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 .
The preliminary amendments are received.
New claim 26 is added.
Claims 1-26 are pending and are being examined.
Claim Rejections - 35 USC § 112
Deposit of the Biological Material
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 3, 4 and 21 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ specific bacterial strains: L. plantarum Lp-202195, L. acidophilus NCFM, L. rhamnosus GG, L. rhamnosus HN001, B. lactis HNO19, B. lactis DSM 15954, B. lactis Bi-07, B. infantis Bi-26, B. breve Bb-18, and B. longum Bl-05.
It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit.
Further it is unclear if the starting materials were readily available to the public at the time of invention.
It does not appear that a deposit(s) was made in this application.
Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Copies of deposit receipt are required.
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 1-26 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.
In claim 1, the Markush group “a blend of bacterial strains selected from the group consisting of Lactobacillus spp. including L. plantarum, L. acidophilus, and L. rhamnosus, and Bifidobacterium spp. including B. lactis, B. infantis, B. breve, and B. longum” is confusing which renders the claim indefinite because the bacterial strains in the claimed blend are not clear. As such, the scope of the claim is not clearly set forth.
Suggestion to obviate the rejection: in claim 1, line 4, before Bifidobacterium spp., insert --selected from the group consisting of--.
In claim 8 the limitation “the bacterial extract of at least one Lactobacillus species…” lacks antecedent basis in the claim. Because claim 1 does not recite a bacterial extract.
Suggestion to obviate the rejection: provide antecedent basis.
In claim 12 the limitation “the bacterial extract of at least one Lactobacillus species…” lacks antecedent basis in the claim. Because claim 1 does not recite a bacterial extract.
Suggestion to obviate the rejection: provide antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4 and 21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In claim 2, the phrase “a blend of bacterial strains comprising L. plantarum, L. acidophilus, L. rhamnosus, and B. lactis” fails to further limit the subject matter of claim 1 upon which claim 2 depends.
Suggestion to obviate the rejection: in claim 2, line 2, replace “comprising” with –are--.
In claim 3, the phrase “a blend of bacterial strains comprising L. plantarum Lp-202195, L. acidophilus NCFM, L. rhamnosus GG, L. rhamnosus HN001, B. lactis HNO19, B. lactis DSM 15954, and B. lactis Bi-07” fails to further limit the subject matter of claim 1 upon which claim 3 depends.
Suggestion to obviate the rejection: in claim 3, line 2, replace “comprising” with –are--.
In claim 4, the phrase “a blend of bacterial strains comprising B. lactis Bi-07, B. infantis Bi-26, B. breve Bb-18, and B. longum Bl-05” fails to further limit the subject matter of claim 1 upon which claim 4 depends.
Suggestion to obviate the rejection: in claim 4, line 2, replace “comprising” with –are--.
In claim 21, the phrase “wherein the blend of bacterial strains comprises B. lactis Bi-07, B. infantis Bi-26, B. breve Bb-18, and B. longum Bl-05” fails to further limit the subject matter of the claim 19 upon which claim 1 depends.
Suggestion to obviate the rejection: in claim 21, line 1, replace “comprises” with –are--.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejection - 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.
A)
Claims 1, 5 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martens et al. (Allergy. 2018, Vol. 73, No. 10, p. 1954-1963).
Regarding claim 1, Martens et al. disclose a dietary supplement, food product, or nutraceutical for use in supporting health in an infant or child, comprising a blend of bacterial strains selected from the group consisting of Lactobacillus spp. including L. plantarum, L. acidophilus, and L. rhamnosus, and Bifidobacterium spp. including B. lactis, B. infantis, B. breve, and B. longum (oral treatment with L. rhamnosus and B. breve in asthma model, etc.) (See for example, p. 1959 left-hand column 2nd paragraph).
Regarding claim 5, Martens et al. disclose the at least one Lactobacillus species is viable and capable of proliferating in the infant or child (Lactobacillus and Bifidobacterium strains are probiotics are live microorganisms and provide health benefits to the host, etc.) (See for example. p. 1955 right-hand column 1st paragraph under Graphical Abstract).
Regarding claim 9, the at least one Bifidobacterium species is viable and capable of proliferating in the infant or child (Lactobacillus and Bifidobacterium strains are probiotics are live microorganisms and provide health benefits to the host, etc.) (See for example. p. 1955 right-hand column 1st paragraph under Graphical Abstract).
Martens et al. therefore anticipate the claimed dietary supplement.
B)
Claims 1, 2, 5, 6, 8, 9, 12-20 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ritter et al. (US 2010/0215738 A1), as evidenced by Reuter G. (Biosci. Microflora. 1997, Vol. 16, p. 43–51).
