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 .
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: control unit in claims 2-8.
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.
For control unit, applicant discloses Fig. 3, ¶¶[0056-0057], ¶[0061]
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 § 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.
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) 1, 9-15, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tong et al. (U.S. Patent Application Publication No. 2007/0179560) hereinafter referred to as Tong; in view of Crosson et al. (U.S. Patent Application Publication No. 2025/0065114) hereinafter referred to as Crosson.
Regarding claim 1, Tong teaches a wearable device (Fig. 3-6), comprising:
a flexible (¶[0019] joints 10, 11 allow flexibility, Fig. 3-6) garment (Fig. 3-6, orthosis 100) configured to fit around at least a portion of a subject’s hand (Fig. 3-6, ¶[0019] hand-wrist orthosis);
a first stimulation pad (¶[0020] electrodes 1-6 self-adhesive electrodes) having an electrode and attached to a first location of the flexible garment (¶[0020] Thenar electrode 5, Fig. 3-6); and
a second stimulation pad (¶[0020] electrodes 1-6 self-adhesive electrodes) having an electrode and attached to a second location of the flexible garment (Fig. 3-6, electrodes elements 1-6)
wherein, when the flexible garment is positioned on the subject’s hand, the first location of the flexible garment is adjacent the thenar eminence of the subject’s hand (¶[0020] Thenar electrode, Fig. 3-6), and wherein the first stimulation pad is configured to deliver electrical stimulus to muscle tissue of the thenar eminence (¶[0020] for stimulating the Thenar muscle group).
Tong teaches the flexible garment that positions electrodes in desired locations on a subject when the garment is worn, in order to deliver electrical stimulation to the desired locations, but does not teach that the hypothenar eminence is one such desired location.
Attention is drawn to the Crosson reference, which teaches transcutaneous electrical stimulation of regions of a subject’s hand and wrist (¶[0108], Fig. 14B), including a first location, and a second location that is adjacent the hypothenar eminence of the subject’s hand (¶[0108] hypothenar region of the palm), and wherein the second stimulation pad is configured to deliver electrical stimulus to muscle tissue of the hypothenar eminence (¶[0108] hypothenar region of the palm).
It would have been obvious to one of ordinary skill in the art to modify the electrode placement of Tong to include an additional electrode region targeting the hypothenar eminence of the hand, as taught by Crosson, because Crosson teaches creating and activating electrode subsets usefully treats different kinds and locations of injuries or conditions on an affected limb (Crosson ¶[0108]).
Regarding claim 9, Tong as modified teaches the device of claim 1.
Tong further teaches wherein the first stimulation pad comprises a body having one or more curved surfaces configured to nest on a portion of the subject’s hand (Fig. 3-6, curvature clearly visible in Fig. 6 for receiving user’s hand and arm).
Regarding claim 10, Tong as modified teaches the device of claim 9.
Tong further teaches wherein the second stimulation pad comprises a body having one or more curved surfaces configured to surround a portion of the subject’s hand (Fig. 3-6, electrodes 1-6 are on the inner surface of the orthosis, therefore corresponding to curves of orthosis).
Regarding claim 11, Tong as modified teaches the device of claim 10.
Tong further teaches wherein the flexible garment comprises a cut-out region for the thumb of the subject’s hand (Fig. 3-6, opening for the thumb visible).
Regarding claim 12, Tong as modified teaches the device of claim 1.
Tong teaches further comprising a third stimulation pad having an electrode and attached to a third location of the flexible garment, wherein a portion of the flexible garment covers a region of the subject’s arm, and the third location of the flexible garment is adjacent the forearm of the subject’s arm, and wherein the third stimulation pad is configured to deliver electrical stimulus to muscle tissue of the arm (Fig. 3-6, ¶[0020] wrist flexor/extensor muscle groups electrodes 1-4).
Regarding claim 13, Tong as modified teaches the device of claim 12.
Tong teaches further comprising a fourth stimulation pad having an electrode and attached to a fourth location of the flexible garment, wherein the fourth location of the flexible garment is adjacent the forearm of the subject’s arm, and wherein the fourth stimulation pad is configured to deliver electrical stimulus to muscle tissue of the arm (Fig. 3-6, ¶[0020] wrist flexor/extensor muscle groups electrodes 1-4)..
Regarding claim 14, Tong as modified teaches the device of claim 13.
Tong does not teach wherein the third location of the flexible garment is adjacent the medial forearm of the subject’s arm, and the fourth location of the flexible garment is adjacent the lateral forearm of the subject’s arm.
