DETAILED ACTION
This is a Non-Final Rejection for Application 18/986,140 filed December 18, 2024. The present application claims priority to and the benefit of Taiwanese Patent Application No. 112151238 under 35 U.S.C. §119, filed on December 28, 2023. Claims 1-10 are currently pending.
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 1-2, 3, 6-8 and 10 are objected to because of the following informalities. Appropriate correction is required.
Claim 1 recites “one end of the second bracket being pivotally being connected to the second spacing adjustment member” in lines 11-12. This recitation should be “one end of the second bracket pivotally connected to the second spacing adjustment member” for proper idiomatic English.
Claim 2 recites “one end of the hip support” in line 7. This recitation should be “the one end of the hip support” to properly refer back to the one end of the hip support recited in line 2.
Claim 4 recites “wherein a difference between the second relative distance and the first relative distance is caused to gradually increases by one or more intermediate coupling structures” in lines 1-3. This recitation should be “wherein a difference between the second relative distance and the first relative distance gradually increases by one or more intermediate coupling structures” for proper idiomatic English.
Claim 6 recites “each of the two knee joint assist mechanisms includes the first bracket” in line 2. This recitation should be “each of the two knee joint auxiliary mechanisms include the first bracket” to remain consistent with terminology and for proper idiomatic English.
Claim 6 further recites “each of the first bracket arranged on the outer side of the lower limb is fixed to the lower limb through the waist fixation mechanism” in lines 4-5. This recitation should be “each of the first brackets configured to be arranged on the outer side of the lower limb are fixed to the lower limb through the waist fixation mechanism” for proper idiomatic English.
Claim 7 recites “wherein each of the two knee joint assist mechanisms includes another first bracket” in lines 1-2. This recitation should be “wherein each of the two knee joint assist mechanisms include another first bracket” for proper idiomatic English.
Claim 8 recites “the second spacing adjustment member are provided with ratchet teeth or tooth grooves” in lines 4-5. This recitation should be “the second spacing adjustment member is provided with ratchet teeth or tooth grooves” for proper idiomatic English.
Claim 10 recites “the other end of the second bracket” twice, in lines 2 and 4, respectively. This recitation should be “the one other end of the second bracket” to remain consistent with terminology used in claim 1.
Claim Rejections - 35 USC § 112(b)
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 1-10 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 1 requires the limitation “wherein the knee joint assist mechanism includes” in lines 2-3. There is a lack of antecedent for this limitation in the claims. This rejection may be overcome with language such as “wherein the knee joint auxiliary mechanism includes” so that it is clear the limitation is referring to the at least one knee joint auxiliary mechanism in lines 1-2.
Claim 1 further requires the limitation “wherein, when the knee joint is in a bent state, the one of the first spacing adjustment member the second distance adjusting member is engaged with an other one of the first spacing adjustment member and the second spacing adjustment member by the basic coupling structures, and a first relative distance is formed between the first distance adjusting member and the second distance adjusting member” in lines 18-22. This paragraph is replete with grammatical errors and a lack of antecedent for multiple terms. For the purposes of examination, the examiner will interpret the paragraph as reciting “wherein, when the knee joint is in a bent state, the one of the first spacing adjustment member and the second spacing adjusting member is engaged with the other one of the first spacing adjustment member and the second spacing adjustment member by the base coupling structures, and a first relative distance is formed between the first spacing adjusting member and the second spacing adjusting member”. Appropriate correction is required.
Claim 3 requires the limitation “wherein the waist fixing mechanism is worn on the lower limb” in lines 1-2. There is a lack of antecedent for this limitation in the claims. This rejection may be overcome with language such as “wherein the waist fixation mechanism is configured to be worn on the lower limb”.
Claim 6 requires the limitation “each of the two knee joint assist mechanisms includes the first bracket, the first spacing adjustment member, the second spacing adjustment member and the second bracket that are arranged on an outer side of the lower limb,” in lines 2-4. There is a lack of antecedent for this limitation in the claims and it is unclear if the two knee joint auxiliary mechanisms are on different lower limbs or the same side of the same lower limb. This rejection may be overcome with language such as “each of the two knee joint auxiliary mechanisms includes the first bracket, the first spacing adjustment member, the second spacing adjustment member and the second bracket configured to be arranged on outer sides of the lower limbs”.
