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 .
Application Status – Continued Examination Under 37 CFR 1.114
Claims 38-58 and 61-72 were previously pending.
A Final Rejection office action was mailed 29 December 2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 March 2026 has been entered.
In their request for continued examination, Applicant has amended claim 38, 53, 63, 68-69, and canceled claims 52, 54-58, 61-62, 64-67, and 70-72.
Therefore, claims 38-51, 53, 63, and 68-69 are now pending and currently under examination.
Priority
Acknowledgement is made for the following priority:
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Applicant’s 27 March 2026 submission verifying the accuracy of the English translation of foreign priority document KR 10-2020-0061875 is acknowledged.
Withdrawn Claim Rejections
In light of Applicant’s amendment to independent claim 38 and cancellation of claims 52, 54-58, 61-62, 64-67, and 70-72, all previous claim rejections are moot and hereby withdrawn.
New Claim Objections/Rejections
It is noted the rejected claims have been modified and therefore the following
objections/rejections have been modified to reflect said amendments (e.g., cancelled claims,
amendments which partially overcome the rejection, newly added claims). In addition, Applicant’s amendments have warranted new claim objections/rejections as discussed below:
Claim Objections
Claim 38 is objected to for the following informalities:
Claim 38 recites [Chemical Formula 1]. If this is intended claim language, the brackets should be removed as it is unclear whether the bracketed language is part of the claim or represents deleted matter.
Claim 38 further recites Q – La – Z and then further list components. The following changes are recommended:
Z is an immunoglobulin Fc fragment; [[and]]
The symbol ‘-’ represents a covalent bond[[:]]; and
Q is a peptide comprising the amino acid sequence of SEQ ID NO: 47 below[[;]]:
Claim 69 is objected to for a probable typographical error: “0.01 mg/mL to 1 mg/mL of a methionine.”
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 38-51, 53, 63, and 68-69 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.
Using ‘consistently essentially of’ in claim language is generally acceptable. However, in claim 38, the problem is how this phrase is being used leading to issues of indefiniteness under 35 U.S.C. 112(b).
Claims 38, 68, and 69 recite, in part:
“…wherein the liquid formulation comprises: an active ingredient consisting essentially of…”
Use of ‘consisting essentially of’ in this manner creates ambiguity about what the active ingredient can include. It could mean:
The active ingredient is only the long-acting conjugate, except for impurities that do not materially affect the basic and novel characteristics;
The liquid formulation may include other active ingredients, in addition to the long-acting conjugate of Chemical Formula 1, if the other active ingredients do not materially affect the basic and novel characteristics;
The concentration of the active ingredient consists essentially of 90 nmol/mL to 552 nmol/mL, but the active ingredient can be included in a concentration outside that range as long as it doesn’t affect the basic and novel characteristics; or
The long-acting conjugate itself can include variants or additional materials.
‘Consisting essentially of’ modifies the active ingredient, while the recited subject matter is a concentration range of a long-acting conjugate rather than a list of components defining the active ingredients. For these reasons, claim 38 is rejected under 35 U.S.C. 112(b). Claims 39-51, 53, 63, and 68-69 are included in this rejection because their dependency on, and requiring each limitation of, rejected claim 38 and failing to cure the defect. For purposes of examination, the claims have been interpreted as the active ingredient is only the long-acting conjugate, except for impurities that do not materially affect the basic and novel characteristics.
Claim 38 is further rejected under 35 U.S.C. 112(b) for the following:
Claim 38 recites –
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As recited, SEQ ID NOs: 48 and 49 contain wildcard residues m and n. However, the sequence disclosure denoting SEQ ID NOs: 48 and 49 as ‘R1’ is absent of wildcard residues:
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Since the recited sequences differ from the sequence disclosure, it is unclear if claim 38 limits R1 to SEQ ID NOs: 48 or 49 (no wildcard residues) or requires the recited sequences contain wildcard residues m and n. A person of ordinary skill (‘POSITA’) could not determine the metes and bounds of this claim and therefore, claim 38 is indefinite. Claims 39-51, 53, 63, and 68-69 are included in this rejection because their dependency on, and requiring each limitation of, rejected claim 38 and failing to cure the defect. For purposes of examination, R1 will be interpreted as selected from: cysteine, m-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-n, m-Ser-Ser-Gly-Gln-Pro-Pro-Pro-Ser-n, or absent.
Claims 38, 68, and 69 are rejected under 35 U.S.C. 112(b) for the following reasons:
Claim 38 recites the buffering agent is selected from “citric acid and a salt thereof, and acetic acid and a salt thereof…” It is unclear if this claim requires the buffering agent is selected from: citric acid or a salt thereof, or acetic acid or a salt thereof; citric acid and a salt thereof, or acetic acid and a salt thereof; or citric acid and a salt thereof, and acetic acid and a salt thereof. Each of these versions represent different claim interpretation. For purposes of examination, this claim will be interpreted as the buffering agent is selected from: citric acid or a salt thereof, or acetic acid or a salt thereof. This interpretation is most aligned with the previous presentation of the claims.
Both claims 68 and 69 recite “…of an acetic acid and a salt thereof as a buffering agent…” It is unclear if these claims require both an acetic acid and a salt thereof as a buffering agent. For purposes of examination, these claims will be interpreted as the buffering agent is selected from an acetic acid or a salt thereof. This interpretation is most aligned with the previous presentation of the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 38-45, 49-51, 53, 63, and 68-69 are rejected under 35 U.S.C. 103 as being unpatentable over Oh (cited in previous office action as: US 2018/0311315 A1, published: 01 November 2018) in further view of Kim (US Patent No. 9,724,420 B2, date of patent: 08 August 2017).
