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, see page 6, filed 07/02/2026, with respect to the drawings have been fully considered and are persuasive. The objections of the drawings have been withdrawn.
Applicant’s arguments, see page 6, filed 07/02/2026, with respect to the claim objections have been fully considered and are persuasive. The objections of claims 1, 8, 9, and 20 have been withdrawn.
Applicant’s arguments, see pages 6-7, filed 07/02/2026, with respect to the rejections of claims 1-20 under 35 USC 103 have been fully considered and are persuasive. Applicant amended independent claim 1 to recite that a moveable portion coupled to the joint, wherein the movable portion is an endoprosthesis of a distal extremity of a digit. Applicant argues that Akhtar in view of Puncreobutr and Petranto fails to disclose these new limitation and the examiner agrees. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Ranft (US PG Pub No. 2010/0274251) in view of Akhtar et al. (US PG Pub. No. 2022/0249257 A1), Puncreobutr et al. (US PG Pub. No. 2020/0253740 A1), and Petranto (US PG Pub No. 2020/0315810) as necessitated by amendment.
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.
Claims 1-3, 5-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ranft (US PG Pub No. 2010/0274251) in view of Akhtar et al. (US PG Pub. No. 2022/0249257 A1) and Puncreobutr et al. (US PG Pub. No. 2020/0253740 A1).
Regarding claim 1, Ranft discloses an endoprosthesis system (Figs. 25-39, endoprosthesis 50) for use within a body of a patient (Figs. 25-39), a movable portion (see annotated Fig. 31 below) coupled to the joint (see annotated Fig. 31 below), wherein the movable portion is an endoprosthesis of a distal extremity of a digit (see annotated Fig. 31 below); and wherein the joint and movable portion are sized and shaped to fit within the skin of a patient (Figs. 25-30) and entirely enclosed within the body of the patient (Figs. 38-39).
PNG
media_image1.png
305
393
media_image1.png
Greyscale
Ranft fails to disclose wherein the endoprosthesis is muscle-driven comprising a bone extension, a joint at a second end of the bone extension; and synthetic tendons coupled to the moveable portion.
Akhtar also discloses a muscle-driven prosthesis system (Fig. 1A, articulating prosthesis 100), the system comprising: a bone extension (see annotated Fig. 1A below, osseointegration abutment 300, Fig. 2A, proximal phalanx); a joint (see annotated Fig. 1A below),a moveable portion (see annotated Fig. 1A below, Fig. 2A, middle phalanx, distal phalanx) coupled to the joint (see annotated Fig. 1A below, Fig. 2A, proximal interphalangeal joint, distal interphalangeal joint); and synthetic tendons. Akhtar teaches wherein the prosthesis is muscle-driven comprising a bone extension (see annotated Fig. 1A below, osseointegration abutment 300, Fig. 2A, proximal phalanx), and a joint (see annotated Fig. 1A below) at a second end of the bone extension (see annotated Fig. 1A below), and synthetic tendons (see annotated Fig. 1A below, artificial tendons 230) coupled to the moveable portion (middle phalanx). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ranft wherein the endoprosthesis is muscle-driven comprising a bone extension, a joint at a second end of the bone extension, and synthetic tendons coupled to the moveable portion, as taught by Akhtar, in order to utilize natural articulation by the user as a muscle driven prosthesis (Paragraph [0054]).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the muscle-driven exoprosthesis system of Akhtar for the endoprosthesis system implanted within the skin of the patient of Ranft.
Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
PNG
media_image2.png
723
541
media_image2.png
Greyscale
Ranft as modified by Akhtar fails to disclose an intramedullary stem extending from a first end of the bone extension; wherein the intramedullary stem is sized and shaped to fit within a skin of a patient.
Puncreobutr also discloses a muscle-driven endoprosthesis system (Paragraph [0046], “interphalangeal joint bone”, Figs. 3A, 3B, implant 104), comprising a hinge joint (Figs. 3A, 3B, hinge joint 117) and bone extension (Figs. 3A, 3B, stem 118). Puncreobutr teaches an intramedullary stem (Figs. 3A, 3B, stem 119) extending form a first end of the bone extension (Figs. 3A, 3B); wherein the intramedullary stem is sized and shaped to fit within a skin of a patient (Paragraphs [0079 and 0082]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ranft’s as modified by Akhtar muscle driven endoprosthesis system to include an intramedullary stem extending from a first end of the bone extension, wherein the intramedullary stem is sized and shaped to fit within a skin of a patient, as taught by Puncreobutr, in order to anchor the prosthetic hinge joint in bone (Paragraph [0043]).
Regarding claim 2, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: a diameter of the intramedullary stem (Puncreobutr Figs. 3A, 3B, stem 119) is less than a diameter of the bone extension (Puncreobutr Figs. 3A, 3B, stem 118).
Regarding claim 3, Ranft as modified by Akhtar and Puncreobutr discloses wherein: the moveable portion (see annotated Fig. 31 above) is a biocompatible material (Ranft Paragraph [0022]).
