DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-37 were previously pending in the present application. By virtue of a Preliminary Amendment, filed by Applicant on 21 November 2022, claims 1-37 were cancelled and claims 38-73 were added. In response to the non-final office action, dated 19 August 2025, Applicant filed an Amendment on 19 November 2025. Pursuant to the newly filed Amendment, claims 38, 61, and 68-70 were amended and claims 59-60 and 73 were cancelled. Therefore, claims 38-58 and 61-72 are now pending and currently under examination.
Priority
The instant application filed on 21 November 2022 is a 371 of PCT/KR2021/006462 filed 24 May 2021. In addition, the instant application claims foreign priority of KR10-2020-0061875 filed 22 May 2020.
Examiner acknowledges receipt of Applicant’s English translation of their disclosure for KR10-2020-0061875, filed on 19 November 2025. However, in accordance with 37 CFR 1.55(g)(4), a statement must be filed together with the English translation stating the translation of the certified copy is accurate. Applicant has filed a statement that the copy of KR10-2020-0061875 is a true copy from the records of the Korean Intellectual Property Office (“Miscellaneous Incoming Letter,” p. 1 – received 19 November 2025) and a statement that an English translation of KR10-2020-0061875 was submitted (“Transmittal Letter,” p. 1 – received 19 November 2025). However, Applicant has not filed a statement that the English translation is accurate as required by 37 CFR 1.55(g)(4) and therefore, the effective filing date remains 22 May 2020.
Withdrawn Claim Rejections
Applicant has amended independent claim 38 to now include a specific sugar alcohol and saccharide and cancelled claim 73. Therefore, all previous claim rejections are moot and hereby withdrawn.
New Claim Rejections
Applicant has amended independent claim 38 and dependent claims 68-71, thereby changing the scope of the claim to include specific sugar alcohols and saccharide at defined w/v ranges. Therefore, Applicant’s amendments have facilitated the new claim rejections presented below.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 55 and 61 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 55, which depends on claim 38, recites: “[t]he liquid formulation of claim 38, wherein the pH of the liquid formulation is 5.0 to 6.5.” However, claim 38 already requires a buffering agent in an amount necessary for maintaining the pH of the liquid formulation in a range of 5.0 to 6.5. If the pH were outside that range, the buffering agent would not be present in an amount necessary to maintain the pH in the range recited by instant claim 38. Therefore, claim 55 fails to further limit claim 38 as both require a pH in a range of 5.0 to 6.5.
Claim 61, which depends from claim 38, recites: “[t]he liquid formulation of claim 38, wherein the liquid formulation comprises: 1% (w/v) to 8% (w/v) of mannitol or sorbitol.” However, claim 38 already requires mannitol or sorbitol in a concentration of 1% (w/v) to 8% (w/v). Therefore, claim 61 fails to further limit claim 38.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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, 49-58, 61-67, and 72 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 Lim (cited in previous office action as: WO 2014/017849 A1, published: 30 January 2014).
As discussed in the previous non-final office action, Oh discloses the base liquid formulation of a long-acting conjugate comprising Chemical Formula 1. While Oh does not explicitly disclose mixing this base liquid formulation with the specific limitations of 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 Lim, which teach formulations and methods to stabilize a long-acting insulinotropic peptide conjugate ([9]). Specifically, Lim’s formulation includes:
a long-acting insulinotropic peptide conjugate at a concentration of 0.1 mg/mL to 200 mg/mL in the liquid formulation ([98]). Based upon the molecular weight of exendin-4, an immunoglobulin Fc fragment of IgG4, and a non-peptidyl polymer ([46]), the concentration of the long-acting conjugate of Chemical Formula 1 falls within the range disclosed by Lim (corresponding to approximately 0.77 nmol/mL to 6,625 nmol/mL).
a buffer which works to maintain the pH of solution to prevent a sharp pH change in the liquid formulation and stabilize the conjugate ([101]). Lim further discloses the long-acting insulin conjugate was most stable in the liquid formulation comprising a buffer consisting of sodium acetate, an isotonic agent consisting of sodium chloride, a sugar alcohol consisting of mannitol, and a surfactant consisting of polysorbate 20, at a pH of 5.6 or 6.0.
sugar alcohol that works to increase the stability of the formulation that includes mannitol and sorbitol at a concentration of 1 to 20% (w/v) ([102]) or additional stabilizers that include sucrose ([112]).
