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 .
Claim Status
Claims 1-38, 44-46, 54, 58, and 59 are cancelled. Claims 39-43, 47-53, 55-57, and 60-68 are pending and under examination.
Priority
This application filed on PCT/EP2022/063746 filed on 5/20/2022, which claims priority to European applications EP22154200.4 filed on 1/31/2022 and EP21175174.8 filed on 5/21/2021.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/26/2026 has been entered.
Information Disclosure Statement
The information disclosure statement filed on 8/26/2026 has been considered by the examiner.
Objections/Rejections Withdrawn
The Payne reference is removed as an evidentiary reference as it is no longer needed, however, the rejection stands under Alderborn.
The rejection under USC 103 over Alderborn and Holmback is withdrawn per applicant’s arguments over Holmback and its combination with Alderborn.
As these rejections are withdrawn, applicant’s arguments toward these rejections are now moot.
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 39-41, 47-49, 51, 55-57 and 60-68 are rejected under 35 U.S.C. 103 as being unpatentable over Alderborn US 20170360715.
Alderborn teaches “The present invention provides a pharmaceutical or cosmetic modified-release (MR) composition for oral use for the treatment of obesity, overweight and/or obesity” (paragraph 27). Alderborn teaches reducing body weight by administering the composition (paragraphs 332 and claim 65 of Alderborn). Alderborn teaches “a modified-release composition comprising orlistat and acarbose, comprising individually distinct parts with different release patterns: a) a first part, G1, comprising from about 5 to about 70% w/w of the total dose of acarbose, b) a second part, G2A, comprising from about 30 to about 95% w/w of the total dose of acarbose, c) a third part, G2B, comprising from about 10 to about 90% w/w of the total dose of orlistat, and d) a fourth part, G3, comprising from about 10 to about 80% w/w of the total dose of orlistat, and the total concentration of acarbose and orlistat, respectively, in the composition is 100% w/w.” (abstract). Alderborn teaches “A modified-release composition according to claim 35, wherein (a) G1 is a DRDC-PRGASTRIC part that releases acarbose in a prolonged manner, (b) G2 is a DREC-RRPROX SI part that releases acarbose and orlistat in the proximal small intestine, and (c) G3 is a DRDC-PRGASTRIC and/or DREC-PRINTESTINAL part that releases orlistat in the proximal part of the small intestine until the end of jejunum.” (claim 36 of Alderborn). Alderborn teaches polysorbate 80 as a non-ionic surfactant for the composition (claim 49 of Alderborn). Alderborn teaches treating conditions like overweight, obesity, type 2 diabetes, impaired glucose tolerance, NAFLD, and metabolic syndrome by administering the composition with the orlistat and acarbose (claims 57 and 60 of Alderborn). Example 1A and example 1B provides for 90mg orlistat and 30mg of acarbose in a multi-unit tablet. This is a 3:1 ratio of orlistat to acarbose. Example 1 (1A and 1B) provides for the multiple unit tablet with granules having acarbose or orlistat with granules having delay coatings or enteric coatings. Example 1E teaches 60 mg orlistat and 20 mg acarbose (also examples 1F and 1H). Alderborn teaches granules with 3.1% orlistat and 27% of hypromellose (HPMC) (example 1C and 1O). In example 1O, there are granules with 3.8% microcrystalline cellulose, 3.1% acarbose, and 8.1% orlistat. Example 1F has granules with 7.2% orlistat, 1.4% acarbose, and 18.2% microcrystalline cellulose, Eudragit L 100-55, Opadry HPMC, and 0.9% polysorbate 80 in G2 granules. Example 1G has 8.1% orlistat, 1.5% acarbose, 20.4% microcrystalline cellulose, Eudragit L 100-55, and 1% polysorbate 80 in G2 granules. Spheronized G1 granules with HPMC are taught in paragraph 390. Coated G1 granules with microcrystalline cellulose and coated with HPMC are taught in paragraph 389. Enteric coated G2 granules with spheronized pellet cores are taught in paragraph 391. G3 granules are taught in paragraph 392. Hydroxypropylmethylcellulose is present in G1 at a concentration of about 10% to about 50% w/w (paragraph 158). Example 4R provides for 39.7% w/w of microcrystalline cellulose in the total granules. Alderborn teaches micronization of orlistat (paragraph 296). Alderborn teaches orlistat nanoparticles of average size of less than 1 micron (paragraphs 297-299). Alderborn teaches administering on the day (paragraph 464). Alderborn teaches taking the oral dosage form with a meal (paragraphs 307 and 341). Alderborn additionally teaches treatment of nonalcoholic fatty liver disease or nonalcoholic steatohepatitis, and thus, as the drug combination of Alderborn are the same as applicant’s claim, Alderborn would have been reducing fat in the liver in such subjects.
