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 .
Claim Status
Claim listing filed on December 12, 2025 is pending. Claims 2-3 and 21 are canceled. Claims 1, 10, and 20 are amended. Claims 4-5 and 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions or species wherein the election was made without traverse in the response filed 05/05/2025. Claims 1 and 6-20 are examined upon their merits.
Withdrawn Rejections
Applicant’s cancelation of Claims 2-3 and 21 have rendered all previous rejections directed to these claims moot.
The rejection of Claims 1 and 6-20 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments. In particular, the at least one agent that enhances a biological activity of IL-13 is defined as an IL-13 peptide having an amino acid sequence that is at least 95% identical to SEQ ID NOs: 1, 2, or 3 (Claims 1 and 20) which overcomes in the indefinite functional language. The indefinite term “homolog” has been deleted. Claim 10 has been amended to comprise treating a subject having a C. difficile infection which no longer contradicts the claim limitations of Claim 1.
The rejection of Claims 1, 6-7, 10-15, and 20 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 28-31 of U.S. Patent No. 10,046,030 is withdrawn in view of Applicant’s amendments. The patented claims do not teach an IL-13 peptide having an amino acid sequence that is at least 95% identical to SEQ ID NOs: 1, 2, or 3 (instant Claims 1 and 20).
Claim Rejections - 35 USC § 112 (Maintained)
The rejection of Claims 1 and 6-20 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 is maintained. 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.
Applicant's arguments filed December 12, 2025 have been fully considered but they are not persuasive. Applicant argues that the Patent Office’s only basis to support a rejection of claim 3 as previously pending was the bare assertion that “95% identity to SEQ ID NO: 1 means that any combination of 7 amino acids could be inserted, deleted, or substituted (5% of 146 amino acids) which results in a genus with substantial variation.” Applicant believes this assertion is insufficient to support a rejection under the written description requirement. Examiner maintains that “95% identity to SEQ ID NOs: 1, 2, or 3” results in a genus of possible IL-13 peptides with substantial amino acid variation (as stated on record in the non-final filed 06/13/2025 and quoted by Applicant above). There are no examples of IL-13 peptide variants, nor is there any specific guidance on preferable mutations in the IL-13 peptides (as stated on record in the non-final filed 06/13/2025). When there is substantial variation within a claimed genus, one must describe a sufficient variety of species to reflect the variation within the genus (MPEP § 2163.05.Ib; emphasis added). The disclosure does not recite a single example of an IL-13 peptide variant or structure-to-function attributes that represent the amino acid variation for the entire genus of IL-13 variants claimed. It is not persuasive that the inventors were in possession of a method of treating or preventing C. difficile by administering a genus of IL-13 variants, because no IL-13 variants were evaluated. Applicant’s arguments have been considered but are not persuasive, and the rejection is maintained.
The rejection of Claims 1 and 6-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained because the specification, while being enabling for the IL-13 peptides comprising SEQ ID NOs: 1, 2, and 3, does not reasonably provide enablement for the genus of IL-13 peptides comprising at least 95% sequence identity to SEQ ID NOs: 1, 2, and 3. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Applicant's arguments filed December 12, 2025 have been fully considered but they are not persuasive. Applicant argues that Applicant need not have actually reduced the invention to practice in order to satisfy the enablement requirement; required experimentation may be complex but that does not necessarily make it undue; and the specification need not disclose what is well-known in the art. However, in all of these arguments, Applicant cited case law without distinctly and specifically pointing out the supposed errors in the Examiner’s action pertaining to the instant claims as is required in a complete response (MPEP § 714.02). Therefore, these arguments do not warrant a complete response and are not persuasive.
Applicant argues that the Patent Office’s only basis to support a rejection of claim 3 as previously pending was the bare assertion that “example species do not adequately represent the scope of agents that enhance IL-13 activity or the scope of IL-13 variants.” Applicant believes this assertion is insufficient to support a rejection under the enablement requirement. It is of record in the non-final rejection filed 06/13/2025 that the specification provides no guidance or direction for which amino acid residues may be inserted, deleted, or substituted in the IL-13 peptide variants such that the functional properties of the invention are preserved (treating or preventing C. difficile) (page 9). There are no examples of IL-13 peptide variants, nor is there any specific guidance on preferable mutations in the IL-13 peptide (as stated on record in the non-final rejection filed 06/13/2025). Because structure is essential to function, a person having ordinary skill in the art would have to perform further experimentation to make a representative number of IL-13 peptide variants (comprising 5% amino acid variation in SEQ ID NOs: 1, 2, and 3) and screen their functional characteristics (treating or preventing C. difficile) in order to practice the invention commensurate with the scope of the claims with a reasonable expectation of success. As of record in the non-final rejection filed 06/13/2025, this level of experimentation required for enabling guidance is considered undue. Applicant’s arguments have been considered but are not persuasive, and the rejection is maintained.
Claim Rejections - 35 USC § 102 (Maintained)
The rejection of Claims 1 and 6-20 under 35 U.S.C. 102(a)(1) as being anticipated by Petri WO 2016/057671 (of record) as evidenced by Cosgrave US 2013/0345322 (of record) is maintained.
Applicant's arguments filed December 12, 2025 have been fully considered but they are not persuasive. Applicant argues that amended Claims 1 and 20 recite “promoting CD206+ macrophage polarization” which is not taught by Petri. However, this amendment to Claim 1 does not change the methodological step of administering an IL-13 peptide to treat or prevent C. difficile. If IL-13 mechanistically treats and/or prevents C. difficile by promoting CD206+ macrophage polarization, then that is an inherent property of the method step of administering IL-13. This newly claimed mechanism of action does not alter the claimed method steps. When the structure recited in the reference is substantially identical to that of the claims (such as IL-13), the claimed properties or functions (such as promoting CD206+ macrophage polarization) are presumed to be inherent (MPEP § 2112.01-.02). A rejection under 35 U.S.C. 102 can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic (MPEP § 2112.III). Further, Examiner notes that the discovery of a previously unappreciated property of a prior art composition or a scientific explanation of the prior art’s functioning (such as a mechanism of action as in the instant claims), does not render the old composition patentably new to the discoverer (MPEP § 2112.I). Therefore, the amended claims are not patentably distinct from the teachings of Petri as evidenced by Cosgrave, because Petri anticipates administering IL-13 to treat or prevent C. difficile. Applicant’s arguments have been considered but are not persuasive, and the rejection is maintained.
Double Patenting (Maintained)
1. The provisional rejection of Claims 1, 6-7, 12-15, and 20 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 15, and 17-18 of copending Application No. 18/839,296 (of record) as evidenced by Cosgrave US 2013/0345322 (of record) is maintained.
Applicant's arguments filed December 12, 2025 have been fully considered but they are not persuasive. Applicant requests that this rejection be held in abeyance until claims are otherwise found allowable in the subject application or in the copending application. MPEP § 804.I.B.1 states: “As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance.” As no terminal disclaimer has been filed and no showing has been made that the copending claims are patentably distinct from the instant claims, the provisional double patenting rejection is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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