DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicants’ response of 11/24/2025 is acknowledged.
Status of Claims
3. Claims 7-12 and 15-26 are pending. Claims 1-6 and 13-14 have been canceled by previous amendment.
Priority
4. Applicant’s claim for domestic priority to 2/22/2019 under 35 U.S.C. 119(e) is acknowledged.
Drawings
5. The drawings filed 12/21/2022 in this application have been accepted. No further action by Applicant is required.
Information Disclosure Statement
6. The information disclosure statement filed 12/21/2022 has been considered. An initialed copy is enclosed.
Election/Restrictions
7. Applicants’ response to restriction without traverse of 11/24/2025 is acknowledged. Applicants elected group I (claims 7-12 and 25-26). Claims 15-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/24/2025.
Claim Objections
8. Claims 8 and 9 are objected to because of the following informalities: Please spell out the full meaning of Wnt, LRP6, PD-1 and SIRP. Appropriate correction is required.
Claim Rejections - 35 USC § 112
9. 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.
10. Claim 12 is 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. This is a biological deposit rejection.
The specification lacks complete deposit information for the deposit of GMS515(pK-FZD), GMS515(pK- LRP6), GMS515(pK-PD-1), GMS515(pK-SIRPa), GMS515(pK-VEGFR2), GMS515(pK- PDGFRa), and GMS515(pK-FGFR-1).
Because it not known whether the strains are publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims require said strains, a suitable deposit for patent purposes is required. Exact replication of the strains is an unpredictable event.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Double Patenting
11. The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal ∆∆upon submission. For more information about e=Terminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
12. Claims 7-11 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11/564,954. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of instant application is drawn to:
Claim 7. A genetically modified Salmonella bacterium comprising:
a recombinant gene encoding a human decoy polypeptide;
the following mutations ∆PmurA::TT araC PBAD murA ∆asdA::TT araC PBAD c2 ∆(wza-wcaM) ∆pmi ∆relA ∆recF ∆sifA ∆endA ∆sseL ∆tlpA MmtA::Ptrc f'..lacossshilA; and
one or more of mutations selected from ∆Ptar::Ptrc f'..laco tar, Mtsr::Ptrc ∆laco tsr, and ∆trg.
Claim 8. The genetically modified Salmonella bacterium of claim 7, wherein the decoy polypeptide disrupts Wnt/-catenin signaling.
Claim 9. The genetically modified Salmonella bacterium of claim 7, wherein the decoy polypeptide is selected from a soluble form of human frizzled (FZD) receptor, a soluble form of human LRP6, a soluble form of human PD-I, and a soluble form of human SIRP-alpha.
Claim 10. The genetically modified Salmonella bacterium of claim 7, wherein the bacterium comprises mutation ∆Ptar::Ptrc!'-. ∆laco tar.
Claim 11. The genetically modified Salmonella bacterium of claim 7, wherein the bacterium comprises mutations ∆Ptar::Ptrc ∆laco tar, ∆Ptsr::Ptrc ∆laco tsr, and ∆trg.
Claims 1-3 of U.S. Patent No. 11/564,954 are drawn to:
Claim 1. A genetically modified Salmonella bacterium comprising:
(i) a recombinant gene encoding a human decoy polypeptide;
(ii) the following modifications ΔPmurA25::TT araC PBAD murA, Δ(wcaM-wca)-8, ΔrelA198::araC PBAD laclTT, Δ(araC PBAD)-18::P22 PR araBAD, ΔpagP81::Plpp IpxE, and ΔendA1123;
(iii) the following modifications ΔPtar::Ptrc ΔlacO888 tar, ΔPtsr::Ptrc ΔlacO888 tsr, and Δtrg.
Claim 2. The genetically modified Salmonella bacterium of claim 1, wherein the decoy polypeptide disrupts Wnt/β-catenin signaling.
Claim 3. The genetically modified Salmonella bacterium of claim 1, wherein the decoy polypeptide is selected from a soluble form of human frizzled (FZD) receptor, a soluble form of human low-density lipoprotein receptor-related protein 6 (LRP6), a soluble form of human programmed cell death protein 1 (PD-1), and a soluble form of human signal regulatory protein alpha (SIRP-alpha).
