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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 30, 2025, has been entered.
Priority
This application was filed March 4, 2020, and claims benefit to the foreign application JP2019-007868 filed on Jan. 21, 2019.
Claim Status
In the response filed on April 28, 2025, Applicant has amended claims 12, 18, and 23-24, and has cancelled claims 1-11, and 14-17.
Currently, claims 12-13, 18-24 are under examination.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The objection of claims 23-24 due to the following informalities: the phrase “having the genotype of each of HLA and KIR” is withdraw due to Applicants amendments to the claims.
The rejection of claims 12, and 21-23 under AIA 35 U.S.C. 103(a) as obvious over Henno et al., (WO 2015/132415 A1; published September 11, 2015, cited in IDS 10/6/2020, prior art of record; hereinafter as “Henno”) in view of Woll, Petter S., et al. (The Journal of Immunology 175.8: 5095-5103; published 2005) is withdrawn due to amendment to the claims.
The rejection of claim 13 under 35 U.S.C. 103 as being unpatentable over Henno et al., (WO 2015/132415 A1; published September 11, 2015, cited in IDS 10/6/2020, prior art of record; hereinafter as “Henno”) in view of Woll, Petter S., et al. (The Journal of Immunology 175.8: 5095-5103; published 2005) as applied to claims 12 and 21-22 above, and further in view of Yonemitsu, et al. (US 2014/0120072 A1, published August 2, 2014; hereinafter as “Yonemitsu”) is withdrawn due to amendment to the claims.
The rejection of claims 18-20 and 24 under AIA 35 U.S.C. 103(a) as being obvious over Henno et al., (WO 2015132415A1; published September 11, 2015, cited in IDS October 6, 2020, hereinafter as “Henno”) in view of Woll, Petter S., et al. (The Journal of Immunology 175.8: 5095-5103; published 2005) and Yonemitsu, et al. (US20140120072A1, published August 2, 2014; hereinafter as “Yonemitsu”) is withdrawn due to amendment to the claims.
The provisional rejection of claims 12-13, and 18-24 on the ground of nonstatutory double patenting as being unpatentable over claim 10 of co-pending Application No. 17/441,439 (the ‘439 application) in view of Henno et al., (WO 2015132415A1; published September 11, 2015, cited in IDS 10/6/2020, prior art of record; hereinafter as “Henno”) and Yonemitsu, et al. (US 20140120072A1, published August 2, 2014; hereinafter as “Yonemitsu”, prior art of record) is withdrawn due to amendment to the claims.
Specification
The disclosure is objected to because it contains an embedded hyperlinks, located on page 17 (i.e. https://doi.org/10.3389/fimmu.2015.00605). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 102
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 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 12-13, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yonemitsu et al., (U.S. Patent No. 9,404,083B2, Application No. 14/129,143, published Aug. 2, 2016).
This rejection is a new rejection necessitated by amendments to the claims. Any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
Regarding claim 12, and 22-23, Yonemitsu discloses a method for producing mixed cell populations including natural killer (NK) cells from a plurality of cell populations originating in a plurality of donors (see e.g. col. 8, Example 1), the method comprising: (1) removing CD3-positive cells from a cell population of mononuclear cells originating in each donor, the cell population including NK cells (see e.g. col. 8, ln. 51-59, Example 1, claim 2); (2) mixing the plurality of the cell populations of mononuclear cells from the plurality of cell populations originating in the plurality of donors (i.e. pooled)(see e.g. col. 8, ln. 51-59, Example 1); and (3) culturing the plurality of the cell populations under conditions effective for proliferation of NK cells to obtain the mixed cell populations including NK cells (see e.g. col. 8-9, Example 1). Yonemitsu discloses wherein the cell populations are prepared from peripheral blood or prepared from apheresis blood (see e.g. col. 15, Example 1 or 4, claims 7-8). Further, Yonemitsu discloses wherein the plurality of donors includes a first donor and a second donor, the cell populations from the first donor having a genotype of at least one of HLA or KIR which is different from a genotype of the cell populations from the second donor (i.e. HLA genotype is different)(see e.g. col. 3-4, Fig. 11).
