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 1-17 were pending in the present application. By virtue of a Preliminary Amendment, filed by Applicant on 13 January 2023, claims 1-17 were amended and claims 18-20 were added.
In response to the non-final office action, dated 15 September 2025, Applicant filed an Amendment received on 15 December 2025. Pursuant to the newly filed Amendment, claims 1-2, 4-14, and 16-17 were amended, claims 3, 15, 18, and 20 were cancelled, and no new claims were added. Therefore, claims 1-2, 4-14, 16-17, and 19 are now pending and currently under examination.
Priority
The instant application filed on 13 January 2023 is a 371 of PCT/KR2021/009124 filed 15 July 2021. In addition, the instant application claims foreign priority of KR10-2020-0087684 filed 15 July 2020.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386 (c) is acknowledged. Receipt of certified copies of papers required by 37 CFR 1.55 is acknowledged.
Applicant has submitted a translation of the foreign priority document, received 15 December 2025. The instant application claims foreign priority of KR10-2020-0087684, filed 15 July 2020, and which finds full support for the instant claims in the received translated document. Therefore, the effective filing date of the instant application is 15 July 2020.
Withdrawn Claim Rejections
Applicant has amended the scope of claim 1 from a composition to method claim. Therefore, the previous 35 U.S.C. 102(a)(1) and 102(a)(2) rejection of claims 1, 6-10, and 13 as being anticipated by Kim (previously cited as: US 2018/0186853 A1; published: 05 July 2018) is moot and hereby withdrawn.
In light of Applicant cancelling claims 3, 15, 18, and 20, all previous rejections of these claims are moot and hereby withdrawn.
Response to Applicant’s Arguments
Applicant's arguments filed 15 December 2025 have been fully considered but they are not persuasive.
Applicant has amended the scope of claim 1 to include a method of treating liver disease wherein the liver disease is selected from the following: steatohepatitis, liver fibrosis, liver inflammation, liver cirrhosis, liver decompensation, hepatocellular carcinoma, and cholestasis liver disease. Applicant further argues Kim (cited in prior office action as: US 2018/0186853 A1; published: 05 July 2018) “discloses glucagon derivatives, but the disclosed uses thereof are limited to uses for metabolic syndrome (specifically, impaired glucose tolerance, hypercholesterolemia, dyslipidemia, obesity, diabetes, hypertension, nonalcoholic steatohepatitis (NASH), atherosclerosis caused by dyslipidemia, atherosclerosis, arteriosclerosis, coronary heart disease, and stroke). See Remarks, p. 9-10. Applicant further argues that accordingly, Kim does not disclose a use for treatment of liver disease. See Remarks, p. 10. Finally, Applicant argues the NASH disclosed in Kim is one of the metabolic syndromes and the liver disease presented in claims 1 and 13 has been specified as specific liver diseases other than NASH. See Remarks, p. 10.
Applicant’s amendments to claims 1 and 13 are not commensurate in scope with Applicant’s arguments. Applicant argues that the liver disease currently presented in claims 1 and 13 “has been specified as specific liver diseases other than NASH.” This is simply not true. It is impossible to argue that the liver diseases presented in claims 1 and 13 do not include NASH when claims 5 and 17, which depend from claims 1 and 13, respectively, recite the liver disease is caused by NASH or is accompanied thereby. Furthermore, NASH is a form of steatohepatitis, which is included in the liver disease of claims 1 and 13.
As an indication of importance given to liver disease in Kim’s invention, the second sentence of Kim’s disclosure delves into the incidence of metabolic syndrome-associated diseases such as liver disease ([0002]). Applicant is attempting to parse the liver diseases and treatment thereof explicitly disclosed by Kim from the currently claimed invention by arguing that the liver diseases disclosed by Kim are caused by metabolic syndrome and as such, Kim is a deficient prior art reference because the currently claimed invention is not directed towards liver diseases caused by metabolic syndrome. See Remarks, p. 9-11. However, the liver diseases now included in independent claims 1 and 13 do not exclude those liver diseases caused by metabolic syndrome. For instance, Applicant claims a method to treat liver inflammation. In their disclosure, Applicant indicates “liver inflammation, known as a major cause of liver disease, is caused by activation of Kupffer cells…due to various genetic and environmental factors” (Specification, p. 2). Activation of Kupffer cells (KCs), as one of ordinary skill in the art would know, is caused by metabolic syndrome as lipid infiltration in the liver triggers liver injury, activates KCs, which then release a large number of inflammatory factors and chemokines. This leads to the recruitment and infiltration of monocyte-derived macrophages which causes inflammation and initiates the fibrotic program.
