Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-38 are currently pending and the claims filed on 07/22/2024 are acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
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 18-20 and 22-28 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.
Each of claims 18-20 and 22-28 recites “desirable probiotics” which is relative term because its meaning “desirable” changes depending on the context or the observer’s perspective, making it difficult to define its exact boundaries. Therefore, the term “desirable” recited in those claims is indefinite. Appropriate correction is requested.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Applicant claims the below claims 1, 18, 30, and 36 filed on 07/22/2024:
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Claims 1-38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schentag et al. (WO2013/148258A1) in view of Wilding et al., “The role of gamma-scintigraphy in oral drug delivery”, Advanced drug delivery reviews, vol. 46, Issues 1-3, March 2001, pages 103-124; Trachtman (US2012/0276201A1); Penhasi et al. (US2008/0260818A1); and Kubo et al. (US2010/0209520A1) and/or Watt (WO1995/035100A1).
Please note that the claimed features of e.g., “first/second enteric coatings solubilized in recited pHs”, “gamma scintigraph evaluation”, “acetaminophen” do not appear to be supported by the provisional application no. 61/781,810 filed on 03/14/2013, and thus, an effective filing date of the instant case is 03/14/2014. Accordingly, WO2013/148258A1 having a filing date of 03/14/2013 and a publication date of 10/03/2013 is valid prior art.
Regarding instant claims 1-3, 5-7, 11, 13-15, 17-25, 30-34 and 36-38, they are rejected by Schentag.
Schentag teaches oral vaccine formulation which deliver an antigen in the vicinity of the distal ileum and the area of appendix or colon (e.g., Fig. 5 and the Examples); to do so, Schentag provides capsule-in-capsule or pill within a pill where the antigen includes virus, inactivated bacteria such as live bacteria (e.g., probiotic bacteria population), inactivated pathogens, etc. (e.g., claims 14, 15, and 18 of prior art) wherein the probiotic live bacteria population exists about up to 1012 organisms which overlaps the instant range of more than 105 to less than 1012 organisms; and as additional therapeutic agent, there are nutritional substance selected from sugar, free fatty acids (=lipid), polypeptides, amino acids, nutritional components, vitamins, antibacterial agent, TNF antagonist, antibiotics such as mitomycin, adriamycin, gemcitabine, cisplatin, peptide, recombinant protein, pentostatin, etc. (see entire document including pages 11, 21, 24 and claim 9 of prior art); ileal brake hormone releasing substance includes GLP-1, GRPP, etc. (page 13, last para.) which reads on the claimed hormone releasing substance to stimulate L-cell hormone release; the vaccine formulation contains a plurality of cores, each of comprising antigen, first enteric coating, and second enteric coating (e.g., claim 1 of prior art); the core can be beads (page 5) or the capsule can be present liquid/powder (the Examples); Fig. 3 illustrates that the formulation itself may be mixtures of microgranules, granules or powders, each of which can be combined within the formulation and protected by the coating until it reaches the pH value above 7.3 and target of GI release at least initially in the ileum, and Fig. 5 teaches that a first composition comprising vaccine antigen which overlaps the instant therapeutic agent encapsulated by an enteric coating layer that solubilizes at pH 5.5 to 6.0 in which pH 6.0 is close enough to the claimed pH of about 6.2 and that the first composition is put into a second composition comprising an antigen encapsulated by an enteric coating layer that solubilizes at 7.3 to 7.6 which overlaps the instant range of pH of about 7 to about 8 and reads on the claimed insoluble pH of less than about 7.0-8.0. It is noted that pH 5.5 to 6.5 is colon pH and pH 7.3 to 7.6 is ileum pH (page 1 of prior art) and therefore, the composition encapsulated by enteric coating layer that solubilizes at pH of 7.3 to 7.6 would not leak in the colon, in the absence of evidence to the contrary, and due to the pH conditions as noted, the formulation would not lose until the delivery formulation reaches the ileum; as the enteric coating layer for delivery to the ileum, poly(dl-lactide-co-glycolide, chitosan (Chi) stabilized with PVA (poly-vinylic alcohol), a lipid, an alginate, carboxymethylethylcellulose (CMEC), cellulose acetate trimellitiate (CAT), hydroxypropylmethyl cellulose phthalate (HPMCP), hydroxypropylmethyl cellulose, ethyl cellulose, color con, food glaze and mixtures of hydroxypropylmethyl cellulose and ethyl cellulose, polyvinyl acetate phthalate (PVAP), cellulose acetate phthalate (CAP), shellac, copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid and ethyl acrylate can be used (e.g., claim 1 of prior art) for delivery to the colon, and polyvinyl acetate phthalate (PVAP), cellulose acetate phthalate (CAP), shellac, copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid and ethyl acrylate and as methylmethacrylates or copolymers of methacrylic acid and methylmethacrylate are preferred including Eudragit® 100 polymer (=methacrylic acid-methyl methacrylate copolymer 1:1) and Eudragit® S100 polymer (=methacrylic acid-methyl methacrylate copolymer 1:2), either alone or in combination which reads on instantly claimed enteric coatings or optionally combined with Eudragit® RL or RS (e.g., page 16-17 and claim 1 of prior art) can be used; the first/second capsules can be fabricated with gelatin or HPMC (e.g., pages 69-70) which reads on the claimed biodegradable film layer; and the coating thickness is 80-120 microns; the probiotic formulation can be combined with other one or more therapeutic agent such as antimicrobial drugs, and anticancer agent, etc. (page 21, third para.), and the composition is used to treat metabolic syndrome and obesity (e.g., Figs. 2-3 and pages 37 and 48); the formulation can be administered in combination with TNF antagonist (page 26, second para.), and the product can contain biocompatible/biodegradable polymers such as HPMC in the form of capsule (e.g., page 56); and the dosage forms include tablets, troches, particles, liquid, powder, capsule, pill, pellets, etc. (e.g., pages 15, 57 and 66)(instant claims 1-3, 5-7, 11, 13- 15, 17-25, 30-34 and 36-38).
