DETAILED ACTION
All objections and rejections raised in prior Office Actions are withdrawn unless restated below.
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 .
Information Disclosure Statement
The information disclosure statement filed 03/18/24 and 5/20/24 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because 37 CFR 1.98(b)(4): “Each foreign patent or published foreign patent application listed in an information disclosure statement must be identified by the country or patent office which issued the patent or published the application, an appropriate document number, and the publication date indicated on the patent or published application.” Several non-patent references are not listed with a date, nor is any publication date apparent from the references, and have been crossed out and not considered. It has been placed in the application file, but the information referred to therein has not been considered as to the merits with respect to the crossed-out references. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112
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 3, 7, 8 and 11-13 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.
Each of claims 3, 7, 8 and 11-13 depend from a method claims being claims 1, 4, 4, 2, 5 and 6, respectively. As such, each of claims 3, 7, 8 and 11-13 recite a product in the format of a product-by-process. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." MPEP 2113(I).
The specification provides the following:
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The specification contains no description that the chemical composition of EPS is changed by culturing a Bifidobacterium in fucose. Rather, the specification describes the culturing/fermenting in presence of fucose only increases quantity of EPS obtained. As such, there is nothing in the record to support that culturing Bifidobacterium in fucose results in any structural change to the EPS produced and the broadest reasonable interpretation of the claims (of all pending claims) is that culturing/fermenting in presence of fucose produces the same EPS by chemical composition as is produced in the absence of EPS or in the alternative that there is an overlap in the structure of the EPS produced with or without glucose.
In view of the above, the following methods would appear to both produce the same EPS product or an EPS product having overlap in structure:
A method for producing an exopolysaccharide (EPS), the method comprising a step A of culturing a bacterium of the genus Bifidobacterium in a culture medium comprising L- fucose.
A method for producing an exopolysaccharide (EPS), the method comprising a step A of culturing a bacterium of the genus Bifidobacterium in a culture medium not comprising L-fucose.
As such, claims 3 and 11, both depending from claim 1, do not require the performance of culturing in a medium comprising L-fucose since the same EPS product as recited in claims 3 and 11 can be produced by a different method not requiring L-fucose. As such, claims 3 and 11 do not require all of the features of claim 1 form which claims 3 and 11 depend.
Regarding claims 7, 8 and 12-13, all depending from claim 4, a fermented product, including a fermented dairy product, is not understood to require such product to include free L-fucose, since such L-fucose presented in a raw material as recited in claim 4 can all be metabolized by Bifidobacterium such that no L-fucose monosaccharide is present in a produced fermented product. Similar to claims 3 and 11 above, there is no established chemical difference between a fermented product produced from a raw material (including dairy raw materials) comprising L-fucose and a raw material not comprising L-fucose. Even accounting for a possible increase in quantity of EPS produced due to presence of L-fucose, the method claims 4-6 do not require any minimum concentration of EPS that would produce increased EPS or make an impact on the chemical composition of any fermented product produced.
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 § 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.
Claim(s) 3, 7, 8 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prasanna et al. (Screening human intestinal Bifidobacterium strains for growth, acidification, EPS production and viscosity potential in low-fat milk, Int. Dairy J. 23, 2012, 36-44).
The rejections under 35 U.S.C. 112(d) set forth above are incorporated herein by reference. As set forth above, the EPS recited in claims 3 and 11 does not require the performance of the methods of claims 1 and/or 2 that a Bifidobacterium be cultured on a medium comprising L-fucose. Similarly, Claims 7, 8 and 12-13 do not require that a fermented product be produced by a method of fermenting a raw material containing L-fucose. There is no understood difference in chemical composition caused by fermentation in the presence of or in the absence of L-fucose as discussed above.
Prasanna, abstract, states:
Bifidobacterium strains of human origin were screened for their ability to grow in milk and produce exopolysaccharides (EPS). Bifidobacterium strains were grown in low-fat UHT milk and were evaluated for their growth, acidification properties, EPS production and ability to increase the viscosity of fermented milk. The strains that grew well in milk were strains of Bifidobacterium breve and Bifidobacterium longum and B. longum subsp. longum. Among the 22 strains, EPS was produced by Bifidobacterium bifidum ALM 35, B. breve NCIMB 8807 (UCC 2003), B. longum subsp. infantis CCUG 52486 and Bifidobacterium infantis NCIMB 702205 at concentrations ranging from 25 to 140 mg L−1. The molecular mass and the composition varied considerably, depending on the strain. Analysis of the correlation between the apparent viscosity of the fermented milk and pH indicated that the EPS produced during the acidification of milk possibly contributed to the viscosity of the milk products.