Alderborn provides for administering modified release granule forms of orlistat and acarbose to subjects to treat overweight and obesity. The improvement in these kind of conditions will increase a subjects quality of life in terms of physical functioning, bodily pains, role limitations, personal or emotional problems, emotional well-being, social functioning, energy, fatigue and general health perception/general health. Alderborn also teaches “The main idea regarding an oral modified-release (MR) pharmaceutical composition of the invention is to reduce pH-dependent degradation of both APIs, slow down GI transit time, increase satiety and reduce weight” (paragraph 133). Thus, a goal of Alderborn is to reduce a subject’s weight if obese or overweight, which would be able to improve health, physical, mental and social functions of the subject.
Alderborn teaches the claims as discussed above including concentrations of acarbose and orlistat based on the totals of the composition as noted above.
Alderborn teaches surfactant to prevent agglomerates or clusters and includes polysorbates like polysorbate 80 (paragraph 300). Alderborn teaches 0.5 to 30% w/w of surfactant in G2 and includes polysorbate 80 (paragraphs 160-161). Alderborn teaches hydroxypropylmethylcellulose as a supplement to hydrophobic polymer and provides for concentrations of 10% to 50% w/w (paragraphs 157-158). Alderborn teaches that G2 is designed for delayed release but then it becomes relatively rapid (paragraph 159). Alderborn teaches G1 is designed for prolonged release (paragraph 155). Alderborn teaches coatings and enteric polymers as coating agent for G2 (paragraphs 163-166) with about 15% to 50% w/w enteric polymer (paragraph 166). Alderborn teaches G3 with a water swellable polymer with no mention of a core particle (paragraphs 168-169). Alderborn provides for G2A and G2B portions (paragraph 170). Alderborn provides more information about granule or pellet structure in paragraphs 171-175). Alderborn provides “the data analysis of the observed in vitro and simulations of GI processing of the formulation and each of the two API concentration-time profiles (acarbose and orlistat) in the different GI compartments are shown in FIGS. 4 and 5” (paragraph 182), and thus, uses simulations to determine GI processing of the drugs. Alderborn provides for the 3 types of pellets (paragraphs 195-201). Alderborn teaches for G1 and G3 for prolonged release of orlistat and/or acarbose optionally with up to 40 minutes delay (paragraph 203). Alderborn teaches G2 being enteric coated but designed for rapid release of the drugs in the small intestine (paragraph 203). Alderborn teaches orlistat and acarbose (114-129). Alderborn teaches “i) release a part of the total dose of acarbose in the stomach, but in a delayed manner in order to ensure that particles with acarbose will be well mixed with the food components and chyme in the postprandial stomach, ii) release a part of the total dose of acarbose and a part of the total dose of orlistat in duodenum and jejunum; this release should be relatively fast, as both acarbose and orlistat should be available to exert their effect in duodenum and jejunum, and iii) release of a part of the total dose of orlistat in duodenum and jejunum.” (paragraphs 31-34). Alderborn teaches microcrystalline cellulose or sugar alcohol based spheres are used as cores (paragraph 389). These would be inert cores as they don’t have drug. G1 and G2 are noted as having cores while G3 does not (paragraphs 389-392). Paragraphs 31-38 provides for duodenum and jejunum.
