Ex Parte den HoedDownload PDFPatent Trial and Appeal BoardNov 6, 201714157609 (P.T.A.B. Nov. 6, 2017) Copy Citation United States Patent and Trademark Office 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/157,609 01/17/2014 Robert den Hoed P07738US0 6525 34082 7590 11/08/2017 7ART FY T AW FTRM PT .f EXAMINER CAPITAL SQUARE PYLA, EVELYN Y 400 LOCUST, SUITE 200 DES MOINES, IA 50309-2350 ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 11/08/2017 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): kconrad@zarleylaw.com crasmu ssen @ zarley law .com emarty @ zarleylaw. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ROBERT DEN HOED Appeal 2017-001008 Application 14/157,609 Technology Center 1600 Before JEFFREY N. FREDMAN, ROBERT A. POLLOCK, and DAVID COTTA, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35U.S.C. § 134 involving claims to a method of making hydrolyzed marine collagen Type II. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Statement of the Case Background “Collagen is a fibrous protein that forms insoluble fibers of high tensile strength” and “showed positive beneficial results for treating degenerative diseases such as osteoarthritis and rheumatoid arthritis and other inflammatory diseases/conditions” (Spec. 1:16—24). An “objective of the present invention is to provide a method of making a collagen powder 1 Appellant does not identify a Real Party in Interest in the Appeal or Reply Briefs as required by 37 C.F.R. 41.37(c)(l)(i). Appeal 2017-001008 Application 14/157,609 consumed in capsule form to improve flexibility and reduce pain” (Spec. 2:9-11). The Claims Claims 1—3, 5, 7—9, 11—13, 15—19, 21, 23, and 24 are on appeal. Independent claim 1 is representative and reads as follows: 1. A method of making hydrolyzed marine collagen Type II, comprising the steps of: mixing marine cartilage, water, an enzyme and a protease enzyme to form a mixture in a digestion tank; heating the mixture at a temperature of approximately 150 °F; deactivating the enzyme and the protease enzyme by adjusting the temperature to between 180 °F and 200 °F; separating bone sediment from the mixture; removing fat from the mixture and heating the mixture to between 140 °F and 170 °F; adding maltodextrin to the mixture; and spray drying the mixture to form a collagen powder. The Issues2 A. The Examiner rejected claims 1—3, 5, 7—9, 11, 13, 16—19, 21, 23, and 24 under 35 U.S.C. § 103(a) as obvious over Ishaq3 and Summers4 (Ans. 2— 12). 2 The Examiner withdrew rejections under 35 U.S.C. § 112(b) (see Ans. 15). 3 Ishaq, US 6,780,841 B2, issued Aug. 24, 2004. 4 Summers et al., US 2013/0035473 Al, published Feb. 7, 2013. 2 Appeal 2017-001008 Application 14/157,609 B. The Examiner rejected claim 12 under 35 U.S.C. § 103(a) as obvious over Ishaq, Summers, and Nielsen5 (Ans. 12—13). C. The Examiner rejected claim 15 under 35 U.S.C. § 103(a) as obvious over Ishaq, Summers, and Stiles6 (Ans. 13—14). A. 35 U.S.C. § 103(a) over Ishaq and Summers The Examiner finds: Ishaq specifically teaches preparing hydrolyzed collagen type II from chicken carcasses as follows: i. suspend whole cartilage in aqueous solution, e.g. water, for about 1 hour at 35°C (i.e. 95°F), pH between 4-8; ii. subsequently remove the water and incubate the cartilage with one or more protease solutions, such as papain, ficin, bromelain, etc., for 2 to 10 hours at temperatures ranging from 35-55°C (i.e. 95-131°F, approximately 150°F), thus forming a hydrolysate; iv. the hydrolysate is sterilized for approximately 30 minutes at temperatures ranging from 95-105°C (i.e. 203- 221°F); and v. the hydrolysate is filtered, concentrated, dried and packaged. Drying can be performed by spray drying (column 5, lines 54-67 to column 6, lines 1-10; Claims 1 and 6). (Ans. 3.) The Examiner finds “Ishaq teaches the hydrolyzed collagen type II can be derived from shark fin (i.e. marine collagen type II) (Claim 15)” (Id.). The Examiner acknowledges “Ishaq does not teach the addition of maltodextrin to the spray dried collagen product” and “does not teach the temperature of approximately 150°F” (Ans. 4—5). 5 Nielsen, US 2002/0182290 Al, published Dec. 5, 2002. 6 Stiles et al., US 2007/0004629 Al, published Jan. 4, 2007. 3 Appeal 2017-001008 Application 14/157,609 The Examiner finds Summers teaches “adding maltodextrin to assist in removing water from the wet hydrolyzed collagen product to result in a dry, powdered collagen type II product” (Ans. 4). The Examiner finds it obvious “to include adding maltodextrin to assist in removing water from the wet hydrolyzed collagen, as taught by Summers, for the predictable result of successfully producing a dried, powdered collagen product in the method of Ishaq” (Ans. 4). The Examiner further finds it obvious “to optimize the incubation temperature as a matter of routine experimentation as it is a recognized result effective variable, having an effect on enzyme activity” (Ans. 5). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Ishaq and Summers render the process of hydrolyzing marine collagen of claim 1 obvious? Findings of Fact 1. Ishaq teaches “a hydrolyzed, denatured collagen type II composition, [and a] method for preparing the composition” (Ishaq 4:57— 59). 2. Ishaq teaches “contemplated sources of collagen type II are mammalian cartilage (e.g. bovine, porcine and avian) and shark fins. However, such forms of collagen type II are generally less effective in absorbing into the gastrointestinal tract” (Ishaq 5:10—13). 3. Ishaq claims: “The hydrolyzed collagen type II of claim 9, wherein said hydrolyzed collagen is derived from a shark fin” (Ishaq 12:12— 13, claim 15). 4 Appeal 2017-001008 Application 14/157,609 4. Figure 1 of Ishaq is reproduced below: CUTTING FRESH CHICKEN STERNAL CARTILAGE [ SUSPENDING THE CARTILAGE IN AN AQUEOUS SOLUTION ------------ ------------- 1________________ TREATING THE CART)lAGE WITH A PROTEOLYTIC 6NXYME TO FORM A HYDROLYSA TE, THE PROTEOLYTIC ENZYOME BEING CAPABLE OF HYDROLYZING COLLAGEN TYPE JI TO FRAGMENTS HAVING AN AVERAGE MOLECULAR WEIGHT OF 1 BETWEEN 99 TO i 6,000 DALTONS 1 r STERILIZING THIl HYDROLYSATE ■ 1 * FILTERING THE H YDROLYSATE. ' .. _ . CONCENTRATING THE HYDROLYSATE ................. ....... .............................. •i * ! DRYING THE HYDROLYSATE TO FORM | POWDER ENRICHED IN COLLAGEN \ TYPE H POWDER I _—--------------—........... .1..,.., ..... ................... ISOLATING THE POWDER ENRICHED IN COLLAGEN TYPE 0 FIGURE I “FIG. 1 is a schematic diagram of the process for preparing the hydrolyzed collagen type II powder of the invention” (Ishaq 4:44-45). 5 Appeal 2017-001008 Application 14/157,609 5. Ishaq teaches “cartilage is incubated with one or more proteases obtainable from a natural source (i.e. papain, ficin, bromelain) for between about 2 and 10 hours, preferably about 6 hours, at about 35° C.-550 C. [95 °F to 131 °F] at a pH of between about 4 and 8 to form a hydrolysate” (Ishaq 5:60-64). 6. Ishaq teaches the “hydrolysate is then sterilized for about 30 minutes at a temperature between about 95° C. and 105° C [203 °F to 221 °F], The sterilized hydrolysate is filtered through diatomaceous earth” (Ishaq 5:67 to 6:2). 7. Ishaq teaches, in Table 2, that the test results on the hydrolyzed collagen type II result in 0.0% fat (Ishaq 7:11) and 100% purity (Ishaq 6:65). 8. Ishaq teaches “the hydrolyzed collagen type II is spray dried using a size 56 pressure nozzle into a heat tunnel” (Ishaq 6:6—7). 9. Summers teaches “creating a collagen mixture of unhydrolyzed eggshell membrane with LOS with Avian collagen” (Summers 11). 10. Summers teaches the process of making the Avian collagen with LOS begins by obtaining Avian cartilage 18, typically in frozen form at step 200. At step 210, the frozen cartilage 18 is thawed by placing the cartilage in a tank 20 containing hot water. Once thawed, an enzyme mixture 22 is added to the thawed cartilage 18 which breaks the cartilage down into liquid form at step 220. Preferably, the enzyme mixture 22 includes a liquid plant derived enzyme 24 such as papain, fien, or bromalin; a bacterial protolitic enzyme 26, such as acid, neutral, or alkelian; and a buffer. (Summers 114.) 6 Appeal 2017-001008 Application 14/157,609 11. Summers teaches as “the enzyme mixture 22 breaks down the cartilage 18, the tank is heated to preferably 140°-160° F. such that the cartilage 18 separates into a top layer of fat 30, a middle layer of liquid digest 32, and a bottom layer of bone chips 34” (Summers 114). 12. Summers teaches: “Once separated, at step 230, the bone chips 34 are swept away from a valve 36 in the bottom of the tank 20 and the liquid digest 32 is pumped through the valve 36 to a holding tank 38” (Summers 115). 13. Summers teaches the “the solid liquid digest is spray dried using pulse combustion. Also, a carrier such as multrodextrine is added to assist in pulling off extra water from the liquid digest 32. This results in a dry powder” (Summers 117). Principles of Law Analysis We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 2—12; FF 1—13) and agree that the claims are obvious over Ishaq and Summers. We address Appellant’s arguments below. Appellant contends “the method disclosed by Ishaq is exclusively directed to avian cartilage, and one of ordinary skill would not equate the method as being instructive with respect to marine cartilage. Summers fails to address this deficiency of Ishaq” (App. Br. 3). Appellant contends the “skilled artisan, however, is not disclosed anything about how the shark fin is prepared to be included in the collagen. Therefore, one of ordinary skill, upon reading the disclosure of Ishaq would not understand the method 7 Appeal 2017-001008 Application 14/157,609 disclosed therein as being applicable to marine cartilage, which would only come about by relying on Applicant’s disclosure” (App. Br. 3). We do not find this argument persuasive. While