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
Applicant’s election without traverse of claims 61-79 in the reply filed on 07/23/2026 is acknowledged. Claims 80-87 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 68 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 68 recites the limitation "the disk" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 61, 66-72, 75, and 76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kirn et al. US Patent Application Publication 2019/0328977.
As to claim 61, Kirn teaches a syringe 60 for withdrawing an aspirate including fat cells from a body for micro fat grafting (Abstract; para. 0060), comprising:
a barrel 64 having first 66 and second 68 portions, the first portion having an inner wall 70 with a lesser diameter than an inner wall 72 of the second portion 68 (Fig. 7; paras. 0012, 0061);
a filter for separating fat cells from the aspirate extends within the second portion of the barrel – where Kirn teaches the syringe 60 has a filter that would extend within the chamber and be positioned between the sleeve 74 and the absorbent 82 (para. 0065) similar to the filter 36 (Fig. 4);
an absorbent 82 positioned between the filter and the second portion inner wall for absorbing the remaining aspirate passing through the filter (Fig. 8; paras. 0063-0065, 0067); and
a plunger 80 for longitudinal movement within the barrel along the first portion inner wall 70 and the filter – where Kirn teaches the filter between the sleeve 74 and the absorbent 82 (para. 0065), the plunger 80 having a gasket 80’ attached to a proximal end of the plunger forming a seal with the first portion inner wall 70 in a first position (inserted) and an inner wall of the filter (between sleeve 74 and absorbent 82) in a second position (retracted) (para. 0062).
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As to claim 66, Kirn teaches the syringe 60 for withdrawing an aspirate including fat cells from a body of claim 61, further comprising a distal support 74 that receives a distal end of the filter (between sleeve 74 and absorbent 82, similar to filter 36) and defines a central aperture through which the plunger extends (Fig. 8; para. 0063).
As to claim 67, Kirn teaches the syringe for withdrawing an aspirate including fat cells from a body of claim 66, wherein the distal support 74 includes a support surface extending radially for engaging the second portion 68 of the barrel (Fig. 8, paras. 0062-0064).
As to claim 68, Kirn teaches the syringe for withdrawing an aspirate including fat cells from a body of claim 66, wherein the distal support 74 further includes an annular ring extending distally from the disk (Fig. 8, element 74) – the examiner interprets “the disk” to mean the sleeve 74 having an annular ring at the end of the distal portion (Fig. 8)
As to claim 69, Kirn teaches the syringe for withdrawing an aspirate including fat cells from a body of claim 68, wherein an inner diameter of the annular ring (of sleeve 74) is larger than the diameter of the central aperture – where Kirn teaches the plunger 80, which has a diameter smaller than the sleeve 74, moves longitudinally within the channels formed by the inner wall 78 of the sleeve 74. Kirn teaches this channel has an inner diameter substantially the same as the inner diameter of a channel generally define by the inner wall 70 extending within the first portion of the barrel 66 (para. 0061). The central aperture of 74 accommodates the plunger which forms a seal with and thus, is smaller than the inner diameter of the annular ring, the annular ring forming a distal ledge at the end of the sleeve 74 (Fig. 8). A third gasket is not positively recited in the claim.
As to claim 70, Kirn teaches the syringe for withdrawing an aspirate including fat cells from a body of claim 61, wherein an outer wall of the filter and the barrel second portion inner wall at least partially define a chamber wherein the absorbent resides – where Kirn teaches the filter of the syringe 60 would extend within the chamber and is positioned between the sleeve 74 and the absorbent 82 (para. 0065), the absorbent is positioned within the chamber formed by inner wall 78 and sleeve 74 (para. 0064). Thus, the absorbent is positioned with the chamber formed by the outer wall of the filter and the inner wall 78, which resides within the inner wall 72 of the second portion 68 (Fig. 8; paras. 0016, 0017, 0061, 0064).
As to claim 71, Kirn teaches the syringe for withdrawing an aspirate including fat cells from a body of claim 70, further comprising a cap 84 engaging a distal end of the barrel 64 and further defining the chamber wherein the absorbent 82 resides (Fig. 8; para. 0064).
As to claim 72, Kirn teaches the syringe for withdrawing an aspirate including fat cells from a body of claim 61, wherein the filter is a mesh (paras. 0010, 0053).
As to claim 75, Kirn teaches the syringe for withdrawing an aspirate including fat cells from a body of claim 61, further comprising at least one detent formed in the plunger 80 for engaging a seal 84, 86 supported by the barrel 64 to provide a tactile change in the plunger movement – where Fig. 8 shows a flared distal end of the plunger.
