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 and amendment to the claims filed 6-26-2026 has been entered into the record. Claims 1-29 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) in the reply filed on 6-26-2026 is acknowledged. Claims 8-29 are withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement has been considered. An initialed copy is enclosed.
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(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 2 and 3 are rejected under 35 U.S.C. 112(a), 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite a disruption or deletion of a “phtcp gene” in the genome of Anaplasma marginale. The protein term is referenced as “membrane-bound phage head-to-tail connector protein (specification page 3, line 1). The phtcp protein is not a recognized family of proteins with similar structure and function. The specification teaches a single gene encoding the protein, where the gene has a specified percent identity of sequence homology or identity with the phtcp gene from the St. Maries strain, GenBank #CP000030, gene tag #AM581). In some forms the phtcp gene will encode a protein having at least a specified percent sequence homology or sequence identity with SEQ ID NO:21 (see specification page 4, paragraph [0010] and paragraph [0072]). Additionally, the specification teaches that the disruption results in a lack of expression of at least a portion of the gene and in some forms less than 90%, or even 5% of the gene is expressed. In some forms no portion of the gene is expressed.
The specification teaches a compete deletion of the phtcp gene identified as gene tag #AM581 in reference strain GenBank # CP000030) encoding a protein set forth as SEQ ID NO:21. The specification does not teach “disruptions” having the property of part of the gene being expressed as contemplated by “disruption” by the specification as filed.
The specification does not teach any variation of the phtcp protein in Anaplasma marginale or the encoded gene. The specification does not teach disruption of any encoded protein variants nor the expression of partial phtcp proteins where the disruption is not a full deletion of the coding sequence. The specification provides no guidance as to partial disruptions with partial expression of the phtcp gene as contemplated within the definition of disruption in the specification. The specification does not teach the correlation of disruption with the effective immunological function in vivo as compared with the gene deletion. While many disruptions can be contemplated, those that provide for effective immunogenic composition as claimed cannot be identified from the vast number of gene disruptions possible (insertions, deletions, mutations etc). The tools and targets of the disruption points are not set forth in the specification. The attenuation or lack thereof is not disclosed. The correlation with a representative number of disruptions with the function as a modified live attenuated immunogen for herd immunization is not set forth in the specification. The general knowledge and level of skill in the art do not supplement the omitted description, because specific, not general guidance is needed. Since the disclosure fails to describe the common attributes or structural characteristics that identify members of the genus of “disrupted phtcp gene”, and because the genus is highly variant, the function of immunogenic is insufficient to provide for functional equivalents (e.g. live attenuated vaccine). One of skill in the art would reasonable conclude that the disclosure of deletion of the entire locus # AM581, fails to provide a representative number of species of disruptions to describe the claimed genus of disruptions having the same functions. Applicants were not in possession of the claimed genus because the specification does not convey to one of skill in the art a representative number of variants in structure and function of any such polypeptide that has the claimed/structure and function. As such the specification lacks written description for the highly variant genus o immunogenic gene disruptions and one skilled in the art would not recognize that applicants had possession of the genus of disruptions for immunological use as set forth in the specification.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.) Adequate written description requires more than a mere statement that it is part of the invention
Claims 2, 3, 4 and 5 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claims 2 and 3 the term “phtcp” is an apparent acronym that has no specific definition in the art. As such, the metes and bounds of the gene cannot be readily ascertained by the skilled artisan.
As to claims 4 and 5, the claims recite an improper Markush group in that the group is not closed and recites “or any combination thereof” instead of “and any combination thereof” therefore it is unclear if any other antigens or elements are members that included in the group. Correction is required.
As to claim 5, the claim recites phrases “such as” and “preferably” rendering the metes and bounds indefinite as it is unclear if the limitations after these phrases are included or excluded by the claim. Clarification is requested.
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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Ganta et al (WO 2018/201153; 11-1-2018; of record on PTOL-1449).
Ganta et al teaches an immunogenic composition comprising Anaplasma marginale having a gene disruption or deletion in the genome thereof (see abstract, paragraph [26-27]). Ganta et al teach that in preferred forms, the gene homology is AMH_581 of Anaplasma marginale preferably having at least 70% to 100 % homology to GenBank # CP000030.1 (pages 12-13 paragraph 29). It is noted that AMH_581 as set forth in Ganta et al is described in the instant application as the gene encoding phtcp and encoded by St. Maries strain, GenBank #CP000030, gene tag #AM581(see the instant specification at page 4, paragraph [0010] and paragraph [0072]). The immunogenic composition comprises known injectable, physiologically acceptable sterile solutions such as saline or aqueous isotonic solutions. The immunogenic compositions can include diluents, isotonic agents, stabilizers or adjuvants. Diluents can include water, saline, dextrose, ethanol, glycerol and the like. Isotonic agents include sodium chloride, dextrose, mannitol, sorbitol, and lactose among others. Stabilizers include albumin and alkali salts of ethylenediamintetratic acetic acid, among others. The immunogenic compositions can comprise additional elements, antigens, carriers, adjuvants, preservatives, stabilizers or combinations thereof (see paragraphs [8-9]). Ganta et al teach that the adjuvants can include various known adjuvants in include various types of emulsions (see page 5, paragraph [10]). Finally, Ganta et al teach that the immunogenic composition may include at least one further pathogen (see paragraph [15]). The pathogens include those listed in claim 5 and include at least, adenovirus, alphavirus, Bordetella bronchiseptica etc. (see pages 8-9). As such, Ganta et al teach deletion or disruption of AMH_581 of Anaplasma marginale as claimed.
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.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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