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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/28/2025 has been entered.
Status of Claims
Claims 1-5, 13-18, and 20-22 are pending. Claims 13-18 and 20 are withdrawn.
Priority
Instant application 17/863,472, filed 07/13/2022 claims priority as follows:
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Terminal Disclaimer
The terminal disclaimer filed on 12/04/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,197,870 and any patent granted on Application Number 19/075,964 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
The amendment filed 12/28/2025 has been entered. Claim 1 is amended. Claims 6-12 and 19 are canceled. Claims 21-22 are new.
Claims 1-11 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,197,870. In view of the filing of a terminal disclaimer over US 11,197,870, the rejection has been rendered moot.
Claims 1-11 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/075,964. In view of the filing of a terminal disclaimer over any patent granted on Application Number 19/075,964, the rejection has been rendered moot.
Claims 1 and 6-11 were rejected under 35 U.S.C. 103 as being unpatentable over Lefebvre (WO 2017048322 A1). In view of the amendment to claim 1, applicant has overcome the rejection. Therefore, the rejection is withdrawn. However, upon further consideration and search, new grounds of rejection are presented below.
Claims 2-4 were rejected under 35 U.S.C. 103 as being unpatentable over Lefebvre (WO 2017048322 A1) in view of Baharaff et al. (WO 2016199137 A1). In view of the amendment to claim 1, applicant has overcome the rejection. Therefore, the rejection is withdrawn. However, upon further consideration and search, new grounds of rejection are presented below.
Claim 5 was rejected under 35 U.S.C. 103 as being unpatentable over Lefebvre (WO 2017048322 A1) in view of Gilat et al. (US 20120214872 A1). In view of the amendment to claim 1, applicant has overcome the rejection. Therefore, the rejection is withdrawn. However, upon further consideration and search, new grounds of rejection are presented below.
Scope of Search
The elected fibrosis species (pulmonary fibrosis) was searched and applicable art was not identified. Therefore, the scope of the search was extended to another recited fibrosis species (fibrosis in the gastrointestinal system) and applicable prior art was identified. See the new rejections below.
Claim Interpretation
Claim 1 recites a method for treating fibrosis…in a human subject afflicted with “said condition”. The phrase “said condition” is being interpreted as referring back to the fibrosis (such as pulmonary fibrosis) treated by the method.
Claim 3 recites “wherein the meal is a high fat meal or a high calorie meal”. The term “high fat meal” is being interpreted as referring to:
a meal wherein approximately 500 to 600 calories are fat calories
according to the definition provided in the Specification at para. [0123]. The term “high calorie meal” is being interpreted as referring to:
a meal of approximately 800 to 1000 calories
according to the definition provided in the Specification at para. [0124].
Claim 5 recites “wherein the human subject has a diet that is high fat and high calorie”. The phrase “diet that is high fat and high calorie” is being interpreted as referring to:
a diet that contains at least 4000 calories per day, of which approximately 50% comes from fat
according to the definition provided in the Specification at para. [0088].
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.
Claims 1-2 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over HALPERN (WO 2017125929 A1; cited in IDS) in view of RIEDER (Science Translational Medicine, vol. 5, no. 190, June 2013).
The applied reference has a common applicant (GALMED RESEARCH AND DEVELOPMENT LTD) and a common joint inventor (BAHARAFF, Allen) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
HALPERN teaches treatment of pathologies associated with dysbiosis/alteration of intestinal flora balance in a subject in need thereof, comprising administering to the subject a composition comprising a therapeutically effective amount of a fatty acid bile acid conjugate (FABAC), particularly aramchol (see entire document; particularly abstract and claims 1-77). HALPERN specifies that pathologies associated with dysbiosis/alteration of intestinal flora balance include irritable bowel syndrome (IBS), inflammatory bowel disease (IBD, including Crohn's Disease and ulcerative colitis). Further, HALPERN discloses in Example 1 the treatment of inflammatory bowel disease in rats, comprising administering Aramchol as the sole active agent in doses of 30 mg/kg, 50 mg/kg, or 80 mg/kg (page 28, Example 1).
HALPERN does not explicitly teach that the method therein treats “fibrosis in the gastrointestinal system” as recited in present claims 1 and 22.
However, the patient population taught by HALPERN (i.e., patients with inflammatory bowel diseases) is considered to overlap substantially with the patient population having “fibrosis in the gastrointestinal system” required by instant claims 1 and 22. For example, see RIEDER, which teaches that Crohn’s disease (CD) and ulcerative colitis (UC) are lifelong relapsing and remitting inflammatory conditions of the gastrointestinal tract; and that the vast majority of CD patients present with inflammation of the gut at diagnosis. The disease eventually progresses to include complications, such as fistulae or strictures (i.e., intestinal fibrosis), in ~70% of patients (page 1, left col., 1st para.). RIEDER additionally teaches that the gut microbiome plays a critical role in gut fibrogenesis associated with inflammatory bowel diseases (page 1, abstract; page 3, section titled “The microbiota in human gut fibrosis”).
