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 a response to applicant’s arguments and amendment filed 01/05/2026. Claims 1, 10-11, 13, 15 and 20-22 are amended. Claims 1-22 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/05/2026, with respect to the rejection(s) of claim(s) 1-8 and 21 under 35 U.S.C. 103 as being unpatentable over Pak; claims 9 and 11 under 35 U.S.C. 103 as being unpatentable over Pak and further in view of Cole; claims 10 and 22 under 35 U.S.C. 103 as being unpatentable over Pak in view of Cole; claims 12-14 under 35 U.S.C. 103 as being unpatentable over Pak in view of Bodduluri; claim 15 under 35 U.S.C. 103 as being unpatentable over Pak in view of Cole and Bodduluri; claim 16 under 35 U.S.C. 103 as being unpatentable over Pak in view of Truckai; and claim 17 under 35 U.S.C. 103 as being unpatentable over Pak in view of Cole and Truckai, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by the amendments to the claims.
Applicant argues Pak does not teach or suggest the second hole having a diameter sized to receive the slotted needle of the implanting instrument and form an end stop and a watertight seal with a tip of the implanting instrument (Remarks, pg. 9).
In response to applicant’s argument, it is respectfully submitted the implanting instrument is not positively recited (see the preamble as discussed in the rejection below). The claim language is only directed to the loading device and the structure of the loading device, such that continual additions of structure to the implanting instrument will not be sufficient in overcoming the rejection unless the implanting instrument is positively recited, as previously discussed and reflected in the system claim 18. Therefore, the rejection is maintained, because the limitations are directed to functional limitations, and the second hole of Pak is considered to be fully capable of being sized appropriately to receive the slotted needle, and further forming an end stop and a watertight seal as claimed.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “sealed connection means for sealed connection” in claims 16-17.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
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) 1-8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Pak (US 2004/0193203 A1) (all references previously of record).
Regarding claim 1, Pak discloses (abstract; paras. [0024]-[0043]; figs. 1-7) a loading device (11) for loading a hair graft into an implanting instrument (60, note the preamble does not positively recite the implanting instrument (i.e. “for loading a hair graft into an implanting instrument”), therefore the structure of the implanting instrument is not required in the claim, and a loading device capable of loading a hair graft into an implanting instrument meets the claimed limitation, paras. [0033]-[0034]) which is separate and distinct from the loading device (see above, structure of the implanting instrument recited functionally and therefore not required by the claim language), wherein the loading device is contactable by the implanting instrument for loading of a hair graft extracted from a donor region of skin (considered to be capable of contact via movement of piston 31 as depicted in figs. 2-6, which indirectly contacts end 42 via spring), and wherein the loading device is further constructed to be separable from the implanting instrument (considered to be capable of separation since 60 detaches to a degree via spring, further note this is a functional limitation and the claim language does not require a specific degree of separation, figs. 2-6) at a time when the implanting instrument is used to implant the loaded hair graft into a recipient region of skin (figs. 2-6), and wherein the implanting instrument has a slotted needle (60 including aperture 62, considered to be a slot; further note the implanting instrument is recited functionally) having an elongate slot extending lengthwise therealong (considered to have a component extending lengthwise, annotated fig. 2) and into which the extracted hair graft is loadable into the needle and implantable from the needle into the recipient region of skin (para. [0032]), the loading device comprising:
a first hole (annotated fig. 2) connected to a central channel (hollow portion of piston 30, para. [0032]; fig. 3) leading into a fluid discharge chamber (first chamber 36, para. [0030]);
a second hole (annotated fig. 2) communicating with the fluid discharge chamber (depicted in figs. 2-6, considered to communicate via piston 31, paras. [0030]-[0032]) and defining a path with the central channel (defines path with hollow portion of piston 30, figs. 2-6) so as to allow the slotted needle of the implanting instrument to be inserted into said path through the second hole (allows reciprocation of piston 31 having a hollow needle configuration 60 on proximal end, note the proximal end as defined in Pak is opposite to the customary, ordinary meaning of ‘proximal’ and is located on the distal end of the device, paras. [0009] and [0033]-[0034]) with the slot of the slotted needle communicable with the fluid discharge chamber (para. [0034]), the second hole having a diameter sized to receive the slotted needle of the implanting instrument (figs. 2-6) and form an end stop and a watertight seal with a tip of the implanting instrument (the implanting instrument is recited functionally as discussed above, therefore the second hole as illustrated in annotated fig. 2 is considered to be fully capable of forming an end stop and a watertight seal with a tip of the implanting instrument); and
connection means (port 38, para. [0030]) from the fluid discharge chamber to a vacuum source (connected to pump 80, paras. [0030] and [0039]; figs. 1-6);
the first hole being constructed to be brought into communication with a first tubing (proximal end 51 of piston 30, considered to be brought into communication with the first hole via reciprocation of piston 30, further note the ‘first tubing’ is recited functionally and therefore not a structural requirement of the claim, see MPEP 2114 and 2173.05(g), para. [0031]; annotated fig. 2) so as to deliver a hair graft (hair graft delivered through needle 60, para. [0035]), such that the hair graft can be loaded into the needle of the implanting instrument (hair graft inserted through needle 60, paras. [0035]-[0036]) by suction applied by the fluid discharge chamber to the slot of the slotted needle (para. [0034]).
