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 .
In view of the appeal brief filed on 1/23/2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejection sets forth below. This office is Non-Final.
Claim Status
Claims 10-13 and 15-20 are pending.
Claims 1-9 and 14 and are cancelled.
Claims 10 and 15-17 are withdrawn as being directed to a non-elected invention, the election having been made on 9/5/2024.
Claims 11-13 and 18-20 have been examined.
Priority
This application is a CON of PCT/US2020/031197 05/01/2020
PCT/US2020/031197 has PRO 62/845,209 05/08/2019
PCT/US2020/031197 has PRO 62/843,221 05/03/2019
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/2/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on 1/30/2-026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US patent # of 10603275, 11464737, 11826464, and 12201721 has been reviewed and accepted. The terminal disclaimer has been recorded.
Withdrawn Rejection
All rejections of record are withdrawn because of new ground of rejection and terminal disclaimer of record.
New Ground of Rejection
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.
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.
Claims 11-13 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dumont et al. (WO 2018/102743 A1, previously cited) in view of Shi et al. (Haemophilia. 2012 July; 18(4): 639–646) and Imran (US 2013/0177527 A1).
Claim 12 is drawn to a method for treating a clotting disorder in a patient comprising:
providing a therapeutic preparation comprising a stabilized Factor VIII (FVIII) in a dosage above 75 IU/kg body weight of the patient; and
delivering the FVIII preparation through intestinal wall into the patient's peritoneal cavity for FVIII release into the blood stream to treat the clotting disorder.
Dumont et al. tech methods of treating hemophilic arthropathy using chimeric clotting factors [Title, abstract, 0159]. Dumont et tech a chimeric protein comprising a FVIII and an Fc region [0191]. Dumont et teach the effective amount of FVIII-Fc chimeric protein, a stabilized FVIII, in a range from about 10 IU/kg to about 300 IU/kg. In one particular embodiment, the effective amount is about 50 IU/kg. In another embodiment, the effective amount is about 100 IU/kg. In another embodiment, the effective amount is about 200 IU/kg [0192], reading on the limitation (i). Dumont et al. teach route of administering FVIII-Fc chimeric protein comprising intravenous, subcutaneous, or others [00101].
Dumont et al. did not teach injection of FVIII-Fc chimeric protein into the patient's peritoneal cavity for FVIII release into the blood stream to treat the clotting disorder.
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Shi et al. teach intraperitoneal (IP) injection of FVIII (Title). Shi et al. teach both VWF and FVIII were absorbed into the vasculature following IP injection and FVIII can reach the circulation from the peritoneal space (p6, Discussion, para 2). Shi et al. show the level of FVIII in plasma decreased quickly within 2 hours after IV administration, while plasma levels of proteins delivered by IP injection steadily increase to their peak over this same time period. After the 2 hour time point, clearance rates are similar for both IV and IP delivery, indicating that the IP route could be an effective route for VWF and FVIII infusion (p6, Discussion, para 3) shown as follows (p10, Fig. 1E). Shi et al. teach benefit of intraperitoneal administration for VWF and FVIII infusion when there is difficulty attaining venous access. Shi et al. further suggest administration of encapsulated VWF or FVIII into peritoneal cavity may lead to a safe and effective long-acting sources of replacement proteins that would be beneficial for VWD or hemophilia A patients (p7, para 4). Because Shi et al. teach (a) FVIII can reach the circulation from the peritoneal space (p6, Discussion, para 2) and (b) benefits of intraperitoneal administration of VWF and FVIII to patients of difficulty attaining venous access and encapsulated VWF or FVIII into peritoneal cavity as a safe and effective long-acting sources of replacement proteins that would be beneficial for VWF or hemophilia for patients (p7, para 4), one of ordinary skill in the art would have found it obvious to administer Dumont’s FVIII-Fc chimeric protein via intraperitoneal (IP) injection, reading on the limitation (ii).
Dumont et al. in view of Shi et al. did not specify the use of a swallowable device with a tissue penetrating member to deliver the FVIII preparation through the patient's intestinal wall and into the patient's peritoneal cavity for FVIII released into the blood stream to treat the clotting disorder.
