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/Restrictions
Claim 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Claim Objections
Claim 2 is objected to because of the following informalities:
Regarding claim 2 line 2, the term “where the where the second strut” should read --where the second strut-- to eliminate the repeated words.
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:
“at least one structural member” of claim 12 line 2
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 line 5-7, the claim reads on “an actuator located on a first side of the knee that imposes a force on the knee; where the force is inclined at an angle to a longitudinal axis of the first strut” and in claim 2 lines 3-5, the claim reads on “an actuator located on a second side of the knee that imposes a force on the knee; where the force is inclined at an angle to a longitudinal axis of the second strut”. However, it is unclear from the written descriptions what inclined angle to the longitudinal axis of the first strut the force is being applied at. Specification page 5 lines 24-26 says “the first force 502 is inclined at an angle of 80 to 100 degrees, preferably 85 to 95 degrees to the second force 504”. However, claim 1 appears to read on second force 504, which appears to be applied at 90 degrees relative to the longitudinal axis of the strut. The relative angle of the force based in the specification appears to be based on the other applied force, however only a first force has been introduced in claim 1. Thus, it is unclear as to what inclined angle the force is applied at within the context of claim 1. Regarding both claims 1 and 2, is a force applied at 90 degrees relative to the axis considered “inclined”? Thus, the specification fails to provide adequate written description about how the claim limitation works.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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 1-12 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.
Regarding claim 1 line 8, the term “a slot” is unclear as to if the term is the same or different than line 4.
Regarding claim 2 line 2, the term “a central portion” is unclear as to if the term is the same or different than claim 1 line 5. In line 3, the term “a central strut” is unclear as to if the term is the same or different than claim 1 line 5. In line 3, the term “an actuator” is unclear as to if the term is the same or different than claim 1 line 5-6. In line 4, the term “a force on the knee” is unclear as to if the term is the same or different than in claim 1 line 6. In line 4, the term “an angle” is unclear as to if the term is the same or different than claim 1 line 7. In line 6, the term “a force that is opposed” is unclear as to if the term is the same or different than “a force” in claim 1 line 6.
Regarding claim 3 line 2, the term “an actuator” is unclear as to if the term is the same or different than claim 1 line 5-6. In line 3, the term “a force” is unclear as to if the term is the same or different than claim 1 line 6. In line 3, the term “the strut” is indefinite because it lacks proper antecedent basis.
Regarding claim 4 line 3, the term “an actuator” is unclear as to if the term is the same or different than claim 1 line 5-6 or claim 2 line 3. In line 4, the term “the strut” is indefinite because it lacks proper antecedent basis.
Claim limitation “at least one structural member” of claim 12 line 2 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. In claim 12, the “at least one structural member” is only described as “rigid”. In the specification, the only mention of the structure is “In this embodiment, at least one structural member of the upper portion, the central portion and the lower portion are manufactured from a rigid material. A rigid material is one which will undergo yield upon the application of a deforming force.” There is no corresponding structure as to what the “at least one structural member” is beyond what material makes it. 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.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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.
Claims 1, 5-8, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor (US 2017/0252200).
Regarding claim 1, Taylor discloses a brace for regeneration of tissue in a knee (Knee brace 60; Figs. 6a, 6b, 7-8; [0024] “he knee brace also may be used with a patient who is suffering pain from arthritis, bone on bone contact, and/or narrowed joint spacing in either left or right knee”) comprising:
a sleeve (attachment straps 86, 88; hold brace 60 to the leg [0159]);
and a first strut (top extension 82); where the first strut comprises an upper portion comprising a first jig (flanges 89a; [0164] “the extensions 82, 84 may connect respectively at their ends opposite to their hinge connections to flanges 89a, 89b shown in ghost form as respectively lying underneath attachment straps 86, 88”); where the first jig comprises a slot for hosting a first strap that is in contact with the sleeve (Fig. 6a on flange 89a, loop 92a acts as a slot to hold securement strap 90a);
a central portion that comprises a central strut (Fig. 6a portion of extension between bend lines 85, 87 corresponding to placement of force device 61) that is in fluid communication with an actuator located on a first side of the knee that imposes a force on the knee (Force device 61; [0141] force device 61 air bladder is inflated/deflated applying force to the knee); where the force is inclined at an angle to a longitudinal axis of the first strut (Fig. 6B inflation/deflation of force device 61 is inflated/deflated to an approximate 90 degree angle relative to the bent extensions 82, 84); and
a lower portion (lower extension 84) that comprises a second jig (flanges 89b; [0164] above); where the second jig comprises a slot for hosting a second strap that contacts the sleeve at an opposite end relative to a position that the first strap contacts the sleeve (Fig. 6a on flange 89b, loop 92b acts as a slot to hold securement strap 90b).