Oh discloses a long-acting conjugate of triple glucagon/GLP-1/GIP receptor agonist. Regarding instant claims 38, 68, and 69, Oh discloses the following:
Conjugate General Formula
The conjugate is represented by Chemical Formula 1: X – La – F ([0019])
Wherein X is a peptide having activities to a glucagon receptor, a glucagon-like peptide-1 (GLP-1) receptor, and a glucose-dependent insulinotropic polypeptide (GIP) receptor ([0021]); L is a linker ([0022]); a is 0 or a positive integer, with the proviso that when a is 2 or greater, each L is independent from each other ([0023]); and F is a material capable of increasing the half-life of X.
F and X may be bound to each other via a covalent chemical bond or F and X may be bound to each other through L via a covalent chemical bond ([0463]).
Peptide (X) General Formula 1 ([0027])
Peptide X is represented by General Formula 1 below:
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Oh discloses Peptide X includes an amino acid sequence selected from SEQ ID NOs: 1 to 102 ([0199]). Meeting all the limitations set forth in General Formula 1, SEQ ID NO: 42 is identical to SEQ ID NO: 9 of the currently claimed application:
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In addition, R1 of both Oh’s General Formula 1 and the currently claimed peptide Q formula (SEQ ID NO: 47) are identical. Oh discloses R1 is selected from SEQ ID NOs: 106, 107, or 108 ([0050]). SEQ ID NOs: 107 and 108 are identical to currently claimed SEQ ID NOs: 48 and 49.
SEQ ID NO: 107 and currently claimed SEQ ID NO: 48:
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SEQ ID NO: 108 and currently claimed SEQ ID NO: 49:
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As in the currently claimed application, Oh discloses the sequence of R1 is sandwiched between variables m and n, where:
m is selected from amino acids that include -Cys- and -Pro- ([0052]); and
n is selected from amino acids that include -Cys-, -Gly-, or is absent ([0052]).
As in the currently claimed application, Oh discloses in General Formula 1, the 16th and 20th amino acids from the N-terminus together form a ring ([0198]) and that ring can be a lactam ring ([0256]).
Linker (La)
Oh discloses L is a linker ([0022]); a is 0 or a positive integer, with the proviso that when a is 2 or greater, each L is independent from each other ([0023]). Oh further discloses the linker can be polyethylene glycol ([0481]).
Material capable of increasing the half-life of X (F)
Oh discloses F is an immunoglobulin Fc region ([0202]).
Liquid Formulation
Oh discloses a pharmaceutical composition of the present invention containing the conjugate and a buffering agent ([0534]). Oh further discloses this composition also contains sugar alcohols such as sorbitol, mannitol, xylitol, erythritol, and maltitol ([0536]). Finally, Oh discloses the pharmaceutical composition may be prepared in any formulation including liquid ([0537]).
As discussed in the previous final office action, Oh specifically discloses the overall conjugate architecture as currently claimed in claim 38. While Oh does not expressly disclose mixing this base liquid formulation with the specific limitations of newly amended claim 38, Oh does contemplate improved stability through addition of other components, including carbohydrates, and stabilizers (“For increasing stability or absorptivity, carbohydrates such as glucose, sucrose, or dextrans, antioxidants such as ascorbic acid or glutathione, chelating agents, low molecular weight proteins, or other stabilizers may be used as pharmaceutical drugs” [0539]). Any deficiency in Oh is cured by the disclosures of Kim, which teaches the architecture of a liquid formulation system as currently claimed. Specifically, Kim teaches albumin-free liquid formulations of a long-lasting peptide-Fc conjugate comprising a peptide, a buffer, a sugar alcohol, and a nonionic surfactant (abstract) as described below:
Buffering Agent
Kim teaches buffering agents to maintain the pH of the liquid formulations so that the pH does not rapidly change, thereby stabilizing the long-lasting conjugate (col. 6, lines 22-25). Regarding instant claims 38 and 53, Kim teaches suitable buffers include citric acid or acetic acid (col. 6, lines 25-30) to maintain a pH of 5.0 to 6.0 in the most preferred embodiments (col. 6, lines 32-35). Kim also teaches these buffers at a concentration of 5-100 mM, more preferably between 5-50 mM. Furthermore, Kim provides working examples of a liquid formulation containing the long-lasting peptide-Fc conjugate and sodium citrate buffer at 20 mM (col. 24, Table 2) and more generally teaches buffer concentrations overlapping the claimed 5 mM to 25 mM range.
Sugar
Kim teaches sugars and sugar alcohols as stabilizers for increasing storage stability of the long-lasting peptide-Fc conjugate (col. 8, lines 3-14) at a concentration between 1-20% w/v, and preferably between 2-15% w/v. Although the working examples of Kim use mannitol, the reference expressly identifies sucrose as a suitable stabilizing sugar (col. 8, line 8) in an amount which overlaps with the instantly claimed range.
Nonionic Surfactant
Kim teaches nonionic surfactants to lower the surface tension of the protein solution to prevent the protein from being adsorbed onto a hydrophobic surface or from aggregating (col. 7, lines 25-28). Kim teaches these include polysorbate-based and poloxamer-based nonionic surfactants at a concentration of 0.2% w/v or less, and preferably 0.001-0.1% w/v (col. 7, lines 33-35). Kim further teaches examples where the long-lasting peptide-Fc conjugate was formulated in a liquid with 0.02% polysorbate 20 and 0.1 mg/mL of methionine (col. 7, lines 42-51).
Methionine
Kim teaches methionine as an additional component of the formulation (col. 7, lines 37-38). Kim teaches methionine functions to stabilize the protein by inhibiting the production of impurities that can be caused by, for example, the oxidative reaction of the protein (col. 7, lines 38-41). Kim teaches methionine in a concentration of 0.001 to 1 mg/mL (col. 6, lines 1-2).
Isotonic Agent
Regarding instant claim 63, Kim teaches use of isotonic agents, such as sodium chloride, to maintain in vivo osmotic pressure when administering the long-lasting peptide-Fc conjugate in solution (col. 7, lines 52-54). Kim also teaches the isotonic agent may further stabilize the long-lasting peptide-Fc conjugate in solution (col. 7, lines 54-56).
