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 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.
Claim Status
Applicant’s amendment of 10/08/2025 is acknowledged. Claims 1, 14, and 16 are amended, and claim 15 remains cancelled. Claims 1-14 and 16-20 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/EP2021/074625 filed on 09/07/2021 and claims foreign priority to EP20208628.6 filed on 11/19/2020 and EP20194828.8 filed on 09/07/2020 as reflected in the filing receipt dated on 10/30/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/05/2025 and 12/12/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Withdrawn Objections and Rejections
Applicant’s amendment to the specification has overcome/rendered moot the previous objection. Thus, the objection is hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(a) rejections. Thus, the rejections are hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 102 rejections. Thus, the rejections are hereby withdrawn.
Applicant’s amendment and introduction of new claims have prompted the new/revised grounds of objection and rejection presented herein. Applicant’s arguments insofar as they pertain to any revised grounds of rejection are addressed herein.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 recites the limitation “wherein the content of the copolymer (A) in the first coating is at least 75% (w/w) in relation to the total weight of the copolymer (A) and the copolymer (B) in the first coating”. However, parent claim 1 requires that the content of copolymer (A) in the first coating is at least 75% (w/w) in relation to the total weight of the first coating, which inherently requires that the content of copolymers other than copolymer (A) in the first coating is 25% (w/w) or less. Thus, whether only copolymers (A) and (B) are present in the first coating, or whether additional components are also present in the first coating, the content of copolymer (A) in relation to the total weight of the copolymers (A) and (B) in the first coating is necessarily 75% (w/w) or greater. As such, the above limitation of claim 17 is redundant and should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
Claims 9 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.
Claim 9 recites the limitation “wherein the content of copolymer (A) in the first coating is at least 25% (w/w) in relation to the total weight of the copolymer (A) and the copolymer (B) in the first coating”. However, parent claim 1 recites that the content of copolymer (A) in the first coating is at least 75% (w/w) in relation to the total weight of the first coating, which inherently requires that the content of copolymers other than copolymer (A) in the first coating is 25% (w/w) or less. Thus, whether only copolymers (A) and (B) are present in the first coating, or whether additional components are also present in the first coating, the content of copolymer (A) in relation to the total weight of the copolymers (A) and (B) in the first coating is necessarily 75% (w/w) or greater. As such, it is unclear how the content of polymer (A) in relation to the total content of copolymers (A) and (B) in the first coating can be as low as 25% (w/w). Because the limitation improperly broadens the scope of the claim, the claim is indefinite.
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.
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 1-4, 6-9, 11-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bjerregaard (WO2014060472A1; 04/24/2014; IDS of 09/13/2024) in view of El-Malah (02/13/2008; PTO-892 of 06/09/2025).
Bjerregaard discloses oral pharmaceutical compositions comprising a GLP-1 peptide and a method for increasing bioavailability of a GLP-1 peptide comprising oral administration of a composition to a subject [pg. 2, lines 15-25]. While the oral route of administration is non-invasive and has a great potential to decrease the patient's discomfort related to drug administration and to increase drug compliance, barriers such as the enzymatic degradation in the gastrointestinal (GI) tract, drug efflux pumps, insufficient and variable absorption from the intestinal mucosa, as well as first pass metabolism in the liver, add to the complexity of developing a GLP-1 therapies with effective bioavailability of a GLP-1 peptide [pg. 2, lines 5-15]. Thus, Bjerregaard discloses compositions comprising a modified release coating, wherein the coating comprises at least one release modifying polymer, such as those sold under the Eudragit® trade name, which may be used to control to modify the rate, the place, or the time at which the GLP-1 peptide is released [pg. 21, lines 10-35]. The site of disintegration and release of the of the solid dosage form may be designed depending on the pH of the targeted area where absorption of the GLP-1 peptide is desired [pg. 21, lines 10-35].
In an exemplary embodiment [example 2, pg. 42-43], a solid oral pharmaceutical composition comprises a VegiCap filled with semaglutide, which is coated with a Eudragit L30-D55:NE 30D 50:50 mixture.
