David A. Miceli et al.

Patent Trials and Appeals BoardAug 26, 2019

13875785 - (D) (P.T.A.B. Aug. 26, 2019)

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. 13/875,785 05/02/2013 David A. Miceli 67191.P3 4004 408 7590 08/26/2019 LUEDEKA NEELY GROUP, P.C. P O BOX 1871 KNOXVILLE, TN 37901 EXAMINER VERAA, CHRISTOPHER ART UNIT PAPER NUMBER 3636 NOTIFICATION DATE DELIVERY MODE 08/26/2019 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): LNG.PATENT@gmail.com docketing@luedeka.com eofficeaction@appcoll.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte DAVID A. MICELI and JOSEPH A. MICELI ____________________ Appeal 2017-011642 Application 13/875,785 Technology Center 3600 ____________________ Before EDWARD A. BROWN, JILL D. HILL, and LEE L. STEPINA, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE1 Appellant2 appeals under 35 U.S.C. § 134 from a rejection of claims 4–14. 3 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 A hearing was conducted on July 31, 2019. 2 The Appeal Brief indicates that Appellant, Tri State Distribution, Inc., is the real party in interest. Appeal Br. 1. 3 Claims 1–3 have been cancelled. Appeal Br. 11 (Claims App.). Appeal 2017-011642 Application 13/875,785 2 CLAIMED SUBJECT MATTER The claims are directed to a method of manufacturing and shipping pharmaceutical containers with pre-applied advertising labels. Claim 4, the sole independent claim on appeal, is reproduced below. 4. A method for a manufacturer of prescription containers to improve the efficiency of a pharmacy prescription labeling process, the method comprising: producing a plurality of empty prescription containers; receiving from the pharmacy a selection of generic information independent from a patient or prescription medicine to be dispensed to the patient at the pharmacy; printing the selected generic information off-site from the pharmacy on a plurality of secondary labels; applying one of the secondary labels to a first exterior surface portion of a plurality of empty prescription containers off-site from the pharmacy; and shipping the plurality of empty prescription containers having pre-applied secondary labels to the pharmacy, wherein each of the plurality of empty prescription containers having pre- applied secondary labels are operable to receive prescription medicine prescribed to particular patients and one or more primary prescription labels having patient and prescription medicine specific information printed thereon at the pharmacy on a second exterior surface portion of the empty prescription container. Appeal Br. 11 (Claims App.). REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: de la Huerga US 7,922,073 B2 Apr. 12, 2011 Miceli Gear US 2008/0262930 A1 US 2010/0329822 A1 Oct. 23, 2008 Dec. 30, 2010 Appeal 2017-011642 Application 13/875,785 3 REJECTION4 Claims 4–14 are rejected under 35 U.S.C. § 103 as unpatentable over Miceli, Gear, and de la Huerga. OPINION The Examiner relies on Miceli to teach most of the steps required by method claim 4, including that advertisements may be selected based on criteria independent of the patient and medicine. Final Act. 5 (citing Miceli ¶¶ 11, 13, 16, 34–36, Figs. 1, 2, 6). In particular, the Examiner finds that Miceli discloses two types of labels for a pharmaceutical container, namely, label 18 (described by Miceli as having the patient name, pharmaceutical, and warnings) and label 30 (advertising selected based on various criteria). Id. The Examiner finds that Miceli does not teach printing advertising labels off-site from the pharmacy and applying them to containers that are provided in bulk to the pharmacy. Id. The Examiner relies in Gear to remedy this deficiency because Gear discloses a method for producing multiple-section documentation that includes sections that are pre-printed in bulk off-site, supplied to a collating machine, and then combined with a customized section that is separately printed for an individual. Id. at 6 (citing Gear ¶¶ 104, 167). The Examiner reasons that it would have been obvious “to print the advertising labels of Miceli off-site from the [sic] where they are combined with the personalized prescription labels, as taught 4 The Examiner withdrew a rejection of claims 1–14 as failing to comply with the written description requirement. Ans. 4; see also Final Act. 3. Appeal 2017-011642 Application 13/875,785 4 by Gear, in order to take advantage of large-scale high quality printing services and still produced individualized labels on the containers.” Id. The Examiner also finds that Miceli “does not teach applying advertising labels onto empty containers off[-]site from the pharmacy.” Final Act. 6 (emphasis added). The Examiner turns to de la Huerga to remedy this deficiency, finding “[d]e la Huerga teaches that blood sample tubes are often labelled with a manufacturer label and then with a second label prepared for a specific patient when samples are collected.” Id. (citing de