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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the heated short length of thermoplastic tape applied to the pulley ring orthotic on the volar aspect of the adjacent phalanx as recited in claims 1, 9, and 17, the dorsal safety release of the pulley ring orthotic as recited in claims 3, 11, and 20, and the length of thermoplastic tape being applied to the middle phalanx and A4 pulley as recited in claims 8, and 16, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-6, 9-14, and 17-20 are objected to because of the following informalities:
Claim 1 recites the limitation “a ring” in line 2, “the pulley ring orthotic” in line 4, “a pulley ring orthotic” in line 6, and “the pulley ring orthotic” in line 9. The first recitation of “a ring” should be amended to recite “a pulley ring orthotic”, and the subsequent recitations should be amended to recite “the pulley ring orthotic” to maintain consistency in the claims and clarity in the claims.
Claim 1 recites the limitation “a length of thermoplastic tape” and “a heated short length of thermoplastic tape”. While not unclear in view of Applicant’s disclosure that Applicant’s invention comprises a first length of thermoplastic tape which is heated to “thermally join the two ends”, and second, shorter length of heated thermoplastic tape to be applied to the first length, Applicant should amend these limitations to recite “a first length of thermoplastic tape”, and “a second, shorter length of thermoplastic tape which is heated and applied” for consistency purposes. Claims 2-8 should be amended to be consistent with the amendments to claim 1.
Claim 2 recites the limitation “formed into a ring”. While not unclear, a ring was presented in claim 1 from which claim 2 depends. Thus, this limitation should be amended to recite “formed into the pulley ring orthotic” to maintain consistency and clarity in the claims.
Claim 2 recites the limitation “a thermal joining connection”. While not unclear, a thermal joining connection was presented in claim 1 from which claim 2 depends. Thus, this limitation should be amended to recite “the thermal joining connection” to maintain consistency and clarity in the claims.
Claims 3-5 recites the limitation “said configured pulley ring orthotic”. While not unclear, this limitation should be amended to recite “the pulley ring orthotic” to maintain consistency and clarity in the claims.
Claim 5 recites the limitation “an injured finger pulley”. While not unclear, the injured pulley was presented in claim 1 from which claim 5 depends. Thus, this limitation should be amended to recite “the injured pulley” to maintain consistency and clarity in the claims.
Claim 6 recites the limitation “an injured finger pulley”. While not unclear, the injured pulley was presented in claim 1 from which claim 6 depends. Thus, this limitation should be amended to recite “the injured pulley” to maintain consistency and clarity in the claims
Claim 9 recites the limitation “a ring” in line 3, “the pulley ring orthotic” in line 6, “a pulley ring orthotic” in line 8, and “the pulley ring orthotic” in line 11. The first recitation of “a ring” should be amended to recite “a pulley ring orthotic”, and the subsequent recitations should be amended to recite “the pulley ring orthotic” to maintain consistency in the claims and clarity in the claims.
Claim 9 recites the limitation “a length of thermoplastic tape” and “a heated short length of thermoplastic tape”. While not unclear in view of Applicant’s disclosure that Applicant’s invention comprises a first length of thermoplastic tape which is heated to “thermally join the two ends”, and second, shorter length of heated thermoplastic tape to be applied to the first length, Applicant should amend these limitations to recite “a first length of thermoplastic tape”, and “a second, shorter length of thermoplastic tape which is heated and applied” for consistency purposes. Claims 10-16 should be amended to be consistent with the amendments to claim 9.
Claim 10 recites the limitation “formed into a ring”. While not unclear, a ring was presented in claim 9 from which claim 10 depends. Thus, this limitation should be amended to recite “formed into the pulley ring orthotic” to maintain consistency and clarity in the claims.
Claim 10 recites the limitation “a thermal joining connection”. While not unclear, a thermal joining connection was presented in claim 9 from which claim 10 depends. Thus, this limitation should be amended to recite “the thermal joining connection” to maintain consistency and clarity in the claims.
Claims 11-13 recites the limitation “said configured pulley ring orthotic”. While not unclear, this limitation should be amended to recite “the pulley ring orthotic” to maintain consistency and clarity in the claims.
