Ex Parte Salatinjants et al

Patent Trial and Appeal Board

Apr 28, 2016

14464519 (P.T.A.B. Apr. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/464,519 08/20/2014 41576 7590 04/28/2016 JOSEPH E. MUETH JOSEPH E. MUETH LAW CORPORATION 800 E. COLORADO BLVD. STE 840 PASADENA, CA 91101-2173 FIRST NAMED INVENTOR Aida Salatinjants UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. 185-102 cc 9536 EXAMINER THOMAS, TIMOTHY P ART UNIT PAPER NUMBER 1628 MAILDATE DELIVERY MODE 04/28/2016 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AIDA SALATINJANTS and ROBERT SALATINJANTS 1 Appeal 2016-002237 Application 14/464,519 Technology Center 1600 Before DONALD E. ADAMS, ULRIKE W. JENKS, and CHRISTOPHER G. P AULRAJ, Administrative Patent Judges. JENKS, Administrative Patent Judge. uECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims a prolongation composition to prolong the residence time of drugs in the circulating plasma of mammals. The Examiner rejects the claims on the grounds of non-statutory obviousness-type double patenting and obviousness. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. 1 According to Appellants, the Real Parties in Interest are Aida Salatinjants, M.D. and Robert Salatinjants. (App. Br. 3.) Appeal2016-002237 Application 14/464,519 STATEMENT OF THE CASE The Specification provides a composition that "increases the half-life, efficacy and pharmacological activity of various medications ... which thereby provides more uniform plasma levels and increases the effect of active drugs. As a result, the dosing-requirement of the active drug is greatly reduced." (Spec. 2.) Claims 1 is on appeal and reads as follows: 1. A prolongation composition comprising: Pectin Potassium bitartrate Tannie acid L-Tyrosine Riboflavin Hexanoic Acid (Caproic acid) Ethyl Alcohol 0.94g 0.48g 0.8g 0.21g 2 ml 10% solution of 15% Ethyl Alcohol 0.06 ml 15% Ethyl Alcohol to make 100 ml. Appellants seek review of the following rejections: I. Claim 1 under 35 U.S.C. § 103(a) over Salatinjants '952, 2 in view ofLerner, 3 Dunn,4 Zanchi, 5 and Okino; 6 and 2 Salatinjants, US 4,708,952 issued Nov. 24, 1987 ("Salatinjants '952"). 3 Lerner et al., WO 99/04764, published Feb. 4, 1999 ("Lerner"). 4 Dunn, US 5,888,533, issued Mar. 30, 1999. 5 Zanchi et al., Colloidal Dispersions of Tannins in Water-Ethanol Solutions, 23 Langmuir 9949--9959 (2007)("Zanchi"). 6 Okino et al., In situ hydrogelation of photocurable gelatin and drug release, 59 J. Biomed. Mater. Res 233-245 (2001 )("Okino"). 2 Appeal2016-002237 Application 14/464,519 II. Claim 1 on the ground of non-statutory obviousness-type double patenting over the claims in Salatinjants '173, 7 in view of Lerner, Dunn, Zanchi, and Okino. I. The Issue: Obviousness over Salatinjants '952 The Examiner's position is that Salatinjants '952 "teaches a composition adapted to prolong the residence time of ... drugs in the circulating plasma of mammals." (Final Act. 6.) The Examiner acknowledges that Salatinjants '952 "uses 0.08 g tannic acid dissolved in either 64 ml or 316 ml water, whereas the instant claims require 0.8 g tannic acid (10 times the amount) in 100 ml of 15% ethanol. This reference does not teach the riboflavin in a 15% ethyl alcohol solution, or the 15% ethanol solvent of the solution, as required in instant claim 1." (Id. at 8.) The Examiner finds that Lerner disclosed the production of sustained- release and controlled-release compositions. These compositions include cellulosic polymers, the "preferred materials include pectin ... the composition is made by dissolving the polymer in a solvent, adding tannic acid, then allowing a precipitate to form. . . . [P]referred solvents for polymer and tannic acid include water, ethanol and mixtures of water and ethanol." (Id. at 9.) Lerner also disclosed liquid formulations of ethanol and tannic acid ranging in concentration from "3% ethanol with 47.5% water and 20% tannic acid ... [additionally] higher amounts of ethanol, such as about 50% ethanol/water ... and amounts over 50% ethanol in water are used with 10% tannic acid." (Id.) 7 Salatinjants, US 4,716,173, issued Dec. 29, 1987 ("Salatinjants '173"). 