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 .
Status of the Claims
Applicant’s submission filed 10 February 2026 has been entered. Claims 1-24 are pending. Claims 5, 7, 11-13, 18, 22, and 24 have been amended. Therefore, prosecution on the merits continues for claims 1-24. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to claims 7, 11-13, and 23
Applicant’s amendments to each of instant claims 7, 11-13, and 23 correct the minor informalities within each claim, thus obviating the objections of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 11-13 and 24 under 35 USC 112(b)
Applicant’s amendments to each of instant claims 11-13 and 24 obviate the rejections of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claims 1-4 and 8-19 under 35 USC 103 over Dranoff in view of Irvine et al
Applicant's arguments filed 10 February 2026 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, asserting in Pages 6-7 of the Remarks filed 10 February 2026 that the ordinary artisan would not have had a reasonable expectation of success in generating the instantly claimed bi-specific genetically modified immune cell given the disclosures of Dranoff and Irvine et al, as Dranoff requires a tumor-specific CAR in combination with the anti-CD83 CAR in order to have a therapeutic benefit. In response, the Examiner first respectfully submits that the asserted therapeutic benefit is not required by, nor recited within, the pending composition claims. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, the composition of Dranoff as modified by Irvine et al need not render obvious the same functions.
Furthermore, the Examiner also respectfully submits that it is not required that the expectation of success be a certainty; only one that is reasonable to a person of ordinary skill. In re Longi, 759 F.2d 887, 897 (Fed. Cir. 1985) (“Only a reasonable expectation of success, not absolute predictability, is necessary for a conclusion of obviousness”). With that, the Examiner respectfully submits that Irvine et al disclose genetically modified immune cells comprising a CAR that is specific for IL-6R, wherein IL-6R is a tumor antigen. See, for example, Paragraph [0203] of Irvine et al. Therefore, in regards to the pending method claims, the ordinary artisan would have expected the genetically modified immune cells comprising the anti-CD83 CAR and an anti-IL-6R CAR to have the same effect as the genetically modified immune cells detailed in Dranoff comprising the anti-CD83 CAR and a tumor-specific CAR.
Applicant has further traversed the rejection, asserting in Page 6 of the Remarks filed 10 February 2026 that the combination of Dranoff and Irvine et al fail to teach Applicant’s unexpected discovery that bi-specific genetically modified immune cells are advantageously suitable to protect transplant recipients from GVHD without any risk for off-target lymphopenia. In response, the Examiner respectfully submits that Applicant has not provided any supporting evidence to this unexpected discovery, and reminds Applicant that a showing of unexpected results must be based on evidence, not argument or speculation. See MPEP § 716.02(a)-(b); In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed Cir. 1997).
Therefore, the rejection is maintained.
RE: Rejection of claims 1-19 under 35 USC 103 over Dranoff in view of Irvine et al, and further in view of Diehl et al
Applicant's arguments filed 10 February 2026 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, citing the same assertions within Pages 6-7 of the Remarks filed 10 February 2026 in regards to the reasonable expectation of success and unexpected results. In response, the Examiner respectfully directs Applicant to the discussion of the 35 USC 103 rejection over Dranoff in view of Irvine et al, where the assertions were addressed.
Therefore, the rejection is maintained.
RE: Rejection of claims 1-4 and 8-24 under 35 USC 103 over Dranoff in view of Irvine et al, and further in view of Ma et al
Applicant's arguments filed 10 February 2026 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, citing the same assertions within Pages 6-7 of the Remarks filed 10 February 2026 in regards to the reasonable expectation of success and unexpected results. In response, the Examiner respectfully directs Applicant to the discussion of the 35 USC 103 rejection over Dranoff in view of Irvine et al, where the assertions were addressed.
Therefore, the rejection is maintained.
New/Maintained Grounds of Rejection
Claim Objections
Claims 11-12 are objected to because of the following informalities:
Regarding claim 11: The instant claim is objected to for reciting “the first co-stimulatory signaling, the second co-stimulatory domain, …”, instead of “the first co-stimulatory signaling domain, the second co-stimulatory signaling domain, …” within Line 2.
