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 .
Terminal Disclaimer
The terminal disclaimer filed on 03/23/2026 disclaiming the terminal portion of the patent being reexamined which would extend beyond the expiration date of Patent 12004989 filed of 03/29/2021 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 11/05/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this submission of the information disclosure statement is being considered by the examiner.
Response to Amendment
3. The amendment filed 03/23/2026 has been entered. Currently, claims 1-20 remain pending in the application. Independent claims 1, 17, and 20 were amended by the Applicant without the addition of new matter to include further narrowing limitations. Additionally, claims 4-5, 9-10, and 14-15 were amended to correct previous claim objections and 35 USC 112(B) rejections that were set forth in the Non-Final Office Action mailed 10/23/2025. Claim 17 is now allowed.
Response to Arguments
4. Applicant’s amendment to independent claims 1 and 17 is sufficient to overcome the previous 35 USC § 103 rejection recited in the Non-Final Office Action mailed 10/23/2025.
Applicant’s arguments, see Remarks on Page 7 to Page 14, filed 03/23/2026, with respect to the rejection under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, the amended claim 1 has changed the scope of the claims and upon further consideration, a new grounds of rejection is made in view of new and current prior art of the record: Sivy (FR 3031897 A1), Buechele et al. (EP 0020943 A1), Yoshikawa (JP 2006271872 A), Pittman et al. (U.S. Patent No. 5323754), Jane (U.S. Patent No. 2354770), Nakamura (U.S. Patent Pub. No. 20160270942), Bolla et al. (U.S. Patent No. 6039706), Geller et al. (U.S. Patent Pub. No. 20060287160), and Neubauer (DE 202018000399).
5. Overall, Examiner notes that Applicant may overcome the prior art of record by amending the claims to distinguish from the prior art. For example, reciting positive limitations such as in claim 19 with –a boundary of the lateral and medial fingers being wrapped--; and/or reciting the elongated member as a –wire-- instead of plate. Furthermore, Applicant may recite negative limitations such as --not—or –without-- to teach away from the prior art, i.e. Applicant’s tab portion 344 is smooth with no protruding head 9 of Sivy or screw head of Pittman. Lastly, Applicant may amend the preamble and/or body of the claim to recite transitional phrases such as –consisting—or -–consisting essentially of—to teach away from prior art combinations.
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.
Claims 1-2, 5-10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sivy (FR 3031897 A1) in view of Buechele et al. (EP 0020943 A1) and in further view of Yoshikawa (JP 2006271872 A) and Pittman et al. (U.S. Patent No. 5323754).
Regarding claim 1, Sivy discloses a splint 1 (Paragraph 11 and Figure 1, device 1 for holding and/or protecting at least two fingers) configured to support an injured digit of a patient, comprising: a band 2 (Paragraph 14 and Figure 1, strip 2) comprising a first end portion 5 (Paragraph 17 and Figure 1, first end part 5 of band 2), a second end portion 6 (Paragraph 17 and Figure 1, second end part 6 of band 2), and a middle portion13 (Paragraph 32 and Figure 1, central portion 13 of band 2) extending between the first end portion and the second end portion; wherein the band 2 comprises a plurality of band slots 11 positioned in series along a longitudinal axis of the band 2; a first tab 7 (Paragraph 19 and Figure 1, lugs 7); the plurality of slots 11 positioned in series along a longitudinal axis of the middle portion of the band 2 sized to receive the first tab 7 for securing the first and second end portions 5,6 of the band 2 together thereby providing the splint in a loop configuration 20 (Paragraph 14 and Figure 1, loop 20 wraps around fingers).
However, Sivy fails to explicitly disclose (1) an elongated plate comprising a flat metal sheet embedded in or at least partially enclosed by the band, the elongated plate comprising (i) the first tab on a first end of the elongated plate configured to be bent upwards or downwards; and (iii) a middle portion between that extends axially through or along the middle portion of the band; wherein the elongated plate further comprises: a plurality of plate slots positioned in series along a longitudinal axis of the middle portion of the elongated plate; (2) (ii) a second tab on a second end of the elongated plate configured to be bent upwards or downwards, and (iii) the middle portion between the first tab and the second tab; and a plurality of slots positioned in series along a longitudinal axis that extend through the middle portion of the elongated plate, wherein the plurality of slots are sized to receive the first tab or the second tab of the elongated plate; (3) the elongated plate embedded or enclosed by the first end portion, the second end portion, and the middle portion of the band; wherein the plurality of band slots and the plurality of plate slots are aligned.
Buechele teaches an analogous band 8 (Abstract, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, covering band 8 formed of rubber elastic material )comprising an analogous elongated plate 1 (Abstract, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, bendable strip sprig steel plate 1 partially enclosed by band 8) comprising a flat metal sheet 1 embedded in or enclosed by the analogous middle portion (Figure 1, middle portion of strip 1 extends axially through the band) of the analogous band 8, the elongated plate 1 comprising (i) the analogous first tab 4 (Abstract, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, bendable tab 4 of elongated strip 1 on first latitudinal end of strip 1 bent along transverse line of neck 5) on a first end of the elongated plate 1 configured to be bent upwards or downwards; and (iii) a middle portion (Figure 1, middle portion of strip 1 extends axially through the band) that extends axially through or along the middle portion of the band 8; wherein the elongated plate 1 further comprises: a plurality of a plurality of plate slots 7 (Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figures 1-2, plurality of plate slots 7 ) positioned in series along an analogous longitudinal axis of the analogous middle portion (Figures 1-2, middle portion between ends 3,4) of the elongated plate 1.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the band and first tab of Sivy, so that there is an elongated plate comprising a flat metal sheet embedded in or at least partially enclosed by the band, the elongated plate comprising (i) the first tab on a first end of the elongated plate configured to be bent upwards or downwards and (iii) a middle portion between that extends axially through or along the middle portion of the band; wherein the elongated plate further comprises: a plurality of plate slots positioned in series along a longitudinal axis of the middle portion of the elongated plate, as taught by Buechele, in order to provide an improved splint with an enhanced band having a bendable elongated member within the band forming a first end tab that advantageously provides quick fastening to form the loop configuration of the band (Buechele, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1).
However, the combination of Sivy in view of Buechele fails to explicitly disclose(2) (ii) a second tab on a second end of the elongated plate configured to be bent upwards or downwards, and (iii) the middle portion between the first tab and the second tab; and a plurality of slots positioned in series along a longitudinal axis of the middle portion of the elongated plate, wherein the plurality of slots are sized to receive the first tab or the second tab of the elongated plate; (3) the elongated plate embedded or enclosed by the first end portion, the second end portion, and the middle portion of the band; wherein the plurality of band slots and the plurality of plate slots are aligned.
Yoshikawa teaches an analogous elongated plate 1 (Page 3/18, Paragraphs 4 to 7 and Figure 1, flexible elongated member 1) comprising an analogous first tab 21 (Page 3/18, Paragraph 7 and Figure 1, upper tab 21) and a second tab 21 (Page 3/18, Paragraph 7 and Figure 1, lower tab 21 on second latitudinal end of the elongated member 1 being bent on a transverse line of base portion 22) on a second end of the analogous elongated plate 1 configured to be bent upwards or downwards, and (iii) the analogous middle portion (Figure 1, middle portion of elongated member 1 between first and second tabs 21) between the analogous first tab 21 and the second tab 21; and a plurality of slots 11 (Page 3/18, Paragraph 7 and Figure 1, series slot openings 11) of the elongated plate 1 positioned in series along a longitudinal axis of the middle portion of the analogous elongated plate 1, wherein the plurality of slots 11 are sized to receive the analogous first tab 21 and/or the second tab 21 of the elongated plate 1.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the band and elongated member Sivy in view of Buechele, so that there is (ii) a second tab on a second end of the elongated plate configured to be bent upwards or downwards, and (iii) the middle portion between the first tab and the second tab; and a plurality of slots positioned in series along a longitudinal axis of the middle portion of the elongated plate, wherein the plurality of slots are sized to receive the first tab and/or the second tab of the elongated plate, as taught by Yoshikawa, in order to provide an improved splint with an enhanced elongated member that has an additional second end tab for providing additional securement via the second tab within a second perforation of the elongated member (Yoshikawa, Page 3/18, Paragraph 7).
However, the combination of Sivy in view of Buechele in view of Yoshikawa fails to explicitly disclose(3) the elongated plate embedded or enclosed by the first end portion, the second end portion, and the middle portion of the band; wherein the plurality of band slots and the plurality of plate slots are aligned.
Pittman teaches an analogous splint (Col. 6, lines 10-30 and Figures 1 and 5, splint comprising through-holes 44-46 of band 18 cover 26 and rigid plate 10. The plate 10 is embedded by middle portion 26 as well as first end portion area 60 and second end portion area 62) comprising an analogous band 18 sleeved over a core analogous elongated plate 10 embedded or enclosed by the analogous first end portion 60, the analogous second end portion 62, and the analogous middle portion 26 of the analogous band 18; wherein the analogous plurality of band slots and the analogous plurality of plate slots 44-46 are aligned.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elongated plate and the band with the respective plate slots and band slots of Sivy in view of Buechele in view of Yoshikawa, so that the elongated plate embedded or enclosed by the first end portion, the second end portion, and the middle portion of the band; wherein the plurality of band slots and the plurality of plate slots are aligned, as taught by Pittman, in order to provide an improved splint with an enhanced band and elongated core plate that is fully enclosed and provided with aligned with band and plate through-holes that allow for fastening therein both slots at the same time for desirable increased securement (Pittman, Col. 6, lines 10-30).
Regarding claim 2, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above. Sivy further discloses wherein the band 2 comprises an elastomeric polymer (Paragraph 44, polymer with good elasticity for mobility of injured finger).
Regarding claim 5, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above. Sivy further discloses wherein center lines of the plurality of slots 11 (Paragraph 19 and Figure 1, slot opening 11 that have an axis that extends transverse to a longitudinal axis of the strip 2) are transverse to the longitudinal axis of the middle portion of the band 2.
Regarding claim 6, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above and further discloses wherein the plurality of band slots(Modification of Figure 1 of Sivy in view of Figure 1 Buechele in view of Figure 1 of Yoshikawa in view of Figure 1 of Pittman: modifying the band 2 of Sivy to have an elongated member comprising a first and second tab, as taught by Buechele, wherein the first and second tab are each inserted through a first and second perforation 11 of the band 2 of Sivy, as taught by Yoshikawa, and a corresponding aligned perforation of the elongated plate member, as taught by Pittman in the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman) comprises a first band slot sized to receive the first tab of the elongated plate and a second band slot sized to receive the second tab of the elongated plate, thereby providing the splint in the loop configuration; and wherein the plurality of plate slots comprises a first plate slot, which is aligned with the first band slot and is sized to receive the first tab of the elongated plate, and a second plate slot, which is aligned with the second band slot, and is sized to receive the second tab of the elongated plate, thereby providing the splint in the loop configuration.
Regarding claim 7, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above and further discloses wherein the at least one elongated member 1 (Buechele, Abstract, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, elongated member 1 is a strip 1 having a greater width than thickness thereby defining a plate) comprises a plate having a width that is greater than a thickness of the plate
Regarding claim 8, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above and further discloses wherein the first tab (Buechele, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1s and 4, narrower tab 4 than plate body 1; Yoshikawa, Page 3/18, Paragraphs 4 to 7 and Figure 1, narrower tab portion 22 ) and the second tab (Yoshikawa, Page 3/18, Paragraphs 4 to 7 and Figure 1, narrower tab portion 22 ) are narrower than the middle portion of the elongated plate (Modification of Figure 1 of Sivy in view of Figure 1 Buechele in view of Figure 1 of Yoshikawa: modifying the band 2 of Sivy to have an elongated member comprising a first and second tab, as taught by Buechele, wherein the first and second tab are each inserted through a first and second perforation 11 of the band 2 of Sivy and a corresponding perforation of the elongated member of Sivy in view of Buechele in view of Yoshikawa).
Regarding claim 9, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above and further discloses wherein the first tab (Buechele, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, first tab is construed as end section 4 as well as portion of strip 1 having a partial portion disposed within the band 8) and the second tab (Modification of Figure 1 of Sivy in view of Figure 1 of Buechele in view of Figure 1 of Yoshikawa in view of Figure 1 of Pittman: second tab is construed as lower second tab of Yoshikawa as well as a partial portion of strip 1 of Buechele, wherein the elongated plate is enclosed by first and second end portion of band, as taught by Pittman) are enclosed, encapsulated, and/or embedded within the first and second end portions of the band 2 (Sivy, Paragraph 14).
Regarding claim 10, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above and further discloses wherein the first tab and the second tab are uncovered protruding (Modification of Figure 1 of Sivy in view of Figure 1 Buechele in view of Figure 1 of Yoshikawa: modifying the band 2 of Sivy to have an elongated member comprising a first tab, as taught by Buechele, and second tab, as taught by Yoshikawa , wherein the tabs are inserted through perforations 11 of the band 2 of Sivy and a corresponding perforation of the elongated member of Sivy in view of Buechele in view of Yoshikawa, such that the tabs protrude from an upper surface in the loop configuration) from the end portions of the band 2 (Sivy, Paragraph 14).
Regarding claim 12, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above but fails to explicitly disclose twenty-three band and plate slots.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the number of band and plate slots of the splint of Sivy in view of Buechele in view of Yoshikawa in view of Pittman to have twenty-three slots since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984); see MPEP 2144.04(iv)(a). In the instant case, the device of Sivy in view of Buechele in view of Yoshikawa in view of Pittman would not operate differently with the claimed number of slots as the slots in the prior art are also intended to provide adjustability for positioning the taps and wrapping the band around correspondingly sized fingers of a patient. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the number “is not limiting and ‘can’ include more or less slots” (specification pp. [0061]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the number of slots of Sivy in view of Buechele in view of Yoshikawa in view of Pittman to have twenty-three slots as an obvious matter of design choice within the skill of the art.
Regarding claim 13, the combination of Sivy in view of Buechele in view of Yoshikawa discloses the invention as described above but fails to explicitly disclose the plurality of band and plate slots are equidistantly spaced along the longitudinal axis of the middle portion of the band and elongated member.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a spacing distance of the slots of the splint of Sivy in view of Buechele in view of Yoshikawa in view of Pittman to have the plurality of slots equidistantly spaced along the longitudinal axis of the middle portion of the band, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984); see MPEP 2144.04(iv)(a). In the instant case, the device of Sivy in view of Buechele in view of Yoshikawa in view of Pittman would not operate differently with the claimed spacing of slots as the slots in the prior art are also intended to provide adjustability for positioning the taps and wrapping the band around correspondingly sized fingers of a patient. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the slots “may” be equidistant or even “may” be varying, indicating various configuration provide the same expected result (specification pp. [0064]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a spacing distance of the slots of the splint of Sivy in view of Buechele in view of Yoshikawa in view of Pittman to have the plurality of slots equidistantly spaced along the longitudinal axis of the middle portion of the band as an obvious matter of design choice within the skill of the art.
Regarding claim 14, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above but fails to explicitly disclose wherein longitudinal distances between adjacent band and plate slots of the plurality of band and plate slots vary, with slots positioned closer to the end portions of the band being closer together than slots positioned closer to a middle point of the band equidistant between the first and second end portions of the band.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a spacing distance of the plate and band slots of the splint of Sivy in view of Buechele in view of Yoshikawa in view of Pittman to have longitudinal distances between adjacent slots of the plurality of slots vary, with slots positioned closer to the end portions of the band being closer together than slots positioned closer to a middle point of the band equidistant between the first and second end portions of the band, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984); see MPEP 2144.04(iv)(a). In the instant case, the device of Sivy in view of Buechele in view of Yoshikawa in view of Pittman would not operate differently with the claimed spacing of slots as the slots in the prior art are also intended to provide adjustability for positioning the taps and wrapping the band around correspondingly sized fingers of a patient. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the slots “may” be equidistant or even “may” be varying, indicating various configuration provide the same expected result (specification pp. [0064]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a spacing distance of the slots of the splint of Sivy in view of Buechele in view of Yoshikawa in view of Pittman to have longitudinal distances between adjacent slots of the plurality of slots vary, with slots positioned closer to the end portions of the band being closer together than slots positioned closer to a middle point of the band equidistant between the first and second end portions of the band, as an obvious matter of design choice within the skill of the art.
Regarding claim 15, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above and further discloses wherein the first tab and the second tab of the elongated plate (Modification of Figure 1 of Sivy in view of Figure 1 Buechele in view of Figure 1 of Yoshikawa: modifying the band 2 of Sivy to have an elongated member comprising a first tab, as taught by Buechele, and second tab, as taught by Yoshikawa , wherein the tabs are inserted through perforations 11 of the band 2 of Sivy and a corresponding perforation of the elongated member of Sivy in view of Buechele in view of Yoshikawa, such that the tabs protrude from an upper surface in the loop configuration) are configured to be bent along bending lines that are transverse (Buechele, Abstract, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, bendable tab 4 of elongated strip 1 on first latitudinal end of strip 1 bent along transverse line of neck 5; Yoshikawa, Page 3/18, Paragraph 7 and Figure 1, lower tab 21 on second latitudinal end of the elongated member 1 being bent on a transverse line of base portion 22) to a longitudinal axis of the middle portion of the elongated plate.
Regarding claim 16, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above and further discloses wherein, in the loop configuration, the first end portion and the second end portion of the band and portions of the plate embedded in or enclosed (Modification of Figure 1 of Sivy in view of Figure 1 of Buechele in view of Figure 1 of Yoshikawa in view of Figure 1 of Pittman: second tab is construed as lower second tab of Yoshikawa as well as a partial portion of strip 1 of Buechele, wherein the elongated plate is enclosed by first and second end portion of band, as taught by Pittman) by the first and second end portions of the band form an overlapping region (Modification of Figure 1 of Sivy in view of Figure 1 Buechele in view of Figure 1 of Yoshikawa: overlap portion to support injured finger formed by first tab of Sivy in view of Buechele within the first perforation of Sivy in view of Buechele and second tab of Yoshikawa within second perforation of Sivy in view of Buechele in view of Yoshikawa) for supporting the injured digit in which the first and second end portions are fixed together by the first tab inserted into one of the plurality of band slots and the second tab inserted into another of the plurality of band slots (Modification of Figure 1 of Sivy in view of Figure 1 Buechele in view of Figure 1 of Yoshikawa: modifying the band 2 of Sivy to have an elongated member comprising a first tab, as taught by Buechele, and second tab, as taught by Yoshikawa , wherein the tabs are inserted through perforations 11 of the band 2 of Sivy and a corresponding perforation of the elongated member of Sivy in view of Buechele in view of Yoshikawa, such that the tabs protrude from an upper surface in the loop configuration).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sivy (FR 3031897 A1) in view of Buechele et al. (EP 0020943 A1) in view of Yoshikawa (JP 2006271872 A) in view of Pittman et al. (U.S. Patent No. 5323754), as applied to claim 1, and in further view of Bolla et al. (U.S. Patent No. 6039706).
Regarding claim 3, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above. Sivy further discloses wherein the band 2 comprises an elastomeric polymer (Paragraph 44, polymer with good elasticity for mobility of injured finger).
However, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman fails to explicitly disclose the elastomeric polymer is polyurethane or silicone.
Bolla teaches an analogous splint 118 (Col. 7, line 50 and Figures 6a-6b, finger splint 139 for wrapping around finger) wherein the analogous band 151 (Col. 7, lines 50-53, Col. 10, lines 30-31, and Figures 6a-6b, band cover 151 formed of elastic polyurethane)comprises an analogous elastomeric polymer (Col. 10, lines 30-31, cover 151 formed of elastic polyurethane) comprising polyurethane.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elastomeric polymer material of the band of Sivy in view of Buechele in view of Yoshikawa in view of Pittman, so that the elastomeric polymer is polyurethane, as taught by Bolla, in order to provide an improved splint with an enhanced band having desirable elastic polyurethane foam material properties (Bolla, Col. 10, lines 30-31).
