 which claim 11 depends. Dignam also teaches wherein connecting the tube with the component adapter comprises the following steps:- Positioning the tube so that the connector at one end of the tube rests against the contact edge of the component orienter and the inverse pyramid of the component orienter protrudes into the connector,- Tightening the four screws of the connector at the end of the tube,- Unscrewing two neighboring screws of the connector,- Removing the tube from the component orienter and positioning the end of the tube on the component adapter,- Tightening the two unscrewed screws. (See complete assembly instructions for the tube, jig, connectors, pylon, and pyramid adapters in Col. 3, line 34 – Col. 4, line 59. Examiner’s Note – The instructions for assembly would be obvious to one having ordinary skill; even though )
Regarding claim 14,
The previously cited reference(s) teach the limitations of claim 4 which claim 14 depends. Dignam also teaches wherein the tube is provided using the following steps:- Providing a tube having a connector at its first end,- Installing a guide tool on the provided tube and aligning it with the connector at the first end, (Col. 12, lines 52 – 56: “FIG. 6(d) shows the telescoping extension of73 from the base section 72 driven by the rotation of bolt 74. FIG. 6(e) is a top view showing an integral guide 76 rigidly attached to 73 encased in and sliding along slot 77 incorporated in the telescope base 72.”) Shifting a measuring element along the guide tool to a desired position, (Col 8, lines 52 – 54: “FIG. 6(e) is a top view of the screw drive system showing a guide rail within a slot to prevent rotation of the extending member as it is being extended.”) wherein the measuring element has a circumferential marking line and an axial marking line, (reference – See Col. 6, lines 38 – 40. See also Hikichi cited below that teaches axial markings.) Marking the position of the measuring element relative to the tube using the circumferential marking line and marking the orientation relative to the tube using the axial marking line,- Cutting the tube according to the marked position - Arrange a connector at the second end of the tube according to the marked orientation. (Dignam teaches also the adjustment of the tube adapters and adjustable link in column 3.)
Regarding claim 17, it is directed to a system or apparatuses to implement the method of steps set forth in claim 14. Dignam teaches the claimed method of steps in claim 14. Therefore, Dignam teaches the system or apparatuses to implement the claimed method of steps in claims 17.
Regarding claim 19, it is directed to method of manufacturing a system to implement the method of steps set forth in claims 1. Dignam teaches the claimed method of steps in claim 1, Dignam also teaches the manufacturing system as a “fabrication of prosthesis” in several paragraphs. Therefore, Dignam teaches the method of manufacturing a system in claim 19.
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.
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dignam in view of Pelz et al. (PG Pub. No. 20230233343), herein “Pelz.”
Regarding claim 6,
The previously cited reference(s) teach the limitations of claim 1 which claim 6 depends. Dignam does not teach that the orientation transmitter is manufactured using an additive manufacturing process. However, Pelz teaches that the prosthetic socket and/or the orientation transmitter are manufactured in method step d) at least partially using an additive manufacturing process. (Pelz teaches an alignment device for a prosthetic: Par. 0029: “The preferred material for the pylon 104 and for the entire prosthesis 100 is a 3D printable thermoplastic. With regard to the pylon 104, the thermoplastic material permits alignment adjustments in the heat zone 128 during a patient fitting, if necessary. In addition, the fit of the socket can be modified via thermoforming any specified region where pressure needs to be increased or decreased. However, a preferred embodiment is a prosthesis that is aligned properly during the design phase and does not require any modifications post-fabrication, and present methods provide a better chance of a patient specific prosthetic that can be used without any post-fabrication methods.” Par. 0029: “The preferred material for the pylon 104 and for the entire prosthesis 100 is a 3D printable thermoplastic. With regard to the pylon 104, the thermoplastic material permits alignment adjustments in the heat zone 128 during a patient fitting, if necessary. In addition, the fit of the socket can be modified via thermoforming any specified region where pressure needs to be increased or decreased. However, a preferred embodiment is a prosthesis that is aligned properly during the design phase and does not require any modifications post-fabrication, and present methods provide a better chance of a patient specific prosthetic that can be used without any post-fabrication methods.” See also Par. 0040: “3D printing” of an “using an alignment jig.” See also Par. 0047. )
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of using orientation transmitter (alignment jig) to align a user with a prosthetic such as a foot with a newly formed prosthetic as in Dignam with using an alignment device that is formed on or attached to a socket wherein the alignment device is manufactured by additive manufacturing process as in Pelz in order to tailor properties, comfort, materials, and dimensions according to individual needs and stiffnesses or softness in different regions of the prosthetic. (Par. 0027 and 0033)
