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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/7/2026 has been entered.
Priority
This application is a national stage entry of PCT/IL2020/050902, filed 8/16/2020. This application claims priority to provisional application 62/887,816, filed 8/16/2019.
Claim Status
Receipt of Remarks/Amendments filed on 1/7/2026 is acknowledged. Claims 1-3, 5-8 and 10 are currently pending and under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Withdrawn Rejections/Objections
The 112(b) rejections made in the previous office action have been withdrawn due to claim amendments.
New/Maintained Claim Objection(s) / Rejection(s)
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.
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.
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.
Claims 1-3, 5, 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (WO 2016/023923 A1) in view of Mahalingam et al. (AAPS PharmSciTech, Vol. 10, No. 1, March 2009) and Jahagirdar et al. (US 2019/0076536 A1; Mar. 14, 2019) as evidenced by Kazi (Biochemical and Biophysical Research Communications 709 (2024)).
Vetter throughout the reference teaches ingestible particles for oral administration and delivery of bioactive agents to the gastrointestinal tract, such as the stomach or the duodenum. (Abstract; pg. pg. 2, line 31-35). Vetter teaches the particle comprises an active core and a coating layer (Abstract; claim 2). The core comprises pharmaceutical composition which comprise lipid components such as capric acid. Vetter teaches the pharmaceutical composition also comprise cholecalciferol (vitamin D3). As evidenced by Kazi, cholecalciferol is a BCS class II compound (see: Introduction of Kazi) and thus reads on instant claim 10. The core comprises pharmacologically inert material which include sucrose (excipient), starch or microcrystalline cellulose (hydrophilic component). The core also comprises carbomer homopolymer (binder). (see Vetter: pg. 20, line 19-24; pages 22-23; example 1; claim 2). Vetter further teaches coating of the active cores with a film coating based on povidone (PVP) (Example 13). Vetter teaches the coating layer can further comprise pore formers (channel forming agent) (pg. 19, line 12-31). Vetter teaches compositions in the form of sachets, capsule or tablets which comprise the ingestible particles wherein the particle diameter ranges from 0.1 mm to 3 mm (100-3000 micron) or the particle diameter can be similar and range from 0.2mm to 0.4mm (200-400 micron) or have a diameter of 1.5mm (1500 micron), which read on the claimed diameter range recited in claim 8. (pg. 30, line 14-20; pg. 4, line 5-7; example 9). Vetter teaches gastroretention may be achieved by rendering the formulation mucoadhesive and the formulation should provide mucoadhesive properties (see: pg. 1, line 24-27; pg. 6, line 25-31).
The teachings of Vetter have been set forth above.
While Vetter teaches the coating layer comprises povidone (PVP), Vetter does not teach the coating layer comprises a combination of PVP and PEO (polyethylene oxide). Vetter also does not teach the PVP and PEO are high molecular weight PVP above 30KD and high molecular weight PEO above 20KD. However, Mahalingam cures this deficiency.
Mahalingam teaches compacts containing bioadhesive polymers (PEO and PVP) for gastroretentive delivery system and evaluated for bioadhesion. It was concluded that PEO in combination with PVP provides bioadhesive dosage form which is suitable for gastroretentive applications (Abstract). Mahalingam teaches that as both dissolution and adhesive properties are required for an ideal gastroretentive formulation, combination of PEO and PVP is complementary to each other in providing a bioadhesive and soluble dosage form. Incorporation of PEO into PVP increased the bioadhesive strength of the compacts. Mahalingam teaches PEO and PVP with higher molecular weights (PEO 303 having a MW of 7000 KD and PVP K-90 having a MW of 360 KD) provided better retention and bioadhesion properties. (Results and Discussion; Table I-III). Compacts containing higher PEO provided higher bioadhesion (Abstract).
While Mahalingam discloses compacts containing higher PEO provided higher bioadhesion, the combination of Vetter and Mahalingam do not expressly teach the ratio of PEO to PVP recited claims 1 and 5. However, Jahagirdar cures this deficiency.
