DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status – Continued Examination Under 37 CFR 1.114
Claims 1-2, 4-14, 16-17, and 19 were previously pending.
A final rejection office action was mailed on 05 February 2026.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05 May 2026 has been entered.
In their request for continued examination, Applicant has not amended, cancelled, or added claims. Therefore, claims 1-2, 4-14, 16-17, and 19 remain pending and are currently under examination.
Information Disclosure Statement (IDS)
The IDS (1) filed on 25 March 2026 has been considered by the examiner. A signed copy is enclosed.
Withdrawn Claim Rejections
Applicant has not amended, cancelled, or added claims and relies upon their argument, filed with their Request for Continued Examination, to overcome all previous claim rejections. As discussed below, Applicant's arguments filed 05 May 2026 have been fully considered but they are not persuasive. Therefore, no claim rejections are withdrawn and all previous claim rejections are maintained as presented below:
Response to Applicant’s Arguments
Independent claims 1 and 13 were previously rejected under 35 U.S.C. 103 as being obvious over Kim (cited in prior office action as US PGPub. No. 2018/0186853). This was a single-reference 103 rejection as Kim’s disclosures, while not amounting to anticipation under 35 U.S.C. 102, allowed for one of ordinary skill in the art, before the effective filing date of the claimed invention (15 July 2020), to pick and choose from embodiments of Kim to arrive at the instantly claimed invention.
Applicant acknowledges Kim performed experiments on weight loss and related parameters for the purpose of treating metabolic syndrome related to body weight or fat mass, and as part of such experiments, confirmed reduction in fat mass in the liver (Remarks, p. 2). Applicant asserts the reduction in fat mass as confirmed in Kim does not necessarily correlate with inflammation and fibrotic changes (Remarks, p. 2). As evidence in support of their assertion, Applicant submits a publication by Bril (“Exhibit A”), who teaches away from the correlation between the degree of intrahepatic triglyceride (IHTG) and resolution of non-alcoholic steatohepatitis (NASH). Applicant argues Bril shows that fat reduction does not guarantee improvement of inflammation and fibrosis, and therefore, a therapeutic effect on liver disease cannot be predicted or expected without actual experiments demonstrating improvement effects on inflammation and fibrosis (Remarks, p. 3). In this respect, Applicant argues, “one of ordinary skill in the art could not expect or predict whether the glucagon derivative set forth in the present claims can exhibit a therapeutic effect on liver disease accompanied by inflammation and fibrosis based solely on the disclosures of Kim” (Remarks, p. 4). Applicant’s remarks will be addressed separately below:
First, Applicant fails to address the most important aspect of Kim’s disclosure. Kim expressly teaches administering an identical compound as what is instantly claimed to prevent and treat non-alcoholic steatohepatitis (NASH) ([0156], [0188]), [0336], [0386], [0470], and claim 32). Applicant’s claimed “liver disease” expressly includes steatohepatitis, which is the genus of disease with which NASH is a species of. Therefore, Kim provides an express motivation to administer the claimed compound for treatment of the claimed liver disease, independent of concerns as to whether liver-fat reduction alone perfectly predicts improvement in every downstream liver pathology. In fact, Applicant has defined the term “treatment” in their disclosure as “all activities that improve or advantageously change the symptoms of liver disease” (Specification, p. 43). Therefore, the instantly claimed invention does not require parameters such as ballooning or fibrosis reduction to meet the limitations of treatment as recited in the instant claims.
Second, Bril does not expressly teach that reduction of liver fat is unrelated to NASH or that compounds reducing liver fat would be ineffective at reduction the symptoms of NASH. Rather, Bril teaches that changes in liver fat should be interpreted with caution because it does not necessarily predict all histological outcomes such as inflammation, ballooning, fibrosis, or complete NASH resolution (Applicant’s Exhibit A, p. 5). Bril still acknowledges that MRI-measured liver fat is used to assess treatment response in fatty liver disease and that changes in intrahepatic triglyceride predicts changes in steatosis (Applicant’s Exhibit A, p. 6). Thus, Bril does not criticize, discredit, or otherwise discourage administration of the identical compound for NASH where the primary reference, Kim, expressly teaches that use. Furthermore, Bril calls for larger studies and examination of agents with different mechanisms of action to confirm whether the disclosed results and observations are generalizable (Applicant’s Exhibit A, p. 21), implying very limited applicability of Bril’s publication.
Therefore, Applicant’s reliance on Bril is not persuasive because Bril does not teach away from administering the claimed compound for treatment of NASH or other metabolic liver diseases. Rather, Bril addresses the narrower question of whether a change in MRI-measured intrahepatic triglyceride content reliably predicts treatment-induced histologic improvement of steatohepatitis.
