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
In view of the Reply filed 6/30/2026, claims 1, 18-31, and 68 are pending; claim 68 is newly added; claims 1 and 18-31 were amended; and claims 2-17 and 32-67 were cancelled. Claims 1, 18-31, and 68 are presently considered.
Election/Restriction
Applicant's election with traverse of Group I (methods, original claims 1-58 and 61-66; renumbered as claims 1-59 and 62-67 in Reply filed 10/28/2025) and the species of Example 8 (orally administered Compound A2 at 150-450 mg twice daily in human patients having ulcerative colitis) in the reply filed on 10/28/2025 was previously acknowledged. The traversal was fully considered but not found persuasive for reasons of record (see, e.g., Action mailed 12/31/2025 at 2-3), and the requirement was made FINAL.
Amended (or new) claims 1, 18-31, and 68 are understood to continue reading upon the originally elected species.
The originally elected species has been understood as follows: The elected species is Example 8 (see, e.g., Spec. filed 6/22/2022 at 98-101 at ¶¶[0321]-[0332]), which is understood to be a prophetic example corresponding to a planned clinical trial, wherein human patients having moderate to severe ulcerative colitis will be orally administered via tablet containing Compound A at 150 mg or 450 mg1, twice daily (BID). “Compound A” was not identified by the Applicant in the response filed 10/28/2025, but was identified by the Examiner (see Requirement mailed 4/30/2025 at footnote 2), as understood to be to be pictured and described at ¶[0198] of the Specification filed 6/22/2022, and contain SEQ ID NO: 5 linked via a DIG (diglycolic acid) linker to a second SEQ ID NO: 5 sequence:
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Applicant identified that the originally elected species read upon claims 1, 7-8, 15-16, 18-40, 46-47, 54-55, 57-59, and 62-67 as filed 10/28/2025 (see Reply filed 10/28/2025 at 22 at last three ¶¶).
Following extensive search and examination of the amended and new claims with respect to the originally elected species, the originally elected species has again been deemed obvious and/or anticipated by the prior art, as applied below. Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
Accordingly, claims 1, 18-31, and 68 are presently considered.
Claims 1, 18-31, and 68 as filed 6/30/2026 are presently considered.
Priority
The priority claim to Provisional 62/959,854 as filed 1/10/2020 is acknowledged.
Information Disclosure Statement
No IDS was filed 6/30/2026.
Claim Objections
Claim 30 is objected to because of the following informalities:
Claim 30 utilizes periods in the units “ng.h/mL”. Per MPEP § 608.01(m), “[e]ach claim . . . ends with a period” and [p]eriods may not be used elsewhere in the claims except for abbreviations”. Here, “ng.h/mL” is not an abbreviation and are therefore its usage is improper. Applicant may address this issue by, for example, writing the units out completely.
Appropriate correction is required.
Withdrawn Claim Rejections
The rejection of claims 18 and 30-34 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn as moot in view of the amendments to claims 18 and 30-31, and the cancellation of claims 32-34.
The rejection of claims 32-34 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 withdrawn as moot in view of the cancellation of claims 32-34.
New or Revised Claim Rejections Necessitated by Applicant Amendment
Claim Rejections - 35 USC § 112(b)
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 23-27, 30-31, and 68 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.
Claims 23-27, 30-31, and 68 are rejected as indefinite. Examiner notes that, although amended claims 23-27, 30-31, and 68 appear to differ from amended claim 1 only by the recitation of a clause reciting hoped-for and desired outcomes that would presumably necessarily and inherently occur upon performance of the positively recited method steps set forth in the body of amended claim 1, it is unclear on the instant record if the clauses recited at instant claims 23-27, 30-31, or 68 are meant to be functional limitations that correspond to some narrower subgenus of methods in a nuanced manner (compare MPEP 2111.02(II) and 2111.04(I) with MPEP 2173.05(g)). For examination purposes, if such clauses merely recite expected, predicted, and hoped-for results obtained upon performance of the active method steps set forth in the body of claim 1, then the claims do not further limit the scope of claim 1 (see, e.g., MPEP 2111.04(I)); alternatively, if such clauses are intended to be functional limitations, then the claims are indefinite per MPEP 2173.05(g) because the clauses do not actually correspond to any structure/function teachings of record commensurate in scope with amended claim 1, which would be reasonably inferred to further limit the structure, patient population, administration route, dosage, and dosage frequency already recited at amended claim 1. Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. . .
Here, if the clauses at amended claims 23-27, 30-31, and 68 are intended to be functional limitations, then the claims merely recite a description of functions or results to be achieved by the invention rather than a description of the actual steps and structures required and capable of achieving the desired functions; therefore the claims are indefinite per MPEP § 2173.05(g). This is reasonable because MPEP § 2173 identifies that the primary purpose of the requirement is to inform the public of the boundaries of what constitutes infringement of the patent, but here it is unclear what species within the scope of claim 1 do or do not infringe upon the scope of amended claims 23-27, 30-31, and 68. Notably, the courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Accordingly, if amended claims 23-27, 30-31, and 68 are assumed to recite further limiting functional limitations consistent with the requirements of 35 USC 112(d), then it is unclear what species within the scope of claim 1 do or do not satisfy the functional limitations of claims 23-27, 30-31, and 68, and because an artisan would be unable to identify infringing from non-infringing species, claims 23-27, 30-31, and 68 are rejected as indefinite. For purposes of examination in view of the prior art, it is reasonably assumed that the clauses at amended claims 23-27, 30-31, and 68 merely recite hoped-for, predicted, and expected results, that are understood to be fully satisfied by the successful completion of the positively recited method steps set forth at instant claim 1 (i.e., amended claims 23-27, 30-31, and 68 presumably do not further limit the scope of amended claim 1). Accordingly, such claims have been alternatively rejected under 35 USC 112(d), below.
Accordingly, claims 23-27, 30-31, and 68 are rejected as indefinite.
Claim Rejections - 35 USC § 112(d)
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.
Claims 18, 23-27, 30-31, and 68 are 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.
Amended claim 18 depends from amended claim 1. Claim 18 is understood to now recite and claim the same identical subject matter as set forth at amended claim 1 because claim 1 recites the range “about 100 mg to about 500 mg”, and amended claim 18 now also recites same range, but in piecemeal fashion that covers the same exact range (e.g., “about 100, about 112.5 mg, ….about 487.5 mg, or about 500.0 mg”). Given the meaning of “about” (e.g., ~±20%), claims 1 and 18 appear to cover the same, identical subject matter. Accordingly, claim 18 is rejected under 35 USC 112(d) for failing to further limit the subject matter of the claim upon which it depends.