As to claim 76, Kirn teaches a syringe 60 for withdrawing an aspirate including fat cells from a body for micro fat grafting (Abstract; para. 0060), comprising:
a barrel 64 having first 66 and second 68 portions, the first portion having an inner wall 70 with a lesser diameter than an inner wall 72 of the second portion 68 (Fig. 7; paras. 0012, 0061);
a filter for separating fat cells from the aspirate extends within the second portion of the barrel – where Kirn teaches the syringe 60 has a filter that would extend within the chamber and be positioned between the sleeve 74 and the absorbent 82 (para. 0065) similar to the filter 36 (Fig. 4);
an absorbent 82 positioned between the filter and the second portion inner wall for absorbing the remaining aspirate passing through the filter (Fig. 8; paras. 0063-0065, 0067); and
a plunger 80 for longitudinal movement within the barrel along the first portion inner wall 70 and the filter – where Kirn teaches the filter between the sleeve 74 and the absorbent 82 (para. 0065), the plunger 80 having a gasket 80’ (see annotated Fig. 8 above) attached to a proximal end of the plunger,
wherein filter separates fat cells from the aspirate while allowing the remaining aspirate to traverse the filter (paras. 0004-0005, 0029, 0033, 0053).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 73, 74, and 77-79 are rejected under 35 U.S.C. 103 as being unpatentable over Kirn et al. US Patent Application Publication 2019/0328977.
As to claims 73 and 74, Kirn does not specifically teach a second filter extending within the chamber and positioned between an outer wall of the filter and the absorbent. However, Kirn does teach an embodiments where the syringe includes a second sleeve having one or more apertures, the second sleeve extending with the second portion of the barrel and at least partially defining the chamber (para. 0015). Thus, based on the teaching of Kirn, one having ordinary skill in the art before the invention was originally filed would be motivated to provide a second filter and absorbent that forms a cartridge to coincide with the second sleeve.
As to claims 77 and 78, Kirn teaches the syringe for withdrawing an aspirate including fat cells from a body of claim 76, wherein the filter is a mesh filter (paras. 0010 and 0053). However, Kirn does not specifically teach the mesh filter is a screen or that the screen is a plastic polymer or metal. However, Kirn teaches a mesh material that functions as a filter. It would have been an obvious matter of design choice to use a mesh screen comprising a plastic polymer or metal, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
As to claim 79, Kirn teaches the filter may comprise a perforated polymer sheet (para. 0053), which provides a plurality of fenestrations. However, Kirn does not teach a plurality of fenestrations in the filter are substantially evenly distributed along an entirety of the filter. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the filter of Kirn with fenestrations evenly distributed along an entirety of the filter. Doing so would aid in separating the liquid portions of the aspirate from the viable fat cells to prevent syringe clogging and improve graft viability (para. 0055).
13. Claims 62-64 are rejected under 35 U.S.C. 103 as being unpatentable over Kirn et al. US Patent Application Publication 2019/0328977 in view of McCullough et al. WO 2018/226565.
As to claim 62, Kirn teaches the present invention substantially as claimed. Kirn does not teach the barrel second portion inner wall defines a notch for receiving a proximal end of the filter. McCullough, from the same field of endeavor teaches an injector housing a syringe assembly comprising a syringe barrel that stores a medicament, a needle assembly, and a filter member (Abstract). McCullough teaches the filter member 120 has a coupling mechanism 124, an annular protrusion or ring that inserts into a corresponding notch or groove on the inner wall of the syringe barrel (Figs. 2B, 2C; para. 0040). McCullough teaches the coupling mechanism may restrict axial movement along axis L (longitudinal) when the medicament is being ejected from the injector (para. 0041). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the syringe of Kirn with a coupling mechanism (protrusion and notch) for the benefits taught in McCullough.
As to claim 63, Kirn/McCullough teach a proximal end of the filter is outwardly flared – McCullough Fig 2C teaches the filter openings 122 may be conically shaped. In these example, any particles which are larger than the dimension D2 will not be able to pass therethrough, and instead will remain disposed within cavity formed by the opening 122 (McCullough paras. 0038-0039).
As to claim 64, Kirn/McCullough teach a proximal support 120d that receives the proximal end of the filter (McCullough Fig. 2D) – where McCullough teaches the filter member 120 includes an elevated or shelf portion 120d, so configured, the lower surface 12b of the filter 120 is disposed a distance away from the second end 112b of the syringe barrel 112. McCullough teaches this configuration may provide for smoother flow of the medicament when being administered to the user (McCullough para. 0043).
Allowable Subject Matter
14.Claim 65 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 65 requires a notch for receiving the proximal end of the filter and a proximal support that receives the proximal filter end combined with the proximal support sealingly engaging the notch. This combination of limitations is not taught or suggested in the cited prior art.
Conclusion
15.The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Gourlay US 2015/0352266, Khouri et al. US 2008/0167613 are cited to show fat processing devices using syringes. Cohen USPN 4137917 is cited to show a syringe with a filter unit.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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