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
The amended claim set filed 4/12/2024 is acknowledged.
Claim 19 is cancelled.
Claims 1-18 will be examined on the merits herein.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. At least one hyperlink is found in the specification in par.24.
The use of the terms ACEF, Farmlabor, Sigma Aldrich, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 objected to because of the following informalities: the claim should start with ‘A” so it reads “A method”. Appropriate correction is required.
Claim 2 objected to because of the following informalities: the claim should start with ‘A” so it reads “A composition”. Appropriate correction is required.
Claim 17 objected to because of the following informalities: the claim recites “E vitamin” whereas other claims recite vitamin E, this is inconsistent and should be corrected for clarity of the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Biological Deposits
Claims 1-18 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 enablement requirement. The claim(s) contains 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.
The specification fails to provide an enabling disclosure, because the specification does not provide evidence that the claimed biological materials are: (1) known and readily available to the public; (2) reproducible from the written description; or, (3) deposited in compliance with the criteria set forth in 37 CFR 1.801-1.809. The specification lacks complete deposit information for the Limosilactobacillus vaginalis BC17 cells. Because it is not clear that the cells possessing the properties of the aforementioned cells are known and publicly available or can be reproducibly isolated without undue experimentation, and because the invention of claims 1-18 claims or uses the aforementioned cells, a suitable deposit for patent purposes is required. Accordingly, filing of evidence of the reproducible production of the aforementioned cells is necessary to practice the instant invention or filing of evidence of deposit is required. Without a publicly available deposit of the aforementioned cells, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the aforementioned cells is an unpredictable event. Applicants must comply with the criteria set forth in 37 CFR 1.801-1.809.
If the deposits are made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the aforementioned cells have been deposited under the Budapest Treaty, that the aforementioned cells will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and that the aforementioned cells will be replaced should they ever become non-viable, would satisfy the deposit requirement made herein.
If the deposits have not been made under the Budapest Treaty, then in order to certify that the deposits meet the criteria set forth in 37 CFR 1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number.
For each deposit made pursuant to these regulations, the specification shall contain:
The accession number for the deposit;
The date of the deposit;
A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
The name and address of the depository.
A viability statement for each deposit of a biological material not made under the Budapest Treaty on the International Recognition of the deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain:
The name and address of the depository;
The name and address of the depositor;
The date of deposit;
The identity of the deposit and the accession number given by the depository; (5) The date of the viability test;
The procedures used to obtain a sample if the test is not done by the depository; and
A statement that the deposit is capable of reproduction.
Applicant must assure that:
Access to the deposit will be available during pendency of the patent application making reference to the deposit.
All restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
In the instant application, at least the following issues exist. Searching Google for the Limosilactobacillus vaginalis BC17 and DSMZ for deposit 34059 did not uncover readily available sources.
If a deposit is made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository, stating that the deposited material is identical to the biological material described in the specification and was in the Applicant’s possession at the time the application was filed.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit along with the necessary statements in order to meet the criteria set forth in 37 CFR 1.801-1.809.
Applicant’s attention is directed to In re Lundak, 773 F.2nd. 1216, 227 USPQ 90 (CAFC 1985) and 37 CRF 1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 112(b)
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.
Claim 15 is 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 15 recites “The semi-solid Semi-composition” this is indefinite as semi-composition is not a known term in the art. The term also lacks antecedent basis as it has not been previously introduced.
In the interest of compact prosecution, the examiner will interpret this as an apparent typographical error and interpret “Semi-composition” as “composition”.
Claim Rejections - 35 USC § 112(d)
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.
Claim 18 is 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.
Claim 18 is drawn to application of “said composition to the skin of the nipples of a breast -feeding woman”.
Claim 18 is drawn to intended use, and does not further limit the method of the claims from which it depends as it does not provide any structural or functional characteristics.
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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2-5, and 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without being markedly different.
