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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims do not set forth an active methodological step.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 22-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “the use” is not a process, machine, manufacture, or composition of matter.
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.
Claim(s) 1-11, 15-17, 19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sannino et al. US 10,179,824 B2 (Sannino) and Joyce, Paul, et al. "Biomaterials that regulate fat digestion for the treatment of obesity." Trends in food science & technology 100 (2020): 235-245 (Joyce) in combination.
Claims 1-11, 15-17, 19, and 21 are drawn to a pharmaceutical composition comprising: a lipase inhibitor; and a hydrophilic polymer crosslinked with a crosslinker, wherein the crosslinked hydrophilic polymer has a media uptake ratio (MUR) of at least 20, and an elastic modulus (G') value in the range of 100 Pa to 10,000 Pa, and wherein a weight ratio of the crosslinked hydrophilic polymer to the lipase inhibitor is greater than 10.
Sannino provides crosslinked carboxymethyl cellulose having high elastic modulus coupled with high absorbance capacity when swollen in simulated gastric fluid / water (1 : 8) and simulated intestinal fluids (Abstract). Sannino further provides methods of making the crosslinked carboxymethylcellulose, compositions comprising the crosslinked carboxymethylcellulose and methods of using the crosslinked carboxymethylcellulose, for example, for treating overweight or obesity or for enhancing glycemic control. Sannino teaches that such crosslinked carboxymethylcelluloses include citric acid crosslinked carboxymethylcelluloses having a high elastic modulus and a high media uptake ratio when determined as set forth therein (column 4, lines 46-57). Coupling high sorption capacity to high elastic modulus is advantageous for a number of applications of these materials in therapies directed to the gastrointestinal tract, such as treatment of obesity and glycemic control.
Sannino teaches that suitable crosslinking agents include polycarboxylic acids, such as oxalic acid or citric acid, divinylsulphone (DVS), aldehydes, such as acetaldehyde, formaldehyde and glutaraldehyde, diglycidyl ether, diisocyanates, dimethyl urea, epichlorohydrin, oxalic acid, phosphoryl chloride, trimetaphosphate, trimethylomelamine, and polyacrolein (column 5, lines 46-63). Sannino teaches that, preferably, the high viscosity carboxymethylcellulose is crosslinked with citric acid. Sannino teaches that the citric acid crosslinked carboxymethylcelluloses preferably have a media uptake ratio in distilled water of at least about 20, about 30, about 40, about 50, about 60, about 70, about 80, about 90 or about 100 (column 13, line 56 to column 14, line 4). Sannino teaches that in certain embodiments, the crosslinked carboxymethylcellulose has a G′ when swollen in SGF/water (1:8) of at least about 1500 Pa to about 3500 Pa (column 15, lines 18-27). In certain embodiments, the crosslinked carboxymethylcellulose has an MUR of about 50 to about 110, about 55 to about 100, about 60 to about 95, about 60 to about 90, or about 60 to about 85. (column 15, lines 28-33).
Sannino teaches that the subject can be, for example, a human subject for whom weight loss will bring health benefits, such as human who is overweight, with a body mass index of 25 to 29.9, or obese (column 16 line 60 to column 17, line 26), with a body mass index of 30 or higher. The subject can also be a human of normal weight, with a body mass index of 18.5 to 24.9, but at risk of unhealthy weight increase. A human subject can also have one or more other conditions or comorbidities, such as prediabetes, diabetes or heart disease, in addition to being overweight or obese. For example, the subject can have one or more of the following: hypertension, such as blood pressure of 140/90 mm Hg or higher; high LDL cholesterol; low HDL cholesterol, for example less than 35 mg/dL; high triglycerides, for example higher than 250 mg/dL; high fasting blood glucose, for example, ≥100 mg/dL; a family history of premature heart disease; physical inactivity; and cigarette smoking.
Sannino teaches that the citric acid crosslinked carboxymethylcellulose can be formulated for oral administration in a capsule, sachet or tablet or suspension (column 17, line 65 to column 18, line 1). Sannino teaches that the tablet or capsule can further include one or more additional agents, such as a pH modifying agent, and/or a pharmaceutically acceptable carrier or excipient (column 19, lines 8-17). Sannino teaches in another embodiment that the pharmaceutical composition comprises the citric acid crosslinked carboxymethylcellulose in combination with another active agent (column 19, lines 28-30).