Imran teaches therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device (Title). Imran teaches one advantage and feature of therapeutic compositions in the swallowable device described herein is that the biologic (therapeutic peptide or protein) drug payload is protected from degradation and hydrolysis by the action of peptidases and proteases in the gastrointestinal (GI) tract [0091]. Imran teaches a delivered therapeutic agent in solid form with a tissue penetrating feature [0096, 0101]. Imran teaches the swallowable device comprising an actuator [0008, 0071] and a tissue penetrating feature controlled by an application force for penetrating the intestinal wall [0099]. Imran teaches tissue penetrating members are positioned within guide tubes which serve to guide and support the advancement of members into tissue such as the wall of the small intestine or other portion of the GI tract. Imran further teaches the depth of penetration can be controlled by the length of member [0064]. Because Imran teaches the benefits of reducing drug dosage [0084, col 1, last para] and protecting degradation and hydrolysis by the action of peptidases and proteases in the gastrointestinal (GI) tract [0091] by using the control released drug delivery device, one of ordinary skill in the art would have found it obvious to use Imran’s controlled release swallowable device instead of injection to deliver a protein drug (e.g., a recombinant FVIII) into the patient's peritoneal cavity to release FVIII into the blood stream via the tissue penetrating member of the device for penetrating the intestinal wall [0064, 0099], reading on claims 12-13.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (I) Dumont et al. (II) Shi et al. because (a) Dumont et al. teach administration of a recombinant FVIII protein to treat hemophilic arthropathy and (b) Shi et al. teach (i) FVIII can reach the circulation from the peritoneal space (p6, Discussion, para 2) and (ii) benefits of intraperitoneal administration of FVIII to patients comprising (1) access to difficulty attaining venous in patients and (2) encapsulated VWF or FVIII into peritoneal cavity as a safe and effective long-acting sources of replacement proteins that would be beneficial for VWD or hemophilia for patients (p7, para 4). The combination would have reasonable expectation of success because both references teach administration of a recombinant FVIII to treat a patient with hemophilia.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine to combine (i) Dumont et al. in view Shi et al. with (ii) Imran’s drug delivery device because Imran teaches beneficial use of a control released drug delivery device for reducing drug dosage [0084, col 1, last para] and protecting degradation and hydrolysis in the gastrointestinal (GI) tract for a protein drug [0091]. The combination would have reasonable expectation of success because all Dumont et al., Shi et al., and Imran teach administration of a protein drug to treat a disease.
With respect to claim 11, Dumont et tech the administered therapeutic agent is a chimeric protein comprising a FVIII and an Fc region [0191].
With respect to claims 18-20, Dumont et al. teach the effective amount of FVIII-Fc chimeric protein is a result effective variable optimized in a range from about 10 IU/kg to about 300 IU/kg. The pharmacokinetic parameters Tmax of claim 18, Cmax of claim 19 and AUC of claim 20 are also result effective variables as a function of administered FVIII-Fc that can be optimized by routine experimentation under the prior art conditions. See MPEP 2144.05 (II)(A). Furthermore, the examiner found Imran’s swallowable medical device comprises identical structural and functional design in comparison to various embodiments of the instant application shown in Figs 1-10, Fig 11 (except for the hand-drawing of Fig 11A-11E), Figs 12-17, Fig 18 (a-f ), and Figs 19-20. Since the prior art device has the same structural and functional design, it must be able to achieve the same pharmacokinetic and pharmacodynamic parameters as claimed. MPEP 2112.01 (I) states “Product and apparatus claims - When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”.
Response to Arguments
Applicant's arguments of appeal brief filed 1/23/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on Dumont et al. in view of Shi et al. and Imran.
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 11-13 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 27 of U.S. Patent No. 8,734,429 B2 (the ‘429 patent) in view of Dumont et al., Shi et al., Imran (US 2013/0177527 A1) and evidenced by Imran et al. (US 12,201,721 B2, the ‘721 patent).
Claim 1 of the ‘429 patent disclosed a swallowable device for delivering a therapeutic agent preparation into an intestinal wall of a patients intestinal tract. To search the scope of a therapeutic agent, the specification of the ‘429 patent disclosed the delivered therapeutic agent are proteins drugs (col 34, line 37-42).
Claim 27 of the ‘429 patent disclosed the swallowable device comprising at least one tissue penetrating member.
Claims 1 and 27 of the ‘429 patent do not teach the therapeutic protein as a FVIII-Fc chimeric protein.
The relevancy of Dumont et al. in view of Shi et al., Imran and evidenced by the ‘721 patent as applied to claims 11-13 and 18-20 is described above not repeated here.
Because Dumont et al. in view of Shi et al., Imran and evidenced by the ‘721 patent teach benefits of intraperitoneal (IP) injection of FVIII into peritoneal space for patients of difficulty attaining venous access and encapsulated FVIII into peritoneal cavity as a safe and effective long-acting sources of replacement proteins that would be beneficial for hemophilia for patients, one of ordinary skill in the art would have found it obvious to beneficially administer the swallowable device taught by claims 1 and 27 of the ‘429 patent and Imran to deliver Dumont therapeutic protein of FVIII-Fc chimeric protein to treat a clotting disorder in a patient.
Thus, claims 1 and 27 of the ‘429 patent in view of Dumont et al., Shi et al., Imran and evidenced by the ‘721 patent are obvious to the instant 11-13 and 18-20.
Response to Arguments
Applicant's arguments of appeal brief filed 1/23/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on claims 1 and 27 of the ‘429 patent in view of Dumont et al., Shi et al., Imran and evidenced by the ‘721 patent.
