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 has amended claims 1, 10 and 12 with added claims 17-18. Claim 1 now recites the limitation that the reference prosthetic limb is further narrowly limited as “the reference prosthetic limb being an existing prosthetic device of a patient.”
Additionally, dependent claim 10 and independent claim 12 are amended to further include the limitation to the foot-ankle complex with the s-shaped posterior and anterior portions “wherein the s-shaped posterior portion and the s-shaped anterior portion are separated from each other by a gap that extends from the terminal portion to the sole portion”
After search and consideration, the examiner determines that dependent claim 10 and independent claim 12 are allowable subject matter.
However, the examiner determines that amended claim 1 necessitates new grounds of rejection.
Claim Objections
Claims 10 and 17 (dependent on claim 10) objected to 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.
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) 1-3, 8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Summit (EP 2 803 337 A2) IDS 12/17/2024 in view of Sanders (US 8,423,167 B2). Evidence provided by https://www.collinsdictionary.com/dictionary/english/truss as to definition of the term “truss” as a noun and as in a structural context (structural framework) in regard to claims 1 and 9
Regarding Claim 1, Summit discloses a method for producing a transtibial
prosthetic device (Fig. 6a paragraphs [0005] – [0007] [0023] where the prosthetic leg appears unitary, CAD and fabrication processes prosthetic leg – 623 and where this prosthetic leg includes a load bearing component that functions as the human tibia (transtibial)), the method comprising:
generating a scan of a reference prosthetic limb, wherein the reference prosthetic limb has a reference socket, a reference pylon, and a reference foot (Fig. 2 paragraphs [0024]- [0028] [0003] leg is scanned to generate a reference prosthetic limb where surface data from scan may be referenced in order to extrapolate the shape of the intact leg through reconstruction; whereby the leg and socket data are used including the pylon which is typically attached to the bottom of the socket).
generating a digital model for the transtibial prosthetic device (paragraph [0026] a digital model is obtained – a continuous three dimensional digital representation), wherein the transtibial prosthetic device comprises i) a socket (Figs. 4a-c paragraph [0032] socket – 445), ii) a pylon comprising a unitary truss structure (Figs. 4a-c paragraph [0032] front member-437 of lower leg – 323 where a truss structure is evident in the figures), and iii) a foot-ankle complex (Figs 4a-c paragraph [0032] foot – 441 is securely coupled to the lower end of the front member – 437), (See also; https://www.collinsdictionary.com/dictionary/english/truss as to definition of the term “truss” as a noun) and
wherein an alignment of the pylon with the socket and with the foot-ankle complex in the digital model is based on the scan (paragraph [0027] leg and socket data are used to form the outer surface of the prosthetic leg with attached pylon (front member)); and
fabricating, using the digital model and 3D printing, the pylon and the foot-ankle complex as a unitary single piece (paragraph [0012] retrieved design data is integrated into the prosthetic leg design and fabricated simultaneously with the rest of the leg, which is inherently unitary).
However, while Summit does scan a reference prosthetic limb, this scan utilizes a user’s intact leg or the end of the user’s amputated limb and not an existing prosthetic limb of a patient’s leg (Figs. 2, 3 paragraphs [0007] [0026] [0028] user’s intact leg – 205 end of the amputated limb – 209).
Sanders discloses a computer aided design and manufacturing of transtibial prosthetic sockets which are fabricated using scanned data (Col. 4 ll. 5-16 method includes can include scanning a reference prosthetic socket surface) which can generate a digital model for a prosthetic device (Fig. 11 abs, Col. 24 ll. 34-41 scanned data is stored in memory). The reference prosthetic socket used can be the shape of another prosthetic socket (Col. 3, ll. 54-55 Col. 4 ll. 44-45 specific type of reference such as another prosthetic socket) including one that is an existing prosthetic socket of a patient (Col. 8 ll 4-6 after making a socket, a new socket can be compared and the practitioner could decide if the socket is acceptable, if it should be modified, or if a new socket should be made; socket actually fabricated and provided to the patient is thereby likely to more closely match the desired socket shape originally created).
Additionally, Sanders suggests that this approach to a reference prosthetic socket can apply to other parts of a prosthetic device including landmark points involving foot regions and areas that would be the focus of reference pylons (Col 17 ll. 34-43 lower limb landmarks)
It would have been obvious for one with ordinary skill in the art before the effective filing date of the invention to have modified the disclosure of Summit with the teaching of Sanders whereby a method for producing a transtibial prosthetic device by generating a scan of a transtibial prosthetic limb having a reference socket pylon and a foot reference, as disclosed by Summit, includes generating a scan of a reference prosthetic limb which is an existing prosthetic device of a patient, as taught by Sanders.
One with ordinary skill in the art would consider this feature advantageous because utilizing an existing prosthetic device of a patient as a reference prosthetic limb eliminates the need to bring the patient back to test fit a limb, determining that a problem exists, making adjustments, and then having the patient come in once again to repeat the process. Thus, this device and system might save time and money and reduce pain to the patient (Col 2 l. 63-Col. 3 l.3).
Regarding Claim 2, the combination of Summit and Sanders disclose all the limitations of claim 1 and Summit further discloses that the reference socket, the reference pylon, and the reference foot have been assembled and aligned by a certified prosthetist/orthotist (CPO) (paragraphs [0013] [0028] [0029] prosthetist specifies and inputs).
Regarding Claim 3, the combination of Summit and Sanders disclose all the limitations of claim 1 and Summit further discloses that generating the scan of the reference prosthetic limb comprises scanning the physical positive model (paragraphs [0024] [0026] surface data of the intact leg obtained through laser scanning).
Regarding Claim 8, the combination of Summit and Sanders disclose all the limitations of claim 1 and Summit further discloses that the alignment of the pylon with the socket and the foot-ankle complex in the digital model comprises:
superimposing the socket with the scan of the reference socket;
positioning the foot-ankle complex based on the scan of the reference foot; and
aligning a distal end of the pylon with a top of the foot-ankle complex and a proximal end of the pylon with a bottom of the socket (Fig. 12 paragraphs [0028] [0065] prosthetist determines exact relative placement of the artificial knee and foot and uses this measurement to determine relative position of socket, knee or pylon and foot; mirror image data is created from the scan of the intact leg and reversed surface created from the scan knee and foot locations are identified with socket and converted into an electronic data file)
Regarding Claim 11, the combination of Summit and Sanders disclose all the limitations of claim 1 and Summit further discloses taking dimensional measurements of the reference prosthetic limb, wherein the dimensional measurements comprise one or more of a width of the reference foot, an anterior-posterior width of the reference socket, a medial foot-socket height of the reference prosthetic limb, and a lateral foot-socket height of the reference prosthetic limb (paragraph [0026] where all the dimensional data is generated using an algorithm connecting adjacent point (point cloud) to produce a continuous three dimensional digital representation and to obtain surface data which would inherently include dimensional measurements).
Claim(s) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Summit (EP 2 803 337 A2) IDS 12/17/2024 and Sanders (US 8,423,167 B2) as applied to claim 1 above, and further in view of Shin (US 2017/0360578 A1) IDS 12/17/2024.
Regarding Claim 4, the combination of Summit and Sanders disclose all the limitations of claim 1 but does not disclose the use of reference markers to the reference prosthetic limb, prior to the generating the scan of the reference prosthetic limb.
Shin, in the same field of endeavor, discloses a method for producing a prosthetic device (abs) whereby body parts can be marked such that the marked area acts as a common point of reference across multiple images whereby imaging data can be obtained using scanning (paragraphs [0056] [0058] laser scanner).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the invention to have modified Summit/Sanders with the teachings of Shin, whereby a method for producing a transtibial prosthetic device by generating a scan of a reference prosthetic limb having a reference socket, pylon and a foot, as disclosed in Summit, would also include reference markers applied to the reference prosthetic limb prior to generating the scan of the reference prosthetic limb, as taught in Shin.
The skilled artisan would be motivated to utilize reference markers because they can provide landmarks in order to register or align multiple images with each other (paragraph [0065]) and can also be used to confirm appropriate scaling (paragraph [0133]).
Regarding Claims 5 and 6, the combination of Summit, Sanders and Shin disclose all the limitations of claim 4 and Shin further discloses that the reference markers are placed on anterior, posterior, medial and lateral locations on the reference socket and that the reference markers are placed on a medial side and a lateral side of the reference foot (Figs. 4B, 4C paragraphs [0064] [0107] where an object model for both foot and socket is generated that represents a body part from including reference markers placed on anterior, posterior, medial and lateral locations on the reference socket and that the reference markers are placed on a medial side and a lateral side of the reference foot as part of the “point cloud” (e.g. a collection of points) with sufficient detail).
Regarding Claim 7, the combination of Summit and Sanders disclose all the limitations of claim 1 but does not disclose the placing of a reference marketer on material after it has been poured into a reference socket to make a physical positive model.
Shin discloses that after generating a prosthesis model from an object model that material is applied including pouring a material into the reference socket to make a physical positive model (paragraphs [0085] [0092] successive layers of material are laid down by computer control);
placing a reference marker on the material while the physical positive model is in the reference socket;
scanning the reference socket while the physical positive model is in the reference socket (paragraph [0065] photogrammetry can utilized landmarks that were added during image data acquisition or can be used to ascertain a reference scale between multiple photographs); and
scanning the physical positive model after removing the physical positive model from the reference socket and then scanning the physical positive model from the reference socket (paragraphs [0093] [0097] image modalities can be used to obtain more information; after scanning removal such that the prosthesis can be modified or refined).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Summit (EP 2 803 337 A2) IDS 12/17/2024 and Sanders (US 8,423,167 B2) as applied to claim 1 above, and further in view of Hunt (US 2014/0288649 A1).
Regarding Claim 9, the combination of Summit and Sanders disclose all the limitations of claim 1 including a unitary truss (Figs. 4a-c paragraph [0032] front member – 437), but it does not discloses a unitary truss structure that is formed of a plurality of elongated supports interconnected at nodes.
Hunt discloses an implant for repairing injured hands and/or wrists, or anterior or posterior lumbar interbody fusion (Figs. 1A-B abs, paragraph [0038]) which is in the shape of a unitary truss structure (Fig. 11 paragraph [0079] external support may be integrated with implant – 400 to form a unitary implant that includes a space truss attached to an external support) that is formed of a plurality of elongated supports interconnected at nodes (Figs. 1A-B paragraph [0039] “truss structure” is a structure having one or more elongate struts connected at joints referred to as nodes, which has variants). See also; https://www.collinsdictionary.com/dictionary/english/truss as to definition of the term “truss” as a noun
It would have been obvious to one with ordinary skill in the art before the effective filing date of the invention to have modified the disclosure of Summit/Sanders with the teaching of Hunt whereby, the pylon comprising a unitary truss structure, as disclosed by Summit, is further defined as a plurality of elongated supports interconnected by nodes, as taught by Hunt.
One with ordinary skill in the art would seek to use a unitary truss that is formed of a plurality of elongated supports interconnected at nodes because this provides support against tensile and compressive forces acting through the pylon (paragraph [0044]).
Allowable Subject Matter
Claims 10 and 12-18 allowed.
The following is an examiner’s statement of reasons for allowance:
The prior art does not disclose, teach or suggest the limitation in amended claim 10 and amended independent claim 12 that the s-shaped posterior portion and the s-shaped anterior portion are separated from each other by a gap that extends from the terminal portion to the sole portion.” See Fig. 1A below:
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The closest prior art, Jonsson (WO 2005/018495 A2), of record, (See Fig. 2A below) does not show an s-shaped posterior portion and an s-shaped anterior portion that are separated from each other by a gap that extends from a terminal portion to a sole portion. Therefore one with ordinary skill in the art would not combine Jonsson with the combination of Summit and Sanders because this modification would change the principle of operation of the amended Summit/Sanders reference (MPEP § 2143.01 VI). See Fig. 2A, Jonsson below:
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Additional prior art references searched and considered included Lindhe (WO 2014/147070 A1), Armstrong (US 2014/0303748 A1), Cho (JP2001276102 A) IDS 01/29/2026 with machine translation, Jang (KR20010093991A) with machine translation and Townsend (US 7,708,784 B2), but these references failed to disclose, teach or suggest the limitation of an s-shaped posterior portion and an s-shaped anterior portion that are separated from each other by a gap that extends from a terminal portion to a sole portion.
Claims 13-18 allowable through dependency on claims 10 and 12.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 WAYNE K. SWIER whose telephone number is (571)272-4598. The examiner can normally be reached M-F generally 8:30 am - 5:30 pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abbas Rashid can be reached at 571-270-7457. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WAYNE K. SWIER/ Examiner, Art Unit 1748 /JACOB T MINSKEY/Primary Examiner, Art Unit 1748
