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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/09/2025 has been entered.
Claim Status
Claims 1-6 are pending. No amendments were filed. The claims as previously submitted 11/07/2024 remain pending. Claims 1-6 are presently considered.
Election/Restrictions
Applicant’s election without traverse of a species of Example 5, as identified below, in the reply filed on 2/02/2024 was previously acknowledged.
The originally elected species was understood to be a species of Example 5 (see, e.g., Spec. filed 10/16/2023 at 33 line 8 to page 34 at line 15), specifically a composition containing ZP1848-acetate (6% acetate, 4.6 equivalents of acetate, 20.3 mM of acetate), and more specifically 20 mg/mL ZP1848-acetate (SEQ ID NO: 1, wherein R1 is H, Z1 is absent, X5 is Thr, X11 is Ala, Z2 is (K)6, and R2 is NH2), 15 mM histidine buffer, 230 mM mannitol, 20.3 mM of acetate, and having a pH of 7.0, in an aqueous composition.
The originally elected species was deemed anticipated and/or obvious in view of the prior art for reasons set forth in the previous action. In response, Applicant has canceled all claims reading upon the originally elected species, and limited the scope of the claims to solid formulations. Per MPEP § 803.02(III)(A), examination has been extended to a non-elected species1 within the scope of independent claim 1.
Amended claim 1 is understood to be limited to solid formulations of ZP1848, which has the sequence
HGEGTFSSELATILDALAARDFIAWLIATKITDKKKKKK-NH2
wherein the solid formulation comprises an acetate salt of “x(CH3CHOOH), wherein x is 1.0 to 8.0”. Accordingly, examination has been extended to obvious compositions as set forth at WO’565 at 32 at lines 1-15, wherein solid compositions of ZP1848-acetate are formed, for example, via lyophilization at a pH of 7.0 (note that the claim is directed to a product, and currently no product-by-process limitations are actually recited that require lyophilization).
Following extensive search and examination, the non-elected species has again been deemed anticipated and/or obvious in view of the prior art as applied below (see, e.g., MPEP § 803.02(III)(A).
Claims 1-6 are presently considered.
Information Disclosure Statement
The IDS filed 2/09/2026 is acknowledged and presently considered.
Related Applications
Examiner notes that US Applications 17/279,691 and 17/276,252 each pertain to highly similar subject matter.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action.
Claim 1 was not amended in the RCE filed 2/09/2026. Claim 1 as filed 11/07/2024 is representative of the pending claims:
1. A solid composition comprising an acetate salt of a glucagon-like peptide 2 (GLP-2) analogue, wherein the acetate salt consists of a compound having the formula:
[(H-HGEGTFSSELATILDALAARDFIAWLIATKITDKKKKKK-NH2) (SEQ ID NO: 1)], x(CH3COOH) where x is 1.0 to 8.0.
Accordingly, claim 1 is directed to products, namely solid compositions comprising acetate salts of a GLP-2 analogue. The applicable claim interpretation is discussed below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“Consists of” or “Consisting of” excludes any elements, step, or ingredient not specified (see, e.g., MPEP § 2111.03(II)). When the phrase "consists of" appears in a clause of the body of a claim, rather than immediately following the preamble, the "consisting of" phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole (see, e.g., MPEP § 2111.03(II)). Here, the “solid composition” may “comprise” an unlimited number of components, but the “acetate salt” must consist of the structure set forth at instant claim 1. Accordingly, the amendments filed 11/07/2024 have not limited or altered the pending claim scope, since additional components are permitted in the “solid composition”.
The structure of ZP1848 (i.e., instant SEQ ID NO: 1) is understood to be the sequence of
HGEGTFSSELATILDALAARDFIAWLIATKITDKKKKKK-NH22
This is a prior art structure, first taught and disclosed in WO2006/117565A13 (Nov. 9, 2006; Larsen et al.) as “1848” or [Gly2, Glu3, Thr5, Ser8, Leu10, Ala 11, 16, 24, 28]hGLP-2(1-33)-(Lys)6-NH2 (see, e.g., WO’565 at 20 at lines 39-40, 22 at lines 4-12, 42 at “1848”, claim 11, 14, passim). Accordingly, the GLP-2 analogue structure is a prior art element. Accordingly, the claim is reasonably inferred to be directed to a solid ZP1848-acetate composition, for example as produced by the process of lyophilization, wherein ZP1848-acetate is reasonably understood to form in the presence of acetic acid, and the amount of acetate associated with ZP1848 would be understood to depend on the charge of the peptide (i.e., the pH of the solution) prior to lyophilization.
The original disclosure provides a reference explaining that “10% total acetate concentration equates to 34 mM, 9% to 30 mM, 8% to 27 mM, 7% to 24 mM and 6% to 20 nM[sic]” (see, e.g., Spec. filed 10/16/2023 at 15 at lines 5-25).
At claim 1, the phrase “x(CH3COOH) where x is 1.0 to 8.0” is understood to be directed to a ratio of molar equivalents. Therefore, when 1 mole of ZP1848 is present, 1-8 moles of acetate must be present. The molecular weight of ZP1848 is understood to be approximately ~4316 and the molecular weight of CH3COOH is 60.052 g/mole. Therefore 1-100 mg/mL of ZP1848 is understood to be ~0.231 mM to ~23.1 mM. Accordingly, this range would imply that when 1-100 mg/mL of ZP1848 is present that acetic acid should be present at approximately ~0.231 mM to ~184.8 mM of CH3COOH. Therefore, for a 10 mg/mL ZP1848 composition, a 1x-8x amount would be 2.31 mM to 18.4 mM of CH3COOH; for a 20 mg/mL ZP1848 composition, a 1x-8x amount would be 4.62 mM to 36.96 mM of CH3COOH; and for a 30 mg/mL ZP1848 composition, a 1x-8x amount would be 6.93 mM to 55.44 mM of CH3COOH. Because CH3COOH is acts as a counterion, it is relevant to note that at a pH of 7, the net charge of ZP1848 is understood to be approximately ~4:
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547
911
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Greyscale
(see search notes).
The term “about” is undefined on record. The term “about” is given its ordinary meaning in view of the biochemical arts, and is understood to mean “within 20 percent” (see, e.g., US 2009/0028832 A1 at ¶[0111]; see also US 2009/0105341 A1 at ¶[0049]; see also US 2012/0178676, at ¶[0277]). Accordingly, with respect to the instant disclosure and with prior art of record, unless the term “about” is otherwise clearly defined, the term is reasonably inferred to indicate a range either “within 20 percent” of a recited number. Therefore, the range of “about 5 mM to about 50 mM” is reasonably inferred to include at least a range of 4 mM to 60 mM; the range of “about 6.6 to about 7.4” is reasonable inferred to include at least a range of 5.28 to 8.88; etc., etc.
Additional claim interpretations are set forth below.
Maintained Claim Rejections
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over WO2006/117565A1 (Nov. 9, 2006; Larsen et al.; cited in previous action).
Claim Interpretation: The applicable claim interpretation has been set forth above in a separate section entitled “Claim Interpretations” above, and/or discussed in preceding rejections. Those interpretations and discussions are incorporated herein unless otherwise explicitly stated. Additional claim interpretations are discussed below.
Regarding instant claims 1-6, WO’565 pertains to GLP-2 analogues, methods of use, and compositions thereof (see, e.g., WO’565 at title, abs, claims, page 32 at line 15 to page 33 at line 6). Regarding instant claims 1-6 and the structure of the GLP-2 analogue , WO’564 teaches and discloses at least compound 1848, which has the following structure:
HGEGTFSSELATILDALAARDFIAWLIATKITDKKKKKK-NH2,
and is identified as [Gly2, Glu3, Thr5, Ser8, Leu10, Ala 11, 16, 24, 28]hGLP-2(1-33)-(Lys)6-NH2 (see, e.g., WO’565 at 20 at lines 39-40, 22 at lines 4-12, 42 at “1848”, claim 11, 14, passim; hereafter Compound 1848 is referred to as ZP1848)4. Accordingly, the GLP-2 peptide analogue is a prior art element, and therefore does not weigh in favor of a determination of non-obviousness. Regarding instant claims 1-6, and the recitation of a “solid composition”, WO’564 pertains to and discloses lyophilized and solid forms of GLP-2 analogues for reconstitution or suspension prior to usage (see, e.g., WO’564 at 31 at lines 5-7; see also WO’564 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38, 34 at lines 24-26). Therefore, solid forms of GLP-2 peptide analogues are prior art elements, and therefore do not weigh in favor of a determination of non-obviousness.
The primary reference differs from the pending claim scope as follows: WO’564 does not explicitly teach or disclose a solid composition of ZP1848-acetate solid wherein acetate is present as “x(CH3COOH) where x is 1.0 to 8.0” as recited and required at instant claim 1.
Regarding claims 1-6, and the interpretation of the phrase at claim 1 reciting “x(CH3COOH) where x is 1.0 to 8.0”, as explained in the claim interpretation section, this limitation is understood to be directed to a ratio of moles. Accordingly, the claim is reasonably understood to read upon at least solid compositions formed via lyophilization of compositions comprising, for example, approximately (i) 10 mg/mL ZP1848 composition and a 1x-8x amount of 2.31 mM to 18.4 mM of CH3COOH; (ii) 20 mg/mL ZP1848 composition and a 1x-8x amount of 4.62 mM to 36.96 mM of CH3COOH; or (iii) 30 mg/mL ZP1848 composition and a 1x-8x amount of 6.93 mM to 55.44 mM of CH3COOH.
Regarding instant claims 1-6 and “x(CH3COOH) where x is 1.0 to 8.0”, the primary reference teaches, discloses, and directs artisans to make and use solid compositions by lyophilizing embodiments comprising acetic acid “most preferably from 0.5 to 50 mM” and a therapeutic peptide at “most preferably from 10 to 30 mg/mL” (see, e.g., WO’565 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38), wherein the pH may range from 4 to 8 but “most preferably from 6.7 to 7.3” (see id). Critically, the prior art expressly teaches that the solution may be lyophilized, which would be understood to form a solid product (e.g., a powder or crystal) (see, e.g., WO’565 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38). Therefore, following the “most preferable” guidance of WO’565 and forming a solid via lyophilization would predictably and expectedly yield a solid product comprising approximately the same material present prior to lyophilization, namely the material corresponding to 10-30 mg/mL of peptide and 0.5 to 50 mM of acetic acid (see, e.g., MPEP § 2144.05(I), noting 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”). Furthermore, an artisan would readily appreciate that a counterion such as acetate would form based upon available charges in the therapeutic peptide, which would depend upon the pH of the lyophilized solution and overall charge/pKa of the therapeutic peptide.
Accordingly, the prior art provides explicit guidance directing artisans to utilize pharmaceutical formulations as presently claimed, comprising the exact same components at the exact same or otherwise overlapping concentrations (see, e.g., MPEP § 2144.05(I), noting 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”).
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(s): The invention is obvious because it is the combination of prior art elements taught by WO’565 (i.e., known GLP-2 analogues in known amounts, known acetic acid in known amounts to form known acetate counterion, known pH of 6.7 to 7.3) according to known methods of making solid compositions via lyophilizing GLP-2 analogue compositions exactly as taught by WO’565, to yield predictable results, namely lyophilized pharmaceutical compositions comprising the lyophilized materials present in 10-30 mg/mL of GLP-2 analogue and 0.5 to 50 mM of acetic acid at a pH of 6.7 to 7.3, wherein such resulting solid compositions were understood to be useful for peptide storage, and reconstitutions of therapeutic formulations for use in the methods taught and disclosed by WO’565 (see, e.g., MPEP § 2143(I)(A), (G); see also MPEP § 2144.05(I), noting 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”). Furthermore, each component merely performs the same function in combination as it does separately.
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 make a pharmaceutical formulation comprising prior art components at known concentration ranges to obtain products exactly as taught and disclosed by the prior art.
Accordingly, claims 1-6 are rejected.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 8,263,552 B2 (Sept. 11, 2012; cited in previous action).
Claim Interpretation: The applicable claim interpretation has been set forth above in a separate section entitled “Claim Interpretations” above, and/or discussed in preceding rejections. Those interpretations and discussions are incorporated herein unless otherwise explicitly stated. Additional claim interpretations are discussed below.
Regarding instant claims 1-6, US’552 pertains to GLP-2 analogues, methods of use, and compositions thereof (see, e.g., US’552 at title, abs, claims 1-8). Regarding instant claims 1-6 and the structure of the GLP-2 analogue , US’552 claims pharmaceutical compositions comprising at least compound 1848, which has the following structure:
HGEGTFSSELATILDALAARDFIAWLIATKITDKKKKKK-NH2,
(see, e.g., US’552 at claims 1-8; hereafter referred to as ZP1848). Accordingly, the GLP-2 peptide analogue is a prior art element, and therefore does not weigh in favor of a determination of non-obviousness. Regarding instant claims 1-6, and the recitation of a composition comprising acetate and ZP1848, US’552 broadly claims all pharmaceutical compositions and compositions comprising at least the GLP-2 peptide analogue of ZP1848 or pharmaceutically acceptable salts thereof (see, e.g., US’552 at claims 1-8). The pending claim scope would readily be understood to fully encompass the pharmaceutical formulations taught, disclosed, and exemplified in the disclosure of US’552, which includes formulations comprising acetic acid “preferably from 0.5 to 50 mM” and therapeutic GLP-2 analogues at “most preferably from 10 to 30 mg/mL”, at a pH of “most preferably from 6.7 to 7.3”(see, e.g., US’552 at col. 28 at line 63 to col. 29 at line 15, col. 29 at lines 15-35, col. 29 at lines 25-55, col. 29 at line 55 to col. 30 at line 9, col. 30 at line 9 to line 26). Accordingly, an artisan would readily appreciate and at once envisage formulations of ZP1848 at a pH of 6.7-7.3 comprising 10-30 mg/mL and 0.5-50 mM of acetic acid.
The primary reference differs from the pending claim scope as follows: US’552 does not explicitly teach, disclose, or claim a solid composition of ZP1848-acetate solid wherein acetate is present as “x(CH3COOH) where x is 1.0 to 8.0” as recited and required at instant claim 1.
Regarding claims 1-6, and the interpretation of the phrase at claim 1 reciting “x(CH3COOH) where x is 1.0 to 8.0”, as explained in the claim interpretation section, this limitation is understood to be directed to a ratio of moles. Accordingly, the instant claims are reasonably understood to read upon at least solid compositions formed via lyophilization of compositions comprising, for example, approximately (i) 10 mg/mL ZP1848 composition and a 1x-8x amount of 2.31 mM to 18.4 mM of CH3COOH; (ii) 20 mg/mL ZP1848 composition and a 1x-8x amount of 4.62 mM to 36.96 mM of CH3COOH; or (iii) 30 mg/mL ZP1848 composition and a 1x-8x amount of 6.93 mM to 55.44 mM of CH3COOH. Therefore, since the prior art teaches the same components at the same concentrations (see discussion above citing US’552 at col. 28 at line 63 to col. 29 at line 15, col. 29 at lines 15-35, col. 29 at lines 25-55, col. 29 at line 55 to col. 30 at line 9, col. 30 at line 9 to line 26), the issue is whether or not it would have been obvious to simply lyophilize the claimed and disclosed formulations to form a solid composition suitable for reconstitution.
Regarding instant claims 1-6 and “x(CH3COOH) where x is 1.0 to 8.0”, the primary reference teaches, discloses, and directs artisans to make and use solid compositions by lyophilizing embodiments comprising acetic acid “most preferably from 0.5 to 50 mM” and a therapeutic peptide at “most preferably from 10 to 30 mg/mL” ”(see, e.g., US’552 at col. 28 at line 63 to col. 29 at line 15, col. 29 at lines 15-35, col. 29 at lines 25-55, col. 29 at line 55 to col. 30 at line 9, col. 30 at line 9 to line 26)., wherein the pH may range from 4 to 8 but “most preferably from 6.7 to 7.3” (see id). Critically, the prior art expressly teaches that the solution may be lyophilized, which would be understood to form a solid product (e.g., a powder or crystal) (see, e.g., US’552 at col. 28 at line 63 to col. 29 at line 15, col. 29 at lines 15-35, col. 29 at lines 25-55, col. 29 at line 55 to col. 30 at line 9, col. 30 at line 9 to line 26). Therefore, following the “most preferable” guidance of the primary reference, and forming a solid via lyophilization would predictably and expectedly yield a solid product comprising approximately the same material present prior to lyophilization, namely the material corresponding to 10-30 mg/mL of peptide and 0.5 to 50 mM of acetic acid (see, e.g., MPEP § 2144.05(I), noting 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”). Furthermore, an artisan would readily appreciate that a counterion such as acetate would form based upon available charges in the therapeutic peptide, which would depend upon the pH of the lyophilized solution and overall charge/pKa of the therapeutic peptide.
Accordingly, the prior art provides explicit guidance directing artisans to utilize pharmaceutical formulations as presently claimed, comprising the exact same components at the exact same or otherwise overlapping concentrations (see, e.g., MPEP § 2144.05(I), noting 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”).
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(s): The invention is obvious because it is the combination of prior art elements taught by the primary reference (i.e., known GLP-2 analogues in known amounts, known acetic acid in known amounts to form known acetate counterion, known pH of 6.7 to 7.3) according to known methods of making solid compositions via lyophilizing GLP-2 analogue compositions exactly as taught by the primary reference, to yield predictable results, namely lyophilized pharmaceutical compositions comprising the lyophilized materials present in 10-30 mg/mL of GLP-2 analogue and 0.5 to 50 mM of acetic acid at a pH of 6.7 to 7.3, wherein such resulting solid compositions were understood to be useful for peptide storage, and reconstitutions of therapeutic formulations for use in the methods taught and disclosed by the primary reference (see, e.g., MPEP § 2143(I)(A), (G); see also MPEP § 2144.05(I), noting 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”). Furthermore, each component merely performs the same function in combination as it does separately.
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 make a pharmaceutical formulation comprising prior art components at known concentration ranges to obtain products exactly as taught and disclosed by the prior art.
Accordingly, claims 1-6 are rejected.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,125,882 B2 (Sep. 8, 2015; cited in previous action).
Claim Interpretation: The applicable claim interpretation has been set forth above in a separate section entitled “Claim Interpretations” above, and/or discussed in preceding rejections. Those interpretations and discussions are incorporated herein unless otherwise explicitly stated. Additional claim interpretations are discussed below.
The primary reference overlaps in scope with the instant claims as explained below (see, e.g., US’882 at claims 1-11, passim). Regarding the GLP-2 analog structure recited at instant claims 1-6, the primary reference claims pharmaceutical compositions comprising GLP-2 analogs and salts thereof comprising at least compound 1848, which has the following structure:
HGEGTFSSELATILDALAARDFIAWLIATKITDKKKKKK-NH2,
(see, e.g., US’882 at claims 1-3 and 5, SEQ ID NO: 36, hereafter referred to as ZP1848). Regarding instant claims 1-6 and solid formulations, US’882 claims embodiments that comprise solid formulations of ZP1848 and all pharmaceutical compositions comprising ZP1848 (see, e.g., US’882 at claims 1-3 and 5).
The primary reference differs from the pending claim scope as follows: US’882 does not explicitly teach, disclose, or claim a solid composition of ZP1848-acetate solid wherein acetate is present as “x(CH3COOH) where x is 1.0 to 8.0” as recited and required at instant claim 1.
Regarding claims 1-6, and the interpretation of the phrase at claim 1 reciting “x(CH3COOH) where x is 1.0 to 8.0”, as explained in the claim interpretation section, this limitation is understood to be directed to a ratio of moles. Accordingly, the instant claims are reasonably understood to read upon at least solid compositions formed via lyophilization of compositions comprising, for example, approximately (i) 10 mg/mL ZP1848 composition and a 1x-8x amount of 2.31 mM to 18.4 mM of CH3COOH; (ii) 20 mg/mL ZP1848 composition and a 1x-8x amount of 4.62 mM to 36.96 mM of CH3COOH; or (iii) 30 mg/mL ZP1848 composition and a 1x-8x amount of 6.93 mM to 55.44 mM of CH3COOH. Therefore, the relevant issue is whether or not such limitations weigh in favor of a determination of non-obviousness.
Regarding instant claims 1-6 and “x(CH3COOH) where x is 1.0 to 8.0”, the primary reference teaches, discloses, and directs artisans to make and use solid compositions by lyophilizing embodiments comprising acetic acid “most preferably from 0.5 to 50 mM” and a therapeutic peptide at “most preferably from 10 to 30 mg/mL” ”(see, e.g., US’882 at col. 31 at line 1 to col. 32 at line 33), wherein the pH may range from 4 to 8 but “most preferably from 6.7 to 7.3” (see id). Critically, the prior art expressly teaches that the solution may be lyophilized, which would be understood to form a solid product (e.g., a powder or crystal) (see, e.g., US’882 at col. 31 at line 1 to col. 32 at line 33). Therefore, following the “most preferable” guidance of the primary reference, and forming a solid via lyophilization would predictably and expectedly yield a solid product comprising approximately the same material present prior to lyophilization, namely the material corresponding to 10-30 mg/mL of peptide and 0.5 to 50 mM of acetic acid (see, e.g., MPEP § 2144.05(I), noting 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”). Furthermore, an artisan would readily appreciate that a counterion such as acetate would form based upon available charges in the therapeutic peptide, which would depend upon the pH of the lyophilized solution and overall charge/pKa of the therapeutic peptide.
Accordingly, the prior art provides explicit guidance directing artisans to utilize pharmaceutical formulations as presently claimed, comprising the exact same components at the exact same or otherwise overlapping concentrations (see, e.g., MPEP § 2144.05(I), noting 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”).
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(s): The invention is obvious because it is the combination of prior art elements taught by the primary reference (i.e., known GLP-2 analogues in known amounts, known acetic acid in known amounts to form known acetate counterion, known pH of 6.7 to 7.3) according to known methods of making solid compositions via lyophilizing GLP-2 analogue compositions exactly as taught by the primary reference, to yield predictable results, namely lyophilized pharmaceutical compositions comprising the lyophilized materials present in 10-30 mg/mL of GLP-2 analogue and 0.5 to 50 mM of acetic acid at a pH of 6.7 to 7.3, wherein such resulting solid compositions were understood to be useful for peptide storage, and reconstitutions of therapeutic formulations for use in the methods taught and disclosed by the primary reference (see, e.g., MPEP § 2143(I)(A), (G); see also MPEP § 2144.05(I), noting 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”). Furthermore, each component merely performs the same function in combination as it does separately.
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 make a pharmaceutical formulation comprising prior art components at known concentration ranges to obtain products exactly as taught and disclosed by the prior art.
Accordingly, claims 1-6 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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,263,552 B2 (Sept. 11, 2012; cited in previous action) in view of WO2006/117565A1 (Nov. 9, 2006; Larsen et al.; cited in previous action).
Claim Interpretation: The applicable claim interpretation has been set forth above in a separate section entitled “Claim Interpretations” above, and/or discussed in preceding rejections. Those interpretations and discussions are incorporated herein unless otherwise explicitly stated. Additional claim interpretations are discussed below.
The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph[1]: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. Accordingly, a comparison of the teachings of the reference claims and the instant pending claims are set forth below:
Regarding instant claims 1-6, US’552 pertains to GLP-2 analogues, methods of use, and compositions thereof (see, e.g., US’552 at title, abs, claims 1-8). Regarding instant claims 1-6 and the structure of the GLP-2 analogue , US’552 claims pharmaceutical compositions comprising at least compound 1848, which has the following structure:
HGEGTFSSELATILDALAARDFIAWLIATKITDKKKKKK-NH2,
(see, e.g., US’552 at claims 1-8; hereafter referred to as ZP1848) or pharmaceutically acceptable salts thereof. Accordingly, the GLP-2 peptide analogue is a prior art element. Regarding instant claims 1-6, and the recitation of a composition comprising acetate and ZP1848, the primary reference recites and claims at least all pharmaceutical salts of ZP1848, which would include all acetate salts derived from acetic acids (see, e.g., US’552 at claim 1).
The primary reference differs from the pending claim scope as follows: US’552 does not explicitly teach, disclose, or claim a solid composition of ZP1848-acetate wherein acetate is present corresponding to “x(CH3COOH) where x is 1.0 to 8.0” as recited and required at the instant claims.
Accordingly, the main difference is the specific salt claimed and the form of the composition. Regarding claims 1-6, and the interpretation of the phrase at claim 1 reciting “x(CH3COOH) where x is 1.0 to 8.0”, as explained in the claim interpretation section, this limitation is understood to be directed to a ratio of moles. Accordingly, the instant claims are reasonably understood to read upon at least solid compositions formed via lyophilization of compositions comprising, for example, approximately (i) 10 mg/mL ZP1848 composition and a 1x-8x amount of 2.31 mM to 18.4 mM of CH3COOH; (ii) 20 mg/mL ZP1848 composition and a 1x-8x amount of 4.62 mM to 36.96 mM of CH3COOH; or (iii) 30 mg/mL ZP1848 composition and a 1x-8x amount of 6.93 mM to 55.44 mM of CH3COOH.
Accordingly, the difference between the issued claims and the instant claims appears to be that the issued claims do not explicitly recite a solid composition comprising “x(CH3COOH) where x is 1.0 to 8.0”. However, this difference appears well within the ordinary knowledge and teachings of the prior art. Regarding instant claims 1-6, and the recitation of a “solid composition”, WO’564 pertains to and discloses lyophilized and solid forms of GLP-2 analogues for reconstitution or suspension prior to usage (see, e.g., WO’564 at 31 at lines 5-7; see also WO’564 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38, 34 at lines 24-26). Therefore, solid forms of GLP-2 peptide analogues are prior art elements. Regarding instant claims 1-6 and a composition comprising ZP1848 and an acetate-based salt comprising “x(CH3COOH) where x is 1.0 to 8.0”, WO’564 teaches, identifies, and directs artisans to make and use solid compositions by lyophilizing embodiments comprising acetic acid “most preferably from 0.5 to 50 mM” and a therapeutic peptide such as ZP1848 (see, e.g., WO’565 at 20 at lines 39-40, 22 at lines 4-12, 42 at “1848”, claim 11, 14, passim) at “most preferably from 10 to 30 mg/mL” (see, e.g., WO’565 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38), wherein the pH may range from 4 to 8 but “most preferably from 6.7 to 7.3” (see id). Critically, the prior art expressly teaches that the solution may be lyophilized, which would be understood to form a solid product (e.g., a powder or crystal) (see, e.g., WO’565 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38). Therefore, following the “most preferable” guidance of WO’565 and forming a solid via lyophilization would predictably and expectedly yield a solid product comprising approximately the same material present prior to lyophilization, namely the material corresponding to 10-30 mg/mL of peptide and 0.5 to 50 mM of acetic acid (see, e.g., MPEP § 2144.05(I), noting 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”). Furthermore, an artisan would readily appreciate that a counterion such as acetate would form based upon available charges in the therapeutic peptide, which would depend upon the pH of the lyophilized solution and overall charge/pKa of the therapeutic peptide. Accordingly, the prior art of WO’565 provides explicit guidance directing artisans to utilize compositions as claimed by the primary reference, wherein such compositions appear to reasonably comprise the exact same components at the exact same or otherwise overlapping concentrations now claimed following the formation of a solid via lyophilization (see, e.g., MPEP § 2144.05(I), noting 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”).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Regarding an 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 in view of a secondary reference has been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims are understood to be directed to the lyophilized products explicitly taught and suggested by the secondary reference, wherein such products fall within the issued claim scope of the primary reference. Accordingly, the present claims appear to merely more specifically claim the embodiments encompassed by the issued claims of the primary reference by incorporating the limitations, lyophilization step, and concentrations disclosed explicitly by the secondary reference. Therefore, the pending claims cannot reasonably be said to be patentably distinct under an obviousness analysis because they fall within the scope of an issued claim, and the only difference appears to have been fully taught and disclosed in the prior art (see, e.g., MPEP § 804(II)(B)(3); see also MPEP §§ 2143(A)).
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. 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 and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1-6 are rejected.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5 of U.S. Patent No. 9,125,882 B2 (Sep. 8, 2015) in view of WO2006/117565A1 (Nov. 9, 2006; Larsen et al.).
Claim Interpretation: The applicable claim interpretation has been set forth above in a separate section entitled “Claim Interpretations” above, and/or discussed in preceding rejections. Those interpretations and discussions are incorporated herein unless otherwise explicitly stated. Additional claim interpretations are discussed below.
The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph[1]: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. Accordingly, a comparison of the teachings of the reference claims and the instant pending claims are set forth below:
The primary reference overlaps in scope with the instant claims as explained below (see, e.g., US’882 at claims 1-3 and 5, passim). Regarding the GLP-2 analog structure recited at instant claims 1-6, the primary reference claims pharmaceutical compositions comprising GLP-2 analogs and salts thereof comprising at least compound 1848, which has the following structure:
HGEGTFSSELATILDALAARDFIAWLIATKITDKKKKKK-NH2,
(see, e.g., US’882 at claims 1-3 and 5, SEQ ID NO: 36, hereafter referred to as ZP1848). Regarding instant claims 1-6 and solid formulations, US’882 claims embodiments that comprise solid formulations of ZP1848 and all pharmaceutical compositions comprising ZP1848 (see, e.g., US’882 at claims 1-3 and 5).
The primary reference differs from the pending claim scope as follows: US’882 does not explicitly teach, disclose, or claim a solid composition of ZP1848-acetate solid wherein acetate is present as “x(CH3COOH) where x is 1.0 to 8.0” as recited and required at instant claim 1.
Regarding claims 1-6, and the interpretation of the phrase at claim 1 reciting “x(CH3COOH) where x is 1.0 to 8.0”, as explained in the claim interpretation section, this limitation is understood to be directed to a ratio of moles. Accordingly, the instant claims are reasonably understood to read upon at least solid compositions formed via lyophilization of compositions comprising, for example, approximately (i) 10 mg/mL ZP1848 composition and a 1x-8x amount of 2.31 mM to 18.4 mM of CH3COOH; (ii) 20 mg/mL ZP1848 composition and a 1x-8x amount of 4.62 mM to 36.96 mM of CH3COOH; or (iii) 30 mg/mL ZP1848 composition and a 1x-8x amount of 6.93 mM to 55.44 mM of CH3COOH. Therefore, the relevant issue is whether or not such limitations weigh in favor of a determination of non-obviousness.
