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 .
Response to Amendment
Applicant’s Amendments, filed 3/2/2026, to claims 1, 22, 31 acknowledged by Examiner. Additionally, applicant cancelled claims 2, 5-6, 10-11, 13, 18-19, 23-24, 30.
Claims 1, 3-4, 7-9, 12, 14-17, 20-22, 25-29, 31 are now pending.
Previous 112b rejections withdrawn in light of the amendments.
Previous 101 rejections withdrawn in light of the amendments.
Previous drawing objections withdrawn.
Previous claim objections withdrawn.
Response to Arguments
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. In regards to Applicant’s argument that Sieller does not provide for a digit immobilizer comprising at least one plate to receive a hand in a flat position, Examiner disagrees. As shown in Fig. 1-3 of Sieller the digit immobilizer 14 extends past the knuckles of the user thus immobilizing the movement of those parts of the digits and furthermore the palm portion of the hand is shown to be held in a flat position thus meeting the claim language. Furthermore, the hand may be configured to fully held in a flat position including the forefingers if desired by the user as the present claims do not require the plates holding the full hand and all of its portions to be immobilized into a flat position. The present claims only provide for being able to “receive a hand in a flat position”. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the digit immobilizer immobilizing the full/whole hand into a full flat position) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Examiner’s Notes
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
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 15-17 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 15 recites “wherein the digit immobilizer comprises a medial plate disposable with or adjacent to the palm of a hand and a lateral plate disposable with or adjacent to the back of the hand”, wherein this is positively claiming the hand relative to the plates of the invention, thus encompassing a human organism.
Claim 16 recites “wherein the digit immobilizer comprises a glove in which the plate(s) may be received to fit directly to a user's hand”, wherein the usage of “to fit” herein is not clear if this is functional language or required structured, if not functional language then this is positively reciting the hand of human relative to the glove, thus encompassing a human organism.
Claim 17 recites “wherein the glove medially receives a first plate to position against the palm, and laterally receives a second plate to position against the back of the hand”, wherein the plates are being positively recited relative the palm and the back of the hand, thus encompassing a human organism.
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 7, 8, 12, 16-17, 25-27 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 7 recites the limitation "a pair of straps", wherein this is confusing as it is unclear if this is referring to the “at least one strap” in claim 1 or some different straps. For interpretation purposes, will be read as being the strap of claim 1.
Claim 8 recites the limitation "the first strap" and “the second strap”. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites “a lateral plate” and “a medial plate” wherein it is unclear if these are a part of the “at least one plate” as established in claim 1 or different plates. For interpretation purposes, will be assumed to be part of the “at least one plate”.
Claim 12 recites the limitation "the static soft tissue-stretching strap”. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the plates”. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites “wherein the digit immobilizer comprises a glove in which the plate(s) may be received to fit directly to a user's hand”, wherein the usage of “may” herein makes it unclear if this is required structure or not.
Claim 17 recites the limitation “a first plate” and “a second plate”. It is unclear if these first and second plates are related to the “at least one plate” of claim 1 as well as “the plates” in claim 16 or if they are new different plates.
Claim 25 recites the limitation "the plates”. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the lateral forearm muscle group”. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 rejected as being dependent on claim 26.
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) 1, 3-4, 7-9, 12, 14-15, 20-22, 25-29 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sieller (US 7156819 B2).
Regarding claim 1, Sieller discloses a therapeutic device 10 for manipulative treatment of soft tissue of a human body (Figures 1-3), the device 10 comprising:
a brace 12 comprising a curved body 12 (Fig. 1-3) configured to partially or completely encompass a portion of an arm (Fig. 1-3 and Col. 3 lines 30-35, brace 12 wraps around forearm of the user, and as seen in figures will wrap completely therein); and
a digit immobilizer 14 (Fig. 1-3, wherein the immobilizer 14 extends past the knuckles of the user thus immobilizing the knuckle digit mobility) comprising at least one plate to receive a hand in a flat position (Fig. 1-3 and Col. 3 line 61 – Col. 4 line 17, wherein there is a stiff palm plate and a stiff back hand plate that is holding the palm and knuckles of the hand in a flat position),
wherein the brace 12 and the digit immobilizer 14 are in communication with one another through at least one strap 28 extending from the curved body 12 of the brace 12 to the at least one plate of the digit immobilizer 14 (See Fig. 1-3, wherein strap 28 can be attached to either the back hand plate or palm side plate of the digit immobilizer 14 and is then also attached to the brace 12).
