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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11, 14, 15, 17-19, 21, and 22 in the reply filed on 12/01/2025 is acknowledged.
Claims 29 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/01/2025.
Claims 1-11, 14, 15, 17-19, 21, and 22 are under current examination.
Information Disclosure Statement
Citations provided without a publication date were not considered by the examiner as indicated by a line through on the IDS. See MPEP 609.04(a):
37 CFR 1.98(b) requires that each item of information in an IDS be identified properly. U.S. patents must be identified by the inventor, patent number, and issue date. U.S. patent application publications must be identified by the applicant, patent application publication number, and publication date. U.S. applications must be identified by the inventor, the eight digit application number (the two digit series code and the six digit serial number), and the filing date. If a U.S. application being listed in an IDS has been issued as a patent or has been published, the applicant should list the patent or application publication in the IDS instead of the application. Each foreign patent or published foreign patent application must be identified by the country or patent office which issued the patent or published the application, an appropriate document number, and the publication date indicated on the patent or published application. Each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue. The place of publication refers to the name of the journal, magazine, or other publication in which the information being submitted was published. See MPEP § 707.05(e), for more information on data that should be used when citing publications and electronic documents. Pending U.S. applications that are being cited can be listed under the non-patent literature section or in a new section appropriately labeled.
Specifically, the non-patent literature citation number NPL2 in the IDS filed 03/21/2025 has not been considered because no publisher or publication location has been provided. The date on which the document became publicly available is also not clear.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
There are sequences in the table on page 38 of the specification that are not associated with a SEQ ID number and no separate sequence listing has been provided with the disclosure.
Specifically:
(A) Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
(B) Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “lipid-based” in line 2. This renders the claim indefinite because it is unclear the extent to which the particle must contain a lipid substance. The term lipid-based could be interpreted to require the presence of a lipid in the particle or could embrace e.g. particles forming comparable structures to those that lipids can form.
Claim 7 requires the erythrocyte to be “contained in or otherwise associated with a particle”. The phrase “otherwise associated with” renders the claim indefinite because it is unclear at what point the association falls within the scope of the claims. The claim could be interpreted to read on erythrocytes associated with other particles simply because they are present in the same container, or could be interpreted to limit the erythrocytes to those e.g. electrostatically or covalently associated with a particle.
Claim 8 recites “lipid-based” in line 1. This renders the claim indefinite because it is unclear the extent to which the particle must contain a lipid substance. The term lipid-based could be interpreted to require the presence of a lipid in the particle or could embrace e.g. particles forming comparable structures to those that lipids can form.
Claim 9 requires the erythrocyte to be “contained in or otherwise associated with a liposome”. The phrase “otherwise associated with” renders the claim indefinite because it is unclear at what point the association falls within the scope of the claims. The claim could be interpreted to read on erythrocytes associated with liposomes simply because they are present in the same container, or could be interpreted to limit the erythrocytes to those e.g. electrostatically or covalently associated with a liposome. In the interest of compact prosecution, the examiner has interpreted the claim to embrace the broader limitations.
Claims depending from rejected claims are also rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 7, 8, 10, 11, 14, 15, 17-19, 12, and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring organism without significantly more.
With regard to claims 1, 3, 4, 15, 21, and 22, the claims recite “an immunogenic composition for administration to a first mammal, said composition comprising erythrocytes and an erythrocytic organism, wherein the erythrocytes are from a second mammal of a species different from the first mammal”. Given the broadest reasonable interpretation, the claims read on an intact red blood cell that has been infected with a parasite, or in the case of claims 21 and 22, with the specific parasites recited in the claim. As intact red blood cells from many species including canine, bovine, and humans naturally become infected with parasites, including the parasites recited in instant claims 21 and 22, the claims read on a product of nature and are therefore directed to a judicial exception. With regard to claims 2, 11, and 14, these claims require the parasite to have been inactivated or killed. As a parasite eventually dies under natural circumstances, these claims also read on a product of nature. With regard to claims 7 and 8, which respectively require the erythrocytes to be contained in or otherwise associated with a particle, and lipid-based particle, these claims read on greater than one erythrocyte associated for example by being present in the same container. As a collection of erythrocytes that are infected with a parasite also exists in nature, these claims also require no additional elements. Claim 10 requires the composition to further comprise a cell targeting ligand. As erythrocytes express cell targeting ligands such as ICAM-4 (see: Hermand JBC Vol 278(7); pp4892-4898: abstract), the claim reads on a plurality of isolated erythrocytes that have been infected with a parasite as explained above. This judicial exception is not integrated into a practical application because the claims do not require any further structural limitations other than the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are required by the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7, 8, 10, 11, 15, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Good et al. (US 2014/0186402; publication date: 07/03/2014) as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003).
