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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coffey et al. (EP 2590604 A1 – Cited by Applicant), hereinafter Coffey.
Regarding claim 1, Coffey discloses a transfer instrument [device 10, see in Fig. 1] that transfers a medical sheet to a treatment site of a living body [device 10 according to the invention that can be used to implant or deploy an implant or other object, preferably directly into an eye, see ¶ 0050; Examiner notes that an implant may be interpreted as a medical sheet or a cell sheet], the transfer instrument comprising:
a first carrier member including a first shaft [tip 13 with components 13a and
13b, see in Fig. 2] and a support portion [head portion 14, see in Fig. 2], the support portion being provided at a distal portion of the first shaft [see Figs. 1-3] and including a first support surface [see Figs. 3-7] on which the medical sheet is placed [see Figs.11 a-c]; and
a second carrier member [urging member 17, see in Fig. 5] including a second shaft and a pressing portion [implant 19, see Fig.11 c], the second shaft extending along an axial
direction of the first shaft [curved sidewalls 15 extending along 13, see Fig.11 c], the pressing portion [at least distal surface 17d extending into implant 19 in Fig. 7 and Fig. 11c] being provided at a distal portion of the second shaft [see Fig. 11 c], wherein the second carrier member is movable relative to the first carrier member so as to allow a pressing surface of the pressing portion to press, in a distal end direction, an outer edge surface of the medical sheet placed on the support surface [see Figs.11 a-b, showing distal surface 17d pressing implant 19 in a distal direction].
Regarding claim 2, Coffey discloses the transfer instrument according to claim 1, wherein the first shaft is formed in a tubular shape; and the second shaft is inserted into a lumen of the first shaft so as to be movable along the axial direction of the first shaft [tubular tip 13 and element 17, see in Figs. 11a-c] .
Regarding claim 3, Coffey discloses the transfer instrument according to claim 1, wherein the pressing portion is configured to slide on the support surface when the outer edge surface of the medical sheet is pressed in the distal end direction by the pressing surface [implant 19 sliding on and away from head portion 14 when pressed, see Figs. 11 a-c].
Regarding claim 19, Coffey discloses a method for transferring a medical sheet to a treatment site of a living body, the method comprising:
positioning a medical sheet on a support surface of a medical instrument [loading an implant 19, for example a patch, into the head portion 14 of the Figure 3 embodiment of the device 10, see in Fig. 10A-10C], the medical instrument including a first carrier member including a first shaft [tip 13 with components 13a and 13b, see in Fig. 2] and a support portion [head portion 14, see in Fig. 2], the support portion being provided at a distal portion of the first shaft [see Figs. 1-3] and including a first support surface [see Figs. 3-7] on which the medical sheet is placed [see Figs.11 a-c]; and
a second carrier member [urging member 17, see in Fig. 5] including a second shaft and a pressing portion [implant 19, see Fig.11 c], the second shaft extending along an axial
direction of the first shaft [curved sidewalls 15 extending along 13, see Fig.11 c], the pressing portion [at least distal surface 17d extending into implant 19 in Fig. 7 and Fig. 11c] being provided at a distal portion of the second shaft [see Fig. 11 c], wherein the second carrier member is movable relative to the first carrier member so as to allow a pressing surface of the pressing portion to press, in a distal end direction, an outer edge surface of the medical sheet placed on the support surface [see Figs.11 a-b, showing distal surface 17d pressing implant 19 in a distal direction]; and
moving the second carrier member relative to the first carrier member to allow a pressing surface of the pressing portion to press, in a distal end direction, an outer edge surface of the medical sheet placed on the support surface [the guiding means 18, 18a, 18b allows the urging member to move substantially along the longitudinal direction, so as to push any implant located in the head portion 14, 14a outwards from the device, see in ¶ 0072].
Regarding claim 20, Coffey discloses the method according to claim 19, further comprising:
inserting the transfer instrument into the living body through an incision [Figure 12 is a diagram of an eye with an incision made for insertion of the device, see ¶ 0049 and Fig. 12];
positioning a distal end of the transfer instrument near the treatment site [The more curved end 19b allows easier deployment of the implant into the eye or other target location, see in ¶ 0085]; and
bringing the medical sheet into contact with the treatment site with the pressing of the outer edge surface of the medical sheet with the pressing surface of the pressing portion of the medical instrument [Figures 11A to 11C depict the process of deploying the implant 19 from the head portion 14, 14a, 14b of device 10, see in ¶ 0091].
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 4-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Coffey (EP 2590604 A1 – Cited by Applicant) in view of Walter et al. (US 20070208422 A1 – Cited by Applicant), hereinafter Walter.
Regarding claim 4, Coffey discloses the transfer instrument according to claim 1.