Regarding claim 13, Yonemitsu discloses the method further (4) removing CD34-positive cells from the cell population of mononuclear cells including NK cells (see e.g. Fig. 16, Example 5, claim 4).
Thus, Yonemitsu anticipates the instant claims.
Claim Rejections - 35 USC § 103
The following is a quotation of AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 18-20, and 24 are rejected under AIA 35 U.S.C. 103(a) as obvious over Yonemitsu et al., (U.S. Patent No. 9,404,083B2, Application No. 14/129,143, published Aug. 2, 2016), in view of Henno et al., (WO 2015132415A1; published September 11, 2015, cited in IDS October 6, 2020, hereinafter as “Henno”, prior art of record), and Campana and Imai (US2006/0093605 A1, published 2006, hereinafter as “Campana”).
This rejection is a new rejection necessitated by amendments to the claims. Any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
The teachings of claims 12-13, and 22-23 apply here as indicated above.
Regarding claim 18 and 24, as stated supra, Yonemitsu discloses a method for producing mixed cell populations including natural killer (NK) cells from a plurality of cell populations originating in a plurality of donors (see e.g. col. 8, Example 1), the method comprising: (1) removing CD3-positive cells from a cell population of mononuclear cells originating in each donor, the cell population including NK cells (see e.g. col. 8, ln. 51-59, Example 1, claim 2); (2) mixing the plurality of the cell populations of mononuclear cells from the plurality of cell populations originating in the plurality of donors (i.e. pooled)(see e.g. col. 8, ln. 51-59, Example 1); and (3) culturing the plurality of the cell populations under conditions effective for proliferation of NK cells to obtain the mixed cell populations including NK cells (see e.g. col. 8-9, Example 1). Yonemitsu discloses wherein the cell populations are prepared from peripheral blood or prepared from apheresis blood (see e.g. col. 15, Example 1 or 4, claims 7-8). Yonemitsu discloses wherein the plurality of donors includes a first donor and a second donor, the cell populations from the first donor having a genotype of at least one of HLA or KIR which is different from a genotype of the cell populations from the second donor (i.e. HLA genotype is different)(see e.g. col. 3-4, Fig. 11). Further, Yonemitsu discloses wherein the mixed cell population have a cytotoxicity activity of 50% or higher in co-culture of the NK cells as effector cells (E) and K562 cells as target cells (T) at a mixing ratio of 1:1 (E:T)(see e.g. cols. 12, 15, and Example 3, Fig. 13).
Regarding claim 18, as stated supra, Yonemitsu discloses pooling mononuclear cells from peripheral blood of volunteers and patients (see e.g. col. 8). Further, Yonemitsu discloses cell amplification of individual donors (fig. 3) and the component faction percentage of NK cells, which represents a percentage ratio of NK cells individually and relative to the entirety of cultured cell (see e.g. col. 8-12, Example 1, fig. 3-5).
Yonemitsu is silent regarding a proliferation ratio wherein the mixed cell population have a higher proliferation ratio than a proliferation ratio of any cell population from a single donor which is the first or second donor.
However, the prior art of Henno teaches that when “NK didn't amplify properly in CD3-non depleted, pooling of umbilical cord blood (UCB) after 9 days amplification (increasing NK% and NK activation status) seemed to overcome the problem. They showed an in vitro similar good cytotoxicity against B lymphoma tumoral cells (overnight, ratio E:T 1: 1)”(page 27, lns. 21-26; Fig. 8-9).
Nevertheless, although Yonemitsu is silent regarding a proliferation ratio, the effect of a mixture (i.e. pooled) of cell populations and at a 1:1 ratio would naturally have a higher proliferation ratio than a proliferation ratio of any cell population from a single donor, which is the first donor or the second donor. Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims."