Ishaq acknowledges that shark fin collagen, along with other sources, may be less effective when administered to the gastrointestinal tract (FF 2), Ishaq claims shark fin as a collagen source (FF 3) and expressly contemplates shark fin as a collagen source (FF 2). While shark fin collagen may be a less preferred embodiment, Ishaq teaches that shark fin collagen is, nonetheless, still an option and cannot be equated to an arrangement that is recognized as not likely to work. See, e.g., Syntex (U.S.A) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005). Appellant contends: [0]ne of ordinary skill in the art clearly understands that marine cartilage [must be] used to produce hydrolyzed marine collagen Type II. Therefore, the Examiner’s assertion that the claim language does not exclude avian cartilage and that “comprising” is open ended becomes moot, when marine collagen Type II is used prior to the term comprising and after the term marine cartilage is further specified. (Reply Br. 3.) We find this argument unpersuasive. As already discussed, Ishaq expressly suggests the use of marine cartilage as a source for collagen (FF 2—3). Moreover, we agree with the Examiner that the use of the open “comprising” language encompasses marine cartilage but does not exclude the presence of other cartilage sources in the starting mixture. See Georgia- Pacific Corp. v. U.S. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999) 8 Appeal 2017-001008 Application 14/157,609 (The transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.”). Appellant contends: [AJbove, the Examiner is using the singular disclosure of the temperature range of 35-55 °C by Ishaq found at col. 5, Ins. 59-64 for the purpose of disclosing Applicant’s claimed subject matter of “mixing marine cartilage, water, an enzyme and a protease enzyme to form a mixture in a digestion tank” and “heating the mixture at a temperature of approximately 150 °F”—not the step of “removing fat from the mixture and heating the mixture to between 140 °F and 170 °F.” However, the Examiner also continues to rely on this same disclosure on pages 7 and 15 of the Final Office Action to reject the claimed subject matter of “removing fat from the mixture and heating the mixture to between 140 °F and 170 °F,” which is improper. (App. Br. 4.) We understand Appellant to be arguing that the Examiner relies upon a single teaching in Ishaq regarding the enzyme treatment step to address both the enzyme treatment step and the removal of fat step recited in claim 1. We find this argument unpersuasive because the Examiner relied upon Ishaq in combination with Summers for these limitations, stating Ishaq shows “the hydrolyzed collagen type II product comprises no fat, thus it is considered that fat has been removed from the product” (Ans. 6) and that Summers teaches “heating the cartilage to 140-160°F . . . and when the cartilage is heated to temperatures in the range disclosed by Ishaq, the cartilage separates from the fat” (Ans. 6—7). The Examiner further explains, in the Answer, the obviousness of a fat removal step, finding that “Summers (paragraph [0014]) discloses 9 Appeal 2017-001008 Application 14/157,609 heating to temperatures ranging from 140-160°F to separate fat from the digested cartilage, thus establishing that it was well known that temperatures ranging from 140-160°F effectively remove fat as required of instant claim 1” (Ans. 18). We agree with the Examiner that Ishaq teaches a process for making hydrolyzed collagen that may include shark fin collagen (FF 2) comprising steps of (i) mixing enzymes, cartilage and water (FF 4, second box), (ii) heating a mixture of enzymes and cartilage at elevated temperatures up to 131 °F (FF 5), (iii) deactivating the enzymes at elevated temperatures including 203 °F (FF 6), (iv) separating bone sediment by filtering (FF 6), and (vii) spray drying the mixture to form a collagen powder (FF 8). While we agree with Appellant that Ishaq does not clearly teach a step (v) of removing fat from the mixture or a step (vi) of adding maltodextrin as required by claim 1, we agree that the Examiner reasonably relies upon Summers, a reference also related to obtaining collagen, for those elements (see Ans. 18). In particular, Summers teaches a method of making collagen comprising steps of (i) mixing enzymes, collagen and hot water (FF 10), (v) heating the enzyme treated mixture at 140 °F to 160 °F to separate fat from the digested collagen (FF 11), (iv) separating bone sediment and fat from the digested collagen (FF 12), and (vi) adding maltodextrin to the digested collagen prior to spray drying (FF 13). We agree with the Examiner that the combination of Ishaq and Summers renders the claim steps obvious because the ordinary artisan, interested in obtaining the purified, and consequently fat free, hydrolyzed collagen disclosed by Ishaq (FF 7) would have had reason to incorporate the 10 Appeal 2017-001008 Application 