Claims 2-5 and 13-15 are directed toward a composition containing Limosilactobacillus vaginalis BC17 hereinafter BC17 in claim 2, live bacterial cells in claim 3, and the composition is a liquid in claim 4, claim 5 is directed toward an oral composition. Claims 13-15 are drawn to supernatant of BC17 cells which comprises extracellular products the cells produce naturally. These claims are a composition of matter (Step 1: YES). The instant specification sets forth that the strain was isolated from the vaginal mucosa of a woman of child-bearing age par.24. Vaginal mucosa contains liquids and care consumed orally by humans, they also end up on the skin. Accordingly, the instant claims encompass compositions comprising naturally occurring bacteria are thereby deemed to be a judicial exception because they are a product of nature.
See MPEP 2106.04(c): “In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. … The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.” The instant specification does not disclose any properties of BC17 or their supernatants that are markedly different as a result of the isolation or aforementioned compositions. Therefore, it appears that, like in Myriad, the bacteria are different due to isolation but not markedly different and therefore the claim recites a product of nature exception. (Step 2A, Prong 1: YES)
This judicial exception is not integrated into a practical application because the claim does not recite any additional elements beyond the bacteria or their supernatant that might integrate the judicial exception into a practical application (Step 2A, Prong 2: NO). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements beyond the bacteria that might amount to significantly more (Step 2B: NO).
Claims 6, and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Claims 6, and 16-17 are directed toward a composition containing BC17 or supernatants thereof. These claims depend on the claims rejected above as being drawn to natural products. These claims are a composition of matter (Step 1: YES). The instant specification sets forth that the strain was isolated from the vaginal mucosa of a woman of child-bearing age par.24. Vaginal mucosa contains liquids and care consumed orally by humans, they also end up on the skin. Accordingly, the instant claims encompass compositions comprising naturally occurring bacteria are thereby deemed to be a judicial exception because they are a product of nature.
See MPEP 2106.04(c): “In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. … The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.” The instant specification does not disclose any properties of BC17 or their supernatants that are markedly different as a result of the isolation or aforementioned compositions. Therefore, it appears that, like in Myriad, the bacteria are different due to isolation but not markedly different and therefore the claim recites a product of nature exception. (Step 2A, Prong 1: YES)
This judicial exception is integrated into a practical application because the claims recite additional elements beyond the bacteria or their supernatant that might integrate the judicial exception into a practical application (Step 2A, Prong 2: YES). Claim 6 recites the addition of vitamins. Claim 16 adds a substance having soothing and regenerating action such as vitamin E, claim 17 adds vitamin E or hyaluronic acid. While the examiner has found all of these have benefits for human application the examiner has found no evidence they add significantly more when combined with BC17 or its supernatants over their individual advantages. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. (Step 2B: NO).
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.
(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 2-6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by D’Alessandro et al. (Probiotic and Metabolic Characterization of Vaginal Lactobacilli for a Potential Use in Functional Foods, Reference 3 in the IDS filed Date04/12/2024) as evidenced by Haug et al. (Bovine milk in human nutrition--a review. Lipids Health Dis. 2007 Sep 25;6:25. doi: 10.1186/1476-511X-6-25. PMID: 17894873; PMCID: PMC2039733).
