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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/08/2026 has been entered.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in DE on 2019-12-18. It is noted, however, that applicant has not filed a certified copy of the English translation of the Foreign Priority Application as required by 37 CFR 1.55.
Response to Amendment
The amendment filed 04/08/2026 has been entered. Claims 1-4 and 6-20 remain pending. Claims 13 and 14 remain withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1, 15, and 18 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.
The Examiner has applied a new rejection below, interpreting the liner to be the inside surface of component 763, and the outside surface of component 763 to be the “inner wall”. The component 750 remains to be interpreted as the socket. The Examiner would like to make it clear that the limitations “socket” and “liner” are being given the broadest reasonable interpretation, to mean “an opening or hollow that forms a holder for something” (see Merriam Webster online definition for socket, noun), and “one that lines or is used to line or back something” (see Merriam Webster definition 1 for liner, noun).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “liner” must be shown or the feature canceled from the claims. 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.
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 1-12 and 15-20 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. Nowhere in the specification . Dependent claims 2-12, 16-17, and 19-20 are rejected for the same reason as they are dependent on claims 1, 15, or 18.
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 1-12 and 15-20 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.
Regarding Claim 1, the claim is unclear as in lines 7-8, the claim states that “internal element as is a single piece with the inner wall and/or the outer wall,” but then states in lines 8-9 that the “internal element comprises at least one partition element that divides the at least one cavity into at least two partial cavities and is only attached to the outer wall.” These two portions of the claim are contradictory, as if the internal element is a single piece with inner wall, it would contradict the last line of the claim stating that the internal element comprises a partition attached only to the outer wall. Furthermore, the last line of the claim is contradicted again in claim 2, as claim 2 requires the internal element to be “attached to” the inner wall (the limitation “extends from the inner wall to the outer wall” requires the internal element to extend from the inner wall to the outer wall, and therefore the internal element would need to be “attached to” the inner wall as well). Claims 2-12 are rejected for the same reason as well, as they are dependent on claim 1. Further clarification is required.
Regarding Claim 15, the claim is unclear as in lines 7-8, the claim states that “internal element as is a single piece with the inner wall and/or the outer wall,” but then states in lines 8-9 that the “internal element comprises at least one partition element that divides the at least one cavity into at least two partial cavities and is only attached to the outer wall.” These two portions of the claim are contradictory, as if the internal element is a single piece with inner wall, it would contradict lines 8-10 of the claim stating that the internal element comprises a partition only attached to the outer wall. Furthermore, the lines 11-12 of claim 15 further contradict lines 8-10 of the claim, as lines 11-12 requires the internal element to be “attached to” the inner wall (the limitation “extends from the inner wall to the outer wall” requires the internal element to extend from the inner wall to the outer wall, and therefore the internal element would need to be “attached to” the inner wall as well). Claims 16-17 are rejected for the same reason as well, as they are dependent on claim 15. Further clarification is required.
Furthermore, regarding claims 1, 15, and 18 and therefore also dependent claims 2-12, 16-17, and 19-20, the limitation “liner”, is not shown or described in the drawings or specification, and therefore it is unclear what structure is encompassed by this term. Further clarification 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.
Claims 1-4, 6, 8 and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20100274364 A1 (hereafter --Pacanowsky--).
Regarding Claim 1, Pacanowsky discloses a prosthesis (see annotated socket 750 in Figure 31 below) comprising: a liner (see annotated liner in Figure 31 below, being the inside surface of 763); and a prosthesis socket (750), wherein the liner is configuration to be positioned between the prosthesis socket and an amputation stump of a wearer of the prosthesis (see annotated liner and socket in Figure 31, the liner being the inside surface of 763 being shaped to receive in a residual limb of a user as mentioned in paragraphs [0022]-[0024]), the prosthesis socket comprising:
an open proximal end for accommodating an amputation stump (see annotated open proximal end in Figure 31 below);
an inner wall;
an outer wall (see annotated inner and outer walls in Figure 31 below), wherein at least one cavity is arranged between the inner wall and the outer wall (see annotated cavity in Figures 31 below);
and at least one internal element extending through the at least one cavity, wherein, the at least one internal element is a single piece with the inner wall and/or outer wall (see annotated internal elements in Figure 31 below), wherein the at least one internal element is a partition element that divides the at least one cavity into at least two partial cavities and is only attached to the outer wall (see annotated partial cavities in Figure 31 below, see annotated internal elements, being partition elements, arranged along the outer wall 762).
PNG
media_image1.png
735
906
media_image1.png
Greyscale
Regarding Claim 2, Pacanowsky discloses the prosthesis according to claim 1, wherein the at least one internal element further comprises at least one support element (see internal elements (squares between channels 765) in Figure 31 above being the portion of the outer wall that connects to the inner wall, the portions being supportive to the connection of the two components), wherein the at least one support element extends from the inner wall to the outer wall (see annotated internal element in Figure 31 above, extending to and from the inner and outer walls).