In light of the foregoing, instant claims 1-3, 5-7, 11, 13-15, 17-25, 30-34 and 36-38 are obvious over Schentag.
Regarding, instant claim 4, it is rejected by Schentag in view of Widing.
Although the applied art alone or in combination does not expressly teach gamma scintigraphy evaluation using 177Lu and 153Sm, such evaluation method is not inventive because such gamma scintigraphy evaluation method is well known before the instant invention was made as taught by Wilding that the non-invasive technique of γ-scintigraphy has been used to follow the gastrointestinal transit and release characteristics of a variety of pharmaceutical dosage forms (abstract).
Regarding claims 8-10, 12, 13 (other species), 26-28, and 35, they are rejected by Schentag in view of Trachtman.
However, Schentag does not expressly teach probiotic materials, and their use of instant claims 8-10, 13, 26-28 and 36. The deficiencies are cured by Trachtman.
Trachtman discloses compositions for treating inflammatory bowel disease (IBD) including ulcerative colitis (UC) and Crohn’s disease (CD) and the composition comprises antibiotics and probiotic formulation (abstract and [0033]-[0035]); the antibiotics includes vancomycin, metronidazole, etc. ([0047]); the probiotic formulation contains lactobacillus, bifidobacterum (e.g., claims 4 and 10 of prior art); the composition is effective to treat imbalance of Clostridum difficlie, e.g., clostridium difficile associated diarrhea (CDAD)(e.g., [0038] and [0057]) (instant claims 8-10, 12, 13, 26-28, and 35).
It would have been obvious to further define probiotic/antibiotic formulations, their uses and therapeutic effects of Schentag with specific bacterial probiotic/antibiotic for treating the related disorders as taught by Trachtman, and thus, such definition and/or selection would have yielded no more than the predictable results.
In light of the foregoing, intant claims 8-10, 12, 13, 26-28 and 35 are obvious over Schentag in view of Trachtman.
Regarding claim 16, it is rejected by Schentag in view of Penhasi
Schentag does not expressly teach atorvastatin of instant claim 16. The deficiency is cured by Penhasi.
Penhasi discloses controlled absorption of statins in the intestine (title); atorvastatin is in a core with delayed coating system; statins are delivered to the GI tract including the lower GI tract and the colon, providing an increased bioavailability ([0026]); using outer coating featuring a polymer disintegrating at pH values above about 5 that overlaps the instant range of between about pH 1.0 to about pH 6.0 and thus statin is protected in acidic stomach environment and is released at that higher pH (instant claim 16).
It would have been obvious to modify the formulation of Schentag with atorvastatin of Penhasi as the active agent in combination with probiotics as a matter of design or choice. This is because both references relate to oral pharmaceutical formulations, and address delivery in the gastrointestinal tract, and thus, incorporating a known probiotic with a known atorvastatin formulation would have been a predictable combination and results of known elements from the standpoint of the ordinary artisan.
In light of the foregoing, instant claim 16 is obvious over Schentag in view of Penhasi.
Regarding claim 29, it is rejected by Schentag in view of Kubo and/or Watts
However, Schentag does not expressly teach specific materials of enteric coating of instant claim 29. The deficiency is cured by Kubo and/or Watts.
Schentag was discussed with respect to instant claim 18 as noted above.
