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 .
Claims 1-20 are pending and under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 2/24/2023 (3) and 7/31/2023 have been considered.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figures 63A-F filed on 2/10/2025 are unclear, including legends and drawings. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Priority
The instant application is a CON of US application No. 16/465,632 which is a national stage of PCT/US2017/066474 filed on 12/14/2017 and claims benefit of US provisional 62/478,744 filed on 3/30/2017, US 62/545,188 filed on 8/14/2017, US 62/ 583,797 filed on 11/9/2017 and US 62/ 62/434,348 filed on 12/14/2016.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1, line 2 from the bottom “GI tissue f the subject” should be spelled as “GI tissue of the subject”.
Claim is objected for the use of abbreviated phrases (FM 202, FM-303, ADC-1012, PTG-200, and many more), which should be described for the first time followed by an abbreviated form placed in a bracket.
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.
Claim 4 is 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.
Regarding claim 4, the phrase "substantially the same time point" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. It is not clear from the term that the level of antibody in GI tissue is measured exactly at the same time with the blood, serum or plasma; or how close time has to be to be substantially the same time point. Therefore, the metes and bounds of the claim cannot be determined. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112
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 and 4-20 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description in this case only sets forth a method of treating ulcerative colitis (UC), IBD or Crohn’s disease in a subject having the disease comprising an anti-IL12/IL-23 antibody selected from the group consisting of briakinumab, guselkumab, tildrakizumab, mirikizumab, ustekinumab, and brazikumab (MEDI2070), and therefore the written description is not commensurate in scope with “a method of treating ulcerative colitis in any subject comprising administering to the subject any anti-IL-12/IL-23 antibody”.
The specification on pg.63, discloses that antibodies that can treat UC are ustekinumab, brazikumab, risankizumab, briakinumab and others. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Some of the factual considerations that are weighed when determining a written description include the level of skill and knowledge in the art, the disclosure of complete or partial structures, the disclosure of physical and or chemical properties, adequate disclosure of the functional characteristics, the correlation between structure and function, and disclosure of methods of making.
Khorrami et al (IDS, Inflam. Bowel Dis. 22: 1662-1669, 2016) teach that antibody ustekinumab against IL-12/23 treats refractory Crohn’s Disease to at least 44% of subjects in a clinical trial (see the Title, pg. 1665, Figures 2-3). Burkoff et al (IDS, Inflamm. Bowel Dis., 12(7): 558-565, 2006) used and anti-TNF monoclonal antibody (infliximab) can be used for treating UC(see pg. 564, right col.). The specification does not disclose that any antibody against IL-12/23 when administered in any subject can treat ulcerative colitis. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1 "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (see Vas-Cath at page 1116).
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states an adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.
As discussed above, the skilled artisan cannot envision the detailed genus of “any anti-IL12/IL-23 Antibody can treat UC any subject” and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of making a mutation. The compound itself is required. See Fiers v.Revel, 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen v.Baird, 30 Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 148 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class.
Therefore, only a method of treating UC, IBD or Crohn’s disease in a subject in need thereof comprising ustekinumab, but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112, first paragraph.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Imran (US 2013/0171247) in view of Khorrami et al (IDS, Inflam. Bowel Dis. 22: 1662-1669, 2016) and van der Schaar (IDS, Gastrointestinal Endosc. 78: 520-528, 2013) and Zilberstein et al (IDS, US 2005/0266074).