With regard to claims 1 and 3, Good discloses an immunogenic composition for use as a vaccine comprising red blood cells (i.e. erythrocytes) infected with merozoites of Plasmodium (i.e. an erythrocytic organism) that were treated with centanamycin or tafuramycin A (abstract). The erythrocytes are derived from mammals (0102), and in an example they are derived from mice (see 0110 – 0121). With regard to the limitation of instant claim 1 requiring that the composition is for administration to a first mammal and the erythrocytes are from a second mammal of a species different than the first, this is an intended use of the composition and does not structurally distinguish the instant invention from that disclosed by Good.
With regard to claims 2 and 11, the parasites within the red blood cells (pRBCs) have been treated chemically with the centanamycin or tafuramycin A, causing attenuation of the parasite (0043).
With regard to claim 4, the composition preferably does not contain an adjuvant.
With regard to claims 7 and 8, these claims read on a plurality of parasite infected red blood cells. Claims 7 and 8 respectively require the erythrocytes to be contained in or otherwise associated with a particle, and lipid-based particle, therefore these claims read on greater than one erythrocyte, which is a lipid-based particle, associated for example by being present in the same container. Mice were administered up to 107 pRBCs in example methods, therefore Good discloses a plurality of parasite infected erythrocytes.
With regard to claim 10, this claim requires the composition to further comprise a cell targeting ligand. As erythrocytes express cell targeting ligands such as ICAM-4 (Hermand: abstract), the claim reads on isolated erythrocytes that have been infected with a parasite as explained above.
With regard to claim 15, the erythrocytes are intact (abstract, 0108).
Claims 17 and 18 limit the first mammal to a non-human animal (Good discloses mice) and to a canine or bovine, respectively. As the first mammal only pertains to the intended use of the composition, limiting the mammal into which the composition is to be administered does not add any structural limitations over the composition disclosed by Good.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7, 8, 10, 11, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Good et al. (US 2014/0186402; publication date: 07/03/2014) as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003).
As noted in the anticipation rejection above Good anticipates claims 1-4, 7, 8, 10, 11, 15, 17, and 18 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103(a) over Good for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
With regard to claim 19, Good does not disclose an example where the infected erythrocytes are derived from a human as required by the current claim language; however, Good does disclose that humans can be infected by the parasite (Plasmodium/malaria; abstract). It would have been prima facie obvious to derive the infected erythrocytes from any animal that is capable of being infected by the parasite, including a human, because one having ordinary skill in the art would have recognized this as a suitable source. See MPEP 2143(I)(A).
Claims 5, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Good et al. (US 2014/0186402; publication date: 07/03/2014) as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003) as applied to claims 1-4, 7, 8, 10, 11, 15, and 17-19 above, and further in view of Giddam et al. (Acta Biomaterialia 44 (2016)295-303).
The relevant disclosure of Good is set forth above and does not disclose including and adjuvant (instant claim 5), a lipid-based adjuvant (claim 6), or a liposome (instant claim 9).
With regard to claim 9, Giddam discloses a whole parasite vaccine that is formed from Plasmodium-infected red blood cells that are subsequently processed to lyse the red blood cell but maintain the malaria-causing organism intact and incorporating the organism into a liposome vaccine (abstract, sections 2.3 – 2.4, page 296). The vaccine formed from lysed red blood cells generates a strong immune response and can be targeted to antigen presenting cells for greater efficiency.
It would have been prima facie obvious to formulate the parasite-containing erythrocytes disclosed by Good in a liposome as required by the instant claims. The skilled artisan would have been motivated to do so in order to increase efficiency of the immune response to the parasite antigens by targeted delivery to the relevant immune cells and had reasonable expectation of success because Giddam describes methodology for doing so.
With regard to claims 5 and 6, which require an adjuvant and a lipid-based adjuvant respectively, the examiner notes that the instant specification defines “adjuvant” as follows: “The term “adjuvant” refers to a compound or mixture that enhances the immune response to an antigen”, and more specifically describes the term “adjuvant” as embracing liposomes having adjuvant function (see pages 26-28 of the specification). As Giddam’s liposomes increase immune response to the vaccine, they fall within the scope of adjuvant and lipid-based adjuvant as these terms are used in the instant application.
With regard to claim 10, as described in the rejection supra, claim 10 is considered prima facie obvious over Good ‘402; however, claim 10 is also obvious over Good in view of Giddam. Giddam also discloses targeting vaccines to antigen presenting cells (abstract).