Active Ingredient
The only element not expressly taught in the combination of Oh and Kim in identical terms is the claimed active concentration of 90 nmol/mL to 552 nmol/mL. However, Oh teaches therapeutically useful long-acting triple agonist conjugates and compositions containing the conjugate, while Kim teaches liquid formulations containing pharmacologically effective amounts of a structurally similar long-lasting peptide-Fc conjugate, including examples at 10 mg/mL (col. 24, Table 2) and 40 mg/mL (col. 33, Table 26). Active ingredient concentration in an injectable peptide-Fc conjugate is a result-effective variable because it affects dose volume, viscosity, stability, and therapeutic exposure. Therefore, it would have been obvious to a POSITA to optimize the concentration of the long-acting conjugate to a pharmacologically effective concentration within the claimed range.
Instant claims 39-42 narrow the peptide Q to claimed SEQ ID NOs, including SEQ ID NO: 9. Oh discloses Peptide X includes an amino acid sequence selected from SEQ ID NOs: 1 to 102 ([0199]). Meeting all the limitations set forth in General Formula 1, SEQ ID NO: 42 is identical to SEQ ID NO: 9 of the currently claimed application:
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To the extent Applicant’s SEQ ID NOs: 1-46, and particularly SEQ ID NO: 9, correspond to the species disclosed by Oh or fall within the expressly taught peptide genus, these claims would have been obvious.
Instant claim 43 narrows R1 to specific embodiments identical to those taught in Oh. R1 of both Oh’s General Formula 1 and the currently claimed peptide Q formula (SEQ ID NO: 47) are identical. Oh discloses R1 is selected from SEQ ID NOs: 106, 107, or 108 ([0050]). SEQ ID NOs: 107 and 108 are identical to currently claimed SEQ ID NOs: 48 and 49.
SEQ ID NO: 107 and currently claimed SEQ ID NO: 48:
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SEQ ID NO: 108 and currently claimed SEQ ID NO: 49:
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As in the currently claimed application, Oh discloses the sequence of R1 is sandwiched between variables m and n, where:
m is selected from amino acids that include -Cys- and -Pro- ([0052]); and
n is selected from amino acids that include -Cys-, -Gly-, or is absent ([0052]).
As in the currently claimed application, Oh discloses in General Formula 1, the 16th and 20th amino acids from the N-terminus together form a ring ([0198]) and that ring can be a lactam ring ([0256]).
Oh discloses an identical R1 segment attached to the peptide as what is represented by SEQ ID NOs: 50, 51, 52, 53, and 54 in the instant application.
SEQ ID NO: 109 in Oh is identical to the currently claimed SEQ ID NO: 50:
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SEQ ID NO: 112 in Oh is identical to the currently claimed SEQ ID NO: 51:
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SEQ ID NO: 113 in Oh is identical to the currently claimed SEQ ID NO: 52:
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SEQ ID NO: 116 in Oh is identical to the currently claimed SEQ ID NO: 53:
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SEQ ID NO: 117 in Oh is identical to the currently claimed SEQ ID NO: 54:
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Regarding instant claim 44, Oh discloses the N- and C-termini of the peptide may be acetylated and/or amidated ([0268]).
Regarding instant claim 45, Oh discloses the immunoglobulin Fc fragment is derived from IgG4 ([0509]).
Regarding instant claim 49, Oh discloses the immunoglobulin Fc region in a deglycosylated or aglycosylated form may be more suitable ([0506]). Oh also discloses an embodiment of the invention using native GLP-1 ([0026]), which is not glycosylated.
Regarding instant claim 50, Oh discloses the linker (L) in the formulation is polyethylene glycol ([0205] and [0206]).
Regarding instant claim 51, Oh discloses the non-peptide linker is in the range of 1kDa to 100 kDa ([0482]).
It would have been obvious to a POSITA, before the effective filing date of the claimed invention, to formulate the long-acting triple agonist peptide-Fc conjugate of Oh using the liquid stabilizer system of Kim because both references concern long-lasting glucagon/GLP-1-related peptide conjugates linked to immunoglobulin Fc fragments. A POSITA would have been motivated to use the stabilizer system of Kim to maintain stability of the peptide-Fc conjugate in liquid form, reduce aggregation and surface adsorption, inhibit oxidative degradation, and provide a pharmaceutically acceptable injectable formulation. Kim teaches such a stabilizer system comprising components at ranges (concentrations and amounts) which overlap with, or are identical to, the instantly claimed formulation. A reasonable expectation of success would have existed because the excipients perform conventional, predictable functions in protein/peptide liquid formulations: a buffer maintains the pH, sucrose stabilizes the protein/peptide conjugate, nonionic surfactant reduces adsorption and aggregation, and methionine inhibits oxidative degradation – all of which is expressly disclosed by Kim.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Oh (cited above) and Kim (cited above) as applied to claims 38-45, 49-51, 53, 63, and 68-69 above, and further in view of Hanmi Science Co. (cited in previous office action as: US 2014/0357843 A1, published: 04 December 2014).
The disclosures of Oh and Kim are discussed above. Regarding instant claim 47, neither Oh nor Kim expressly disclose the limitations of claim 47.
Hanmi Science Co. (US 2014/0357843 A1; hereinafter ‘Hanmi’) discloses immunoglobulin Fc variants that have an increased binding affinity for FcRn (abstract). The Fc variants disclosed by Hanmi show a high binding affinity for FcRn and can increase in vivo half-life of a physiologically active polypeptide ([0017]). Hanmi discusses the advantageous nature of the Fc variant where the protein conjugate having a prolonged in vivo half-life, in which the immunoglobulin Fc variant is covalently linked to the physiologically active polypeptide via a non-peptidyl polymer, can be effectively used for the preparation of a long-acting formulation of protein drugs with remarkably low administration frequency ([0017]). Finally, Hanmi discloses the physiologically active peptide useful in the invention can be GLP-1 ([0056]).
