DETAILED ACTION
Applicant’s response filed on 01/15/2026 is duly acknowledged.
Claims 1-20 as currently presented are pending in this application.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-11; directed to “A vaccine composition comprising a Brucella…”) in the reply filed on 01/15/2026 (see REM, p. 5) is acknowledged.
Claims 12-20 (drawn to non-elected invention of Group II) have been withdrawn.
Claims 1-11 (elected invention of Group I, without traverse; directed to “A vaccine composition comprising a Brucella…”) have been examined on their merits in this action hereinafter.
Priority
This application is a CON of 16/757,509 (filed on 04/20/2020, now a USPAT 11,717,566), which is a 371 of PCT/US18/56703 (filed on 10/19/2018), claiming domestic benefit from a US PRO 62/575,144 (filed on 10/20/2017).
Claim Objections
Claims 4, 5 and 10 are objected to because of the following informalities:
Claims 4 and 10 recite deletion variants of several genes that have not been properly italicized (see claim 4, line 3; and claim 10, line 3). Applicants are advised to follow proper nomenclature for genes (for example, DvirB12), as done for genes recited in the instant claims 3 and 5, for instance.
Claim 5 recites the limitations “wherein the vaccine comprises DvjbR/DIVA, l6M/DvjbR/DIVA, or any combination thereof”, which should be amended to recite “wherein the one or more attenuating gene knockouts comprise DvjbR/DIVA, l6M/DvjbR/DIVA, or any combination thereof”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112- New Matter Issue
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 4 and 10 (as currently presented) 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 entire scope of the claimed invention.
Claims 4 and 10 as presented are reproduced below:
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Insertion of the limitation “further comprising a diagnostic gene knockout” of “one or more antibiotic resistance genes in the Brucella canis or combination thereof” does not have support in the specification or original disclosure as filed. The insertion of this limitation is a new concept because it neither has literal support in the as-filed specification by way of generic disclosure, nor are there specific examples of the newly limited genus which would show possession of the concept of the use of a strain with “a diagnostic gene knockout” of “one or more antibiotic resistance genes in the Brucella canis or combination thereof”. Contrary to that, the parent specification of record (see 16/759,509 from which the instant application is derived as a CON) discloses the vaccine composition that further comprises “one or more antibiotic resistance genes in the Brucella canis” (see parent specification, claims 7 and 13 as per original claim set dated 04/20/2020; and “Summary of the Invention” on p.2, lines 24-25 and 34-35, for instance). No disclosure for such gene knockout(s) of one or more antibiotic resistance gene(s) have been disclosed and/or contemplated on record as per original disclosure in the parent application 16/757,509 (or in the current specification of record in 18/366,358; see p. 3, para [0010]-[0011], for instance).
This is a matter of written description, not a question of what one of skill in the art would or would not have known. The material within the four corners of the as-filed specification must lead to the generic concept. If it does not, the material is new matter. Declarations and new references cannot demonstrate possession of a concept after the fact. Thus, the insertion of “a diagnostic gene knockout” of “one or more antibiotic resistance genes in the Brucella canis or combination thereof” is considered to be the insertion of new matter for the above reasons. Appropriate correction is required.
NOTE: In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bandara et al (“Bandara”, US 2007/0036823 A1; cited by applicants in IDS dated 08/07/2023).
Claim 1 as presented is as follows:
“1. (Original): A vaccine composition comprising:
a Brucella canis comprising one or more attenuating gene knockouts; and
a pharmaceutically acceptable vaccine carrier, wherein the vaccine is used for a prophylaxis, an amelioration of symptoms, a treatment, or any combinations thereof against brucellosis in a human or an animal subject.”
See also limitations of dependent claims 2 and 6, as presented.
Regarding instant claim 1, Bandara discloses a vaccine composition comprising: a Brucella canis comprising one or more attenuating gene knockouts; and a pharmaceutically acceptable vaccine carrier (see Title, claims 1 and 5; para [0018]- "The invention provides compositions and methods for treating and preventing Brucellosis. The methods involve eliciting an immune response to pathogenic, virulent bacteria of the genus Brucella by administering a composition comprising attenuated, recombinant Brucella strains"; para [0037]- "The Brucella species or strain that is modified for use in the practice of the present invention (i.e. the species or strain which is genetically manipulated to produce or derive the recombinant, attenuated Brucella bacteria) may be any suitable Brucella species or strain. Examples include ... Brucella canis" (see Bandara, claims 13 and 17, in particular); para [0043] "The compositions of the present invention include substantially purified attenuated, recombinant Brucella bacteria ....and a pharmacologically suitable carrier. The preparation of such compositions for use as vaccines is well known to those of skill in the art"). Bandara discloses wherein the vaccine is used for a prophylaxis in a human or an animal subject (para [0047] - "In addition, the compositions of the present invention may be used either prophylactically to prevent a mammal from contracting Brucellosis, or after the fact to treat a known (or suspected) infection in order to ameliorate symptoms of the disease").
