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 .
Response to Argument and Amendment
The response filed on 7/22/26 has been entered.
Applicants’ arguments filed 7/22/26 have been fully considered but they are not deemed to be persuasive.
Claims 1-3 and 6-20 are pending in this office action.
Claims 1-20 rejected under 35 USC 112 relating to prevention is withdrawn based on Applicant’s amendment to the claims.
Claim(s) 1-3, 5-18 and 20 is/are rejected under 35 U.S.C. 102(a2) as being anticipated by Phillipson et al. (WO 2016/102660)is withdrawn due to the amendment to the claims and Applicant’s argument.
Claim Rejections - 35 USC § 112
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 1-3 and 6-20 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. This is a written description rejection
MPEP § 2163 states that, “[n]ew or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389,1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
It is noted that the specification fails to provide express, implicit, or inherent disclosure for the generic recitation of “immune checkpoint inhibitor”. Further, the recitation of specific immune checkpoint inhibitor such as cytotoxic T lymphocyte-associated protein 4 (CTLA-4), programmed cell death receptor 1 (PD-1), and programmed death ligand 1 (PD-L1) cannot provide support for all immune checkpoint inhibitor.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim 1 is a broad generic, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless. The specification lack sufficient variety of species to reflect this variance in the genus. Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 103
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-3, 6-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phillipson et al. (WO 2016/102660) in view of Som et al. World J. Clinical Cases 2019; Feb 26; 7(4);405-418) and KR 102297619
Phillipson teaches with regards to instant claim 1, an administering the use of lactic acid bacteria for wound healing in a subject (see abstract) wherein the lactic acid bacteria is transformed (ie., engineered to express protein (see abstract) for treating induced colitis and induced enteropathy (see Fig. 33) and thus promotes resolution and or wound healing. Wherein the protein is an immune cell as required by instant claim 2 (see abstract), expressing a protein comprising CXCL12 1α; CXCL17 and Ym1 having an amino acid Seq ID No:3 (as required by instant claims 3 and 6, see pg. 3, lines 16+, wherein the sequence is at least 80% identity (see pg. 4, lines 20+), wherein the therapy induced enteropathy is a radiation induced (see pg. 16, lines 3+, as required by instant claim 5) wherein the LAB is transformed with a plasmid (see abstract, as required by instant claim 7), includes nucleotide sequences (see pg. 8, lines 25+as required by instant claim 8). With regards to instant claim 9, Phillipson teaches wherein the plasmid comprises the sakacin P regulon (see pg. 13, lines 8+) and the inducible promoter is the PorfX promoter from the sakacin P regulon (see claim 7, as required by instant claim 10), wherein the plasmid is derived from the plasmid designated pSIP411 (as required by instant claim 11, see claim 8) and the method wherein encoding the protein which nucleotide sequence is codon -optimize d for expression (see pg. 5, lines 34+, as required by instant claim12), wherein the nucleotide sequence comprises SEQ ID NO’s. 1 , 4, 7, 10, 13 and 16.(see pg. 14, lines 13+, as required by instant claim 13), wherein the LAB are a strain of genus Lactobacillus (see pg. 15, lines 11+, as required by instant claim 14) and Lactobacillus reuteri (see pg. 15, lines 11+, as required by instant claim 15) and Lactobacillus reuteri strain R2LC (see pg. 15, lines 11+, as required by instant claim 16) in a pharmaceutical composition and acceptable excipients (see pg. 16, lines 33+, as required by instant claim 17) and the bacteria maybe lyophilized (as required by instant claim 18, see pg. 17, lines 16+) wherein the LAB expresses the protein under the control of an inducible promoter (see pg. 17, lines 25+, as required by instant claim 20).
However, fails to teach immune checkpoint inhibitor.
Som teaches immune checkpoint inhibitors affecting various organs including the gastrointestinal tract and causing diarrhea and colitis administering an immune checkpoint inhibitor Program death ligand 1 and promotes inflammation.
‘619 teaches engineered lactic acid bacteria comprises CXCL12 and Ym1, used in wound healing and treatment of overt colitis and the protein selected from CXCL12-1α (as required by instant claim 3) having the amino acid sequence set forth in SEQ ID NO: 6 or 5 or an amino acid sequence having at least 95% sequence identity to said sequence (as required by instant claim 6) wherein the LAB is a protein (as required by instant claim 7) wherein the promoter is a ProfX promoter from the sakacin P regulon (as required by instant claim 10) wherein the nucleotide sequence encoding the protein is characterized in that it is codon-optimized for expression in lactic acid bacteria, comprising the sequences of SEQ ID NO: 1, SEQ ID NO: 4, SEQ ID NO: 7, SEQ ID NO: 10, SEQ ID NO: 13 and SEQ ID NO: 16 (as required by instant claims 8, 12-13) and the plasmid is characterized in that it is derived from a plasmid named pSIP411(as required by instant claim 11)’ the LAB is a genus lactobacillus .