Regarding claim 13,
The previously cited reference(s) teach the limitations of claim 10 which claim 13 depends. Pelz teaches that wherein the orientation transmitter is manufactured at the same time as the prosthetic socket. (Par. 0010: “More recent efforts focus on digital fabrication and additive manufacturing. Summit U.S. Pat. 8,366,789 describes a method to create an exoskeletal prosthetic limb that can be simultaneously printed in one piece from a single material. Although the designs disclosed in this patent are novel, exoskeletal systems have lost favor over endoskeletal systems due to many limiting factors. One such important factor is the inability to adjust the design post-fabrication, which is a common problem for all amputees and even more important for new amputees whose amputated limb will change shape significantly during the first several months to 1 year. If exoskeletal devices are used for these newer amputees, the patient will either endure a painful, poorly functioning socket or must go back to the prosthetist to be remeasured and a new device constructed. One disclosed design includes elongated members that span the length of the lower leg having front and rear members that resemble the outer shape of the contralateral limb. Weight is distributed between the front and rear members. These members are coupled with a basic solid foot and are printed in a single photopolymer material. The use of a single material has significant disadvantages in functionality, because regions that would benefit from being stiff have to compromise with regions that should be flexible and compliant. Further, while the vat photopolymerization method, specified by Summit as the preferred printer type, can produce detailed parts with fine features, photopolymers generally have lower strength, flexibility, and durability compared to thermopolymers.”)
Claims 7 – 9, 15, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dignam in view of Hikichi et al. (PG Pub. No. 20060106465 A1), herein “Hikichi.”
Regarding claim 7,
The previously cited reference(s) teach the limitations of claim 1 which claim 7 depends. Dignam does not teach markings of the orientation transmitter. However, Hikichi teaches that the orientation transmitter comprises a plurality of markings applied to or in the outer surface of the prosthetic socket, wherein the manufactured prosthetic socket is placed in a holding device to connect it to the component adapter, wherein the prosthetic socket is oriented relative to the holding device by means of the markings. (Abstract: “An apparatus for restoring the alignment of the support socket with other structural components during the fabrication of a leg prosthesis comprising a stand with base, a means to secure the lower aspect of the leg prosthesis to the stand base, and a laser source attached to the top of the stand that emits visible cross-beams downward onto the leg prosthesis when the prosthesis is mounted on the stand base. The method of the invention uses the described apparatus with leg prosthesis mounted thereon to mark points on the inside of a check or test socket that coincide with the laser cross-beams; transferring these marks from the check socket to the permanent support socket; and re-aligning the permanent support socket with the lower aspect prosthetic components by mounting the leg prosthesis with permanent support socket on the alignment apparatus and matching the marks to the laser cross-beams. A removable base plate allows for a number of leg prostheses to be fabricated concurrently, using the same alignment apparatus. The method and apparatus of the present invention reduces the time and expense of orthotic fabrication while increasing the accuracy of alignment of the finished prosthetic product.”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of using orientation transmitter (alignment jig) to align a user with a prosthetic such as a foot with a newly formed prosthetic as in Dignam with having an alignment system that has markings as in Hikichi in order to provide a method and apparatus to facilitate the restoration of alignment of the permanent support socket with the adjacent prosthetic component during the fabrication process. (Par. 0011)
Regarding claim 8,
The previously cited reference(s) teach the limitations of claim 7 which claim 8 depends. Hikichi also teaches that the orientation transmitter comprises at least four, preferably at least six markings, by means of which the prosthetic socket is aligned in three independent spatial directions relative to the holding device. (See figure 1 showing 4 markings made by laser beams)
Regarding claim 9,
The previously cited reference(s) teach the limitations of claim 7 which claim 9 depends. Dignam also teaches that wherein for connecting the tube to the component adapter, the component adapter is arranged in a predetermined orientation and position relative to the holding device. (Col. 3, lines 3 – 14: “In the junction of the attachment plate and the upper end of the pylon, there are adaptors that can change the angles or orientation of the pylon relative to the socket by mean of set screws that can be manipulated by the prosthetist to obtain a “best fit.” Also at the distal end of the pylon there are adaptors that can change the angle or orientation of the pylon relative to the plane of the ankle attachment. This adjustable link, the so called pyramid adapter, was patented by Otto Bock in 1969 and is used worldwide. The adapter consists of two pairs of set screws surrounding a pyramid, allowing adjustment, within a limited swing angle, in two planes.”)