Appropriate correction is required.
Regarding claim 12: The instant claim is objected to for reciting “the first intracellular signaling, …”, instead of “the first intracellular signaling domain, …” within Line 2.
Appropriate correction is required.
Claim Interpretation
Under the broadest reasonable interpretation of instant claim 23, the “optional” limitation is not required.
Instant claims 5-6 require the bi-specific genetically modified immune cell to comprise a single chain variable fragment (scFv) that binds CD83, wherein the scFv that binds CD83 comprises the same heavy chain variable region and/or the same light chain variable region as a reference anti-CD83 antibody, wherein the reference anti-CD83 antibody is GMB00*, Clone 20D04, Clone 11G05, Clone 14C12, Clone 020B08, Clone 006G05, Clone 96G08, or Clone 95F04. Applicants have defined such regions – including the complementary determining regions for both the heavy and light chain variable regions – in Table 1 (Pages 45-50) of the instant Specification as filed 21 July 2022.
Instant claim 7, which is dependent upon instant claim 6, requires the bi-specific genetically modified immune cell to comprise a single chain variable fragment (scFv) that binds CD83, wherein the scFv that binds CD83 comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 59-71 (emphasis added). Therefore, the broadest reasonable interpretation of this limitation in claim 7 encompasses the full-length amino acid sequences of SEQ ID NOs: 59-71, or any consecutive amino acid portion of SEQ ID NOs: 59-71.
*It is of note that the Examiner is interpreting instant claim 6 to also include the heavy chain variable region and/or the light chain variable region of GMB00*, as these are the heavy and light chain variable regions comprised within SEQ ID NO: 71 (as recited instant claim 7). See Table 1 in the instant Specification.
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 11-12 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.
Regarding claim 11: The instant claim recites the limitation “the first co-stimulatory signaling, the second co-stimulatory domain, and/or the co-stimulatory domain is a co-stimulatory signaling domain of CD27…” in Lines 2-3 (emphasis added). There is insufficient antecedent basis for this limitation in the claim, as parent claim 2 requires multiple “co-stimulatory domains”. Accordingly, a claim is indefinite when it contains words or phrases whose meaning is unclear. See In re Packard, 751 F.3d 1307, 1314, 110 USPQ2d 1785, 1789 (Fed. Cir. 2014). The lack of clarity could arise if two different levers are recited earlier in the claim, the recitation of "said lever" in the same or subsequent claim would be unclear where it is uncertain which of the two levers was intended. See MPEP § 2173.05(e).
Appropriate correction is required.
Regarding claim 12: The instant claim recites the limitation “the first intracellular signaling, the second intracellular signaling domain, and/or the intracellular signaling domain is a CD3ζ signaling domain” in Lines 2-3 (emphasis added). There is insufficient antecedent basis for this limitation in the claim, as parent claim 2 requires multiple “intracellular signaling domains”. Accordingly, a claim is indefinite when it contains words or phrases whose meaning is unclear. See In re Packard, 751 F.3d 1307, 1314, 110 USPQ2d 1785, 1789 (Fed. Cir. 2014). The lack of clarity could arise if two different levers are recited earlier in the claim, the recitation of "said lever" in the same or subsequent claim would be unclear where it is uncertain which of the two levers was intended. See MPEP § 2173.05(e).
Appropriate correction is required.
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.
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.
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.
Claims 1-4 and 8-19 remain rejected under 35 U.S.C. 103 as being unpatentable over Dranoff (US 2020/0281973 A1, of record) in view of Irvine et al (US 2020/0230221 A1, of record).
Dranoff is considered prior art under 35 USC 102(a)(2), with an effective filing date of 04 March 2016. Irvine et al is considered prior art under 35 USC 102(a)(2), with an effective filing date of 19 September 2017.
Regarding claims 1-2: Dranoff discloses immune effector cells comprising a first chimeric antigen receptor (CAR) that binds a B-cell antigen and a second CAR which binds a tumor antigen (Abstract; Paragraphs [0003], [0006], [0046], [0066], [0071], [0172], [0175]). Dranoff further discloses that the first and second CARs each comprise an antigen binding domain specific for the respective antigens, a co-stimulatory domain, and an intracellular domain (Paragraphs [0007], [0020]-[0023], [0175]).