Alderborn does not directly provide that the treatment with dosing regimen that would reduce central adiposity or fat in the liver, however, it teaches orlistat and acarbose, amounts of applicant’s claims, dosage forms of applicant’s claims and treating subjects with obesity and overweightness. Alderborn’s teachings also provide the option of treating such individuals with fatty liver diseases.
One of ordinary skill in the art before the time of filing would have worked within the overlapping concentrations of orlistat and acarbose for each portion (G1, G2A, G2B and G3) based on total composition concentration from Alderborn to provide for total concentrations and concentrations based on part for each of the drugs with a reasonable expectation of success in making the formulation that would provide for modified release of these drugs when administered (MPEP 2144.05). One of ordinary skill in the art before the time of filing would also have adjusted the amounts of structural components such as coatings and enteric and other polymers to provide for compositions with the proper release of each drug based on Alderborn’s teachings of overlapping concentrations and the desired to adjust release of each drug from each portion of the formulation. Thus, one would have a reasonable expectation of success in providing the formulations of the claims by teachings of Alderborn with the ability to provide for modified release of the drugs to provide some release in the stomach and other release in the small intestine (duodenum and jejunum are parts of the small intestine). This would allow for a treatment that would be administered to patients to treat conditions such as obesity, overweightness and type II diabetes to improve the lives of those subjects by managing weight and treating disease.
Claims 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Alderborn US 20170360715 and Hollywood et al (Journal of Obesity, 2010, volume 2011, pages 1-7).
Alderborn teaches the claims as discussed above. Alderborn teaches in regard to acarbose, “By inhibiting the luminal digestion and subsequent absorption of carbohydrates, the concentrations of glucose in blood sugar increases slower postprandially, and the patient's insulin need is reduced” (paragraph 129). Alderborn teaches that orlistat acts by preventing intestinal absorption of dietary fats through inhibition of luminal digestion (paragraph 118).
Alderborn does not teach a timing of the administration. Alderborn does not teach reducing body fat percentage or sagittal abdominal diameter (requires administering the drugs for longer time frames).
Hollywood teaches predicting weight loss of orlistat in a 6 month study (half year, 26 weeks) (abstract, also Method). Hollywood provides the majority of subjects lost weight (abstract).
Therefore, one of ordinary skill in the art before the time of filing would have used durations of at least 6 months (26 weeks) in treating patients by teachings of Hollywood with a modified release form of orlistat and acarbose in claimed amounts by the combined teachings of Alderborn and Hollywood with Alderborn teaching treatment of subjects with obesity and overweightness with orlistat/acarbose combinations that are taught in its disclosure. There would be a reasonable expectation of reducing weight while on the treatment for the duration taught in Hollywood as Hollywood provides a majority of subjects on orlistat losing weight during this period.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Alderborn US 20170360715 and Bilgic WO2012093973A2.
Alderborn teaches the claims as discussed above. Alderborn does teach 120 mg of orlistat that is available for treatment of obesity (paragraph 17). Thus, this dose is used in the prior art for treatment of obesity.
Alderborn does not teach using 40 mg of acarbose.
Bilgic teaches formulations of acarbose to treat adiposity and hyperlipoidemia (abstract). Bilgic teaches 20-200 mg of acarbose as an amount of the active (Detailed Description, 4th paragraph in). Example 2 of Bilgic provides a formulation with 40% by weight of a 100% formulation which can allow for 40 mg for every 100 mg.
One of ordinary skill in the art before the time of filing would have been able to produce a 120mg orlistat/40 mg acarbose formulation as Alderborn provides that 120 mg orlistat is a known dose in the art and Bilgic provides a range that would contain the 40 mg value for acarbose known to treat adiposity (excessive body fat tissue). Therefore, there was a reasonable expectation of success in combining amounts and ranges of these compounds of the prior art to make a functional formulation to treat patients with excessive body fat.
