DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status and Formal Matters
The instant application has a specification and an auxiliary PDF. The specification is what is being considered in this case.
Priority
The instant application was filed 06/25/2025 and is a continuation of 18513577 , filed 11/19/2023, which is a continuation of 17457806 , filed 12/06/2021 , which is a continuation of 16699383 , filed 11/29/2019 ,which is a continuation of 16105017 , filed 08/20/2018 which is a Continuation of 15626971 , filed 06/19/2017 ,which is a continuation of 15484842 filed 04/11/2017 which is a Continuation of 15412712 , filed 01/23/2017 which is a Continuation of 15349371 , filed 11/11/2016 ,which is a Continuation of 15349420 , filed 11/11/2016 ,which is a continuation of 13503325 , filed 05/31/2012 ,which is a continuation of 13503325 which is a National Stage entry of PCT/US2011/059370 , International Filing Date: 11/04/2011 and claims priority from Provisional Application 61447735 , filed 03/01/2011.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/26/2025 is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Claim 1 recites, “the microbe.” The claim does not previously recite,” microbe.” While the claim previously microbial, claims are clearer and more concise when the language is consistent throughout. Thus the claims should be amended to provide antecedent basis or the same language throughout
Appropriate correction is required.
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 1-2 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 recites, “non-viable microbial biofilm cellular mass.” The recitation of non-viable microbial biofilm cellular mass suggests there are viable microbial biofilm cellular mass. The specification provides no definition or standard of how to differentiate non-viable microbial biofilm cellular mass from viable microbial biofilm cellular mass. Further it is unclear non-viable is with respect to the microbe or the biofilm. Further it is unclear if viable is relative to the microbe or biofilm as a substance or after ingestion, as acid bile kills many microbes. Further the specification teaches, “Gastrointestinal probiotics secrete biofilm that protects the mucosal surface against intestinal infection by pathogenic biofilm-forming organisms.” (page 4) Thus it is unclear how a biofilm is viable.
Further claim 1 recites, “edible ingredients that are generally regarded as safe (GRAS).” This suggests there are edible ingredients that are generally regarded as non-safe. The specification recites, “GRAS” twice. The specification provides no standard to differentiate generally regarded as safe from generally regarded not safe. Thus the metes and bounds are unclear.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Doyle et al (US Publication 2006/0073129) as evidenced by Gudina et al (Letters in Applied Microbiology Vol. 50, pp 419-424, 2010).
Doyle teaches treating food processing facilities or food products, which have, or could have, a first population of microorganisms disposed thereon by inoculating the surface with a composition that includes a second population of microorganisms. (Emphasis added; See paragraph 0058; claim 34). Doyle further disclose that it should be appreciated that a goal of the inoculation is to contact a surface with a sufficient quantity of biofilm so that a second population of microorganisms contained in the biofilm can colonize the surface and inhibit the growth of a first population of microorganisms. (See paragraph 0058). Doyle further set forth that it should be appreciated that having a probiotic microorganism in a biofilm facilitates the competitive microorganism’s ability to inhibit the growth of undesirable microorganisms. (Emphasis added; See again paragraph 0058). Doyle et al further disclose that the second microorganism population includes Lactobacillus. (See claim 26).
Gudina et al (Letters in Applied Microbiology Vol. 50, pp 419-424, 2010) set forth that Lactobacillus inherently secretes a biosurfactant. (See abstract).
