DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-56 are pending in the instant application.
Applicant’s election of the invention of group I, drawn to cells comprising an inactive ADAM17 gene, and the cell species of an induced pluripotent stem cell (iPSC) derived immune cell in the reply filed on January 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4, 26-28, 31-40, and 50-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 21, 2026 as discussed above.
Claims 1-3,5-25,29-30 and 41-49 are under examination in this office action.
Information Disclosure Statement
The IDS received 4/21/2023 is acknowledged and the references cited therein have been considered.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5-25, 29, 41, and 43-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pomeroy et al.
Pomeroy et al. disclose that knocking out ADAM17 in NK cells via CRISPER/CAS9 leads to cells having significantly improved activity, cytokine production and cancer cell cytotoxicity as well as being able to be grown to clinically relevant numbers without losing activity (see entire document, particularly the abstract). Such cells expressed multiple NK cell markers including CF56, NKG2D, NKp46, CD16, CD107, and IFNg (see particularly Figures 1 and 2). The genetically engineered NK cells are disclosed as originating from peripheral blood mononuclear cells (PBMC) and being expanded in vitro (see particularly pages 54 and 59). The engineered NK cells demonstrated in vivo killing activity in a murine cancer model (see particularly Figure 4). The engineered cells demonstrated increased ADCC activity as compared to controls (see particularly Figure 2).
It should be noted that applicant has claimed a product, namely a genetically modified cell, and that many claims recite intended results if such cells were placed in various environments or settings. As per MPEP 2111.02, statement of purpose or intended use for a product serve to distinguish the claimed product from the art only when such a use necessitates a structural difference in the claimed product relative to that previously known in the art. It should be pointed out that the working example of the instant specification discloses that CRISPER/CAS9 was used to eliminate ADAM17 expression, and since the modified NK cells were made via the same technique there is no evidence presently of record to suggest that there is any structural difference between that which was made and is being claimed by applicant and the prior art NK cells as disclosed by Pomeroy et al. Additionally, as is set forth in MPEP 2112, further characterization of an existing product does not restore patent eligibility. See for example Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) as well as In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Therefore, the prior art anticipates the presently claimed inventions.
Claims 1, 3, 5-25, 29, 30, 41, and 43-49] are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Moriarity et al. (US 2020/0208111).
Moriarity et al. disclose methods for making genome edited NK cells using CRISPER/CAS9 technology (see entire document, particularly the abstract and claims). Their working examples include making ADAM17 knockout cells (see particularly example 2B, Figures 10 and 12, and paragraph [0089]). Such edited cells are disclosed as being present in compositions with or without additional therapeutic agents for administration to patients (see for example paragraphs 0099-0104]).
It should be noted that applicant has claimed a product, namely a genetically modified cell, and that many claims recite intended results if such cells were placed in various environments or settings. As per MPEP 2111.02, statement of purpose or intended use for a product serve to distinguish the claimed product from the art only when such a use necessitates a structural difference in the claimed product relative to that previously known in the art. It should be pointed out that the working example of the instant specification discloses that CRISPER/CAS9 was used to eliminate ADAM17 expression, and since the modified NK cells were made via the same technique there is no evidence presently of record to suggest that there is any structural difference between that which was made and is being claimed by applicant and the prior art NK cells as disclosed by Moriarity et al. Additionally, as is set forth in MPEP 2112, further characterization of an existing product does not restore patent eligibility. See for example Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) as well as In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Therefore, the prior art anticipates the presently claimed inventions.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Pomeroy et al. as applied to claims 1, 3, 5-25, 29, 41, and 43-49 above, and further in view of Zeng et al. (US2019/0359940).
The teachings of Pomeroy et al. have been discussed above and differ from that which is presently claimed in that while the genetically deficient ADAM17 NK cells of Pomeroy et al. were disclosed as being in pharmaceutical compositions for administration, such compositions are not explicitly disclosed as being a “kit”.
Zeng et al. disclose that innate immune cells including NK cells are present in kit form (see entire document, particularly the title, abstract, and claims).
Therefore it would have been obvious to artisans to place the genetically deficient NK cells of Pomeroy et al. into a kit Artisans would be motivated to do so in order to facilitate easier administration of the NK cells of Pomeroy et al. in methods such as those disclosed by Pomeroy et al.
Claims 2 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Pomeroy et al. as applied to claims 1, 3, 5-25, 29, 41, and 43-49 above, and further in view of Saetersmoen et al.
The teachings of Pomeroy et al. have been discussed above and differ from that which is presently claimed in that the genetically deficient ADAM17 NK cells of Pomeroy et al. were made from PBMC rather than induced pluripotent stem cells (iPSC) as is presently claimed.
Saetersmoen et al. disclose that NK cells can readily be derived from iPSC (see entire document, particularly the abstract). They disclose that iPSC cells have advantages over cells from other sources like PMBC, such advantages including the ability to undergo essentially unlimited expansion in vitro without loosing potency (see particularly the right column of page 60).
Therefore it would have been obvious to artisans to use iPSC rather than PBMC when making the genetically deficient NK cells of Pomeroy et al. Artisans would be motivated to do so in order to produce an essentially unlimited number of NK cells that could be used for therapeutic purposes such as those disclosed by Pomeroy et al. and/or Saetersmoen et al.
Claims 2 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Moriarity et al. (US 2020/0208111) as applied to claims 1, 3, 5-25, 29, 30, 41, and 43-49 above, and further in view of Saetersmoen et al.
The teachings of Moriarity et al. have been discussed above and differ from that which is presently claimed in that the genetically deficient ADAM17 NK cells of Moriarity et al. were made from PBMC rather than induced pluripotent stem cells (iPSC) as is presently claimed.
Saetersmoen et al. disclose that NK cells can readily be derived from iPSC (see entire document, particularly the abstract). They disclose that iPSC cells have advantages over cells from other sources like PMBC, such advantages including the ability to undergo essentially unlimited expansion in vitro without losing potency (see particularly the right column of page 60).
Therefore it would have been obvious to artisans to use iPSC rather than PBMC when making the genetically deficient NK cells of Moriarity et al. Artisans would be motivated to do so in order to produce an essentially unlimited number of NK cells that could be used for therapeutic purposes such as those disclosed by Moriarity et al. and/or Saetersmoen et al.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641