Claims 50, 52 and 53 is rejected under 35 U.S.C. 103 as being unpatentable over Alderborn US 20170360715 and Zhao CN 102872062 A (2013, Google English Translation).
Alderborn teaches the claims as discussed above.
Alderborn does not teach doses of claims 52 and 53 or the three times a day of claim 50.
Zhao teaches orlistat from 30 mg – 150 mg and acarbose from 1.5 mg to 300 mg (claim 6 of Zhao). Zhao also teaches a formulation to treat obese patients (abstract). In embodiment 10, Zhao teaches every day, gavage was three times.
One of ordinary skill in the art before the time of filing would have used doses of orlistat up to 150 mg and values of acarbose within the ranges of Zhao and administer the combination three times a day with food by the combined teachings of Alderborn and Zhao as these were seen as amounts and times of administration for an orlistat/acarbose formulation for treating obese patients. Zhao provides for overlapping ranges that include values of applicant’s claims for amounts of orlistat and acarbose (see MPEP 2144.05). There was a reasonable expectation of success in using such amounts of orlistat and acarbose while also providing the dose three times a day in producing a method of treating obesity with a combination of orlistat and acarbose.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Alderborn US 20170360715 and Pandey US 20100317642A1.
Alderborn teaches the claims as discussed above and provides for taking the dosage with meals.
Alderborn does not teach three times a day (TID) for administration.
Pandey teaches pharmaceutical compositions of orlistat (abstract). Pandey teaches 120 mg orlistat three times daily is recommended dose after each meal (paragraph 4).
One of ordinary skill in the art before the time of filing would have seen three times daily orlistat as a recommended dosage by the teachings of the prior art. Therefore, there was a reasonable expectation of success of using a composition with such amounts of orlistat three times a day with meals as it is a recommended practice of the prior art.
Response to Applicant’s Arguments over the Rejections under USC 103 over Alderborn
Note that Payne is removed as an evidentiary reference as there are no longer limitations to quality of life. Note Payne was an evidentiary reference for quality of life after treating overweight or obese patients. The teachings of the claims primarily were taken from Alderborn’s teachings of orlistat and acarbose formulations and methods, which included treating patients that were overweight or obese.
It is noted that applicant moved in limitations of the claims formerly found in claims 54 and 58-59. These were also noted by the teachings of Alderborn as Alderborn provided drug amounts, overlapping drug concentration ranges and G1, G2, and G3 portions with structures, polymers and/or coatings as claimed.
Applicant argues that although Alderborn provides for formulation ingredients and amounts or overlapping amounts, Alderborn does not provide a method of treating obesity and/or overweightness in a subject with the formulation. Applicant is arguing that without disclosing a method of having done the treatment, the results could not be shown to be achieved. It remains that Alderborn indicates that it is for treating obesity and overweightness within its uses while also teaching an administrated form. Alderborn recognizes using its formulations to reduce weight in a subject. When providing such a formulation to the subjects that Alderborn notes for using the treatment (subjects who are obese or overweight), reducing weight and other applicant noted results would be achieved in the subject. Note in MPEP 2112 – “SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY”. The recognition of other results (e.g. reduced fat in liver) that would go along with an overweight or obese subject reducing their weight would not make the claimed method, which was recognized by teachings of Alderborn, patentable. Note that as Alderborn uses the same drug combination (orlistat and acarbose) in a similar administered form, it will lead to reduction in central adiposity (amounts to fat loss around the central portion of the body) based on it being a similar treatment and also recognized for treating obese and overweight subjects.
Applicant argues there is nothing in Alderborn to provide for routine adjusting/optimization. Alderborn recognizes its formulation for reducing weight. This allows one of ordinary skill in the art to adjust concentrations in the different parts of the dosage form to provide for desired weight loss results in a subject. There is a reasonable expectation of success in treating an obese or overweight subject to reduce weight by teachings of Alderborn, and thus, a reason to make optimizations. It is also noted that Alderborn teaches formulations with 60 mg orlistat and 20 mg of acarbose. Thus, it provides these amounts particularly.