Response to Applicant’s Arguments
Applicant's arguments filed 19 November 2025 have been fully considered but they are not persuasive.
Applicant first argues Lim is deficient because the formulation of Lim includes both a long-acting insulin conjugate and a long-acting insulinotropic peptide conjugate as active substances, while the currently claimed invention and the formulation disclosed by Oh only include a conjugate of a peptide having activities to a glucagon receptor, a glucagon-like peptide-1 (GLP-1) receptor, and a glucose-dependent insulinotropic polypeptide (GIP) receptor (see Oh [0018]). Applicant argues that because Lim’s formulation additionally includes a long-acting insulin conjugate, one of ordinary skill would not be motivated to combine the two references. Examiner disagrees with this reasoning. Claim 38, in its broadest reasonable interpretation, includes a long-acting conjugate of glucagon/GLP-1/GIP trigonal agonist represented by General Formula 1, but also includes any other component through the use of open-ended claim language such as “comprising.” Therefore, the liquid formulation of instant claim 38 could also include a long-acting insulin conjugate. Applicant attempts to import claim limitations from the Specification (see Remarks, p. 13). However, the court has long held this argument is unavailable to Applicants:
If everything in the specification were required to be read into the claims, or if structural claims were to be limited to devices operated precisely as a specification-described embodiment is operated, there would be no need for claims. Nor could an applicant, regardless of the prior art, claim more broadly than that embodiment. Nor would a basis remain for the statutory necessity that an applicant conclude his specification with “claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” SRI Int'l v. Matsushita Elec. Corp., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (en banc) (quoting 35 U.S.C. § 112).
Applicant argues that it is “a natural fact that the specific formulation of a liquid preparation should be specifically identified, depending on the type of specific active substance for which stability is to be increased” (see Remarks, p. 14). However, Applicant’s own claims do not reflect this self-imposed principal as instant claim 38 is left open-ended and without specificity.
Second, Applicant argues that Oh does not disclose any specific composition for a liquid formulation for stably providing a trigonal agonist (see Remarks, p. 12) and therefore, no motivation occurs to apply the formulation of Lim (see Remarks, p. 14). While Examiner concedes Oh does not disclose each and every limitation of instant claim 38, Oh does contemplate a liquid formulation that includes components to improve the stability of an identical trigonal agonist (see above). In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Oh does contemplate the addition of other components, including carbohydrates, such as glucose and sucrose, low molecular weight proteins, and stabilizing agents to improve the stability of the formulation ([0539]). Lim teaches specific sugar alcohols and stabilizers at a range of pH and concentrations to improve a liquid formulation that contains an insulinotropic peptide conjugate. The disclosures of Lim merely exemplify that techniques to improve a liquid formulation containing an insulinotropic peptide conjugate were widely known in the art at the time of the claimed invention (Lim’s disclosures were publicly available 30 January 2014) and available for Applicant’s to pick and choose from the components and ranges disclosed by Lim to apply to the formulation that was previously and publicly disclosed by Applicants in Oh (both the instant application and Oh share the same assignee Hanmi Pharmaceutical Company, LTD). If Applicant stumbled upon a specific combination of components at ranges previously disclosed by Lim which improved the base formulation already disclosed in Oh, the invention is not novel, but expected as Lim already disclosed these components were used to increase stability.
Finally, Applicant argues that Lim’s working examples, specifically in terms of pH levels, w/v mannitol, and duration of stability show the techniques in Lim are not applicable to the currently claimed invention and that the currently claimed invention “has the remarkable effect of maintaining stability for an extremely long period of over 6 months” (see Remarks, pp. 14 and 15; see also Specification – Table 17, p. 66). First, Lim provided not only working examples, but ranges with which successful stabilization occurs. Applicant’s currently claimed invention includes ranges fall within the ranges disclosed by Lim and therefore, the results are not unexpected if Lim teaches success within those ranges. Second, Applicant’s claim of “remarkable effect” as it relates to stability over long periods of time is not commensurate in scope with the currently claimed invention. These ‘unexpected’ results cited by Applicant are as follows:
the results occur at long-acting conjugate concentrations of 183.79 nmol/mL and 551.37 nmol/mL, while claim 38 includes broad concentrations of the long-acting conjugate at a range of 18nmol/mL to 920 nmol/mL.