Regarding claim 15, Dignam also teaches the main element of some elements of claim 15 (which is an independent claim); Dignam teaches an alignment element and connectors. Hikichi teaches that a guide tool (stand) with an alignment element to be aligned with a connector at one end of a tube,- a measuring element, that is connected or connectable to the guide toll such that it can be shifted along the guide tool,- wherein the measuring element has a circumferential marking line and an axial marking line. (Par. 0028: “The alignment apparatus of the present invention is illustrated from the front in FIG. 1. Alignment apparatus 10 comprises a stand 12 with a base 14. A bracket 16 affixed to the top of stand 12 extends forward from the top of stand 12 and is used to mount a laser source 18 that points downward. Two base pins 20 attached to the top surface of base 14 are received by and hold in place the removable base plate 30 that is described with reference to FIG. 2.” See also the figures esp. figures 1 and 8. Examiner’s Note – The amendment changed claim 15 from a dependent claim into an independent claim; and therefore is probably restrictable as being an independent and distinct invention from claim 1.)
Regarding claim 16, Dignam also teaches the main element of some elements of claim 15 (which is an independent claim); Dignam teaches an alignment element and connectors. Hikichi teaches that an orienter for a method according to any of claims 10 to 13, having a contact edge and an inverted pyramid, the contact edge being annular, preferably circular and the inverted pyramid being tilted relative to the plane defined by the contact edge by a predetermined angle in a predetermined direction, wherein preferably the predetermined angle is not zero degrees. (Par. 0047: “Socket 54 is aligned relative to the lower prosthetic components using jig 58 to align the transferred points on the inside surface of socket 54 with the laser cross-beams 26. Proper alignment is marked, jig 58 is removed, and socket 54 is permanently secured to the adjacent structural component with correct orientation. See figures 2, 4, 6, 7, and 8 that shows may show the orienter as item 58. Examiner’s Note – The amendment changed claim 15 from a dependent claim into an independent claim; and therefore is probably restrictable as being an independent and distinct invention from claim 1.)
Regarding claim 18, it is directed to a system or apparatuses to implement the method of steps set forth in claim 14 with the additional element of a second orienter. Dignam teaches the claimed method of steps in claim 14. Hikichi teaches the second orienter in figures 2 – 8. Examiner’s Note – Figure 3 shows a slot based insert into tube (just above arrow 50) wherein another slot based insert would be obvious below tube 52 into connector 36 in figure 6.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Layman et al. (US PG Pub. No. 20140188260) is pertinent art to the instant application and teaches a digitally produced prosthetic that has alignment functions with a prosthetic component (item 23). See abstract and paragraph 0014.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAD G ERDMAN whose telephone number is (571)270-0177. The examiner can normally be reached Mon - Fri 7am - 3pm or 4pm EST..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kenneth Lo can be reached at (571) 272-9774. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAD G ERDMAN/Primary Examiner, Art Unit 2116
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