Claim 7 requires the limitation “the two knee joint assist mechanisms” in lines 1-2. There is a lack of antecedent for this limitation in the claims. This rejection may be overcome with language such as “the two knee joint auxiliary mechanisms”.
Claim 10 requires the limitation “the knee joint assist mechanism” in line 1. There is a lack of antecedent for this limitation in the claims. This rejection may be overcome with language such as “the knee joint auxiliary mechanism”.
Claim 10 further requires the limitation “the user's shoe” in line 3. There is a lack of antecedent for this limitation in the claims. This rejection may be overcome with language such as “a user's shoe”.
Claims 2, 4-5 and 8-9 are rejected for depending from and not curing the deficiencies of a rejected claim.
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 1-10 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).
The claims are replete with claims encompassing a human organism. Any mention of a part of a human must be functionally claimed as the apparatus claimed cannot require a part of a human in its structure.
Claims 1 requires the limitations “at least one knee joint auxiliary mechanism arranged at least on a side of a lower limb of a user”; “one end of the first bracket being connected to a waist fixation mechanism and fixed to the lower limb”; “another end of the first bracket corresponding to a position of a knee joint of the lower limb” ; and “one end of the second bracket being pivotally being connected to the second spacing adjustment member at a position corresponding to the knee joint”. The limitations require a lower limb of a user and a knee joint which do not fall under the scope of patentable subject matter. This rejection may be overcome with language such as “at least one knee joint auxiliary mechanism configured to be arranged at least on a side of a lower limb of a user”; “one end of the first bracket being connected to a waist fixation mechanism and configured to be fixed to the lower limb”; “another end of the first bracket configured to correspond to a position of a knee joint of the lower limb” ; and “one end of the second bracket being pivotally being connected to the second spacing adjustment member at a position configured to correspond to the knee joint”.
Claim 2 requires the limitations “a hip support having one end connected to the waist fixation belt and supporting a hip”; “wherein the waist fixation belt is sleeved onto a lower side of the user's anterior superior iliac spine”; and “wherein the hip support is a plate-shaped structure corresponding to a shape of the hip”. The limitations require a hip and the user's anterior superior iliac spine which do not fall under the scope of patentable subject matter. This rejection may be overcome with language such as “a hip support having one end connected to the waist fixation belt and configured to support a hip”; “wherein the waist fixation belt is configured to be sleeved onto a lower side of the user's anterior superior iliac spine”; and “wherein the hip support is a plate-shaped structure configured to correspond to a shape of the hip”.
Claim 3 requires “wherein the waist fixing mechanism is worn on the lower limb”; “the waist fixation belt sleeved onto the waist” ; and “two thigh fixation belts respectively sleeved onto two upper thighs”. The limitations require the lower limb, the waist and two upper thighs which do not fall under the scope of patentable subject matter. This rejection may be overcome with language such as “wherein the waist fixation mechanism is configured to be worn on the lower limb”; “the waist fixation belt is configured to be sleeved onto the waist” ; and “two thigh fixation belts configured to be respectively sleeved onto two upper thighs”.
Claim 6 requires “the second bracket that are arranged on an outer side of the lower limb” and “each of the first bracket arranged on the outer side of the lower limb is fixed to the lower limb”. The limitations require the outer sides of the lower limbs and the lower limbs which do not fall under the scope of patentable subject matter. This rejection may be overcome with language such as “the second bracket configured to be arranged on outer sides of the lower limbs” and “each of the first brackets arranged on the outer sides of the lower limbs are configured to be fixed to the lower limbs”.
Claim 7 requires “another second bracket that are arranged on an inner side of the lower limb”; and “the first brackets respectively arranged on the outer side and the inner side of the lower limb are both fixed to the lower limb”. The limitations require the outer and inner sides of the lower limbs and the lower limbs which do not fall under the scope of patentable subject matter. This rejection may be overcome with language such as “another second bracket that are configured to be arranged on an inner side of the lower limb”; and “the first brackets configured to be respectively arranged on the outer side and the inner side of the lower limb are both configured to be fixed to the lower limb”.