3 Appeal2016-002237 Application 14/464,519 The Examiner concludes that [I]t would have been obvious to one of ordinary skill in the art at the time of the instant invention to modify Drug No. 2 solution taught by Salatinjants ['952], by using 10 [t]imes the amount of tannic acid from that of the Salatinjants prolongation composition, i.e., 0.8g [tannic acid] /100 ml, which would be achieved by dissolving the components in 15% ethanol, instead of water. It would have further been obvious to optimize the solution amount to 100 ml volume, giving the prolongation composition of claim 1. The motivation to increase the ratio of tannic acid by a factor of 10 would have been an expectation that by increasing the amount of tannic acid to this level a solution/metastable colloid dispersion would have been formed, which could be orally ingested, and would precipitate when introduced into the aqueous stomach and intestine environment, providing longer, controlled release of quinine or another drug, over that taught by Salantinjants ['952]. The use of the precise amounts of 0.8g/100 ml and 15% ethanol would have been the result of routine optimization within the general parameters discussed in these prior art references. (Id. at 15.) The issues are: (1) Does the evidence of record support the Examiner's conclusion that the combination of references teaches the inclusion of ethanol in a solution containing tannic acid and pectin; (2) does the evidence support increasing the tannic acid concentration; and (3) if the evidence supports a conclusion of obviousness have Appellants provided sufficient rebuttal evidence to overcome the obviousness rejection? Findings of Fact We adopt the Examiner's findings and analysis concerning the scope and content of the prior art. The following facts are repeated for reference convemence. 4 Appeal2016-002237 Application 14/464,519 FF 1. Salatinjants '952 teaches compositions to prolong the residence time of drugs, specifically sulfa and cinchona alkaloid drugs (Salatinjants '952, col. 1, 11. 57-59; Final Act. 6). FF2. The prolongation compositions of Salatinjants '952 are as follows: The composition of Drug No. 1 was: Hexanoic Acid: 0.06 grams Tannie Acid: 0.08 grams Pectin: 0.94 grams Riboflavin 10%: 2.00 grams Water to make 6 7 ml. The composition of Drug No. 2 was: Hexanoic Acid: 0.06 grams Tannie Acid: 0.08 grams Pectin: 0.94 grams Riboflavin 10%: 2.00 grams Potassium Hydrogen Tartrate: 0.48 grams L-Tyrosine: 0.21 grams Water to make 3 16 ml. (Salatinjants '952, col. 2, 11. 35--48; Final Act.7-8.) FF3. Additionally, Salatinjants '952 teaches a third prolongation composition, Drug. No. 3, containing: Potassium Hydroxide Tartrate: 0.48 g Tannie Acid: 0.08 grams Pectin: 0.94 grams L-Tyrosine: 0.21 grams Water to make 3 16 ml. (Salatinjants '952, col. 3, 11. 30-35.) Salatinjants teaches that the level of quinine drug in the blood after 24 hours using Drug 3 is the same as that when using Drug 2 which was found to be effective at prolonging residence time in mammals. (See Salatinjants '952, col. 3, 11. 25--40.) Administering the composition either intramuscularly or via the oral 5 Appeal2016-002237 Application 14/464,519 rout provides the same effect. (See Salatinjants '952, col. 3, 11. 38- 40.) FF4. Lerner teaches controlled release or sustained release compositions including liquid compositions that comprise a polymer and tannic acid or tannin. (Lerner Abstract.) Lerner teaches that "[t]he polymer may or may not form a precipitate when mixed with the tannic acid or tannin." (Lerner 23, 11. 3--4; see also Final Act. 9.) FF5. Lerner teaches: For controlling the release of a pharmaceutical or other agent from the solid compositions disclosed herein, the agent can be entrapped in the polymer:tannic acid matrix. The extent of such entrapment, and thereby the extent of sustained release, is controlled by the choice of polymer. The solvents used to prepare the polymer-tannic complex can be useful as release-adjusting agents, since they can strongly affect the release rate. (Lerner 22, 11. 11-17.) FF6. Lerner teaches that the preferred solvents for the polymer, including cellulosic polymer and tannic acid or tannin, include "but are not limited to, water, ethanol, and mixtures of water and ethanol, isopropanol, mixtures of water and isopropanol, n-propanol, and mixtures of water and n-propanol." (Lerner 23, 11. 22-27; see also 24, 11. 2-9.) FF7. Lerner teaches that the "preferred polymers comprising the microcapsules microspheres, nanocapsules or nanospheres ... [include] pectin." (Lerner 19, 11. 15-21; Final Act. 9 ("the polymer includes cellulosic polymers ... ; preferred materials include pectin.").) 