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
Claims 1-4, 13, 19, 21, 33-34, 38, 95 and 97 are pending.
Claims 95 and 97 are withdrawn.
Claims 1-4, 13, 19, 21, 33-34 and 38 are under examination.
Withdrawn Claim Objections
The objections to claims 2-3 due to informalities as set forth in the previous office action are withdrawn in view of Applicant’s amendments.
Withdrawn Claim Rejections - 35 USC § 112 (a)
Scope of Enablement
The rejection of claims 1-4, 13, 19, 21, 33-34 and 38 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification did not enable the full scope of the claims is withdrawn in view of Applicant’s amendments.
Moot Claim Rejections - 35 USC § 112 (a)
Scope of Enablement
The rejection of claims 5-7, 14-15, 22 and 39 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification did not enable the full scope of the claims is moot in view of the cancellation of these claims.
Moot Claim Rejections - 35 USC § 112 (b)
The rejection of claims 5-7, 14-15, 22 and 39 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.
Claim Interpretation
Amended claim 1 recites the contingent limitation of “if 65% or less of the cells express HLA-DR, b) transducing the immune cell population with a nucleic acid vector to express an exogenous nucleic acid sequence, thereby providing an engineered immune cell population.” Similarly, amended claim 33 recites the contingent limitation “if 65% or less of the cells express HLADR, b) transducing the immune cell population with a nucleic acid vector to express an exogenous nucleic acid sequence, thereby providing an engineered immune cell population.”
Applicant is directed to MPEP 2111.05 (II) which states that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016) for an analysis of contingent claim limitations in the context of both method claims and system claims. Therefore, in the instant case, because step b) does not occur if the contingent limitation of 65% or less of the cells express HLADR is not met, the broadest reasonable interpretation of instant claims 1 and 33 requires only those steps that must be performed which is the detecting step of step a).
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.
Claims 1-4, 13, 19, 21, 33-34 and 38 remain 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.
Claims 1 and 33 each recite the contingent limitation “if 65% or less of the cells express HLA-DR, b) transducing the immune cell population with a nucleic acid vector to express an exogenous nucleic acid sequence.” While a contingent limitation on its own does not render a claim indefinite, claims 1 and 33 are each indefinite for the reasons stated below.
Claim 1 recites the preamble “ex vivo manufacturing engineered immune cells” and the thereby clause of “providing an engineered immune cell population” As stated above (see claim interpretation above), because step b) does not occur if the contingent limitation of 65% or less of the cells express HLADR is not met, the broadest reasonable interpretation of instant claims 1 and 33 requires only those steps that must be performed which is the detecting step of step a). It is unclear how the method can be a method for “ex vivo manufacturing engineered immune cells” and also have the result of “providing an engineered immune cell population” in the condition where the contingent limitation of step a) does not occur, and therefore there is no nexus between this option of the claimed method steps and the preamble and thereby clause and the metes and bounds of the claim are indefinite.
Similarly, claim 33 recites the preamble of a method of “of ex vivo manufacturing immune cells with improved in vitro functionality,” the thereby clause of “providing an engineered immune cell population” and the wherein clause that “the engineered immune cell population exhibits improved in vitro functionality as compared to an additional engineered immune cell population originated from an additional immune cell population where more than 65% of the cells express HLA-DR.” As stated above (see claim interpretation above), because step b) does not occur if the contingent limitation of 65% or less of the cells express HLA-DR is not met, the broadest reasonable interpretation of instant claims 1 and 33 requires only those steps that must be performed which is the detecting step of step a). It is unclear how the method can be a method for “ex vivo manufacturing engineered immune cells with improved in vitro functionality” and also have the result of “providing an engineered immune cell population” as well as the result of “exhibits improved in vitro functionality as compared to an additional engineered immune cell population originated from an additional immune cell population where more than 65% of the cells express HLA-DR” in the condition where the contingent limitation of step a) does not occur, and therefore there is no nexus between this option of the claimed method steps and the preamble as well as the thereby and wherein clauses and the metes and bounds of the claim are indefinite.
By nature of their ultimate dependency on claims 1 or 33, claims 2-4, 13, 19, 21, 34 and 38 are also rejected.
Claim 13 recites “the modifying.” However, claim 1, upon which claim 13 depends, does not recite “a modifying” step. Therefore the scope of the claim is indefinite because it is unclear what the metes and bounds of the modifying step are intended to encompass.