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying at least KSR example rationale (G), it would have been prima facie obvious to administer aramchol to a patient having inflammatory bowel disease with fibrosis in the gastrointestinal system in view of HALPERN’s teaching that aramchol treats alleviates gut microbial dysbiosis and inflammatory bowel disease; and in view of RIEDER’s teaching that the gut microbiota plays a unique role in the development of intestinal fibrosis in IBD patients.
Additionally, please note that while HALPERN does not explicitly teach treating fibrosis in the gastrointestinal system, the patient population having inflammatory bowel disease and the patient population having gastrointestinal fibrosis associated with inflammatory bowel disease is overlapping. In this regard, note MPEP 2144.05, which is drawn to the obviousness of overlapping subject matter and states that “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 the instant case, the subpopulation of patients having GI fibrosis associated with IBD overlaps with or lies inside of the population having IBD taught by HALPERN.
Accordingly, in view of the foregoing, claims 1 and 22 are obvious over HALPERN in view of RIEDER.
With respect to claim 2, HALPERN teaches human doses for aramchol ranging from 300-600 mg (page 20, lines 17-19), which reads on “greater than 300 mg of Aramchol” and overlaps with 400 mg and 600 mg recited by the claim. Accordingly, in view of the foregoing, claim 2 is obvious over HALPERN in view of RIEDER.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over HALPERN in view of RIEDER applied to claims 1-2 and 22 above, further in view of BAHARAFF (WO 2016199137 A1; published 15 December 2016; previously cited).
The teachings of HALPERN in view of RIEDER are disclosed above and at least those teachings are incorporated by reference herein and applied to claims 3-4.
With respect to claim 3, HALPERN in view of RIEDER teaches the method of claim 1, but is silent about administering with water or at the same time as/within 30 minutes of a meal.
BAHARAFF is drawn to low dose compositions of aramchol salts, particularly salts of Aramchol having advantageous physicochemical properties suitable for human administration (see Abstract and page 2, lines 9-23). BAHARAFF discloses that advantageous properties include increased solubility, absorption and exposure, and higher bioavailability; as well as improved flow properties resulting in easier processing into solid dosage formulations such as tablets or capsules (see page 2, lines 15-20). BAHARAFF teaches that advantageous doses of Aramchol include about 300 to 400 mg of the active ingredient (page 3, lines 15-16). Moreover, BAHARAFF teaches embodiments wherein 300 to 400 mg of Aramchol, or 400 mg of Aramchol, is administered daily to a subject (page 7, lines 20-25).
BAHARAFF teaches that Aramchol can be administered in various dosage forms including solutions, and teaches administering Aramchol to male Wistar rats as a solution in phosphate-buffered saline (PBS), which is an aqueous solution (page 35, Example 6). Additionally, BAHARAFF discloses tablet formulations of Aramchol, and tablet formulations are frequently administered with water to help them pass down the esophagus and into the stomach for absorption.
It would have therefore been prima facie obvious to a person having ordinary skill in the art to administer Aramchol with water in view of BAHARAFF.
With respect to claim 4, BAHARAFF teaches daily, weekly, and monthly administration of Aramchol, but does not specify administering Aramchol over the course of at least 40 weeks, 52 weeks, 72 weeks, 96 weeks, 2 years, 3 years, or 4 years.
However, differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. See MPEP 2144.05. In the instant case, the length of the dosing period for Aramchol is considered a result-effective variable that would change depending on a particular patient’s needs. The length of treatment varies for individual patients and a skilled artisan (such as a physician) is capable of determining the length of treatment through routine optimization. Absent a showing of criticality, routine optimization by a skilled artisan is prima facie obvious.
Therefore claims 3-4 are prima facie obvious over HALPERN in view of RIEDER and BAHARAFF.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over HALPERN in view of RIEDER applied to claims 1-2 and 22 above, further in view of GILAT (US 20120214872 A1; published 10 March 2015; previously cited).
The teachings of HALPERN in view of RIEDER are disclosed above and at least those teachings are incorporated by reference herein and applied to claim 5.
With respect to claim 5, HALPERN in view of RIEDER teaches the method of claim 1, but is silent about the human subject having a diet that is high fat and high calorie and/or resistant to lifestyle intervention or is resistant to diet intervention.
GILAT is drawn to bile salt fatty acid conjugates, including Aramchol, and the use of such compounds for dissolving cholesterol gallstones in bile, preventing the occurrence or recurrence of said gallstones, reducing or preventing arteriosclerosis, reducing cholesterol concentration in blood, treating fatty liver, and treating hyperglycemia, insulin resistance, and diabetes (see abstract, para. [0004], and [0006]-[0009].
