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 1-10 are pending in this application and are being examined.
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 1-10 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: Lacticaseibacillus paracasei CGMCC No. 28149.
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 applicant’s specification (for example, paragraph [0033]). 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 2-4 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 2 reads “An application of the strain of Lacticaseibacillus paracasei according to claim 1 for preparing a drug for a prevention and/or a treatment of hypersensitive rhinitis”, which is confusing and renders the claim indefinite because from the way claim 2 is written it is unclear what applicant is trying to encompass by the claim. In addition if applicant is claiming a method, no method steps(s) is/are set forth.
Suggestion to obviate the rejection: amend to better define the claimed subject matter or cancel the claim(s).
In claim 3 the Markush group “comprises alleviation of symptoms of hypersensitive rhinitis, inhibition of immune responses caused by hypersensitive rhinitis, inhibition of inflammatory responses caused by hypersensitive rhinitis and/or repair of lesions of nasal mucosa caused by hypersensitive rhinitis” is indefinite because the Markush grouping is not a closed group of alternatives.
Suggestion to obviate the rejection: for example, in claim 3, line 2, replace “comprises” with --is selected from the group consisting of--, and line 4, replace “and/or” with –or--.
In claim 4 the Markush group “comprises reducing the frequency of nasal scratching, sneezing and / or nasal discharge in patients with hypersensitive rhinitis” is indefinite because the Markush grouping is not a closed group of alternatives.
Suggestion to obviate the rejection: for example, in claim 4, line 2, replace “comprises” with --is selected from the group consisting of--, and lines 2-3, replace “and/or” with –or--.
Claim 5 recites the limitation "the strain of Lacticaseibacillus paracasei " in claim 4. There is insufficient antecedent basis for this limitation in the claim.
Suggestion to obviate the rejection: replace “4” with –1--.
In claim 7 the Markush group “comprises the strain of Lacticaseibacillus paracasei , a drug carrier and/or a pharmaceutical adjuvant” is indefinite because the Markush grouping is not a closed group of alternatives.
Suggestion to obviate the rejection: for example, in claim 7, line 1, replace “comprises” with --is selected from the group consisting of--, and line 2, replace “and/or” with –or--.
In claim 8 the Markush group “comprises a microcapsule, a microsphere, a nanoparticle and/or a liposome.” is indefinite because the Markush grouping is not a closed group of alternatives.
Suggestion to obviate the rejection: for example, in claim 8, line 1, replace “comprises” with --is selected from the group consisting of--, and line 2, replace “and/or” with –or--.
In claim 9 the Markush group “comprises an excipient and / or an additive” is indefinite because the Markush grouping is not a closed group of alternatives.
Suggestion to obviate the rejection: for example, in claim 9, line 1, replace “comprises” with --is selected from the group consisting of--, and line 2, replace “and/or” with –or--.
In claim 10 the Markush group “comprises microcrystalline cellulose, hydroxypropyl methylcellulose and/or refined lecithin.” is indefinite because the Markush grouping is not a closed group of alternatives.
Suggestion to obviate the rejection: for example, in claim 10, line 1 replace “comprises” with --is selected from the group consisting of--, and line 2, replace “and/or” with –or--.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In claim 7, the phrase “the strain of Lacticaseibacillus paracasei” fails to further limit the subject matter of the claims upon which it depends, because the preceding claims 5 and 6 already recite the product comprises the strain of Lacticaseibacillus paracasei.
Suggestion to obviate the rejection: delete “the strain of Lacticaseibacillus paracasei”.
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
(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.
Claims 1-6 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.
Claims 1-5 are drawn a strain of Lacticaseibacillus paracasei, and a composition comprising the strain of Lacticaseibacillus paracasei.
The broadest reasonable interpretation of instant claims includes bacteria Lacticaseibacillus paracasei (which is a naturally occurring human intestinal microbiota) is (See for example, p. 434 right-hand column 3rd paragraph of Peng et al.). Thus, the claims 1-5 as a whole are directed to a judicial exception.
In addition, there is no evidence of any markedly different functional characteristic other than the inherent natural functions or properties of the claimed Lacticaseibacillus paracasei strain.Therefore, claims as a whole do not amount to significantly more than the exception itself (Answer to Step 2B: No).