The VegiCap filled with semaglutide reads on the core comprising a GLP-1 receptor agonist as recited in claim 1, wherein the semaglutide reads on a species of GLP-1 receptor agonist recited in claims 1 and 11. The instant specification discloses that Eudragit NE 30D corresponds to poly(ethyl acrylate-co-methyl methacrylate), wherein the molar ratio of ethyl acrylate repeating units to methyl methacrylate repeating units is 2:1 [instant spec., pg. 5, lines 10-15]. Thus, Eudragit NE 30D reads on the copolymer (A) of claims 1-4. The instant specification also discloses that Eudragit L30-D55 corresponds to poly(methacrylic acid-co-ethyl acrylate), wherein the molar ratio of methacrylic acid repeating units to ethyl acrylate repeating units is 1:1 [instant spec., pg. 6, lines 20-30]. Thus, Eudragit L30-D55 reads on the copolymer (B) of claims 1-2 and 6-7. Because Eudragit L30-D55 consists only of methacrylic acid repeating units to ethyl acrylate repeating units, it also reads on the copolymer (B) of claim 8.
Regarding claim 9: While Bjerregaard is silent on the unit of measure for the mixture of Eudragit L30-D55:NE 30D in the coating, the mixture is added to coat the capsule to a final content based on % w/w [pg. 42, lines 3-5]. Therefore, one of ordinary skill in the art would conclude that the 50:50 mixture of Eudragit L30-D55:NE 30D would equate to a copolymer (A) content of 50% w/w in relation to the total weight of the copolymer (A) and the copolymer (B) in the coating, which lies within and thus reads on the instantly claimed range.
Regarding claims 14 and 16: Bjerregaard further discloses that the composition is administered orally to a subject for medical treatments relating to diabetes, including prevention and/or treatment of all forms of diabetes such as type 2 diabetes, eating disorders such as obesity, and cardiovascular diseases, among other diseases and disorders [pg. 32, lines 1-35, pg. 33, lines 1-25]. Bjerregaard specifies that the subject to whom the composition is administered orally is a patient in need thereof [pg. 33, lines 18-22]. While Bjerregaard is silent on the amount of composition administered to the subject in need thereof, the dosage would necessarily be a therapeutically effective amount in order to prevent and/or treat the above diseases and disorders. Applicant’s instant specification further supports that a physician will determine the actual dosage of GLP-1 receptor agonist which will be most suitable for an individual subject [instant spec., pg. 30, lines 5-15]. Thus, the disclosure of Bjerregaard anticipates the instantly claimed methods.
However, Bjerregaard does not explicitly disclose that the amount of Eudragit NE 30D is at least 75% w/w in relation to the total weight of the first coating as recited in claim 1, or the further limitations of claims 13 or 17-19.
El-Malah evaluates the suitability of Eudragit® NE 30D and Eudragit® L 30D-55 polymer blend as a coating material for use in delayed release applications [pg. 220, l. col.]. Eudragit® NE 30D:L 30D-55 dispersions were then blended at ratios 50:50, 67:33, 75:25, and 80:20 and adjusted to a final weight [pg. 220, section 2.2], suggesting that the ratios represent w/w, and the free films were subject to a dissolution study [pg. 220-221, section 2.5]. Increasing Eudragit® NE 30D concentration increased miscibility of the films, which in turn influenced dissolution [abstract]. The ability of Eudragit® NE 30D and Eudragit® L 30D-55 blend at the two ratios, 75:25 and 80:20, to delay verapamil HCl release was investigated by testing the dissolution behavior of drug loaded beads with and without coating in a step function pH medium [pg. 224, section 3.5]. The correlation between lag time and percent weight gain for the 80:20 blend was higher than that observed with the 75:25 blend, indicating that the 80:20 blend is more efficient in delaying drug release [pg. 224-226, sections 3.5 and 3.6]. El-Malah thus concludes that Eudragit® blends of NE 30D and L 30D-55 at 80% or greater NE 30D content could be used to extend drug release lag time to meet potential patient needs [pg. 226, section 4].
Regarding the amount of copolymer (A) recited in claims 1 and 17-19: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Bjerregaard by manipulating the content of Eudragit® NE 30D, which corresponds to instantly claimed copolymer (A), relative to Eudragit® L 30D-55, which corresponds to instantly claimed copolymer (B), within the coating mixture. One of ordinary skill in the art would have been motivated to use either 75% w/w or 80% or greater w/w Eudragit® NE 30D, as taught by El-Malah, as a starting point for routine optimization in order to extend the drug release lag time of semaglutide, which Bjerregaard teaches as an effective approach for increasing the oral bioavailability of the drug. One of ordinary skill in the art would have a reasonable expectation of success because El-Malah teaches that lag time can be controlled by manipulating the concentration of Eudragit® NE 30D in the drug coating blend, and Bjerregaard acknowledges that modified release coatings can be used to control the rate of GLP-1 peptide delivery.
Because the coating blend of consists of Eudragit® NE 30D and Eudragit® L 30D-55, the resulting content of Eudragit® NE 30D is equal to the amount of the copolymer relative to the total weight of the coating, which lies within and thus reads on the amount recited in claim 1. The amounts of Eudragit® NE 30D taught by El-Malah, at 75% w/w or at 80% or greater w/w, lie within the ranges recited in claims 17 and 18, respectively, and overlap the range recited in instant claim 19. Regarding claim 19, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to adjust the concentration of Eudragit® NE 30D relative to Eudragit® L 30D-55 within the range of 80% or greater w/w because El-Malah teaches that this amount is suitable for extending drug release lag time to meet potential patient needs. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding claim 13: The composition taught by the combination of Bjerregaard and El-Malah, whereby a capsule comprising semaglutide is coated with Eudragit® NE 30D (80% w/w) and Eudragit® L 30D-55 (20% w/w), is nearly identical to the composition of Applicant’s Example 28 [instant spec., pg. 56] – the only difference being the use of Eudragit® NE 30D as copolymer (A) rather than Eudragit® NM 30D, which the instant specification teaches is one of two preferred alternatives to Eudragit® NE 30D [instant spec., pg. 5, lines 12-15]. As evidenced by the dissolution profile of Applicant’s Example 28 [instant spec., fig. 4], the composition taught by the combination of Bjerregaard and El-Malah would necessarily possess the instantly claimed dissolution profile. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Note MPEP 2112.01.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bjerregaard (WO2014060472A1; 04/24/2014; IDS of 09/13/2024) in view of El-Malah (02/13/2008; PTO-892 of 06/09/2025), as applied to claims 1-4, 6-9, 11-14, and 16-20 above, and further in view of Yao (CN105832691A; 08/10/2016; PTO-892 of 06/09/2025).
The combination of Bjerregaard and El-Malah teaches the inventions of claims 1-4, 6-9, 11-14, and 16-20 as discussed in detail above and incorporated herein.
However, the prior art combination does not expressly teach that the copolymer (A) of the composition further comprises 0.5 to 20 mol-% 2-(trimethylammonio)ethyl methacrylate chloride repeating units as recited in claim 5, or that the composition further comprises a second coating exterior to the first coating, wherein the second coating comprises copolymer (C) as recited in claim 10.
Yao teaches a sustained release preparation of dulaglutide, a GLP-1 receptor agonist, composed of a tablet core, a sustained release layer, a pH control layer, and a flora trigger layer [abstract, 0004]. Orally administered drugs can prevent peptide drugs from being destroyed by gastric and intestinal enzymes, thereby improving their bioavailability, and reduce irritation to the gastrointestinal tract, thereby improving patient compliance [0007, 0010]. The pH control layer coats the sustained-release coated tablet core and is selected from one or more of Eudragit® L100, Eudragit® S100, Eudragit® FS, Eudragit® E, acrylic resin II, and acrylic resin III [0028, 0044]. Both Eudragit® L100 and Eudragit® S100 read on the copolymer (C) of claim 10 as evidenced by the instant specification [pg. 7, lines 24-30, pg. 8, lines 1-3].