Coffey fails to disclose wherein the second carrier member includes a liquid supply flow path through which a liquid is supplied to the medical sheet placed on the support surface.
However, Walter discloses wherein the second carrier member includes a liquid supply flow path through which a liquid is supplied to the medical sheet placed on the support surface [the plunger 50 can be configured to advance based on pressurized fluid and/or rod actuation. If pressurized fluid alone is used, no separate plunger arm or plunger arm channel is required (not shown). In any event, where a plunger 50 is employed, the plunger 50 may be configured directly (gently) contact a trailing edge of the rolled disc 25c, or may be configured to push indirectly, such as by pushing an intermediate fluid such as a gel (comprising, for example, a viscoelastic material) forward, thereby pushing the disc forward, see in ¶ 0100].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that the second carrier member includes a liquid supply flow path through which a liquid is supplied to the medical sheet placed on the support surface in order to assist in expelling the medical sheet.
Regarding claim 5, Coffey discloses the transfer instrument according to claim 1.
Coffey fails to disclose wherein the pressing surface extends upward with an inclination in the distal end direction.
However, Walter discloses wherein the pressing surface extends upward with an inclination in the distal end direction [see cross section in Fig. 5; Plunger 50 is shaped to incline upwards towards the distal end].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that the pressing surface extends upward with an inclination in the distal end direction in order to prevent the medical sheet from moving backwards.
Regarding claim 6, Coffey discloses the transfer instrument according to claim 1.
Coffey fails to disclose wherein the pressing portion is formed to be wider in the distal end direction when viewed from above.
However, Walter discloses wherein the pressing portion is formed to be wider in the distal end direction when viewed from above [plunger 50 wider at distal end, see in Fig. 5].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that the pressing portion is formed to be wider in the distal end direction when viewed from above in order to be able to fully expel the medical sheet out.
Regarding claim 7, Coffey discloses the transfer instrument according to claim 1.
Coffey fails to disclose wherein the pressing surface is curved in an arc shape in a proximal end direction when viewed from above.
However, Walter discloses wherein the pressing surface is curved in an arc shape in a proximal end direction when viewed from above [pressing surface of plunger 50 is curved in an arc shape towards the proximal end from all views, see in Fig. 5].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that the pressing surface is curved in an arc shape in a proximal end direction when viewed from above in order to be advantageously shaped to expel the medical sheet when activated.
Regarding claim 8, Coffey, as modified, discloses the transfer instrument according to claim 2.
Coffey fails to disclose the transfer instrument further comprising:
an outer cylinder through which the first shaft is inserted; and wherein the support portion is flexible and formed in a sheet shape;
the support portion is formed to be wider than an inner diameter of the outer cylinder;
the support portion and the medical sheet are retracted into the outer cylinder with the support portion and the medical sheet undergoing curved deformation when the first shaft and the second shaft are moved in a proximal end direction relative to the outer cylinder; and
the support portion and the medical sheet retracted in the outer cylinder are unfolded when the first shaft and the second shaft are moved in the distal end direction relative to the outer cylinder to be exposed from the outer cylinder.
However, Walter discloses an outer cylinder through which the first shaft is inserted [Injector barrel 10, see in Fig. 1a]; and wherein the support portion is flexible and formed in a sheet shape [15 flexible and formed in a sheet shape, see Fig. 1b];
the support portion is formed to be wider than an inner diameter of the outer cylinder [diameter of 15 vs diameter of 10, see in Fig. 1a];
the support portion and the medical sheet are retracted into the outer cylinder with the support portion and the medical sheet undergoing curved deformation when the first shaft and the second shaft are moved in a proximal end direction relative to the outer cylinder [see in Fig. 1b]; and
the support portion and the medical sheet retracted in the outer cylinder are unfolded when the first shaft and the second shaft are moved in the distal end direction relative to the outer cylinder to be exposed from the outer cylinder [see in Fig. 1a].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that the transfer instrument further comprises: an outer cylinder through which the first shaft is inserted; and wherein the support portion is flexible and formed in a sheet shape; the support portion is formed to be wider than an inner diameter of the outer cylinder; the support portion and the medical sheet are retracted into the outer cylinder with the support portion and the medical sheet undergoing curved deformation when the first shaft and the second shaft are moved in a proximal end direction relative to the outer cylinder; and the support portion and the medical sheet retracted in the outer cylinder are unfolded when the first shaft and the second shaft are moved in the distal end direction relative to the outer cylinder to be exposed from the outer cylinder in order to transport medical sheets of larger sizes through smaller incisions.
Regarding claim 9, Coffey, as modified, discloses the transfer instrument according to claim 8.
Coffey fails to disclose wherein a maximum width of the pressing portion is smaller than a width of the support portion and larger than an outer diameter of the second shaft.
