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.
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 09/02/2025 has been entered. Claims 1-4 and 6-20 remain pending. Claim 5 has been cancelled. Claims 13 and 14 remain withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 09/02/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that components 763 and 765 of Pacanowsky cannot be considered inner and outer walls of the socket in which the partition is arranged only on the outer wall, the Examiner respectfully disagrees. The socket is the entirety of 750, as explained in the rejections below. The term “wall” is being given its broadest reasonable interpretation, in that wall means “a material layer enclosing space” (see Merriam Webster online definition 5). The term “outer” is being given its broadest reasonable interpretation, in that outer means “situated farther out” (see Merriam Webster online definition 2a). Since both components 763 and 765 are material layers enclosing space, and the component 765 is situated farther out relative to component 763, being the inner wall. The socket 750 is being interpreted to have an inner and outer wall, the inner wall being 763 and the outer wall being 765. Regarding the channels 765 (having the partitions (squares) in between them) being arranged only on the outer wall, the channels are formed into the outer wall 763 (see paragraph [0130]). The channels are therefore arranged only on the outer wall. The term “arranged” is being given its broadest reasonable interpretation, in that arranged means “to put into a proper order or into a correct or suitable sequence, relationship, or adjustment” (see Merriam Webster online definition 1). The partitions, or internal elements, are “put into a suitable relationship” with the outer wall through the process of either removing material from the outer wall, or through the use of a positive mold (see paragraph [0130]). The leftover square shaped material from the process are the partition/internal elements. If the inner wall is removed from the outer wall, the channels would still be present as they are molded and arranged into the outer wall. The internal elements are required by the claim to be in between the outer and the inner wall, in a cavity between the two, which is the case as illustrated by the rejection below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
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 and 15 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 a partition element that divides the cavity into two partial cavities and is arranged only on 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 arranged only on 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 “on” the inner wall (the limitation “wherein the at least one internal element is a support element, which preferably 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 “on” the inner wall as well). 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 8-10 that the “internal element comprises a partition element that divides the cavity into two partial cavities and is arranged only on 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 arranged only on the outer wall. Furthermore, the lines 11-12 of claim 15 further contradict lines 8-10 of the claim, as lines 11-12 require the internal element to be “on” the inner wall (the limitation “wherein a plurality of the support elements extend through the at least one cavity 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 “on” the inner wall as well). 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 socket (see annotated socket 750 in Figure 31 below) with 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 cavity into two partial cavities and is arranged only on the outer wall (see annotated partial cavities in Figure 31 below, see annotated internal elements, being partition elements, arranged along the outer wall 762).
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Regarding Claim 2, Pacanowsky discloses the prosthesis socket according to claim 1, wherein the at least one internal element is a 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), which preferably 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 socket according to claim 2, wherein at least 25, preferably at least 100, especially preferably at least 500 support elements extend in the at least one cavity 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 socket according to claim 2, wherein at least one support element, preferably a plurality of support elements, 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 6, Pacanowsky discloses the prosthesis socket according to claim 1, wherein the at least one partition element has at least one opening that connects the two partial cavities (see annotated opening in Figure 31 below).
Regarding Claim 8, Pacanowsky discloses the prosthesis socket to claim 1, wherein a plurality of internal elements are partition elements that preferably run parallel to each other (see partition elements in Figure 31 above being parallel to one another).
Regarding Claim 15, Pacanowsky discloses a prosthesis socket (see annotated socket in Figure 31 above) for a lower leg prosthesis 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 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 prosthesis socket according to claim 15, wherein at least 25, preferably at least 100, especially preferably at least 500 support elements extend in the at least one cavity from the inner wall to the outer wall (see Figure 31 above illustrating more than 25 support elements).
Regarding Claim 17, Pacanowsky discloses the prosthesis socket according to claim 15, wherein at least one support element, preferably a plurality of support elements, 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 prosthesis socket (see annotated socket 750 in Figure 31 above) with 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 in the form of at least one partition element (see annotated internal elements in Figure 31 above), the partition element dividing at least one cavity into two partial cavities (see annotated partial cavities in Figure 31 above); wherein the 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 prosthesis socket 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 socket 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).
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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 socket 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).
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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 socket 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 prosthesis socket according to claim 19.
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 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 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]).
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 socket according to claim 1.
Pacanowsky fails to disclose wherein the prosthesis socket comprises at least a first insert element that has a contact surface which is designed 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).
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Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention for the socket 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 socket according to claim 11, wherein the prosthesis socket has at least a second insert element that features a contact surface, which is designed 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
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 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.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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