DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendment and response filed on 2/19/2026 has been received and entered into the case.
Claim 5 is canceled, claims 10-27 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-4 and 6-9 have been considered on the merits. All arguments have been considered.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/93,500, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The instant claim 1 discloses the composition comprising an amount of the abTCR+ T cells between about 5.0x106 and 9.42x106 abTCR+ T cells per kg of the recipients body weight. This limitation is not supported by the ‘500 application. Thus, the priority claim is granted only for the filing date of the instant application which is 3/22/2023.
It is noted that the previous OA mailed on 9/15/2025 contained an error that the incorrect application number was cited. The above priority determination discloses a correct application number and the priority date granted.
Response to Amendment
The claim set filed on 2/19/2026 contains track changes that should be removed from the claim set. Furthermore, the amendment to the claims is not clearly visible and the claim amendment is not in compliance under 37 CFR1.121. Appropriate correction is required.
While the claim amendment is not in compliance with the requirement, however, for the expedited prosecution, the claims are examined as the amendment is recognizable.
The claim rejection under 35 USC 112(b) has been withdrawn due to the instant amendment.
Claim Rejections - 35 USC § 101 (maintained)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 and 6-9 stand rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon, i.e. product of nature, without significantly more.
The claim(s) recite(s) a composition comprising human HSCs from a donor, human facilitating cells (FCs) from the donor, and human alpha beta TCR+ T cells from the donor. Under the broadest reasonable interpretation, the naturally occurring counterpart in its natural state for the claimed composition is considered is a human blood, or a donor blood, as the blood contains all the claimed components of the claimed composition. The instant claims do not particularly disclose any additional element that makes the nature-based product markedly different from the naturally occurring counterpart. As the naturally occurring counterpart comprises all the claimed components, the characteristics of the claimed composition would be expected from the naturally occurring counterpart, i.e. human blood. Each of the components in the composition is naturally occurring product as they are present in the blood. The only additional limitation is the amount of alpha beta TCR+ T cells, and the amount does not make the composition significantly different from the naturally occurring blood. The quantity of the components do not necessarily render the composition markedly different in the absence of any evidence to the contrary. Furthermore, the amount of the alpha beta TCR+ T cells is disclosed in the claims as per kilogram of the recipient’s body weight. Under the broadest reasonable interpretation, the amount is interpreted as any number as the recipient’s body weight is not particularly defined. Regarding the dependent claims directed to the phenotype of FCs, the FCs having the claimed phenotype are also considered to be present in the blood, and thus, the limitation directed to the phenotypes of hFCs does not make the claimed composition significantly different from the naturally occurring counterpart. Thus, the claims are directed to a judicial exception, i.e. a product of nature (STEP 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because there is no additional element that integrates the judicial exception to a practical application (STEP 2A, Prong Two: NO).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no additional element other than the amount of the alpha beta TCR+ T cells, and the quantity of the alpha beta TCR+ T cells in the composition as claimed do not significantly add more to the judicial exception (STEP 2B: NO).
Based on the above discussion, the instant claims are not eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102 (maintained)
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-4 and 6-9 stand rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Ildstad et al. (US2011/0110909; IDS ref.).
Regarding claim 1-3, Ildstad et al. teach a therapeutic cellular composition comprising human hematopoietic stem cells (HSCs) having a phenotype of CD34+; human facilitating cells (hFCs), and human alpha beta TCR+ T cells (para. 7). Ildstad et al. teach that the number of the alpha beta TCR+ T cells are about 5.0x106 alpha beta TCR+ T cells/kg recipient body weight (para. 7).
Regarding claim 1 directed to the hFCs comprising cells having a phenotype of CD8+/abTCR-/CD56dim/neg and cells having a phenotype of CD8+/abTCR-/CD56bright, Ildstad et al. teach the phenotypes (para. 7).
Regarding claim 4 directed to the therapeutic amount between about 5.43x106 and 9.42x106 alpha beta TCR+ T cells/kg of the recipient’s body weight, it is noted that the term “about 5.43x106” is anticipated by the teaching of “about 5.0x106” by Ildstad et al. as the teaching of Ildstad et al. is considered either overlapping or touching the claimed range. See MPEP2131.03(II).
Regarding claim 6, Ildstad et al. teach that the cells have a phenotype of CD8+/abTCR-/CD56dim/neg are predominantly CD3epsilon+/CD19- (para. 6 and 38).
Regarding claim 7, Ildstad et al. teach that the cells have a phenotype of CD8+/abTCR-/CD56bright are predominantly CD3 epsilon-/CD19+ (para. 6 and 38).
Regarding claim 8, Ildstad et al. teach that the hFCs include cells having a phenotype of CD8+/abTCR-/dgTCR+/CD3epsilon+/CD19+ (para. 6 and 38).
