12424841 (P.T.A.B. Jun. 15, 2016)

Ex Parte Daly

Patent Trial and Appeal BoardJun 15, 2016

12424841 (P.T.A.B. Jun. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/424,841 04/16/2009 PAULC. DALY 24737 7590 06/17/2016 PHILIPS INTELLECTUAL PROPERTY & STANDARDS 465 Columbus A venue Suite 340 Valhalla, NY 10595 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. 2000P02326 USOl 1330 EXAMINER SMITH, CHAIM A ART UNIT PAPER NUMBER 1792 NOTIFICATION DATE DELIVERY MODE 06/17/2016 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): marianne.fox@philips.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PAUL C. DALY Appeal2014-004078 Application 12/424,841 Technology Center 1700 Before BRADLEY R. GARRIS, ROMULO H. DELMENDO, and MICHAEL P. COLAIANNI, Administrative Patent Judges. DELMENDO, Administrative Patent Judge. DECISION ON APPEAL The Applicant (hereinafter the "Appellant") 1 appeals under 35 U.S.C. Â§ 134(a) from a final decision of the Primary Examiner to reject claims 1- 21.2 We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. 1 The Appellant identifies the Real Party in Interest as "RIC Investments, LLC, the assignee of record, which is a subsidiary of Koninklijke Philips Electronics N.V." (Appeal Brief filed August 14, 2013, hereinafter "Appeal Br.," 2). 2 Appeal Br. 2; Final Office Action entered May 9, 2013, hereinafter "Final Act., 1. Appeal2014-004078 Application 12/424,841 BACKGROl.J1'-JD The subject matter on appeal relates to a packaged sucrose solution and to a method of providing a sucrose solution to an infant (Specification, hereinafter "Spec.," i-f 8). According to the Appellant, it was known in the art that such sucrose solutions provide "analgesic and calming effects on infants" and that "[ s ]tudies have indicated that the minimum concentration of sucrose needed to produce effective analgesia for procedural pain may be about 18%" (id. i-fi-1 4, 6). We heard oral arguments from the Appellant's counsel on June 7, 2016. A written transcript will be entered into the electronic record when it is made available. Representative claim 1 is reproduced from page 37 of the Appeal Brief (Claims App.), with key limitations indicated in italicized text, as follows: 1. A packaged solution for use in conjunction with a medical procedure on an infant, comprising: a cup-shaped container defining a cavity therein opening to a mouth; a volume of a solution within the cavity, the solution comprising water and about 10% to about 50% sucrose; and a cover disposed over the mouth and sealing the solution within the cavity, wherein the container has a container volume that is at least 50% larger than the volume of the solution, and wherein the volume of the solution is larger than a volume of a unit dose of the solution for the medical procedure on the infant. THE REJECTIONS The Examiner rejected the claims as follows: I. Claims 1, 5-8, 11-13, and 15-19 under 35 U.S.C. Â§ 102(b) as anticipated by Central Medical Supplies: Neonatal, Hawaii 2 Appeal2014-004078 Application 12/424,841 "1l ~ .. â€¢ .. rT""I , r"I , 'T'l\Jf '"' AÂ£\ / r"I r"I .. , â€¢ /.. â€¢ ro, iv1e01ca1 l oot~weer'" L4/o ~ucrose ~omuon ~neremaner "Hawaii Medical")3; II. Claims 2, 4, 9, 10, 14, 20, and 21under35 U.S.C. Â§ 103(a) as unpatentable over Hawaii Medical; III. Claims 10 and 21 as unpatentable over Hawaii Medical in view of Zentner4; IV. Claims 1-12, 20, and 21under35 U.S.C. Â§ 103(a) as unpatentable over Lazure5 in view of the Appellant's admitted prior art (hereinafter "AAPA")6 and various additional references including Bublitz7; and V. Claims 13-19 under 35 U.S.C. Â§ 103(a) as unpatentable over AAP A in view of various references including Lazure and Bublitz. (Examiner's Answer entered October 25, 2013, hereinafter "Ans.," 2-8; Final Act. 4--21.) DISCUSSION 1. Rejection I The Examiner found that Hawaii Medical describes every limitation recited in claims 1, 5-8, 11-13, and 15-19 (Final Act. 4--6). According to 3 The Examiner found that the Hawaii Medical document published on November 27, 2004 (Form PT0-892 entered Dec. 6, 2012), which is more than one year before the actual filing date (i.e., April 16, 2009) of the current application. The Appellant does not dispute the Examiner's finding (Appeal Br. 10). 