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 .
Priority
This application was filed Dec. 21, 2021, and is a 371 application of PCT/CN2020/091781 filed on May 22, 2020, which claims benefit to the foreign application CN2019105475423 filed on June 24, 2019.
Claim Status
In the response filed on August 18, 2025, Applicants have amended claim 1, 4, and 6, cancelled claims 2-3, and filed new claims 17 and 18.
Applicant’s election without traverse of Group I, claims 1-12 and 15-16, and species of insect baculovirus expression system, human peripheral blood mononuclear cells and CRISPR/Cas system in the reply filed on March 12, 2025, is acknowledged. Claims 13-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Currently, claims 1, 4-12 and 15-18 are under consideration in this office action.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The objection of claim 1 because of the following informalities: spelling the acronym of “PAP-GM-CSF” to prostatic acid phosphatase (PAP) and granulocyte-macrophage colony stimulating factor (GM-CSF), spelling the acronym of “DC cell” to dendritic cell, spelling the acronym of “PD-1” to programmed death 1, is withdrawn due to Applicants amendments.
The objection of claim 3 is objected to because of the grammar in the sequence identifier, it is suggested to have the sequence identifier to be preceded by "SEQ ID NO:,” is withdrawn due to Applicants amendments.
The rejection of claim 3 and 6 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn due to Applicants amendments.
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.
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, 4-7, 9, 11-12, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Laus et al., (WO1997/024438A1, published 2004, prior art of record), Chen Guoyou (CN110079539A, published Aug. 2, 2019, and claims priority to Jan. 25, 2018), Zhang et al., (Scientific reports 8.1: 5549, published 2018, cited on IDS 12/21/2021, prior art of record), Redman et al., (Urol Oncol.;35(12):694-700, published 2017, prior art of record), and Laus et al., (US2004/0161413A1, published 2004; hereinafter as “Laus 2004,” prior art of record).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on May 19, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
Regarding claim 1, 9, and 11, Laus discloses a preparation method for a Cytotoxic T lymphocyte comprising the following steps of inducing a Cytotoxic T lymphocyte by using a dendritic cell (DC)(i.e. antigen presenting cell, APC) sensitized (i.e. pulsed)(see e.g. pg. 9-13, Examples 5-6) with a tumor antigen PAP-GM-CSF fusion protein (see e.g. abstract, claim 1, pg. 1-4, Example 1-6, fig. 1,2, 6-7). Further, Laus discloses the DC cell is selected from a human peripheral blood mononuclear cell (PBMC)(see e.g. pg. 16-21, Examples 1 and 5). Further, Laus discloses the tumor antigen PAP-GM-CSF fusion protein (i.e. SEQ ID NO: 2, fig. 1-2) having a peptide linker (i.e. amino acids Gly-Ser), the PAP upstream of the tumor antigen that comprises a signal peptide (see spec. page 8; See Search Results (20250402_100616_us-17-621-687a-2.align150.rag) and Score alignment of SEQ ID NO: 2 (Database) to SEQ ID NO: 2 (Query) below is 100%).
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Regarding claim 1, 9, and 11, Laus does not explicitly disclose wherein a nucleotide sequence of the tumor antigen PAP-GM-CSF is shown in SEQ ID:1.
However, the instant claims recite “a nucleotide sequence of the tumor antigen PAP-GM-CSF is shown in SEQ ID: 1.” According to Technology Center 1600 procedure the examiner is instructed to interpret this type of claim language broadly: Claim language such as claim 1 encompasses sequences and nucleic acids that comprise the full-length sequence of SEQ ID NO: 1 or any fragment or portion of SEQ ID NO: 1.
However, the prior art of Chen Guoyou (CN110079539A) discloses fragments of SEQ ID: 1 (see Search Results 2, file “us-17-621-687a-1.align50.rng”) and Score alignment of SEQ ID NO: 1 (Database) to SEQ ID NO: 2 (Query) below is a Query March of 74.9% and Similarity is 84.3%).
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Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Laus to incorporate a nucleotide sequence of the tumor antigen PAP-GM-CSF is shown in SEQ ID:1 as taught by Chen Guoyou because Laus discloses method relating to therapeutic compositions consist of antigen presenting cells activated by contact with a polypeptide complex constructed by joining together a dendritic cell-binding protein and a polypeptide antigen (see e.g. abstract). Further, both Laus and Chen Guoyou disclose encoding a prostatic acid phosphatase/granulocyte-macrophage colony-stimulating factor PAP/GM-CSF nucleotide Sequence (see claim 1 of Chen Guoyou and sec. c of Laus). and Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods to yield predictable results with a reasonable expectation of success. Furthermore, an artisan of ordinary skill in the art of (i.e. recombinant cell technology) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Laus is silent regarding knocking out programmed cell death (PD-1 gene) of the Cytotoxic T lymphocyte.