Regarding claim 5, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: the joint (see annotated Akhtar Fig. 1A above, Fig. 2A, proximal interphalangeal joint, distal interphalangeal joint) is a 1-degree-of-freedom (Akhtar Paragraph [0095]) hinge joint (Akhtar Paragraph [0073]).
Regarding claim 6, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: an angular movement (angular movement shown in Akhtar Fig. 2A) of the joint (see annotated Akhtar Fig. 1A above, Fig. 2A, proximal interphalangeal joint, distal interphalangeal joint) allows movement between 0 and 135 degrees (Akhtar Fig. 4, 80 to 160 degrees). Ranft as modified by Akhtar and Puncreobutr range overlaps the claimed range of between 0 and 135 degrees. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ranft as modified by Akhtar and Puncreobutr angular movement to have an angular movement range between 0 and 135 degrees as claimed, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 7, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: the joint is a multiple-degree-of-freedom joint (Akhtar Paragraph [0095] disclosing “at least one” degree of freedom).
Regarding claim 8, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: the synthetic tendons (Akhtar artificial tendons 230) include a first synthetic tendon coupled to the moveable portion (Akhtar Fig. 1A, actuation point 110) on a first side of the joint (see annotated Akhtar Fig. 1A above) and a second synthetic tendon coupled to the moveable potion (Akhtar Fig. 1A, actuation point 110) on a second side of the joint (see annotated Akhtar Fig. 1A above).
Regarding claim 9, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: the synthetic tendons include multiple individual strands (Akhtar Paragraph [0112], “braided PET” shows multiple strands) of biocompatible material (Akhtar Paragraphs [0026 and 0112]).
Regarding claim 10, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: the multiple strands of biocompatible material are coupled together along their length (Akhtar Paragraphs [0111 and 0112]).
Regarding claim 11, Ranft as modified by Akhtar and Puncreobutr further discloses further comprising: a plurality of tendon attachment structures (Akhtar Fig. 1A, actuation points 110) on the moveable portion (see annotated Akhtar Fig. 1A below, Fig. 2A, middle phalanx, distal phalanx).
Regarding claim 12, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: the plurality of tendon attachment structures define an aperture (Akhtar Paragraphs [0039 and 0066], see annotated Akhtar Fig. 2B below, channels) to receive a first of the plurality of synthetic tendons (Akhtar Paragraphs [0039 and 0066]).
PNG
media_image3.png
769
592
media_image3.png
Greyscale
Regarding claim 13, Ranft as modified by Akhtar and Puncreobutr further discloses further comprising: a sleeve over-molded onto the moveable portion (Akhtar Paragraph [0119], silicone sleeve).
Regarding claim 14, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: the sleeve is a compliant biocompatible material (Akhtar Paragraph [0119], silicone sleeve).
Regarding claim 15, Ranft as modified by Akhtar and Puncreobutr further discloses wherein: the sleeve is a silicone rubber (Akhtar Paragraph [0119], silicone sleeve).
Regarding claim 16, Ranft as modified by Akhtar and Puncreobutr does not explicitly disclose wherein: the sleeve (Akhtar Paragraph [0119], silicone sleeve) is between 1mm and 6mm thick. However, there is no evidence of record that establishes that changing the thickness of the sleeve would result in a difference in function of the sleeve of Ranft as modified by Akhtar and Puncreobutr further. Further, a person having ordinary skill in the art, being faced with modifying the thickness of the sleeve of Ranft as modified by Akhtar and Puncreobutr further would have a reasonable expectation of success in making such a modification and it appears the sleeve would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the sleeve thickness “may” be within the claimed range and offering other acceptable ranges (e.g., between 1mm and 12mm, 1mm and 8mm, 2mm and 6mm, and 2mm and 5mm; see instant specification at Paragraph [0054]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve thickness of Ranft as modified by Akhtar and Puncreobutr further to have a thickness between 1mm and 6mm as claimed as an obvious matter of design choice within the skill of the art.
Regarding claim 20, Ranft as modified by Akhtar and Puncreobutr further discloses further comprising: a second hinge joint (see annotated Akhtar Fig. 1A above, Fig. 2A, distal interphalangeal joint), the second hinge joint being at a distal end of the moveable portion (see annotated Akhtar Fig. 1A above, Fig. 2A, middle phalanx).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ranft (US PG Pub No. 2010/0274251) in view of Akhtar et al. (US PG Pub. No. 2022/0249257 A1) and Puncreobutr et al. (US PG Pub. No. 2020/0253740 A1) as applied to claim 1 above, and further in view of Petranto (US PG Pub No. 2020/0315810).
Regarding claim 4, Ranft as modified by Akhtar and Puncreobutr fails to disclose wherein: the bone extension is a biocompatible material. Petranto also discloses an endoprosthesis system (implant 200) having a bone extension (Fig. 9, proximal stem 202). Petranto teaches wherein: the bone extension is a biocompatible material (Paragraph [0100]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Akhtar’s in view of Puncreobutr bone extension to be formed of a biocompatible material, as taught by Petranto, in order to ensure the prosthesis system is medical grade (Paragraph [0100]).
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 KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.L.C./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
Prosecution Insights