Amended claims 23-27, 30-31, and 68 all depend from amended claim 12, However, amended claim 1 is understood to be limited to treatments using the single compound present in the originally elected species; therefore, the successful completion of the positively recited steps of amended claim 1 is reasonably understood to necessarily and inherently result in the outcomes recited at claims 23-27, 30-31, and 68. This is reasonable because, per MPEP 2111.04(I), “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and MPEP 2111.04(I) further explains that courts have held that a "‘clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Here, claims 23-27, 30-31, and 68 do not recite additional steps, structural limitations, or “hand-of-man” limitations beyond what is already recited at instant claim 1 (see, e.g., MPEP 2111.04(I)), because the recited clauses at each claim do not correspond to any particular structure/function relationship of record that imparts any step- or structure-related limitations beyond those recited at amended claim 1 and present in the originally elected species. Therefore, if the same compound and steps are performed, it is reasonably inferred that such steps would necessarily result in the same outcomes because a chemical composition and its properties are inseparable. Accordingly, claims 23-27, 30-31, and 68 appear to not further limit the scope of instant claim 1 (see, e.g., MPEP 2111.04), and are therefore these claims are rejected under 35 USC 112(d) for failing to further limit the subject matter of the claim upon which it depends. If Applicant disagrees, and alleges that the clauses claims 23-27, 30-31, and 68 are functional limitations that further limit the scope of claim 1, and therefore satisfy 35 USC 112(d), Applicant should explicitly identify which species of methods within the scope of claim 1 are not enabled at (and therefore excluded by the language of) each dependent claim. This should be coupled with identification of a clear structure/function relationship set forth in the originally filed disclosure.
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 § 103
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.
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, 18-31, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over US 10059744 (Aug. 28, 2018; cited in previous action).
Claim interpretation: The applicable claim interpretation has been set forth in preceding rejections, and those interpretations are incorporated into the instant rejection. “About” is understood to mean ±20%. Additional interpretations are set forth below.
Regarding instant claims 1, 18-31, and 68, and the treatment of ulcerative colitis by orally administering dimeric α4β7 integrin antagonist structure comprising two peptides of instant SEQ ID NO: 5 dimerized by a linker moiety bound to the D-lys residues and a diglycolic acid (DIG), wherein the two peptides comprise a thioether bond between the 2-methylbenzoyl and the Pen residue: US’744 claims and discloses methods of treating subjects for inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease (see, e.g., US’744 at claims 28-30), by orally administering (see, e.g., US’744 at claims 25-27 and 31) pharmaceutical formulations comprising peptide dimer compounds comprising two peptides, each comprising the sequences of 2-methylbenzoyl-(N-Me-Arg)-Ser-Asp-Thr-Leu-Pen-Phe(4-tBu)-(β-homo-Glu)-(D-Lys)-OH (see, e.g., US’744 at claims 9, 16, and SEQ ID NOs: 270 and 223), and wherein the two peptide comprise a thioether bond between the 2-methylbenzyoyl and the Pen residues, and wherein the two peptides are linked by a linker moiety bound to the D-lys amino acids of the two peptides, and wherein the linker moiety is diglycolic acid (DIG) (see, e.g., US’744 at claims 9, 16, and SEQ ID NOs: 270 and 223, Table 5 at cols. 91-92 at SEQ ID NO 223; Table 7 at cols. 105-106 at SEQ ID NO: 223 and co. 102 at lines 2-8). Accordingly, the prior art is understood to teach and disclose methods of treating ulcerative colitis by orally administering the same compound as presently claimed. Regarding instant claim 1 and route of administration, US’744 claims and discloses methods of treating subjects for inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease (see, e.g., US’744 at claims 28-30), by orally administering such compounds (see, e.g., US’744 at claims 25-27 and 31; see also US’744 at col. 6 at lines 45-50, col. 74 at lines 49-66, col. 76 at lines 24-60). Regarding instant claim 1, 28-29, and the treatment of IBD, including ulcerative colitis and Crohn’s disease, US’744 claims and discloses methods of treating subjects for inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease (see, e.g., US’744 at claims 28-30), by orally administering such compounds (see, e.g., US’744 at claims 25-27 and 31; see also US’744 at col. 75 at lines 25-40, col 78 at lines 37-45, claims 28-31). Regarding claims 1, 22, and a pharmaceutically acceptable salt that is an acetate salt, US’744 claims and discloses methods of treating subjects for inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease (see, e.g., US’744 at claims 28-30), by orally administering such compounds (see, e.g., US’744 at claims 25-27 and 31; see also US’744 at col. 6 at lines 45-50, col. 74 at lines 49-66, col. 76 at lines 24-60), wherein the pharmaceutically acceptable salt may be an acetate salt (see, e.g., US’744 at col. 11 at lines 44-60, claims 18-19).
The difference between the primary reference and the instant claims is as follows: US’744 does not claim or explicitly exemplify a method wherein the dimeric α4β7 integrin antagonist structure identified above was administered to patients, twice daily, at “about 150 mg” or “about 450 mg” (see, e.g., claim 1, 18-31, 68, and originally elected species).
Regarding instant claims 1, 18-31, 68, and administration of “about 100 mg to about 500 mg”, “about 150 mg”, or “about 450 mg[2]” of an dimeric α4β7 integrin antagonist, US’744 teaches and discloses that the compounds and methods could be predictably practiced by administering to humans “for example, from 0.0001 to 300 mg/kg body weight daily and more usually 1 to 300 mg/kg body weight” (see, e.g., US’744 at col. 80 at lines 40-46), wherein administration could be “once daily” or “twice daily” (see, e.g., US’744 at col. 6 at lines 20-35, col. 78 at lines 13-25). The exemplified dosage range of “1 to 300 mg/kg” in “mg/kg” is reasonably inferred to overlap with the instantly claimed amounts (“mg”) because adult humans may weigh at least between 60-100 kg, which means for example, that for a 75 kg adult, a 2 mg/kg to 6 mg/kg would necessarily yield a dosage of 150 mg to 450 mg as presently claimed once daily; likewise, 4 mg/kg to 12 mg/kg, for a 75 kg adult human, would necessarily yield a suitable dosages of 150 mg to 450 mg for twice daily administration, as presently claimed. Accordingly, it is clear that the prior art range overlaps in scope with the instantly claimed dosages. Accordingly, the prior art teaches and directs artisans to use the same or overlapping dosage and dosage frequencies as instantly claimed (see, e.g., MPEP § 2144.05(I), explaining that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”).