6 Appeal2016-002237 Application 14/464,519 FF8. The Examiner finds "that pectin is known as a cellulosic polymer with gelation properties, i.e., within the general class of polymers discussed by Lerner, and is specifically mentioned as a suitable polymer material." (Final Act. 10.) FF9. Lerner teaches liquid formulations that contain a range of gelatin, ethanol, and tannic acid concentration. Gelatin is exemplified in Lerner's formulations at concentrations of 10% (see Lerner, 35, 38, 41 ), 27 .5% (see id. at 48), 28% (see id. at 46). Tannie acid is exemplified at a concentration 10% (see id. at 35, 38, 41), 20% (see id. at 46), 20.1 % (see id. at 48). Ethanol is exemplified at a concentration of 3% (see id. at 46), 3.2 % (see id. at 48), 39% (see id. at 41), 39.5% (see Lerner 38), 40% (see id. at 35), 57% (see id. at 41), and 60% (see id. at 38). Principle of Law "Obviousness does not require absolute predictability of success." In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). Furthermore, the Supreme Court pointed out in KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), that solving a problem by selecting from a limited number of known options is obvious: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that 7 Appeal2016-002237 Application 14/464,519 instance the fact that a combination was obvious to try might show that it was obvious under § 103. Id. at 421. Analysis "[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification." In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). Thus, we begin with claim interpretation because before a claim is properly interpreted, its scope cannot be compared to the prior art. We look to the Specification to determine the meaning of "prolongation" as recited in the claim. The Specification does not provide a specific definition for the term "prolongation" but explains that the composition "increases the half-life, efficacy and pharmacological activity of various medications ... , which thereby provides more uniform plasma levels and increases the effect of active drugs." (Spec. 2.) Example 3 of the Specification shows the use of the prolongation solution with Decoquinate, an anti-protozoa! agent. The administered drug with the prolongation solution shows an even plasma level concentration over an eight hour time, whereas the drug without the use of the prolongation solution shows an initial spike in the concentration of the drug in plasma and then the "level dropped between 1 and 8 hours by 50% in plasma and by almost as much in liver." (Spec. 6.) The Examiner explains that"[ e ]xtending the release of a given drug results in more drug present in the blood plasma at some time point in the future; i.e., prolongation" (Ans. 23-24). This interpretation is consistent with the description of prolongation in the Specification and, therefore, is reasonably interpreted by the ordinary artisan to describe a sustained-release or controlled-release profile. 8 Appeal2016-002237 Application 14/464,519 Next, we consider whether the recitation of "prolongation" in the preamble provides any structural information with respect to the composition. 8 When read in light of the Specification, we find that the word "prolongation" merely describes the function of the composition once the composition is administered to a subject. As such, "the preamble offers no distinct definition of any of the claimed invention's limitations, but rather merely states, for example, the purpose or intended use of the invention, then the preamble is of no significance to claim construction because it cannot be said to constitute or explain a claim limitation." Pitney Bowes Inc. v. Hewlett Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). Although, we understand that prolongation as used in the Specification is directed to describing the intended use of the composition, which in this case is to provide a sustained release profile, because this limitation occurs in the preamble and does not define a structural element it is interpreted as an intended use limitation. Upon consideration of the evidence on this record, and each of Appellants contentions, we find that the preponderance of evidence of record supports the Examiner's finding that claim 1 is unpatentable. We agree with the Examiner's fact finding and responses to Appellants' arguments as set forth in the Final Action and Answer. 8 Additionally, we note that the claim uses the transitional phrase "comprising" when reciting the specific elements, meaning that the composition can contain additional ingredients and still fall within the scope of the claim. See Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). 9 Appeal2016-002237 Application 14/464,519 Appellants contend that "[t]he citation of Salatinjants '952 is evidence of resort to hindsight. Salatinjants '952 does not fit with any of the secondary citations." (App. Br. 11.) We are not persuaded by Appellants' contention and agree with the Examiner (see Ans. 4--5). Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392, 1395, (CCPA 1971). Here, the Examiner looks to Salatinjants '952, Lerner, as well as Dunn for insights in formulating pharmaceutical compositions to achieve desirable drug release profiles when administering the compositions to a patient. Salatinjants '952 teaches a prolongation solution to allow an active agent to remain at higher concentration levels in the plasma over a longer period of time (FF1-FF3). Lerner is similarly interested in "maintain[ing] a desired level of medicament" (Lerner 1) in the subject and explains that the "[r]elease of the desired agent can be adjusted to a predetermined period of time and for a predetermined concentration" (id.). Lerner achieves creating the desired drug release profile by creating compositions that combine tannic acid with polymers in the presence of water, ethanol and mixtures thereof (see FF4--FF6, FF8). The ordinary artisan in the field of pharmaceutical formulations, therefore, would have been aware of technology that uses tannic acid to extend the release of the drug over time in order to achieve a sustained-release of controlled-release drug profile. We find no error with the Examiner's reliance on the combination of references. 10 Appeal2016-002237 Application 14/464,519 Appellants contend that "[t]he compositions of Lerner. .. , Dunn and Okino ... , are technologically unrelated to the prolongation of the presence of a drug once circulating in vivo in blood plasma." (App. Br. 14.) Appellants contend that "[a] tannin and pectin containing combination is not suggested by Lerner." (App. Br. 18, see also 16-23.) We agree with the Examiner's position that Appellants err in attacking the references individually, as the rejection is based on a combination of references (Ans. 3). See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The references cannot be read in isolation, but for what they teach in combination with the prior art as a whole. See id. Here, Salatinjants '952, Lerner, as well as Dunn are directed to formulating pharmaceutical compositions for the purpose of achieving sustained-release or controlled-release drug profiles. Lerner explains that the release of a pharmaceutical agent depends on the entrapment of the drug "in the polymer:tannic acid matrix. The extent of such entrapment, and thereby the extent of sustained release, is controlled by the choice of polymer" (FF5). Although we recognize that Lerner exemplifies the production of solid compositions, the reference also discloses and claims liquid compositions (FF4, see also Lerner claims). We find no error in the Examiner's reliance on Lerner's liquid compositions in formulating the rejection. Appellants contend that the combination of references lacks "motivation to switch to ethanol and increase tannic acid by tenfold." (App. Br. 25; see also Reply Br. 5 ("amount of tannic acid is increased by ten times and 15% ethyl alcohol is the solvent in lieu of water").) Appellants contend that tannic acid is soluble in water hence "that the use of 0.8 grams 11 Appeal2016-002237 Application 14/464,519 of tannic acid did not provide reason to 'shift' to ethyl alcohol." (Reply Br. 7.) Whether or not tannic acid alone is highly soluble as argued by Appellants (Reply Br. 6) is irrelevant to the question whether of tannic acid in conjunction with the other ingredients remains highly soluble. The Examiner recognizes that "tannins are water-soluble phenolic compounds that can interact with proteins and precipitate them out" (Final. Act. 10, citing Zanchi 9949, see also Final Act. 11-15). Thus, tannic acid in the presence of proteins does not appear to be as soluble as tannic acid alone since it can precipitate proteins out of solution. Based on the teachings of Salatinjants '952 the ordinary artisan would understand that compositions that minimally contain a combination of potassium hydrogen tartrate, tannic acid, pectin, and L-tyrosine are functional for increasing plasma concentration of a drug (FF1-FF3). As recognized by Appellants (see Reply Br. 10) Salatinjants '952 shows that compositions containing tannic acid and pectin without L-tyrosine are not able to prolong the plasma concentration of a drug. As pointed out by the Examiner, the issue is not whether to include tannic acid and/or pectin into a prolongation solution, as those components are already included in the composition taught by Salatinjants '952. (See Ans. 9-10.) The question is whether it would have been obvious to modify the Salatinjants '952 composition to arrive at a IO-fold increase in tannic acid in a 15% ethanol solution based on the teachings of Salatinjants '952, Lerner, and Dunn. The Examiner concludes that the ordinary artisan would recognize tannic acid as a controlled release excipient, which provides the reason to focus on tannic acid in the Drug No. 2 formulation of Salatinjants, in order to increase its 12 Appeal2016-002237 Application 14/464,519 concentration. Increasing the amount of tannic acid would have been expected to hold (adsorb, complex or bind) a larger quantity of a given drug in the body where administered, leading to an expectation of extending release of the drug (and increasing