DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s species election without traverse of (i) conjugating the microvesicle to an antibody having an affinity to phosphatidylserine and (ii) TNF-alpha receptor in the reply filed on 8/12/2026 is acknowledged.
3. Claims 17-28 are pending. Claims 1-16 are canceled. Claims 20-22 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/12/2026.
4. Claims 17-19 and 23-27 are under examination.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on 4/26/2022, 3/13/2023, 5/18/2028 and 6/12/2024 have been considered by the examiner.
Abstract
6. The abstract of the disclosure is objected to for containing legal phraseology.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
7. Claims 17 and 23-25 are objected to because of the following informalities:
Claim 17 is objected to because the phrase “the steps of” is recited twice in lines 2-3.
Claim 23 is objected to for using the word “conjugating” to describe a binding between antibody and antigen (phosphatidylserine on the microvesicle). In biochemistry, the term “conjugated to” in general means chemically linked by a covalent bond. For example, an antibody conjugated to a toxin directly or via a linker. The binding between antibody and antigen is noncovalent. An appropriate word to describe the interaction between antibody and antigen is binding.
Claim 24 is objected to for using the word “conjugating” for the same reasons discussed above for claim 23. In this case, there is no covalent bond between the microvesicle and the antigen-presenting cell. The bispecific antibody is capable of binding to the microvesicle and an antigen-presenting cell.
Claim 25 is objected to for a typographical error. the term “Fe” should be corrected to “Fc”.
Claim Rejections - 35 USC § 112
8. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
9. Claims 23-25 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 23 depends from claim 17. Claim 17 recites “generating a vaccine using the antigen”. Claim 23 recites “the step of generating a vaccine comprises conjugating the microvesicle to an antibody having an affinity to phosphatidylserine”, which implies that the vaccine is generated using the microvesicle. Therefore, claim 23 does not specify a further limitation of the subject matter claimed in claim 17. Claims 24 and 25 depend from claim 23 and are rejected for the same reasons.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112
10. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
11. Claims 23-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of generating a vaccine comprising binding the microvesicle to an antibody having an affinity to phosphatidylserine, wherein the antibody is a bispecific antibody that is capable of selectively binding an antigen-presenting cell, does not reasonably provide a method of generating a vaccine comprising conjugating (covalently linking) the microvesicle to an antibody having an affinity to phosphatidylserine, wherein the antibody is a bispecific antibody that is capable of selectively conjugating (covalently linking) the microvesicle with an antigen-presenting cell. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
For this rejection, the term “conjugating” is interpreted as “chemically linking by a covalent bond”.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
''Factors to be considered in determining whether a disclosure would
require undue experimentation have been summarized by the board in Ex
parte Forman. They include (1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented, (3) the presence or
absence of working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the predictability
or unpredictability of the art, and (8) the breadth of the claims.''
The nature of the invention
Claim 23 is drawn to the method of claim 17, wherein the step of generating a vaccine comprises conjugating the microvesicle to an antibody having an affinity to phosphatidylserine.
Claim 24 is drawn to the method of claim 23, wherein the antibody is a bispecific antibody capable of selectively conjugating the microvesicle with an antigen-presenting cell.
Claim 25 is drawn to the method of claim 23, wherein the antibody comprises an Fc portion.
The nature of the invention is a method of making a cancer vaccine.
The invention is in a class of invention, which the CAFC has characterized as ''the unpredictable arts such as chemistry and biology.'' Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The breadth of the claims
The breadth of the claims encompasses covalently linking an antibody to microvesicles and covalently linking microvesicle to antigen presenting cell via a bispecific antibody.
Working examples and guidance in the specification
The instant specification provides no working examples and guidance on covalently linking an antibody to microvesicle and covalently linking microvesicle to antigen presenting cell via a bispecific antibody.
The state of the prior art and the unpredictability of the art
Yang et al (Microbiology Spectrum, 2014, 2(1): 1-13) teaches “Antibodies bind antigens via noncovalent bonds, such as hydrogen bonds, ionic, hydrophobic, and Van der Waals forces, and their interactions depend strongly on the distance between two interacting molecules. While each individual bond is weak, the collective noncovalent bonds between the antibody and antigen can be strong when all the interacting molecules work together synergistically” (page 1).
