The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 3-30-2026 is acknowledged. Claims 3 and 14-18 have been amended.
Election/Restrictions
Applicant’s election of Group III in the reply filed on 3-30-2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-18 are pending. Claims 2 and 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 2 and 3-10 are currently under examination.
Claim Objections
Claim 3 is objected to for reciting claim language drawn to a non-elected invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 13-15 and 17 of copending Application 18/269,878. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to strains of Christensenella minuta with the same 16S rRNA. As clearly set forth on page 28 of the instant specification Christensenella minuta DSM 33407 and Christensenella minuta DSM 33715 have the same 16S rDNA and have a 99.69% genome homology. Consequently, the claims of the copending (patented claims) encompass the rejected claims.
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, 3, 4, 6 and 8-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Laws of nature or natural phenomena include naturally occurring principles/ relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature (MPEP2106.04(b)).
“The law of nature and natural phenomenon exceptions reflect the Supreme Court's view that the basic tools of scientific and technological work are not patentable, because the "manifestations of laws of nature" are "part of the storehouse of knowledge," "free to all men and reserved exclusively to none." Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter" under Section 101. Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980). "Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity." Id. Nor can one patent "a novel and useful mathematical formula," Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978); electromagnetism or steam power, O’Reilly v. Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or "[t]he qualities of ... bacteria, ... the heat of the sun, electricity, or the qualities of metals," Funk, 333 U.S. at 130, 76 USPQ at 281; see also Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1853).”
Products of nature are analyzed under 35 USC 101 through the “markedly different characteristics analysis”. MPEP 2106.04(c) as a part of step 2A prong one of the analysis.
“If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites another exception (such as a law of nature or abstract idea, or a different natural phenomenon). For claims where the entire claim is a single nature-based product (e.g., a claim to "a Christensenella minuta strain "), once a markedly different characteristic in that product is shown, no further analysis would be necessary for eligibility because no product of nature exception is recited (i.e., Step 2B is not necessary because the answer to Step 2A is NO). For claims including limitations in addition to the nature-based product, further eligibility analysis is required.
If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.
Claims 1, 3, 4, 6 and 8-9 recite the following natural product:
The Christensenella minuta strain deposited with the DSM under the accession number DSM 33715.
MPEP2106.04(C) II sets forth:
Appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include:
• Biological or pharmacological functions or activities;
• Chemical and physical properties;
• Phenotype, including functional and structural characteristics; and
• Structure and form, whether chemical, genetic or physical.
“To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.” (MPEP2106.04 (c)II. C).
Comparing the relevant characteristics between the product of claims 1, 3, 4, 6 and 8-9and its naturally occurring counterpart, the examiner finds no markedly difference characteristics between the characteristics. Naturally occurring the ABC transporter complex ATP binding proteins or (components thereof) are naturally affected by environmental factors.
If there are no markedly different characteristics between the product of the claim and the naturally occurring counterpart, the claim is probed for the presence of additional limitations. The claimed additional elements are analyzed alone or in combination to determine if the natural product is sufficiently different than is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the natural product, the claim fails to integrate the natural product into a practical application (MPEP 2106.04(d).III).
There are no additional limitations to the natural product in claim 1, 3, 4, 6 and 8-9.
The recitation of the phrase “acceptable excipient” is not considered an additional limitation as it conveys no structural limitations and encompasses natural conditions.
The recitation of the phrase “in a form suitable for oral…” is not considered an additional limitation as it conveys no structural limitations and encompasses natural conditions.
Considering the additional limitations in addition to the natural product together as a whole, the additional elements do not rise to the level of significantly more than the natural product.
In combination, the lack of additional limitations, acted upon by the judicial exception (or natural law, or natural product), fail to rise to the level of significantly more. No additional limitation has clearly been identified.
The claims have all been examined to identify the presence of a naturally occurring product or natural phenomena. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. Individually, the limitations of the claims and the claims as a whole have been found lacking.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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 and 3-10 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 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.
It is apparent that the Christensenella minuta strain represented by the DSM accession number DSM 33715 required in order to practice the invention. Specifically, it is noted that claims 1 and 3 recite deposited material and that claims 4-10 depend from claims reciting deposited material The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of Christensenella minuta strain represented by the DSM accession number DSM 33715 in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
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.
Claim 1 and 3-10 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 is rendered vague and indefinite by the use of the phrase “… Christensenella minuta filed as DSM accession number DSM 33715.”. It is unclear what it meant to be engendered by said phrase. Is said phrase referring to a biological deposit? If so, it is suggested that the phrase “the Christensenella minuta strain deposited with the DSM under the accession number accession number DSM 33715” be used instead.
Claim 3 is rendered vague and indefinite by the use of the phrase “…at least one bacterial strain of Christensenella minuta strain with the accession number DSM 33715.”. It is unclear what is meant to be engendered by said phrase as the use of “at least one bacterial strain” suggests that multiple strains share the same accession number. As written, it is impossible to determine the metes and bounds of the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 April 13, 2026
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