Claim 9 requires “a ring shape surrounding the user's leg.” The limitation requires the user’s leg which does not fall under the scope of patentable subject matter. This rejection may be overcome with language such as “a ring shape configured to surround the user's leg.”
Claims 4-5, 8 and 10 are rejected for depending from and not curing the deficiencies of a rejected claim.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0401245 (Johnson et al.).
Regarding claim 1, Johnson discloses an assist device for a knee joint (Johnson discloses an adjustable knee ankle foot orthosis for unloading weight from a knee joint afflicted with osteoarthritis. Johnson discloses multiple embodiments throughout their application and states that [0475], “Although various features of the invention may be described in the context of a single embodiment, the features may also be provided separately or in any suitable combination. Conversely, although the invention may be described herein in the context of separate embodiments for clarity, the invention may also be implemented in a single embodiment.” A single embodiment comprising the HKAFO 80 as shown in Fig. 8 with the lower portion 84 being the KAFO 11 as shown in Fig. 1 and the geared pivoting hinge assembly 5 being the variable radius polycentric distracting hinge apparatus 45 as shown in Fig. 4 is being interpreted as an assist device for a knee joint. Even though Johnson does not disclose this combination in a single embodiment, [0475] provides support for a singular embodiment to comprise this combination. The rejection will be based upon this combination.), the assist device comprising:
at least one knee joint auxiliary mechanism arranged at least on a side of a lower limb of a user (The KAFO 11 is interpreted as a knee joint auxiliary mechanism and is configured to be arranged at least on a side of a lower limb of a user.),
wherein the knee joint assist mechanism includes: a first bracket, one end of the first bracket being connected to a waist fixation mechanism and fixed to the lower limb through a waist fixation belt of the waist fixation mechanism (The KAFO 11 comprises an upper frame 1 and the hip orthosis components 81-83 comprise a waist fixation mechanism with belt 81 being indirectly connected to the upper frame 1. See [0154].);
a first spacing adjustment member connected to another end of the first bracket corresponding to a position of a knee joint of the lower limb (The distracting hinge 45 comprises a first gear face disposed on the lower end of the upper arm which is interpreted as a first spacing adjustment mechanism. See [0135]. The first gear face is configured to correspond to a position of a knee joint of the lower limb.);
a second spacing adjustment member movably engaged with the first spacing adjustment member (The distracting hinge 45 comprises a second gear face disposed on the upper end of the lower arm which is interpreted as a second spacing adjustment mechanism. See [0135].); and
a second bracket, one end of the second bracket being connected to the second spacing adjustment member at a position corresponding to the knee joint (The second gear face is disposed on the upper end of the lower arm.), and
one other end of the second bracket contacting a ground (The lower end of the lower arm is configured to contact a ground. Contacting a ground is an intended use recitation.);
wherein one of the first spacing adjustment member and the second spacing adjustment member is provided with a plurality of base coupling structures and one or more support coupling structures having sizes that are larger than sizes of the plurality of base coupling structures (The first and second gear faces comprises a plurality of teeth. The size of the teeth are being interpreted as their radius from the respective pivot points 43, 44. Therefore, the teeth corresponding with the radius r2 shown in Fig. 4 are interpreted as one or more support coupling structures while the teeth corresponding with the radius r1 are interpreted as a plurality of base coupling structures. radius r2 has a larger size than radius r2.);
wherein, when the knee joint is in a bent state, the one of the first spacing adjustment member the second distance adjusting member is engaged with an other one of the first spacing adjustment member and the second spacing adjustment member by the basic coupling structures, and a first relative distance is formed between the first distance adjusting member and the second distance adjusting member (The first and second gear faces engage one another and in a flexed position, which correspond to when the knee joint is in a bent state, the teeth corresponding with the radius r1 are engaged forming a first relative distance. The first relative distance is the radius r1.);
wherein, when the knee joint is in an extended state, the one of the first spacing adjustment member and the second spacing adjustment member is engaged with the other one of the first spacing adjustment member and the second spacing adjustment member by the one or more support coupling structures, and a second relative distance is formed between the first spacing adjustment member and the second spacing adjustment member, with the second relative distance being greater than the first relative distance (The first and second gear faces engage one another and in an extended position, which correspond to when the knee joint is in an extended state, the teeth corresponding with the radius r2 are engaged forming a second relative distance greater than the first. The second relative distance is the radius r2.).