Regarding instant claim 2, Bandara further discloses wherein the composition comprises an adjuvant (para [0043] - "The vaccine preparations of the present invention may further comprise an adjuvant..." ).
Regarding instant claim 6, Bandara further discloses wherein the vaccine is administered by a subcutaneous route (see para [0044] - "In preferred embodiments, the mode of administration is subcutaneous or intramuscular").
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.
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.
Claims 1, 2, 4, 6 and 7 (as currently presented) are rejected under 35 U.S.C. 103 as being unpatentable over Bandara et al ("Bandara"; US 2007/0036823 Al; cited in applicant's IDS dated 08/07/2023) taken with Ficht et al ("Ficht"; US 2014/0248354 Al; cited in applicant's IDS dated 08/07/2023).
Claims 1, 2 and 6 have been discussed.
Claims 4 and 7 have been reproduced below:
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Detailed teachings of Bandara as they relate to a live, attenuated Brucella canis vaccine composition of instant claims 1, 2 and 6 have been discussed above, and are further relied upon herein in the same manner.
Regarding instant claim 4, Bandara discloses the vaccine composition of claim 1, but does not disclose wherein it further comprises a diagnostic gene knockout comprising a differentiation of infected animals from vaccinated animals (DIVA) mutant that includes DvirB12.
However, Ficht discloses an attenuated Brucella vaccine composition comprising a DIVA diagnostic gene knockout comprising DvirB12 (Claim 1 - "A vaccine composition comprising: a Brucella strain comprising one or more attenuating gene knockouts and further comprising a diagnostic gene knockout; and an encapsulating agent comprising vitelline protein B capable of releasing the Brucella strain at a predetermined rate."; Claim 9 - "The vaccine composition of claim 1, wherein the vaccine further comprises a marker for serological testing, wherein the marker is DIVA mutant is DvirB12"; see also para [0011], and claim 8 reciting knockouts for mucR, virB2, manB/A genes).
Thus, it would have been obvious to one of ordinary skill in the art to have used the DIVA mutant of Ficht in the vaccine of Bandara, as both teach attenuated Brucella vaccines and DIVA mutants, including DvirB12 would have been an effective diagnostic marker for differentiating infected from immunized animals.
Regarding instant claim 7, Bandara discloses the vaccine composition of claim 1 but does not disclose wherein it further comprises an encapsulating agent that is an alginate bead or a microsphere.
However, Ficht discloses an attenuated Brucella vaccine composition comprising an alginate bead or a microsphere (para [0010] - "The present invention in one embodiment discloses a vaccine composition comprising: (i) a Brucella strain comprising one or more attenuating gene knockouts and further comprising a diagnostic gene knockout and (ii) an encapsulating agent comprising vitelline protein B capable of releasing the Brucella strain at a predetermined rate. In one aspect the composition disclosed hereinabove comprises an optional adjuvant or a pharmaceutically acceptable carrier. In another aspect the encapsulating agent is an alginate bead or a microsphere"). Thus, it would have been obvious to one of ordinary skill in the art to provide the attenuated Brucella vaccine composition in an suitably encapsulated form using alginate beads or microspheres as taught by Ficht, at least for the benefit of sustained release of the attenuated Brucella vaccine composition in a subject being immunized.
Although, Ficht does not specifically disclose wherein the Brucella strain is Brucella canis, given the detailed teachings from Bandara for a live attenuated Brucella vaccine, wherein the vaccine composition having knockout genes or attenuated Brucella strains may include Brucella abortus, Brucella suis, Brucella melitensis, Brucella neotomae, Brucella canis ... " (see Bandara, page 2, [0021], for instance), a person of ordinary skill in the art would have found it obvious and would have been motivated to prepare such a vaccine composition for the purposes of treating canine brucellosis, unless evidence and/or data provided to the contrary (which is currently lacking on record).
Thus, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2 1 1 1.0 1, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 3 19, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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.
Claims 1-11 (as currently presented) are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 of U.S. Patent No. 11,717,566 B2 (issued on August 8, 2023, to same inventors and assignee, from parent application 16/757,509). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claim 1 of the US patent ‘566 is also directed to a vaccine composition comprising essentially the same Brucella canis mutant strain and a carrier, which has been reproduced as below:
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It is to be noted that the composition in the issued claim 1 of US ‘566 represents an species of the generic compositions as currently recited in instant claims 1 and 11 under examination in the instant CON application. Since, the product claims as currently recited appear to be in a genus-species relationship, an ODP rejection is deemed proper.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657