Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
This action is in response to the papers filed June 10, 2026.
Claim Amendments
Applicant’s amendment to the claims filed on 06/10/2026 is acknowledged.
Claims 4 and 6 have been cancelled.
Claims 1 and 5 are amended.
Claims 1-3, 5, 7-13 are pending.
Claims 7-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1-3 and 5 are under examination.
Election/Restrictions
The following is a summary of the restriction/election requirements in the present application. See, the Requirement for Restriction/Election mailed 11/17/2025.
In the reply filed 01/14/2026, applicant elected without traverse Invention I, drawn to a method of manufacturing a pharmaceutical composition.
As previously stated in the Office action mailed 03/09/2026, the species election requirement between the different cancer types has been withdrawn.
Claim 7-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/14/2026.
Effective Filing Date
The instant application 18/170,671 was filed on 02/17/2023. No earlier priority claims have been made. Therefore, the effective filing date of the claims is 02/17/2023.
Withdrawal of Prior Rejections/Objections
Rejections and/or objections not reiterated from the previous Office action mailed 03/09/2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This rejection is newly applied, necessitated by amendment.
The preamble of claim 1 recites “[a] method of manufacturing pharmaceutical composition for treating cancer a modified nature killer (NK) cell with a phenotype of CD3-CD19-CD14-CD56hiCD16dimNKG2D+CD11c+CD86+HLA-DR+CD83- and an antigen-specific T cell with a phenotype of 4-lBB+CD8+.” The language is unclear and renders the scope of the claim indefinite.
In particular, there appears that language was omitted between “pharmaceutical composition for treating cancer” and “a modified nature killer (NK) cell,” and it is unclear how the recitation “a modified nature killer (NK) cell with a phenotype of CD3-CD19-CD14-CD56hiCD16dim NKG2D+CD11c+CD86+HLA-DR+CD83- and an antigen-specific T cell with a phenotype of 4-lBB+CD8+” further limits the claimed invention.
Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0260115 A1 to Lee et al.
This rejection is newly applied, necessitated by amendment.
Lee discloses a method, comprising:
obtaining mononuclear cells from a subject;
contacting the mononuclear cells with a first culturing medium comprising IL-15, IL-12 and IL-18 for about 1-6 day(s) to obtain a cultured cell population; and
contacting the cultured cell population with a second culturing medium comprising IL-15 and IL-12 for about 1-6 day(s) after contacting with the first culturing medium.
See, e.g., Abstract; Figure 7; paragraphs 14-15, 20-21, 24; claims 8, 14, 15, and 20.
Claim 1 further recites that the method is performed to manufacture a pharmaceutical composition for treating cancer, and the mononuclear cells are obtained from a subject with cancer.
Lee discloses the disclosed process is performed to manufacture a pharmaceutical composition for treating cancer (par. 4-5, 8, 49, 62), and the mononuclear cells are obtained from a subject with cancer (par. 10, 44, 59; claim 5).
Claim 1 further recites that a negative selection of CD3-CD19-CD14- is not performed on the mononuclear cells prior to the contact step. This limitation is anticipated by Lee for at least the following reasons:
MPEP 2173.05(i) instructs:
Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). In describing alternative features, the applicant need not articulate advantages or disadvantages of each feature in order to later exclude the alternative features. See Inphi Corporation v. Netlist, Inc., 805 F.3d 1350, 1356-57, 116 USPQ2d 2006, 2010-11 (Fed. Cir. 2015). The mere absence of a positive recitation is not basis for an exclusion. However, a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). "Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.' ... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172).
In this case, Lee teaches a step of negative selection of CD3-CD19-CD14- cells may be performed prior to contacting with the first culturing medium. See, e.g., paragraphs 25, 75; claim 21. Lee does not explicitly disclose the negative limitation recited by claim 1: “wherein a negative selection of CD3-CD19-CD14- cells is not performed on the mononuclear cells prior to the contact step.” However, since Lee describes that the negative selection of CD3-CD19-CD14- cells may be performed prior to contacting with the first culturing medium in one embodiment of the disclosed invention, the disclosure reasonably conveys to ordinary skill in the art that such a step of negative selection is optional and may be excluded from the disclosed process. Therefore, one of ordinary skill in the art would have understood that the negative limitation of claim 1 is necessarily present in the Lee disclosure. For these reasons, the Lee disclosure is found to anticipate the negative limitation of claim 1, prior to the effective filing date of the instantly claimed invention.
