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 .
Election/Restrictions and Claim Status
It is noted that claim 2 is listed as an original claim but includes underlining in line 1. Applicants are reminded to make amendments in accord with 37 CFR 1.121(c) and to use the appropriate claim identifier. The amendment of 4/2/26 has been considered.
Applicant’s election of Group 1 in the reply filed on 4/2/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Although applicants request rejoinder, a request for rejoinder is not the same as pointing out errors in the restriction requirement. Burden is not necessarily a consideration under unity of invention and there are many different ways to make peptides (solid phase peptide synthesis, solution phase peptide synthesis, recombinant DNA expression, isolation from a natural source, etc.).
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/2/26.
Applicant’s election without traverse of the species of chenodeoxycholate and GLP-1RA of SEQ ID NO:5 in the reply filed on 4/2/26 is acknowledged. Since Table 1 is not legible (see specification objection below), the elected peptide is interpreted as SEQ ID NO:5 as set forth in the sequence listing. Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 8-15 and 19 require excipient B which is not the elected chenodeoxycholate. With respect to claims 6-7, the last paragraph of page 36 of the specification suggests that CDC (chenodeoxycholate ) reads on claim 6 but not claim 7 and although unclear the claims have been interpreted in such fashion. Claims 8 appears to require a compound as in claim 7 and is thus drawn to a non-elected species as discussed above. Claim 16 recites excipient B which was not elected. Claim 18 requires 2 excipients while only CDC was elected.
Claims 7-16 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/2/26.
Claims 1-6, 17 and 20 are being examined.
Priority
The priority information is found in the filing receipt dated 1/14/25.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/15/26, 7/9/25, 4/10/25, 11/1/24, 8/9/24 and 5/9/24 have been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The tables in the specification are not legible (see pages 27-30, etc.)
The replacement tables provided 4/2/26 are also not legible.
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities:
The last line of claim 3 recites ‘Dehydrocholic’. There is no need to capitalize such word at this location in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 17 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites ‘large physiological active substance’. The determination of what falls within the scope of the claim is subjective. The specification describes ‘large physiological active substances’ as macromolecules (page 25 lines 30-32) but such description is subjective. The specification describes ‘molecular weight known in the art’ (page 9 lines 26-27) but such description is not specific. Although the specification provides examples, exemplification is not a definition. Further, claim 2 includes analogs and it is not clear which analogs meet the limitation of being large. None of dependent claims 2-6, 17 and 20 clarify the claim scope.
Claim 6 recites ‘tight junction open bile acid’. The meaning of such phrase is unclear. It does not appear to be an art recognized phrase. It is unclear if the intent is to describe where the compound originates from or if the intent is to describe a function or if the intent is something else. Although figure 2 caption (page 7) refers to tight junction openness, the determination and boundaries of what is tight junction open versus non-tight junction open is unclear and subjective.
Claim 20 refers to a composition and then recites ‘administered orally’. Such language makes it unclear if claim 20 is a product claim or a method claim. A composition that is intended for oral administration is not necessarily the same as a composition that has been administered. The scope of claim 20 is unclear.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification. Claim 6 has been interpreted as including chenodeoxycholic acid.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 17 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
(1) Scope of the invention/Partial structure/disclosure of drawings:
Claim 1 recites ‘large physiologically active substance’ and claim 2 recites ‘polypeptide, protein, polysaccharide, nucleotide or analog thereof’. No limitation is put on the type of analog. An almost limitless number of analogs and substances are possible. None of claims 3-6, 17 or 20 further limit the substance.
Claim 1 recites ‘a bile acid or a derivative thereof’. No limitation is put on the type of derivative.
Claim 1 recites ‘derivative thereof having CYP450 inhibition, antioxidant effect or gastrointestinal enzyme activity inhibition effect’. No limitation is put on the type of derivative other than having the recited function.
Claim 6 also appears to recite functional language.
The specification generically refers to ‘monoclonal antibodies, antigen sections’ and ‘enzymes, binding proteins, cell receptors, signaling proteins, signaling molecules’ and oligonucleotides (page 10).
(2) Level of skill and knowledge in the art/predictability in the art:
The level of skill in the art is high.
(3) Physical and/or chemical properties and (4) Functional characteristics:
Claim 1 recites ‘large physiologically active substance’ and claim 2 recites ‘polypeptide, protein, polysaccharide, nucleotide or analog thereof’. No limitation is put on the type of analog. An almost limitless number of analogs and substances are possible. None of claims 3-6, 17 or 20 further limit the substance.
Claim 1 recites ‘derivative thereof having CYP450 inhibition, antioxidant effect or gastrointestinal enzyme activity inhibition effect’. No limitation is put on the type of derivative other than having the recited function.
