MAGER, JENNIFER et al.Download PDFPatent Trials and Appeals BoardDec 6, 201915349336 - (D) (P.T.A.B. Dec. 6, 2019) 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. 15/349,336 11/11/2016 JENNIFER MAGER 3712036-02763 1069 29157 7590 12/06/2019 K&L Gates LLP-Chicago P.O. Box 1135 Chicago, IL 60690 EXAMINER STEELE, AMBER D ART UNIT PAPER NUMBER 1658 NOTIFICATION DATE DELIVERY MODE 12/06/2019 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): USpatentmail@klgates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JENNIFER MAGER, ZAMZAM FARIBA ROUGHEAD, HEIDI STORM, and JAMES SCOTT TERESI1 Appeal 2019-005062 Application 15/349,336 Technology Center 1600 Before ERIC B. GRIMES, FRANCISCO C. PRATS, and DAVID COTTA, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a tube feed formulation, which have been rejected for obviousness, lack of adequate description in the Specification, and, provisionally, for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE “[T]he present disclosure provides a nutritional composition (e.g., oral nutritional supplements, tube feed formulations, etc.) including at least five 1 Appellant identifies the real party in interest as Nestec S.A. Appeal Br. 2. We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appeal 2019-005062 Application 15/349,336 2 different processed whole food components; a source of protein, a source of fat, a source of carbohydrate, and a source of vitamins and minerals.” Spec. ¶ 2. “In [one] embodiment, the present nutritional compositions have an osmolality that is less than or equal to 400 mOsm/kg water.” Id. ¶ 175. “Osmolality is . . . a measure of the osmoles of solute per kilogram of solvent (osmol/kg tube feeding or Osm/kg tube feeding).” Id. Claims 1–5, 7, 8, and 23–31 are on appeal. Claim 1, reproduced below, is illustrative: Claim 1: A tube feed formulation comprising at least five different whole food components; the tube feed formulation further comprising a source of vitamins and/or minerals; the tube feed formulation further comprising a source of protein; the tube feed formulation further comprising a source of carbohydrate; the tube feed formulation further comprising a source of fat; and the tube feed formulation has an osmolality up to 400 mOsm/kg water. The claims stand rejected as follows: Claims 1–5, 7, 8, 23–26, and 28–31 under 35 U.S.C. § 103(a) as obvious based on Klein,2 McEwen,3 and Molenaar4 (Ans. 4); Claims 1–5, 7, 8, and 23–31 under 35 U.S.C. § 103(a) as obvious based on Klein, McEwen, Molenaar, Anthony,5 and Ernest6 (Ans. 7); 2 Marsha Dunn Klein & Suzanne Evans Morris, Homemade Blended Formula Handbook; Mealtime Notions, LLC; Tucson, AZ; pp. 1–199 (2007). 3 McEwen et al., US 2001/0043958 A1 (publ. Nov. 22, 2001). 4 Molenaar, US 2007/0202153 A1 (publ. Aug. 30, 2007). 5 Anthony et al., US 2006/0229256 A1 (publ. Oct. 12, 2006). 6 Ernest, US 2005/0070498 A1 (publ. Mar. 31, 2005). Appeal 2019-005062 Application 15/349,336 3 Claims 23 and 28 under 35 U.S.C. § 112, first paragraph, for lack of adequate written description (new matter) (Ans. 3); and Claims 1–5, 7, 8, and 23–31, provisionally, for obviousness-type double patenting based on claims 1, 4–15, 18, and 20 of application 13/805,932 (Ans. 13). OPINION Obviousness The Examiner has rejected all of the claims except claim 27 as obvious based on Klein, McEwen, and Molenaar. The Examiner has also rejected all of the claims as obvious based on Klein, McEwen, Molenaar, Anthony, and Ernest. Appellant presents the same arguments with respect to both rejections. See Appeal Br. 5–11. We will therefore address them together. The Examiner finds that Klein teaches “tube feeding formulas comprising ‘real’ foods including processed fruits, processed vegetables, processed meat, and/or processed grains.” Ans. 4. The Examiner finds that Klein also “teaches the importance of individuals receiving homemade blended formulas receiving enough hydration.” Id. The Examiner finds that Klein “do[es] not specifically teach an osmolality up to 400 mOsm/kg water,” but McEwen teaches “a liquid nutritional product with osmolality below 700 mOsm/kg H2O and more preferably below 600 mOsm/kg H2O.” Id. at 5. The Examiner also notes that McEwen teaches that “products with high osmolality increase the possibility of causing diarrhea.” Id. at 18. Appeal 2019-005062 Application 15/349,336 4 The Examiner finds that Molenaar discloses ranges of energy content distribution between fat, protein, and carbohydrates that overlap the distribution ranges recited in claim 7. Id. at 6. The Examiner also finds that “Molenaar teaches liquid complete nutritional compositions comprising a relatively low osmolality, avoiding excessive osmolality, and osmolality between 360 and 480 mOsm.” Id. at 18. The Examiner concludes that the cited references show that all of the elements of the claimed composition were known in the