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
Amendments
In the reply filed on 08/12/2026, Applicant has amended claims 1, 52 and 61, and has canceled claims 49-51.
Claim Status
Claims 1 and 52-67 are pending.
Claims 62-67 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/11/2026.
Claims 1 and 52-61 are considered on the merits.
New Claim Objections
Claim 61 is objected to because of the following informalities:
Amended claim 61 recites “serum-free cryopreservation medium” in the last line. It is recommended to change to “a serum-free cryopreservation medium”.
Appropriate correction is required.
Withdrawn Claim Rejections - 35 USC § 112
The prior rejection of claims 1 and 49-61 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reciting a relative term “small” and a subjective term “preferably” in claim 1 and trademarks in claim 61 is withdrawn in light of Applicant’s cancelation of claims 49-51 and amendments to claims 1 and 61.
Maintained 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 and 52-60 stand rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Paspaliaris (US 2017/0368107 A1, cited in IDS 12/16/2022).
With respect to claim 1, as amended with new limitation “cells that are larger than 5 μm are excluded by the filtering step”, the limitation “small blood stem cells (SBSCs)” is examined as pluripotent stem cells derived from peripheral blood having a diameter of <5 μm (see specification [0080]).
Paspaliaris teaches a pluripotent stem cell population that is referred to as peripheral blood derived pluripotent stem cells (PBD-PSCs) (see e.g., [0007]), and teaches the PBD-PSCs are 2.5-4.5 μm in diameter (e.g., [0009]). Thus, Paspaliaris’ PBD-PSCs are equivalent to the claimed small blood stem cells (SBSCs).
In regard to a method of isolating SBSCs from peripheral blood, Paspaliaris teaches in a working example (Example 15) a method of isolating PBD-PSCs (i.e., SBSCs) from peripheral blood (see [0312]). Specifically, Paspaliaris teaches the method recited as italicized below:
“Two hundred mL of peripheral blood was removed from a 71 year old female patient suffering with dry macular degeneration using typical venipuncture. Sodium citrate was used as the anticoagulant”, thus teaches mixing peripheral blood with an anticoagulant such as sodium citrate prior to centrifuging in claims 54-55.
“The PBD-PSCs were isolated using a combination of centrifugation and filtration. The blood was first centrifuged for 10 minutes at 300 g”, thus teaches the first centrifuging the peripheral blood to isolate plasma from the peripheral blood, wherein the peripheral blood is centrifuged at a speed that is 300xg in amended claim 1.
“The plasma layer was removed and was centrifuged for another 10 minutes at 800 g. The plasma supernatant was centrifuged again at 1100 g for 10 minutes”, thus teaches the second centrifuging the plasma to isolate a population of cells comprising the SBSCs in a cell pellet, wherein the plasma is centrifuged at a speed that is 1100xg in amended claim 1.
“The cell layer at the bottom (i.e., a cell pellet in claim 1) was removed and placed in 5 mL of sterile saline and resuspended”, thus teaches resuspending the population of cells comprising the SBSCs in a liquid in claim 1 and the cells being resuspended in an isotonic solution in claim 52, and the isotonic solution being 0.9% saline in claim 53. It is noted that the sterile saline of Paspaliaris for resuspending cells and intravenous infusion into patients is necessarily the normal saline (0.9% saline) for clinical use. Furthermore, Paspaliaris teaches the PBD-PSC are cultured in growth medium (see e.g., [0230]), thus also teaches the isotonic solution being growth medium in claim 53.
“The solution of suspended cells was then filtered through a 5 µm filter”, thus teaches filtering the resuspended population of cells comprising the SBSCs through a filter having a pore size being 5 µm wherein cells that are larger than 5 µm are excluded by the filtering step thereby isolating the SBSCs in amended claim 1 (see [0312]).
With respect to claims 56-60, directed to the population of cells comprising the SBSCs comprise cells having multiple markers or staining with a dye, it must be noted that these wherein clauses do not recite an active step in the claimed method, but only the results of the centrifugation and filtration steps to isolate SBSCs as taught by Paspaliaris. MPEP 2111.04 I states a whereby clause (or a wherein clause) “in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore, these wherein clauses do not provide any patentable weight in determining patentability of the claimed method. Nevertheless, Paspaliaris teaches the PBD-PSCs (i.e., SBSCs) express multiple pluripotency markers and hematopoietic stem cell markers (thus teaches claim 56), including pluripotency markers SOX2 and OCT4 (thus teaches claim 57), mesenchymal stem cell marker PTH1R (thus teaches claim 58), and hematopoietic stem cell markers CD90 and CD133 (thus teaches claim 59) (see e.g., [0219]), and teaches the cells carry the pluripotent stem cell marker Kyoto probe 1 (e.g., [0161], see Fig 6), thus teaches claim 60.