Yao further teaches that Eudragit® RL30D, Eudragit® RS30D, Eudragit® NE, and Eudragit® NM are suitable penetrants [0034]. Eudragit® RL30D and Eudragit® RS30D correspond to poly(ethyl acrylate-co-methyl methacrylate-co-2-(trimethylammonio)ethyl methacrylate chloride) with molar ratios of 1:2:0.2 and 1:2:0.1, respectively, as evidenced by the instant specification [pg. 5, lines 24-35]. The molar ratios of Eudragit® RL30D and Eudragit® RS30D equate to approximately 6.3 mol-% and 3.2 mol-% of 2-(trimethylammonio)ethyl methacrylate chloride, respectively, and thus read on the copolymer (A) recited in claim 5.
Regarding claim 5: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by the combination of Bjerregaard and El-Malah by substituting Eudragit® NE 30D with an alternative penetrant such as Eudragit® RL30D or Eudragit® RS30D, as taught by Yao. One of ordinary skill in the art would have been motivated to exchange one known penetrant for another, according to known methods, in order to optimize the bioavailability of the released GLP-1 receptor agonist, as taught by Yao, which is dependent on the desired targeted area of release among other factors, as taught by Bjerregaard.
Regarding claim 10: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Bjerregaard by further including a pH control layer such as Eudragit® L100 or Eudragit® S100, as taught by Yao, exterior to the first coating, which controls the rate of drug release and is akin to Yao’s sustained release layer. One of ordinary skill in the art would have been motivated to include an exterior pH control layer in order to better control the site of disintegration and release of the of the solid dosage form, which Bjerregaard teaches can be controlled in a pH-dependent fashion based on the desired targeted area of release.
One of ordinary skill in the art would reasonably expect success in modifying the prior art as proposed because Yao teaches that the above polymers are suitable for controlling the release of a GLP-1 receptor agonist, and Bjerregaard supports the use of various Eudragit® release modifying polymers to control the rate, the place, or the time at which the GLP-1 peptide is released.
Response to Arguments
Applicant’s arguments submitted on 10/08/2025 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that a skilled artisan would not have been motivated to combine the teachings of the references to obtain the presently claimed invention. Specifically, Applicant argues that a skilled person knowing the teachings of Bjerregaard and trying to provide a solid oral pharmaceutical composition with improved properties, such as improved dissolution properties, would not have been motivated to employ at least 75% w/w of copolymer (A), and that this deficiency is not overcome by any of the other cited documents. This argument was not found to be persuasive.
First, the Examiner notes that “improved dissolution properties” is not a claimed feature of the instant invention. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner further notes that it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by Applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). Note: MPEP 2144(IV).
In this case, Bjerregaard discloses barriers to GLP-1 peptide oral bioavailability (e.g., enzymatic degradation in the GI tract), and explicitly teaches that its composition’s coating can be modified to control the rate, the place, or the time at which the GLP-1 peptide is released. Therefore, one of ordinary skill in the art looking to modify the composition of Bjerregaard to achieve a particular release profile would reasonably look to El-Malah, which compares drug coating blends comprising the same two polymers as Bjerregaard and finds that lag time and drug dissolution can be controlled by manipulating the relative concentrations of polymers in the coating. Based on the prior art teachings, an ordinarily skilled artisan would be motivated to increase the content of Eudragit® NE 30D in the coating to 80% w/w or greater, which El-Malah teaches is known to improve the miscibility of the coating blend thereby preventing premature dissolving of pH-dependent Eudragit® L 30D-55 in order to delay the release of semaglutide (i.e., avoid enzymatic degradation in the GI tract) and increase its oral bioavailability at its target destination [see El-Malah, pg. 224-225, section 3.5, which is cited in the rejections of record].
Regarding Applicant’s argument that El-Malah does not tie its copolymer content to any specific percentages in tablets and not with biologics: The instant claims do not require that the composition is in tablet form, as this limitation is written using the alternative claim language “or”. Even if it were a required feature, because El-Malah teaches drug beads comprising a coating having instant copolymer (A) within the instantly claimed range, a skilled artisan could reasonably apply this coating to any similar solid form (e.g., tablet, capsule, etc.). While El-Malah is silent as to the use of its coating blend in the context of peptides, coating blends comprising the same two polymers are known to be suitable for use in delivering peptide drugs, as evidenced by Bjerregaard.