Applicant uses the Van Gaal reference (provided in an IDS) to indicate that dosing and clinical effect was not predictable. Van Gaal tested different doses of orlistat and showed the 120 mg TID dose was most effective rather than the higher 240 mg dose. First, this is not a reference used in the examiner’s rejections. Second, the motivation for adjusting doses would flow from teachings of Alderborn with Alderborn even teaching some of the doses of applicant’s claims such as 60 mg orlistat and 20 mg acarbose (Alderborn was the cited art). One of ordinary skill in the art would routinely adjust dosing based on Alderborn for desirable results in weight loss. Applicant mentions the claims having an option of 150 mg orlistat and 50 mg of acarbose, which is higher than the 120/40 TID arm. Again, note that Van Gaal only provides a dose study with orlistat whereas the claims are to a combination of orlistat with acarbose as the active agents. The data in figure 2 appears to show the 120/40 and 150/50 arms both exhibit weight loss, but are not significantly different from one another. Applicant is also reminded that the 150/50 dose was formerly indicated to be obvious under the combined teachings of Alderborn and Holmback and not the teachings of Alderborn alone.
Applicant argues that Alderborn only provides a preliminary study, however, the full teachings of the reference must be considered. Alderborn provides for the use of its formulation for weight reduction in subjects including obese and overweight subjects by administering such a formulation. Therefore, Alderborn provides the teachings to obviate the method being claimed. As explained the use of the similar formulation of the same drugs to the same patient groups would lead to one or both the effects the method is indicated to provide.
Due to the withdrawal of Holmback as prior art for the Alderborn and Holmback rejection, new art is included to teach claims 42-43, 50, 52 and 53.
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 39-41, 47-49, 51, 55-57, and 60-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26 and 27 in view of claims 1-25 of U.S. Patent No. 10561617 in view of Alderborn US 20170360715.
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘617 claims a materially similar formulation for treatment of subjects with obesity.
‘617 claims do not provide for other orlistat and acarbose amounts of the claims, micronized form of orlistat and microcrystalline cellulose.
Alderborn teaches surfactant to prevent agglomerates or clusters and includes polysorbates like polysorbate 80 (paragraph 300). Alderborn teaches 0.5 to 30% w/w of surfactant in G2 and includes polysorbate 80 (paragraphs 160-161). Alderborn teaches hydroxypropylmethylcellulose as a supplement to hydrophobic polymer and provides for concentrations of 10% to 50% w/w (paragraphs 157-158). Alderborn teaches that G2 is designed for delayed release but then it becomes relatively rapid (paragraph 159). Alderborn teaches G1 is designed for prolonged release (paragraph 155). Alderborn teaches coatings and enteric polymers as coating agent for G2 (paragraphs 163-166) with about 15% to 50% w/w enteric polymer (paragraph 166). Alderborn teaches G3 with a water swellable polymer with no mention of a core particle (paragraphs 168-169). Alderborn provides for G2A and G2B portions (paragraph 170). Alderborn provides more information about granule or pellet structure in paragraphs 171-175). Alderborn provides “the data analysis of the observed in vitro and simulations of GI processing of the formulation and each of the two API concentration-time profiles (acarbose and orlistat) in the different GI compartments are shown in FIGS. 4 and 5” (paragraph 182), and thus, uses simulations to determine GI processing of the drugs. Alderborn provides for the 3 types of pellets (paragraphs 195-201). Alderborn teaches for G1 and G3 for prolonged release of orlistat and/or acarbose optionally with up to 40 minutes delay (paragraph 203). Alderborn teaches G2 being enteric coated but designed for rapid release of the drugs in the small intestine (paragraph 203). Alderborn teaches orlistat and acarbose (114-129). Alderborn teaches “i) release a part of the total dose of acarbose in the stomach, but in a delayed manner in order to ensure that particles with acarbose will be well mixed with the food components and chyme in the postprandial stomach, ii) release a part of the total dose of acarbose and a part of the total dose of orlistat in duodenum and jejunum; this release should be relatively fast, as both acarbose and orlistat should be available to exert their effect in duodenum and jejunum, and iii) release of a part of the total dose of orlistat in duodenum and jejunum.” (paragraphs 31-34). Alderborn teaches microcrystalline cellulose or sugar alcohol based spheres are used as cores (paragraph 389). These would be inert cores as they don’t have drug. G1 and G2 are noted as having cores while G3 does not (paragraphs 389-392). Paragraphs 31-38 provides for duodenum and jejunum.