Accordingly, Paspaliaris anticipates instant claims.
Response to Traversal:
Applicant’s arguments filed on 08/12/2026 are acknowledged.
Applicant argues that Paspaliaris describes isolation of PBD-PSCs via magnetic antibody positive selection of PTH1R, CD90, and CD133 and negative selection of CD45. (Paspaliaris at [0301]). This method is distinct from the present claims which recite isolation of SBSCs via centrifugation and filtration exclusively. The ability of the present claims to isolate SBSCs from peripheral blood using only centrifugation and filtration steps represents a significant advantage over the methods of Paspaliaris. (Remarks, p. 4-5).
Applicant’s arguments have been fully considered but they are not persuasive.
In response to Applicant’s recitation of Paspaliaris at [0301] (Working Example 12), Paspaliaris indeed discloses two methods of isolating PBD-PSCs (i.e., SBSCs) from peripheral blood, i.e., one is exemplified in Example 12 ([0301]) using positive and negative antibody selection as recited by Applicant, and the other is exemplified in Example 15 ([0312]) using “a combination of centrifugation and filtration” (quoted from [0312], emphasized by examiner). Thus, Paspaliaris expressly discloses a method of isolating SBSCs via a combination of centrifugation and filtration, that does not appear to be distinct from that recited in the present claims. The fact that Paspaliaris discloses the other method based on antibodies does not negate Paspaliaris’ teaching of the method using a combination of centrifugation and filtration, which anticipates the instantly claimed method. Accordingly, the claimed method does not represent a significant advantage over the method of Paspaliaris.
Furthermore, in response to Applicant’s argument that the present claims recite isolation of SBSCs via centrifugation and filtration exclusively or using only centrifugation and filtration steps (Remarks, p. 5, underlined by examiner), Applicant is reminded that the instant claim 1 recites a method of isolating SBSCs “comprising” centrifugation and filtration steps, and that the transitional term "comprising" is inclusive or open-ended, and does not exclude additional, unrecited elements or method steps. See MPEP 2111.03 (I). Thus, the present claimed method “comprising” centrifugation and filtration steps encompasses a method that includes additional, unrecited steps, such as steps of positive and negative selection of SBSCs based on antibodies. Accordingly, Applicant’s purported “significant advantage” is not commensurate in scope with the claimed method. See MPEP 716.02(d).
Maintained 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 and 52-61 stand rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris (US 2017/0368107 A1, cited in IDS 12/16/2022) in view of Futrega et al., (Sci Rep. 2016:6:23886. P. 1-10. Prior art of record).
Claims 1 and 52-60 stand anticipated by Paspaliaris, thus Paspaliaris makes obvious the claims.
Claim 61 is directed to the method further comprising a cryopreservation step.
As stated supra, Paspaliaris teaches the PBD-PSCs (i.e., SBSCs) are isolated for the treatment or amelioration or inhibition of a disorder, disease or disease state (e.g., [0016]).
However, Paspaliaris does not specifically teach the cells are cryopreserved.
Nevertheless, cryopreservation of cells is a conventional and routine step in cell culture and transplantation therapy. For example, Futrega teaches a method of isolating hematopoietic stem cells for transplantation to a mouse model (e.g., abstract). Futrega teaches after isolating the hematopoietic stem cells, “CD34+ cells were cryopreserved in 10% DMSO and 90% FBS, slowly frozen to -80 °C overnight and stored in liquid nitrogen until use” (p. 7, last para “CD34+ cell isolation”), thus teaches the step of resuspending the isolated blood stem cells in a cryopreservation medium, freezing the blood stem cells at -80 °C and transferring the frozen blood stem cells to liquid nitrogen (i.e., about -150 °C), and the cryopreservation medium is 10% DMSO and 90% FBS (i.e., about 10:1 serum:DMSO) in claim 61.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of isolating SBSCs from peripheral blood for transplantation disclosed by Paspaliaris, by combining a step of cryopreserving the stem cells as suggested by Futrega with a reasonable expectation of success. Since cryopreservation of cells is a conventional and routine step in cell transplantation therapy as evidenced by Futrega, and since Futrega reduces to practice cryopreserving blood stem cells for future use in transplantation, one of ordinary skill in the art would have had a reason to combine cryopreserving the isolated SBSCs in the method of Paspaliaris in order to achieve long-term preservation of SBSCs for future therapeutic use. Furthermore, since Paspaliaris teaches the SBSCs are isolated from human for administering into human patients (e.g., Example 15), one of ordinary skill in the art would have had a reason to use human serum in the cryopreservation medium in order to avoid xenogeneic rejection.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 08/12/2026 are acknowledged.