The preamble of claim 1 further recites “[a] method of manufacturing pharmaceutical composition for treating cancer a modified nature killer (NK) cell with a phenotype of CD3-CD19-CD14-CD56hiCD16dimNKG2D+CD11c+CD86+HLA-DR+CD83- and an antigen-specific T cell with a phenotype of 4-lBB+CD8+.”
As instructed by MPEP 2111.02, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation).
In this case, the preamble of claim 1 does not positively recite any distinct definition of any of the claimed invention’s limitations, e.g., the body of the claim does not describe a modified NK cell nor an antigen-specific T cell. Also, Lee teaches a step of isolating from the cultured cell population a modified NK cell with a phenotype of CD3-CD19-CD14-CD56hiCD16dim NKG2D+CD11c+CD86+HLA-DR+CD83-. See, e.g., par. 16, claim 8, and fig. 7. For these reasons, the preamble of claim 1 is not found to patentably distinguish the instantly claimed invention from the prior art.
Accordingly, claim 1 is anticipated by the prior art.
Regarding dependent claim 2, Lee teaches the mononuclear cells are derived from peripheral blood, cord blood or bone marrow. See, e.g., paragraphs 11, 17; claim 9.
Regarding dependent claim 3, Lee teaches the first and second culturing medium comprises a hematopoietic cell medium. See, e.g., paragraphs 18, 22; claims 10, 16.
Regarding dependent claim 5, Lee teaches the first culturing medium comprises human platelet lysate. See, e.g., paragraphs 19, 23; claim 13, 19.
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 1-3 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,195,759 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate the instant claims.
This rejection is newly applied, necessitated by amendment.
The reference claims recite a method, comprising
obtaining mononuclear cells from a subject;
contacting the mononuclear cells with a first culturing medium comprising IL-15, IL-12 and IL-18 for about 3-6 days to obtain a cultured cell population; and
contacting the cultured cell population with a second culturing medium comprising IL-15 and IL-12 for about 3-6 days after contacting with the first culturing medium.
See reference claims 1, 8.
The reference claims further cite the process produces a pharmaceutical composition for treating cancer (claims 2-3), and the mononuclear cells are obtained from a subject with cancer (claim 5).
Instant claim 1 further recites that a negative selection of CD3-CD19-CD14- is not performed on the mononuclear cells prior to the contact step. This limitation is anticipated by the reference claims for at least the following reasons:
MPEP 2173.05(i) instructs:
Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). In describing alternative features, the applicant need not articulate advantages or disadvantages of each feature in order to later exclude the alternative features. See Inphi Corporation v. Netlist, Inc., 805 F.3d 1350, 1356-57, 116 USPQ2d 2006, 2010-11 (Fed. Cir. 2015). The mere absence of a positive recitation is not basis for an exclusion. However, a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). "Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.' ... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172).
In this case, the reference claims do not explicitly recite the negative limitation recited by instant claim 1: “wherein a negative selection of CD3-CD19-CD14- cells is not performed on the mononuclear cells prior to the contact step.” However, only dependent reference claim 12 recites a step of negative selection of CD3-CD19-CD14- cells is performed prior to contacting with the first culturing medium. Therefore, since reference claim 12 is dependent upon and necessarily limiting the method of reference claim 8, one of ordinary skill in the art would have understood that the negative selection step is not required by reference claim 8, and, therefore, the negative selection step may be excluded from the method according to reference claim 8. Accordingly, the reference claims would have reasonably conveyed to one of ordinary skill in the art that the negative limitation of instant claim 1 is necessarily present in at least reference claim 8. For these reasons, the reference claims are found to anticipate the negative limitation of instant claim 1.