However, Walter discloses wherein a maximum width of the pressing portion is smaller than a width of the support portion and larger than an outer diameter of the second shaft [maximum width of 50 is smaller than the width of 25, while larger than the outer diameter of the proximal portion of 50, see in Fig. 5].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that a maximum width of the pressing portion is smaller than a width of the support portion and larger than an outer diameter of the second shaft in order to for the pressing portion to be large enough to push out the medical sheet but not small enough to retreat too far back into the transfer instrument.
Regarding claim 10, Coffey, as modified, discloses the transfer instrument according to claim 8, wherein the pressing portion is flexible [flexible urging member, see in ¶ 0006] and a width of the pressing surface is larger than the inner diameter of the outer cylinder [Examiner notes that since the flexible urging member is flexible, the width of the pressing surface can be larger than the inner diameter of the outer cylinder and still fit inside of the outer cylinder].
Regarding claim 11, Coffey, as modified, discloses the transfer instrument according to claim 8, wherein the support portion includes a pair of protrusions protruding upward from both sides of the support surface in a width direction [retaining lips 22a and side walls to keep the support portion curved, creating protrusions on both sides, see Fig. 7 and Fig. 10b].
Regarding claim 12, Coffey, as modified, discloses a transfer instrument according to claim 11, wherein the pressing portion is provided with a retaining slit into which the pair of protrusions are inserted in a retracted state where the support portion and the medical sheet are retracted in the outer cylinder [retaining lips 22a on each side to keep the support portion curved during retraction, see Fig. 7].
Regarding claim 14, Coffey discloses a transfer instrument [device 10, see in Fig. 1] that transfers a medical sheet to a treatment site of a living body [device 10 according to the invention that can be used to implant or deploy an implant or other object, preferably directly into an eye, see ¶ 0050; Examiner notes that an implant may be interpreted as a medical sheet or a cell sheet], the transfer instrument comprising:
a first carrier member including a first shaft [tip 13 with components 13a and
13b, see in Fig. 2] and a support portion [head portion 14, see in Fig. 2], the support portion being provided at a distal portion of the first shaft [see Figs. 1-3] and including a first support surface [see Figs. 3-7] on which the medical sheet is placed [see Figs.11 a-c]; and
a second carrier member [urging member 17, see in Fig. 5] including a second shaft and a pressing portion [implant 19, see Fig.11 c], the second shaft extending along an axial
direction of the first shaft [curved sidewalls 15 extending along 13, see Fig.11 c], the pressing portion [at least distal surface 17d extending into implant 19 in Fig. 7 and Fig. 11c] being provided at a distal portion of the second shaft [see Fig. 11 c], wherein the second carrier member is movable relative to the first carrier member so as to allow a pressing surface of the pressing portion to press, in a distal end direction, an outer edge surface of the medical sheet placed on the support surface [see Figs.11 a-b, showing distal surface 17d pressing implant 19 in a distal direction];
the pressing portion is configured to slide on the support surface when the outer edge surface of the medical sheet is pressed in the distal end direction by the pressing surface [implant 19 sliding on and away from head portion 14 when pressed, see Figs. 11 a-c].
Coffey fails to disclose that the pressing portion is wider in the distal end direction when viewed from above and wherein the pressing surface extends upward with an inclination in the distal end direction.
However, Walter discloses that the pressing portion is wider in the distal end direction when viewed from above [towards distal end, plunger 50 is wider, see in Fig. 5] and wherein the pressing surface extends upward with an inclination in the distal end direction [see cross section in Fig. 5; Plunger 50 is shaped to incline upwards towards the distal end].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that the pressing portion is wider in the distal end direction when viewed from above and wherein the pressing surface extends upward with an inclination in the distal end direction in order to provide a pressing portion with a pressing surface that is shaped advantageously to prevent backwards movement of the implant and fully expel the medical sheet when activated.
Regarding claim 15, Coffey, as modified, discloses the transfer instrument according to claim 14, wherein the first shaft is formed in a tubular shape; and the second shaft is inserted into a lumen of the first shaft so as to be movable along the axial direction of the first shaft [tubular tip 13 and element 17, see in Figs. 11a-c].
Regarding claim 16, Coffey, as modified, discloses the transfer instrument according to claim 14.
Coffey fails to disclose wherein the second carrier member includes a liquid supply flow path through which a liquid is supplied to the medical sheet placed on the support surface.
However, Walter discloses wherein the second carrier member includes a liquid supply flow path through which a liquid is supplied to the medical sheet placed on the support surface [the plunger 50 can be configured to advance based on pressurized fluid and/or rod actuation. If pressurized fluid alone is used, no separate plunger arm or plunger arm channel is required (not shown). In any event, where a plunger 50 is employed, the plunger 50 may be configured directly (gently) contact a trailing edge of the rolled disc 25c, or may be configured to push indirectly, such as by pushing an intermediate fluid such as a gel (comprising, for example, a viscoelastic material) forward, thereby pushing the disc forward, see in ¶ 0100].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that the second carrier member includes a liquid supply flow path through which a liquid is supplied to the medical sheet placed on the support surface in order to assist in expelling the medical sheet.