Applicant further argues that El-Malah suggests that increasing the percentage of the copolymer would result in a weaker dissolution profile compared to the allegedly stronger dissolution profile seen with the presently claimed compositions and, thus, provides an implicit teaching away from the claimed invention. This argument was not found to be persuasive. Again, the Examiner notes that the feature upon which Applicant’s argument depends is not a claimed feature of the instantly claimed composition, nor is it clear what Applicant means by the relative terms “weaker” or “stronger” dissolution profiles.
If the “stronger” dissolution profile to which Applicant is referring is that of instant claim 13, the composition taught by the combination of Bjerregaard and El-Malah would necessarily possess the instantly claimed dissolution profile, as discussed in detail in the prior art rejections of record. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Note MPEP 2112.01.
Applicant further cites El-Malah’s Figures 8A and 8B to support the assertion that El-Malah teaches away from the instantly claimed invention. However, these studies compare the dissolution profiles of drugs coated to different theoretical weight gains, which is a function of the amount of coating material applied to the drug form [see formula on pg. 221 of El-Malah], not the amount of each copolymer within the coating blend itself, which is Applicant’s instantly claimed feature. The content of each copolymer within the coating is actually held constant for the experiments depicted in Fig. 8A and 8B (Eudragit® NE 30D and Eudragit® L 30D-55 at (A) 75:25 ratio and (B) 80:20 ratio) and, thus, these figures do not teach that increasing the content of copolymer (A) would result in a “weaker” dissolution profile. To the contrary, El-Malah’s Fig. 6 [pg. 225], which does compare the dissolution profiles of coatings having various copolymer blend ratios, portrays a very similar trend to Applicant’s Fig. 2 (later cited by Applicant as representing “improved” dissolution properties) wherein increasing the content of copolymer (A) in the coating blend leads to a delay in drug dissolution followed by a relatively rapid increase in drug release.
Applicant further argues that the presently claimed compositions exhibit surprisingly improved dissolution properties that weigh in favor of non-obviousness, asserting that Applicant’s Fig. 2 demonstrates that compositions having a content of copolymer (A) in the first coating of at least 75% w/w show improved dissolution properties compared coatings having only 50% w/w copolymer (A). This argument was not found to be persuasive.
Both coating conditions appear to exhibit similarly rapid dissolution rates following a lag period, the only apparent differences in behavior being that increasing the content of copolymer (A) in the coating to 75% w/w or greater results in a longer lag period, which is clearly expected from the teachings of El-Malah. Absent a clearer distinction of what is meant by “improved dissolution properties” and objective evidence of significantly different and unexpected dissolution rates between Applicant’s claimed composition and that of the closest prior art, the instantly claimed composition appears to behave exactly as expected based on the prior art teachings. Accordingly, Applicant’s showing of allegedly unexpected results is insufficient to overcome the case of prima facie obviousness established on record.
In view of the foregoing, the prior art rejections of record are maintained.
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 1-14 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 15-19 of copending Application No. 18/840,653 in view of Bjerregaard (WO2014060472A1; 04/24/2014; IDS of 09/13/2024).
App. ‘653 claim 1 is identical to instant claim 1, except that App. ‘653 claim 1 more broadly recites that the core comprises a peptide or protein drug rather than a GLP-1 receptor agonist and does not recite the content of copolymer (A) as instantly claimed. App. ‘653 claim 2 recites that the first coating comprises a copolymer (A) in combination with a copolymer (B) and/or a copolymer (D). The combination of a copolymer (A) with a copolymer (B) reads on instant claim 2. The further limitations to copolymer (A) recited in App. ‘653 claims 3-5 are identical to those recited in instant claims 3-5. The further limitations to copolymer (B) recited in App. ‘653 claims 6-8 are identical to those recited in instant claims 6-8. The content of copolymer (A) in relation to the total weight of the copolymer (A) and the copolymer (B) in the first coating recited in recited in App. ‘653 claim 9 is identical to that recited in instant claim 9. App. ‘653 claim 10 recites that the composition further comprises a second coating identical to that recited in instant claim 10. App. ‘653 claim 11 recites that the peptide or protein drug has a molecular weight of equal to or less than about 300 kDa. App. ‘653 claim 15 recites that the composition is an oral dosage form, which reads on instant claim 12. App. ‘653 claim 16 recites that the composition is in the form of a capsule or tablet, and claim 17 recites that the core is in the form of a multiparticulate, a granulate, or pellets, which both read on instant claim 20. App. ‘653 claims 18 recites that the content of copolymer (A) in relation to the total weight of the copolymer (A) and the copolymer (B) in the first coating is at least 50% (w/w), which overlaps and thus renders obvious the ranges recited in instant claims 17-19. App. ‘653 claims 19 recites that the content of copolymer (A) in relation to the total weight of the copolymer (A) and the copolymer (B) in the first coating is at least 80% (w/w), which lies within and reads the ranges recited in instant claims 17-18 and overlaps and thus renders obvious the range recited in instant claim 19.