Dranoff further discloses that the first CAR binds B-cell antigen CD83 (Paragraphs [0009], [0140], [0302]).
Dranoff does not disclose that the antigen binding domain of the second CAR is an antigen binding domain that is specific for interleukin 6 receptor (IL-6R), as required by instant claim 1.
Irvine et al, however, disclose immune cells comprising multiple CARs, wherein one of the CARs comprises an antigen recognition domain that is specific for the tumor antigen IL-6R (Paragraphs [0104], [0150]-[0155], [0180]-[0183], [0199], [0203], [0225]).
Therefore, it would have been prima facie obvious to have substituted the tumor antigen binding domain of the second CAR of Dranoff for the IL-6R antigen binding domain of Irvine et al, as doing so would be a simple substitution of one antigen binding domain for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the instant invention would have recognized that IL-6R is a viable tumor antigen, and would have thereby been able to substitute the antigen binding domains with predictable results.
Consequently, Dranoff as modified by Irvine et al render obvious an effector immune cell comprising a first CAR that binds CD83 and a second CAR which binds IL-6R, wherein the first and second CARs each comprise an antigen binding domain specific for the respective antigens, a co-stimulatory domain, and an intracellular domain (claim 2). This therefore renders obvious the bi-specific genetically modified immune cell of instant claim 1.
Regarding claims 3 and 15: Following the discussion of claim 1, Dranoff further discloses that the effector immune cell can instead comprise a bi-specific CAR, wherein the CAR comprises a first and second antigen binding domain, a co-stimulatory domain, and an intracellular signaling domain (Paragraphs [0041], [0188]-[0189], [0406]; Figure 1). This therefore reads on the bi-specific genetically modified immune cell of instant claim 3, as well as the bi-specific CAR of instant claim 15.
Regarding claims 4 and 16: Following the discussions of claims 1 and 15, Dranoff further discloses that the CD83 antigen binding domain is in the format of a single chain variable fragment (scFv) (Paragraphs [0018], [0082], [0182]). This therefore reads on the bi-specific genetically modified immune cell of instant claim 4, as well as the bi-specific CAR of instant claim 16.
Regarding claims 8 and 17: Following the discussion of claims 1 and 15, Dranoff further discloses that the second antigen binding domain is in the format of a scFv (Paragraphs [0019], [0082], [0182]). This therefore reads on the bi-specific genetically modified immune cell of instant claim 8, as well as the bi-specific CAR of instant claim 17.
Regarding claim 9: Following the discussion of claim 1, Irvine et al further disclose that the tumor-associated antigen is CD126, which is synonymous with IL-6Rα (Paragraph [0203]; see Page 2 of instant Specification). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claim 10: Following the discussion of claim 1, Dranoff further discloses that the second antigen binding domain is in the format of a scFv (Paragraphs [0019], [0082], [0182]). Dranoff further discloses that the scFv retains the specificity of the intact antibody from which it is derived (Paragraph [0086]).
Dranoff further discloses that a well-known anti-IL6 antibody molecule – or IL-6R inhibitor – is tocilizumab (Paragraph [0773]).
Therefore, it would have been prima facie obvious to have substituted the IL-6R antigen binding domain of Dranoff in view of Irvine et al with a tocilizumab scFv antigen binding domain, as doing so would be a simple substitution of one known IL-6R scFv for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the tocilizumab and IL-6R scFv antigen binding domains are functionally comparable, and thereby would have been able to substitute the scFv antigen binding domains with predictable results.
Consequently, Dranoff as modified by Irvine et al render obvious an effector immune cell comprising a first CAR that binds CD83 and a second CAR which binds IL-6R, wherein the second CAR comprises a tocilizumab scFv antigen binding domain. This therefore renders obvious the bi-specific genetically modified immune cell of instant claim 10.