Regarding claim 5, Taylor discloses the actuator located on the first side of the knee (Force device 61) comprises an actuator bladder (Bladder 70) that is contained in an actuator shell (Base 62); where the actuator bladder is activated by pressurized air ([0141] “The air pump 64 and tube 66 may be used with port 68 to inflate and/or deflate the force device 61 such as in the case where the force device 61 is an air bladder”).
Regarding claim 6, Taylor discloses the actuator shell comprises a central passage through which the actuator bladder protrudes (Fig. 6B air device 61, specifically the bladder 70, protrudes from base 62 with curved line 63 in the central area).
Regarding claim 7, Taylor discloses the actuator shell is reversibly attached to the central strut ([0141] “a force device 61 adjacent to his or her left or right knee joint and on the inside or outside of his or her knee”, meaning force device 61’s base 62 is attachable to the inside or outside of the strut to contact the inside or outside of the knee) and where the central strut comprises a port for the pressurized air (port 68) and wherein the port is in fluid communication with the actuator bladder (port 68 and bladder 70 [0151]).
Regarding claim 8, Taylor discloses the central portion can swivel about the upper portion and/or the lower portion of the first strut ([0158] base 62 of force device 61 is connected to knee flexor 80, hinging the central portion about the extensions 82, 84).
Regarding claim 12, Taylor discloses the upper portion, the central portion and the lower portion all comprise at least one structural member that is rigid ([0160] Extensions 82, 84 and knee flexor 80 substantially rigid material).
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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor as applied to claim 1 above, and further in view of Ruetenik (US 2018/0104082).
Regarding claim 2, Taylor discloses a brace comprising a first strut that is interchangeably worn (see Taylor title “for use from either the inside or the outside of the left or right knee), but is silent as to a second strut that lies opposite the first strut. However, Ruetenik teaches a second strut that lies opposite the first strut (see Ruetenik Fig. 1A knee distractor apparatus with pressurized air filled knee stretch cylinders 100 on each side of the sides of knee braces 202, 204). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first strut on one side of the leg of Taylor with the duplication of a second strut on the opposite side of the leg as taught by Ruetenik so as to evenly treat both sides of the knee as necessary and as a duplication of parts having supportive struts and an inflatable actuator on both sides of the knee (see MPEP 2144.04(VI)(B)).
Modified Taylor discloses where the where the second strut also comprises a central portion that comprises a central strut (see Taylor Fig. 6a portion of extension between bend lines 85, 87 corresponding to placement of force device 61, on the duplicated second strut as taught by Ruetenik) in fluid communication with an actuator located on a second side of the knee that imposes a force on the knee (see Taylor force device 61; [0141] force device 61 air bladder is inflated/deflated applying force to the knee, on the duplicated second strut as taught by Ruetenik); where the force is inclined at an angle to a longitudinal axis of the second strut (see Taylor Fig. 6B inflation/deflation of force device 61 is inflated/deflated to an approximate 90 degree angle relative to the bent extensions 82, 84, on the duplicated second strut as taught by Ruetenik); where the actuator on the second side of the knee applies a force that is opposed to the force applies by the actuator on the first side of the knee (see Taylor in view of Ruetenik, duplicating the single strut leg brace to a double strut leg brace, wherein the inflation of left and right force devices 61 would be opposing forces on either side of the knee).