Thus, the claims require functional characteristics.
There is no specific disclosed correlation between structure and function particularly related to what structures are adequate to result in the functions as recited in the claims. There is no structure/function correlation provided as to what modification can be made to allow for active substances or compounds with the recited function. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus and that the applicant was not in possession of the claimed genus.
(5) Method of making the claimed invention/actual reduction to practice:
The specification refers to manufacture according to methods in Korean patent applications (pages 25-26 connecting paragraph). However, mere manufacturing does not show that it would have the functionalities claimed.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 17 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) compositions. This judicial exception is not integrated into a practical application because there is no additional elements that apply or use the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as discussed below.
This 101 rejection is consistent with the most recent training provided by the office (see MPEP 2106) which will be referred to as 'guidance'.
In comparison to the subject matter eligibility test as set forth in the guidance, the claims are drawn to compositions. Thus the answer to step 1 is yes.
Component 1 of the composition can be a substance which can be a polypeptide. The instant specification recites many naturally occurring polypeptides including glucagon, GLP-1, insulin and cell receptors (pages 9-10 connecting paragraph).
Component 2 of the composition can be chenodeoxycholic acid. Pavlovic et al. (cited with IDS 7/9/25) teach chenodeoxycholic acid as being synthesized in the liver (page 2 first paragraph of section ‘Physiochemical properties of bile acids’) and recites numerous other natural bile acids in Table 1 (page 4).
In relation to prong one of step 2a of the guidance the answer is yes because the components of the composition can correspond to natural products (i.e. products of nature which are a natural phenomenon).
In relation to prong two of step 2a, the instant claims are product claims and do not require any additional elements that apply the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Thus the answer to prong two of step 2a is no.
In relation to step 2b, the claims refer to a composition which can correspond to the components in water which itself is naturally occurring. The instantly claimed compositions are like the novel bacterial mixture of Funk Brothers which contained multiple naturally occurring components, which was held ineligible because each species of bacteria in the mixture (like each component in the peptide composition) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”). The claims do not require any additional features that add significantly more to the exceptions.
Further, there is no evidence of any markedly different characteristic. MPEP 2106.04(c) II C recognizes that a change cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Thus the answer to step 2b is no because there is not adequate evidence to conclude that the claims include significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pechenov et al. (WO 2019087083 as cited with IDS 5/15/26; ‘Pechenov’).
Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract). Pechenov teach various permeation enhances combined with SEQ ID NO:3 (section 0305 beginning on page 62) where SEQ ID NO:3 is set forth on page 21. Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table).
In relation to the substance and polypeptide of claims 1-2, Pechenov teach compositions with SEQ ID NO:3 (section 0305 beginning om page 62) where SEQ ID NO:3 is set forth on page 21.
In relation to excipient A of claims 1-6, Pechenov specifically teach sodium chenodeoxycholate (page 63 9th entry in Table). Although unclear, sodium chenodeoxycholate has been interpreted as reading on claim 6.
In relation to the composition of claims 1 and 20 and ratio of claim 17, Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table) which is a ratio of 1:250. Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract).
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.
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.
Claim(s) 1-6, 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pechenov et al. (WO 2019087083 as cited with IDS 5/15/26; ‘Pechenov’) in view of Annathur et al. (US 2013/0164310; ‘Annathur’).
Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract). Pechenov teach that GLP-1 peptide analogs are generally amphiphilic and to achieve systemic exposure that permeation enhancers can be used for improved absorption (section 0005). Pechenov teach chenodeoxycholic acid as a permeation enhancer (section 0174). Pechenov teach various permeation enhances combined with SEQ ID NO:3 (section 0305 beginning om page 62) where SEQ ID NO:3 is set forth on page 21. Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table). As shown in Table 2 (pages 62-63), 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient. In example 7, Pechenov teach the use of chenodeoxycholic acid for improved bioavailability (section 0316). Pechenov recognize various applications including reducing food intake (section 0236).
Pechenov does not recite instant SEQ ID NO:5.
Annathur recognizes that GLP1 has been shown to reduce food intake (section 0008). Annathur teach that GLP1 has a short in vivo half-life and is rapidly degraded and that exendin4 homologues have improved properties (section 0009). In claim 6, Annathur teach Exendin4 homologues including SEQ ID NO:71 where the sequence is set forth on page 126. Annathur suggest oral administration (section 0185).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Pechenov because Pechenov teach that GLP-1 peptide analogs are generally amphiphilic and to achieve systemic exposure that permeation enhancers can be used for improved absorption (section 0005) and teach in Table 2 (pages 62-63) that 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient. Based on the advantageous properties of sodium chenodeoxycholate one would have been motivated to combine with other known GLP-1 peptide analogs including the peptides taught by Annathur including SEQ ID NO:71 (claim 6). Further, Annathur teach that GLP1 has a short in vivo half-life and is rapidly degraded and that exendin4 homologues have improved properties (section 0009) and suggest oral administration (section 0185) so one would have been motivated to prepare in an appropriate composition. One would have had a reasonable expectation of success because Pechenov teach in Table 2 (pages 62-63), 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient. In example 7, Pechenov teach the use of chenodeoxycholic acid for improved bioavailability (section 0316).
