DETAILED ACTION
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
Status of Claims
Claims 1-16 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 6-25-2024 has been considered. An initialed copy is enclosed.
Claim Rejections - 35 USC § 112
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.
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(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.
Claims 1-16 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. This is a deposit rejection.
The specification at pages 17 and 26 recite the deposit of the strains CECT 7894 and CECT 30646 respectively under the Budapest Treaty, the date of deposit and the address of the depository.
Since the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claim 14 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. In the instant case, the claim recites “particularly” and recites a deposited B. bifidum strain CECT 30646. It is unclear if the claim is limited to that “particular” strain or not and the skilled artisan would be unable to ascertain the metes and bounds of the claim.
Claims 2, 3, 5-7 and 16 are rejected under 35 U.S.C. 112(d), 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. The listing of disorders “for use” in a product claim does not further limit the independent claim 1 as they provides no additional structure or element to the composition. 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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Instant claim 1 and dependent claims 2, 3, 5-8 and 16 are drawn to a probiotic composition Bifidobacterium longum subsp longum strain CECT 7894 and derivatives thereof having specific activities and characteristics recited in the claims. Dependent claim 4 and claim 12 provide for the addition of at least one human milk oligosaccharide in combination with a second probiotic Bifidobacterium bifidium strain (claim 15). The claims are drawn to a composition that is a probiotic comprising strains of Bifidobacterium and further comprising human milk oligosaccharides. The broadest reasonable interpretation is that the composition of matter comprises a probiotic strain(s) of bacteria alone of in combination with human milk and are therefore composed of matter and at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of instant claims is directed to a statutory category, i.e., a composition of matter (Step 1: YES). The as-filed specification at lines 7-15 of page 3 documents that the B. longum subsp longum strain is a human gut origin strain and Bifidobacterium bifidium (CECT 30646) at lines 30-35 of page 26 was isolated from human breast milk and therefore the invention encompasses strains isolated from a naturally occurring source, i.e., from nature. Therefore, the claimed strain(s) are naturally occurring strains alone or in combination with a naturally occurring substance from which one of the strains was isolated, i.e. human breast milk. The combination of all three judicial exceptions does not provide for something more. The claimed oligosaccharides claimed are natural components found in human milk. There is no evidence that the claimed bacterium strain(s) are modified in any way and the strain(s) are markedly different from what exist in nature. Additionally, derivation procedures are described encompass naturally occurring mutagenesis that would provide for anything but screening naturally occurring bacteria strains for the requisite and claimed properties. Mere screening naturally occurring bacteria for desirable properties as recited in the claims does not provide for something that is not naturally occurring. The Supreme Court has made it clear in Myriad that eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature. Unlike the Chakrabarty bacterium, which was new “with markedly different characteristics from any found in nature” Diamond v. Chakrabarty, 447 U.S. 303 (1980) at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the multiple additional plasmids and resultant “capacity for degrading oil”, there is no indication that the instantly claimed strain(s) or derivatives are genetically manipulated or structurally modified in any marked or significant way such that the structural difference results in change of properties of the strain(s). The properties of the “derivatives” are inseparable from said naturally occurring strain(s) and therefore are a handiwork of nature. In Chakrabarty and Myriad, the marked difference inquiry was focused on the modified structural characteristics of the product, not how it was used or how it was made. Note that “….. patents cannot issue for the discovery of phenomena of nature”. Le Roy v. Tatham, 14 How. 156, 175 (1853). The qualities of the bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.” See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. at 130, 1948. In Funk Brothers, the Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. In the instant case, having two natural strains of Bifidobacterium bacterium strains in a liquid composition or in natural human milk does not add significantly more to the natural products such that it is practically applied. Thus, each component of the instantly claimed product is a ‘product of nature’ exception, and the claims are directed to a judicial exception (Step 2A Prong One: YES). Judicial exceptions include all natural products including those derived from natural sources or patients such as naturally occurring microorganisms, proteins, peptides, glycoproteins, glycopeptides, carbohydrates, and other substances found in or derived therefrom, or from nature. Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claims amount to significantly more than the exceptions. Having the two naturally occurring strains in a composition does not amount to significantly more. There is nothing that provides significantly more or that integrates the claimed naturally occurring strains or said strains in human milk, i.e., the judicial exceptions, into a practical application (Step 2A Prong Two: NO). No elements or claim limitations apply or use the exception(s) in any meaningful way and integrate the law of nature into a practical application. The term “for use in the treatment” has no meaningful limitation on the scope of the claims an only indicates what the probiotic may be useful for. The limitation ‘composition’ merely indicates a field of use in which to apply the judicial exceptions and therefore fail to provide meaningful limits on the claims. The term “configured for” does not place any structure on the claims that is not naturally occurring either as separate entities or combined. The claims when considered as a whole do not amount to significantly more than ‘products of nature’ (Step 2B: NO). Therefore, the claims are not directed to a patent eligible subject matter. The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
Claim Interpretation
It is noted for all the claims the recitation of “for use in the treatment of non-intestinal conditions…..” is viewed as the intended use of the probiotic Bifidobacterium spp. and does not provide any patentable weight to the claimed composition for other uses.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-11 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tintore et al (Archives of Clinical Microbiology, Aug 2017, pages 1-11; of record on PTOL-1449).
Tintore et al teach the probiotic Bifidobacterium longum CECT 7894 in a probiotic composition see page 6, Table 3, column 1). The genotypic and functional characteristics cited in claims 1, 9 and 10 are inherent characteristics of the probiotic CECT 7894 strain. Moreover, the deposited strain is publicly available. As set forth supra, intended use does not structurally limit the composition and as such the claims are anticipated.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Glycom A/S (WO 2019/229711, 12-5-2019; of record on PTOL-1449) in view of Tintore et al (Archives of Clinical Microbiology, Aug 2017, pages 1-11; of record on PTOL-1449).
