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 § 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 1-16 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.
With respect to Claim 1, the claim recites “so the fluid flows through the filter elements and the filter elements and/or the at least one medium element.” This phrase should be rewritten to recite “so the fluid flows through the filter elements and/or the at least one medium element.”
Claims 2-14 are rejected because they depend from rejected claim 1.
Regarding claim 3, the phrase "preferably a retaining grid" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 4, the phrase "preferably a filter plate" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
With respect to Claim 15, 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 15 recites the broad recitation “a surgical suction system”, and the claim also recites “in particular a tissue collector” (lines 2-3), which is the narrower statement of the range/limitation.
Claim 15 recites the broad recitation “upstream of at least one filter element”, and the claim also recites “in particular upstream of the filter element” (lines 16-17), 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.
Claim 16 is rejected because it depends from rejected claim 15.
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.
Claims 1, 4-7, and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeng (US 2021/0145459).
With respect to Claim 1, Jeng teaches a tissue collector for a surgical suction system (Figure 3; paragraphs [0051-0052]), the tissue collector comprising:
a fluid inlet 44;
a fluid outlet 46;
a collection chamber 41 between the fluid inlet 44 and the fluid outlet 46;
at least one upstream filter element 48 in the collection chamber 41;
at least one downstream filter element 49 in the collection chamber 41, the filter elements being one after the other in a fluid-flow direction and each having a respective array of fluid passage openings wherein the diameters of the fluid-passage openings of the upstream filter element 48 are greater than the diameters of the downstream filter element 49 (paragraph [0052]: see pore size specifications); and
at least one medium element 47 on at least the upstream filter element 48 (Figure 3) so that fluid flows through the filter elements (48, 49) and the at least one medium element 47 and filters out autologous tissue components and the filtered fluid can then flow through the outlet 46 of the collection chamber 41. See Figure 34 and [0051-0056]).
With respect to Claim 4, Jeng teaches that the diameters of the fluid-passage openings of the upstream filter element 48 are in the range of 0.5-8 mm (paragraph [0054]), such that the upstream filter element functions as a filter plate.
With respect to Claim 5, Jeng teaches that the diameters of the fluid-passage openings of the downstream filter element 49 are in the range of 0.2-2.5 mm (paragraph [0054]).
With respect to Claim 6, Jeng teaches that the downstream filter element 49 may be formed as a sieve having a floor provided with the fluid passage openings (paragraph [0019]: the second filger may comprise a basket mesh or a substantially frustoconical configuration).
With respect to Claim 7, Jeng teaches that the medium element 47 is flat and upstream of the upstream filter element 48. See Figure 3.
With respect to Claim 13, Jeng teaches that the Jeng teaches that collection chamber has at least one upstream part and at least one downstream part that are releasably connected to each other (Abstract: “the tissue trap includes a filter in a housing configured between a removable inflow chamber and a removable outflow chamber”).
With respect to Claim 14, Jeng teaches that the filter elements (48, 49) and/or medium element 47 can be removed/separated from the collection chamber so that the tissue collector is of modular construction (Abstract: “the tissue trap includes a filter in a housing configured between a removable inflow chamber and a removable outflow chamber”).
With respect to Claim 15, Jeng teaches a method of separating autologous tissue components from a fluid using the devive as claimed (see the rejection of Claim 1 above). Specifically, the method comprises:
drawing fluid through the fluid inlet 44 a fluid containing autologous tissue components (Abstract; paragraphs [0051-0056]),
passing the fluid through the collection chamber 41, at least one upstream filter element 48, and at least one downstream filter element 49;
wherein the diameter of the fluid-passage openings of the upstream filter element 48 are greater than the diameters of the downstream filter element 49 (paragraph [0052]: see pore size specifications); and
passing fluid through at least one medium element 47 on at least the upstream filter element 48 (Figure 3) so that fluid flows through the filter elements (48, 49) and the at least one medium element 47 and filters out autologous tissue components and the filtered fluid can then flow through the outlet 46 of the collection chamber 41.
wherein the filtered fluid subsequently flows via a fluid outlet 46 from the tissue collector. See Figure 34 and [0051-0056]);
With respect to Claim 16, Jeng teaches that the autologous tissue components comprise bone fragments, bone marrow, blood clots, and/or fat. See Abstract and at least paragraphs [0008-0010], [0016-0018], [0026], [0088], and [0108].
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jeng.
With respect to Claim 8, Jeng teaches the tissue collector of claims 1 and 7 wherein the medium element 47 is directly upstream of the first filter element 48, but does not specifically teach that the flat medium element fits in a holding seat of the upstream filter element on an upstream face thereof facing the fluid inlet.
However, it has been held that mere changes in shape do not constitute patentable improvements in the art when said changes do not result in a non-obvious change in functionality. In re Dailey et al., 149 USPQ 47. In this case, Jeng’s medium element 47 and upstream filter 48 are disposed in an abutting relationship, and it unclear why the specific means of attachment between these filter elements would have an appreciable effect on their functionality. Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art prior to the effective filing date of the instant application to make the flat medium element fit in a holding seat of the upstream filter on the upstream face thereof facing the fluid inlet, or whatever form or shape was desired or expedient, because a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Jeng in view of Hogue (US 2019/0255229).
With respect to Claims 2 and 3, Jeng does not specifically teach that the tissue collector comprises an extreme upstream filter element having an array of fluid passageway openings, the extreme upstream filter having fluid passage openings that are greater in diameter that those of the upstream filter, or more specifically with a diameter of 3-25mm, to define a retaining grid.
Hogue teaches an adipose tissue filtration system comprising a fluid inlet 24, fluid outlet 29, and a plurality of filter elements (50, 52, 54, 56, 58) disposed therebetween (Figures 3-8b; paragraph [0035]). The plurality of filter elements (50, 52, 54, 56, 58) have sequentially decreasing aperture diameters from the first flat filter disk 50 to the last filter disk 58, thereby allowing fat and tissue particles of sequentially decreasing particle sizes to be filtered of the fluid [0035]. Specifically, the first filter may have a dimension that is greater than 2 mm (which reasonably suggests the claimed range of 3-25mm with sufficient specificity), such that large particles may be filtered out by the first filter (paragraph [0034-0035]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Jeng’s tissue collector to have an additional disk-shaped extreme upstream filter having a diameter of 3-25mm as suggested by Hogue, in order to trap large fat and tissue particles traveling through the flow path before the fluid is passed to the filter elements with sequentially smaller pore sizes.
Allowable Subject Matter
Claims 9-12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to Claim 9, it is unclear why one of ordinary skill would have further modified the device of Jeng and Hogue to have the claimed locking arrangement because Jeng and Hogue do not reasonably suggest that the extreme upstream filter would be directly connected to the upstream filter.
With respect to Claim 10-12, it is unclear why one of ordinary skill in the art would have modified Jeng’s device to make the medium element a bulk material medium element that is disposed on the downstream filter element. Instead, Jeng’s medium element is disposed on the upstream filter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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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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/PHILIP R WIEST/ Primary Examiner, Art Unit 3781