Accordingly, it would have been obvious for one of ordinary skill in the art to have the methods of Yonemitsu with a proliferation ratio wherein the mixed cell population have a higher proliferation ratio than a proliferation ratio of any cell population from a single donor as taught by Henno because Yonemitsu discloses that the NK cells from mononuclear cells may be separated by umbilical cord blood and peripheral blood (see e.g. col. 4). Therefore, a person of ordinary skill in the art would have naturally had a higher proliferation ratio with the mixed cell population compared to a single donor with a reasonable expectation of success because Yonemitsu discloses that the amplification methods of NK cells may be employed to both umbilical cord blood and peripheral blood. Additionally, the prior art of Campana discloses that contact of NK cells with K562 cells is known to augment NK cell proliferation (see e.g. page 7, col. 2). Furthermore, Yonemitsu teaches that as many as six times the number of NK cells are obtained (Yonemitsu, col. 6). Therefore, a person of skill in the art would have been motivated to modify the methods of Henno in order to ensure that the maximum number of NK cells would be obtained. Moreover, a person of ordinary skill in the art would have combined similar NK cell amplification methods, which would have led to predictable results with a reasonable expectation of success. Furthermore, an artisan of ordinary skill in the art of (i.e. NK cell amplification methods) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Regarding claim 19-20, as stated supra, Yonemitsu discloses a pharmaceutical composition for adoptive immunotherapy cell therapy, which comprises the mixture of cell populations, and a pharmaceutical composition for treating infectious disease and/or cancer (see e.g. abstract, col. 3-6).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant argues that the claims have been amended to recite that the cell populations are from "peripheral blood or prepared from apheresis blood." (Remarks, page 6).
Applicant arguments are acknowledged, have been fully considered, and have been deemed persuasive. Therefore, the rejection has been withdrawn due to the amendments to the claims. However, upon further consideration, a new ground(s) of rejection is made in view of Yonemitsu et al., in view of Henno et al and Campana.
Applicant asserts that “although both umbilical cord blood (UCB) and peripheral blood (PB) may be recognized NK cell sources, they are not treated as equivalent nor are they considered interchangeable” (Remarks, page 7). Applicant argues that “Henno focus on the uniqueness of UCB and provides no reasonable reason or motivation for one skilled in the art to substitute UCB with PB as a source”(Remarks, page 7).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
It is acknowledged that both umbilical cord blood (UCB) and peripheral blood (PB) may be recognized NK cell sources. In response to Applicants arguments the obviousness rejection is not substituting one cell population for another. As discussed above, the prior art of Yonemitsu discloses that the NK cells from mononuclear cells may be separated by umbilical cord blood and peripheral blood (see e.g. col. 4). Furthermore, an artisan of ordinary skill in the art of (i.e. NK cell amplification methods) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007). In the instant case, it would have been obvious for a person of ordinary skill in the art to modify NK cell methods based on amplification methods of NK cell populations whether or not those NK cell population were derived from UCB or PB sources.
Applicant asserts that Henno teaches away from choosing PB and shows that NK amplification was lowed in mixed cultures when CD3-positive cells are removed (page 27, Table 4)(Remarks, page 7).
Applicant arguments are acknowledged, have been fully considered, and have been deemed partially persuasive.
In response to Applicant argument the previous rejection has been withdrawn due to the amendments to the claims. However, upon further consideration, a new ground(s) of rejection is made in view of Yonemitsu et al., in view of Henno et al and Campana.
In response to Applicants argument that Henno teaches away from choosing PB, the prior art of Henno is not cited for teaching NK cell that are prepared from PB. Contrary to applicants’ assertion Table 4 discloses the possibility of pooling activated NK cells 9 days after activation and without prior CD3-depletion. It is noted that the pooling at day zero is 90% of B lymphoma lysis and that UCB donor 1 has 74% and UCB donor 2 has 91%. The Examiner believes that Applicant is comparing the donor 2 (91%) to the pooling at day zero (90%). However, the pooling at day 9 was 91%, which was the same as donor 2%. Therefore, it is unclear how the Applicant believe Table 4 of Henno discloses NK amplification was lowed in mixed (i.e. pooling) cultures. Furthermore, it is noted that this table discloses NK cells without prior CD3-depletion, which Henno discloses that this is “signific but lower NK amplification”. Thus, if Henno had prior CD3-depletion then NK amplification might naturally be increased. Contrary to Applicants assertion the CD3-positive cells were not removed (see page 27 of Henno).