Claims 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sivy (FR 3031897 A1) in view of Buechele et al. (EP 0020943 A1) in view of Yoshikawa (JP 2006271872 A) in view of Pittman et al. (U.S. Patent No. 5323754), as applied to claim 1 and 16, respectively, and in further view Jane (U.S. Patent No. 2354770) and Nakamura (U.S. Patent Pub. No. 20160270942).
Regarding claim 4, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above and further discloses wherein the at least one elongated member 1 (Buechele, Abstract, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, elongated member 1 is a strip 1 having a greater width than thickness thereby defining a plate; Yoshika, Page 3/18, Paragraphs 4 to 7 and Figure 1, elongated member with 25 cm length, 1-2mm thick, and 25mm wide) comprises a plate having a width that is greater than a thickness of the plate.
However, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman fails to explicitly disclose (1) wherein the band is from about 15 cm to about 60 cm in length, about 5 mm to about 20 mm in width, and about 1.0 mm to about 5.0 mm thick.
Jane teaches an analogous splint (Col. 2, lines 15-17 and Figure 9, toe shield) wherein the analogous splint (Col. 2, lines 15-17 and Figure 9) is in the analogous loop configuration (Col. 2, lines 15-17 and Figure 9, toe shield forms loops on middle and little toes with fourth toe supported on upper surface of a central portion of the toe shield) with a first finger of a hand of the patient, a second finger of the hand adjacent to the first finger, and a third finger of the hand adjacent to the second finger Col. 2, lines 15-17 and Figure 9, shield is wrapped around two adjacent appendages to a central injured appendage).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the loop configuration of Sivy in view of Buechele in view of Yoshikawa in view of Pittman, so that in the loop configuration, the splint is in the loop configuration with a first finger of a hand of the patient, a second finger of the hand adjacent to the first finger, and a third finger of the hand adjacent to the second finger, as taught by Jane, in order to provide an improved splint with an enhanced loop that encircles adjacent appendages with the middle appendage separated from the adjacent appendage by the loop configuration (Jane, Col. 2, lines 15-17).
However, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane fails to explicitly disclose (1) wherein the band is from about 15 cm to about 60 cm in length, about 5 mm to about 20 mm in width, and about 1.0 mm to about 5.0 mm thick.
Nakamura teaches an analogous splint 1 (Paragraphs 34, 39, 42, 49, and Figure 3b, interdigital pad 1) with the analogous loop configuration (Figure 3B, loop configuration formed on adjacent digits with central injured digits supported on upper surface of a central portion of the interdigital pad 1) having an analogous overlapping region 2,31,42 (Figure 3B, overlap of portions 2,31,42 that extend from dorsal surfaces of adjacent side uninjured toes) extend from dorsal surfaces of the uninjured appendages.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify an overlapping region of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane, so that the overlapping region extends from dorsal surfaces of the uninjured fingers, as taught by Nakamura, in order to provide an improved splint with an enhanced overlapping region located at dorsal sides of adjacent fingers for increased separation and support of the injured appendage therebetween (Nakamura, Paragraphs 34, 39, 42, and 49).
Therefore, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane in view of Nakamura discloses an overlapping region is configured to be a length (Modification of Figure 1 of Sivy in view of Figure 1 of Buechele in view of Figure 1 of Yoshikawa in view of Figure 9 of Jane in view of Figure 3b of Nakamura: modifying the loop configuration forming the overlapping region of Sivy in view of Buechele in view of Yoshikawa, so that the loop configuration forms a first loop on a first adjacent finger to the central injured finger and a second loop on a second adjacent finger to the central injured finger, as taught by Jane. Furthermore, the overlapping region of Sivy in view of Buechele in view of Yoshikawa in view of Jane is modified such that the overlapping region is located on a dorsal side of the adjacent uninjured fingers, as taught by Nakamura, such that the overlapping region of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane in view of Nakamura has an outward facing surface engaging a volar surface of the injured central finger in flexion and extension) to contact a dorsal surface of a first finger of a hand of the patient, a volar surface of a second finger of the hand adjacent to the first finger, and a dorsal surface of a third finger of the hand adjacent to the second finger.
However, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane in view of Nakamura fails to explicitly disclose (1) wherein the band is from about 15 cm to about 60 cm in length, about 5 mm to about 20 mm in width, and about 1.0 mm to about 5.0 mm thick.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the band of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane in view of Nakamura to be about 15 cm to about 60 cm in length, about 5 mm to about 20 mm in width, and about 1.0 mm to about 5.0 mm thick since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984); see MPEP 2144.04(iv)(a). In the instant case, the device of Sivy in view of Buechele in view of Yoshikawa in view of Jane in view of Nakamura would not operate differently with the claimed size as the band and elongated plate of the prior art is also intended to reside and wrap around correspondingly sized fingers of a patient. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the sizes are “about”, which is a relative indefinite term unbounding the claimed ranges (specification pp. [0055] and [0058]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the band of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane in view of Nakamura to be about 15 cm to about 60 cm in length, about 5 mm to about 20 mm in width, and about 1.0 mm to about 5.0 mm thick as an obvious matter of design choice within the skill of the art.