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, there is no additional elements recited in the claims, and the phrase “product” (in claim 5) and food or drug (claim 6), are specified at a high level of generality, and thus are not considered ‘significantly more’ than the judicial exception.
Therefore, claims 1-6 do not integrate the judicial exception into a practical application of that exception (Answer to Step 2A Prong Two: No).
In addition, depositing and obtaining an accession/registration number (claim 1) 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.
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 1-6 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.
Claims 1-7 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 Peng et al. (Pediatr. Allergy Immunol. 2005, Vol. 16, No. 5, p. 433-438).
Regarding claims 1 and 2, Peng et al. disclose a strain of Lacticaseibacillus paracasei (Lactobacillus paracasei 33, it should be noted that Lacticaseibacillus paracasei is formerly Lactobacillus paracasei) (See for example, p. 434 right-hand column 3rd paragraph).
Regarding claim 2, Peng et al. disclose strain of Lacticaseibacillus paracasei according to claim 1 for preparing a drug for a prevention and/or a treatment of hypersensitive rhinitis (a capsule containing freeze dried Lactobacillus paracasei 33, or LP33, and LP33 improve the quality of life in human cases or perennial rhinitis, etc.) (See for example, p. 434 right-hand column 3rd paragraph, and p. 434 left-hand column 1st paragraph last 3 lines).
Regarding claims 3-4, Peng et al. disclose the prevention and/or the treatment of hypersensitive rhinitis comprises alleviation of symptoms of hypersensitive rhinitis, inhibition of immune responses caused by hypersensitive rhinitis, inhibition of inflammatory responses caused by hypersensitive rhinitis and/or repair of lesions of nasal mucosa caused by hypersensitive rhinitis, and the alleviation of symptoms of hypersensitive rhinitis comprises reducing the frequency of nasal scratching, sneezing and / or nasal discharge in patients with hypersensitive rhinitis (LP33 improve the quality of life in human cases or perennial rhinitis, and LP33 alleviate the symptoms caused by allergic rhinitis) (See for example, p. 434 left-hand column 1st paragraph last 3 lines, and p. 435 “Results” both columns and Table 4., p. 436 left-hand column 3rd paragraph, and p. 437 left-hand column 1st paragraph).
Regarding claim 5, Peng et al. disclose a product comprising the strain of Lacticaseibacillus paracasei of claim 4 (a capsule containing freeze dried powder Lactobacillus paracasei 33) (See for example, p. 434 right-hand column 3rd paragraph).
Regarding claim 6, Peng et al. disclose a product comprises a food or a drug (a capsule containing freeze dried powder Lactobacillus paracasei 33) (See for example, p. 434 right-hand column 3rd paragraph).
Regarding claim 7, Peng et al. disclose the drug comprises the strain of Lacticaseibacillus paracasei, a drug carrier and/or a pharmaceutical adjuvant (a capsule containing freeze dried powder Lactobacillus paracasei 33) (See for example, p. 434 right-hand column 3rd paragraph).
In this case, although the strain of Lacticaseibacillus paracasei, disclosed by Peng et al. does not have the claimed deposit number of, CGMCC No. 28149. but it appears to be the same as the claimed Lacticaseibacillus paracasei strain. It should be noted that a single strain can be deposited under different deposit numbers. Therefore, Peng et al. anticipate the subject matter of claims 1-7.
In alternative,
Regarding claims 1 and 2, Peng et al. teach a strain of Lacticaseibacillus paracasei (Lactobacillus paracasei 33, it should be noted that Lacticaseibacillus paracasei is formerly Lactobacillus paracasei) (See for example, p. 434 right-hand column 3rd paragraph).
Regarding claim 2, Peng et al. teach strain of Lacticaseibacillus paracasei according to claim 1 for preparing a drug for a prevention and/or a treatment of hypersensitive rhinitis (a capsule containing freeze dried Lactobacillus paracasei 33, or LP33, and LP33 improve the quality of life in human cases or perennial rhinitis, etc.) (See for example, p. 434 right-hand column 3rd paragraph, and p. 434 left-hand column 1st paragraph last 3 lines).
