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 Status
In the amendment filed 1st, September, 2026, Applicant cancelled claims 4-5, and added new claim 53.
Claims 1-3, 6-12, 17-21, 24-33, 36, 38-47 and 49-53 are pending.
Claims 38-47 are withdrawn.
Claims 1-3, 6-12, 17-21, 24-33, 36, and 49-53 are under examination.
Moot Claim Rejections - 35 USC § 112(b)
The rejection of claims 4-5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is moot in view of the cancellation of these claims.
Withdrawn Claim Rejections - 35 USC § 112(b)
The rejection of claims 6-10 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Claim Rejections - 35 USC § 112(b)
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 3 remains 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 3 recites the term “discontinuously” which renders the scope of the claim indefinite because the metes and bounds of this term as they apply to the claim are indefinite. The plain and ordinary meaning of “discontinuously” is to stop and start again (see Applicant’s remarks pg. 12). The scope of the claim is unclear because it is not clear what combinations of starting and stopping are encompassed by Applicant’s claims for the step of contacting the HP cells with the fifth differentiation culture medium and whether other specific medias and timings are intended to be encompassed by this limitation, and what those medias and timings encompass.
Response to Arguments
Applicant’s arguments, filed 1st, September, 2026, have been fully considered but are not found persuasive.
Applicant argues “Applicant submits that those skilled in the art understand the metes and bounds of amended claim 3 when read in light of the specification. Amended claim 3 replaces "throughout" with "in". Therefore, one of skill in the art would understand that the medium is used discontinuously in the recited step.”
Applicant argues “Applicant submits that Stage 2 corresponds to the transition from HP cells to iNK cells, lasting 2-4 weeks as shown in Figure 1; therefore, the step may last 2-4 weeks. Moreover, "FIG. 6 demonstrates that NKSFM used discontinuously or continuously during Stage 2 significantly promoted iNK cell differentiation efficiency (CD56+cell % (Fig. 6A) and CD56+cell number (Fig. 6B)) as compared with the other basal media used during Stage 2." Further, as shown in Table 2.2 of Example 6, different basal media may be used in week 1 and week 2 of Stage 2. For example, for #5-7, IF-4 medium is used in week 1, while NKM, NKSFM-EP, or NKSFM medium is used in week 2. According to Table 1.1, IF-4 medium does not contain Nicotinamide, Heparin sodium, and Human Platelet Lysate, while NKSFM contains all three. Therefore, based on the disclosure of the present application, one of ordinary skill in
the art would understand that the basal medium containing the combination of nicotinamide,
heparin sodium, and human platelet lysate does not need to be used continuously during the
differentiation process from HP cells to iNK cells; i.e., it can be replaced with other basal media
in between” (pg. 12).
Applicant argues “As "discontinuously" is defined in Cambridge Dictionary as "in a way that has breaks, or that stops and starts again", one of skill in the art would have understood that using a specific medium in a step discontinuously means to use it intermittently, i.e., using the basal medium containing the combination of nicotinamide, heparin sodium, and human platelet lysate so that it has breaks or other basal media is used between the use of the basal medium containing the nicotinamide, heparin sodium, and human platelet lysate” (pg. 12).
In response, the claim is still indefinite for the reasons set forth above. Regarding Applicant’s arguments concerning stage 2 (pg. 12), these specific embodiments do not clarify the full scope of the breadth of the term “discontinuously” as it applies to the claim. Further, these specific embodiments indicate that the term “discontinuously” may encompass conditions such as timings, numbers of starts and stops, and components that are not specifically defined by the claim or the specification. Therefore, one of ordinary skill would not be able to clearly identify the metes and bounds of the claimed term.
Withdrawn Claim Rejections - 35 USC § 112
Improper Markush
The rejection of claim 29 on the basis that it contains an improper Markush grouping of alternatives as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Moot Provisional Non-Statutory Double Patenting
U.S. Co-Pending Application No. 18025588
The provisional rejection of claims 4-5 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 11-15, 19-21 of U.S. Co-pending Application No. 18025588 as set forth in the previous office action is moot in view of the cancelation of these claims.