Regarding claim 1, Ritter et al. disclose a dietary supplement, food product, or nutraceutical for use in supporting health in an infant or child, comprising a blend of bacterial strains selected from the group consisting of Lactobacillus spp. including L. plantarum, L. acidophilus, and L. rhamnosus, and Bifidobacterium spp. including B. lactis, B. infantis, B. breve, and B. longum (a probiotic composition, mixtures of species or strains, comprising Lactobacillus spp. including L. plantarum, L. acidophilus, and L. rhamnosus and Bifidobacterium spp. including B. lactis, B. infantis, B. breve, and B. longum, and the subject in need includes human adult or child) (See for example, p. 13 paragraphs [0144], [0145], [0146] and p. 29 paragraph [0288]).
Regarding claim 2, Ritter et al. disclose the blend of bacterial strains comprising L. plantarum, L. acidophilus, L. rhamnosus, and B. lactis (See for example, p. 13 paragraphs [0145] and [0146]).
Regarding claim 5, Ritter et al. disclose the at least one Lactobacillus species is viable and capable of proliferating in the infant or child (live cultured bacteria) (See for example, p. 13 paragraph [0149] and p. 14 paragraph [0151]).
Regarding claims 6 and 8, Ritter et al. inherently disclose the at least one Lactobacillus species is not capable of proliferating in the infant or child, the bacterial extract of at least one Lactobacillus species is present, because before the effective filing date of the invention Reuter disclose probiotic microbial preparation which contains live and/or dead cells including their metabolites, etc.) (See for example, p. 43 left-hand column “Definitions of Probiotics, …“). As such, Ritter et al. inherently disclose the limitations of claims 6 and 8.
Regarding claim 9, Ritter et al. disclose the at least one Bifidobacterium species is viable and capable of proliferating in the infant or child (live cultured bacteria) (See for example, p. 13 paragraph [0142] and p. 14 paragraph [0151]).
Regarding claim 12, Ritter et al. inherently disclose the bacterial extract of at least one Bifidobacterium species is present, because before the effective filing date of the invention Reuter disclose probiotic microbial preparation which contains live and/or dead cells including their metabolites, etc.) (See for example, p. 43 left-hand column “Definitions of Probiotics, …“). As such, Ritter et al. inherently disclose the limitations of claim 12.
Regarding claim 13, Ritter et al. disclose the dietary supplement further comprising at least one nutritionally active ingredient (e.g., a dairy product) (See for example, p. 14 paragraph [0150]).
Regarding claim 14, Ritter et al. disclose the at least one nutritionally active ingredient is selected from the group consisting of a vitamin, a micronutrient, a mineral, a prebiotic fiber, a fatty acid, and an amino acid, or any combination thereof (in combination with prebiotics, and vitamins, etc. ) (See for example, p. 14 paragraph [0150], and p. 18 paragraph [0173]- Continued on right-hand column).
Regarding claim 15, Ritter et al. disclose the at least one nutritionally active ingredient is selected from the group consisting of vitamin D3, lactoferrin, and zinc gluconate (administered with milk and dairy products) (See for example, p. 14 paragraph [0154]).
Regarding claim 16, Ritter et al. disclose the dietary supplement comprising at least one human milk oligosaccharide (preparation which contains live and/or dead cells including their metabolites, etc.) (See for example, p. 43 left-hand column “Definitions of Probiotics, …“). As such, Ritter et al. inherently disclose the limitations of claims 6, 8 and 12.
Regarding claim 17, Ritter et al. disclose the dietary supplement is formulated for oral administration (oral formulation) (See for example, p. 19 paragraph [0181]).
Regarding claim 18, Ritter et al. disclose the dietary supplement in which the oral formulation is a capsule, microcapsule, tablet, granule, powder, troche, pill, suspension, solution, or syrup (e.g., as soft gel capsules) (See for example, p. 19 paragraph [0181]).
Regarding claim 19, Ritter et al. disclose a method for improving gastrointestinal health in an infant or child, comprising the steps of: providing a dietary supplement including a blend of bacterial strains selected from the group consisting of Lactobacillus spp. including L. plantarum, L. acidophilus, and L. rhamnosus, and Bifidobacterium spp. including B. lactis, B. infantis, B. breve, and B. longum; and administering the blend to the infant or child by oral administration (method for improving overall GI health, improving symptoms, and suitable amount of probiotic per serving used that allows an effective microbiota in GI, and the subject in need includes human adult or child) (See for example, p. 25 paragraph [0248], p. 14 paragraph [0150] p. 19 paragraph [0181] and p. 29 paragraph [0288]).
Regarding claim 20, Ritter et al. disclose the gastrointestinal health is improved in the infant or child by reducing a symptom selected from gas, bloating, constipation, loose stool, diarrhea, or other discomfort (improving symptoms including diarrhea, abdominal pain, gas bloating) (See for example, p. 25 paragraph [0248]).