The claims of current application and U.S. Patent No. 11/564,954 both recite genetically modified Salmonella bacterium which are not patently distinct.
13. Claims 7,10,11 are rejected on the ground of non-statutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,717,542 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
the claim of instant application is drawn to:
Claim 7. A genetically modified Salmonella bacterium comprising:
a recombinant gene encoding a human decoy polypeptide;
the following mutations ∆PmurA::TT araC PBAD murA ∆asdA::TT araC PBAD c2 ∆(wza-wcaM) ∆pmi ∆relA ∆recF ∆sifA ∆endA ∆sseL ∆tlpA MmtA::Ptrc f'..lacossshilA; and
one or more of mutations selected from ∆Ptar::Ptrc f'..laco tar, Mtsr::Ptrc ∆laco tsr, and ∆trg.
Claim 10. The genetically modified Salmonella bacterium of claim 7, wherein the bacterium comprises mutation ∆Ptar::Ptrc!'-. ∆laco tar.
Claim 11. The genetically modified Salmonella bacterium of claim 7, wherein the bacterium comprises mutations ∆Ptar::Ptrc ∆laco tar, ∆Ptsr::Ptrc ∆laco tsr, and ∆trg.
Claim 1 of U.S. Patent No. 11/717,542 B2 is drawn to:
Claim 1. A genetically modified tumoricidal Salmonella bacterium, wherein the bacterium is a self-eradicating, genetically modified χ3761 Salmonella bacterium comprising
ΔPmurA25::TT araC PBAD murA,
Δ(wcaM-wca)-8 ΔrelA198::araC PBAD laclTT,
Δ(araC PBAD)-18::P22 PR araBAD,
ΔpagP81::Plpp IpxE,
ΔendA1123 ΔPtar::Ptrc ΔlacO888 tar,
ΔPtsr::Ptrc ΔlacO888 tsr,
Δtrg,
ΔpvkA,
and ΔpykF, wherein the bacterium comprises a lysis vector pYA3681 expressing murA in the presence of arabinose, the lysis vector comprising pBR ori araC* PBAD SD-GTG asdA SD-GTG murA P22 PR anti-sense mRNA.
The claims of current application and U.S. Patent No. 11,717,542 B2 both recite genetically modified Salmonella bacterium which are not patently distinct.
Claim Rejections - 35 USC § 103
14. 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.
15. Claims 7-11 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Curtiss Roy III US (2017/0306338A1), in view of Yun et al. (US 2017/0275340A1). Art of record, applicants search report.
The claims are drawn to:
Regarding claim 7 Curtiss Roy III US 2017/0306338A discloses recombinant bacterium that maybe used to inhibit the growth of a tumor or a tumor cell. Due to their clinical significance Salmonella are considered to particularly useful ( see ,Paras.{0019}-[0020]). Curtiss Roy III US 2017/0306338A teaches a bacterium comprising APtar:: PtrcAlacotar, APtsr: :Ptrc Alac :Otsr, and Atrg mutations(By way of non-limiting example, a bacterium may comprise a APtar: :PtrcAlacO888tar mutation. By way of non-limiting example, a bacterium may comprise a APtsr::PtrcAlacO888tsr mutation,{Para.(0024};Non-limiting examples of suitable mutations may include the Atrg...mutations, Para.{0025]). Curtiss Roy III fails to explicitly disclose encoding a human decoy polypeptide.
Yun et al. US 2017/0275340A1 teach decoy polypeptides such as soluble LRP6 that disrupt Wnt signaling. Yun et al. teach that the present invention relates to an anti-cancer composition containing Wnt decoy receptor which inhibits activation of Wnt signaling involved in tumor development, Para. [0002]; Yun et al. teach that as results , the present inventors have discovered that novel soluble Wnt receptor, sLRP6E1E2, inhibits activation of Wnt signaling Pathway in a cancer cell throrough binding to Wnt 3 a protein , thereby reducing tumor growth , proliferation and metastasis and inducing apoptosis of tumor cells, Para.{0007}).