Accordingly, the difference between the issued claims and the instant claims appears to be that the issued claims do not explicitly recite a solid composition comprising “x(CH3COOH) where x is 1.0 to 8.0”. However, this difference appears well within the ordinary knowledge and teachings of the prior art. Regarding instant claims 1-6, and the recitation of a “solid composition”, WO’564 pertains to and discloses lyophilized and solid forms of GLP-2 analogues for reconstitution or suspension prior to usage (see, e.g., WO’564 at 31 at lines 5-7; see also WO’564 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38, 34 at lines 24-26). Therefore, solid forms of GLP-2 peptide analogues are prior art elements. Regarding instant claims 1-6 and a composition comprising ZP1848 and an acetate-based salt comprising “x(CH3COOH) where x is 1.0 to 8.0”, WO’564 teaches, identifies, and directs artisans to make and use solid compositions by lyophilizing embodiments comprising acetic acid “most preferably from 0.5 to 50 mM” and a therapeutic peptide such as ZP1848 (see, e.g., WO’565 at 20 at lines 39-40, 22 at lines 4-12, 42 at “1848”, claim 11, 14, passim) at “most preferably from 10 to 30 mg/mL” (see, e.g., WO’565 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38), wherein the pH may range from 4 to 8 but “most preferably from 6.7 to 7.3” (see id). Critically, the prior art expressly teaches that the solution may be lyophilized, which would be understood to form a solid product (e.g., a powder or crystal) (see, e.g., WO’565 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38). Therefore, following the “most preferable” guidance of WO’565 and forming a solid via lyophilization would predictably and expectedly yield a solid product comprising approximately the same material present prior to lyophilization, namely the material corresponding to 10-30 mg/mL of peptide and 0.5 to 50 mM of acetic acid (see, e.g., MPEP § 2144.05(I), noting 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”). Furthermore, an artisan would readily appreciate that a counterion such as acetate would form based upon available charges in the therapeutic peptide, which would depend upon the pH of the lyophilized solution and overall charge/pKa of the therapeutic peptide. Accordingly, the prior art of WO’565 provides explicit guidance directing artisans to utilize compositions as claimed by the primary reference, wherein such compositions appear to reasonably comprise the exact same components at the exact same or otherwise overlapping concentrations now claimed following the formation of a solid via lyophilization (see, e.g., MPEP § 2144.05(I), noting 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”).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Regarding an 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 in view of a secondary reference has been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims are understood to be directed to the lyophilized products explicitly taught and suggested by the secondary reference, wherein such products fall within the issued claim scope of the primary reference. Accordingly, the present claims appear to merely more specifically claim the embodiments encompassed by the issued claims of the primary reference by incorporating the limitations, lyophilization step, and concentrations disclosed explicitly by the secondary reference. Therefore, the pending claims cannot reasonably be said to be patentably distinct under an obviousness analysis because they fall within the scope of an issued claim, and the only difference appears to have been fully taught and disclosed in the prior art (see, e.g., MPEP § 804(II)(B)(3); see also MPEP §§ 2143(A)).
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. 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 and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1-6 are rejected.
Response to Arguments
Applicant's arguments filed 2/09/2026 have been fully considered but they are not persuasive. Applicant traverses the rejections at pages 2-5 of the Reply filed 2/09/2026, and these arguments are addressed below.
Because the claims at issue were not amended in the Reply filed 2/09/2026, and because all rejections are maintained, the Examiner’s prior responses to arguments of record (i.e., allegations of unexpected results, unclaimed limitations, etc.) remain pertinent, and those responses are incorporated herein.
Previous Declaration by Villadsen
The Examiner’s analysis of the Declaration of Villadsen filed 11/07/2024 was set forth on record in a previous action (see, e.g., Action mailed 4/11/2025 at pages 30-35). The Declaration was found to contain factually incorrect and unsupported statements contradicted by prior art placed on record by the Examiner, and was not found persuasive for reasons of record (see id). Examiner acknowledges Applicant’s recognition in the Reply filed 2/09/2026 that the prior declaration of record contains “an incorrect statement” and acknowledges Applicant’s statements that “additional data were collected and these earlier statements [by the Declarant] were determined to be incorrect” (see, e.g., Reply filed 2/09/2026 at 2 at 3rd ¶).
35 USC 103
Arguments premised upon the Declaration are considered in a separate section below, but are not found persuasive: It is the Examiner’s understanding that Applicant raises multiple arguments regarding the pending rejections under 35 USC 103, based upon the Moller Declaration filed 2/09/2026, such as alleging that the prior art is inoperable or otherwise not enabling to obtain solid forms of ZP1848-acetate as presently claimed (see, e.g., Reply filed 2/09/2026 at 2 at § “Rejections under 35 U.S.C. § 103” to p. 4 at 2nd full ¶). These arguments are considered in view of the Declaration in a separate section below, but have not found persuasive to rebut obviousness or otherwise establish a showing of inoperability for reasons set forth below.
Applicant appears to refer to unclaimed product-by-process limitations and other unclaimed limitations: It is the Examiner’s understanding that Applicant is attempting to differentiate the claimed product over the prior art by repeatedly referring to unclaimed product-by-process steps (e.g., a process lacking trifluoroacetate, a process wherein counterion content is “controlled”, a process requiring “applying a mobile phase during the final chromatographic step”, a process that avoids “impermissible amounts of acetate” that “could be contaminated by salts”, a process that “utilize[es] only acetic acid throughout the isolation and preparation of the claimed solid formulation” that “proved to be necessary”, a process requiring “complete removal of TFA”, a process requiring “careful control of the ion content and order of operations when generating a lyophilized solid”, etc.) or unclaimed limitations (e.g., improved shelf-life of reconstituted liquid formulations, pharmaceutically acceptable viscosity, oligomerization”, etc.) (see, e.g., Reply filed 2/09/2026 at 2 at § “Rejections under 35 U.S.C. § 103” to p. 4 at 2nd full ¶). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., unclaimed product-by-process steps and unclaimed limitations) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant appears to refer to unclaimed inventions: Upon review, it is the Examiner’s understanding that Applicant is referring to an unclaimed, unexamined invention, namely a method of making a product. Examination is limited at this time to a product, and a change in invention will not be permitted.
Applicant fails to identify, with specificity, what they are citing: Examiner notes that Applicant refers to three documents “collectively” as “Larsen” (see, e.g., Reply filed 2/09/2026 at 2 at final ¶), and then subsequently refers to “Larsen” at specific pages and line numbers (see, e.g., Reply filed 2/09/2026 at 3 at 3rd ¶). It is unclear what document is being referred to by these citations, since the references do not refer to a single reference, and therefore such arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant fails to acknowledge or address the merits of the rejections: Examiner notes that Applicant fails to address or dispute the merits of the rejections or the explicit rationales relied upon by the Examiner to support a determination of obviousness (e.g., MPEP § 2143(I)(A), (G); MPEP § 2144.05(I), etc.; see rejections above). Accordingly, these rationales and the underlying facts supporting these rationales (i.e., prior art ranges, concentrations, methods, compounds, etc.) that are not specifically addressed are understood to be undisputed on the instant record.
Applicant appears to suggest that the instant disclosure is not enabling for the claimed invention: It is the Examiner’s understanding that Applicant is attempting to allege that the prior art is not enabling and is inoperable to obtain the claimed invention because (i) “high amounts of trifluoroacetate” are present in the prior art (see, e.g., Reply filed 2/09/2026 at 2 at final ¶); (ii) that the “choice by Applicant to utilize only acetic acid throughout the isolation and preparation of the claimed solid formulation. . . proved to be necessary” (see, e.g., Reply filed 2/09/2026 at 4 at 3rd full ¶); (iii) “complete removal of TFA . . . is necessary” (see, e.g., Reply filed 2/09/2026 at 4 at 4th full ¶); and (iv) “careful control of the ion content and order of operations when generating [the claimed product] is critical” (see, e.g., Reply filed 2/09/2026 at 4-5 at bridging ¶). However, the instant disclosure of Application No. 18/487666 fails to mention or address any need to avoid “high amounts of trifluoroacetate” or to achieve “complete removal of TFA”, and fails to identify any methods wherein such compounds were obtained by utilizing “only acetic acid throughout the isolation and preparation of the claimed solid formulation. . . [which Applicant admits] proved to be necessary” (see, e.g., instant disclosure). Accordingly, if Applicant means to allege that any disclosure lacking such guidance is not enabling, then this would mean that the instant disclosure as filed would also not be enabling. Currently, both the instant disclosure and 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)). Applicant is directed to MPEP § 716.07, which explains that, when an Applicant alleges that a reference relied upon is inoperative, the claims represented by applicant must distinguish from the alleged inoperative reference disclosure. In re Crosby, 157 F.2d 198, 71 USPQ 73 (CCPA 1946). See also In re Epstein, 32 F.3d 1559, 31 USPQ2d 1817 (Fed. Cir. 1994) (lack of diagrams, flow charts, and other details in the prior art references did not render them nonenabling in view of the fact that applicant’s own specification failed to provide such detailed information, and that one skilled in the art would have known how to implement the features of the references; emphasis added).