Regarding claim 9, Ildstad et al. teach that the hFCs include cells having a phenotype of CD8+/abTCR-/B220+/CD11c+/CD11b- (para. 6 and p.17, claim 5).
Thus, the reference anticipates the claimed invention.
Double Patenting (maintained)
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 1-4 and 6-9 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 8,632,768. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘768 patent disclose a method of making a therapeutic composition comprising human HSCs and hFCs and alpha beta TCR+ T cells at about 5.0x106 cells per kg recipient body weight. It is considered that the amount of “about 5.0x106” of the ‘768 patent renders the claimed amount of “about 5.43x106” (claim 4). While the claims of the ‘768 patent do not particularly disclose the phenotypes of the hFCs (claims 5-9), however, the method steps of the ‘768 patent do not deplete hFCs present in a donor source including bone marrow or blood, and thus, the hFCs having the claimed phenotype would be inherently present in the composition. Furthermore, the specification of the ‘768 patent disclose that the phenotype of hFCs include those claimed in the instant application.
Thus, the claims of the ‘768 patent render the claims of the instant application obvious.
Claims 1-4 and 6-9 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,452,184. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘184 patent disclose a therapeutic cellular composition comprising hHSCs, hFCs and alpha beta TCR+ T cells at the amount of about 5.0x106 cells per kilogram of the recipient’s body weight. It is considered that the amount of “about 5.0x106” of the ‘184 patent renders the claimed amount of “about 5.43x106” (claim 4). Claims 6-9 of the ’184 patent also disclose that the hFCs of the composition have a phenotype of claims 6-9.
Thus, the claims of the ‘184 patent anticipate the claims of the instant application, and thus render them obvious.
Claims 1-4 and 6-9 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,291,686. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘686 patent disclose a method of making a therapeutic composition comprising human HSCs and hFCs and alpha beta TCR+ T cells at about 5.0x106 cells per kg recipient body weight. It is considered that the amount of “about 5.0x106” of the ‘686 patent renders the claimed amount of “about 5.43x106” (claim 4). While the claims of the ‘686 patent do not particularly disclose the phenotypes of the hFCs (claims 5-9), however, the method steps of the ‘686 patent do not deplete hFCs present in a donor source including bone marrow or blood, and thus, the hFCs having the claimed phenotype would be inherently present in the composition. Furthermore, the specification of the ‘686 patent disclose that the phenotype of hFCs include those claimed in the instant application.
Thus, the claims of the ‘686 patent render the claims of the instant application obvious.
Response to Arguments
With regard to the priority claim, it is acknowledged that the priority determination contained error in identifying the prior applications and the earliest priority date was not properly determined. As indicated above, the priority date granted is corrected as 3/22/2023, which is the filing date of the instant application as the ‘500 application fails to support the limitation of the instant claims. This redetermination of the priority date does not change the status of the pending art rejection. Any inconvenience is regretted.
Regarding the 112b rejection, the instant amendment overcame the rejection and thus, the rejection has been withdrawn.
Regarding the 101 rejection, applicant argued that the claimed therapeutic cellular composition contains an amount of alpha beta TCR+ T cells that differs from the amount naturally found in blood. The Examiner respectfully disagrees with the argument. The claimed composition comprises naturally occurring cells. The amount of human alpha beta TCR+ T cells in the composition do not change the characteristics of the naturally occurring cells in the composition. Regardless of the quantity of the cells in a composition, which can be any number as the absolute number was not claimed, i.e. the range of the T cells as claimed per kilogram of the recipient’s body, the combination of the three naturally occurring population reads on the naturally occurring blood. Thus, the claimed composition is directed to a judicial exception without any significantly different characteristics. Applicant asserted that the claimed amount of the cells is greater than is generally considered to be therapeutic surprisingly promoted chimerism and engraftment. Whether or not there is a therapeutically effective amount of the claimed cells, the quantity does not change the characteristics of the cells. The inquiry of the subject matter eligibility is whether the claimed product exhibit markedly different characteristics from its naturally occurring counterpart in the absence of any other element in the composition. The claimed cells are naturally occurring, and there is no evidence that the naturally occurring counterpart, would not have the same effect when they are in the same amount as claimed, particularly the intended purpose is merely disclosed as therapeutic without any particular target condition. The subject eligibility is not determined based on the quantity of naturally occurring product or the intended purpose.
Regarding the 102 rejection, applicant alleged that the instant application is entitled to a priority date of 5/30/2008 and thus, the reference is not a prior art. The Examiner respectfully disagrees with this allegation. The priority determination in the previous OA was incorrect and the priority determination has been corrected and the earliest priority date is given to the filing date of the instant application, which is 3/22/2023. Thus, Ildstad reference is a proper prior art and thus, the 102 rejection is maintained.
Regarding the double patenting rejection, applicant requested the rejections be held in abeyance until allowable subject matter is found. Thus, the rejections are maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631