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 .
Claim Objections
Claims 1 and 3 are objected to because of the following informalities: Claims 1 and 3 recite “the rod” in lines 11 and 3, respectively, which should read “the central rod” for consistency purposes. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Claim 3 recites “a hair graft” in line 3 which should read “the hair graft” for consistency purposes. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Claim 6 recites “the bevel” in line 2 which should read “the sharp bevel-shaped tip” for consistency purposes. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Claim 7 recites “the longitudinal direction thereof” in line 2. While it is inherent that the central rod has a longitudinal direction, applicant is requested to amend the claim to read “a longitudinal direction” for consistency purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the incision" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the orifice" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1 and 4-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bodduluri et al. (US 2007/0078473 A1).
Regarding claim 1, Bodduluri discloses a device (tool assembly 30; Figs. 1-2) for implantation of hair grafts (harvested follicular unit 72; Figs. 6A-6B), comprising: a handpiece (including at least tubular extension 24 of housing 22) extending along a longitudinal axis (along the longitudinal axis of 24; Figs. 1-2), wherein the handpiece has a channel (channel within harvesting cannula 38) to which a source of vacuum is connectable (a vacuum source may be selectively placed in communication with the harvesting cannula lumen; [0036]); a piston (any one of distal chuck portion 43a, pin vise 43, elongated body 46 and/or flanges 48; [0032]; Fig. 4) movable along the longitudinal axis between a rest position at a rearward end of the handpiece (in which harvesting cannula 38 is retracted; Fig. 6B) and an action position (in which harvesting cannula 38 is extended and/or rotated; Fig. 6B; [0032]), wherein the piston is biased to the rest position (as elongated body 46 includes recessed section 44 of flanges 48 which seats annular retaining member 50 with the tubular drive member, thereby retaining the harvesting cannula 38 when the tool 32 is coupled with the motor drive assembly 60; [0032]; further spring 53 is seated in the recess 49 of the elongate body 46 and applies a proximally-directed, “pulling” force on 46 i.e. 43a, 43, and 48; [0033]), wherein in the rest position the piston defines a chamber (interpreted as the lumen of 38 and 38 is fixedly attached to 43a, in particular between the distal end of 38 and the distal end of obturator 52) in the handpiece in communication with vacuum from the channel (as the vacuum is in communication with the harvesting cannula lumen; [0032]), the chamber being forward of the piston (as the open space between the distal end of the harvesting cannula 38 and the distal end of the obturator 52 is distal 43a, 43, 46, 48); a hollow needle (harvesting cannula 38) extending beyond a sheath (implanting cannula 36) at a forward end of the handpiece (Fig. 4); and a central rod (obturator 52) extending into the hollow needle (38) and being movable relative to the hollow needle (as 52 is slidably positioned in an interior lumen of the harvesting cannula 38; [0033]), wherein a cross-section of the rod is configured with a space with respect to the needle to communicate vacuum in the chamber to an interior of the needle to aspirate a hair graft into the needle (Figs. 6A-6B; as the vacuum source in communication with the harvesting cannula lumen applies a proximally-directed “pulling” force to facilitate grasping and extracting the follicular unit, as well as to help retain the follicular unit in the harvesting cannula lumen after it has been harvested; [0036]).
Regarding claim 4, Bodduluri discloses wherein the handpiece has a stop (set of slots) at the rearward end thereof, and wherein the piston (48) rests against the stop in the rest position (as flanges 48 engage a corresponding set of slots in tubular drive member through housing 93, which is near the proximal end of housing 22, as 60 is within 22; [0032]; Figs. 1, 4-5).
Regarding claim 5, Bodduluri discloses wherein the needle (38) comprises a sharp bevel-shaped tip (serrated tip 40; Fig. 3; [0030]) configured to form an incision into a scalp for implantation of the hair graft ([0030]).
Regarding claim 6, Bodduluri discloses wherein the needle (38) is mounted for rotational motion so as to allow rotation of the sharp bevel-shaped tip (40) with respect to an orifice (as 38 is rotated about a longitudinal axis of the harvesting cannula 38 i.e. rotated with respect to the orifice or opening of implanting cannula 36; [0032]).
Regarding claim 7, Bodduluri discloses wherein the central rod (52) is adjustable along the longitudinal direction thereof so as to adjust an implantation depth of the hair graft (via control of motor 66; [0038]).