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.
Provisional Non-Statutory Double Patenting
U.S. Co-Pending Application No. 18025588
Claims 1-3, 4-5, 7-10, 17-21, 24-26 and 49-52 remain provisionally rejected and new claim 53 is newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-15 and 19-21 of U.S. Co-pending Application No. 18025588.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for promoting the directed differentiation of pluripotent stem
cells (PSCs) makes obvious the method of instant application.
Although the claims at issue are not identical, they are not patentably distinct for the reasons stated below.
Regarding claim 1, U.S. Co-pending App ‘588 claims method for promoting the directed differentiation of pluripotent stem cells (PSCs), comprising the steps of:
contacting the PSCs with a maintenance culture medium to form embryoid bodies (EBs) (claim 1);
contacting the EBs with a first differentiation culture medium, or with the first
differentiation culture medium and a second differentiation culture medium sequentially,
to form mesodermal cells (claims 1-2);
contacting the mesodermal cells with a third differentiation culture medium to
form hemogenic endothelial (HE) cells (claims 1-2).
contacting the HE cells with a fourth differentiation culture medium to form
hematopoietic progenitor (HP) cells (claim 2).
Regarding claim 1, U.S. Co-pending App ‘588 separately claims contacting the HP cells with a fifth differentiation culture medium to obtain immature iNK cells (claim 3) and it would be obvious to combine the separately claimed embodiments.
Regarding claim 1, U.S. Co-pending App ‘588 separately claims a basal medium supplemented with the combination of (i) a nicotinamide-based compound, (ii) a heparin-based compound, and (iii) a human platelet lysate is used as a basal medium of the fourth differentiation culture medium and/or a basal medium of the fifth differentiation culture medium (claim 11) and it would be obvious to combine the separately claimed embodiments.
Regarding claims 2-3, further to the discussion of claim 1 above, as stated above, U.S. Co-pending App ‘588 claims a basal medium supplemented with the combination of (i) a nicotinamide-based compound, (ii) a heparin-based compound, and (iii) a human platelet lysate is used as a basal medium of the fourth differentiation culture medium and a basal medium of the fifth differentiation culture medium (claim 11), using the basal medium supplemented with the combination of (i) a nicotinamide-based compound, (ii) a heparin-based compound, and (iii) a human platelet lysate for both the fourth and the fifth differentiation encompasses both continuous use (instant claim 2) and discontinuous use (instant claim 3) one of ordinary skill would have at once envisaged either of these two options.
Regarding claim 7, further to the discussion of claim 1 above, as stated above, U.S. Co-pending App ‘588 claims using the basal medium supplemented with the combination of (i) nicotinamide-based compound, (ii) heparin-based compound, and (iii) human platelet lysate for the fourth and fifth differentiation culture medium (claim 11), and it would be obvious to one of ordinary skill to use this medium for the duration of the culture step of both of the fourth and the fifth differentiation medias.
Regarding claim 8, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 claims the concentrations of the nicotinamide-based compound in the fourth and fifth differentiation culture media are each from 0.5 to 20 mM (claim 12).
Regarding claim 9, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 claims the concentrations of the heparin-based compound in the fourth and fifth differentiation culture media are each from 0.1 to 100 μg/mL (claim 13).
Regarding claim 10, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 claims the concentrations of the human platelet lysate in the fourth and fifth differentiation culture media are each from 0.1 % to 20% by volume (claim 14).
Regarding claim 17, further to the discussion of claim 1 above U.S. Co-pending App ‘588 claims the first and second differentiation culture media are further supplemented with a Wnt signaling pathway activator (claim 1), and the Wnt signaling pathway activator in the second differentiation culture medium is same or different and has an equal or lower concentration as compared to the
Wnt signaling pathway activator in the first differentiation culture medium (claim 4) and it would be obvious to combine these separately claimed embodiments.