In relation to the substance and polypeptide of claims 1-2, Pechenov teach compositions with SEQ ID NO:3 (section 0305 beginning om page 62) where SEQ ID NO:3 is set forth on page 21. In claim 6, Annathur teach Exendin4 homologues including SEQ ID NO:71 where the sequence is set forth on page 126.
In relation to excipient A of claims 1-6, Pechenov specifically teach sodium chenodeoxycholate (page 63 9th entry in Table). Pechenov teach chenodeoxycholic acid as a permeation enhancer (section 0174). Although unclear, sodium chenodeoxycholate has been interpreted as reading on claim 6.
In relation to the composition of claims 1 and 20 and ratio of claim 17, Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table) which is a ratio of 1:250. Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract).
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 1-6, 17 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 18039184 (reference application; ‘184’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
184 recites oral pharmaceutical compositions (claim 1) that can contain a GLP-1 (claim 2) specifically SEQ ID NO:20 (claim 3) and recites chenodeoxycholic acid (claim 20) where the components are in a specific ratio (claim 25).
In relation to the substance and polypeptide of claims 1-2, 184 recites oral pharmaceutical compositions (claim 1) that can contain a GLP-1 (claim 2) specifically SEQ ID NO:20 (claim 3).
In relation to excipient A of claims 1-6, 184 recites chenodeoxycholic acid (claim 20)
In relation to the composition of claims 1 and 20 and ratio of claim 17, 184 recites formulations with components which are in a specific ratio (claim 25).
Claims 1-6, 17 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18039130 (130) in view of Pechenov et al. (WO 2019087083 as cited with IDS 5/15/26; ‘Pechenov’).
This is a provisional nonstatutory double patenting rejection.
130 recites compositions (claims 1 and 23) that can contain a GLP-1 (claim 2) specifically SEQ ID NO:20 (claim 3) and recites oral administration (claim 23).
130 does not recite chenodeoxycholic acid.
Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract). Pechenov teach that GLP-1 peptide analogs are generally amphiphilic and to achieve systemic exposure that permeation enhancers can be used for improved absorption (section 0005). Pechenov teach chenodeoxycholic acid as a permeation enhancer (section 0174). Pechenov teach various permeation enhances combined with SEQ ID NO:3 (section 0305 beginning om page 62) where SEQ ID NO:3 is set forth on page 21. Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table). As shown in Table 2 (pages 62-63), 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient. In example 7, Pechenov teach the use of chenodeoxycholic acid for improved bioavailability (section 0316). Pechenov recognize various applications including reducing food intake (section 0236).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 130 because 130 recites compositions specifically those of GLP-1 for oral administration (claims 2-3 and 23). Since Pechenov teach that GLP-1 peptide analogs are generally amphiphilic and to achieve systemic exposure that permeation enhancers can be used for improved absorption (section 0005) and teach in Table 2 (pages 62-63) that 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient one would have been motivated to include chenodeoxycholate in the compositions of 130 based on the advantageous properties. One would have had a reasonable expectation of success because Pechenov teach in Table 2 (pages 62-63), 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient. In example 7, Pechenov teach the use of chenodeoxycholic acid for improved bioavailability (section 0316).
In relation to the substance and polypeptide of claims 1-2, 130 recites compositions (claim 1) that can contain a GLP-1 (claim 2) specifically SEQ ID NO:20 (claim 3). Pechenov teach compositions with SEQ ID NO:3 (section 0305 beginning om page 62) where SEQ ID NO:3 is set forth on page 21
In relation to excipient A of claims 1-6, Pechenov specifically teach sodium chenodeoxycholate (page 63 9th entry in Table). Pechenov teach chenodeoxycholic acid as a permeation enhancer (section 0174). Although unclear, sodium chenodeoxycholate has been interpreted as reading on claim 6.
In relation to the composition of claims 1 and 20 and ratio of claim 17, Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table) which is a ratio of 1:250. Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract).
Claims 1-6, 17 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-12, 14, 16-20, 22, 27 and 30-53 of copending Application No. 17615504 (504) in view of Pechenov et al. (WO 2019087083 as cited with IDS 5/15/26; ‘Pechenov’).
