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 .
Specification
The use of the term Velcro in paragraphs [0017], [0036], [0086], and [0092], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1-3, 5-18, and 20 are objected to because of the following informalities:
Claim 1 recites the limitation “an ankle brace for a hypothetical user having a leg including an ankle joint complex extending from below a gastrocnemius at the proximal side to behind the neck of a fifth metatarsal on the distal side”. This limitation should either be amended to include “configured to” language, or to remove the unnecessary limitations of “for a hypothetical user having a leg including an ankle joint complex extending from below a gastrocnemius at the proximal side to behind the neck of a fifth metatarsal on the distal side”.
Claim 1 recites the limitation “the brace” in line 3. This limitation should be amended to recite “the ankle brace” to maintain consistency in the claims.
Claim 1 recites the limitation “biocompatible elastomeric sheet material” in line 3. This limitation should be amended to recite “a biocompatible elastomeric sheet material” to properly present the limitation.
Claim 1 recites the limitation “a through thickness of from 1 to 7mm” in line 4. This limitation should be amended to remove either “of” or “from” as the use of both is grammatically incorrect.
Claim 1 recites the limitation “and a that” in line 4. This limitation should be amended to remove “a”.
Claim 1 recites the limitation “having web of material” in line 4. This limitation should be amended to recite “a web of material”.
Claim 1 recites the limitation “the web” in line 6. This limitation should be amended to recite “the web of material” to maintain consistency in the claims.
Claim 2 recites the limitation “the web” in line 1 and 2. This limitation should be amended to recite “the web of material” to maintain consistency in the claims.
Claim 2 recites the limitation “there between”. This limitation should be amended to recite “therebetween” to properly recite the adverb.
Claim 3 recites the limitation “the brace” in line 2. This limitation should be amended to recite “the ankle brace” to maintain consistency in the claims.
Claim 5 recites the limitation “the web” in line 2. This limitation should be amended to recite “the web of material” to maintain consistency in the claims.
Claim 6 recites the limitation “the web” in line 2. This limitation should be amended to recite “the web of material” to maintain consistency in the claims.
Claim 7 recites the limitation “the web” in line 2. This limitation should be amended to recite “the web of material” to maintain consistency in the claims.
Claims 8-15 each recites “the elastomeric material”. These limitations should be amended to recite “the biocompatible elastomeric sheet material” to maintain consistency in the claims.
Claim 16 recites the limitation “the reinforcing fiber”. This limitation should be amended to recite “the reinforcing fibers and fillers” to maintain consistency in the claims.
Claim 17 recites the limitation “the brace” in line 1. This limitation should be amended to recite “the ankle brace” to maintain consistency in the claims.
Claim 18 recites the limitation “the web” in line 2. This limitation should be amended to recite “the web of material” to maintain consistency in the claims.
Claim 20 recites the limitation “the joint”. This limitation should be amended to recite “the ankle joint” to maintain consistency in the claims.
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.
Claim 1 recites the limitation “closure means” (for closing the web of material) in line 5 without reciting sufficient structure material, or acts to entirely perform the recited function of closing the web of material in the claim. After consultation of Applicant’s specification, closure means is considered to encompass “buttons, hooks, latches, ratchet mechanisms, post and pin, groove and slide, hook and loop, post and loop, Velcro, cables, and zippers to name a few” as recited in [0017] of applicant’s specification and known equivalents thereof.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In regards to claim 1, the limitation “a top opening sized to fit below the belly of the gastrocnemius” positively recites part of the human body.
In regards to claim 1, the limitation “a bottom opening sized to fit posterior to the neck of the fifth metatarsal” positively recites part of the human body.
To obviate a rejection under 35 USC 101, the Office suggests that any claim that would include a human being, or part thereof, within its scope should use “adapted to___” or “adapted for ___” or “configured to” or configured for” to define the metes and bounds of the claimed subject matter which is a permissible form of expression.
Claims 2-20 are rejected under 35 U.S.C. 101 as being dependent from a rejected claim and therefore, contain the same offending limitations.
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.
Claim 1-20 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.