As discussed above, it would have been prima facie obvious to target Good’s vaccine to antigen presenting cells as required by instant claim 10. The skill artisan would have been motivated to do so in order to increase the chances of a strong immune response in the patient and had reasonable expectation of success because Giddam discloses a method of doing so.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Good et al. (US 2014/0186402; publication date: 07/03/2014) as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003) as applied to claims 1-4, 7, 8, 10, 11, 15, and 17-19 above, and further in view of Anderson et al. (US 20100061992; publication date: 03/11/2010).
The relevant disclosure of Good is set forth above. Good does not disclose a killed or attenuated vaccine as required by instant claim 14.
Anderson discloses that antigens associated with infectious diseases include whole bacteria, whole virus, whole fungi, whole parasites, fragments thereof, lysates thereof, killed versions thereof (0245).
It would have been prima facie obvious to use a killed or inactivated erythrocytic organism (i.e. the parasites disclosed by Good) because one having ordinary skill would have recognized these as a known source of antigen. See MPEP 2144.07.
Claims are 21 and 22 rejected under 35 U.S.C. 103 as being unpatentable over Good et al. (US 2014/0186402; publication date: 07/03/2014) as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003) as applied to claims 1-4, 7, 8, 10, 11, 15, and 17-19 above, and further in view of Good et al. (US 20190224293; publication date: 07/25/2019).
The relevant disclosure of Good ‘402 is set forth above. Good does not disclose the specific erythrocytic organisms required by instant claims 21 and 22.
Good ‘293 discloses that red blood cells infected with apicomplexan parasites can be used for malaria (i.e. Plasmodium) or for species such as babesia (abstract).
It would have been prima facie obvious to formulate a vaccine according to Good ‘402 directed to a babesia species as required by instant claims 21 and 22 because this would merely have been combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)(A)).
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 7, 8, 10, 11, 15, 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims
1-18 of U.S. Patent No. 9539316; and
claims 1-20 of U.S. Patent No. 11406694
as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003).
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims render obvious the instant claims.
Inter alia the claims of the ‘316 and ‘694 patents embrace an immunogenic composition comprising red blood cells infected with said blood-stage malaria parasites (an erythrocytic organism) that have been pre-treated with tafuramycin A or an analog or derivative thereof, prior to administration to a subject, said pre-treatment being effective to attenuate, but not kill said blood stage malaria, and an immunologically acceptable carrier, or a method of eliciting in an animal a protective immune response to an apicomplexan parasite by administering such a complex. With regard to the ‘316 patent, the cells are treated with a chemical to attenuate the parasite and are therefore chemically attenuated. With regard to the ‘694 patent, the parasite is attenuated by administering a delayed death agent; however, MPEP 2144.04(IV)(C) indicates that any order of steps is prima facie obvious, therefore it would have been obvious to administer the chemical to attenuate the parasite within the red blood cells prior to administering the red blood cell-based vaccine resulting in a chemically attenuated erythrocytic organism in the composition. The compositions are free of adjuvant. With regard to the limitation of instant claim 1 requiring that the composition is for administration to a first mammal and the erythrocytes are from a second mammal of a species different than the first as well as the limitations of instant claims 17 and 18 further specifying the first mammal, this is an intended use of the composition and does not structurally distinguish the instant invention from that embraced by the cited patents. With regard to claims 7 and 8, these claims read on a plurality of parasite infected red blood cells. Claims 7 and 8 respectively require the erythrocytes to be contained in or otherwise associated with a particle, and lipid-based particle, therefore these claims read on greater than one erythrocyte, which is a lipid-based particle, associated for example by being present in the same container. With regard to claim 10, this claim requires the composition to further comprise a cell targeting ligand. As erythrocytes express cell targeting ligands such as ICAM-4 (Hermand: abstract), the claim reads on isolated erythrocytes that have been infected with a parasite as explained above. Although the patented claims do not recite a limitation requiring the red blood cells (erythrocytes) to have been derived from a second mammal, specifically a human, the claims indicate that humans are susceptible to developing malaria. As such ). It would have been prima facie obvious to derive the infected erythrocytes from any animal that is capable of being infected by the parasite, including a human, because one having ordinary skill in the art would have recognized this as a suitable source. See MPEP 2143(I)(A).
Claims 5, 6, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims
1-18 of U.S. Patent No. 9539316; and
claims 1-20 of U.S. Patent No. 11406694
as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003) as applied to claims 1-4, 7, 8, 10, 11, 15, 17-19 above, and further in view of Giddam et al. (Acta Biomaterialia 44 (2016)295-303).
The relevant limitations of the ‘316 and ‘694 patents are set forth above. Neither patent limits the composition to one containing an adjuvant.
