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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/20/26 has been entered.
Applicants' arguments, filed 3/20/26, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 1, 5, 9, 12-13 are 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.
The term “amount effective” in claims 1, 5, and 9 is a relative term which renders the claim indefinite. The term “amount effective” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Neither the specification, nor the claims, recite a concentration range for the alkaline phosphatase such that the artisan would be aware of what constitutes an amount effective. That amount is reasonably expected to vary based on route of administration, insofar as the route of administration affects bioavailability. Embodiments of the inventive compositions include unit doses for mouthwashes (see Table 1 at p. 5 of Specification), wherein an amount of “0 units IAP/ml” was the only evidence of an ineffective amount. Accordingly, for purpose of examination, the term will be interpreted as an amount of alkaline phosphatase greater than zero (0).
Claim Rejections - 35 USC § 102/103
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)(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.
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.
Claim(s) 1, 5, 9, 12, 13 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Furlan Freguia et al., (US 2022/0202914).
Furlan Freguia et al. teaches “methods and compositions for preventing, treating, or reducing chemotherapy treatment-mediated side effects, including gastrointestinal (GI) side effects, comprising administering to a subject intestinal alkaline phosphatases (IAP)” (Abstract).
“In some embodiments, the administration an IAP and/or pharmaceutical compositions (and/or additional therapeutic agents) is any one of oral, intravenous, and parenteral” (p. 16, para. [0096]). The prior art teaches pharmaceutically acceptable carriers for intravenous (IV) injection insofar as it teaches, “Dosage forms suitable for parenteral administration (e.g. intravenous, intramuscular, intraperitoneal, subcutaneous and intra-articular injection and infusion) include, for example, solutions, suspensions, dispersions, emulsions, and the like” (p. 16, para. [0099]); and further, “the formulations of the AP-based agents, such as an IAP, may additionally comprise a pharmaceutically acceptable carrier or excipient. As one skilled in the art will recognize, the formulations can be in any suitable form appropriate for the desired use and route of administration” (Id. para. [0100]).
“Compositions for oral delivery can be in the form of tablets, lozenges, aqueous or oily suspensions, granules, powders, sprinkles, emulsions, capsules, syrups, or elixirs, for example” (Id. para. [0097]). .
“Individual doses of the AP-based agent, such as the IAP, can be administered in unit dosage forms (e.g. tablets or capsules) containing, for example, from about 0.01 mg to about 1,000 mg . . . “ (p. 18, para. [0113]), as well as “a range of about 0.01 mg/kg to about 100 mg/kg of body weight of the subject . . .” (p. 18-19, para. [0115]).
The “effective amount” for the instant claimed method and compositions is interpreted as amounts (greater than zero) suitable for oral and intravenous administration insofar as the claims require oral and intravenous administration. Accordingly, the unit dosage forms of the prior art are inherently effective for treating and preventing disease by prevention of biofilm and plaque formation.
“Where . . . the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 USC 102, on “prima facie obviousness” under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products.” In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
The prior art is anticipatory insofar as it teaches compositions comprising alkaline phosphatase and a method of administering alkaline phosphatase to a subject.
Assuming, purely arguendo, that the teaching is insufficient to rise to the level of anticipation, it would have been obvious to administer the IAP to a subject at the time of applicant’s filing in the form of a tablet, capsule, or intravenous formulation in view of the prior art.
Since the prior art composition contains substantially the same components in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties, such as treating or preventing a disease selected from . . .”; “prevent biofilm and plaque formation”; “break down lipoteichoic acid (LTA), and lipopolysaccharide (LPS) in the gut . . .”; “prevent Fusobacterium nucleation and Porphyromonas ginigivalis . . .”; “prevent formation of beta-amyloid in plaque . . .”.
Technological Background
1) The prior art made of record and considered pertinent to applicant's disclosure Levitskii et al., (SU 808084). Levitskii et al. is pertinent for teaching a toothpaste formulation “to increase anti-caries activity” (2nd p., lines 6-7), wherein the toothpaste comprises “alkaline phosphatase” (Id.).
The prior art teaches a specific embodiment of the toothpaste comprising: Dicalcium phosphate 40-60%, Glycerol 25-35%, Alkaline phosphatase 0.1-0.3%, Sodium carboxymethylcellulose 1-3%, Tween 2-5%, Xylitol 2-5%, Sodium benzoate 0.2-1%, Menthol 0.01-0.03%, Odorant 0.2-0.8%, water the rest (see 2nd page of transalation, lines 8-15).
“Cleaning the teeth with the proposed toothpaste for two months resulted in a 25.3% reduction in caries compared to the group in which the cleaning was carried out simply with a hygienic paste” (Id at lines 20-21).
2) The prior art made of record and considered pertinent to applicant's disclosure Alam et al., (Ann Surg. 2014). Alam et al. is pertinent for teaching “we believe that the oral supplementation with IAP during antibiotic treatment may represent a novel way to prevent bacterial infections due to Salmonella, C. difficile, and perhaps other enteric pathogens in humans” (p. 8, conclusion). Note: Fusobacterium and Porphyromonas are enteric human pathogens.
Response to Arguments
Applicant argues, the reasons for administering IAP to a patient via tablet, capsule or intravenous injection in Furlan Freguia is different from the intended use of the claims, e.g., treating or preventing atherosclerosis. Therefore, Furlan Friguia does not anticipate or make obvious the claimed method and product (p. 7-10).
The Examiner disagrees.
“The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant” [emphasis added] (see MPEP 2144, citing e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)).
Furthermore, “[w]hen the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art.” In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990).
The prior art teaches tablets and capsules as carrier for the IAP as well as the step of administering IAP to a subject
The effect of administering, as claimed, would necessarily follow insofar as "[p]roducts of identical chemical composition can not have mutually exclusive properties." MPEP 2112.01. A chemical composition and its properties are inseparable. (Id.) Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. (Id.).
The instant claims are not rendered patentable by recitation of properties not shown or suggested in the prior art. The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
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