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 .
Status of claims
Claims 2-8, 10-20 and 24-35 as amended on 12/23/2025 are currently pending.
Claims 2-8, 10-16, 25, 26 and 29-31 were withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions. Applicant timely traversed the restriction requirement in the reply filed on 5/05/2022.
Claims 17-20, 24, 27, 28 and 32-35 as amended on 12/23//2025 are under examination in the instant office action.
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.
Claims 17-20, 24, 27, 28 and 32-35 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0279175 (Kaznessis et al), US 10,738,315 (Wirth et al), Cook et al (“Lactococcus lactis as a versatile vehicle for tolerogenic immunotherapy”. Frontiers in Immunology, January 2018, Vol. 8, article 1961, pages 1-16), US 6,605,286 (Steidler et al) and Jacouton et al (“Anti-tumoral Effects of Recombinant Lactococcus lactis Strain Secreting IL-17A Cytokine”. Frontiers in Microbiology. January 2019, volume 9, article 3355, pages 1-7) and
The cited document US 2016/0279175 (Kaznessis et al) discloses a recombinant bacteria (entire document including abstract, example 1; par. 0111; table 5); wherein the bacteria comprises:
a) a nucleic acid with regions coding for a lactococcal (prokaryotic) chloride inducible promoter (par. 0072; par. 0110; table 5) and a “heterologous” polypeptide having a therapeutic effect that is an antimicrobial protein (AMP); and
b) a regulator gene for controlling activity of the chloride inducible regulator that is activator protein GadR (par. 0074; par. 0110; table 5).
The recombinant bacteria of the cited document US 2016/0279175 (Kaznessis et al) is a non-pathogenic probiotic bacteria Lactococcus lactis subsp cremoris (par. 0111); and it is effective in controlling infection by Enterococcus (example 1, par. 0102). The recombinant bacteria are provided in pharmaceutical compositions in liquid or dried forms (par. 0083). The compositions with recombinant bacteria are reconstituted in liquids or media with chloride (par. 0128; par. 0136).
In a particular embodiment, the cited recombinant bacteria disclosed by US 2016/0279175 (Kaznessis et al) comprises a “heterologous” polypeptide that is bacteriocin derived from prokaryotic organism or from bacteria (par. 0105) but not “eukaryotic” polypeptide. However, the cited US 2016/0279175 (Kaznessis et al) clearly teaches and suggests to incorporate into recombinant bacteria a wide array of polypeptides (see par. 0145) including “eukaryotic” polypeptides produced by mammals (see table 2 at page 5; see par. 0060, line 3).
The prior art demonstrates that recombinant bacteria Lactococcus lactis subsp cremosis with a prokaryotic inducible promoter are used for delivery of “eukaryotic” polypeptides such as various interleukins and growth factors including colony stimulating factor as evidenced by US 10,738,315 (Wirth et al); for example: see col. 18, line 45; col. 10, lines 15-55; col. 32, lines 12-13; col. 38, lines 3-5 and 40-47; claims 1, 19, 23.
The prior art, for example: US 6,605,286 (Steidler et al) teaches that recombinant bacteria belonging to Lactococcus lactis (col. 5, lines 13-15) with prokaryotic promoters (col. 6, lines 40-66) are capable and have been used for delivery of “eukaryotic” polypeptides including claim-recited IL-7, GM-CSF, INF α/β, INF-gamma (col. 5, lines 38-45).
The prior art, for example: the cited reference by Cook et al, also teaches that genetically modified strains belonging to Lactococcus lactis including Lactococcus lactis subsp cremoris are versatile bio-factories of heterologous proteins (abstract, figure 1) and versatile heterologous protein delivery system that provide for a large variety “heterologous” therapeutic proteins including various cytokines including interleukins (page 5) and interferons (page 6).
The prior art also teaches and demonstrates that recombinant Lactococcus lactis subsp cremoris bacteria provide for expression of anti-tumor heterologous polypeptide as intended for treating tumor in a subject; for example: see the cited refence by Jacouton (entire document including abstract).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to modify a recombinant bacteria taught by US 2016/0279175 (Kaznessis et al) with a “heterologous” therapeutic polypeptide derived from eukaryotic organisms as suggested by US 2016/0279175 (Kaznessis et al) with a reasonable expectation of success in using a recombinant bacteria as a delivery vehicle of “heterologous” therapeutic polypeptide derived from eukaryotic organisms including polypeptides with anti-tumor effects because the prior art US 2016/0279175 (Kaznessis et al) clearly suggests to provide a recombinant bacteria with “heterologous” therapeutic polypeptides including eukaryotic polypeptides produced by mammals and because prior art including US 10,738,315 (Wirth et al), Cook and Jacouton teach that a recombinant Lactococcus lactis bacteria including Lactococcus lactis subsp cremosis with a prokaryotic inducible promoter is used for delivery of “eukaryotic” polypeptides including animal interleukins and growth factors including various interleukins, interferons, colony stimulating factors.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 12/23/2025 have been fully considered but they are not found persuasive.
With regard to claim rejection under 35 U.S.C. 103 Applicants argue that the teaching of the primary reference US 2016/0279175 (Kaznessis et al) cannot be combined with the teaching of the cited US 6,605,286 (Steidler et al) because (Kaznessis et al) discloses a system with chloride-inducible promoter and encoding for a heterologous “prokaryotic” antimicrobial peptide but the teaching of Steidler is directed to the use of a promoter that is preferably expressed constitutively (response page 8 of 9) which is not the purpose of the claimed system.
This arguments is not found persuasive because the disclosure of US 6,605,286 (Steidler et al) is relied upon in the office action and would be acknowledged by one of skill in the art for the teaching that recombinant bacteria, belonging to Lactococcus lactis (col. 5, lines 13-15) and having prokaryotic promoters (col. 6, lines 40-66), are capable and have been used for delivery of “eukaryotic” polypeptides including claim-recited IL-7, GM-CSF, INF α/β, INF-gamma (col. 5, lines 38-45).
The cited primary reference US 2016/0279175 (Kaznessis et al) clearly teaches the same arrangement of recombinant genes including prokaryotic chloride inducible promoter, prokaryotic regular gene and therapeutic heterologous polypeptide in the same recombinant Lactococcus lactis subsp cremosus within the broadest meaning of the pending claims. Moreover, although in the particular embodiment of the cited US 2016/0279175 (Kaznessis et al) therapeutic heterologous polypeptide is a prokaryotic polypeptide, the cited US 2016/0279175 (Kaznessis et al) clearly teaches and suggests to incorporate into recombinant bacteria a wide array of polypeptides (see par. 0145) including “eukaryotic” polypeptides produced by mammals (see table 2 at page 5; see par. 0060, line 3).
The secondary reference by Jacouton is relied upon in the office action for the teaching about delivery of “eukaryotic” heterologous polypeptide by recombinant bacteria Lactococcus lactis subsp cremoris, wherein the recombinant expression system is clearly “inducible” by stress or chloride as disclosed therein (page 2, col. 2, par. 2, lines 3-4) within the broadest meaning of the pending claims.
Therefore, the claims are properly rejected under 35 USC § 103.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. 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.
Vera Afremova
January 26, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
Prosecution Insights