However, Pak fails to explicitly disclose wherein the fluid discharge chamber has a height of approximately 1.5 mm.
There is no evidence of record that establishes that changing the height of the fluid discharge chamber would result in a difference in function of the device of Pak. Further, a person having ordinary skill in the art, being faced with modifying the height of the fluid discharge chamber of Pak, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed height. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the fluid discharge chamber has a height of “approximately” 1.5 mm, and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid discharge chamber of Pak to have a height of approximately 1.5 mm as an obvious matter of design choice within the skill of the art.
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Annotated Figure 2 of Pak
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Annotated Figure 2 of Pak
Regarding claim 2, Pak (as modified) teaches the device of claim 1. Pak further discloses wherein the fluid discharge chamber has dimensions such that the fluid discharge chamber is able to allow both a passage of fluid, inclusive of air or water, between the central channel and the connection means of the fluid discharge chamber (vacuum present in chamber 36 and needle 60 when vacuum is applied, chamber 36 considered to be appropriately dimensioned for creation of vacuum between hollow portion of piston 30 and port 38, para. [0034]; figs. 2-6), and the loading of a hair graft into the needle of the implanting instrument (graft loaded into needle 60, para. [0035]), inserted into the central channel via the second hole (piston 31 extends through second hole, depicted in annotated fig. 2 and figs. 3-6).
Regarding claim 3, Pak (as modified) teaches the device of claim 1. Pak further discloses wherein the central channel is rectilinear (depicted as forming a straight line, which is consistent with para. [0077] of the instant spec. describing channel 17 as rectilinear, and the Merriam-Webster dictionary definition “moving in or forming a straight line”, figs. 2-6).
Regarding claim 4, Pak (as modified) teaches the device of claim 1.
Pak further discloses wherein the connection means of the fluid discharge chamber is a vacuum conduit (38, para. [0030]) positioned in the loading device (figs. 2-6), intended to be connected to the vacuum source (80, para. [0039]) via an outlet hole (annotated fig. 2).
However, Pak (as modified) teaches fails to teach the connection means substantially parallel to the central channel.
There is no evidence of record that establishes that changing the orientation of the connection means to be substantially parallel would result in a difference in function of the device of Pak (paras. [0027] and [0031] of the instant spec., further note original claim 5 recites the connection means positioned laterally and perpendicularly to the channel, instead of substantially parallel as recited in original claim 4, which is an alternative orientation of the connection means and therefore not critical). Further, a person having ordinary skill in the art, being faced with modifying the device of Pak, would have a reasonable expectation of success in making such a modification, and it appears the device would function as intended being given the claimed orientation. Lastly, applicant has not disclosed that the claimed range solves any stated problem (paras. [0027] and [0031] of the instant spec.) and therefore there appears to be no criticality placed on the orientation of the connection means as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the orientation of the vacuum port 38 of Pak (as modified) to be substantially parallel to the hollow portion of piston 30 as an obvious matter of design choice within the skill of the art.
Regarding claim 5, Pak (as modified) teaches the device of claim 1. Pak further discloses wherein the connection means of the fluid discharge chamber is a vacuum conduit (38, para. [0030]) positioned laterally and perpendicularly to the central channel (depicted as laterally spaced from hollow portion of piston 30 and oriented perpendicularly relative to piston 30, figs. 2-6).