4 US 3,248,290 issued April 26, 1966. 5 US 4,054,207 issued October 18, 1977. 6 Spec. i-fi-1 3---6. 7 US 4,211,338 issued July 8, 1980. 3 Appeal2014-004078 Application 12/424,841 the Examiner (Ans. 2---6), Hawaii ivledical is available as prior art because the disclosure of parent Application 09/670, 781, filed September 27, 2000, (hereinafter "'781 Application") from which 35 U.S.C. Â§ 120 benefit is claimed does not include a sufficient written description of a packaged container having "a container volume that is at least 50% larger than the volume of the solution," as recited in claim 1 (Ans. 2---6). 8 The Appellant does not dispute the Examiner's finding that Hawaii Medical describes every limitation of the rejected claims (Appeal Br. 10- 21). Rather, the Appellant contends that the Examiner's rejection constitutes "legal error" because the subject application is a continuation of the '781 Application, which has a filing date that precedes Hawaii Medical' s November 27, 2004 publication date, and the claimed subject matter is supported by the '781 Application, thereby removing Hawaii Medical from the realm of prior art (Appeal Br. 10). According to the Appellant (id. at 11-12), the disputed claim limitation ("a container volume that is at least 50% larger than the volume of the solution") recited in claim 1 is supported by at least the description on pages 4--5 and Figure 1 of the '781 Application, as filed. For the reasons given by the Examiner and below, we find that the parent '781 Application does not contain a sufficient written description of the Appellant's claimed subject matter including the requirement that the "container volume ... is at least 50% larger than the volume of the solution" 8 Claims 13 and 20, which are the only other independent claims on appeal, recite "the container having a container volume that is at least 50% larger than the volume of the solution" and "the container has a container volume that is at least 100% larger than the volume of the solution," respectively (Appeal Br. 38, 39--40). 4 Appeal2014-004078 Application 12/424,841 (claims 1 and 13) or the "container volume is at least 100% larger than the volume of the solution" (claims 3, 20). Because the claimed subject matter is not described in the '781 Application in the manner required under 35 U.S.C. Â§Â§ 112 and 120, the claims are not entitled to benefit of the '781 Application's earlier filing date. Therefore, Hawaii Medical is available as prior art under 35 U.S.C. Â§ 102(b). The Appellant does not argue that the '781 Application provides explicit literal support for the claimed subject matter including the limitation at issue. Rather, the Appellant's position is best summarized in the Appellant's own words as follows: Because the '781 [A ]pplication discloses that the container volume is greater than 40mL, and that the solution volume can be 20mL according to various embodiments, the '781 [A ]pplication inherently and unambiguously discloses that the container can have "a container volume that is at least 50% larger than the volume of the solution," as recited in claim 1 of the present application. (Appeal Br. 11-12.) The Appellant's position lacks merit. Contrary to the Appellant's belief, the '781 Application does not describe a range of container volumes that can be expressed as "greater than 40mL" (id.). As found by the Examiner (Ans. 3), a specific container volume (or range of values for the container volume) is not described in the '781 Application at all. The 40 mL reference on page 5 of the '781 Application is for the volume of the solution-not the container-as shown in Figure 1 and that volume is shown to be smaller than the volume of the container by some unspecified degree. Thus, at most, one skilled in the relevant art would have drawn a reasonable inference that container 10, as shown in Figure 1 of the '781 Application, 5 Appeal2014-004078 Application 12/424,841 has some volume that is larger than the volume of the sucrose solution---40 mL or 20 mL-by some unspecified degree and that it may have been obvious to reduce the volume of the sucrose solution to other unspecified volumes ('781 Application at 5, 11. 