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 .
Claims 7, 13-14 and 16-18 are under consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 10/13/2025 has been entered.
Affidavits/Declarations
The Declaration under 37 CFR 1.132 filed 10/13/2025 is insufficient to overcome the rejection(s) of:
Claims 7 and 13-14 under 35 U.S.C. 103 as being unpatentable over Selvaraj (Selvaraj, et al., US 2015/0071987A1; Published 03/12/2015, of record) in view of Patel (Patel, et al., Biomaterials 2016 74:231); and
Claims 7 and 13-14 under USC § 103 as being unpatentable over Selvaraj (Selvaraj, et al., US 2015/0071987A1; Published 03/12/2015, of record) in view of Patel (Patel, et al., Biomaterials 2016 74:231) Das Roy (Das Roy, et al., Genes and Cancer (2017) 8:536-549, of record);
as set forth in the last Office action because:
Declarant attempts to differentiate the instant claimed invention from the primary art cited (dubbed “Selvaraj 2015” by Declarant) in both of the 35 USC § 103 rejections articulated in the previous Office Action. Declarant argues that Selvaraj 2015 only discusses DC hybrid vaccines only in the context of fusing dendric cells as originally reported by Wang (Wang, et. al., J. Immunol, 1998, 161:5516, of record; “Wang 1998”), as cited by Declarant. Declarant states that the DC pulsing approach tumor membrane vesicles carrying tumor antigens are taken up and internalized by DCs, processed and presented to T cells to activate the immune system.
Declarant contends that the DC-tumor cell hybrid vaccine is a fundamentally approach when compared to the instant claimed ex vivo DC pulsing method. Declarant states that in the DC-tumor hybrid vaccine approach, DCs are fused with tumor agents using an agent such as PEG and have not, to declarant’s knowledge DC-tumor hybrid vaccines have not led to any approved clinical products. Declarant concludes by discussing how Patel discussed adding glycolipid-anchored antigens and injecting directly into the patient, and, as such, does not teach TMV-pulsed DCs as a vaccine.
Declarant’s arguments are not persuasive because Declarant’s contentions do not substantively differentiate the instant method, said method comprising administration of DCs that have been pulsed with tumor membrane vesicles (TMVs) to a patient having cancer from the method(s) articulated in the prior art references. The Selvaraj 2015 reference does not limit itself to DC vaccines comprising DC-tumor cell hybrids only. For example, at ¶ 0150, Selvaraj 2015 teaches explicitly the administration of the particle compositions of Selvaraj 2015 in combination with numerous anti-cancer agents, including systemic administration of cytokines, antibody-based targeted therapies and concomitant administration of DC-based cancer vaccines (Selvaraj 2015, ¶ 0149-0150). Selvaraj even points to the unique properties and abilities of DCs—the ability to take up and process antigens, move into secondary lymphoid tissues and activate both helper and cytotoxic T cells (Selvaraj 2015, ¶ 0150). Selvaraj 2015 even goes so far to say that preparing a DC vaccine cancer vaccine typically involves loading DCs with known tumor-specific antigens, antigenic peptides, cDNA, and/or RNA isolated from tumor cells and that a goal of the work of Selvaraj 2015 is to develop improved methods for the delivery of antigens to DCs and that fusion of DCs to tumor cells is only one such approach (Selvaraj 2015, ¶ 0150). Selvaraj 2015 even teaches a DC vaccine used to treat prostate cancer comprising DCs that activated are activated via ex vivo “pulsing” with a fusion protein comprising both the GM-CSF immunostimulatory agent and the PAP antigen (Selvaraj 2015, ¶ 0151-0152).
At the their most fundamental level, the particles of Selvaraj are multifunctional structures that bring at least one immunostimulatory agent into proximity with at least one cancer-associated antigen, with Selvaraj teaching that these multifunctional, adjuvant/antigen-comprising structures are capable of activating and eliciting antigen-based responses in DCs as well as teaching specific embodiments of the adjuvant/antigen-comprising structures of Selvaraj that are structures derived from tumor membranes and comprising GPI-anchored immunostimulatory compounds GM-CSF and IL-12 as well as the HER2 antigen embedded within the tumor membrane-derived multifunctional structure.
