DETAILED ACTION
This Office action is based on the amendments filed September 18, 2025 for application 18/411,611. Claims 1-10, as amended, 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 . 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.
Response to Amendments and Arguments
Applicant’s amendments to claims 1, 2, and 8-10 to include the limitation that the tape is “substantially inelastic” overcomes the rejection over Lin since the tape taught by Lin has a transverse texture made to have highly extensible and elastic stretchability. However, upon further consideration, a new ground(s) of rejection is made in view of Hicken et al. (US 2015/0217098).
With respect to claims 3-7, Applicant’s arguments that Lin only teaches disposing the tape over joints and not over a muscle belly are not persuasive since these are limitations that are related to the intended use of the claimed device (i.e., functional language that recites a feature by what it does rather than by what it is). Intended use limitations must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the medical adhesive tape taught by Lin is capable being applied to skin in the manner recited in the claims thereby capable of providing the same effects on the muscle. Since claims 3-7 do not require the tape to be substantially inelastic, the rejection over Lin is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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.
Claims 1-10 appear to be directed to structure of an apparatus but are also replete with process limitations of using the apparatus in a way as to raise question as to whether the claims are directed to the apparatus or a process, thus it is unclear which invention Applicant is intending to cover. Ex parte Lyell, 17 USPQ2d 1548 (BPAI 1990). See MPEP 2173.05(p). An individual claim should recite either an apparatus or a process. Therefore, for examination purposes, claims 1-10 have been examined to be directed to only the structure of the device, which must only be capable of the performing the functional limitations as a matter of intended use.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hicken et al. (US 2015/0217098).
Regarding claim 1, Hicken discloses a taping structure (tape) capable of controlling tone in a skeletal muscle without penetrating skin, the skeletal muscle inherently including a lateral surface and a medial surface, a proximal myotendinous junction and a distal myotendinous junction, Golgi tendon organs, Ruffini’s endings, interstitial type III and IV muscle receptors, and muscle spindle fibers, the taping structure comprising:
an elongated medical adhesive tape capable of being applied to the skin (¶ 0026: “The therapeutic elastic tape may adhere to or be attached to the user”) over muscle belly between, and avoiding, the proximal and distal myotendinous junctions thereby activating proprioceptors and mechanoreceptor structures in the muscle to immobilize the nuclear bar and nuclear change fibers to inhibit transmission of sensory information to the central nervous system and inhibit firing of a motor neuron to stop the extrafusal muscle fibers from contracting, thereby limiting muscle tone and muscle contraction;
wherein the tape is substantially inelastic (¶ 0027: “the medicated tape may also be configured in non-stretch embodiments”) and capable of being applied parallel to activated muscle spindle fibers and disposed near but not touching the skin, the tape is capable of extending over at least a portion of the muscle belly without reaching either myotendinous junction.
The limitations regarding the intended application of the tape and the resulting effects are recitations of the intended use of the claimed invention which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the tape taught by Hicken is capable being applied to skin the manner recited thereby providing the same effects on the muscle.
Regarding claim 2, Hicken discloses that the tape is configured to be applied in a predetermined pattern to an area of a muscle or muscle group and in additional layers of tape in the predetermined pattern (¶ 0052 & 0082).
Regarding claim 8, Hicken discloses an apparatus (tape) capable of controlling tone in a skeletal muscle, the skeletal muscle inherently including lateral and a medial surfaces, each lateral and medial surface having proximal and distal segments, the skeletal muscle further inherently including proximal and distal myotendinous regions, the apparatus comprising:
a web of tape section capable of joining the original origin of the muscle to enclose at least a portion of the muscle, the web of tape section being substantially inelastic (¶ 0027: “the medicated tape may also be configured in non-stretch embodiments”) and further comprising:
at least a first piece of adhesive tape (a first segment) capable of being applied to skin covering the origin in series along at least one of the myotendinous regions (¶ 0052 & 0082); and
at least a second piece of adhesive tape (a second segment) capable of being applied to skin covering an edge of at least a portion of one of the lateral and medial surfaces, thereby activating proprioceptors and mechanoreceptor in the muscle, wherein the at least a second piece of adhesive tape is configured to be applied to the skin at a new point of insertion (¶ 0052 & 0082).
