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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/06/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6 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.
Claim Status
The drawing objection and 35 U.S.C. 112(b) rejection have been overcome.
Claim 7 is cancelled. Claims 1-6 are examined 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Connection element in claim 1. Page 3, lines 17-18 of the specification indicates a plate is used to connect the measuring jig to the prosthetic limb.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-6 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.
Claim 1 recites “a connection element for connecting to a prosthetic” in line 9. It is unclear what is being connected to the prosthetic. Dependent claims 2-6 are likewise rejected.
Claim 3 recites “an open end of the deformable measuring bag” in lines 6-7. It is unclear if the is the same open end of a deformable measuring bag recited in claim 1 line 2 or a separate and distinct open end of the deformable measuring bag. The Examiner interprets them to be the same open end. Dependent claims 4-5 are likewise rejected.
Claim 6 recites “an open end of the deformable measuring bag” in line 6. It is unclear if the is the same open end of a deformable measuring bag recited in claim 1 line 2 or a separate and distinct open end of the deformable measuring bag. The Examiner interprets them to be the same open end.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (GB 2 116 432 A) in view of Laghi (US 5,503,543 A).
Regarding claim 1, Thompson teaches a deformable measuring bag (10 and 12, inner wall and intermediate wall, fig. 2) having an open end (22, proximal end, fig. 1) and an air evacuation tube (16, pipe, fig. 1) coupled to said deformable measuring bag and connectable to a vacuum source (pg. 1, lines 7-25 and pg. 3, lines 3-9).
Thompson fails to teach a plurality of connection rings, a connection element and a plurality of supports extending vertically between the connection rings and connection element. However, Laghi teaches a method for prosthetic casting while standing that includes a deformable measuring bag that is connected to a plurality of connection rings (26, 28, upper mounting plate and upper clamping plate, fig. 2);
a plurality of supports surrounding said deformable measuring bag (18, rods, fig. 1); and
a connection element for connecting to a prosthetic limb (20, 34, lower support plate and lower mounting plate, fig. 3), wherein the plurality of supports extend vertically between the connection rings and the connection element (fig. 1), and
wherein the open end of the deformable measuring bag is configured to receive a stump of a residual limb of a standing patient when the stump is inserted through the connection rings and when the connection element is connected to the prosthetic limb (col 3 lines 21-32).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Thompson to include a plurality of connection rings, a connection element and a plurality of supports extending vertically between the connection rings and the connection element as taught by Laghi in order to enable precise adjustment of the height of the machine to accommodate patients of differing heights (abstract, Laghi).
Regarding claim 2, Thompson further teaches wherein said deformable measuring bag comprises an inner portion (10, inner wall, fig. 2) and an outer portion (12, intermediate wall, fig. 2).
Regarding claim 6, Thompson further teaches a method for creating a prosthesis using the system of claim 1, the method comprising:
taking measurements of a shape of a residual limb of a standing patient while the patient puts loads on the residual limb with the patient being both stationary and in motion (page 3 lines 49-70); and
forming a socket of a prosthesis based on said measurements (page 3 lines 24-70),
comprising inserting said residual limb into an open end of a deformable measuring bag (page 3 lines 24-41) that contains a hardenable material (14, beads, fig. 2),
pressing said deformable measuring bag against said residual limb to ensure a uniform and controllable pressure at all contact points of said deformable measuring bag with said residual limb (page 3 lines 49-70),
sucking air out of said deformable measuring bag by vacuum to set a shape of said deformable measuring bag, during which the patient applies different loads while walking and standing (page 3 lines 49-70); and
sucking air out of said deformable measuring bag by vacuum in order to set a final shape of said socket (page 3 lines 49-70).
Thompson fails to teach a prosthetic limb is positioned beneath a lower portion of the bag. However, Laghi further teaches when a prosthetic limb is positioned beneath a lower portion of the bag (fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Thompson to include a prosthetic limb is positioned beneath a lower portion of the bag as taught by Laghi in order to enable precise adjustment of the height of the machine to accommodate patients of differing heights (abstract, Laghi).
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson in view of Laghi as applied to claim 1 above, and further in view of Erenstone (US 2017/0246013 A1).
Regarding claim 3, Thompson further teaches a method for creating a prosthesis using the system of claim 1, the method comprising:
filling the deformable measuring bag with a hardenable material (14, beads, fig. 2);
inserting a stump of a residual limb of a standing patient into an open end of the deformable measuring bag at an upper portion of the bag (page 3 lines 24-70);
pressing the deformable measuring bag against the stump to ensure a uniform and controllable pressure at all contact points of the deformable measuring bag with the stump (page 3 lines 49-70);
sucking air out of the deformable measuring bag by vacuum to set a shape of the bag, during which the patient can apply different loads while walking or standing (page 3 lines 49-70);
allowing the hardenable material to harden in the bag and form a negative mold (page 3 lines 1-9);
pouring a hardenable substance into said negative mold and allowing said hardenable substance to harden to form a positive mold (page 4 lines 43-57);
Thompson fails to teach a prosthetic limb is positioned beneath a lower portion of the bag. However, Laghi further teaches extending a lower portion of the bag toward said prosthetic limb when the prosthetic limb is positioned beneath the lower portion of the bag (fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Thompson to include a prosthetic limb is positioned beneath a lower portion of the bag as taught by Laghi in order to enable precise adjustment of the height of the machine to accommodate patients of differing heights (abstract, Laghi).
Thompson in view of Laghi fails to teach 3D modeling. However, Erenstone discloses a method for producing a customized prosthetic socket that includes extracting said positive mold (page 4, lines 43-57) and scanning said positive mold to create a 3D computer file (¶ [0018], fig. 3); and printing a prosthetic socket using said 3D file (¶ [0021], fig. 8). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Thompson in view of Laghi to include 3D modeling as taught by Erenstone in order to reduce the time an expense associated with manufacturing a socket (¶ [0005], Erenstone).
Regarding claim 5, Thompson and Laghi fail to teach pressure release points. However, Erenstone further discloses adding pressure release points for pressure sensitive areas on the stump (¶ [0019]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Thompson and Laghi to include pressure release points as taught by Erenstone in order to reduce pressure points that form proximately to any sensitive areas of a residual limb that require lower density areas (¶ [0019], Erenstone).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson in view of Laghi and Erenstone as applied to claim 3 above, and further in view of Helmy (US 5888230 A).
Regarding claim 4, Thompson in view of Davis and Erenstone fails to teach pressure sensors. However, Helmy discloses a method for creating a comfortable filling of a prosthetic over an amputee's limb stump that includes sensors (36, sensors, fig. 5) to sense pressure between the stump and the bag (col 6 lines 15-28). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Thompson in view of Davis and Erenstone to include pressure sensors as taught by Helmy in order to ascertain there has been a reduction in pressure (col 6 lines 15-28, Helmy).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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