As stated above, the Selvaraj 2015 reference is not limited to DC-vaccines that are DC/tumor cell hybrid cells and one of ordinary skill in the art, having read and understood the Selvaraj 2015 reference, would realize that it is obvious that the adjuvant/antigen-comprising structures comprising GM-CSF, IL-12 and HER2 would be capable of activating DCs based on Selvaraj 2015’s teaching that the adjuvant/antigen particles of Selvaraj 2015 are an improved method for delivering antigens to/activating DCs. One of skill in the art would also realize that it is obvious these resultant activated DC will target cells expressing the HER2 antigen, which is widely known to be a tumor-associated antigen associated with breast cancer, based on Selvaraj 2015’s teaching that exposing DCs to the GM-CSF/PAP antigen fusion protein resulted activated DCs targeting the PAP antigen. It is within the purview of one of skill in the art to see the nexus between the two: both the GM-CSF/PAP antigen fusion protein and the GM-CSF/IL-12/HER2 tumor membrane-derived particles activate DCs via exposing the DCs to immunostimulatory compounds in close proximity to an antigen, with the antigen that the DCs are exposed to in the case of the GM-CSF/IL-12/HER2 particles of Selvaraj 2015 being HER2.
Regarding Applicant’s further arguments related to further alleged specific limitations of DC-hybrid vaccines (e.g., antigen loss during fusion, the culture tumor cells required for production being difficult, etc.…) are not particularly persuasive due to the fact that, as stated and articulated above, Selvaraj 2015 provides sufficient teaching and suggestion to cause one of skill in the art to deduce that DCs activated by the GM-CSF/IL-12/HER2 particles of Selvaraj 2015 would form a DC vaccine capable of treating HER2-expressing breast cancer with a reasonable expectation of success.
Rejections Maintained
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.
Claim(s) 7 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj (Selvaraj, et al., US 2015/0071987A1; Published 03/12/2015, of record) in view of Patel (Patel, et al., Biomaterials 2016 74:231, of record).
Selvaraj teaches a method of tumor treatment or tumor vaccination comprising administration of a therapeutic composition comprising gycosyl-phosphatidylinositol (GPI) anchored immunostimulatory molecules (Selvaraj, Abstract). Selvaraj teaches that the therapeutic composition comprises tumor cell membranes that are modified to contain one or more GPI-anchored immunostimulatory molecules (Selvaraj, ¶ 0007). Selvaraj discloses that the GPI-anchored immunostimulatory molecules are IL-12 and GM-CSF (Selvaraj, ¶ 0031). Selvaraj teaches that the therapeutic composition comprising membrane particles further comprises a tumor antigen that is HER2 (Selvaraj, ¶ 0012-0013). Selvaraj teaches that the HER2-comprising particles are used in a method of treating breast cancer wherein said breast cancer expresses HER2 (Selvaraj, ¶ 0022-0023). Selvaraj teaches that autologous DCs may be pulsed with an antigen in combination with GM-CSF in order to generate antigen-specific DC vaccines (Selvaraj, ¶ 0151). Selvaraj teaches that GM-CSF directs the antigen to DC receptors, which results in DCs capable of activating T cells that target cells expressing that antigen (Selvaraj, ¶ 0003) and that IL-12 binds to IL-12 receptors on antigen presenting cells (e.g. DCs), resulting in increased activation and antigen presentation (Selvaraj, ¶ 0179). Selvaraj also teaches that the tumor membrane particles of Selvaraj may be used in methods to deliver tumor antigens to DCs and that DC vaccines are used to treat breast cancer (Selvaraj, ¶ 0151). Regarding claim 13, Selvaraj teaches that the particles of Selvaraj are administered in conjunction with a wide range of chemotherapeutics, including but not limited to cisplatin, cyclophosphamide and gemcitabine (Selvaraj, ¶ 0015-0016). Regarding the limitation of claim 7 that the microvesicles come from the patient being treated, Selvaraj teaches that the particle of Selvaraj is an autologous cancer cell membrane vesicle (Selvaraj, Claim 5).
Selvaraj does not explicitly teach of DCs that have been pulsed with the HER2/GPI-anchored IL-12/GPI-anchored GM-CSF tumor microparticles of Selvaraj and administration of said pulsed DCs as a method of treating HER2-positive breast cancer. Selvaraj does not teach that the tumor microparticles are tumor membrane vesicles that have been homogenized and separated by centrifugation having diameters ranging from about 50 nm to about 7000 nm and have an average diameter of 200 nm.