Jahagirdar teaches bioadhesive composition wherein bioadhesion is achieved with polymer having affinity for gastrointestinal mucosa, wherein the bioadhesive polymer include combination of PEO and PVP (claim 43). In example 2, Jahagirdar teaches bioadhesive composition comprising an active ingredient, excipient as well as PEO and PVP in a 66.7:33.3 ratio.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Vetter, Mahalingam and Jahagirdar and combine PEO with PVP having the molecular weights taught by Mahalingam. As discussed supra, Vetter teaches gastroretention may be achieved by rendering the formulation mucoadhesive and the formulation should provide mucoadhesive properties. Mahalingam teaches that as both dissolution and adhesive properties are required for an ideal gastroretentive formulation, combination of PEO and PVP is complementary to each other in providing a bioadhesive and soluble dosage form. Incorporation of PEO into PVP increased the bioadhesive strength of the compacts. Mahalingam teaches PEO and PVP with higher molecular weights (PEO 303 having a MW of 7000 KD and PVP K-90 having a MW of 360 KD) provided better retention and bioadhesion properties. Therefore, one skilled in the art would have been strongly motivated to include the combination of PEO and PVP having the molecular weights taught by Mahalingam in the coating layer of Vetter’s formulation.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Vetter, Mahalingam and Jahagirdar and include PEO and PVP in a ratio taught by Jahagirdar. As discussed supra, the combination of Vetter and Mahalingam already teaches PEO and PVP for bioadhesion and Jahagirdar also teaches PEO and PVP combination for bioadhesion and a ratio which is close to the ratio recited in the instant claims. Thus, it would have been obvious to one skilled in the art to incorporate the teachings of Jahagirdar for the amounts/ratio of PEO and PVP since Jahagirdar also teaches this combination for bioadhesion. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). See: MPEP 2144.05(I). Further, as discussed supra, Mahalingam teaches compacts containing higher PEO provided higher bioadhesion and it would have been obvious to one skilled in the art to manipulate the amounts/ratio of the PEO and PVP to obtain optimal bioadhesive properties.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (WO 2016/023923 A1) in view of Mahalingam et al. (AAPS PharmSciTech, Vol. 10, No. 1, March 2009) and Jahagirdar et al. (US 2019/0076536 A1; Mar. 14, 2019) as evidenced by Kazi (Biochemical and Biophysical Research Communications 709 (2024)) as applied to claims 1-3, 5, 7-8 and 10 above, and further in view of BASF (BASF The Chemical Company, Soluble Kollidone grades, May 2013).
The teachings of Vetter, Mahalingam and Jahagirdar have been set forth above.
The combination of Vetter, Mahalingam and Jahagirdar do not teach wherein the pore forming agent comprises low molecular weight PVP below 30 KD. However, BASF cures this deficiency.
BASF teaches Kollidon (povidone or PVP) and specifically Kollidon 25 (MW of less than 30KD) applicable in film coating and used as pore forming agent. (see: entire document).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Vetter, Mahalingam, Jahagirdar and BASF and include Kollidon 25 as the pore forming agent in the coating layer of Vetter. As discussed supra, Vetter teaches the coating layer can further comprise pore formers and BASF teaches Kollidon 25 being applicable in film coating and used as pore forming agent. Thus, it would have been obvious to one skilled in the art to use Kollidon 25 since it was known to be used as a pore forming agent in film coatings.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant argued that Mahalingam indicates that even in its most bioadhesive formulation, PEO does not exceed 40% and PVP is never below 58%, and that no formulation came close to the 70:30 to 50:50 PEO:PVP ratio taught by applicant.
In response, as discussed supra, Mahalingam discloses compacts containing higher PEO provided higher bioadhesion (Abstract). Jahagirdar also teaches bioadhesive combination comprising PEO and PVP in a 66.7:33.3 ratio. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123. While Mahalingam’s formulation expressly disclosed do not use PEO in higher amounts than PVP, Mahalingam does recognize that high PEO content provides better adhesion. Further, as discussed supra, applicant have not provided enough evidence to conclude that the claimed ratios are critical and provide unexpected results. Thus, absence any unexpected results, prima facie case of obviousness exists to optimize the ratio of PEO to PVP to determine optimal bio adhesion.
Applicant argued that Mahalingam is focused on solid compact dosage forms, not microparticles and there is no mention that PEO/PVP blend is to be used in a coating layer over a microparticle core. In contrast, applicant’s invention relies on a precise coating layer of a particulate core. It was argued that it would not be logical to try to combine the teachings of Vetter and Mahalingam because they teach different technologies.