prior art and that it would have been obvious to combine them for the predictable result of providing nutrition using “a particular known technique (blenderization and tube feeding formulations) . . . as part of the ordinary capabilities of one skilled in the art.” Id. at 7. We agree with the Examiner that the composition of claim 1 would have been obvious based on the cited references. Klein teaches homemade blended formulas for tube feeding, including “a complete diet of homemade blended foods.” Klein 1. As one example, Klein describes a tube feeding formulation consisting of “a nice home cooked meal with vegetables, protein and carbohydrates for dinner.” Id. at 30. Klein discusses the protein, fat, and carbohydrate content of different whole food components. Id. at 63–66. Klein therefore discloses a tube feeding formulation with the components and nutritional sources recited in claim 1. Klein does not disclose or suggest an osmolality of less than 400 mOsm/kg water for its compositions. However, McEwen discloses “an elemental nutritional product useful for providing nutritional support to patients suffering from malabsorption conditions.” McEwen ¶ 1. McEwen Appeal 2019-005062 Application 15/349,336 5 states that “[p]roducts with a high osmolality increase the possibility of the product causing diarrhea. . . . The osmolality of these product[s] should be maintained at a level below 700 mosm/kg H2O, more preferably below 600 mosm/kg H2O.” Id. ¶ 74. Molenaar discloses “concentrated liquid nutritional products . . . for the treatment of cachexia.” Molenaar ¶ 1. Molenaar states that its composition should have “a relatively low osmolarity, so as to allow quick passage through the stomach.” Id. ¶ 22.7 More specifically, “[t]he osmolarity of the composition is preferably between 360 and 480 mOsm, preferably between 390 and 430 mOsm.” Id. ¶ 42. Molenaar describes its composition as “a thin liquid.” Id. ¶ 43. Based on McEwen and Molenaar, it would have been obvious to a person of ordinary skill in the art to formulate Klein’s tube feed formulation so that it had an osmolality of 400 mOsm/kg water or less, because McEwen discloses that high osmolality increases the possibility of causing diarrhea, and suggests a preferred osmolality of no more than 600 mOsm/kg water. Molenaar suggests a low osmolarity, preferably 390–430 mOsm, to allow quick passage through the stomach. Thus, a skilled artisan would have recognized that an osmolality of, for example, 390–400 mOsm/kg water would allow for quick passage through the stomach without increasing the possibility of diarrhea. 7 Molenaar refers to “osmolarity” and claim 1 refers to “osmolality,” but Appellant does not argue that the claimed composition is distinguished on the basis of the different terminology. See Reply Br. 5. Appeal 2019-005062 Application 15/349,336 6 Appellant argues that “the skilled artisan would understand that th[e] formula of Klein would intrinsically have a very high osmolality--above 400 mOs/Kg--due to the high water content and osmolality of the ingredients used.” Appeal Br. 6. Appellant, however, does not point to any evidence to support this assertion, and “[a]ttorney’s argument in a brief cannot take the place of evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). In any event, the rejection is based on modifying Klein’s composition to have the recited osmolality. Appellant also argues that the Examiner has not explained why one of ordinary skill in the art “would have sought to optimize the osmolality of the formula of Klein alone or in combination with the liquid nutritional product of McEwen. Moreover, there is no reason or motivation for the skilled artisan to combine Klein and McEwen.” Appeal Br. 6. This argument is not persuasive, because McEwen discloses that liquid nutrition products with a high osmolality increase the possibility of causing diarrhea, and therefore teaches that an osmolality below 600 mOsm/kg water is preferred. McEwen ¶ 74. The Examiner also (Ans. 18) pointed to Molenaar’s disclosure of a product having a relatively low osmolarity, preferably 390–430 mOsm, to allow quick passage through the stomach. Molenaar ¶¶ 22, 42. These teachings would have provided those skilled in the art with a reason to modify Klein’s tube feed composition to have an osmolality within the claimed range. Appellant argues that “the cited references do not provide any teachings on how to adjust the osmolality of formulations to which blended whole food ingredients with intrinsically high osmolality (such as that in Appeal 2019-005062 Application 15/349,336 7 Klein) have been added.” Appeal Br. 6. “Molenaar does not provide any teachings on how to adjust the osmolality of the formula of Klein.” Id. at 7. This argument is also unpersuasive, because both Molenaar and McEwen describe preferred osmolality (or osmolarity) ranges for their