Patel teaches on the subject of antigen delivery via plasma membrane vesicles (PMVs) incorporating GPI-anchored antigens (Patel, Abstract). Patel teaches that the PMVs of Patel are prepared by homogenation followed by centrifugation, resulting in the formation of vesicles containing lipid bilayer, making them amenable to protein transfer using GPI anchored immunostimulatory molecules (Patel, p 3, ¶ 1). Patel teaches that GPI-anchored proteins are produced by producing DNA constructs comprising the CD59 GPI-signal sequence attached to sequences for immunostimulatory molecules such as HER2, B7-1 and IL-12 (Patel, p 4, ¶ 1). Patel teaches that PMVs comprising HER2, IL-12 and B7-1 (all GPI-anchored) had an average diameter of 331.8 nm (Patel, p 9, ¶ 1).
It would be prima facie obvious to one of ordinary skill in the art in view of the teachings of Selvaraj to generate DCs that have been pulsed with the HER2/GPI-anchored IL-12/GPI-anchored GM-CSF tumor microparticles and to administer said pulsed DCs as a method of treating HER2-positive breast cancer. Selvaraj teaches that the tumor microvesicles of Selvaraj may be used in methods of directing tumor antigens to DCs. Selvaraj also teaches that the IL-12 and the GM-CSF anchored to the tumor microvesicles of Selvaraj both enhance the immunogenic that antigens have on DCs. Selvaraj also teaches that DC-based vaccines may be used to treat to treat breast cancer and that HER2 is a target antigen for breast cancer. All of these teachings coupled with the direct suggestion of Selvaraj to use the tumor microvesicles of Selvaraj to direct antigens towards DCs creates a motivation to generate the aforementioned tumor microvesicle-pulsed DCs and use them in a method of treating HER2-positive breast cancer that would be obvious to one of ordinary skill in the art. The motivation is the desire to better treat HER2-positive breast cancer. The nexus of this application of the teachings of Selvaraj is the tumor microvesicle-pulsed DCs themselves. Selvaraj teaches both a use of such DCs (to treat HER2-positive breast cancer) as well as means to generate such DCs via the tumor microvesicles of Selvaraj. One of ordinary skill in the art would have a reasonable expectation of success generating the aforementioned HER2 specific, tumor microvesicle-pulsed DCs and using said DCs in a method of treating HER2-positive breast cancer because: 1) Selvaraj teaches microvesicles comprising the HER2 antigen and further comprising GPI-anchored IL-12 and GM-CSF, 2) Selvaraj teaches that HER2 is an important breast cancer-associated antigen and 3) Selvaraj directly suggest the use of these microvesicles to better direct antigens toward DCs.
Regarding claim 13 specifically, Selvaraj also teaches that cancer may also be treated with chemotherapy agents such as cisplatin as well as with DC based vaccines. Combinations of two compositions each taught individually in the prior art to be useful for the same purpose for use in that purpose are considered prima facie obvious combinations. In the instant case, Selvaraj teaches both chemotherapy agents as well as DC-based vaccines to be useful for the treatment of cancer and thus a combination of DC-based vaccines and chemotherapy agents for the treatment of cancer is a prima facie obvious combination (See MPEP § 2144.06).
It would be further obvious to combine the teachings of Selvaraj discussed above with the PMV protein transfer process taught by Patel. The net result of this combination would be PMVs prepared by the homogenation/centrifugation method of Patel, said PMVs comprising HER2, IL-12 and GM-CSF (all GPI anchored). One of ordinary skill in the art would be motivated to do this in order to have a reliable, known method of developing the microparticles of Selvaraj comprising multiple GPI-anchored immunostimulatory compounds. One of ordinary skill in the art would have a reasonable expectation of success using the homogenation/centrifugation method of Patel to produce the HER2/IL-12/GM-CSF microparticles of Selvaraj because Patel teaches a known method to produce such particles comprising multiple GPI-anchored immunostimulatory compounds that work for any immunostimulatory compound wherein the DNA sequence is known.