Regarding instant amended claims 23-27, 30-31, and 68, the successful completion of the positively recited steps set forth in the body of amended claim 1 is reasonably understood to necessarily and inherently result in the outcomes recited at claims 23-27, 30-31, and 68. This is reasonable because, per MPEP 2111.04(I), “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and MPEP 2111.04(I) further explains that courts have held that a "‘clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Here, claims 23-27, 30-31, and 68 do not recite additional steps, structural limitations, or “hand-of-man” limitations beyond what is already recited at instant claim 1 (see, e.g., MPEP 2111.04(I)), because the recited clauses at each claim do not correspond to any particular structure/function relationship of record that imparts any step- or structure-related limitations beyond those recited at amended claim 1. Accordingly, amended claims 23-27, 30-31, and 68 are rejected for the reasons applied to amended claim 1, above. If Applicant disagrees, Applicant should explicitly identify what species of method within the scope of amended claim 1 is not fully enabled to satisfy the limitations set forth at amended claims 23-27, 30-31, and 68.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason: It would have been obvious to treat IBD, such as ulcerative colitis, exactly as claimed and suggested by the prior art, namely by administering a known compound via a known administration route (oral, BID) to a known patient population (ulcerative colitis) at the concentration(s) explicitly suggested by the prior art (i.e., 1 to 300 mg/kg body weight) because the prior art provides an explicit teaching and suggestion to treat patients having the same diseases by orally administering the same compounds (see, e.g., MPEP § 2143(I)(G)), and the prior art explicitly directs artisans to use an overlapping concentration range (see, e.g., MPEP § 2144.05(I), explaining that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”); accordingly, the prior art elements would merely perform their art-recognized functions to predictably and expectedly yield the treatment of patients having ulcerative colitis, exactly as taught and suggested by the prior art.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the art to utilize a known compound in a known method for which it is taught, by a known administration route, within a known concentration range, and at a known dosage frequency, to achieve the exact treatment and outcome taught by the prior art.
Accordingly, claims 1, 18-31, and 68 are rejected.
Claims 1, 18-31, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over US9714270B2 (Jul. 25, 2017; cited in previous action).
Claim interpretation: The applicable claim interpretation has been set forth in preceding rejections, and those interpretations are incorporated into the instant rejection. “About” is understood to mean ±20%. Additional interpretations are set forth below.
The primary reference pertains to the treatment of ulcerative colitis by administering a dimeric α4β7 integrin antagonist to patients (see, e.g., US’270 at title, abs, claims 1 and 19-20).
Regarding instant claims 1, 18-31, and 68, and twice daily oral administration of a compound for the treatment of ulcerative colitis, US’270 claims methods of treating a subject in need of treatment for IBD, ulcerative colitis, and Crohn’s disease by “providing” an “effective amount” of a peptide within the scope of claim 1 (see, e.g., US’270 at claims 1 and 20). The term “providing” is understood to encompass twice daily oral administration (see, e.g., US’270 at claim 20, col. 2 at lines 40-45, col. 6 at lines 37 to 45, col. 71 at line 54 to col. 72 at line 5, col. 73 at lines 29-31, col. 75 at lines 17-30). Regarding instant claims 1, 18-31, and 68, and the treatment of ulcerative colitis by orally administering dimeric α4β7 integrin antagonist structure comprising two peptides of instant SEQ ID NO: 5 dimerized by a linker moiety bound to the D-lys residues and a diglycolic acid (DIG), wherein the two peptides comprise a thioether bond between the 2-methylbenzoyl and the Pen residue: US’270 claims methods of treating a subject in need of treatment for ulcerative colitis (see, e.g., US’270 at claims 1 and 20), by administering compounds of claim 1 (see id), which includes dimeric α4β7 integrin antagonist peptides linked by a diglycolic acid (DIG) (see, e.g., US’270 at claims 1, 5, 10-19), which would be readily understood to include exemplified embodiments such as SEQ ID NO: 223 (see, e.g., US’270 at Table 5 at Col. 87-88, showing illustrative thioether dimer SEQ ID NO: 223; see also US’270 at US’270 at Table 7 at col. 101-102, showing “*”, which denotes highest assayed potency of “<25 nM” as explained at col. 96 at lines 20-28, for both Cell-Adhesion of α4β7 and PBMC IC50), wherein SEQ ID NO: 223 is understood to be a dimer comprising the sequence of 2-methylbenzoyl-(N-Me-Arg)-Ser-Asp-Thr-Leu-Pen-Phe(4-tBu)-(β-homo-Glu)-(D-Lys)-OH (see, e.g., US’270 at Table 5 at col. 87-88, showing structure of SEQ ID NO: 223), wherein the dimer is formed by a linkage between each D-Lys residue via a diglycolic acid (DIG) linker, and wherein the two peptides comprise a thioether bond between the 2-methylbenzoyl and the Pen residue (see, e.g., US’270 at Table 5 at col. 87-88, col. 319-322 at description of SEQ ID NO: 223 at field codes <210> to <400>; see also US’270 at exemplifications at Figs. 1-2 and 5, exemplifying general construction and structures of dimers conjugated via a DIG linker and having thioether bonds between the 2-methylbenzoyl and Pen residues). Regarding claims 1, 22, and a pharmaceutically acceptable salt that is an acetate salt, US’270 directs artisans to utilize acetate salts (see, e.g., US’270 at col. 11 at lines 43-60, claims 1, 5, 10-19).
The difference between the primary reference and the instant claims is as follows: the primary reference does not claim or explicitly exemplify a method wherein the dimeric α4β7 integrin antagonist structure identified above was administered at “about 150 mg” or “about 450 mg” (see, e.g., claim 1, 18-20, 32, and originally elected species).