Regarding claim 17, Coffey, as modified, discloses the transfer instrument according to claim 15.
Coffey fails to disclose further comprising: an outer cylinder through which the first shaft is inserted; and wherein the support portion is flexible and formed in a sheet shape; the support portion is formed to be wider than an inner diameter of the outer cylinder; the support portion and the medical sheet are retracted into the outer cylinder with the support portion and the medical sheet undergoing curved deformation when the first shaft and the second shaft are moved in a proximal end direction relative to the outer cylinder; and the support portion and the medical sheet retracted in the outer cylinder are unfolded when the first shaft and the second shaft are moved in the distal end direction relative to the outer cylinder to be exposed from the outer cylinder.
However, Walter discloses an outer cylinder through which the first shaft is inserted [Injector barrel 10, see in Fig. 1a]; and wherein the support portion is flexible and formed in a sheet shape [15 flexible and formed in a sheet shape, see Fig. 1b];
the support portion is formed to be wider than an inner diameter of the outer cylinder [diameter of 15 vs diameter of 10, see in Fig. 1a];
the support portion and the medical sheet are retracted into the outer cylinder with the support portion and the medical sheet undergoing curved deformation when the first shaft and the second shaft are moved in a proximal end direction relative to the outer cylinder [see in Fig. 1b]; and
the support portion and the medical sheet retracted in the outer cylinder are unfolded when the first shaft and the second shaft are moved in the distal end direction relative to the outer cylinder to be exposed from the outer cylinder [see in Fig. 1a].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that the transfer instrument further comprises: an outer cylinder through which the first shaft is inserted; and wherein the support portion is flexible and formed in a sheet shape; the support portion is formed to be wider than an inner diameter of the outer cylinder; the support portion and the medical sheet are retracted into the outer cylinder with the support portion and the medical sheet undergoing curved deformation when the first shaft and the second shaft are moved in a proximal end direction relative to the outer cylinder; and the support portion and the medical sheet retracted in the outer cylinder are unfolded when the first shaft and the second shaft are moved in the distal end direction relative to the outer cylinder to be exposed from the outer cylinder in order to transport medical sheets of larger sizes through smaller incisions.
Regarding claim 18, Coffey, as modified, discloses the transfer instrument according to claim 17, wherein
the pressing portion is flexible [flexible urging member, see in ¶ 0006];
a width of the pressing surface is larger than the inner diameter of the outer cylinder [Examiner notes that since the flexible urging member is flexible, the width of the pressing surface can be larger than the inner diameter of the outer cylinder and still fit inside of the outer cylinder]; and
the pressing portion is provided with a retaining slit into which the pair of protrusions are inserted in a retracted state where the support portion and the medical sheet are retracted in the outer cylinder [retaining lips 22a on each side to keep the support portion curved during retraction, see Fig. 7].
Coffey fails to disclose wherein a maximum width of the pressing portion is smaller than a width of the support portion and larger than an outer diameter of the second shaft.
However, Walter discloses wherein a maximum width of the pressing portion is smaller than a width of the support portion and larger than an outer diameter of the second shaft [maximum width of 50 is smaller than the width of 25, while larger than the outer diameter of the proximal portion of 50, see in Fig. 5].
Coffey and Walter are both analogous to the claimed invention because they are in the same field of surgical tools for implants. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Walter to include that a maximum width of the pressing portion is smaller than a width of the support portion and larger than an outer diameter of the second shaft in order to for the pressing portion to be large enough to push out the medical sheet but not small enough to retreat too far back into the transfer instrument.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Coffey (EP 2590604 A1 – Cited by Applicant) in view of Karpiel et al. (US 20100106068 A1), hereinafter Karpiel.
Regarding claim 13, Coffey, as modified, discloses the transfer instrument according to claim 1.
Coffey fails to disclose wherein the transfer instrument further comprises: an endoscope that captures an image of the support portion, the pressing portion, and the medical sheet.
However, Karpiel discloses the use of an endoscopic device with functions of delivering a sheet material to a defect of an internal bodily organ [see in ¶ 0020].
Coffey and Karpiel are both analogous to the claimed invention because they are in the same field of surgical implant delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Coffey to incorporate the teachings of Karpiel and include that the transfer instrument also comprises an endoscope that captures an image of the support portion, the pressing portion, and the medical sheet to allow for visual guidance during the delivery of the medical sheet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
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/HY KHANH DOAN/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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