The instantly claimed invention is broadly drawn to a method of treating ulcerative colitis, IBD or Crohn’s disease in a subject comprising administering to the subject an ingestible device comprising: an ingestible housing comprising a reservoir, the reservoir containing a pharmaceutical formulation comprising a therapeutically effective amount of an anti-IL- 12/IL-23 antibody; a release mechanism having a closed state wherein the pharmaceutical formulation is retained in the reservoir and an open state which allows for the release of the pharmaceutical formulation from the reservoir to the exterior of the ingestible device; an actuator which controls the transition of the release mechanism from the closed state to the open state; a detector for detecting a location of the ingestible device in the subject's gastrointestinal (GI) tract; and a processor coupled to the detector and to the actuator, wherein the processor triggers the actuator to cause the release mechanism to transition from the closed state to the open state when the ingestible device is located in the cecum, wherein the cecum has been predetermined to be proximal to one or more disease sites, thereby releasing the pharmaceutical formulation comprising the anti-IL-12/IL-23 antibody from the ingestible device when the ingestible device is located in the cecum of the subject, wherein the one or more disease site is in the colon (claim 1), wherein the anti-IL-12/23 antibody is ustekinumab (claims 2-3), The method of claim 1, wherein the ratio of the level of the anti-IL-12/IL-23 antibody in the GI tissue to the level of the anti-IL-12/IL-23 antibody in the blood, serum, or plasma of a subject at substantially the same time point following administration of the device is about 2.8 to about 6.0 (claim 4), wherein the concentration of the anti-IL-12/IL-23 antibody released at the desired location in the GI tract is 10%, 25%,50%, 75%, 100%, 200%, 300%, 400%, 500%, 1000%, or 2000% greater than the concentration of the anti-IL-12/IL-23 antibody in plasma (claim 5), wherein the concentration Cmax of the anti-IL-12/IL-23 antibody in the plasma of the subject is less than 1 pg/mL, less than 0.3 pg/mL, less than 0.1 pg/mL, or less than 0.01 pg/mL (claim 6). The method of claim 1, wherein the amount of the anti-IL-12/IL-23 antibody administered orally is less than an amount that is therapeutically effective when the anti-IL- 12/IL-23 antibody is administered systemically (claim 7), wherein the pharmaceutical composition is released in the distal portion of the ileum, the cecum, or the ascending colon of the subject (claim 8), wherein the distal portion of the ileum, the cecum, or the ascending colon has been predetermined to be proximal to one or more disease sites (claim 9), wherein the one or more disease sites is in the colon (claim 10), wherein releasing the pharmaceutical composition in the distal portion of the ileum, the cecum, or the ascending colon distributes the anti-IL-12/IL-23 antibody in all segments of the colon (claim 11), wherein the disease of the GI tract is ulcerative colitis (claim 12). The method of claim 1, further comprising releasing the pharmaceutical formulation comprising the anti-IL-12/IL-23 antibody as a bolus (claim 13). The method of claim 1, wherein the pharmaceutical composition is a solution of the anti-IL-12/IL-23 antibody in a liquid medium (claim 14), wherein the pharmaceutical composition is a suspension of the anti-IL-12/IL-23 antibody in a liquid medium (claim 15). The method of claim 1, wherein, before being released, the pharmaceutical composition is disposed in an ingestible device (claim 16), wherein the ingestible device comprises: a storage reservoir configured to store the pharmaceutical composition before the pharmaceutical composition is released; and a device configured to provide a gas pressure sufficient to release the pharmaceutical composition from of the ingestible device (claim 17), wherein the ingestible device further comprises a safety device configured to relieve a pressure within the ingestible when the pressure exceeds a threshold level (claim18), wherein the reservoir is configured to attach to the housing of the ingestible device (claim 19), and wherein the reservoir is configured to friction fit with the ingestible device (claim 20).
Regarding claims 1-3, and 16-20, Imran teaches a method of treating ulcerative colitis in a subject (see paragraph [0092]), the method comprising: orally administering to the subject an ingestible device (device 10) comprising: an ingestible housing (housing of device 10, see Fig. 1b) comprising a reservoir (reservoir 27), the reservoir containing a pharmaceutical formulation (medication 100, see par. [0061]); a release mechanism (tissue penetrating member 40) having a closed state (tissue penetrating member 40 enclosed within device 10) wherein the pharmaceutical formulation is retained in the reservoir (reservoir 27) and an open state (tissue penetrating member 40 advanced into tissue) which allows for the release of the pharmaceutical formulation from the reservoir (reservoir 27) to the exterior of the ingestible device (device 10); an actuator (actuating mechanism 60) which controls the transition of the release mechanism (tissue penetrating member 40) from the closed state (tissue penetrating member 40 enclosed within device 10) to the open state (tissue penetrating member 40 advanced into tissue) (see par. [0076]-[0077]); a detector (sensor 67) for detecting a location of the ingestible device in the subject’s gastrointestinal (Gl) tract (see par. [(0076]-[0077]); and a processor (processor 29) coupled to the detector (sensor 67) and to the actuator, wherein the processor triggers the actuator to cause the release mechanism to transition from the closed state (tissue penetrating member 40 enclosed within device 10) to the open state (tissue penetrating member 40 advanced into tissue) when the ingestible device (device 10) is located in a predetermined location (small intestine or other location in the GI tract — see paragraph [0077]), thereby releasing the pharmaceutical formulation (medication 100) from the ingestible device (device 10). Regarding claims 8-10, Imran teaches that when the ingestible device (device 10) is located in the predetermined location (small intestine or other location in the GI tract see paragraph [0076]- [0077]). However, Imran fails to suggest that pharmaceutical composition comprising an anti-IL-12/IL-23 antibody including ustekinumab in an effective amount in the cecum of a subject from the ingestible device when the ingestible device is in the cecum of the subject.
