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 .
Restriction/Election
Applicant’s election without traverse of Group I (Claims 1-9) in the reply filed on January 28, 2026 is acknowledged. Claims 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 28, 2026.
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 8 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 8 refers to a “state variable" It is unclear what a “state variable” is. Furthermore, there is no mention of specific stated variables in either the dependent claim 8 or independent claim 1.
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 1-2,6,8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gale US 20170306288
Gale discloses a method for cryopreserving a plurality of cell clusters of biological cells (sperm), comprising the steps of: fractionating the cell clusters into at least two fractions in dependency on at least one property of the cell clusters, collecting the fractions in different containers, and cryopreserving the cell clusters of the at least two fractions, wherein at least one specific pretreatments methods (pretreatment with carrier fluid –paragraph 36, placement into a cryotube or straw—Paragraph 42, and/or placed into individual aliquots—Paragraph 44 of Gale) and specific freezing methods (cryopreservation such as cryogenic freezer or liquid nitrogen—Paragraph 37) are used for each fraction (Abstract, Paragraphs 5-10, 36-47, Figure 1 of Gale) as in instant Clam 1. Gale discloses wherein the fractionating of the cell clusters takes place on the basis of the property of size of the cell clusters (Abstract and Paragraph 6) as in instant Claim 2. Gale discloses the fractioning of the cell clusters comprises a fluid fractionation (Abstract of Gale), in which the cells clusters are separated in a fluid environment (Abstract of Gale), the fractions are collected in the containers in which cryopreserving subsequently takes place to provide frozen fractions, the frozen fractions are provided for storage in a cryobank without interrupting the cold chain, and the fractionating and cryopreserving are carried out in an automated manner (Abstract and Paragraphs 42,44, 46-47 of Gale) as in instant Claim 6. Gale discloses wherein the size property is detected by sensing (Paragraphs 36,41-4246,49,54) as in instant Claim 8. Gale discloses the addition step of thawing the cell clusters in the at least two fractions, wherein specific thawing methods are used for each fraction (Paragraphs 44-45) as in instant Claim 9.
The reference anticipates the claim limitations.
Claims 1,6,8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gilligan (US 20180208894)
Gilligan discloses a method for cryopreserving a plurality of cell clusters of biological cells (sperm), comprising the steps of fractioning the cell clusters into at least two fractions in dependency on at least one property of the cell clusters, collecting the fractions in different containers, and cryopreserving the cell clusters of the at least two fractions wherein at least one specific pretreatment methods and freezing methods are used for each fraction (Paragraphs 9-10,14-15,17,24,75,79,93,99) as in instant Claim 1. Gilligan discloses the fractioning of the cell clusters comprises fluidic fractionation (Paragraph 24 of Gilligan), in which the cell clusters are separated in a fluid environment (Paragraphs 24 and 93 of Gilligan details how the sperm are in a fluid medium during separation), the fractions are collected in containers in which the cryopreserving subsequently takes place to provide frozen fractions (Paragraphs 146-147), the frozen fractions are provided for storage in a cryobank without interrupting a cold chain (Paragraphs 64,161,190-191,316 of Gilligan), the fractioning and cryopreservation are carried out in an automated manner (Paragraphs 96 and 108 of Gilligan) as in instant Claim 6. Gilligan discloses wherein at least one of the at least one property of the cell clusters is detected by sensing (Paragraphs 96-97 of Gilligan) as in instant Claim 8. Gilligan discloses an additional step of thawing the cell clusters in the at least two fractions, wherein specific thawing methods are used for each fraction (Paragraph 104) as in instant 9.
The reference anticipates the claim limitations.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Veraitch (AU 2017357650)
Veraitch discloses method for cryopreserving a plurality of cell clusters of biological cells, comprising the steps of: fractioning the cell clusters into at least two fractions in dependency on at least one property of cell clusters, collecting the fractions in different containers, and cryopreserving the cell clusters of at least two fractions, wherein at least one specific pretreatment methods and/ specific freezing methods are used for each fraction (Figure 19e and Figure 20e, Page 4, lines 4-11, Page 5, lines 13-21) as in instant Claim 1. Veraitch discloses wherein the fractioning of the cell clusters takes place on a basis of at least one property of size (Figures 19a-20e and Paragraphs 125-126) as in instant Claim 2. Veraitch states that the fractions can go into auxiliary containers connected to a primary container which will generally be an optimal cell culture temperature (37 degrees C), or room temperature (22 degrees C), or freezing such as minus (20 degrees C) of the cell culture; or even minus 80 degrees Celsius where cryopreservation is required (Page 5, lines 15-21 of Veraitch). Veraitch even states that its fractioning device may have one or more auxiliary containers configured to maintain a variety of temperatures (therefore each container is exposed to different temperatures and/or cryopreservation rates and some containers with fractions are not even exposed to cryopreservation for any length of time duration) (Page 4, ln 5-11). Having fractions in containers at all of the stated temperatures (37°C,22°C, -20°C, -80°C) would result with some fractions being cryopreserved for a duration of time while other fractions in the other containers are not cryopreserved for any time duration. Temperatures of -20°C and -80°C specifically involve cryopreservation. Having fractions in containers at all of the stated temperatures would also result in some fractions in some containers being pretreated for cryopreservation while other fractions in other separate containers are not pretreated for cryopreservation at any time. Page 4 of Veraitch states that the auxiliary containers may be configured to contain different elements. In one example, a first auxiliary container may be configured to contain a cell culture medium, while another may be configured to contain a viral vector, another may be configured to contain magnetic beads, growth factors, etc. (Page 4, lines 31-35). This is stating that some auxiliary containers are exposed to certain conditions for a duration of time while some auxiliary containers with fractions are not exposed to those same conditions for any duration of time as in instant Claims 3-5
The reference anticipates the claim limitations.
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 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Veraitch (AU 2017357650) in view of Wu “Acoustofluidic separation of cells and particles” Microsystem and Nanoengineering (2019) 5:32. Wu is already disclosed by applicant in an IDS document.
Veraitch applies as above to teach claims 1-5. Veratich teaches that each distinct blood cell type can be isolated into separate containers (Figures 19-20 of Veratich). Veratich does not specifically state that the cells are isolated using acoustics (sound waves). However, Wu teaches that acoustics can be used to successfully isolate distinct cell types from a blood specimen (Abstract, Pages 6-8, Figure 8). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the acoustics taught by Wu to successfully isolate out blood cells. An artisan of ordinary skill in the art would have been motivate to have used acoustics/sound waves with the process of Veraitch since the sound waves/acoustics can successfully isolate out each distinct blood cell type (Figure 3 of Wu). Because acoustics/sound waves can successfully isolate out distinct types of blood cells, there would have been a high expectation for success (Figure 3 of Wu) as in instant Claim 7.
Veratich teaches a method in which different types of blood cells are isolated out of a sample. Veratich does not teach that the cells are isolated out using sound waves; however, an artisan would have been motivated to have used such a method of isolation because Wu teaches that acoustics can be used to isolate out specific blood cells. 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.
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