Regarding claim 3, Sieller discloses the invention of claim 1 above.
Sieller further discloses wherein the curved body 12 of the brace 12 comprises a gap at opposing ends of the curved body 12. (Fig. 1, curved body 12 has a gap at opposing ends of its curve).
Regarding claim 4, Sieller discloses the invention of claim 3 above.
Sieller further discloses wherein the brace 12 comprises at least one fastener 30 spanning the gap to secure the brace 12 firmly in place on a user’s arm (Fig. 1-3).
Regarding claim 7, Sieller discloses the invention of claim 1 above.
Sieller further discloses comprising a pair of straps 28 (Fig. 1-3, the strap portions of strap 28 on either side of the clamp 50 may be viewed as one strap) extending respectively from a distal end 54 of the curved body 12 of the brace 12 to one of the plates 14 of the digit immobilizer 14 (Fig. 1-3, the straps 28 may extend from guides 54 of the curved body 12 to the plates 14, the guides 14 being at a distal outer end of the curved body 12, wherein the guides 54 are at the relatively same position of the instant application Fig. 1 guides 36).
Regarding claim 8, Sieller discloses the invention of claim 7 above.
Sieller further discloses comprising wherein the first strap 28 extends from a distal end 54 of the curved body 12 on a lateral-facing portion of the brace 12 to a lateral plate 14 (Fig. 3, the strap 28 has a first strap portion that may extend on a lateral sides of the brace 12 and plate 14 therein), and
the second strap 28 extends from a distal end 54 of the curved body 12 on a medial-facing portion of the brace 12 to a medial plate 14 (Fig. 3, the strap 28 has a second strap portion that extends on a medial sides of the brace 12 and plate 14 therein).
Regarding claim 9, Sieller discloses the invention of claim 1 above.
Sieller further discloses wherein the at least one strap 28 is a soft tissue-stretching strap or a strengthening strap (Col. 4 lines 49-58, wherein the strap 28 is an elastic tensioning member, wherein as shown in Fig. 1-3 may be used for either the concept of soft-tissue stretching by holding the hand in a flexion or extension position, and also provides strengthening if the user were to resist said tensioning member using their muscles).
Regarding claim 12, Sieller discloses the invention of claim 1 above.
Sieller further discloses the static soft tissue-stretching strap 28 (Col. 4 lines 49-58, wherein the strap 28 is an elastic tensioning member, wherein as shown in Fig. 1-3 may be used for either the concept of soft-tissue stretching by holding the hand in a flexion or extension position, and also provides strengthening if the user were to resist said tensioning member using their muscles) has a fixable length such that when in place extending between the brace 12 and the digit immobilizer 14, one of extension or flexion of the wrist is limited (Fig. 1-3, the length is fixable by deciding if the strap 28 is attached or not, thus when attached in certain configurations the extension or the flexion of the wrist may be limited).
Regarding claim 14, Sieller discloses the invention of claim 9 above.
Sieller further discloses wherein the strengthening strap 28 comprises an elastic resistance member having an elastic resistance (Col. 4 lines 49-58, wherein the strap 28 is an elastic tensioning member, wherein as shown in Fig. 1-3 may be used for either the concept of soft-tissue stretching by holding the hand in a flexion or extension position, and also provides strengthening if the user were to resist said tensioning member using their muscles) such that when the strengthening strap 28 is in place extending between the brace 12 and the digit immobilizer 14, resistance force is placed on the wrist against one of extension or flexion (Fig. 1-3, depending on the placement of strap 28 flexion or extension must be resisted against).
Regarding claim 15, Sieller discloses the invention of claim 9 above.
Sieller further discloses wherein the digit immobilizer 14 comprises a medial plate disposable with or adjacent to the palm of a hand (Fig. 2, there is a medial plate adjacent a palm) and a lateral plate disposable with or adjacent to the back of the hand (Fig. 3, there is a plate adjacent the back of the hand).
Regarding claim 20, Sieller discloses the invention of claim 1 above.