Regarding claim 11: Following the discussion of claim 2, Dranoff further discloses that the co-stimulatory domain is a co-stimulatory signaling domain of CD28 (Paragraphs [0024], [0028], [0041], [0081], [0110], [0422]). This therefore reads on the bi-specific genetically modified immune cell of the instant claim.
Regarding claim 12: Following the discussion of claim 2, Dranoff further discloses that the intracellular signaling domain is a CD3ζ signaling domain (Paragraphs [0028], [0108]-[0109], [0180], [0422]). This therefore reads on the bi-specific genetically modified immune cell of the instant claim.
Regarding claims 13 and 19: Following the discussion of claims 2 and 15, Dranoff further discloses that the CARs each further comprise a hinge domain and transmembrane domain (Paragraphs [0007], [0025]-[0027], [0080], [0183], [0406], [0408]-[0412]). This therefore reads on the bi-specific genetically modified immune cell of instant claim 13, as well as the bi-specific CAR of instant claim 19.
Regarding claim 14: Following the discussion of claim 1, Dranoff further discloses that the effector immune cell is a T cell (Paragraphs [0046], [0076], [0113], [0406]). This therefore reads on the bi-specific genetically modified immune cell of the instant claim.
Regarding claim 18: Following the discussion of claim 15, Dranoff further discloses that the co-stimulatory domain is a co-stimulatory signaling domain of CD28, while the intracellular signaling domain is a CD3ζ signaling domain (Paragraphs [0024], [0028], [0041], [0081], [0108]-[0110], [0180], [0422]). This therefore reads on the bi-specific CAR of the instant claim.
Claims 1-19 remain rejected under 35 U.S.C. 103 as being unpatentable over Dranoff (US 2020/0281973 A1, of record) in view of Irvine et al (US 2020/0230221 A1, of record), and further in view of Diehl et al (US 2014/0286950 A1, of record on IDS filed 17 October 2022).
The discussion of Dranoff as modified by Irvine et al regarding claims 1-4 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Dranoff as modified by Irvine et al render obvious claims 1-4 and 8-19. Diehl et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 5-7: As aforementioned in the discussion of claim 4 above, Dranoff as modified by Irvine et al render obvious an effector immune cell comprising a first CAR that binds CD83 and a second CAR which binds IL-6R, wherein the first and second CARs each comprise a scFv antigen binding domain specific for the respective antigens, a co-stimulatory domain, and an intracellular domain.
Dranoff nor Irvine et al teach that the CD83 scFv comprises an amino acid sequence selected from the group consisting of instant SEQ ID NOs: 59-71, as required by instant claim 7.
Diehl et al, however, disclose compositions comprising anti-CD83 agonist antibodies, wherein the anti-CD83 agonist antibody can be a scFv (Abstract; Paragraphs [0010], [0073], [0124], [0183], [0204], [0216]).
Diehl et al further disclose that the anti-CD83 agonist antibody comprises a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO: 30, and the light chain variable domain comprising the amino acid sequence of SEQ ID NO: 36 (Paragraphs [0010], [0016], [0133]-[0135], [0347]; claims 19, 29). Accordingly, the heavy chain and light chain sequences of the anti-CD83 agonist antibody share identity with “an” amino acid sequence set forth in instant SEQ ID NO: 71. It is of note that the heavy chain and light chain sequences are also identical to instant SEQ ID NOs: 19 and 20, respectively, which are directed to sequences of the CD83 GBM00 (Table 1 of the instant Specification). See the sequence alignments at the end of this Office action.
Therefore, it would have been prima facie obvious to have substituted the CD83 antigen binding domain of Dranoff in view of Irvine et al with the anti-CD83 agonist antibody scFv comprising the heavy chain variable domain of SEQ ID NO: 30 and the light chain variable domain of SEQ ID NO: 36 of Diehl et al, as doing so would be a simple substitution of one known CD83 scFv for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the two CD83 scFvs are functionally comparable, and thereby would have been able to substitute the scFv antigen binding domains with predictable results.