Claim 1 recites the limitation "the proximal side" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is also unclear as to what structure Applicant is referring to the proximal side of (the leg, the gastrocnemius, or the ankle joint). For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 1 recites the limitation "the neck" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "a neck".
Claim 1 recites the limitation "the distal side" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is also unclear as to what structure Applicant is referring to the distal side of (the leg, the gastrocnemius, or the ankle joint). For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 1 recites the limitation “the first portion of the web” in line 6. There is insufficient antecedent basis for this limitation in the claim for the first portion of the web as the first portion is recited to be a first portion (of the sleeve of biocompatible material) having web of material. For the purpose of examination, Examiner will interpret this limitation as “the first portion having the web of material”.
Claim 1 recites the limitation "the belly of the gastrocnemius" in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "a belly of the gastrocnemius".
Claim 1 recites the limitation "the distal end of the first portion" in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "a distal end of the first portion".
Claim 1 recites the limitation "the proximal end of the second portion" in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "a proximal end of the second portion".
Claim 1 recites the limitation "the distal portion of the second portion" in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "a distal portion of the second portion".
Claim 3 recites the limitation "the medial or lateral side" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "a medial or a lateral side".
Claim 3 contains the trademark/trade name Velcro. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “hook and loop fastening mechanism” and, accordingly, the identification/description is indefinite.
Claim 4 recites the limitation "the fenestration" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "a fenestration".
Claim 5 recites the limitation "the fenestration" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "a fenestration".
Claim 6 recites the limitation “the first portion of the web” in line 1. There is insufficient antecedent basis for this limitation in the claim for the first portion of the web as the first portion is recited to be a first portion (of the sleeve of biocompatible material) having web of material. For the purpose of examination, Examiner will interpret this limitation as “the first portion having the web of material”.
Claim 7 recites the limitation “the first portion of the web” in line 1. There is insufficient antecedent basis for this limitation in the claim for the first portion of the web as the first portion is recited to be a first portion (of the sleeve of biocompatible material) having web of material. For the purpose of examination, Examiner will interpret this limitation as “the first portion having the web of material”.
Claim 14 contains the trademark/trade name Versaflex CL30, and CL2000X, E1040AL. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “specific materials” and, accordingly, the identification/description is indefinite.
Regarding claim 14, the phrase "or commercial equivalents" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or commercial equivalents"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 18 recites the limitation "the web of the second portion" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "a fenestration".
Claim 18 recites the limitation “a durometer that is 10 to 90 points higher on the Shore A scale”. The claim does not define what the durometer of the framework is higher than which renders the claim unclear. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 19 recites the limitation “the proximal area of the first portion” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "the proximal end of the first portion".
Claim 19 recites the limitation “the distal area of the second portion” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as "the distal end of the second portion".
Claim 19 recites the limitation “the first second” in line 3. This limitation is unclear as to what is being claimed. For the purpose of examination, Examiner will interpret this limitation as “the first anchor”.
Claim 20 recited the limitation “the framework includes linking members”. This limitation is held to be unclear because claim 19 recites “the frame work includes linking members”. Therefore, it is unclear as to if the linking members of claim 20 are new linking members or the same linking members as presented in claim 19. For the purpose of examination, Examiner will interpret these limitations as being the same.
Claim 20 recites the limitation “the anatomic orientation”. There is insufficient antecedent basis for the limitation in the claims. For the purpose of examination, Examiner will interpret this limitation as “an anatomic orientation”.
Claim 20 recites the limitation “the lateral collateral ligamentous complex” in line 2. There is insufficient antecedent basis for the limitation in the claims. For the purpose of examination, Examiner will interpret this limitation as “a lateral collateral ligamentous complex”.
Claims 2, 8-13, and 15-17 are rejected under 35 U.S.C. 112(b) as being dependent from a rejected claim and therefore, contain the same offending limitations.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-7, and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watts (US 9,827,131 B2).