products, which is an indication that those skilled in the art were aware of how to modify a particular liquid formulation to adjust its osmolality to a desired level. We note that Appellant’s Specification describes desired osmolality ranges for the claimed composition (Spec. ¶ 175), but provides no guidance on how to achieve them, a further indication that those skilled in the art were aware of how to adjust osmolality. See also id. (defining osmolality as simply the amount of solute per kilogram of solvent). Appellant has not provided evidence that adjusting osmolality would not have been a routine procedure to those of ordinary skill in the art. Regarding claim 7,8 Appellant argues that “the cited references do not provide any teachings on how to adjust the energy contents of the formula of Klein alone or in combination with the liquid nutritional composition of Molenaar.” Appeal Br. 8. Appellant also argues that “there is no reason or motivation for the skilled artisan to combine Klein and Molenaar.” Id. at 9. These arguments are unpersuasive. Molenaar itself provides a reason to adjust the energy contents of Klein’s composition to values within the ranges recited in claim 7, because Molenaar teaches that its composition 8 Claim 7 is directed to “[t]he tube feed formulation of Claim 1, wherein the source of fat provides 25% to 35% of the total energy of the tube formulation, the source of protein provides 25% to 30% of the total energy of the tube formulation, and the source of carbohydrates provides 45% to 65% of the total energy of the tube formulation.” Appeal 2019-005062 Application 15/349,336 8 “provides a balanced, liquid concentrated food product.” Molenaar ¶ 27 (emphasis added). Thus, a skilled artisan would recognize that the claimed levels of energy content are suitable for providing a balanced food product. With regard to Appellant’s argument that the references do not teach how to adjust the energy contents of Klein’s composition, we note that Klein discloses numerous sources of protein, fat, and carbohydrates that can be included in its composition. Klein 63–66. Klein also discloses recommended amounts of protein for children of different ages (id. at 63), as well as the protein content of different foods (id. at 63–64); states that 25–40% of the energy in a child’s diet should come from fats (id. at 65); and states that “[a]bout half of the calories in a healthy diet come from carbohydrates” (id. at 66). Appellant has not persuasively explained why the guidance provided by Klein would not be sufficient to allow a skilled artisan to adjust the energy contents of its composition to meet the values recommended by Molenaar. In summary, we affirm the rejection of claims 1 and 7 under 35 U.S.C. § 103(a) based on Klein, McEwen, and Molenaar. Claims 2–5, 8, 23– 26, and 28–31 fall with claim 1 because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(iv) (2018). For the same reasons, we affirm the rejection of claims 1 and 7 under 35 U.S.C. § 103(a) based on Klein, McEwen, Molenaar, Anthony, and Ernest. Claims 2–5, 8, and 23–31 fall with claim 1 because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2019-005062 Application 15/349,336 9 New Matter The Examiner has rejected claims 23 and 28 on the basis that the Specification does not provide support for “a polypeptide comprising arginine, citrulline, or glutamine,” as recited in claim 23, or for “a protein hydrolysate,” as recited in claim 28. Ans. 3–4. Appellant does not present any arguments addressing the new matter rejection in the Appeal Brief or Reply Brief. We therefore affirm the rejection. See 37 C.F.R. § 41.37(c)(1)(iv) (The Appeal Brief must contain “[t]he arguments of appellant with respect to each ground of rejection.”); MPEP § 1205.02 (9th Ed., Rev. 08.2017 (Jan. 2018)) (“If a ground of rejection stated by the examiner is not addressed in the appellant’s brief, appellant has waived any challenge to that ground of rejection and the Board may summarily sustain it.”). Provisional Obviousness-type Double Patenting The Examiner has provisionally rejected all of the claims for obviousness-type double patenting based on the claims of application 13/805,932. Ans. 13. Appellant does not present any arguments addressing the provisional rejection in the Appeal Brief or Reply Brief. We therefore affirm it. See 37 C.F.R. § 41.37(c)(1)(iv); MPEP § 1205.02. Appeal 2019-005062 Application 15/349,336 10 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–5, 7, 8, 23–26, 28– 31 103(a) Klein, McEwen, Molenaar 1–5, 7, 8, 23–26, 28– 31 1–5, 7, 8, 23–31 103(a) Klein, McEwen, Molenaar, Anthony, Ernest 1–5, 7, 8, 23–31 23, 28 112, first paragraph Written Description 23, 28 1–5, 7, 8, 23–31 Provisional Obviousness-type Double Patenting 1–5, 7, 8, 23–31 Overall Outcome 1–5, 7, 8, 23–31 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation