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 .
The response filed 6-15-2026 has been entered into the record.
Status of Claims
Claims 1,2 5-8, 12, 14-17 and 23-26 are pending.
Election/Restrictions
Applicant’s election of Group 2, claims 6-8, 12, 14-16 and 25 in the reply filed on 6-15-2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 2, 5, 17, 23, 24 and 26 are withdrawn from consideration as drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement filed 8-6-2024 has been considered. An initialed copy is enclosed.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or on a PTOL1449, they have not been considered.
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 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6-8, 12, 14-16 and 25 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 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.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: 1) scope or breadth of the claims; 2) nature of the invention; 3) relative level of skill possessed by one of ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or direction provided by the inventor; 7) presence or absence of working examples; and 8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
While all of the factors have been considered, only those deemed necessary to establish a prima facie case are set forth below.
Scope or breadth of the claims
The instant claims are broadly drawn to a method of administering a vaccine formulation comprising a polypeptide comprising SEQ ID NO:3 or 5 to a host to stimulate an immune response against Camplylobacter bacteria. The administration can be any of intranasal, intramuscular, intradermal, subcutaneous or orally via drinking water. The breath of the Campylobacter genus is substantial with greater than 31 recognized species. The administered polypeptide is not required to be purified and can be in any amount administered by any route.
Knowledge of the prior art
The dictionary definition of vaccine is "A prophylactic or therapeutic material containing antigens derived from one or more pathogenic organisms which, on administration to man or animal, will stimulate active immunity and protect against infection with these or related organism (i.e. produce protective immunity)." (The Dictionary of Immunology, Herbert et al eds, Academic Press, 1995) would clearly realize the deficiency of this specification with respect to the use of the vaccines composition for protection against the genus Campylobacter. The art is replete with evidence that the ability to produce an antibody (immunogenicity) is insufficient to correlate with protection from infection. See for example Feng et al (Infection and Immunity, 64(1):363-365, 1996) that teaches that P55, is an immunogenic but nonprotective 55-kilodalton Borrelia burdorferi protein in murine lyme disease. Chandrashekar et al (US Patent 6,248,329) teach that “Although many investigators have tried to develop vaccines based on specific antigens, it is well understood that the ability of an antigen to simulated antibody productions does not necessarily correlate with the ability of the antigen t o stimulate an immune response capable of protecting an animal from infection…” (column 1, lines 35-41). As such, one skilled in the art would have ample reasons to doubt the ability to use the claimed composition comprising the polypeptide and fragments thereof as a vaccine for the genus of Campylobacter without more evidence.
The claims are drawn to administering a “vaccine composition” to provide for an immune response against a genus of bacterial. The teachings of the specification are devoid of any teaching that animals generate antibodies that bind the polypeptide(s) or other immune response against the genus of endogenous Campylobacter p450 polypeptides and therefore is not clear that the polypeptides of the invention are capable of generating an antibody that is protective of the genus. Vaccines by definition trigger an immunoprotective response in the host vaccinated and mere antigenic response is insufficient. It is well recognized in the vaccine art, that it is unclear whether an antigen(s) derived from a pathogen will elicit protective immunity. Ellis, R.W. (Chapter 29 of "VACCINES" [Plotkin, S.A. et al. (eds) published by W. B. Saunders company (Philadelphia) in 1988, especially page 571, 2nd full paragraph] exemplifies this problem in the recitation that "The key to the problem (of vaccine development) is the identification of that protein component of a virus or microbial pathogen that itself can elicit the production of protective antibodies.... and thus protect the host against attack by the pathogen". The specification fails to teach that the claimed polypeptide is able to perform as a vaccine against the genus by demonstration of binding to the other species of Camphylobacter and the art does not teach the protein sequences of p450 polypeptides from other species of Campylobacter, then the skilled artisan would be unable to reasonably predict vaccine efficacy against any other species of Campylobacter. Similarly, the specification does not teach that the response provided in the animal models for C. jejuni and C. coli provides for an immune response in a representative number of other species within the genus by antibody binding or any other art accepted models (e.g. bactericidal antibodies) that reasonably correlate with vaccine responses. Since, the specification does not this information one skilled in the art would have reason to doubt the alleged use as a vaccine operative for protection of the genus of Camphylobacter species. The courts have held that it is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. (Genentech Inc. v. Novo Nordisk A/S Ltd., 42 USPQ2d 1001). Moreover, the specification must have been enabling at the time the invention was made and developments after the time of filing are of no consequence to what one skilled in the art would have believed at the time of filing (In re Wright, 27 USPQ2d 1510). In the absence of a teaching of the claimed polypeptides are effective as a vaccine for the claimed genus of bacteria, the specification is not be enabled for such. In view of the unpredictability of the art, the lack of teachings of the specification, it would require undue experimentation on the part of the skilled artisan to practice the invention as claimed.
Guidance provided by inventor/working examples
The specification teaches that oral immunization with purified recombinant polypeptides having a dose of 240 ug/ broiler chicken comprising SEQ ID NO:3 or 5, alone in water for oral delivery or by intramuscular injection with an effective amount of an antigen provides for an immune response that reduces colonization of two strains of Camplylobacter jejuni and a single strain of Campylobacter coli (see Figure 4 and associated description in specification).
Level or degree of predictability
The degree of unpredictability is high, given that the similarity or identity of other P450 proteins in the Campylobacter genus as compared to the instant SEQ ID NO:3 and 5 is unknown. Those regions responsible for the effect of providing for the vaccine response to reduce colonization are not described. The uncharacterized variation or conservation of the polypeptide across the genus is unknown. The specification does not teach vaccine responses from the administration of either SEQ ID NO:3 or 5 at any dose across a representative number of species of Campylobacter. In applications directed to inventions in arts but where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.
Quantity of experimentation
In light of the foregoing factors, the evidence as a whole suggests that the specification, in light of the level of knowledge in the art, does not enable one of ordinary skill to make or use the invention over the full scope of the instant claims without undue experimentation. Consequently, the claims are prima facie non-enabled.
Claim 24 is rejected under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim defines a sequence that has less structure than the sequences set forth in claim 6. As such, the claim broadens the scope of the independent claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 6, 7, 8, 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jacobs et al (EP1043029, 2000; of record on PTOL-1449).
Jacobs et al teach immunization of broiler chickens with Campylobacter jejuni 81116 that lacked flagella (“flagellaless”; page 7, paragraph [0038]). The immunization was performed with inactivated bacteria suspended in PBS and a Freunds Incomplete adjuvant. Vaccine emulsions contained approximately 109 bacterial per ml. Chickens were vaccinated intramuscularly with 1 ml of whole cell vaccine (see page 8, paragraph [0044]). Vaccines were able to eliminate wild type Campylobacter jejuni 81116 from the caecum. The polypeptide as recited in the claim is neither purified nor defined by a dose or route of immunization. As such, the flagella-less vaccination anticipates the claimed invention as the wile-type polypeptide of SEQ ID NO:5 is inherently present in the flagella-less strain used for immunization, absent evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. 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.
/Patricia Duffy/Primary Examiner, Art Unit 1645
Prosecution Insights