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 .
This is a Final Office Action in response to amendment filed on Jun 11, 2026.
Claims 6, 12, and 14 are canceled. Claims 1, 5, 8 and 23 are amended. Claims 1, 5, 8-11, 13, 16-17, and 20-25 remain pending and examined on their merit herein.
Response to Amendment
The rejection of claims 1, 5-6, 8-14, 16-17, and 20-25 under 35 U.S.C. 101 is withdrawn in view of amendment to the claims.
Improper Incorporation by Reference
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office.
The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 35 U.S.C. 1.57(g).
The attempt to incorporate subject matter into this application by reference to node 23596 of the bac120 phylogenetic tree from the Genome Taxonomy Database (GTDB) release 89; or the he Genome Taxonomy Database (GTDB) release 89, is ineffective because the incorporation of essential material in the specification by reference to a publication is improper. Given that these subject matters are regarded by Applicant as the invention, they are effectively essential material.
Therefore, the disclosure is objected to.
Response to Applicant’s Remarks:
Applicant argued that person skilled in the art would be able to understand and identify the claimed MRCA based on the disclosure provided in the present application, including Figure 2, in combination with routine phylogenetic methods. This argument has not been found persuasive.
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 1, 8, 10, 11, 13, 16-17, and 20-25 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 rejected as being indefinite for the recitation of “a derivative thereof”. The Specification states:
[0142] A derivative of the strains deposited under accession number V21/015887 or V21/015888 may be a daughter strain (progeny) or a strain cultured (subcloned) from the original. A derivative of a strain of the invention may be modified, for example at the genetic level, without ablating the biological activity. In particular, a derivative strain of the invention is therapeutically active. A derivative strain will have comparable activity to the original strains from which it is derived (i.e., the strains deposited under accession numbers V21/015887 or V21/015888). In particular, a derivative strain will elicit comparable effects in at least one disease model (e.g., colitis) as shown in the Examples, which may be identified by using the culturing and administration protocols described in the Examples. A derivative of any one of the V21/015887 or V21/015888 strains will generally be a biotype of the respective V21/015887 or V21/015888 strains. (Emphasis added by Examiner)
The Specification has not clearly defined the metes and bounds of the derivative strains. The cited Specification above uses the open languages “may”, “may be”, or “for example”, therefore failing to provide an exclusive definition. While the Specification points to some “particular” scenarios, even there the relative language of “comparative activity” and the vagueness of terms such as “therapeutically active” renders the definition not clear or exclusive. Therefore, it is unclear what amount of chemical or genetic modification is permitted as implied by the recitation of "derivative thereof." It is unclear how the composition is to be varied as referred to in the claims, there is no way for the person of skill in the art to ascribe a discrete and identifiable definition to said phrase.
Dependent claims are included in this rejection for their failure to correct the deficiency of the base claim.
Response to Applicant’s Remarks:
Applicant argued that “The term "derivative" should be given an interpretation in line with that generally understood in the field of microbiology, i.e., a substance, organism,molecule, or material that is directly derived from a parent biological entity by natural processes or intentional modification, and which retains identifiable structural, genetic, or functional characteristics of that parent entity”; and that “This understanding is expressly supported by the
specification as filed. Paragraph [0142] states that "[a] derivative of a strain of the invention may be modified,for example at the genetic level, without ablating the biological activity.” . (original emphasis). This argument has not been found persuasive. For example, Applicant has not defined what are the “identifiable structural, genetic, or functional characteristics” or “biological activity” that must be attained by a strain to be qualified as being “derivative”.
Claim 20 is rejected as being indefinite for the recitation of an “agent” that impairs the “signal transducer and activator of transcription 3 (STAT3) signaling pathway”. It is not clear what are the metes and bounds of “STATs signaling pathway” and “agent”.
