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 Arguments
Applicant's arguments filed 7/6/2026 have been fully considered but they are not persuasive. Applicant argues that Austen does not teach removal of tissue and therefore cannot be relied upon for teaching tissue is minced as it is harvested. For clarification, the primary reference Knowlton is relied upon for teaching that tissue is removed, and Austen is relied upon for teaching cutting members within a coring needle lumen. Although Austen is not necessarily required to disclose the function of removing tissue, Austen discloses tissue removal throughout the disclosure.
Austen makes clear throughout the disclosure that some amount of tissue is removed in the procedure, as stated in the abstract “..method and apparatus are provided for damaging and/or removing portions of subcutaneous fatty tissue…” (also see [0004-0005]; [0032]). Austen discloses vacuum applied to assist in moving the harvested tissue through the needle for removal [0049]. Figures 5A-C show tissue (230) being harvested and separated by a flap in the needle [0050]. In discussing the embodiment of Figure 8A at [0059], the phrase “The apparatus 800 can facilitate mechanical disruption of fatty tissue without removing a substantial amount thereof from the surrounding tissue” is in reference to the dermis layer surrounding the exterior of the needle. Austen clearly states that tissue enters the lumen of the needle (800) and is damaged by the cutters (810). Taken in context with the remainder of the disclosure, it is understood that the device functions to disrupt and removing tissue. Austen also teaches that the device can be used for a variety of purposed, such as removing tissue for various purposes [0065]. Therefore, the needle with internal cutters taught by Austen is considered to be applicable to the Knowlton apparatus and method of tissue removal.
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) 1, 2, 6, 8-11, 14-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2019/0307480 (Knowlton) in view of US Patent App. Pub. No. 2014/0277055 (Austen, Jr.).
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]).
Knowlton fails to disclose that the dermal columns are minced as they are harvested. Austen discloses another tubular cutting device (700) adapted to core tissue and remove harvested tissue through the tubular needle via suction ([0049]). Austen teaches the concept of forming cutters (810) along the interior of the tubular member that mince tissue moving through the lumen as it is being harvested (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 Knowlton to include internal cutters, as taught by Austen, as the modification merely involves a combination of known tissue coring needles according to known methods that obtains a predictable result of mincing tissue in the coring needle as it is being harvested.
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 10, 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).
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].
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]).
Knowlton fails to disclose a mincing device coupled to the harvesting device. Austen discloses another tubular cutting device (700) adapted to core tissue and remove harvested tissue through the tubular needle via suction ([0049]). Austen teaches the concept of forming cutters (810), or a mincing device, along the interior of the tubular member that mince tissue moving through the lumen as it is being harvested (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 Knowlton to include a mincing device (internal cutters) coupled to the harvesting device (coring needle), as taught by Austen, as the modification merely involves a combination of known tissue coring needles according to known methods that obtains a predictable result of mincing tissue in the coring needle as it is being harvested.
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(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Austen, as applied to claim 1 above, and further 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].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references generally disclose tissue removal devices that morcellate tissue as it is harvested.
WO 92/11816 (Sorensen)
US 6,039,748 (Savage et al.)
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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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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