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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 9, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities:
Each of “Biotin,” “Selenium,” “Zinc,” “Copper,” and “Lutein” should not be capitalized.
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.
Claims 1 – 15 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.
Claims 1, 14 and 15 recite deposited bacterial Lactobacillus rhamnosus and Bifidobacterium longum. The specification does not provide clear evidence that the claimed biological material is known and readily available to the public; reproducible; and deposited per the deposit rules under 37 C.F.R 1.801 - 1.809.
Every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112. Courts have recognized the necessity and desirability of permitting an applicant for a patent to supplement the written disclosure in an application with a deposit of biological material which is essential to meet some requirement of the statute with respect to the claimed invention. See, e.g., Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345-46, 56 USPQ2d 1332, 1337-38 (Fed. Cir. 2000), cert. denied, 121 S.Ct. 1957 (2001) (explaining how deposit may help satisfy enablement requirement); Merck and Co., Inc. v. Chase Chemical Co., 273 F. Supp. 68, 155 USPQ 139 (D. N.J. 1967); In re Argoudelis, 434 F.2d 666, 168 USPQ 99 (CCPA 1970). To facilitate the recognition of deposited biological material in patent applications throughout the world, the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was established in 1977, and became operational in 1981. The Treaty requires signatory countries, like the United States, to recognize a deposit with any depository which has been approved by the World Intellectual Property Organization (WIPO).
The deposit rules (37 CFR 1.801 - 1.809) set forth examining procedures and conditions of deposit which must be satisfied in the event a deposit is required. The rules do not address the substantive issue of whether a deposit is required under any particular set of facts. (MPEP 2402).
Since the microorganisms Lactobacillus rhamnosus CECT 30580 and Bifidobacterium longum CECT 30616 are recited in the claims, they is essential to the invention recited in those claims. They must therefore be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganisms are not so obtainable or available, a deposit of the microorganisms may satisfy the requirements of 35 U.S.C. § 112. The specification does not disclose a repeatable process to obtain the microorganisms and it is not apparent if the microorganisms are readily available to the public. Moreover, because no taxonomic information appears in the specification, it is not clear what the microorganisms actually are.
However, since a deposit has been made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants, someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his/her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 C.F.R. § 1.808.
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 – 15 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.
Claims 1, 2, 12, 14 and dependents are drawn to a probiotic composition however are rendered indefinite for reciting “preferably” and “most preferred” because it is unclear whether the limitations that follow the language is required by the claim. The phrases amount to a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation which does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 1 and its dependents are further indefinite for reciting "such as" because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In claim 5, the recitation of “is formulated for” renders the claim indefinite because it is unclear whether the phrase recites an intended use of the product, method steps that must be carried out to fulfill an unrecited product by process. For purposes of examination, the claim is interpreted to mean the pharmaceutical composition is a solid formulation selected from the recited forms.
In claim 6, the recitation of “is formulated for” renders the claim indefinite because it is unclear whether the phrase recites an intended use of the product, method steps that must be carried out to fulfill an unrecited product by process. For purposes of examination, the claim is interpreted to mean the pharmaceutical composition is a liquid formulation selected from the recited forms.
Regarding claim 7, it is unclear how the recitation of “nutritional supplement” further defines a “nutritional composition” as the phrases are synonyms and neither the claim language nor specification defines either phrase. Clarification is required.
Claim 9 is rendered indefinite because it is unclear if the claim is changing the composition or further defining the composition. For example, incorporating each of the claims on which it depends, the claim appears to require that the probiotic composition be a biotin, selenium, zinc, copper or lutein comprising probiotics, which is unclear. For purposes of examination, the claim is interpreted to mean that the probiotic composition further comprises biotin, selenium, zinc, copper, lutein or combinations thereof.
In claim 11, the recitation of “is provided” renders the claim indefinite because it is unclear if the phrase intends to encompass unrecited, intended use method steps.
Claim 13 is drawn to a probiotic composition however is rendered indefinite for reciting “at least” in combination with a specified range because it is unclear if the concentration can be more than the recited range or if the recited range is the required amount.