No unexpected results commensurate in scope with the requirements of MPEP § 716.02 have been placed on record to date.
Accordingly, all applicable arguments pertaining to the 35 USC 103 rejections have been fully considered but not found persuasive. Therefore, the rejections are maintained as set forth above.
Double-Patenting
It is the Examiner’s understanding that Applicant’s basis for traversing the NSDP rejections is to refer to the arguments raised in the section traversing the rejections under 35 USC 103 (see, e.g., Reply filed 2/09/2026 at 5 at § Double Patenting Rejections). This is not persuasive for the reasons provided above, and for reasons previously set forth on record (see, e.g., Action mailed 4/11/2025 at 29-30, incorporated herein)
A proper response to a rejection for nonstatutory double patenting is filing of a TD, amendment to distinguish from the reference patent, or persuasive arguments as to why the rejection is incorrect. See MPEP 804 I. B. 1. and 804.02 II. A rejection may not be held in abeyance.
Summary
Accordingly, all applicable arguments have been fully considered but not found persuasive for reasons set forth above, below, and previously on record. Therefore, the rejections are maintained as set forth above.
Response to Declaration of Moller under 37 C.F.R. §1.132
The affidavit under 37 CFR 1.132 filed 2/09/2026 is insufficient to overcome the rejections of record. A detailed explanation of why the affidavits or declarations are insufficient is provided below. The legal standards of review and consideration of Declarations under 37 C.F.R. §1.132 are discussed at MPEP § 716.01.
Interest of the Expert in the Outcome of the Case
Per MPEP 716.01(c)(III), in assessing the probative value of an expert opinion, the examiner must consider the interest of the expert in the outcome of the case. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert, denied, 475 U.S. 1017 (1986). Here, the Declarant is named inventor, and therefore has a clear interest in the outcome of the case.
Nature of the Matter Sought to be Established
Per MPEP 716.01(c)(III), in assessing the probative value of an expert opinion, the examiner must consider the nature of the matter sought to be established. Ashland Oil, Inc., 776 F.2d 281.
Here, it is understood that the Declarant seeks to establish that the prior art is inoperable or not enabling for making solid formulations of ZP1848-acetate as presently claimed (see, e.g., Reply filed 2/09/2026 at 2 at § “Rejections under 35 U.S.C. § 103” to p. 4 at 2nd full ¶;.see also Dec. filed 2/09/2026 at ¶3 to ¶12).
The requirements to rebut a presumption of enablement and operability is discussed at MPEP § 716.07.
Opinions as to Legal Conclusions
As an initial matter, Examiner notes that per MPEP 716.01(c)(III), any opinions expressed by Declarant regarding legal conclusions are not entitled to any weight. However, the underlying basis for any opinion as to legal conclusions has been fully considered as detailed below.
Acknowledgement That Prior Declaration Contained Incorrect Statements
As an initial matter, the Examiner’s analysis of the prior Declaration of Villadsen filed 11/07/2024 was set forth on record in a previous action (see, e.g., Action mailed 4/11/2025 at pages 30-35). That prior Declaration was found to contain factually incorrect and unsupported statements contradicted by prior art placed on record by the Examiner, and was not found persuasive for reasons of record (see id). In the instant Declaration, the Declarant admits and acknowledges that the prior Declaration contained “earlier statements” that “were determined to be incorrect” (see, e.g., Dec. filed 2/09/2026 at ¶3).
Presence or absence of factual support for the expert’s opinion
Per MPEP 716.01(c)(III), in assessing the probative value of an expert opinion, the examiner must consider the presence or absence of factual support for the expert’s opinion. Ashland Oil, Inc., 776 F.2d 281.
It is the Examiner’s understanding that Declarant generally alleges that the prior art references of WO2006/117565A1, US 8263552 B2, and US 9125882 B2 are each inoperable or not enabling for making solid formulations of ZP1848-acetate as presently claimed (see, e.g. Dec. filed 2/09/2026 at ¶3 to ¶12). However, the burden is on the Applicant to rebut the presumption that each prior art reference is fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
The requirements to rebut a presumption of enablement and operability is discussed at MPEP § 716.07. Therefore, the relevant issue is with respect to the instant Declaration is whether or not the Declarant has satisfied their burden under MPEP § 716.07.
As an initial matter, Examiner notes that, if the Declarant’s statements are correct, it would suggest that the instant disclosure is not operable or enabling for the claimed invention because the instant Declaration does not reflect the necessary and critical steps identified by the Declarant and Applicant. Specifically, Declarant alleges that
As described in more detail below, preparing the claimed solid acetate salt form via lyophilization can be impossible in the presence of counter-anions to strong acids which are typically present with the peptide following its manufacture (i.e., chloride anions or trifluoroacetate anions).
(see, e.g., Dec. filed 2/09/2026 at ¶5, emphasis added).
“one must first process the peptide to remove counter-ions of strong acids. . .
(see, e.g., Dec. filed 2/09/2026 at ¶6, emphasis added).
Only once those counter-ions of strong acids are removed can the claimed acetate salt forms be reliably prepared”
(see, e.g., Dec. filed 2/09/2026 at ¶6, emphasis added).
“To arrive at the solid compositions of the claimed invention, one must remove/exchange the counter-anions of any stronger acids for acetate, and only then can the stabilizing advantage of the acetate salt form be realized”
(see, e.g., Dec. filed 2/09/2026 at ¶12, emphasis added).
Importantly, the use of acetic acid in the mobile phase during purification facilitated the exchange of other counterions with acetate, so that only the claimed acetate salts are formed.
(see, e.g., Dec. filed 2/09/2026 at ¶7).
I have observed that when acetic acid is added to the chloride or trifluoroacetate salts of analogous GLP-2 peptides without the purification described in Example 1, the subsequent lyophilization can result in salt forms that are mixtures, including the counter ions of stronger acids (i.e., TFA or HCI) left over from the synthetic process for making the peptides.
(see, e.g., Dec. filed 2/09/2026 at ¶8).
The presence of histidine and arginine cause additional acetate to be retained in the lyophilized solid beyond what is provided
(see, e.g., Dec. filed 2/09/2026 at ¶9).
Declarant also refers to “The criticality of salt exchange for the preparation of the claimed acetate salt of ZP1848” (see, e.g., Dec. filed 2/09/2026 at ¶10, emphasis added), and is understood to suggest that to create the claimed product an artisan must use “HPLC purification of ZP1848 using acetic acid in the mobile phrase” (see, e.g., Dec. filed 2/09/2026 at ¶4). Apparently, the Declarant’s statements and description have been interpreted by the Applicant to mean that
Thus, careful control of the ion content and order of operations when generating a lyophilized solid ZP1848• x(CH3COOH) composition is critical…
(see, e.g., Reply filed 2/09/2026 at 4-5 at bridging ¶, emphasis added).
…the complete removal of TFA from the Larsen compositions is necessary…
(see, e.g., Reply filed 2/09/2026 at 4-5 at bridging ¶, emphasis added).
However, such statements do not find support in the originally filed disclosure of Application 18/487,666, and neither Declarant nor Applicant identify where critical order of operations, criticality of counterion exchange or required steps one “must” perform are actually identified in the originally filed disclosure commensurate with the instant claim scope and commensurate with Declarant’s averred statements. At best, the instant disclosure provides the limited guidance at Example 1 (see, e.g., Spec. filed 10/16/2023 at page 29 at lines 15-26), which identifies that an unspecified formulation having unknown amounts of mannitol, arginine, histidine, acetic acid, and peptide, and having an unspecified pH was synthesized using routine processes wherein “the crude peptide was purified using preparative reversed-phase HPLC”, wherein “[t]he peptide was converted to the desired acetate salt form by applying a mobile phase during the final chromatographic step with an appropriate concentration of acetic acid and subsequent lyophilization” (see, e.g., Spec. filed 10/16/2023 at page 29 at lines 15-26). However, the originally filed specification does not teach, disclose, or recite any guidance regarding criticality of “ion content and order of operations, “complete removal of TFA”, “presence of counter-anions to strong acids”, that “[t]he presence of histidine and arginine cause additional acetate to be retained”, etc., etc. This is relevant because to establish inoperability or lack of enablement under MPEP § 716.07, a declarant must distinguish the claimed invention and original disclosure relative to the prior art at issue:
Where the affidavit or declaration presented asserts that the reference relied upon is inoperative, the claims represented by applicant must distinguish from the alleged inoperative reference disclosure. In re Crosby, 157 F.2d 198, 71 USPQ 73 (CCPA 1946). See also In re Epstein, 32 F.3d 1559, 31 USPQ2d 1817 (Fed. Cir. 1994) (lack of diagrams, flow charts, and other details in the prior art references did not render them nonenabling in view of the fact that applicant’s own specification failed to provide such detailed information, and that one skilled in the art would have known how to implement the features of the references).