In regards to claim 1, Watts discloses An ankle brace (1; see [col 3 ln 54-63]; see figure 1) for a hypothetical user having a leg including an ankle joint complex extending from below a gastrocnemius at the proximal side to behind the neck of a fifth metatarsal on the distal side (see col 3 ln 54-col 4 ln 12]), the brace (1) comprising a sleeve of biocompatible elastomeric sheet material (silicone elastomer; see [col 4 ln 56-60]) having a through thickness of from 1 to 7 mm (.00195M thick or 1.95mm; see [col 9 ln 30-35]), and a that has a first portion (14; see [col 3 ln 54-57]; see figure 1) having web of material (web of silicone elastomer) which is closed by closure means (38 and 40; see [col 6 ln 33-45]; see figure 4) to form a first continuous loop about a first axis (see figure 2) and a second portion (12; see [col 3 ln 54-57]; see figure 1) that forms a second continuous loop about a second axis (see figure 1); and the first portion (14) of the web having a proximal end which includes a top opening (see figure 1) sized to fit below the belly of the gastrocnemius of the hypothetical user (see [col 3 ln 60-65] the device is placed on about the ankle and thus sits below the belly (the thickest portion of) the calf muscle) and the distal end of the first portion being connected to the proximal end of the second portion at a conjunction of the first portion (14) and the second portion (12; the lower end of 14 and the upper end of 12 are connected at a “conjunction; see figure 3), and the distal portion of the second portion including a bottom opening sized to fit posterior to the neck of the fifth metatarsal of the hypothetical user (see [col 4 ln 13-27]).
In regards to claim 2, Watts discloses the invention as discussed above.
Watts further discloses wherein the web (web of silicone elastomer of 14) has a first edge and a second edge (18 and 20; see [col 5 ln 33-42]; see figure 4) and a discontinuity there between (gap between 18 and 20; see figure 4) and the web (web of silicone elastomer of 14) is configured so that the discontinuity (gap) is not directly over an Achilles tendon of the hypothetical user (see figure 3 that the gap is located on a side of 1, and not the direct rear of 1 in the location of the user’s Achilles tendon).
In regards to claim 3, Watts discloses the invention as discussed above.
Watts further discloses wherein the closure means (38 and 40) is attached to a band, strap, cable or tab (34; see [col 6 ln 25-30]; see figure 4) which extends from the medial or lateral side of the brace (1; see figure 4) and includes one or more of Velcro, C-hooks, pin and post, zipper, tongue and groove, buttons, latch and hook, anchor and anchor receptacle, and laces (see [col 6 ln 35-40]).
In regards to claim 4, Watts discloses the invention as discussed above.
Watts further discloses wherein the fenestration (apertures for malleoli; see [col 4 ln 25-27]) is a through hole (an aperture is a “through hole”).
In regards to claim 5, Watts discloses the invention as discussed above.
Watts further discloses wherein the fenestration (apertures for malleoli; see [col 4 ln 25-27]) is an area of decreased resistance in the web (web of silicone elastomer of 14; an aperture is a region without material and therefore is an area of “decreased resistance”).
In regards to claim 6, Watts discloses the invention as discussed above.
Watts further discloses wherein the first portion (14) of the web (web of silicone elastomer of 14) includes at least one opening for the lateral malleolus (apertures for malleoli; see [col 4 ln 25-27]).
In regards to claim 7, Watts discloses the invention as discussed above.
Watts further discloses wherein the first portion (14) of the web (web of silicone elastomer of 14) includes at least one opening for the medial malleolus (apertures for malleoli; see [col 4 ln 25-27]).
In regards to claims 15, Watts discloses the invention as discussed above.
Watts further discloses wherein the elastomeric material (silicone elastomer) is compounded with an additional material selected from the group comprising other elastomers (see [col 9 ln 10-16] in reference to the silicone elastomer being contemplated as being formed from compounded silicone elastomers), cross-linking agents, reinforcing fibers and fillers (see [col 4 ln 43-55] in reference to the silicone elastomer being integrally formed with 16 and thereby compounded with 16, which is formed from carbon fiber), antimicrobial agents, colorants, and fragrances.
In regards to claims 16, Watts discloses the invention as discussed above.
Watts further discloses wherein the reinforcing fiber (16) is selected from glass, steel, and carbon fiber (carbon fiber; see [col 4 ln 43-55]).
