DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments and Arguments
2. Claims 1, 4, 5, 10-13, 16-21 and 23 are pending.
Claims 2, 3, 6-9, 14, 15 and 22 have been cancelled.
Claim 23 has been added.
Claims 1, 10, 16, 17, 20 and 21 have been amended.
Claims 1, 4, 5, 10-13, 16-21 and 23 are examined on the merits.
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
4. The rejection of claims 1, 4, 5, 10-13, 16-21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement set forth in the first action on the merits (FAOM) mailed July 22, 2025 has been withdrawn in light of Applicant’s amendment and argument within the Remarks, both submitted October 22, 2025. Claims 2, 3, 6-9, 14, 15 and 22 have been cancelled.
5. Claim 14 has been cancelled, hence the 112(b) rejections set forth in the first action on the merits (FAOM) on page 11, segments 10-12, mailed July 22, 2025 has been withdrawn, see Listing of the Claims submitted October 22, 2025.
New Grounds of Objection
Claim Objections
6. Claim 16 is objected to because of the following informality: the acronym, PBS57 is cited on line 6, however the Specification notes it as “PBS-57”. For consistency throughout the application, Applicant is requested to amend the acronym in the claim and cite as it is through the Specification, “PBS-57”.
Correction is required.
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 103
7. 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.
8. The rejection of claim(s) 1, 4, 5, 10-13 and 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al., WO 2018/045058 A1 (published 08 March 2018/ IDS reference #1 submitted October 4, 2022), and further in view of Kohane et al., US 2005/0123596 (published June 9, 2002), Ford et al., US 2016/0340437 A1 (published November 24, 2016) and Downey et al., (FEBS Letters 583: 1627-1640, available online 27 June 2019). Claims 2, 3, 6-9, 14, 15 and 22 have been cancelled.
In the Remarks, Applicant initially details their claimed invention, see Remarks submitted October 22, 2025, pages 4 and 5.
Applicant follows the details with the statement, “…the claims as amended are not made obvious by the cited combination of art” and notes each reference and its teachings, see pages 5-8. And while pointing out particulars of what the individual references do not teach, these assertions do not obviate the instant rejection.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The combination of references teaches the claimed invention. The claims contain open language or comprising language, hence additional components such as chemokines or cytokines do not preclude Goldberg’s teachings as noted in the Remarks, see page 6, 1st full paragraph (para.). Goldberg continues to teach a vaccine composition comprising activator(s) of innate-like T cells and additional therapeutic agents within a biodegradable scaffold with biomaterial, PLGA, PLA and/or PGA.
Kohane makes clear, tumor and pathogen antigens can be encapsulated within a microparticle with diameters overlapping Applicant’s and agents are able to presented on the surface of the microparticle, see entire document.
The Ford reference was relied upon for the teaching of the human CD48 polypeptide specific binding agent, which can be encapsulated in microparticles with additional therapeutic agents, see page 4, Specific Binding…segment; page 7, Therapeutic Methods; and Combination Therapies beginning on page 9.
Although, Applicant’s states, “Downey provides only a vague hope that a method of targeting MAIT cells could be developed.”, see Remarks, page 7, last sentence.
“Obviousness does not require absolute predictability of success…all that is required is a reasonable expectation of success.” In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988)). Applicant has provided no evidence to rebut the reasonable expectation of success suggested by the prior art.
Downey makes it plain an invariant ab TCR is able to bind glycolipid (alpha-galactosylceramide (a-GalCer) antigens exposed on the MHC class I-like molecule, CD1d, thereby recognizable by the targeted population of innate-like T cells and “[m]ucosal-associated invariant T (MAIT) cells are able to perform innate-like immunity functions upon recognition of small molecule vitamin B metabolites preces by the MHC, class I-related protein-1 (MR1)”, see the entire document, in particular the abstract; page 1628; and pages 1634-1636.
The combination of these teachings does not differ from Applicants’ claimed invention, nor what is exemplified in Applicants’ teachings herein. Hence, the same results would render the same effects as espoused by Applicant.
Applicant has not presented any scientific evidence that would dissuade the Office from the combination of references. The combination of references would not change the principle of operation of the prior art invention being modified, hence the teachings of the references are sufficient to render the claims prima facie obvious.
Moreover, the modification of the primary reference in light of the secondary references is proper because the applied references are so related that the appearance of features shown in one would suggest the application of those features to the other. See In re Rosen, 673 F.2d 388, 213 USPQ 347 (CCPA 1982); In re Carter, 673 F.2d 1378, 213 USPQ 625 (CCPA 1982), and In re Glavas, 230 F.2d 447, 109 USPQ 50 (CCPA 1956). Further, it is noted that case law has held that a designer skilled in the art is charged with knowledge of the related art; therefore, the combination of old elements, herein, would have been well within the level of ordinary skill. See In re Antle, 444 F.2d 1168,170 USPQ 285 (CCPA 1971) and In re Nalbandian, 661 F.2d 1214, 211 USPQ 782 (CCPA 1981). The combination of references would not change the principle of operation of the prior art invention being modified, hence the teachings of the references are sufficient to render the claims prima facie obvious. For the reasons of record and cited herein, the rejection is maintained.