One of ordinary skill in the art before the time of filing would have worked within the overlapping concentrations of orlistat and acarbose for each portion (G1, G2A, G2B and G3) based on total composition concentration from Alderborn to provide for total concentrations and concentrations based on part for each of the drugs with a reasonable expectation of success in making the formulation that would provide for modified release of these drugs when administered (MPEP 2144.05) when considering claims of ‘617. One of ordinary skill in the art before the time of filing would also have adjusted the amounts of structural components such as coatings and enteric and other polymers to provide for compositions with the proper release of each drug based on Alderborn’s teachings of overlapping concentrations and the desired to adjust release of each drug from each portion of the formulation. Thus, one would have a reasonable expectation of success in providing the formulations of the claims by teachings of Alderborn with the ability to provide for modified release of the drugs to provide some release in the stomach and other release in the small intestine (duodenum and jejunum are parts of the small intestine). This would allow for a treatment that would be administered to patients to treat conditions such as obesity and type II diabetes to improve the lives of those subjects by managing weight and treating disease. Therefore, one of ordinary skill in the art before the time of filing would have used durations of 2 weeks or more in treating patients with a modified release form of orlistat and acarbose by the teachings of Alderborn. There would be a reasonable expectation of success of utilizing modified release forms of these drugs in time durations of the claims to get results. As Alderborn provides for the treatment formulation of applicant’s claims (modified release form of orlistat and acarbose including 90/30 and 120/40 and administering it to subjects with obesity for treatment, similar results would be obtained.
Claims 39-41, 47-49, 51, 55-57, and 60-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 15 in view of claims 1-13 of U.S. Patent No. 11975105 in view of Alderborn US 20170360715.
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘105 claims a materially similar formulation for treatment of subjects with obesity.
‘105 claims do not provide other orlistat and acarbose amounts of the claims, micronized form of orlistat and microcrystalline cellulose.
Alderborn teaches surfactant to prevent agglomerates or clusters and includes polysorbates like polysorbate 80 (paragraph 300). Alderborn teaches 0.5 to 30% w/w of surfactant in G2 and includes polysorbate 80 (paragraphs 160-161). Alderborn teaches hydroxypropylmethylcellulose as a supplement to hydrophobic polymer and provides for concentrations of 10% to 50% w/w (paragraphs 157-158). Alderborn teaches that G2 is designed for delayed release but then it becomes relatively rapid (paragraph 159). Alderborn teaches G1 is designed for prolonged release (paragraph 155). Alderborn teaches coatings and enteric polymers as coating agent for G2 (paragraphs 163-166) with about 15% to 50% w/w enteric polymer (paragraph 166). Alderborn teaches G3 with a water swellable polymer with no mention of a core particle (paragraphs 168-169). Alderborn provides for G2A and G2B portions (paragraph 170). Alderborn provides more information about granule or pellet structure in paragraphs 171-175). Alderborn provides “the data analysis of the observed in vitro and simulations of GI processing of the formulation and each of the two API concentration-time profiles (acarbose and orlistat) in the different GI compartments are shown in FIGS. 4 and 5” (paragraph 182), and thus, uses simulations to determine