Regarding instant claims 1, 18-31, and 68, and administration of “about 100 mg to about 500 mg”, or “about 150 mg” of an dimeric α4β7 integrin antagonist, US’270 claims methods of treating a subject in need of treatment for IBD, ulcerative colitis, and Crohn’s disease by “providing” an “effective amount” of a peptide within the scope of claim 1 (see, e.g., US’270 at claims 1 and 20). The term “effective amount” is understood to include at least the exemplified dosage range of “1 to 300 mg/kg body weight” (see, e.g., US’270 at col. 77 at lines 44-50). The exemplified dosage range of “1 to 300 mg/kg” in “mg/kg” is reasonably inferred to overlap with the instantly claimed amounts (“mg”) because adult humans may weigh at least between 60-100 kg, which means for example, that for a 75 kg adult, a 2 mg/kg to 6 mg/kg would necessarily yield a dosage of 150 mg to 450 mg as presently claimed once daily; likewise, 4 mg/kg to 12 mg/kg, for a 75 kg adult human, would necessarily yield a suitable dosages of 150 mg to 450 mg for twice daily administration, as presently claimed. Accordingly, it is clear that the prior art range overlaps in scope with the instantly claimed dosages (see, e.g., MPEP § 2144.05(I), explaining that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”).
Regarding instant amended claims 23-27, 30-31, and 68, the successful completion of the positively recited steps set forth in the body of amended claim 1 is reasonably understood to necessarily and inherently result in the outcomes recited at claims 23-27, 30-31, and 68. This is reasonable because, per MPEP 2111.04(I), “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and MPEP 2111.04(I) further explains that courts have held that a "‘clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Here, claims 23-27, 30-31, and 68 do not recite additional steps, structural limitations, or “hand-of-man” limitations beyond what is already recited at instant claim 1 (see, e.g., MPEP 2111.04(I)), because the recited clauses at each claim do not correspond to any particular structure/function relationship of record that imparts any step- or structure-related limitations beyond those recited at amended claim 1. Accordingly, amended claims 23-27, 30-31, and 68 are rejected for the reasons applied to amended claim 1, above. If Applicant disagrees, Applicant should explicitly identify what species of method within the scope of amended claim 1 is not fully enabled to satisfy the limitations set forth at amended claims 23-27, 30-31, and 68.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason: It would have been obvious to treat IBD, such as ulcerative colitis, exactly as claimed and suggested by the prior art, namely by administering a known compound via a known administration route (oral, BID) to a known patient population (ulcerative colitis) at the concentration(s) explicitly suggested by the prior art (i.e., 1 to 300 mg/kg body weight) because the prior art provides an explicit teaching and suggestion to treat patients having the same diseases by orally administering the same compounds (see, e.g., MPEP § 2143(I)(G)), and the prior art explicitly directs artisans to use an overlapping concentration range (see, e.g., MPEP § 2144.05(I), explaining that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”); accordingly, the prior art elements would merely perform their art-recognized functions to predictably and expectedly yield the treatment of patients having ulcerative colitis, exactly as taught and suggested by the prior art.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the art to utilize a known compound in a known method for which it is taught, by a known administration route, within a known concentration range, and at a known dosage frequency, to achieve the exact treatment and outcome taught by the prior art.
Accordingly, claims 1, 18-31, and 68 are rejected.
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, 18-31, and 68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 17-20 of U.S. Patent No. 9714270B2 (Jul. 25, 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1, 18-31, and 68 are directed to methods of treating subjects for IBD (e.g., ulcerative colitis and Crohn’s disease) by orally administering a dimeric α4β7 integrin antagonist or pharmaceutically acceptable salt thereof at “about 150 mg” or “about 450 mg” (see, e.g., instant claims 1, 18-31, and 68). However, US’270 claims methods of treating a subject in need of treatment for IBD, ulcerative colitis, and Crohn’s disease by “providing” an “effective amount” of a peptide within the scope of claim 1 (see, e.g., US’270 at claims 1, 5, 17-20).
The difference between the issued claims and the instant claims are as follows: The issued claims do not explicitly (i) recite oral administration, once or twice daily, using 150 mg or 450 mg dosages, as required by claims 1, 18-20 and 32-34 or (ii) the dimeric α4β7 integrin antagonists specifically set forth at instant claims 1, 7-8, and 15-16.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, claim 20 recites “providing”, which is understood and interpreted to fully encompass twice daily oral administration (see, e.g., US’270 at claim 20, col. 2 at lines 40-45, col. 6 at lines 37 to 45, col. 71 at line 54 to col. 72 at line 5, col. 73 at lines 29-31, col. 75 at lines 17-30). Furthermore, claim 1 recites “pharmaceutically acceptable salt thereof”, which is defined to include acetate salts (see, e.g., US’270 at col. 11 at lines 43-60, claims 1, 5, 10-19).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, claim 20 recites and requires providing an “effective amount” (see, e.g., US’270 at claim 20). The phrase “effective amount” is understood to include at least the exemplified dosage range of “1 to 300 mg/kg body weight” (see, e.g., US’270 at col. 80 at lines 40-46). The exemplified dosage range of “1 to 300 mg/kg” in “mg/kg” is reasonably inferred to overlap with the instantly claimed amounts (“mg”) because adult humans may weigh at least between 60-100 kg, which means for example, that for a 75 kg adult, a 2 mg/kg to 6 mg/kg would necessarily yield a dosage of 150 mg to 450 mg as presently claimed once daily; likewise, 4 mg/kg to 12 mg/kg, for a 75 kg adult human, would necessarily yield a suitable dosages of 150 mg to 450 mg for twice daily administration, as presently claimed. Accordingly, it is clear that the prior art range overlaps in scope with the instantly claimed dosages (see, e.g., MPEP § 2144.05(I), explaining that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”).