14/157,609 fat and bone separation step of Summers because Summers teaches separation of the digested collagen product away from fat and bone to obtain a more highly purified collagen product (FF 11—12). See Aventis Pharma Deutschland GmbHv. Lupin, Ltd., 499 F.3d 1293, 1301 (Fed. Cir. 2007) (“[I]f it is known that some desirable property of a mixture derives in whole or in part from a particular one of its components, or if the prior art would provide a person of ordinary skill in the art with reason to believe that this is so, the purified compound is prima facie obvious over the mixture even without an explicit teaching that the ingredient should be concentrated or purified.”). Therefore, to the extent that Ishaq only teaches one of the steps required, the enzyme digesting step, Summers resolves this concern by teaching both an enzyme digesting step (FF 10) and a fat separation step (FF 11) in collagen purification, rendering the use of both steps in the collagen purification process of Ishaq obvious. Appellant contends the “Examiner has rejected the heating step on the basis that when rearranged, the claimed subject matter is obvious as the prior art provides for the predictable use of heating having the expected result of separating fat for its removal” (App. Br. 6). Appellant contends that, however “there is no obvious reason to combine the references as suggested. More particularly, the order cannot be arranged as asserted because Applicant has not used the step of heating for their predictable use of fat removal as recognized by the prior art” (Id.). Appellant contends: “As drafted, claims 1 and 24 provide a definite sequence as to the removal of the 11 Appeal 2017-001008 Application 14/157,609 fat prior to the heating, which is provided in a single step within each respective claim” (Id.; cf. Reply Br. 4—5). Whether claim 1 requires a specific order or not, we find this argument unpersuasive for two reasons. First, Summers expressly teaches performing, in the same order as claim 1, the steps of (i) digesting cartilage with enzymes (FF 10) and (v) heating the enzyme treated mixture at 140 °F to 160 °F to separate fat from the digested collagen (FF 11). Thus, the ordinary artisan combining the teachings of Ishaq and Summers would have reasonably performed the fat separation step subsequent to the enzyme digestion step as taught by Summers (FF 10—11). Second, Summers specifically teaches that fat may be removed from a collagen mixture by heating at temperatures between 140 °F to 160 °F (FF 11) and Appellant provides no unexpected results or other reasons why performance of this step at any point during the collagen purification process would not have been obvious. See In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) (“[T]he burden of showing unexpected results rests on he who asserts them.”). We find the underlying logic similar to that in Burhans, a case in which there were four process steps, and each of the steps was disclosed in the prior art, differing only order of the steps. In re Burhans, 154 F.2d 690, 692 (CCPA 1946). The court was unpersuaded of patentability, finding that “[tjhere is no merit in the point here in the absence of any proof in the record that the order of performing the steps produces any new and unexpected results.” Id. We conclude that the same reasoning applies in the instant case because there is no indication in either Appellant’s arguments or the 12 Appeal 2017-001008 Application 14/157,609 Specification that the order of performance of these known purification steps results in any unexpectedly improved degree of purity or quality of the final collagen product. Conclusion of Law The evidence of record supports the Examiner’s conclusion that Ishaq and Summers render the process of hydrolyzing marine collagen of claim 1 obvious. B. and C. 35 U.S.C. § 103(a) over Ishaq, Summers, and Nielsen or Stiles Appellant does not separately argue these obviousness rejections, instead relying upon the same arguments relied upon to overcome the rejection over Ishaq and Summers. The Examiner provides sound fact-based reasoning for combining either Nielsen or Stiles with Ishaq and Summers (see Ans. 12—14). Having affirmed the obviousness rejection of claim 1 over Ishaq and Summers for the reasons given above, we also find that the further obvious combination with either Nielsen or Stiles renders the rejected claims obvious for the reasons given by the Examiner. SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Ishaq and Summers. Claims 2, 3, 5, 7—9, 11, 13, 16—19, 21, 23, and 24 fall with claim 1. We affirm the rejection of 12 under 35 U.S.C. § 103(a) as obvious over Ishaq, Summers, and Nielsen. 13 Appeal 2017-001008 Application 14/157,609 We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as obvious over Ishaq, Summers, and Stiles. 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 14 Copy with citationCopy as parenthetical citation