Regarding claim 18, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above but fails to explicitly disclose (1) the splint is configured to at least two supporting digits and the injured digit; (2) the overlapping region is configured to be of sufficient length to contact dorsal surfaces of the at least two supporting digits and a volar surface of the injured digit.
Jane teaches an analogous splint (Col. 2, lines 15-17 and Figure 9, toe shield) in an analogous loop configuration (Col. 2, lines 15-17 and Figure 9, toe shield forms loops on middle and little toes with fourth toe supported on upper surface of a central portion of the toe shield) is configured to at least two supporting digits and the injured digit (Col. 2, lines 15-17 and Figure 9, toe shield forms loops on middle and little toes with fourth toe supported on upper surface of a central portion of the toe shield).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the loop configuration of Sivy in view of Buechele in view of Yoshikawa in view of Pittman, so that in the loop configuration, the splint is configured to at least two supporting digits and the injured digit, as taught by Jane, in order to provide an improved splint with an enhanced loop that encircles adjacent appendages with the middle appendage separated from the adjacent appendage by the loop configuration (Jane, Col. 2, lines 15-17).
However, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane fails to explicitly disclose (2) the overlapping region is configured to be of sufficient length to contact dorsal surfaces of the at least two supporting digits and a volar surface of the injured digit.
Nakamura teaches an analogous splint 1 (Paragraphs 34, 39, 42, 49, and Figure 3b, interdigital pad 1) the analogous overlapping region 2,31,42 (Figure 3B, overlap of portions 2,31,42 that extend from dorsal surfaces of adjacent side uninjured toes) is configured to be of sufficient length to contact dorsal surfaces of the at least two supporting digits and a volar surface of the injured digit.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the overlapping region of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane, so that the overlapping region extends from dorsal surfaces of the uninjured fingers, as taught by Nakamura, in order to provide an improved splint with an enhanced overlapping region located at dorsal sides of adjacent fingers for increased separation and support of the injured appendage therebetween (Nakamura, Paragraphs 34, 39, 42, and 49).
Therefore, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane in view of Nakamura discloses the overlapping region is configured to be a length (Modification of Figure 1 of Sivy in view of Figure 1 of Buechele in view of Figure 1 of Yoshikawa in view of Figure 9 of Jane in view of Figure 3b of Nakamura: modifying the loop configuration forming the overlapping region of Sivy in view of Buechele in view of Yoshikawa, so that the loop configuration forms a first loop on a first adjacent finger to the central injured finger and a second loop on a second adjacent finger to the central injured finger, as taught by Jane. Furthermore, the overlapping region of Sivy in view of Buechele in view of Yoshikawa in view of Jane is modified such that the overlapping region is located on a dorsal side of the adjacent uninjured fingers, as taught by Nakamura, such that the overlapping region of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane in view of Nakamura has an outward facing surface engaging a volar surface of the injured central finger in flexion and extension) to contact a dorsal surface of a first finger of a hand of the patient, a volar surface of a second finger of the hand adjacent to the first finger, and a dorsal surface of a third finger of the hand adjacent to the second finger.
9. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sivy (FR 3031897 A1) in view of Buechele et al. (EP 0020943 A1) in view of Yoshikawa (JP 2006271872 A) in view of Pittman et al. (U.S. Patent No. 5323754), as applied to claim 1, and in further view Geller et al. (U.S. Patent Pub. No. 20060287160).
Regarding claim 11, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above but fails to explicitly disclose wherein the flat metal sheet comprises stainless steel.
Geller teaches an analogous elongated plate 14 (Paragraph 22 and Figures 1-2, elongated flat weight member 22 is stainless steel for wrapping around finger) comprising analogous flat metal sheet of stainless steel.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to substitute a spring steel material of the elongated flat metal sheet of Sivy in view of Buechele in view of Yoshikawa in view of Pittman, for a stainless steel material of Geller, in order to provide an improved splint with an enhanced splint providing increased strength as well as weighted support for the user’s finger (Geller, Paragraph 22).
10. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sivy (FR 3031897 A1) in view of Buechele et al. (EP 0020943 A1) in view of Yoshikawa (JP 2006271872 A) in view of Pittman et al. (U.S. Patent No. 5323754) in view of Jane (U.S. Patent No. 2354770) in view of Nakamura (U.S. Patent Pub. No. 20160270942), as applied to claim 18, and in further view Neubauer (DE 202018000399).
Regarding claim 19, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane in view of Nakamura discloses the invention as described above but fails to explicitly disclose wherein the injured digit comprises a middle finger or a ring finger of a hand of the patient, and the at least two supporting digits comprise at least two of a pinky finger, ring finger, middle finger, or index finger of the patient.