GI processing of the drugs. Alderborn provides for the 3 types of pellets (paragraphs 195-201). Alderborn teaches for G1 and G3 for prolonged release of orlistat and/or acarbose optionally with up to 40 minutes delay (paragraph 203). Alderborn teaches G2 being enteric coated but designed for rapid release of the drugs in the small intestine (paragraph 203). Alderborn teaches orlistat and acarbose (114-129). Alderborn teaches “i) release a part of the total dose of acarbose in the stomach, but in a delayed manner in order to ensure that particles with acarbose will be well mixed with the food components and chyme in the postprandial stomach, ii) release a part of the total dose of acarbose and a part of the total dose of orlistat in duodenum and jejunum; this release should be relatively fast, as both acarbose and orlistat should be available to exert their effect in duodenum and jejunum, and iii) release of a part of the total dose of orlistat in duodenum and jejunum.” (paragraphs 31-34). Alderborn teaches microcrystalline cellulose or sugar alcohol based spheres are used as cores (paragraph 389). These would be inert cores as they don’t have drug. G1 and G2 are noted as having cores while G3 does not (paragraphs 389-392). Paragraphs 31-38 provides for duodenum and jejunum.
One of ordinary skill in the art before the time of filing would have worked within the overlapping concentrations of orlistat and acarbose for each portion (G1, G2A, G2B and G3) based on total composition concentration from Alderborn to provide for total concentrations and concentrations based on part for each of the drugs with a reasonable expectation of success in making the formulation that would provide for modified release of these drugs when administered (MPEP 2144.05) when considering claims of ‘617. One of ordinary skill in the art before the time of filing would also have adjusted the amounts of structural components such as coatings and enteric and other polymers to provide for compositions with the proper release of each drug based on Alderborn’s teachings of overlapping concentrations and the desired to adjust release of each drug from each portion of the formulation. Thus, one would have a reasonable expectation of success in providing the formulations of the claims by teachings of Alderborn with the ability to provide for modified release of the drugs to provide some release in the stomach and other release in the small intestine (duodenum and jejunum are parts of the small intestine). This would allow for a treatment that would be administered to patients to treat conditions such as obesity and type II diabetes to improve the lives of those subjects by managing weight and treating disease. Therefore, one of ordinary skill in the art before the time of filing would have used durations of 2 weeks or more in treating patients with a modified release form of orlistat and acarbose by the teachings of Alderborn. There would be a reasonable expectation of success of utilizing modified release forms of these drugs in time durations of the claims to get results. As Alderborn provides for the treatment formulation of applicant’s claims (modified release form of orlistat and acarbose including 90/30 and 120/40 and administering it to subjects with obesity for treatment, similar results would be obtained.
Claims 39-41, 47-49, 51, 55-57, and 60-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 53 and 54 in view of claims 1-17 of US Patent 12629340 in view of Alderborn US 20170360715.
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘545 claims a materially similar formulation for treatment of subjects with obesity.
‘545 claims do not provide for other orlistat and acarbose amounts of the claims, micronized form of orlistat and microcrystalline cellulose.