21-22). But a disclosure of a particular container having an unspecified volume that is larger than a 40 mL or 20 mL sucrose solution by some unspecified degree is insufficient to support a range of container volumes expressed as "at least 50% larger than the volume of the solution," as recited in claim 1. In re Lukach, 442 F .2d 967, 970 (CCPA 1971) ("[T]he description of a single embodiment of broadly claimed subject matter constitutes a description of the invention for anticipation purposes ... whereas the same information in a specification might not alone be enough to provide a description of that invention for purposes of adequate disclosure."). Thus, although the disclosure that "the exemplary 40 ml volume of solution 18 in internal chamber 12 may be reduced to a lesser volume, for example 20 ml, as desired" ('781 Application at 5, 11. 21-22) may have rendered something falling within the scope of the disputed limitation obvious to a person having ordinary skill in the art, obviousness is not the appropriate standard to measure compliance with the written description requirement of 35 U.S.C. Â§ 112, i-f 1. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) ("[D]escription which renders obvious the invention ... is not sufficient."). Moreover, the phrase "at least 50% larger" in the disputed limitation broadly includes not only the specified lower endpoints of 50% and 100% 6 Appeal2014-004078 Application 12/424,841 -t , -t -t â€¢ -t , -t , â€¢ Â£""" â€¢, 0 r-T""l-t â€¢ -t -t , -t ro â€¢ -t Dut a1so mgner percent vames up to mnmty.J ine Appellant, nowever, raus to direct us to any description that forms a basis for sufficient descriptive support for selecting 50% and 100% as lower endpoints or higher values encompassed by the disputed limitation (e.g., 1000% ). In re Wertheim, 541 F.2d 257, 263-264 (CCPA 1976) ("By pointing to the fact that claim 1 reads on embodiments outside the scope of the description, the PTO has satisfied its burden."). The Appellant's additional arguments specific to claims 5-8, 11-13, and 15-19 fail to sufficiently address the Examiner's position with respect to the lack of sufficient written description for the claimed subject matter including the relative container volume as specified in the claims. Therefore, we uphold Rejection I. 2. Rejections II & III Claim 2 recites (Appeal Br. 37): 2. The packaged solution of claim 1, wherein: the volume of the solution is 20 mL or larger; the container volume is larger than 40 mL; and the unit dose is 2 mL or less. As we discussed above in section 1, the '781 Application fails to include a sufficiently specific description of a range of container volumes of "larger than 40 mL." Although the unspecified volume of the container shown in Figure 1 falls within the scope of "larger than 40 mL," it does not 9 Although claim 1 recites "wherein the volume of the solution is larger than a volume of a unit dose of the solution for the medical procedure on the infant" (Appeal Br. 37), the claim places no limitation on the actual volumetric capacity of the container. Therefore, as written, claim 1 reads on any container volume, provided that the volume is larger than the solution volume by at least 50%. 7 Appeal2014-004078 Application 12/424,841 constitute a description for a range of container volumes expressed as "larger than 40 mL" (e.g., 41 mL, 42 mL, or 1000 mL). Similarly, the '781 Application lacks a sufficient description of a range of solution volumes expressed as "20 mL or larger." Although solution volumes of 20 mL and 40 mL are described ('781 Application at 5, 11. 21-22), the '781 Application contains no description of solution volumes such as 60 mL. The Appellant's additional arguments with respect to claims 4, 9, 10, 14, 20, and 21 do not alter our analysis regarding our lack of written description finding for the specified range of container volumes relative to the solution volume. Therefore, we uphold Rejections II and III. 3. Rejections IV & V With respect to claim 1, the Examiner found that Lazure describes a packaged product including a cup-shaped container, which may include doses of liquid medicines or individual servings of food (Final Act. 10-11 ). Relying on the Appellant's AAPA and other references, the