Neubauer teaches an analogous splint 1 (Paragraphs 13, 17, 19 and Figures 2 and 4, finger fixing device 1 for middle or ring configured as injured finger with adjacent finger on both medial and lateral sides of injured finger also being supported by the splint 1) wherein the injured digit comprises a middle finger or a ring finger of a hand of the patient, and the at least two supporting digits comprise at least two of a pinky finger, ring finger, middle finger, or index finger of the patient.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify an applied sizing of the splint of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Jane in view of Nakamura, so that the splint is sized such that the injured digit comprises a middle finger or a ring finger of a hand of the patient, and the at least two supporting digits comprise at least two of a pinky finger, ring finger, middle finger, or index finger of the patient, as taught by Neubauer, in order to provide an improved splint with an enhanced sizing that wraps and supports the injured fingers as well as adjacent finger, such as the pinky, ring, middle, or index finger for versatility of application to different fingers as well as stabilizing support throughout the majority of the fingers of the hand (Neubauer, Paragraphs 13, 17, 19).
11. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sivy (FR 3031897 A1) in view of Buechele et al. (EP 0020943 A1) in view of Yoshikawa (JP 2006271872 A) in view of Pittman et al. (U.S. Patent No. 5323754), as applied to claim 1, and in further view Nakamura (U.S. Patent Pub. No. 20160270942).
Regarding claim 20, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman discloses the invention as described above and further discloses a method of treating an injured digit of a patient with the splint of claim 1, the method comprising: inserting the first tab of the elongated plate of the splint of claim 1 into a first band slot of the plurality of band slots and an aligned first plate slot of the plurality of plate slots and inserting the second tab of the elongated plate into a second aligned band and plate slot of the plurality of band and plate slots, thereby connecting the first end portion and the second end portion of the band together such that the splint is in the loop configuration (Modification of Figure 1 of Sivy in view of Figure 1 Buechele in view of Figure 1 of Yoshikawa in view of Figure 1 of Pittman: modifying the band 2 of Sivy to have an elongated member comprising a first and second tab, as taught by Buechele, wherein the first and second tab are each inserted through a first and second perforation 11 of the band 2 of Sivy, as taught by Yoshikawa, and a corresponding aligned perforation of the elongated plate member, as taught by Pittman in the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman), with the first end portion of the band and a portion of the elongated plate overlapping (Modification of Figure 1 of Sivy in view of Figure 1 Buechele in view of Figure 1 of Yoshikawa: overlap portion to support injured finger formed by first tab of Sivy in view of Buechele within the first perforation of Sivy in view of Buechele and second tab of Yoshikawa within second perforation of Sivy in view of Buechele in view of Yoshikawa) the second end portion of the band and another portion of the elongated plate forming an overlapping region configured to support the injured digit.
However, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman fails to explicitly disclose once the splint of claim 1 is in the loop configuration, sliding the splint onto the patient; and positioning the injured limb and/or appendage so that the injured limb and/or appendage rests against an outwardly facing surface of the overlapping region of the band.
Nakamura teaches an analogous splint 1 (Paragraphs 34, 39, 42, 49, and Figure 3b, interdigital pad 1) is in the analogous loop configuration, sliding (Paragraphs 34, 39, 42, 49, and Figure 3b, pad 1 slid onto toes) the analogous splint 1 onto the patient; and having the analogous overlapping region 2,31,42 (Figure 3B, overlap of portions 2,31,42 that extend from dorsal surfaces of adjacent side uninjured toes) extend from dorsal surfaces of the uninjured appendages.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the overlapping region of Sivy in view of Buechele in view of Yoshikawa in view of Pittman, so that the overlapping region extends from dorsal surfaces of the uninjured fingers with the splint slid onto the patient, as taught by Nakamura, in order to provide an improved splint that is simple to don via sliding with an enhanced overlapping region located at dorsal sides of adjacent fingers for increased separation and support of the injured appendage therebetween (Nakamura, Paragraphs 34, 39, 42, and 49).
Therefore, the combination of Sivy in view of Buechele in view of Yoshikawa in view of Pittman in view of Nakamura discloses positioning the injured limb and/or appendage so that the injured limb and/or appendage rests against an outwardly facing surface (Modification of Figure 1 of Sivy in view of Figure 1 of Buechele in view of Figure 1 of Yoshikawa in view of Figure 3b of Nakamura: modifying the loop configuration forming the overlapping region of Sivy in view of Buechele in view of Yoshikawa, so that the loop configuration forms a first loop on a first finger and a second loop on a second finger. Furthermore, the overlapping region of Sivy in view of Buechele in view of Yoshikawa is modified such that the overlapping region is located on a dorsal side of the adjacent uninjured fingers, as taught by Nakamura, such that the overlapping region of Sivy in view of Buechele in view of Yoshikawa in view of Nakamura has an outward facing surface engaging a volar surface of the injured central finger in flexion and extension) of the overlapping region of the band 2 (Sivy, Paragraph 14).
