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 .
DETAILED ACTION
Claims 1-4 and 6-11 are pending.
The following rejections are new and are not necessitated by amendment, therefore the action is non-final.
Drawings
The drawings are objected to because the first sheet of the drawings shows FIG. 1b but does not show FIG. 1a. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: The term “Figure” should be replaced with “FIG.”.
Appropriate correction is required.
Claim Objections
Claims 1-3, 6, and 8-11 are objected to because of the following informalities:
In claims 1-2, “Streptococcus salivarius” and “Lactobacillus plantarum” should be italicized since they recite the scientific name of the bacteria.
In claims 1-2, the phrase “characterized by comprising” should be replaced with “comprising”
In claim 1, the term “stable” in line 7 should be deleted.
In claim 2, the limitation “24 ml/100 ml” of natural flavoring should be replaced by “2-4 ml/100 ml” as this latter limitation seems to be the intend of Applicant. See specification page 9 line 7.
In claim 2, “4x1012” should be replaced with “4x1012”.
In claims 1-3, 6, and 8, “selected from” should be replaced with “selected from the group consisting of” since the limitation recites a Markush grouping.
Claim 8, step g) recites finally, However, step g) is not the final step. Applicant may consider deleting the term “finally”.
In claim 8, “forming a maximum layer of 1 cm thick” should be replaced with “forming a layer with a thickness of less than 1 cm”.
In claim 8, the acronym “UV” should be replaced by the full name the first time it appears.
In claim 9, “stages” should be replaced with “steps” to be consistent with the terminology of claim 8.
In claims 10-11, “The use” should be replaced with “A method of using” since the claim recites method steps.
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 8 and 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.
Claim 8 recites the limitations "the inoculum" and “the strains” in step e). There is insufficient antecedent basis for this limitation in the claim. Applicant may consider amending the claim the recite “prepare an inoculum by reactivating at least one..” in order to obviate the rejection.
In claim 8, the set of brackets around the phrases "6-9 g/100 mL", “25-50 mg/100 mL”, “3-5 g/100 mL”, and “1-2 mL/100 mL” renders the claim indefinite because it is unclear whether the limitations inside the set of brackets are part of the claimed invention.
In claim 8, the set of parentheses around the phrases " the number of samples depends on the initial concentration", “2500 rpm, 5 min”, “0.9% NaCl”, and “25oC” renders the claim indefinite because it is unclear whether the limitations inside the set of parentheses are part of the claimed invention.
In claim 8, step f) lacks clarity and renders the claim indefinite. The claim recites “1 mL aliquots”. It is not clear if the aliquots are from the pectin solution, microorganisms, or both. It is also not clear how the microorganism pill or tablet was formed.
Claim 8 recites the limitation "the same diluent" in step g). There is insufficient antecedent basis for this limitation in the claim. Applicant may consider amending the claim to recite “in the physiological solution” in order to obviate the rejection.
Claim 8 contains the trademark/trade name Eppendorf. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe tubes and, accordingly, the identification/description is indefinite.
Claim 9, which depend from claim 8, does not cure the deficiency and is also rejected.
Claim Rejections - 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 1-2, 4, 6-7, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Burton (Journal of medical microbiology 62.6 (2013): 875-884) in view of Romanoschi (US 2016/0296474 A1, published 10/13/2016)
Regarding claim 1, Burton teaches an oral composition comprising Streptococcus salivarius, flavoring agents, and sugar, and teaches Streptococcus salivarius has anti-caries activity (Abstract, para. “Preparation of test material”).
Burton does not teach the composition comprises pectin, citric acid, and dextrose.
However, Romanoschi teaches a gummy composition comprising pectin, citric acid, glucose, and flavoring agent, and teaches that the composition comprises probiotics ([0019], [0089], claim 6).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Burton by adding pectin, citric acid, and glucose as suggested by Romanoschi. One of ordinary skill in the art would be motivated to do so in order to form a chewable composition to deliver the probiotic. Since both Burton and Romanoschi teach a desire to form a composition to orally deliver a probiotic, there is a reasonable expectation of success.
