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 .
Claim Status
The amended claim set filed on 24 July 2025 is acknowledged. Claims 1-20 are currently pending. Of those, claims 1-2 and 4-13 are amended. There are no new claims and claims 14-20 are withdrawn. No claims are cancelled. Claims 1-13 will be examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24 July 2025 was filed after the mailing date of the Non-Final Office Action on 3 March 2025. The submission, which was submitted with the appropriate fee, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Applicants’ arguments filed 24 July 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 3 March 2025 will be referred to as “NFOA.”
Objection(s) and Rejection(s) Withdrawn
The objection to the disclosure is withdrawn in view of the amendments to the specification.
The objection to claims 1-2 and 5-10 is withdrawn in view of the amendments to the claims.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(b)
Claim 13 remains 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.
Applicant argues (Remarks, pg. 8-9) that the term “comparable” is not indefinite because the instant specification teaches that the growth curve of the recombinant B. pertussis is “comparable” to that of the wild type strain when the those growth curves vary by less than 20%.
This argument has been fully considered but is not persuasive. Regarding the alleged definition of the term “comparable” cited by the applicant, the standard of “vary[ing] by less than 20%” is an example, not a definition of the term in the specification. The specification reads (pg. 5, ln. 31 – pg. 6, ln. 2): “For example, the values of the elapsed time and growth rate in standard fermentation processes of the population of recombinant Bordetella pertussis bacteria and a population of the wild type gram-negative bacteria are comparable. More particularly, the values of elapsed time and growth rate for the population of recombinant Bordetella pertussis bacteria and the population of wild type Bordetella pertussis bacteria vary by less than 20%, for example, less than 15%, less than 10% or less than 5%.” The broadest reasonable interpretation of the limitation “a growth curve of a bacterial population of said bacteria is comparable to a growth curve of a population of a parental strain” is broader than the example of “the values of ‘growth rate’ and ‘elapsed time’ for the population of recombinant Bordetella pertussis bacteria and the population of wild type Bordetella pertussis bacteria ‘vary by less than 20%.’” (Remarks, pg. 8) Thus, one of ordinary skill in the art would not be able to determine the scope of the invention based on the teachings of the specification because the example taught in the specification is narrower than what is recited in the claim. See MEP 2173.05(b).
Claim Rejections - 35 USC § 102
Claim(s) 1-3, 7, and 9-13 remain rejected under 35 U.S.C. 102(a)(2) as being anticipated by van der Ley et al. (US 2020/0085933 A1; herein “van der Ley”) for the reasons of record and the reasons herein.
Applicant argues (Remarks, pg. 9-10) that van der Ley does not teach an exogenous “genomic” lpxA gene or “genomic insertion” of a heterologous lpxD gene and only teaches episomal expression of exogenous lpxA and heterologous lpxD, citing van der Ley, pg. 18, Table 1.
This argument has been fully considered but is not persuasive. Regarding the argument that van der Ley does not teach genomic expression or genomic insertion of the recited genes, it is reiterated that van der Ley teaches, “B. pertussis B1917 strains were constructed wherein either the chromosomal lpxA gene or the lpxD gene was replaced with the corresponding P. aeruginosa versions.” (para. 221; see also NFOA, para. 18) The use of the word “replaced” indicates that the corresponding P. aeruginosa genes were put in the place of the chromosomal B. pertussis lpxA or lpxD genes, i.e., chromosomal expression of an lpxA gene comprising mutations at positions 170 and 229 relative to instant SEQ ID NO: 1 or chromosomal insertion of a heterologous lpxD gene.
Regarding the teachings of Table 1 on pg. 18 of van der Ley, the bacterial strains listed in the table refer to those used in Example 1 (para. 190) and do not include the B1917 strain from Example 2 (para. 221) that is taught as having either the chromosomal lpxA or lpxD genes “replaced” with P. aeruginosa lpxA or lpxD.
Claim Rejections - 35 USC § 103
Claims 1-13 remain rejected under 35 U.S.C. 103 as being unpatentable over van der Ley (US 2020/0085933 A1) in view of Sweet et al. (2002, J Biol Chem; herein “Sweet”) for the reasons of record and the reasons herein.
Applicant argues (Remarks, pg. 11-13) that neither van der Ley or Sweet, alone or in combination, teaches or suggests the claimed B. pertussis comprising an exogenous genomic lpxA gene or genomic insertion of a heterologous lpxD gene.
This argument has been fully considered but is not persuasive. This argument is not persuasive because van der Ley does teach a recombinant B. pertussis comprising either genomic exogenous lpxA or genomic heterologous lpxD from P. aeruginosa (para. 221), as is discussed in para. 13-14 above.
Applicant argues (Remarks, pg. 11-14) that the present inventors unexpectedly found that the claimed recombinant B. pertussis does not exhibit the growth defects associated with episomal expression of an exogenous lpxA gene in B. pertussis. Applicant points to data from van der Ley (Fig. 2A-B) demonstrating growth defects in the BL213 strain, which expresses P. aeruginosa lpxA from a plasmid.
This argument has been fully considered but is not persuasive. Regarding the assertion of unexpected results, Applicant does not cited any evidence of unexpected results. MPEP 716.02(b) states (emphasis added): The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.") Although the instant specification asserts that the recombinant B. pertussis of the present invention unexpectedly does not exhibit growth abnormalities, applicant has not pointed to any data supporting this statement, nor has applicant shown that the hypothetical data is actually unexpected (note that the specification does not use the word “unexpected”) and is of both statistical and practical significance.
Regarding the data from van der Ley cited by the applicant, the data does not correspond to the B1917 strain taught in Example 2 of van der Ley, which teaches the replacement of chromosomal lpxA or lpxD. Because the strain being in the data being argued is different than the B1917 strain discussed in the previous rejection (i.e., does not include all of the elements recited in the instant claim(s)), there is no nexus between the data and the claimed invention. Nexus is presumed when the applicant or patent owner shows that the asserted objective evidence of record is tied to a certain product and that product includes the claimed features, and is coextensive with them. See Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373, 2019 USPQ2d 483355 (Fed. Cir. 2019). Applicant has also not shown that the allegedly unexpected result is a result of the claimed modifications to the bacteria that is part of the obviousness rejection, rather than an inherent feature from van der Ley’s strain that has chromosomally inserted rather than plasmid expressed genes. See MPEP 2112.
Conclusion
No claim is allowed.
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 BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645