In particular, GILAT teaches that FABACs (particularly Aramchol) reduce diet induced hypercholesteremia in several animal species even as the animals continue to consume a high cholesterol, high fat diet (see para. 0014).
Applying KSR example rationale (G), it would have been prima facie obvious to include patients consuming a diet that is high calorie and high fat in the method taught by HALPERN in view of RIEDER because, as taught by GILAT, Aramchol has beneficial effects in such patients. A person having ordinary skill could have co-administered Aramchol to patients consuming a high fat diet as taught by GILAT with a reasonable expectation of success. Further, a skilled artisan would have been motivated to apply the teachings of GILAT in view of the advantages taught therein.
GILAT does not provide the same definition for “high fat diet” provided in the instant specification (a meal wherein approximately 500 to 600 calories are fat calories).
However, differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. See MPEP 2144.05. In the instant case, the number of fat calories in the “high fat diet” is considered a result-effective variable. Absent a showing of criticality, optimizing result-effective variables is deemed routine optimization.
Accordingly, claim 5 is prima facie obvious over HALPERN in view of RIEDER and GILAT.
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 1-2 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,166,964 (“US ‘964”) in view of RIEDER (Science Translational Medicine, vol. 5, no. 190, June 2013).
US ‘964 recites (claim 1) a method for treating dysbiosis of the gastrointestinal (GI) tract or a gastrointestinal pathology associated with pathogenic alteration of an intestinal flora balance in a subject in need thereof, the comprising administering a composition comprising a therapeutically effective amount of 3β-arachidylamido-7α, 12α-dihydroxy-5-cholan-24-oic acid (Aramchol), or a pharmaceutically acceptable salt thereof. US ‘964 further recites (claim 7) wherein the disease or disorder is selected from the group consisting of: irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), short bowel syndrome (SBS), celiac disease, small intestinal bacterial overgrowth (SIBO), gastroenteritis, leaky gut syndrome, and gastric lymphoma. US ‘964 further recites (claim 12) wherein said composition comprises the aramchol as a sole active ingredient.
With respect to claims 1 and 22, US ‘964 recites administering aramchol to treat, for example, IBD, but does not recite treating “fibrosis in the gastrointestinal system”. However, the patient population recited in US ‘964 (i.e., patients with inflammatory bowel diseases) is considered to overlap substantially with the patient population having “fibrosis in the gastrointestinal system” required by instant claims 1 and 22.
For example, see RIEDER, which teaches that Crohn’s disease (CD) and ulcerative colitis (UC) are lifelong relapsing and remitting inflammatory conditions of the gastrointestinal tract; and that the vast majority of CD patients present with inflammation of the gut at diagnosis. The disease eventually progresses to include complications, such as fistulae or strictures (i.e., intestinal fibrosis), in ~70% of patients (page 1, left col., 1st para.). RIEDER additionally teaches that the gut microbiome plays a critical role in gut fibrogenesis associated with inflammatory bowel diseases (page 1, abstract; page 3, section titled “The microbiota in human gut fibrosis”).
Applying at least KSR example rationale (G), it would have been prima facie obvious to administer aramchol to a patient having inflammatory bowel disease with fibrosis in the gastrointestinal system in view of the US ‘964 recitation that aramchol treats alleviates gut microbial dysbiosis and inflammatory bowel disease; and in view of RIEDER’s teaching that the gut microbiota plays a unique role in the development of intestinal fibrosis in IBD patients.
Additionally, please note that while US ‘964 does not explicitly recite treating fibrosis in the gastrointestinal system, the patient population having inflammatory bowel disease and the patient population having gastrointestinal fibrosis associated with inflammatory bowel disease is overlapping. In this regard, note MPEP 2144.05, which is drawn to the obviousness of overlapping subject matter and states that “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 the instant case, the subpopulation of patients having GI fibrosis associated with IBD overlaps with or lies inside of the population having IBD recited by US ‘964.
Accordingly, in view of the foregoing, claims 1 and 22 are unpatentable over US ‘964 in view of RIEDER.
With respect to claim 2, US ‘964 recites administering a “therapeutically effective amount” of aramchol but does not explicitly state an amount reading on claim 2. However, support for the phrase “therapeutically effective amount” in US ‘964 includes col. 15, lines 44-48, which states “For example, without limitation, an effective amount for oral administration to human subjects may be a daily dose of 10-800 mg, 30-700 mg, 50-600 mg, 10-400 mg or 300-600 mg.” The amount ranging from 300-600 mg reads on “greater than 300 mg of Aramchol” and overlaps with 400 mg and 600 mg recited by the claim.