Regarding claims 3-4, Peng et al. teach the prevention and/or the treatment of hypersensitive rhinitis comprises alleviation of symptoms of hypersensitive rhinitis, inhibition of immune responses caused by hypersensitive rhinitis, inhibition of inflammatory responses caused by hypersensitive rhinitis and/or repair of lesions of nasal mucosa caused by hypersensitive rhinitis, and the alleviation of symptoms of hypersensitive rhinitis comprises reducing the frequency of nasal scratching, sneezing and / or nasal discharge in patients with hypersensitive rhinitis (LP33 improve the quality of life in human cases or perennial rhinitis, and LP33 alleviate the symptoms caused by allergic rhinitis) (See for example, p. 434 left-hand column 1st paragraph last 3 lines, and p. 435 “Results” both columns and Table 4., p. 436 left-hand column 3rd paragraph, and p. 437 left-hand column 1st paragraph).
Regarding claim 5, Peng et al. teach a product comprising the strain of Lacticaseibacillus paracasei of claim 4 (a capsule containing freeze dried powder Lactobacillus paracasei 33) (See for example, p. 434 right-hand column 3rd paragraph).
Regarding claim 6, Peng et al. teach a product comprises a food or a drug (a capsule containing freeze dried powder Lactobacillus paracasei 33) (See for example, p. 434 right-hand column 3rd paragraph).
Regarding claim 7, Peng et al. teach the drug comprises the strain of Lacticaseibacillus paracasei, a drug carrier and/or a pharmaceutical adjuvant (a capsule containing freeze dried powder Lactobacillus paracasei 33) (See for example, p. 434 right-hand column 3rd paragraph).
In this case, although the strain of Lacticaseibacillus paracasei, disclosed by Peng et al. does not have the claimed deposit number of, CGMCC No. 28149, however it appears to be the same as the claimed Lacticaseibacillus paracasei 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 the benefits of Lacticaseibacillus paracasei in alleviating the symptoms caused by allergic rhinitis, would have been motivated to isolate a Lacticaseibacillus paracasei by known and available techniques taught by the prior art and obtain a deposit number and further use it according to the teachings of Peng et al. with a reasonable expectation or success in providing the claimed subject matter of claims 1-7.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable Peng et al. (Pediatr. Allergy Immunol. 2005, Vol. 16, No. 5, p. 433-438) in view of e Silva et al. (AAPS PharmSciTech., 2013, Vol. 14, No. 1, p. 121-127).
The teachings of Peng et al. with respect to the limitations of claims 1-7 were discussed above.
Peng et al. do not teach the drug carrier comprises a microcapsule, a microsphere, a nanoparticle and/or a liposome (claim 8), the pharmaceutical adjuvant comprises an excipient and/or an additive (claim 9), and the additive comprises microcrystalline cellulose, hydroxypropyl methylcellulose and/or refined lecithin (claim 10).
However, regarding claims 8-10, before the effective filing date of the invention, e Silva et al. teach formulating Lactobacillus paracasei or Lacticaseibacillus paracasei , with a drug carrier comprises a microcapsule, a microsphere, a nanoparticle and/or a liposome, and the additive comprises microcrystalline cellulose, hydroxypropyl methylcellulose and/or refined lecithin (tablets of probiotic Lactobacillus paracasei microparticles with excipient microcrystalline cellulose) (See for example, p. 122 left-hand column 1st, 4th and 5th paragraphs, and p. 124 right-hand column 4th paragraph).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been motivated to apply well-known and available techniques of formulating probiotic bacteria Lacticaseibacillus paracasei (a.k.a. Lactobacillus paracasei ) taught by the prior art (teachings of e Silva et al.) with a reasonable expectation or success in providing the claimed subject matter of claims 1-10. Because, e Silva et al. formulating Lactobacillus paracasei or Lacticaseibacillus paracasei , with a drug carrier comprises a microcapsule, a microsphere, a nanoparticle and/or a liposome, and the additive comprises microcrystalline cellulose, hydroxypropyl methylcellulose and/or refined lecithin.
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.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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