Regarding claim 18, further to the discussion of claims 1 and 17 above, U.S. Co-pending App ‘588 claims the Wnt signaling pathway activator is selected from the group consisting of Kenpaullone, 1-Azakenpaullone, CHIR99021, CHIR98014, NP031112, TWS119, AZD2858, AZD1080, SB415286, LY2090314, ARA014418, SB216763, BIO-Acetoxime, (5-Methyl-lH-pyrazol-3-yl)-(2- phenylquinazolin-4-yl)amine, 2-Thio(3-iodobenzyl)-5-( 1-pyridyl)[ 1,3,4 ]-oxadiazole, alpha-4- Dibromoacetophenone, 3-(l-(3-Hydroxypropyl)-1H-pyrrolo[2,3-b ]pyridin-3- yl]-4-pyrazin-2-yl-pyrrole-2,5-dione, 2-Chloro-1-( 4,5-dibromo-thiophen-2-yl)-ethanone, GF109203X, and any combination thereof (claim 8).
Regarding claim 19, further to the discussion of claims 1 and 17 above, U.S. Co-pending App ‘588 claims the second differentiation culture medium has the same composition as that of the first differentiation culture medium except that the concentration of the Wnt signaling pathway activator in the second differentiation culture medium is lower than the concentration of the Wnt signaling pathway activator in the first differentiation culture medium (claim 5).
Regarding claim 20, further to the discussion of claims 1 and 17 above, U.S. Co-pending App ‘588 claims the concentration of the Wnt signaling pathway activator in the second differentiation culture medium is from 0.5 to 4 μM, and the concentration of the Wnt signaling pathway activator in the first differentiation culture medium is from 4 to 8 μM (claim 6).
Regarding claim 21, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 claims the nicotinamide-based compound comprises nicotinamide, and the heparin-based compound comprises heparin sodium (claim 15).
Regarding claim 24, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 claims the first to fourth differentiation culture media are each independently further supplemented with a VEGF at a concentration of 15 to 100 ng/mL (claim 19).
Regarding claim 25, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 claims the first to fifth differentiation culture media are chemically defined serum-free and xeno-free differentiation culture media (claim 20).
Regarding claim 26, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 claims the method is carried out under 3D culture condition (claim 21).
Regarding claim 49, further to the discussion of claims 1 and 17 above, U.S. Co-pending App ‘588 claims the third differentiation culture medium is further supplemented with a Wnt signaling pathway inhibitor (claim 1).
Regarding claim 50, further to the discussion of claims 1, 17 and 49 above, U.S. Co-pending App ‘588 claims the concentration of the Wnt signaling pathway inhibitor in the third differentiation culture medium is from 1 to 30 μM (claim 7).
Regarding claim 51, further to the discussion of claims 1, 17 and 49 above, U.S. Co-pending App ‘588 claims the Wnt signaling pathway inhibitor is selected from the group consisting of iCRT3, IWP-O1, IWP-2, IWP-3, IWP-4, Ciclopirox, Cardamonin, Diethyl benzylphosphonate, Disodium Pamidronate Hydrate, Ginsenoside Rh4, KY-05009, Isoquercitrin, Gigantol, JW55, MSAB, IWR-1-endo, FH535, WIKI4, KYA1797K, NCB-0846, iCRT14, Adavivint, M435-1279, and XAV939, and any combination thereof (claim 9).
Regarding claim 52, further to the discussion of claims 1, 17 and 49 above, U.S. Co-pending App ‘588 claims the third differentiation culture medium (claim 1) and is silent to a TGF-β signaling pathway inhibitor and it would therefore be obvious not to include a TGF-β signaling pathway inhibitor in this embodiment.
Regarding claim 53, further to the discussion of claims 1 and 27-28 above, U.S. Co-pending App ‘588 claims the expansion and maturation culture medium is further supplemented with SB431542 (claim 8).
Since the instant application claims are obvious over cited application claims, said claims are not patentably distinct.