Therefore, Applicant’s newly filed amendments do not cure any deficiencies in Kim as the scope of Applicant’s claims remains inclusive of liver diseases caused by metabolic syndrome. Kim, independently, would possibly be a deficient reference if Applicant claimed treatment of liver diseases such as Wilson’s disease (genetic) or Hepatitis B (viral). However, these treatments would be in direct contradiction with Applicant’s disclosure, which discloses that the examples show the present invention reduces triglycerides in the liver tissue and “has preventative and therapeutic effects on metabolic liver diseases including steatosis by reducing fat in liver tissue” (Specification, p. 36). Moreover, Applicant discloses that fat deposition in liver tissue induces inflammation, leading to the progression of other liver diseases” (Specification, p. 36). Applicant has shown no evidence the current invention can treat liver diseases exclusive of those caused by metabolic syndrome and as such, Applicant’s arguments are not persuasive.
New Claim Rejections Necessitated by Amendment
As previously stated, Applicant has amended the scope of claim 1 from a use claim without active steps to a now claimed method. Therefore, Applicant’s amendments have facilitated new claim rejections presented below as incorporated into the previous rejections of the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 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:
PNG
media_image1.png
122
685
media_image1.png
Greyscale
([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:
PNG
media_image2.png
257
881
media_image2.png
Greyscale
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:
PNG
media_image2.png
257
881
media_image2.png
Greyscale
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]).
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
PNG
media_image2.png
257
881
media_image2.png
Greyscale
SEQ ID NO: 22
PNG
media_image3.png
238
870
media_image3.png
Greyscale
SEQ ID NO: 23
PNG
media_image4.png
239
874
media_image4.png
Greyscale
SEQ ID NO: 27
PNG
media_image5.png
245
834
media_image5.png
Greyscale
SEQ ID NO: 33
PNG
media_image6.png
242
877
media_image6.png
Greyscale
SEQ ID NO: 35
PNG
media_image7.png
267
883
media_image7.png
Greyscale
SEQ ID NO: 37
PNG
media_image8.png
237
889
media_image8.png
Greyscale
SEQ ID NO: 38
PNG
media_image9.png
241
887
media_image9.png
Greyscale
SEQ ID NO: 40
PNG
media_image10.png
233
886
media_image10.png
Greyscale
SEQ ID NO: 41
PNG
media_image11.png
236
871
media_image11.png
Greyscale
SEQ ID NO: 42
PNG
media_image12.png
230
876
media_image12.png
Greyscale
SEQ ID NO: 44
PNG
media_image13.png
231
881
media_image13.png
Greyscale
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
PNG
media_image14.png
237
525
media_image14.png
Greyscale
SEQ ID NO: 44 of ‘725 is identical to instant SEQ ID NO: 44
PNG
media_image15.png
235
540
media_image15.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, 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
PNG
media_image16.png
238
702
media_image16.png
Greyscale
SEQ ID NO:17
PNG
media_image17.png
237
703
media_image17.png
Greyscale
‘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.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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:
PNG
media_image18.png
235
693
media_image18.png
Greyscale
‘227 and instant SEQ ID NO: 22:
PNG
media_image19.png
236
691
media_image19.png
Greyscale
‘227 and instant SEQ ID NO: 27
PNG
media_image20.png
241
742
media_image20.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.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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
PNG
media_image21.png
226
697
media_image21.png
Greyscale
‘688 and instant SEQ ID NO: 22
PNG
media_image22.png
234
739
media_image22.png
Greyscale
‘688 and instant SEQ ID NO: 27
PNG
media_image23.png
230
698
media_image23.png
Greyscale
‘688 and instant SEQ ID NO: 37
PNG
media_image24.png
226
699
media_image24.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.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
Copending application 17/927,150
Claims 1-2, 5-14, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-36 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
32-36 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
PNG
media_image25.png
231
692
media_image25.png
Greyscale
‘150 claims the peptide is represented by Formula 2, which includes potential embodiments of the currently claimed General Formula 1. ‘150 further claims the peptide of Formula 2 is part of a conjugate represented by Formula 1. ‘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 32-36 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 32-36 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 32-36 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
32-36 and 42
4 and 16
‘150, in claims 32-36 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 32-36 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 32-36 and 42 of 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.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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
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, Julie Wu can be reached at (571) 272-5205. 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
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643