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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on 04/07/2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/07/2026.
Status of Claims
Claims 1-20 are pending. Claims 11-20 are withdrawn. Claims 1-10 will be examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/GB2022/052762, filed on 11/02/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 on filed on 6/13/2024.
Information Disclosure Statement
The Information Disclosure Statement filed on 05/01/2024 has been considered. Signed copies are enclosed.
Claim Objections
Claim 1 is objected to because of the following informalities: there is no reason for "and combinations thereof; and" to be italicized that the Examiner knows of apart from formatting error. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: a space is needed between "or" and "combinations " on line 3. There is no reason for "or combinations thereof" in line 5 or "or" in line 3 to be italicized. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Lactobacillus rhamnosus and Pediococcus acidilactici are italicized in other claims 1, 4, and 9, but not in claim 6, lines 2, 3, 4, and 5. Examiner requests consistency in formatting. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “wherein the at least one postbiotic strain of bacteria comprises at least one of a postbiotic strain of Lactobacillus acidophilus wherein the postbiotic strain of Lactobacillus acidophilus is HA-122, and a postbiotic strain of Lactobacillus plantarum wherein the postbiotic strain of Lactobacillus plantarum is HA- 119.” The use of “at least one” in line 2 and “and” in line 3 renders the claim indefinite. The use of “at least one” seems to imply that HA-122 and/or HA-119 can be used (i.e. only one is required, but both can be present if desired), but the use of “and” seems to imply that both HA-122 and HA-119 must be present. Thus “at least one” and “and” contradict each other and render the claim indefinite, as one of ordinary skill in the art would not be able to tell if one or both strains are required. If both strains are required, Examiner suggests removing “at least one of”. If only one strain is required, Examiner suggests amending “and” in line 3 to “or”, or amending line 2 to read “ at least one selected from the group consisting of”, to adhere to proper Markush group formatting (see MPEP §2117).
Claim 6 recites “the at least one probiotic strain of bacteria comprises a probiotic strain of Lactobacillus rhamnosus wherein the probiotic strain of Lactobacillus rhamnosus is GG, a probiotic strain of Pediococcus acidilactici wherein the probiotic strain of Pediococcus acidilactici is HA-524, a probiotic strain of Bifidobacterium longum wherein the probiotic strain of Lactobacillus reuteri is HA-188.” The use of “at least one” and “comprises” renders the claim indefinite. The use of “at least one” seems to imply that each of these strains (GG, HA-524, and/or HA-188) can be used independently or together (i.e. only one is required, but two or three can be present if desired), but the use of “comprises” seems to imply that all three strains must be present, as "comprises" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. MPEP 2111.03, see Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986). Thus “at least one” and “comprises” contradict each other. If all three strains are required, examiner suggests removing the language in line 1 so the claim recites “wherein the probiotic strains comprise”. Further clarity could be added by including the word “and” in the list. If only one of the strains is required, Examiner suggests adding “or” to the recitation of the list of strains, so that only one of the strains are required.
Additionally, claim 6 recites, in lines 4-5, “a probiotic strain of Bifidobacterium longum wherein the probiotic strain of Lactobacillus reuteri is HA-188.” This is indefinite because B. longum and L. reuteri are known in the art to be different species of bacteria. There is no situation in which a strain of B. longum would be referred to as the name L. reuteri. Moreover, HA-188 is a recited in the specification as a preferred strain of L. reuteri. Appropriate correction is required. Examiner suggests replacing Bifidobacterium longum with Lactobacillus reuteri in line 5. Additionally, if the term Bifidobacterium longum is kept in the claim, Examiner requires appropriate italicization of the term in line with claims 1, 4, and 9.
Claim 7 recites “the composition of claim 1, further comprising at least one of: a vitamin…, a yeast, fungi, enzyme, botanical, mineral, prebiotic molecule…, and a postbiotic molecule…” It is unclear if claim 7 is intended to require at least one of each category listed in claim 7, as suggested by the word “and”, or if claim 7 only requires one category listed in claim 7, as suggested by the phrase “at least one of”. Appropriate clarification is required. If only one of the categories is required, Examiner suggests amending the “and” in line 11 to read “or”, or amending line 1 to read “further comprising at least one selected from the group consisting of:”, to be consistent with proper Markush group terminology (see MPEP §2117). If all categories are required, Examiner suggests removing the language “at least one of” in line 1.
Additionally, claim 7 is indefinite as it is unclear if “fungi, enzyme, botanical, mineral, prebiotic molecule, compound, or composition” require only one item from these categories, or if multiple items are required, due to the lack of either an article (a/an) or consistent pluralization. Appropriate correction is required.
Claim 8 is indefinite due to the recitation of “preferably” in line 2 and “most preferably” in line 3. It is unclear if the further limitation that follows ‘preferably’ is required by the claim or not. Therefore, one of ordinary skill in the art would not be able to determine the scope of the claims.