Alderborn teaches surfactant to prevent agglomerates or clusters and includes polysorbates like polysorbate 80 (paragraph 300). Alderborn teaches 0.5 to 30% w/w of surfactant in G2 and includes polysorbate 80 (paragraphs 160-161). Alderborn teaches hydroxypropylmethylcellulose as a supplement to hydrophobic polymer and provides for concentrations of 10% to 50% w/w (paragraphs 157-158). Alderborn teaches that G2 is designed for delayed release but then it becomes relatively rapid (paragraph 159). Alderborn teaches G1 is designed for prolonged release (paragraph 155). Alderborn teaches coatings and enteric polymers as coating agent for G2 (paragraphs 163-166) with about 15% to 50% w/w enteric polymer (paragraph 166). Alderborn teaches G3 with a water swellable polymer with no mention of a core particle (paragraphs 168-169). Alderborn provides for G2A and G2B portions (paragraph 170). Alderborn provides more information about granule or pellet structure in paragraphs 171-175). Alderborn provides “the data analysis of the observed in vitro and simulations of GI processing of the formulation and each of the two API concentration-time profiles (acarbose and orlistat) in the different GI compartments are shown in FIGS. 4 and 5” (paragraph 182), and thus, uses simulations to determine GI processing of the drugs. Alderborn provides for the 3 types of pellets (paragraphs 195-201). Alderborn teaches for G1 and G3 for prolonged release of orlistat and/or acarbose optionally with up to 40 minutes delay (paragraph 203). Alderborn teaches G2 being enteric coated but designed for rapid release of the drugs in the small intestine (paragraph 203). Alderborn teaches orlistat and acarbose (114-129). Alderborn teaches “i) release a part of the total dose of acarbose in the stomach, but in a delayed manner in order to ensure that particles with acarbose will be well mixed with the food components and chyme in the postprandial stomach, ii) release a part of the total dose of acarbose and a part of the total dose of orlistat in duodenum and jejunum; this release should be relatively fast, as both acarbose and orlistat should be available to exert their effect in duodenum and jejunum, and iii) release of a part of the total dose of orlistat in duodenum and jejunum.” (paragraphs 31-34). Alderborn teaches microcrystalline cellulose or sugar alcohol based spheres are used as cores (paragraph 389). These would be inert cores as they don’t have drug. G1 and G2 are noted as having cores while G3 does not (paragraphs 389-392). Paragraphs 31-38 provides for duodenum and jejunum.
One of ordinary skill in the art before the time of filing would have worked within the overlapping concentrations of orlistat and acarbose for each portion (G1, G2A, G2B and G3) based on total composition concentration from Alderborn to provide for total concentrations and concentrations based on part for each of the drugs with a reasonable expectation of success in making the formulation that would provide for modified release of these drugs when administered (MPEP 2144.05) when considering claims of ‘617. One of ordinary skill in the art before the time of filing would also have adjusted the amounts of structural components such as coatings and enteric and other polymers to provide for compositions with the proper release of each drug based on Alderborn’s teachings of overlapping concentrations and the desired to adjust release of each drug from each portion of the formulation. Thus, one would have a reasonable expectation of success in providing the formulations of the claims by teachings of Alderborn with the ability to provide for modified release of the drugs to provide some release in the stomach and other release in the small intestine (duodenum and jejunum are parts of the small intestine). This would allow for a treatment that would be administered to patients to treat conditions such as obesity and type II diabetes to improve the lives of those subjects by managing weight and treating disease. Therefore, one of ordinary skill in the art before the time of filing would have used durations of 2 weeks or more in treating patients with a modified release form of orlistat and acarbose by the teachings of Alderborn. There would be a reasonable expectation of success of utilizing modified release forms of these drugs in time durations of the claims to get results. As Alderborn provides for the treatment formulation of applicant’s claims (modified release form of orlistat and acarbose including 90/30 and 120/40 and administering it to subjects with obesity for treatment, similar results would be obtained.
Claims 39-43, 47-53, 55-57, and 60-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-33, 38, 41, 43-59 of copending Application No. 18/562,765 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for administering to subjects that are overweight or obese a materially same formulation of orlistat and acarbose. The claims of ‘765 provide for amounts overlapping with 150 mg orlistat (also claim 41 of ‘765).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments over the Rejection under Non-statutory Double Patenting
Applicant argues the rejections be withdrawn per applicant’s amendments, however, the claims still provide for treating conditions in subjects including obesity and overweightness with combinations of orlistat and acarbose. The combination with Alderborn provide for dose amounts, dosing regimens and dose forms that obviate these as existing doses, regimens and dose forms for orlistat and acarbose and treatments therewith. The claims of copending ‘765 substantially overlap with applicant’s claims on their own.
Conclusion
No claims are allowed.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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