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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 4/14/2026. Claims 1-9, and 21-23 are pending. Claims 7-9 are withdrawn. Claims 1-6 and 21-23 are considered on the merits.
Applicant's response, with traverse, to the Restriction/Election requirement filed on 4/14/26 is acknowledged. The applicant elected Group I which includes claims 1-6 and new claims 21-23.
The Applicant argues that all inventions are linked by the same inventive concept which is the isolation method of claim 1, in particular, the double sedimentation steps. However claims 7-9 are drawn to individual cells. While 7-9 limit these cells are obtained by the method of claim 1, this is a product by process limitation. M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). In this case Jaatinen et al. does not teach the separation method of claim 1, but continues to teach the HSC cells with the claimed markers.
Therefore, the Restriction/Election requirement is therefore made FINAL and the elected species and the claims they include will now be examined on the merits.
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 1-6 and 21-23 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.
Claim 1, step b) state the following separation of cells from umbilical cord blood after it is treated with a sedimentation agent including hydroxy ethyl starch, gelatin, chitosan, and
combinations thereof:
b) adding red blood cell lysis buffer to the leucocyte rich plasma to obtain leucocyte concentrate, wherein the red blood cell lysis buffer comprises ammonium chloride and a protein combination comprising at least one protein derived from umbilical cord blood and maternal blood, wherein the leucocyte concentrate is of red blood cells;
This is confusing for the following reasons:
Sedimentation agents including hydroxy ethyl starch generally aggregate red blood cells to facilitate their removal by centrifugation. It is not clear how the “leucocyte concentration is of red blood cells” since these have been sedimented and/or should have been lysed by the red blood cell lysis buffer. No further red blood cells should be present, only the debris from the lysis step. The cells present should be nucleated blood cells after erythrocyte lysis.
Since the leucocyte concentrate is red blood cells, it is unclear how steps c)-e) are executed because the cells captured by the immunomagnetic beads are hematopoietic stem cells (HSCs), natural killer cells (NKs), and T-cells, which are not red blood cells.
A “leucocyte concentrate is of red blood cells” is contradictory since leucocytes (white blood cells) are counterparts to red blood cells.
Therefore it is not completely clear how the steps a) and b) obtain the cells with immunomagnetic beads of c)-e) since it is not clear they are present in a leucocyte concentrate that is red blood cells.
Applicant may wish to amend the claims to include the location of the cells as the steps are executed. For example:
Separating leucocytes form umbilical cord blood by using a sedimentation reagent in a sedimentation buffer to obtain a leucocyte rich plasma comprising a mixture of HSCs, NKs, and T-cells, wherein the sedimentation reagent is selected from the group consisting of hydroxy ethyl starch, gelatin, chitosan, and combinations thereof;
Adding red blood cell lysis buffer to the leucocyte rich plasma, wherein the red blood cell lysis buffer comprises ammonium chloride and a protein combination comprising at least one protein derived from umbilical cord blood and maternal
blood, to obtain a leucocyte concentrate comprising a mixture of HSCs, NKs, and T-cells;
incubating the leucocyte concentrate with CD34+, CD133+ and CD38-
immunomagnetic beads for obtaining hematopoietic stem cells;
incubating the leucocyte concentrate with CD56+ and CD3- immunomagnetic
beads for obtaining natural killer cells; and
incubating the leucocyte concentrate with CD3+ immunomagnetic beads for
obtaining T cells.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “the leucocyte concentrate is of red blood cells” is new matter unsupported by the Specification. While the Specification discloses “the leucocyte concentrate is free of red blood cells” [0013], [0059], [0063-0064], it does not disclose the contrary where the leucocyte concentrate is red blood cells.
Closest Prior Art
The Closest Prior art is Dose et al. (US 9885032) and Pierzchalsi et al. (PLOS One, 2013). Both teach isolating different cells from the same blood sample using immunomagnetic beads with markers specific to particular cells. Zhang et al. (WO 2014/123879, in IDS 12/19/23) teach isolating NK cells from umbilical cord blood that also comprises MSC and T-cells expressing specific markers [0074-0078]. Sanghavi et al. (WO 2020/161746) teach using a lysate of a combination of umbilical cord blood (fetal blood) and maternal blood (Fig. 1) in media as a tissue culture supplement to improve the viability for numerous cells including chondrocytes, osteoblasts, and hematopoietic stem cells (Examples 1, 2, and 12).
None of these references appear to teach the limitations of claim 1, step b).
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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