DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group III, claim 21, in the reply filed on 7/14/26 is acknowledged.
Additionally, the following Species were elected:
For all claims: protein, bacterial, fungal, protozoic or viral. Applicant elects, for search purposes and without traverse, viral.
For claim 4: the vaccine. For a vaccine from claim 4, Applicant elects, for search purposes and without traverse, COVID-19.
For all claims: elect the lysis cassette and the promoter. For a lysis cassette and promoter, Applicant elects, for search purposes and without traverse, the ssej promoter with the phage phil 74 lysis gene.
For claim 14: the specific promoter. For an exogenous inducible promoter for use in claim 14, Applicant elects, for search purposes and without traverse, salR.
Applicants have amended the non-elected claims 2-14 from a product to a method which now depends on claim 21. They have also amended the method claims 32 and 33 to depend on claim 21. Accordingly, claims 2-14, 32 and 33 are now part of elected Group III. Because claims 2-14, 32 and 33 previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between Groups I and III as set forth in the Office action mailed on 7/14/26 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 18-20, 28 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 2-6, 9-14, 21, 32 and 33 are currently under examination.
Claim Rejections - 35 USC § 112-2nd paragraph
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 2-6, 9-14, 21, 32 and 33 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.
Claims 2-6, 9-14, 21, 32 and 33 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of all of the different bacterial cells with different genes and proteins to be used in the claimed method is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The instant claims relate to an extremely large number of possible compounds/products as the active ingredient in the broadly claimed methods, i.e. 'a [= any] non-pathogenic bacterial cell expressing an [= any] exogenous immunogenic protein intracellularly, wherein the cell comprises a [= any] lysis gene or [= any] lysis cassette operably linked to an [= any] intracellularly induced Salmonella promoter'. Written support and enablement is found for only a very small proportion of the compounds/products claimed, i.e. certain Salmonella vehicles (based on AflhD, Aasd of strain VNP20009) into which certain plasmids were transformed - allowing for the generation of so called 'ID-GFP' and 'ID- OVA' Salmonella (cf. application: Example 1, p. 55, I. 24 - p. 57, I.1 - 7, I. 22 - 30, p. 58, I. 24 - p. 59, I. 25). Despite support and disclosure being provided only for said engineered 'non- pathogenic Salmonella cell', the present claims are not so limited.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claims 2-6, 9-14, 21, 32 and 33 are vague and indefinite because it the mere recitation of a name to describe the invention, e.g., the recombinant bacterial cells expressing an exogenous immunogenic protein intracellularly, wherein the cell comprises a lysis gene and a lysis cassette operably linked to an intracellularly induced Salmonella protein, is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. Neither the claimed bacterial cells, the exogenous immunogenic protein to be expressed intracellularly, nor the lysis gene/s or lysis cassette/s, etc., have been clearly defined by concrete technical features. The claim should provide any structural properties, such as the actual nucleic acid sequence encoding said protein and genes/cassestte, which would allow for one to identify the composition to be used in the treatment methods without ambiguity. The mere recitation of a generic name does not adequately define the population of bacterial cells to be administered. The metes and bounds of the invention cannot readily be understood. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow one to identify what is being claimed. Further, the term 'exogenous immunogenic protein' used is not necessarily limiting, as in principle any protein is immunogenic.
Appropriate clarification and/or correction is required.
Claim 4 is vague and indefinite claim since the scope is uncertain because the trademark or trade name cannot be used properly to describe any particular material or product. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product would not only render a claim indefinite but would also constitute an improper use of the trademark or trade name." (MPEP 2173.05(u); emphasis added). It is noted that claim 4 describes several vaccines by tradename or manufacturer and the structure associated with the vaccine is unclear. Appropriate clarification and/or correction is required.
Specification
The use of the vaccine names which are a trade name or a mark used in commerce, has been noted in this application. See pages 2-3. Any trademark term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112-Written Description
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.
