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 .
Terminal Disclaimer
The terminal disclaimer filed on 6/14/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,660,117 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
The previous objection of claims 1, 3, 6 and 7 due to minor informalities has been withdrawn in light of applicant’s amendments made 6/08/2026.
The previous rejection of claim(s) 5-6 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 5-6 on 6/08/2026.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. However, Rassman et al. (US 2005/0096687 A1) is now relied upon to teach an annular space that is in fluid communication with the space and the hollow needle.
Claim Objections
Claims 1, 3, 5-6 and 8 are objected to because of the following informalities: Claims 1, 3, 5-6 and 8 recite “the needle” which should read “the hollow needle” 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.
Claim 6 is 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 6 recites the limitation "the sharp bevel-shaped tip" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4-5 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bodduluri et al. (US 2007/0078473 A1) in view of Rassman et al. (US 2005/0096687 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); 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 central 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]); and an extension (distal stepped portion of elongate body 46) of the piston (any one of distal chuck portion 43a, pin vise 43, elongated body 46 and/or flanges 48; [0032]; Fig. 4), wherein an outer diameter of the extension (distal stepped portion of 46) is less than an outer diameter of the piston (at least 46 has an outer diameter less than flanges 48 and less than proximal stepped portion of 46), the extension (46) surrounding a portion of the central rod (52; Fig. 4).
Bodduluri fails to explicitly disclose the extension defines an annular space that is in fluid communication with the space and the hollow needle because Bodduuluri is silent to where the vacuum source is selectively placed in communication with the harvesting cannula lumen to apply 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]).
However, Rassman teaches a device for implantation of hair grafts (apparatus 1100; Figs. 11A-11D) comprising an actuator chamber (1106), similar to elongate body (46) of Bodduluri, in communication with a vacuum (vacuum 1122), the actuator chamber surrounding a portion of a central rod (connected rod 1108), similar to obturator (52) of Bodduluri, to define an annular space (space within 1106) that is in fluid communication with a space of the central rod (as 1108 is formed with braided wires or a porous material to allow vacuum suction to be applied therethrough; [0102]) and a hollow needle (hair graft chamber 1104) such that suction is created within a chamber defined by the lumen of the hollow needle ([0103]).
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 extension of Bodduluri to be directly connected to the vacuum source in light of the teachings of Rassman, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Such a modification would cause the smaller diameter extension of the elongated body 46 to define an annular space (space between 43a and 46) that is in fluid communication with the space and the harvesting cannula 38 in order for suction to be applied around the obturator 52 and within the harvesting cannula 38 to facilitate grasping and extracting of the follicular unit as well as to help retain the follicular unit in the harvesting cannula lumen after it has been harvested ([0036]; Figs. 6A-6B).
Regarding claim 4, Bodduluri modified discloses the invention as claimed, and Bodduluri further 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 modified discloses the invention as claimed, and Bodduluri further 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 7, Bodduluri modified discloses the invention as claimed, and Bodduluri further 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 modified discloses the invention as claimed, and Bodduluri further 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(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 Rassman et al. (US 2005/0096687 A1), as applied to claim 1 above, and further in view of Knowlton (US 2018/0344343 A1).
Regarding claims 2-3, Bodduluri modified 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 central rod to aspirate the 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 modified 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 Rassman et al. (US 2005/0096687 A1), as applied to claim 1 above, and further 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.
Allowable Subject Matter
Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Bodduluri et al. (US 2007/0078473 A1) in view of Rassman et al. (US 2005/0096687 A1) in view of Knowlton (US 2018/0344343 A1), does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of dependent claim 6, which recites, inter alia “wherein the needle is mounted for rotational motion so as to allow rotation of a sharp bevel-shaped tip with respect to the orifice”. Bodduluri in view of Rassman teaches the line to the vacuum source directly connected to the elongate body 46, which is equivalent to the vacuum manifold 1072 of Knowlton carrying the orifice (aperture 1075; Fig. 108). Thus, the orifice of modified Bodduluri is also directly connected to the elongate body 46 which is fixedly attached to the harvesting cannula 38. Bodduluri discloses the harvesting cannula 38 is rotatable relative to the hub 34 i.e., the implanting cannula 36, but the modification taught would not allow the harvesting cannula 38 to rotate relative to the orifice as the two are fixedly connected to one another.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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