Regarding claim 6, Pak (as modified) teaches the device of claim 1. Pak further discloses having a substantially cylindrical form (instrument 11 depicted as having a cylindrical shape, figs. 2-6) with a proximal side, a distal side, and a longitudinal side connecting the proximal and the distal sides (annotated fig. 3, note the claim language does not specify the ‘proximal side’ being at the proximalmost end of the device; therefore, annotated fig. 3 depicts a proximal side, which is considered proximal to the distal side and meets the claimed limitation).
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Annotated Figure 3 of Pak
Regarding claim 7, Pak (as modified) teaches the device of claim 6. Pak further discloses wherein the proximal side comprises the second hole (annotated figs. 2 and 3), and the distal side comprises the first hole of the central channel (annotated figs. 2 and 3).
Regarding claim 8, Pak (as modified) teaches the device of claim 1. Pak further discloses wherein the first hole and the second hole are aligned in a longitudinal axis of the central channel (annotate fig. 2, considered to be aligned longitudinally along instrument 11).
Regarding claim 21, Pak (as modified) teaches the device of claim 1. Pak further discloses wherein the loading device is constructed to be worn on a first hand of an operator while the implanting instrument is handled by a second hand of the operator (instrument 11 held between forefinger and thumb, considered to be constructed appropriately to be held/handled in a first or second hand of a user and therefore worn by an operator, para. [0025]).
Claim(s) 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Pak as applied to claim 1 above, and further in view of Cole (US 2008/0050805 A1).
Regarding claim 9, Pak (as modified) teaches the device of claim 1.
Pak further discloses wherein the connection means connects the fluid discharge chamber to the vacuum source (port 38 provides connection to pump 80, para. [0030]; figs. 1-6).
However, Pak (as modified) teaches fails to teach wherein the first tubing connects the central channel to a hair graft tank.
Cole teaches (paras. [0002] and [0021]-[0023]; fig. 1), in the same field of endeavor, a device for loading hair grafts (tissue board assembly 100 used to store tissue grafts during follicular dissection procedure, considered to aid in loading hair grafts by providing storage for hair grafts, para. [0023]) comprising storing hair grafts in a tank (hair grafts stored in containers 105 of tissue board assembly 100 containing a preservation liquid, para. [0023]), for the purpose of appropriately preserving tissue grafts to ensure successful transplantation of hair follicles, effecting the yield of successfully transplanted follicles or slivers to the donor site (paras. [0002] and [0023]).
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 piston of Pak (as modified) to be connected to a hair graft tank, in order to preserve the tissue grafts when desired, ensuring successful transplantation of hair follicles and effecting the yield of successfully transplanted follicles or slivers to the donor site, based upon the suggestions and teachings of Cole (paras. [0002] and [0023]).
Regarding claim 11, Pak (as modified) teaches the device of claim 1.
However, Pak (as modified) fails to teach a storage tray for hair grafts configured to facilitate the suction of a hair graft into the loading device according to claim 1, the storage tray comprising at least one well configured to contain a hair graft and whose dimensions allow maintenance of the hair graft in a given position enabling the suction of the hair graft into the loading device.
Cole teaches (paras. [0002] and [0045]; fig. 8), in the same field of endeavor, a storage tray for hair grafts configured to facilitate suction of a hair graft into a device (tissue board assembly 800, allows user to work on extracted tissue grafts using tools, therefore considered to be capable of facilitating suction with a tool, para. [0045]) comprising at least one well (recessed work area 801) configured to contain a hair graft (holds hair grafts in thin film of solution, para. [0045]) and whose dimensions allow maintenance of the hair graft in a given position enabling the suction of the hair graft into the device for loading hair grafts (considered to have appropriate dimensions for enabling suction and maintaining the hair graft in a given position, since tissue board assembly 800 allows a user to work on extracted tissue grafts in a specified area, para. [0045]), for the purpose of appropriately preserving tissue grafts to ensure successful transplantation of hair follicles, effecting the yield of successfully transplanted follicles or slivers to the donor site (paras. [0002], [0023] and [0045]).
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 system of Pak (as modified) to include the tissue board assembly of Cole providing the capability of storage of the tissue grafts, in order to preserve the tissue grafts when desired, ensuring successful transplantation of hair follicles and effecting the yield of successfully transplanted follicles or slivers to the donor site, based upon the suggestions and teachings of Cole (paras. [0002], [0023] and [0045]).