D’Alessandro teaches “each strain, two identical samples were prepared containing UHT bovine milk with an inoculum of 8–9 log CFU/mL. The first one was used to perform the simulated gastro-duodenal digestion test immediately; the second one was incubated at 4 °C for 7 days” p.4 par.2, and “Cell loads of L. vaginalis BC16 (a) and L. vaginalis BC17 (b) after the simulated stomach–duodenum passage, immediately after the inoculation in milk” p.11 fig.8. Regarding claims 2-5 this is a liquid composition comprising milk and live BC17 cells. Regarding claim 6, milk also contains Vitamin E as evidenced by Haug p.3 table.I.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Asan-Ozusaglam et al. ( (2021). A new probiotic candidate bacterium from human milk: Limosilactobacillus vaginalis MA-10. Acta Alimentaria AAlim, 50(1), 13-21. https://doi.org/10.1556/066.2020.00073) in view of Parolin et al. (Isolation of Vaginal Lactobacilli and Characterization of Anti-Candida Activity. PLOS ONE 10(6): e0131220. https://doi.org/10.1371/journal.pone.0131220(Year: 2015) ) in further view of Greenberg et al. (Neonatal candidiasis: diagnosis, prevention, and treatment. J Infect. 2014 Nov;69 Suppl 1(0 1):S19-22. doi: 10.1016/j.jinf.2014.07.012. Epub 2014 Aug 13. PMID: 25129318; PMCID: PMC4252884).
Regarding claim 1, Asan-Ozusaglam teaches Limosilactobacillus vaginalis MA-10 hereinafter MA-10 is found in breast milk p.1 title, as such it would be transferred to neonates or suckling’s during breast feeding and would be considered a natural inoculum to the infant microbiome. Asan-Ozusaglam teaches “The deterioration of commensal microbiota homeostasis causes a wide range of diseases. Most of the bacterial groups, such as Lactobacillus, Lactococcus, Bacillus, Bifidobacterium, which are naturally found in the gastrointestinal tract, are frequently used as food and health-promoting supplements to re-establish homeostasis” Asan-Ozusaglam teaches “MA-10 isolated from human milk were examined in vitro. MA-10 strain exhibited appropriate probiotic effects including non-haemolytic activity and high tolerance to gastrointestinal conditions. The results of the antimicrobial, antioxidant, and anti-cholesterol activity assays also indicated that MA-10 strain can beneficially affect host health with these properties” p.20 conclusions. Because of the aforementioned a person having ordinary skill in the art would have found it obvious to administer MA-10 to neonate or sucklings humans as a natural beneficial probiotic.
Asan-Ozusaglam does not teach the strain is capable of bifidogenic promotion or that it is BC17.
Parolin teaches Lactobacillus strains were isolated from vaginal swabs of healthy premenopausal women, and discloses Limosilactobacillus vaginalis BC17 hereinafter BC17 as one of these isolates p.1 abstract. Parolin teaches that BC17 has fungistatic or fungicidal activity against Candida isolates p.7 table.2.
Greenberg teaches Infection with Candida species is associated with significant morbidity and mortality in infants p.1 Abstract.
It would have been obvious to a person having ordinary skill in the art to combine the teachings of Asan-Ozusaglam with Parolin and Greenberg in order to arrive at administration of BC17 to sucklings or neonates. A person having ordinary skill in the art would have been motivated to provide a healthy natural probiotic and prevent candida spp. infection. Subsequently a person having ordinary skill in the art would have wished to validate the effective change in the microbiota and would have discovered that Bifidobacteria were increased as evidenced by the instant specification par.25 and fig.1. And this would have made it obvious to administer BC17 for to increase bifidobacteria in order to reduce deterioration of commensal microbiota causing a wide range of diseases.
Claims 2-3, 7, 9, and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Parolin (Isolation of Vaginal Lactobacilli and Characterization of Anti-Candida Activity. PLOS ONE 10(6): e0131220. https://doi.org/10.1371/journal.pone.0131220(Year: 2015) ) in view of US 20200138881 A1 (PGPub published 7/5/2020) hereinafter 881 as evidenced by Wikipedia (Lactobacillaceae_24_February_2021_Wikipedia.pdf).
