DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. The information disclosure statement (IDS) submitted on 12/12/23 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
Claim Status
3. The amendment, filed 12/12/23, has been entered. Claims 1-8 and 11-12 are pending and under examination. Claims 9 and 10 are cancelled. Claims 11 and 12 are newly added.
Claim Objections
4. Claim 1 is objected to because of the following informalities: missing article(s). Proper claim construction includes an “A” (or “An”) for the beginning of an independent claim and “The” for the beginning of a dependent claim; see MPEP 608.01. Appropriate correction is required.
5. Claim 2 is objected to because of the following informalities: improper use of an acronym/abbreviation. Acronyms and abbreviations must be spelled out and/or defined upon first use, in order to be understood without requiring reference to the specification (i.e. see MPEP 2173.05(s); claims are to be complete in themselves); therefore, “MRS” in claim 2, must be explained/defined. Appropriate correction is required.
6. Claim 6 is objected to because of the following informalities: improper recitation of species names. Latin names of microorganisms are properly recited with the genus name (i.e. first part of binomial identifier) capitalized and species name (i.e. second part of binomial identifier) in lower case, with both in italics, and having the genus name spelled out upon first usage, in order to be understood without requiring reference to the specification (i.e. see MPEP 2173.05(s); claims are to be complete in themselves). Thus, for example, “spirulina” is properly written as “Spirulina” upon its first usage. Similarly, “arthrospira” should be “Arthrospira”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
7. Claims 1 and 4-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nature-based product (e.g. naturally occurring bacteria) without significantly more.
The claims recite Bifidobacterium animalis subsp. lactis BLa36 for relieving constipation, named as Bifidobacterium animalis subsp. lactis strain BLa36, which has been deposited in the China General Microbiological Culture Collection Center on December 2, 2021 with a deposit number of CGMCC No. 24029, and a deposit address of No. 3, No. 1 Courtyard, West Beichen Road Chaoyang District Beijing which appears to be a naturally occurring bacterial species; see Wang et al. 2021 (Effect of Bifidobacterium animalis subsp. lactis MN-Gup on constipation and the composition of gut microbiota; Beneficial Microbes 12(1): 31-42; page 32, left column) and Aoki et al. 2016 (Effect of Bifidobacterium animalis subsp. lactis GCL2505 on the physiological function of intestine in a rat model; Food Science & Nutrition 4(6): 782-790; page 783, left column). Therefore, the product claims are directed to a statutory category (i.e. Step 1 of the Subject Matter Eligibility analysis is yes).
However, this judicial exception is not integrated into a practical application because the naturally occurring bacterium does not appear to be markedly different from its naturally occurring counterpart, in its natural state, since it does not appear to have been modified in any way. Therefore, the product claims are directed to a judicial exception (i.e. nature-based products; Step 2A prong 1 is yes) that is not integrated into a practical application (i.e. Step 2A, prong 2 is no).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements in claim 1. For claims 7 and 8, the additional element appears to be another judicial exception (i.e. another naturally occurring bacteria). For claims 4, 5, and 6 the additional elements encompass a protective agent in general, and skimmed milk powder in particular and/or a prebiotic. However, these additional elements are not sufficient to amount to significantly more than the judicial exception because there is no indication that any of these additional element(s) changes any structural or functional features of the judicial exception per se. Therefore, all the components in the composition function as they would individually, and a mere mixture or aggregation of products, natural or not, does not structurally and/or functionally change the nature-based product from what exists in the environment and that in order to be eligible, every embodiment within the broadest reasonable interpretation of the claim must be eligible.
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exception (i.e. naturally occurring bacteria). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually because the additional element(s) are recited at a high level of generality and are well-understood, routine, conventional activities engaged in by the scientific community; as evidence by Wang 2021 and Aoki 2016 (see art rejections below). Consequently, the additional element(s) are not sufficient to make the judicial exception eligible for patent protection (Step 2B is no).
Therefore, based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are consequently rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1-8 and 11-12 are rejected under 35 U.S.C. 112(a) 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 biological deposit rejection.
The invention appears to employ novel biological materials, specifically a newly isolated strain of Bifidobacterium animalis subspecies lactis identified as strain BLa36.
Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under 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 specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent”, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 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, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information; however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Although Applicants have noted on page 2 (and in claim 1) that the biological material was deposited in the China General Microbiological Culture Collection Center on December 2, 2021 with a deposit number of CGMCC No. 24029, and a deposit address of No. 3, No. 1 Courtyard, West Beichen Road Chaoyang District Beijing; a statement regarding deposition under Treaty of Budapest and a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent; or a statement including (a)-(e) above, is required to satisfy the conditions set forth in 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 102/103
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. Claims 1-6 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wang et al. 2021 (Effect of Bifidobacterium animalis subsp. lactis MN-Gup on constipation and the composition of gut microbiota; Beneficial Microbes 12(1): 31-42).