Kubo teaches an oral pharmaceutical preparation for delivering a drug such as Lactobacillus preparation to colon, said preparation comprising: (1) a core comprising at least a pharmaceutically acceptable vehicle; (2) an inner layer covering said core and comprising said drug; (3) an intermediate layer covering said inner layer and comprising a cationic polymer soluble or swellable at a pH of not more than 6.6; and (4) an outer layer covering said intermediate layer and comprising an anionic polymer soluble at a pH of not less than 7.0 (See claims 1 and 5 and figure 1 of Kubo). Here, the Lactobacillus preparation of Kubo read on the instantly claimed biodegradable probiotic formulation. The inner layer further includes water soluble polymer such as hydroxypropyl cellulose (claims 7-8 of Kubo). Kubo also discloses methyl(meth)acrylate/butyl(meth)acrylate/(meth)acrylic acid dimethylaminoethyl copolymer 1:2:1 and is commercially available as Eudragit E-100 as cationic polymer of inner layer (see claims 10, 11, 13 and 14 and [0050] of Kubo). Please note that Eudragit EPO is a micronized powder form of Eudragit E-100 as evidenced by Der-Yang et al (see US2008/0311201A1 - [0060], IDS of 01/24/2020 in parent application 16/446053) and which is poly (butyl methacrylate, (2-dimethylaminoethyyl)methacrylate, methyl methacrylate) 1:2:1, and Eudragit E-100 reads on the claimed first enteric coating. Further, Kubo teaches (meth)acrylic acid/methyl(meth)acrylate copolymer 1:1, e.g., Eudragit S-100 as the anionic polymer (see claims 10, 11, 13 and 14 and [0054] and [0060] of Kubo) and this anionic polymer in the outer layer is not soluble at a normal pH of the stomach but is soluble at a pH of the small intestine, and thus the core covered with the intermediate layer can be protected by the outer layer until reaching colon (See [0053] of Kubo). The coating amount of inner layer is 1-50% ([0043]) and the coating amount of the intermediate layer is 15-75%, or 30 to 60% ([0051]); the composition of Kubo comprises enteric polymer coatings for preventing degradation of the drug at stomach pH and promoting release of the drug at a pH of more than 6 (colon) or more than 7.0 (ileum). Further, since Kubo requires pH-dependent Eudragit polymers for each targeted sites, dissolving certain polymers at intended pH and release probiotics would be an obvious; and Kubo further teaches the composition is useful to treat inflammatory bowel disease such as Crohn's disease and ulcerative colitis ([0005] and claim 5 of Kubo). Further coating thickness for the inner, intermediate, and outer layers are uniform which is advantageous in that it prevents the preparation from bursting out of a thin coated portion and starting a drug release earlier than expected ([0032]) (instant claim 29 - coating materials of Eudragit EPO and S100).
Watts teaches a colonic drug delivery composition comprising a starch capsule containing the drug and the starch capsule is provided with a coating such that the drug is predominantly released from the capsule in the colon and/or terminal ileum (e.g., claim 1); the starch of capsule includes hydroxypropyl cellulose (e.g., page 4, third para.); the coating comprises a material which dissolves at a pH of 5 or above (e.g., claim 2); the coating comprises methyl methacrylate or a copolymer of methacrylic acid and methyl methacrylate which is biodegradable by enzyme or bacteria present in colon (e.g., claim 5) such as Eudragits which are copolymers of methacrylic acid and methylmethacrylate. Preferred compositions are based on Eudragit L100 and Eudragit S100. Eudragit L100 dissolves at pH 6 and upwards and comprises 48.3 % methacrylic acid units per g dry substance; Eudragit S I00 dissolves at pH 7 and upwards and comprises 29.2% methacrylic acid units per g dry substance. Preferred coating compositions are based on Eudragit L100 and Eudragit S100 in the range 100 parts L100:0 parts S100 to 20 parts L100:80 parts S100. The most preferable range is 70 parts L100:30 parts S100 to 80 parts L100:20 parts S10. As the pH at which the coating begins to dissolve increases, the thickness necessary to achieve colon specific delivery decreases (page 6, second para.). In one embodiment, the composition requires enteric coating of a mixture of Eudragit S-100 (13g) and L-100 (39g) (ratio 3:1) which is applied to HPMC–coated starch capsule (Example 1). That is, the 3:1 (75:25) mixture of Eudragit S-100 and L-100 of this prior art reads on the the claimed second coating (instant claim 29 - coating material and coating amount).
It would have been prima facie obvious to further define the copolymer of first/second enteric Eudragit materials of Schentag with specific Eudragit polymers of Kubo/Watts because selection of specific Eudragits for the first/second enteric coatings would have achieved no more than the predictable results, e.g., disintegrating/delayed properties, in the absence of evidence to the contrary. Although Kubo/Watts does not expressly teach the claimed coating amount (mg/cm2), Kubo teaches the amount (%) and thus intended coating amounts would be optimized depending on the desired purpose, used polymers, solubility, pH, etc.