Of note is additional pertinent prior art which shares the same Applicant and/or Inventor(s) as the currently claimed application:
Hwang (US Patent No. 10,233,230 B2; date of patent: 19 March 2019): discloses pharmaceutical compositions for the treatment of non-alcoholic fatty liver disease (abstract). Hwang discloses the long-acting GLP-1/glucagon receptor dual agonist linked to Fc fragment has an effective result in weight loss and lowering liver triglyceride and blood cholesterol (col. 2, lines 23-33). Hwang further discloses the composition of the invention can prevent or treat non-alcoholic fatty liver disease by reducing liver triglycerides (col. 3, lines 45-55). The administration of the composition of the invention, Hwang discloses, significantly reduces liver weight and contributes to the prevention of fibrosis, inflammation, and fat accumulation in the liver (col. 3, lines 55-67). Therefore, Hwang confirmed the composition of the invention can be used for the treatment of various non-alcoholic liver diseases (col. 4, lines 2-12). The long-acting GLP-1/glucagon receptor dual agonists taught by Hwang as suitable for use in the invention are similar to General Formula 1 (instant SEQ ID NO: 46) as shown below:
Hwang’s SEQ ID NO: 23 compared to instant SEQ ID NO: 46 if the following wildcard amino acids were selected:
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X2: Aib; X7: T; X14: L; X16: E; X17: K; X19: A; X20: K; X21: E; X30: absent.
The only difference between Hwang’s claimed SEQ ID NO: 23 and instant General Formula I is a single conservative amino acid sequence substitution at position 1.
Hwang teaches a nearly identical sequence linked covalently to an immunoglobulin Fc region (col. 5, lines 1-18), wherein administration of such reduces liver triglycerides and decreases liver weight col. 3, lines 45-55). Hwang further discloses the administration can be used to treat non-alcoholic fatty liver disease including non-alcoholic fatty liver, nonalcoholic steatohepatitis, cirrhosis, liver cancer, etc. (col. 10, lines 45-51).
Therefore, Hwang teaches a nearly identical composition as the instantly claimed invention used to treat liver diseases such as nonalcoholic steatohepatitis, cirrhosis, and liver cancer by reducing liver weight and liver triglycerides. While the sequence of Hwang is not identical (1 conservative amino acid substitution) and requires picking and choosing from the wildcards of General Formula I, Hwang’s disclosure shows the Applicant and/or Inventor were at least contemplating, prior to the effective filing date of the claimed invention, the connection between a reduction in liver weight and liver triglycerides as it relates to the treatment of the instantly claimed diseases of steatohepatitis, liver cirrhosis, and hepatocellular carcinoma even further showing Bril’s failure as teaching away from the prior art.
Hwang is cited as rebuttal/background evidence regarding the state of the prior art and is not necessary to the claim rejections below, which are based upon Kim’s express teaching of administering an identical compound as what is instantly claimed to treat NASH.
For these reasons, the previously held claim rejections below are maintained:
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5-14, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (previously cited as: US 2018/0186853 A1; published: 05 July 2018).
Kim discloses glucagon derivatives and a composition comprising a long-acting conjugate of the same (title).
Regarding instant claims 1 and 13:
Kim discloses ‘General Formula 1’ represented by SEQ ID NO: 45 as pictured below:
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([0024]).
Kim discloses ‘General Formula 2’ represented by SEQ ID NO: 46. ‘General Formula 2’ is a narrower embodiment of ‘General Formula 1’ and depicted below:
Y-Aib-QGTF-X7-SD-X10-S-X12-Y-L-X15-X16-X17-R-A-X20-X21-F-V-X24-W-L-M-N-T-X30
([0158], emphasis added).
In the above formula, the bold areas represent locations that differ from the currently claimed General Formula 1 and require a wildcard selection to arrive at the currently claimed General Formula 1. However, the limitations of the wildcard selections include the choice of amino acid residue which allows arrival at the currently claimed General Formula 1.
Furthermore, Kim discloses a pharmaceutical composition for treating or preventing metabolic syndrome, which contains: i) a peptide including the amino acid sequence of General Formula 1, and ii) at least one compound or material having a therapeutic activity for metabolic syndrome ([0024]). Kim discloses the pharmaceutical composition contains a pharmaceutically acceptable carrier, excipient, or diluent ([0391]).
Finally and pertaining to the most recent amendment to claim 1, Kim discloses the metabolic syndrome treated by General Formula 1 can include nonalcoholic steatohepatitis (NASH) ([0156]).
Regarding instant claim 2 and 14, Kim discloses a specific conjugate embodiment whereby a glucagon derivative is linked to a biocompatible material capable of increasing in vivo half-life, which correlates to Chemical Formula 1 X – L – F ([0136]). The instantly claimed invention can be formulated from the embodiments disclosed by Kim including:
X: a glucagon derivative represented by SEQ ID NO: 20 ([0130], [0131]) is 100% identical to SEQ ID NO: 20 of the instant application as shown below:
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L: the peptide of SEQ ID NO: 20 and an immunoglobulin Fc are linked by polyethylene glycol (PEG), which contains multiple repeating units of ethylene glycol ([0138]).
F: the peptide is linked to an immunoglobulin Fc region and the conjugate compound is termed a long-acting conjugate capable of extending the half-life of the peptide to which it is linked ([0136], [0140], [0151]).
Finally, Kim discloses the components of the embodiment can be covalently linked ([0371]).
Regarding instant claims 5 and 17, Kim discloses the metabolic syndrome with which the glucagon peptide derivative or glucagon derivative conjugate is used to treat is nonalcoholic steatohepatitis (NASH) ([0008], [0156], [0188], [0336]).
