DETAILED ACTION
This is a Non-Final Rejection for Application 19/003,564 filed December 27, 2024. This application is a continuation under 35 U.S.C. §111(a) of the U.S. Application No. 16/621,501, filed December 11, 2019, which, pursuant to 35 U.S.C. §371, is the national phase application of PCT International Application No.: PCT/US2018/037397, filed June 13, 2018, designating the United States and published in English, which claims the benefit of and priority to U.S. Provisional Application No. 62/519,079 filed June 13, 2017. Claims 30-50 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
Claim 35 is objected to because of the following informalities: the recitation “at least one of an adjustable dial, a ratchet” in line 3 lacks proper grammar and should be corrected to language such as “at least one of an adjustable dial and a ratchet”. Appropriate correction is required.
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.
Claim 50 is 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 50 recites the limitation "the tension adjustment system" in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a tension adjustment system prior to this limitation so it is unclear what the limitation is further limiting. For the purposes of examination, the tension adjusting system will be interpreted as referring to the one or more tensile elements.
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.
Claim 46 is 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). Claim 46 recites the limitation “one or more remote joint anchors positioned remote from the one or more target joints” in lines 1-2. This limitation recites the one or more target joints as a necessary structure in the apparatus thereby encompassing subject matter that is excluded from the scope of patentable subject matter under 35 U.S.C. 101. This rejection may be overcome with language such as “one or more remote joint anchors configured to be positioned remote from the one or more target joints”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 30-41 and 44-50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0276308 (DiAngelo et al.).
Regarding claim 30, DiAngelo discloses a soft brace (DiAngelo discloses a back support device comprising upper 101 and lower 102 support components which together form the basis of the back support device. See [0059] and Fig. 1.), comprising:
one or more tensile elements configured to limit motion, or adjust alignment, of one or more target joints in a spine of a patient (DiAngelo further discloses the use of tensioning bands 304 to adjust load sharing characteristics of the device. See [0099] and Figs. 7A-7B. There are one or more tensioning bands 304 and they are capable of adjusting the alignment of one or more target joints in a spine of a patient since the bands 304 adjust the forces applied to the device and therefore, the patient.),
wherein a placement of the one or more tensile elements relative to the one or more target joints and a tension of each of the one or more tensile elements provides resistance against motion, or adjust the alignment, of the one or more target joints (The bands 304 are capable of adjusting the alignment of one or more target joints in a spine of a patient since the bands 304 adjust the forces applied to the device and therefore, the patient.);
one or more soft tissue anchors configured to be positioned on a body around the one or more target joints, the one or more anchors being configured to anchor one or more of the one or more tensile elements to the body to provide force distribution relative to the one or more target joints (Upper support component 101 is interpreted as a soft tissue anchor. The support 101 is configured to be positioned on a body around the one or more target joints and is configured to anchor one or more of the bands 304 to the body to provide force distribution relative to the one or more target joints. See Fig. 7A.); and
one or more sensors configured to measure activity of the one or more target joints to provide feedback regarding usage of the soft brace and at least one of a load and a motion of the one or more target joints (DiAngelo further discloses using sensors to adjust the tensioning means 306 which determines the tension of the bands 304. The sensors are bend sensors, stretch sensors, load cells, tension sensors, tensioning and/or stabilizing pulleys in the band path for reporting the posture of the patient and therefore, the target joints. See [0118] and [0216]-[0218].).
Regarding claim 31, DiAngelo discloses the soft brace of claim 30, wherein the one or more tensile elements have a length at rest and a length in motion such that the one or more tensile elements provide tension during motion (The bands 304 inherently have a length at rest and a length in motion since the bands 304 have a length as shown in Fig. 1. Since the bands 304 provide a tension force, they are configured to provide tension during motion.).
Regarding claim 32, DiAngelo discloses the soft brace of claim 30, further comprising an adjustment mechanism configured to customize an amount of resistance against motion, or adjust the alignment, imposed on the one or more target joints (Tensioning means 306 is an adjustment mechanism that is configured to customize an amount of resistance imposed on the bands 304 which are therefore imposed on the one or more target joints.).
Regarding claim 33, DiAngelo discloses the soft brace of claim 32, wherein the adjustment mechanism customizes the amount of resistance manually such that a length of the one or more tensile elements is configured to be adjusted to customize the amount or resistance against motion, or the alignment (Tensioning means 306 is capable of customizing the amount of resistance manually such that a length of the bands 304 is configured to be adjusted to customize the amount or resistance against motion, or the alignment.).