Attention is drawn to the Crosson reference, which teaches transcutaneous electrical stimulation of regions of a subject’s hand and wrist (¶[0108], Fig. 14B), including a third location of the flexible garment adjacent the medial forearm of the subject’s arm, and a fourth location of the flexible garment adjacent the lateral forearm of the subject’s arm (Fig. 14B, electrodes span a circumferential and longitudinal array over the entire forearm, including at least medial and lateral forearm locations).
It would have been obvious to one of ordinary skill in the art to modify the electrode placement of Tong to include an additional electrode region targeting the medial and lateral portions of a forearm, as taught by Crosson, because Crosson teaches creating and activating electrode subsets usefully treats different kinds and locations of injuries or conditions on an affected limb (Crosson ¶[0108]).
Regarding claim 15, Tong as modified teaches the device of claim 13.
Tong further teaches wherein the electrodes of the stimulation pads positioned in the first and third locations of the flexible garment deliver electrical stimulus in a pair, and the electrodes in the second and fourth locations of the flexible garment deliver electrical stimulus in a pair (each of the locations of Tong deliver stimulus in an electrode pair (¶[0021] active and indifferent poles, notable this is an interpretation under BRI as this claim does not specify that only two electrodes are active, or successfully define the pair as comprising a specific two electrodes, instead “the electrodes of the stimulation pads” at all of the four locations simply deliver stimulation in “a pair” broadly recited).
Regarding claims 17-18, Tong as modified teaches the device of claim 13.
Tong does not teach wherein the first location and second location on the flexible garment are separated by a distance ranging between 1 cm and 10 cm, or wherein the first location and third location on the flexible garment are separated by a distance ranging between 4 cm and 50 cm, and the third location and fourth location on the flexible garment are separated by a distance ranging between 1 cm and 15 cm.
However, Tong as modified does teach that the electrode/stimulation locations should be located on the relative anatomical structures claimed by applicant, including thenar and hypothenar palm locations, and medial and lateral forearm locations. Further Tong teaches that electrodes should be suitably located for each patient anatomy (Tong ¶[0020]). Therefore, Tong teaches the relative distances of a human hand, palm, and forearm and that PHOSITA would have a reasonable expectation of success in locating the electrode/stimulation locations within the ranges of human anatomical distances. The Examiner considers that the claimed distances in claims 17-18 are specifically targeting the range of human anatomical differences in locating the claimed anatomical structures/references. Therefore, Tong as modified would meet these ranges.
Nevertheless, as Tong teaches that the location of stimulation is results-effective and configurable on a per patient basis.
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to modify the electrode distances of Tong as modified to include between 1 and 10 cm between the thenar and hypothenar stimulation locations, between 4cm and 50 cm between the thenar and forearm locations, and between 1 cm and 15 cm between the medial and lateral forearm locations, because courts have held “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 233, 235 (CCPA 1955) and PHOSITA would have arrived at these claimed ranges by modifying stimulation locations to suit an individual patient’s anatomy.
Regarding claim 19, Tong as modified teaches the device of claim 18.
Tong further teaches wherein the electrodes of the stimulation pads are configured to deliver an electrical stimulus in the range 0-100 mA (Table 1, 0 to 100mA) at 0-50 V (Table 1, 0 to 5 Volts is within this claimed range).
Regarding claim 20, Tong as modified teaches the device of claim 19.
Tong further teaches wherein the electrodes of the stimulation pads are configured to deliver an electrical stimulus at a 40Hz frequency (Table 1, 40 Hz) with 250 µs pulse width (Table 1, 0-500 µs includes 250 µs; while the µ did not render in document 2007/0179560, parent document Patent No. 7,162,305 includes matching Table 1 with the µ rendered correctly).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tong and Crosson as applied to claim 1 above, and further in view of Andon et al. (U.S. Patent Application Publication No. 2020/0375269) hereinafter referred to as Andon.
Regarding claim 2, Tong as modified teaches the device of claim 1.
Tong as modified does not teach further comprising a tightening unit, the tightening unit comprising a control unit and a plurality of tightening lines, wherein the plurality of tightening lines are connected to the control unit and the flexible garment, and wherein the control unit is configured to adjust the tension on the plurality of tightening lines.
Attention is brought to the Andon reference, which teaches an arm sleeve (¶[0133]) with a tightening unit, the tightening unit comprising a control unit (¶[0134] adaptive adjustment engine and automatic adjustment) and a plurality of tightening lines (¶[0133] laces in a crisscross pattern between a series of lace guides and an adjustment zone), wherein the plurality of tightening lines are connected to the control unit and the flexible garment (¶[0133] laces in a crisscross pattern between a series of lace guides and an adjustment zone), and wherein the control unit is configured to adjust the tension on the plurality of tightening lines (¶[0134] adaptive adjustment engine and automatic adjustment, Figs. 12B-12E ¶[0136]).