Regarding instant claims 6 and 7, as previously discussed, the peptide administered to the mice is represented by SEQ ID NO: 20 ([0472]) and is 100% identical to SEQ ID NO: 20 of the instant application as shown below:
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Regarding instant claims 8, 9, and 10, each directed to a physiological effect after administration of the composition recited in instant claim 1, Kim discloses an identical composition as what is administered in instant claim 1 (see Experimental Example 2 ([0493])). In addition, Kim discloses administering said composition to a subject used as a model to measure the therapeutic effect on metabolic syndrome such as nonalcoholic steatohepatitis ([0492], [0494]). What is claimed in instant claims 8, 9, and 10 are inherent properties that occur as a result of administering the compound of instant claim 1. Prior art has disclosed both an identical composition and administration of the identical composition as that which is currently claimed in claim 1. Although Kim is silent as to the inherent characteristics of instant claims 8, 9, and 10, these physiological effects would flow naturally from administering an identical composition to a subject. See MPEP § 2112(I-III). In addition, Kim seems to already contemplate some of the physiological effects of administering the composition, further supporting inherency of the composition:
The peptide derivative of the present invention may be used for treating metabolic syndrome other than obesity such as obesity-related diseases like nonalcoholic steatohepatitis (NASH) ([0336]) and obesity-related inflammation ([0335]).
The peptide derivative of the present invention could play an additional role in reducing blood cholesterol ([0496]).
The decrease of fat in the liver can be measured as a method for measuring the therapeutic effect of metabolic syndrome such as obesity, diabetes, nonalcoholic steatohepatitis, etc. ([0492]).
Regarding instant claims 11 and 19, Kim discloses the C-terminus of the peptide including the amino acid sequence of General Formulas 1 or 2 may be amidated ([0127], [0418]).
Regarding instant claim 12, Kim discloses the non-peptide linker, which includes PEG, has a molecular weight of 1 kDa to 100 kDa ([0355]). This range is identical to that which is instantly claimed.
Regarding the sequences disclosed in the instant application, Kim teaches the peptide of General Formula 1 can include an amino acid sequence selected from SEQ ID NOs: 2 to 44 ([0129]). The sequences disclosed by Kim share the same SEQ ID NO as the instant application and are identical to those sequences disclosed in the instant application (e.g., SEQ ID NO: 20 disclosed by Kim corresponds to SEQ ID NO: 20 of the instant application and is identical).
SEQ ID NO: 20
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SEQ ID NO: 22
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SEQ ID NO: 23
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SEQ ID NO: 27
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SEQ ID NO: 33
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SEQ ID NO: 35
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SEQ ID NO: 37
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SEQ ID NO: 38
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SEQ ID NO: 40
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SEQ ID NO: 41
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SEQ ID NO: 42
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SEQ ID NO: 44
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Kim discloses a pharmaceutical composition for treating or preventing metabolic diseases, including NASH, comprising a peptide represented by SEQ ID NO: 20, which is identical to currently claimed SEQ ID NO: 20 ([0131]) and a specific embodiment of General Formula 1.
The difference between the applied reference and the claimed invention is that the applied references may not teach the instantly claimed method with particularity so as to amount to anticipation. See MPEP “[t]he identical invention must be shown in as complete detail as is contained in the ... claim.” Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990). Kim discloses various embodiments of peptides used to treat metabolic diseases requiring the skilled artisan to choose from the disclosed peptides to treat the disclosed metabolic diseases.
However, the applied reference discloses the elements of the claimed method with sufficient guidance, particularity, and with a reasonable expectation of success for the skilled artisan, that the invention would be prima facie obvious to one of ordinary skill in the art. Kim discloses all the claim limitations with a reasonable expectation of success – therefore, it would be obvious to modify the method of treating NASH by administering a glucagon variant comprising General Formula 1 of Kim, with administering a peptide comprising SEQ ID NO: 20 (identical to instant SEQ ID NO: 20) to treat NASH, because Kim discloses successful treatment of metabolic disease, including NASH, by administering any of the disclosed peptides in Kim which include the peptide comprising SEQ ID NO: 20.
Claims 4 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (previously cited) as applied to claims 1-2, 5-14, 17, and 19 above, and further in view of Malik (previously cited as: “Preventative care in cholestatic liver disease: pearls for the specialist and subspecialist; published: 10 June 2019).
The disclosures of Kim are discussed above. While Kim discloses compositions used to treat a metabolic disorder such as hypercholesterolemia, dyslipidemia, obesity, diabetes, hypertension, nonalcoholic steatohepatitis (NASH), and atherosclerosis caused by dyslipidemia, Kim does not explicitly disclose the composition is used to treat cholestasis liver disease as required by instant claims 4 and 16.
Malik teaches cholestatic liver diseases (CLDs) encompass a variety of disorders of abnormal bile formation and/or flow (abstract). Malik further discloses CLDs often lead to progressive hepatic insult and injury following the development of cirrhosis and associated complications (abstract). Many such complications are clinically silent until they manifest with severe sequelae, including metabolic disturbances (abstract). Malik focuses on preventative measures aimed at mitigating morbidity due to the symptoms, complications, and diseases associated with Primary Biliary Cirrhosis (PBC) and Primary Sclerosing Cholangitis (PSC) (p. 118).