Regarding instant claims 1, 18-31, and 68, the dimeric α4β7 integrin antagonists, claims 1, 5, 17-19 of US’270 define a genus of compounds that overlap in scope with the instant claims 1, 7-8, and 15-16 as explained below. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim and to identify obvious variants of a claimed invention (see, e.g., MPEP § 804(II)(B)(1)). Here, US’270 at claim 20 recites methods of administering any compounds within the scope of claim 1 (see, e.g., US’270 at claims 1 and 20), which would be readily understood to include at least dimeric α4β7 integrin antagonist peptides linked by a diglycolic acid (DIG) (see, e.g., US’270 at claims 1, 5, 10-19), including the exemplified embodiments such as SEQ ID NO: 223 (see, e.g., US’270 at Table 5 at Col. 87-88, showing illustrative thioether dimer SEQ ID NO: 223; see also US’270 at US’270 at Table 7 at col. 101-102, showing “*”, which denotes highest assayed potency of “<25 nM” as explained at col. 96 at lines 20-28, for both Cell-Adhesion of α4β7 and PBMC IC50), wherein SEQ ID NO: 223 is understood to be a dimer comprising the sequence of 2-methylbenzoyl-(N-Me-Arg)-Ser-Asp-Thr-Leu-Pen-Phe(4-tBu)-(β-homo-Glu)-(D-Lys)-OH (see, e.g., US’270 at Table 5 at col. 87-88, showing structure of SEQ ID NO: 223), wherein the dimer is formed by a linkage between each D-Lys residue via a diglycolic acid (DIG) linker, and wherein the two peptides comprise a thioether bond between the 2-methylbenzoyl and the Pen residue (see, e.g., US’270 at Table 5 at col. 87-88, col. 319-322 at description of SEQ ID NO: 223 at field codes <210> to <400>; see also US’270 at exemplifications at Figs. 1-2 and 5, exemplifying general construction and structures of dimers conjugated via a DIG linker and having thioether bonds between the 2-methylbenzoyl and Pen residues). The structure corresponding to SEQ ID NO: 223 described above is identical to the structure of the originally elected species.
Regarding instant amended claims 23-27, 30-31, and 68, the successful completion of the positively recited steps set forth in the body of amended claim 1 is reasonably understood to necessarily and inherently result in the outcomes recited at claims 23-27, 30-31, and 68. This is reasonable because, per MPEP 2111.04(I), “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and MPEP 2111.04(I) further explains that courts have held that a "‘clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Here, claims 23-27, 30-31, and 68 do not recite additional steps, structural limitations, or “hand-of-man” limitations beyond what is already recited at instant claim 1 (see, e.g., MPEP 2111.04(I)), because the recited clauses at each claim do not correspond to any particular structure/function relationship of record that imparts any step- or structure-related limitations beyond those recited at amended claim 1. Accordingly, amended claims 23-27, 30-31, and 68 are rejected for the reasons applied to amended claim 1, above. If Applicant disagrees, Applicant should explicitly identify what species of method within the scope of amended claim 1 is not fully enabled to satisfy the limitations set forth at amended claims 23-27, 30-31, and 68.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim a substantially and materially overlapping method of treating IBD, wherein both claim sets read upon species of administering the same compounds to the same patient population at the same (or overlapping) dosage, via the same (or obvious) route of administration to achieve the same predicted and expected outcomes (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are understood to be directed to obvious variants of the issued claims because it is well-within the ordinary skill in the art to practice a known, issued, and claimed method using known compounds at known concentrations, wherein administration is via known routes (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(G), 2144.05(I).
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to a subgenus of methods as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1, 18-31, and 68 are rejected.
Claims 1, 18-31, and 68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10059744 (Aug. 28, 2018)
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1, 18-31, and 68 are directed to methods of treating subjects for IBD (e.g., ulcerative colitis and Crohn’s disease) by orally administering a dimeric α4β7 integrin antagonist at “about 150 mg” or “about 450 mg” (see, e.g., instant claims 1, 18-31, and 68). However, US’744 claims methods of treating a subject in need of treatment for IBD, ulcerative colitis, and Crohn’s disease by orally administering an “effective amount” of a dimeric peptide α4β7 integrin antagonist (see, e.g., US’744 at claims 1, 9, 19, 28-31), wherein the dimeric peptide α4β7 integrin antagonist is a dimer formed from SEQ ID NO: 223 (i.e., 2-methylbenzoyl-(N-Me-Arg)-Ser-Asp-Thr-Leu-Pen-Phe(4-tBu)-(β-homo-Glu)-(D-Lys)-OH), wherein the two peptides are linked by a linker moiety bound to the D-lys amino acids of the two peptides, wherein the linker is diglycolic acid (DIG), and wherein each peptide comprises a thioether bond between the 2-methylbenzyoyl and the Pen residues (see, e.g., US’744 at claims 1-23; see esp. claim 23 referring to SEQ ID NO: 223). Regarding acetate salts, US’744 explicitly claims acetate salts (see, e.g., US’744 at claim 18). In sum, the issued claims of US’744 claim methods of treating the same diseases by orally administering the same dimeric α4β7 integrin antagonist present in the originally elected species.
The difference between the issued claims and the instant claims are as follows: The issued claims do not explicitly recite once or twice daily administration using 150 mg or 450 mg dosages.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, claim 28 recites “providing”, which is understood and interpreted to fully encompass twice daily oral administration (see, e.g., US’744 at claim 28, col. 6 at lines 20-50, col. 74 at lines 60-66, col. 78 at lines 15-25).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, claim 28 recites and requires providing an “effective amount” (see, e.g., US’744 at claim 28). The phrase “effective amount” is understood to include at least the exemplified dosage range of “1 to 300 mg/kg body weight” (see, e.g., US’744 at col. 80 at lines 40-46). The exemplified dosage range of “1 to 300 mg/kg” in “mg/kg” is reasonably inferred to overlap with the instantly claimed amounts (“mg”) because adult humans may weigh at least between 60-100 kg, which means for example, that for a 75 kg adult, a 2 mg/kg to 6 mg/kg would necessarily yield a dosage of 150 mg to 450 mg as presently claimed once daily; likewise, 4 mg/kg to 12 mg/kg, for a 75 kg adult human, would necessarily yield a suitable dosages of 150 mg to 450 mg for twice daily administration, as presently claimed. Accordingly, it is clear that the prior art range overlaps in scope with the instantly claimed dosages (see, e.g., MPEP § 2144.05(I), explaining that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”).