In light of the foregoing, instant claim 29 is obvious over Schentag in view of Kubo/Watts.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of patent no. 9,907,755B2 having application no. 14/771830.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require an oral delivery system for delivering an active ingredient-containing formulation targeted to both the ileum and proximal colon of a subject; the system comprising: a biodegradable first capsule comprising a first formulation targeted to the colon, wherein the first capsule comprises a reverse enteric coating that solubilizes at pH about 6.2 to about 6.5 which is below pH of 6.9; and a biodegradable second capsule that includes the first capsule and a second formulation targeted to the ileum, wherein the second capsule comprises an enteric coating that solubilizes at pH of about 7-8, wherein the second capsule releases the first capsule and the probiotic formulation targeted to the ileum in the ileum upon administration to a patient, and once released, the first capsule is solubilized in the colon of the patient and releases the probiotic formulation targeted to the colon. Both inventions require probiotics which may be human bacterial fecal flora. Further, both inventions are characterized in capsule-in-capsule structure for delivery to ileum and colon, respectively and replacing one active agent with another within that capsule-in-capsule structure would have achieved predictable results with a reasonable expectation of success, in the absence of evidence to the contrary.
Consequently, the instantly claimed subject matter would be obvious over the patent ‘755 subject matter.
Claims 1-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of patent no. 10,369,111B2 having application no. 15/874543.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require an oral delivery system for delivering an active ingredient-containing formulation targeted to both the ileum and proximal colon of a subject; the system comprising: a biodegradable first capsule comprising a first formulation targeted to the colon, wherein the first capsule comprises a reverse enteric coating that solubilizes at pH about 6.2 to about 6.5 which is below pH of 6.9; and a biodegradable second capsule that includes the first capsule and a second formulation targeted to the ileum, wherein the second capsule comprises an enteric coating that solubilizes at pH of about 7-8, wherein the second capsule releases the first capsule and the probiotic formulation targeted to the ileum in the ileum upon administration to a patient, and once released, the first capsule is solubilized in the colon of the patient and releases the probiotic formulation targeted to the colon. Both inventions require probiotics which may be human bacterial fecal flora, and HPMC capsule.
Both inventions are characterized in capsule-in-capsule structure for delivery to ileum and colon, respectively and replacing one active agent with another within that capsule-in-capsule structure would have achieved predictable results with a reasonable expectation of success, in the absence of evidence to the contrary.
Consequently, the instantly claimed subject matter would be obvious over the patent ‘111 subject matter.
Claims 1-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of patent no. 10,588,857B2 having an application no. 14/387979.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require an oral delivery system for delivering an antigen (e.g., virus or bacteria) formulation targeted to both the appendix, ileum and/or proximal colon of a subject; the system comprising: first capsule comprising antigen (e.g., virus or bacteria) formulation targeted to the colon, wherein the first capsule comprises an enteric coating; and a second capsule that includes the first capsule and an antigen (e.g., virus or bacteria) formulation targeted to the ileum, wherein the second capsule comprises an enteric coating wherein the second capsule releases the first capsule and the antigen (e.g., virus or bacteria) targeted to the ileum in the ileum upon administration to a patient, and once released, the first capsule is solubilized in the colon of the patient and releases the antigen formulation targeted to the colon.
The difference between the claimed invention and the patent ‘857 is that the patent ‘857 requires virus or bacteria antigen, but the claimed invention requires various therapeutic agents including human bacterial fecal flora. However, both inventions are characterized in capsule-in-capsule structure for delivery to ileum and colon, respectively and replacing one active agent with another within that capsule-in-capsule structure would have achieved predictable results with a reasonable expectation of success, in the absence of evidence to the contrary.
Consequently, the instantly claimed subject matter would be obvious over the patent ‘857 subject matter.
Claims 1-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of patent no. 11,590,083 B2 having application no. 16/446053.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require an oral delivery system for delivering an active ingredient-containing formulation targeted to both the ileum and proximal colon of a subject; the system comprising: a biodegradable first capsule comprising a first formulation targeted to the colon, wherein the first capsule comprises a reverse enteric coating that solubilizes at pH about 6.2 to about 6.5 which is below pH of 6.9; and a biodegradable second capsule that includes the first capsule and a second formulation targeted to the ileum, wherein the second capsule comprises an enteric coating that solubilizes at pH of about 7-8, wherein the second capsule releases the first capsule and the probiotic formulation targeted to the ileum in the ileum upon administration to a patient, and once released, the first capsule is solubilized in the colon of the patient and releases the probiotic formulation targeted to the colon. Both inventions require probiotics which may be human bacterial fecal flora, and HPMC capsule.
Both inventions are characterized in capsule-in-capsule structure for delivery to ileum and colon, respectively and replacing one active agent with another within that capsule-in-capsule structure would have achieved predictable results with a reasonable expectation of success, in the absence of evidence to the contrary.
Consequently, the instantly claimed subject matter would be obvious over the copending ‘053 subject matter.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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