Moot Claim Rejections - 35 USC § 112(d)
The rejection of claim 39 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends as set forth in the previous office action is moot in view of the cancellation of this claim.
Moot Claim Rejections - 35 USC § 102
The rejection of claim 39 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Cooper et al. (WO-2020097132-A1; published 14th, May, 2020; henceforth “Cooper”) as set forth in the previous office action is moot in view of the cancellation of this claim.
Withdrawn Claim Rejections - 35 USC § 102
The rejection of claims 33 and 38 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Cooper et al. (WO-2020097132-A1; published 14th, May, 2020; henceforth “Cooper”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Moot Claim Rejections - 35 USC § 102
The rejection of claim 39 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Cooper et al. (WO-2020097132-A1; published 14th, May, 2020; henceforth “Cooper”) as set forth in the previous office action is moot in view of the cancellation of this claim.
Examiner’s Remark
Applicant’s amendments introduced a contingent limitation which changed the scope of the claims and the prior art of Lee et al. (Sci Rep. 2020 Oct 20;10(1):17753.; see IDS filed 18th, March, 2024; henceforth “Lee”) is now applied under 35 U.S.C. 102 for the reasons set forth below as necessitated by amendment.
New 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.
(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 1-4, 13, 19, 33 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kust et al. (Front Immunol. 2021 May 3:12:662128. eCollection 2021.; henceforth “Kust”).
Regarding claims 1 and 33, Kust discloses a method comprising:
Detecting HLA-DR expression in cells of an immune cell population (Figure 1; pg. 3 “Flow Cytometry”).
Regarding claims 1 and 33, as stated above (see claim interpretation above), the claim recites the contingent limitation of “if 65% or less of the cells express HLA-DR, b) transducing the immune cell population with a nucleic acid vector to express an exogenous nucleic acid sequence, thereby providing an engineered immune cell population.” In accordance with MPEP 2111.05 (II), because step b) is a contingent limitation, the broadest reasonable interpretation of the instantly claimed method requires only step a) which must be performed and does not include step b) that is not required to be performed because the condition of 65% or less of the cells express HLA-DR is not met.
Specifically, regarding claims 1 and 33, specific embodiments of Kust of the CD3-CD56- cells (“CD3−CD56− fraction (in healthy donors, this fraction is mainly represented by B cells)” pg. 4 col. 1) result in a detected level of greater than 65% HLA-DR+ cells, as noted in Figure 1 (copied below for reference), and therefore, for these disclosed populations specifically (the donors or patients CD3-CD56- cells ex vivo population noted below) , the condition of “65% or less of the cells express HLA-DR is not met” and step b) is not required to be performed.
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Therefore, regarding claims 1 and 33, because specific embodiments of Kust disclose step a) of detecting HLA-DR expression level in cells of an immune population as part of an ex-vivo method, and the step b) is not required to be met because the required condition of “65% or less of the cells express HLA-DR” is not met by these specific embodiments, for the reasons set forth above, Kust anticipates instant claims 1 and 33 because Kust anticipates all the required active method steps of the instantly claimed method.
Regarding claims 2-4, 13 and 38, these claims each further limit step b) of claims 1 and 33 respectively. As set forth above (see claims 1 and 33 rejections above), because the condition for the conditional limitation of “65% or less of the cells express HLA-DR” is not met by the specific cited embodiments of Kust , In accordance with MPEP 2111.05 (II), step b) is not required to be performed and these claims are therefore met by Kust for the reasons stated above.
Regarding claim 19, further to the discussion of claim 1 above, Kust discloses the immune cell population is obtained from a healthy donor (“Healthy Donors”; Figure 1; Materials and Methods “Subjects and Ethics Statement” and “Isolation of Cell Subpopulations” pg. 2 col. 2 and pg. 3 col. 1).
Regarding the wherein clause of claim 33, the wherein clause further limits the result of step b), which, as set forth above, is a contingent limitation is and is not met by the specific cited embodiments of Kust and in accordance with MPEP 2111.05 (II), step b) is not required to be performed and these claims are therefore met by Kust for the reasons stated above.
Accordingly, Kust anticipates instant claims.
