DETAILED ACTION
Examiner acknowledges receipt of the reply filed 2/12/2026, in response to the non-final office action mailed 11/12/2025.
Claims 1, 2, 7, 10, and 14-17 are pending. Claims 4, 5, 12, 13, and 18 have been cancelled. Claim 14 remains withdrawn from further consideration for the reasons made of record.
Claims 1, 2, 7, 10, and 15-17 are being examined on the merits in this office 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Claim Objections- withdrawn
The objection of claims 1, 2, 15, and 17 is withdrawn in view of the amendment filed 2/12/2026.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claims 1, 4, 5, 7, 15, 16, and 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description), is withdrawn in view of the amendment filed 2/12/2026.
The rejection of claims 1, 2, 4, 5, 7, 10, and 15-18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 2/12/2026.
The rejection of claims 1, 2, 4, 5, 7, 10, and 15-18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (enablement), is withdrawn in view of the amendment filed 2/12/2026.
Claim Rejections - 35 USC § 103- withdrawn
The rejection of claims 1, 2, 4, 5, 7, 10, and 15-18 under 35 U.S.C. 103 as being unpatentable over Kim et al (U.S. 2021/0338779- earliest effective filing date 10/04/2018; hereinafter referred to as Kim 2- previously cited), and further in view of Bokvist et al (U.S. Pat. 9474780- previously cited), as evidenced by Lilly patent notice (accessed 7/22/2025 at URL lilly.com/patents- previously cited), is withdrawn in view of the common ownership statement pursuant to 35 U.S.C. 102(b)(2)(C) filed 2/12/2026.
Double Patenting- withdrawn
The rejection of claims 1, 2, 4, 5, 7, 10, and 15-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11261227 (hereinafter referred to as “the ‘227 patent” - previously cited), in view of Bokvist et al (U.S. Pat. 9474780- previously cited), as evidenced by Lilly patent notice (accessed 7/22/2025 at URL lilly.com/patents- previously cited), is withdrawn in view of the amendment filed 2/12/2026. The claims of the ’27 patent do not disclose SEQ ID NO:37.
The rejection of claims 1, 2, 4, 5, 7, 10, and 15-18 on the ground of nonstatutory double patenting as being unpatentable over claims 100, 125-137, 139, and 140 of copending Application No. 17282661 (hereinafter referred to as “the ‘661 application” - previously cited), in view of Bokvist et al (U.S. Pat. 9474780- previously cited), as evidenced by Lilly patent notice (accessed 7/22/2025 at URL lilly.com/patents- previously cited), is withdrawn in view of the amendment filed 12/29/2025 in the ‘661 application.
Response to Arguments
Applicant's arguments filed 2/12/2026 have been fully considered but they are not persuasive with respect to the maintained rejections.
Upon further consideration of the claims and claim scope, new objection and rejections are set forth herein.
An action on the merits is set forth herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claim Rejections - 35 USC § 103- maintained
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, 7, 10, and 15-17 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (U.S. 2018/0186853- July 2018- previously cited), and further in view of Bokvist et al (U.S. Pat. 9474780- previously cited), as evidenced by Lilly patent notice (accessed 7/22/2025 at URL lilly.com/patents- previously cited). The rejection is maintained from the office action mailed 11/12/2025, but has been amended to reflect claims filed 2/12/2026.
Kim et al is the PGPUB of Pat No 10696725, cited in the ODP rejection. Patent 11667688 (also cited in the ODP rejection) is a CON of the ‘725 patent).
