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 .
Election/Restriction
This action is responsive to remarks filled June 29th, 2026. Applicant noted the typographical error in the designation of Species A and B’s figures in the office action mailed 04/08/2026.
For clarity of record, this application contains claims directed to the following patentably distinct species of reinforced suspension sleeves:
Species A: Figs 7-10, a straight shaped sleeve (elected by phone on 7/21/26, without traverse); and
Species B: Figs 1-6, 11A, and 12A, a sleeve featuring a bend in the middle.
The species (prostheses sleeve with varying bending elements) require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). Therefore, prompting examination with an undue search burden, as the species are independent and distinct, and are not obvious variants of each other based on the current record.
This Requirement is therefore made Final.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10 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.
Applicant's arguments filed June 29th, 2026 have been fully considered but they are not fully persuasive.
Applicant’s argument regarding the definition of layers were found persuasive.
In response to applicant's point on page 6, the Office agrees the range Shneider discloses two separate ranges, one range in the claims and a separate range in the specification, the ranges are still within the claimed ranges. While Schneider does not teach the specific range, the claimed ranges are within the ranges taught by Schneider.
Applicant argument on page 5 regarding the definition of a layer are found persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
On page 5 of remarks, regarding combination teaching away, to better provide natural flexion’, specifically away: ‘it places a fabric reinforcement layer at the bend’. While the claim operates differently from the combination, it does not meet the criteria of teaching away. Nothing in the Schneider teaches that the proposed modification would have resulted in an either invention being inoperable. The combination would merely operate differently than the claimed invention. Applicant notes, “reinforcement resists”. However, Examiner notes reinforcement of suspension sleeves aim to provide more natural joint flexion while providing stability (reinforcement of areas therein). These two aims are not mutually exclusive. Furthermore, Schneider teaches including added layers to the invention for reduced sticking of the sleeve to garments, see [0009]. Any added layers would constitute a reinforcement of the sleeve. Therefore, Schneider is compatible with added layers, including the reinforcements of Kelley.
In response to applicant's argument that Gottieb is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Gottieb is analogous art, in the field of limb reinforcement, as its sealing ring is used in conjunction with the fabric layer 16, as shown in Figure 5.
In response to applicant's argument that Kelley’s sleeve is only to provide heat transfer with in the sleeve (pages 4 and 6 of remarks), a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the sleeve of Kelley would have structural reinforcement as supplied by the recited layering of Fig 22.
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.
Claim(s) 1, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Laghi et al. US 20100023134 A1, herein referred to as Laghi, in view of Schneider et al. 20100076357 A1, herein referred to as Schneider.
Regarding claim 1, Laghi discloses a fabric reinforced suspension sleeve (Fig 1, 1; [0009]) comprising: an open proximal end (Fig 3, shown open end); an exterior fabric layer (Fig 3, 6; [0030]); an inner cushion layer (Fig 3, 7; [0034]]) further comprising a midsection (bent section shown in Fig 2).
But Laghi fails to disclose further comprising a midsection bent at an angle between 5 and 60 degrees, at the midsection bent to the angle of the inner cushion layer.
Schneider teaches a prosthesis sleeve comprising an open distal end; and a midsection bent at an angle between 5 and 60 degrees ([0008] Schneider teaches a middle bend “between 50 and 35. degree., more particularly in the range of between 10 degree and 25. degree” While Schneider does not teach the specific range, the claimed ranges are within the ranges taught by Schneider), at the midsection bent to the angle of the inner cushion ([0002-0003] Schneier teaches inner and outer surface, two layers for which bend exists for meeting claimed limitation).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify Laghi to incorporate comprising an open distal end; and a midsection bent at an angle between 5 and 60 degrees, at the midsection bent to the angle of the inner cushion layer, as taught and suggested by Schneider in order to better provide natural flexion (Schneider [0008]).
Regarding claim 4, Laghi as modified by Schneider discloses the invention substantially as claimed and as discussed above with respect to claim 1. Additionally, Laghi teaches
the inner cushion layer is an elastomer comprising a styrene triblock copolymer [0016].
Regarding claim 8, Laghi as modified by Schneider discloses the invention substantially as claimed and as discussed above with respect to claim 1. Additionally, Laghi teaches wherein the fabric reinforcement layer further comprises an inner elastomer layer Laghi [0008]).