Sieller further discloses wherein the device is useful in the treatment of tendons, ligaments, or muscles in the arm (this is completely functional language, based on the functionality outlined in Col. 3 lines 10-24, the device may be used for treatment of tendons, ligaments, and muscles in the wrist as part of an arm).
Regarding claim 21, Sieller discloses the invention of claim 1 above.
Sieller further discloses wherein the device is useful in the treatment of carpal tunnel syndrome, tendonitis, epicondylitis (i.e., tennis elbow), and hand-arm vibration syndrome (e.g., treatment of lateral epicondylitis) (this is completely functional language, based on the functionality outlined in Col. 3 lines 10-24, the device may be used for treatment of carpal tunnel syndrome, tendonitis, epicondylitis (i.e., tennis elbow), and hand-arm vibration syndrome (e.g., treatment of lateral epicondylitis) considering the device of Sieller has ultimately the same structures therein as the present claims and disclosure).
Regarding claim 22, Sieller discloses a therapeutic method for rehabilitating soft tissue of a human body, the method (Fig. 1-3) comprising the following steps:
providing a therapeutic device 10 (Fig. 1-3) comprising:
a brace 12 comprising a curved body 12 that partially or completely encompasses a portion of an arm (Fig. 1-3 and Col. 3 lines 30-35, brace 12 wraps around forearm of the user, and as seen in figures will wrap completely therein); and
a digit immobilizer 14 (Fig. 1-3, wherein the immobilizer 14 extends past the knuckles of the user thus immobilizing the knuckle digit mobility) comprising at least one plate to receive a hand in a flat position (Fig. 1-3 and Col. 3 line 61 – Col. 4 line 17, wherein there is a stiff palm plate and a stiff back hand plate that is holding palm and knuckles of the hand in a flat position),
wherein the brace 12 and the digit immobilizer 14 are in communication with one another through at least one strap 28 extending from the curved body 12 of the brace 12 to the at least one plate of the digit immobilizer 14 (See Fig. 1-3, wherein strap 28 can be attached to either the back hand plate or palm side plate of the digit immobilizer 14 and is then also attached to the brace 12);
placing the digit immobilizer 14 on a user’s hand and placing the brace 12 on a portion of the user’s arm (Fig. 2-3); and
attaching the at least one strap 28 between the brace 12 and the digit immobilizer 14 for a desired therapeutic effect (Fig. 2-3, Col. 4 line 66 – Col. 5 line 30, strap 28 allows for selecting extension and flexion on user’s wrist).
Regarding claim 25, Sieller discloses the invention of claim 22 above.
Sieller further discloses wherein the placing step further comprises looping bands 34 around the plates 14 of the digit immobilizer 14 (Fig 1-3 and Col. 3 line 61 – Col. 4 line 6) and fasteners 30 on the brace 12 are tightened such that the digit immobilizer 14 is firmly engaged with the user's hand and the brace 12 is firmly engaged with the user's arm (Fig 1-3 and Col. 3 line 61 – Col. 4 line 6).
Regarding claim 26, Sieller discloses the invention of claim 22 above.
Sieller further discloses the desired therapeutic effect is stretching of the lateral forearm muscle group of a user's forearm (Col. 3 lines 10-24 and Fig. 1-3, the flexion movement of the wrist stretches the lateral forearm muscle group), and
wherein attaching the strap 28 between the brace 12 and the digit immobilizer 14 comprises attachment of a first end of the strap 28 to an outer surface 26 of a medial plate 14 and a second end of the strap 28 to a medial engagement loop 54 on the brace 12 (Fig. 2, wherein the strap 28 has an end at the medial plate 14 at the palm at outer anchor 26 and has an additional attachment end at the guide loop 54 on a medial side of the body 12); or
wherein the desired therapeutic effect is stretching of a medial forearm muscle group of a user's forearm (Col. 3 lines 10-24 and Fig. 1-3, the extension movement of the wrist stretches the medial forearm muscle group), and
wherein attaching the strap 28 between the brace 12 and the digit immobilizer 14 comprises attachment of a first end of the strap 28 to an outer surface 26 of a lateral plate 14 and a second end of the strap 28 to a lateral engagement loop 54 on the brace 12 (Fig. 3, wherein the strap 28 has an end at the lateral plate 14 at outer anchor 26 at the back of the hand and has an additional attachment end at the guide loop 54 on a lateral side of the body 12).
