DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant's amendments filed 5/11/2026 have been entered. Claims 1, 2, 5-9, 11, 12, 16, 18, 19, 22, 23, 46, 47, 52, 60, 71, and 73 remain pending, and are subject to the election requirement dated 3/11/2026. References not included with this Office action can be found in a prior action.
Election/Restrictions
Applicant’s election without traverse of Group I, presently claims 1, 2, 5-9, 11, 12, 16, and 18, in the reply filed on 5/11/2026 is acknowledged.
Claims 19, 22, 23, 46, 47, 52, 60, 71, and 73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/11/2026.
Claims 1, 2, 5-9, 11, 12, 16, and 18 are under consideration on the merits.
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 7, 11, and 16 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.
The term “derivative” in claims 7 and 11 is a relative term which renders the claim indefinite. The term “derivative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Particularly, it is unclear what core elements/structure of L. reuteri ATCC PTA 6475 (for claim 7) or what core structure of dalazatide (for claim 11) is or is not required to be conserved in any “derivative” thereof as claimed. Correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 9, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mehlin et al. (US 2020/0262877; provided in the IDS dated 1/03/2024).
Mehlin teaches peptide compositions comprising potassium channel antagonists (claim 64 and [0106]) and in a separate embodiment envisions recombinantly expressing the peptides in a prokaryotic host cell ([0159]-[0160]), reading on claim 1, and the intended use of claim 9. Mehlin teaches probiotic or commensal bacteria to produce peptide to use in GI treatment ([0340]), reading on claim 2. Mehlin further teaches Kv1.3 peptide inhibitors ([0208]), alternatively reading on the peptides of claim 9. Mehlin teaches iberiotoxin and peptide derivatives thereof ([0146]), reading on claim 16. Mehlin teaches that the peptides are secreted into the culture media by the microorganisms ([0161], e.g. extracting the proteins/peptides from the microorganism culture medium), reading on claim 18.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to combine the potassium channel antagonist peptides with the recombinant microorganisms both taught by Mehlin into a single composition. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Mehlin expressly considers the combination. The skilled artisan would have been motivated to do so because the combination would be predictably advantageous to produce the potassium channel antagonist peptides from the recombinant microorganisms of Mehlin; see M.P.E.P. § 2143(I)(A).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mehlin as applied to claim 1 above, and further in view of Van Pijkeren et al. (US 10,376,563; Reference A).
The teachings of Mehlin are relied upon as set forth above. Mehlin further teaches treating subjects suffering from gastrointestinal disorder by administering an effective dosage of a potassium channel antagonist (Example 10), reading in-part on claims 5-7.
Regarding claim 5, Mehlin does not teach wherein the microorganism is Lactobacillus. Regarding claim 6, Mehlin does not teach wherein the microorganism is Lactobacillus reuteri. Regarding claim 7, Mehlin does not teach wherein the microorganism is Lactobacillus reuteri ATCC PTA 6475.
Van Pijkeren teaches L. reuteri comprising a recombinant gene and for introducing a polypeptide into the bloodstream of the subject by administering the microorganism to the gastrointestinal tract of the subjects (Abstract), reading on claims 5 and 6. Van Pijkeren teaches L. reuteri ATCC PTA 6475 and it’s derivative strain, Lactobacillus reuteri VPL1014, as exemplary bacterial strains (Column 13, lines 43-52 and Table 1) for expressing murine IL-22 (Column 16, line 39-64 and immediately under Table 3) and which secrete mIL-22 into the culture medium (Column 3, lines 31-37, Fig. 3, and Column 17, lines 40-49), reading on claims 5-7.
Regarding claims 5-7, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the generic microorganisms of Mehlin with the L. reuteri ATCC PTA 6475 or it’s derivative strain, Lactobacillus reuteri VPL1014, of Van Pijkeren. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Van Pijkeren and Mehlin are directed in-part towards treatment of gastrointestinal disorder in subjects in need thereof, and are both in-part directed towards recombinant microorganisms recombinantly expressing polypeptides or peptides for treating gastrointestinal disorder in subjects in need thereof. The skilled artisan would have been motivated to do so because Mehlin doesn’t particularly specify any species recombinant microorganism for expressing the potassium channel antagonists, and so the substitution of Van Pijkeren’s L. reuteri strains would be predictably advantageous when combined with Van Pijkeren’s methods to recombinantly express the potassium channel antagonists of Mehlin.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mehlin as applied to claim 1 above, and further in view of Van Pijkeren et al. (US 10,376,563; Reference A) and as evidenced by Wang et al. (PNAS (January 3rd, 2023), 120(2), 3 pages 1-9; provided in the IDS dated 3/02/2026).
L. reuteri strain LJ01 is plainly understood as synonymous for L. reuteri recombinantly expressing IL-22 as evidenced by Wang (see page 2, 1st paragraph under “Results”). Note that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference; see M.P.E.P. § 2112(II). As such, prior art L. reuteri strain(s) recombinantly expressing IL-22 are reasonably construed as reading on the L. reuteri strain LJ01 of claim 8 and absent any showing to the contrary.