Claim(s) 10 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Pak in view of Cole.
Regarding claim 10, Pak discloses (abstract; paras. [0024]-[0043]; figs. 1-7) a method of use of a loading device (11) for loading hair grafts into an implanting instrument (60, note the preamble does not positively recite the implanting instrument (i.e. “for loading a hair graft into an implanting instrument”), therefore the structure of the implanting instrument is not required in the claim, and a loading device capable of loading a hair graft into an implanting instrument meets the claimed limitation, paras. [0033]-[0034]) which is separate and distinct from the loading device (see above, structure of the implanting instrument recited functionally and therefore not required by the claim language), wherein the loading device is contactable by the implanting instrument for loading of a hair graft extracted from a donor region of skin (considered to be capable of contact via movement of piston 31 as depicted in figs. 2-6, which indirectly contacts end 42 via spring), and wherein the loading device is further constructed to be separable from the implanting instrument (considered to be capable of separation since 60 detaches to a degree via spring, further note this is a functional limitation and the claim language does not require a specific degree of separation, figs. 2-6) at a time when the implanting instrument is used to implant the loaded hair graft into a recipient region of skin (figs. 2-6), and wherein the implanting instrument has a slotted needle (60 including aperture 62, considered to be a slot; further note the implanting instrument is recited functionally) having an elongate slot extending lengthwise therealong (considered to have a component extending lengthwise, annotated fig. 2) and into which the extracted hair graft is loadable into the needle and implantable from the needle into the recipient region of skin (para. [0032]), wherein the loading device includes:
a first hole (annotated fig. 2) connected to a central channel (hollow portion of piston 30, para. [0032]; fig. 3) leading into a fluid discharge chamber (first chamber 36, para. [0030]);
a second hole (annotated fig. 2) communicating with the fluid discharge chamber (depicted in figs. 2-6, considered to communicate via piston 31, paras. [0030]-[0032]) and defining a path with the central channel (defines path with hollow portion of piston 30, figs. 2-6) so as to allow the slotted needle of the implanting instrument to be inserted into said path through the second hole (allows reciprocation of piston 31 having a hollow needle configuration 60 on proximal end, note the proximal end as defined in Pak is opposite to the customary, ordinary meaning of ‘proximal’ and is located on the distal end of the device, paras. [0033]-[0034]) with the slot of the slotted needle communicable with the fluid discharge chamber (para. [0034]), the second hole having a diameter sized to receive the slotted needle of the implanting instrument (figs. 2-6) and form an end stop and a watertight seal with a tip of the implanting instrument (the implanting instrument is recited functionally as discussed above, therefore the second hole as illustrated in annotated fig. 2 is considered to be fully capable of forming an end stop and a watertight seal with a tip of the implanting instrument); and
connection means (port 38, para. [0030]) from the fluid discharge chamber to a vacuum source (connected to pump 80, paras. [0030] and [0039]; figs. 1-6);
the first hole being constructed to be brought into communication with a first tubing (proximal end 51 of piston 30, considered to be brought into communication with the first hole via reciprocation of piston 30, further note the ‘first tubing’ is recited functionally and therefore not a structural requirement of the claim, see MPEP 2114 and 2173.05(g), para. [0031]; annotated fig. 2) so as to deliver a hair graft (hair graft delivered through needle 60, para. [0035]) such that the hair graft can be loaded into the needle of the implanting instrument (hair graft inserted through needle 60, paras. [0035]-[0036]) by suction applied by the fluid discharge chamber to the slot of the slotted needle (para. [0034]),
wherein the method of use comprises:
connecting the first tubing to the first hole (proximal end 51 of piston 30 considered to be connected to the first hole through reciprocation within instrument 11, annotated fig. 2),
inserting the needle (60) of the implanting instrument, in a sealed manner, into the second hole (inserted through structure of device and movement of piston 31), in such a way that it penetrates into at least part of the central channel (penetrates hollow portion of piston 30, figs. 2-6) with the slot of the slotted needle being communicable with the fluid discharge chamber (para. [0034]),
bringing a free end (proximal end of piston 30) of the first tubing into contact with the hair graft located in a solution (graft positioned in needle 60, graft may be within a fluid medium, considered to be a solution, paras. [0016] and [0035]),
vacuum sealing the fluid discharge chamber (paras. [0009] and [0034]-[0035], chambers 36 and 37 are sealed chambers and therefore considered vacuum sealed when vacuum is applied), whereby the hair graft is loaded into the needle of the implanting instrument by suction applied by the fluid discharge chamber to the slot of the slotted needle (para. [0034]), and
separating the implanting instrument from the loading device (depicted in figs. 2-6, distinction made between 60 and 11 as needle is distally advanced and therefore separated from 11) in preparation for implantation of the loaded hair graft from the needle into the recipient region of skin (figs. 2-6).