While Andon does not teach electrical stimulation, the form and function of an adjustable sleeve device is considered reasonably pertinent to combine with the adjustable sleeve wearable device of Tong, as both inventions are fitted to a forearm of a user, and require the same considerations for anatomical fit and user comfort.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the forearm wearable of Tong as modified to include an automated tightening system, as taught by Andon, because adjustability improves long-term comfort and improvement in functionality during activities (Andon ¶[0007]).
Regarding claim 3, Tong as modified teaches the device of claim 2.
Andon teaches further comprising one or more pressure sensors attached to the flexible garment and configured to measure pressure on the skin of the subject, wherein the one or more sensors are communicatively connected to the control unit (¶[0144] pressure sensor provides information used to determine the compression applied by the adaptive sleeve).
Claim(s) 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tong, Crosson, and Andon as applied to claim 3 above, and further in view of Longinotti-Buitoni et al. (U.S. Patent Application Publication No. 2014/0070957) hereinafter referred to as Longinotti.
Regarding claim 4, Tong as modified teaches the device of claim 3.
Tong as modified does not teach wherein the control unit is voice-activated for adjusting the tension on the plurality of tightening lines and activating the electrodes of the stimulation pads.
As above, Andon teaches adjusting the tension on the plurality of tightening lines and activating the electrodes of the stimulation pads automatically via a control unit, but does not go so far as to teach voice-activation.
Attention is drawn to the Longinotti reference, which teaches a control unit of a wearable garment (¶[0174]) that is voice-activated (¶[0098] voice command).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable garment control of Tong as modified to include voice-activation, as taught by Longinotti, because it provides a hands-free option for users engaged in other activities (Longinotti, ¶[0238]).
Regarding claim 5, Tong as modified teaches the device of claim 4.
Andon further teaches wherein the control unit adjusts the tension on the plurality of tightening lines based on one or more pressure signals received from the one or more pressure sensors (¶[0144] pressure sensor provides information used to determine the compression applied by the adaptive sleeve, see also ¶[0270]).
Regarding claim 6, Tong as modified teaches the device of claim 5.
Andon further teaches wherein the tightening unit comprises a housing having a plurality of holes, wherein the plurality of tightening lines extend through the plurality of holes to connect to the control unit (Fig. 12B, element 1230 adaptive engine) positioned inside the housing (Fig. 12A-E, lace guides 1210 may comprise eyelets, tubes, or tunnels, ¶[0005]).
Regarding claim 7, Tong as modified teaches the device of claim 6.
Andon further teaches wherein the control unit comprises at least one motor connected to the plurality of tightening lines within the housing, wherein the at least one motor is configured to rotate to adjust the tension on the plurality of tightening lines (Fig. 12B, Fig. 9A-F, ¶[0113], ¶[0117] elements of the motor are described with reference to Fig. 9B, motorized adaptive lacing engine, in ¶[0118] laces are loaded to a spool).
Regarding claim 8, Tong as modified teaches the device of claim 7.
Andon further teaches wherein the tightening unit and the plurality of tightening lines are removably connected to the flexible garment (¶[0088], ¶[0123] easily removed for cleaning of the garment).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tong and Crosson as applied to claim 1 above, and further in view of Goroszeniuk (U.S. Patent Application Publication No. 2009/0048642) hereinafter referred to as Goroszeniuk.
Regarding claim 16, Tong as modified teaches the device of claim 13.
Tong does not teach wherein the third and fourth stimulation pads each comprise a body having a convex surface.
Attention is drawn to the Goroszeniuk reference, which teaches transcutaneous neurostimulation, comprising stimulation pads with a convex surface (Fir. 3A-C, the electrodes comprise a protruding convex surface).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation pads of Tong as modified to include a convex surface, as taught by Goroszeniuk, because the curved surface allows for effective pressure and lower skin resistance to eliminate a burning risk, and distributes current evenly (Goroszeniuk ¶[0016]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. Patent Application Publication No. 2012/0245483 to Lundqvist teaches round, soft, dry, convex electrodes in a garment and configuring the size of the electrode to the muscle to be stimulated for patient comfort.
U.S. Patent Application Publication No. 2008/0208287 to Palermo et al. teaches transcutaneous neurostimulation of the palm of a hand, and forearm.
U.S. Patent Application Publication No. 2019/0038236 to Hays et al. teaches voice command integration with medical devices for beneficially being hands-free
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA L STEINBERG/Examiner, Art Unit 3792