Sannino explicitly teaches Hydrogel A as prepared in Example 3 and Hydrogel B as prepared in Example 6. Hydrogel A or Hydrogel B is embraced by an instant hydrophilic polymer crosslinked with a crosslinker, wherein the crosslinked hydrophilic polymer has a media uptake ratio (MUR) of at least 20 and an elastic modulus (G') value in the range of 100 Pa to 10,000 Pa, wherein the crosslinked hydrophilic polymer is in the form of a powder having a particle size in the range of 0.01 mm to 5 mm. Sannino teaches that the crosslinked carboxymethylcellulose may be useful for treating overweight or obesity or for enhancing glycemic control. Sannino teaches that the subject can be, for example, a human subject for whom weight loss will bring health benefits, such as human who is overweight or obese. Sannino teaches that the crosslinked carboxymethylcellulose may be formulated into a capsule. Sannino further teaches that the pharmaceutical composition comprises the citric acid crosslinked carboxymethylcellulose in combination with another active agent.
Sannino differs from the instantly claimed invention in that Sannino does not explicitly teach a pharmaceutical composition comprising a lipase inhibitor. However, this deficiency would have been obvious in view of the teachings of Joyce.
In the instant case, the references may be combined to show obviousness because Sannino and Joyce are each drawn to the treatment of obesity, pre-diabetes and/or diabetes. They are from the same field of endeavor, and/or are reasonably pertinent to a pharmaceutical composition comprising a lipase inhibitor and a crosslinked hydrophilic polymer.
Joyce teaches that bioactive materials that regulate the fat digestion and absorption process have revealed promising preclinical and clinical findings with respects to modulating calorie intake and thus, weight gain (Abstract). Joyce teaches that orlistat is the only FDA approved anti-obesity therapy with a localized mechanism of action within the gastrointestinal tract. Joyce teaches that a wide range of natural and synthetic small molecule therapeutics have been identified as potential lipase inhibitors, which have been reviewed extensively in the past (page 237). However, the only lipase inhibitor currently globally marketed and licensed is orlistat, a reversible inhibitor that covalently attaches to the serine residue of both gastric and pancreatic lipases’ active site. Orlistat is a potent and selective lipase inhibitor with a dose-dependent pharmacological activity, whereby at therapeutic doses (typically 120 mg), approximately 30% of ingested fat remains undigested by lipase and therefore is excreted.
In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983).
In the absence of unexpected results, it would have been obvious to combine the composition of Sannino with orlistat. Use of materials in combination, each of which is known to function for intended purpose, is generally held to be prima facie obvious as the idea of combining them flows logically from their having been individually taught in the prior art. In the instant case, Sannino teaches a pharmaceutical composition comprising a crosslinked hydrophilic polymer (e.g., Hydrogel A or B) useful for the treatment of obesity, pre-diabetes, and/or diabetes. Joyce teaches the use of orlistat, a lipase inhibitor, to treat obesity. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Thus, claims that require no more than the combination of two anti-obesity compositions together in order to treat obesity, pre-diabetes, and/or diabetes in a patient set forth prima facie obvious subject matter.
Regarding the instantly claimed weight ratio(s) of the crosslinked hydrophilic polymer to the lipase inhibitor, generally differences in weight ratio will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such weight ratio is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
All of the instant limitations are taught by the combination of Sannino and Joyce. A person of ordinary skill in the art would have had a reason to combine the teachings of Sannino and Joyce. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Sannino and Joyce. Thus, claims 1-11, 15-17, 19, and 21 would have been obvious based on the preponderance of the evidence.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sannino et al. US 10,179,824 B2 (Sannino) and Joyce, Paul, et al. "Biomaterials that regulate fat digestion for the treatment of obesity." Trends in food science & technology 100 (2020): 235-245 (Joyce) in combination as applied to claims 1-11, 15-17, 19, and 21 above, and further in view of Hamada, Yoji, et al. "The alpha-glucosidase inhibitor miglitol affects bile acid metabolism and ameliorates obesity and insulin resistance in diabetic mice." Metabolism 62.5 (2013): 734-742 (Hamada).