Additionally, regarding claim 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “strains” in claim 9, lines 2, 3, 5, and 7, is used by the claim to mean “number of bacteria,” while the accepted meaning is “a subspecies of bacteria.” The term is indefinite because the specification does not clearly redefine the term. One of ordinary skill in the art would be able to recognize that there are not 1 x 108 strains of each of these bacteria known in the art. Furthermore, it would be unreasonable to add that number of unique strains to a composition. Finally, the claim additionally recites “CFU”, interpreted as ‘colony forming units’, which is a known term for “number of bacteria” in the art. It is unclear if the claim is reciting 1x108 strains at 20 x 109 CFU/strain, of if each of the 1x108 strains is present at 20 x 109 CFU, if the total number of bacteria is 20x109 CFU and that is made of 1x108 strains of each bacterial species, or if each bacterial strain is present in the range of 1x108 to 20x109 CFU. Examiner suggests that the last option is the most reasonable, and suggests amending the claim to remove the term “strains of”, so that each instance would read, for example, “the total amount of Bifidobacterium longum in the composition is greater than about 1 x 108 but less than about 20 x 109 CFU at the point of manufacture…”.
Additionally, claim 9 recites “ the total amount of strains of Lactobacillus acidophilus in the composition is greater than about 1 mg but less than about 10 mg…” in line 8-9 and similar language regarding Lactobacillus plantarum in lines 9 and 10. Milligrams, or mg, cannot be a measure of strains, which means “a subspecies of bacteria.” Examiner suggests that removing the term “strains of”, so that the claim reads similar to “the total amount of Lactobacillus acidophilus in the composition is greater than about 1 mg but less than about 10 mg…”, would rectify the issue at hand, as mg is an appropriate measure for a postbiotic bacterial composition.
Claim Interpretation
In view of the several indefinite claims recited above, Examiner sets forth the following claim interpretations for the purposes of applying prior art:
Claim 5 is interpreted as requiring either post-biotic strain HA-122 or HA-119.
Claim 6 is interpreted as requiring one of GG, HA-524, and HA-188.
Claim 7 is interpreted as further comprising one of the listed components.
Claim 8 is interpreted as requiring vitamin C in any concentration.
Claim 9 is interpreted as requiring between 1x108 and 20x109 CFU at the point of manufacture for Bifidobacterium longum, Lactobacillus rhamnosus, Pediococcus acidilactici, or Lactobacillus reuteri, and 1-10 mg of Lactobacillus plantarum or Lactobacillus acidophilus. As claim 9 depends from claim 4, claim 9 is interpreted as part of claim 4, which only requires one probiotic and one postbiotic strain (one selected from each group above).
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 and 3-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) a combination of probiotic and postbiotic bacterial strains. This judicial exception is not integrated into a practical application because no method is recited. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because all elements of the claims are drawn to judicial exceptions of natural products, and no markedly different characteristics are demonstrated.
Applicant’s claims recite a composition comprising at least one probiotic strain of bacteria and at least one postbiotic strain of bacteria, wherein the probiotic strain is selected from a group of known probiotics. Therefore, the claim is directed to a composition of matter, which is one of the statutory categories of invention (Step 1: yes).
The claim is then analyzed to determine whether it is directed to any judicial exception. The recited species of bacteria (Lactobacillus rhamnosus, Pediococcus acidilactici, Bifidobacterium longum, and Lactobacillus reuteri) are naturally occurring and unmodified. There is no indication in the specification that the claimed bacteria have any characteristics (structural, functional, or otherwise) that are different from the naturally occurring bacteria. A postbiotic is defined in the specification as “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host” in paragraph [0080] of the specification. The same paragraph defines a postbiotic strain as a “postbiotic microorganism”. Simply put, a postbiotic strain comprises dead bacteria. Dead bacteria occur in nature, and as these bacteria are not disclosed as having any unique characteristics, they are also considered to be naturally occurring. Therefore, the composition of claim 1 contains judicial exceptions.
Further dependent claims do not rectify this judicial exception. Claims 3, 4, 5, and 6 further define the probiotic and postbiotic bacterial strains, and claim 9 recites the amount of each strain present in a composition. These strains are not taught in the specification or the art to be modified from naturally occurring bacteria in any way. Therefore, these claims do not amount to significantly more than the judicial exception. Additionally, claims 7 and 8 do not add significantly more, as they merely recite additional limitations that are also naturally occurring (for example, vitamin C). Claim 10 only recites a form of the product, and does not substantially alter the composition.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
There is no indication in the specification that the claimed mixture of bacteria has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring bacteria. The specification demonstrates that a combination of four strains of probiotic bacteria and two strains of postbiotic bacteria, when administered as a capsule, improves skin elasticity and smoothness and reduction in wrinkles. However, several of the claimed species are known to have a beneficial effect on skin on their own. For example, Lactobacillus rhamnosus strain GG has been shown to affect atopic dermatitis (see Kalliomaki et al., The Lancet 357.9262 (2001): 1076-1079), and postbiotic heat-inactivated Lactobacillus acidophilus is known to have a positive dermatological impact, as evidenced by WO 2022/013897 (Romagnoli et al.).