Accordingly, Doyle et al disclose of each and every limitation of the instantly filed claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-2 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of copending Application No. 18/707357. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The claims of 357 are drawn to A method for alleviating toxicity caused by a toxin wherein said method comprises administering, to a subject in need of alleviation of such toxicity, a composition that comprises a Lactobacillus fermentum bacterium grown in a biofilm phenotype and/or an extract from said L. fermentum and/or said biofilm.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 357 encompass a species of the instant claims as Lactobacillus fermentum bacterium grown in a biofilm phenotype and/or an extract from said L. fermentum and/or said biofilm encompass the limitations of the claims.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7 of U.S. Patent No. 11,826,390 . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The claims of 390 are drawn to A method of inhibiting a viral infection in a subject in need thereof, wherein the method comprises administering to the subject in need of such viral inhibition, a virally inhibiting effective amount of a composition comprising an isolated bioactive Lactobacillus fermentum bacterial strain grown as biofilm, and/or comprising a virus-inhibiting extract of said biofilm, wherein the Lactobacillus fermentum strain is Lactobacillus fermentum Qi6 having Accession No. PTA-122195.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 390 encompass a species of the instant claims as isolated bioactive Lactobacillus fermentum bacterial strain grown as biofilm, and/or comprising a virus-inhibiting extract of said biofilm, wherein the Lactobacillus fermentum strain is Lactobacillus fermentum Qi6 having Accession No. PTA-122195 encompass the limitations of the claims.
Claim1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,457,633 . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The claims of 633 are drawn to A method for enhancing a barrier against microbial contamination of a surface, wherein said method comprises applying to the surface a composition comprising inactivated Lactobacillus spp. that had been grown as biofilm, wherein the composition enhances a barrier function such that, when the composition is applied to a surface, that surface becomes less susceptible to microbial contamination; and wherein said Lactobacillus spp. is L. fermentum Qi6 having Accession No. PTA-122195. Dependent claim 2 draws the surface to intestine, mount, stomach, trachea.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 633 encompass a species of the instant claims as said Lactobacillus spp. is L. fermentum Qi6 having Accession No. PTA-122195 encompass the limitations of the claims.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,495,800. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The claims of 800 are drawn to A method for enhancing a barrier against chemical, viral and/or microbial contamination of a surface, wherein said method comprises applying to the surface a composition comprising inactivated Lactobacillus spp. that had been grown as a biofilm, wherein when the composition is applied to the surface, the surface becomes less susceptible to microbial, viral and/or chemical contamination, and wherein the bacterial strain is L. fermentum Qi6 having Accession No, PTA-122195. Dependent claims are drawn to wherein the surface is selected from skin, intestine, stomach, lung, eye, mouth, nose, ear, trachea, vagina, and esophagus of a subject.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 800 encompass wherein the bacterial strain is L. fermentum Qi6 having Accession No, PTA-122195 encompass the limitations of the claims.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,004,772. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The claims of 772 are drawn to A method for inhibiting microbial growth on a surface or in a composition, wherein the method comprises applying to the surface or composition a microbial growth-inhibiting amount of a preparation comprising a bioactive Lactobacillus fermentum strain having an Accession No. PTA-122195 grown as a biofilm. Dependent claim draws the invention to wherein the preparation is edible.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 772 encompass preparation comprising a bioactive Lactobacillus fermentum strain having an Accession No. PTA-122195 grown as a biofilm encompass the limitations of the claims.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,617,726. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The claims of 726 are drawn to a composition comprising Lactobacillus fermentum Qi6 having Accession No. PTA-122195, grown as a biofilm, and a carrier. Dependent claims draw the invention to that is formulated for oral administration to a human or animal.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 726 Lactobacillus fermentum Qi6 having Accession No. PTA-122195, grown as a biofilm, and a carrier encompass the limitations of the claims.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,564, 957. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The claims of 957 are drawn to A method of treating a pathological condition, wherein the method comprises administering, to a subject in need of such treatment, a therapeutically effective amount of a composition comprising a Lactobacillus fermentum strain having an Accession No. PTA-122195 grown as a biofilm, or a bioactive extract of said L. fermentum strain, wherein the pathological condition is selected from psoriasis, icthyosis, sarcoidosis, acne, dermatitis, burns, diaper rash, actinic keratosis, dermatomycoses, dermatosis, ectodermal dysplasia, atopic dermatitis, contact dermatitis, sebortheic dermatitis, vulgaris and filaggrin deficiency, and bacterial infections of a mucosal surface or skin.