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 1-21, 36-127 have been canceled. Claims 128-144 have been added. Claims 22-35 and 128-144 are pending and examined on the merits.
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 22-35 and 128-144 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite selecting the whole-cell cancer vaccine for the subject when the HLA allele profile of the subject matches the HLA allele profile of the whole cell cancer vaccine. Claims 23-33, 128-143 list the various human HLA alleles, all of which are known in the art. Absent an active method step based on the selection, “selecting” is an abstract idea. This judicial exception is not integrated into a practical application because no active method step relying on the abstract idea to add a meaningful limitation to the method. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the listing of various human HLA alleles in the dependent claims are well-known in the art.
Claim Rejections - 35 USC § 112
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.
Claim 34 is 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 34 states that the whole cancer cell vaccine is selected for the subject when one or more alleles in the HLA allele profile of the subject match the HLA allele profile of the whole cell cancer vaccine. However, claim 22(c) requires that the whole cell cancer vaccine is selected for the subject when the HLA allele profile of the subject matches the HLA allele profile of the whole cell vaccines. Thus, claim 34 fails to further modify claim 22.
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.
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 22-35 and 128-144 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.
It is unclear if the HLA genes recited in claims 23-33, 128-143 refer to the HLA genes in the sample obtained from the subject, or if the HLA genes refer to those of the whole cell cancer vaccine.
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 22-24, 34 and 144 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Podack (WO2010/045573).
Podack discloses a method of treating cancer with a whole cell lung cancer vaccine expressing exogenous HLA-A1 and HLA-A2 (paragraph [0066] lines 2-4), comprising subjecting patients with lung cancer to HLA typing (paragraph [0064], line 12) and selecting the patients who are HLA-A1 or HLA-A2 to receive the HLA-matched vaccine. The method of Podack meets the limitations of claim 22 for detecting the presence or absence of one or more alleles, HLA-A1 or HLA-A2, in a sample obtained from the subject; comparison of the subjects HLA typing to the HLA-A1 and HLA-A2 in the transfected whole cell lung cancer vaccine, and selecting the transfected whole cell lung cancer vaccine for patients who were HLA-A1 or HLA-A2 (paragraph [0067] lines 2-3). This method also meets the limitations of claim 23 for a HLA-class I gene, claim 24 for a HLA-A gene and claim 144 for lung cancer.
Claims 22, 23, 24, 28, 29, 31, 34, 35, 128, 129, and 144 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peretz et al (WO2012/156969).
Peretz et al disclose screening methods and means for identifying patients amenable for treatment with partially matched allogeneic cell vaccine (abstract). Peretz et al disclose that matching the HLA phenotype of the donor cells and the recipient is essential for efficient cell-mediated cytotoxicity in response to vaccine treatment (page 1, lines 4-6 of the bottom paragraph). Peretz et al disclose that in the absence of HLA compatibility, vaccines rely on antigen presenting cells to process and present antigens in the context of the host HLA to elicit an immune effect (page 1, lines 6-8). Peretz et al disclose that this can lead to CD8 responses in addition to regulatory T cells (pages 1-2, bridging sentence).
Peretz et al disclose a method of tumor cell vaccination comprising administering to a subject one or more cell lines that are allogeneic to the subject but express at least one HLA allele identical to the HLA allele of the subject (page 5, lines 1-4), wherein the specific cell lines are SH-M-20, SH-M-20-A2, SH-M-21, SH-O-30 and SH-L-40 (page 5, third full paragraph) which meets that limitation in claims 1, and 34 and claim 35 because “at least one allele” reads on a match of two or more alleles Peretz et al disclose that SH-M-20 expresses HLA-A2, A24 , A33, B35, and CW04/12 (page 5, lines 1-5); SH-M-20-A2 expresses HLA-A24 and HLA-A2 (pages 5-6, bridging paragraph); SH-M-21 expresses HLA-A2, A24 and B33 (page 6, first full paragraph); SH-L-40 expresses HLA-A2, A26, A28, B14, B35, DRB01, DRB104 (page 6, second full paragraph); and SH-O-30 expresses HLA-A2, 03, 25, B08/18, DRB1 (page 6, third full paragraph), thus fulfilling the requirement for an allele profile for the whole cell cancer vaccine by which to compare the HLA alleles of the subject, because by necessity the HLA alleles of the subject have to be detected as comprising or not comprising the HLA alleles of the tumor cell lines to be used as the vaccine, to determine that the subject has a common allele or alleles with the vaccine. The method of Peretz et al meets the limitations of claim 23 for both class I and class II because the DRB genes are MHC II; claim 24 for HLA-A, B and C; claim 28 for an HLA class II beta subunit gene; claim 29 for a HLA-DR gene; claim 31 for a HLA-DRB1. Because the allele profile of the whole cell cancer vaccines of ); SH-L-40 and SH-O-30 express both class I and class II alleles comprising HLA-A and HLA-DR, one of skill in the art can envisage that they will be selected for a subject with a cancer expressing the same HLA-A and HLA-DR alleles, thus anticipating claims 128 and 129. Peretz et al disclose that the subject has melanoma, lung carcinoma or ovarian carcinoma (page 8, lines 18-19) which meets the limitations of claim 144.