the results occur using 20 mM sodium acetate, while claim 38 merely require any buffering agent at any concentration necessary to achieve a pH in a range of 5.0 to 6.5. Claims 52 to 58 further limit the buffering agent, pH, and concentration, but the claims still are not commensurate in scope with the results cited by the applicant.
the results occur at a single pH of 5.1, while claim 38 requires a pH in the range of 5.0 to 6.5.
the results occur with the following additional components: 8% w/v, no isotonic agent, 0.02% polysorbate 20 and 0.1 mg/mL methionine. Claim 38 requires either mannitol or sorbitol at 1 to 8% (w/v) and/or sucrose at 4 to 10% (w/v); is silent on the addition of polysorbate 20 and methionine. Claim 62 requires the use of an isotonic agent; claim 66 indicates the nonionic surfactant can be selected from: poloxamer 188, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, and a combination thereof; and claim 67 requires the stabilizer is selected from: arginine, glycine, methionine, and a combination thereof.
the results occur at a storage temperature of 25°C ± 2°C, yet the claims are silent regarding storage temperatures.
Therefore, the claims are broadly encompassing a variety of components at ranges of pH and concentrations, yet citing to a very specific example to show unexpected results. Furthermore, Applicant uses this reasoning to show Lim is deficient as a prior art reference while citing only a specific working example within Lim. See MPEP 2123(I),(II) stating patents are relevant as prior art for all they contain and nonpreferred and alternative embodiments constitute prior art. For the reasons stated above, this argument is not considered persuasive.
With that said, Examiner’s assertion remains that Oh, in further view of Lim, makes obvious the following as pertaining to the instant claims:
Oh discloses a long-acting conjugate of triple glucagon/GLP-1/GIP receptor agonist. Regarding instant claim 38, 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]).
Therefore, regarding instant claim 38, Oh discloses each of the limitations of currently claimed Chemical Formula 1. In terms of the additional components of the liquid formulation, Oh discloses a liquid formulation of a pharmaceutical composition that includes a buffering agent and a sugar alcohol. While, Oh does not explicitly disclose this liquid formulation in the ranges set forth in instant claim 38 (concentration of the long-acting conjugate, pH, and w/v of sugar alcohol and/or saccharide), these deficiencies are made obvious by the disclosures of Lim.
Lim discloses a liquid formulation of long-acting insulin and insulinotropic peptide (title). Lim further discloses a liquid formulation comprising a combination of long-acting insulin, insulinotropic peptide, and albumin-free stabilizer which includes a buffer, sugar alcohol, a non-ionic surfactant, and an isotonic agent, and a method of preparing the liquid formulation (abstract). The embodiment of the invention in Lim is a long-acting protein conjugate formed by linking a known physiologically active polypeptide and immunoglobulin Fc region through covalent bonding using a non-peptidyl polymer as a linker ([7]). Lim further discloses the liquid formulation is not at risk of viral contamination, provides excellent storage stability for the peptide conjugates and thus, is more cost-effective, and maintains protein activity in the body for a longer period of time compared to other conventional formulations of insulin and insulinotropic peptide ([15]).
Lim further discloses the ranges recited in instant claim 38:
Lim discloses the long-acting insulin conjugate has a concentration of 0.1 mg/mL to 200 mg/mL in the liquid formulation ([98]). Based upon the molecular weight of exendin-4, an immunoglobulin Fc fragment of IgG4, and a non-peptidyl polymer ([46]), the concentration of the long-acting conjugate of Chemical Formula 1 falls within the range disclosed by Lim (corresponding to approximately 0.77 nmol/mL to 6,625 nmol/mL).
Lim discloses the buffer works to maintain the pH of solution to prevent a sharp pH change in the liquid formulation and stabilize the conjugate ([101]). Lim further discloses the long-acting insulin conjugate was most stable in the liquid formulation comprising a buffer consisting of sodium acetate, an isotonic agent consisting of sodium chloride, a sugar alcohol consisting of mannitol, and a surfactant consisting of polysorbate 20, at a pH of 5.6 or 6.0.