Allowable Subject Matter
12. Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
13. The following is a statement of reasons for the indication of allowable subject matter:
Claim 17 would be allowable for disclosing wherein, in the loop configuration, the splint is configured to be wrapped around at least two supporting digits, which are adjacent to the injured digit, and to support the injured digit on an outwardly facing surface of the overlapping region, with the injured digit moved vertically downward during flexion of a proximal interphalangeal joint of the injured digit, and with the injured digit moved vertically upward during extension of the proximal interphalangeal joint of the injured digit.
Regarding claim 17, Sivy discloses a splint 1 (Paragraph 11 and Figure 1, device 1 for holding and/or protecting at least two fingers) configured to support an injured appendage of a patient, the splint 1 comprising: a band 2 (Paragraph 14 and Figure 1, strip 2) comprising a first end portion 5 (Paragraph 17 and Figure 1, first end part 5 of band 2), a second end portion 6 (Paragraph 17 and Figure 1, second end part 6 of band 2), and a middle portion 13 (Paragraph 32 and Figure 1, central portion 13 of band 2) extending between the first and second end portions 5,6 of the band 2; a first tab 7 (Paragraph 19 and Figure 1, lugs 7); and at least one first perforation 11 (Paragraph 19 and Figure 1, openings 11 to receive lugs 7 to form loop 20) through the band 2 sized to receive the first tab 7 for securing the end portions 5,6 of the band 2 together forming at least one loop 20 (Paragraph 14 and Figure 1, loop 20 wraps around fingers) sized to wrap around at least a portion of the injured appendage for supporting the injured limb appendage.
Buechele (EP 0020943 A1) teaches an analogous band 8 (Abstract, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, covering band 8 formed of rubber elastic material ) and at least one elongated member 1 (Abstract, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, bendable strip 1 partially enclosed by band 8) formed from a bendable material at least partially enclosed by the analogous band 8, the at least one elongated member 1 comprising (i) the analogous first tab 4 (Abstract, Page 2/17, Paragraph 6 to Page 3/17 Paragraph 1, and Figure 1, bendable tab 4 of elongated strip 1 on first latitudinal end of strip 1 bent along transverse line of neck 5) on a first latitudinal end of the at least one elongated member 1 capable of being bent along a bending line transverse to a longitudinal axis of the analogous middle portion (Figure 1, middle portion of band 8) of the analogous band 8, and (iii) a middle portion (Figure 1, middle portion of strip 1 extends axially through the band) of the elongated member 1 that extends axially through the band.
Yoshikawa (JP 2006271872 A) teaches an analogous elongated member 1 (Page 3/18, Paragraphs 4 to 7 and Figure 1, flexible elongated member 1) comprising an analogous first tab 21 (Page 3/18, Paragraph 7 and Figure 1, upper tab 21) and a second tab 21 (Page 3/18, Paragraph 7 and Figure 1, lower tab 21 on second latitudinal end of the elongated member 1 being bent on a transverse line of base portion 22) on a second latitudinal end of the at least one analogous elongated member 1 capable of being bent along a bending line transverse to a longitudinal axis of a middle portion of the analogous elongated member 1, and (iii) the analogous middle portion (Figure 1, middle portion of elongated member 1 between first and second tabs 21) of the analogous elongated member 1 between the first tab and the second tab.
Liebowitz (US 20070021700 A1) teaches an analogous splint (Paragraph 31 and Figure 3) that is on the proximal phalanx and allows flexion and extension of the distal interphalangeal to move upwards and downwards in extension and flexion.
Pittman . (U.S. Patent No. 5323754) teaches an analogous splint (Col. 6, lines 10-30 and Figures 1 and 5, splint comprising through-holes 44-46 of band 18 cover 26 and rigid plate 10. The plate 10 is embedded by middle portion 26 as well as first end portion area 60 and second end portion area 62) comprising an analogous band 18 sleeved over a core analogous elongated plate 10 embedded or enclosed by the analogous first end portion 60, the analogous second end portion 62, and the analogous middle portion 26 of the analogous band 18; wherein the analogous plurality of band slots and the analogous plurality of plate slots 44-46 are aligned.
Based on the structures of Buechele, Yoshikawa, Liebowitz, Pittman, and any other prior art of record it would be improper hindsight to modify Sivy so that “the injured digit moved vertically downward during flexion of a proximal interphalangeal joint, and with the injured digit moved vertically upward during extension of the proximal interphalangeal joint” in combination with the other recited elements of claim 17. One of ordinary skill would instead be drawn to the structure of Sivy, Buechele, Yoshikawa, Liebowitz for the location of the splint on the finger portions. Although Liebowitz has the splint on the proximal phalanx of the injured and adjacent finger, Liebowitz’s splint also extends to the middle phalanx such that a proximal interphalangeal joint is not defined as providing extension or flexion . Therefore, none of the prior art in combination suggest the amended claim limitations, which provides the desired finger location parameters. Therefore the combination of features is considered to be allowable.
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.
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/MICHAEL MILO/
Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
Prosecution Insights