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 .
DETAILED ACTION
1. Claims 1-19 are currently pending and under examination.
Priority
2. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/981,883, filed on September 19, 2020.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on December 16, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Claim Objections
4. Claim 1 and 3-4 are objected to because of the following informalities: the genus name Staphylococcus, as well as the full species name (e.g., Staphylococcus aureus), should always be italicized in scientific writing. Appropriate correction is required.
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 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.
5. Claims 1-19 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 claimed invention.
Independent claim 1 is drawn to a method of treating and/or preventing an infection caused by Staphylococcus bacteria in a subject in need thereof, the method comprising administering to the subject, an antibody obtained from a body fluid of a mammal not immunized with isolated Staphylococcus genus bacteria, isolated part thereof, an isolated Staphylococcus genus bacteria protein, and/or isolated part of fraction by a process comprising: (i) binding the antibody to the resin of a hydrophobic charge induction chromatography at neutral pH, while removing other proteins; and (ii) eluting the antibody from the hydrophobic charge induction chromatography resin to obtain the antibody.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus of infections associated with staphylococcus bacteria in a subject or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession of the claimed invention. In the instant case, to fulfill the written description requirement, a representative number of infections associated with Staphylococcus to be treated and prevented as well as a representative number of antibodies obtained from a body fluid of a mammal.
A representative number of species means that the species that are adequately described are representative of the entire genus. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the claimed genus.
There are more than 30 types of Staphylococcus bacteria. The bacteria Staphylococcus aureus causes the most infections. There are several strains of S. aureus and they can cause different infections and are generally treated with different antibiotics. A staph skin infection begins when a cut or other wound gets infected with staph bacteria. Early signs of a skin infection include redness, warmth, swelling, tenderness, and blisters. But staph infections can occur spontaneously in healthy people without a wound. A person can also develop a staph infection after a stem cell or organ transplant.
Staph infections are often limited to a small area of a person’s skin. Symptoms include boils, which are pus-filled lumps; a painful rash called impetigo; and cellulitis, an infection of the deeper layers of the skin that results in redness and swelling. If a staph infection involves the deeper layers of skin and soft tissues, such as muscles and fat, it can enter the bloodstream and spread to the bones, joints, and organs, causing more serious damage. Staph can release toxins that can cause blood poisoning, which may be life threatening. Staph can infect anyone at any age, but certain people are at higher risk for developing a serious infection (see NYU Langone Health; Preventing Staphylococcal Infections | NYU Langone Health, accessed August 20, 2026).
Further, NYU teaches that there are several steps you can take to prevent a staph infection which include: clean and cover wounds, wash hands thoroughly, avoid sharing personal items, and wash up before and after a hospital visit.
The specification describes isolation and purification of IgG (collected from bovine milk). Polyclonal anti S. aureus Hla H35L IgG was obtained. The specification further describes using said IgG for the determination of toxin binding by ELISA as well as antibody binding to drug resistant S. pseudintermedius. Further, in clinical trials the same antibody formulation treated intertrigo and pyotraumatic dermatitis.
The specification, however, does not adequately describe the breadth of the invention as claimed. The claims require the treatment and prevention of any infection caused by Staphylococcus bacteria in a subject. Said treatment and prevention is to occur when the subject is administered any antibody obtained from a body fluid of a mammal that has not been immunized. The claims are broad requiring any antibody having the ability to treat and prevent any infection caused by Staphylococcus bacteria.
As it pertains to prevention, to be a prophylactic method as claimed, must induce a protective immune response demonstrated by challenge experiments in an acceptable animal model. The specification does not provide substantive evidence that the broadly claimed method can induce protective immunity. This demonstration is required for the skilled artisan to be able to use the claimed composition for their intended potential purpose of prevention. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the administration of the claimed composition, i.e. would not be able to accurately predict if protective immunity has been induced.
It is clear the specification does not adequately describe the methods as claimed as there are no examples geared towards the method as claimed. This demonstration is extremely important and is done by adequately providing the means and effectiveness of any antibody as it pertains to Staphylococcus infections, so much so that a skilled artisan could readily be aware of it without undue burden and could administer said composition for the methods as claimed with some modicum of success.
Written description requirement 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. The Guidelines further state, "[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus.
Therefore, absent a detailed and particular description of a representative number, or at least a substantial number of the genus of antibodies as related to the infections as claimed, the skilled artisan could not immediately recognize or distinguish members of the claimed genus. Therefore, because the art is unpredictable, in accordance with the Guidelines, the description of a particular derivative is not deemed representative of the genus of immunogenic compositions to which the claims refer and hence do not meet the written description requirements.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 1-19 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.
Claim 1 is rendered vague and indefinite by the use of the phrase “Staphylococcus genus bacteria, isolated part thereof, an isolated Staphylococcus genus bacteria protein, and/or isolated part of fraction”. It is unclear what is meant by said phrase, as it is not explicitly defined in the specification. Specifically, what constitutes an “isolated part thereof” and “isolated part of fraction”? What core features/structures must be maintained? As written, it is impossible to determine the metes and bounds of the claimed invention.
Conclusion
7. No claim is allowed.
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hook et al., WO 02/074324 A1 which suggest the use of antibodies for treating and preventing staphylococcal infections in a human or animal. Hook does not teach the process by which the antibody is obtained.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 August 20, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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