Kim et al teach a pharmaceutical composition for treating metabolic syndromes comprising i) a peptide comprising the amino acid sequence of the following General Formula 1 and ii) at least one compound or material having a therapeutic activity for metabolic syndrome: (General Formula 1, SEQ ID NO: 45) X1-X2-QGTF-X7-SD-X10-S-X12-X13-X14-X15-X16-X17- X18-X19-X20-X21-F-X23-X24-W-L-X27-X28-X29-X30, wherein X1 is tyrosine; X2 is X2 is α-methyl-glutamic acid, aminoisobutyric acid (Aib), D-alanine, glycine, Sar (N-methylglycine), serine, or D-serine; X7 is threonine, valine, or cysteine; X10 is tyrosine or cysteine; X12 is lysine or cysteine; X13 is tyrosine or cysteine; X14 is leucine or cysteine; X15 is aspartic acid, glutamic acid, or cysteine; X16 is glutamic acid, aspartic acid, serine, α-methyl-glutamic acid, or cysteine, or is absent; X17 is aspartic acid, glutamine, glutamic acid, lysine, arginine, serine, cysteine, or valine, or is absent; X18 is alanine, aspartic acid, glutamic acid, arginine, valine, or cysteine, or is absent; X19 is alanine, arginine, serine, valine, or cysteine, or is absent; X20 is lysine, histidine, glutamine, aspartic acid, lysine, arginine, α-methyl-glutamic acid, or cysteine, or is absent; X21 is aspartic acid, glutamic acid, leucine, valine, or cysteine, or is absent; X23 is isoleucine, valine, or arginine, or is absent; X24 is valine, arginine, alanine, cysteine, glutamic acid, lysine, glutamine, α-methyl-glutamic acid, or leucine, or is absent; X27 is isoleucine, valine, alanine, lysine, methionine, glutamine, or arginine, or is absent; X28 is glutamine, lysine, asparagine, or arginine, or is absent; X29 is threonine, or is absent; and X30 is cysteine, or is absent (claim 1, paras. [0025]-[0109]). Table 1 of Kim discloses peptides of SEQ ID NOs:1-44. SEQ ID NO: 37 of Kim et al have 100% identity with instant SEQ ID NO: 37. Table 1 of Kim et al expressly taught the same Table 1 of the instant application. Kim et al teach that the compound or material having a therapeutic activity for metabolic syndrome includes a glucagon-like peptide-1 (GLP-1) receptor agonist and GIP (claim 14). Kim et al teach that the pharmaceutical composition is formulated to be administered by an oral or parenteral route, such as through skin, intravenously, intramuscularly, intra-arterially, intramedullarily, intrathecally, intraventricularly, pulmonarily, transdermally, subcutaneously, intraperitoneally, intranasally, intragastrically, topically, sublingually, vaginally, or rectally (para. [0396], [0385]). Kim et al teach that the peptides can be used to treat impaired glucose tolerance, hypercholesterolemia, dyslipidemia, obesity, diabetes, and nonalcoholic steatohepatitis (NASH), (claim 32, para. [0156], [0386]-[0387]).
However, Kim et al do not expressly teach administering a GLP-1 receptor and a GIP receptor dual agonist.
Bokvist et al. teach dual incretin peptide mimetic compounds that agonize receptors for both human glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) [reads on dual agonist GLP-1/GIP receptor] (abstract). Bokvist et al. identify tirzepatide as one of the dual agonists (e.g., claim 15). The Lilly Patent Notice reference confirms that Bovkist et al teach the structure of tirzepatide. Bokvist et al. teach that the GLP-1/GIP receptor dual agonists can be used to treat metabolic syndrome, including dyslipidemia, and obesity (cols. 5, 22). Bokvist et al. teach GLP-1/GIP receptor dual agonists are formulated as pharmaceutical compositions administered by parenteral routes (e.g., subcutaneous, intravenous, intraperitoneal, intramuscular, or transdermal) (cols. 7, 21). An effective amount can be readily determined by the attending diagnostician, as one skilled in the art, by the use of known techniques and by observing results obtained under analogous circumstances. In determining the effective amount for a patient, a number of factors are considered by the attending diagnostician, including, but not limited to: the species of mammal; its size, age, and general health; the specific disease or disorder involved; the degree of or involvement or the severity of the disease or disorder; the response of the individual patient; the particular compound administered; the mode of administration; the bioavailability characteristics of the preparation administered; the dose regimen selected; the use of concomitant medication; and other relevant circumstances (cols 5-8).
It would have been obvious to one of ordinary skill in the art to administer a pharmaceutical composition comprising a peptide of Kim et al (e.g., SEQ ID NO: 37), and a GLP-1/GIP receptor dual agonist of Bokvist et al., e.g. tirzepatide, to treat a person with metabolic syndrome (specifically, obesity). Kim et al. expressly taught administering a combination of a claimed peptide and another therapeutic agent that could be used to treat metabolic syndrome, e.g. includes a glucagon-like peptide-1 (GLP-1) receptor agonist and GIP. Instant SEQ ID NO: 37 has 100% identity with SEQ ID NOs: 37 of Kim et al. Bokvist et al. expressly taught GLP-1/GIP receptor dual agonists, e.g., tirzepatide, that could be administered to treat metabolic syndrome (specifically, obesity). Kim et al taught administering a pharmaceutically effective amount that could be determined by a physician (para. [0458]). Bokvist et al. taught administering an effective amount of tirzepatide (e.g., cols. 5-8, claims 17-18). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06. Since both Kim et al and Bokvist et al. taught obesity treatment, it further would have been obvious to one of ordinary skill the art before the effective filing date of the claimed invention that the combination could be used to treat obesity. There would have been a reasonable expectation of success because the individual compounds were taught as obesity therapeutics, with the expectation that the combination results in third formulation with equivalent or better activity. Similarly, since the individual compounds are suggested for obesity treatment, there is a reasonable expectation that the combined formulation would also serve to treat obesity. Both references further taught the same patient populations and routes of administration, e.g., intravenous and subcutaneous, and therapeutically effective amounts. The invention would have been prima facie obvious to one of ordinary skill the art before the effective filing date of the claimed invention.
