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 Amendments/Arguments
In view of Applicant’s amendments filed 22 January 2026, previous rejection of claims under 35 U.S.C. 103 is hereby withdrawn.
Applicant’s arguments, see pgs. 6-10 of Remarks, filed 22 January 2026, with respect to amended, independent claim 1 have been fully considered and are persuasive. The previous rejection of claim 1, and thus all dependent claims, under 35 U.S.C. 103 have been withdrawn.
However, new grounds for rejection of newly amended, independent claim 1, and thus all dependent claims, under 35 U.S.C. 112(b) have been added.
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.
Claims 1-4 and 9-14 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation wherein the micronizing of the adipose tissue and the tissue and cells constituting the adipose tissue is moving the adipose tissue mixed solution through a plurality of screen through holes sequentially, back and forth repeatedly, or both … performed by using at least one process of tearing, scratching, and disintegration”, and the claim also recites “wherein the micronizing is performed by tearing the adipose tissue as the adipose tissue mixed solution moves back and forth through the sharp edges” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-4 and 9-14 are rejected for being dependent on rejected base claim 1.
NOVELTY
The closest prior art to the instant application is United States Patent Application Publication US 2018/0155691 to Shani et al. (herein Shani); “A new Nonenzymatic Method and Device to Obtain a Fat Tissue Derivative Highly Enriched in Pericyte-Like Elements by Mild Mechanical Forces From Human Lipoaspirates” to Bianchi et al. (herein Bianchi); and United States Patent Application US 6,358,474 to Dobler et al. (herein Dobler).
Shani discloses a method of mechanical isolation of cell from fat (i.e., adipose tissue) (see [0139]) comprising: washing lipoaspirate fat by adding 100 ml of saline followed by thorough mixing and centrifugation at 328xg for 10 minutes (i.e., “preparing adipose tissue); adding 100 ml saline to the washed fat to form a fat/saline mixture (i.e., “diluting the adipose tissue with a diluent to prepare an adipose tissue mixed solution”); mechanically disrupting the fat/saline mixture in a food processor at 1300 RPMs for 15 seconds at room temperature (i.e., “micronizing the adipose tissue, and tissue and cells constituting the adipose tissue, in the adipose tissue mixed solution”); and centrifuging the mechanically disrupted fat/saline mixture at 328xg for 10 minutes followed by separation of sedimented SVF (stromal vascular fraction) cells from floating adipocytes (i.e., “separating the adipose tissue and the tissue and cells constituting the adipose tissue, in the micronized adipose tissue mixed solution”) (see [0140]). Shani discloses the dilution ratio of the diluent directly affects the mechanical disruption process (see [0071]) which has a directly affects the number of SVF cells recovered (see [0140]).
Bianchi discloses a method of mechanically separating tissue and cells using a Lipogems device, wherein the method comprises passing an aspirated fat/saline mixture through a large filter (i.e., screen with through holes) followed by passing the aspirated fat/saline mixture though a second cutting hexagonal filter (i.e., another screen with through holes) (see Fig. 1). Fig. 1 of Bianchi discloses the through holes of both filters are of uniform size and shape. Bianchi discloses the method reduces tissue and cells of adipose tissue into clusters of 200 to 800 micrometers (see pg. 2064, Materials and Methods). Fig. 1 of Bianchi discloses the second filter reduces the adipose tissue to smaller clusters than the first filter or in other words the sizes of the through holes of both filters are different and are arranged sequentially according to the size of the through hole. Furthermore, as the second filter is a cutting hexagonal filter, the filter must have sharp edges protruding from a portion of the through hole to be capable of performing the function of cutting (see Fig. 1 of Bianchi) as cutting is defined as removing something with a sharp-edged implement as defined by the Oxford English Dictionary. The range of 200 to 800 micrometers falls within the claimed range of 10 µm to 4,000 µm.
Dobler discloses an apparatus for isolating cell material from a tissue system and/or liquid utilizing a flat separating disc (i.e., screen) comprising openings (i.e., plurality of screen through holes), wherein the openings comprise a filter membrane and the separating disc comprises pointed or angular projections for tearing up the tissue sample to a size of 100 µm (see abstract; Col. 3, lines 45-52; Col. 5, lines 5-17). In other words, Dobler discloses that utilizing sharp edges to perform tearing on a tissue sample to micronize components of the tissue sample to pass through a filter is well known in the art of isolating cellular material from a tissue sample.
However, none of the cited prior art, alone or in combination, teaches nor fairly suggests “a plurality of screen through holes … a plurality of screens comprise sharp edges formed by a plurality of protrusions protruding toward a center of the through hole” as recited in instant, independent claim 1. In other words, none of the cited prior art teaches nor renders obvious performing micronizing of an adipose tissue mixed solution by moving the mixed solution through a plurality of screens comprising a plurality of through holes, wherein the through holes comprise sharp edges protruding toward the center of each through hole to tear the adipose tissue in the mixed solution.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797