Claims 1-4, 13, 19, 33 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (Sci Rep. 2020 Oct 20;10(1):17753.; see IDS filed 18th, March, 2024; henceforth “Lee”)
Regarding claims 1 and 33, Lee discloses an ex vivo method (the method is performed in cells from donors and therefore an ex vivo method; see Cryopreserved human PBMCs from healthy donors” from “Human NK cell and B cell expansion” pg. 8 1st para.) comprising:
detecting HLA-DR expression in cells of an immune cell population (see Supplementary Figure S2, copied below).
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Regarding claims 1 and 33, as stated above (see claim interpretation above), the claim recites the contingent limitation of “if 65% or less of the cells express HLA-DR, b) transducing the immune cell population with a nucleic acid vector to express an exogenous nucleic acid sequence, thereby providing an engineered immune cell population.” In accordance with MPEP 2111.05 (II), because step b) is a contingent limitation, the broadest reasonable interpretation of the instantly claimed method requires only step a) which must be performed and does not include step b) that is not required to be performed because the condition of 65% or less of the cells express HLA-DR is not met.
Specifically, regarding claims 1 and 33, specific embodiments of the population of pre-expansion B cells, post-expansion NK cells, post expansion CD4 T cells, and Post Expansion CD8 T cells) result in a detected level of greater than 65% HLA-DR+ cells, as noted in Figure S2 and therefore, for these disclosed populations specifically (the condition of “65% or less of the cells express HLA-DR is not met” and step b) is not required to be performed.
Regarding the preamble of claims 1 and 33, as set forth above, Lee anticipates the required active method steps for disclosed conditions. Furthermore, it is noted that the method of Lee includes genome editing (see “HLA disruption in human T cells by multiplex genome editing” Figure 2; see also Methods pg. 7 “gRNA design and synthesis” and “Human T cell transfection and expansion”) and therefore is a method of manufacturing engineered immune cells.
Regarding the wherein clause of claim 33, the wherein clause further limits the result of step b), which, as set forth above, is a contingent limitation is and is not met by the specific cited embodiments of Lee and in accordance with MPEP 2111.05 (II), step b) is not required to be performed and these claims are therefore met by Lee for the reasons stated above.
Regarding claims 2-4, 13 and 38, these claims each further limit step b) of claims 1 and 33 respectively. As set forth above (see claims 1 and 33 rejections above), because the condition for the conditional limitation of “65% or less of the cells express HLA-DR” is not met by the specific cited embodiments of Lee, in accordance with MPEP 2111.05 (II), step b) is not required to be performed and these claims are therefore met by Lee for the reasons stated above.
Regarding claim 19, further to the discussion of claim 1 above, Lee discloses the immune cell population is obtained from a healthy human donor (“Cryopreserved human PBMCs from healthy donors” from “Human NK cell and B cell expansion” pg. 8 1st para.).
Regarding claim 21, further to the discussion to claim 1 above, Lee discloses detecting a level of expression in the post-expansion NK cells of CD56 (Methods pg. 8 “Flow cytometry and cell sorting”). The specific embodiment of the post-expansion NK cells are “CD56+ NK cells” and therefore the contingent limitation of “15% or less of the cells express CD56” is not met and the “transducing the immune cell population” step is not required to be performed.
Regarding claim 34, further to the discussion of claim 33 above, Lee teaches detecting a level of expression of the biomarker TIGIT for T-cell phenotyping (Methods pg. 8 “Flow cytometry and cell sorting”). Although is silent to the expression level of TIGIT, as stated above, Lee specifically teaches the embodiment of a T cell population of post expansion CD4 and post expansion CD8 cells that have an expression of greater than 65% of HLA-DR (see Figure S2). Therefore, because the contingent limitation of “65% or less of the cells express HLA-DR” is already not met, the contingent limitation of “ performing the step (b) if 65% or less of the cells express HLA-DR and 30% or less of the cells express TIGIT” also is not met. Therefore, because the conditional limitations are not met by this specific population, the transducing step is not required to be performed.
Accordingly, Lee anticipates instant claims.
Moot Claim Rejections - 35 USC § 103
The rejection of claim 39 under 35 U.S.C. 103 as being unpatentable over Lee et al. (Sci Rep. 2020 Oct 20;10(1):17753.; see IDS filed 18th, March, 2024; henceforth “Lee”) in view of June et al. (WO-2013/126729-A1; henceforth “June”) as set forth in the previous office action is moot in view of the cancellation of this claim.