Claim 14 recites the limitation “an injured finger pulley”. While not unclear, the injured pulley was presented in claim 9 from which claim 14 depends. Thus, this limitation should be amended to recite “the injured pulley” to maintain consistency and clarity in the claims.
Claim 17 recites the limitation “length of thermoplastic tape” in section (i), “stretching said heated length of thermoplastic tape” in section (iii), and “wrapping the stretched length of thermoplastic tape” in section (iv). The limitations of sections (iii) and (iv), while not unclear, should be amended to recite “stretching said length of thermoplastic tape”, and “wrapping said length of thermoplastic tape” to maintain consistency in the claims.
Claim 17 recites the limitation “the thermoplastic tape” in lines 8, 9, . While not unclear, this limitation should be amended to recite “the length of thermoplastic tape” to maintain consistency and clarity in the claims.
Claim 17 recites the limitation “a length of thermoplastic tape” in section (i), and “a heated short length of thermoplastic tape” in section (v). While not unclear in view of Applicant’s disclosure that Applicant’s invention comprises a first length of thermoplastic tape which is heated, and second, shorter length of heated thermoplastic tape to be applied to the first length, Applicant should amend these limitations to recite “a first length of thermoplastic tape”, and “a second, shorter length of thermoplastic tape which is heated and applied” for consistency purposes. Claims 18-20 should be amended to be consistent with the amendments to claim 17.
Claim 17 recites the limitation “the configured pulley ring orthotic”. While not unclear, this limitation should be amended to recite “the pulley ring orthotic” to maintain consistency and clarity in the claims.
Claims 18-20 recites the limitation “said configured pulley ring orthotic”. While not unclear, this limitation should be amended to recite “the pulley ring orthotic” to maintain consistency and clarity in the claims.
Appropriate correction is required.
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 1-20 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.
Claim 1 recites the limitation "the pulley ring orthotic" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the pulley ring orthotic”, and the recitation of “a ring” found in line 2 as “a pulley ring orthotic”.
Claim 1 recites the limitation "the volar aspect of the adjacent phalanx" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a volar aspect of an adjacent phalanx”.
Claim 1 recites the limitation “each individual patient’s injured finger” in line 8. This limitation is considered to be unclear given only a single patient is presented earlier in the claim. It is therefore unclear as to if Applicant is claiming additional patients, or additional fingers of the originally recited patient. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 1 recites the limitation "the pressure" in line 10. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a pressure”.
Claim 1 recites the limitation "the injured pulley" in line 10. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an injured pulley”.
Claim 4 recites the limitation “each patient’s injured finger”. This limitation is considered to be unclear given only a single patient is presented earlier in claim 1. It is therefore unclear as to if Applicant is claiming additional patients, or additional fingers of the originally recited patient. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 7 recites the limitation "the a2 pulley" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an a2 pulley”.
Claim 7 recites the limitation "the proximal phalanx" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a proximal phalanx”.
Claim 8 recites the limitation "the a4 pulley" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an a4 pulley”.
Claim 8 recites the limitation "the middle phalanx" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a middle phalanx”.
Claim 9 recites the limitation "the pulley ring orthotic" in line 6. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the pulley ring orthotic”, and the recitation of “a ring” found in line 3 as “a pulley ring orthotic”.
Claim 9 recites the limitation "the volar aspect of the adjacent phalanx" in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a volar aspect of an adjacent phalanx”.
Claim 9 recites the limitation “each individual patient’s injured finger” in line 10. This limitation is considered to be unclear given only a single patient is presented earlier in the claim. It is therefore unclear as to if Applicant is claiming additional patients, or additional fingers of the originally recited patient. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 9 recites the limitation "the pressure" in line 11. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a pressure”.
Claim 9 recites the limitation "the injured pulley" in line 11. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an injured pulley”.
Claim 12 recites the limitation “each patient’s injured finger” in line 2. This limitation is considered to be unclear given only a single patient is presented earlier in claim 9. It is therefore unclear as to if Applicant is claiming additional patients, or additional fingers of the originally recited patient. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 15 recites the limitation "the a2 pulley" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an a2 pulley”.
