DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the preliminary amendment filed on July 23, 2024. As directed by the amendment: claims 1, 3-5, 7-15, and 18 have been amended, claims 19-21 have been added, claim 2 has been canceled. Thus claims 1, 3-21 are presently pending in this application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 23, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: axial spines 301 (see [0058] of instant specification). The examiner notes that reference number 131 in Figs. 3A-B appears to refer to the axial spines of the axial strip, and reference number 131 is not the specification. Therefore, the examiner interprets the axial spines 301 to refer to reference number 131 in the figures. 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. 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
Claim 7 is objected to because of the following informalities: claim 7 recites “The expandable introducer of of claim 1”, should read “The expandable introducer of claim 1”. Appropriate correction is required.
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, 3-4, 7-8, 10-11, 15, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Furnish et al. (US 20160074067), hereinafter Furnish, in view of Zhou et al. (US 20160296730), hereinafter Zhou.
Regarding claim 1, Furnish discloses an expandable introducer (Fig. 1, expandable introducer sheath 10) comprising: an introducer hub (Fig. 1, hub 20); and an introducer sheath (Fig. 1-2, sheath body 14) coupled to the introducer hub and extending distally therefrom (Fig. 2, sheath body 14 coupled to hub 20 and extending distally therefrom), the introducer sheath including: a mesh tube (Figs. 3-4 and 7, reinforcement member 26); a liner disposed inside the mesh tube (Fig. 4, inner layer 22, disposed within reinforcement member 26), the liner defining a central lumen (Fig. 4, inner layer 22 defines inner lumen); wherein the introducer sheath is radially expandable from a radially unexpanded state wherein the central lumen has a first diameter (Fig. 4-5 and [0029], introducer sheath 10 is expandable from an original/static diameter within the central lumen) to a radially expanded state wherein the central lumen has a second diameter larger than the first diameter (Fig. 5-7 and [0029], introducer sheath 10 may expand to an expanded diameter within the central lumen); wherein the liner in the radially unexpanded state includes a fold (Fig. 4, inner layer 22 has fold 36 in unexpanded state), and wherein the liner unfolds to expand to the radially expanded state (Fig. 4 and [0035], fold 36 facilitates the radial expansion of the introducer sheath 10 via its unfolding).
Furnish fails to disclose an axial strip disposed between the liner and the mesh tube, the axial strip bonding the liner to the mesh tube. However, Zhou discloses an axial strip disposed between the liner and the mesh tube (Fig. 9 and [0078], longitudinally extending strip 70 disposed between inner layer 42 and its adjacent surrounding outer layer 40 (equivalent positional relationship as the inner layer 22 and the reinforcement member 26 of Furnish)), the axial strip bonding the liner to the mesh tube (Fig. 9 and [0078], strip 70 bonds/adheres the inner layer 42 and outer layer 40).
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 Furnish to incorporate the disclosures of Zhou and modify the expandable introducer to have an axial strip disposed between the liner and the mesh tube, the axial strip bonding the liner to the mesh tube. Doing so would prevent free rotation of the layers of the introducer with respect to each other while also not affecting the folded configuration of the inner layer nor inhibiting expansion capabilities to ensure the effect on the push force of the device is minimized (Zhou, [0078]).
Regarding claim 3, Furnish, in view of Zhou, discloses the expandable introducer of claim 1.
However, Furnish, in view of Zhou, does not expressly disclose wherein the first diameter is in the range of about 3 mm to about 5 mm.
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 device of Furnish, in view of Zhou, to have a first diameter in the range of about 3 mm to about 5 mm, 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). In the instant case, the modified device of Furnish would not operate differently with first diameter range and Furnish discloses in Fig. 4-5 and [0030-0031] that the introducer sheath is constructed such that its contracted state may easily insert into and travel within a blood vessel. Therefore, the device would function appropriately having the claimed first diameter range. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the first diameter "may be" in the range of about 3 mm to about 5 mm (instant specification [0058]).
Regarding claim 4, Furnish, in view of Zhou, discloses the expandable introducer of claim 3.
However, Furnish, in view of Zhou, does not expressly disclose wherein the second diameter is in the range of about 8 mm to about 10 mm.