Regarding claims 4, 7-13, Khorrami et al teach treating ulcerative colitis in subject in need thereof comprising administering an antibody against IL-12/IL-23, wherein the antibody is ustekinumab (see the Title, pg. 1665, Figures 2-3). Therefore, it would have been obvious to one ordinary skill in the art to use the antibody ustekinumab for treating UC in a pharmaceutical composition in the delivery device taught by Imran. Regarding claims 5-6, the concentration of the anti-IL-12/IL-23 antibody at the desired location can be optimized by one skill in the art.
Generally, differences in concentrations of components of a formulation, amount of release of formulation, timing, dosages will not support the patentability of subject matter encompassed by the prior art. Such formulations are results-effective variables which can be optimized. In in re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980), it was held that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Further, in In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious.
Regarding claims 14-16, 18-20, Van der Schaar teaches an ingestible electronic drug delivery and monitoring system that is an electronic capsule comprising a drug reservoir, a pH and temperature sensor/detector, a microprocessor and wireless transceiver (abstract). van der Schaar teaches location of the capsule can be monitored in real time (abstract). The capsule is pictured in figure 3 with medication compartment, dispense hole (for dispensing drug), rolling rock seal, venting holes (to relieve pressure), screw rod driven piston (that drives out drug from device), click connection, actuator, pH sensing ISFET, electronics and a reference electrode (figure 3). The data analysis section provides for ileocecal valve passage based on a timed pH change (figures 4 and 5). Van der Schaar teaches various release profiles including controlled and rapid release for drugs (Methods section).
Regarding claim 17-18, Zilberstein teaches an ingestible device (ingestible pill 10) which detects entry of the ingestible device (ingestible pill 10) into a predetermined location (see par. [0194]- [0195], [0198], and [0202]), the predetermined location being the cecum (see par. [0194]-[0195], [0198], and [0202]), wherein the cecum has been predetermined to be proximal to one or more disease sites (the colon, see par. [0057], [0194]-[0195], [0198], and [0202)) and Imran teaches the device (see above). They teach that the delivery can be monitored based on flora or chemical analyses (see abstract) and imaging the colon using a detector which produces electronic signal (Fig. 6B).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of instant filing to incorporate detectors that can localize the capsule device near or within the colon and to trigger the release of a drug (chemical or electrical signal) that is the antibody ustekinumab against IL-12/IL-23 to treat ulcerative colitis when the capsule device arrives at the proper location based on teachings of the prior art. Each of the references provides for a capsule device/formulation that targets the intestines including areas near or within the colon and the ileocecal region (MPEP 2144.06). One of ordinary skill in the art at the time would have been motivated to use antibody ustekinumab for treating UC, IBD or Crohn’s disease as taught by Khorrami et al by using the device modification taught by van der Schaar and Zilberstein et al to the delivery device of Imran (treating same disease UC using a delivery device at the disease target). Further, one would have a reasonable expectation of success in using ustekinumab as anti-IL-12/IL-23 antibody for treating UC as taught by Khorrami et al in combination Imran which teaches oral delivery of a pharmaceutical for treating UC using a delivery device in small intestine and as suggested by Zilberstein and van der Schaar for delivering the composition in the cecum of a subject where the disease UC occurs. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
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 1-3, 7-14, and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 14-19 of U.S. Patent No. 11,597,762. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating ulcerative colitis, IBD or Crohn’s disease in a subject comprising administering to the subject an ingestible device comprising: an ingestible housing comprising a reservoir, the reservoir containing a pharmaceutical formulation comprising a therapeutically effective amount of an anti-IL- 12/IL-23 antibody; a release mechanism having a closed state wherein the pharmaceutical formulation is retained in the reservoir and an open state which allows for the release of the pharmaceutical formulation from the reservoir to the exterior of the ingestible device; an actuator which controls the transition of the release mechanism from the closed state to the open state; a detector for detecting a location of the ingestible device in the subject's gastrointestinal (GI) tract; and a processor coupled to the detector and to the actuator, wherein