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 .
Claims 1-8 are pending and are being examined.
Objection(s):
Claims:
Claims 1-8 are objected to because of the following informalities:
In claim 1, line 1, replace “[Claim 1]” with –Claim 1.--, line 1, replace “Limosilactobacillus gasseri” with --Limosilactobacillus gasseri--, and line 2 replace “(KCCM13018P)” with –deposited under accession number KCCM13018P--.
In claim 2, line 1, replace “[Claim 2]” with –Claim 2.--.
In claim 3, line 1, replace “[Claim 3]” with –Claim 3.--.
In claim 4, line 1, replace “[Claim 4]” with –Claim 4.--.
In claim 5, line 1, replace “[Claim 5]” with –Claim 5.--.
In claim 6, line 1, replace “[Claim 6]” with –Claim 6.--, and line 2, replace “Lactobacillus gasseri” with --Lactobacillus gasseri--, and replace “(KCCM13018P)” with –deposited under accession number KCCM13018P--.
In claim 7, line 1, replace “[Claim 7]” with –Claim 7.--, and line 3, replace “Lactobacillus gasseri” with --Lactobacillus gasseri--, and replace “(KCCM13018P)” with –deposited under accession number KCCM13018P--.
In claim 8, line 1, replace “[Claim 8]” with –Claim 8.--.
Appropriate correction is required.
Title:
The title of the invention is objected to because of the phrase “Novel”.
In the title delete “Novel”.
Appropriate correction is required.
Abstract:
The abstract is objected to for the following:
In the abstract replace “Lactobacillus gasseri” (all occurrences) with --Lactobacillus gasseri--,
Appropriate correction is required.
Specification:
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
In claim 1 the phrase “Limosilactobacillus gasseri”. Because the specification fails to provide proper antecedent basis for the “Limosilactobacillus gasseri”.
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.
Claims 1-8 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ a specific strain(s): Limosilactobacillus gasseri LM1065 (KCCM13018P) and Lactobacillus gasseri LM1065 (KCCM13018P).
It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit.
Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted in the abstract of applicant’s specification. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Copy of deposit receipt is/are required.
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 1-8 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 1 recites the limitation "Limosilactobacillus gasseri LM1065 (KCCM13018P)”, while claims 7 and 8 recite the limitations “Lactobacillus gasseri LM1065 (KCCM13018P)”, this is confusing which renders the claims indefinite because it is not exactly clear which strain(s) is/are being claimed.
Suggestion to obviate the rejection: amend to better defined the claimed strain.
In claim 6 the phrase “culture fluid, fragments and extracts” ais indefinite because it is unclear what are being encompassed by these recitations.
Suggestion to obviate the rejection: delete the phrase.
In claim 7, the phrase “culture fluid, fragments and extracts” ais indefinite because it is unclear what are being encompassed by these recitations.
Suggestion to obviate the rejection: delete the phrase.
Claim Rejections - 35 USC § 101
(Law of Nature or Natural Product)
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.
Claim 1-8 are rejected under 35 U.S.C. 101 because;
The claimed invention is directed to a judicial exception, i.e., a natural product without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
According to Section I of the 2019 Revised Patent Subject Matter Eligibility Guidance, “the judicial exceptions are for subject matter that has been identified as the ‘‘basic tools of scientific and technological work,’’ which includes ‘‘abstract ideas’’ such as mathematical concepts, certain methods of organizing human activity, and mental processes; as well as laws of nature and natural phenomena”, and “the USPTO has set forth a revised procedure, rooted in Supreme Court caselaw, to determine whether a claim is ‘‘directed to’’ a judicial exception under the first step of the Alice/Mayo test (USPTO Step 2A).” (Also see “2019 Revised Patent Subject Matter Eligibility Guidance, Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019 / Notices, p. 50-57”).
Step 2A asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? In the context of the flowchart in MPEP § 2106, subsection III, Step 2A determines whether:
• The claim as a whole is not directed to a judicial exception (Step 2A: NO) and thus is eligible at
Pathway B, thereby concluding the eligibility analysis;
or
• The claim as a whole is directed to a judicial exception (Step 2A: YES) and thus requires further analysis at Step 2B to determine if the claim as a whole amounts to significantly more than the exception itself.
Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
In this case, claims 1-8 read:
Claim 1. A composition comprising a strain of Limosilactobacillus gasseri LM1065 (KCCM13018P).
Claim 2. The composition of Claim 1, wherein the strain reduces the production amount of NO in blood.
Claim 3. The composition of Claim 1, wherein the strain reduces IL-6 gene expression.
Claim 4. The composition of Claim 1, wherein the strain increases the ratio of prostaglandin E1/prostaglandin E2 (PGE1/PGE2) in blood.
Claim 5. The composition of Claim 1, wherein the strain increases the level of DGLA in blood.
Claim 6. A food composition of relieving menstrual pain, comprising: one or more of a strain of Lactobacillus gasseri LM1065 (KCCM13018P), and culture fluid, fragments and extracts of the strain as active ingredients.
Claim 7. A pharmaceutical composition of preventing or treating premenstrual syndrome, comprising: one or more of a strain of Lactobacillus gasseri LM1065 (KCCM13018P), and culture fluid, fragments and extracts of the strain as active ingredients.
Claim 8. The pharmaceutical composition of preventing or treating premenstrual syndrome of Claim 7, wherein the premenstrual syndrome includes one or more selected from the group consisting of edema, breast pain, digestive disorders, headache, back pain, lower abdominal pain, abdominal distention, constipation, diarrhea, depression, and insomnia.
In this case, Lactobacillus gasseri , also known as Limosilactobacillus gasseri is a naturally occurring lactic acid bacteria isolated from food, for example, natural inhabitant of intestines of men and women, and vaginal microbiota, etc. (See for example, p. 1 2nd paragraph of Lactobacillus gasseri according to Wikipedia). Thus, the claim as a whole is directed to a judicial exception.
As indicated above, step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
In this case, as explained above claims 1-8 are directed to a judicial exception, i.e., a naturally occurring Lactobacillus gasseri strain.
Moreover, there is no evidence that the claimed Lactobacillus gasseri has a function or property that is not associated with the inherent property of the Lactobacillus gasseri naturally, i.e., there is no evidence of any markedly different functional characteristic other than the inherent natural functions/properties of reduces the production amount of NO in blood, reduces IL-6 gene expression, increases the ratio of prostaglandin E1/prostaglandin E2 (PGE1/PGE2) in blood, increases the level of DGLA in blood, and preventing or treating premenstrual syndrome. Therefore, claims 1-8 as a whole do not amount to significantly more than the exception itself (Answer to Step 2B: No).
Also, the additional elements, a food composition or a pharmaceutical composition (claims 6-8) comprising the Lactobacillus gasseri, are all well understood, routine, and conventional activities, which are also specified at a high level of generality, previously known in the art and routinely taken by others, thus are not sufficient to ensure that the claims amount to significantly more than the judicial exception, i.e., a tablet (See for example, p.155 right-hand column 1st paragraph of Itoh et al.).
In addition, isolating, depositing and obtaining an accession/registration number do not consider to improve the judicial exception or do not use the judicial exception in a particular technological environment such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Therefore, claims 1-8 do not integrate the judicial exception into a practical application of that exception (Answer to Step 2A Prong Two: No).
In Funk Brothers the Supreme court concluded that naturally-occurring bacteria, isolated from their natural surroundings, was not patent eligible: “[t]he qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of the knowledge of all men…manifestations of laws of nature, free to all…and reserved exclusively to none…” the qualities of the bacteria being “.. the work of nature…unaltered by the hand of man.”.
Therefore, the subject matter of claims 1-8 as a whole is not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102/103
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.
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 1-8 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 Itoh et al. (Cytotechnology, 2011, Vol. 63, p. 153–161, Epub 2010 Dec 10, which is also cited in IDS filed on 01/15/2024).
Regarding claim 1, Itoh et al. disclose a composition comprising a strain of Limosilactobacillus (a.k.a. Lactobacillus) gasseri (a.k.a. Lactobacillus gasseri) (a tablet comprising Lactobacillus gasseri OLL288809) (See for example, p. 155 right-hand column 1st paragraph).