Malik teaches fatty infiltration in the liver, which often occurs in the presence of predisposing metabolic conditions including diabetes, obesity, and elevated triglyceride levels, can further promote progression to chronic liver disease and cirrhosis through hepatic inflammation and subsequent fibrosis and necrosis. (p. 121). Malik teaches patients with PBC are also often diagnosed with hyperlipidemia, including elevated high-density lipoproteins cholesterol, and lipoprotein X accumulation (p. 121). Finally, Malik teaches the aforementioned measures may prevent additional hepatic injury and accelerated progression to advanced fibrosis or cirrhosis (p. 124).
Regarding instant claims 4 and 16, Kim discloses a glucagon derivative used to treat a metabolic disorder such as hypercholesterolemia, dyslipidemia, obesity, diabetes, hypertension, nonalcoholic steatohepatitis (NASH), and atherosclerosis caused by dyslipidemia. Furthermore, Kim administers the glucagon derivative comprising SEQ ID NO: 20 to high-fat diet-induced obesity mice to show the therapeutic effects of the disclosed composition ([0493]).
While Kim does not disclose the composition is used to treat cholestasis liver disease PBC or PSC as required by instant claims 4 and 16, Kim does show the composition is used to treat obesity, dyslipidemia, obesity-related inflammation, and hepatic inflammation. It is important to note here that the instant specification defines treatment as referring “to all activities that improve or advantageously change the symptoms of liver disease by administering the glucagon derivative, a conjugate including the same, or the composition” (p. 43).
Malik teaches measures aimed at mitigating morbidity due to the symptoms, complications, and diseases associated with PBC and PSC that include weight reduction and management of metabolic conditions such as diabetes, obesity, elevated triglyceride levels, and hyperlipidemia.
Regarding claims 4 and 16, it would have been obvious to one of ordinary skill in the art to modify the method of Kim for treating metabolic disorders such as obesity, diabetes, and dyslipidemia by administering SEQ ID NO: 20 with the teachings of Malik, who teaches each of these metabolic disorders disclosed in Kim are responsible for the symptoms and disease progression associated with PBC and PSC. This would produce a method of treating PBC and PSC by administering SEQ ID NO: 20 and thus, arriving at what is claimed in instant claims 4 and 16. This is obvious because treatment includes management of the symptoms associated with the disease. So, because Kim discloses treatment of obesity, diabetes, and dyslipidemia by administering SEQ ID NO: 20 and Malik teaches these metabolic disorders are responsible for the symptoms and disease progression associated with PBC and PSC, it would be obvious that management of PBC and PSC symptoms would be accomplished by administering Kim’s SEQ ID NO: 20. There would be a reasonable expectation of success in doing so because SEQ ID NO: 20 was disclosed by Kim as a successful method to treat obesity, diabetes, and dyslipidemia and therefore, as taught by Malik, successful treatment of these diseases would also manage the symptoms and disease progression of PBC and PSC. Therefore, one of ordinary skill would reasonably expect administering SEQ ID NO: 20 would successfully treat PBC and PSC.
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 issued patents that fall under this double patenting rejection as outlined below.
US Patent 10,696,725 B2 (date of patent: 30 June 2020)*
*The published application of US Patent 10,696,725 B2, US 2018/0186853, was used as prior art in the 35 USC 103 claim rejections as discussed above
Claims 1, 5-10, 13, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 14 of U.S. Patent No. 10,696,725 B2 (hereinafter ‘725). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 10,696,725 Claims
Instant Claims
Reasoning
1, 13, 14
1, 5-10, 13, and 17
General Formula 2 of ‘725 and the possible wildcard embodiments are identical to General Formula 1 of instant claim 1. Furthermore, ‘725 discloses the peptide of General Formula 1 is used in a method to treat liver disease (nonalcoholic steatohepatitis).
SEQ ID NO: 33 of ‘725 is identical to instant SEQ ID NO: 33
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SEQ ID NO: 44 of ‘725 is identical to instant SEQ ID NO: 44
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Instant claims 8, 9, and 10 are included in this rejection as flowing naturally from the administration of an identical composition as discussed above (see also MPEP §2112(I-III)).
Claims 1, 13, and 14 of ‘725 are drawn to a peptide used to treat liver disease and further embodiments as discussed above. Therefore, instant claims 1, 5-10, 13, and 17 are anticipated by claims 1, 13, and 14 of the ‘725 patent.
Claims 2, 11, 12, 14, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-13 of U.S. Patent No. 10,696,725 B2 (hereinafter ‘725) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 10,696,725 Claims
Instant Claims
Reasoning
1 and 6-13
2, 11, 12, 14, and 19
‘725, in claims 1 and 6-12, is drawn to the peptide of General Formula 1 that is linked to an immunoglobulin Fc region thereby containing the limitations of Chemical Formula 1 in instant claims 2 and 14. However, ‘725 does not claim covalent bonds between the peptide and linker and linker an immunoglobulin Fc region. Kim makes obvious this covalent bond as Kim expressly discloses such a bond exists between an identical conjugate used to treat NASH (see above discussion).