This is a provisional nonstatutory double patenting rejection.
504 recites compositions (claims 1 and 31) that can contain a GLP-1 (claim 7) and recites oral administration (claim 31).
504 does not recite chenodeoxycholic acid.
Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract). Pechenov teach that GLP-1 peptide analogs are generally amphiphilic and to achieve systemic exposure that permeation enhancers can be used for improved absorption (section 0005). Pechenov teach chenodeoxycholic acid as a permeation enhancer (section 0174). Pechenov teach various permeation enhances combined with SEQ ID NO:3 (section 0305 beginning om page 62) where SEQ ID NO:3 is set forth on page 21. Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table). As shown in Table 2 (pages 62-63), 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient. In example 7, Pechenov teach the use of chenodeoxycholic acid for improved bioavailability (section 0316). Pechenov recognize various applications including reducing food intake (section 0236).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 504 because 504 recites compositions specifically those of GLP-1 for oral administration (claims 7 and 31). Since Pechenov teach that GLP-1 peptide analogs are generally amphiphilic and to achieve systemic exposure that permeation enhancers can be used for improved absorption (section 0005) and teach in Table 2 (pages 62-63) that 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient one would have been motivated to include chenodeoxycholate in the compositions of 504 based on the advantageous properties. One would have had a reasonable expectation of success because Pechenov teach in Table 2 (pages 62-63), 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient. In example 7, Pechenov teach the use of chenodeoxycholic acid for improved bioavailability (section 0316).
In relation to the substance and polypeptide of claims 1-2, 504 recites compositions (claim 1) that can contain a GLP-1 (claim 7). Pechenov teach compositions with SEQ ID NO:3 (section 0305 beginning om page 62) where SEQ ID NO:3 is set forth on page 21
In relation to excipient A of claims 1-6, Pechenov specifically teach sodium chenodeoxycholate (page 63 9th entry in Table). Pechenov teach chenodeoxycholic acid as a permeation enhancer (section 0174). Although unclear, sodium chenodeoxycholate has been interpreted as reading on claim 6.
In relation to the composition of claims 1 and 20 and ratio of claim 17, Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table) which is a ratio of 1:250. Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract).
Claims 1-6, 17 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12338270 (270 as cited with IDS 5/15/26) in view of Pechenov et al. (WO 2019087083 as cited with IDS 5/15/26; ‘Pechenov’).
270 recites peptides (claim 1).
270 does not recite chenodeoxycholic acid.
Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract). Pechenov teach that GLP-1 peptide analogs are generally amphiphilic and to achieve systemic exposure that permeation enhancers can be used for improved absorption (section 0005). Pechenov teach chenodeoxycholic acid as a permeation enhancer (section 0174). Pechenov teach various permeation enhances combined with SEQ ID NO:3 (section 0305 beginning om page 62) where SEQ ID NO:3 is set forth on page 21. Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table). As shown in Table 2 (pages 62-63), 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient. In example 7, Pechenov teach the use of chenodeoxycholic acid for improved bioavailability (section 0316). Pechenov recognize various applications including reducing food intake (section 0236).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 270 because 270 recites peptides (claim 1) similar to Pechenov (see page 21). Since Pechenov teach that GLP-1 peptide analogs are generally amphiphilic and to achieve systemic exposure that permeation enhancers can be used for improved absorption (section 0005) and teach in Table 2 (pages 62-63) that 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient one would have been motivated to include chenodeoxycholate in the compositions of 270 based on the advantageous properties. One would have had a reasonable expectation of success because Pechenov teach in Table 2 (pages 62-63), 25 mg/ml sodium chenodeoxycholate had the highest permeability coefficient. In example 7, Pechenov teach the use of chenodeoxycholic acid for improved bioavailability (section 0316).
In relation to the substance and polypeptide of claims 1-2, 270 recites a peptide (claim 1). Pechenov teach compositions with SEQ ID NO:3 (section 0305 beginning om page 62) where SEQ ID NO:3 is set forth on page 21
In relation to excipient A of claims 1-6, Pechenov specifically teach sodium chenodeoxycholate (page 63 9th entry in Table). Pechenov teach chenodeoxycholic acid as a permeation enhancer (section 0174). Although unclear, sodium chenodeoxycholate has been interpreted as reading on claim 6.
In relation to the composition of claims 1 and 20 and ratio of claim 17, Pechenov specifically teach 0.1 mg/ml SEQ ID NO:3 with 25 mg/ml sodium chenodeoxycholate (page 63 9th entry in Table) which is a ratio of 1:250. Pechenov teach formulations for oral administration of GLP-1 peptide analogs (abstract).
Conclusion
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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