Thus, the mixture does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception.
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.
(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.
Claim(s) 1, 2, 6, 7, 9, and 10 are rejected under 35 U.S.C. 102(1) as being anticipated by NZ 724753 A, O'Neill et al., published 04/27/2018.
O’Neill teaches a composition comprising Lactobacillus rhamnosus GG (see page 7, numbered paragraph 1). Page 6, line 22, recites that the composition may be a mixture of “lysates, live, or inactivated probiotic bacteria”. Therefore, O’Neill teaches the composition of claim 1, comprising at least one bacteria strain of L. rhamnosus and a postbiotic strain. O’Neill further teaches that the composition can additionally comprise Lactobacillus reuteri and Bifidobacterium longum (see page 5, third paragraph). O’Neill teaches that the bacteria may be inactivated by heat, or tyndallized, on page 18, line 35, and in the explanation of Figure 2, anticipating claim 2. Page 19 teaches that the invention relates to the strain of L. rhamnosus known as GG in line 13, thereby anticipating claim 6. As the composition comprises cell lysates, the composition comprises postbiotic compound, composition, cell, or cell components, anticipating claim 7. Page 29 recites that “suitable doses of probiotic bacteria (intact or lysed) may be in the range 104 to 1012 cfu,” and Example 1, page 32, discloses 1x108 CFU of bacteria, thereby anticipating claim 9. Finally, page 29 discloses formulation of the composition into drinks, or liquids for oral administration, on lines 22-24, anticipating claim 10. Therefore, O’Neill et al. teach claims 1, 2, 6, 7, 9, and 10.
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.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over NZ 724753 A, O'Neill et al., published 04/27/2018, in view of WO 2022/013897, Romagnoli et al., EFD 07/15/2020.
O’Neill teaches a composition comprising Lactobacillus rhamnosus GG (see page 7, numbered paragraph 1). Page 6, line 22, recites that the composition may be a mixture of “lysates, live, or inactivated probiotic bacteria”. Therefore, O’Neill teaches the composition of claim 1, comprising at least one bacteria strain of L. rhamnosus and a postbiotic strain. O’Neill further teaches that the composition can additionally comprise Lactobacillus reuteri and Bifidobacterium longum (see page 5, third paragraph). O’Neill teaches that the bacteria may be inactivated by heat, or tyndallized, on page 18, line 35, and in the explanation of Figure 2, teaching claim 2. Page 19 teaches that the invention relates to the strain of L. rhamnosus known as GG in line 13, thereby teaching claim 6. As the composition comprises cell lysates, the composition comprises postbiotic compound, composition, cell, or cell components, teaching claim 7. Page 29 recites that “suitable doses of probiotic bacteria (intact or lysed) may be in the range 104 to 1012 cfu,” and Example 1, page 32, discloses 1x108 CFU of bacteria, thereby teaching claim 9. Finally, page 29 discloses formulation of the composition into drinks, or liquids for oral administration, on lines 22-24, teaching claim 10. Therefore, O’Neill et al. teach claims 1, 2, 6, 7, 9, and 10.
O’Neill does not teach that the postbiotic strain of bacteria is Lactobacillus acidophilus HA-122 or Lactobacillus plantarum HA-119. O’Neill does not teach the inclusion of vitamin C.
Romagnoli et al. (hereinafter Romagnoli) teach a composition comprising L. acidophilis lysate and L. plantarum lysate and vitamin C (see claim 1 and page 5, lines 1-10). Romagnoli teaches that the strains of L. acidophilus HA-122 and L. plantarum HA-119 on page 7, line 16, and in claim 4. Claim 4 also teaches that the bacteria are inactivated by heat by means of the tindalization method. Therefore, Romagnoli teaches the postbiotic strains of claim 2-5. Table 1 of Romagnoli teaches that the vitamin C is present in .1-2% and the bacteria are present in .1-1%. In the instant specification, the tyndalized bacteria are present in .8% w/w. Therefore, Romagnoli also teaches claims 8 and 9.
