DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 9-15, 65-67, and 86-89 in the reply filed on September 4, 2025 is acknowledged.
Claim Objections
1. Claims 9-15, 65-67 and 86-89 are objected to because of the following informalities: Claims 9-15, 65-67 and 86-89 all depend on non-elected claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
2. Claim(s) 9-14, 65-66 and 86-88 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Delisa et al.
The claims are drawn to a method of eliciting an immune response in a mammal, said method comprising providing a cell transformed with a construct suitable to overexpress and display on the surface of the cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides, and administering the cell to the mammal under conditions effective to elicit the immune response.
Delisa et al (US Publication 2010/0233195) disclose of displaying a protein on a cell surface comprising transforming a cell with a nucleic acid construct encoding a ClyA protein fused to a second protein. (See claim 1). Delisa et al further disclose that the second protein is an antigenic protein or peptide, and more specifically, antigens from Streptococcus species or Influenza virus. (See claims 6-7, paragraph 0050). Delisa et al further disclose of Brucella antigens. (See claim 41). Delisa et al further disclose of transfected E. coli strains. (See Example 29). Delisa et al further set forth that ClyA was “significantly enriched” relative to other luminal and membrane bound proteins. (See Example 13). Delisa et al further disclose of administering the transfected cells to elicit an immune response. (See claim 40).
Accordingly, Delisa et al disclose of each and every limitation of the instantly filed claims.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
3. Claims 9-15, 65-66 and 86-88 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Delisa et al in view of Hacker et al.
The claims are drawn to a method of eliciting an immune response in a mammal, said method comprising providing a cell transformed with a construct suitable to overexpress and display on the surface of the cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides, and administering the cell to the mammal under conditions effective to elicit the immune response, wherein the cell is E. coli Nissle.
The teachings of Delisa et al are set forth above.
Delisa et al do not teach of E. coli Nissle.
Hacker et al (US Publication Number 2006/0094117) teach a non-pathogenic E. coli strain DSM6601 host cell (also known as Nissle strain) in an analogous art for the purpose of providing a cloning vehicle [0018] that is a good acceptor of foreign DNA which will express a plurality of genes and proteins [0019] and used in hindering or preventing the growth of other pathogenic microorganisms. (See paragraph 0019).
It would have been prima facie obvious to one of ordinary skill in the art to use the E. coli strain (Nissle) of Hacker in place of the generic teaching of E. coli host cells as taught by Delisa et al, since both references teach non-pathogenic strains of E. coli for recombinant host for expression of foreign DNA and Hacker et al teach the additional advantage of strain Nissle as lacking plasmid DNA that are known to be carriers of pathogenicity factors [005], and is an especially good acceptor of foreign DNA [Hacker, 0019].
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that if a technique has been used to improve one method, and a person of ordinary skill would recognize that it would be used in similar methods in the same way, using the technique is obvious unless its application is beyond that person’s skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Thus, it would have been obvious to apply a known technique (transforming recombinant E. coli hosts) to a know product (Nissle strain of non-pathogenic E. coli is a good acceptor of foreign DNA for expression) to be used in a known method (of making recombinant E. coli Nissle transfected with ClyA-immunogen) that is ready for improvement to yield predictable results.
4. Claims 9-14, 65-67 and 86-88 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Delisa et al in view of Fischer et al.
The claims are drawn to a method of eliciting an immune response in a mammal, said method comprising providing a cell transformed with a construct suitable to overexpress and display on the surface of the cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides, and administering the cell to the mammal under conditions effective to elicit the immune response, wherein the infection is influenza and the antigenic protein is H1N1.
The teachings of Delisa et al are set forth above.
Delisa et al do not teach of H1N1.
Fischer et al (US Publication Number 2009/0081202) teach that antigenic compositions that comprise fusion polypeptides [0204] that comprise a plurality of conserved epitopes to infuenza viruses (type A, B, and C [0128-0134]), to include H1N1 hemagglutinin [0032 “HA”, 0055] fused to one or more microbial peptides that can be expressed on one or more carriers [0204; 0208] in an analogous art for the purpose of obtaining easily manufactured and stored compositions that evidence improved production capacity and vaccine availability; remain effective through at least two Flu seasons so as to reduce production requirements; require lower concentrations of protein; reduce undesirable immune responses; enhance protection even when a new human virus emerges or mutations occur in circulating strains; or any combination thereof [0020].
It would have been prima facie obvious to one of ordinary skill in the art to use the Influenza virus H1N1 hemagglutinin of Fischer et al in place of the generic teaching of Influenza virus as taught by Delisa et al, since both references teach fusion proteins that combine Influenza virus peptides or proteins for surface expression.
5. Claims 9-14, 65-66 and 86-89 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Delisa et al in view of Chen et al.
The claims are drawn to a method of eliciting an immune response in a mammal, said method comprising providing a cell transformed with a construct suitable to overexpress and display on the surface of the cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides, and administering the cell to the mammal under conditions effective to elicit the immune response, wherein the antigenic protein or peptide is Mycobacterium paratuberculosis 74F.
The teachings of Delisa et al are set forth above.
Delisa et al do not teach of Mycobacterium paratuberculosis 74F.
Chen et al (Vaccine Vol. 26, pp 1253-1262, 2008) teach that at the time of the invention it was routine in the art to elicit immune responses via administration of Mycobacterium paratuberculosis 74F proteins. (See abstract).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to use the Mycobacterium 74F protein as taught by Chen et al in place of the generic teaching of bacterial immunogens as taught by Delisa et al, since both references teach immunizing with proteins for eliciting an immune response.
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.
6. Claims 9-15, 65-67 and 86-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10,918,706. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to a method of eliciting an immune response in a mammal, said method comprising providing a cell transformed with a construct suitable to overexpress and display on the surface of the cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides, and administering the cell to the mammal under conditions effective to elicit the immune response, are anticipated by the claims of ‘706 drawn to method of eliciting an immune response in a mammal, said method comprising providing a probiotic cell transformed with a construct suitable to overexpress and display on the surface of the cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides, and administering the cell to the mammal under conditions effective to elicit the immune response. (See claim 1).
7. Claims 9-15, 65-67 and 86-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 9,808,517. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to a method of eliciting an immune response in a mammal, said method comprising providing a cell transformed with a construct suitable to overexpress and display on the surface of the cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides, and administering the cell to the mammal under conditions effective to elicit the immune response, are anticipated by the claims of ‘517 drawn to method of eliciting an immune response in a mammal, said method comprising providing a probiotic cell transformed with a construct suitable to overexpress and display on the surface of the cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides, and administering the cell to the mammal under conditions effective to elicit the immune response. (See claims 29-44).
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 September 22, 2025