However, Zhang discloses a method for generating gene knockouts (i.e. PD-1) in human antigen (Ag)-specific cytotoxic T-Lymphocyte (CTLs) using clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR-associated protein 9 (Cas9) genome editing (see e.g. abstract).
Regarding claims 1, 12, and 18, Zhang discloses knocking out programmed cell death (PD-1) gene of a Cytotoxic T lymphocyte to obtain a PD-1 knock-out Cytotoxic T lymphocyte (see e.g. page 2-3, fig. 1).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the cytotoxic T lymphocyte methods of Laus to incorporate knocking out PD-1 gene of the cytotoxic T lymphocyte as taught by Zhang because Zhang teaches that tumour-specific T-cells with a loss-of-function mutation in the PD1 gene could provide an alternative cancer treatment (see page 7). Incorporating the KO PD-1 gene from the cytotoxic T lymphocytes as taught by Zhang would have led to predictable results with a reasonable expectation of success because both teach Laus and Zhang teach methods of cytotoxic T lymphocytes as therapeutic methods for cancer. Additionally, the prior art of Redman discloses that therapeutic dendritic-cell vaccines like Sipuleucel-T (i.e. Provenge® and see specification para. 5) with inhibiting immune checkpoint inhibitors (i.e. PD-1) may synergize and improve clinical outcomes in prostate cancer (see e.g. abstract, pages 697-698). Therefore, a person of ordinary skill in the art would have combined methods of preparing cytotoxic T lymphocytes as therapeutic methods for cancers, which would have led to predictable results with a reasonable expectation of success. Furthermore, an artisan of ordinary skill in the art of (i.e. immunotherapies for prostate cancer) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Regarding claim 4 and 17, Laus discloses wherein the tumor antigen PAP-GM-CSF is expressed by a genetic engineering method of the insect cell baculovirus expression system and the tumor antigen PAP-GM-CSF is obtained by purification after being expressed by the genetic engineering method (i.e. insect cell baculovirus expression system)(see e.g. pg. 10, 17-25, fig 4, 9, Example 2).
Regarding claims 5-6, Laus discloses wherein the purification is implemented by ultrafiltration (e.g. immunoaffinity chromatography) and continuous column chromatography such as hydrophobic chromatography (i.e. hydrophobic column Capto Butyl)(see e.g. pages 10-11, 17-18, 23-25).
Regarding claim 7, and 15-16, Laus discloses a typical purification of the tumor antigen PAP-GM-CSF resulted in greater than 90% (see e.g. page 23-25).
Although Laus does not explicitly state that the purity of the tumor antigen PAP-GM-CSF is no less than 98%.
Nevertheless, a person of ordinary skill in the arts could have arrived at these concentrations by routine optimization. It would have been obvious for a person of ordinary skill in the art at the time of the invention to modify the method of Laus to obtain no less than 98% purity of the tumor antigen PAP-GM-CSF with a reasonable expectation of success. Furthermore, the prior art of Laus 2004 discloses that PAP-GM-CSF (i.e. PA2024) was purified by three sequential column chromatography steps to obtain more than 95% homogeneity (see e.g. para. 171, Example 2). Therefore, it would have been obvious to optimize the purity of the tumor antigen PAP-GM-CSF to obtain no less than ninety eight percent with a reasonable expectation of success.