Regarding claim 8, Bodduluri discloses wherein the central rod (52) has a circular cross-section and wherein vacuum in the chamber is communicated to the interior of the needle via an annular gap around the circumference of the central rod (Figs. 1-6B; as the vacuum source is communicated through 38 which surrounds 52; [0036]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bodduluri et al. (US 2007/0078473 A1) in view of Knowlton (US 2018/0344343 A1).
Regarding claims 2-3, Bodduluri fails to disclose wherein the handpiece has an orifice that vents the chamber to an outside of the handpiece so as to allow fingertip control of vacuum in the chamber, wherein closure of the orifice creates a vacuum in the chamber such that the vacuum in the chamber is communicated via the space in the cross-sectional shape of the rod to aspirate a hair graft into the needle.
However, Knowlton teaches a device (Fig. 108) for implantation of hair grafts (skin plugs; [0462]) comprising a handpiece (carrier 1071 including vacuum manifold 1072; Fig. 108) that has a channel (port 1074) to which a source of vacuum is connectable (vacuum source not shown; [0464]), wherein the handpiece has an orifice (aperture 1075) that vents a vacuum chamber to an outside of the handpiece so as to allow fingertip control of vacuum in the chamber (for manual control of the vacuum; [0465]), wherein closure of the orifice creates a vacuum in the chamber ([0465]). Alternatively, the vacuum component is controlled electronically ([0465]), similar to that of Bodduluri.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handpiece of Bodduluri to include an orifice that vents the chamber to an outside of the handpiece so as to allow fingertip control of the vacuum in the chamber by closing the orifice as taught by Knowlton in order to provide manual control of the vacuum being applied to the hair graft. Further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded the predictable result of controlling a vacuum being applied to a hair graft.
3. Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bodduluri et al. (US 2007/0078473 A1) in view of Franco et al. (US 2021/0145476 A1).
Regarding claim 9, Bodduluri fails to disclose wherein the central rod has a cross-section comprised of at least one of cross-sections that are cruciform, polygonal, star-shaped and hollow.
However, Franco teaches a device (hair transplant device 10; Fig. 1) comprising a handpiece (housing 12), wherein the handpiece has a channel to which a source of vacuum is connectable (as suction is applied to the user interface 18; [0067]; [0072]), a hollow needle (coring needle 30), and a central rod (pin 50) extending into the hollow needle (Figs. 1, 6A-6C), wherein the central rod (50) has a hollow cross-section (as 18 and 50 include central lumen 58 through which suction or negative pressure may be provided into the coring needle 30 to provide additional control and force for removing the skin core 102 from the donor site 100; [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cross-section of the central rod of Bodduluri to be hollow as taught by Franco in order to provide a more central and larger source of suction to the hair graft.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,660,117. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, U.S. Patent No. 11,660,117 claims a device for implantation of hair grafts, comprising: a handpiece extending along a longitudinal axis (claim 1, lines 1-2), wherein the handpiece has a channel to which a source of vacuum is connectable (claim 1, lines 4-5); a piston movable along the longitudinal axis between a rest position at a rearward end of the handpiece and an action position, wherein the piston is biased to the rest position, wherein in the rest position the piston defines a chamber in the handpiece in communication with vacuum from the channel, the chamber being forward of the piston (claim 1, lines 6-12); a hollow needle extending beyond a sheath at a forward end of the handpiece (claim 1, lines 13-14; claim 2, lines 3-4); and a central rod extending into the hollow needle and being movable relative to the hollow needle, wherein a cross-section of the rod is configured with a space with respect to the needle to communicate vacuum in the chamber to an interior of the needle to aspirate a hair graft into the needle (claim 1, lines 15-19).
Regarding claim 2, U.S. Patent No. 11,660,117 claims wherein the handpiece has an orifice that vents the chamber to an outside of the handpiece so as to allow fingertip control of vacuum in the chamber (claim 1, lines 10-12).
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,660,117. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 5, U.S. Patent No. 11,660,117 claims wherein the needle comprises a sharp bevel-shaped tip configured to form the incision into a scalp for implantation of the hair graft (claim 3, lines 1-3).
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,660,117. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 6, U.S. Patent No. 11,660,117 claims wherein the needle is mounted for rotational motion so as to allow rotation of the bevel with respect to the orifice (claim 4, lines 1-3).