Claims 2-6, 9-14, 21, 32 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The technical evidence disclosed in the description is limited to certain Salmonella vehicles (based on AflhD, Aasd of strain VNP20009) into which certain plasmids were transformed - allowing for the generation of so called 'ID-GFP' and 'ID- OVA' Salmonella (cf. application: Example 1, p. 55, I. 24 - p. 57, I. 1 - 7, I. 22 - 30, p. 58, I. 24 - p. 59, I. 25). The matter for which protection is sought is not clearly defined. The claims attempt to define the subject-matter in terms of the result to be achieved, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. Of note: at the time of filing it had known from Raman et al (Nature Communications. 2021. Vol 12 (1) 1-14; provided by Applicants) that in fact, not any such 'protein' were able to affect tumor growth (cf. Raman: p. 6, left-hand side column, first full paragraph) - the scope of said claims therefore, is considered as encompassing non-working embodiments. In addition, in view of the limited technical evidence provided, the subject matter of said claims, i.e. being directed to medical uses of the respective 'non-pathogenic bacterial cell' cannot be considered finding fair support in the description over the whole breadth of the claimed scope either. Following from the above, the skilled artisan cannot be considered as sufficiently enabled to carry out the invention over the whole breadth of the claimed scope without any undue burden of experimentation.
The instant claims relate to an extremely large number of possible compounds/products as the active ingredient in the broadly claimed methods, i.e. 'a [= any] non-pathogenic bacterial cell expressing an [= any] exogenous immunogenic protein intracellularly, wherein the cell comprises a [= any] lysis gene or [= any] lysis cassette operably linked to an [= any] intracellularly induced Salmonella promoter'.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed vaccines for treating any cancer such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014).
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed vaccines for treating any cancer such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). To satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02.
However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
Claim Rejections - 35 USC § 112-Enablement
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.
Claims 2-6, 9-14, 21, 32 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The instant claims relate to an extremely large number of possible compounds/products as the active ingredient in the broadly claimed methods, i.e. 'a [= any] non-pathogenic bacterial cell expressing an [= any] exogenous immunogenic protein intracellularly, wherein the cell comprises a [= any] lysis gene or [= any] lysis cassette operably linked to an [= any] intracellularly induced Salmonella promoter'. Written support and enablement is found for only a very small proportion of the compounds/products claimed, i.e. certain Salmonella vehicles (based on AflhD, Aasd of strain VNP20009) into which certain plasmids were transformed - allowing for the generation of so called 'ID-GFP' and 'ID- OVA' Salmonella (cf. application: Example 1, p. 55, I. 24 - p. 57, I.1 - 7, I. 22 - 30, p. 58, I. 24 - p. 59, I. 25). Despite support and disclosure being provided only for said engineered 'non- pathogenic Salmonella cell', the present claims are not so limited.
The technical evidence disclosed in the description is limited to certain Salmonella vehicles (based on AflhD, Aasd of strain VNP20009) into which certain plasmids were transformed - allowing for the generation of so called 'ID-GFP' and 'ID- OVA' Salmonella (cf. application: Example 1, p. 55, I. 24 - p. 57, I. 1 - 7, I. 22 - 30, p. 58, I. 24 - p. 59, I. 25). The claims attempt to define the subject-matter in terms of the result to be achieved, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. Of note: at the time of filing it had known from Raman et al (Nature Communications. 2021. Vol 12 (1) 1-14; provided by Applicants) that in fact, not any such 'protein' were able to affect tumor growth (cf. Raman: p. 6, left-hand side column, first full paragraph) - the scope of said claims therefore, is considered as encompassing non-working embodiments. In addition, in view of the limited technical evidence provided, the subject matter of said claims, i.e. being directed to medical uses of the respective 'non-pathogenic bacterial cell' cannot be considered finding fair support in the description over the whole breadth of the claimed scope either. Following from the above, the skilled artisan cannot be considered as sufficiently enabled to carry out the invention over the whole breadth of the claimed scope without any undue burden of experimentation.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”
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 and/or use the invention commensurate in scope with these claims.
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) 2-6, 9-14, 21, 32 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raman et al (Nature Communications. 2021. Vol 12 (1) 1-14; provided by Applicants) and Forbes et al (WO 2016/025582; provided by Applicants) in view of Liang et al (Cancer Letters. 2019. 448: 168-181; provided by Applicants) and Abdumalamir et al (Cancer Therapy. 2013. 8(8): 10-23, provided by Applicants).
Raman and Forbes teach a non-pathogenic Salmonella cell expressing an exogenous immunogenic protein, e.g. GFP intracellularly, wherein the cell comprises a lysis gene or lysis cassette operably linked to an intracellularly induced Salmonella promoter, i.e. PsseJ-LysE.