la Huerga 1:47–63, 2:5–17). The Examiner determines that it would have been obvious to apply the advertising labels taught by Miceli when the containers are manufactured, as taught by de la Huerga, prior to supplying a pharmacy with the containers, while specific pharmaceutical information is applied on a separate label when medicine is dispensed (the prescription labels still being prepared by the pharmacist). Id. (citing de la Huerga 1:64– 69). The Examiner reasons that doing so would allow the advertising labels to be applied to the containers more efficiently and precisely. Id. Non-analogous Art Appellant contends that neither Gear nor de la Huerga is analogous art. Appeal Br. 4. Our reviewing court has set forth a two-prong test for determining whether a prior art reference is analogous: (1) whether the reference is from the same field of endeavor as the claimed invention, and (2) even if the reference is not within the same field of endeavor, whether the reference is reasonably pertinent to the particular problem with which the inventor is involved. In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011). Thus, a reference is analogous art if it satisfies either prong of the test. We address each of these prongs below. Appeal 2017-011642 Application 13/875,785 5 (Gear) Field of Endeavor Appellant contends that the relevant field of endeavor is limited to the dispensing and labeling of prescription containers at a pharmacy. Appeal Br. 4. Appellant then summarizes the disclosure of Gear and states, “Gear has absolutely no relevance to a method of improving the prescription dispensing and labeling process by shipping a prescription container with a pre-printed label containing generic information for subsequent labeling of the prescription container at a pharmacy with prescription specific information.” Id. at 5–6. In response, the Examiner contends that none of the recited steps is required to occur at a pharmacy, and, therefore, Appellant’s statement of the field of endeavor is incorrect. Ans. 4–5. The Examiner then states: Gear solves the same problem of how to increase efficiency in a printing process with the same solution of combining a bulk printing process for generic information with a low-volume printing process for customized information. This is clearly analogous to the [A]ppellant’s problem. After all, a printed label is a type of document. Id. at 5. In reply, Appellant asserts that the majority of information printed on a prescription container is unique to the patient and printed on-demand at the pharmacy, and Gear is not related to labeling, much less labeling a container. Reply Br. 1–2.5 5 This appears to misstate the claim requirements inasmuch as the final printing step is not recited in claim 4. Rather, claim 4 requires the “the plurality of empty prescription containers having pre-applied secondary labels are operable to receive prescription medicine prescribed to particular patients and one or more primary prescription labels having patient and prescription medicine specific information printed thereon at the pharmacy.” Appeal Br. 11 (Claims App.) (emphasis added). Appeal 2017-011642 Application 13/875,785 6 Appellant has the better position on this point because the Examiner appears to mix the two distinct prongs of the analogous art test. Appellant’s Specification explains the field of the invention, stating “[t]his disclosure relates generally to labeling of prescription containers.” Spec. ¶ 2. This statement is not dispositive of the field of endeavor inquiry, and, in view of the entire Specification, it appears to be a statement of the field of endeavor combined with the commercial sector in which this field of endeavor is to be implemented. See Spec. ¶¶ 2–3, 21. Rather than require the substrate containers to be “pharmaceutical containers,” we determine that the field of endeavor is the labeling of containers, but not necessarily pharmaceutical containers. The Examiner’s description of Gear as being analogous to Appellant’s problem does not relate Gear’s teachings to the labeling of containers. Rather, this statement would seem to address the second prong of the analogous art inquiry, namely, whether Gear is reasonably pertinent to the problem addressed by the inventor. We agree with Appellant that Gear, which discloses a method of producing a multiple-section publication document, is not in Appellant’s field of endeavor. (Gear) Reasonably Pertinent to the Particular Problem “A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor’s attention in considering his problem.” In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). “[F]amiliar items may have obvious uses beyond their primary purposes.” KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 402 (2007). Appeal 2017-011642 Application 13/875,785 7 Appellant argues that, because “Gear does not involve printing of labels or any type of labeling process [, and does not] relate to any type