Regarding Claim 3, Pacanowsky discloses the prosthesis according to claim 2, wherein the at least one support element comprises at least 25 support elements extending in at least one partial cavity of the at least two partial cavities from the inner wall to the outer wall (see Figure 31 above illustrating more than 25 support elements).
Regarding Claim 4, Pacanowsky discloses the prosthesis according to claim 2, wherein the at least one support element, is arranged perpendicular to the inner wall and/or perpendicular to the outer wall (see support elements in Figure 31 above being perpendicular to the inner and outer wall).
Regarding Claim 6, Pacanowsky discloses the prosthesis according to claim 1, wherein the at least one partition element has at least one opening that connects the at least two partial cavities (see annotated opening in Figure 31 below).
Regarding Claim 8, Pacanowsky discloses the prosthesis to claim 1, wherein the at least one internal element comprises a plurality of internal elements comprising a plurality of partition elements that run parallel to each other (see partition elements in Figure 31 above being parallel to one another).
Regarding Claim 15, Pacanowsky discloses a lower leg prosthesis comprising: a liner (see annotated liner in Figure 31 below, being the inside surface of 763); and a prosthesis socket (750), wherein the liner is configuration to be positioned between the prosthesis socket and an amputation stump of a wearer of the prosthesis (see annotated liner and socket in Figure 31, the liner being the inside surface of 763 being shaped to receive in a residual limb of a user as mentioned in paragraphs [0022]-[0024]), the prosthesis socket comprising: an open proximal end to accommodate an amputation stump (see annotated open proximal end in Figure 31 above), an inner wall, and an outer wall (see annotated inner and outer walls in Figure 31 above); at least one cavity arranged between the inner wall and the outer wall (see annotated cavity in Figure 31 above); a plurality of internal elements; wherein the plurality of internal elements are support elements which extend through the at least one cavity, each internal element is a single piece with the inner wall and/or outer wall (see annotated internal elements in Figure 31 above), wherein the plurality of internal elements comprises a partition element that divides the at least one cavity into two partial cavities and is arranged only on the outer wall (see annotated partial cavities in Figure 31 above, see annotated internal elements, being partition elements, arranged along the outer wall 762); and wherein a plurality of the support elements extend through the at least one cavity from the inner wall to the outer wall (see annotated internal element in Figure 31 above, extending to and from the inner and outer walls).
Regarding Claim 16, Pacanowsky discloses the lower leg prosthesis of claim 15, wherein the plurality of support elements comprises at least 25 support elements extending in the at least one partial cavity of the at least two partial cavities from the inner wall to the outer wall (see Figure 31 above illustrating more than 25 support elements).
Regarding Claim 17, Pacanowsky discloses the lower leg prosthesis of claim 15, wherein the plurality of support elements arranged is perpendicular to the inner wall and/or perpendicular to the outer wall (see support elements in Figure 31 above being perpendicular to the inner and outer wall).
Regarding Claim 18, Pacanowsky discloses a lower leg prosthesis (see annotated socket 750 in Figure 31 above) comprising: a liner (see annotated liner in Figure 31 below, being the inside surface of 763); and a prosthesis socket (750), wherein the liner is configuration to be positioned between the prosthesis socket and an amputation stump of a wearer of the prosthesis (see annotated liner and socket in Figure 31, the liner being the inside surface of 763 being shaped to receive in a residual limb of a user as mentioned in paragraphs [0022]-[0024]), the prosthesis socket comprising: an open proximal end for accommodating an amputation stump (see annotated open proximal end in Figure 31 above), an inner wall and an outer wall (see annotated inner and outer walls in Figure 31 above), wherein at least one cavity is arranged between the inner wall and the outer wall (see annotated cavity in Figures 31 above), and at least one internal element comprising at least one partition element (see annotated internal elements in Figure 31 above), the at least one partition element dividing the at least one cavity into two partial cavities (see annotated partial cavities in Figure 31 above); wherein the at least one partition element is arranged only on the outer wall of the prosthesis socket (see annotated partial cavities in Figure 31 above, see annotated internal elements, being partition elements, arranged along the outer wall 762).
Regarding Claim 19, Pacanowsky discloses the lower leg prosthesis of claim 18, wherein the at least one partition element has at least one opening that connects the two partial cavities (see annotated openings in Figure 31 above).
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 7, 9, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20100274364 A1 (hereafter --Pacanowsky--).
Regarding Claim 7, the embodiment of the socket of 750 of Pacanowsky discloses the prosthesis according to claim 6.
Pacanowsky fails to disclose wherein at least one support element extends through the at least one opening of the at least one partition element.
An alternate embodiment of Pacanowsky teaches support elements (785) (see Figure 32 below, see also paragraph [0132]) extending through openings/gaps (see annotated openings) between cavities (783).