Wang teaches compositions for alleviating constipation in mice and humans comprising Bifidobacterium animalis subsp. lactis cultured and then suspended in skimmed milk (e.g. see page 32, right column; and Figure 1; meeting limitations found in instant claims 1, 4 and 5). Wang teaches the bacteria were cultured overnight in MRS broth at 37°C (e.g. page 32, right column; meeting limitations found in instant claims 2 and 3). Wang teaches methods for assessing the preventative effects of the composition comprising administering 2 x 109 (low dose) to 2 x 1010 cfu (high dose) of bacteria per day to mice and 1010 cfu of bacteria in a yogurt (i.e. a foodstuff) to human subjects (e.g. see page 32, right column; and page 33, right column; Figure 2; and section 3, results; meeting limitations found in instant claims 1, 4, 11 and 12).
With regards to the prebiotics listed in claim 6, Wang teaches the yogurt composition comprised raw milk (see Supplementary Table 1, reproduced below) which necessarily contains prebiotics such as lactoferrin and oligosaccharides including, inter alia, oligofructose and oligogalactose:
PNG
media_image1.png
221
660
media_image1.png
Greyscale
While Wang does not teach the Bifidobacterium animalis subsp. lactis is strain BLa36, deposited in the China General Microbiological Culture Collection Center on December 2, 2021 with a deposit number of CGMCC No. 24029, and a deposit address of No. 3, No. 1 Courtyard, West Beichen Road Chaoyang District Beijing, the bacteria are deemed to be the same, or substantially the same, as evidenced by the same Latin name and being useful for the same purpose of treating constipation. Therefore, absence convincing evidence to the contrary, Wang anticipates the invention as claimed because Bifidobacterium animalis subsp. lactis and its functional properties cannot be separated; see MPEP 2112.01. Further, MPEP 2112.01 also states that “When the PTO shows a sound basis for believing that the inventions of the Applicant and the prior art are the same, the Applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Alternatively, it would have been prima facie obvious to substitute one Bifidobacterium animalis subsp. lactis strain for another because both would be used for the same purpose of treating constipation. Accordingly, Wang teaches, or at least renders obvious, the composition and method as claimed because (1) Bifidobacterium animalis subsp. lactis cannot be separated from its properties, and/or (2) the prior art teaches a product and method that only differ from the claimed invention by the substitution of a single component (i.e. substitution of the Bifidobacterium animalis subsp. lactis strain) and KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill.
Therefore, the claimed invention is at least prima facie obvious, if not anticipatory, in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claim Rejections - 35 USC § 103
16. Claims 1-8 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. 2021 (Effect of Bifidobacterium animalis subsp. lactis MN-Gup on constipation and the composition of gut microbiota; Beneficial Microbes 12(1): 31-42) in view of Aoki et al. 2016 (Effect of Bifidobacterium animalis subsp. lactis GCL2505 on the physiological function of intestine in a rat model; Food Science & Nutrition 4(6): 782-790).
The teachings of Wang are set forth above. In addition, Wang teaches that constipation is one of the most prevalent health issues worldwide, affecting approximately 14.8% of the U.S. population, and 8.2% of the Chinese population; and that constipation seriously effects health-related quality of life; and represents an economic burden on healthcare services (see page 31, introduction).
Therefore, the difference between the prior art and the invention is the use of a second strain of Bifidobacterium animalis subsp. lactis (i.e. strain BLa80) found in dependent claims 7 and 8.
However, Aoki also teaches a strain of Bifidobacterium animalis subsp. lactis useful for treating constipation (e.g. see introduction; and page 783, methods; and Figure 2). Aoki teaches the art recognizes that several strains of Bifidobacterium animalis ssp. lactis proliferate in the human intestine following ingestion with remarkable proliferation in the cecum (e.g. page 786, right column).
With regards to the strain identification number of BLa80, it is noted that the prior art bacteria and the claimed bacteria are deemed to be the same, or substantially the same, as evidenced by the same Latin name and being useful for the same purpose of treating constipation; see MPEP 2112.01.
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine the different compositions each comprising strains of Bifidobacterium animalis subsp. lactis because both were taught as useful in treating the same condition of constipation and MPEP 2144.06 states that combining equivalents known for the same purpose is obvious: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted; emphasis added) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Further, the person of ordinary skill in the art would have been motivated to make the modification, with a reasonable expectation of success, because constipation was one of the most prevalent health issues worldwide, affecting a large proportion of populations with serious effects on health-related quality of life; and represented an economic burden on healthcare services, as taught by Wang. Therefore, the combination leads to expected results because each element performs the same function as it does individually.
With specific regards to the mass ratio (i.e. a measure of relative concentrations) in claim 8, it is noted that the claimed ratio encompasses an equal mix (1:1) of each bacteria. Further, MPEP 2144.05 states, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)." In the instant case, it is the Office’s position that the relative concentration of the two strains is a results-effective variable(s) and thus there is motivation for one of ordinary skill to optimize it through routine experimentation (see MPEP 2144.05II(B)).
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e. multiple compositions comprising strains of Bifidobacterium animalis subsp. lactis useful for treating constipation) were known in the art. In addition, combining these elements yields a composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, it would have been obvious to a person of ordinary skill in the art to combine these prior art elements according to a known method to yield predictable results.
Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
17. No claims are allowed.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
February 12, 2026