Claim 13 is further indefinite for reciting multiple ranges within the claim. The multiple ranges amount to a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation which does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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)(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.
(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.
Claims 1 – 14 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Simon (US 2019/0282637) as evidenced by Rejuvenation Science (2026).
Regarding claims 1 - 3, 7 and 14, Simon teaches nutritional and therapeutic (pharmaceutical) probiotic compositions comprising Lactobacillus rhamnosus, L. casei, L. paracasei, L. reuteri, Bifidobacterium animalis subspecies lactis, and B. longum (0015), wherein the composition can be used in treating alopecia or alopecia areata (0128).
Regarding claim 4, the compositions include pharmaceutical carriers (0034).
Regarding claims 5 - 6 and 8, the compositions may be in forms such as capsule, tablet, liquid solutions, drops for oral use (e.g., beverage) (0102, 0137).
Regarding claim 9, the compositions may further include zinc (Table 5) or a Rejuvenation Science Maximum Vitality multivitamin which includes biotin, selenium, zinc, copper and lutein (see Maximum Vitality Product sheet) (0061).
Regarding claim 10, the compositions may further include Bacillus species (0015).
Regarding claim 11, the composition is provided in unit doses (or single dosage form) (0022, 0048, Table 3).
Regarding claim 12, the bacteria are included at 30 - 720 billion (3x109 - 7.2x1011) CFUs, which falls within the claimed ranges.
Regarding claim 13, Simon teaches a composition wherein 10 bacteria are included and are within 10% by CFUs (concentration) of each other (0048, Table 1). Table 1 shows that 5 of the 10 bacteria are those claimed, which is interpreted to mean that the bacteria concentration of these bacteria are about 50% of the total concentration of bacteria, which falls within the claimed ranges.
Thus, the reference anticipates the claimed subject matter.
Claims 1 – 8 and 10 – 14 are rejected under 35 U.S.C. 102a1 as being anticipated by Navarro López et al. (US 10912802).
Regarding claims 1 - 3, 7, 10 and 14, Navarro López teaches nutritional and therapeutic (pharmaceutical) probiotic compositions comprising Lactobacillus rhamnosus, L. casei, L. paracasei, L. reuteri, Bifidobacterium animalis subspecies lactis, B. longum and Kluyveromyces (abstract, claims, col.7 line 33 - 51). Although the reference does not teach the compositions for the claimed used, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claim 4, the compositions includes pharmaceutical carriers or excipients (col.4 - 5).
Regarding claims 5 - 6 and 8, the compositions may be in forms as claimed (claims 7 - 10).
Regarding claim 11, the composition is provided in unit doses (col.14).
Regarding claims 12 and 13, the bacteria are included at 106 - 109 CFUs; or at least 31%, 32%, 33%, 34% or 35% relative to the total concentration of microorganisms present (col.8, claims 12 - 13).
Thus, the reference anticipates the claimed subject matter.
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Simon (US 2019/0282637) or Navarro López et al. (US 10912802).
Regarding claim 14, Simon teaches nutritional and therapeutic (pharmaceutical) probiotic compositions comprising Lactobacillus rhamnosus, L. casei, L. paracasei, L. reuteri, Bifidobacterium animalis subspecies lactis, and B. longum (0015); while Navarro López teaches probiotic compositions comprising B. animalis lactis, B. longum and L. rhamnosus (abstract, claims).
Regarding claim 15, the references do not teach the compositions wherein the bacteria are the deposited strains. However, the claimed species are clearly disclosed as effective probiotics and neither reference limits the species to particular strains. In this regard, it would have been obvious to one of ordinary skill in the art to substitute other strains of L. rhamnosus and B. longum in the compositions of Simon or Navarro López, there being a finite number of identified solutions (e.g. one species), and with a reasonable expectation for successfully obtaining an effective probiotic composition.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
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.