Examiner found further that it was known in the art that sucrose solutions are analgesics for reducing pain suffered by infants (id. at 11 ). Because Lazure teaches liquid medicines or servings of food, the Examiner concluded that a person of ordinary skill in the art would have provided a sucrose solution packaged in accordance with Lazure' s teachings as matter of "obvious substitution of one conventional product for another conventional product to be packaged" (id.). Regarding the limitation "wherein the container has a container volume that is at least 50% larger than the volume of the solution" recited in claim 1, the Examiner explained that "the particular volume ratio between the container and its contents are [sic, is] seen to have been an obvious result effective variable, routinely and obviously determinable, as well as an obvious matter 8 Appeal2014-004078 Application 12/424,841 of choice to the ordinarily skilled artisan" (id. at 12). In support, the Examiner referred to "Bublitz, wherein the volume of the container is clearly more than 50% larger than the volume of liquid therein" (id.; Ans. 8, citing Bublitz's Figs. 1 and 2). According to the Examiner, "it is ... plain common sense to reduce the volume of a liquid in a container slightly below the rim when an object, in this case a pacifier, is to be dipped to prevent overflow and the attendant spillage that would be required to be cleaned up" (Ans. 7). The Appellant contends that the particular volume ratio between the container and its content is not a result-effective variable (Appeal Br. 31- 32). According to the Appellant, "[c]onventional solution packaging does not purposefully include a significant amount of dead space in or around a product" (id. at 31 ). The Appellant argues that, by contrast, "the presence of significant dead space in the container [of the claimed invention] is an advantage" in terms of "prevent[ing] the container from tipping when a pacifier is left in the container between dosings" (id. at 31-32). Further, the Appellant argues that the combination of Lazure and Bublitz is flawed because Bublitz "teach[ es] the inclusion of head space in a cup-shaped container to receive a pressure build up from a volatile liquid"-a concern that is not relevant in the proposed combination (id. at 33). The Appellant's arguments are unpersuasive to show reversible error. The Appellant does not refer to any evidence in support of the argument that "[ c ]onventional solution packaging does not purposefully include a significant amount of dead space in or around a product" (id. at 31 ). Indeed, the Appellant's argument is contradicted by Bublitz's Figures 1 and 2, which show containers with substantial headspace. Furthermore, we find no merit 9 Appeal2014-004078 Application 12/424,841 in the Appellant's position that Bublitz is only concerned with volatile products. Contrary to the Appellant's argument, Bublitz teaches that when the container is subject to temperatures above the temperature at which the container is sealed, pressure buildup, which can cause problems to the seal, "may result from pressure buildup in the head space above the product ... or may result from containing a volatile product" (Bublitz, col. 3, 11. 8-10) (emphasis added). Therefore, the Appellant is incorrect in arguing that Bublitz is concerned only with volatile product. Finally, we find no reversible error in the Examiner's position that providing sufficient headspace would have been an obvious design choice. The Appellant does not direct us to any evidence establishing that a person of ordinary skill in the art would have considered the under filling of sucrose solution to prevent overflow that would otherwise occur when a pacifier is dipped into the container to be, e.g., unexpected. Perfect Web Techs., Inc. v. InfoUSA, Inc. 587 F.3d 1324, 1329 (Fed. Cir. 2009) (an analysis of obviousness "may include recourse to logic, judgment, and common sense available to the person of ordinary skill that do not necessarily require explication in any reference or expert opinion"). For these reasons, we uphold Rejections IV and V. SUMMARY Rejections I-V are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l). AFFIRMED 10