In response, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, as discussed supra, Vetter teaches gastroretention may be achieved by rendering the formulation mucoadhesive and the formulation should provide mucoadhesive properties. Mahalingam teaches that as both dissolution and adhesive properties are required for an ideal gastroretentive formulation, combination of PEO and PVP is complementary to each other in providing a bioadhesive and soluble dosage form. Mahalingam teaches PEO and PVP with higher molecular weights (PEO 303 having a MW of 7000 KD and PVP K-90 having a MW of 360 KD) provided better retention and bioadhesion properties. Therefore, one skilled in the art would have been strongly motivated to include the combination of PEO and PVP having the molecular weights taught by Mahalingam in the coating layer of Vetter’s formulation. Further, applicant state that polymer film formation behavior and adhesion of high MW PEO/PVP when used as a coating versus compact dosage form are different. In response, the examiner argues that while applicant make these claims, there is no evidence provided by the applicant to support that one skilled in the art would have been discouraged from using the high MW PEO/PVP taught by Mahalingam in the coating of Vetter’s composition. As discussed supra, Vetter already teaches the coating layer comprises PVP and that gastroretention may be achieved by rendering the formulation mucoadhesive wherein the formulation should provide mucoadhesive properties. Mahalingam teaches that as both dissolution and adhesive properties are required for an ideal gastroretentive formulation, combination of PEO and PVP is complementary to each other in providing a bioadhesive and soluble dosage form. Even if Mahalingam does not teach that PEO/PVP blend is to be used in a coating layer, Vetter already teaches PVP in a coating layer and Mahalingam teaches combination of PEO and PVP is complementary to each other in providing a bioadhesive. Thus, one skilled in the art would have been motivated to complement PVP of Vetter’s coating layer with PEO as suggested by Mahalingam.
Applicant argued that Jahagirdar is silent on the molecular weights of PVP and PEO used. It was argued that Jahagirdar fails to teach PEO and PVP combination in a coating layer and the example 2 of Jahagirdar does not teach the PEO and PVP used in the coating layer.
In response, firstly, the examiner makes the same argument as above with regards to Jahagirdar not teaching PEO/PVP combination in a coating layer because similar to Mahalingam, Jahagirdar also teaches bioadhesion is achieved with polymer having affinity for gastrointestinal mucosa, wherein the bioadhesive polymer include combination of PEO and PVP. As discussed supra, the combination of Vetter and Mahalingam already teach utilizing a combination of high MW PEO and PVP for bioadhesion and Mahalingam teaches compacts containing higher PEO provided higher bioadhesion. Jahagirdar is utilized because Jahagirdar also teaches PEO and PVP combination for bioadhesion and a ratio which is close to the ratio recited in the instant claims. As discussed supra, applicant have not provided enough evidence to conclude that the claimed ratios are critical and provide unexpected results. Thus, absence any unexpected results, prima facie case of obviousness exists to optimize the ratio of PEO to PVP to determine optimal bioadhesion.
Applicant argued the data in the present application demonstrates a statistically significant improvement (e.g., 359 N at 60:40 vs 322 N at 70:30), suggesting an unexpected result. The 11% improvement is statistically significant (p<0.01). This result was unexpected since Mahalingam teaches higher PVP improves adhesion, while applicant show greater adhesion with increased PEO.
In response, as discussed supra, Mahalingam teaches that PEO in combination with PVP provides bioadhesive dosage form which is suitable for gastroretentive applications (Abstract). Mahalingam teaches that adhesive properties are required for an ideal gastroretentive formulation and combination of PEO and PVP is complementary to each other in providing a bioadhesive and soluble dosage form. Incorporation of PEO into PVP increased the bioadhesive strength of the compacts. Mahalingam teaches PEO and PVP with higher molecular weights (PEO 303 having a MW of 7000 KD and PVP K-90 having a MW of 360 KD) provided better retention and bioadhesion properties. Thus, the prior art expressly teaches the combination of high MW PEO and PVP and wherein this combination provides enhanced bioadhesive performance. Further, Mahalingam also teaches compacts containing higher PEO provided higher bioadhesion (Abstract), thus, applicant’s argument that Mahalingam teaches higher PVP improves adhesion is not persuasive.