Regarding instant claim 47, Hanmi discloses an Fc variant that is identical to SEQ ID NO: 76 of the instant application as shown below:
SEQ ID NO: 73 disclosed by Hanmi and instant SEQ ID NO: 76
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Hanmi discloses SEQ ID NO: 73 is ‘HMC001’ (p. 23) and has proline as its first amino acid in the N-terminus region ([0038]).
Regarding dependent claim 47, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to arrive at the currently claimed invention. Both Oh and Kim disclose a peptide conjugate liquid formulation comprising a peptide, linker, and material capable of increasing the half-life of the peptide. Furthermore, both Oh and Kim disclose the material capable of increasing the half-life of the peptide is FcRn-binding material such as an IgG Fc region. Hanmi discloses Fc variants that have an increased binding affinity for FcRn, including the Fc variant represented by SEQ ID NO: 73, which is identical to the Fc variant claim in instant claim 47. Therefore, one of ordinary skill in the art would anticipate success by substituting the Fc variant disclosed by Hanmi in the peptide-conjugate disclosed by Oh and Kim because Hanmi teaches their disclosed Fc variants display optimal FcRn binding capabilities. A simple substitution of one known equivalent element for another obtains predictable results and a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation, but of ordinary skill and common sense (KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
Claims 46 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Oh (cited above) and Kim (cited above) as applied claims 38-45, 49-51, 53, 63, and 68-69 above, and further in view of Hanmi Science Co. (cited above) and Lee (cited in previous office action as: US 2018/0271995 A1, published 27 September 2018).
The teachings of Oh, Kim, and Hanmi are disclosed above. Oh discloses the linker contains a reactive group that can be linked to an amine group located at the N-terminus of the Fc region ([0484]). However, none of the aforementioned references teach the limitations as disclosed in instant claims 46 and 48.
Lee discloses a physiologically active polypeptide conjugate comprising multiple physiologically active polypeptides and immunoglobulin Fc regions (abstract). Lee discloses the physiologically active peptide can be a glucagon-like peptide ([0120]). Lee further discloses the immunoglobulin Fc region is in a dimeric form comprising two polypeptide chains linked by a disulfide bond ([0078], [0239]). The various Fc derivatives disclosed by Lee have improved structural stability against heat, pH, etc. ([0241]). Finally, Lee discloses the Fc region is linked through the N-terminus (pg. 49, claim 12).
Note the Fc variants taught by Hanmi, specifically the variant represented by SEQ ID NO: 73, contains a proline at the N-terminus (see above).
Regarding dependent claims 46 and 48, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to arrive at the currently claimed invention. Oh and Kim disclose the base invention of peptide-linker-Fc region conjugate. Hanmi discloses an optimal Fc region variant where proline is positioned at the N-terminus. Finally, Lee discloses the peptide-linker-Fc region conjugate comprising two Fc regions as having improved stability when subjected to heat and pH. In light of the combined references, one of ordinary skill in the art would substitute a single Fc region with two Fc regions in the conjugate because Lee discloses this embodiment as having improved stability. Furthermore, the combined references teach the linker is connected at the Fc N-terminus region through an amine group located within such. Hanmi teaches an optimal Fc variant with proline in the N-terminus position. One of ordinary skill in the art would know proline is capable of forming bonds through its secondary amine group and therefore, the combined references disclose what is claimed in instant claims 46 and 48.
Response to Applicant’s Arguments
Applicant argues the claimed liquid formulation has the remarkable effect of maintaining stability for over 6 months (see Specification at p. 65-66, Table 17). While Applicant’s remarks have been considered, they are not found to be persuasive for the following reasons:
Applicant’s stability studies showing this remarkable effect are limited to a single species and does not reasonably establish unexpected results across the full breadth of claim 38, including the full active concentration range, both citrate and acetate buffers, the full sucrose range, all recited surfactants, the full methionine range, and the broad genus of conjugates encompassed by Chemical Formula 1 (Q – La – Z).
The linker, L, is comprised of repeating ethylene glycol units of a, from 0 to infinity. When a is 2 or more, each L is independent of each other.
Z is any immunoglobulin Fc fragment.
The peptide, Q, represented by claimed SEQ ID NO: 47 contains 15 wildcard residues where the amino acids represented by the wildcard are selected from at least two to as many as four residues at some positions.
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As shown above, SEQ ID NO: 47 contains 30 amino acids, so half of the amino acids (15) are chosen from a group of unrelated amino acids (e.g., alanine, glutamine, or cysteine). In addition, the final wildcard residue at position 30 may be connected to R1, where R1 is chosen from:
A cysteine residue;
8 amino acid residues represented by SEQ ID NO: 48 plus two wildcard residues;
9 amino acid residues represented by SEQ ID NO: 49 plus two wildcard residues; or
R1 is entirely absent.
Therefore, Applicant’s claimed genus of Chemical Formula 1 is extremely broad.
Applicant’s working examples use a single embodiment of a long-acting conjugate of Chemical Formula 1 as follows:
Q –
SEQ ID NO: 9
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R1 –
m-(SEQ ID NO: 49)-n, whereby m = proline and n = cysteine.
La –
The linearly modified polyethylene glycol linker, maleimide-PEG-aldehyde, with a molecular weight of 10 kDa.
Z –
A homodimer of two chains of SEQ ID NO: 76.
Example 1 (Specification, p. 57-58): stability evaluations use mannitol (sugar alcohol), not sucrose (disaccharide), and are therefore not relevant to the showing of unexpected results commensurate in scope with the claimed invention.