Claims 6, 11-12, 27-33 and 36 are provisionally rejected and new claim 53 is newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-15, 19-21 of U.S. Co-pending Application No. 18025588 in view of Unannounced Inventor (CN-111235105-A; ANHUI NUWACELL BIOTECHNOLO GY CO. LTD; Published 5th, June, 2020; citations refer to attached translation; henceforth “Nuwacell”).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of U.S. Co-pending App ‘588 are incorporated herein in their entirety.
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for promoting the directed differentiation of pluripotent stem
cells (PSCs) makes obvious the method of instant application.
Although the claims at issue are not identical, they are not patentably distinct for the reasons stated below.
Regarding claim 6, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 is silent to using the same basal medium for the first to third differentiation basal media.
Nevertheless, regarding claim 6, U.S. Co-pending App ‘588 teaches using IMDM as a basal media for multiple steps of differentiating pluripotent stem cells into NK cells (pg. 5).
Therefore, regarding claim 6, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method as claimed by U.S. Co-pending App ‘588 and combine the known prior art element of using the same basal media for the differentiation steps of Nuwacell to obtain the predictable result of a basal media. One of ordinary skill would have been motivated to do so because Nuwacell teaches using the same basal media for differentiation steps is effective in a method for obtaining NK cells from pluripotent stem cells (pg. 5) and also and Nuwacell also provides a reasonable expectation of success for this.
Regarding claim 11, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 does not claim seeding the HP cells on a cell culture surface coated with a Notch pathway activator and an adhesion molecule.
Nevertheless, regarding claim 11, Nuwacell teaches a method step of seeding HP cells on a cell culture surface coated with a Notch pathway activator (claims 6-8; see also pg. 7 and 9) and an adhesion molecule as part of a method to differentiate HP cells into NK cells. Nuwacell teaches the combined use of small molecule reagents, cytokines and cell matrix further increases the proportion of blood precursor cells and facilitates the production of subsequent clinical grade cell preparations (pg. 14 Example 3).
Therefore, regarding claim 11, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method as claimed by U.S. Co-pending App ‘588 and combine the known prior art element of the of seeding HP cells on a cell culture surface coated with a Notch pathway activator and an adhesion molecule to obtain the predictable result of differentiation HP cells into NK cells. One of ordinary skill would have been motivated to do so as taught by Nuwacell to further increase the proportion of blood precursor cells and facilitates the production of subsequent clinical grade cell preparations (pg. 14 Example 3). Regarding the reasonable expectation of success, Nuwacell evidences a method step of seeding HP cells on a cell culture surface coated with a Notch pathway activator (claims 6-8; see also pg. 7 and 9) and an adhesion molecule as part of a method to differentiate HP cells into NK cells (see also pg. 14 Example 3).
Regarding claim 12, further to the discussion claims 1 and 11 above, Nuwacell specifically teaches and suggests the Notch pathway activators of DLL4, DLL1, Jagged-1, Jagged-2, variants thereof, and any combination thereof (claim 8), and the adhesion molecule is selected from VCAMl, Fibronectin, Laminin, Vitronectin, MAdCAM-1, ICAM, variants thereof (claim 8) and it would therefore be obvious to use these specific Notch pathway activators and adhesion molecules suggested by Nuwacell for the reasons set forth above.
Regarding claim 27, further to the discussion of claim 1 above, U.S. Co-pending App ‘588 does not claim a step for expanding and maturing the immature iNK cells.
Nevertheless, regarding claims 27, Nuwacell teaches a method step of contacting NK cells with a differentiation culture medium that is a basal medium supplemented with the combination of (i) a nicotinamide-based compound, (ii) a heparin-based compound, and (iii) a human platelet lysate (“basic differentiation medium to which interleukins and a substance promoting the maturation and expansion of NK cells are added” claim 9 and “the substance promoting NK cell maturation and expansion is selected from one or more of human AB plasma, human platelet lysate, Vitamin A, nicotinamide, Vitamin E and Heparin” claim 10; see also pg. 4 20th para.; pg. 8 4th para.; pg. 13 9th para) to promote NK cell maturation and expansion (pg. pg. 4 20th para.; pg. 8 4th para.; pg. 13 9th para).