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Johnson does not directly disclose the first spacing adjustment member pivotally connected to the other end of the first bracket and the one end of the second bracket being pivotally being connected to the second spacing adjustment member.
However, Johnson does disclose in [0037], “all or part of the brace frame may be constructed as a flexible series of subunits or “building blocks” that may functionally attach to other components and can pivot or flex relative to the adjacent subunits.” Additionally, It would have been an obvious matter of design choice to pivotally connect the gears to the upper and lower arms, since such a modification would have involved making a component adjustable. The court has held that adjustability, where needed, is not a patentable advance, and because there is an art-recognized need for adjustment a substitution of a component for an adjustable component is obvious. In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the gears to pivotally connect to the upper and lower arms of Johnson. As a result, Johnson teaches the first spacing adjustment member pivotally connected to the other end of the first bracket (The first gear is pivotally connected to the lower end of the upper arm.); and
the one end of the second bracket being pivotally being connected to the second spacing adjustment member (The second gear is pivotally connected to the upper end of the lower arm.). A skilled artisan would have been motivated to do so because Johnson teaches that components of the brace frame can pivot relative to adjacent components. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to knee orthotics.
Regarding claim 2, Johnson discloses the assist device according to claim 1, wherein the waist fixation mechanism further includes a hip support having one end connected to the waist fixation belt and supporting a hip; wherein the waist fixation belt is sleeved onto a lower side of the user's anterior superior iliac spine; wherein the hip support is a plate-shaped structure corresponding to a shape of the hip, and one end of the hip support is detachably connected to the waist fixation belt through a hip support fixing member (The vertical support 82 is interpreted as a hip support and has one end connected to the belt 81. The belt 81 is capable of being sleeved onto a lower side of the user's anterior superior iliac spine. The vertical support 82 is plate-shaped and corresponds to the shape of the hip. See [0154]. Additionally, Johnson claims in claim 27 “at least two attachable or permanently affixed connection mechanisms connecting the hip orthosis component to the knee orthosis component” and discloses in [0478] ““Attachable” as used herein can mean releasably attachable, such as a component that can be attached and then detached”.).
Regarding claim 3, Johnson discloses the assist device according to claim 1, wherein the waist fixing mechanism is worn on the lower limb and pants-shaped, and the waist fixation mechanism includes the waist fixation belt sleeved onto the waist; wherein, the first bracket of the at least one knee joint auxiliary mechanism is fixed to the lower limb through the waist fixation mechanism (The hip orthosis components 81-83 are worn on the lower limb and are pants-shaped. The belt 81 is sleeved onto the waist and the upper arm is fixed to the lower limb through the hip orthosis components 81-83.).
Johnson does not directly disclose two thigh fixation belts respectively sleeved onto two upper thighs, and two thigh lifting belts connected between the waist fixation belt and the two thigh fixation belts.
However, it would have been an obvious matter of design choice to apply a second knee ankle orthotic onto the other leg of the user such that the entire device is symmetrical, since such a modification would have involved a mere duplication of a component. A duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to duplicate the hip orthosis components 82-83, KAFO 11 and hinge 45 to the other side of the belt 81 of Johnson. As a result, Johnson discloses two thigh fixation belts respectively sleeved onto two upper thighs, and two thigh lifting belts connected between the waist fixation belt and the two thigh fixation belts (The proximal supports 30, which is duplicated to both legs of the wearer along with KAFO 11, are interpreted as two thigh fixation belts. Additionally, the vertical supports 82, which is duplicated to both legs of the wearer, are interpreted as two thigh lifting belts connected between the waist fixation belt and the two thigh fixation belts.). A skilled artisan would have been motivated to do so because such as modification merely involves duplicating components of Johnson such that both legs of a user may be supported. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to HKAFOs.
Regarding claim 4, Johnson discloses the assist device according to claim 1, wherein a difference between the second relative distance and the first relative distance is caused to gradually increases by one or more intermediate coupling structures between the base coupling structures and the one or more support coupling structures, with heights of the one or more intermediate coupling structures gradually increase from a direction from the base coupling structures to the one or more support coupling structures (The teeth between the teeth corresponding to the radii r1 and r2 are interpreted as intermediate coupling structures. The middle teeth gradually increase the relative distance, and therefore the tooth height, of the pivot points such that the relative distance gradually increases from r1 to r2.).