Claim 15 recites the limitation "the proximal phalanx" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a proximal phalanx”.
Claim 16 recites the limitation "the a4 pulley" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an a4 pulley”.
Claim 16 recites the limitation "the middle phalanx" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a middle phalanx”.
Claim 17 recites the limitation “an orthosis” in line 2. It is unclear as to if this recitation is the same as the finger orthosis presented in line 1 or a new orthosis. For the purpose of examination, Examiner will interpret the two orthosis as being the same.
Claim 17 recites the limitation “the phalanx” in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a phalanx”.
Claim 17 recites the limitation “the dorsal aspect” in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a dorsal aspect”.
Claim 17 recites the limitation “the adjacent phalanx” in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an adjacent phalanx”.
Claim 17 recites the limitation “a pulley ring orthotic” in line 9. This limitation is unclear as to if the pulley ring orthotic is the same orthosis to be applied to a human finger as presented earlier in the claim, or a new orthotic. For the purpose of examination, Examiner will interpret the first recitation of “an orthosis” in line 2 as “a pulley ring orthotic”.
Claim 17 recites the limitation “the tendon” in line 11. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a tendon”.
Claim 17 recites the limitation “the volar aspect” in line 14. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a volar aspect”.
Claim 17 recites the limitation “the pressure” in line 16. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a pressure”.
Claims 2-3, 5-6, 10-11, 13-14, and 18-20 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim, and therefore, contain the same offending limitations.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites the limitation “wherein said patient’s injured finger includes an injured finger pulley. This claim fails to limit claim 1 from which the claim depends as claim 1 recites “a patient’s injured finger…the pressure applied to the injured pulley”. Therefore, claim 6 does not present any limitations which limits claim 1.
Claim 14 recites the limitation “wherein said patient’s injured finger includes an injured finger pulley. This claim fails to limit claim 9 from which the claim depends as claim 9 recites “a patient’s injured finger…the pressure applied to the injured pulley”. Thereby claiming an injured finger which includes an injured pulley. Therefore, claim 14 does not present any limitations which limits claim 9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-8 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).
In regards to claim 1, the limitation “on the volar aspect of the adjacent phalanx” in line 5, positively recites part of the human body.
In regards to claim 1, the limitation “a patient’s injured finger” in line 7 positively recites part of the human body.
In regards to claim 1, the limitation “each individual patient’s injured finger” in line 8 positively recites part of the human body.
In regards to claim 1, the limitation “on the volar aspect of the adjacent phalanx” in line 10, positively recites part of the human body.
In regards to claim 1, the limitation “the injured pulley” in line 10, positively recites part of the human body.
In regards to claim 4, the limitation “finger range of motion and active range of motion” positively recites a function of part of the human body.
In regards to claim 5, the limitation “an injured finger pulley while using the injured finger and engaging in strenuous activity” positively recites a part of the human body, and a function of part of the human body.
In regards to claim 6, the limitation “wherein said patient’s injured finger includes an injured pulley” positively recites part of the human body.
In regards to claim 7, the limitation “wherein said injured finger pulley includes the A2 pulley and the adjacent phalanx is the proximal phalanx” positively recites part of the human body.
In regards to claim 8, the limitation “wherein said injured finger pulley includes the A4 pulley and the adjacent phalanx is the middle phalanx” positively recites part of the human body.
Claims 2 and 3 are rejected under 35 U.S.C. 101 as being dependent on claim 1 and therefore, contain the same offending limitations which are directed to or encompassing a human organism.
To obviate a rejection under 35 USC 101, the Office suggests that any claim that would include a human being, or part thereof, within its scope should use “adapted to___” or “adapted for ___” or “configured to” or configured for” to define the metes and bounds of the claimed subject matter which is a permissible form of expression.
Claim Rejections - 35 USC § 103
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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Screen captures from YouTube video clip entitled "Trigger finger orthosis (ring design) - Orficast Instructional Movie 14", uploaded on 04/25/2016 by user "Orfit Industries". Retrieved from https://www.youtube.com/watch?v=BGVA7XChKD0 (hereinafter Orfit TFO) in view of Cuypers et al. (US 2009/0075542 A1) (hereinafter Cuypers) and Screen captures from YouTube video clip entitled "Epicondylitis ring - Orficast Instructional Movie 18", uploaded on 04/29/2016 by user "Orfit Industries". Retrieved from https://www.youtube.com/watch?v=Hgb8WYgPdNU (hereinafter Orfit ER).
In regards to claim 1, Orfit TFO discloses A finger orthosis (trigger finger orthosis; see title), comprising:
(a) a length of thermoplastic tape having two ends (length of Orficast™ thermoplastic tape; see images 1 and 2; two ends seen explicitly in images 3 and 5) formed into a ring (trigger finger orthosis ring; see title; see images 4-6) by a joining connection of said two ends (see video description and image 4); and
wherein said length of thermoplastic tape (length of Orficast™ thermoplastic tape) is configured into a pulley ring orthotic (see 112b interpretation above; trigger finger orthosis ring; see image 4-6) to be applied to a patient’s injured finger (see video description; see image 4-6), whereby the length of said thermoplastic tape (length of Orficast™ thermoplastic tape) is predetermined to result in a diameter ring size to fit each individual patient’s injured finger being so applied (see description of image 2 that the length of Orficast™ thermoplastic tape is measured to circumference of the user’s finger and cut accordingly; thereby the length of Orficast™ thermoplastic tape is predetermined to result in a diameter ring size to fit each individual patient’s injured finger being so applied as claimed).
Orfit TFO does not disclose the two ends of the length of thermoplastic tape a joined by a thermal joining connection of said two ends;
(b) a heated short length of thermoplastic tape applied to the pulley ring orthotic on the volar aspect of the adjacent phalanx; and
said applied heated short length of thermoplastic tape to the pulley ring orthotic on the volar aspect of the adjacent phalanx increases the pressure applied to the injured pulley.
However, Cuypers teaches the specific material of the length of thermoplastic tape utilized in the “Orfit TFO” video (hybrid fabric; see [abstract]; see figure 1; the hybrid fabric taught by Cuypers corresponds to “Orficast™ thermoplastic tape as discussed by Applicant’s specification [0045]), wherein the material is intended to be heated to the molten state, such that superimposed layers show good adhesion to one another (see [0027]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the joining of the two ends of the length of thermoplastic tape as disclosed by Orfit TFO and to have joined the two ends via a thermal joining connection of said two ends and superimposing the two ends as taught by Cuypers in order to have provided an improved joining of the two ends of the length of thermoplastic tape that would add the benefit of having a good adhesion to one another (see [0027]).
Orfit TFO as now modified by Cuypers still does not disclose a heated short length of thermoplastic tape applied to the pulley ring orthotic on the volar aspect of the adjacent phalanx; and
said applied heated short length of thermoplastic tape to the pulley ring orthotic on the volar aspect of the adjacent phalanx increases the pressure applied to the injured pulley.
However, Orfit ER teaches an analogous ring orthosis (Epicondylitis ring orthosis; see image 2) made from an analogous thermoplastic tape (ring orthosis made from Orficast™ thermoplastic tape; see image 1) for the analogous purpose of treating an injured tendon of a user (treatment of epicondylitis includes application of pressure to the lateral extensor tendon attached to the epicondyle); further comprising a heated short length of thermoplastic tape (extra piece of Orficast™ material; see images 4-6) applied to the ring orthotic (Epicondylitis ring orthosis) on the tendon to be treated (see description of images 4-6 that the extra piece of material is heated and applied to the flattened portion which is intended to be placed over the user’s tendon).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pulley ring orthosis as disclosed by Orfit TFO as now modified by Cuypers and to have included the heated short length of thermoplastic tape applied to the ring orthotic to be placed on the tendon to be treated as taught by Orfit ER in order to have provided an improved pulley ring orthosis that would add the benefit of providing additional material which applies additional compressive forces to the tendon to be treated (i.e. the tendon and associated pulley located on the volar aspect of the user’s finger in the case of Orfit TFO).