The teachings of Mehlin are relied upon as set forth above. Mehlin further teaches treating subjects suffering from gastrointestinal disorder by administering an effective dosage of a potassium channel antagonist (Example 10), reading in-part on claim 8.
Regarding claim 8, Mehlin does not teach wherein the microorganism is Lactobacillus reuteri LJ01.
Van Pijkeren teaches L. reuteri comprising a recombinant gene and for introducing a polypeptide into the bloodstream of the subject by administering the microorganism to the gastrointestinal tract of the subjects (Abstract), reading on claim 8. Van Pijkeren teaches L. reuteri ATCC PTA 6475 and it’s derivative strain, Lactobacillus reuteri VPL1014, as exemplary bacterial strains (Column 13, lines 43-52 and Table 1) for expressing murine IL-22 (Column 16, line 39-64 and immediately under Table 3) and which secrete mIL-22 into the culture medium (Column 3, lines 31-37, Fig. 3, and Column 17, lines 40-49), reading on claim 8 as evidenced by Wang.
Regarding claim 8, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the generic microorganisms of Mehlin with the L. reuteri ATCC PTA 6475 or it’s derivative strain, Lactobacillus reuteri VPL1014, of Van Pijkeren as evidenced by Wang. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Van Pijkeren and Mehlin are directed in-part towards treatment of gastrointestinal disorder in subjects in need thereof, and are both in-part directed towards recombinant microorganisms recombinantly expressing polypeptides or peptides for treating gastrointestinal disorder in subjects in need thereof. The skilled artisan would have been motivated to do so because Mehlin doesn’t particularly specify any species recombinant microorganism for expressing the potassium channel antagonists, and so the substitution of Van Pijkeren’s L. reuteri strains as evidenced by Wang would be predictably advantageous when combined with Van Pijkeren’s methods to recombinantly express the potassium channel antagonists of Mehlin.
Regarding claim 8, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.". Once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to show the prior art product lacks the claimed function/property. See M.P.E.P. § 2112(V). In this case, the L. reuteri ATCC PTA 6475 or it’s derivative strain, Lactobacillus reuteri VPL1014, of Van Pijkeren is substantially identical to the claimed the L. reuteri strain LJ01 because they both recombinantly express IL-22 as evidenced by Wang. Therefore, the burden is shifted back to Applicant to show that Van Pijkeren’s L. reuteri strains do not necessarily or inherently possess the characteristics of the claimed L. reuteri strain.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mehlin as applied to claims 1 and 9 above, and further in view of Tarcha et al. (PLoS One (2017), 12(7), e0180762; Reference U).
The teachings of Mehlin are relied upon as set forth above. Mehlin further teaches specific Kv1.3 peptide inhibitors ([0208] and Tables 13 and 14), reading in-part on claim 11.
Regarding claim 11, Mehlin does not teach dalazatide.
Tarcha teaches that dalazatide is a specific inhibitor of the Kv1.3 potassium channel, and wherein Kv1.3 channels are expressed in activated memory T cells (Abstract), reading on claim 11.
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting dalazatide of Tarcha for the specific Kv1.3 peptide inhibitors of Mehlin because dalazatide and the peptides of Mehlin are both explicitly taught as being useful for THE SAME PURPOSE as Kv1.3 inhibitors. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mehlin as applied to claims 1 and 11 above, and further in view of Pennington et al. (Mar. Drugs (2015), 13, 529-542; provided in the IDS dated 3/02/2026).
The teachings of Mehlin are relied upon as set forth above. Mehlin further teaches specific Kv1.3 peptide inhibitors ([0208] and Tables 13 and 14), reading in-part on claims 11 and 12. Mehlin teaches that SEQ ID NO: 6, 19, and 39 inhibit 6 Kv1.1 and Kv1.3 channels, SEQ ID NO: 19 inhibits Kv1.1, Kv1.2, and Kv1.3 channels, and that SEQ ID NO: 2 inhibits Kv1.2 and Kv1.3 channels (Table 14), reading in-part on claims 11 and 12.
Regarding claims 11 and 12, Mehlin does not teach ShK-235.
Pennington teaches peptide analogs of ShK, wherein ShK is a Kv1.3 peptide inhibitor (Abstract). Pennington teaches ShK-235 comprises Q16K, M21I, and a C-terminal alanine addition (A-OH) relative to ShK (the 1st paragraph of subheading 2.1 and Figure 3), which improves the selectivity of ShK-235 for Kv1.3 over Kv1.1 (the paragraph spanning pages 533-534).
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the ShK-235 for the Kv1.3 inhibitor peptides of Mehlin. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Paddington and Mehlin are directed towards Kv1.3 inhibitor peptides. The skilled artisan would have been motivated to do so because Paddington teaches that ShK-235 is more selective for Kv1.3 channels versus Kv1.1 channels, and so the substitution would be predictably advantageous in Mehlin’s composition to yield a more selective Kv1.3 inhibitor peptide.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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