However, Pak fails to disclose wherein the fluid discharge chamber has a height of approximately 1.5 mm; and the solution located in a tank.
There is no evidence of record that establishes that changing the height of the fluid discharge chamber would result in a difference in function of the device of Pak. Further, a person having ordinary skill in the art, being faced with modifying the height of the fluid discharge chamber of Pak, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed height. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the fluid discharge chamber has a height of “approximately” 1.5 mm, and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid discharge chamber of Pak to have a height of approximately 1.5 mm as an obvious matter of design choice within the skill of the art.
Pak (as modified) still fails to teach the solution located in a tank.
Cole teaches (paras. [0002] and [0021]-[0023]; fig. 1), in the same field of endeavor, a method of use for loading hair grafts (tissue board assembly 100 used to store tissue grafts during follicular dissection procedure, considered to aid in loading hair grafts by providing storage for hair grafts, para. [0023]) comprising storing hair grafts in a solution in a tank (hair grafts stored in containers 105 of tissue board assembly 100 containing a preservation liquid, para. [0023]), for the purpose of appropriately preserving tissue grafts to ensure successful transplantation of hair follicles, effecting the yield of successfully transplanted follicles or slivers to the donor site (paras. [0002] and [0023]).
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 method of Pak (as modified) to include the tissue board assembly of Cole providing the capability of storage of the tissue grafts, in order to preserve the tissue grafts when desired, ensuring successful transplantation of hair follicles and effecting the yield of successfully transplanted follicles or slivers to the donor site, based upon the suggestions and teachings of Cole (paras. [0002] and [0023]).
Regarding claim 22, Pak (as modified) teaches the method of claim 10. Pak further discloses wherein the loading device is constructed to be worn on a first hand of an operator while the implanting instrument is handled by a second hand of the operator (instrument 11 held between forefinger and thumb, considered to be constructed appropriately to be held/handled in a first or second hand of a user and therefore worn by an operator, para. [0025]).
Claim(s) 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pak as applied to claim 1 above, and further in view of Bodduluri (US 2007/0106306 A1).
Regarding claim 12, Pak (as modified) teaches the device of claim 1.
Pak further discloses a hair graft suction device (pump 80, para. [0039]) configured to insert a hair graft into the loading device according to claim 1 (vacuum captures graft, paras. [0039]-[0041]).
However, Pak (as modified) fails to teach the suction device comprising a support and a housing for a rigid tube configured to be connected to the first tubing of the loading device, the housing being mobile in relation to the support and configured so as to be moved in order to bring the rigid tube into contact with a hair graft.
Bodduluri teaches (para. [0051]), in the same field of endeavor, a suction device (robotics system 25, which may include a vacuum unit, paras. [0046] and [0097]; fig. 1) comprising a support (32, paras. [0046] and [0051]-[0052]; fig. 1) and a housing (robotic arm 27, fig. 1) for a rigid tube (hair follicular unit harvesting tool 40 including an elongate shaft, note the rigid tube is recited functionally and therefore not a structural requirement of the claim, paras. [0059]-[0060]; figs. 2-3) configured to be connected to the first tubing of the device for loading hair grafts (considered to be capable of connection with a secondary tubing structure, since the harvesting tools disclosed are made up of multiple structures connected to each other, paras. [0060] and [0076]; figs. 2-3 and 10-12), the housing being mobile in relation to the support (robotic arm 27 moves in six degrees of freedom relative to base 32, paras. [0046] and [0051]) and configured so as to be moved in order to bring the rigid tube into contact with a hair graft (robotic arm 27 moves harvesting tool 40 into contact with scalp for removal of a follicular unit, paras. [0060]-[0061]), for the purpose of providing the capability of performing an automated procedure for identifying position and orientation of a large number of hair follicular units in a region of interest on a patients scalp for accurate harvesting of the follicular units (paras. [0004] and [0067]).