The U.S. Federal Circuit has explicitly stated that in order to make a prima facie case of obviousness, the suggestion and motivation to combine the references need not be explicitly stated in the text of the references. In DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 80 USPQ2d 1641 (Fed. Cir. 2006), the Court writes, “the suggestion test is not a rigid categorical rule. The motivation need not be found in the references sought to be combined, but may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself. In re Dembiczak, 175 F.3d 994, 999 [50 USPQ2d 1614] (Fed. Cir. 1999). As we explained in Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1472 [43 USPQ2d 1481] (Fed. Cir. 1997), ‘there is no requirement that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art.’” See Dystar at 1645. “Our suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.” See Dystar at 1650. In this case, Kim et al and Bokvist et al. taught peptides (SEQ ID NO: 37 of Kim et al and tirzepatide of Bokvist et al) that could be used to treat the same patient population (metabolic syndrome, specifically obesity), therapeutically effective amounts, as well as the same routes of administration.
Accordingly, claims 1 and 16 are rendered obvious. Regarding claims 2 and 17, Kim et al teach that the peptide is linked to a biocompatible material [immunoglobulin Fc region] by a linker by covalent bond (e.g., paras. [0136]-[0155], [0345], [0350]-[0371] Ex 5 reduced to practice a conjugate comprising peptide of SEQ ID NO:20 and an immunoglobulin Fc linked by polyethylene glycol; claims 19-31).
Regarding claim 7, Kim et al that the C- terminus of the peptide is amidated (para. [0127], [0324]). Regarding claim 10, Kim et al teach that the non-peptide linker may be in the range of 1-100 kDa (para. [0355]). Example 5 reduced to practice a conjugate comprising 10 kDa PEG. Example 6 discloses a 3.4 kDa PEG conjugate. Regarding claim 15, Kim et al teach that the peptides reduced body weight and fat weight (paras. [0335]-[0336] , experimental Exs 1-2, Fig 1).
Claims 1, 2, 7, 10, and 15-17 are obvious in view of the teachings of the cited references.
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
Response to arguments
Applicant traverses the rejection at pp. 10-13 of the reply filed 2/12/2026. Applicant summarizes the reasoning of the 103 rejection as i) Kim and Bokvist each teach a peptide used for treatment of metabolic syndrome; ii) “negative teaching” of applicant is based solely on teachings of Bovkist alone; no teaching suggesting interference between the two drugs existed in the cited references; and iii) synergy effect or unexpected results asserted by applicant is limited to some working examples/specific sequences, and does not overcome the 103 rejection (reply filed 2/12/2026 at pp. 10-11).
Applicant asserts that the instant claims are nonobvious over the cited references. Applicant asserts that the unexpected “synergistic” results of effect of body weight reduction, improvements in insulin sensitivity, and an improvement in NASH and liver fibrosis via co-administration of SEQ ID NO:37 and tirzepatide are commensurate in scope with the instant claims (p. 11).
Applicant clarifies their previous argument regarding the cited reference Bokvist and a “negative teaching”. Applicant asserts that Bokvist weakens motivation to combine with Kim and Kim 2 (reply at pp. 11-12). Applicant asserts that a negative teaching is considered sufficient [to suggest interference between the two co-administered substances] were there exists a substantial teaching that can reasonably cause a person skilled in the art to avoid a specific combination (p. 12). Applicant states “Bokvist clearly mentions that glucagon receptor stimulation should be minimized in chronic treatment, which is sufficient teaching for a person skilled in the art to recognize a combination including a glucagon derivative as an inappropriate option”. Id. Applicant further asserts that a GLP-1/GIP dual agonist fundamentally lowers blood glucose by suppressing glucagon secretion among blood glucose-lowering agents, which is physiologically directly contradictory to the direction of action of a glucagon derivative that activates the glucagon receptor for blood glucose lowering. Applicant further states “[S]ince one activates the glucagon signal and the other suppresses the glucagon signal, in view of the common general technical knowledge of a person skilled in the art, it is natural and reasonable to consider that co-administration of these two drugs would raise concerns of effect cancellation or antagonistic action”. Id.
Examiner has reviewed and considered applicants arguments but is not persuaded.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Examiner reminds applicant that patents and applications are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).
Kim et al teach a pharmaceutical composition for treating metabolic syndromes comprising i) a peptide comprising the amino acid sequence of the following General Formula 1 and ii) at least one compound or material having a therapeutic activity for metabolic syndrome (claim 1). Kim et al expressly teach that the compound or material having a therapeutic activity for metabolic syndrome includes a glucagon-like peptide-1 (GLP-1) receptor agonist and GIP (e.g., claim 14). Kim et al teach that the peptides can be used to treat impaired glucose tolerance, hypercholesterolemia, dyslipidemia, obesity, diabetes, and nonalcoholic steatohepatitis (NASH), (claim 32, para. [0156], [0386]-[0387]). SEQ ID NO:37 of Kim et al has 100% identity with instant SEQ ID NO:37. glucagon suppresses appetite and activates hormone-sensitive lipase of adipocytes to facilitate lipolysis, thereby showing an anti-obesity effect (para [0007]).