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11,660,117. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, U.S. Patent No. 11,660,117 claims a device for implantation of hair grafts, comprising: a handpiece extending along a longitudinal axis (claim 1, lines 1-2), wherein the handpiece has a channel to which a source of vacuum is connectable (claim 1, lines 4-5); a piston movable along the longitudinal axis between a rest position at a rearward end of the handpiece and an action position, wherein the piston is biased to the rest position, wherein in the rest position the piston defines a chamber in the handpiece in communication with vacuum from the channel, the chamber being forward of the piston (claim 1, lines 6-12); a hollow needle extending beyond a sheath at a forward end of the handpiece (claim 1, lines 13-14; claim 8, lines 4-5); and a central rod extending into the hollow needle and being movable relative to the hollow needle, wherein a cross-section of the rod is configured with a space with respect to the needle to communicate vacuum in the chamber to an interior of the needle to aspirate a hair graft into the needle (claim 1, lines 15-19).
Regarding claim 2, U.S. Patent No. 11,660,117 claims wherein the handpiece has an orifice that vents the chamber to an outside of the handpiece so as to allow fingertip control of vacuum in the chamber (claim 1, lines 10-12).
Regarding claim 3, U.S. Patent No. 11,660,117 claims wherein closure of the orifice creates a vacuum in the chamber such that the vacuum in the chamber is communicated via the space in the cross-sectional shape of the rod to aspirate a hair graft into the needle (claim 8, lines 3-8).
Claims 1 and 7 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,660,117 in view of Bodduluri et al. (US 2007/0078473 A1).
Regarding claim 1, U.S. Patent No. 11,660,117 claims a device for implantation of hair grafts, comprising: a handpiece extending along a longitudinal axis (claim 1, lines 1-2), wherein the handpiece has a channel to which a source of vacuum is connectable (claim 1, lines 4-5); a piston movable along the longitudinal axis between a rest position at a rearward end of the handpiece and an action position, wherein the piston is biased to the rest position, wherein in the rest position the piston defines a chamber in the handpiece in communication with vacuum from the channel, the chamber being forward of the piston (claim 1, lines 6-12); a hollow needle extending into a sheath at a forward end of the handpiece (claim 1, lines 13-14); and a central rod extending into the hollow needle and being movable relative to the hollow needle, wherein a cross-section of the rod is configured with a space with respect to the needle to communicate vacuum in the chamber to an interior of the needle to aspirate a hair graft into the needle (claim 1, lines 15-19).
U.S. Patent No. 11,660,117 fails to explicitly disclose the needle extending beyond the sheath.
However, Bodduluri teaches a device (tool assembly 30; Figs. 1-2) for implantation of hair grafts (harvested follicular unit 72; Figs. 6A-6B), comprising: a handpiece (including at least tubular extension 24 of housing 22) extending along a longitudinal axis (along the longitudinal axis of 24; Figs. 1-2), wherein the handpiece has a channel (channel within harvesting cannula 38) to which a source of vacuum is connectable (a vacuum source may be selectively placed in communication with the harvesting cannula lumen; [0036]); a piston (any one of distal chuck portion 43a, pin vise 43, elongated body 46 and/or flanges 48; [0032]; Fig. 4) movable along the longitudinal axis between a rest position at a rearward end of the handpiece (in which harvesting cannula 38 is retracted; Fig. 6B) and an action position (in which harvesting cannula 38 is extended and/or rotated; Fig. 6B; [0032]), wherein the piston is biased to the rest position (as elongated body 46 includes recessed section 44 of flanges 48 which seats annular retaining member 50 with the tubular drive member, thereby retaining the harvesting cannula 38 when the tool 32 is coupled with the motor drive assembly 60; [0032]; further spring 53 is seated in the recess 49 of the elongate body 46 and applies a proximally-directed, “pulling” force on 46 i.e. 43a, 43, and 48; [0033]), wherein in the rest position the piston defines a chamber (interpreted as the lumen of 38 and 38 is fixedly attached to 43a, in particular between the distal end of 38 and the distal end of obturator 52) in the handpiece in communication with vacuum from the channel (as the vacuum is in communication with the harvesting cannula lumen; [0032]), the chamber being forward of the piston (as the open space between the distal end of the harvesting cannula 38 and the distal end of the obturator 52 is distal 43a, 43, 46, 48); a hollow needle (harvesting cannula 38) extending beyond a sheath (implanting cannula 36) at a forward end of the handpiece (Fig. 4); and a central rod (obturator 52) extending into the hollow needle (38) and being movable relative to the hollow needle (as 52 is slidably positioned in an interior lumen of the harvesting cannula 38; [0033]), wherein a cross-section of the rod is configured with a space with respect to the needle to communicate vacuum in the chamber to an interior of the needle to aspirate a hair graft into the needle (Figs. 6A-6B; as the vacuum source in communication with the harvesting cannula lumen applies a proximally-directed “pulling” force to facilitate grasping and extracting the follicular unit, as well as to help retain the follicular unit in the harvesting cannula lumen after it has been harvested; [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of U.S. Patent No. 11,660,117 to extend beyond the sheath in order to core around the hair graft to improve harvesting.