the amount of the drug in the blood plasma at a time point such as 24 hours). Increasing the concentration of a controlled release excipient as an engineering variable to extend the release time of a drug. (Ans. 9--10.) We find no error in the Examiner's reasoning based on the teaching of the combined references. Appellants contend that "[t]he Examiner's rejection is based on picking and choosing from multiple citations." (App. Br. 15.) We are not persuaded. We note that instant rejection is on the grounds of obviousness, and Arkley explains that "picking and choosing may be entirely proper in the making of a 103, obviousness rejection." In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Here, the Examiner relies on the combination of Salatinjants '952, Lerner, Dunn, as well as other references to arrive at a pharmaceutical formulation that achieves a sustained drug release profile when administering the composition to patients. As recognized by the Examiner, Salatinjants '952 does not disclose a composition that contains the recited concentration of tannic acid or ethanol (see Final Act. 9; see also FF1-FF3). "[E]ach of Lerner, Dunn, Zanchi are reasonably pertinent to tannic acid containing formulations that promulgate (or closely related controlled release) drug formulations and pertinent to adding around 15% ethanol to achieve a concentration increase of tannic acid by 10-fole to a level of 0.8 g/100 ml solution" (Ans. 17). Dunn supports the teaching of Lerner, that tannic acid, i.e., the material used in Salatinjants['952] Drug No. 2 formulation, is a release controlling component (controlling and delaying the 13 Appeal2016-002237 Application 14/464,519 release of a drug). Extending the release of a given drug results in more drug present in the blood plasma at some time point in the future; i.e., prolongation. Thus, Dunn is directly relevant to drug prolongation of a composition that contains tannic acid. Dunn is relevant for explaining a function of tannic acid, which is not recognized by Salatinjants (Ans. 23-24.) "Lerner unambiguously establishes this component provides controlled release of a wide range of pharmaceutical agents (controlled release, which increases drug at a later time point, such as 24 hours, also results in prolongation). Lerner uses ethanolic solutions bracketing the instant claimed 15%, rendering them obvious" (Ans. 33). "Lerner does not teach ethanol as effecting controlled release; it is tannic acid that is taught to be a controlled release material. Ethanol is used as a solvent to dissolve tannic acid and other components, at amounts both below and above 15% ethanol, each in exemplary formulations. Thus, 15% is obvious via routine optimization within the prior art range" (Ans. 36). We agree with the Examiner's position that tannic acid is reasonably disclosed in the references as being a controlled release material while ethanol is used to dissolve the polymer tannic acid mixtures (see FF1-FF9). We find no error in the Examiner's prima facie case that relies on multiple reference for a rejection under 35 U.S.C. § 103(a). We consider Appellants' Declarations. The Examiner explains that the Salatinjants Declaration9 (Salatinjants Dec- I) is insufficient to overcome the prima facie case of obviousness because "1) the results are considered expected, and evidence of obviousness; 2) however, even if they are 9 Declaration under 37 C.F.R. § 1.132 by Dr. Aida Salatinjants, signed September 24, 2014. 14 Appeal2016-002237 Application I 4/464,5 I 9 considered unexpected, they are not commensurate in scope with the claims and 3) they do not show superior results over all ... compounds of the prior art, i.e. over the closest combination of quinine+ Drug No. 2, taught by Salatinjants." (Final Act. 20.) We agree with the Examiner's position that Appellants have not shown any criticality or unexpected results with respect to the I 5% ethanol or 8% tannic acid in the recited prolongation composition as claimed. Indeed, the Specification in reference to the prolongation compositions as exemplified in Examples I and 2 states that these "figures are approximations on the order of 0± I 0%." (Spec. 4 (emphasis added), see also Summary of Invention.) In other words, the Specification acknowledges that there is no criticality in the concentrations of the claimed ingredients. The Examiner further explains that the Supplemental Salatinjants Declaration 10 (Salatinjants Dec-2) is also insufficient to overcome the prima facie case of obviousness (see Final Act. 2I-22). The Examiner explains: This declaration reports the ingredients in Exhibit I, which lack L-Tyrosine and potassium bitartrate and tannic acid is present at 0.8 g. Comparison is made to Paragraph 7 of the ... [Salatinjants Dec-I. The Salatinjants Dec-2] indicates that primaquine was not detected at 24 hours, whereas the formulation containing L-Tyrosine and potassium bitratrate in Item 7 of the ... [Salatinjants Dec- I] showed primaquine was still present (at variable amounts ranging from O.OI6 to 0.483 µg/ml) at 24 hours. While this result is interesting, and suggests a role for L-Tyrosine and/or potassium bitartrate on primaquine prolongation (if reproducible and statistically significant), it does not represent a comparison to the closest prior art composition. 