Kim et al further disclose dosing strategies for adjusting the contents of GLP-1 and glucagon that may be more effective in treatment (para [0013], [0391]).
Applicant relies on a singular excerpt from Bokvist et al: "stimulation of glucagon and GLP-2 receptors should be minimized during chronic treatment of T2D patients in order to maximize glucose lowering and reduce potential long term carcinogenic risks" (reply filed 10/24/2025 at p. 17; reply filed 2/12/2026 at pp.11-12). The excerpt of Bokvist et al has been taken out of context.
Bokvist et al. disclose:
Dosing of GLP-1 analogues has been found to be limited by adverse effects, such as nausea and vomiting, and as a consequence dosing most often cannot reach full efficacy for glycemic control and weight loss. GIP alone has very modest glucose-lowering ability in type 2 diabetic humans. Both native GIP and GLP-1 are inactivated rapidly by the ubiquitous protease, DPP IV, and therefore, can only be used for short-term metabolic control.
Glucagon is a 29-amino acid peptide produced by the pancreas, and when bound to glucagon receptor, signals the liver to release glucose leading to an increase in blood glucose. GLP-2, a peptide that like GLP-1 is produced from processing of proglucagon, is known to be associated with cellular proliferation in the gut. Thus, stimulation of glucagon and GLP-2 receptors should be minimized during chronic treatment of T2D patients in order to maximize glucose lowering and reduce potential long term carcinogenic risks.
…
Applicants as part of the present invention that non-natural amino acids can have unexpected effects on the balance of agonist activity between GIP and GLP-1. Non-natural amino acids also increase the likelihood that a peptide may be seen as foreign and set off undesirable immune reactions, such as human immunogenicity and injection site reactions.
Fatty acids, through their albumin binding motifs, can improve the pharmacokinetics of a peptide by extending the half-life, for example. While use of fatty acids can improve peptide half-life, it was discovered by Applicants as part of the present invention that the length, composition, and placement of the fatty acid chain and the linker between the peptide and the fatty acid chain can have unexpected effects on the balancing of the GIP and GLP-1 agonist activity.
Tolerability of certain GLP-1 analogues has been found to prevent a dose of the GLP-1 analogue that reaches better efficacy for glycemic control and weight loss. The most common side effects assigned to GLP-1 analogues are nausea and vomiting but some compounds may also impact heart rate. The HPA axis is part of a physiological stress response and GLP-1 has been found to stimulate the HPA axis in rats resulting in increased corticosterone levels providing a potential link to adverse events such as increased heart rate. As part of the present invention, Applicants unexpectedly found that a compound of the present invention did not lead to elevated corticosterone levels like seen with semaglutide in a rat model and so possibly can be dosed to higher efficacy levels than GLP-1R-selective agents.
There remains a need to provide a compound that is a balanced co-agonist of GIP and GLP-1 receptors, but is selective AGAINST related glucagon and GLP-2 receptors. Also, there remains a need to provide a compound with balanced co-agonist activity of GIP and GLP-1 receptors which may provide weight loss given activity found in animal models. Additionally, there remains a need to provide a compound with balanced co-agonist activity of GIP and GLP-1 receptors that delivers adequate stability against DPP IV and other forms of degradation, but while still maintaining a low immunogenicity potential. Also, there remains a need to provide a compound with balanced co-agonist activity of GIP and GLP-1 receptors that supports potential once-weekly dosing in humans.
Accordingly, certain compounds of the present invention have lower potential for immunogenicity and injection site reactions than certain GIP-GLP-1 co-agonist compounds in the art. Certain compounds of the present invention have potential for producing weight loss in patients based on animal energy expenditure data. Furthermore, certain compounds of the present invention have a balanced co-agonist activity against GIP and GLP-1 receptors and selectivity against both glucagon and GLP-2 receptors, low immunogenicity potential, and pharmacokinetic (PK) characteristics that support once-weekly dosing in humans. Accordingly, an embodiment of the present invention provides a compound of Formula I [which encompasses tirzepatide].
Col 1, ll. 36- col. 2, l. 53. Emphasis added. Thus, Bokvist et al discloses design and synthesis of peptides that displayed selectivity for GIP and GLP-1 receptors versus receptors for glucagon and GLP-2. As noted above, Bokvist et al teach that the peptides were used to treat metabolic syndrome, including dyslipidemia and obesity (cols. 5, 22). Bokvist et al. identify tirzepatide as one of the dual agonists (e.g., claim 15). Bokvist et al discloses adjusting the effective amount/dose of the dual agonist (cols 7-8).
Examiner maintains “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06.