As such, Prasanna teaches an EPS produced by B. breve and a fermented dairy product appearing to have the same structure as the same recited in claims 3, 7, 8 and 11-13.
Claim(s) 1-5, 7, 11 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mulder et al. (WO 2020/035623 A1).
“The inventors have developed new compositions comprising a bacterial strain of the species Bifidobacterium breve that can be used in stimulating the immune system and treating and preventing disease in a subject. The inventors have identified that strains of the species Bifidobacterium breve can potently activate the immune system.” Mulder, page 2, ln. 32-35.
“The inventors have also characterised a strain of Bifidobacterium breve that is particularly potent at stimulating the immune system and have identified that its potency may be mediated by its exopolysaccharide (EPS). The invention therefore preferably uses a composition comprising a bacterial strain of the species Bifidobacterium breve that comprises a complete EPS locus and/or expresses EPS on its surface, for stimulating the immune system in subject.” Mulder, page 3, lines 20-27.
“In further aspects, the invention provides a composition comprising a bacterial strain of the species Bifidobacterium breve for treating or preventing bacterial infections in a subject. The examples demonstrate that B. breve, and particularly the B. breve strains of the invention, have potent antimicrobial activity.” Mulder, page 4, ln. 15-18.
“The Bifidobacterium breve bacterium deposited under accession number NCIMB 42380 was tested in the Examples and is also referred to herein as strain 751, MRX004 or MRx0004.” Mulder, page 9, ln. 10-11.
“In preferred embodiments, the bacteria of the invention carries EPS on its surface. The examples demonstrate that EPS modulates the exposure of proteins on the cell surface.” Mulder, page 15, ln. 5-6.
“The compositions of the invention may be formulated as a food product. For example, a food product may provide nutritional benefit in addition to the therapeutic effect of the invention, such as in a nutritional supplement . . . . Another important group includes milk beverages, such as whey beverages, fermented milks, condensed milks, infant or baby milks; flavoured milks, ice cream; milk-containing food such as sweets.” Mulder, pages 34-35.
“Preferably, the bacteria used in the invention is able to ferment raffinose, for example when cultured in an appropriate suspension medium (such as API suspension medium) at 37°C for 4 hours. The examples suggest that the most effective B. breve strains are able to ferment raffinose, and it is involved in EPS production. In further preferred embodiments, the bacteria used in the invention is able to
ferment one or more, such as 2, 3, 4, 5, 6 or all 7 of: a-galactosidase, β-galactosidase, a-glucosidase
and β -glucosidase, a-arabinose, mannose and raffinose, for example when cultured in an appropriate
suspension medium (such as API suspension medium) at 37°C for 4 hours.
Mulder, page 64, sets forth:
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Fig. 5 of Mulder indicates that fucose is L-fucose.
As such, Mulder disclose a Bifidobacterium breve that is known to produce EPS when cultured and appears to produce some amount of EPS regardless of the precise identity of a carbon source and/or precise conditions of such culturing. In particular, Mulder, page 64, states culturing B. breve MRX004 on a medium (L-fucose media on test strip cupule) comprising L-fucose as to meet the features of claims 1-3 and 11 wherein it appears that some amount of EPS is produced when B. breve MRX004 is cultured.
Regarding claim 4, “The "fermented product raw material" is not particularly limited as long as it is a raw material for a fermented product.” Specification, para. [0061]. In view of the broad definition of a “fermented product raw material” in the specification, the L-fucose carbon source described on page 64 of Mulder is a “fermented product raw material” that becomes a fermented product after culture of B. breve therein with associated EPS as discussed above as recited in claims 4, 5, 7 and 12.
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.
Claim(s) 1-8 and 10-13 (all pending claims) is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulder et al. (WO 2020/035623 A1) as applied to claims 1-5, 7, 11 and 13 above, and further in view of Heuvelin et al. (A Bifidobacterium Probiotic Strain and Its Soluble Factors Alleviate Chloride Secretion by Human Intestinal Epithelial Cells, J. Nutrition 140, 2010, 7-11), Thibault et al. (Effects of Long-term Consumption of a Fermented Infant Formula (with Bifidobacterium breve c50 and Streptococcus thermophilus 065) on Acute Diarrhea in Healthy Infants, J. Pediatric Gastroenterology Nutrition 39, 2004, 147-52) and Choi et al. (Safety evaluation of the human-identical milk monosaccharide, L-fucose, Regulatory Toxicology Pharma. 72, 2015, 39-48).