Regarding instant amended claims 23-27, 30-31, and 68, the successful completion of the positively recited steps set forth in the body of amended claim 1 is reasonably understood to necessarily and inherently result in the outcomes recited at claims 23-27, 30-31, and 68. This is reasonable because, per MPEP 2111.04(I), “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and MPEP 2111.04(I) further explains that courts have held that a "‘clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Here, claims 23-27, 30-31, and 68 do not recite additional steps, structural limitations, or “hand-of-man” limitations beyond what is already recited at instant claim 1 (see, e.g., MPEP 2111.04(I)), because the recited clauses at each claim do not correspond to any particular structure/function relationship of record that imparts any step- or structure-related limitations beyond those recited at amended claim 1. Accordingly, amended claims 23-27, 30-31, and 68 are rejected for the reasons applied to amended claim 1, above. If Applicant disagrees, Applicant should explicitly identify what species of method within the scope of amended claim 1 is not fully enabled to satisfy the limitations set forth at amended claims 23-27, 30-31, and 68.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim a substantially and materially overlapping method of treating IBD, wherein both claim sets read upon species of administering the same compounds to the same patient population at the same (or overlapping) dosage, via the same (or obvious) route of administration to achieve the same predicted and expected outcomes (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are understood to be directed to obvious variants of the issued claims because it is well-within the ordinary skill in the art to practice a known, issued, and claimed method using known compounds at known concentrations, wherein administration is via known routes (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(G), 2144.05(I).
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to a subgenus of methods as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1, 18-31, and 68 are rejected.
Claims 1, 18-31, and 68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,840,581 (Dec. 12, 2023; cited in previous action).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1, 18-31, and 68 are directed to methods of treating subjects for IBD (e.g., ulcerative colitis and Crohn’s disease) by orally administering a dimeric α4β7 integrin antagonist at “about 150 mg” or “about 450 mg” (see, e.g., instant claims 1, 18-31, and 68). However, US’581 claims methods of treating a subject in need of treatment for IBD, ulcerative colitis, and Crohn’s disease (see US’581 at claims 1 and 9-16) by “providing” or orally administering (see US’581 at claims 1, 7, 17) an “effective amount” of a dimeric peptide α4β7 integrin antagonist (see, e.g., US’581 at claims 1), wherein the dimeric peptide α4β7 integrin antagonist is a dimer formed from SEQ ID NO: 223 (i.e., 2-methylbenzoyl-(N-Me-Arg)-Ser-Asp-Thr-Leu-Pen-Phe(4-tBu)-(β-homo-Glu)-(D-Lys)-OH), wherein the two peptides are linked by a linker moiety bound to the D-lys amino acids of the two peptides, wherein the linker is diglycolic acid (DIG), and wherein each peptide comprises a thioether bond between the 2-methylbenzyoyl and the Pen residues (see, e.g., US’581 at claims 1-5; see esp. claims 4-5 referring to SEQ ID NO: 223). Regarding acetate salts, US’581 explicitly claimed acetate salts (see, e.g., US’581 at claim 8). In sum, the issued claims of US’581 claim methods of treating the same diseases by “providing” or orally administering the same dimeric α4β7 integrin antagonist present in the originally elected species.
The difference between the issued claims and the instant claims are as follows: The issued claims do not explicitly require oral administration of SEQ ID NO: 223, once or twice daily, using 150 mg or 450 mg dosages, as required by instant claims 1, 18-31, and 68.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, claim 1 recites “providing”, which is understood and interpreted to fully encompass twice daily oral administration (see, e.g., US’581 at col. 6 at lines 5-60, col. 76 at lines 35-46, col. 80 at lines 50-55).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, claim 20 recites and requires providing an “effective amount” (see, e.g., US’581 at claim 1). The phrase “effective amount” is understood to include at least the exemplified dosage range of “1 to 300 mg/kg body weight” (see, e.g., US’581 at col. 80 at lines 50-55).The exemplified dosage range of “1 to 300 mg/kg” in “mg/kg” is reasonably inferred to overlap with the instantly claimed amounts (“mg”) because adult humans may weigh at least between 60-100 kg, which means for example, that for a 75 kg adult, a 2 mg/kg to 6 mg/kg would necessarily yield a dosage of 150 mg to 450 mg as presently claimed once daily; likewise, 4 mg/kg to 12 mg/kg, for a 75 kg adult human, would necessarily yield a suitable dosages of 150 mg to 450 mg for twice daily administration, as presently claimed. Accordingly, it is clear that the prior art range overlaps in scope with the instantly claimed dosages (see, e.g., MPEP § 2144.05(I), explaining that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”).
Regarding instant amended claims 23-27, 30-31, and 68, the successful completion of the positively recited steps set forth in the body of amended claim 1 is reasonably understood to necessarily and inherently result in the outcomes recited at claims 23-27, 30-31, and 68. This is reasonable because, per MPEP 2111.04(I), “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and MPEP 2111.04(I) further explains that courts have held that a "‘clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Here, claims 23-27, 30-31, and 68 do not recite additional steps, structural limitations, or “hand-of-man” limitations beyond what is already recited at instant claim 1 (see, e.g., MPEP 2111.04(I)), because the recited clauses at each claim do not correspond to any particular structure/function relationship of record that imparts any step- or structure-related limitations beyond those recited at amended claim 1. Accordingly, amended claims 23-27, 30-31, and 68 are rejected for the reasons applied to amended claim 1, above. If Applicant disagrees, Applicant should explicitly identify what species of method within the scope of amended claim 1 is not fully enabled to satisfy the limitations set forth at amended claims 23-27, 30-31, and 68.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim a substantially and materially overlapping method of treating IBD, wherein both claim sets read upon species of administering the same compounds to the same patient population at the same (or overlapping) dosage, via the same (or obvious) route of administration to achieve the same predicted and expected outcomes (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are understood to be directed to obvious variants of the issued claims because it is well-within the ordinary skill in the art to practice a known, issued, and claimed method using known compounds at known concentrations, wherein administration is via known routes (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(G), 2144.05(I).
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to a subgenus of methods as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1, 18-31, and 68 are rejected.
Claims 1, 18-31, and 68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,626,146 (Apr. 21, 2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1, 18-31, and 68 are directed to methods of treating subjects for IBD (e.g., ulcerative colitis and Crohn’s disease) by orally administering a dimeric α4β7 integrin antagonist at “about 150 mg” or “about 450 mg” (see, e.g., instant claims 1, 18-31, and 68). Here, the claims of US’146 recite pharmaceutical formulations comprising the same or overlapping compounds (see, e.g., US’146 at claims 1-22), including the originally elected species (see, e.g., US’146 at claims 18-20). Although the claims do not recite a method of orally administering such compounds, twice daily, at 150 or 450 mg, to treat IBD (i.e., ulcerative colitis), in view of Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010), the Examiner is allowed to look at the specification of the patent to determine the use of the claimed compound. Here, the specification discloses that the compound(s) may be administered to patients to treat IBD and ulcerative colitis (see, e.g., US’146 at col. 2 at lines 5-15, col. 6 at lines 10-15), via oral administration (see, e.g., US’146 at col. 6 at lines 40-45), twice daily (see, e.g., US’146 at col. 6 at lines 15-26), at 1-300 mg/kg (see, e.g., US’146 at col. 80 at lines 42-46). Accordingly, in view of Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010), the instantly claimed method is not patentably distinct over the claimed compound of US’146.