Regarding instant claim 1, because App. ‘653 claim 19 recites that the content of copolymer (A) in relation to the total weight of the copolymer (A) and the copolymer (B) in the first coating is at least 80% (w/w), and an ordinarily skilled artisan could immediately envisage an embodiment wherein the first coating consists of (A) and (B), the weight of (A) + (B) corresponds to the total weight of the first coating, and as such, the content of (A) recited in App. ‘653 claim 19 reads on the amount recited in instant claim 1.
Regarding instant claim 19, it would have been obvious for a person of ordinary skill in the art to adjust the concentration of copolymer (A) within the range of 50% or greater (w/w) because claim 18 of App. ‘653 recites that this amount is suitable for making a solid oral pharmaceutical composition comprising: a core comprising a peptide drug and a first coating. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
The claims of App. ‘653 differ from the instant claims in that the claims of App. ‘653 do not recite that the core comprises a GLP-1 receptor agonist as recited in instant claims 1 and 11, that the composition has a dissolution profile as recited in instant claim 13, or the method of instant claims 14 or 16.
The teachings of Bjerregaard are as set forth above and incorporated herein.
Regarding instant claims 1 and 11, it would have been obvious to one of ordinary skill in the art to modify the solid oral pharmaceutical composition recited in the claims of App. ‘653 by selecting semaglutide, a GLP-1 receptor agonist taught by Bjerregaard, as the peptide drug which the core comprises. It would have been obvious and one of ordinary skill in the art would have a reasonable expectation of success because Bjerregaard teaches an orally administered composition comprising a core and a coating, which as discussed in detail above corresponds to copolymers (A) and (B) recited in the instant claims (and, consequently, the claims of App. ‘653), that successfully increases the bioavailability of semaglutide administered to a subject.
Regarding instant claim 13, the composition taught by the combination of App. ‘653 claim 19 (which depends from claim 1 modified above) and Bjerregaard, whereby a core comprising semaglutide is coated with at least 80% w/w copolymer (A) and the copolymer (B), is identical to the composition of Applicant’s Example 28 [instant spec., pg. 56]. As evidenced by the dissolution profile of Applicant’s Example 28 [instant spec., fig. 4], the composition taught by the combination of App. ‘563 claims and Bjerregaard would necessarily possess the instantly claimed dissolution profile. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Note MPEP 2112.01.
Regarding the method of instant claims 14 and 16, it would have been obvious to one of ordinary skill in the art to administer the composition taught by the combination of App. ‘563 claims and Bjerregaard using the method taught by Bjerregaard. One of ordinary skill in the art would have been motivated to orally administer the composition to a patient in need thereof, as taught by Bjerregaard, because the reference teaches that such compositions can be used to treat and/or prevent of all forms of diabetes such as type 2 diabetes, eating disorders such as obesity, and cardiovascular diseases, among other diseases and disorders. Because Bjerregaard teaches a species of the composition taught by the combination of App. ‘653 claims and Bjerregaard, as discussed above, one of ordinary skill in the art would have a reasonable expectation of success in both administering the composition and treating and/or preventing the diseases and disorders in the manner taught by Bjerregaard.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s request in the Remarks filed 10/08/2025 for the double patenting rejections of record to be held in abeyance is acknowledged. However, this request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejections will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejections.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
Prosecution Insights