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 .
Claim Rejections - 35 USC § 112
Biological Deposit
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 1-12 are rejected under 35 U.S.C.§ 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
• It is apparent that L. acidophilus PBS066 (also known as LA001), having deposit number DSM 24936 (also deposited under LMG p-29512), and L. rhamnosus LRH020, having deposit number DSM 25568 (also deposited under LMG p-29513); B. breve BB077 (also known as PBS077), having deposit number LMG P-30157 (also deposited under DSM 25173), and B. longum BLG240 (also known as PBS108), having deposit number LMG P-29511 (also deposited under DSM 25174) are required to practice the claimed invention. As such the biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the aforementioned bacterial strains.
• The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. Applicant claims the use of a specific strains of bacteria in the composition of claim 1 and its dependent claims, 2-12. Therefor it is by definition, not possible to make the composition of claim 1 without access to the specified strains of bacteria above. It would be effectively impossible to reisolate those exact strains of bacteria from known sources of the same species, and would require an undue investment of time and resources for one skilled in the art to even attempt it. Since such an endeavor would require isolating and sequencing bacteria until isolates with the same sequences are found by chance. This would be a monumental and unnecessary effort that would be easily avoided by providing access to the strains above via an acceptable deposit of viable culture, that is made available to the public.
• It is noted that although the strains are recited in the claims as having deposit numbers with DSM and LMG, a search of their catalogues on 26FEB26 did not yield any results that correspond with the above strains or deposit numbers. It is further noted that L. rhamnosus LRH020 should have had any restrictions on the public availability of the strain irrevocably removed on 05JUL22.
• If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
Indefiniteness
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 1-12 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. This is because claim 1 recites “A probiotic composition comprising or alternatively consisting of” it is unclear whether the composition comprises (open claim language) or consists of (closed claim language) the strains of bacteria PBS066, LRH020, BB077 and BLG240. This renders the claim indefinite and by virtue of their dependence on claim 1, also claims 2-12. For the purposes of examination claim 1 is construed as comprising the strains PBS066, LRH020, BB077 and BLG240. This is the most reasonable interpretation since “consisting of” was recited as an alternative to “comprising”.
Claims 3-7 & 9 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 above claims are rejected for reciting “for use according to claim 1”, claim 1 does not provide any claim limitations based on intended use, and claim 1 is a composition claim, not reciting any active steps. Therefore, the dependent claims above are construed as reciting the composition of claim 1.
Regarding claim 9, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 11, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) over the Advanced Pro-Veflora 50 Billion as archived 28JAN21 (IDS, NPL document 1).
Regarding claims 1-9: a probiotic composition comprising L. acidophilus PBS066 (also known as LA001), having deposit number DSM 24936 (also deposited under LMG p-29512), and L. rhamnosus LRH020, having deposit number DSM 25568 (also deposited under LMG p-29513); B. breve BB077 (also known as PBS077), having deposit number LMG P-30157 (also deposited under DSM 25173), and B. longum BLG240 (also known as PBS108), having deposit number LMG P-29511 (also deposited under DSM 25174); in the form suitable for oral or topical administration and as a food supplement. With the following intended uses: as a medicament, in a method for modulating allergy-like inflammatory activity, prevention and/or treatment of allergies, respiratory allergies, seasonal allergies, such as hay fever, allergic rhinitis, chronic seasonal allergic rhinitis, allergic rhinoconjunctivitis and allergic asthma, or allergies related to Staphylococcus aureus and Clostridium difficile in adults, the elderly and pediatric subjects.
Advanced Pro-VeFlora 50 Billion, is a probiotic composition that comprises the exact strains of the instant application, and has been available for purchase since at least 2019 in the form of a food supplement for oral administration, as evidenced by the reviews on the manufacturer’s website, snapshots are provide in the file titled AdvancedPro-VeFlora50Billion.pdf. The intended uses of the instant application are considered further limiting, for the purposes of proper dependency of claims, but do not entitle the applicant to a patent for a known composition. Any effects of the composition as it relates to allergies, although not recited in the description of Advanced Pro-VeFlora 50 Billion, must be inherent to the composition and thus must have been present as well, even though they were not observed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GREGORY WILLKEEN whose telephone number is (571)272-6184. The examiner can normally be reached 9:00-5:00 Mon-Fri.
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, Melenie L. Gordon can be reached at (571) 272-1113. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.A.W./Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651