Consequently, Dranoff as modified by Irvine et al and Diehl et al render obvious an effector immune cell comprising a first CAR that binds CD83 and a second CAR which binds IL-6R, wherein the first CAR comprises a CD83 scFv antigen binding domain having the heavy chain and light chain variable domains of SEQ ID NOs: 30 and 36, respectively of Diehl et al. As SEQ ID NOs: 30 and 36 of Diehl et al are comprised within instant SEQ ID NO: 71 and have the complementary determining regions of GMB00 (claim 5), this therefore renders obvious the bi-specific genetically modified immune cell of instant claims 6-7, “wherein the scFv that binds CD83 comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 59-71).
Claims 1-4 and 8-24 remain rejected under 35 U.S.C. 103 as being unpatentable over Dranoff (US 2020/0281973 A1, of record) in view of Irvine et al (US 2020/0230221 A1, of record), and further in view of Ma et al (US 2018/0187149 A1, of record).
The discussion of Dranoff as modified by Irvine et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Dranoff as modified by Irvine et al render obvious claims 1-4 and 8-19. Ma et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 20: As aforementioned in the discussion of claim 1, Dranoff as modified by Irvine et al render obvious an effector immune cell comprising a first CAR that binds CD83 and a second CAR which binds IL-6R, wherein the first and second CARs each comprise an antigen binding domain specific for the respective antigens, a co-stimulatory domain, and an intracellular domain.
Dranoff further discloses that the effector immune cells can be allogeneic or autologous to the subject in which they are to be administered (Paragraphs [0058]-[0059], [0095]-[0096], [0557], [0615]). With that, Dranoff discloses that the allogeneic effector immune cell can lack expression of a functional T cell receptor and/or HLA class I/II molecules (Paragraphs [0557]-[0561).
Dranoff nor Irvine et al teach the administration of the CAR-expressing effector immune cells to suppress an alloreactive immune response in a subject, wherein alloreactive donor cells are suppressed, as required by instant claim 20.
Ma et al, however, disclose the generation of allogeneic T cells expressing multiple CARs – including a CAR specific for IL-6R – that are modified to inactivate components of TCR involved in MHC recognition, wherein the TCR-deficient T cells do not cause graft versus host disease (GVHD) due to the prevention of the TCR’s recognition of alloantigen (Abstract; Paragraphs [0010], [0068]-[0069], [0076]-[0077], [0082]-[0084], [0125]-[0129], [0132], [0254]).
Therefore, it would have been prima facie obvious to have modified the CAR-expressing effector immune cells rendered obvious by Dranoff and Irvine et al such that the cells do not provoke an alloreactive immune response when administered to the subject in need thereof, as detailed in Ma et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to administer such cells that suppress an alloreactive immune response, as doing so prevents GVHD, and would have had a reasonable expectation of success due to the fact the disclosures of Dranoff (Paragraphs [0006], [0072], [0076], [0141], [0193]), Irvine et al (Paragraphs [0031], [0041]-[0042], [0107], [0180]), and Ma et al (Paragraphs [0076], [0162]-[0163], [0190]) are all concerned with the development of immune cells comprising multiple CARs ultimately for the treatment of cancer. Therefore, the ordinary artisan would recognize that the methods of the prior art require minimal adaptation to arrive at the instantly claimed method. See MPEP § 2143(I)(G).
Consequently, Dranoff as modified by Irvine et al and Ma et al render obvious a method of administering the CAR-expressing effector immune cells to a subject in need thereof, wherein the effector immune cells have been modified such that they suppress an alloreactive immune response from alloreactive donor cells in the subject. This therefore renders obvious the method of the instant claim.
Regarding claims 21 and 23: Following the discussion of claim 20, Dranoff further discloses that the cells may be administered to the patient prior to a bone marrow transplant (Paragraph [0755]).
Dranoff further discloses that T cells and dendritic cells are considered hematopoietic cells from blood marrow (Paragraphs [0552], [0616]).
This therefore reads on the method of the instant claims, as the subject is in need of a bone marrow transplant (claim 23), wherein the bone marrow cells are comprised of T cells and/or dendritic cells (claim 21).