Moot Claim Rejections - 35 USC § 103
The rejection of claims 5-7, 14-15, 22 and 39 under 35 U.S.C. 103 as being unpatentable over Lee et al. (Sci Rep. 2020 Oct 20;10(1):17753.; see IDS filed 18th, March, 2024; henceforth “Lee”) in view of June et al. (WO-2013/126729-A1; henceforth “June”) as set forth in the previous office action is moot in view of the cancellation of these claims.
Withdrawn Claim Rejections - 35 USC § 103
The rejection of claims 21 and 34 under 35 U.S.C. 103 as being unpatentable over Lee et al. (Sci Rep. 2020 Oct 20;10(1):17753.; see IDS filed 18th, March, 2024; henceforth “Lee”) in view of June et al. (WO-2013/126729-A1; henceforth “June”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments, and to apply a rejection under 35 U.S.C. 102 necessitated by amendment above.
Examiner’s Remark
As set forth above, the amended claims include contingent limitations that are addressed with rejections under 35 U.S.C. 102 necessitated by amendment above. For the sake of compact prosecution, the alternative condition that the conditional limitation of claims 1 and 33 is met is considered below.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 13, 19, 33 and 38 remain rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Sci Rep. 2020 Oct 20;10(1):17753.; see IDS filed 18th, March, 2024; henceforth “Lee”) in view of June et al. (WO-2013/126729-A1; henceforth “June”).
Regarding claims 1-3 and 33, Lee discloses a method of manufacturing engineered immune cells (CD3+ Human T cells from healthy donors; Methods pg. 7 “Human T cell transfection and expansion”) comprising:
a’) modifying the immune cell population (“HLA disruption in human T cells by multiplex genome editing” Figure 2; see also Methods pg. 7 “gRNA design and synthesis” and “Human T cell transfection and expansion”) comprising reducing or eliminating expression or activity of an endogenous gene (“T cells lacking surface HLA molecules: pg. 4 last para.; see also Figure 2 “Efficient HLA disruption in human T cells by multiplex genome editing”, Figure 3 “HLA-I/II-negative human T cells” and Figure 4 “HLA-II ablation in HLA-I-negative T cells” ), thereby providing an engineered immune cell population and
a) detecting an HLA-DR expression level of 65% or less in an immune cell population (see Figure 2B, copied below, where HLA-DR expression level is less than 20%, which is within the claimed range of “65% or less”) (instant claims 1 and 33)
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Annotated Figure 2B of Lee.
However, regarding claims 1-3 and 33, although Lee teaches cells obtained by the method that edit multiple HLA targets in allogenic T cells may offer great potential for universal CAR-T cell therapy (pg. 2 1st para.), Lee is silent to transducing the population of cells to express an exogenous nucleic acid sequence (instant claim 1), where the exogenous nucleic acid sequence comprises a chimeric antigen receptor (CAR) nucleic acid sequence (instant claim 2), and a costimulatory domain nucleic acid sequence (instant claim 3).
Nevertheless, regarding claims 1-3 and 33, June teaches modifying the population of cells to express an exogenous nucleic acid sequence (instant claim 1), where the exogenous nucleic acid sequence comprises a chimeric antigen receptor (CAR) nucleic acid sequence (instant claim 2) (Human T cells were electroporated with mRNA to express the CD28:CD3zeta domain, CD28:CD2:CD3zeta or the CD2:CD3zeta domains” Example 1; see also ““T cell genetically engineered to express a CAR”; pg. 4 last para, pg. 5; pg. 21 3rd para.), and a costimulatory domain nucleic acid sequence (instant claim 3) (“CD2 signaling domain” pg. 1 2nd para.; pg. 2-5, 7, 9, 13, 21-22, 28, 51, 59-60; claims 1, 5-6, 9-10, 14, 17, 21-24, 27, 29, 35, 40, 42). June teaches making T cells expressing a CAR so they can be used for the treatment of a patient with cancer (“genetically modified T cells expressing a CAR for the treatment of a patient with cancer” pg. 8). June teaches T lymphocytes modified with chimeric-antigen receptors (CARs) bearing the CD3-zeta signaling domain exhibit moderate levels of target tumor cytolysis and the incorporation of costimulatory signaling domains significantly increases target cell killing (pg. 1). June teaches the CD2 signaling domain regulates cytokine production at the tumor site (pg. 9 1st para.)