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 device of Furnish, in view of Zhou, to have a second diameter in the range of about 8 mm to about 10 mm, 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). In the instant case, the modified device of Furnish would not operate differently with second diameter range and Furnish discloses in Fig. 4-5 and [0030-0031] that the introducer sheath is constructed such that its expanded state may allow for a larger medical device to be advanced into a blood vessel, past any calcification present in the vessel. Therefore, the device would function appropriately having the claimed second diameter range. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the second diameter "may be" in the range of about 8 mm to about 10 mm (instant specification [0058]).
Regarding claim 7 and Furnish, in view of Zhou, Furnish further discloses the expandable introducer of of claim 1, wherein the liner is a thin, flexible plastic tube configured to expand from a folded state to an unfolded state in response to a device being advanced through the central lumen (Fig. 4-5 and [0032, 0035], inner layer 22 is made of a thin and flexible layer of a polymeric material such as PTFE/ePTFE/polyethylene, which may expand to its unfolded state as medical device 12 is advanced through its lumen).
Regarding claim 8 and Furnish, in view of Zhou, Furnish further discloses the expandable introducer of claim 1, wherein the liner comprises a single fold that is configured to unfold to radially expand the liner in response to a device being advanced through the central lumen (Fig. 4-5 and [0035], inner layer 22 comprises a singular fold, which unfolds to facilitate radial expansion as medical device 12 is advanced through its lumen).
Regarding claim 10 and Furnish, in view of Zhou, Furnish further discloses the expandable introducer of claim 1, wherein the liner comprises polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) ([0032], inner layer 22 is comprised of ePTFE), fluorinated ethylene propylene (FEP), and/or perfluoroalkoxy (PFA).
Regarding claim 11, Furnish, in view of Zhou, discloses the expandable introducer of claim 1.
However, Furnish, in view of Zhou, does not expressly disclose wherein the liner has a thickness in the range of about 0.05 mm to about 0.40 mm.
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 device of Furnish, in view of Zhou, to have a liner thickness in the range of about 0.05 mm to about 0.40 mm, 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). In the instant case, the modified device of Furnish would not operate differently with the liner thickness range and Furnish discloses in Fig. 4 and [0032, 0035] that the inner layer 22 is constructed as a thin layer of elastomeric material which may unfold to facilitate radial expansion in order to ease axial movement of a medical device through the sheath/the vessel. Therefore, the device would function appropriately having the claimed liner thickness range. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the liner "may have" a thickness in the range of about 0.05 mm to about 0.40 mm (instant specification [0055]).
Regarding claim 15, Furnish, in view of Zhou, discloses the expandable introducer of claim 1, as explained above. As noted above, Furnish fails to disclose the axial strip and is thus silent to wherein the axial strip includes an axial spine. However, Zhou further discloses wherein the axial strip includes an axial spine (Fig. 9 and [0078], axial strip may be a thin bonding line, thus making it an axial spine).
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 Furnish, in view of Zhou, to further incorporate the disclosures of Zhou and modify the axial strip to include an axial spine.
Doing so would prevent free rotation of the layers of the introducer with respect to each other while also not affecting the folded configuration of the inner layer to ensure the effect on the push force of the device is minimized (Zhou, [0078]).
Regarding claim 19, Furnish discloses an expandable introducer (Fig. 1, expandable introducer sheath 10) comprising: an introducer hub (Fig. 1, hub 20); and an introducer sheath (Fig. 1-2, sheath body 14) coupled to the introducer hub and extending distally therefrom (Fig. 2, sheath body 14 coupled to hub 20 and extending distally therefrom), the introducer sheath including: a mesh tube (Figs. 3-4 and 7, reinforcement member 26); a liner disposed inside the mesh tube (Fig. 4, inner layer 22, disposed within reinforcement member 26), the liner defining a central lumen (Fig. 4, inner layer 22 defines inner lumen); wherein the introducer sheath is radially expandable from a radially unexpanded state wherein the central lumen has a first diameter (Fig. 4-5 and [0029], introducer sheath 10 is expandable from an original/static diameter within the central lumen) to a radially expanded state wherein the central lumen has a second diameter larger than the first diameter (Fig. 5-7 and [0029], introducer sheath 10 may expand to an expanded diameter within the central lumen).
