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 Group 1 (claims 1-4, 7-8, and 15-18) in the reply filed on 29 December 2025 is acknowledged.
Claim withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected 20-28, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 December 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a).
Examiner notes that the first and second cutting zones are identified, but which parts correspond specifically to the first and second cutting blades is unclear. There has been no labeling or identification assigned to the first and second cutting blades in either the specification or the drawings of the instant application. Examiner recommends including labels for the first and second cutting blades in the figures, such as in Figure 5B of the instant application which shows the cutting zones in more detail.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 18 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 18 recites the limitation "the rotational axis" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim as only a first rotational axis and a second rotational axis have been previously recited and not just a rotational axis. It is unclear if this is the first or second rotational axis, or an entirely different rotational axis. Examiner believes this to be the second rotational axis and will be examined as such. Examiner recommend amending the claim to read “the second rotational axis” or the correct equivalent thereof.
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 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Graziano, et. al. (US 20180236457 A1).
Regarding claim 1, Graziano teaches a disaggregating device for biological material comprising rotating blades within a chamber (Abstract) (apparatus for the disaggregation of tissue). Graziano teaches the disaggregating device comprises a hollow body 11 with an inner chamber 12 defined by an upper 12a and lower 12b zone separated by a disaggregating grid 13 with a helical blade 14b above the grid 13 and a scraper 14c below the grid 13, the blade 14b and scraper 14c rotating around shaft 14a (Fig. 2, 3B; par. 0060-0064, 0068) . Graziano teaches the helical blade 14b in the upper chamber 12a rotates to physically process the tissue before the tissue is further processed by grid 13 and scrapper 14c (Fig. 2, 3B; par. 0100) (a first cutting zone comprising: a first cutting blade configured to rotate about a first rotational axis). Graziano teaches the inner chamber 12 is defined by an upper loading area with a cover 15 for loading a tissue sample parallel to the rotating shaft 14a creating a 0 degree angle (Fig. 2; par. 0056) (an opening for the ingress of tissue, the opening being oriented at an angle to the first rotational axis).
Regarding claim 2, Graziano teaches the blade 14b is in a curved helical shape (Fig. 3B; par. 0061) (wherein the first cutting blade is helical).
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.
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 4, 7, 8, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Graziano, et. al. (US 20180236457 A1) in view of Liao, et. al. (US 20050139704 A1).
Regarding claim 4, modified Graziano teaches the apparatus further comprises a second zone 12b below grid 13 with a scraper 14c that also rotates about rotating shaft 14a (Fig. 2, 3B; par. 0060-0064, 0068) (additionally comprising a second cutting zone comprising a second… blade, wherein the second…blade is configured to rotate about a second rotational axis). Graziano teaches the scrapper 14c does further process the tissue (par. 0100).
Graziano is silent to the second cutting zone specifically comprising a second cutting blade.
Liao teaches a tissue homogenizing apparatus to cut and filter tissue pieces (Abstract). Liao teaches the apparatus comprises a first zone (between opening 111 and filter 131) with a pair of vanes 122 that are rotated about a vertical axis created by driving mechanism 121 and a second zone (between filters 131 and 132) with a pair of blades 123 used to cut tissue (Fig. 1-4; par. 0013-0017) (a second cutting zone comprising a second cutting blade, wherein the second cutting blade is configured to rotate about a second rotational axis). Liao teaches a blade specifically for cutting in the lower zone allows for homogenized tissue pieces (par. 0014).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to substitute the scrapper blades of Graziano with the helical cutting blades of Liao in order to homogenize the size of the processed tissue pieces. Because both apparatuses are hollow chamber divided into two sections with each section contributing to the physical processing of tissue for later analysis, substituting the scrapper for a helical blade in a first chamber as provided by Liao, provides a likewise sought after functionality wherein the substitution would yield predictable results. MPEP 2143(I)(G).
Examiner notes that the first and second rotational axis are coaxial; however, as per the specification of the instant application, a coaxial orientation with a singular driving mechanism is well with the scope of the claim (Specification, par. 0015).
Regarding claim 7, modified Graziano teaches an electric motor to drive bladed rotor 14 (par. 0122) (wherein the first and second cutting blades are configured in use to be rotated about their respective axes by one or more drive mechanisms).
Regarding claim 8, modified Graziano teaches the driving mechanism rotates the blades 14 and scrapper 14c in the same direction, see the curved arrow at the top of Figure 3B (par. 0124-0126) (wherein the one or more drive mechanisms are configured to rotate the first and second cutting blades in the same direction).
Regarding claim 15, modified Graziano teaches tissue passes through the opening defined by hollow body 11 and covered by cover 15 to the first zone 12a interacting with blades 14b, through grid 13 into the second zone 12b, where the tissue interacts with scrapper 14c (modified to be a cutting blade in view of Liao in claim 4), (Fig. 2, 3B; par. 0056) (wherein the apparatus is configured in use for the tissue to be sequentially passed through the first cutting zone followed by the second cutting zone).