Claim 3 is is rejected under 35 U.S.C. 103 as being unpatentable over Taylor as applied to claim 1 above, and further in view of Auberger et al. (US 2015/0230962; hereinafter “Auberger”).
Regarding claim 3, Taylor is silent as to the first jig is in contact with an actuator chamber that contains an actuator that increases a length of the first strut; where the actuator contained in the actuator chamber imposes a force along the longitudinal axis of the strut. However, Auberger teaches the first jig is in contact with an actuator chamber (see Auberger Fig. 2 main body 20 on thigh, contacts actuator unit 7 as part of thigh unit 2) that contains an actuator that increases a length of the first strut (see Auberger [0043] actuator unit 7 has a longitudinal course; [0046] “change in the lengths of the actuator unit during flexion” meaning the thigh unit 2 including main body 20 as a whole lengthens as the actuator unit moves); where the actuator contained in the actuator chamber imposes a force along the longitudinal axis of the strut (see Auberger [0047] actuator unit 7 provides axial force [longitudinal]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first strut and first jig of Taylor with the addition of an actuator increasing the length of the first strut as taught by Auberger so as to provide adjustable fit the device to the user and assist in comfort of mobility while wearing the brace.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Ruetenik as applied to claim 2 above, and further in view of Auberger.
Regarding claim 4, modified Taylor discloses the second strut also comprises an upper portion that is in communication with the central portion (see Taylor upper portion comprising structures such as extension 82, with flanges 89a, connected to placement of force device 61, on the duplicated second strut as taught by Ruetenik), where the upper portion comprises a jig (see Taylor flanges 89a; [0164] “the extensions 82, 84 may connect respectively at their ends opposite to their hinge connections to flanges 89a, 89b shown in ghost form as respectively lying underneath attachment straps 86, 88”, on the duplicated second strut as taught by Ruetenik). Modified Taylor is silent as to an actuator contained in an actuation chamber; where the actuator imposes a force along the longitudinal axis of the strut.
However, Auberger teaches an actuator contained in an actuation chamber (see Auberger Fig. 2 main body 20 on thigh, contacts actuator unit 7 as part of thigh unit 2) ; where the actuator imposes a force along the longitudinal axis of the strut (see Auberger [0047] actuator unit 7 provides axial force [longitudinal]; [0043] actuator unit 7 has a longitudinal course; [0046] “change in the lengths of the actuator unit during flexion” meaning the thigh unit 2 including main body 20 as a whole lengthens as the actuator unit moves).Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second jig of modified Taylor with the addition of an actuator increasing the length of the second strut as taught by Auberger so as to provide adjustable fit the device to the user and assist in comfort of mobility while wearing the brace.
Claim 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor as applied to claim 7 above, and further in view of Griffith et al. (US 2015/0290794; hereinafter “Griffith”).
Regarding claim 9, Taylor is silent as to the actuator bladder comprises an elastomer (see Taylor [0153] “The air bladder 70 may be made of any appropriate material”). However, Griffith teaches the actuator bladder comprises an elastomer (see Griffith [0040] actuators 110 comprising chambers 310 which are inflated/deflated can be elastic and return to deflated configuration when not inflated). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator bladder of Taylor with the actuator bladder comprising an elastomer as taught by Griffith as this would have been an obvious substitution for one known type of bladder material for another and would yield predictable results, i.e. function to inflate.
Regarding claim 10, modified Taylor discloses the elastomer comprises a polychloroprene (see Griffith [0040] inflatable actuator 110 can comprises flexible sheet material such as polychloroprene).
Regarding claim 11, modified Taylor discloses the elastomer comprises a polysiloxane, a fluoroelastomer (see Griffith [0040] inflatable actuator 110 can comprises flexible sheet material such as rubber).
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant' s disclosure.
Cormier et al. (US 2005/0070831) is cited to show a adjustable knee brace.
Stewart (US 2017/0239119) is cited to show a knee distraction apparatus.
Johnson et al. (US 11,612,506) is cited to show an unloading knee apparatus for distraction of the joint.
Cadichon (US 7,553,289) is cited to show a distraction knee brace with elastic members.
Nace (US 10,744,021) is cited to show an inflating knee brace.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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