Regarding claims 2-3, Parolin teaches Healthy vaginal microbiota is dominated by Lactobacillus spp., which form a critical line of defense against pathogens, including Candida spp., and vulvovaginal candidiasis (VVC) is a common infection compromising the quality of life of many women, Candida albicans is the most frequent etiologic agent. Parolin further teaches Lactobacillus strains were isolated from vaginal swabs of healthy premenopausal women, and discloses BC17 as one of these isolates p.1 abstract. Parolin teaches that BC17 has fungistatic or fungicidal activity against Candida isolates p.7 table.2. Parolin further teaches a major potential application of this study concerns the identification of active Lactobacillus strains to propose as probiotics for prophylaxis and/or adjuvant therapy of VVC. Parolin teaches Candida isolates inhibited by lactobacilli supernatants p.7 table 2 which reads on claim 3.
Parolin does not teach specific compositions and formats for these proposed probiotics such as solids, tablets or semi-solids.
881 teaches Probiotic Lactobacillus crispatus for use in treating bacterial vaginosis par.12, 16. 881 teaches Probiotics, are defined by the FAO and the WHO as living microorganisms which, when administered in adequate amounts, confer a beneficial health effect on the host par.2. 881 teaches probiotic composition options in par.20 which include excipients for oral administration, vitamins such as vitamin A, vitamin B, vitamin C, vitamin D and vitamin E. 881 also teaches topical administration compositions including a hydrogel par.2.
It is noted that Lactobacillus and Limosilactobacillus are in the same phylogenetic family of lactic acid bacteria, Wikipedia p.1 par.1, as they are closely related they are likely to both work in similar formats.
Regarding claim 7, 881 teaches the probiotic composition in the form of a vaginal tablet, which is a solid composition par.46.
Regarding claim 9, 881 teaches the probiotic can be administered orally par.20.
Regarding claim 13, Parolin teaches cell free supernatants of BC17 have anti-fungal activity as taught above. Therefore, it would not be necessary to keep cells alive to achieve a desired antifungal activity, a person having ordinary skill in the art would have been motivated to create formulations with supernatants for longer shelf left and storage.
Regarding claim 14-15, 881 also teaches topical administration compositions including a hydrogel par.2.
Regarding claim 12, 16, and 17, 881 teaches vitamin E in par.20 and the instant specification teaches vitamin E has a soothing and regenerating action par.69.
It would have been obvious to a person having ordinary skill in the art to combine the teachings of Parolin with 881 in order to arrive at a variety of compositions comprising BC17 cells or supernatant as discussed above for use as probiotics with a variety of formats for differing needs. A person having ordinary skill in the art would have been motivated to expand their customer base by offering customers a wide variety of formats for their particular needs and desires in order to inoculate the vaginal microbiome and prevent Candida fungal infections.
There would have been reasonable expectation of success because both 881 and Parolin are applying these compositions to lactic acid bacteria isolated from the vagina for probiotic purposes.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Asan-Ozusaglam in view of Parolin and Greenberg as applied to claim 1 above, and further in view of 881 as applied to claim 13 above.
Regarding claim 18, as indicated above Asan-Ozusaglam in view of Parolin and Greenberg teach claim 1, and Parolin and 881 teach claim 13 however the above rejection does not address application of the topical composition to the skin and nipples of a breast-feeding woman.
It would have been obvious to configure the a composition for the skin and nipples as an alternative way to administer BC17 to a neonate or suckling that would already be used to breast feeding because they can be fussy and it would be convenient to administer during an activity that was already common and the neonate or suckling would be used to.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Parolin and 881 as applied to claim 7 above, and further in view of US 20140234371 A1 published 8-21-2014.
Regarding claim 8, as indicated above Parolin and 881 teach claim 7, however the above rejection does not address the composition in a lyophilized form.
371 teaches probiotics may be lyophilized for improving stress resistance or manufacturing, processing and/or storage characteristics of a gram-positive bacterium, preferably a lactic acid bacterium par.32.
It would have been obvious to a person having ordinary skill in the art to combine the teachings of Parolin and 881 with 371 in order to arrive at lyophilized bacterial cells. A person having ordinary skill in the art would have been motivated to improve storage characteristics such that they would last longer on the shelf.
