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 .
Election/Restrictions
Claims 6-10 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 20, 2026.
Applicant’s election of claims 1-13, 20-25 in the reply filed on August 20, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claims 1-4, 12, 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Umar (US 10159508).
Regarding claim 1, Umar discloses a micro-coring system, comprising: a harvesting tool (12) configured to harvest and transfer at least one tissue core from a donor site to a recipient site, the at least one tissue core has a diameter between about 1.0 mm and 3.0 mm (C:1, L:20-30).
Regarding claim 2, Umar discloses all of the limitations set forth in claim 1, wherein the harvesting tool is configured to transfer the harvested cores to a carrier medium (the limitation ‘configured to transfer the harvested cores to a carrier medium’ is a functional limitation, which is not given full patentable weight. As long as the prior art is capable of performing the recited functions and meets the structural limitations, the prior art meets the limitations).
Regarding claim 3, Umar discloses all of the limitations set forth in claim 2, wherein the harvesting tool is configured to extract tissue cores and populate the carrier medium to generate an autograft of a predetermined size and shape (the limitation ‘configured to extract tissue cores and populate the carrier medium to generate an autograft of a predetermined size and shape’ is a functional limitation, which is not given full patentable weight. As long as the prior art is capable of performing the recited functions and meets the structural limitations, the prior art meets the limitations).
Regarding claim 4, Umar discloses all of the limitations set forth in claim 1, wherein the harvesting tool is configured to transfer the harvested cores to a patient wound site (the limitation ‘configured to transfer the harvested cores to a patient wound site’ is a functional limitation, which is not given full patentable weight. As long as the prior art is capable of performing the recited functions and meets the structural limitations, the prior art meets the limitations).
Regarding claim 12, Umar discloses all of the limitations set forth in claim 1, wherein the at least one tissue core comprises skin adnexa having at least one hair follicle, at least one sweat gland, and at least one sebaceous gland (the limitation ‘at least one tissue core’ is not positively recited in claim 1. Therefore, as long as the at least one tissue core is capable of comprising skin adnexa having at least one hair follicle, sweat gland, and sebaceous gland, the prior art meets the limitations).
Regarding claim 13, Umar discloses all of the limitations set forth in claim 1, wherein when harvesting and transferring the at least one tissue core from the donor site to the recipient site, the harvesting tool is configured to harvest and transfer a set of tissue cores defining between about a 10% to 20% core density from the donor site to the recipient site (this limitation is a functional limitation. As long as the prior art meets the structural requirements and is capable of performing the recited functions, the prior art meets the limitations).
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.
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 20180161056) in view of Umar (US 10159508).
Regarding claims 5 and 20, Kim et al (hereafter Kim) discloses a harvesting tool (100), comprising: a coring tool (cutting edge of 100) defining an aperture extending along a longitudinal axis of the coring tool between a first end and a second end of the coring tool (figure 2A); the first end of the coring tool defining a cutting edge (figure 2B, distal end) disposed about an outer periphery of the first end of the coring tool, and an extractor pin (200) disposed within the aperture defined by the coring tool and extending along the longitudinal axis of the coring tool, the extractor pin configured to extract a core from the coring tool (figure 2C). Kim does not teach the cutting edge having a diameter of between about 1.0 mm and 3.0 mm. However, Umar teaches it was known in the art at the time of the invention to make the cutting edge of a coring tool have a diameter of between 1.0mm and 3.0mm for harvesting a follicular unit (C:1, L:20-30). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the cutting edge of Kim have a diameter of between 1.0mm and 3.0mm, as taught as a known diameter for follicular punches at the time of the invention by Umar, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding claim 11, Kim in view of Umar teaches all of the limitations set forth in claim 5, wherein Kim teaches the extractor pin (200) comprises a longitudinal axis and defines a central aperture that extends along the longitudinal axis and configured to be disposed in fluid communication with a vacuum source (figure 2C).
Regarding claim 21, Kim in view of Umar teaches all of the limitations set forth in claim 20, wherein the extractor pin is slidably disposed within the aperture defined by the coring tool (figure 2C).
Regarding claim 22, Kim in view of Umar teaches all of the limitations set forth in claim 21, wherein the extractor pin is configured to be disposed between a first longitudinal position relative to the coring tool as the harvesting tool advances into a tissue location and a second longitudinal position relative to the coring tool as the harvesting tool disposes a tissue core within a carrier medium (this limitation is a functional limitation. As long as the prior art meets the structural requirements and is capable of performing the recited functions, the prior art meets the limitations).
Regarding claim 23, Kim in view of Umar teaches all of the limitations set forth in claim 22, wherein the extractor pin defines an aperture extending along a longitudinal axis of the extractor pin, the aperture configured to carry air from the harvesting tool as the core enters the coring tool (figure 2C).
Regarding claim 24, Kim in view of Umar teaches all of the limitations set forth in claim 22, wherein the extractor pin defines an aperture extending along a longitudinal axis of the extractor pin, the aperture configured to be coupled to a vacuum source (figure 2C, 210).
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 20180161056) in view of Umar (US 10159508), as applied to claim 22 above, and further in view of Umar (US 20110160746).
Regarding claim 25, Kim in view of Umar teaches all of the limitations set forth in claim 22, wherein Umar (US 20110160746, hereafter Umar ‘746) further teaches a coring tool for follicular units defining a spiral slot extending between a sharpened edge and a distal location relative to the sharpened edge of the coring tool (figures 5, 6, paragraph 0045) in order to enhance the suction-like effect that gently sucks the cut tissue towards the coring tool as it descends into the tissue by creating mini vortices that impart a suction effect on the tissue surrounding a fast rotating punch. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to include a spiral slot extending between the sharpened edge of Kim in view of Umar and a distal location relative to the sharpened edge, as taught as a known surface profile for the distal end of a follicular punch in order to enhance the suction-like effect that gently sucks the cut tissue towards the coring tool as it descends into the tissue by creating mini vortices that impart a suction effect on the tissue surrounding a fast rotating punch.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/ Primary Examiner, Art Unit 3771
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