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 .
Claim Objections
Claims 1, 3-4 are objected to because of the following informalities:
Claim 1 is objected to for referring to “an styrene” but it is believed this should read “a styrene”.
Further, the claim refers multiple times to “a resting position” but it is unclear whether or not the resting positions are the same or different.
Claims 3-4 are objected to for referring to “a resting position” when claim 1, from which these claims depend, have already identified a “resting positions” and it is unclear how, if at all, these resting positions relate to the previously claimed resting positions..
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: the specification at [0066] refers to “SEEPS” but this appears to be an acronym without spelling out what this is referring to.
Appropriate correction is required.
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: “locking mechanism” in claim 1.
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 1-5 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 pre-AIA the applicant regards as the invention.
Claim limitation “locking mechanism” of claim 1 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not describe or detail any structural features of the locking mechanism at any location the mechanism is mentioned. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Remaining claims are rejected for depending on a rejected claim.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halldorsson et al. (US 20150057763 A1) hereinafter known as Halldorsson in view of Fay (US 6231617 B1), further in view of Doddroe et al. (US 20110208321 A1) hereinafter known as Doddroe, Laghi (US 8357206 B2), and Laghi et al. (US 20100274363 A1) hereinafter known as Laghi ‘363.
Regarding claim 1 Halldorsson discloses a prosthetic liner comprising:
a fabric covering ([0007]) having an open proximal end (Figure 1 item 34) and a closed distal end (Figure 1 item 36) knit into a tubular shape (Figure 1; [0001] tubular; [0008] continuously knit), the covering comprising a proximal region (e.g. top region) and a distal region (e.g. bottom region), wherein the distal region is stitched such that it has a lower distal longitudinal elongation from a resting position ([0055]-[0056] the proximal end first stitch has a greater longitudinal elongation than the distal region) and wherein the proximal region has a proximal longitudinal elongation of 55-125% from a resting position ([0055]-[0056] the proximal end first stitch has a greater longitudinal elongation than the distal region; [0014] the greater elongation region can be 70-225%),
wherein the distal region is stitched using a distal stitching selected from the group consisting of: weft, warp, stockingette, garter, seam, fagoting, tricot, elongated, plated, slip, dip, or basket stitches (Figure 6 shows weft stitching),
a locking mechanism region below the distal region ([0045] reinforced distal end which includes a connection 22 for attaching to a prosthetic),
a silicone elastomeric gel layer (Figure 1 item 30; [0031] silicone) residing on an interior surface of the fabric covering ([0031] the liners have silicone inside, with the textile cover forming the outer periphery), and
a low-extensibility material ([0031] reinforcement layer)
but is silent with regards to the distal region being stitched so the elongation is 0-30%,
the locking mechanism region housing a locking mechanism,
the low-extensibility material being a single-piece comprising polyester that forms a composite with the gel layer and fabric covering, and its extent/width.
However, regarding claim 1 Fay teaches wherein a reinforcement, low-extensibility material (Abstract: arms are made of a longitudinally non-stretchable material) can be formed of a single-piece (Figure 5a item 30) and comprise polyester (Column 6 lines 1-2 Dacron) and extend up from the closed distal end of a liner (Figure 4 item 30) up to the closed distal end between 4-12 inches (Column 1 lines 65-66, and Column 6 lines 37-43 the arms can extend the entire way up the side (e.g. up to the open proximal end), as well as be truncated fingers. See also Figure 3 showing truncated fingers. While the figures are not understood to be drawn to-scale, they are not considered to be completely inaccurate either. Since Fay teaches the overall length of the liner is 14 inches, and the fingers 20 are truncated, somewhere around halfway up the liner, the person of ordinary skill at the time the invention was field would have found it obvious for the low-extensibility material of Fay to extend around 7 inches, which falls within the required range of 4-12 inches.) Halldorsson and Fay are involved in the same field of endeavor, namely prosthetic liner systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of Halldorsson so that the reinforcement material was formed from a single-piece and extends upward form the closed distal end as is taught by Fay in order to ensure the distal end of the liner is reinforced, thus spreading the negative pressure generated during the swing phase of a gait substantially over the inner surface to inhibit the common milking effect. As regards the low-extensible material, fabric, and elastomeric gel layer forming a composite, Merriam-Webster defines “composite” as “made up of distinct parts”. The Combination is understood to meet this limitation.
Further, regarding claim 1 Doddroe teaches wherein a strip of material designed to prevent longitudinal stretchability is present on a liner, it can have a width of 1.5-8 inches ([0053]). Halldorsson and Doddroe are involved in the same field of endeavor, namely liners which adjust axial elongation. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of the Halldorsson Fay Combination so that the width of the reinforcement material is between 0.5-4 inches as is taught by Doddroe in order to ensure the material can provide enough axial stability to the liner while still allowing some flexibility for the liner to stretch and accommodate a residual limb.