Applicant argues that it would not be obvious to one of skill in the art to isolate SBSCs with only centrifugation and filtration steps when antibody-based isolation is a crucial step of the method of Paspaliaris. Applicant additionally submits that one would have to substantively redesign the teachings of Paspaliaris to arrive at the claimed invention so much so that it would change the principle of operation of the prior art and that a finding of lack of inventive step cannot be grounded in such a manner. The skilled person could not have envisioned the unexpected benefits of isolating the PBD-PSCs by centrifugation in the absence of immunoaffinity based on the cited art. Futrega as cited by the Examiner merely describes a cryopreservation procedure. Futrega describes hematopoietic stem cells, which are not SBSCs, nor are they equivalent to SBSCs. (Remarks, p. 6-7).
Applicant’s arguments have been fully considered but they are not persuasive.
In response to Applicant’s argument that Paspaliaris discloses an antibody-based isolation, Applicant is referred to the response above. Specifically, Paspaliaris expressly discloses a method of isolating SBSCs from peripheral blood using a combination of centrifugation and filtration, that does not appear to be distinct from that recited in the present claims. Accordingly, one of ordinary skill in the art would not have to substantively redesign the teachings of Paspaliaris to arrive at the claimed invention, and it would not change the principle of operation of the prior art Paspaliaris. Furthermore, Applicant’s purported “unexpected benefits” of isolating the PBD-PSCs by centrifugation in the absence of immunoaffinity is not commensurate in scope with the claimed method that encompasses a method that includes additional, unrecited steps, such as an immunoaffinity step. See MPEP 716.02(d).
In response to Applicant’s argument that Futrega merely describes a cryopreservation procedure on hematopoietic stem cells, which are not SBSCs, nor equivalent to SBSCs, Applicant is reminded that a 35 U.S.C. § 103 based test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, as stated supra, Paspaliaris expressly discloses a method of isolating SBSCs from peripheral blood using a combination of centrifugation and filtration, that anticipates the present claims. Futrega is cited to make obvious an additional cryopreservation procedure to preserve the isolated blood stem cells. Accordingly, one of ordinary skill in the art would have had a reason to combine cryopreserving the isolated SBSCs in the method of Paspaliaris in order to achieve long-term preservation of SBSCs for future therapeutic use. Furthermore, since Futrega reduces to practice a cryopreservation step using a cryopreservation medium on peripheral blood stem cells that is routine and conventional, one of ordinary skill in the art would have had a reasonable expectation of success in combining the cryopreservation step and medium of Futrega in the method of Paspaliaris to achieve long-term preservation of SBSCs, which is a subpopulation of peripheral blood stem cells.
New Provisional Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 52-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending claims 2-5 of copending Application No. 19/547,463 (‘463, the claim set filed on 05/26/2026 after the prior Office action mailed on 05/12/2026 in the instant application) in view of Paspaliaris (US 2017/0368107 A1, cited in IDS 12/16/2022) and Futrega et al., (Sci Rep. 2016:6:23886. P. 1-10. Prior art of record). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims of ‘463 recite a method of isolating a population of mammalian cells which express PTH1R from peripheral blood, the method comprising a) centrifuging a mammalian peripheral blood sample such that a precipitate comprising platelets and a population of cells that express PTH1R is obtained (copending claim 2, equivalent to the two centrifuging steps in instant claim 1), b) resuspending the precipitate (equivalent to the resuspending step in instant claim 1), c) filtering the resuspension (equivalent to the filtering step in instant claim 1), such that a population of cells that i) express a) PTH1R (related to instant claims 56 and 58), and b) Oct4 or Sox2 (related to instant claims 56 and 57), ii) are 2.5-4.5 µm in diameter, and iii) are capable of being stained by Kyoto Probe-1 staining are obtained (copending claim 2, related to instant claim 60), wherein the population of cells is positive for CD90 or CD133 (copending claim 4, related to instant claims 56 and 59), wherein the filter includes pores sized 5 µm (copending claim 5, related to instant claim 1). It is noted that the copending PTH1R positive and Oct4 or Sox2 positive (thus being pluripotent) cells that are isolated from peripheral blood and that are 2.5-4.5 µm in diameter are equivalent to the instantly claimed small blood stem cells (SBSCs) isolated from peripheral blood.