Claims 1, 18-31, and 68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/139,254 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets appear to be directed to the treatment of IBD in a subject (compare instant claims with App’254 at claims 1 and 16-19), by orally administering the same compound (compare instant claims 1, 18-31, and 68, and elected species with App’254 at claims 1, 10, and structure “(I)”), at the same or overlapping concentration (compare instant claims 1 and 18-20 with App’254 at claims 3-5, identifying that the ranges at claim 1 encompass 50-1000 mg), twice daily (compare instant claims with App’254 at claim 15). Accordingly, although drafted differently, the copending claim sets are not patentably distinct from each other because they appear to claim the same or substantially identical subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 18-31, and 68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of copending Application No. 19/303,188 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets appear to be directed to the treatment of IBD in a subject (compare instant claims with App’188 at claims 1, 26-38), by orally administering (compare instant claims with App’188 at claims 1, 34-44) the same compound (compare instant claims 1, 18-31, and 68, and elected species with App’188 at claims 1-30, SEQ ID NO: 223), at the same or overlapping concentration (compare instant claims 1, 18-31, and 68 with App’188 at claim 34, reciting an “effective amount”, which is exemplified as meaning at least 1 to 300 mg/kg at ¶[00740] of the disclosure of App’188), twice daily (compare instant claims with App’188 at claim 41). Accordingly, although drafted differently, the copending claim sets are not patentably distinct from each other because they appear to claim the same or substantially identical subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive. Examiner notes that multiple arguments have been rendered moot in view of the new and revised rejections necessitated by Applicant’s amendments. Remaining applicable arguments are addressed below.
35 USC 103
Applicant addresses the rejections under 35 USC 103, jointly (see, e.g., Reply filed 6/30/2026 at 9 at final ¶ to 12 at 2nd full ¶), and therefore these arguments have been addressed jointly below.
It is the Examiner’s understanding that the Applicant does not dispute that the prior art teaches the same compound, applied to the same patient population, to treat the same diseases, via an oral administration route, at an overlapping concentration range, given once or twice daily (see, e.g., Reply filed 6/30/2026 at 9 at final ¶ to 12 at 2nd full ¶). Accordingly, it is the Examiner’s understanding that Applicant has not disputed that a proper prima facie case of obviousness was established by the Examiner.
It is the Examiner’s understanding that Applicant is attempting to rebut prima facie obviousness by alleging unexpected results and specifically criticality of range commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02, wherein such results are sufficient to rebut prima facie obviousness (see, e.g., Reply filed 6/30/2026 at 10 at 2nd full ¶ to 12 at 1st full ¶). However, to establish such unexpected results, the allegations must be timely and supported by objective evidence (see, e.g., 37 C.F.R. 1.132; see MPEP §§ 716.01, 716.01(a), 716.01(c)); to be of probative value the proffered evidence must be related to the claimed invention (see MPEP §§ 716.01(b), discussing nexus requirement and noting that "[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention"); the evidence must establish that the expected results occur to an unexpected extent (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein a comparison of the claimed invention with the closest prior art of record is provided (see, e.g., MPEP § 716.02(e)). Furthermore, even if evidence satisfying MPEP §§ 716.02, 716.02(a), 716.02(b), 716.02(d), and 716.02(e) is set forth on record, such evidence may not be sufficient to rebut prima facie obviousness because the evidence of expected and unexpected results must be weighed (see, e.g., MPEP § 716.02(c)(I)) and the totality of the record considered (see, e.g., MPEP §§ 716.01(d), 716.02(f)), including teachings in the prior art and evidence of expected results which weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)).
Here, the allegations of unexpected results and criticality of range are understood to be premised upon the data shown at Example 7 (see, e.g., Reply filed 6/30/2026 at 10 at 2nd full ¶ to 12 at 1st full ¶). Notably, the citations provided by the Applicant do not appear to correspond to the filed specification, but rather to the published application (US20230063321; hereafter “PGPub”).
As an initial matter, Example 7 does not pertain to any individual actually having IBD, ulcerative colitis, or Crohn’s disease (see, e.g., PGPub at ¶¶[0322]-[0323]), and therefore Example 7 does not actually pertain to patients being treated for such diseases; therefore, the nexus with the claimed subject matter is tenuous at best (see MPEP §§ 716.01(b), discussing nexus requirement and noting that "[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention"). Here, the novelty is the receptor response in healthy patients, but no actual treatment of a disease, as claimed, is shown. Applicant fails to address the relevance of such data to the patentability of the instant claims relative to prior art directing artisans to treat the same patients with the same compound via the same administration route, once or twice daily, at an overlapping concentration, in order to achieve the same result (i.e., treatment of IBD) (see, e.g., MPEP § 716.02(b)(II), noting that the burden is on Applicant to fully explain proffered data).
Second, the proffered data fails to establish criticality of range commensurate in scope with the pending claim scope and requirements of MPEP §716.02(d) at least because the proffered data is not commensurate in scope with the pending claim scope. Specifically, the claim scope recites “about 100 mg to about 500 mg, once or twice daily”, wherein “about” is undefined, but reasonably inferred to encompass at least ±20%. Accordingly, the pending claim scope reads upon at least oral administration of 80 mg to 600 mg “once or twice daily”, but the proffered data fails to include any data below this range. This is pertinent because, per MPEP § 716.02(d)(II), “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960)”. Here, zero evidence of any unexpected results at 80 mg or “outside” the range (e.g., below 80 mg) were actually tested at all. Therefore, no evidence of criticality of unexpected results over the full range presently claimed has been shown on record.