PNG
media_image2.png
233
309
media_image2.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention to have the openings of the socket embodiment 750 to further include at least one support element extending through the at least one opening of the at least one partition element, as by doing so would prevent deformation (e.g., collapsing) of the cavities, as well as would increase the structural strength of the material forming the socket as taught by Pacanowsky (see paragraph [0132]).
Regarding Claim 9, the embodiment of the socket of 750 of Pacanowsky discloses the prosthesis according to claim 1.
An alternate embodiment of Pacanowsky teaches a connection means for a distal prosthesis component is arranged on a distal end of the prosthesis socket (as interpreted under 112f, see instant specification disclosing the connection means designed as an adapter; see annotated connection means 618 in Figure 17 below interpreted as an adapter since it connects to a distal prosthesis 104, see also paragraph [0073] and Figure 2 denoting and illustrating that 104 is a distal prosthesis component that connects the socket to the foot 102).
PNG
media_image3.png
564
674
media_image3.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention to have the openings of the socket embodiment 750 to further include a connection means for a distal prosthesis component is arranged on a distal end of the prosthesis socket, as it is taught by Pacanowsky, that the various embodiments described in the specification can be combined to provide further embodiments, including couplers, mandrels, fasteners and other components and features disclosed being able to be mixed and matched based on the desired installation (see paragraph [0140]).
Regarding Claim 10, Pacanowsky discloses the prosthesis according to claim 1.
Pacanowsky fails to disclose wherein the prosthesis socket is a prosthesis socket for a prosthesis for treating a lower limb, preferably a lower leg prosthesis. However, this is implied as Pacanowsky, wherein the prosthesis socket is a prosthesis socket for a prosthesis for treating a lower limb, preferably a lower leg prosthesis, for embodiment 600 (see Abstract, see also paragraph [0073]), the embodiment of Figure 31 being a different embodiment of this type of device.
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention for the prosthesis socket 750 be a prosthesis socket for a prosthesis for treating a lower limb, preferably a lower leg prosthesis, as it is taught by Pacanowsky that the various embodiments described in the specification can be combined to provide further embodiments, including couplers, mandrels, fasteners and other components and features disclosed being able to be mixed and matched based on the desired installation (see paragraph [0140]).
Regarding Claim 20, the embodiment of the socket of 750 of Pacanowsky discloses the lower leg prosthesis according to claim 19.
Pacanowsky fails to disclose further comprising at least one support element extending through the at least one opening of the at least one partition element.
An alternate embodiment of Pacanowsky teaches support elements (785) (see Figure 32 above, see also paragraph [0132]) extending through openings/gaps (see annotated openings) between cavities (783).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention to have the openings of the socket embodiment 750 to further comprise at least one support element extending through the at least one opening of the at least one partition element, as by doing so would prevent deformation (e.g., collapsing) of the cavities, as well as would increase the structural strength of the material forming the socket as taught by Pacanowsky (see paragraph [0132]).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 20100274364 A1 (hereafter --Pacanowsky--), as applied to claim 1 above, and further view of US 20110118854 A1 (hereafter-- Halldorsson--).
Regarding Claim 11, Pacanowsky discloses the prosthesis according to claim 1.
Pacanowsky fails to disclose wherein the prosthesis comprises at least a first insert element that has a contact surface which is configured to correspond to the inner wall of the prosthesis socket.
Halldorsson discloses a socket liner comprising of an open proximal end, and an outer layer (12) with an outer and inner wall (see annotated inner and outer walls in Figure 6 below). Halldorsson teaches a first insert element (16) that has a contact surface which is designed to correspond to the inner wall of the prosthesis socket (see annotated contact surface in Figure 6 below), as well as a second insert element (14) that features a contact surface (see annotated contact surface of insert 14 in Figure 6 below), which is designed to correspond to a surface of the first insert element that is opposite the contact surface (see inserts 14 and 16 in Figure 6 below).
PNG
media_image4.png
554
766
media_image4.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention for the prosthesis of Pacanowsky to further include two inserts inside of inner wall 763, one having a contact surface which is designed to correspond to the inner wall of the prosthesis socket, and the other having a contact surface, which is designed to correspond to a surface of the first insert element that is opposite the contact surface, as by doing so would provide cushioning for at least the anterior of the liner, particularly for the tibia of a trans-tibial amputee, as well as would provide a soft pad over bony areas of a residual limb, to improve skin condition or mitigate issues due to a breakdown of the skin at such areas as taught by Halldorsson (see paragraph [0013]).
Regarding Claim 12, Pacanowsky as modified discloses the prosthesis according to claim 11, wherein the prosthesis socket has at least a second insert element that features a contact surface, which is configured to correspond to the inner wall of the prosthesis socket and/or a surface of the first insert element that is opposite the contact surface (see claim 11 rejection above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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 571-272-9062. 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.
/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Prosecution Insights