Glycom teaches a composition comprising human milk oligosaccharide (HMO) preferably mixtures of human milk oligosaccharides (HMOs) selected from the group or 2’-FL, LNnT, LNT, DFL and 6’SL (see abstract; paragraph bridging pages 12-13). The HMOs are packaged into various dosages for daily administration (see pages 5-6; page 8, line 20-page 9, line 11; pages 14-15) by various different methods for administration by different methods and can be combined with other ingredients. Glycom teach that the MNOs preferentially restore dysbiotic intestinal microbiota by increasing the present of bifidobacteria including Bifidobacterium longum and/or Bifidobacterium bifidum (see page 7, lines 20-25). Glycom teach that the compositions may include other components that increase the abundance of bifidobacteria including Bifidobacterium longum and/or Bifidobacterium bifidum. Glycom teach that the composition can also be a nutritional composition (page 15, lines 9-11) and that the nutritional composition can contain other conventional ingredients including prebiotics and probiotics (see page 17, lines 13-19). Glycom claim a composition comprising a human milk oligosaccharides configured for administration and comprise a bifidobacterium, for example Bifidobacterium longum and/or Bifidobacterium bifidum (see claims 1-8 page 28). Glycom differs by not exemplifying the mixture of human milk oligosaccharides, Bifidobacterium longum and Bifidobacterium bifidum and where the Bifidobacterium longum is the deposited CECT 7894 strain.
Tintore et al teach the probiotic Bifidobacterium longum CECT 7894 in a probiotic composition see page 6, Table 3, column 1). The genotypic and functional characteristics cited in the claims necessarily present and characteristics the probiotic CECT 7894 strain on deposit and are publicly available.
It would have been prima facie obvious to one having ordinary skill in the art at the time of filing to form a composition according to Glycom comprising the preferred mixtures of HMOs, the bifidobacteria species Bifidobacterium longum and Bifidobacterium bifidum because Glycom teaches the desirability of such a combination and further it would have been obvious to use the probiotic Bifidobacterium longum CECT 7894 of Tintore et al because Tintore et al teach the use of the CECT 7894 strain is a probiotic strain for in vivo use. Further, it would have been obvious to one having ordinary skill in the art at the time of filing to configure the composition and at a dosage for any suitable administration and timing according to Glycom as Glycom teaches that the HMOs and pharmaceutics and nutritional compositions may be so modified. Glycom teaches that composition comprising a human milk oligosaccharides along with bifidobacterium, for example Bifidobacterium longum and/or Bifidobacterium bifidum for use in the methods. As such the combination is prima facie obvious. The substitution of a known probiotic strain in the composition is prima facie obvious.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Glycom A/S (WO 2019/229711, 12-5-2019; of record on PTOL-1449) and Tintore et al (Archives of Clinical Microbiology, Aug 2017, pages 1-11; of record on PTOL-1449) and applied to claims 1-16 and further in view of Shu et al (LWT – Food Science and Technology 119, 108862, 2020).
The combination of Glycom and Tintore et al is set forth supra. The combination differs by not using the deposited strain B. bifidum CECT 30646. It is noted that the specification teaches that CECT 30646 is also known as B. Bifidum BB01 to the art (see page 26, line 32-35). The deposition of a strain known to the art does not distinguish that strain from that of use in the art.
Shu et al teach probiotic goat milk tablets comprising B. bifidum BB01(see section 2.1). Shu et al teach effective formulation of B. bifidum BB01 with goat milk for use of a probiotic.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the composition and at a dosage for any suitable administration as set forth for the combination of Glycom and Tintore et al supra by using the known probiotic B. bifidum BB01 strain of Shu et al in the composition because Glycom teach that the HMOs and pharmaceutics and nutritional compositions may be so modified. Glycom teaches that composition comprising a human milk oligosaccharides along with a bifidobacterium, for example Bifidobacterium longum and/or Bifidobacterium bifidum for use in the methods. As such the combination is prima facie obvious the substitution of the known probiotic B. bifidum BB01 strain in the composition is prima facie obvious. As the combination of HMOs, B. longum and B. bifidum was contemplated by Glycom, the use of known probiotic strains therein is prima facie obvious. Additionally, Glycom teaches the configuration for administration, and it would have been obvious to configure the composition for the desired routes and times of administration.
Citation of Relevant Art
Saiki et al (Bioscience, Biotechnology and Biochemistry;2016; of record on PTOL-1449) teach Bifidobacterium pseudolongum subsp pseudolongum SBC8868 provides for 7.1 of poly P (nmol/mg protein) which is at least 10 times more than Bifidobacterium longum subsp longum SBC8314, 0.3 of poly P (nmol/mg protein). See Table 1, column 1. While this species provides for the functional limitation of poly P production the ANI of Bifidobacterium pseudolongum species as compared to the CECT 7894 strain is not provided in the art. Moreover, see page 97, Table 5 of Nomoto et al (Bioscience of Microbiota, Food and Health Vol 36(3):91-99, 2017) teach that even among the species of pseudolongum, the ANI values are less than 99%. There is no evidence that Bifidobacterium pseudolongum subsp pseudolongum SBC8868 strain would have the requisite ANI to the genome of the CECT 7984.
Conclusion
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/Patricia Duffy/Primary Examiner, Art Unit 1645