Further, regarding claim 1 Laghi teaches that liners are connected to their prosthetic socket/device by a locking mechanism (Column 7 lines 35-38). Halldorsson and Laghi are involved in the same field of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of the Halldorsson Fay Doddroe Combination so that the connection mechanisms of the prior art connected to the prosthetic devices with a locking mechanism as is taught by Laghi in order to prevent the socket from falling off the liner and providing a prosthetic which does not come disconnected unless desired, which would otherwise present a safety issue.
Further, regarding claim 1 Laghi ‘363 teaches that styrene-based polymers are useable as elastomeric materials for prosthetic liners ([0035]). Halldorsson and Laghi ‘363 are involved in the same field of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of the Halldorsson Fay Doddroe Laghi Combination so that it’s gel material was styrene-based as is taught by Laghi ‘363 since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. In re Leshing, 125 USPQ 416 (CCPA 1960) and Sinclair & Carroll Co. v. Interchemical Corp., 65 USPQ 297 (1945). Applicant’s specification also supports the interchangability of silicone and styrene-based materials ([0066]).
Claim 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halldorsson, Fay, Doddroe, Laghi, and Laghi ‘363 as is applied above in view of Helmy (US 5593454 A).
Regarding claim 2 the Halldorsson Fay Doddroe Laghi Laghi ‘363 Combination teaches the liner of claim 1 substantially as is claimed,
wherein Halldorsson further discloses the low extensibility material facing the fabric covering ([0031] the reinforcement material is considered “facing” every direction, since it is a three-dimensional object which extends in every direction),
but is silent with regards to the low-extensibility material comprising urethane.
However, regarding claim 2 Fay teaches that a liner’s low-extensibility material can include a reinforcing mesh (Column 6 lines 1-3), and Helmy teaches that polyurethane is commonly included within a reinforcing mesh for a prosthetic liner (Column 3 lines 41-44). Halldorsson and Helmy are involved in the same field of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of the Combination so that the material of the low-extensibility material included urethane as is taught by Helmy since Fay teaches urethane is commonly included within a reinforcing mesh.
Claims 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halldorsson, Fay, Doddroe, Laghi, and Laghi ‘363 as is applied above in view of Laghi et al. (US 8246694 B2) hereinafter known as Laghi ‘694.
Regarding claim 3 the Halldorsson Fay Doddroe Laghi Laghi ‘363 Combination teaches the liner of claim 1 substantially as is claimed,
but is silent with regards to the distal region having a distal horizontal stretch of 10-200% from a resting position.
However, regarding claim 3 Laghi ‘694 teaches a prosthetic liner’s less elongating region can include a horizontal stretch of 10-200% from a resting position (Column 5 lines 33-35). Halldorsson and Laghi ‘694 are involved in the same filed of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the horizontal stretch of the distal region of the liner of the Combination to fall within the range taught by Laghi ‘694 in order to create an elongation ratio between the two regions that will act to prevent or reduce buckling (Laghi ‘694 Column 5 lines 38-41). The Examiner notes that when correlating this adjustment to the Combination, the less elongating region corresponds to the distal region (see Halldorsson [0055]-[0056]).
Regarding claim 4 the Halldorsson Fay Doddroe Laghi Laghi ‘363 Combination teaches the liner of claim 1 substantially as is claimed,
but is silent with regards to the proximal region having a proximal horizontal stretch of 100-175% from a resting position.
However, regarding claim 4 Laghi ‘694 teaches a prosthetic liner’s more elongating region can include a horizontal stretch of 100-175% from a resting position (Column 5 lines 23-25). Halldorsson and Laghi ‘694 are involved in the same filed of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the horizontal stretch of the proximal region of the liner of the Combination to fall within the range taught by Laghi ‘694 in order to create an elongation ratio between the two regions that will act to prevent or reduce buckling (Laghi ‘694 Column 5 lines 38-41). The Examiner notes that when correlating this adjustment to the Combination, the more elongating region corresponds to the proximal region (see Halldorsson [0055]-[0056]).
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halldorsson, Fay, Doddroe, Laghi, and Laghi ‘363 as is applied above in view of Laghi et al. (US 9216099 B2) hereinafter known as Laghi ‘099.
Regarding claim 5 the Halldorsson Fay Doddroe Laghi Laghi ‘363 Combination teaches the liner of claim 1 substantially as is claimed,
wherein Halldorsson further discloses an intermediate region (this is inherent, and is considered to be the fabric part of the prosthetic that occupies the middle-most region between the proximal and distal region where the proximal and distal regions meet at a continuous blend (Halldorsson [0056]),
but is silent with regards to the intermediate longitudinal and horizontal elongation percentages.
However, regarding claim 5 Laghi ‘099 teaches that the fabrics used within a prosthetic liner (which occupies an intermediate region by the Examiner’s definition provided above), has a longitudinal elongation of 14-40% and a horizontal elongation of 80-120% (Column 8 lines 35-39). Halldorsson and Laghi ‘099 are involved in the same field of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of the Combination so that the horizontal and longitudinal elongations match the claimed ranges as is taught by Laghi ‘099 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. See MPEP 2144.05(II)(A). In this case, determining what range of elongation for the intermediate region is considered obvious to discover.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/02/26
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