Claims 1 – 8, 11 – 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 8 of U.S. Patent No. 12691148. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Regarding claims 1 – 2 and 14, the patent claims a composition comprising Bifidobacterium animalis subsp. lactis (B. lactis), Bifidobacterium longum and Lactobacillus casei, for use in treating atopic dermatitis (claim 1). Although the reference does not claim the compositions for the claimed used, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claim 3, the probiotic composition is a pharmaceutical composition or a nutritional composition (claim 2).
Regarding claim 4, the pharmaceutical composition comprises a pharmaceutically acceptable carrier and/or an excipient (claim 3).
Regarding claims 5 - 8, 11, the pharmaceutical composition is formulated for administration in liquid form or in solid form (claim 4) such as tablets, lozenges, sweets, chewable tablets, chewing gum, capsules, sachets, powders, granules, coated particles or coated tablets, tablets and gastro-resistant tablets and capsules and dispersible strips and/or films (claim 5); liquid formulations such as oral solutions, suspensions, emulsions and syrups (claim 6); a food or a nutritional supplement (claim 7); or vegetable juices, ice cream, infant formula, milk, yogurt, cheese, fermented milk, milk powder, cereals, baked goods, milk-based products, meat products and beverages (claim 8), which are interpreted as dingle dose forms.
Regarding claim 12, the bacteria are included at 107 - 108 CFUs (claim 1).
Claims 1 – 8 and 10 – 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12576116. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Regarding claims 1 - 8, 10 - 14, the patent claims a probiotic composition comprising Bifidobacterium animalis subsp. lactis (B. lactis), Bifidobacterium longum and Lactobacillus casei, wherein B. lactis is B. lactis CECT 8145, B. longum is B. longum CECT 7347 and L. casei is L. casei CECT 9104, wherein B. longum concentration is 35% with respect to the total concentration of microorganisms present in the composition; B. lactis concentration is 35% with respect to the total concentration of microorganisms, and L. casei concentration is 30% with respect to the total concentration of microorganisms; the total concentration of microorganisms of the strains B. lactis, L. casei and B. longum in the composition is from 107 to 108 CFU and the probiotic composition is a food selected from the group consisting of fruit or vegetable juices and infant formula (powder).
Although the reference does not claim the compositions for the claimed used, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Claims 1 – 8 and 10 – 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 13 of U.S. Patent No. 10912802. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Regarding claims 1 - 3 and 14, the patent claims a probiotic composition comprising microorganisms of Bifidobacterium animalis subs. lactis (B. lactis), Bifidobacterium longum and Lactobacillus rhamnosus, wherein the concentration of B. longum with respect to the total concentration of microorganisms present in the composition is at least 30%, wherein B. lactis is B. lactis CECT 8145, B. longum is B. longum ES1 CECT 7347 and L. rhamnosus is L. rhamnosus CECT 8361 (claim 1). Although the reference does not claim the compositions for the claimed used, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claim 4, the pharmaceutical composition comprises a pharmaceutically acceptable carrier and/or an excipient (claim 5).
Regarding claims 5 - 8 and 11, the pharmaceutical composition is formulated for administration in liquid form or in solid form; tablets, lozenges, sweets, chewable tablets, chewing gum, capsules, sachets, powders, granules, coated particles or coated tablets, tablets and gastro-resistant tablets and capsules and dispersible strips and films; oral solutions, suspensions, emulsions and syrups; fruit or vegetable juices, ice cream, infant formula, milk, yogurt, cheese, fermented milk, milk powder, cereals, baked goods, milk-based products, meat products and beverage (claims 6 - 10).
Regarding claim 10, the composition further comprises a microorganism selected from the group consisting of Lactobacillus sp., Streptococcus sp., Bifidobacterium sp., Saccharomyces sp., Kluyveromyces sp. and combinations thereof (claim 11).
Regarding claims 12 - 13, total concentration of microorganisms of the strains B. lactis, L. rhamnosus and B. longum in the composition is between 103 and 1012 CFU and the concentration of B. longum with respect to the total concentration of microorganisms present in the composition is at least 30% (claims 12 - 13).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