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 957 encompass composition comprising a Lactobacillus fermentum strain having an Accession No. PTA-122195 grown as a biofilm encompass the limitations of the claims and administration encompasses eating.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,440, 521. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The claims of 521 are drawn to A composition comprising an isolated Lactobacillus fermentum bacterial strain grown as biofilm, and/or comprising a bioactive extract of said biofilm, wherein the biological activity of the bioactive extract, is selected from antimicrobial activity, promoting commensal bacterial growth, enhancing skin or mucous membrane barrier function and enhancing a skin innate immune function, wherein the bacterial strain is Lactobacillus fermentum Qi6 having Accession No. PTA-122195. Claim 8 is drawn to A method for improving the barrier function and/or the condition of a mucous membrane of a subject, wherein said method comprises administering, to the mucous membrane of the subject, an effective amount of the composition of claim 1. Claim 12 requires wherein the mucous membrane is in the gastrointestinal tract.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 521 encompass Lactobacillus fermentum bacterial strain grown as biofilm, and/or comprising a bioactive extract of said biofilm, wherein the biological activity of the bioactive extract encompass the limitations of the claims and administration encompasses eating.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,713,631. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
Independent claim of 631 is drawn to An antimicrobial method that comprises contacting microbes with a biologically-active composition produced by a method comprising: (1) growing a microbial biofilm within a reactor vessel, wherein the biofilm is contacted with a biological growth medium within said reactor vessel; (2) harvesting said biofilm by removing the biofilm from the reactor vessel thereby obtaining a fraction comprising biologically-active biofilm cellular mass; (3) combining said fraction with an appropriate carrier to form said biologically active composition. Dependent claims are drawn to wherein the composition comprises a food product and wherein the microbe is a Lactobacillus..
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 631 encompass wherein the microbe is a Lactobacillus. encompass the limitations of the claims and administration encompasses eating.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,004,771. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The independent claim of 771 is drawn to A composition for oral consumption comprising a biologically-active composition, wherein the biologically-active composition is obtained by a method comprising the steps of: (a) growing biofilm cellular mass, which has biological activity, in a biological growth medium; (b) rendering said biofilm cellular mass non-viable; and (c) combining said non-viable biofilm cellular mass with an edible material to form said edible composition that comprises said non-viable biofilm cellular mass, wherein the microbe is a Lactobacillus.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 771 encompass wherein the microbe is a Lactobacillus. encompass the limitations of the claims and administration encompasses eating.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,925,908. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The independent claim of 908 is drawn to A liquid composition for oral consumption comprising biologically-active biofilm cellular mass, a liquid edible material, and further comprising exopolysaccharides produced by the biofilm. Dependent claims are drawn to according to claim 1, wherein the biofilm cellular mass is a Lactobacillus biofilm cellular mass.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 901 encompass Lactobacillus biofilm cellular mass encompass the limitations of the claims and administration encompasses eating.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,191,277. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The independent claim of 277 is drawn to An inhaler device containing a composition comprising biologically-active biofilm cellular mass of a Lactobacillus microbe, wherein the biofilm cellular mass is nonviable, and wherein the biological activity of non-viable biofilm cellular mass is anti-microbial activity and/or anti-inflammatory activity.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 277 encompass Lactobacillus biofilm cellular mass encompass the limitations of the claims and an inhaler is oral consumption.
Claims 1-2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,825,848. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims are drawn to A composition for oral consumption comprising non-viable microbial biofilm cellular mass, wherein the microbe is selected from the group consisting of Bacteroides, Bifidobacterium, and Lactobacillus; and exopolysaccharides; wherein the composition further comprises edible ingredients that are generally regarded as safe (GRAS).
The claims of 848 are drawn to A liquid probiotic composition for oral consumption comprising biologically-active biofilm cellular mass, a liquid edible material, and further comprising exopolysaccharides produced by the biofilm. Dependent claims are drawn to wherein the edible material comprises ingredients that are generally regarded as safe (GRAS) and wherein the biofilm cellular mass is a Lactobacillus biofilm cellular mass.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the time of the invention the claims of 848 encompass Lactobacillus biofilm cellular mass encompass the limitations of the instant claims.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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/Steven Pohnert/Primary Examiner, Art Unit 1683