Applicant asserts that Yonemitsu is cited for allegedly teaching removing CD34-positive cells and a cytotoxic activity and that Yonemitsu does not remedy the deficiency of the combination of Henno and Woll (Remarks, page 8).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
In response to Applicant argument, as discussed above, Yonemitsu discloses the method of further removing CD34-positive cells from the cell population of mononuclear cells including NK cells (see e.g. Fig. 16, Example 5, claim 4).
Claim 21 is rejected under AIA 35 U.S.C. 103(a) as obvious over Yonemitsu et al., (U.S. Patent No. 9,404,083B2, Application No. 14/129,143, published Aug. 2, 2016), as applied to claims 12-13, and 22-23 above, and further in view of Fujisaki, Hiroyuki, et al. (Cancer research 69.9: 4010-4017, published 2009).
This rejection is a new rejection necessitated by amendments to the claims.
The teachings of claims 12-13, and 22-23 apply here as indicated above.
Regarding claim 21, Yonemitsu discloses that “while carrying out further experiments of amplifying NK cells, it was found that the component fraction of CD3-positive cells relative to the entirety of culture cells may exceed 30%” (see e.g. col. 13).
Yonemitsu does not explicitly disclose wherein steps (1), (2), and (3) are performed in this order.
However, Fujisaki discloses the methods of NK Cell Activation and Expansion System (NKAES) (see e.g. page 4010, Fig. 1), wherein steps (1) removing CD3-positive cells from a cell population of mononuclear cells originating in each donors, (2) mixing the plurality of cell populations of mononuclear cells from the plurality of cell populations originating in the plurality of donors, and (3) culturing the plurality of cell population conditions effective for proliferation of NK cells to obtain the mixed cell populations including NK cells are performed in this order (see e.g. pages 4010-411)
Accordingly, it would have been obvious for one of ordinary skill in the art would have to remove CD3-positive cells at the beginning as taught by Fujisaki and modify the expanding and amplifying NK cell methods as taught by Yonemitsu because Yonemitsu suggests that CD3-positive cells relative to the entirety of culture cells may increase with further culturing (see e.g. col. 13). A person would have had a reasonable expectation of success because Yonemitsu discloses carrying out the step of removing CD3-positive cells more than once (see e.g. col. 13, fig. 15). Furthermore, an artisan of ordinary skill in the art of (i.e. amplification of NK cells) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 12-13, and 18-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, and 9 of U.S. Patent No. 11,723,924 in view of in view of Yonemitsu, et al. (US 20140120072A1, published August 2, 2014; hereinafter as “Yonemitsu”, prior art of record) and Henno et al., (WO 2015132415A1; published September 11, 2015, cited in IDS 10/6/2020, prior art of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims. More specifically, the patented claims are not identical because no single patented claim discloses all of the limitations of any of the instant claims; however, each of the limitations of the instant claims are disclosed by separate patented claims, or rendered obvious by the accompanying prior art. The fact that each of the elements were claimed in the patent application, just not in a single claim, still renders obvious the instant invention because each of the features, though separately claimed, can be physically combined into a single embodiment.