10 Declaration under 37 C.F.R. § 1. I32 by Dr. Aida Salatinjants, signed February I2, 20I5. I5 Appeal2016-002237 Application 14/464,519 (Final Act. 21-21.) In other words, the results described in either the Salatinjants Dec-I or the Salatinjants Dec-2 do not provide sufficient evidence to establish that the prolongation effect is due to the concentration of tannic acid, ethanol, or a combination of both. Instead, as the Examiner pointed out, these results suggest that the prolongation effect in these experiments is due to the presence of L-Tyrosine and potassium bitartrate both of which are already taught in the prior art. We conclude that the evidence cited by the Examiner supports a prima facie case of obviousness with respect to claim 1, and Appellants have not provided sufficient rebuttal evidence or evidence of secondary considerations that outweighs the evidence supporting the prima facie case. II. The Issue: Obviousness-Type Double Patenting The issue with respect to this rejection is whether the instant claim is properly rejected for non-statutory obviousness-type double patenting in light of the additionally cited references? Findings of Fact FFIO. Claim 1 of Salatinjants '173 recites: A composition adapted to prolong the residence time of drugs in the circulating plasma of mammals including humans compnsmg about 48 parts by weight potassium hydrogen tartrate, about 8 parts by weight tannic acid, about 94 parts by weight pectin, about 21 parts by weight L-tyrosine, about 6 parts by weight hexanoic acid, and about 200 parts by weight 10% riboflavin. (Salatinjants-2, col. 4, 11. 42--49 (formatting added).) 16 Appeal2016-002237 Application 14/464,519 Principle of Law "Obviousness-type double patenting is a judicially created doctrine intended to prevent improper timewise extension of the patent right by prohibiting the issuance of claims in a second patent which are not 'patentably distinct' from the claims of a first patent." In re Braat, 937 F.2d 589, 592 (Fed. Cir. 1991 ). "It requires rejection of an application claim when the claimed subject matter is not patentably distinct from the subject matter claimed in a commonly owned patent." In re Berg, 140 F.3d 1428, 1431 (Fed. Cir. 1998). Analysis Appellants contend that "[ t ]here is no motivation to combine Salatinjants '173 with the secondary references for the reasons set forth above in relation to the '952 patent combined with the same secondary citations" (App. Br. 28). The argument is unpersuasive for the same reasons discussed above (I.) with respect to claim 1. Additionally, Appellants contend that "[t]he Salatinjants '952 and '1 73 patents have expired. There[ fore, there] can be no 'double' patenting of these patents." (App. Br. 28; see also Reply Br, 14.) We are note persuaded, as Explained by the Examiner, [ t ]he doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond the term of a patent. . . . Double patenting results when the right to exclude granted by a first patent is unjustly extended by the grant of a later issued patent or patents. In re Van Ornum, 686 F.2d 937, ... (CCPA 1982). Note that in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, ... (Fed. Cir. 2014), the court found an earlier-expiring patent, which was issued after the later-expiring patent, may be used to invalidate the later- expiring patent. 17 Appeal2016-002237 Application 14/464,519 (Ans. 40-41, citing MPEP 804.) Double patenting issues arise between pending applications and a patent, as noted by the Examiner, Appellants have not directed us to any case law or to any sections in the MPEP that would support their position that double patenting cannot be raised between a patent that has expired and a pending application. Accordingly, we affirm the rejection on the grounds of non-statutory obviousness-type double patenting. SUMMARY We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) over Salatinjants '952, in view of Lerner, Dunn, Zanchi, and Okino. We affirm the rejection of claim 1 on the ground of non-statutory obviousness-type double patenting over the claims in Salatinjants '173, in view of Lerner, Dunn, Zanchi, and Okino. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 18