Therefore, regarding claim 27, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method as claimed by U.S. Co-pending App ‘588 and combine the known prior art element of the step for expanding and maturing the immature iNK cells by contacting NK cells with a differentiation culture medium that is a basal medium supplemented with the combination of (i) a nicotinamide-based compound, (ii) a heparin-based compound, and (iii) a human platelet lysate of Nuwacell to obtain the predictable result of a method step of expanding and maturing NK cells. One of ordinary skill would have been motivated to do so as taught by Nuwacell to promote NK cell maturation and expansion (pg. pg. 4 20th para.; pg. 8 4th para.; pg. 13 9th para). Regarding the reasonable expectation of success, Nuwacell evidences a method step of expanding and maturing NK cells (pg. 8).
Regarding claim 28, further to the discussion of claims 1 and 27 above, Nuwacell teaches and suggests the expansion medium comprising a basal medium supplemented with the combination of (i) a nicotinamide-based compound, (ii) a heparin-based compound, and (iii) a human platelet lysate and it would be obvious to use this media for the reasons set forth above.
Regarding the feeder cells of claim 28, Nuwacell teaches the method step does not use feeder cells during expansion so that the method is suitable for the production and application of subsequent clinical-grade cell preparations (pg. 9) and it would therefore be obvious to exclude feeder cells during the expansion made obvious by Nuwacell above for this purpose.
Regarding claims 29 and 53, further to the discussion of claims 1 and 27-28 above, Nuwacell teaches the expansion and maturation culture medium is further supplemented with one or more of IL-2, IL-10, IL-18(pg. 9) and SB431542 (pg. 12) and it would be obvious to use these supplements for the reasons set forth above.
Regarding claim 30, further to the discussion of claims 1 and 27-28 above, Nuwacell teaches a concentration of nicotinamide of 1-10 mmol/L (pg. 13) (which lies within the claimed range of “from 0.5 to 20 mM”) in the expansion media and it would be obvious to use this nicotinamide concentration for the reasons set forth above.
Regarding claim 31, further to the discussion of claims 1 and 27-28 above, Nuwacell teaches a concentration of heparin-based compound of heparin of 0-100 µg/mL (pg. 13) (which overlaps with the claimed range of “0.1 to 100 μg/mL”) in the expansion media and it would be obvious to use this nicotinamide concentration for the reasons set forth above.
Regarding claim 32, further to the discussion of claims 1 and 27-28 above, Nuwacell teaches a concentration of human platelet lysate of 1-10% (pg. 13) (which lies within the claimed range of “0.1 % to 20% by volume”) in the expansion media and it would be obvious to use this nicotinamide concentration for the reasons set forth above.
Regarding claims 30-32, in the case where the claimed ranges "overlap or lie inside ranges disclosed 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). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See M.P.E.P. §2144.05. Therefore, the ranges of nicotinamide (instant claim 30), heparin (instant claim 31) and human platelet lysate (instant claim 32), taught and suggested by Nuwacell above which lie within or overlap with the claimed ranges, render the instantly claimed ranges obvious.
Regarding claim 33, further to the discussion of claims 1 and 27-28 above, Nuwacell teaches the nicotinamide-based compound comprises nicotinamide (pg. pg. 4 20th para.; pg. 8 4th para.; pg. 13 9th para). Although Nuwacell is silent to heparin sodium, this is a well-known obvious species of heparin-based compounds and further would be obvious to use because U.S. Co-pending App ‘588 separately claimed heparin sodium as a preferred species of heparin-based compound (claim 15).