Regarding the average diameter limitation of claim 16, the method of Patel produces particles with a diameter of 338.1 nm and not 200 nm and a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.) (See MPEP § 2144.05(I)).
Response to Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
Applicant first argues that the claims subject to this 35 USC § 103 rejection are not obvious. Nearly the entirety of this line of argumentation is highly similar (and at times identical) to the arguments submitted by Declarant in the Declaration submitted 10/13/2025 and, as such, most of the counterarguments are the same and have been addressed in the response to Declarant above. Briefly, Applicant, like Declarant, attempts to differentiate the instant claimed invention from the Selvaraj 2015 reference by arguing that Selvaraj 2015 teaches DC-tumor cell hybrid DC vaccines only and does not teach DC vaccines comprising DCs that have been pulsed ex vivo with GM-CSF/IL-12/HER2 comprising, tumor membrane vesicle-derived particles or methods of treating breast cancer comprising administering such DC vaccines. As articulated in the response to Declarant above, although Selvaraj 2015 does not explicitly teach HER2-targeting DC vaccines prepared by pulsing DCs ex vivo with GM-CSF/IL-12/HER2 comprising, tumor membrane vesicle-derived particles, the fact that Selvaraj 2015 teaches both: A) that tumor membrane-derived particles comprising GPI-anchored immunostimulatory compounds (such as GM-CSF and IL-12) and further comprising an embedded antigen activate DCs and B) that pulsing DCs ex vivo with a GM-CSF/PAP antigen fusion ex vivo resulted a DC vaccine targeting the PAP antigen provides more than sufficient teaching and suggestion to cause one of skill in the art to expect that pulsing DCs ex vivo with GM-CSF/IL-12/HER2 comprising, tumor membrane vesicle-derived particles will result in a HER2-targeting DC vaccine with a reasonable expectation of success. Regarding Applicant’s arguments regarding the use of such DC vaccines to treat TNBC, the inclusion of the Das Roy reference in the 35 USC § 103 rejection below remedies this alleged “deficiency” because Das Roy teaches MUC-1 as an antigen that is expressed (and therefore targetable) in TNBC.
Applicant also makes arguments related to Secondary Considerations, pointing out that the examiner must ask if the improvement is more than the predictable use of prior art elements in their established function. Applicant points sections of the reference Munoz 2021 (Munoz, et al., Internat. J. of Molec. Sci 2021 22(16):8377), of record) to support Applicant’s contention that the alleged improvement associated with the instant claimed invention is more than the predictable use of prior art elements. Applicant Cites Munoz 2021, p5, Section 3.2 (last paragraph) and Munoz 2021, p 7 section 3.4. Both of these sections of the Munoz reference report that DCs pulsed ex vivo with particles comprising both GM-CSF, IL-2 and antigen possessed stronger anti-tumor effects when compared to DCs pulsed with particles with either antigen alone or antigen + either of anchored immunostimulatory agents alone. Applicant cites Institute Pasteur v Precision Biosciences (Fed. Cir. 2012), which held that an invention was not obvious because one of skill in the art would not have reasonably predicted the successful adaptation of a GIIE endonuclease to promote targeted gene transfer into non-chromosomal DNA in prokaryotic cells to target chromosomal DNA in eukaryotic cells. Applicant alleges that, similarly, it was not predictable whether pulsing DCs with TMVs comprising GPI-anchored immunostimulatory agents would result in superior uptake of vesicles, DC activation and cytokine production or that adaptive transfer of TMV-pulsed DCs to tumor-bearing mice would result in inhibition of breast cancer growth.
None of the above arguments of the preceding are persuasive because all of the design elements combined to arrive at the instant claimed DC vaccine are taught in the prior art and behave in a highly predictable manner. For example, Selvaraj 2015 teaches the HER2 antigen/immunostimulatory agent particles of Selvaraj 2015 are capable of activating DCs. Selvaraj 2015 also teaches that DCs can be pulsed ex vivo with a different combined antigen/immunostimulatory agent structure that is the GM-CSF/PAP antigen fusion of Selvaraj 2015 to form DC vaccines that recognize and target the PAP antigen. Putting those two teachings together and coming to the conclusion that DCs pulsed ex vivo with the HER2 antigen/immunostimulatory agent particles of Selvaraj 2015 is likely to produce a HER2-targeting DC vaccine is simply a logical assembly of known art elements that, when tested, behave very predictably. Selvaraj 2015 teaches that both GM-CSF and IL-12 work to activate DCs. It is entirely predictable that exposing DCs to an antigen in the presence of multiple immunostimulatory agents would result in higher levels of DC activation when compared exposure to the same antigen with a single ISI only. It is also well within the purview of one of skill in the art to predict that a HER2-targeting DC vaccine is likely to treat HER2-expressing breast cancer and that a MUC1-targeting DC vaccine is likely to treat TNBC due to the teachings of Das Roy.