With regard to claim 9, Giddam discloses a whole parasite vaccine that is formed from Plasmodium-infected red blood cells that are subsequently processed to lyse the red blood cell but maintain the malaria-causing organism intact and incorporating the organism into a liposome vaccine (abstract, sections 2.3 – 2.4, page 296). The vaccine formed from lysed red blood cells generates a strong immune response and can be targeted to antigen presenting cells for greater efficiency.
It would have been prima facie obvious to formulate the parasite-containing erythrocytes embraced by the cited patents in a liposome as required by the instant claims. The skilled artisan would have been motivated to do so in order to increase efficiency of the immune response to the parasite antigens by targeted delivery to the relevant immune cells and had reasonable expectation of success because Giddam describes methodology for doing so.
With regard to claims 5 and 6, which require an adjuvant and a lipid-based adjuvant respectively, the examiner notes that the instant specification defines “adjuvant” as follows: “The term “adjuvant” refers to a compound or mixture that enhances the immune response to an antigen”, and more specifically describes the term “adjuvant” as embracing liposomes having adjuvant function (see pages 26-28 of the specification). As Giddam’s liposomes increase immune response to the vaccine, they fall within the scope of adjuvant and lipid-based adjuvant as these terms are used in the instant application.
With regard to claim 10, as described in the rejection supra, claim 10 is considered prima facie obvious over Good ‘402; however, claim 10 is also obvious over Good in view of Giddam. Giddam also discloses targeting vaccines to antigen presenting cells (abstract).
As discussed above, it would have been prima facie obvious to target the patented vaccine to antigen presenting cells as required by instant claim 10. The skill artisan would have been motivated to do so in order to increase the chances of a strong immune response in the patient and had reasonable expectation of success because Giddam discloses a method of doing so.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims
1-18 of U.S. Patent No. 9539316; and
claims 1-20 of U.S. Patent No. 11406694
as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003) as applied to claims 1-4, 7, 8, 10, 11, 15, 17-19 above, and further in view of Anderson et al. (US 20100061992; publication date: 03/11/2010).
The relevant limitations of the ‘316 and ‘694 patents are set forth above. Neither patent limits the composition to one where the parasite/erythrocytic organism has been inactivated or killed.
Anderson discloses that antigens associated with infectious diseases that can be used in the methods of the invention include whole bacteria, whole virus, whole fungi, whole parasites, fragments thereof, lysates thereof, killed versions thereof (0245).
It would have been prima facie obvious to use a killed or inactivated erythrocytic organism (i.e. the parasites embraced by the cited patents) because one having ordinary skill would have recognized these as a known source of antigen. See MPEP 2144.07.
Claims 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims
1-18 of U.S. Patent No. 9539316; and
claims 1-20 of U.S. Patent No. 11406694
as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003) as applied to claims 1-4, 7, 8, 10, 11, 15, 17-19 above, and further in view of Good et al. (US 20190224293; publication date: 07/25/2019).
The relevant limitations of the ‘316 and ‘694 patents are set forth above. Neither patent limits the composition to one containing the parasitic/erythrocytic organisms required by instant claims 21 and 22.
It would have been prima facie obvious to formulate a vaccine according to Good ‘402 directed to a babesia species as required by instant claims 21 and 22 because this would merely have been combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)(A)).
Claims 1-11, 14, 15, 17, 18, 21 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16, 17, 19, 23, 24, and 26 of copending Application No. 19478143 (reference application) as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘143 application embrace a composition comprising an erythrocytic organism selected from those recited in instant claims 21 or 22 and a plurality of erythrocytes wherein the organism is attenuated, inactivated or killed via chemical agents, wherein the erythrocytes are lysed. The composition comprises or lacks an adjuvant and may be associated with a liposome. With regard to claim 10, this claim requires the composition to further comprise a cell targeting ligand. As erythrocytes express cell targeting ligands such as ICAM-4 (Hermand: abstract), the claim reads on a plurality of isolated erythrocytes that have been infected with a parasite as described above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 19 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16, 17, 19, 23, 24, and 26 of copending Application No. 19478143 (reference application) as evidenced by Hermand et al. (JBC Vol 278(7); pp4892-4898; publication date: 02/14/2003) as applied to claims 1-11, 14, 15, 17, 18, 21 and 22 above, and further in view of Good et al. (US 2014/0186402; publication date: 07/03/2014).
The relevant limitations of the ‘143 claims are set forth above. The claims do not require the organism from which the erythrocytes are derived to be human.
Good discloses that humans can be infected by malaria parasites (Plasmodium/malaria; abstract). It would have been prima facie obvious to derive the infected erythrocytes from any animal that is capable of being infected by the parasite, including a human, because one having ordinary skill in the art would have recognized this as a suitable source. See MPEP 2143(I)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617