Regarding claim 36, further to the discussion of claims 1 and 27-28 above, Nuwacell teaches the expansion and maturation culture medium is a chemically defined serum-free and xeno-free culture medium (“the method uses serum-free medium and does not use feeder cells during induction of differentiation and expansion” pg. 9) for the production and application of subsequent clinical-grade cell preparations (pg. 9) and it would therefore be obvious to use chemically defined serum-free and xeno-free culture medium for this purpose in the expansion and maturation culture medium suggested above.
Since the instant application claims are obvious over cited application claims, in view of Nuwacell, said claims are not patentably distinct.
Response to Arguments
It is noted that in the remarks filed 1st, September, 2026, Applicant requests that the Office hold the rejections in abeyance until the claims of the subject application or the claims of the reference application are deemed allowable. Applicant has not specifically argued the rejection.
In response, because the instant Application has the same patent term filing date as the reference Application, the provisional double patenting rejections as being unpatentable over co-pending Application No. 18/025,588 and as being unpatentable over co-pending Application No. 18/025,588 in view of CN-111235105-A to Nuwacell remain rejected above.
Examiner’s Remark
The remaining rejections in this Application are the provisional non-statutory double patenting rejections above and the rejection under 35 U.S.C. 112(b) above. Applicant is directed to MPEP 1490 which specifies procedure when provisional non-statutory double patenting rejections are the only rejections remaining in an Application. Relevant portions are copied below for Applicant’s convenience. For additional information, Applicant is directed to MPEP 1490.
Application under Examination Has the Same Patent Term Filing Date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application or includes a compliant terminal disclaimer in the application under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.
Applicant is directed to MPEP 804 which defines the Patent Term Filing Date:
The patent term filing date of an original utility or plant application filed on or after June 8, 1995 is the earliest of:
(1) The actual filing date of the application; or
(2) The filing date of the earliest application for which the application claims the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c). See 37 CFR 1.78. See also MPEP § 211
For example, if an original (non-reissue; see MPEP § 201.02) patent application has no specific reference to any earlier-filed application under 35 U.S.C. 120, 121, 365(c), or 386(c), then the patent term filing date is the date that the application was actually filed. However, if an original patent application does include one or more specific references to an earlier-filed application under 35 U.S.C. 120, 121, 365(c), or 386(c), then the patent term filing date is the filing date of the earliest reference application for which the benefit is properly claimed. See MPEP § 2701. For an application to properly claim the benefit of an earlier-filed application, it must meet the requirements of 37 CFR 1.78 (e.g., having a (joint) inventor in common, copendency, timeliness, and a proper reference). See 37 CFR 1.78 and MPEP § 211.01 et seq. It does not require a determination that the earlier-filed application discloses the invention in a manner provided by 35 U.S.C. 112(a). In other words, the issue of entitlement of a claimed invention to the benefit of the filing date of an earlier-filed application does not affect the expiration date of a patent containing the claims, and therefore need not be considered when determining the patent term filing date for the purpose of a double patenting analysis.
Benefit claims under 35 U.S.C. 119(e) and foreign priority claims under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) or (b) are not taken into account when determining the term of an issued patent (see 35 U.S.C. 154(a)(2) and (a)(3) ), and therefore, are not taken into account in determining the patent term filing date of an application.
Therefore, in the instant case, the instant Application is a 371 of PCT/CN2022/136199 12/02/2022 and therefore the patent term filing date of the instant Application is the international filing date of PCT/CN2022/136199 which is 2nd, December, 2022. Because the reference Application of co-pending Application No. 18/025,588 is also 2nd, December, 2022,in accordance with the guidance set forth in MPEP 1490 (b), the provisional nonstatutory double patenting rejection is maintained above.
Examiner’s Remark
As set forth previously, the prior art does not teach or fairly suggest including basal medium supplemented with the combination of (i) a nicotinamide-based compound, (ii) a heparin-based compound, and (iii) a human platelet lysate during a step of forming hemogenic endothelial (HE) cells or a step of forming hematopoietic progenitor (HP) cells and therefore the claims are free of the prior art. However, the claims are not allowable for the reasons set forth 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
No claim is allowable.
Correspondence
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