In regards to routine optimization, MPEP 2144.05(II)(A) states, “generally differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (‘It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.’)”.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant argues that the independent claims have been amended to incorporate the limitations of cancelled claims 2 and 3 (Remarks, pages 5-7). Applicant notes that the Examiner did not reject claim 3 (currently cancelled) as being unpatentable over unpatentable over Laus et al., Zhang et al., Redman et al., and Laus 2004 (Remarks, page 5). Thus, Applicant asserts that the amended independent claim 1 and dependent Claims 4-7, 9, 11-12, and 15-16 are now patentable over Laus et al., Zhang et al., Redman et al., and Laus 2004 (Remarks, page 5).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
In response to Applicants arguments the independent claim 1 now recites “a nucleotide sequence of the tumor antigen PAP-GM-CSF is shown in SEQ ID: 1.” According to Technology Center 1600 procedure the examiner is instructed to interpret this type of claim language broadly: Claim language such as claim 1 encompasses sequences and nucleic acids that comprise the full-length sequence of SEQ ID NO: 1 or any fragment or portion of SEQ ID NO: 1. As discussed above, the prior art of Chen Guoyou (CN110079539A) discloses fragments of SEQ ID: 1 (see Search Results 2, file “us-17-621-687a-1.align50.rng”) and Score alignment of SEQ ID NO: 1 (Database) to SEQ ID NO: 2 (Query) below is a Query March of 74.9% and Similarity is 84.3%). In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Claim 8 are rejected under 35 U.S.C. 103 as being unpatentable over Laus et al., (WO1997/024438A1, published 2004, prior art of record), Chen Guoyou (CN110079539A, published Aug. 2, 2019, and claims priority to Jan. 25, 2018), Zhang et al., (Scientific reports 8.1: 5549, published 2018, cited on IDS 12/21/2021, prior art of record), Redman et al., (Urol Oncol.;35(12):694-700, published 2017, prior art of record), and Laus et al., (US 2004/0161413A1, published 2004; hereinafter as “Laus 2004,” prior art of record)., as applied to claims 1, 4-7, 9, 11-12, and 15-18 above, and further in view of Felberbaum RS. (Biotechnol J. May;10(5):702-14. Epub; published 2015) and Invitrogen, L. T. ("Guide to Baculovirus Expression Vector Systems (BEVS) and insect cell culture techniques." Instruction Manual, published 2002; hereinafter as “Invitrogen”), and Shang, et al. (Journal of Biotechnology 255: 37-46, published 2017).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on May 19, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
The teachings of Laus et al., apply here as indicated above.
Regarding claim 8, as discussed above, Laus discloses a preparation method for the tumor antigen PAP-GM-CSF (see e.g. abstract, claim 1, pg. 1-4, Example 1-6, fig. 1,2, 6-7). Laus discloses step (1), (2), and (3) of constructing PAP-GM-CSF expression vectors used for transfecting insect (i.e. SF21) cell lines (see e.g. fig. 3) and screening to obtain a recombinant bacmid (i.e. PAP-GM-CSF)(see e.g. page 17-18), corresponding to the claim limitation of transfecting and screening the recombinant bacmid into an insect cell. Further, Laus discloses that after the cell has an obvious pathological change (i.e. positive plaques), collecting the supernatant which is the first-generation baculovirus (i.e. generating viral stocks) (see e.g. pages 17-18). Further, Laus discloses subsequent rounds of infecting fresh SF21 cells, which reads on the claim limitation of step (4) infecting the insect cell with the first-generation baculovirus and collecting the second-generation baculovirus or the third-generation baculovirus. Additionally, Laus discloses the claim limitation of step (5) expressing PAP-GM-CSF (i.e. PAPHGM-BAC) by using a suspended insect cell infected and acclimated with the second-generation baculovirus or the third-generation baculovirus (see e.g. pages 17-18).
Laus is silent regarding where step (1) discloses constructing a shuttle plasmid pFast-Bac1 and step (2) regarding the transforming the shuttle plasmid into Escherichia coli (E. coli).
However, the prior art of Felberbaum discloses that the baculovirus expression vector system (BEVS) is an established manufacturing platform for the production of viral vaccines and gene therapy vectors (see e.g. page 702), where the BEVS-derived product like Provenge® (i.e. Sipuleucel-T from Dendreon) uses insect (i.e. Sf-21) cells to produce an antigen used in the prostate cancer immunotherapy (see e.g. abstract, page 704, Table 1).