The limitations regarding the intended application of the tape and the resulting effects are recitations of the intended use of the claimed invention which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the tape taught by Hicken is capable being applied to skin the manner recited thereby providing the same effects on the muscle.
Regarding claim 9, Hicken discloses an apparatus (tape) capable of controlling tone in a skeletal muscle, the apparatus:
(a) comprising a tape structure of a shape and size configured to be applied to outline an original muscle within the muscle, wherein the tape structure is substantially inelastic (¶ 0027: “the medicated tape may also be configured in non-stretch embodiments”) and further comprises:
(A) at least a first piece of adhesive tape (a first segment) capable of being applied proximally to skin and of a size and shape that can extend laterally from a starting point to an end point (¶ 0052 & 0082);
(B) at least a second piece of adhesive tape (a second segment) capable of being applied medially to skin and a length that extends from the starting point to the end point (¶ 0052 & 0082); and
(C) at least a third piece of adhesive tape (a second segment) capable of being applied to define a new smaller version of the muscle itself located within the muscle (¶ 0052 & 0082).
The limitations regarding the intended application of the tape and the resulting effects are recitations of the intended use of the claimed invention which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the tape taught by Hicken is capable being applied to skin the manner recited thereby providing the same effects on the muscle.
Regarding claim 10, Hicken discloses a means (tape) capable of increasing tension in at least a portion of a skeletal muscle, the means comprising:
tape capable of being applied proximally to skin covering a new point of origin to create a new point of origin, wherein the tape capable of being applied proximally is substantially inelastic (¶ 0027: “the medicated tape may also be configured in non-stretch embodiments”) and further comprises:
at least a first piece of adhesive tape (a first segment) capable of being applied laterally originating at skin covering the new point of origin and extending towards a new point of insertion and ending at skin covering the new point of insertion (¶ 0052 & 0082); and
at least a second piece of adhesive tape (a second segment) capable of being applied to define the new point of insertion from skin covering the new point of insertion and extending from lateral to medial to skin covering the new point of origin (¶ 0052 & 0082).
The limitations regarding the intended application of the tape and the resulting effects are recitations of the intended use of the claimed invention which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the tape taught by Hicken is capable being applied to skin the manner recited thereby providing the same effects on the muscle.
Claims 3-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (US 2009/0182256).
Regarding claim 3, Lin discloses a taping structure (medical adhesive tape) configured to be applied to a joint thereby capable of controlling tone in associated skeletal muscles, the joint inherently including at least one tendon and associated skeletal muscles inherently including at least one agonist muscle and at least one antagonist muscle, each inherently including a distal surface and a proximal surface, a distal myotendinous junction and a proximal myotendinous junction, and the joint and associated skeletal muscles inherently having Golgi tendon organs, nuclear bag and nuclear chain fivers, and muscle spindle fibers, the taping structure comprising:
a fist piece of dynamic medical tape having a size and shape that permits the tape to be applied in tension to a skin surface of the at least one agonist muscle without penetrating the skin, while avoiding muscle bellies, and configured to extend across the joint in parallel to at least one tension to thereby place the Golgi tendon organs in tension, resulting in eliciting increased muscle tone in the agonist muscle (Figs. 1, 6-8, 10-12, & 14-21; ¶ 0002 & 0035).
The limitations regarding the intended application of the tape and the resulting effects are recitations of the intended use of the claimed invention which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the medical adhesive tape taught by Lin is capable being applied to skin in the manner recited thereby providing the same effects on the muscle.
Regarding claim 4, the first piece of dynamic adhesive medical tape of the taping structure taught by Lin is capable of lengthening the antagonist muscle spindle fibers and immobilizing the nuclear bag and nuclear chain fibers to thereby inhibit muscle tone in the antagonist muscle and eliciting muscle tone in the agonist muscle as matter of intended use.
Regarding claims 5-7, the first piece of dynamic adhesive medical tape of the taping structure taught by Lin is capable of extending across the joint to capture at least a part of the joint tendons and/or the entire joint tendon and/or the myotendinous junction of the muscle associated with the joint as a matter of intended use.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached on 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 12/22/2025