Lim discloses sugar alcohols act to increase the stability in combination with the conjugates. Specifically, Lim discloses the concentration of sugar alcohol is preferably 1 to 20% (w/v) ([102]).
Regarding claim 38, 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 discloses an identical chemical formulation as described in instant claim 38 ‘Chemical Formula 1.’ Lim discloses a similar invention comprising a liquid formulation of a long-acting conjugate where the conjugate is a combination of insulin and an insulinotropic peptide. Lim further discloses additional components of the liquid formulation including a buffering agent and a sugar alcohol which serve to increase the stability of the liquid formulation and retain the biological activity of the peptide. Lim teaches these components in ranges that include the currently claimed ranges in instant claim 38 (MPEP 2144.05(I)). Therefore, one of ordinary skill in the art would anticipate success by modifying the components of the base invention in Oh with the ranges taught in Lim to be successful.
Regarding the dependent claims of the currently claimed invention:
Regarding instant claims 39, 40, 41, and 42, Oh discloses an identical peptide to SEQ ID NO: 9 that is part of the liquid formulation as discussed above.
Regarding instant claim 43, 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]).
Regarding instant claims 52 and 53, Oh discloses the liquid formulation can include a pharmaceutically acceptable salt and in particular, may include a salt derived from acetic acid ([0272]).
Regarding instant claims 54, 55, 56, 57, and 58, Lim discloses the buffer works to maintain the pH of solution to prevent a sharp pH change in the liquid formulation, which could have a detrimental effect on stability ([101]). Lim discloses the pH of the buffer is preferably 4.0 to 8.0 ([101]). Lim discloses pH of the liquid formulation as low as 5.0 ([158], Table 3) and as high as 6.0 ([173]).
Regarding instant claim 61, Oh discloses the liquid formulation may include mannitol or sorbitol ([0536]) and Lin teaches the concentration of a sugar alcohol, including mannitol and sorbitol, at 1 to 20% (w/v) ([102]).
Regarding instant claims 62 and 63, Lim discloses the liquid formulation contains a non-ionic surfactant and an isotonic agent ([11]). Lim further discloses the non-ionic surfactant reduces the surface tension of the protein solution to prevent the absorption or aggregation of proteins onto a hydrophobic surface ([104]).
Regarding instant claims 64 and 72, Lim discloses the non-ionic surfactant is preferably at a low concentration of less than 0.2% (w/v), more preferably at 0.001% to 0.05% ([105]). Lim discloses it is inappropriate to use a non-ionic surfactant at a high concentration in the liquid formulation because it induces interference effects when measuring protein concentration and determining protein stability through analytic methods ([105]).
Regarding instant claims 65, 66, and 72, Lim discloses the non-ionic surfactant of the liquid formulation can be a poloxamer, specifically poloxamer 188 ([148], Table 1), or polysorbate, specifically polysorbate 20, polysorbate 40, polysorbate 60, or polysorbate 80 ([104]).
Regarding instant claim 67, Lim discloses addition of a stabilizer to the liquid formulation that may include methionine ([100]). Lim further discloses the addition of methionine as a stabilizer further stabilizes the target protein by suppressing the formation of impurities, which may occur due to oxidation of the protein in solution ([107]). Finally, Lim discloses the concentration of methionine at 0.005% to 0.1% (w/v) of a total volume of solution ([107]).
Regarding dependent claims 39-45, 49-58, 61-67, and 72, 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 discloses an identical chemical formulation as described in instant claim 38 ‘Chemical Formula 1’ and additional limitations of the instant claims. Lim discloses a similar invention comprising a liquid formulation of a long-acting conjugate where the conjugate is a combination of insulin and an insulinotropic peptide. Lim further discloses additional components and limitations of the liquid formulation including a buffering agent and a sugar alcohol which serve to increase the stability of the liquid formulation and retain the biological activity of the peptide. Lim teaches these components in ranges that include the currently claimed ranges in instant claim 38 (MPEP 2144.05(I)). Therefore, one of ordinary skill in the art would anticipate success by modifying the components of the base invention in Oh with the ranges taught in Lim to be successful.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Oh (previously cited) in further view of Lim (previously cited) and Hanmi Science Co. (cited in previous office action as: US 2014/0357843 A1, published: 04 December 2014).