Regarding claim 22: Following the discussion of claim 20, Dranoff further discloses that the subject can be administered an agent that inhibits PD-1 (Paragraph [0777]). Dranoff further discloses that PD-1 is a well-known checkpoint inhibitor (Paragraph [0545]). This therefore reads on the method of instant claim, as the subject is undergoing a therapy that involves a checkpoint inhibitor.
Regarding claim 24: As aforementioned in the discussion of claim 20, Ma et al disclose that the CAR-expressing effector immune cells are modified to inactivate TCR genes and prevent recognition of an alloantigen (Paragraph [0254]). As the bone marrow cells themselves are not being modified, they will have an intact immunity against target antigens. This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 20.
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.
Any inquiry concerning this communication or earlier communications from the examiner
should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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, Christopher Babic can be reached at (571) 272-8507. 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.
/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
Sequence Alignments
GMB00 Heavy Chain Variable Region (Qy – instant SEQ ID NO: 19; Db – Diehl et al SEQ ID NO: 30)
Query Match 100.0; Length 120; Matches 120; Gaps 0
Qy 1 QVQLKESGPGLVKPSQSLSLTCSVTGFSITTGGYWWTWIRQFPGQKLEWMGYIFSSGNTN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLKESGPGLVKPSQSLSLTCSVTGFSITTGGYWWTWIRQFPGQKLEWMGYIFSSGNTN 60
Qy 61 YNPSIKSRISITRDTSKNQFFLQLNSVTTEGDTARYYCARAYGKLGFDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YNPSIKSRISITRDTSKNQFFLQLNSVTTEGDTARYYCARAYGKLGFDYWGQGTLVTVSS 120
*CDRs are underlined
GMB00 Light Chain Variable Region (Qy – instant SEQ ID NO: 20; Db – Diehl et al SEQ ID NO: 36)
Query Match 100.0%; Length 111; Matches 111; Gaps 0
Qy 1 QPVLTQSPSASASLGNSVKITCTLSSQHSTYTIGWYQQHPDKAPKYVMYVNSDGSHSKGD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QPVLTQSPSASASLGNSVKITCTLSSQHSTYTIGWYQQHPDKAPKYVMYVNSDGSHSKGD 60
Qy 61 GIPDRFSGSSSGAHRYLSISNIQPEDEADYFCGSSDSSGYVFGSGTQLTVL 111
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GIPDRFSGSSSGAHRYLSISNIQPEDEADYFCGSSDSSGYVFGSGTQLTVL 111
*CDRs are underlined
Anti-CD83 scFv 13 (Qy – instant SEQ ID NO: 71; Db – Diehl et al SEQ ID NO: 36)
Query Match 49.1%; Length 120; Best Local Similarity 100.0%; Gaps 0
Qy 1 QVQLKESGPGLVKPSQSLSLTCSVTGFSITTGGYWWTWIRQFPGQKLEWMGYIFSSGNTN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLKESGPGLVKPSQSLSLTCSVTGFSITTGGYWWTWIRQFPGQKLEWMGYIFSSGNTN 60
Qy 61 YNPSIKSRISITRDTSKNQFFLQLNSVTTEGDTARYYCARAYGKLGFDYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YNPSIKSRISITRDTSKNQFFLQLNSVTTEGDTARYYCARAYGKLGFDYWGQGTLVTVSS 120
Anti-CD83 scFv 13 (Qy – instant SEQ ID NO: 71; Db – Diehl et al SEQ ID NO: 36)
Query Match 44.5%; Length 111; Best Local Similarity 100.0%; Gaps 0
Qy 136 QPVLTQSPSASASLGNSVKITCTLSSQHSTYTIGWYQQHPDKAPKYVMYVNSDGSHSKGD 195
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QPVLTQSPSASASLGNSVKITCTLSSQHSTYTIGWYQQHPDKAPKYVMYVNSDGSHSKGD 60
Qy 196 GIPDRFSGSSSGAHRYLSISNIQPEDEADYFCGSSDSSGYVFGSGTQLTVL 246
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Db 61 GIPDRFSGSSSGAHRYLSISNIQPEDEADYFCGSSDSSGYVFGSGTQLTVL 111