‘725 does not claim the limitations of instant claims 11, 12, and 19. However, Kim expressly discloses these limitations as being applicable to an identical conjugate used to treat NASH (see above discussion).
Claims 1 and 6-13 of ‘725 are drawn to a peptide linked to an immunoglobulin Fc region used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim. Therefore, instant claims 2, 11, 12, 14, and 19 are made obvious by claims 1 and 6-13 of the ‘725 patent in further view of Kim.
Claims 4 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-14 of U.S. Patent No. 10,696,725 B2 (hereinafter ‘725) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018) and Malik (“Preventative care in cholestatic liver disease: pearls for the specialist and subspecialist; published: 10 June 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 10,696,725 Claims
Instant Claims
Reasoning
1 and 6-14
4 and 16
‘725, in claims 1 and 6-14, is drawn to a peptide and peptide conjugate linked to an immunoglobulin Fc region used to treat liver disease. However, ‘725 does not claim the peptide and peptide conjugate for use in treating cholestasis liver disease PBC and/or PSC as required by instant claims 4 and 16.
In combination, Kim and Malik expressly disclose these limitations as being applicable to an identical peptide and peptide conjugate (see above discussion).
Claims 1 and 6-14 of ‘725 are drawn to a peptide and peptide linked to an immunoglobulin Fc region used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim and Malik. Therefore, instant claims 4 and 16 are made obvious by claims 1 and 6-14 of the ‘725 patent in further view of Kim and Malik.
US Patent 11,135,271 B2 (date of patent: 05 October 2021)
Claims 1-2, 5, 8-12, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,135,271 B2 (hereinafter ‘271) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Claim of US 11,135,271
Instant Claims
Reasoning
1-10
1-2, 5, 8-12, and 19
‘271, in claims 1-10, is drawn to a peptide comprising the amino acid sequence of General Formula 1. ‘271 is further drawn to the peptide of General Formula 1 represented by SEQ ID NOs: 16 and 17, which is identical to instant SEQ ID NOs: 16 and 17 respectively as shown below:
SEQ ID NO: 16
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SEQ ID NO:17
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‘271 claims only a composition and not the method of treating liver disease.
Kim also discloses a peptide of General Formula 1 that is used to treat a liver disorder. Kim further discloses the peptide of SEQ ID NOs: 16 and 17, also identical to both ‘271 and the instant application SEQ ID NOs: 16 and 17, is used to treat liver disorders including NASH.
Claims 1-10 of ‘271 are drawn to a peptide used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim. Therefore, instant claims 1-2, 5, 8-12, and 19 are made obvious by claims 1-10 of the ‘271 patent in further view of Kim.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,135,271 B2 (hereinafter ‘271) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018) and Malik (“Preventative care in cholestatic liver disease: pearls for the specialist and subspecialist; published: 10 June 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Claim of US 11,135,271
Instant Claim
Reasoning
1-10
4
‘271, in claims 1-10, is drawn to a peptide comprising the amino acid sequence of General Formula 1.
‘271 claims only a composition and not the method of treating liver disease. Kim teaches this peptide, including embodiments of SEQ ID NOs: 16 and 17, is used to treat liver disorders (NASH).
However, Kim does not disclose this peptide is used in treating specific liver disease cholestasis PBC and/or PSC.
Malik makes obvious the disclosures by Kim, including the peptide claimed by ‘271, can also be used to treat PBC and/or PSC. In light of Kim teaching these peptides are useful in treating metabolic disorders, liver inflammation, diabetes, and obesity - each of which Malik teaches furthers disease progression and symptoms of PBC and PSC.
Claims 1-10 of ‘271 are drawn to a peptide used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim and Malik. Therefore, instant claim 4 is made obvious by claims 1-10 of the ‘271 patent in further view of Kim and Malik.
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US Patent 11,142,559 B2 (date of patent: 12 October 2021)
Claims 1-2, 5-14, 17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 13-18 of U.S. Patent No. 11,142,559 B2 (hereinafter ‘559) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 11,142,559 Claims
Instant Claims
Reasoning
1-8 and 13-18
1-2, 5-14, 17, and 19
General Formula 2 of ‘559 and the possible wildcard embodiments are identical to General Formula 1 of instant claim 1. Claimed embodiments of the ‘559 peptide, represented by SEQ ID NOs: 2-11, 13-15, and 18-44, are identical to those sequences currently claimed in the instant application.
‘559 additionally claims the peptide of General Formula 1 is covalently linked to an immunoglobulin Fc region by polyethylene glycol.
However, ‘559 claims the composition is used to treat congenital hyperinsulinism not liver disease.
In view of Kim, who discloses an identical General Formula, identical sequences, and an identical conjugate (peptide – linker – immunoglobulin Fc region) to both ‘559 and the currently claimed invention is used to treat liver disease (NASH), the composition of ‘559 renders obvious that which is claimed in instant claims 1-2, 5-14, 17, and 19.
Instant claims 8, 9, and 10 are included in this rejection as flowing naturally from the administration of an identical composition as discussed above (see also MPEP §2112(I-III)).