Therefore, regarding claims 1-3 and 33, 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 of Lee, and combine the known prior art elements of teaches modifying the population of cells to express an exogenous nucleic acid sequence (instant claim 1) comprising a CAR (instant claim 2) and a costimulatory domain nucleic acid sequence (instant claim 3) of June to obtain the predictable result of a genetically modified T-cell that expresses a CAR and a costimulatory domain. One of ordinary skill would have been motivated to do so as taught by June to be used for treatment of a patient with cancer (“genetically modified T cells expressing a CAR for the treatment of a patient with cancer” pg. 8), and as taught by Lee so that the cells could be used for universal CAR-T cell therapy (pg. 2 1st para.). One of ordinary skill would also have been specifically motivated to combine the CD2 co-stimulatory domain of June to regulate cytokine production at the tumor site (pg. 9 1st para.) and to significantly increases target cell killing (pg. 1). Regarding the reasonable expectation of success, June evidences modifying a T-cell to express an exogenous nucleic acid sequence that comprises a CAR sequences and a co-stimulatory domain sequence (Example 1).
Regarding claim 4, further to the discussion of claims 1-3 above, the exogenous nucleic acid sequence suggested by June above (see claims 1-3 rejection above), comprises an exogenous nucleic acid with a CAR and a costimulatory domain as a single nucleic acid (SEQ ID NO: 1 of June; Figure 1: Example 1), and it would be obvious to use this single nucleic acid of June that would be expressed as a single transcript for the reasons set forth above.
Regarding claim 13, further to the discussion of claim 1 above, as set forth above (see claim 1 rejection above), Lee teaches reducing or eliminating expression or activity of an endogenous gene “Efficient HLA disruption in human T cells by multiplex genome editing”, Figure 3 “HLA-I/II-negative human T cells” and Figure 4 “HLA-II ablation in HLA-I-negative T cells” ).
Regarding claim 19, further to the discussion of claim 1 above, Lee teaches the immune cell population is obtained from or derived from a healthy donor (CD3+ Human T cells from healthy donors; Methods pg. 7 “Human T cell transfection and expansion”).
Regarding claims 33 and 38 further to the discussion of claim 1 above, the engineered immune cell population suggested by Lee in view of June above comprises a CAR and a co-stimulatory domain that are not present in a non-edited population (see claims 1-3 rejection above), and as stated above, June teaches that including the co-stimulatory domain significantly increases target cell killing (pg. 1). Therefore, the suggested method would results in a population that would have improved target cell killing which is a type of improved in vitro cytotoxicity as claimed. When compared the control T-cells of Lee which have a higher expression of HLA-DR (see Lee Figure 2B), and also have an expression of HLA-DR of greater than 65% (see Figure 2B CD8 graph), meets the broadest reasonable interpretation of “an additional engineered immune cell population that originated from an additional immune cell population expressing HLA-DR at a level greater than about 65%.” Because the control cells of Lee have not been edited to comprise the CAR and the co-stimulatory domain, it would have been obvious to one of ordinary skill in the art that the population as suggested by Lee in view of June, which does comprise the CAR and the co-stimulatory domain, would have the improved target cell killing which is a type of improved in vitro cytotoxicity as claimed as compared to the control population of Lee.
Hence, the claimed invention as a whole was prima facie obvious.
Response to Arguments
Applicant’s arguments, filed 24th, June, 2026, have been fully considered but are not found persuasive.
Applicant argues “MPEP 2144 states that omission of an element with retention of the element's function is an indicium of non-obviousness. The amended claims 1 and 33 recite a method of measuring expression of HLA-DR in the cell population, and if 65% or less of the cells express HLA-DR,
engineering the cell population by introducing a transgene. Despite not eliminating HLA-DR expression in up to 65% of the cells, the cells are successfully engineered to express the transgene and have the anti-tumor properties desired e.g., in June, see Example 2, Figures 1A-B. Achieving the same properties without undertaking the gene editing step taught by Lee is an indication of non-obviousness. For this reason, withdrawal of the 35 U.S.C. §103 rejection of claims 1, 33 and claims dependent thereon is respectfully requested” (pg. 7-8).
In response this is not found persuasive because Applicant is not appreciating the broadest reasonable interpretation of instant claims. Instant claims use the transitional phrase “comprising” which is open ended and does not exclude additional, unrecited elements (see MPEP 2111.03 – Transitional Phrases). Therefore, the additional gene editing steps of Lee are not excluded from instant claims and still meet instant claim limitations.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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