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 .
Applicant’s election without traverse of Group I, claims 1, 4-12 and 14-17 and the species: a Bacteroides glycolipid provided in an unconjugated, cell-free and membrane-free form, in the reply filed on 21 July 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 § 818.03(a)).
Claims 1, 4-12, and 14 encompass the elected species.
Claims 2-3 and 15-17, 20, 23, 24 and 26 are withdrawn as being directed to a nonelected invention.
Claims 1, 4-12 and 14 are presented for examination on the merits.
Claim Rejections - 35 USC § 102
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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4 and 14 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ernst et al (US 2019/0367959 A1).
Ernst et al. teaches a method for stimulating an anti-viral immune response in a subject (para [0011] "rationally-designed adjuvants based on molecules that stimulate the host innate immune system are used alone or in other immunogenic compositions to
combat disease. Provided herein are chemically defined lipooligosaccharide/lipid A-based adjuvants that are safe, easy to produce, and effective in conferring protection against a wide variety of pathogenic bacteria and viruses.") comprising administering to the subject an effective amount of a Bacteroides glycolipid (para [0126] "Embodiments of the disclosure employ Gram negative bacterial strains to produce a desired composition including from Bacteroides, Bacteroides fragilis"), comprising a diglucosamine substituted with one or more acyl chains (para [0151] "Construction of rationally-designed LOS/lipid A structures with modified lipid A structures using bacterial
enzymatic combinatorial chemistry (BECC) is encompassed in the disclosure, strain backgrounds were chosen as they produce a bisphosphorylated tetra-acylated lipid A structure thus allowing easy analysis of any resulting modification(s)", para [0066] "In specific embodiments, the compositions comprise one or more sugar units with attached acyl chains. In certain aspects, the compositions comprise a disaccharide. the compositions comprise one, two, or three sugars in specific embodiments the simple sugars are glucosamine", i.e. diglucosamine), on a regular basis (para [0118] "A suitable regime for initial administration and booster administrations are also variable, but are typified by an initial administration followed by subsequent inoculation(s) or other administration(s)."), wherein the immune response protects the subject against a viral infection resulting from exposure to a virus (para [0086] "The compositions of the
present disclosure may be used for medicinal purposes of any kind, but in specific embodiments, the lipid A mimetic compositions are employed as an immunogenic composition alone", para [0088] "The delivery of the lipid A mimetic in an immunogenic composition may occur prior to exposure of the individual to a pathogen and/or following exposure of the individual to a pathogen. In some cases, the lipid A mimetic-comprising immunogenic composition is given to an individual as part of a routine medical practice in preventative measures", para [0089] "the immunogenic composition of the disclosure is useful for measles, rubella, mumps, yellow fever, typhoid fever, smallpox, polio, chickenpox, human papilloma virus (HPV), influenza, Haemophilus influenzae type B, rotavirus, pneumonia, hepatitis A, hepatitis B, hepatitis C West Nile Virus, Dengue, Japanese encephalitis virus").
Ernst et al. further teaches said regular basis is daily, every two days, every 3 days, every 4 days, every 5 days, every 6 days, weekly, every two weeks, or monthly (para [0118] "[an] immunogenic composition is administered in a manner compatible with the dosage formulation, and in such amount as will be therapeutically effective and
immunogenic A suitable regime for initial administration and booster administrations are also variable, but are typified by an initial administration followed by subsequent inoculation(s) or other administration(s).", para [0119] "In many instances, it will be desirable to have multiple administrations of the immunogenic composition, usually not exceeding six normally be at from two to twelve-week intervals, more usually from three to five week intervals").
Thus the cited reference is deemed to anticipate the cited claims.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim(s) 1, 4-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ernst et al (US 2019/0367959 A1).
Ernst et al. is relied upon for the teachings described above.
The cited document does not explicitly disclose that the subject is immunocompromise and/or has received or is receiving antibiotics. However, stimulating an immune-response would be particularly critical for such subjects and would thus be well within the purview of the skill practitioner treating such patients.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge. See Philips v. Google & Microsoft 2020.
The adjustment of particular conventional working conditions is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. V. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) As both dosages, routes of administration, dosage frequency and timing are known to the ordinary artisan, it would have been obvious to optimize the mode of administration as well as dosage amounts and frequency. It also would have been prima facie obvious to optimize the dosage regimen for an additive or synergistic therapeutic result because the general conditions of the dosages are disclosed in the prior art and it is not inventive to discover the optimum or workable ranges by routine experimentation and the art expects that dosages of the invention will vary depending upon such factors as the subject's age, weight, height, sex, general medical conditions and previous medical conditions.
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655
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