Regarding claim 16, modified Graziano teaches the first zone further comprises an outlet for tissues and liquids via upper surface of grid 13 (Fig. 3; par. 0016) (wherein the first cutting zone comprises…a first outlet for the tissue). Graziano teaches tissue and fluid enters the second zone through the lower surface of grid 13 and leaves the second zone through filter 132 (Fig. 3) (wherein the second cutting zone comprises a second inlet…for the tissue). Graziano teaches grid 13 serves as the conduit between the first zone and second zone connecting the outlet of the first zone to the inlet of the second zone (Fig. 2, 3B) (wherein a conduit connects the first outlet to the second inlet).
Graziano is silent to wherein the first cutting zone comprises a first inlet and wherein the second cutting zone comprises a second outlet.
Liao teaches the first zone further comprises openings 113 (Fig. 3; par. 0016) and the second zone further comprises a filter 132 where tissue that is entirely processed exits (Fig. 3) (wherein the first cutting zone comprises a first inlet) (wherein the second cutting zone comprises… a second outlet). Liao teaches openings 113 help with overall downward flow of solution through the system (par. 0016-0017. Liao teaches the filter 132 offers a way to physically separate fully processed tissue pieces for the tissue pieces still being processed (par. 0014).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the already present inlets and outlets to and from the two zone of Graziano to further include a first inlet to the first zone and a second outlet from the second zone as taught by Liao in order to encourage flow through the system and to physically separate processes tissue from the tissue that still need to be processed. Because both apparatuses are hollow chamber divided into two sections with each section contributing to the physical processing of tissue for later analysis, combining the additional inlet and outlet as provided by Liao, provides likewise sought functionality wherein the combination yields a predictable result. MPEP 2143(I)(A).
Regarding claim 17, modified Graziano teaches the first zone 12a, grid upper surface, grid lower surface, and second zone 12b while leading to scrapper 14c (modified in view of Liao to be cutting blades) rotating about shaft 14a of rotor 14 all form a 0 degree angle from the second rotational axis (Fig. 3) (wherein the second inlet is configured in use to communicate tissue into the second cutting zone at an angle to the second rotational axis of the second cutting blade).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Graziano, et. al. (US 20180236457 A1) as applied to claims 1 in view of Qiao, et. al. (CN 211704703 U; citations made with respect to attached English machine translation and original document).
Regarding claim 3, Graziano teaches the opening to hollow body 11 is parallel to rotor 14 (Fig. 2, 3B).
Graziano is silent to wherein the opening is oriented substantially perpendicularly to the first rotational axis.
Qiao teaches a device for collecting and storing discarded tissues (par. 0005). Qiao teaches the device comprises a first collection chamber 1 that leads to a filter 6 physically attached to opening 3 (Fig. 3; par. 0021). Qiao teaches the opening 3 is perpendicular to blade 14 that spins about rotating shaft 13 (Fig. 1; par. 0021) (wherein the opening is oriented substantially perpendicularly to the first rotational axis). Qiao teaches the angled/perpendicular opening to the cutting chamber allows thorough separation of the tissue in order to be effectively treated to prevent spread of disease (par. 0013).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the parallel first opening of Graziano to be perpendicular as taught by Qiao in order to thoroughly separate the tissue for physical processing by the blades and subsequent processing. Because both systems are hollow containers that collect and physically process tissue sample through rotating blades, modifying the angle at which the opening for the tissue sample is introduced to the axis of rotation to be perpendicular as provided by Qiao, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Graziano, et. al. (US 20180236457 A1) and Liao, et. al. (US 20050139704 A1) as applied to claim 17 respectively and in further view of Qiao, et. al. (CN 211704703 U; citations made with respect to attached English machine translation and original document).
Regarding claim 18, modified Graziano teaches the first zone 12a, grid 13 upper surface, grid 13 lower surface, and second zone 12b while leading to scrapper 14c (modified in view of Liao to be cutting blades) rotating about rotor 14 are parallel to one another (Fig. 3).
Modified Graziano is silent to the connections being substantially perpendicular.
Qiao teaches a device for collecting and storing discarded tissues (par. 0005). Qiao teaches the device comprises a first collection chamber 1 that leads to a filter 6 physically attached to opening 3 (Fig. 3; par. 0021). Qiao teaches the opening 3 is perpendicular to blade 14 that spins about rotating shaft 13 (Fig. 1; par. 0021) (wherein the second inlet is configured in use to communicate tissue into the second cutting zone to the rotational axis of the second cutting blade). Qiao teaches the angled/perpendicular opening to the cutting chamber allows thorough separation of the tissue in order to be effectively treated to prevent spread of disease (par. 0013).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the parallel second opening of modified Graziano to be perpendicular as taught by Qiao in order to thoroughly separate the tissue for physical processing by the blades and subsequent processing. Because both systems are hollow containers that collect and physically process tissue sample through rotating blades, modifying the angle at which the opening for the tissue sample is introduced to the axis of rotation to be perpendicular as provided by Qiao, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Apfel (US 8871159 B1) teaches an apparatus for processing tissue comprising a chamber with blades to physically process the inserted tissue (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758