Raman shows that 'bacterial delivery of constitutively active caspase-3 blocks the growth of hepatocellular carcinoma and lung metastases, and increases survival in mice (cf. Raman: abstract, Fig. 1 - 7, p. 2 - 9, p. 10, Supplementary information: Table 1: IDSal, flhDCreporting, sifA ID Sal, AsseJ ID Sal, NIPP1-CD Sal, CT Casp-3 Sal, Table 2: P4, P7, P8, P11, P12, cf.) . Raman discloses ‘intracellular delivery of protein drugs', i.e. ID Salmonella expressing or NIPP1-CD or CT Casp-3 in vitro and in vivo (cf. D1: p. 6, right-hand side column - p. 7, Fig. 6, 7, Supplementary Fig. 2 - 6, Table 1: CT Casp-3 Sal). Raman shows that 'delivery of CT Casp-3 was effective against both liver cancer and triple negative breast cancer in mice [and] significantly reduced growth of two liver cancer models: BNL-MEA and Hepa 1 - 6 Raman did not determine any T-cell responses.
Forbes discloses an attenuated Salmonella strain comprising a lysis gene or cassette operably linked to an intracellularly induced Salmonella promoter. In one embodiment, the promoter is a promoter for one of the genes in Salmonella pathogenicity island 2 type III secretion system (SPI2-T3SS) selected from the group SpiC/SsaB, SseF, SseG, SseI, SseJ, SseK1, SseK2, SifA, SifB, PipB, PipB2, SopD2, GogB, SseL, SteC, SspH1, SspH2, or SirP. In one embodiment, a Salmonella gene is under the regulation of an inducible promoter, wherein the gene is selected from ftsW, ftsA, ftsZ, murE, mukF, imp, secF, eno, hemH, tmk, dxs, uppS, cdsA, accA, pssA, msbA, tsf, trmD, cca, infB, rpoA, rpoB, rpoC, holA, dnaC, or eng. In one embodiment, the Salmonella strain further comprises a plasmid that expresses DNA, shRNA, non-coding RNA and/or a peptide. See abstract, Examples 1 - 4, Fig. 1 - 6.
However Raman and Forbes differ from said known medical use of the ID Salmonella expressing CT Casp-3 for the treatment of cancer in vivo in that they do not particularly describe that “the subject has previously been exposed to the exogenous immunogenic protein, wherein the exogenous immunogenic protein is not from the same species as the subject” as recited in instant claim 21.
However, the instant specification does not disclose any comparative tests, i.e. taking CT Casp-3 Sal as a control. In as far as the specific embodiment was concerned, i.e. ID-OVA - Salmonella transformed with a plasmid that encodes for the production of intracellular release of ovalbumin the application disclosed experiments to 'test whether pre-existing, vaccine generated immunity could be retargeted against cancer' by administering antigen-delivering ID Salmonella to vaccinated, tumor-bearing mice and found that tumor growth in mice injected with ID-OVA Salmonella was significantly reduced compared to mice injected with control ID-GFP (cf. application: Example 1, p. 63. I. 23 - 29, Fig. 2B p. 64, I. 17 - 31, Fig. 4, 5).
In as far as the specific embodiment is concerned, the technical effect/s disclosed in the specification can be considered as the provision of ID Salmonella as means for the formation of antitumor immunity (cf. application: p. 66, I. 4 - p. 68, I.14). However, the instant specification does not disclose any unexpected technical effect/s associated with the difference identified above over the state / over the whole breadth of the claim's scope of general claim 21. Therefore, the technical problem to be solved is considered as the provision of further medical use/s of ID Salmonella expressing a different 'exogenous protein' - possibly to (a) different patient group/s. The instant specification also lacks any demonstrated technical effect/s over the state of the art.
At the time of filing it had been known in the state of the art that Salmonella induced tumor suppression is not only mediated by intrinsic anti-tumor activity of Salmonella itself but also by the host immune responses, including inflammatory and T cell-dependent immune responses.’ See Liang et al: abstract, p. 170, right-hand side column - p. 171, right-hand side column, I. 5, Tab. 1 and Abdumalamir et al in the abstract, p. 17, VII. Therefore, the features 'an anti-tumor, CD4 T cell specific immune response' and/or 'CD8 T cell specific immune response' as disclosed by Raman’s teaching by means of 'implicit disclosure'. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to treat cancer using the bacterial cells of prior art wherein the subject has been previously exposed or vaccinated against said protein.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 9/3/26
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