Thus, as now combined Orfit TFO as now modified by Orfit ER discloses said applied heated short length of thermoplastic tape (extra piece of Orficast™ material as taught by Orfit ER) to the pulley ring orthotic (trigger finger orthosis ring of Orfit TFO) on the volar aspect of the adjacent phalanx increases the pressure applied to the injured pulley (see discussion of benefits for including the extra material as taught by Orfit ER above).
In regards to claim 2, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO as now modified by Cuypers further discloses wherein said length of thermoplastic tape having two ends (length of Orficast™ thermoplastic tape of Orfit TFO) is folded (see Orfit TFO image 3) before being formed into a ring (trigger finger orthosis ring) by a thermal joining connection of said two ends (thermal joining of the two ends as taught by Cuypers).
In regards to claim 3, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said configured pulley ring orthotic (trigger finger orthosis ring) includes a dorsal safety release (hook and loop fastening mechanism; see image 5; a hook and loop fastening mechanism allows for an easy mechanism to “release” the pressure, and thus is considered a dorsal safety release).
In regards to claim 4, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said configured pulley ring orthotic (trigger finger orthosis ring) when accurately fitted to each patient’s injured finger does not limit finger range of motion and active range of motion (see image 6).
In regards to claim 5, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said configured pulley ring orthotic (trigger finger orthosis ring) allows healing of an injured finger pulley while using the injured finger and engaging in strenuous activity (the trigger finger orthosis ring applies pressure, functions as a pulley protector (See video description) and allows for unrestricted movement of the finger (see image 6) thus, the trigger finger orthosis ring allows healing claimed).
In regards to claim 6, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said patient’s injured finger includes an injured finger pulley (see video description that the trigger finger orthosis ring functions as a pulley protector, thus the injured finger includes an injured finger pulley).
In regards to claim 7, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said injured finger pulley includes the A2 pulley and the adjacent phalanx is the proximal phalanx (see image 6 that the trigger finger orthosis ring is applied over the proximal phalanx and the A2 pulley).
In regards to claim 8, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO as now modified by Cuypers and Orfit ER does not explicitly disclose wherein said wherein said injured finger pulley includes the A4 pulley and the adjacent phalanx is the middle phalanx. Though intended placement does not inhibit the structure, design or disclosure of Orfit TFO as now modified by Cuypers and Orfit ER, for full clarity it is obvious that Orfit TFO as now modified by Cuypers and Orfit ER’s device may be formed in the manner seen in images 1-6 of Orfit TFO on the user’s injured finger on the middle phalanx over the user’s A4 pulley.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known that the intended placement for the configured pulley ring orthotic being applied on an injured finger, wherein said injured finger pulley includes the A4 pulley and the adjacent phalanx is the middle phalanx does not inhibit the structure, design or disclosure of Orfit TFO as now modified by Cuypers and Orfit ER and Orfit TFO as now modified by Cuypers and Orfit ER’s device is fully capable of being formed in the manner seen in images 1-6 of Orfit TFO on the middle phalanx over the user’s A4 pulley of the user’s injured finger.
In regards to claim 9, Orfit TFO discloses A method of making a finger orthosis (trigger finger orthosis; see title; see images 1-6), comprising the steps of:
(a) providing a length of thermoplastic tape having two ends (length of Orficast™ thermoplastic tape; see images 1 and 2; two ends seen explicitly in images 3 and 5)
(b) forming said length of thermoplastic tape (length of Orficast™ thermoplastic tape) into a ring (trigger finger orthosis ring; see title; see images 4-6) by bringing said two ends together (see video description and image 4); and
wherein said length of thermoplastic tape (length of Orficast™ thermoplastic tape) is configured into a pulley ring orthotic (see 112b interpretation above; trigger finger orthosis ring; see image 4-6) to be applied to a patient’s injured finger (see video description; see image 4-6), whereby the length of said thermoplastic tape (length of Orficast™ thermoplastic tape) is predetermined to result in a diameter ring size to fit each individual patient’s injured finger being so applied (see description of image 2 that the length of Orficast™ thermoplastic tape is measured to circumference of the user’s finger and cut accordingly; thereby the length of Orficast™ thermoplastic tape is predetermined to result in a diameter ring size to fit each individual patient’s injured finger being so applied as claimed).