The preamble limitation “formulated with probiotics to provide stability to beneficial chemical-microbial properties in oral health” is an intended use limitation. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02(II)
The limitations “wherein the pectin acts as a natural thickener that when combined with sugar and the citric acid forms a gel that stabilizes microorganisms stable and simultaneously promotes anti-adhesive activity against pathogens”, “wherein the dextrose provides necessary nutrients to microorganisms to keep said microorganisms alive without stimulating the proliferation of said microorganisms”, “wherein the citric acid regulates the pH of the matrix, conserves the gel and acts as an emulsifier”, and “wherein the flavoring gives the matrix organoleptic properties” are characteristics of the components of the composition. Since Romanoschi teaches the same components, then these characteristics will also be present.
Regarding claim 2, Burton teaches that the composition comprises 3.6x109 CFU of S. salivarius. Applicant discloses 4x1012 CFU/ml is equal to 2x109 CFU of composition (specification page 12 lines 12-13). Romanoschi teaches that the composition comprises 4% by weight of pectin which falls within the instant limitation of 3-5 g/100 mL of pectin, 2% flavoring agent, about 10% glucose syrup, and 0.05% citric acid which falls within the instant limitation 25-50 mg/100 mL of citric acid ([0088], [0089], Table 8). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Burton by optimizing the amount of microorganism and glucose in the composition, as suggested by Burton and Romanoschi. One of ordinary skill in the art would be motivated to do so in order to form an effective and safe composition.
Regarding claim 4, Romanoschi teaches that the composition is viscoelastic (claim 5).
Regarding claim 6, Burton teaches that Streptococcus salivarius colonized the mouth of the subjects which is understood as the strain is in active state (Abstract).
Regarding claim 7, Burton teaches that Streptococcus salivarius was added to lozenges (para. “Preparation of test material”).
Regarding claim 10, Burton teaches administering the composition comprising Streptococcus salivarius to the mouth of the subjects and teaches the composition was readministered for a period of 3 month with a twice-daily dosing (para. “Preparation of test material”, Table 3, page 883 left column first para.).
Regarding claim 11, Burton teaches the composition has anti-caries effect and reduced plaques (Abstract). The limitation “wherein the probiotics counteracts or prevents caries, prevents bad breath, removes tartar, removes yellowing from teeth and other oral conditions” is the result of the method steps and does not require further steps. MPEP 2111.04 states that whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Burton and Romanoschi as applied to claim 1 above, and further in view of Peot (Joanna Peot, Oral Care Flavor Trends: Mint, Herbs and Fruit, 12/30/2008, retrieved from www.perfumerflavorist.com/fragrance/oral-care/news/21871159/oral-care-flavor-trends-mint-herbs-and-fruit)
Burton and Romanoschi do not teach that the flavoring agent is mint.
However, Peot teaches that mint is used in oral care products and is associated with cleanliness and fresh breath (page 1, para 1 and 2).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition taught by Burton by adding mint as flavoring agent as suggest by Peot. One of ordinary skill in the art would be motivated to do so in order to add a refreshing aroma and taste to the composition. Since Peot teaches mint flavoring is popular choice for oral care products, there is a reasonable expectation of success.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Burton and Romanoschi as applied to claim 1 above, and further in view of Cook (Journal of the American Pharmaceutical Association 8.2 (1919): 116-120), Li (CN 104328025, published 02/04/2015), Keyser (Innovative food science & emerging technologies 9.3 (2008): 348-354), Perez (European Food Research and Technology 231.5 (2010): 813-819), and Adams (WO 2004/001022A1, published12/31/2003).
Regarding claim 8, Romanoschi teaches heating water and glucose to 90oC, adding pectin, followed by citric acid and flavoring agent ([0177]) and heating the composition to 104oC. Romanoschi teaches mixing the ingredients, cooling the composition to 90° C, and pouring the composition into molds to form gummy composition ([0176]). Romanoschi teaches the composition is stable during storage under ambient conditions and teaches storing the composition for 5 days at 20-25oC ([0009], [0172], [0173]).