Regarding Claim 8 , modified Curtiss Roy III discloses the genetically modified Salmonella bacterium of claim 7. Curtiss Roy III fails to explicitly disclose wherein the decoy polypeptide disrupts Wnt/Beta-catenin signaling.
Yun et al. teach decoy polypeptides such as soluble LRP6 that disrupt Wnt signaling Yun et al. teach relates to an anti-cancer composition containing Wnt decoy receptor which inhibits activation of Wnt signaling involved in tumor development ,Para (0002); Yun et al. teach as results , the present inventors have discovered that novel soluble Wnt receptor, sLRP6E1E2, Inhibits activation of Wnt signaling Pathway in a cancer cell through binding to Wnt3 a protein, thereby reducing tumor growth, proliferation and metastasis and inducing apoptosis of tumor cells, Para.(0007)).
Regarding Claim 9 , modified Curtiss Roy III discloses the genetically modified Salmonella bacterium of claim 7. Curtiss Roy III discloses fails to explicitly disclose wherein the decoy polypeptide is selected from a soluble form of human frizzled(FZD)
Receptor , a soluble form of human LRP6,a soluble form of human PD-1 , and a soluble form of human SIRP-alpha.
Yun et al. teach teaches decoy polypeptides such as soluble LRP6 that disrupt Wnt signaling. Yun et al. teach that the present invention relates to an anti-cancer composition containing Wnt decoy receptor which inhibits activation of Wnt signaling involved in tumor development, Para {0002); Yun et al. teach that as results ,the present inventors have discovered that novel soluble Wnt receptor,sLRP6E1E2,inhibits activation of Wnt signaling Pathway in a cancer cell through binding to Wnt3a protein, thereby reducing tumor growth proliferation and metastasis and inducing apoptosis of tumor cells, Para.[0007}).
Regarding Claim 25, Curtiss Roy III discloses the genetically modified Salmonella bacterium of claim 7. Curtiss Roy III further discloses a method of treating a tumor in a subject in need thereof comprising administering a genetically modified Salmonella bacterium of claim 7 to the subject, whereby the genetically modified Salmonella bacterium treats tumor cells in the subject (A further aspect of the invention encompasses methods of using a recombinant bacterium of the invention. For instance, in one embodiment the invention provides a method for inhibiting tumor growth. The method generally comprises administering e recombinant bacterium of the invention to a subject, Para. [0131]).
Regarding Claim 26, Curtiss Roy III discloses the method of claim 13. Curtiss Roy III further discloses wherein administering comprises oral administration or intratumoral injection of the genetically modified Salmonella bacterium (A pharmaceutical composition may be administered orally, Para. [0130]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Curtiss Roy III with the teaching of Yun et al. for the purpose of using a recombinant Salmonella bacterium to deliver to soluble receptors such as LRP6 that can reduce Wnt signaling in cancer cells as a method of treating cancer. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Curtiss Roy III with the teaching of Yun et al. because Curtiss Roy III discloses recombinant bacterium that may be used to inhibit the growth of a tumor or a tumor cell with Salmonella which are considered to particularly useful for the same purpose. No more than routine skill would have been required for one of ordinary skill in the art at the time of the invention to incorporate Yun et al.. for the purpose of using a recombinant Salmonella bacterium to deliver to soluble receptors such as LRP6 that can treat cancer by reducing Wnt signaling in cancer cells. Furthermore, Yun et al. teach decoy polypeptides such as soluble LRP6 will additionally disrupt Wnt signaling and gene regulating expression in a cancer cells.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination 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 element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine known compositions thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
13. No claims are allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHATOL S SHAHNAN SHAH whose telephone number is (571)272-0863. The examiner can normally be reached Mon-Tue, Thurs-Fri 12pm-8pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary B. Nickol can be reached on 571-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHATOL S SHAHNAN SHAH/ Examiner, Art Unit 1645 December 13, 2025
/JANA A HINES/ Primary Examiner, Art Unit 1645