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 .
Receipt is acknowledged of Applicant’s Restriction Requirement Response and Amendment filed on 12/30/2025; and IDS filed on 12/30/2025 and 05/02/2023.
Claims 33-39 have been canceled.
Claims 13-15, 17-19, 27-29, 31 are directed to non-elected species
Claims 1-32 are pending in the instant application.
Claims 13-15, 17-19, 27-29, 31 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election of Group I (claims 1-in-part, 4-32) and specie elections of “high outputostomy”, “about 50mg”, “administered twice monthly”, “wherein the patient does not experience substantial adverse effects” in the reply filed on 12/30/2025 is acknowledged, wherein Applicant states these elections reads upon claims 1, 4-12, 16, 20, 21, 23-26, 30, 32 for prosecution on the merits. 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)).
Note, claims 13-15, 17-19, 27-29, 31 are directed to non-elected species.
Note, the following rejection is based upon art which was found incidental to the search for the elected species. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
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 1-12, 16, 20-26, 30, 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 8,236,760. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent recites a method for treating short bowel syndrome in a subject in need thereof, comprising: providing a composition comprising exendin-4 (SEQ ID NO:3), a fragment of exendin-4 having the sequence disclosed by SEQ ID NO: 4, a fragment of exendin-4 having the sequence disclosed by SEQ ID NO: 5, exenatide (SEQ ID NO: 1), or combinations thereof, and a pharmaceutically acceptable excipient or carrier; and administering a therapeutically effective amount of the composition to the subject to treat the short bowel syndrome(see claim 1), wherein exenatide is a GLP-1 receptor agonist.
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 112, 2nd paragraph
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, 4-5, 7-8, 10-11, 16, 20-21, 24 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.
The term “long-acting” in claim 1 is a relative term which renders the claim indefinite. The term “long” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instance when is the acting NOT long?
Claims 1, 4-5, 7-8, 10, 16, 21, 24 contain the term "GLP-1", which is not defined by the claims. Claims must stand alone to define the invention, and should not rely on the description or the drawings to give them meaning (see Ex Parte Fressola, 27 USPQ 2d 1608). Thus, claim 1, at the very least, should define "GLP-1" by its formal chemical name; once "GLP-1" is defined, the term "GLP-1" may be subsequently recited.
Claim 11 recites “about 50 mg to about 50 mg”. This appears to be a typographical error, wherein the second 50 mg should be 150 mg.
The term “substantial” in claims 20 ad 32 is a relative term which renders the claim indefinite. The term “substantial” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instance when is the adverse effects NOT substantial?
Regarding claims 20 and 32, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 4, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PIMENTEL et al (US 8,236,760).
PIMENTEL teaches a method for treating short bowel syndrome in a subject in need thereof, comprising: providing a composition comprising exendin-4 (SEQ ID NO:3), a fragment of exendin-4 having the sequence disclosed by SEQ ID NO: 4, a fragment of exendin-4 having the sequence disclosed by SEQ ID NO: 5, exenatide (SEQ ID NO: 1), or combinations thereof, and a pharmaceutically acceptable excipient or carrier; and administering a therapeutically effective amount of the composition to the subject to treat the short bowel syndrome(see claim 1), wherein exenatide is a GLP-1 receptor agonist.
Note, the prior art’s method would have substantial adverse effect as claimed by Applicant, because the prior art’s method has the same ingredient and active steps as claimed by Applicant, unless proven otherwise.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HVISTENDAHL et al (Effect of Liraglutide Treatment on Jejunostomy Output in Patients With Short Bowel Syndrome: An Open-Label Pilot Study. Journal of Parenteral and Enteral Nutrition. 2018 Jan; 42(1):112-121; see IDS filed on 05/02/2023).
Regarding claim 1, HVISTENDAHL teaches treating short bowel syndrome (see title) comprised of subcutaneously administering once daily a GLP-1 (glucagon-like peptide-1) receptor agonist, such as liraglutide (see abstract) and exenatide (see pg. 113, 1st col). Additional disclosures include: expanding the half-life from <2 minutes in the native peptide to 13 hours in the dipeptidyl peptidase-4-resistant GLP-1 analogue, wherein plasma half-lives of peptide hormones are currently a "hot topic" when developing new therapeutic pharmaceuticals for treatment within the SBS indication (see pg. 119, 1st col).
Regarding claim 2, HVISTENDAHL teaches the patient has high output ostomy (see pg. 120, 1st col).
Regarding claim 3, HVISTENDAHL teaches the patient has end-jejunostomy (see abstract).
Regarding claim 4, HVISTENDAL teaches exenatide.
Claim Rejections - 35 USC § 103
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 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) 1-12, 16, 20-26, 30, 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over HVISTENDAHL et al (Effect of Liraglutide Treatment on Jejunostomy Output in Patients With Short Bowel Syndrome: An Open-Label Pilot Study. Journal of Parenteral and Enteral Nutrition. 2018 Jan; 42(1):112-121; see IDS filed on 05/02/2023) in view of SCHELLENBERGER et al (US 2010/0323956) and BIOSPACE (Diabetes Drug VRS-859 (Exenatide-XTEN) Featured at American Diabetes Association Annual Scientific Meeting. (2010)).
As discussed above, HVISTENDAHL teaches Applicant’s invention,
HVISTENDAHL does not teach fusing with a half-life extension polypeptide, such as unstructured polypeptide.
SCHELLENBERGER teaches the prior art had known of fusion proteins comprising one or more extended recombinant polypeptides with a non-repetitive sequence and/or unstructured conformation (XTEN) linked to glucose regulating peptide (GP) (see [0007]), wherein GPXTEN fusion proteins exhibits enhanced pharmacokinetic properties compared to GP not linked to XTEN, wherein the enhanced properties include but are not limited to longer terminal half-life, larger area under the curve, increased time in which the blood concentration remains within the therapeutic window, increased time between consecutive doses, and decreased dose in moles over time (see [0013]). Additional disclosures include: GLP-1 (see [0133]); exenatide and exendin-4 linked to AE864 (see [0068]-[0069]), wherein GLP-1 analogs can be used as glucose regulating peptides in the GPXTEN (see [0131]), which would include exenatide (see [0131]),wherein exenatide reads on Applicant’s SEQ ID NO: 1 (see Applicant’s specification after [0043]); the XTEN is fused to the glucose regulating peptide on an N- or C-terminus of the glucose regulating peptide (see [0024]).
BIOSPACE teaches the prior art had known of exenatide-XTEN (see title).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate fusing with a half-life extension polypeptide, such as unstructured polypeptide, with a GLP-1 agonist, such as exenatide or exendin-4. The person of ordinary skill in the art would have been motivated to make those modifications, because the half-life extension polypeptide would increase the half-life of GLP-1 agonist, and reasonably would have expected success because both references dealt with the same field of endeavor, such as GLP-1 agonist.
The references do not specifically teach dosing in the amounts and time, such as once monthly, as claimed by Applicant. The dosing amount and timing of a specific active ingredient in a method is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal dosing amount and timing in order to best achieve the desired results, such as therapeutic effective treatment, decreasing of adverse effect, etc. Especially when the prior art teaches the half-life extension polypeptide (XTEN) will increase “time in which the blood concentration remains within the therapeutic window, increased time between consecutive doses, and decreased dose in moles over time”. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosing amount would have been obvious at the time of Applicant's invention.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
Prosecution Insights