Romanoschi does not explicitly recite a beaker. However, one of ordinary skill in the art would understand that a container capable of holding the boiling liquid is used. Romanoschi does not teach adding the components in the same order. However, one of ordinary skill in the art would be motivated to optimize the order of adding the ingredients in order to effectively dissolve the components. MPEP 2144.04.IV.C states that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Romanoschi’s method formed a matrix composition as the instant method and there is no indication that the order of adding the components resulted in new or unexpected results.
Burton and Romanoschi do not teach distilled water.
However, Cook teaches that distilled water is used in pharmaceuticals in order to eliminate any dissolved solids in addition to bacterial life and toxins (page 116 first para, page 119 first para.).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Burton by adding distilled water as suggested by Cook. One of ordinary skill in the art would be motivated to do so in order to eliminate the presence of bacteria or their toxins in the composition.
Burton, Romanoschi, and Cook do not teach mixing at a speed of 250 to 500 rpm or 100 to 150 rpm.
However, Li teaches a method of preparing a composition comprising sugar, citric acid, and pectin the method comprises heating the composition at 85oC and stirring for 5 minutes at 500 rpm (para. Description). Li teaches sterilizing the composition using UV light for 10-25 minutes and preserving it in sterile bottles (Title, para. Description, para. Claims)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Burton by optimizing the temperature of the mixture and optimizing the mixing speed, and to sterilize the composition using UV light, as suggested by Li. One of ordinary skill in the art would be motivated to do so in order to effectively dissolve and mix the different components and sterilize the composition.
Burton, Romanoschi, Cook, and Li do not teach forming a maximum layer of 1 cm thick.
However, Keyser teaches that the penetration of UV light into juices is about 1 mm (page 349 left column).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Burton by forming 1 mm layer of the composition and sterilizing it using UV, as suggested by Keyser. One of ordinary skill in the art would be motivated to do so in order to effectively sterilize the solution.
Burton, Romanoschi, Cook, Li, and Keyser do not teach performing a count of the bacteria by means of a Neubauer chamber.
However, Perez teaches enumerating bacteria using Neubauer chamber and teaches that Neubauer chamber rendered consistent and reliable data for
viable cell counts of bacteria (Abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Burton by performing a cell count using Neubauer chamber as suggested by Perez. One of ordinary skill in the art would be motivated to do so to reliably and accurately count the bacterial cells.
Burton, Romanoschi, Cook, Li, Keyser, and Perez do not teach washing the cells and resuspending in NaCl.
However, Adams teaches a method of preparing bacterial cells and teaches growing the cells in medium, transferring an aliquot into tubes, washing the cells twice in 0.85% NaCl with centrifugation (3500 x g, 5 min) between each wash, resuspending the cells in 0.85% NaCl, and dispensing aliquots (3.5 mL) of the bacterial suspension in
sterile tube (page 68 lines 5-12).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Burton by growing the bacteria, washing the bacterial cells with NaCl solution, and dispensing aliquots into tubes as suggested by Adams. One of ordinary skill in the art would be motivated to do so in order to wash all culture medium and resuspend the cells in NaCl. One of ordinary skill in the art would be motivated to optimize the size of the aliquot as well as the number of washes in order to control the amount and quality of the cells.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Burton, Romanoschi, Cook, Li, Keyser, Perez, and Adams as applied to claim 8 above, and further in view of Bykowski (Current protocols in microbiology 11.1 (2008): A-4D).
Regarding claim 9, Burton, Romanoschi, Cook, Li, Keyser, Perez, and Adams do not teach that steps “e" to "h" are carried out in a laminar flow hood under aseptic conditions and with sterile material.
However, Bykowski teaches aseptic technique and laboratory procedures that can reduce the risk of microorganism’s culture contaminations comprising the use of a laminar flow hood.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Burton by handling the bacteria using aseptic techniques in a laminar flow hood as suggested by Bykowski.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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, LOUISE W HUMPHREY can be reached at 571-272-5543. 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.
/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
Prosecution Insights