Regarding claim 7, U.S. Patent No. 11,660,117 discloses wherein the central rod is adjustable along the longitudinal direction thereof so as to adjust an implantation depth of the hair graft (claim 5, lines 1-4).
Claims 1 and 8 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,660,117 in view of Bodduluri et al. (US 2007/0078473 A1).
Regarding claim 1, U.S. Patent No. 11,660,117 claims a device for implantation of hair grafts, comprising: a handpiece extending along a longitudinal axis (claim 1, lines 1-2), wherein the handpiece has a channel to which a source of vacuum is connectable (claim 1, lines 4-5); a piston movable along the longitudinal axis between a rest position at a rearward end of the handpiece and an action position, wherein the piston is biased to the rest position, wherein in the rest position the piston defines a chamber in the handpiece in communication with vacuum from the channel, the chamber being forward of the piston (claim 1, lines 6-12); a hollow needle extending into a sheath at a forward end of the handpiece (claim 1, lines 13-14); and a central rod extending into the hollow needle and being movable relative to the hollow needle, wherein a cross-section of the rod is configured with a space with respect to the needle to communicate vacuum in the chamber to an interior of the needle to aspirate a hair graft into the needle (claim 1, lines 15-19).
U.S. Patent No. 11,660,117 fails to explicitly disclose the needle extending beyond the sheath.
However, Bodduluri teaches a device (tool assembly 30; Figs. 1-2) for implantation of hair grafts (harvested follicular unit 72; Figs. 6A-6B), comprising: a handpiece (including at least tubular extension 24 of housing 22) extending along a longitudinal axis (along the longitudinal axis of 24; Figs. 1-2), wherein the handpiece has a channel (channel within harvesting cannula 38) to which a source of vacuum is connectable (a vacuum source may be selectively placed in communication with the harvesting cannula lumen; [0036]); a piston (any one of distal chuck portion 43a, pin vise 43, elongated body 46 and/or flanges 48; [0032]; Fig. 4) movable along the longitudinal axis between a rest position at a rearward end of the handpiece (in which harvesting cannula 38 is retracted; Fig. 6B) and an action position (in which harvesting cannula 38 is extended and/or rotated; Fig. 6B; [0032]), wherein the piston is biased to the rest position (as elongated body 46 includes recessed section 44 of flanges 48 which seats annular retaining member 50 with the tubular drive member, thereby retaining the harvesting cannula 38 when the tool 32 is coupled with the motor drive assembly 60; [0032]; further spring 53 is seated in the recess 49 of the elongate body 46 and applies a proximally-directed, “pulling” force on 46 i.e. 43a, 43, and 48; [0033]), wherein in the rest position the piston defines a chamber (interpreted as the lumen of 38 and 38 is fixedly attached to 43a, in particular between the distal end of 38 and the distal end of obturator 52) in the handpiece in communication with vacuum from the channel (as the vacuum is in communication with the harvesting cannula lumen; [0032]), the chamber being forward of the piston (as the open space between the distal end of the harvesting cannula 38 and the distal end of the obturator 52 is distal 43a, 43, 46, 48); a hollow needle (harvesting cannula 38) extending beyond a sheath (implanting cannula 36) at a forward end of the handpiece (Fig. 4); and a central rod (obturator 52) extending into the hollow needle (38) and being movable relative to the hollow needle (as 52 is slidably positioned in an interior lumen of the harvesting cannula 38; [0033]), wherein a cross-section of the rod is configured with a space with respect to the needle to communicate vacuum in the chamber to an interior of the needle to aspirate a hair graft into the needle (Figs. 6A-6B; as the vacuum source in communication with the harvesting cannula lumen applies a proximally-directed “pulling” force to facilitate grasping and extracting the follicular unit, as well as to help retain the follicular unit in the harvesting cannula lumen after it has been harvested; [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of U.S. Patent No. 11,660,117 to extend beyond the sheath in order to core around the hair graft to improve harvesting.