Moreover, as discussed supra, Jahagirdar also teaches bioadhesive composition wherein bioadhesion is achieved with polymer having affinity for gastrointestinal mucosa, wherein the bioadhesive polymer include combination of PEO and PVP (claim 43). In example 2, Jahagirdar teaches bioadhesive composition comprising an active ingredient, excipient as well as PEO and PVP in a 66.7:33.3 ratio, which merely overlaps the claimed ratio. Regarding the argument of the data in the present application demonstrating a statistically significant improvement (e.g., 359 N at 60:40 vs 322 N at 70:30), the examiner argues that the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.") see MPEP 716.02. While an 11% improvement may be considered statistically significant, applicant have not shown any evidence of this also being of a practical significance. Further, Jahagirdar expressly teaches PEO and PVP in ratio of 66.7:33.3, which is closer to the claimed ratio in dependent claim 5 and thus, applicant’s comparison (ratio of 70:30) is not to the closest prior art. Moreover, independent claim 1 recites ratio between PEO and PVP is 70:30 to 50:50, thus applicant’s argument that a ratio of 60:40 having significant improvement over 70:30 are not commensurate in scope with the claimed ratio.
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, 5-8 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7-10 of copending Application No. 17/635,390 (US20220287981A1) in view of Mahalingam et al. (AAPS PharmSciTech, Vol. 10, No. 1, March 2009), Jahagirdar et al. (US 2019/0076536 A1; Mar. 14, 2019), Vetter et al. (WO 2016/023923 A1) as evidenced by Kazi (Biochemical and Biophysical Research Communications 709 (2024)).
The ‘390 application claims a microparticle for the administration of a pharmaceutical composition at the upper gastrointestinal tract (duodenum) comprising a core comprising at least one pharmaceutical composition and at least one excipient; and a first coating layer comprising a bioadhesive material, a channel forming agent (claim 1, 3). The core further comprises hydrophilic component and a binder (claim 2). The channel forming agent is a low molecular weight PVP below 30 KD (claims 7-8). A product comprising the microparticles of different diameter (claim 9). A product comprising the microparticles of substantially similar diameter (claim 10).
‘390 does not claim the bioadhesive comprises a combination of high molecular weight PEO and PVP and the ratios thereof. ‘390 also does not claim the composition includes a drug from class I or II. However, Mahalingam, Jahagirdar and Vetter cure these deficiencies.
The teachings of Mahalingam, Jahagirdar and Vetter have been set forth above.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘390, Mahalingam and Jahagirdar and include high molecular weight PEO and PVP as taught by Mahalingam in a ratio disclosed by Jahagirdar. ‘390 already teaches including bioadhesive components in the coating layer and Mahalingam teaches that as both dissolution and adhesive properties are required for an ideal gastroretentive formulation, combination of PEO and PVP is complementary to each other in providing a bioadhesive and soluble dosage form. Incorporation of PEO into PVP increased the bioadhesive strength of the compacts. Mahalingam teaches PEO and PVP with higher molecular weights (PEO 303 having a MW of 7000 KD and PVP K-90 having a MW of 360 KD) provided better retention and bioadhesion properties. Jahagirdar also teaches PEO and PVP combination for bioadhesion and a ratio which is close to the ratio recited in the instant claims. Thus, it would have been obvious to one skilled in the art to incorporate the teachings of Jahagirdar for the amounts/ratio of PEO and PVP since Jahagirdar also teaches this combination for bioadhesion.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘390, Vetter, Mahalingam and Jahagirdar and include vitamin D3 (class II drug) as taught in Vetter because Vetter also teaches microparticles having a core and a coating and the composition comprising vitamin D3 which can be used depending on the need of the patient (e.g., vitamin D deficiency). Thus, incorporating a class II drug such as vitamin D3 in to the composition of ‘390 would have been obvious.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant made similar argument, as with the 103 rejection above, wherein it was argued that ‘390 does not teach combination or ratio of PEO/PVP recited in instant claims.
In response, the examiner acknowledges this in the rejection above and Mahalingam and Jahagirdar cure this deficiency. As discussed supra, ‘390 already teaches including bioadhesive components in the coating layer and Mahalingam teaches that as both dissolution and adhesive properties are required for an ideal gastroretentive formulation, combination of PEO and PVP is complementary to each other in providing a bioadhesive and soluble dosage form. Incorporation of PEO into PVP increased the bioadhesive strength of the compacts. Mahalingam teaches PEO and PVP with higher molecular weights (PEO 303 having a MW of 7000 KD and PVP K-90 having a MW of 360 KD) provided better retention and bioadhesion properties. Jahagirdar also teaches PEO and PVP combination for bioadhesion and a ratio which is close to the ratio recited in the instant claims. Thus, it would have been obvious to one skilled in the art to incorporate the teachings of Jahagirdar for the amounts/ratio of PEO and PVP since Jahagirdar also teaches this combination for bioadhesion.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616