Claims 1-8 and 13-18 of ‘559 are drawn to a peptide used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim. Therefore, instant claims 1-2, 5-14, 17 and 19 are made obvious by claims 1-8 and 13-18 of the ‘559 patent in further view of Kim.
Claims 4 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 13-18 of U.S. Patent No. 11,142,559 B2 (hereinafter ‘559) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018) and Malik (“Preventative care in cholestatic liver disease: pearls for the specialist and subspecialist; published: 10 June 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 11,142,559 Claims
Instant Claims
Reasoning
1-8 and 13-18
4 and 16
‘559, in claims 1-8 and 13-18, is drawn to a peptide and peptide conjugate linked to an immunoglobulin Fc region. However, ‘559 does not claim the peptide and peptide conjugate for use in treating cholestasis liver disease PBC and/or PSC as required by instant claims 4 and 16.
In combination, Kim and Malik expressly disclose these limitations as being applicable to an identical peptide and peptide conjugate (see above discussion).
Claims 1-8 and 13-18 of ‘559 are drawn to a peptide and peptide linked to an immunoglobulin Fc region used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim and Malik. Therefore, instant claims 4 and 16 are made obvious by claims 1-8 and 13-18 of the ‘559 patent in further view of Kim and Malik.
US Patent 11,261,227 B2 (date of patent: 01 March 2022)
Claims 1-2, 5-14, 17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,261,227 B2 (hereinafter ‘227) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 11,261,227 Claims
Instant Claims
Reasoning
1-6
1-2, 5-14, 17, and 19
Claimed embodiments of the ‘227 peptide, represented by SEQ ID NOs: 20, 22, and 27, are identical to those sequences currently claimed in the instant application.
‘227 and instant SEQ ID NO: 20:
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235
693
media_image19.png
Greyscale
‘227 and instant SEQ ID NO: 22:
PNG
media_image20.png
236
691
media_image20.png
Greyscale
‘227 and instant SEQ ID NO: 27
PNG
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241
742
media_image21.png
Greyscale
‘227 additionally claims the peptide of claim 1 is linked to an immunoglobulin Fc region by polyethylene glycol.
However, ‘227 claims a composition and not a method of treating liver disease.
In view of Kim, who discloses identical peptides and an identical conjugate (peptide – linker – immunoglobulin Fc region) to both ‘227 and the currently claimed invention is used to treat liver disease (NASH), the composition of ‘227 renders obvious that which is claimed in instant claims 1-2, 5-14, 17, and 19.
Instant claims 8, 9, and 10 are included in this rejection as flowing naturally from the administration of an identical composition as discussed above (see also MPEP §2112(I-III)).
Claims 1-6 of ‘227 are drawn to a peptide used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim. Therefore, instant claims 1-2, 5-14, 17, and 19 are made obvious by claims 1-6 of the ‘227 patent in further view of Kim.
Claims 4 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,261,227 B2 (hereinafter ‘227) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018) and Malik (“Preventative care in cholestatic liver disease: pearls for the specialist and subspecialist; published: 10 June 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 11,261,227 Claims
Instant Claims
Reasoning
1-6
4 and 16
‘227, in claims 1-6, is drawn to a peptide and peptide conjugate linked to an immunoglobulin Fc region. However, ‘227 does not claim the peptide and peptide conjugate for use in treating cholestasis liver disease PBC and/or PSC as required by instant claims 4 and 16.
In combination, Kim and Malik expressly disclose these limitations as being applicable to an identical peptide and peptide conjugate (see above discussion).
Claims 1-6 of ‘227 are drawn to a peptide and peptide linked to an immunoglobulin Fc region used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim and Malik. Therefore, instant claims 4 and 16 are made obvious by claims 1-6 of the ‘227 patent in further view of Kim and Malik.
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US Patent 11,667,688 B2 (date of patent: 06 June 2023)
Claims 1, 5-10, 13, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,667,688 B2 (hereinafter ‘688). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 11,667,688 Claims
Instant Claims
Reasoning
1-7
1, 5-10, 13, and 17
The peptides used in the method of treating liver disease (NASH) in ‘688 claim 1 are identical to what is currently claimed.
‘688 and instant SEQ ID NO: 20
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226
697
media_image22.png
Greyscale
‘688 and instant SEQ ID NO: 22
PNG
media_image23.png
234
739
media_image23.png
Greyscale
‘688 and instant SEQ ID NO: 27
PNG
media_image24.png
230
698
media_image24.png
Greyscale
‘688 and instant SEQ ID NO: 37
PNG
media_image25.png
226
699
media_image25.png
Greyscale
Instant claims 8, 9, and 10 are included in this rejection as flowing naturally from the administration of an identical composition as discussed above (see also MPEP §2112(I-III)).
Claims 1-7 of ‘688 are drawn to a peptide used to treat liver disease and further embodiments as discussed above. Therefore, instant claims 1, 5-10, 13, and 17 are anticipated by claims 1-7 of the ‘688 patent.