Example 2 (Specification, p. 58-59): stability evaluations use 20 mM sodium citrate, pH at 5.5, 8% sucrose, no isotonic agent, 0.02% polysorbate 20, and 0.1 mg/mL methionine. The long-acting conjugate concentration is 183.79 nmol/mL.
Example 3 (Specification, p. 60-61): stability evaluations use mannitol (sugar alcohol), not sucrose (disaccharide), and are therefore not relevant to the showing of unexpected results commensurate in scope with the claimed invention.
Example 4 (Specification, p. 61-62): stability evaluations use mannitol (sugar alcohol), not sucrose (disaccharide), and are therefore not relevant to the showing of unexpected results commensurate in scope with the claimed invention.
Example 5 (Specification, p. 62-63): stability evaluations use 20 mM sodium acetate, pH at 5.1, 8% sucrose, no isotonic agent, 0.02% polysorbate 80, and 0.1 mg/mL methionine. The long-acting conjugate concentration is 183.79 nmol/mL.
Example 6 (Specification, p. 63-64): stability evaluations use 20 mM sodium acetate, pH at 5.1, 8% sucrose, no isotonic agent, 0.02% polysorbate 20 or no surfactant, and 0.1 mg/mL methionine or no methionine. The long-acting conjugate concentration is 183.79 nmol/mL.
Example 7 (Specification, p. 65-66 stability evaluations use 20 mM sodium acetate, pH at 5.1, 8% sucrose, no isotonic agent, 0.02% polysorbate 20, and 0.1 mg/mL methionine. The long-acting conjugate concentration is 183.79 nmol/mL or 551.37 nmol/mL.
Therefore, the stability evaluations use a single embodiment of Chemical Formula 1 at two different concentrations (183.79 nmol/mL or 551.37 nmol/mL) mixed with:
a single concentration of sucrose (8% w/v);
a buffering agent that is either 20 mM sodium acetate or 20 mM sodium citrate;
pH at 5.1 or 5.5;
no isotonic agent;
a surfactant that is either 0.02% polysorbate 20 or 0.02% polysorbate 80; and
0.1 mg/mL methionine.
Compare this to the scope of claim 38 where Chemical Formula 1 allows for significant variation, yet only one embodiment was used in the stability studies. Therefore, while examiner acknowledges the validity of SEQ ID NO: 9 linked to a homodimer of two chains of SEQ ID NO: 76 via 10 kDa of maleimide-PEG-aldehyde shows high stability at 25°C for 6 weeks using the disclosed formulations, this is not commensurate in scope with claim 38.
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.
There are several co-pending applications and patents that fall under this double patenting rejection. All rejections refer to previously cited references as follows:
Oh (US 2018/0311315 A1, published: 01 November 2018);
Kim (US Pat. No. 9,724,420 B2, date of patent: 08 August 2017);
Hanmi Science Co. (US 2014/0357843 A1, published: 04 December 2014; hereinafter ‘Hanmi’); and
Lee (US 2018/0271995 A1, published 27 September 2018).
The discussion of these refences above are fully incorporated henceforth.
Co-pending application 18/723,182
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 22-24, and 35-36 of copending Application No. 18/723,182 (reference application ‘182) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘182 recite a method of treating disease requiring drug action in the liver by administering an identical composition as what is instantly claimed. Specifically, ‘182 claims a General Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘182, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in General Formula 1 of ‘182 is identical to R1 in the instant application (particularly ‘182 SEQ ID NOs: 112, 113, 116, and 117 are identical to instant SEQ ID NOs: 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘182 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘182 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘182.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 22-24, and 35-36 of copending Application No. 18/723,182 (reference application ‘182) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘182 recite a method of treating disease requiring drug action in the liver by administering an identical composition as what is instantly claimed. Specifically, ‘182 claims a General Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘182, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in General Formula 1 of ‘182 is identical to R1 in the instant application (particularly ‘182 SEQ ID NOs: 112, 113, 116, and 117 are identical to instant SEQ ID NOs: 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘182, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘182.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 22-24, and 35-36 of copending Application No. 18/723,182 (reference application ‘182) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘182 recite a method of treating disease requiring drug action in the liver by administering an identical composition as what is instantly claimed. Specifically, ‘182 claims a General Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘182, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in General Formula 1 of ‘182 is identical to R1 in the instant application (particularly ‘182 SEQ ID NOs: 112, 113, 116, and 117 are identical to instant SEQ ID NOs: 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘182, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘182.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/565,628
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7-15, and 18 of copending Application No. 18/565,628 (reference application ‘628) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘628 recite a method of treating metabolic syndrome, liver disease, lung disease, or respiratory infections by administering an identical composition as what is instantly claimed. Specifically, ‘628 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘628, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘628 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘628 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘628.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7-15, and 18 of copending Application No. 18/565,628 (reference application ‘628) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘628 recite a method of treating metabolic syndrome, liver disease, lung disease, or respiratory infections by administering an identical composition as what is instantly claimed. Specifically, ‘628 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘628, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘628, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘628.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 22-24, 27-30, and 35-36 of copending Application No. 18/565,628 (reference application ‘628) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘628 recite a method of treating metabolic syndrome, liver disease, lung disease, or respiratory infections by administering an identical composition as what is instantly claimed. Specifically, ‘628 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘628, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘628, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘628.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/041,151
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 28, 32-34, and 45 of copending Application No. 18/041,151 (reference application ‘151) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘151 recite a method for lowering blood pressure by administering an identical composition as what is instantly claimed. Specifically, ‘151 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘151, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘151 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘151 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘151.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 28, 32-34, and 45 of copending Application No. 18/041,151 (reference application ‘151) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘151 recite a method for lowering blood pressure by administering an identical composition as what is instantly claimed. Specifically, ‘151 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘151, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘151, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘151.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 28, 32-34, and 45 of copending Application No. 18/041,151 (reference application ‘151) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘151 recite a method for lowering blood pressure by administering an identical composition as what is instantly claimed. Specifically, ‘151 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘151, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘151, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘151.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/040,869
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, and 13-14 of copending Application No. 18/040,869 (reference application ‘869) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘869 recite a method for preventing or treating obesity or a non-alcoholic fatty liver disease by administering an identical composition as what is instantly claimed. Specifically, ‘869 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘869, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘869 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘869 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘869.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, and 13-14 of copending Application No. 18/040,869 (reference application ‘869) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘869 recite a method for preventing or treating obesity or a non-alcoholic fatty liver disease by administering an identical composition as what is instantly claimed. Specifically, ‘869 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘869, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘869, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘869.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, and 13-14 of copending Application No. 18/040,869 (reference application ‘869) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘869 recite a method for preventing or treating obesity or a non-alcoholic fatty liver disease by administering an identical composition as what is instantly claimed. Specifically, ‘869 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘869, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘869, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘869.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/032,076