The combination of Sannino and Joyce differs from the instantly claimed invention in that said combination does not explicitly teach a pharmaceutical composition further comprising an amylase inhibitor or a glucosidase inhibitor; however, this deficiency would have been obvious in view of the teachings of Hamada.
In the instant case, the references may be combined to show obviousness because Sannino, Joyce, and Hamada are each drawn to the treatment of obesity, pre-diabetes and/or diabetes. They are from the same field of endeavor, and/or are reasonably pertinent to a pharmaceutical composition comprising a lipase inhibitor and a crosslinked hydrophilic polymer.
Hamada teaches that alpha-glucosidase inhibitors (α-GIs) show various anti-diabetic or anti-obesity effects in addition to the suppression of postprandial hyperglycemia (Abstract). Based on recent observations that bile acids (BAs) are involved in glucose and energy homeostasis, Hamada examined the ability of miglitol, an α-GI, to influence BA metabolism and ameliorate insulin resistance and obesity. Hamada teaches that miglitol significantly increased BAs in both feces and portal blood while the hepatic BA level was reduced. The drug clearly enhanced active GLP-1 secretion into the portal blood and there was a good positive correlation between the active GLP-1 levels and portal blood BA concentrations. D2 expression in brown adipose tended to increase in association with the elevated BA concentrations. Miglitol ameliorated body weight gain, glucose intolerance, insulin resistance and inflammatory adipokine upregulation that were induced by a high-fat diet.
In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983).
In the absence of unexpected results, it would have been obvious to combine the composition of Sannino with orlistat and miglitol. Use of materials in combination, each of which is known to function for intended purpose, is generally held to be prima facie obvious as the idea of combining them flows logically from their having been individually taught in the prior art. In the instant case, Sannino teaches a pharmaceutical composition comprising a crosslinked hydrophilic polymer (e.g., Hydrogel A or B) useful for the treatment of obesity, pre-diabetes, and/or diabetes. Joyce teaches the use of orlistat, a lipase inhibitor, to treat obesity. Hamada teaches miglitol ameliorated body weight gain, glucose intolerance, insulin resistance and inflammatory adipokine upregulation that were induced by a high-fat diet. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Thus, claims that require no more than the combination of two or more anti-obesity compositions together in order to treat obesity, pre-diabetes, and/or diabetes in a patient set forth prima facie obvious subject matter.
Regarding the instantly claimed weight ratio(s) of the crosslinked hydrophilic polymer to the lipase inhibitor, generally differences in weight ratio will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such weight ratio is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
All of the instant limitations are taught by the combination of Sannino, Joyce, and Hamada. A person of ordinary skill in the art would have had a reason to combine the teachings of Sannino, Joyce, and Hamada. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Sannino, Joyce, and Hamada. Thus, claims 12-14 would have been obvious based on the preponderance of the evidence.
Claim(s) 18, 20, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sannino et al. US 10,179,824 B2 (Sannino) and Joyce, Paul, et al. "Biomaterials that regulate fat digestion for the treatment of obesity." Trends in food science & technology 100 (2020): 235-245 (Joyce) in combination as applied to claims 1-11, 15-17, 19, and 21 above.
Sannino differs from the instantly claimed invention in that Sannino does not explicitly teach a method comprising forming a composition comprising a lipase inhibitor and a crosslinked hydrophilic polymer; however, this deficiency would have been obvious in view of the teachings of Joyce for the reasons set forth above.
All of the instant limitations are taught by the combination of Sannino and Joyce. A person of ordinary skill in the art would have had a reason to combine the teachings of Sannino and Joyce. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Sannino and Joyce. Thus, claims 18, 20, and 22-24 would have been obvious based on the preponderance of the evidence.
Conclusion
Claims 1-24 are pending. Claims 1-24 are rejected. No claims are allowed.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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, Renee Claytor can be reached at (571) 272-8394. 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.
/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/
Prosecution Insights