Regarding claim 34, DiAngelo discloses the soft brace of claim 32, wherein the adjustment mechanism is configured to receive measured activity data from the at least one sensor to adjust the amount of resistance, automatically, using at least one of motors and actuators such that a length of the one or more tensile elements is configured to be adjusted to customize the amount of resistance against motion, or the alignment (The tensioning means 306 may employ powered and automatically adjusted dials, e.g., responsive to sensors. See [0118]. Tensioning means 306 is capable of customizing the amount of resistance such that a length of the bands 304 is configured to be adjusted to customize the amount or resistance against motion, or the alignment.).
Regarding claim 35, DiAngelo discloses the soft brace of claim 32, wherein a tension level of the one or more tensile elements is gradually and continuously controlled using a mechanical system including at least one of an adjustable dial, a ratchet (The tensioning means 306 may employ powered and automatically adjusted dials, e.g., responsive to sensors. See [0118].).
Regarding claim 36, DiAngelo discloses the soft brace of claim 32, wherein a tension level in at least one of the one or more tensile elements is adjusted to provide a predefined resistance against a motion, or the alignment, of the target joint (The bands 304 are capable of adjusting the alignment of one or more target joints in a spine of a patient since the bands 304 adjust the forces applied to the device thereby resisting motion.).
Regarding claim 37, DiAngelo discloses the soft brace of claim 30, further comprising a guiding system configured to route the one or more tensile elements across the brace to maintain an orientation of the one or more tensile elements during a range of motion, or the alignment, of the one or more target joints (DiAngelo further discloses pulley wheels 303 that act as a guiding system to route the bands 304 across the brace to maintain an orientation of the bands 304 during a range of motion, or the alignment, of the one or more target joints. See [0121] and Fig. 7A.).
Regarding claim 38, DiAngelo discloses the soft brace of claim 37, wherein the guiding system is configured to route at least one of the one or more tensile elements through an approximate center of rotation of at least one of the one or more target joints (The pulley wheels 303 route the bands 304 through an approximate center of rotation of the target joints. The center of rotation is interpreted as the transverse axis of the spine, which the bands are approximate to. See Figs. 7A-7B and 10A-10D.).
Regarding claim 39, DiAngelo discloses the soft brace of claim 30, wherein the brace is configured to provide dynamic joint protection such that the brace is configured to protect the one or more target joints during excessive movement without affecting the motion of the one or more target joints during normal movement (The back support device may be configured to provide dynamic joint protection such that the brace is configured to protect the one or more target joints during excessive movement without affecting the motion of the one or more target joints during normal movement through the use of the body guides 202. See [0089]. The body guides 202 allow the rod 204, 205 to move relatively free vertically and laterally within the confines of the body guides 202. See [0121].).
Regarding claim 40, DiAngelo discloses the soft brace of claim 30, wherein the brace is configured to provide targeted joint protection such that the brace is configured to protect against an excessive range of motion in one or more degrees of freedom (The back support device may be configured to provide targeted joint protection such that the brace is configured to protect the one or more target joints during excessive movement in at least one degree of freedom through the use of the body guides 202. See [0089]. The body guides 202 allow the rod 204, 205 to move relatively free vertically and laterally within the confines of the body guides 202. See [0121].).
Regarding claim 41, DiAngelo discloses the soft brace of claim 30, wherein at least a portion of the one or more soft tissue anchors include semi-rigid non-textile components (The support component 101 is fabricated from a material that has elasticity, or is compliant, and that can be adjusted to fit snugly around the user. See [0060]. DiAngelo discloses that a suitable material to include is Shore-A 80 polyurethane rubber, which is semi-rigid and non-textile. See [0069].).
Regarding claim 44, DiAngelo discloses the soft brace of claim 30, further comprising one or more sensors to provide feedback on the tension of the one or more tensile elements (DiAngelo further discloses using sensors to adjust the tensioning means 306 which determines the tension of the bands 304. The sensors are bend sensors, stretch sensors, load cells, tension sensors, tensioning and/or stabilizing pulleys in the band path for reporting the posture of the patient and therefore, the target joints. See [0118] and [0216]-[0218].).