Examiner finds no evidence from the prior art that suggests a combination of drugs would be expected to interfere with each other during use of the composition. As the art does not suggest or contemplate that the combination of a peptide of SEQ ID NO:37) and a GLP-1/GIP receptor dual agonist of tirzepatide interferes with individual activity during use in treatment. It is further noted that the respective references each teach administration of a pharmaceutically effective amount can be determined by a physician/ diagnostician. Thus, it would have been routine optimization on the part of the skilled artisan to adjust the dosage.
Even if applicant did properly establish unexpected results, caselaw reiterated the principle from Newell Cos. v. Kenny Mfg. Co., 9 USPQ2d 1417, 1426 (Fed. Cir. 1988) that the mere presence of secondary considerations does not necessarily overcome a strong case of obviousness. See Pfizer Inc. v. Apotex Inc., 82 U.S.P.Q.2d 1321, 1338-39 (Fed. Cir. 2007) (quoting In re Chupp, 816 F.2d 643, 646 (Fed. Cir. 1987)). Secondary considerations are only one factor in determining obviousness.
The rejection is maintained for at least these reasons, and those previously made of record.
Examiner further refers Applicant to Lee et al (J Obes Met Synd 26:155-160 (2017))- cited but not relied upon. Lee et al teach that anorectic gut hormone, glucagon-like peptide 1 (GLP-1), is widely used to treat obesity and diabetes (p. 155). GLP-1 exhibits an anti-diabetic effect in addition to the above-mentioned anti-obe-sity effect. GLP-1 potentiates glucose-stimulated insulin secre-tion and enhances glucose homeostasis. GLP-1 agonists usually provide significant weight reduction and glucose improvement, but only a few patients achieve adequate weight/glucose control and often experience dose-limiting adverse effects such as nausea and risk of pancreatitis. Id. GIP is a gut hormone synthesized by K cells in the mucosa of the duodenum and the jejunum of the gastrointestinal tract by binding to gastric inhibitory polypeptide receptor. Several stud-ies have investigated the combination effects of GLP-1 and GIP on metabolic diseases. Central co-administration of GLP-1 and GIP synergistically decreased food intake and body weight. Id. Co-administration of GLP-1 and GIP decreased fat mass and body weight (20.8%) and re-duced food intake more than GLP-1 or GIP alone (p. 156). In preclinical and clinical studies, the combination of GLP-1 and glucagon showed anti-diabetic and anti-obesity synergistic effects (p. 157). Thus, prior to the instant application it was known that activation at the GIP, GLP-1 and glucagon receptors correlated with anti-diabetic and anti-obesity effects. Lee et al further teach a GLP-1/GIP/glucagon triagonist which activates at the GIP, GLP-1 and glucagon receptors and correlated with anti-diabetic and anti-obesity effects (pp. 158, Table 1).
Examiner acknowledges that the triagonst is one molecule directed/optimized for binding to the 3 receptors (GIP, GLP-1, and glucagon) whereas the claimed combination is drawn to a glucagon derivative and a GIP/GLP-1 dual agonist. However, Lee establishes that the prior art knew that activation at the 3 receptors provided therapeutic treatment of obesity and diabetes (Table 1, pp. 158).
Applicant’s assertions of “common general technical knowledge” and that co-administration of the claimed glucagon derivative and a GIP/GLP-1 dual agonist would “raise concerns of effect cancellation or antagonistic action” are directly contradicted by what was known and taught in the prior art, e.g., combination of glucagon derivative and a GIP/GLP-1 dual agonist to treat diabetes and obesity.
Examiner refers Applicant to Lee et al generally, for the teachings of synergism with the claimed combination of peptides.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 7, 10, and 15-17 remain/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10696725 (hereinafter referred to as “the ‘725 patent” - previously cited), in view of Bokvist et al (U.S. Pat. 9474780- previously cited), as evidenced by Lilly patent notice (accessed 7/22/2025 at URL lilly.com/patents-previously cited). The rejection is maintained from the office action mailed 11/12/2025, but has been amended to reflect claims filed 2/12/2026.