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 device of Pak (as modified) to be included in image-guided robotics system 25 as a component of the harvesting tool, in order to provide the capability of performing an automated procedure for identifying position and orientation of a large number of hair follicular units in a region of interest on a patients scalp for accurate harvesting of the follicular units, based upon the suggestions and teachings of Bodduluri (paras. [0004] and [0067]).
Regarding claim 13, Pak (as modified) teaches the device of claim 12. Pak (as modified) further teaches the hair suction device according to claim 12, comprising: a camera (28, para. [0048]; fig. 1 of Bodduluri) configured to record an image of the hair graft located in a container (cameras 28 acquire image data by capturing several fields-of-view including depth of a hair graft and therefore considered to be capable of capturing an image of the hair graft in varying locations including within a container, paras. [0048]-[0049] and [0057] of Bodduluri), and a controller (system controller, para. [0048] of Bodduluri) configured to analyze a precise position of the hair graft (moves robotic arm 27 in response to processing image data of location of hair follicles, paras. [0048]-[0049] of Bodduluri).
Regarding claim 14, Pak (as modified) teaches the device of claim 1.
Pak further discloses an assembly comprising the loading device (11) according to claim 1 and a hair graft suction device (pump 80, para. [0039]).
However, Pak (as modified) fails to teach wherein the hair graft suction device comprises a support and a housing for a rigid tube configured to be connected to the first tubing of the device for loading hair grafts, the housing being mobile in relation to the support and configured so as to be moved in order to bring the rigid tube into contact with a hair graft.
Bodduluri teaches (para. [0051]), in the same field of endeavor, a suction device (robotics system 25, which may include a vacuum unit, paras. [0046] and [0097]; fig. 1) comprising a support (32, paras. [0046] and [0051]-[0052]; fig. 1) and a housing (robotic arm 27, fig. 1) for a rigid tube (hair follicular unit harvesting tool 40 including an elongate shaft, note the rigid tube is recited functionally and therefore not a structural requirement of the claim, paras. [0059]-[0060]; figs. 2-3) configured to be connected to the first tubing of the device for loading hair grafts (considered to be capable of connection with a secondary tubing structure, since the harvesting tools disclosed are made up of multiple structures connected to each other, paras. [0060] and [0076]; figs. 2-3 and 10-12), the housing being mobile in relation to the support (robotic arm 27 moves in six degrees of freedom relative to base 32, paras. [0046] and [0051]) and configured so as to be moved in order to bring the rigid tube into contact with a hair graft (robotic arm 27 moves harvesting tool 40 into contact with scalp for removal of a follicular unit, paras. [0060]-[0061]), for the purpose of providing the capability of performing an automated procedure for identifying position and orientation of a large number of hair follicular units in a region of interest on a patients scalp for accurate harvesting of the follicular units (paras. [0004] and [0067]).
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 device of Pak (as modified) to be included in image-guided robotics system 25 as a component of the harvesting tool, in order to provide the capability of performing an automated procedure for identifying position and orientation of a large number of hair follicular units in a region of interest on a patients scalp for accurate harvesting of the follicular units, based upon the suggestions and teachings of Bodduluri (paras. [0004] and [0067]).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pak as applied to claim 1 above, and further in view of Cole and Bodduluri.
Regarding claim 15, Pak (as modified) teaches the device of claim 1.
Pak further discloses an assembly comprising the loading device (11) according to claim 1 and a hair graft suction device (pump 80, para. [0039]).
However, Pak (as modified) fails to teach a storage tray, wherein the hair graft suction device comprises a support and a housing for a rigid tube configured to be connected to the first tubing of the loading device, the housing being mobile in relation to the support and configured so as to be moved in order to bring the rigid tube into contact with a hair graft, and wherein the storage tray comprises at least one well configured to contain the hair graft and whose dimensions allow maintenance of the hair graft in a given position enabling the suction of the hair graft into the loading device.