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-14 and 18-20 of copending Application No. 18/032,076 (reference application ‘076) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘076 recite both an identical composition and a method for preventing or treating vasculitis by administering an identical composition as what is instantly claimed. Specifically, ‘076 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘076, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘076 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose an identical composition to what is claimed and also used in the method of ‘076 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘076.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-14 and 18-20 of copending Application No. 18/032,076 (reference application ‘076) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘076 recite both an identical composition and a method for preventing or treating vasculitis by administering an identical composition as what is instantly claimed. Specifically, ‘076 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘076, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘076, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘076.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-14 and 18-20 of copending Application No. 18/032,076 (reference application ‘076) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘076 recite both an identical composition and a method for preventing or treating vasculitis by administering an identical composition as what is instantly claimed. Specifically, ‘076 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘076, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘076, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘076.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application 18/031,958 (notice of allowance mailed 20 May 2026; no patent number assigned)
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 16 of Application No. 18/031,958 (reference application ‘958) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘958 recite a method for preventing or treating sequelae following respiratory infectious diseases by administering an identical composition as what is instantly claimed. Specifically, ‘958 claims a Chemical Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘958, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘958 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘958 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘958.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 16 of Application No. 18/031,958 (reference application ‘958) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘958 recite a method for preventing or treating sequelae following respiratory infectious diseases by administering an identical composition as what is instantly claimed. Specifically, ‘958 claims a Chemical Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘958, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘958, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘958.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 16 of Application No. 18/031,958 (reference application ‘958) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘958 recite a method for preventing or treating sequelae following respiratory infectious diseases by administering an identical composition as what is instantly claimed. Specifically, ‘958 claims a Chemical Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘958, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘958, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘958.
Co-pending application 18/031,940
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 13-18 of copending Application No. 18/031,940 (reference application ‘940) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘940 recite a method for preventing or treating lupus-associated disease by administering an identical composition as what is instantly claimed. Specifically, ‘940 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘940, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘940 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘940 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘940.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 13-18 of copending Application No. 18/031,940 (reference application ‘940) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘940 recite a method for preventing or treating lupus-associated disease by administering an identical composition as what is instantly claimed. Specifically, ‘940 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘940, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘940, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘940.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 13-18 of copending Application No. 18/031,940 (reference application ‘940) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘940 recite a method for preventing or treating lupus-associated disease by administering an identical composition as what is instantly claimed. Specifically, ‘940 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘940, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘940, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘940.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/028,424
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/028,424 (reference application ‘424) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘424 recite a method for preventing or treating a bone disease by administering an identical composition as what is instantly claimed. Specifically, ‘424 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘424, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘424 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘424 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘424.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/028,424 (reference application ‘424) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘424 recite a method for preventing or treating a bone disease by administering an identical composition as what is instantly claimed. Specifically, ‘424 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘424, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘424, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘424.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/028,424 (reference application ‘424) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘424 recite a method for preventing or treating a bone disease by administering an identical composition as what is instantly claimed. Specifically, ‘424 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘424, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘424, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘424.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/028,420
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-13 of copending Application No. 18/028,420 (reference application ‘420) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘420 recite a method for preventing or treating a neurodegenerative disease by administering an identical composition as what is instantly claimed. Specifically, ‘420 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘420, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘420 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘420 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim the present invention is obvious over co-pending application ‘420.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-13 of copending Application No. 18/028,420 (reference application ‘420) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘420 recite a method for preventing or treating a neurodegenerative disease by administering an identical composition as what is instantly claimed. Specifically, ‘420 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘420, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘420, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘420.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-13 of copending Application No. 18/028,420 (reference application ‘420) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘420 recite a method for preventing or treating a neurodegenerative disease by administering an identical composition as what is instantly claimed. Specifically, ‘420 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘420, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘420, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘420.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/028,348
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15-17 of copending Application No. 18/028,348 (reference application ‘348) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘348 recite a method for preventing or treating multiple sclerosis by administering an identical composition as what is instantly claimed. Specifically, ‘348 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘348, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘348 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘348 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘348.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15-17 of copending Application No. 18/028,348 (reference application ‘348) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘348 recite a method for preventing or treating multiple sclerosis by administering an identical composition as what is instantly claimed. Specifically, ‘348 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘348, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘348, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘348.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15-17 of copending Application No. 18/028,348 (reference application ‘348) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘348 recite a method for preventing or treating multiple sclerosis by administering an identical composition as what is instantly claimed. Specifically, ‘348 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘348, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘348, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘348.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/016,145
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9-11 of copending Application No. 18/016,145 (reference application ‘145) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘145 recite a method for treating liver disease by administering an identical composition as what is instantly claimed. Specifically, ‘145 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘145, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘145 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘145 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘145.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9-11 of copending Application No. 18/016,145 (reference application ‘145) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘145 recite a method for treating liver disease by administering an identical composition as what is instantly claimed. Specifically, ‘145 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘145, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘145, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘145.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9-11 of copending Application No. 18/016,145 (reference application ‘145) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘145 recite a method for treating liver disease by administering an identical composition as what is instantly claimed. Specifically, ‘145 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘145, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘145, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘145.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 17/917,846