Response to Applicant’s Arguments
Applicant argues independent claim 38 is not obvious and therefore, all rejections over Oh, Lim, Hanmi, and Lee, individually or in combinations, are not valid. See discussion above as to Examiner’s reasoning why the 35 U.S.C. 103 rejection of claim 38 over Oh and Lee is maintained. For those reasons, the claim rejection in further view of Hanmi is also maintained.
The disclosures of Oh (US 2018/0311315 A1) and Lim (WO 2014/017849 A1) are discussed above. Regarding instant claim 47, neither Oh nor Lim explicitly disclose the limitations of this claim. However, this deficiency is cured by Hanmi Science Co. (US 2014/0357843 A1; hereinafter ‘Hanmi’),
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 Lim disclose a peptide conjugate comprising a peptide, linker, and material capable of increasing the half-life of the peptide. Furthermore, both Oh and Lim 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 Lim 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 (previously cited) in further view of Lim (previously cited), Hanmi Science Co. (previously cited), and Lee (cited in previous office action as: US 2018/0271995 A1, published 27 September 2018).
Response to Applicant’s Arguments
Applicant argues independent claim 38 is not obvious and therefore, all rejections over Oh, Lim, Hanmi, and Lee, individually or in combinations, are not valid. See discussion above as to Examiner’s reasoning why the 35 U.S.C. 103 rejection of claim 38 over Oh and Lee is maintained. For those reasons, the claim rejection in further view of Hanmi and Lee is also maintained.
The teachings of Oh, Lim, 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]). While none of the aforementioned references teach the limitations as disclosed in instant claims 46 and 48, this deficiency is made obvious over Lee.
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 Lim 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.
Claims 68-71 are rejected under 35 U.S.C. 103 as being unpatentable over Oh (previously cited) in further view of Lim (previously cited) and Flink (US 8,846,618 B2; date of patent: 30 September 2014).
The teachings of Oh and Lim are discussed above. While a combination of Oh and Lim disclose the addition of sucrose as a stabilizer for a GLP-1 conjugate, neither reference explicitly discloses the specific concentration of sucrose as now required by instant claims 68-71. However, this deficiency in the combination of references is overcome and made obvious by the teachings of Flink.
Flink discloses pharmaceutical formulations of GLP-1 compounds and methods for preparation thereof (abstract). Specifically, as it relates to the range of sucrose concentration now required by instant claims 68-71, Flink teaches the addition of sucrose as an isotonic agent, which is known in the art as a stabilizer (col. 15, lines 1-7). Furthermore, Flink teaches the concentration of the isotonic agent between 1 to 50 mg/mL, which overlaps with the range of 4% to 10% (w/v) of sucrose in the instant claims.
Therefore, 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 Lim disclose a peptide conjugate comprising a peptide, linker, and additional components to increase the stability of the formulation. Oh contemplates use of sucrose for this purpose, but does not explicitly teach the specific concentrations as required by instant claims 68-71. However, Flink teaches sucrose at a concentration between 0.1% to 5% (w/v) is suitable for stabilizing a GLP-1 composition. Therefore, one of ordinary skill in the art would anticipate achieving desired stability in a GLP-1 formulation at a concentration of sucrose between 4 to 10% (w/v) because Flink teaches success with such. See MPEP 2144.05. (In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
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)
Lim (WO 2014/017849 A1, published: 30 January 2014)
Hanmi Science Co. (US 2014/0357843 A1, published: 04 December 2014; hereinafter ‘Hanmi’)
Lee (US 2018/0271995 A1, published 27 September 2018).
Flink (US 8,846,618 B2; date of patent: 30 September 2014).
The discussion of these refences above are fully incorporated henceforth.
Response to Applicant’s Arguments
Applicant argues independent claim 38 is not obvious and therefore, all rejections over Oh, Lim, Hanmi, and Lee, individually or in combinations, are not valid. See discussion above as to Examiner’s reasoning why the 35 U.S.C. 103 rejection of claim 38 over Oh and Lee is maintained. For those reasons, all double patenting rejections are maintained.
Co-pending application 18/723,182
Claims 38-45, 49-58, 61-67, and 72 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. 18/723,182 (reference application ‘182) in view of Oh and Lim.