One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a). The motivation to combine can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their commonly known purpose. Section MPEP 2144.07. Therefore, the combined references would have resulted in the instant claimed invention with a reasonable expectation of success.
Claim(s) 1-3, 6- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phillipson et al. (WO 2016/102660) in view of Som et al. World J. Clinical Cases 2019; Feb 26; 7(4);405-418) and KR 102297619
Phillipson teaches with regards to instant claim 1, an administering the use of lactic acid bacteria for wound healing in a subject (see abstract) wherein the lactic acid bacteria is transformed (ie., engineered to express protein (see abstract) for treating induced colitis and induced enteropathy (see Fig. 33) and thus promotes resolution and or wound healing. Wherein the protein is an immune cell as required by instant claim 2 (see abstract), expressing a protein comprising CXCL12 1α; CXCL17 and Ym1 having an amino acid Seq ID No:3 (as required by instant claims 3 and 6, see pg. 3, lines 16+, wherein the sequence is at least 80% identity (see pg. 4, lines 20+), wherein the therapy induced enteropathy is a radiation induced (see pg. 16, lines 3+, as required by instant claim 5) wherein the LAB is transformed with a plasmid (see abstract, as required by instant claim 7), includes nucleotide sequences (see pg. 8, lines 25+as required by instant claim 8). With regards to instant claim 9, Phillipson teaches wherein the plasmid comprises the sakacin P regulon (see pg. 13, lines 8+) and the inducible promoter is the PorfX promoter from the sakacin P regulon (see claim 7, as required by instant claim 10), wherein the plasmid is derived from the plasmid designated pSIP411 (as required by instant claim 11, see claim 8) and the method wherein encoding the protein which nucleotide sequence is codon -optimize d for expression (see pg. 5, lines 34+, as required by instant claim12), wherein the nucleotide sequence comprises SEQ ID NO’s. 1 , 4, 7, 10, 13 and 16.(see pg. 14, lines 13+, as required by instant claim 13), wherein the LAB are a strain of genus Lactobacillus (see pg. 15, lines 11+, as required by instant claim 14) and Lactobacillus reuteri (see pg. 15, lines 11+, as required by instant claim 15) and Lactobacillus reuteri strain R2LC (see pg. 15, lines 11+, as required by instant claim 16) in a pharmaceutical composition and acceptable excipients (see pg. 16, lines 33+, as required by instant claim 17) and the bacteria maybe lyophilized (as required by instant claim 18, see pg. 17, lines 16+) wherein the LAB expresses the protein under the control of an inducible promoter (see pg. 17, lines 25+, as required by instant claim 20).
However, Phillipson fails to teach the immune checkpoint inhibitor. And fails to teach , the LAB is in the form of a capsule coated with an enteric coating, the reference nonetheless teaches administration oral admission includes capsules it is within the purview of the skilled artisan to formulate the LAB in a capsule with an enteric coating, MPEP 2143 states "when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." Therefore, the skilled artisan would have had reason to try these methods with the reasonable expectation that at least one would be successful.
. Som teaches immune checkpoint inhibitors affecting various organs including the gastrointestinal tract and causing diarrhea and colitis administering an immune checkpoint inhibitor Program death ligand 1 and promotes inflammation.
‘619 teaches engineered lactic acid bacteria comprises CXCL12 and Ym1, used in wound healing and treatment of overt colitis and the protein selected from CXCL12-1α (as required by instant claim 3) having the amino acid sequence set forth in SEQ ID NO: 6 or 5 or an amino acid sequence having at least 95% sequence identity to said sequence (as required by instant claim 6) wherein the LAB is a protein (as required by instant claim 7) wherein the promoter is a ProfX promoter from the sakacin P regulon (as required by instant claim 10) wherein the nucleotide sequence encoding the protein is characterized in that it is codon-optimized for expression in lactic acid bacteria, comprising the sequences of SEQ ID NO: 1, SEQ ID NO: 4, SEQ ID NO: 7, SEQ ID NO: 10, SEQ ID NO: 13 and SEQ ID NO: 16 (as required by instant claims 8, 12-13) and the plasmid is characterized in that it is derived from a plasmid named pSIP411(as required by instant claim 11)’ the LAB is a genus lactobacillus .
One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a). The motivation to combine can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their commonly known purpose. Section MPEP 2144.07. Therefore, the combined references would have resulted in the instant claimed invention with a reasonable expectation of success.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 8/25/26
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