Regarding claim 45, DiAngelo discloses the soft brace of claim 30, further comprising, one or more motors configured to control tension in the one or more tensile elements based on feedback information from the one or more sensors (The tensioning means 306 may employ powered and automatically adjusted dials, e.g., responsive to sensors. See [0118] and [0233]. The dials are motorized.).
Regarding claim 46, DiAngelo discloses the soft brace of claim 30, further comprising one or more remote joint anchors positioned remote from the one or more target joints, the one or more remote joint anchors configured to couple one or more of the one or more tensile elements to a remote joint to provide force distribution relative to the one or more target joints (Lower support component 102 is remote from the spine and is configured to couple the bands 304 to a remote joint to provide force distribution relative to the spine, namely the hip.).
Regarding claim 47, DiAngelo discloses the soft brace of claim 30, wherein the one or more tensile elements are configured to extend from around a torso from a position on the front of the torso to a position on the back of the torso such that the one or more tensile elements are configured to provide resistance against at least one of thoracic spine motion and lumbar spine motion (As shown in Fig. 10C, the bands 304 are configured to extend from a position on the front of the torso to the back of the torso such that the bands 304 are configured to provide resistance against lumbar and thoracic spine movement.).
Regarding claim 48, DiAngelo discloses the soft brace of claim 30, wherein the soft brace is configured to prevent lateral bending and stabilization of the thoracic spine or the lumbar spine (The back support device of DiAngelo is configured to prevent lateral bending and stabilization of the thoracic spine and the lumbar spine because of the medial elements which restrict excessive movement of the spine in the lateral direction.).
Regarding claim 49, DiAngelo discloses the soft brace of claim 30, wherein the soft brace is configured to avoid interrupting with rib cage expansion during breathing (The back support device is configured to avoid interrupting with rib cage expansion during breathing. See [0018] and [0068].).
Regarding claim 50, DiAngelo discloses the soft brace of claim 30, further comprising a guiding system configured to adjust the location of the tension adjustment system for proper control of motion, or alignment, of the one or more target joints (DiAngelo further discloses pulley wheels 303 that act as a guiding system to route the bands 304 across the brace to maintain an orientation of the bands 304 during a range of motion, or the alignment, of the one or more target joints. See [0121] and Fig. 7A.).
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.
Claim(s) 42 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0276308 (DiAngelo et al.) in view of US 2013/0012853 (Brown).
Regarding claim 42, DiAngelo discloses the soft brace of claim 30.
DiAngelo does not disclose the soft brace being disposed upon a garment formed of a breathable mesh or a mesh spacer.
However, DiAngelo discloses that the device is configured to be worn by a user under normal clothing. See [0058]. Additionally, Brown discloses a spine band disposed upon a garment, which comprises a panel made of mesh. See [0144] of Brown.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the back support device of DiAngelo to be disposed under a garment made of mesh as taught by Brown. This results in DiAngelo in view of Brown teaching that it is obvious for the soft brace to be disposed upon a garment formed of a breathable mesh or a mesh spacer (DiAngelo provides support for placement under a garment and Brown provides support for a garment in the analogous art that comprises a mesh material.). A skilled artisan would have been motivated to do so because one of ordinary skill in the art would recognize that mesh material used in garments allow for better air flow and increased flexibility due to the openings. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to back supports with garments.
Regarding claim 43, DiAngelo in view of Brown discloses the soft brace of claim 42.
DiAngelo in view of Brown as previously modified does not disclose wherein the garment includes at least a waistband portion and a pad configured to conform to a torso of the patient.
However, Brown further discloses that the garment 10 comprises a belt 34 and one or more pads 82. See [0088] and Fig. 3 and [0130] and Fig. 8.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add a waistband portion and a pad to the garment of DiAngelo as taught by Brown. This results in DiAngelo in view of Brown teaching that it is obvious for the garment to include at least a waistband portion and a pad configured to conform to a torso of the patient (DiAngelo provides support for a garment and Brown provides support for a waistband portion and a pad, which is configured to conform to a torso of the patient.). A skilled artisan would have been motivated to do so because one of ordinary skill in the art would recognize that a waistband would help secure the garment to the user and prevent the garment catching on the back support of DiAngelo and Brown teaches that the pads stimulate the wearer's proprioception ([0017]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to back supports with garments.
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