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 Lim disclose the composition used in the method of ‘182 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, 27-30, and 35-36 of copending Application No. 18/723,182 (reference application ‘182) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘182 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, 27-30, and 35-36 of copending Application No. 18/723,182 (reference application ‘182) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘182 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also teach the linker is attached to the Fc region through an amine group at the N-terminus. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 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. 18/723,182 (reference application ‘182) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘182 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose the composition used in the method of ‘628 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘628 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘628 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘628 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose the composition used in the method of ‘151 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘151 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘151 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘151 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, and 11-14 of copending Application No. 18/040,869 (reference application ‘869) in view of Oh and Lim.
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 Lim disclose the composition used in the method of ‘869 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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 11-14 of copending Application No. 18/040,869 (reference application ‘869) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘869 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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 11-14 of copending Application No. 18/040,869 (reference application ‘869) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘869 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, and 11-14 of copending Application No. 18/040,869 (reference application ‘869) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘869 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 12-20 of copending Application No. 18/032,076 (reference application ‘076) in view of Oh and Lim.
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 Lim 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, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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 1-9 and 12-20 of copending Application No. 18/032,076 (reference application ‘076) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim 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, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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 1-9 and 12-20 of copending Application No. 18/032,076 (reference application ‘076) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim 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, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 12-20 of copending Application No. 18/032,076 (reference application ‘076) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘076 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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.
Co-pending application 18/031,958
Claims 38-45, 49-58, 61-67, and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 16 of copending Application No. 18/031,958 (reference application ‘958) in view of Oh and Lim.
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 Lim disclose the composition used in the method of ‘958 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, the present invention is obvious over co-pending application ‘958.
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, and 16 of copending Application No. 18/031,958 (reference application ‘958) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘958 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, and Hanmi, the present invention is obvious over co-pending application ‘958.
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, and 16 of copending Application No. 18/031,958 (reference application ‘958) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘958 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘958.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable unpatentable over claims 1, 2, and 16 of copending Application No. 18/031,958 (reference application ‘958) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘958 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, the present invention is obvious over co-pending application ‘958.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/031,940
Claims 38-45, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose the composition used in the method of ‘940 with the addition of those limitations set forth in instant claims 38-45 and 49-73. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘940 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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 11-9 and 13-18 of copending Application No. 18/031,940 (reference application ‘940) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘940 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable unpatentable over claims 11-9 and 13-18 of copending Application No. 18/031,940 (reference application ‘940) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘940 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72are 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 Lim.
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 Lim disclose the composition used in the method of ‘424 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘424 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘424 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable unpatentable over claims 1-13 of copending Application No. 18/028,424 (reference application ‘424) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘424 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/028,420 (reference application ‘420) in view of Oh and Lim.
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 Lim disclose the composition used in the method of ‘420 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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 11-13 of copending Application No. 18/028,420 (reference application ‘420) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘420 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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 1-13 of copending Application No. 18/028,420 (reference application ‘420) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘420 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable unpatentable over claims 1-13 of copending Application No. 18/028,420 (reference application ‘420) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘420 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72are 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 Lim.
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 Lim disclose the composition used in the method of ‘348 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘348 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘348 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable unpatentable over claims 1-13 and 15-17 of copending Application No. 18/028,348 (reference application ‘348) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘348 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-11 of copending Application No. 18/016,145 (reference application ‘145) in view of Oh and Lim.
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 Lim disclose the composition used in the method of ‘145 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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 6-11 of copending Application No. 18/016,145 (reference application ‘145) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘145 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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 6-11 of copending Application No. 18/016,145 (reference application ‘145) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘145 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-11 of copending Application No. 18/016,145 (reference application ‘145) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘145 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose the composition used in the method of ‘846 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘846 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘846 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘846 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose the composition used in the method of ‘228 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘228 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘228 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘228 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose an identical composition as ‘055 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose an identical composition as ‘055 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose an identical composition as ‘055 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘055 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 23-25, 37, 41, 42, and 61 of copending Application No. 17/416,880 (reference application ‘880) in view of Oh and Lim.
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 Lim disclose the identical composition of ‘880 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, 37, 41, 42, and 61 of copending Application No. 17/416,880 (reference application ‘880) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘880 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, 37, 41, 42, and 61 of copending Application No. 17/416,880 (reference application ‘880) in view of Oh, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘880 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 23-25, 37, 41, 42, and 61 of copending Application No. 17/416,880 (reference application ‘880) in view of Oh, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘880 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose the composition used in the method of ‘682 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘682 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘682 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, 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.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘682 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, 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.
