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 Applicants Claims Amendments/Remarks
The claims have been amended in a manner which raise new issues of concern. The former rejections are withdrawn and new rejection are put forward. The claim now recites a 1. pretreatment, a 2. fractioning step, and 3. exposure to dielectrophorectic forces or sound waves. The instant set of claims does not clearly establish a relationship/chronological flow between these three components, making the claim indefinite.
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 1-2,4,6,8-9 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 1 is indefinite because it recites that the cell clusters, “are arranged at different positions in a flow profile of the fluid flow under an effect of at least one of dielectrophoretic force or sound wave in the fluid force.” The claim also mentions fractioning but does not clearly establish a relationship between the dielectrophorectic force or the sound waves in the fluid force. It is not clearly established how the fractioning is related to the dielectrophorect force or the sound waves. Furthermore, it is not clear what the pretreatment is and how it relates to fractioning, dielectrophorectic force, or the sound waves.
Claim 1 recites, “the plurality of cell clusters of biological cells is selected form cell-matrix clusters grown in vivo, spherical clusters of cells, and cell-matrix clusters growth artificially in vitro.” This phrase is indefinite since it states that the cell clusters are harvested from in-vitro and in-vivo sources. In vivo means within the body and in-vitro is outside the body so the two conditions conflict and thus cannot be performed simultaneously. If the cell clusters can be harvested from different source, it would be best to list the sources and use the term “or” instead of “and.” For purposes of examination, examiner will interpret this to mean that any cell can be used.
Claim 4 recites the following, “wherein the pretreatment methods for the fractions differ in terms of a time profile of at least one of the pretreatment parameters.” This does not better clarify what the pretreatment process is or how it relates to a fractioning, dielectrophorectic forces, or sound waves. The process is difficult to envision and is therefore, indefinite.
Establishing a clear flow of the process and defining each stage would greatly help with correcting the indefiniteness.
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 1-2,8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fleuring (US 20190307946) in view of Gale (US 20170306288) and Polluck (Chapter 16 Dielectrophoretic Cell Sorting from Bioelectrochemistry, pages 445-455.
Fleuring teaches fractioning the cell cluster into at least two fractions depending on at least one property of the cell clusters, wherein the fractionating of the cell clusters comprise fluid fractionation with acoustics, in which the cell clusters are separated in a fluid environment, and the fractionating of the cell clusters further comprises fractionation in a fluid flow, wherein the cell clusters are arranged at different positions in a flow profile of the fluid flow under an effect of sound waves in the fluid flow. (Figure 1-2 , Paragraphs 147-148,109, and Pages 1 of Fleuring), collecting the fractions in different containers (Figure 1-2), the pretreatment method for fractions differ in term of at least a movement of pretreatment medium (the cells go different ways—Figure 1-2 of Fleuring).
Fleuring teaches that the collection vessel used to store the cells can be subsequently frozen. However, Fleuring does not specifically teach how cryopreservation is associated with collection vessels in a sorting system and/or if the cell clusters after being frozen can be thawed. However, paragraphs 46-47 of Gale teaches that cells can be sorted and cryopreserved based on their cell type. Paragraph 47 of Gale specifically states that that “tissue sampling processing system can have different disposal modules for sorting different incoming tissue types (e.g. sperm cells, blood cells, and stem cells). Paragraph 47 of Gale specifically states that individual sperm cells can be further isolated. When freezing isolated cells (sperm cells) versus (collections of blood and/or stem cells), there will be more pressure placed on one individual cells during freezing compared to freezing cells (stem and blood cells in bulk). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have combined the acoustic system of Fleuring with the cryopreservation system taught by Gale. An artisan would have been motivated to have combined both system so that the sorting samples could be successfully cryopreserved until need for a procedure (Paragraph 3 of Gale) as in instant Claim 1.
Fleuring teaches that use of acoustic to sort the cells but does not mention that the sorting is done by dielectrophoretic forces. However, Pollock mentions that cell sorting can be accomplished using dielectrophoretic forces (Chapter 16—Dielectrophoretic Cell Sorting). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used dielectrophorectic cell sorting in place of acoustic cell sorting as taught by Fleuring since DEP can sort out cells (Chapter 16 of Pollock). Because Pollock teaches that DEP can effectively sort cells, there would have been a high expectation for success (Chapter 16 of Pollock).
Dependent Claims taught by Fleuring
Fleuring teaches wherein the fractioning of the cell clusters takes place on a basis of at least one property size and shape (Paragraphs 73-74,95 of Fleuring ) as in instant Claim 2. Fleuring teaches wherein at least one of the at least one property of the cell clusters and at least one state variable of the at least two fractions are detected by sensing, and said at least one state variable comprises at least a size of the cell cluster (Paragraphs 73-74, 95 of Fleuring) as in instant Claim 8.
Dependent Claims taught by Gale
Gale teaches thawing the cell clusters in at least two fractions, wherein specific thawing methods are used for each fraction (Paragraphs 44-46 of Gale) as in instant Claim 9.
Fleuring teaches that cells can be sorted into individual containers based on their size. Fleuring uses acoustic forces and not DEP; an artisan would have been motivated to have used DEP since that to can separate cells. Furthermore, an artisan would have been motivated to have used the cryopreservation method taught by Gale in order to successfully cryopreserve the samples for further cryopreservation use. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predicable results to one of ordinary skill in the art at the time of the invention (See KSR Internation Co. v. Teleflex Inc. 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and cell fractionation. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
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 LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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