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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 6, 8, 9, 18-23, and 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Pub. No. 2019/0307480 (Knowlton).
Knowlton discloses a method for providing an autologous bio-filler to a patient (abstract; [0794]), the method comprising:
harvesting dermal columns or “dermal plugs” from a harvesting site (abstract; see especially Fig. 31; [0794-0803]);
mincing the dermal columns into microsegments, the microsegments forming the autologous bio-filler (abstract; also see description of attaching a mincing blade and a “pixel solution” in the chamber at [0794; 0802]; Fig. 204);
and injecting the autologous bio-filler into a recipient site of the patient (abstract; [0802]).
Regarding claim 2, Knowlton discloses a “pixel solution” is added to the collection chamber during mincing to form the filler [0802]. Knowlton further discloses the fluid added to the microsegments may be hyaluronic acid or saline [0794; 0812], which are known sterile fluids.
Regarding claim 6, harvesting the dermal columns includes guiding a coring needle through a dermis of the patient substantially perpendicular to a skin surface of the patient (see Figures 64-67, 87, 120).
Regarding claim 8, Knowlton discloses the use of a suction to pull pixels or “dermal columns” through the scalpets or “coring needles” (see Fig. 77-79; see vacuum port in Figure 199; [0800]).
Regarding claim 9, Knowlton discloses removing an epidermis of the patient at the harvesting site prior to harvesting the dermal columns [0803].
Regarding claim 18: Knowlton discloses a system for providing an autologous bio-filler to a patient [0813], the system comprising:
a harvesting device configured to harvest a dermal column from a harvesting site of the patient (see description of scalpet device at [0801]; Fig. 199-201);
a mincing device configured to mince the dermal column into microsegments, the microsegments forming the autologous bio-filler (see description of mincing device at [0802]; Fig. 204);
and an injecting device configured to inject the autologous bio-filler into a recipient site of the patient (see Fig. 205; [0802]).
Regarding claim 19, the harvesting device comprises a plurality of coring needles (“scalpets” [0581]).
Regarding claim 20, the injecting device is a needle syringe (Fig. 205; [0802]).
Regarding claim 21, the coring needle is one of a two-point edged or a multi-point edged coring needle (see Fig. [0581].
Regarding claim 22, Knowlton discloses a “pixel solution” is added to the collection chamber during mincing to form the filler [0802]. Knowlton further discloses the fluid added to the microsegments may be hyaluronic acid or saline [0794; 0812], which are known sterile fluids.
Regarding claim 23, Knowlton further comprises a guide configured to guide the coring needle into a dermis of the patient to harvest the dermal column (any of the coring needle/ scalpet array housings meet the broadest reasonable interpretation of “guide”).
Regarding claim 25, the guide (handle/housing) includes a base configured to rest upon a skin surface of the patient (see housing portion resting on skin surface in Fig. 112-114A; [0663-0664]) and an angled portion extending from the base (the suction lumen forming the angled portion), the guide being sized to permit the coring needle to be guided through the guide at a harvesting angle (wherein the harvesting angle being perpendicular to the patient’s skin meets the broad limitation).
Regarding claim 26, Knowlton discloses a motor coupled to the coring needle and configured to rotate the coring needle (see description of rotation of coring needles at abstract; Fig. 43-47; 0550-0555; see description of motor at 0467; 0568; 0700; 0714].
Regarding claim 27, Knowlton discloses further comprising a vibrating source (Fig. 75) coupled to the coring needle and configured to vibrate the coring needle [0141]; [0505]; [0587].
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.
Claim(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of US 2017/0143374 (Bellomo et al.).
In regards to claim 3, Knowlton discloses harvesting the dermal columns includes guiding a coring needle through a dermis of the patient (see Figures 64-67, 87, 120), but fails to disclose the needle is oriented substantially parallel to a skin surface of the patient.
Bellomo discloses another method of harvesting dermal tissue from a patient (abstract; [0053]), and teaches that a coring needle (see 3010 in Figure 3B; [0111]) may be oriented parallel to the skin (Fig. 3A-D), as this method aids in separating the desired tissue to be harvested from other layers of skin [0099]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to orient the coring needle of the Knowlton method parallel to the skin, as Bellomo teaches that this aids in harvesting target layers of skin.
Regarding claim 4, Knowlton discloses harvesting the dermal columns further includes rotating the coring needle as it is guided through the dermis (see Fig. 64-67 of Knowlton). Bellomo also discloses rotating the needle [0019]; [0121].
Regarding claim 5, Knowlton discloses further comprising a vibrating source (Fig. 75) coupled to the coring needle and configured to vibrate the coring needle [0141]; [0505]; [0587].
Claim(s) 10, 11, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of US Patent App. Pub. No. 2014/0277055 (Austen, Jr.).
Regarding claims 10 and 11, Knowlton discloses a the dermal harvesting system of claim 1 but fails to disclose the coring needle has internal cutters for mincing the dermal column. Austen discloses another tubular cutting device (700) adapted to core tissue via suction ([0049]). Austen teaches the concept of forming cutters (810) along the interior of the tubular member that assist in cutting tissue moving through the lumen (see description of cutting blades on the inner wall of the needle 120 [0060]; Fig. 8A-C). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the coring needle of Knowlton to include internal cutters, as taught by Austen, as the modification merely involves a combination of known coring needles according to known methods that obtains a predictable result of severing tissue that has been removed from a target site.
Further regarding claim 11, Knowlton discloses a needle syringe (Fig. 205; [0802]) for injecting an autologous bio-filler into a recipient site of the patient (see Fig. 205; [0802]).
Regarding claim 14, Knowlton further comprises a harvesting guide configured to guide the coring needle into a dermis of the patient to harvest the dermal column (any of the coring needle/ scalpet array housings meet the broadest reasonable interpretation of “guide”). For example, a guide (handle/housing) includes a base configured to rest upon a skin surface of the patient (see housing portion resting on skin surface in Fig. 112-114A; [0663-0664]).
Regarding claim 15, Knowlton discloses a motor coupled to the coring needle and configured to rotate the coring needle (see description of rotation of coring needles at abstract; Fig. 43-47; 0550-0555; see description of motor at 0467; 0568; 0700; 0714].
Regarding claim 16, Knowlton discloses further comprising a vibrating source (Fig. 75) coupled to the coring needle and configured to vibrate the coring needle [0141]; [0505]; [0587].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774