Regarding claim 27, Sieller discloses the invention of claim 26 above.
Sieller further discloses the step of adjusting the length of the strap 28 to lock the wrist in a forearm extensor stretching position or a forearm flexor stretching position (Fig. 1-3, the strap 28 may be locked in the position of Fig. 2 or Fig. 3 as shown thus adjusting the length of the strap 28 for those motions of extensor or flexor).
Regarding claim 28, Sieller discloses the invention of claim 22 above.
Sieller further discloses wherein the desired therapeutic effect is strengthening of muscle, and the strap is a strengthening strap (Col. 1 lines 5-35, the invention and thus the strap is used for therapeutic benefit and treatment/rehab of the muscles of the user, thus the strap 28 shown in Fig. 1-3 is a strengthening strap).
Regarding claim 29, Sieller discloses the invention of claim 28 above.
Sieller further discloses wherein the strengthening strap 28 comprises an elastic resistance member having an elastic resistance (Col. 4 lines 49-58, wherein the strap 28 is an elastic tensioning member, wherein as shown in Fig. 1-3 may be used for either the concept of soft-tissue stretching by holding the hand in a flexion or extension position, and also provides strengthening if the user were to resist said tensioning member using their muscles) such that when the strengthening strap 28 is in place extending between the brace 12 and the digit immobilizer 14, resistance force is placed on the wrist against one of extension or flexion (Fig. 1-3, depending on the placement of strap 28 flexion or extension must be resisted against).
Regarding claim 31, Sieller discloses a kit for a therapeutic device for manipulative treatment of soft tissue of a human body (Fig. 1-3, device 10 is inherently/implicitly also a kit containing all of its components, a kit does not provide any specific patentable weight on its own, see Col. 2 lines 55-62, wherein the device may be provided as a kit), the kit comprising:
a brace 12 comprising a curved body 12 configured to partially or completely encompass a portion of an arm (Fig. 1-3 and Col. 3 lines 30-35, brace 12 wraps around forearm of the user, and as seen in figures will wrap completely therein);
a digit immobilizer 14 (Fig. 1-3, wherein the immobilizer 14 extends past the knuckles of the user thus immobilizing the knuckle digit mobility) comprising at least one plate to receive a hand in a flat position (Fig. 1-3 and Col. 3 line 61 – Col. 4 line 17, wherein there is a stiff palm plate and a stiff back hand plate that is holding palm and knuckles of the hand in a flat position); and
a strap 28 attachable at one end to the curved body 12 of the brace 12 and at the other end to the at least one plate of the digit immobilizer 14 (Fig. 2-3, Col. 4 line 66 – Col. 5 line 30, strap 28 allows for selecting extension and flexion on user’s wrist, by selecting placement on the palm plate or back hand plate).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sieller (US 7156819 B2) in view of Zurbuchen (US 3182657 A).
Regarding claim 16, Sieller discloses the invention of claim 1 above.
Sieller does not disclose wherein the digit immobilizer comprises a glove in which the plate(s) may be received to fit directly to a user's hand.
However, Zurbuchen teaches an analogous hand immobilizer comprising a glove 1 (Fig. 1-4, device is a hand mitt being a glove) in which analogous plates 6 (Fig. 3 and Col. 2 line 30 – Col. 3 line 6, two plates 6, one against the palm and the other for placement against the back of the hand, receivable within the glove 1 pockets therein) may be received to fit directly to a user’s hand (Fig. 1-4, Col. 2 lines 1-13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modified the digit immobilizer 14 of Sieller to have the glove structure and plates as taught by Zurbuchen above, in order to provide improved hand immobilization into a full flat shape while still permitting forefinger movement as desired by Sieller (Sieller Col. 2 lines 40-54) (Zurbechen Col. 2 lines 1-13, thus not teaching away), wherein Zurbechen would also provide air flow for the hand while still being immobilized (Zurbechen Col. 1 lines 29-55).
Regarding claim 17, Sieller in view of Zurbechen discloses the invention of claim 16 above.
Zurbechen further teaches wherein the glove 1 medially receives a first plate 6 to position against the palm (Fig. 3, lower plate 6 goes against the palm), and laterally receives a second plate 6 to position against the back of the hand (Fig. 3, upper plate 6 goes against the back of the hand).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (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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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786