Claims 2, 11, 12, 14, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,667,688 B2 (hereinafter ‘688) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 11,667,688 Claims
Instant Claims
Reasoning
1-7
2, 11, 12, 14, and 19
‘688, in claims 1-7, is drawn to a peptide linked to an immunoglobulin Fc region thereby containing the limitations of Chemical Formula 1 in instant claims 2 and 14. However, ‘688 does not claim covalent bonds between the peptide and linker and linker an immunoglobulin Fc region. Kim makes obvious this covalent bond as Kim expressly discloses such a bond exists between an identical conjugate used to treat NASH (see above discussion).
‘688 does not claim the limitations of instant claims 11, 12, and 19. However, Kim expressly discloses these limitations as being applicable to an identical conjugate used to treat NASH (see above discussion).
Claims 1-7 of ‘688 are drawn to a peptide linked to an immunoglobulin Fc region used to treat liver disease (NASH) and further embodiments as discussed above and in further view of the express teachings of Kim. Therefore, instant claims 2, 11, 12, 14, and 19 are made obvious by claims 1-7 of the ‘688 patent in further view of Kim.
Claims 4 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,667,688 B2 (hereinafter ‘688) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018) and Malik (“Preventative care in cholestatic liver disease: pearls for the specialist and subspecialist; published: 10 June 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
US 11,667,688 Claims
Instant Claims
Reasoning
1-7
4 and 16
‘688, in claims 1-7, is drawn to a peptide and peptide conjugate linked to an immunoglobulin Fc region used to treat liver disease. However, ‘688 does not claim the peptide and peptide conjugate for use in treating cholestasis liver disease PBC and/or PSC as required by instant claims 4 and 16.
In combination, Kim and Malik expressly disclose these limitations as being applicable to an identical peptide and peptide conjugate (see above discussion).
Claims 1-7 of ‘688 are drawn to a peptide and peptide linked to an immunoglobulin Fc region used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim and Malik. Therefore, instant claims 4 and 16 are made obvious by claims 1-7 of the ‘688 patent in further view of Kim and Malik.
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Copending application 17/927,150*
*rejection modified based on Applicant’s claim amendments in this application.
Claims 1-2, 5-14, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32, 35-36 and 42 of copending Application No. 17/927,150 (hereinafter ‘150) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
17/927,150 Claims
Instant Claims
Reasoning
32, 35-36 and 42
1-2, 5-14, 17, and 19
Claimed embodiments of the ‘150 peptide, represented by SEQ ID NOs: 2-11 and 13-45, are identical to those sequences currently claimed in the instant application.
For instance, ‘150 and instant SEQ ID NO: 37
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231
692
media_image26.png
Greyscale
‘150 Formula 1 is identical to Chemical Formula 1 of the instant application.
However, ‘150 claims a composition and not a method of treating liver disease.
In view of Kim, who discloses identical peptides and an identical conjugate (peptide – linker – immunoglobulin Fc region) to both ‘150 and the currently claimed invention is used to treat liver disease (NASH), the composition of ‘150 renders obvious that which is claimed in instant claims 1-2, 5-14, 17, and 19.
Instant claims 8, 9, and 10 are included in this rejection as flowing naturally from the administration of an identical composition as discussed above (see also MPEP §2112(I-III)).
Claims 32, 35-36 and 42 of ‘150 are drawn to a peptide and peptide conjugate used to treat liver disease as discussed above and in further view of the express teachings of Kim. Therefore, instant claims 1-2, 5-14, 17, and 19 are made obvious by claims 32, 35-36 and 42 of the ‘150 patent application in further view of Kim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32, 35-36 and 42 of copending Application No. 17/927,150 (hereinafter ‘150) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018) and Malik (“Preventative care in cholestatic liver disease: pearls for the specialist and subspecialist; published: 10 June 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
17/927,150 Claims
Instant Claims
Reasoning
32, 35-36 and 42
4 and 16
‘150, in claims 32, 35-36 and 42, is drawn to a peptide and peptide conjugate linked to an immunoglobulin Fc region. However, ‘150 does not claim the peptide and peptide conjugate for use in treating cholestasis liver disease PBC and/or PSC as required by instant claims 4 and 16.
In combination, Kim and Malik expressly disclose these limitations as being applicable to an identical peptide and peptide conjugate (see above discussion).
Claims 32, 35-36 and 42 of ‘150 are drawn to a peptide and peptide linked to an immunoglobulin Fc region used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim and Malik. Therefore, instant claims 4 and 16 are made obvious by claims 32, 35-36 an d 42of the ‘150 patent application in further view of Kim and Malik.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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Copending application 18/285,753
Claims 1-2, 5-14, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, and 14-15 of copending Application No. 18/285,753 (hereinafter ‘753) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
18/285,753 Claims
Instant Claims
Reasoning
1-5, 8, and 14-15
1-3, 5-15, and 17-20
Claimed embodiments of the ‘753 peptide and peptide conjugate, represented by SEQ ID NOs: 13-25, 27, 29, 31, 33, and 35-45, are identical in structure and identification number to those sequences currently claimed in the instant application.
‘753 claims the peptide is represented by General Formula 1, which includes potential embodiments of the currently claimed General Formula 1. ‘753 further claims the peptide of General Formula 1 is part of a conjugate represented by Formula 1. ‘753 Formula 1 is identical to Chemical Formula 1 of the instant application.