Accordingly, in view of the foregoing, claim 2 is unpatentable over US ‘964 in view of RIEDER.
Claims 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,166,964 (“US ‘964”) in view of RIEDER applied to claims 1-2 and 22 above, further in view of BAHARAFF (WO 2016199137 A1; published 15 December 2016; previously cited).
The recitations of US ‘964 and teachings of RIEDER are disclosed above and at least those teachings are incorporated by reference herein and applied to claims 3-4.
With respect to claim 3, US ‘964 in view of RIEDER teaches the method of claim 1, but is silent about administering with water or at the same time as/within 30 minutes of a meal.
BAHARAFF is drawn to low dose compositions of aramchol salts, particularly salts of Aramchol having advantageous physicochemical properties suitable for human administration (see Abstract and page 2, lines 9-23). BAHARAFF discloses that advantageous properties include increased solubility, absorption and exposure, and higher bioavailability; as well as improved flow properties resulting in easier processing into solid dosage formulations such as tablets or capsules (see page 2, lines 15-20). BAHARAFF teaches that advantageous doses of Aramchol include about 300 to 400 mg of the active ingredient (page 3, lines 15-16). Moreover, BAHARAFF teaches embodiments wherein 300 to 400 mg of Aramchol, or 400 mg of Aramchol, is administered daily to a subject (page 7, lines 20-25).
BAHARAFF teaches that Aramchol can be administered in various dosage forms including solutions, and teaches administering Aramchol to male Wistar rats as a solution in phosphate-buffered saline (PBS), which is an aqueous solution (page 35, Example 6). Additionally, BAHARAFF discloses tablet formulations of Aramchol, and tablet formulations are frequently administered with water to help them pass down the esophagus and into the stomach for absorption.
It would have therefore been prima facie obvious to a person having ordinary skill in the art to administer Aramchol with water in view of BAHARAFF.
With respect to claim 4, BAHARAFF teaches daily, weekly, and monthly administration of Aramchol, but does not specify administering Aramchol over the course of at least 40 weeks, 52 weeks, 72 weeks, 96 weeks, 2 years, 3 years, or 4 years.
However, differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. See MPEP 2144.05. In the instant case, the length of the dosing period for Aramchol is considered a result-effective variable that would change depending on a particular patient’s needs. The length of treatment varies for individual patients and a skilled artisan (such as a physician) is capable of determining the length of treatment through routine optimization. Absent a showing of criticality, routine optimization by a skilled artisan is prima facie obvious.
Therefore claims 3-4 are unpatentable over US ‘964 in view of RIEDER and BAHARAFF.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,166,964 (“US ‘964”) in view of RIEDER applied to claims 1-2 and 22 above, further in view of GILAT (US 20120214872 A1; published 10 March 2015; previously cited).
The recitations of US ‘964 and teachings of RIEDER are disclosed above and at least those teachings are incorporated by reference herein and applied to claim 5.
With respect to claim 5, US ‘964 in view of RIEDER teaches the method of claim 1, but is silent about the human subject having a diet that is high fat and high calorie and/or resistant to lifestyle intervention or is resistant to diet intervention.
GILAT is drawn to bile salt fatty acid conjugates, including Aramchol, and the use of such compounds for dissolving cholesterol gallstones in bile, preventing the occurrence or recurrence of said gallstones, reducing or preventing arteriosclerosis, reducing cholesterol concentration in blood, treating fatty liver, and treating hyperglycemia, insulin resistance, and diabetes (see abstract, para. [0004], and [0006]-[0009].
In particular, GILAT teaches that FABACs (particularly Aramchol) reduce diet induced hypercholesteremia in several animal species even as the animals continue to consume a high cholesterol, high fat diet (see para. 0014).
Applying KSR example rationale (G), it would have been prima facie obvious to include patients consuming a diet that is high calorie and high fat in the method taught by US ‘964 in view of RIEDER because, as taught by GILAT, Aramchol has beneficial effects in such patients. A person having ordinary skill could have co-administered Aramchol to patients consuming a high fat diet as taught by GILAT with a reasonable expectation of success. Further, a skilled artisan would have been motivated to apply the teachings of GILAT in view of the advantages taught therein.
GILAT does not provide the same definition for “high fat diet” provided in the instant specification (a meal wherein approximately 500 to 600 calories are fat calories).
However, differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. See MPEP 2144.05. In the instant case, the number of fat calories in the “high fat diet” is considered a result-effective variable. Absent a showing of criticality, optimizing result-effective variables is deemed routine optimization.
Accordingly, claim 5 is unpatentable over US ‘964 in view of RIEDER and GILAT.
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-5 and 22 are rejected. Claim 21 is objected to. Claims 13-18 and 20 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621