Tsuchikama et al (Protein Cell, 2018, 9(1): 33-46) teaches that the antibody-drug conjugate (ADC), a humanized or human monoclonal antibody conjugated with highly cytotoxic small molecules (payloads) through chemical linkers, is a novel therapeutic format and has great potential to make a paradigm shift in cancer chemotherapy (abstract). ADCs comprise monoclonal antibodies and cytotoxic agents (payloads) covalently conjugated through chemical linkers (Fig. 1A) (page 34, column 1, para 2). Though it is important to select optimal target-specific antibodies and potent payloads based on type of cancer cells, the conjugation and linker chemistries are also crucial components for successful construction of an ADC (page 35, column 1, para 2). The linker moiety covalently tethers the antibody and payload components. Its molecular design and properties are critical determinant factors for ADC efficacy in terms of pharmacokinetics (PK)/pharmacodynamics (PD) and therapeutic window. To maximize these parameters, various types of linkers have been developed and evaluated in vitro and in vivo. Several criteria must be met for successful ADC construction. (1) The linker needs to possess sufficient stability in plasma so that ADC molecules can circulate in the bloodstream and localize to the tumor site without premature cleavage. Instability of the linker causes premature liberation of the toxic payload and undesired damage to non-target healthy cells, which can lead to systemic toxicity and adverse effects (page 35, column 1, para 2).
The prior art does not teach how to covalently link an antibody to microvesicles, and covalently link microvesicles to antigen presenting cells via a bispecific antibody.
Level of skill in the art
The level of the skill in the art is deemed to be high
Conclusion
In view of the unpredictability of the art, the lack of working examples and guidance provided in the specification balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation to make the vaccine comprising conjugating (covalently linking) the microvesicle to an antibody having an affinity to phosphatidylserine, wherein the antibody is a bispecific antibody that is capable of selectively conjugating (covalently linking) the microvesicle with an antigen-presenting cell.
Claim Rejections - 35 USC § 103
12. 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.
13. Claims 17, 18, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lentz (US 6,231,536, date of patent: 5/15/2001), in view of Holaday (US 2013/0202644A1, pub. date: 8/8/2013).
Regarding claims 17, 26 and 27, Lentz teaches a method of treating a patient having a solid tumor (claim 2), the method comprises selective removal of sTNFR-1 and sTNFR-2 from the blood of the patient by means of extracorporeal ultrapheresis using immobilized antibodies that are immunoreactive with sTNFR-1 and sTNFR-2 (column 2, lines 1-40, and claims 6-8) (which reads on immunopheresis), wherein the method further comprises vaccinating the patient with vaccine against the tumor (claim 9). Both TNFR-1 and TNFR-2 are receptors for TNF-alpha (TNFα).
Regarding claim 17, Lentz et al. does not teach that the vaccine is generated using microvesicles obtained from the patient, wherein the microvesicles comprise a tumor associated antigen from the tumor of the patient.
Regarding claim 18, Lentz does not teach that the microvesicles are isolated (extracted) using an affinity means to a molecule found on microvesicles.
Holaday teaches a method for treating cancer in an animal comprising administering to the animal an effective amount of a composition comprising dendritic cells electroporated with exosomes derived from the tumor (tumor exosomes), or tumor exosome lysates ([0010], claims), wherein the tumor exosomes are isolated from blood (which are tumor derived microvesicles in circulation) or tumor biopsy ([0017] and [0049]), wherein the exosomes encompass intact exosomes and a fragment thereof including tumor proteins derived from a tumor exosome ([0021], wherein the dendritic cells and the tumor exosomes are derived from the animal to be treated ([0023]), and the animal is human (claim 5). Holaday teaches that exosome may be isolated from the sample using affinity chromatography techniques that recognize the proteins (e.g. EGF receptor, ICAM-1, VEGF) expressed on the surface of exosomes and the affinity chromatography techniques may also employ antibodies or other materials that bind to a previously identified exosome biomarker that is shown to be located on the exterior of the exosome. ([0017]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the vaccine of Holaday in the method of Lentz. One of ordinary skill in the art would have been motivated to do so because Holaday teaches that dendritic cell vaccine can be prepared by loading dendritic cells with either tumor antigens or tumor exosomes and used for treating cancer (claims). One of ordinary skill in the art would have had a reasonable expectation of success because Holaday teaches a method for treating cancer in a patient comprising administering to the patient dendritic cells electroporated with tumor exosomes isolated from blood or tumor biopsy of the patient to be treated ([0010], ([0017], [0021], [0023], [0049] and claims).