Here, like In re Epstein, arguments alleging that the prior art references did not teach alleged necessary and required aspects not taught by the instant disclosure are not sufficient to establish lack of operability under MPEP § 716.07, because lack of “other details in the prior art reference [does] not render them nonenabling in view of the fact that applicant’s own specification failed to provide such detailed information”. In sum, if the lack of such details renders the prior art inoperable or non-enabling, it implies that the instant disclosure is also not enabling since it lacks such details of critical and necessary steps identified by the Declarant; however, for purposes of MPEP § 716.07, the lack of details that are also missing from the instant disclosure is not sufficient to satisfy the Declarant’s burden under MPEP § 716.07 because it does not distinguish the instant disclosure over the prior art.
Regarding the limited guidance actually found in the instant disclosure, Examiner acknowledges that the instant specification discloses at Example 15 guidance relied upon by the Declarant (see, e.g., Dec. filed 2/09/2026 at ¶¶4, 7, Part 2 at page 7), pertaining to an unspecified formulation having an unspecified pH, wherein the guidance identifies that
The peptide was converted to the desired acetate salt form by applying a mobile phase during the final chromatographic step with an appropriate concentration of acetic acid and subsequent lyophilization”
(see, e.g., Spec. filed 10/16/2023 at page 29 at lines 15-26).
Accordingly, a relevant issue under MPEP § 716.07, is whether or not this disclosure distinguishes the instant claim scope relative to the prior art, thereby rendering the prior art inoperable or non-enabling. Upon review, Examiner notes that ion-exchange was well-known in the prior art, as evidenced by the prior art references relied upon in the rejections, which each exemplifies a method for “counter ion exchange from trifluoroacetate to acetate” after synthesis (see, e.g., WO’565 at p. 44 at lines 25-36; see also US’552 at col 42 at lines 4-25; see also US’882 at col. 44 at lines 4-25):
Counter ion exchange from trifluoroacetate to acetate of Compound 1846. The purified synthetic peptide product of compound 1846 is isolated as a trifluoroacetate salt, due to the presence of trifluoroacetic acid (0, 1 % v/v) in the HPLC buffers used for the purification of the crude synthetic peptide product.
In order to exchange the counter ion trifluoroacetate with acetate, a solution of the peptide was passed through a column packed with strong base ion exchange resin on the acetate (Dowex 1 x8). 365 mg Compound 1 is dissolved in 40 ml water. The solution is passed through a column containing 40 ml strong base ion exchange resin on the acetate (Dowex 1x8; capacity 1.33 meq/ml 35 resin). The resin is then washed with 4 x 30 ml water and the eluate is collected and lyophilized resulting in 312 mg acetate salt with a purity according to HPLC analysis of 97%.
Accordingly, the prior art clearly and unambiguously taught and disclosed methods of forming acetate salts of GLP-2 analogues by “exchang[ing] the counter ion trifluoroacetate with acetate”, wherein the GLP-2 analogue was “passed through a column packed with strong base ion exchange resin on acetate”, and following washing steps, “the eluate is collected and lyophilized” (see, e.g., WO’565 at p. 44 at lines 25-36; see also US’552 at col 42 at lines 4-25; see also US’882 at col. 44 at lines 4-25). Accordingly, performing a counter ion exchange from trifluoroacetate to acetate following synthesis of a GLP-2 analogue was well-known and routine in the prior art. Accordingly, such disclosures fail to distinguish the prior art over the instant claims and therefore does not establish inoperability or lack of enabling disclosure of WO’565, US’552, or US’882.
Declarant alleges
The Larsen references do not exemplify or prophetically describe a process for making the presently claimed ZP1848 acetate formulation…
(see, e.g., Dec. filed 2/09/2026 at ¶5).
This appears to be factually incorrect, because each prior art reference literally teaches and directs artisans to utilize the process of lyophilization of the identical peptide with the same or overlapping amounts of acetic acid as instantly disclosed (see rejections above; see, e.g., WO’564 at 31 at lines 5-7; see also WO’564 at 32 at lines 1-14, 32 at lines 15-30, 32 at line 31 to p. 33 at line 6, 33 at line 7 to 22, 33 at lines 24-38, 34 at lines 24-26; see also US’552 at col. 28 at line 63 to col. 29 at line 15, col. 29 at lines 15-35, col. 29 at lines 25-55, col. 29 at line 55 to col. 30 at line 9, col. 30 at line 9 to line 26; see, e.g., US’882 at col. 31 at line 1 to col. 32 at line 33). Accordingly, the references clearly teach and exemplify lyophilization methods to create solid compositions of the same exact peptide, having the same or overlapping amounts of the same, exact components, including histidine, arginine, mannitol, and acetic acid, wherein the compound is at the same or overlapping pH as exemplified on the instant record (see rejections above; see, e.g., WO’564 at 31 at lines 5-15, page 32 at line 1 to page 33 at line 38). Regarding counterion exchange of TFA with acetate prior to lyophilization, the prior art references explicitly teach, disclose, and exemplify processes required to exchange the counter ion of trifluoroacetate with acetate (see, e.g., WO’565 at p. 44 at lines 25-36; see also US’552 at col 42 at lines 4-25; see also US’882 at col. 44 at lines 4-25). Accordingly, Declarant’s assertions that the reference “do not exemplify or prophetically describe a process…” is unsupported by objective evidence and contradicted by the disclosures of the prior art references of record. Accordingly, such incorrect statements do not satisfy the requirements of MPEP § 716.07.
It is the Examiner’s understanding that Applicant is alleging and providing experimental evidence showing that using specific experimental conditions, that it is possible to not obtain the instantly claimed invention (see, e.g., Dec. filed 2/09/2026 at ¶3 to ¶12, Appendix Part 1 at 5, Appendix Part 2 at 6). However, it is prima facie unclear what the relevance the explicitly tested conditions are to the claimed invention and to the prior art of record. Notably, the prior art at issue does not recite nor require TFA to be present; in fact, the prior art explicitly exemplifies the exact compounds and overlapping concentrations of each used to create the instantly claimed invention, and the prior art expressly details how to perform a counter ion exchange of trifluoroacetate with acetate prior to lyophilization (see, e.g., WO’565 at p. 44 at lines 25-36; see also US’552 at col 42 at lines 4-25; see also US’882 at col. 44 at lines 4-25). Furthermore, it is prima facie unclear what nexus the tested embodiments share with the instantly claimed product, which is not limited to the concentrations, formulation, molar ratios, or pH tested (compare instant claims with Dec. filed 2/09/2026 at Appendix Part 1 at 5, Appendix Part 2 at 6). Accordingly, such data has been fully considered, but the experimental evidence provided appears to be no more than an example showing that “it is possible to operate within the disclosure without obtaining the alleged product” if a counter-ion exchange is not performed as taught by the prior art in an embodiment having an unclaimed pH, unclaimed histidine buffer concentration, unclaimed mannitol concentration, unclaimed arginine concentration, and unclaimed molar ratios of such components. This is pertinent because MPEP § 716.07 states that the declaration “must rebut the presumption of operability by a preponderance of the evidence” (see also In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980)), and that
Further, since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969). It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker. The failures of experimenters who have no interest in succeeding should not be accorded great weight. In re Michalek, 162 F.2d 229, 74 USPQ 107 (CCPA 1947); In re Reid, 179 F.2d 998, 84 USPQ 478 (CCPA 1950).