Orfit TFO does not disclose (c) thermally joining said two ends;
(d) applying a heated short length of thermoplastic tape applied to the pulley ring orthotic on the volar aspect of the adjacent phalanx; and
said applied heated short length of thermoplastic tape to the pulley ring orthotic on the volar aspect of the adjacent phalanx increases the pressure applied to the injured pulley.
However, Cuypers teaches the specific material of the length of thermoplastic tape utilized in the “Orfit TFO” video (hybrid fabric; see [abstract]; see figure 1; the hybrid fabric taught by Cuypers corresponds to “Orficast™ thermoplastic tape as discussed by Applicant’s specification [0045]), wherein the material is intended to be heated to the molten state, such that superimposed layers show good adhesion to one another (see [0027]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the joining of the two ends of the length of thermoplastic tape as disclosed by Orfit TFO and to have joined the two ends via a thermal joining connection of said two ends and superimposing the two ends as taught by Cuypers in order to have provided an improved joining of the two ends of the length of thermoplastic tape that would add the benefit of having a good adhesion to one another (see [0027]).
Orfit TFO as now modified by Cuypers still does not disclose a heated short length of thermoplastic tape applied to the pulley ring orthotic on the volar aspect of the adjacent phalanx; and
said applied heated short length of thermoplastic tape to the pulley ring orthotic on the volar aspect of the adjacent phalanx increases the pressure applied to the injured pulley.
However, Orfit ER teaches an analogous ring orthosis (Epicondylitis ring orthosis; see image 2) made from an analogous thermoplastic tape (ring orthosis made from Orficast™ thermoplastic tape; see image 1) for the analogous purpose of treating an injured tendon of a user (treatment of epicondylitis includes application of pressure to the lateral extensor tendon attached to the epicondyle); further comprising applying a heated short length of thermoplastic tape (extra piece of Orficast™ material; see images 4-6) to the ring orthotic (Epicondylitis ring orthosis) on the tendon to be treated (see description of images 4-6 that the extra piece of material is heated and applied to the flattened portion which is intended to be placed over the user’s tendon).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pulley ring orthosis as disclosed by Orfit TFO as now modified by Cuypers and to have included the step of applying a heated short length of thermoplastic tape to the ring orthotic to be placed on the tendon to be treated as taught by Orfit ER in order to have provided an improved pulley ring orthosis that would add the benefit of providing additional material which applies additional compressive forces to the tendon to be treated (i.e. the tendon and associated pulley located on the volar aspect of the user’s finger in the case of Orfit TFO).
Thus, as now combined Orfit TFO as now modified by Orfit ER discloses said applied heated short length of thermoplastic tape (extra piece of Orficast™ material as taught by Orfit ER) to the pulley ring orthotic (trigger finger orthosis ring of Orfit TFO) on the volar aspect of the adjacent phalanx increases the pressure applied to the injured pulley (see discussion of benefits for including the extra material as taught by Orfit ER above).
In regards to claim 10, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO as now modified by Cuypers further discloses wherein said length of thermoplastic tape having two ends (length of Orficast™ thermoplastic tape of Orfit TFO) is folded (see Orfit TFO image 3) before being formed into a ring (trigger finger orthosis ring) by a thermal joining connection of said two ends (thermal joining of the two ends as taught by Cuypers).
In regards to claim 11, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said configured pulley ring orthotic (trigger finger orthosis ring) includes a dorsal safety release (hook and loop fastening mechanism; see image 5; a hook and loop fastening mechanism allows for an easy mechanism to “release” the pressure, and thus is considered a dorsal safety release).
In regards to claim 12, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said configured pulley ring orthotic (trigger finger orthosis ring) when accurately fitted to each patient’s injured finger does not limit finger range of motion and active range of motion (see image 6).