Co-pending application 17/187,098
Claims 38-45, 49-58, 61-67, and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 13-16, and 17-23 of copending Application No. 17/187,098 (reference application ‘098) in view of Oh and Lim.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘098 recite an identical composition as what is instantly claimed. Specifically, ‘098 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘098, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘098 is identical to R1 in the instant application (particularly ‘098 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 ‘098 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘098 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, the present invention is obvious over co-pending application ‘098.
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, 13-16, and 17-23 of copending Application No. 17/187,098 (reference application ‘098) in view of Oh, Lim, and Hanmi.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘098 recite an identical composition as what is instantly claimed. Specifically, ‘098 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘098, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘098 is identical to R1 in the instant application (particularly ‘098 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 ‘098 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘098 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, and Hanmi, the present invention is obvious over co-pending application ‘098.
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, 13-16, and 17-23 of copending Application No. 17/187,098 (reference application ‘098) in view of Oh, Lim, Hanmi, and Lee.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘098 recite an identical composition as what is instantly claimed. Specifically, ‘098 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘098, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘098 is identical to R1 in the instant application (particularly ‘098 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 ‘098 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘098 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, Hanmi, and Lee, the present invention is obvious over co-pending application ‘098.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 13-16, and 17-23 of copending Application No. 17/187,098 (reference application ‘098) in view of Oh, Lim, and Flink.
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims in ‘098 recite an identical composition as what is instantly claimed. Specifically, ‘098 claims a Formula 1 comprising a peptide, linker, and immunoglobulin Fc region. The claimed peptide in ‘098, represented by SEQ ID NO: 42, is identical to instant SEQ ID NO: 9. Furthermore, R1 in Chemical Formula 1 of ‘098 is identical to R1 in the instant application (particularly ‘098 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 ‘098 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the composition used in the method of ‘098 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, the present invention is obvious over co-pending application ‘098.
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, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose the identical composition of ‘426 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘426 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘426 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, Hanmi, and Lee, the present invention is obvious over U.S. Patent ‘426.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘426 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, the present invention is obvious over patent ‘426.
U.S. Patent No. 10,400,020
Claims 38-45, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose the identical composition of ‘020 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘020 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘020 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, Hanmi, and Lee, the present invention is obvious over U.S. Patent ‘020.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘020 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, the present invention is obvious over patent ‘020.
U.S. Patent No. 10,981,967
Claims 38-45, 49-58, 61-67, and 72are 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 Lim.
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 Lim disclose the identical composition of ‘967 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘967 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘967 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, Hanmi, and Lee, the present invention is obvious over U.S. Patent ‘967.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘967 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, the present invention is obvious over patent ‘967.
U.S. Patent No. 11,332,508
Claims 38-45, 49-58, 61-67, and 72 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 Lim.
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 Lim disclose the identical composition of ‘508 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Therefore, in light of the disclosures of Oh and Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘508 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, 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, Lim, 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, Lim, 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 (for example, the addition of a buffering agent or sugar alcohol), both Oh and Lim disclose the identical composition of ‘508 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Furthermore, Hanmi discloses an optimal Fc region variant represented by SEQ ID NO: 73, identical to instant SEQ ID NO: 76, that has a proline at the N-terminus, capable of binding through the nitrogen. Finally, 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, Lim, Hanmi, and Lee, the present invention is obvious over U.S. Patent ‘508.
Claims 68-71 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, Lim, and Flink.
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 Lim disclose the composition used in the method of ‘508 with the addition of those limitations set forth in instant claims 38-45, 49-58, 61-67, and 72. Oh and Lim teach the addition of these components helps to stabilize and optimize the embodiment. Oh and Lim also sucrose as a stabilizing agent. Furthermore, Flink discloses a range of sucrose concentration suitable for stabilization of a GLP-1 formulation. Therefore, in light of the disclosures of Oh, Lim, and Flink, the present invention is obvious over patent ‘508.
Conclusion
Claims 38-58 and 61-72 are rejected. No claim is allowed.
Communication
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A Rossi whose telephone number is (571) 272-0138. The examiner can normally be reached M-F 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIA A ROSSI/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644