Regarding claim 8, Felberbaum discloses that bacmid technology allow researchers to quickly and easily construct recombinant baculoviruses in E. coli rather than by homologous recombination in insect cells (see pages 703-704). Felberbaum further cites laboratory kits such as Bac-to-Bac® baculovirus expression system from Invitrogen (i.e. Life Technologies)(see e.g. pages 10-13), and Invitrogen discloses transforming the FastBac1 plasmids into E. coli (see e.g. fig. 1-3).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the cytotoxic T lymphocyte methods of Laus to incorporate the baculovirus plasmid (pFast-Back1) and the step of transforming the plasmid into E. coli as taught by Felberbaum and Invitrogen because Felberbaum discloses that a person of ordinary skill in the art would have been motivated to use quick and easy bacmid technology (see e.g. pages 703-704). Additionally, the prior art of Shang discloses that the pFastBac™ vectors elevate protein expression yields in insect cells and to reduce protein production costs (see e.g. abstract and page 45). Therefore, it would have been obvious for a person of ordinary skill in the art to incorporate the skeleton vector with improved protein expression in insect cells. Furthermore, incorporating theFast-Bac1 plasmid and transforming the shuttle plasmid into E. coli (as taught by Felberbaum, Invitrogen, and Shang) with the cytotoxic T lymphocyte methods of Laus would have led to predictable results with a reasonable expectation of success, because Laus, Felberbaum, Invitrogen, and Shang all teach methods of generating fusion proteins with a baculovirus system. Furthermore, an artisan of ordinary skill in the art of (i.e. baculovirus expression system) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant argues regarding claim 8 that the independent claim has been amended to incorporate the limitations of cancelled claims 2 and 3 (Remarks, pages 5-7). Applicant asserts that the rejection is “respectfully traversed, and reconsideration is respectfully requested in view of the amendments and remarks herein” (Remarks, pages 5-6).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive. Applicants’ arguments have been addressed supra.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Laus et al., (WO1997/024438A1, published 2004, prior art of record), Chen Guoyou (CN110079539A, published Aug. 2, 2019, and claims priority to Jan. 25, 2018), Zhang et al., (Scientific reports 8.1: 5549, published 2018, cited on IDS 12/21/2021, prior art of record), Redman et al., (Urol Oncol.;35(12):694-700, published 2017, prior art of record), and Laus et al., (US 2004/0161413A1, published 2004; hereinafter as “Laus 2004,” prior art of record), as applied to claims 1, 4-7, 8-9, 11-12, and 15-18 above, and further in view of Chen, Bing-guan, et al. (The Journal of the American Society of Hematology 91.12: 4652-4661, published 1998).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on May 19, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
The teachings of Laus et al., apply here as indicated above.
Regarding claim 10, as discussed above, Laus discloses wherein sensitizing the dendritic cell with the tumor antigen PAP-GM-CSF protein (see e.g. abstract, claim 1, pg. 1-4, Example 1-6, fig. 1,2, 6-7), and discloses the dendritic cell binding proteins may be IL-4 or tumor necrosis factor (TNF)(see e.g. pages 5-6, figs. 1-2, and 10).
Laus does not explicitly state the step of adding the dendritic cell into a lymphocyte serum-free medium containing recombinant human (rh) GM-CSF and rhIL-4; and after culturing, adding the tumor antigen PAP-GM-CSF and TNF-α for induction to obtain the dendritic cell.
However, the prior art of Chen discloses adding dendritic cells into a lymphocyte serum-free media (i.e. X-VIVO-15, see e.g. page 4653, specification para. 34) containing rhGM-CSF and rhIL-4; and after culturing, adding the tumor antigen PAP-GM-CSF and TNF-α for induction to obtain the dendritic cell (see e.g. pages 4652-4654, and 4659; figs. 1, and 4, and table 1).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the cytotoxic T lymphocyte methods of Laus to incorporate IL-4 and TNF-α as taught by Chen because Chen discloses that it was well known in the prior art to obtain dendritic cells have been generated from culturing with recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF), rhIL-4, and TNF-α (see e.g. page 4652). A person of ordinary skill in the art would have incorporated GM-CSF and IL-4 because Chen discloses that rhGM-CSF and IL-4 facilitated the generation of a relatively large number of dendritic cells from peripheral blood mononuclear cells (PBMC) and resulted in cells with typical DC morphology (veils) and phenotype (see e.g. page 4657). Further, Chen discloses that rhGM-CSF and rhIL-4 with the addition TNF-α demonstrated dendritic cells with potent T-cell allostimulatory capacity in vitro and was necessary for achieving optimum effects on dendritic cells (see e.g. page 4657). Thus, incorporating the rhGM-CSF, rhIL-4, and TNF-α as taught by Chen with the cytotoxic T lymphocyte methods of Laus would have led to predictable results with a reasonable expectation of success, because both teach Laus and Chen teach methods of generating tumor-pulsed (i.e. sensitized) dendritic cells. Furthermore, an artisan of ordinary skill in the art of (i.e. immunotherapies for cancer) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant argues regarding claim 10 that the independent claim has been amended to incorporate the limitations of cancelled claims 2 and 3 (Remarks, pages 5-7). Applicant asserts that the rejection is “respectfully traversed, and reconsideration is respectfully requested in view of the amendments and remarks herein” (Remarks, pages 6-7).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive. Applicants’ arguments have been addressed supra.
Conclusion
No claim is allowed.
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.
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JOSEPHINE GONZALES
Examiner
Art Unit 1631
/JOSEPHINE GONZALES/ Examiner, Art Unit 1631
/JAMES D SCHULTZ/ Supervisory Patent Examiner, Art Unit 1631