In regards to claim 17, Watts discloses the invention as discussed above.
Watts further discloses wherein brace (1) is formed by molding or casting (see [col 9 ln 25-30]).
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.
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) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watts in view of Pedicano (US 2010/0043266 A1).
In regards to claims 8-13, Watts discloses the invention as discussed above.
Watts does not disclose wherein the elastomeric material is a thermoplastic elastomer as recited in each claim 8-13.
However, Pedicano teaches an analogous device for being worn on a user’s joint (100; see [0012]; see figure 1) which is formed from an analogous elastomeric material (see [abstract]); wherein the elastomeric material is a thermoplastic elastomer (see [0038] in reference to the wristband being made from Versaflex™ CL30) for the purpose of providing the beneficial properties of allowing the device to stretch as much as 200%, providing a soft touch, very good clarity and colorability, overmold adhesion to polypropylene, and good ozone/UV stability (see [0038]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elastomeric material as disclosed by Watts and to have substituted the material as disclosed by Watts for the thermoplastic elastomer (Versaflex™ CL30) as taught by Pedicano in order to have provided an improved ankle brace that would add the beneficial properties provided by the material of Pedicano of allowing the device to stretch as much as 200%, providing a soft touch, very good clarity and colorability, overmold adhesion to polypropylene, and good ozone/UV stability (see [0038]) thereby enabling the ankle brace to conform and stretch to fit a user, increase user comfort, increase the customization of coloring the brace, and provide a material which is stable when utilized outdoors.
Furthermore, such a modification is held to be obvious since it has been held that “(w)here a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509 (BPAI, 2007) (citing KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1396 (2007) (see MPEP 2143 I B). Accordingly, Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results. In the instant case substitution of the material of Watts for the material of Pedicano yields the predictable results of allowing the device to stretch, conform, and provide support to a user’s ankle joint.
With regards to the remaining limitations of claims 8-13. The remaining limitations are each drawn to material properties of the thermoplastic elastomer which are not explicitly disclosed by the combination of Watts as now modified by Pedicano. However, Watts as now modified by Pedicano’s ankle brace being made from Versaflex™ CL30 is the same material as utilized by Applicant’s ankle brace (see Applicant’s specification [0114]) and therefore, is expected to exhibit the claimed material properties of claims 8-13 since it has been held that “(w)here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (see MPEP 2112.01)).
In regards to claims 14, Watts discloses the invention as discussed above.
Watts does not disclose wherein the elastomeric material is a thermoplastic elastomer sold under the trademarks Versaflex CL30, and CL2000X from PolyOne F-115 A/B 15 Shore A Polyurethane Elastomer, and E1040AL from Quatumcast Material or commercial equivalents.
However, Pedicano teaches an analogous device for being worn on a user’s joint (100; see [0012]; see figure 1) which is formed from an analogous elastomeric material (see [abstract]); wherein the elastomeric material is a thermoplastic elastomer sold under the trademarks Versaflex CL30, and CL2000X from PolyOne F-115 A/B 15 Shore A Polyurethane Elastomer, and E1040AL from Quatumcast Material or commercial equivalents (see [0038] in reference to the wristband being made from Versaflex™ CL30) for the purpose of providing the beneficial properties of allowing the device to stretch as much as 200%, providing a soft touch, very good clarity and colorability, overmold adhesion to polypropylene, and good ozone/UV stability (see [0038]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elastomeric material as disclosed by Watts and to have substituted the material as disclosed by Watts for the thermoplastic elastomer (Versaflex™ CL30) as taught by Pedicano in order to have provided an improved ankle brace that would add the beneficial properties provided by the material of Pedicano of allowing the device to stretch as much as 200%, providing a soft touch, very good clarity and colorability, overmold adhesion to polypropylene, and good ozone/UV stability (see [0038]) thereby enabling the ankle brace to conform and stretch to fit a user, increase user comfort, increase the customization of coloring the brace, and provide a material which is stable when utilized outdoors.