Accordingly, proffered evidence showing that it is possible to “operate within the disclosure without obtaining the alleged product” is insufficient to rebut a presumption of operability and enablement because the prior art is presumed fully enabled, and the prior art establishes that an artisan would readily understand how to exchange counterions, and specifically how to exchange acetate for TFA prior to lyophilization (see, e.g., WO’565 at p. 44 at lines 25-36; see also US’552 at col 42 at lines 4-25; see also US’882 at col. 44 at lines 4-25). Accordingly, such evidence is insufficient to rebut the presumption that the prior art is fully enabled.
Following review of the Declarant’s arguments, Examiner notes that the arguments raised appear to be highly reminiscent of similar issues and arguments addressed in Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007). That case pertained to amlodipine besylate drug product, which was sold in a solid tablet form in the United States under the trademark Norvasc®. Amlodipine and the use of besylate anions were both known at the time of the invention. Amlodipine was known to have the same therapeutic properties as were being claimed for the amlodipine besylate, but Pfizer discovered that the besylate form had better manufacturing properties (e.g., reduced "stickiness"). On the basis of this alleged advantage, Pfizer argued that the results of forming amlodipine besylate would have been unpredictable and therefore nonobvious. In that case, the court rejected the notion that unpredictability could be equated with nonobviousness here, because there were only a finite number (53) of pharmaceutically acceptable salts to be tested for improved properties, and the court found that one of ordinary skill in the art having problems with the machinability of a compound would have looked to forming a salt of the compound and would have been able to narrow the group of potential salt-formers to a group of 53 anions known to form pharmaceutically acceptable salts, which would be an acceptable number to form "a reasonable expectation of success." Similarly, here it is undisputed that the GLP-2 analogue at issue is a prior art element or that acetate salts were already known in the art, or that the prior art explicitly directed artisans to formulations that would inherently and intrinsically form acetate salts. Rather, the distinction is that the Declarant appears to be alleging in the instant case that an artisan would not be enabled to simply exchange one counterion for another (i.e., forming acid addition salt forms) as a routine matter in the chemical arts. However, the holding of Pfizer, Inc. v. Apotex, Inc necessarily determined that exchanging one such salt for another in a chemical compound was already obvious to artisans at least circa 2000, as would be necessary to reach the holding in that case. Accordingly, arguments premised upon an assumption that one of ordinary skill in the art could not perform a routine counter ion exchange is not persuasive.
Accordingly, all proffered arguments have been fully considered but not found persuasive because prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), and the burden is on the Declarant to rebut that presumption by providing objective evidence commensurate in scope with the requirements of MPEP § 716.07, wherein the evidence must be sufficient to rebut the presumption of operability by a preponderance of the evidence (see, e.g., MPEP § 716.07; see also In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980)). Here, the preponderance of the evidence does not weigh in favor of the Declarant’s position as explained above.
Summary
Per MPEP § 716.01(d), the ultimate determination of patentability must be based on consideration of the entire record and notes that submission of evidence of patentability does not mandate a conclusion of patentability in and of itself. Accordingly, the Declaration has been fully considered but is not found persuasive because it does not rebut the presumption of enablement and operability of the prior art in the manner discussed at MPEP § 716.07. At this time, the record suggests that exchanging a counter ion trifluoroacetate with acetate prior to lyophilizing a GLP-2 analogue was well-known in the prior art (see, e.g., WO’565 at p. 44 at lines 25-36; see also US’552 at col 42 at lines 4-25; see also US’882 at col. 44 at lines 4-25), and therefore the prior art continues to be presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), because the Declarant has failed to rebut this presumption by a preponderance of the evidence (see, e.g., MPEP § 716.07; see also In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980)).
Accordingly, the rejections are maintained.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 7,745,403 B26 teaches, discloses, and claims a highly similar sequence as instantly claimed, but US’403 differs from the sequence of instant claim 1 and claim 7(a) because SEQ ID NO: 34 is not identical to the sequence shown at instant claims 1 and 7.
US20070231308A17 pertains to related GLP-2 sequences (see, e.g., id. at title, abs, claims).
US20170137487A18 pertains to related GLP-2 sequences, and corresponds to abandoned Application 15/411,649.
U.S. 8,163,696 B29 discloses the peptide of ZP1848 and salts thereof, for use in the treatment of inflammatory bowel disease (see, e.g., US’696 at claims 1-4). The disclosure is largely cumulative with respect to instant WO’565 as applied above.
U.S. 9,580,487 B210 (Feb. 28, 2017; cited in previous action) discloses the peptide of ZP1848 and salts thereof, for use in the treatment of various diseases (see, e.g., US’487 at claims). The disclosure is largely cumulative with respect to instant WO’565 as applied above.
Lee et al.11 that measured viscosity may differ for a solution depending upon the assay and equipment used (see, e.g., Lee at title, abs, Fig. 1 on 1475, Fig. 2 on 1476).
US9636407B212 discloses a method of forming a solid composition via lyophilizing wherein the resulting compound comprised peptide-acetate (see, e.g., id. at claim 7-10). US’407 was previously cited on record to show that the prior Declarant’s assertions were contradicted by the prior art (see, e.g., Action mailed 4/11/2025 at pages 30-35). In a subsequent declaration, a different Declarant admitted that the prior Declaration contained statements that “were determined to be incorrect” (see, e.g., Dec. filed 2/09/2026 at ¶3).
US20060276626A113 discloses methods for drying a peptide-acetate formulation by lyophilizing or spray drying, but obtaining a peptide with acetate (see also US20060276626A1 at ¶¶[0098]-[0105]). US’626 was previously cited on record to show that the prior Declarant’s assertions were contradicted by the prior art (see, e.g., Action mailed 4/11/2025 at pages 30-35). In a subsequent declaration, a different Declarant admitted that the prior Declaration contained statements that “were determined to be incorrect” (see, e.g., Dec. filed 2/09/2026 at ¶3).
Valery14 discloses that at least circa 2004, peptide acetate powders were commercially available and sold (see, e.g., Valery at title, abs, 2485 at col II at §§ Materials). Valery was previously cited on record to show that the prior Declarant’s assertions were contradicted by the prior art (see, e.g., Action mailed 4/11/2025 at pages 30-35). In a subsequent declaration, a different Declarant admitted that the prior Declaration contained statements that “were determined to be incorrect” (see, e.g., Dec. filed 2/09/2026 at ¶3).
Conclusion
No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 It is the Examiner’s understanding that Applicant mistakenly refers to claims 1-6 as “newly elected” and as “these elected species” (see, e.g., Reply filed 5/23/2024 at 4 at § Species election). This is incorrect because only a single species election has been issued on record. Per MPEP 803.02(III)(A), when claims are amended to exclude an elected species, examination proceeds to a non-elected species.
2 The molecular weight of approximately ~4316. The molecular weight of CH3CHOOH is ~61.0599.
3 Cited in previous action.
4 This structure satisfied the requirements of the formula pertaining to instant SEQ ID NO: 1 at original claim 7 wherein R1 is H, Z1 is absent, X5 is Thr, X11 is Ala, Z2 is (K)6, and R2 is NH2.
[1] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
[1] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
5 See, e.g., Spec. filed 10/16/2023 at page 29 at lines 15-26.
6 Cited in previous action.
7 Cited in previous action.
8 Cited in previous action.
9 Cited in previous action.
10 Cited in previous action.
11 Lee et al. (Comparison tests for plasma viscosity measurements, International Communications in Heat and Mass Transfer, Volume 39, Issue 10, 2012, Pages 1474-1477, ISSN 0735-1933; cited in previous action; hereafter “Lee”.
12 Cited in previous action.
13 Cited in previous action.
14 Valéry et al., Self-association process of a peptide in solution: from beta-sheet filaments to large embedded nanotubes. Biophys J. 2004 Apr;86(4):2484-501. doi: 10.1016/S0006-3495(04)74304-0. PMID: 15041685; PMCID: PMC1304096; hereafter “Valery”; cited in previous action.