Cole teaches (paras. [0002] and [0045]; fig. 8), in the same field of endeavor, a storage tray for hair grafts configured to facilitate suction of a hair graft into a device (tissue board assembly 800, allows user to work on extracted tissue grafts using tools, therefore considered to be capable of facilitating suction with a tool, para. [0045]) comprising at least one well (recessed work area 801) configured to contain a hair graft (holds hair grafts in thin film of solution, para. [0045]) and whose dimensions allow maintenance of the hair graft in a given position enabling the suction of the hair graft into the device for loading hair grafts (considered to have appropriate dimensions for enabling suction and maintaining the hair graft in a given position, since tissue board assembly 800 allows a user to work on extracted tissue grafts in a specified area, para. [0045]), for the purpose of appropriately preserving tissue grafts to ensure successful transplantation of hair follicles, effecting the yield of successfully transplanted follicles or slivers to the donor site (paras. [0002], [0023] and [0045]).
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 system of Pak (as modified) to include the tissue board assembly of Cole providing the capability of storage of the tissue grafts, in order to preserve the tissue grafts when desired, ensuring successful transplantation of hair follicles and effecting the yield of successfully transplanted follicles or slivers to the donor site, based upon the suggestions and teachings of Cole (paras. [0002], [0023] and [0045]).
Pak (as modified) still fails to teach wherein the hair graft suction device comprises a support and a housing for a rigid tube configured to be connected to the first tubing of the loading device, the housing being mobile in relation to the support and configured so as to be moved in order to bring the rigid tube into contact with a hair graft.
Bodduluri teaches (para. [0051]), in the same field of endeavor, a suction device (robotics system 25, which may include a vacuum unit, paras. [0046] and [0097]; fig. 1) comprising a support (32, paras. [0046] and [0051]-[0052]; fig. 1) and a housing (robotic arm 27, fig. 1) for a rigid tube (hair follicular unit harvesting tool 40 including an elongate shaft, note the rigid tube is recited functionally and therefore not a structural requirement of the claim, paras. [0059]-[0060]; figs. 2-3) configured to be connected to the first tubing of the device for loading hair grafts (considered to be capable of connection with a secondary tubing structure, since the harvesting tools disclosed are made up of multiple structures connected to each other, paras. [0060] and [0076]; figs. 2-3 and 10-12), the housing being mobile in relation to the support (robotic arm 27 moves in six degrees of freedom relative to base 32, paras. [0046] and [0051]) and configured so as to be moved in order to bring the rigid tube into contact with a hair graft (robotic arm 27 moves harvesting tool 40 into contact with scalp for removal of a follicular unit, paras. [0060]-[0061]), for the purpose of providing the capability of performing an automated procedure for identifying position and orientation of a large number of hair follicular units in a region of interest on a patients scalp for accurate harvesting of the follicular units (paras. [0004] and [0067]).
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 device of Pak (as modified) to be included in image-guided robotics system 25 as a component of the harvesting tool, in order to provide the capability of performing an automated procedure for identifying position and orientation of a large number of hair follicular units in a region of interest on a patients scalp for accurate harvesting of the follicular units, based upon the suggestions and teachings of Bodduluri (paras. [0004] and [0067]).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pak as applied to claim 1 above, and further in view of Truckai (US 2018/0221054 A1).
Regarding claim 16, Pak (as modified) teaches the device of claim 1.
However, Pak fails to disclose an accessory channel opening perpendicularly from a longitudinal face of the loading device into the central channel; the accessory channel having an accessory hole opening into the central channel and an accessory opening opposite the accessory hole and positioned in the longitudinal face of the loading device, and the accessory channel having, projecting outwards at the accessory opening, a sealed connection means for sealed connection to a third tubing configured to be connected to a pressure sensor.
Truckai teaches (paras. [0036]-[0037], [0039] and [0050]; figs. 1-5 and 10a-c), in the analogous art of the claimed invention, a tissue resection system including a device (100) comprising a channel (interior channel 186, para. [0033]) and an accessory channel (pressure sensing channel, which extends through third flow channel 210 and fitting 144 to flexible tubing 218 via connector 145, para. [0037]) opening perpendicularly from a longitudinal face of the device into the central channel (fig. 2 depicts connector 145 extending perpendicularly relative to a longitudinal face of the device, which opens into channel 186, para. [0033]), the accessory channel having an accessory hole (hole formed in fitting 144 for connection to connector 145, considered to have a hole extending to channel 186, annotated fig. 10c) opening into the central channel (considered to open into channel 186, fig. 10c) and an accessory opening (opening formed in connector 145, annotated fig. 10c) opposite the accessory hole (considered to be formed on opposite side relative to opening depicted in annotated fig. 10c) and positioned in the longitudinal face of the device (connector 145 positioned in a longitudinal face of the handle, depicted in fig. 10c), the accessory channel having, projecting outwards at the accessory opening (opening depicted as projecting outwards, fig. 10c), a sealed connection means for sealed connection (connector 145 couples fluid flow tubing to controller console 150, considered to provide a sealing structure for fluid flow from controller 150 to the device, paras. [0032] and [0050]) to a third tubing (218) configured to be connected to a pressure sensor (165), for the purpose of controlling or maintaining fluid pressure at a pre-selected level in a working space in response to signals from the pressure sensor (para. [0048]).