14. Claims 17-19, 23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Lentz (US 6,231,536, date of patent: 5/15/2001), in view of Holaday (US 2013/0202644A1, pub. date: 8/8/2013), further in view of Ezrin (WO 2014/152873A1, pub date: 9/25/2014).
For this rejection, the term “conjugating” in claim 23 is interpreted as “binding”.
The teachings of Lentz and Holaday have been set forth above as they apply to claims 17, 18, 26 and 27.
Regarding claims 19, 23 and 25, Lentz and Holaday do not teach that the microvesicles are isolated (extracted) using a chromatography technique which employs an antibody that binds to a phosphatidylserine on the microvesicles, wherein the antibody comprises a Fc region.
Regarding claim 19, Ezrin teaches that in preferred embodiments, the microvesicles are obtained by immunoaffinity capture which uses of an anti-phosphatidylserine antibody which binds to microvesicles having phosphatidylserine molecule with the polar side of the molecule expressed on its outer surface ([0076] and [0085]).
Regarding claim 23, Ezrin teaches that the microvesicles are obtained by immunoaffinity capture which uses of an anti-phosphatidylserine antibody which binds to microvesicles ([0076] and [0085]). The immunoaffinity capture would comprise a step of binding the microvesicles to an anti-phosphatidylserine antibody.
Regarding 25, Ezrin teaches that antibody is a monoclonal antibody or a polyclonal antibody ([0077], which in general comprises a Fc region, or at least renders an antibody comprising an Fc portion obvious.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Lenz and Holaday to use an anti-phosphatidylserine antibody to isolate microvesicles in view of Ezrin. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Ezrin teaches that in preferred embodiments, the microvesicles can be obtained using the immunoaffinity capture which employs an anti-phosphatidylserine antibody which binds to microvesicles having phosphatidylserine molecule with the polar side of the molecule expressed on its outer surface ([0076] and [0085]).
15. Claims 17-19 and 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Lentz (US 6,231,536, date of patent: 5/15/2001), in view of Holaday (US 2013/0202644A1, pub. date: 8/8/2013), Ezrin (WO 2014/152873A1, pub date: 9/25/2014), further in view of Wang et al. (J Immunol Methods, 2005, 306: 80-92).
For this rejection, the term “conjugating” in claims 23 and 24 is interpreted as “binding”.
The teachings of Lentz, Holaday and Ezrin have been set forth above as they apply to claims 17-19, 23 and 25-27.
Regarding claim 24, Lentz, Holaday and Ezrin do not teach isolating microvesicles using a bispecific antibody that binds to phosphatidylserine on the microvesicles and an antigen-presenting cell.
Wang et al. teaches that administration of ex vivo antigen-loaded DC into mice stimulates protective T cell responses against pathogens and tumors, however the disadvantage is that isolation of DC from individual patients is very laborious and costly. As an alternate strategy, direct delivery of antigens to DC may be a desirable treatment (page 89, column 2). Wang et al. teaches a method of in vivo targeting antigen to dendritic cells with a bispecific antibody that binds to DEC-205 expressed on dendritic cells and biotin, wherein the biotin is capable of binding to a biotinylated antigen (abstract). Wang et al. teaches that bispecific targeting of biotinylated antigens to DC could be an alternative, convenient method to deliver antigens to DC, and could be an alternative method to ex vivo stimulation of DC to overcome DC defects and for treatment of cancer (abstract). Wang et al. teaches that targeting of multiple tumor marker antigens to DC using their bispecific antibodies may provide strong immunity against tumors (page 89, column 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a bispecific antibody that binds to phosphatidylserine (PS) on tumor microvesicles and DEC-205 on dendritic cells (DCs) for purpose of in vivo delivery of tumor microvesicles to DCs in view of Wang. One of ordinary skill in the art would have been motivated to do so because Wang et al. teaches that isolation of DC from individual patients to make ex vivo antigen-loaded DCs is very laborious and costly, and a bispecific antibody that binds to antigens and DEC-205 can deliver antigens to DCs in vivo. One of ordinary skill in the art would have had a reasonable expectation of success because methods of making bispecific antibodies were well known in the art, and a bispecific antibody that binds to PS on tumor microvesicle and DEC-205 would deliver tumor microvesicles to DCs in vivo.