Furnish fails to disclose an axial strip disposed between the liner and the mesh tube, the axial strip bonding the liner to the mesh tube, wherein the axial strip extends only partially around the circumference of the liner, and wherein the liner is bonded to the mesh tube only through the axial strip. However, Zhou discloses an axial strip disposed between the liner and the mesh tube (Fig. 9 and [0078], longitudinally extending strip 70 disposed between inner layer 42 and its adjacent surrounding outer layer 40 (equivalent positional relationship as the inner layer 22 and the reinforcement member 26 of Furnish)), the axial strip bonding the liner to the mesh tube (Fig. 9 and [0078], strip 70 bonds/adheres the inner layer 42 and outer layer 40), wherein the axial strip extends only partially around the circumference of the liner (Fig. 9, strip 70 extends around only a portion of the circumference of inner layer 42), and wherein the liner is bonded to the mesh tube only through the axial strip (Fig. 9 and [0078], adherence between inner layer 42 and outer layer 40 is only at the axial strip).
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 Furnish to incorporate the disclosures of Zhou and modify the expandable introducer to have an axial strip disposed between the liner and the mesh tube, the axial strip bonding the liner to the mesh tube, wherein the axial strip extends only partially around the circumference of the liner, and wherein the liner is bonded to the mesh tube only through the axial strip. Doing so would prevent free rotation of the layers of the introducer with respect to each other while also not affecting the folded configuration of the inner layer nor inhibiting expansion capabilities to ensure the effect on the push force of the device is minimized (Zhou, [0078]).
Regarding claim 20 and Furnish, in view of Zhou, Furnish further discloses the expandable introducer of claim 19, wherein the liner in the radially unexpanded state includes a fold (Fig. 4, inner layer 22 has fold 36 in unexpanded state), and wherein the liner unfolds to expand to the radially expanded state (Fig. 4 and [0035], fold 36 facilitates the radial expansion of the introducer sheath 10 via its unfolding).
Regarding claim 21, Furnish, in view of Zhou, discloses the expandable introducer of claim 20, as explained above. As noted above, Furnish fails to disclose the axial strip and is thus silent to wherein the fold in the liner is located circumferentially spaced from the axial strip. However, Zhou further discloses wherein the fold in the liner is located circumferentially spaced from the axial strip (Fig. 9 and [0078], the strip 70 is positioned circumferentially away from folded region 66/68 of inner layer 42).
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 Furnish, in view of Zhou, to further incorporate the disclosures of Zhou and modify the expandable introducer such that the fold in the liner is located circumferentially spaced from the axial strip. Doing so would prevent free rotation of the layers of the introducer with respect to each other while also not affecting the folded configuration of the inner layer to ensure the effect on the push force of the device is minimized (Zhou, [0078]).
Claims 5-6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Furnish (US 20160074067), in view of Zhou (US 20160296730), as applied to claim 1 above, and further in view of Zhou et al. (US 20160296332), hereinafter Zhou2.
Regarding claim 5, Furnish, in view of Zhou, discloses the expandable introducer of claim 1.
Furnish, in view of Zhou, fails to disclose wherein the mesh tube comprises a braided, mesh material comprising a plurality of braided fibers arranged in a braided or mesh pattern to form an open-cell fibrous wall material. However, Zhou2 discloses wherein the mesh tube comprises a braided, mesh material comprising a plurality of braided fibers arranged in a braided or mesh pattern to form an open-cell fibrous wall material (Fig. 3 and [0063], expandable mesh layer 22 is a braided material formed of thread material arranged in a woven braid with porous openings to promote the expansion and flexibility).
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 Furnish, in view of Zhou, to incorporate the disclosures of Zhou2 and modify the mesh tube to comprise a braided, mesh material comprising a plurality of braided fibers arranged in a braided or mesh pattern to form an open-cell fibrous wall material. Doing so would provide a mesh tube layer which both obtains flexibility and some push stiffness, while also promoting expansion, such that the overall introducer may provide a good balance of stiffness, expansion/recovery, and low resistance to the passage of implants/devices within (Zhou2, [0063, 0067]).