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-13, and 15-16 of copending Application No. 17/917,846 (reference application ‘846) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘846 recite a method for treating hyperlipidemia by administering an identical composition as what is instantly claimed. Specifically, ‘846 claims a General Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘846, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in General Formula 1 of ‘846 is identical to R1 in the instant application (particularly ‘846 SEQ ID NOs: 109, 112, 113, 116 and 117 are identical to instant SEQ ID NOs: 50, 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘846 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘846 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘846.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-13, and 15-16 of copending Application No. 17/917,846 (reference application ‘846) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘846 recite a method for treating hyperlipidemia by administering an identical composition as what is instantly claimed. Specifically, ‘846 claims a General Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘846, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in General Formula 1 of ‘846 is identical to R1 in the instant application (particularly ‘846 SEQ ID NOs: 109, 112, 113, 116 and 117 are identical to instant SEQ ID NOs: 50, 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘846, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘846.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-13, and 15-16 of copending Application No. 17/917,846 (reference application ‘846) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘846 recite a method for treating hyperlipidemia by administering an identical composition as what is instantly claimed. Specifically, ‘846 claims a General Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘846, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in General Formula 1 of ‘846 is identical to R1 in the instant application (particularly ‘846 SEQ ID NOs: 109, 112, 113, 116 and 117 are identical to instant SEQ ID NOs: 50, 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘846, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘846.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 17/792,228
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 19 of copending Application No. 17/792,228 (reference application ‘228) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘228 recite a method for treating lung disease by administering an identical composition as what is instantly claimed. Specifically, ‘228 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘228, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘228 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘228 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘228.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 19 of copending Application No. 17/792,228 (reference application ‘228) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘228 recite a method for treating lung disease by administering an identical composition as what is instantly claimed. Specifically, ‘228 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘228, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘228, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘145.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 19 of copending Application No. 17/792,228 (reference application ‘228) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘228 recite a method for treating lung disease by administering an identical composition as what is instantly claimed. Specifically, ‘228 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘228, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘228, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘228.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 17/700,055
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 13, 14, 18 and 20 of copending Application No. 17/700,055 (reference application ‘055) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘055 recite a composition for treating metabolic syndrome by administering an identical composition as what is instantly claimed. Specifically, ‘055 claims a General Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘055, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in General Formula 1 of ‘055 is identical to R1 in the instant application (particularly ‘055 SEQ ID NOs: 109, 112, 113, 116 and 117 are identical to instant SEQ ID NOs: 50, 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘055 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose an identical composition as ‘055 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘055.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 13, 14, 18 and 20 of copending Application No. 17/700,055 (reference application ‘055) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘055 recite a composition for treating metabolic syndrome by administering an identical composition as what is instantly claimed. Specifically, ‘055 claims a General Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘055, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in General Formula 1 of ‘055 is identical to R1 in the instant application (particularly ‘055 SEQ ID NOs: 109, 112, 113, 116 and 117 are identical to instant SEQ ID NOs: 50, 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘055, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘055.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 13, 14, 18 and 20 of copending Application No. 17/700,055 (reference application ‘055) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘055 recite a composition for treating metabolic syndrome by administering an identical composition as what is instantly claimed. Specifically, ‘055 claims a General Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘055, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in General Formula 1 of ‘055 is identical to R1 in the instant application (particularly ‘055 SEQ ID NOs: 109, 112, 113, 116 and 117 are identical to instant SEQ ID NOs: 50, 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘055, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘055.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 17/416,880
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 23-25, and 37 of copending Application No. 17/416,880 (reference application ‘880) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘880 recite an identical composition as what is instantly claimed. Specifically, ‘880 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘880, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘880 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the identical composition of ‘880 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘880.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 23-25, and 37 of copending Application No. 17/416,880 (reference application ‘880) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘880 recite an identical composition as what is instantly claimed. Specifically, ‘880 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘880, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘880, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘880.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 23-25, and 37 of copending Application No. 17/416,880 (reference application ‘880) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘880 recite an identical composition as what is instantly claimed. Specifically, ‘880 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘880, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘880, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘880.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 17/414,682
Claims 38-45, 49-51, 53, 63, and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 15-19, and 31-33 of copending Application No. 17/414,682 (reference application ‘682) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘682 recite a method for preventing or treating liver disease by administering an identical composition as what is instantly claimed. Specifically, ‘682 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘682, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘682 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the composition used in the method of ‘682 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over co-pending application ‘682.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 47 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 15-19, and 31-33 of copending Application No. 17/414,682 (reference application ‘682) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘682 recite a method for preventing or treating liver disease by administering an identical composition as what is instantly claimed. Specifically, ‘682 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘682, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘682, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over co-pending application ‘682.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 15-19, and 31-33 of copending Application No. 17/414,682 (reference application ‘682) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘682 recite a method for preventing or treating liver disease by administering an identical composition as what is instantly claimed. Specifically, ‘682 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘682, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9.
Regarding the limitations set forth in the instant invention that differ from ‘682, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘682.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Patent No. 10,370,426
Claims 38-45, 49-51, 53, 63, and 68-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 8-11 of U.S. Patent No. 10,370,426 (hereinafter ‘426) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘426 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘426 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘426, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Formula 1 of ‘426 is identical to R1 in the instant application (particularly ‘426 SEQ ID NOs: 109, 112, 113, 116 and 117 are identical to instant SEQ ID NOs: 50, 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘426 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the identical composition of ‘426 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over U.S. Patent ‘426.
Claim 47 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 8-11 of U.S. Patent No. 10,370,426 (hereinafter ‘426) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘426 recite an identical composition as what is instantly claimed and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘426 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘426, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Formula 1 of ‘426 is identical to R1 in the instant application (particularly ‘426 SEQ ID NOs: 109, 112, 113, 116 and 117 are identical to instant SEQ ID NOs: 50, 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘426, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over U.S. Patent ‘426.