In regards to claim 13, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said configured pulley ring orthotic (trigger finger orthosis ring) allows healing of an injured finger pulley while using the injured finger and engaging in strenuous activity (the trigger finger orthosis ring applies pressure, functions as a pulley protector (See video description) and allows for unrestricted movement of the finger (see image 6) thus, the trigger finger orthosis ring allows healing claimed).
In regards to claim 14, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said patient’s injured finger includes an injured finger pulley (see video description that the trigger finger orthosis ring functions as a pulley protector, thus the injured finger includes an injured finger pulley).
In regards to claim 15, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said injured finger pulley includes the A2 pulley and the adjacent phalanx is the proximal phalanx (see image 6 that the trigger finger orthosis ring is applied over the proximal phalanx and the A2 pulley).
In regards to claim 16, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO as now modified by Cuypers and Orfit ER does not explicitly disclose wherein said wherein said injured finger pulley includes the A4 pulley and the adjacent phalanx is the middle phalanx. Though intended placement does not inhibit the structure, design or disclosure of Orfit TFO as now modified by Cuypers and Orfit ER, for full clarity it is obvious that Orfit TFO as now modified by Cuypers and Orfit ER’s device may be formed in the manner seen in images 1-6 of Orfit TFO on the middle phalanx over the user’s A4 pulley of the user’s injured finger.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known that the intended placement for the configured pulley ring orthotic being applied on an injured finger, wherein said injured finger pulley includes the A4 pulley and the adjacent phalanx is the middle phalanx does not inhibit the structure, design or disclosure of Orfit TFO as now modified by Cuypers and Orfit ER and Orfit TFO as now modified by Cuypers and Orfit ER’s device is fully capable of being formed in the manner seen in images 1-6 of Orfit TFO on the user’s injured finger on the middle phalanx over the user’s A4 pulley.
Furthermore, it has been held that “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (see MPEP 2112.01(I)). In the present case, the device recited in method claims 9 and 16 is identical to the device recited in claims 1 which is unpatentable over Orfit TFO as now modified by Cuypers and Orfit ER (see claim rejection above). Since the prior art device of Orfit TFO as now modified by Cuypers and Orfit ER is the same as the device for carrying out the claimed method, it is obvious that the device will perform the claimed process and, therefore, the method claimed is considered to be obvious in view of the prior art device.
In regards to claim 17, Orfit TFO discloses A method of treating a finger injury (see video description) using a finger orthosis (trigger finger orthosis; see title; see images 1-6), comprising the steps of:
(a) applying an orthosis (see 112b interpretation above; trigger finger orthosis) to a human finger (see images 1-6) to provide tendon support at an injured finger pulley (see video description that the trigger finger orthosis acts as a pulley protector and therefore provides tendon support as claimed), the method comprising the steps of:
(i) providing a length of thermoplastic tape (length of Orficast™ thermoplastic tape; see images 1 and 2);
(iii) stretching said length of thermoplastic tape (length of Orficast™ thermoplastic tape; see image 2 that the original length of thermoplastic tape is measured to the user’s finger circumference; see image 4 that after being wrapped around the user’s finger, any excess material of the length of thermoplastic tape is trimmed off, said excess material which requires trimming would not be present unless the original length of thermoplastic tape were stretched);
(iv) wrapping the stretched length of thermoplastic tape (length of Orficast™ thermoplastic tape) about the phalanx adjacent to the injured finger pulley with ends of the thermoplastic tape being joined on the dorsal aspect of the adjacent phalanx (see image 4), the ends of the thermoplastic tape being joined to define a pulley ring orthotic (trigger finger orthosis ring; see video description; see images 4-6) encircling the injured finger pulley and the adjacent phalanx (see image 6), the pulley ring orthotic (trigger finger orthosis ring) being in tension to apply pressure to the tendon to press the tendon towards the adjacent phalanx (not only is the length of Orficast™ thermoplastic tape initially stretched to wrap around the user’s finger (thereby creating tension in the material; see discussion above); but additionally a hook and loop fastening mechanism is included onto the trigger finger orthosis ring for the purpose of fastening and adjusting tension to apply pressure to the tendon as claimed (see image 5));
forming said length of thermoplastic tape (length of Orficast™ thermoplastic tape) into a ring (trigger finger orthosis ring; see title; see images 4-6) by bringing said two ends together (see video description and image 4).