Furthermore, such a modification is held to be obvious since it has been held that “(w)here a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509 (BPAI, 2007) (citing KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1396 (2007) (see MPEP 2143 I B). Accordingly, Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results. In the instant case substitution of the material of Watts for the material of Pedicano yields the predictable results of allowing the device to stretch, conform, and provide support to a user’s ankle joint.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watts in view of Gildersleeve et al. (US 2014/0276315 A1) (hereinafter Gildersleeve).
In regards to claims 18, Watts discloses the invention as discussed above.
Watts does not disclose further including a framework which cooperates with the web of the first portion and the web of the second portion and comprises a material of a durometer that is 10 to 90 points higher on the Shore A scale.
However, Gildersleeve teaches an analogous ankle brace (ankle support; see [0005]) comprising an analogous sleeve of biocompatible elastomeric sheet material (sleeve; see [0032]; see [0071] in reference to the materials for the sleeve); further including a framework (106; see [0054]; see figure 1) which cooperates with the web of the first portion and the web (upper portion of the sleeve) of the second portion (lower portion of the sleeve; see figure 1) for the purpose of dynamically biasing a joint toward a particular state of extension or flexion (see [0058]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ankle brace as disclosed by Watts and to have included the framework as taught by Gildersleeve in order to have provided an improved ankle brace that would add the benefit of providing a framework which dynamically biases a joint toward a particular state of extension or flexion (see [0058]).
Watts as now modified by Gildersleeve does not explicitly disclose the framework comprises a material of a durometer that is 10 to 90 points higher on the Shore A scale.
However, Gildersleeve teaches that the material of the framework can be varied to provide areas of increased thickness, or stiffness, inclusion of a stiffener material (see [0069]), is constructed from a material configured to change density based on one or more factors, such as, for example, temperature, impact, and/or conformity (See [0073]), and can be formed from different elastomeric materials to provide different characteristics (see [0075-0076]), each property, and material affecting the shore hardness level of the elastomeric material. Thus, the shore hardness of the material of the framework is considered to be a result effective variable in that changing the material properties which changes the shore hardness of the framework affects the ability of framework to provide support to a user’s joint. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the framework of Watts as now modified by Gildersleeve to be the shore hardness as claimed as it involves only adjusting the composition of a component disclosed to require adjustment.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the framework of Watts as now modified by Gildersleeve by forming the framework from a combination of materials, stiffening components, thicknesses, and densities to result in the claimed shore hardness of the framework as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of customizing the framework to provide a desired resistance/support to the user’s ankle joint (See Gildersleeve [abstract]).
In regards to claim 19, Watts as now modified by Gildersleeve discloses the invention as discussed above.
Watts as now modified by Gildersleeve further discloses wherein the framework (106 of Gildersleeve) includes a first anchor (108 of Gildersleeve; see Gildersleeve [0062] and figure 1) at the proximal area of the first portion (upper area of 14 of Watts; see Gildersleeve figure 1, 106 of Gildersleeve would be similarly positioned and anchored by 108 to 14 of Watts) and a second anchor (anchor forming toe opening of 106 of Gildersleeve; see Gildersleeve figure 1) at the distal area of the second portion (upper area of 12 of Watts; see Gildersleeve figure 1, 106 of Gildersleeve would be similarly positioned and anchored by the opening of 106 for receiving a user’s toes to 12 of Watts), and the framework (106 of Gildersleeve) includes linking members (individual segments of 106 of Gildersleeve between 108 and the indicated opening; see Gildersleeve figure 1) that cooperate to extend between and connects the first second and the second anchor (see Gildersleeve figure 1).
In regards to claim 20, Watts as now modified by Gildersleeve discloses the invention as discussed above.
Watts as now modified by Gildersleeve further discloses wherein the framework (106 of Gildersleeve) includes linking members (individual segments of 106 of Gildersleeve between 108 and the indicated opening; see Gildersleeve figure 1) that act as stiffening ribs in the anatomic orientation of the lateral collateral ligamentous complex of the joint (see Gildersleeve [0069]; the use of a stiffening material in 106 acts as claimed).
Conclusion
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/DANIEL A MILLER/Examiner, Art Unit 3786