Claims 46 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 8-11 of U.S. Patent No. 10,370,426 (hereinafter ‘426) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘426 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘426 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘426, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Formula 1 of ‘426 is identical to R1 in the instant application (particularly ‘426 SEQ ID NOs: 109, 112, 113, 116 and 117 are identical to instant SEQ ID NOs: 50, 51, 52, 53, and 54, respectively).
Regarding the limitations set forth in the instant invention that differ from ‘426, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over U.S. Patent ‘426.
U.S. Patent No. 10,400,020
Claims 38-45, 49-51, 53, 63, and 68-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 8, 11-16, and 19-23 of U.S. Patent No. 10,400,020 (hereinafter ‘020) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘020 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘020 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘020, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘020 is identical to R1 in the instant application (particularly ‘020 SEQ ID NOs: 107 and 108 are identical to instant SEQ ID NOs: 51, 52, 53, and 54).
Regarding the limitations set forth in the instant invention that differ from ‘020 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the identical composition of ‘020 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over U.S. Patent ‘020.
Claim 47 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 8, 11-16, and 19-23 of U.S. Patent No. 10,400,020 (hereinafter ‘020) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘020 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘020 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘020, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘020 is identical to R1 in the instant application (particularly ‘020 SEQ ID NOs: 107 and 108 are identical to instant SEQ ID NOs: 51, 52, 53, and 54).
Regarding the limitations set forth in the instant invention that differ from ‘020, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over U.S. Patent ‘020.
Claims 46 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 8, 11-16, and 19-23 of U.S. Patent No. 10,400,020 (hereinafter ‘020) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘020 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘020 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘020, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘020 is identical to R1 in the instant application (particularly ‘020 SEQ ID NOs: 107 and 108 are identical to instant SEQ ID NOs: 51, 52, 53, and 54).
Regarding the limitations set forth in the instant invention that differ from ‘020, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over U.S. Patent ‘020.
U.S. Patent No. 10,981,967
Claims 38-45, 49-51, 53, 63, and 68-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 9, 11, 13, 14-17, 19, 20, 23-28, and 30-37 of U.S. Patent No. 10,981,967 (hereinafter ‘967) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘967 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘967 claims a Chemical Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘967, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘967 is identical to R1 in the instant application (particularly ‘967 SEQ ID NOs: 107 and 108 are identical to instant SEQ ID NOs: 51, 52, 53, and 54).
Regarding the limitations set forth in the instant invention that differ from ‘967 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the identical composition of ‘967 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over U.S. Patent ‘967.
Claim 47 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 9, 11, 13, 14-17, 19, 20, 23-28, and 30-37 of U.S. Patent No. 10,981,967 (hereinafter ‘967) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘967 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘967 claims a Chemical Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘967, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘967 is identical to R1 in the instant application (particularly ‘967 SEQ ID NOs: 107 and 108 are identical to instant SEQ ID NOs: 51, 52, 53, and 54).
Regarding the limitations set forth in the instant invention that differ from ‘967, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over U.S. Patent ‘967.
Claims 46 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 9, 11, 13, 14-17, 19, 20, 23-28, and 30-37 of U.S. Patent No. 10,981,967 (hereinafter ‘967) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘967 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘967 claims a Chemical Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘967, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘967 is identical to R1 in the instant application (particularly ‘967 SEQ ID NOs: 107 and 108 are identical to instant SEQ ID NOs: 51, 52, 53, and 54).
Regarding the limitations set forth in the instant invention that differ from ‘967, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over U.S. Patent ‘967.
U.S. Patent No. 11,332,508
Claims 38-45, 49-51, 53, 63, and 68-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-12, and 18-19 of U.S. Patent No. 11,332,508 (hereinafter ‘508) in view of Oh and Kim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘508 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘508 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘508, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘508 is identical to R1 in the instant application (particularly ‘508 SEQ ID NOs: 107 and 108 are identical to instant SEQ ID NOs: 51, 52, 53, and 54).
Regarding the limitations set forth in the instant invention that differ from ‘508 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Kim disclose the identical composition of ‘508 with the addition of those limitations set forth in instant claims 38-45, 49-51, 53, 63, and 68-69. Oh and Kim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Kim, the present invention is obvious over U.S. Patent ‘508.
Claim 47 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-12, and 18-19 of U.S. Patent No. 11,332,508 (hereinafter ‘508) in view of Oh, Kim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘508 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘508 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘508, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘508 is identical to R1 in the instant application (particularly ‘508 SEQ ID NOs: 107 and 108 are identical to instant SEQ ID NOs: 51, 52, 53, and 54).
Regarding the limitations set forth in the instant invention that differ from ‘508, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73 that is identical to instant SEQ ID NO: 76. Therefore, in light of the disclosures of Oh, Kim, and Hanmi, the present invention is obvious over U.S. Patent ‘508.
Claims 46 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-12, and 18-19 of U.S. Patent No. 11,332,508 (hereinafter ‘508) in view of Oh, Kim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims in ‘508 recite an identical composition and a method of treating metabolic syndrome by administering this identical composition. Specifically, ‘508 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘508, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘508 is identical to R1 in the instant application (particularly ‘508 SEQ ID NOs: 107 and 108 are identical to instant SEQ ID NOs: 51, 52, 53, and 54).
Regarding the limitations set forth in the instant invention that differ from ‘508, Lee discloses two Fc region polypeptides linked by a disulfide bond that are more stable in the conjugate. Therefore, in light of the disclosures of Oh, Kim, Hanmi, and Lee, the present invention is obvious over U.S. Patent ‘508.
Conclusion
Claims 38-51, 53, 63, and 68-69 are rejected. No claim is allowed.
Communication
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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