Regarding claims 12-13 and 18-24, the patented ‘924 claims recites: Claim 1 recites “a population of NK cells having the following characteristics (1), (2), and (3): (1) the NK cell is CD16-positive, highly expresses CD56, and is CD57-negative; (2) the NK cell is NKG2C-positive, is NKG2A-negative or lowly expresses NKG2A, and is CD94-positive; and (3) when the NK cell is used as effector cells (E), and co-cultured with K562 cells as target cells (T) at a mixing ratio (E:T) of 1:1, the NK cells show a cytotoxicity of 50% or higher”. Claim 5 and 9 recites “a method for preparing the population according to claim 1, which comprises the following steps: collecting peripheral blood monocytes from a healthy volunteer using Ficoll; adding CD3 beads to the obtained peripheral blood monocytes, and incubating the monocytes and the beads at 4° C. for 15 minutes; adding a separation buffer to the monocytes and the beads to obtain a suspension, and centrifuging the suspension at 300×g for 10 minutes; removing a supernatant from the centrifuged suspension to obtain a residue, suspending the residue in a separation buffer, and adding the resulting suspension to LD Column wetted beforehand with the separation buffer; collecting an eluate from the LD Column, and centrifuging the eluate at 500×g for 5 minutes; removing a supernatant from the centrifuged eluate to obtain resultant cells, and suspending the resultant cells in NK medium I at a density of 5×105 cells/mL which are collected as primary NK cells; culturing the primary NK cells in a medium in a CO2 incubator at 37° C. under 5% CO2 atmosphere; collecting the cells on day 14 of the culturing step as the population; and wherein the medium is COSMEDIUM 008 containing 5% of human AB type serum which is obtained by inactivation at 56° C. for 30 minutes.” Claim 6 recites “The method according to claim 5, wherein the population of primary NK cells has undergone the step of removing CD3-positive cells”.
The co-pending ‘924 application does not explicitly teach a mixed cell populations. However, as stated above, the prior art of Henno et al. teaches a method for producing a mixed (i.e. pooling) cell populations including natural killer (NK) cells from different donors (i.e. plurality of donors)(abstract; Example 1-3; Tables 1-2; Fig. 1-3). Further, Henno et al teaches that NK expressing inhibitory receptors when the recipient doesn't express the corresponding HLA (absence of inhibitory signal = iKIR-HLA mismatch) lead to better tumor killing without leading to graft versus host disease (GvHD).” (page 2, para. 1).
Accordingly, it would have been obvious for a person of ordinary skill in the arts to choose a mixed NK cell as the immune cells because it could have been done with predictable results and a reasonable expectation of success. Further, Henno et al teaches that a Natural Killer (NK) cells are a fundamental component of the innate immune system (page 1, para. 2).
The co-pending ‘439 application does not explicitly teach removal of CD34-positive cells. However, as discussed above, the prior art of Yonemitsu et al teaches removing CD34-positive cells from the cell population of mononuclear cells including NK cells (para. 10, 22, 57-59, 109-113; Fig. 16-17; Example 5; claim 4 and 15). Therefore, a person of ordinary skill in the art would have been motivated to practice the method of Henno et al and remove the CD34-positive cells as taught by Yonemitsu with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to do so because CD34 positive cells are not natural killer (NK) cells. Methodologically, Henno et al and Yonemitsu et al both teaches that NK cells may be isolated and identified using flow cytometry (FACS) to obtain a specific cellular composition in the culture (Henno et al see pg 24 and 30, and Yonemitsu et al para. 22, 31, 33).Therefore, a person of ordinary skill in the art would also have been motivated to remove CD34 positive cells to create a pure population of NK cells and avoid contamination of other cell types.
As discussed above, as taught by Henno et al., which teaches a pharmaceutical composition according to claim 19, which is for treating an infectious disease and/or cancer (abstract, page 1, lns.5-8, page 17, ln. 29 to page 18, ln. 1, claim 20). A person of ordinary skill in the art would have been motivated to use the NK cells as the immune cells because Henno et al teaches that a Natural Killer (NK) cells are a fundamental component of the innate immune system (page 1, para. 2). Furthermore, because as taught by Henno et al., that a pharmaceutical composition comprising a population of pooled and activated and/or expanded cells, particularly NK cells, obtained or obtainable by the method (pg. 16, lns 17-20), it could have been done with predictable results and a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Prior art made of record:
Somanchi, Srinivas S., and Dean A. Lee. (Natural Killer Cells: Methods and Protocols. New York, NY: Springer New York, 175-193, published 2016, hereinafter “Somanchi”).
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JOSEPHINE GONZALES
Examiner
Art Unit 1631
/JOSEPHINE GONZALES/ Examiner, Art Unit 1631
/JAMES D SCHULTZ/ Supervisory Patent Examiner, Art Unit 1631