There would have been reasonable expectation of success because 371 teaches lyophilization in lactic acid bacteria.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Parolin and 881 as applied to claim 7 above, and further in view of Hoffman (Ultra–fast disintegrating ODTs comprising viable probiotic bacteria and HPMC as a mucoadhesive, European Journal of Pharmaceutics and Biopharmaceutics, Volume 139, Year: 2017).
Regarding claim 10, as indicated above Parolin and 881 teach claim 7, however the above rejection does not address a rapid release tablet.
Hoffman teaches for the administration of probiotics to the patient, an adequate dosage form ensuring on the one hand storage stability of the active principle and on the other hand high patient adherence is mandatory. ODTs have the typical advantages of solid dosage forms including accurate dosing, high stability and easy manufacturing with means of standard equipment for tablet production. Moreover, orodispersible tablets disintegrate rapidly in the mouth, without the need for additional water for intake, because the tablets disintegrate due to the remaining saliva available in the mouth. Hence, it is not necessary to suck an ODT for several minutes like a lozenge. It is an appropriate dosage form for patients having difficulties with swallowing tablets or hard gelatin capsules, which occurs in 1 to 2 out of 4 patients p.1 par.2.
It would have been obvious to a person having ordinary skill in the art to combine the teachings of Parolin and 881 with Hoffman in order to arrive at a rapid release tablet for oral administration. A person having ordinary skill in the art would have been motivated to administer to patients having difficulties swallowing.
There would have been reasonable expectation of success because Hoffman teaches this for use with probiotics as well.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Parolin and 881 as applied to claim 7 above, and further in view of Hoffman and US 20070123460 A1 published 5/31/2007 hereinafter 460.
Regarding claim 11, as indicated above Parolin and 881 teach claim 7, however the above rejection does not address a sustained release tablet for buccal administration.
460 teaches the use of Lactobacillus GG par.16 and further teaches oral formulations can be in sustained release formulations and buccal tablets. par.112.
It would have been obvious to a person having ordinary skill in the art to combine the teachings of Parolin and 881 with 460 in order to arrive at a sustained release buccal tablet formulation. A person having ordinary skill in the art would have been motivated to avoid gag reflexes of patients having difficulties with swallowing tablets or hard gelatin capsules as taught by Hoffman p.1 par.2.
There would have been reasonable expectation of success because 460 teaches the use of buccal tablets in another lactobacillus.
Allowable Subject Matter
Prior to the filing of the instant application, it was not known in the art that supernatant of BC17 induced growth of Bifidobacteria. Therefore, it would not have been obvious to a person having ordinary skill in the art to administer it to neonates or suckling humans after birth for the sole purpose of promoting bifidobacteria.
Closest Prior Art
D’Alessandro teaches the closest prior art as detailed in the 102 rejection above. D’Alessandro does not teach or suggest that BC17 should be used for bifidogenic promotion in neonates or suckling humans. Asan-Ozusaglam ( (2021). A new probiotic candidate bacterium from human milk: Limosilactobacillus vaginalis MA-10. Acta Alimentaria AAlim, 50(1), 13-21. https://doi.org/10.1556/066.2020.00073) teaches another strain in the species is found in breast milk p.1 title, as such it would be transferred to neonates or suckling’s during breast feeding. However, Asan-Ozusaglam does not teach or suggest that the strain is capable of bifidogenic promotion.
Therefore, it would not have been obvious for a person having ordinary skill in the art prior to the effective filing date to administer BC17 to a suckling or neonate human for the promotion of bifidobacteria.
Conclusion
No claims are allowed.
Inquiry Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUDOLPH E. SLOUP Jr. IV Ph.D. whose telephone number is (571)272-7899. The examiner can normally be reached Monday to Friday, 9am to 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, Joanne Hama can be reached at (571) 272-2911. 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.
/RUDOLPH E. SLOUP Jr. IV Ph.D./
Examiner, Art Unit 1645
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
Prosecution Insights