Claims 11-13 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,493,253 B2 (the ‘253 patent) in view of Dumont et al., Shi et al., Imran (US 2013/0177527 A1) and evidenced by Imran et al. (US 12,201,721 B2, the ‘721 patent).
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Claim 1 of the ‘253 patent disclosed a therapeutic preparation comprising a swallowable device to deliver a therapeutic agent as follows. The specification of the ‘253 patent disclosed the therapeutic agent are protein drugs (col 6, line 61-64).
Claim 1 of the ‘253 patent do not teach the therapeutic protein as a FVIII-Fc chimeric protein.
The relevancy of Dumont et al. in view of Shi et al., Imran and evidenced by the ‘721 patent as applied to claims 11-13 and 18-20 is described above not repeated here.
Because Dumont et al. in view of Shi et al., Imran and evidenced by the ‘721 patent teach benefits of intraperitoneal (IP) injection of FVIII into peritoneal space for patients of difficulty attaining venous access and encapsulated FVIII into peritoneal cavity as a safe and effective long-acting sources of replacement proteins that would be beneficial for hemophilia for patients, one of ordinary skill in the art would have found it obvious to beneficially administer the swallowable device taught by claim 1 of the ‘253 patent and Imran to deliver Dumont therapeutic protein of FVIII-Fc chimeric protein to treat a clotting disorder in a patient.
Thus, claim 1 of the ‘253 patent in view of Dumont et al., Shi et al., Imran and evidenced by the ‘721 patent are obvious to the instant 11-13 and 18-20.
Response to Arguments
Applicant's arguments of appeal brief filed 1/23/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on claim 1 of the ‘253 patent in view of Dumont et al., Shi et al., Imran and evidenced by the ‘721 patent.
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Claims 11-13 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,596,359 B2 (the ‘359 patent) in view of Dumont et al., Shi et al., Imran (US 2013/0177527 A1) and evidenced by Imran et al. (US 12,201,721 B2, the ‘721 patent).
Claim 1 of the ‘359 patent disclosed a therapeutic preparation comprising a swallowable device to deliver a therapeutic agent. The specification of the ‘359 patent disclosed the therapeutic agent are protein drugs (col 6, line 61-64).
The relevancy of Dumont et al. in view of Shi et al., Imran and evidenced by the ‘721 patent as applied to claims 11-13 and 18-20 is described above not repeated here.
Because Dumont et al. in view of Shi et al., Imran and evidenced by the ‘721 patent teach benefits of intraperitoneal (IP) injection of FVIII into peritoneal space for patients of difficulty attaining venous access and encapsulated FVIII into peritoneal cavity as a safe and effective long-acting sources of replacement proteins that would be beneficial for hemophilia for patients, one of ordinary skill in the art would have found it obvious to beneficially administer the swallowable device taught by claim 1 of the ‘359 patent and Imran to deliver Dumont therapeutic protein of FVIII-Fc chimeric protein to treat a clotting disorder in a patient.
Thus, claim 1 of the ‘359 patent in view of Dumont et al., Shi et al., Imran and evidenced by the ‘721 patent are obvious to the instant 11-13 and 18-20.
Response to Arguments
Applicant's arguments of appeal brief filed 1/23/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on claim 1 of the ‘359 patent in view of Dumont et al., Shi et al., Imran and evidenced by the ‘721 patent.
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Claims 11-13 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,806,504 B2 (the ‘504 patent) in view of Dumont et al. (WO 2018/102743 A1) Shi et al., Imran (US 2013/0177527 A1) and evidenced by Imran et al. (US 12,201,721 B2, the ‘721 patent).
Claim 1 of the ‘504 patent disclosed a therapeutic preparation comprising a swallowable device to deliver a therapeutic agent. The specification of the ‘504 patent disclosed the therapeutic agent are protein drugs (col 11, line 58-60).
The relevancy of Dumont et al. in view of Shi et al., Imran and evidenced by the ‘721 patent as applied to claims 11-13 and 18-20 is described above not repeated here.
Because Dumont et al. in view of Shi et al., Imran and evidenced by the ‘721 patent teach benefits of intraperitoneal (IP) injection of FVIII into peritoneal space for patients of difficulty attaining venous access and encapsulated FVIII into peritoneal cavity as a safe and effective long-acting sources of replacement proteins that would be beneficial for hemophilia for patients, one of ordinary skill in the art would have found it obvious to beneficially administer the swallowable device taught by claim 1 of the ‘504 patent and Imran to deliver Dumont therapeutic protein of FVIII-Fc chimeric protein to treat a clotting disorder in a patient.
Thus, claim 1 of the ‘504 patent in view of Dumont et al., Shi et al., Imran and evidenced by the ‘721 patent are obvious to the instant 11-13 and 18-20.
Response to Arguments
Applicant's arguments of appeal brief filed 1/23/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on claim 1 of the ‘504 patent in view of Dumont et al., Shi et al., Imran and evidenced by the ‘721 patent.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
19-May-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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