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 2-12-2026 has been entered into the record.
Status of Claims
Claims 1-5, 7, 8, 10, and 12-15 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
It is noted that the priority document is not in English and no certified translation has been provided. As such, the filing date of the 371 Application PCT/JP2022/034873 of 9/20/2022 has been determined to be the effective filing date for prior art purposes in this Office Action.
Election/Restrictions
Applicant’s election of Group I (claims 1-5, 12 and 15) without traversed in the reply filed on 2-12-2026 is acknowledged. Claims 7, 8, 10, 13 and 14 are withdrawn from consideration as drawn to non-elected inventions.
Information Disclosure Statement
The information disclosure statements have been considered. Initialled copies are enclosed.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See paragraphs [0012] and [0052].
Claim Objections
Applicant is advised that should claims 12 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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 2, 4 and 5 are 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. As to claim 2, the claim recites “portions thereof” which broaden the claims because claim 1 does not provide for inclusion of fragments in the scope. As to claims 4 and 5, these claims recite intended use of the vaccine and do not structurally properly limit the vaccine of claim 1. Consequently, these claims are not found to properly further limit the subject matter of claim 1. 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 12 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a product of nature.
Claims 1, 2, 4, 5, 12 and 15 are directed to compositions comprising a non-encapsulated Streptococcus species, a dead bacterium of the same species or portions thereof. Claims 12 and 15 limit the species to S. uberis. The composition of claim 3 further comprises a pharmaceutically acceptable adjuvant and the bacterium strain as recited therein. Because the claimed strain(s) are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of instant claims is directed to a statutory category, i.e., a composition of matter (Step 1: YES). The as-filed specification does not require mutation or any other specific genetic manipulation of non-encapsulated Streptococcus species. The art teaches that acapsular/non-encapsulated strains of Streptococci exist in nature. See for example Almedia et al (J. Vet. Med., B 42:331-337, 1995; of record) at page 332 Materials and Methods teach “encapsulated and non-encapsulated strains of S. uberis isolated from cows with mastitis”. Therefore, the compositions comprising the claimed strain(s) are naturally occurring strains when either live or dead. The portions thereof are also naturally occurring. There is no evidence and the claims do not require that the claimed Streptococcus bacterial strain(s) are modified in any way and the strain(s) or are markedly different from what exist in nature. Supreme Court has made it clear in Myriad that eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature. Unlike the Chakrabarty bacterium, which was new “with markedly different characteristics from any found in nature” Diamond v. Chakrabarty, 447 U.S. 303 (1980) at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the multiple additional plasmids and resultant “capacity for degrading oil”, there is no indication that the instantly claimed strain(s) are genetically manipulated or structurally modified in any marked or significant way such that the structural difference results in change of properties of the strain(s). Furthermore, the functional properties such as immunogenicity or vaccines represent the inherent qualities, properties or characteristics inseparable from said naturally occurring strain(s) and therefore are a handiwork of nature. In Chakrabarty and Myriad, the marked difference inquiry was focused on the modified structural characteristics of the product, not how it was used or how it was made. Note that “….. patents cannot issue for the discovery of phenomena of nature”. Le Roy v. Tatham, 14 How. 156, 175 (1853). The qualities of the bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.” See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. at 130, 1948. In Funk Brothers, the Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. In the instant case, having natural strains in a pharmaceutically acceptable adjuvant is recited at such a high level that it does not add significantly more to the natural products such that it is practically applied. Thus, each component of the instantly claimed product is a ‘product of nature’ exception, and the claims are directed to a judicial exception (Step 2A Prong One: YES). Judicial exceptions include all natural products including those derived from natural sources or patients such as naturally occurring microorganisms, proteins, peptides, glycoproteins, glycopeptides, carbohydrates, and other substances found in or derived therefrom, or from nature. Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claims amount to significantly more than the exceptions. Having the occurring strains in a composition does not amount to significantly more. There is nothing that provides significantly more or that integrates the claimed naturally occurring strains i.e., the judicial exceptions, into a practical application (Step 2A Prong Two: NO). No elements or claim limitations apply or use the exception(s) in any meaningful way and integrate the law of nature into a practical application. The limitation ‘vaccine’ or “composition” merely indicates a field of use in which to apply the judicial exceptions and therefore fail to provide meaningful limits on the claims. The claims as a whole do not amount to significantly more than ‘products of nature’ (Step 2B: NO). Therefore, the claims are not directed to a patent eligible subject matter.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
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 1-5, 12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Almedia et al (J. Vet. Med., B 42:331-337, 1995; of record).
Almedia et al teach encapsulated and non-encapsulated strains of S. uberis isolated from cows with mastitis. Almedia et al teach vaccination and challenge of cows with an immunogen that contained 2x109 CFU of formalin-inactivated S. uberis UT101 (encapsulated) and UT102 (non-encapsulated) strains emulsified with incomplete Freund’s adjuvant. Cows were challenged intramammarily with 2 ml of a suspension of approximately 4.3 x104 CFU of S. uberis 21 days after drying off (see page 332, Materials and methods paragraphs entitled: Micro-organisms and Growth Conditions and Vaccination and Challenge Routine). As such, Almedia et al anticipate the claimed invention absent evidence to the contrary.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Wisselink et al (Veterinary Microbiology 84:155-168, 2002; of record).
Wisselink et al teach live and killed vaccines based on a non-encapsulated mutant of Streptococcus suis serotype 2. The non-encapsulated formalin inactivated mutant and live non-encapsulated strains (see Abstract). Wisselink et al teach that the formalin inactivated non-encapsulated variant partially protected against challenged whereas the CM-live vaccine was less protective. The formalin-inactivated vaccines were prepared as a water-in-oil emulsion in the WO adjuvant. The live vaccine was prepared with the CoVaccine Adjuvant a non-mineral oil-in-water emulsion (see page 157, sections 2.2 and 2.3.). Streptococcus suis is knonw to cause mastitis although it is not the most common mastitis-causing pathogens. As such, claims 1-5 are anticipated.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Prado et al (Veterinary Immunology and Immunopathology 141:201-208, 2011).
Prado et al teach recombinant S. uberis adhesion molecule (rSUAM) induces antibodies that reduce adherence to and internalization of S. uberis into bovine mammary epithelial cells (see abstract). Prado et al tech the vaccination of cows using 200 ug rSUAM in sterile pyrogen-free water plus Emulsigen DTM or 400 ug rSUAM in sterile pyrogen-free water plus Emulsigen-DTM. As such the compositions of Prado et al anticipate claims 1-5, 12 and 15 as rSUAM is a portion of S. suis strains.
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.
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 .
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
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