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 II, claims 27-31 in the reply filed on 11/19/2025 is acknowledged. Claims 1-18 have been canceled. Claims 19-26 are withdrawn from consideration as being drawn to a non-elected invention.
Priority
This application is a CON of 16/471,058 filed 06/19/2019 now PAT 11,529,380
which is a 371 of PCT/AU2017/051453 filed 12/22/2017.
Information Disclosure Statement
The information disclosure statement filed 11/19/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Specifically, while some of the cited prior art are found in the parent application 16/471058, now US patent 11529380, the citations directed to A10, B13, 16, B17, C1-C8, C13 and C14 are not found in the instant application or parent application.
Drawings
The drawings were received on 5/22/2023. These drawings are found acceptable by the Examiner.
Specification
The disclosure is objected to because of the following informalities:
(a) The specification is objected at page 22, line 10 for typo at the recitation of “SE ID NO:”. It is should recite ---SEQ ID NO: ---..
(b) The disclosure is objected to at page 29, line 26 and Example 2 at page 32 because the disclosure comprises of sequences of <10 nucleotides in the Table S8 at pages 61-65 that are not represented by a proper sequence identifier (SEQ ID NO:) as discussed at MPEP 2417 and supported in the RAW sequence listing and CRF filed in the instant invention.
Appropriate correction is required.
List of References in Specification
It appears that Applicant has cited a list of references in the specification at pages 45-48. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, applications, or other information submitted for consideration by the Office, and MPEP 609.04(a), subsection I, states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 27-31 are rejected under 35 U.S.C. 101 because the claims are directed to a non-statutory subject matter, a natural correlation without significantly more. The claims 27-31 are directed to a composition comprising -Prevotella copri and -a further ingredient that is beneficial for a pregnant or lactating women, wherein the further ingredient is folate or vitamin D, iron, and/or carbohydrate.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. 593 (2010) (slip op., at 5). “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words “apply it.” See, e.g., Benson, supra, at 71–72.
Based upon consideration of the claims as a whole, the present claims fail to meet elements required for patent eligibility.
Regarding Step 1 of the subject matter eligibility test set forth at MPEP 2106III, the claims are directed the statutory category of a product.
Regarding Step 2A, prong one, the claim recites the judicial exception of a natural product/natural correlation. The claims ae directed a composition comprising -Prevotella copri and -a further ingredient that is beneficial for a pregnant or lactating women, wherein the further ingredient is folate or vitamin D, iron, and/or carbohydrate. The claims when reviewed individually do not recite compose of components, i.e., Prevotella copri, vitamin D, folate, carbohydrates and iron, are natural products that are not markedly different in structure from naturally occurring products. As in Mayo Collaborative Services V. Prometheus, the claimed recited relationship of the components as a composition is a natural phenomenon/natural product that exists apart from any human action. See also Cleveland Clinic Foundation v. True Health Diagnostic, LLC, 2018-1218 (Fed Cir. 2019) which states that “The re-phrasing of the claims does not make them less directed to a natural law.”
Regarding step 2A, prong 2, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
Herein, the claims do not recite components or elements that integrate the recited judicial exception into a practical application of the exception. The limitation “beneficial for a pregnant or lactating woman’ is considered an ‘intended use’ of the claimed composition and does not impose meaningful limits on the judicial exception because it merely describes how the composition might be use.
Regarding Step 2B, the next question is whether the remaining elements/steps amount to significantly more than the judicial exception. In this case, the claims do not recite any additional element that amount the significantly more than the judicial exception. Accordingly, the claims lack subject matter eligibility under 101.
Claim Rejections - 35 USC § 102
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 (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.
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.
(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.
12. Claim(s) 27-31 is/are rejected under 35 U.S.C. 102(a)(1) and alternatively 35 USC 102(a)(2) as being anticipated by von Maltzahn et al (US 2016013702, July 28, 2016, effective filing date Oct. 2015).
Regarding claim 27-31, von Maltzahn et al teach a composition comprising carbohydrate [0141] – [0142], [0184], iron [0271], vitamin D [0272] and microbe such as Prevotella copri DSM 18205 [0046] (see also [0360] – [0508] and [0564]). Thus, Von Maltzahn et al meets the limitations of the claims.
Conclusion
13. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681
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