Regarding claim 6, Furnish, in view of Zhou and Zhou2, discloses the expandable introducer of claim 5, as explained above. As noted above, Furnish, in view of Zhou, does not disclose the plurality of braided fibers, and is thus silent to wherein the plurality of braided fibers comprise a polymeric material. However, Zhou2 further discloses wherein the plurality of braided fibers comprise a polymeric material (Fig. 3 and [0063], braided fibers comprise polyethylene terephthalate (PET)).
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 Furnish, in view of Zhou and Zhou2, to further incorporate the disclosures of Zhou2 and modify the plurality of braided fibers to comprise a polymeric material. Doing so would provide a mesh tube layer which both obtains flexibility and some push stiffness, while also promoting expansion, such that the overall introducer may provide a good balance of stiffness, expansion/recovery, and low resistance to the passage of implants/devices within (Zhou2, [0063, 0067]).
Regarding claim 18, Furnish, in view of Zhou, discloses the expandable introducer of claim 1.
Furnish, in view of Zhou, fails to disclose wherein the introducer sheath includes a proximal portion coated with a substantially non-porous expandable layer to assist with establishing a hemostatic seal when the expandable introducer is introduced to a patient's vasculature. However, Zhou2 discloses wherein the introducer sheath includes a proximal portion coated with a substantially non-porous expandable layer to assist with establishing a hemostatic seal when the expandable introducer is introduced to a patient's vasculature (Fig. 2 and 7, [0068-0071], sheath 3 may have an outer layer which extends to a proximal end of the sheath which has a portion that comprises a non porous elastic wall 54 which may temporarily expand for passage of a device such as implant 5 and seals off the inner lumen 32 of the device).
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 Furnish, in view of Zhou, to incorporate the disclosures of Zhou2 and modify the introducer sheath to include a proximal portion coated with a substantially non-porous expandable layer to assist with establishing a hemostatic seal when the expandable introducer is introduced to a patient's vasculature. Doing so would provide a layer which encapsulates the rest of the structure of the introducer sheath to both seal off the lumen and to allow for temporary expansion of the lumen when a device passes through, then urge the lumen back to its original diameter when the pressure of a passing device is no longer present (Zhou2, [0070-0069]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Furnish (US 20160074067), in view of Zhou (US 20160296730), as applied to claim 1 above, and further in view of Fitterer et al. (US 20180161064), hereinafter Fitterer.
Regarding claim 9, Furnish, in view of Zhou, discloses the expandable introducer of claim 1.
Furnish, in view of Zhou, fails to disclose wherein the liner comprises two or more folds that are configured to unfold to radially expand the liner in response to a device being advanced through the central lumen. However, Fitterer discloses wherein the liner comprises two or more folds that are configured to unfold to radially expand the liner in response to a device being advanced through the central lumen (Fig. 6, 9 and [0078, 0089, 0101-0103], liner 20 comprises 3 folds 34 which are configured to unfold and radially expand liner when a medical device is advanced through the lumen 22).
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 Furnish, in view of Zhou, to incorporate the disclosures of Fitterer and modify the liner to comprise two or more folds that are configured to unfold to radially expand the liner in response to a device being advanced through the central lumen. Doing so would help provide a liner which in the delivery position would have a smaller diameter than the diameter of the liner in the expanded position, while also providing the desired unfolding capabilities/configuration of the liner (Fitterer, [0076, 0077]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Furnish (US 20160074067), in view of Zhou (US 20160296730), as applied to claim 1 above, and further in view of Cottone et al. (US 20200222664), hereinafter Cottone.
Regarding claim 12, Furnish, in view of Zhou, discloses the expandable introducer of claim 1.
Furnish, in view of Zhou, fails to disclose wherein the axial strip comprises a high durometer polymer. However, Cottone discloses wherein the axial strip comprises a high durometer polymer (Fig. 30 and [0149], a PEBAX powder is applied as bonding. Examiner notes: PEBAX is considered a high durometer powder as stated in instant specification [0056]).
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 Furnish, in view of Zhou, to incorporate the disclosures of Cottone and modify the axial strip to comprise a high durometer polymer. Doing so would provide the device with a bonding material which has a melting temperature which is less than that of the material of the liner, so that the material may be heated and applied to the liner to effectively attach the liner to the surrounding mesh tube (Cottone, [0149]).