It is not clear what are encompassed by the STAT3 signaling pathway. It is unclear whether a “STAT3 signaling pathway” could be referring to “classical STAT3 signaling pathway”, or could be further including other downstream or second effects, or “cross-talk” with other cellular processes. Furthermore, it is unclear whether the agent is directly or indirect acts on any component of the vaguely defined “STAT3 signaling pathway”.
Claims 21-22 are included in this rejection.
Response to Applicant’s Remarks:
Applicant argued that “The present specification provides clear and sufficient guidance as to the meaning and scope of the "STAT3 signalling pathway." As described in Section 4.3 of the specification, the STAT3 signalling pathway is a well-recognized and defined biological pathway, encompassing activation of STAT3 (e.g., by phosphorylation), its dimerization, nuclear translocation, and regulation of downstream gene expression” and that “A person skilled in the art would readily understand that this term includes both the canonical STAT3 activation cascade and its biologically relevant downstream signalling effects”. This argument has not been found persuasive. For example, Applicant has not defined what are the “biologically relevant” vs irrelevant.
Claims 8-9 are rejected as being indefinite for the recitation of phylogenetic descendant of the MRCA, and the reliance of defining MRCA by the phylogenetic classification is as defined by the GTDB (Parks et al., 2018) or, the phylogenetic classification is as defined in release 89 (r89) of the GTDB. However, Applicant has not provided an access to the node 23596 of the bac120 phylogenetic tree from the Genome Taxonomy Database (GTDB) release 89, or provided the algorithm and parameters for computing said node. Given the fact that the online database are subject to change, and/or that the computation results are highly dependent on the algorithm and parameters, the claimed MRCA is variable and not defined. Therefore, the metes and bounds of the claims are not clear.
Response to Applicant’s Remarks:
Applicant argued that “explicit reference to the GTDB dataset and release parameters used”. As discussed above, relying on a source that is subject to change is defective.
Claim Rejections - 35 USC § 112
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 11 is newly 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. Claim 11 is dependent on claim 1 which recites, as amended, lyophilized bacterial strain. Claim 11 states the bacterial strain is viable or non-viable which fails to further limit claim 1 since there are the only possible states the bacterial could be in. 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 § 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, 5, 10, 11, 13, 16-17, and 20-25 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.
The claims require the Intestinicoccus colisanans strain deposited under accession number V21/015887 or V21/015888. However, the specification lacks complete deposit information for the deposit of V21/015887 or V21/015888. It is not clear that strains possessing the identical properties of V21/015887 or V21/015888 are known and publicly available or can be reproducibly isolated from nature without undue experimentation.
Exact replication of a strain is an unpredictable event. Although applicant has provided a written description of a method for selecting the claimed strain, this method will not necessarily reproduce cells which are chemically and structurally identical to those claimed. Undue experimentation would be required to screen all of the possible species to obtain the claimed cells.
Because one skilled in the art could not be assured of the ability to practice the invention as claimed in the absence of the availability of the V21/015887 or V21/015888, a suitable deposit for patent purposes, evidence of public availability of the V21/015887 or V21/015888 strains or evidence of the reproducibility without undue experimentation is required.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required. As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claims 1, 5, 8-11, 13, 16-17, and 20-25 remain 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims broadly recite 1) the Intestinicoccus colisanans strain deposited under accession number V21/015887 or V21/015888, 2) derivatives of the deposited strains; 3) bacterial strain with a 16S rRNA sequence about 99% identical to any of SEQ ID NOs: 1, 2 or 7-10; and 4) phylogenetic descendant of the MRCA of I. colisanans and I. sp002305575.
The specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, "derivatives thereof and descendant of the MRCA of I. colisanans and I. sp002305575” alone is insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, applicant was not in possession of the claimed genus.
Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. The protein itself is required. See Fiers v. Revel, 25 USPQ 2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts., 18 USPQ2d 1016.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." Generally, in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See Enzo Biochem, 323 F.3d 956, 966, 63 USPQ2d 1609, 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004).
Response to Applicant’s Remarks:
The rejections are maintained for, at least, the reasons regarding “derivative” as discussed above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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