Third, Applicant appears to rely upon data that is statistically suspect, such as the reliance upon “94.5% compared to 86.5% for the 450 twice-daily regimen” (see, e.g., Reply filed 6/30/2026 at 11). Specifically, Applicant cites numbers, but in the absence of either the reported experimental error or the unreported statistical significance; for example, as established by reference to Table 21, ROmax for 900 mg QD was 94.5±2.61, and the ROmax for 450 mg BID was 86.5±4.11 (see instant Table 21). Accordingly, it appears Applicant is suggesting that a potential difference between ~91.89 (i.e., 94.5-2.61) and ~90.61 (i.e., 86.5+4.11) is both practically and statistically significant. However, no actual evidence of statistical or practical significance of such a small experimental difference is actually provided on record as required by MPEP §§ 716.02(b)(I)-(II).
Fourth, furthermore, all data shows that all “benefits” reported occur for all samples tested at all concentrations, and therefore such “benefits” appear to merely reflect a necessary and inherent outcome of practicing the prior art methods within the parameters already taught by the prior art (see, e.g., Example 7). This is pertinent because, per MPEP § 716.02, “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected”. Here, simply showing that a detectable difference exists among species that differ with respect to dosage does not establish unexpected results or criticality of range commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02. Rather, as expected in view of the prior art, the reported properties appear to be highly similar and the differences do not appear both statistically or practically significant, or otherwise commensurate in scope with the instant claims. Rather, the proffered data appears to confirm the expected and predicted results of the prior art, namely that the same compound as claimed, administered to the same patient population as claimed, via the same administration route as claimed, at the same dosage frequencies as claimed, and at the same or overlapping dosage as claimed, achieves the same therapeutic benefit as taught by the prior art (e.g., treatment of IBD, ulcerative colitis, and Crohn’s disease). Critically, per MPEP § 716.02(c)(II), evidence of expected results weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)).
Fifth, upon consideration of the totality of the proffered evidence, it appears that the Applicant has discovered that following the explicit guidance of the prior art, by administering a known compound to a known patient population via a known administration route at known dosage frequencies and within known dosage ranges to treat IBD, exactly as taught and suggested by the prior art, achieves benefits not expressly contemplated by the prior art (see, e.g., Reply filed 6/30/2026 at 10 at 2nd full ¶ to 12 at 1st full ¶, referring to “beneficial effects” that “were not disclosed in” the prior art). The discovery of “benefits effects” does not equate to “unexpected results” commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02 because the proffered data suggests all such “beneficial effects” are actually shared to some extent by all other dosages and dosage frequencies tested, which suggests such “beneficial effects” merely reflect necessary and inherent outcomes obtained by following the guidance of the prior art. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Here, the alleged benefits are simply obtained by following the exact guidance provided by the prior art, and all other differences are obvious. Therefore, the discovery of such additional advantages does not support non-obviousness relative to the closest prior art of record.
Accordingly, upon weighing the totality of evidence of record, the weight of evidence weighs in favor of a determination of obviousness because it is currently undisputed that prima facie obviousness has been established, and no unexpected results commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02 have been placed on record for reasons discussed above.
Benefits not contemplated by the prior art: It is the Examiner’s understanding that Applicant does not dispute that the prior art teaches and directs artisans to utilize the same compound, administered to the same patient population, via the same administration route, at the same dosage frequency, at the same or overlapping dosage, to achieve the same therapeutic benefit (e.g., treatment of IBD), but that Applicant is alleging that the claimed invention is patentably distinct relative to the prior art because it achieves benefits not expressly contemplated by the prior art (see, e.g., Reply filed 6/30/2026 at 10 at 2nd full ¶ to 12 at 1st full ¶, referring to “beneficial effects” that “were not disclosed in” the prior art). In response to applicant's arguments regarding beneficial results not contemplated by the prior art, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Here, any such benefit would be understood to result from merely optimizing the dosage and dosage frequency explicitly taught by the prior art, which is well-within the ordinary skill in the art (see, e.g., MPEP § 2144.05(I), noting that where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists; see, e.g., MPEP § 2144.05(I), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."). Accordingly, the “beneficial effects” identified by the Applicant do not weigh in favor of non-obviousness wherein they merely result by following the explicit guidance of the prior art and utilizing a known compound, administered to a known patient population, via a known administration route, at a known dosage frequency, at a known and overlapping dosage range, to achieve a known, expected, and predicted therapeutic benefit (e.g., treatment of IBD). Accordingly, such arguments are not persuasive because such benefits would result from merely following the guidance of the prior art.
Double Patenting
Applicant addresses the non-statutory double patenting rejections collectively (see, e.g., Reply filed 6/30/2026 at 12 at 3rd ¶ to 5th ¶), and therefore these arguments have been addressed collectively below.
It is the Examiner’s understanding that Applicant does not dispute that the claims at issue are directed to, encompass, or render obvious the same compound, administered to the same patient population, via the same administration route, at the same dosage frequency, at the same or overlapping dosage, to achieve the same therapeutic benefit (e.g., treatment of IBD). Rather, it is the Examiner’s understanding that Applicant is alleging that the claims at issue are patentably distinct because “the beneficial effects of the claimed dosing regimen were not disclosed in and could not have been predicted from the disclosures of the '744 and '270” and “because the dosage ranges described in those patents also encompass dosages that were shown in the instant application to not provide the same beneficial effects” (see, e.g., Reply filed 6/30/2026 at 12 at 3rd ¶ to 5th ¶). Arguments pertaining to unexpected results, criticality of range, and allegations of benefits not contemplated by the prior art have been fully considered but not found persuasive for reasons set forth above in response to those same arguments raised in view of the rejections under 35 USC 103; those responses are incorporated herein.
Conclusion
All applicable arguments have been fully considered but not found persuasive as explained above. Accordingly, the claims remain rejected for reasons of record set forth above in new or revised rejections, wherein all new or revised rejections were necessitated by Applicant amendment.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 Note that this is “mg”, not “mg/kg”.
2 These claims have been rejected above under 35 USC 112(b) because it is unclear if these claims recite functional limitations or merely recite hoped-for and desired results fully satisfied by the positively recited language set forth in the body of the claim upon which they depend. The instant rejection under 35 USC 112(d) addresses the Examiner’s understanding, which is that the claims are not further limiting, do not correspond to functional limitations, and instead merely recite hoped-for and desired results fully satisfied by the performance of the structures and steps in the independent claim.
[2] Note that claims 1 and 18-20 refer to a range of “mg” only, rather than “mg/kg”.
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