Regarding claim 13, Furnish, in view of Zhou, discloses the expandable introducer of claim 1.
Furnish, in view of Zhou, fails to disclose wherein the axial strip comprises a polyamide 12 material and/or a polyether block amide material. However, Cottone discloses wherein the axial strip comprises a polyamide 12 material and/or a polyether block amide material (Fig. 30 and [0149], a PEBAX (polyether block amide) powder is applied as bonding).
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 Furnish, in view of Zhou, to incorporate the disclosures of Cottone and modify the axial strip to comprise a polyamide 12 material and/or a polyether block amide material. Doing so would provide the device with a bonding material which has a melting temperature which is less than that of the material of the liner, so that the material may be heated and applied to the liner to effectively attach the liner to the surrounding mesh tube (Cottone, [0149]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Furnish (US 20160074067), in view of Zhou (US 20160296730), as applied to claim 1 above, and further in view of Fine et al. (US 20230056245), hereinafter Fine.
Regarding claim 14, Furnish, in view of Zhou, discloses the expandable introducer of claim 1.
Furnish, in view of Zhou, fails to disclose wherein the axial strip extends about 70 deg. to about 180 deg. around a circumference of the mesh tube with the introducer sheath in the radially unexpanded state. However, Fine discloses wherein the axial strip extends about 70 deg. to about 180 deg. around a circumference of the mesh tube with the introducer sheath in the radially unexpanded state (Fig. 58 and [0197], bond strip 144 may cover about 90 deg. of outer layer circumference).
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 Furnish, in view of Zhou, to incorporate the disclosures of Fine and modify the axial strip to extend about 70 deg. to about 180 deg. around a circumference of the mesh tube with the introducer sheath in the radially unexpanded state. Doing so would further aid in preventing the liner and mesh tube from bunching up in response to frictional forces when being advanced through the patient's vasculature (Fine, [0196]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Furnish (US 20160074067), in view of Zhou (US 20160296730), as applied to claim 15 above, and further in view of Sasamine et al. (US 20210220607), hereinafter Sasamine.
Regarding claim 16 and Furnish, in view of Zhou, Furnish further discloses the expandable introducer of claim 15, wherein the mesh tube comprises a thin, rigid wire (Fig. 7B and [0036], reinforcement member 26 comprises a spine 38 comprised of a thin rigid wire).
Furnish, in view of Zhou, fails to disclose wherein the axial spine comprises a thin, rigid wire. However, Sasamine discloses wherein the axial spine comprises the thin, rigid wire (Fig. 2 and [0044], the metal wire(s) of the reinforcement layer 260 (similar to spine 38 of reinforcement member 26 of Furnish) may then include a weld/solder joint which may extend along the longitudinal length of layer 260 as a thin, rigid wire bonding spine).
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 Furnish, in view of Zhou, to incorporate the disclosures of Sasamine and modify the axial spine to comprise a thin, rigid wire. Doing so would further provide an attachment which utilizes the wires properties to form a bonding connection which thus provides bonding with sufficient strength for clinical applications (Sasamine, [0003, 0044]).
Regarding claim 17 and Furnish, in view of Zhou, Furnish further discloses the expandable introducer of claim 15, wherein the mesh tube comprises two or more thin, rigid wires (Fig. 9-10 and [0038], reinforcement member 26 comprises a plurality of axial struts 46 comprised of a thin rigid wire).
Furnish, in view of Zhou, fails to disclose wherein the axial spine comprises two or more thin, rigid wires. However, Sasamine discloses wherein the axial spine comprises two or more thin, rigid wires (Fig. 2 and [0044], the metal wire(s) of the reinforcement layer 260 (similar to struts of reinforcement member 26 of Furnish) may then include weld/solder joints which may extend along the longitudinal length of layer 260 as thin, rigid wire bonding spines).
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 Furnish, in view of Zhou, to incorporate the disclosures of Sasamine and modify the axial spine to comprise two or more thin, rigid wires. Doing so would further provide an attachment which utilizes the wires properties to form a bonding connection which thus provides bonding with sufficient strength for clinical applications (Sasamine, [0003, 0036]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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