Regarding claim 8, U.S. Patent No. 11,660,117 discloses wherein the central rod has a circular cross-section and wherein vacuum in the chamber is communicated to the interior of the needle via an annular gap around the circumference of the central rod (claim 6, lines 1-4).
Claims 1 and 9 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11,660,117 in view of Bodduluri et al. (US 2007/0078473 A1).
Regarding claim 1, U.S. Patent No. 11,660,117 claims a device for implantation of hair grafts, comprising: a handpiece extending along a longitudinal axis (claim 1, lines 1-2), wherein the handpiece has a channel to which a source of vacuum is connectable (claim 1, lines 4-5); a piston movable along the longitudinal axis between a rest position at a rearward end of the handpiece and an action position, wherein the piston is biased to the rest position, wherein in the rest position the piston defines a chamber in the handpiece in communication with vacuum from the channel, the chamber being forward of the piston (claim 1, lines 6-12); a hollow needle extending into a sheath at a forward end of the handpiece (claim 1, lines 13-14); and a central rod extending into the hollow needle and being movable relative to the hollow needle, wherein a cross-section of the rod is configured with a space with respect to the needle to communicate vacuum in the chamber to an interior of the needle to aspirate a hair graft into the needle (claim 1, lines 15-19).
U.S. Patent No. 11,660,117 fails to explicitly disclose the needle extending beyond the sheath.
However, Bodduluri teaches a device (tool assembly 30; Figs. 1-2) for implantation of hair grafts (harvested follicular unit 72; Figs. 6A-6B), comprising: a handpiece (including at least tubular extension 24 of housing 22) extending along a longitudinal axis (along the longitudinal axis of 24; Figs. 1-2), wherein the handpiece has a channel (channel within harvesting cannula 38) to which a source of vacuum is connectable (a vacuum source may be selectively placed in communication with the harvesting cannula lumen; [0036]); a piston (any one of distal chuck portion 43a, pin vise 43, elongated body 46 and/or flanges 48; [0032]; Fig. 4) movable along the longitudinal axis between a rest position at a rearward end of the handpiece (in which harvesting cannula 38 is retracted; Fig. 6B) and an action position (in which harvesting cannula 38 is extended and/or rotated; Fig. 6B; [0032]), wherein the piston is biased to the rest position (as elongated body 46 includes recessed section 44 of flanges 48 which seats annular retaining member 50 with the tubular drive member, thereby retaining the harvesting cannula 38 when the tool 32 is coupled with the motor drive assembly 60; [0032]; further spring 53 is seated in the recess 49 of the elongate body 46 and applies a proximally-directed, “pulling” force on 46 i.e. 43a, 43, and 48; [0033]), wherein in the rest position the piston defines a chamber (interpreted as the lumen of 38 and 38 is fixedly attached to 43a, in particular between the distal end of 38 and the distal end of obturator 52) in the handpiece in communication with vacuum from the channel (as the vacuum is in communication with the harvesting cannula lumen; [0032]), the chamber being forward of the piston (as the open space between the distal end of the harvesting cannula 38 and the distal end of the obturator 52 is distal 43a, 43, 46, 48); a hollow needle (harvesting cannula 38) extending beyond a sheath (implanting cannula 36) at a forward end of the handpiece (Fig. 4); and a central rod (obturator 52) extending into the hollow needle (38) and being movable relative to the hollow needle (as 52 is slidably positioned in an interior lumen of the harvesting cannula 38; [0033]), wherein a cross-section of the rod is configured with a space with respect to the needle to communicate vacuum in the chamber to an interior of the needle to aspirate a hair graft into the needle (Figs. 6A-6B; as the vacuum source in communication with the harvesting cannula lumen applies a proximally-directed “pulling” force to facilitate grasping and extracting the follicular unit, as well as to help retain the follicular unit in the harvesting cannula lumen after it has been harvested; [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of U.S. Patent No. 11,660,117 to extend beyond the sheath in order to core around the hair graft to improve harvesting.
Regarding claim 9, U.S. Patent No. 11,660,117 discloses wherein the central rod has a cross-section comprised of at least one of cross-sections that are cruciform, polygonal, star-shaped and hollow (claim 7, lines 1-4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Okuda (US 2013/0226214 A1) is noted for teachings a device for implanting hair grafts with a moveable needle and rod. Boudjema (US 5,827,297) is noted for teaching a hair graft implantation device with suction (Fig. 3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771