Claim(s) 7, 13-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj (Selvaraj, et al., US 2015/0071987A1; Published 03/12/2015, of record) and Patel (Patel, et al., Biomaterials 2016 74:231, of record) as applied to claims 7 and 13-14 above and in further view of Das Roy (Das Roy, et al., Genes and Cancer (2017) 8:536-549, of record).
The combined teachings of Selvaraj and Patel are discussed above. In addition to the teachings of Selvaraj discussed above, Selvaraj also teaches that the tumor antigen bound to the microvesicles of Selvaraj is MUC-1 (Selvaraj, Claim 9).
The combined teachings of Selvaraj and Patel do not teach a method of treating triple negative breast cancer, said method comprising the administration of DCs that have been pulsed with tumor microvesicles comprising a tumor antigen and GPI-anchored IL-12 and GM-CSF
Das Roy teaches that 92% of TNBC cases are positive for MUC1 (Das Roy, p 538, Table 1c).
It would be prima facie obvious to one of ordinary skill in the art to apply the teachings of Das Roy to the teachings of Selvaraj and Patel discussed above with the net result being a method of treating triple negative breast cancer (TNBC) comprising the administration of DCs that have been exposed ex vivo to autologous tumor microvesicles comprising glycosylated MUC1 as well as GPI-anchored GM-CSF and IL-12 in combination with any one of the chemotherapeutics also taught by Selvaraj. One of ordinary skill in the art would be motivated to make such an application in order to better treat TNBC. As discussed above, Selvaraj teach a method of treating HER2 positive breast cancer comprising the administration of DCs that have been pulsed with tumor microvesicles comprising HER2 as well as GPI-anchored GM-CSF and IL-12 in combination with any number of chemotherapeutics. TNBC is a clinically significant form of breast cancer that does not express HER2 and thus HER2-based DC vaccines would not be likely to have an effect on TNBC. Das Roy teaches that 92% of TNBC cases do express MUC1 and Selvaraj teaches that MUC1 may be used as the tumor antigen on the tumor microvesicles instead of HER-2. One of ordinary skill in the art would have a reasonable expectation of success substituting the HER2 microvesicles taught by the teachings of Selvaraj with MUC1 (also taught by Selvaraj) microvesicles to generate DCs for use in a method of treating TNBC because one of ordinary skill in the art would reasonably deduce that MUC1-based microvesicle vaccines would be likely to affect TNBC because TNBC does not express HER2 but does express MUC1.
Response to Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
Applicant argues that the Das Roy reference does not teach or suggest a DC cancer treatment method of treating breast cancer using DCs pulsed ex vivo with tumor membrane vesicles obtained from tumor tissue from a human patient. Applicant further argues that Das Roy merely reports the use of an anti-MUC1 antibody to aid in the early detection of breast cancer and that Das Roy does not make up for the alleged “deficiencies” of Selvaraj 2015 and Patel.
This line of argumentation is not persuasive because one of ordinary skill in the art would readily realize that the pulsing DCs ex vivo with the membrane particles of Selvaraj 2015, which comprise HER2 as the anti-tumor antigen, would not give rise a DC vaccine capable of being used in methods of treating TNBC because TNBC is HER2 negative. One of ordinary skill in the art would also readily realize Das Roy’s teaching that 92% of TNBC cells express MUC1 means that pulsing DCs ex vivo with MUC1-comprising particles instead of HER2-comprising particles would give rise to a DC vaccine recognizing MUC1, which could be used to treat TNBC because Das Roy teaches that MUC1 is highly expressed in TNBC and, as such, is a suitable target antigen.
Conclusion
Claims 7, 13-14 and 16-18 are rejected.
No claims are allowed.
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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643