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.
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 22-35 and 128-144 are rejected under 35 U.S.C. 103 as being unpatentable over Peretz et al (WO2012/156969) in view of Reinherz et al (WO2012/083240).
Peretz et al teach the limitations of claims 22, 23, 24, 28, 29, 31, 34, 35, 128, 129, and 144 for the reasons set forth above. Peretz et al do not specifically teach detecting the presence or absence of the HLA alleles recited in claims 25-27, 30, 32, 33, 130-143.
Peretz et al suggest that the HLA I matching may direct activation of T cells by the vaccine without the need for antigen presenting by the host immune system (page 12, lines 21-22).
The exemplary cell lines of Peretz et al, represent melanoma, ovarian and lung carcinomas (page 7, lines 24-25, 31-32; page 8, lines 3-4 and 7-8). However, Peretz et al teach that the invention can also be used beyond melanoma, ovarian and lung carcinomas to treat generic carcinomas, leukemia, sarcoma, myeloma and lymphoma (page 35, lines 14-17). Peretz et al teach that in one embodiment the cell lines used as vaccines are allogenic to the subject but express at least one HLA allele identical to an HLA of the cell line (page 49, liines14-17). Peretz et al teach the SH-M-20, SH-M-20-A2, SH-M-21, SH-O-30 and SH-L-40 cell lines as a specific embodiments of the invention (page 49, lines 26-28). Thus, one of skill in the art would reasonable conclude that Peretz et al was not limiting the whole cell cancer vaccines of the invention to the SH-M-20, SH-M-20-A2, SH-M-21, SH-O-30 and SH-L-40 cell lines because they are taught as specific embodiments and because Peretz et al teach that the invention is applicable to the treatment of generic carcinomas, leukemia, sarcoma, myeloma and lymphoma were are not represented by the SH-M-20, SH-M-20-A2, SH-M-21, SH-O-30 and SH-L-40 cell lines.
Peretz et al do not specifically teach comparing the HLA allele profile of the subject to the HLA-allele profile of the whole cell cancer vaccine, wherein the alleles were those of claims 25-27, 30, 32, , 33, 130-143.
Reinherz et al teach oligonucleotide-based microarrays for providing high resolution assays for determining donor-recipient compatibility (abstract). Reinherz et al teach a complete set of capture oligonucleotides targeting classical HLA molecules (paragraph [00131] and [0136]) which meet those limitations not taught by Peretz in claims 25, 26, 27, 30, 32, 33, 130-143. In addition to those taught by Peretz et al.
It would have been prima facie obvious at the time prior to the effective filing date to use the complete set of capture oligonucleotides of Reinhertz et al to determine an allelic profile of a whole cell cancer vaccine and the allelic profile of a sample from a subject. One of skill in the art would have been motivated to do so in order to detect the presence or absence of one or more HLA genes in a sample obtained from the subject such that the maximum number of patients can be treated. One of skill in the art would have been motivated to provide a high resolution allelic profiles of both the whole cell cancer vaccine and the sample from the subject in order to accurately match the at least one common allele such that the whole cell vaccine. One of skill in the art would have been motivated to do so because Peretz et al teach that matching the HLA phenotype of the donor cells and the recipient is essential for efficient cell-mediated cytotoxicity in response to vaccine treatment and that in the absence of HLA compatibility, vaccines rely on antigen presenting cells to process and present antigens in the context of the host HLA to elicit an immune effect and this can lead to an undesired TREG response.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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