Claim 1 of the ‘725 patent recites an isolated peptide comprising the amino acid sequence of the following General Formula 2: (General Formula 2, SEQ ID NO: 46) 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 wherein X7 is threonine, valine, or cysteine; X10 is tyrosine or cysteine; X12 is lysine or cysteine; X13 is Y, X14 is L; X15 is aspartic acid or cysteine; X16 is glutamic acid or serine; X17 is lysine or arginine; X18 is R, X19 is A; X20 is glutamine or lysine; X21 is aspartic acid or glutamic acid; X23 is V; X24 is valine or glutamine; and X26 is L; X27 is M; X28 is N, X29 is T; and X30 is cysteine or is absent, with the proviso that a peptide of the amino acid sequence of SEQ ID NO: 12 is excluded. Claim 4 of the ‘725 patent recites that the peptide is a glucagon derivative capable of activating a glucagon receptor. Claim 5 of the ‘725 patent recites SEQ ID NOS: 13, 15, 19, 33, and 36 to 44. At least SEQ ID NOs: 33, 37, and 38, have 100% identity with instant SEQ ID NOs: 33, 37, and 38. Claims 11 and 12 of the ‘725 patent recite a pharmaceutical composition comprising the peptide. Claims 13, 14, and 21 of the ‘725 patent recite a method for treating metabolic syndrome (hypercholesterolemia, obesity and nonalcoholic steatohepatitis) comprising the peptide (SEQ ID NO: 37). Claims 15-20 of the patent recite a pharmaceutical composition comprising the peptide and at least one compound or material having a therapeutic activity for metabolic syndrome (selected from a Markush grouping including a GLP-1 agonist and GIP- claim 17). Claims 26 and 27 of the ‘725 patent recite a method for treating metabolic syndrome (hypercholesterolemia, obesity and nonalcoholic steatohepatitis) comprising a peptide or conjugate thereof (SEQ ID NOS: 33, and 36- 44) and at least one compound or material having a therapeutic activity for metabolic syndrome. The ‘725 patent specification discloses that the pharmaceutically effective amount can be determined by a physician (col. 29). “[T]he specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application.
However, the claims of the ‘725 patent do not expressly teach administering a GLP-1 receptor and a GIP receptor dual agonist.
Bokvist et al. teach dual incretin peptide mimetic compounds that agonize receptors for both human glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) [reads on dual agonist GLP-1/GIP receptor] (abstract). Bokvist et al. identify tirzepatide as one of the dual agonists (e.g., claim 15). The Lilly Patent Notice reference confirms that Bokvist et al teach the structure of tirzepatide. Bokvist et al. teach that the GLP-1/GIP receptor dual agonists can be used to treat metabolic syndrome, including dyslipidemia, obesity, and diabetes (cols. 5, 22). Bokvist et al. teach GLP-1/GIP receptor dual agonists are formulated as pharmaceutical compositions administered by parenteral routes (e.g., subcutaneous, intravenous, intraperitoneal, intramuscular, or transdermal) (cols. 7, 21). Bokvist et al. taught administering an effective amount of tirzepatide (e.g., cols. 5-8, claims 17-18).
It would have been obvious to one of ordinary skill in the art to administer a pharmaceutical composition comprising a peptide of the ‘725 patent (e.g., a peptide of SEQ ID NO: 37 which is encompassed within the scope of instant formula I/SEQ ID NO: 46), and a GLP-1/GIP receptor dual agonist of Bokvist et al. to treat a person with metabolic syndrome (specifically, obesity). Claims 5, 14, 16, and 27 taught SEQ ID NO: 37 which has 100% identity with instant SEQ ID NO: 37. The claims the ‘725 patent expressly taught administering a combination of a claimed peptide and another therapeutic agent that could be used to treat metabolic syndrome. Bokvist et al. expressly taught GLP-1/GIP receptor dual agonists, e.g., tirzepatide, that could be administered to treat metabolic syndrome (specifically, obesity), as well as therapeutically effective amounts. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06. The skilled artisan would have had a reasonable expectation of success because the ‘725 patent claims and cited reference taught the same patient population, and therapeutically effective amounts.
Accordingly, claims 1 and 16 are rendered obvious.
Regarding claims 2 and 17, claims 6-12, 26, and 27 of the ‘725 patent recited that the peptide is linked to a biocompatible material [immunoglobulin Fc region] via a linker by covalent bond. Regarding claim 7, claim 3 of the ‘725 patent recites at the C terminus of the peptide is amidated. Regarding claim 10, the ‘725 patent specification discloses that the non-peptide linker may be in the range of 1-100 kDa (col. 20]). Example 5 of the ‘725 patent reduced to practice a conjugate comprising 10 kDa PEG. Example 6 of the ‘725 patent discloses a 3.4 kDa PEG conjugate. “[T]he specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application. Regarding claim 15, claim 3 of the ‘725 patent recites that the peptides can be used to treat obesity [reads on reduce body weight and fat weight]. In the alternative, the step of administering the combination of the peptide of the ‘725 patent and tirzepatide to an obese patient would inherently result in body weight and fat weight loss.
Claims 1, 2, 7, 10, and 15-17 are obvious in view of the claims of the ‘725 patent and the cited reference.
Response to arguments
Applicant traverses the rejection at p. 13 of the reply filed 2/12/2026. Applicant refers to the rebuttal arguments under the 103 rejection set forth above. Applicant asserts that the reference claims of the reference patents or co-pending applications, when combined with the cited references do not render the present claims of the subject application obvious. Id.
Examiner has reviewed and considered applicants arguments but is not persuaded.
Please see Examiner’s counter-arguments under the 103 rejection above which are incorporated herein. The rejection is maintained for at least these reasons and those previously made or record.
Claims 1, 2, 7, 10, and 15-17 remain/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11667688 (hereinafter referred to as “the ‘688 patent” - previously cited), in view of Bokvist et al (U.S. Pat. 9474780- previously cited), as evidenced by Lilly patent notice (accessed 7/22/2025 at URL lilly.com/patents- previously cited). The rejection is maintained from the office action mailed 11/12/2025, but has been amended to reflect claims filed 2/12/2026.
Claim 1 of the ‘688 patent recites a method for treating metabolic syndrome, comprising administering (i) an isolated peptide or (ii) an isolated conjugate in which the isolated peptide is linked to a biocompatible material capable of increasing in vivo half-life, to a subject in need thereof, wherein the peptide comprises the amino acid sequence SEQ ID NO: 37, wherein the metabolic syndrome is selected from the group consisting of impaired glucose tolerance, hypercholesterolemia, dyslipidemia, obesity, hypertension, nonalcoholic steatohepatitis (NASH), atherosclerosis caused by dyslipidemia, atherosclerosis, arteriosclerosis, coronary heart disease, and stroke. SEQ ID NO: 37 of the ‘688 patent has 100% identity with instant SEQ ID NO:37. Claim 8 of the ‘688 patent recite further comprising administering a compound or material having a therapeutic activity for metabolic syndrome (selected from a Markush grouping including a GLP-1 agonist and GIP- claim 9). The ‘688 patent specification discloses that the pharmaceutically effective amount can be determined by a physician (col. 29). “[T]he specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application.
However, the claims of the ‘688 patent do not expressly teach administering a GLP-1 receptor and a GIP receptor dual agonist.
Bokvist et al. teach dual incretin peptide mimetic compounds that agonize receptors for both human glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) [reads on dual agonist GLP-1/GIP receptor] (abstract). Bokvist et al. identify tirzepatide as one of the dual agonists (e.g., claim 15). The Lilly Patent Notice reference confirms that Bokvist et al teach the structure of tirzepatide. Bokvist et al. teach that the GLP-1/GIP receptor dual agonists can be used to treat metabolic syndrome, including dyslipidemia, obesity, and diabetes (cols. 5, 22). Bokvist et al. teach GLP-1/GIP receptor dual agonists are formulated as pharmaceutical compositions administered by parenteral routes (e.g., subcutaneous, intravenous, intraperitoneal, intramuscular, or transdermal) (cols. 7, 21). Bokvist et al. taught administering an effective amount of tirzepatide (e.g., cols. 5-8, claims 17-18).
It would have been obvious to one of ordinary skill in the art to administer a pharmaceutical composition comprising a peptide of the ‘688 patent (e.g., a peptide of SEQ ID NO: 37 which is encompassed within the scope of instant formula I/SEQ ID NO: 46), and a GLP-1/GIP receptor dual agonist of Bokvist et al. to treat a person with metabolic syndrome (specifically, obesity). Claims 1-3 of the ‘688 patent taught SEQ ID NO: 37 which has 100% identity with instant SEQ ID NO:37. The claims the ‘688 patent expressly taught administering a combination of a claimed peptide and another therapeutic agent that could be used to treat metabolic syndrome. Bokvist et al. expressly taught GLP-1/GIP receptor dual agonists, e.g., tirzepatide, that could be administered to treat metabolic syndrome (specifically, obesity). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06. The skilled artisan would have had a reasonable expectation of success because the ‘688 patent claims and cited reference taught the same patient population, and therapeutically effective amounts.
Accordingly, claims 1 and 16 are rendered obvious.
Regarding claims 2 and 17, claims 2-8 of the ‘688 patent recited that the peptide is linked to a biocompatible material [immunoglobulin Fc region] via a linker by covalent bond. Regarding claim 7, claim 4 of the ‘688 patent recites at the C terminus of the peptide is amidated. Regarding claim 10, the ‘688 patent specification discloses that the non-peptide linker may be in the range of 1-100 kDa (col. 20]). Example 5 of the ‘227 patent reduced to practice a conjugate comprising 10 kDa PEG. Example 6 of the ‘227 patent discloses a 3.4 kDa PEG conjugate. “[T]he specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application. Regarding claim 15, the step of administering the combination of the peptide of the ‘688 patent and tirzepatide to an obese patient would inherently result in body weight and fat weight loss.
Claims 1, 2, 7, 10, and 15-17 are obvious in view of the claims of the ‘688 patent and the cited reference.
Response to arguments
Applicant traverses the rejection at p. 13 of the reply filed 2/12/2026. Examiner refers Applicant to the above rebuttal arguments which are also applicable to this ODP rejection and incorporated herein. The rejection is maintained.
Claims 1, 2, 7, 10, and 15-17 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-14, 16, 17, and 19 of copending Application No. 18016165 (hereinafter referred to as “the ‘165 application” - previously cited), in view of Bokvist et al (U.S. Pat. 9474780) - previously cited, as evidenced by Lilly patent notice (accessed 7/22/2025 at URL lilly.com/patents- previously cited). The rejection is maintained from the office action mailed 11/12/2025, but has been amended to reflect claims filed 2/12/2026.
This is a provisional nonstatutory double patenting rejection.
Claim 1 of the ‘165 application recites a method for treating a liver disease comprising administering to a subject in need thereof an effective amount of a pharmaceutical composition, said pharmaceutical composition comprising a peptide of General Formula 1 Y-X2-QGTF-X7-SDYSKY-X14-D-X16-X17-R-X19-X20-X21-FVQWLMNT-X30 (General Formula 1, SEQ ID NO: 46) wherein, X2 is aminoisobutyric acid (Aib); X7 is threonine (T), valine (V), or cysteine (C); X14 is leucine (L) or cysteine (C); X16 is glutamic acid (E) or serine (S);X17 is lysine (K), arginine (R), or cysteine (C); X19 is alanine (A) or cysteine (C); X20 is lysine (K) or glutamine (Q); X21 is aspartic acid (D) or glutamic acid (E); and X30 is cysteine (C) or is absent, (with the proviso that when the amino acid sequence of General Formula 1 is identical to SEQ ID NO: 1 or SEQ ID NO: 12, it is excluded), and wherein the liver disease is selected from the recited group. Claims 4 and 5 of the ‘165 application recite liver steatosis and NASH. Claim 13 of the ‘165 application recite peptides sequences, e.g. SEQ ID NOS: 37, which has 100% identity with instant SEQ ID NO:37.
However, the claims of the ‘165 application do not expressly teach administering a GLP-1 receptor and a GIP receptor dual agonist.
Bokvist et al. teach dual incretin peptide mimetic compounds that agonize receptors for both human glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) [reads on dual agonist GLP-1/GIP receptor] (abstract). Bokvist et al. identify tirzepatide as one of the dual agonists (e.g., claim 15). The Lilly Patent Notice reference confirms that Bokvist et al teach the structure of tirzepatide. Bokvist et al. teach that the GLP-1/GIP receptor dual agonists can be used to treat metabolic syndrome, including dyslipidemia, obesity, and diabetes (cols. 5, 22). Bokvist et al. teach GLP-1/GIP receptor dual agonists are formulated as pharmaceutical compositions administered by parenteral routes (e.g., subcutaneous, intravenous, intraperitoneal, intramuscular, or transdermal) (cols. 7, 21). Bokvist et al. taught administering an effective amount of tirzepatide (e.g., cols. 5-8, claims 17-18).
It would have been obvious to one of ordinary skill in the art to administer a pharmaceutical composition comprising a peptide of the ‘165 application (e.g., a peptide of SEQ ID NO: 37 which is encompassed within the scope of instant formula I/SEQ ID NO: 46), and a GLP-1/GIP receptor dual agonist of Bokvist et al. to treat a person with metabolic syndrome (specifically, hepatic steatosis, NASH). Claims 6, 7, and 13 of the ‘165 application taught SEQ ID NO:37 and 38, which has 100% identity with instant SEQ ID NO:37. The claims of the ‘165 application expressly taught administering a combination of a claimed peptide and another therapeutic agent that could be used to treat hepatic steatosis, NASH. Bokvist et al. expressly taught GLP-1/GIP receptor dual agonists, e.g., tirzepatide, that could be administered to treat metabolic syndrome (specifically, hepatic steatosis, NASH). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06. The skilled artisan would have had a reasonable expectation of success because the ‘165 application claims and cited reference taught the same patient population, and therapeutically effective amounts.
Accordingly, claims 1 and 16 are rendered obvious.
Regarding claims 2 and 17, claims 2 and 14 of the ‘165 application recite that the peptide is linked to a biocompatible material [immunoglobulin Fc region] via a linker by covalent bond. Regarding claim 7, claim 11 of the ‘165 application recites at the C terminus of the peptide is amidated. Regarding claim 10, claim 12 of the ‘165 application recite that the formula weight of the ethylene glycol repeating unit moiety in L is in the range of 1 kDa to 100 kDa. Regarding claim 15, the step of administering the combination of the peptide of the ‘165 application and tirzepatide to a patient with NASH would inherently reduce NAS scores.
Claims 1, 2, 7, 10, and 15-17 are obvious in view of the claims of the ‘165 application and the cited reference.
Response to arguments
Applicant traverses the rejection at p. 13 of the reply filed 2/12/2026. Examiner refers Applicant to the above rebuttal arguments which are also applicable to this ODP rejection and incorporated herein. The rejection is maintained.
Conclusion
No claims are allowed.
Claims 1, 2, 7, 10, and 14-17 are pending. Claim 14 is withdrawn.
Claims 1, 2, 7, 10, and 15-17 are rejected.
THIS ACTION IS MADE FINAL. 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 KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
/JULIE HA/Primary Examiner, Art Unit 1654