Goldberg teaches drug delivery compositions comprising one or more activators of adaptive immune response, activator of innate immune response, additional therapeutic agents and a biomaterial, see page 37, section 000166; and page 38, section 000167.
An activator of adaptive immune response is an anti-CD244 antibody and a single chain of said antibody, comprising a variable region domain, see sections 000255 and 000256 on pages 60 and 61; and claims 79 and 80 on page 157.
There may be more than one activator of innate immune response including a biologic and an adjuvant, see page 42, section 000186. Biologics include vaccines, as well as “…may be isolated from a variety of natural sources (e.g., human, animal, microorganism) and may be produced by biotechnological methods and other technologies.”, as well as adjuvants, see page 13, section 00044; page 45, section 000202; page 52, section 000222; section 000684 spanning pages 128 and 129; and section 000699, page 133.
The drug delivery composition is biodegradable and comprises…poly(lactic-co-glycolic) acid (PGLA), polylactic acid (PLA), polyglycolic acid (PGA), polyethylene glycol (PEG), PEG diacrylate (PEGDA), and/or combinations thereof.”, see page 4, section 00016; page 39, section 000171; and page 42, section 000184.
Goldberg does not teach a vaccine composition, wherein the agent that specifically binds to CD244 is on the surface of the microparticle and is a human CD48 polypeptide antigen.
Goldberg also does not teach a vaccine composition includes an effective dose of an antigen (tumor antigen, pathogen antigen) and the adjuvant is a MHC-related protein and antigen recognized by the targeted population of innate-like T cells, the innate-like T cells are mucosal-associated invariant T (MAIT) cells, invariant natural killer T (iNKT) cells and the MHC-related protein is CD1d complexed with a-galactosylceramide.
However, Kohane teaches biodegradable microparticles for the administration of encapsulated therapeutic agents including “…antigenic epitopes of a pathogen or tumor.”, see page 1, sections 0003, 0004 and 0007; page 2, sections 0011 and 0017. Kohane teaches a targeting agent may be on the surface of the particle, see page 7, sections 0072 and 0073. The microparticles range in diameter size from 5 nanometers (0.005 micrometers) to 50 micrometers, see page 1, abstract; page 1, section 0007; page 10, section 0102; page 15, section 0138.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to encapsulate a therapeutic, diagnostic or prophylactic agent(s) to form a biodegradable microparticle to manufacture a vaccine composition for methods of treatment, see Goldberg, sections 00035, 00039-0042 spanning pages 8-12; and Kohane abstract and entire document.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the teachings of both Goldberg and Kohane to manufacture a drug delivery composition to treat cancer, tumor metastasis and “…improve the presentation of vaccine antigens to CD8+ cells, thereby enhancing the CTL response to peptide/protein vaccines”, see abstracts of both documents; Kohane, page 1, section 0004, and page 14, section 0136; and Goldberg, section 000251 on page 59.
Moreover, Ford teaches “[a]n exemplary…CD48 polypeptide specific binding agent…capable of binding a certain portion of the 2B4 [CD244, SLAMf4]...”, see page 3, section 0044; and page 4, section 0052.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a CD48 polypeptide antigen within the taught therapeutic composition because it is capable of modulating the activity or function of 2B4 (CD244, SLAMf4), see page 4, section 0052.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the teachings in Ford because the taught specific binding agent can be encapsulated with additional therapeutic agents in drug delivery microparticle agents for treatment of immune compromised individuals, such as an individual with cancer, see page 3, section 0047; Therapeutic Methods and Combination Therapies spanning pages 7-10 of Ford. This human CD48 polypeptide antigen is regarded by the Examiner as a biologic activator of adaptive immune response. A biologic is a protein and able to “…[activate] the adaptive immune system. Such activation can restore antitumor function by neutralizing inhibitory immune checkpoints or by triggering co-stimulatory receptors, ultimately generating helper and/or effector T cell responses against immunogenic antigens expressed by cancer cells and producing memory B cell and/or T cell populations. In certain embodiments, the activator of adaptive immune response involves modulation of adaptive immune response and/or leukocyte trafficking.”, see section 00057 spanning pages 16 and 17; and page 60, sections 000253 and 000254.
Additionally, Downey teaches “…(MAIT) cells are a subset of T cells that perform innate-like immunity functions upon recognition of small molecule vitamin B metabolites presented by the MHC, class I-related protein-1 (MR1).”, see abstract on page 1627; and Figure 1(D) on page 1628. Downey also teaches “…invariant natural killer T (iNKT) cells express an invariant ab TCR which binds to glycolipid antigens exposed on the MHC class I-like molecule, CD1d.”, see Figure 1(C) caption on page 1628.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include within the taught therapeutic composition an MHC-related protein, MR1 complexed with a microbial derived metabolite because once recognized by MAIT cells, the said cells are highly activated in viral infections and target a host of microbes, see abstract; and page 1631, 1st column, last paragraph.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the teachings in Downey, the MAIT cells will produce cytokines, which are both anticancerous, as well as antibacterial, see abstract. Hence, all the teachings of the three components in combination would render an efficacious anticancer therapeutic delivery composition for treatment, see all documents in their entireties.
9. Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al., WO 2018/045058 A1 (published 08 March 2018/ IDS reference #1 submitted October 4, 2022), and further in view of Kohane et al., US 2005/0123596 (published June 9, 2002), Ford et al., US 2016/0340437 A1 (published November 24, 2016) and Downey et al., (FEBS Letters 583: 1627-1640, available online 27 June 2019).
In anticipation of an argument against Ford and Goldberg, the Examiner preemptively emphasizes Applicant has not provided scientific evidence as to why the 2B4 antibody of Ford, nor the anti-CD244 of Goldberg will not be function in an agonistic manner. Applicant has asserted “…Ford is directed to methods in which 2B4 (also known as CD244) is blocked, while in Applicant’s methods an agonist is used.”, see Remarks submitted October 22, 2025, 2nd paragraph (para.). However, “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).“, see MPEP 2123, section II.
Goldberg teaches drug delivery compositions comprising one or more activators of adaptive immune response, activator of innate immune response, additional therapeutic agents and a biodegradable scaffold with biomaterial, see page 37, section 000166; and page 38, section 000167.
An activator of adaptive immune response includes an anti-CD244 antibody, see sections 000255 and 000256 on pages 60 and 61; and claims 79 and 80 on page 157.
There may be more than one activator of innate immune response including a biologic and an adjuvant, see page 42, section 000186. Biologics include vaccines, as well as “…may be isolated from a variety of natural sources (e.g., human, animal, microorganism) and may be produced by biotechnological methods and other technologies.”, as well as adjuvants, see page 13, section 00044; page 45, section 000202; page 52, section 000222; section 000684 spanning pages 128 and 129; and section 000699 on page 133.
The drug delivery composition is biodegradable and comprises…poly(lactic-co-glycolic) acid (PGLA), polylactic acid (PLA), polyglycolic acid (PGA), polyethylene glycol (PEG), PEG diacrylate (PEGDA), and/or combinations thereof.”, see page 4, section 00016; page 39, section 000171; and page 42, section 000184.
Goldberg does not teach a vaccine composition with a microparticle from 0.1 mm to 5 mm including an effective dose of an antigen (tumor antigen, pathogen antigen) and CD1d complexed with a-galactosylceramide.
However, Kohane teaches biodegradable microparticles for the administration of encapsulated therapeutic agents including “…antigenic epitopes of a pathogen or tumor.”, see page 1, sections 0003, 0004 and 0007; page 2, sections 0011 and 0017. The microparticles range in diameter size from 5 nanometers (0.005 micrometers) to 50 micrometers, see page 1, abstract; page 1, section 0007; page 10, section 0102; and page 15, section 0138.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to encapsulate a therapeutic, diagnostic or prophylactic agent(s) to form a biodegradable microparticle from 0.1 mm to 5 mm and manufacture a vaccine composition for methods of treatment, see Goldberg, sections 00035, 00039-0042 spanning pages 8-12; and Kohane abstract and entire document.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the teachings of both Goldberg and Kohane to manufacture a drug delivery composition to treat cancer, tumor metastasis and “…improve the presentation of vaccine antigens to CD8+ cells, thereby enhancing the CTL response to peptide/protein vaccines”, see abstracts of both documents; Kohane, page 1, section 0004, and page 14, section 0136; and Goldberg, section 000251 on page 59.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the teachings in Ford because the taught specific binding agent can be encapsulated with additional therapeutic agents in drug delivery microparticle agents for treatment of immune compromised individuals, such as an individual with cancer, see page 3, section 0047; and Therapeutic Methods and Combination Therapies spanning pages 7-10 of Ford. In certain embodiments, the activator of adaptive immune response involves modulation of adaptive immune response and/or leukocyte trafficking.”, see section 00057 spanning pages 16 and 17; and page 60, sections 000253 and 000254.
Additionally, Downey teaches “…(MAIT) cells are a subset of T cells that perform innate-like immunity functions upon recognition of small molecule vitamin B metabolites presented by the MHC, class I-related protein-1 (MR1).”, see abstract on page 1627; and Figure 1(D) on page 1628. Downey also teaches “…invariant natural killer T (iNKT) cells express an invariant ab TCR which binds to glycolipid (alpha-galactosylceramide (a-GalCer) antigens exposed on the MHC class I-like molecule, CD1d.”, see Figure 1(C) caption on page 1628.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include within the taught therapeutic composition an MHC-related protein, MR1 complexed with a microbial derived metabolite because once recognized by MAIT cells, the said cells are highly activated in viral infections and target a host of microbes, see abstract; and page 1631, 1st column, last paragraph.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the teachings in Downey, the MAIT cells will produce cytokines, which are both anticancerous, as well as antibacterial, see abstract. Hence, all the teachings of the three components in combination would render an efficacious anticancer therapeutic delivery composition for treatment, see all documents in their entireties.
Conclusion
10. 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.
11. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached on 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
18 December 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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