It would have been obvious to one of ordinary skill in the art, before the effective filing date, to combine the invention of O’Neill with the postbiotics taught by Romagnoli. One would be motivated to do so, as Romagnoli teaches that the postbiotic composition and the vitamin C both have a positive effect on skin parameters, and the composition of O’Neill also seeks to improve skin appearance while potentially altering the skin microbiome. One would have a reasonable expectation of success as the composition of O’Neill, which contains both live probiotic and postbiotic bacteria, can be administered via topical or oral administration. Additionally, Romagnoli, on page 3, lines 3-4, discloses that a positive hypolipidemic effect of Lactobacillus lysates as a food supplement. Adding the postbiotic lysates of the topical composition of Romagnoli to the oral composition of O’Neill would allow for an additional positive effect on the skin. Therefore, the instant claims 1-10 are rendered obvious over O’Neill in view of Ramagnoli.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 109043548 A, Liu et al., published 12/21/2018 in view of CN 113413406 A, Wang et al., published 09/21/2021. All page/paragraph numbers refer to the English translation provided.
Liu et al. (hereinafter Liu) teach a composition comprising collagen, Acerola cherry powder, and Lactic acid bacteria in claim 1. Claim 5 and paragraph [0022] recite possible Lactic acid bacteria strains, including Bifidobacterium longum, Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus acidophilus, and Lactobacillus plantarum, teaching the probiotic strains of claim 1. Liu further discloses, in claim 6 and paragraph [0023], that the strain of L. reuteri is HA-188, teaching claim 6. Moreover, the strain of L. rhamnosus listed in the same paragraph is Rosell-11. Both strains GG and Rosell-11 are common, commercially available, probiotic strains. They are both named as appropriate for the claimed composition in the specification (see the table in paragraph [0113]). As the specification does not give any support for specifically using strain GG over strain Rosell-11, and as the specification names both strains as options for the composition, they are considered obvious variants of one another. As such, it would be obvious to substitute the obvious variant strain Rosell-11 with the claimed strain of GG, further teaching claim 6.
Liu further teaches that the Acerola cherry powder is a source of vitamin C, thereby teaching claims 7 and 8. Claim 2 of Liu discloses the cherry powder as 5-30% of the composition, and that vitamin C makes up 17% of the cherry powder. 17% of 5-30% of the composition is .85-5% final w/w vitamin C in the composition of Liu. Instant claim 8 discloses between 1% and 19% w/w of vitamin C, when the final weight is 420 mg as disclosed in paragraph [0124]. Therefore, Liu even teaches the concentration of vitamin C disclosed in claim 8. Claim 8 of Liu and paragraphs [0026-27] disclose that each bacteria is present in the range of 1x109 – 1x1010 CFU, teaching instant claim 9. Finally, Liu teaches, in claim 14 and in the examples, the composition in the form of a capsule, powder, or liquid for oral administration. Therefore, Liu teaches a composition comprising the probiotic strains of instant claims 1 and 6-10.
Liu does not teach a postbiotic strain of bacteria, or that the postbiotic strain is Lactobacillus acidophilus HA-122 or Lactobacillus plantarum HA-119. However, Liu does disclose these species as appropriate for inclusion in the composition.
Wang et al., hereinafter Wang, teaches inactivated probiotics, or live probiotic strains that have been killed via tyndallization (heat killing) are postbiotics (see page 8, paragraph [n0008]). Wang teaches a composition of inactivated probiotics, their metabolites, and soybean powder in claim 1. In claim 2 and paragraph [n0009], Wang further teaches the inactivated probiotic is L. acidophilus or L. plantarum. Paragraph [n0010] discloses L. acidophilus strain HA-122 and L. plantarum strain HA-119, as well as L. reuteri HA-188 and L. rhamnosus GG, teaching the postbiotic strains of claims 1-6. Additionally, as these are postbiotic cells, they teach claim 7. Paragraphs [n0044] and [n0048] teach strains HA-122 and HA-119 in 10x109, teaching claim 9. Paragraph [n0013] teaches that the dosage forms can be capsules, powders, or liquids for oral consumption, teaching instant claim 10.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to combine the prebiotic composition of Liu with the postbiotic composition of Wang. One would be motivated to do so to overcome the problems with the storage and transportation of live bacteria, as recited in Wang paragraph [n0029]. If some of the live bacteria of Liu were to not survive storage and transport, Wang demonstrates the bacteria would still have an effect. Adding the postbiotic strains of Wang would add to this effect. One would have reasonable expectation of success, as each both Wang and Liu teach the same bacteria, including the same strains, in some cases, for oral consumption. No unexpected effect can be discerned in the application to be linked to the living status of the bacterial strains. In particular, the effects of the combined use of probiotic and postbiotic strains of bacteria does not appear to extend beyond a simple additional effect. Therefore, the combination of Liu and Wang renders the instant claims 1-10 obvious.
Conclusion
No claims are allowed.
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/AMELIA STEPHENS/ Examiner, Art Unit 1645
/ANNE M. GUSSOW/ Supervisory Patent Examiner, Art Unit 1683
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