As discussed above, Mulder states “The compositions of the invention may be formulated as a food product. For example, a food product may provide nutritional benefit in addition to the therapeutic effect of the invention, such as in a nutritional supplement . . . . Another important group includes milk beverages, such as whey beverages, fermented milks, condensed milks, infant or baby milks; flavoured milks, ice cream; milk-containing food such as sweets.” Mulder, pages 34-35.
However, Mulder does not directly state that such fermented milks or baby milks to be actively fermented by the taught B. breve of Mulder.
Heuvelin, page 9, right col., describes: “The bifidobacterium strain Bb C50 is a probiotic bacterial strain used in a fermented milk formula (Calisma) devoted to infant nutrition and previously recognized as bifidogenic, immunostimulatory in humans and experimental models, and protective in inflammatory conditions.” Thibault, abstract, describes a study wherein infants “consumed daily either a fermented infant formula (FF) (fermentation with Bifidobacterium breve C50 and Streptococcus thermophilus 065) or a standard infant formula (SF) of the same nutritional composition.” “During this period children were randomly assigned (computer generated randomization list, blocks size of four) to receive either formula fermented with BbC50 and St065 (FF, Calisma®) or standard infant formula (SF, Gallia®).” Thibault, page 148, left col.
As such, Heuvelin and Thibault teach a commercial dairy/milk infant formula that is produced by being fermented with a strain of Bifidobacterium breve. While Heuvelin and Thibault do not teach the details of production of such infant formula, such formula is understood to at a minimum be produced by culturing/fermenting a starting dairy-based material (i.e. a fermented product raw dairy material) with the strain of Bifidobacterium breve.
However, the B. breve C50 taught by Heuvelin and Thibault cannot be assumed to produce EPS. However, Heuvelin and Thibault affirmatively teach that it is beneficial for a milk/dairy infant formula to be activity fermented by C. breve. As such, in implementing embodiments of Mulder in accordance with “The compositions of the invention may be formulated as a food product. For example, a food product may provide nutritional benefit in addition to the therapeutic effect of the invention, such as in a nutritional supplement . . . . Another important group includes milk beverages, such as whey beverages, fermented milks, condensed milks, infant or baby milks” an ordinarily skilled artisan at the time of filing would have been motivated to produce such “fermented milks” or “infant or baby milk” being a fermented composition that is fermented by action of the EPS-producing C. breve strains taught by Mulder. An ordinarily skilled artisan at the time of filing would have been motivated to do this since Heuvelin and Thibault teach that fermentation/culturing with a C. breve strain imparts advantageous properties to a milk-based infant formula, which an ordinarily skilled artisan at the time of filing would recognize to not be limited to the specific B. breve C50 strain in view of Mulder teaching that it is appropriate to combine the EPS-producing C. breve of Mulder with infant milk/formula. “Incidence, duration of diarrhea episodes, and number of hospital admissions did not differ significantly between groups. Episodes were less severe in the FF (fermented formula) group.” Thibault, abstract.
Regarding additional requirement in claim 4 that the fermented product raw material comprises L-fucose (i.e. the infant milk/formula prior to fermentation), Choi, abstract, sets forth:
L-Fucose is a natural monosaccharide present in mammals where it is found predominantly as an O-glycosidically linked component of glycoproteins, glycolipids, and oligosaccharides. It is also present in its free form in human breast milk (human milk monosaccharide). l-Fucose plays important roles in the development of the immune and nervous systems and is involved in cognitive function and memory formation. The human-identical milk monosaccharide l-fucose is therefore proposed for use in infant formulas to better simulate the free saccharides present in human breast milk. As part of the safety evaluation of l-fucose, a subchronic dietary toxicity study preceded by an in utero phase was conducted in Sprague–Dawley rats. l-Fucose was without maternal toxicity or compound-related adverse effects on female reproduction and general growth and development of offspring at a maternal dietary level up to 1%, equivalent to a dose of 1655 mg/kg body weight (bw)/day. During the subchronic phase, no compound-related adverse effects were observed in first generation rats at dietary levels of up to 1% (highest level tested), corresponding to doses of 516 and 665 mg/kg bw/day in males and females, respectively. l-Fucose was non-genotoxic in a series of in vitro genotoxicity/mutagenicity tests. These results support the safe use of l-fucose in infant formula and as a food ingredient at levels equivalent to those present in human breast milk.