Double Patenting
16. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
17. Claims 17-19 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-29 of copending Application No. 19/775,364 (reference application), in view of Ezrin (WO 2014/152873A1, pub date: 9/25/2014), and Wang et al. (J Immunol Methods, 2005, 306: 80-92).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.Attorney Docket No. IMM-AugmentationNP1
Regarding claims 17, 26 and 27, the claims of copending application disclose a method of augmenting radiation therapy in treating a tumor or a patient, comprising the steps of: (a) performing radiation therapy on the patient; and (b) extracorporeally removing a soluble tumor necrosis factor-alpha receptor (sTNFalphaR) from the patient, thereby augmenting the radiation therapy,
wherein the method further comprising administering a vaccine comprising dendritic cells (DC), and the DC are pulsed with a tumor-associated antigen (TAA) prior to administering to the patient, wherein the TAA is selected from tumor-derived microvesicles in circulation (which would require extracting tumor-derived microvesicles from circulation,
where the method further comprising after step (b) performing therapeutic apheresis one or more additional times to remove sTNFalphaR from the patient.
Regarding claims 18, 19 and 23, the claims of the copending application does not disclose that the microvesicle is isolated (extracted) using an affinity means to a molecule found the microvesicle, wherein the molecule is phosphatidylserine (PS), the affinity means employs an antibody that binds to PS on the microvesicle, wherein the antibody comprises a Fc region.
Ezrin teaches that in preferred embodiments, the microvesicles are obtained using the immunoaffinity capture which uses of an anti-phosphatidylserine antibody which binds to microvesicles having phosphatidylserine molecule with the polar side of the molecule expressed on its outer surface ([0076] and [0085]), wherein the antibody is a monoclonal antibody or a polyclonal antibody ([0077], which in general comprises a Fc region, or at least renders an antibody comprising an Fc portion obvious.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the copending application to use an anti-phosphatidylserine antibody to isolate microvesicles in view of Ezrin. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Ezrin teaches that in preferred embodiments, the microvesicles can be obtained using the immunoaffinity capture which employs an anti-phosphatidylserine antibody which binds to microvesicles having phosphatidylserine molecule with the polar side of the molecule expressed on its outer surface ([0076] and [0085]).
Regarding claim 24, the copending application and Ezrin do not teach isolating microvesicles using a bispecific antibody that binds to phosphatidylserine on the microvesicles and an antigen-presenting cell.
Wang et al. teaches that administration of ex vivo antigen-loaded DC into mice stimulates protective T cell responses against pathogens and tumors, however the disadvantage is that isolation of DC from individual patients is very laborious and costly. As an alternate strategy, direct delivery of antigens to DC may be a desirable treatment (page 89, column 2). Wang et al. teaches a method of in vivo targeting antigen to dendritic cells with a bispecific antibody that binds to DEC-205 expressed on dendritic cells and biotin, wherein the biotin is capable of binding to a biotinylated antigen (abstract). Wang et al. teaches that bispecific targeting of biotinylated antigens to DC could be an alternative, convenient method to deliver antigens to DC, and could be an alternative method to ex vivo stimulation of DC to overcome DC defects and for treatment of cancer (abstract). Wang et al. teaches that targeting of multiple tumor marker antigens to DC using their bispecific antibodies may provide strong immunity against tumors (page 89, column 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a bispecific antibody that binds to phosphatidylserine (PS) on tumor microvesicles and DEC-205 on dendritic cells (DCs) for purpose of in vivo delivery of tumor microvesicles to DCs in view of Wang. One of ordinary skill in the art would have been motivated to do so because Wang et al. teaches that isolation of DC from individual patients to make ex vivo antigen-loaded DCs is very laborious and costly, and a bispecific antibody that binds to antigens and DEC-205 can deliver antigens to DCs in vivo. One of ordinary skill in the art would have had a reasonable expectation of success because methods of making bispecific antibodies were well known in the art, and a bispecific antibody that binds to PS on tumor microvesicle and DEC-205 would deliver tumor microvesicles to DCs in vivo.
Conclusion
18. No claims are allowed.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached on Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached on 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG SANG/Primary Examiner, Art Unit 1643