Regarding claim 5, Johnson discloses the assist device according to claim 4, wherein a maximum value of the difference between the second relative distance and the first relative distance is configured to be corresponding to a maximum pain point of the user (The maximum value between the radius r1 and the radius r2 is capable of corresponding to a maximum pain point of the user as that value is entirely dependent on the user.).
Regarding claim 6, Johnson discloses the assist device according to claim 5.
Johnson does not directly disclose two of the knee joint auxiliary mechanism, and each of the two knee joint assist mechanisms includes the first bracket, the first spacing adjustment member, the second spacing adjustment member and the second bracket that are arranged on an outer side of the lower limb, and each of the first bracket arranged on the outer side of the lower limb is fixed to the lower limb through the waist fixation mechanism.
However, it would have been an obvious matter of design choice to apply a second knee ankle orthotic onto the other leg of the user such that the entire device is symmetrical, since such a modification would have involved a mere duplication of a component. A duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to duplicate the hip orthosis components 82-83, KAFO 11 and hinge 45 to the other side of the belt 81 of Johnson. As a result, Johnson discloses two of the knee joint auxiliary mechanism, and each of the two knee joint assist mechanisms includes the first bracket, the first spacing adjustment member, the second spacing adjustment member and the second bracket that are arranged on an outer side of the lower limb, and each of the first bracket arranged on the outer side of the lower limb is fixed to the lower limb through the waist fixation mechanism (By duplicating the device such that it is symmetrical, there are two knee joint assist mechanisms with all of the same components. Fig. 8 shows that the device is configured to be worn on an outer side of the lower limb.). A skilled artisan would have been motivated to do so because such as modification merely involves duplicating components of Johnson such that both legs of a user may be supported. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to HKAFOs.
Regarding claim 7, Johnson discloses the assist device according to claim 6, wherein each of the two knee joint assist mechanisms includes another first bracket, another first spacing adjustment member, another second spacing adjustment member, and another second bracket that are arranged on an inner side of the lower limb, and the first brackets respectively arranged on the outer side and the inner side of the lower limb are both fixed to the lower limb through the waist fixation mechanism (By duplicating the device such that it is symmetrical, there are two knee joint assist mechanisms with all of the same components. Fig. 8 shows that the device is configured to be worn on an outer and inner side of the lower limb. Both the inner and outer sides of KAFO 11 comprises an upper arm, first gear, second gear and a lower arm as shown in Fig. 1.).
Regarding claim 8, Johnson discloses the assist device according to claim 5, wherein the first spacing adjustment member is a ratchet, and the second spacing adjustment member is a ratchet or a ratchet base; wherein the plurality of base coupling structures and the one or more support coupling structures of the first spacing adjustment member are ratchet teeth, and the second spacing adjustment member are provided with ratchet teeth or tooth grooves corresponding to the plurality of base coupling structures and the one or more support coupling structures of the first spacing adjustment member (Both the first gear and the second gear comprise ratchet teeth that engage one another and correspond to the plurality of base coupling structures and the one or more support coupling structures. The first and second gears are interpreted as being ratchets.).
Regarding claim 9, Johnson discloses the assist device according to claim 5, wherein the knee joint auxiliary mechanism includes at least one leg fixation member in a ring shape surrounding the user's leg (In [0126], Johnson discloses that a strapping system is incorporated into the brace frame despite not being shown. Additionally, there are multiple attachment points including a slot disposed on the proximal support 30 for a strap to attach to. A strap with proximal support 30 is interpreted as a leg fixation member which would have a ring shape when surrounding a user’s leg.).
Regarding claim 10, Johnson discloses the assist device according to claim 5, wherein the knee joint assist mechanism includes at least one foot fixation member, which is arranged at the other end of the second bracket and is detachably connected to the second bracket and a side surface of the user's shoe to fix the other end of the second bracket to the user's foot (As shown in Fig. 1 the lower arm includes a foot fixation member, the ankle-foot portion of the KAFO, AFO 8. The AFO is detachably connected to the lower end of the lower arm and connects to a side surface of a user’s shoe when worn with shoes. See [0159].).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786