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 Interpretation
Claim 1 clearly states that the invention is a liquid cryopreservation solution. For clarification, claims referring to the liquid comprising cells or tissue types (for example, a mammalian cell or umbilical cord blood) will be interpreted as “products for which the invention is to be used to cryopreserve” and not as an ingredient in the cryopreservation medium itself.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 taught 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.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Muratani et al. (JP 2021000027A).
Regarding claims 1, 2, and 5: Muratani teaches the generation of an animal cell cryopreservation solution comprising the step of suspending animal cells in said animal cell cryopreservation solution and freezing it. (57) Muratani teaches use of propylene glycol (Claim 3) to be used in the place of DMSO (0031) with a concentration between 5 to 20% propylene glycol (0032), reading on the claimed range of 2.5 to 8.75% (claim 1) and 2.5-5% (claim 2). Muratani further teaches that the present invention results in an improved cell proliferation rate after thawing. (0046) Additionally, Muratani teaches that the cryopreservation solution contains an isotonic solution as a main component (claim 11), as it offers a high cell survival rate when used. (0109)
In the case where the claimed ranges "overlap or lie inside ranges taught by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range)
"[A] prior art reference that teaches a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). However, if the reference’s taught range is so broad as to encompass a very large number of possible distinct compositions, this might present a situation analogous to the obviousness of a species when the prior art broadly teaches a genus. Id. See also In re Baird, 16 F.3d 380, 383, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994) ("[a] disclosure of millions of compounds does not render obvious a claim to three compounds, particularly when that disclosure indicates a preference leading away from the claimed compounds."); MPEP § 2144.08; and subsection III.D below for an additional discussion on consideration of prior art disclosures of a broad range.
As such, it would have been within the scope of skill for a person of ordinary skill in the art to optimize the percentage of propylene glycol based on the teachings of Muratani to arrive at the claimed range of 2.5 to 8.75% (claim 1) and 2.5-5% (claim 2), respectively.
Regarding claim 3: Muratani teaches that the addition of a polysaccharide such as dextran to said suspension of cells (in this example, mesenchymal stem cells) in order to maintain the cells in solution for up to several days. (0010)
Regarding claim 4: Muratani teaches the addition of trehalose to the media, stating that trehalose is known to have high biocompatibility and functions as an antifreeze in insects and plants, making it an effective substance in cell cryopreservation solutions, (0012) stating trehalose specifically as an example of the invention. (0042)
Regarding claim 6: Muratani teaches an embodiment of the invention which uses acetate Ringer’s solution in the media, resulting in a high cell survival rate of 80%. (0109)
Regarding claim 7: Muratani teaches an example of the invention in which mesenchymal stem cells were cryopreserved and a high cell survival rate was obtained. (0114)
Regarding claims 8 and 11: Muratani teaches an example of the invention (the invention being said cryopreservation solution) in which mammalian cells such as primate or human may be used. (0051)
Regarding claim 9: Following the discussion of claim 8 above, Muratani further teaches that use of human mesenchymal stem cells or human hematopoietic stem cells is “particularly preferable”
Regarding claim 10: Muratani teaches an embodiment of the invention in which umbilical cord blood is collected for use with the claimed invention. (0006)
Regarding claim 12: Muratani teaches a protocol in which the cryopreservation solution of the claimed invention was used to cryopreserve mesenchymal stem cells. The MSCs were thawed and cultured either in DMEM or adipocyte differentiation medium for 14 days, reading on the requirement of claim 12 of said cells being frozen, thawed, and cultured for 5 days or more. (0110)
Regarding claims 13-15: Muratani teaches use of the claimed invention to cryopreserve hematopoietic stem cells (0051). Muratani further teaches use of the following:
A concentration of propylene glycol reading on the range of 2.5-5.0%, as discussed in the rejection of claim 2
Use of dextran, as discussed in the rejection of claim 3
Use of trehalose, as discussed in the rejection of claim 4
Regarding claims 16-20: Muratani teaches that the invention is intended to be used with mammalian cells (0051). Muratani further teaches use of the following:
Use of dextran, as discussed in the rejection of claim 3
Use of trehalose, as discussed in the rejection of claim 4
A concentration of an isotonic solution reading on the range of 2.5-5.0%, as discussed in the rejection of claim 5
Use of acetated Ringer’s solution, as discussed in the rejection of claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tracy Vivlemore, can be reached on (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HANNA MARIE THUESON/ Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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