However, the copending claims are silent on the two centrifuging steps or the speed recited in instant claim 1, or the resuspension solution being isotonic such as 0.9% saline in instant claims 52-53, or mixing with anticoagulant such as sodium citrate prior to centrifuging in instant claims 54-55, or a cryopreserving step in claim 61.
Paspaliaris teaches a pluripotent stem cell population that is referred to as peripheral blood derived pluripotent stem cells (PBD-PSCs) (see e.g., [0007]), and teaches the PBD-PSCs are 2.5-4.5 μm in diameter (e.g., [0009]). Thus, Paspaliaris’ PBD-PSCs are equivalent to the instantly claimed small blood stem cells (SBSCs) and the cell population in the copending claims. In regard to a method of isolating SBSCs from peripheral blood, Paspaliaris teaches in a working example (Example 15) a method of isolating PBD-PSCs (i.e., SBSCs) from peripheral blood (see [0312]). Specifically, Paspaliaris teaches the method recited as italicized below: “Two hundred mL of peripheral blood was removed from a 71 year old female patient suffering with dry macular degeneration using typical venipuncture. Sodium citrate was used as the anticoagulant”, thus teaches mixing peripheral blood with an anticoagulant such as sodium citrate prior to centrifuging in instant claims 54-55. “The PBD-PSCs were isolated using a combination of centrifugation and filtration. The blood was first centrifuged for 10 minutes at 300 g”, thus teaches the first centrifuging the peripheral blood to isolate plasma from the peripheral blood, wherein the peripheral blood is centrifuged at a speed that is 300xg in instant claim 1. “The plasma layer was removed and was centrifuged for another 10 minutes at 800 g. The plasma supernatant was centrifuged again at 1100 g for 10 minutes”, thus teaches the second centrifuging the plasma to isolate a population of cells comprising the SBSCs in a cell pellet, wherein the plasma is centrifuged at a speed that is 1100xg in instant claim 1. “The cell layer at the bottom was removed and placed in 5 mL of sterile saline and resuspended”, thus teaches resuspending the population of cells comprising the SBSCs in a liquid in instant claim 1 and the cells being resuspended in an isotonic solution in instant claim 52, and the isotonic solution being 0.9% saline in instant claim 53. “The solution of suspended cells was then filtered through a 5 µm filter”, thus teaches filtering the resuspended population of cells comprising the SBSCs through a filter having a pore size being 5 µm wherein cells that are larger than 5 µm are excluded by the filtering step thereby isolating the SBSCs in instant claim 1 (see [0312]).
Futrega teaches a method of isolating hematopoietic stem cells for transplantation to a mouse model (e.g., abstract). Futrega teaches after isolating the hematopoietic stem cells, “CD34+ cells were cryopreserved in 10% DMSO and 90% FBS, slowly frozen to -80 °C overnight and stored in liquid nitrogen until use” (p. 7, last para “CD34+ cell isolation”), thus teaches the step of resuspending the isolated blood stem cells in a cryopreservation medium, freezing the blood stem cells at -80 °C and transferring the frozen blood stem cells to liquid nitrogen (i.e., about -150 °C), and the cryopreservation medium is 10% DMSO and 90% FBS (i.e., about 10:1 serum:DMSO) in instant claim 61.
Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the recitation from copending claims 2-5 of ‘463, by substituting the centrifuging step with a two-step centrifugation and choosing the resuspension solution and combining mixing with an anticoagulant as suggested by Paspaliaris and by combining cryopreserving the isolated cells as suggested by Futrega with a reasonable expectation of success. Since Paspaliaris reduces to practice a method of isolating PBD-PSCs (that are equivalent to the instantly claimed SBSCs and the cell population in the copending claims) with two-step centrifugation, anticoagulant prior to centrifugation and the resuspension solution, and since Futrega reduces to practice a cryopreservation step and a cryopreservation medium for preserving the isolated cells, one of ordinary skill in the art would have had a reason to combine the teaching of Paspaliaris and Futrega in the method recited in the copending claims in order to obtain and preserve SBSCs from peripheral blood.
Since the instant application claims are obvious over cited application claims, in view of Paspaliaris and Futrega, said claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims in the copending application have not in fact been patented.
Response to Traversal:
Applicant’s arguments filed on 08/12/2026 are acknowledged and have been discussed above.
Conclusion
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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Douglas (Doug) Schultz can be reached on (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANJIAN ZHU/Examiner, Art Unit 1631
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