Orfit TFO does not disclose (ii) heating said length of thermoplastic tape;
(vi) heating a short length of thermoplastic tape;
(vi) applying the heated short length of thermoplastic tape to the pulley ring orthotic on the volar aspect of the adjacent phalanx;
wherein the heated short length of thermoplastic tape is applied to increase the tension in the configured pulley ring orthotic, and thereby increase the pressure applied to the injured pulley.
However, Cuypers teaches the specific material of the length of thermoplastic tape utilized in the “Orfit TFO” video (hybrid fabric; see [abstract]; see figure 1; the hybrid fabric taught by Cuypers corresponds to “Orficast™ thermoplastic tape as discussed by Applicant’s specification [0045]), wherein the material is intended to be heated to the molten state, such that superimposed layers show good adhesion to one another (see [0027]) and said heating permits the varying the drape, shape memory and mouldability of the thermoplastic melting material (see [0032]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of applying the orthosis as disclosed by Orfit TFO and to have heated the length of thermoplastic tape prior to stretching, wrapping, and joining the two ends of the length of thermoplastic tape as taught by Cuypers in order to have provided an improved method of manipulating the length of thermoplastic tape that would add the benefits of heating which permits the varying the drape, shape memory and mouldability of the thermoplastic melting material (see [0032]) and an improved joining of the two ends of the length of thermoplastic tape that would add the benefit of having a good adhesion to one another (see [0027]).
Orfit TFO as now modified by Cuypers still does not disclose (vi) heating a short length of thermoplastic tape;
(vi) applying the heated short length of thermoplastic tape to the pulley ring orthotic on the volar aspect of the adjacent phalanx;
wherein the heated short length of thermoplastic tape is applied to increase the tension in the configured pulley ring orthotic, and thereby increase the pressure applied to the injured pulley.
However, Orfit ER teaches an method of applying a analogous ring orthosis (Epicondylitis ring orthosis; see image 2) made from an analogous thermoplastic tape (ring orthosis made from Orficast™ thermoplastic tape; see image 1) for the analogous purpose of treating an injured tendon of a user (treatment of epicondylitis includes application of pressure to the lateral extensor tendon attached to the epicondyle); further comprising (vi) heating a short length of thermoplastic tape (extra piece of Orficast™ material; see images 4-6);
(vi) applying the heated short length of thermoplastic tape (extra piece of Orficast™ material) to the ring orthotic (Epicondylitis ring orthosis) on the tendon to be treated (see description of images 4-6 that the extra piece of material is heated and applied to the flattened portion which is intended to be placed over the user’s tendon).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of applying the pulley ring orthosis as disclosed by Orfit TFO as now modified by Cuypers and to have included the step of applying a heated short length of thermoplastic tape to the ring orthotic to be placed on the tendon to be treated as taught by Orfit ER in order to have provided an improved pulley ring orthosis that would add the benefit of providing additional material which applies additional compressive forces (i.e. tension) to the tendon to be treated (i.e. the tendon and associated pulley located on the volar aspect of the user’s finger in the case of Orfit TFO).
Thus, as now combined Orfit TFO as now modified by Orfit ER discloses the heated short length of thermoplastic tape (extra piece of Orficast™ material as taught by Orfit ER) is applied to increase the tension in the configured pulley ring orthotic (trigger finger orthosis ring of Orfit TFO) and thereby increase the pressure applied to the injured pulley (see discussion of benefits for including the extra material as taught by Orfit ER above).
In regards to claim 18, Orfit TFO as now modified by Cuypers and Orfit ER discloses the invention as discussed above.
Orfit TFO further discloses wherein said configured pulley ring orthotic (trigger finger orthosis ring) w