The preamble of instant claim 1 further recites “[a] method of manufacturing pharmaceutical composition for treating cancer a modified nature killer (NK) cell with a phenotype of CD3-CD19-CD14-CD56hiCD16dimNKG2D+CD11c+CD86+HLA-DR+CD83- and an antigen-specific T cell with a phenotype of 4-lBB+CD8+.”
As instructed by MPEP 2111.02, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation).
In this case, the preamble of instant claim 1 does not positively recite any distinct definition of any of the claimed invention’s limitations, e.g., the body of the claim does not describe a modified NK cell nor an antigen-specific T cell. Also, reference claim 8 recites a step of isolating from the cultured cell population a modified NK cell with a phenotype of CD3-CD19-CD14-CD56hiCD16dim NKG2D+CD11c+CD86+HLA-DR+CD83-. See, e.g., par. 16, claim 8, and fig. 7. For these reasons, the preamble of instant claim 1 is not found to patentably distinguish the instantly claimed invention from the reference claims.
Therefore, instant claim 1 is anticipated by the reference claims.
Regarding instant claim 2, the patent claims recite the mononuclear cells are derived from peripheral blood, cord blood or bone marrow. See claims 6, 9.
Regarding instant claim 3, the patent claims recite the first and second culturing medium comprises a hematopoietic cell medium. See claims 1, 8.
Regarding instant claim 5, the patent claim recite the first culturing medium comprises human platelet lysate. See claims 10-11.
Response to Arguments
Applicant’s remarks filed 06/10/2026 have been carefully considered, but are not found persuasive for the following reasons:
Applicant argues that depletion of CD3+CD19+CD14+ cells is a fundamental feature of Lee’s manufacturing process, and Lee consistently discloses initiation of the culture process with a population from which CD3+CD19+CD14+ cells have been removed. Therefore, the negative limitation recited by claim 1, “wherein a negative selection of CD3-CD19-CD14- cells is not performed on the mononuclear cells prior to the contact step,” distinguishes the instantly claimed process from Lee’s manufacturing process. In addition, Applicant argues that the working examples in the present application provide comparative data showing that omission of the negative-selection step produces a different cellular composition exhibiting enhanced T-cell activation, improved cancer-cell killing activity, and substantially increased cell yield, which would have been unexpected from the Lee disclosure. See, pages 8-12 of applicant’s reply. The argument is reiterated with respect to the nonstatutory double patenting rejection. See, pages 12-13 of applicant’s reply.
The argument is not found persuasive because the negative limitation excluding negative selection of CD3-CD19-CD14- cells prior to contacting with the first culturing medium is found to be anticipated by Lee.
In this case, Lee teaches: “In a preferred embodiment, the method may further comprise negative selecting the mononuclear cells for cells with a phenotype of CD3-CD19-CD14- prior to contacting with the first culturing medium” (par. 25). See also, par. 75 and claim 21. Accordingly, Lee explicitly teaches that the manufacturing process may further comprise negative selection of CD3-CD19-CD14- cells prior to contacting with the first culturing medium, and such a description reasonably conveys that Lee’s manufacturing process may not further comprise negative selection of CD3-CD19-CD14- cells prior to contacting with the first culturing medium. See, MPEP 2173.05(i); In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."); and Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) ("Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.' ... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172)).
The examiner’s position is further supported by the requirements of 35 U.S.C. 112(d), which requires a claim in dependent form to further limit the subject matter of the claim upon which it depends. In this case, the Lee disclosure (US 2021/0260115 A1) has issued as US Patent No. 12,195,759 B2. Claim 8 recites the manufacturing process, but only dependent claim 12 recites that a step of negative selection of CD3-CD19-CD14- cells is performed prior to contacting with the first culturing medium. Accordingly, since dependent claim 12 is necessarily limiting to the subject matter in claim 8, the claims as a whole reasonably convey that the negative selection step may be excluded from the manufacturing process of claim 8.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2022/0325245 A1 to Rezvani et al. discloses methods for expanding NK cells for treating diseases. See, Abstract. NK cells may be isolated from a starting population of mononuclear cells by either (1) depleting CD3+, CD14+, and/or CD19+ cells for negative selection of NK cells or (2) positively selecting CD56+ cells. See, par. 79.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James D Schultz can be reached at (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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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
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