Regarding claim 10, Laghi as modified by Schneider discloses the invention substantially as claimed and as discussed above with respect to claim 1. Additionally, Laghi teaches wherein the fabric reinforcement layer has a length of at least three inches (Laghi [0014]).
Claim(s) 2-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Laghi in view of Schneider, and further in view of Kelley US 20140025183 A1, herein referred to as Kelley.
Regarding claim 2, Laghi as modified by Schneider discloses the invention substantially as claimed and as discussed above with respect to claim 1, but fails to explicitly disclose wherein the inner cushion layer is silicon.
However, in the same field of endeavor, Kelley teaches a fabric reinforced suspension sleeve (Fig 22, 300 prosthetic suspension sleeve) comprising: an open proximal end (Fig 22, top end); an open distal end (Fig 22, bottom end); an exterior fabric layer (Fig 22, fabric material 315 [0160]); an inner cushion layer (Figure 22, layer 330); and wherein the inner cushion layer is silicone ([0004]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify Laghi as modified by Schneider to incorporate wherein the inner cushion layer is silicone, as taught and suggested by Kelley in order to provide comfort to a user (Kelley [0004]).
Regarding claim 3, Laghi as modified by Schneider and Kelley discloses the invention substantially as claimed and as discussed above with respect to claim 2. Additionally, Kelley teaches wherein the inner cushion layer is a thermoplastic elastomer (Kelley [0004]).
Regarding claim 5, Laghi as modified by Schneider and Kelley discloses the invention substantially as claimed and as discussed above with respect to claim 2, but fails to explicitly disclose further comprising a proximal circumferential band and a distal circumferential band incorporated on the fabric reinforcement layer.
Additionally, in another embodiment, Kelley teaches further comprising a proximal circumferential band (Kelley Fig 22, circumferential band 325) and a distal circumferential band incorporated on the fabric reinforcement layer (Kelley [0065], plurality of bands in particular location such as distal).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify Laghi as modified by Schneider and Kelley to incorporate further comprising a proximal circumferential band and a distal circumferential band incorporated on the fabric reinforcement layer, as taught and suggested by Kelley in order to support the residual limb therein (Kelley [0158]).
Regarding claim 6, Laghi as modified by Schneider and Kelley discloses the invention substantially as claimed and as discussed above with respect to claim 5. Additionally, Kelley teaches further comprising a plurality of longitudinal retention strips incorporated on the fabric reinforcement layer (Kelley [0116]).
Regarding claim 7, Laghi as modified by Schneider and Kelley discloses the invention substantially as claimed and as discussed above with respect to claim 6. Additionally, Kelley teaches comprising a proximal circumferential band (Kelley Fig 22, circumferential band 325) and a distal circumferential band incorporated on the fabric reinforcement layer (Kelley [0065], plurality of bands in particular location such as proximal).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laghi in view of Schneider, and further in view of Gottlieb et al. WO 2015169289 A1, herein referred to as Gottlieb.
Regarding claim 9, Laghi as modified by Schneider discloses the invention substantially as claimed and as discussed above with respect to claim 1, but fails to explicitly disclose wherein the fabric reinforcement layer has a length that is 25% of a total length of the fabric reinforced suspension sleeve.
However, in the same field of endeavor, Gottieb teaches a reinforced sleeve (Fig 1, 1) comprising: an open proximal end (Fig 1, 12); an open distal end (Fig 1, 13); an exterior fabric layer (Fig 1, 16); an inner cushion layer (18); and wherein the fabric reinforcement layer has a length that is 25% of a total length of the reinforced suspension sleeve (Gottieb pg 3: “The installation situation of the sealing ring 1 on the stump receptacle 2 is shown in FIG. 5, in which the proximal region 21, which relates approximately to 1/3 to 1/5 of the total length of the stump receptacle 2, can be recognized. In the proximal region 21, the base body 10 of the sealing ring 1 lies tightly against, the proximal region 17 of the sealing ring 1 projects beyond the proximal edge of the butt receiving means 2 and the sealing lip 18 extends substantially perpendicularly radially to the side wall of the butt joint. .sub.Λ n”).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify Laghi as modified by Schneider to incorporate wherein the fabric reinforcement layer has a length that is 25% of a total length of the fabric reinforced suspension sleeve, as taught and suggested by Gottieb for sealing a stump (Gottieb pg 3)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards 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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/A.F./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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