Regarding claim 22, Ritter et al. disclose the dietary supplement further includes at least one nutritionally active ingredient selected from the group consisting of vitamin D3, lactoferrin, zinc gluconate, and a human milk oligosaccharide (administered with milk and dairy products) (See for example, p. 14 paragraph [0154]).
Ritter et al. therefore anticipate the claimed dietary supplement and the method for improving gastrointestinal health.
Claim Rejection - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ritter et al. (US 2010/0215738 A1) as evidenced by Reuter G. (Biosci. Microflora. 1997, Vol. 16, p. 43–51) as applied to claims 1, 2, 5, 6, 8, 9, 12-20 and 22 above, and further in view of Pique et al. (Int J Mol Sci. 2019 May 23;20(10):2534, p. 1-30).
The teachings of Ritter et al. as evidenced by Reuter with respect to the limitations of claims 1, 2, 5, 6, 8, 9, 12-20 and 22 were discussed above in details.
Regarding claims 3, 4, and 21, although Ritter et al. do not teach, a blend of bacterial strains comprising L. plantarum Lp-202195, L. acidophilus NCFM, L. rhamnosus GG, L. rhamnosus HN001, B. lactis HNO19, B. lactis DSM 15954, and B. lactis Bi-07 (claim 3), a blend of bacterial strains comprising B. lactis Bi-07, B. infantis Bi-26, B. breve Bb-18, and B. longum Bl-05 (claim 4), and the blend of bacterial strains comprises B. lactis Bi-07, B. infantis Bi-26, B. breve Bb-18, and B. longum Bl-05 (claim 21), the bacterial strains taught by Ritter et al. although have different designations, but they appear to be the same as or obvious variants of the claimed bacterial strains. As such, the strains of Bifidobacterium species and Lactobacillus species in the claimed blends would have been obvious.
Ritter et al. do not teach the at least one Lactobacillus species is not capable of proliferating in the infant or child (claim 6), the at least one Lactobacillus species is heat-killed (claim 7), the at least one Bifidobacterium species is not capable of proliferating in the infant or child (claim 10), and the at least one Bifidobacterium species is heat-killed (claim 11).
However, regarding claims 6, 7, 10 and 11, before the effective filing date of the invention Pique et al. teach favorable properties of applying heat-killed probiotic bacteria without incurring the risks associated with live microorganisms especially in neonates with the pharmaceutical advantages in terms of transport and storage, and the heat-killed probiotics (see for example, p. 2 8th paragraph, p. 3 paragraph 2., and p. 8 3rd paragraph below figure 2).
Therefore, an ordinary person skill in the art before the effective filing date of the invention knowing the favorable properties of applying heat-killed probiotic bacteria without incurring the risks associated with live microorganisms especially in neonates with the pharmaceutical advantages in terms of transport and storage (as taught by Pique et al.) would have been motivated to apply heat-killed Lactobacillus species and Bifidobacterium species with a reasonable expectation of success in providing the claimed dietary supplement of claims 6, 7, 10 and 11.
B)
Claims 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Martens et al. (Allergy. 2018, Vol. 73, No. 10, p. 1954-1963).
Regarding claim 23, Martens et al. teach a method for improving respiratory function in a subject, comprising the steps of: providing a dietary supplement including a blend of bacterial strains selected from the group consisting of Lactobacillus spp. including L. plantarum, L. acidophilus, and L. rhamnosus, and Bifidobacterium spp. including B. lactis, B. infantis, B. breve, and B. longum; and administering the blend to the subject by oral administration (oral treatment with L. rhamnosus and B. breve in asthma model, and reduction of chronic inflammation relevant to respiratory allergies) (See for example, p. 1959 left-hand column 2nd paragraph, and p. 1958 Table 2).
Regarding claim 24, Martens et al. teach the respiratory function is improved in the infant or child by treating a condition or reducing a symptom derived from bronchopulmonary dysplasia (BPD), respiratory inflammation (treatment decreased the levels of proinflammatory cytokines in murine asthma model, and reduction of chronic inflammation relevant to respiratory allergies) (See for example, p. 1959 left-hand column 2nd paragraph, and p. 1958 Table 2).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to apply the teachings of Martens et al. and provide a dietary supplement including a blend of bacterial strains selected from the group consisting of Lactobacillus spp. including L. plantarum, L. acidophilus, and L. rhamnosus, and Bifidobacterium spp. including B. lactis, B. infantis, B. breve, and B. longum; and administering the blend to the infant or child by oral administration with a reasonable expectation of success to provide the claimed method for improving respiratory function in an infant or child.
Moreover, regarding daily dosage and CFUs (claims 25 and 26), the daily dosage of the bacterial strains provided in the method taught by prior art would have been optimized by a person of ordinary skill in the art before the effective filing date of the invention by routine optimization according to the needs of a particular subject and the symptoms.
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
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)272-8037. 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.
/KADE ARIANI/Primary Examiner, Art Unit 1651