the processor triggers the actuator to cause the release mechanism to transition from the closed state to the open state when the ingestible device is located in the cecum, wherein the cecum has been predetermined to be proximal to one or more disease sites, thereby releasing the pharmaceutical formulation comprising the anti-IL-12/IL-23 antibody from the ingestible device when the ingestible device is located in the cecum of the subject, wherein the one or more disease site is in the colon (claim 1), wherein the anti-IL-12/23 antibody is Ustekinumab, The method of claim 1, wherein the amount of the anti-IL-12/IL-23 antibody administered orally is less than an amount that is therapeutically effective when the anti-IL- 12/IL-23 antibody is administered systemically (claim 7), wherein the pharmaceutical composition is released in the distal portion of the ileum, the cecum, or the ascending colon of the subject (claim 8), wherein the distal portion of the ileum, the cecum, or the ascending colon has been predetermined to be proximal to one or more disease sites (claim 9), wherein the one or more disease sites is in the colon (claim 10), wherein releasing the pharmaceutical composition in the distal portion of the ileum, the cecum, or the ascending colon distributes the anti-IL-12/IL-23 antibody in all segments of the colon (claim 11), wherein the disease of the GI tract is ulcerative colitis (claim 12). The method of claim 1, further comprising releasing the pharmaceutical formulation comprising the anti-IL-12/IL-23 antibody as a bolus (claim 13). The method of claim 1, wherein the pharmaceutical composition is a solution of the anti-IL-12/IL-23 antibody in a liquid medium, wherein the ingestible device comprises: a storage reservoir configured to store the pharmaceutical composition before the pharmaceutical composition is released; and a device configured to provide a gas pressure sufficient to release the pharmaceutical composition from of the ingestible device (claim 17), wherein the ingestible device further comprises a safety device configured to relieve a pressure within the ingestible when the pressure exceeds a threshold level (claim18), wherein the reservoir is configured to attach to the housing of the ingestible device (claim 19), and wherein the reservoir is configured to friction fit with the ingestible device are taught in claims 1-4 and 14-19 of U.S. Patent No. 11,597,762.
Claim1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 14-19 of U.S. Patent No. 11,597,762 in view of Jones et al. (US Pub. No. 20220071894, CON PCT/US2017/066527 which claims priority of US 62/434369 filed on 12/14/2016).
The teachings of claims 1-4 and 14-19 of U.S. Patent No. 11,597,762 are set forth above. Claims 1-4 and 14-19 of U.S. Patent No. 11,597,762 do not teach the administration of anti-IL-12/IL-23 antibody wherein the level of the antibody in the GI tissue to the level the anti-IL-12/IL-23 antibody in the blood, serum, or plasma of a subject at substantially the same time point following administration of the device is about 2.8 to about 6.0, and wherein the concentration of the anti-IL-12/IL-23 antibody released at the desired location in the GI tract is 10%, 25%,50%, 75%, 100%, 200%, 300%, 400%, 500%, 1000%, or 2000% greater than the concentration of the anti-IL-12/IL-23 antibody in plasma.
Jones et al. teach delivering therapeutic drugs need to be dispensed to specified locations withing the small intestine or large intestine, which is more effective than oral administration (see paragraph [0003]). They teach to use a therapeutic device that comprises a housing, a reservoir containing a pharmaceutical formulation and a release mechanism for releasing said formulation from the device [0016]. They teach that the release of the formulation at the desired location is 10%, 25%, 50%, 75%, 100%, 200%, 300%, 400% or greater than the concentration in plasma (see claim 386). They teach that the devices or compositions described herein can result in a ratio of GI tissue concentration of the antibody to the blood serum or plasma concentration of the antibody about 2.8 to 6.0, 2.8 to 5.8 or 2.8 to 5.6 (see paragraph [0987]). Regarding claim 15, they teach that the formulation is in a liquid form that released from the device [0029].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of instant filing to achieve the release of a drug wherein the desired release at the desired location is 10%, 25%, 50%, 75%, 100%, 200%, 300%, 400% or greater than the concentration in plasma as taught by Jones et al using the antibody ustekinumab against IL-12/IL-23 to treat ulcerative colitis as taught in claims1-4 and 14-19 of U.S. Patent No. 11,597,762. One would have a reasonable expectation of success in using ustekinumab as anti-IL-12/IL-23 antibody for treating UC wherein the release of anti-IL-12/IL-23 at a desired location and wherein the release is 10%, 25%, 50%, 75%, 100%, 200%, 300%, 400% or greater than the concentration in plasma as taught by Jones et al
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674