However, ‘753 claims a composition and not a method of treating liver disease.
In view of Kim, who discloses identical peptides and an identical conjugate (peptide – linker – immunoglobulin Fc region) to both ‘753 and the currently claimed invention is used to treat liver disease (NASH), the composition of ‘753 renders obvious that which is claimed in instant claims 1-2, 5-14, 17, and 19.
Instant claims 8, 9, and 10 are included in this rejection as flowing naturally from the administration of an identical composition as discussed above (see also MPEP §2112(I-III)).
Claims 1-5, 8, and 14-15 of ‘753 are drawn to a peptide and peptide conjugate used to treat liver disease as discussed above and in further view of the express teachings of Kim. Therefore, instant claims 1-2, 5-14, 17, and 19 are made obvious by claims 1-5, 8, and 14-15 of the ‘753 patent application in further view of Kim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, and 14-15 of copending Application No. 18/285,753 (hereinafter ‘753) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018) and Malik (“Preventative care in cholestatic liver disease: pearls for the specialist and subspecialist; published: 10 June 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
18/285,753 Claims
Instant Claims
Reasoning
1-5, 8, and 14-15
4 and 16
‘753, in claims 1-5, 8, and 14-15, is drawn to a peptide and peptide conjugate linked to an immunoglobulin Fc region. However, ‘753 does not claim the peptide and peptide conjugate for use in treating cholestasis liver disease PBC and/or PSC as required by instant claims 4 and 16.
In combination, Kim and Malik expressly disclose these limitations as being applicable to an identical peptide and peptide conjugate (see above discussion).
Claims 1-5, 8, and 14-15 of ‘753 are drawn to a peptide and peptide linked to an immunoglobulin Fc region used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim and Malik. Therefore, instant claims 4 and 16 are made obvious by claims 1-5, 8, and 14-15 of the ‘753 patent application in further view of Kim and Malik.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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Copending application 18/723,147
Claims 1-2, 5-14, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 12, 13, 16-19, and 21-23 of copending Application No. 18/723,147 (hereinafter ‘147) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
18/723,147 Claims
Instant Claims
Reasoning
1, 2, 12, 13, 16-19, and 21-23
1-2, 5-14, 17, and 19
Claimed embodiments of the ‘147 peptide and peptide conjugate, represented by SEQ ID NOs: 13, 15, 19, 33, and 36-45, are identical in structure and identification number to those sequences currently claimed in the instant application.
‘147 claims the peptide is represented by General Formula 2, which includes potential embodiments of the currently claimed General Formula 1. ‘147 further claims the peptide of General Formula 2 is part of a conjugate represented by Chemical Formula 1. ‘147 Chemical Formula 1 is identical to Chemical Formula 1 of the instant application.
However, ‘147 claims a method for treating disease requiring drug action in the liver, not specifically a liver disease.
In view of Kim, who discloses identical peptides and an identical conjugate (peptide – linker – immunoglobulin Fc region) to both ‘147 and the currently claimed invention is used to treat liver disease (NASH), the composition of ‘147 renders obvious that which is claimed in instant claims 1-2, 5-14, 17, and 19.
Instant claims 8, 9, and 10 are included in this rejection as flowing naturally from the administration of an identical composition as discussed above (see also MPEP §2112(I-III)).
Claims 1, 2, 12, 13, 16-19, and 21-23 of ‘147 are drawn to a peptide and peptide conjugate used to treat liver disease as discussed above and in further view of the express teachings of Kim. Therefore, instant claims 1-2, 5-14, 17, and 19 are made obvious by claims 11, 2, 12, 13, 16-19, and 21-23 of the ‘147 patent application in further view of Kim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1, 2, 12, 13, 16-19, and 21-23 of copending Application No. 18/723,147 (hereinafter ‘147) in further view of Kim (US 2018/0186853 A1; published: 05 July 2018) and Malik (“Preventative care in cholestatic liver disease: pearls for the specialist and subspecialist; published: 10 June 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
18/723,147 Claims
Instant Claims
Reasoning
1, 2, 12, 13, 16-19, and 21-23
4 and 16
‘147, in claims 1, 2, 12, 13, 16-19, and 21-23, is drawn to a peptide and peptide conjugate linked to an immunoglobulin Fc region. However, ‘147 does not claim the peptide and peptide conjugate for use in treating cholestasis liver disease PBC and/or PSC as required by instant claims 4 and 16.
In combination, Kim and Malik expressly disclose these limitations as being applicable to an identical peptide and peptide conjugate (see above discussion).
Claims 1, 2, 12, 13, 16-19, and 21-23 of ‘147 are drawn to a peptide and peptide linked to an immunoglobulin Fc region used to treat liver disease and further embodiments as discussed above and in further view of the express teachings of Kim and Malik. Therefore, instant claims 4 and 16 are made obvious by claims 1, 2, 12, 13, 16-19, and 21-23 of the ‘147 patent application in further view of Kim and Malik.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-2, 4-14, 16-17, and 19 are rejected. No claim is allowed.
Communication
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-Th 7:30-5:30 (MST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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