As such, it is openly suggested that L-fucose be added to infant formula in order to simulate the free saccharides present in human breast milk. As such, at the time of filing an ordinarily skilled artisan would have been motivated to add L-fucose to any infant formula including any infant formula to be fermented by an EPS-producing C. breve as taught by Mulder. Adjustment to the sequence of adding ingredients in a process is prima facie. MPEP 2144.04IV(C). Regardless, Thibault, abstract, states: “consumed daily either a fermented infant formula (FF) (fermentation with Bifidobacterium breve C50 and Streptococcus thermophilus 065) or a standard infant formula (SF) of the same nutritional composition,” which indicates the composition of fermented infant formulas are not changed after fermentation with C. breve such that the prior art suggests that where L-fucose is added to an infant formula it is added prior to any fermenting/culturing with C. breve, or in the alternative an ordinarily skilled artisan would have recognized success in producing a fermented diary infant formula by addition of L-fucose before or after fermentation with B. breve producing EPS.
Performance of the above meets the features of claim 4 and all claims depending from claim 4 (claims 5-8 and 12-13) including a fermented dairy product produced according to the method of claim 4 as well as the features of claim 1-3 and 11 wherein it is understood that the C breve strains of Mulder discussed above will produce EPS whenever cultured on a nutritive media.
Regarding claim 10, “promoting” production of an EPS has a broadest reasonable interpretation of being compatible with or allowing for the production of EPS. Claim 10 does not set forth a requirement that increased production of EPS occurs and no reference to which any increase in EPS is to be measured is provided for in the claim. Regardless, "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985); MPEP 2145(II). Any “promoting” production of EPS caused by culturing/fermentation of C. breve strains caused by the presence of L-fucose that is an infant formula or other composition fermented by C. breve as taught by Mulder is recognition of another advantage which would flow naturally from following the suggestion of the prior art.
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 3 and 11 rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature or natural phenomenon without significantly more. The claim(s) recite(s) an EPS as a product-by-process. This judicial exception is not integrated into a practical application because the claims do not recite any claim features other than EPS. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons below.
MPEP 2106(III) directs that claims drawn to 1) a composition of matter (step 1), 2) a law of nature or a natural phenomenon or a product of nature (step 2A) and 3) lacking recitation of additional elements that make the claims directed to significantly more than a judicial exception (step 2B) are ineligible for patenting under 35 U.S.C. 101. See MPEP 2106(III), flow chart. Step 2A into two prongs as set forth in MPEP 2106.04(II)(A).
“If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.” MPEP 2106.04(c). “It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” MPEP 2106.04(b)(II).
“The markedly different characteristics analysis is part of Step 2A Prong One, because the courts use this analysis to identify product of nature exceptions.” MPEP 2106.04(c). “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.” MPEP 2106.04(c)(II).
Examiners should keep in mind that if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.” MPEP 2106.04(c)(I).
The rejected claims are drawn to a composition of matter. As indicated by Prasanna et al. (Screening human intestinal Bifidobacterium strains for growth, acidification, EPS production and viscosity potential in low-fat milk, Int. Dairy J. 23, 2012, 36-44), EPS meeting the features of claims 3 and 11 is a product of nature produced by naturally-occurring B. breve bacteria. The rejections under 35 U.S.C. 102(a)(1) over Prasanna and the rejections under 35 U.S.C. 112(d) above are incorporated herein by reference.
Since the natural product (e.g. EPS) recited in the claims is naturally-occurring, for step 2A, prong 1, “there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.
Regarding, step 2A, prong 2, “Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? In Prong Two, examiners evaluate whether the claim as a whole integrates the exception into a practical application of that exception.” MPEP 2106(II)(A)(2). Regarding Step 2B for the claims, “Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception”?
The rejected claim do not recite any additional claim features other than an EPS that includes natural products such that the claims do not recite eligible subject matter in view of the analysis of Steps 1, 2A and 2B as discussed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD M EPSTEIN whose telephone number is (571)272-5141. The examiner can normally be reached Mon-Fri 9:00a-5:30p.
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
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