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 device of Pak (as modified) to further include an accessory channel for connection to a pressure sensor, in order to control or maintain fluid pressure at a pre-selected level in a working space in response to signals from the pressure sensor, providing feedback to the user to ensure the appropriate amount of vacuum is being applied to the device, based on the suggestions and teachings of Truckai (para. [0048]).
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Annotated Figure 10C of Truckai
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pak in view of Cole as applied to claim 10 above, and further in view of Truckai.
Regarding claim 17, Pak (as modified) teaches the device of claim 10.
However, Pak (as modified) fails to teach wherein the loading device further includes an accessory channel opening perpendicularly from a longitudinal face of the loading device into the central channel; the accessory channel having an accessory hole opening into the central channel and an accessory opening opposite the accessory hole and positioned in the longitudinal face of the loading device, and the accessory channel having, projecting outwards at the accessory opening, a sealed connection means for sealed connection to a third tubing configured to be connected to a pressure sensor, wherein the method further comprises confirming that the hair graft is present and has been loaded into the implanting instrument by reference to the pressure sensor.
Truckai teaches (paras. [0036]-[0037], [0039] and [0050]; figs. 1-5 and 10a-c), in the analogous art of the claimed invention, a tissue resection system including a device (100) comprising a channel (interior channel 186, para. [0033]) and an accessory channel (pressure sensing channel, which extends through third flow channel 210 and fitting 144 to flexible tubing 218 via connector 145, para. [0037]) opening perpendicularly from a longitudinal face of the device into the central channel (fig. 2 depicts connector 145 extending perpendicularly relative to a longitudinal face of the device, which opens into channel 186, para. [0033]), the accessory channel having an accessory hole (hole formed in fitting 144 for connection to connector 145, considered to have a hole extending to channel 186, annotated fig. 10c) opening into the central channel (considered to open into channel 186, fig. 10c) and an accessory opening (opening formed in connector 145, annotated fig. 10c) opposite the accessory hole (considered to be formed on opposite side relative to opening depicted in annotated fig. 10c) and positioned in the longitudinal face of the device (connector 145 positioned in a longitudinal face of the handle, depicted in fig. 10c), the accessory channel having, projecting outwards at the accessory opening (opening depicted as projecting outwards, fig. 10c), a sealed connection means for sealed connection (connector 145 couples fluid flow tubing to controller console 150, considered to provide a sealing structure for fluid flow from controller 150 to the device, paras. [0032] and [0050]) to a third tubing (218) configured to be connected to a pressure sensor (165), for the purpose of controlling or maintaining fluid pressure at a pre-selected level in a working space in response to signals from the pressure sensor (para. [0048]).
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 device of Pak (as modified) to further include an accessory channel for connection to a pressure sensor, in order to control or maintain fluid pressure at a pre-selected level in a working space in response to signals from the pressure sensor, providing feedback to the user to ensure the appropriate amount of vacuum is being applied to the device, based on the suggestions and teachings of Truckai (para. [0048]).
Pak (as modified) further teaches confirming that the hair graft is present and has been loaded into the implanting instrument (capturing and loading as depicted in figs. 2-6 of Pak considered to encompass confirmation that hair graft is present, paras. [0040]-[0043] of Pak) by reference to the pressure sensor (combination considered to further teach reference to pressure sensor via feedback to user of vacuum being applied to the device in Pak (as modified)).
Allowable Subject Matter
Claims 18-20 are allowed.
Regarding base claim 18, the closest prior art of record to Pak (previously cited) discloses a loading device (11) and an implanting instrument (60), but fails to disclose the implanting instrument positively recited in addition to the loading device and distinct from the loading device as claimed. As previously discussed, Pak discloses the implanting instrument 60 as a distinct structure but residing within loading device 11.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRIGID K BYRD/Examiner, Art Unit 3771