Regarding claims 7 and 8, Itoh et al. disclose a pharmaceutical composition of preventing or treating premenstrual syndrome, comprising: one or more of a strain of Lactobacillus gasseri LM1065 (KCCM13018P), and culture fluid, fragments and extracts of the strain as active ingredients, wherein the premenstrual syndrome includes one or more selected from the group consisting of edema, breast pain, digestive disorders, headache, back pain, lower abdominal pain, abdominal distention, constipation, diarrhea, depression, and insomnia (a tablet comprising Lactobacillus gasseri OLL288809 shows significant pain relief and reduce pain intensity at non-menstrual period, etc.) (See for example, p. 155 right-hand column 1st paragraph, p. 159 right-hand column 1st paragraph, and p. 160 left-hand column 2nd paragraph).
No explicit data was available for the production amount of NO in blood, IL-6 gene expression, the ratio of prostaglandin E1/prostaglandin E2 (PGE1/PGE2) in blood, and the level of DGLA in blood (claims 2-5). However, the Lactobacillus gasseri of Itoh et al. shares all the identifying characteristics of the claimed , therefore Itoh et al. composition appears to be the same as, or in alternative an obvious variant of, the claimed composition, as such it inherently possess the claimed properties which are not disclosed.
Moreover, although the strain of Lactobacillus gasseri taught by Itoh et al. does not have the claimed designation numbers of, LM1065 (KCCM13018P), but it appears to be the same as the claimed Lactobacillus gasseri strain. It should be noted that a single strain can be deposited under different deposit numbers.
Therefore, Itoh et al. anticipates the subject matter of claims 1-8.
In alternative,
Regarding claim 1, Itoh et al. teach a composition comprising a strain of Limosilactobacillus (a.k.a. Lactobacillus) gasseri (a.k.a. Lactobacillus gasseri) (a tablet comprising Lactobacillus gasseri OLL288809) (See for example, p. 155 right-hand column 1st paragraph).
Regarding claims 7 and 8, Itoh et al. teach a pharmaceutical composition of preventing or treating premenstrual syndrome, comprising: one or more of a strain of Lactobacillus gasseri LM1065 (KCCM13018P), and culture fluid, fragments and extracts of the strain as active ingredients, wherein the premenstrual syndrome includes one or more selected from the group consisting of edema, breast pain, digestive disorders, headache, back pain, lower abdominal pain, abdominal distention, constipation, diarrhea, depression, and insomnia (a tablet comprising Lactobacillus gasseri OLL288809 shows significant pain relief and reduce pain intensity at non-menstrual period, etc.) (See for example, p. 155 right-hand column 1st paragraph, p. 159 right-hand column 1st paragraph, and p. 160 left-hand column 2nd paragraph).
No explicit data was available for the production amount of NO in blood, IL-6 gene expression, the ratio of prostaglandin E1/prostaglandin E2 (PGE1/PGE2) in blood, and the level of DGLA in blood (claims 2-5). However, the Lactobacillus gasseri of Itoh et al. shares all the identifying characteristics of the claimed , therefore Itoh et al. composition appears to be the same as, or in alternative an obvious variant of, the claimed composition, as such it inherently possess the claimed properties which are not disclosed/taught.
Moreover, although the strain of Lactobacillus gasseri taught by Itoh et al. does not have the claimed designation numbers of, LM1065 (KCCM13018P), however the strain appears to be the same as the claimed Lactobacillus gasseri strain. It should be noted that a single strain can be deposited under different deposit numbers. Moreover, a person of ordinary skill in the art before the effective filing date of the invention knowing that Lactobacillus gasseri is capable of preventing or treating premenstrual syndrome, would have been motivated to isolate a Lactobacillus gasseri by known and available techniques taught by the prior art and obtain a deposit number and further use it in the method according to the teachings of Itoh et al. with a reasonable expectation or success in providing the claimed compositions, including food and pharmaceutical compositions of claims 1-8.
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 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, Adam Weidner can be reached at (571)272-3045. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KADE ARIANI/Primary Examiner, Art Unit 1651