of dispensing or collection system in which certain information must be printed ‘on demand’ at the time of dispensing or collection,” Gear is not reasonably pertinent to the problem addressed by Appellant. Appeal Br. 5. As noted above, the Examiner’s response is that Gear solves the same problem of increasing efficiency in a printing process and does so by printing generic information with a bulk process and printing customized information with a low-volume process. Ans. 5. In reply, Appellant argues that Gear is not related to labeling any type of container. Reply Br. 6. The Examiner has the better position on this point. Appellant’s Specification states: The present disclosure advantageously enables a pharmacy to continue in their normal manner of providing prescription containers with labels having SIG, Purpose, and Auxiliary information, yet also having labels thereon containing desired black and white designs with detailed graphic images and custom color advertising and other color printings not achievable using the printers used by pharmacies to print prescription labels at the pharmacy. Spec. ¶ 8. Thus, Appellant’s invention allows two different types of information presented on labels, and, in particular one of the types is not achievable using pharmacies’ local printers. The Specification describes an intent to achieve this goal economically. See Spec. ¶ 34. Gear teaches printing two different types of information in a document. See Gear ¶¶ 104–105, 167. Specifically, Gear states: The customised section generator 240 includes a processor 242 and associated database 244 configured to generate a Appeal 2017-011642 Application 13/875,785 8 customised section 248, bearing content determined by the information in the content request 213. The customised section 248 is printed by a digital printing press 246. The customised section 248 includes a machine-readable tag 250 which includes information from the content request 213. In particular, the customised section 248 can include customised or personalised content (i.e. text and imagery), personalised advertisements and so on. As will be described in more detail below, the tag 250 provides instructions to control a collating machine 252. Gear ¶¶ 104–105; see also id. Abstract. Thus, as the Examiner finds (Final Act. 6), Gear discloses a customized section that is separately printed for an individual. Gear further discloses providing a large number of identical preprinted sections produced by high-volume printing processes such as offset lithography and that the cost of producing the pre-printed sections is low. Id. ¶ 167. Thus, like the goal described in Appellant’s Specification, Gear seeks to use two different printer capabilities to provide a combination of two types of printing (one being customized, the other being high-volume pre- printed). We do not agree with Appellant that the fact that claim 4 recites that the printing is on labels, and that the labels are then applied to the surfaces of prescription containers, distinguishes the teachings of Gear such that a person of ordinary skill in the art would not consider Gear reasonably pertinent to the relevant problem. As the Examiner correctly points out (Ans. 5), a printed label is a type of document. Further, it is not necessary for the substrate upon which the printing occurs in Gear to be identical to the substrate recited in claim 4, rather, Gear’s teachings must be reasonably pertinent to the problem addressed by Appellant. This criterion is satisfied because the benefits appear to be the same with the substrates disclosed by Appeal 2017-011642 Application 13/875,785 9 Gear and Appellant’s substrates. For example, the benefits provided by the system discussed in Gear (increased cost efficiency and quality of printing (see Gear ¶ 21)) are practically identical to the benefits allegedly provided by the claimed invention (providing “economically achievable” printing for advertising that is not achievable using single color printers) (see Spec. ¶ 35, Appeal Br. 5)). Accordingly, we agree with the Examiner that Gear is reasonably pertinent to the problem addressed by Appellant, and, therefore, qualifies as analogous art. (de la Huerga) Field of Endeavor Arguing that de la Huerga is not in the same field of endeavor as the claimed invention, Appellant states, “[t]he cited ‘Background of the Invention’ portion of Huerga likewise has no relevance to the dispensing or labeling of prescription containers. In this regard, the cited background portion of Huerga is directed to the traditional process of labeling blood sample test tubes.” Appeal Br. 6 (emphasis added). Appellant goes on to assert that “[w]hile the labeling of blood sample test tubes described in Huerga’s background does involve applying a ‘manufacturer label’ to shipped test tubes and subsequent labeling of the test tubes at the collection facility, it must be recognized that the labeling of blood sample tubes is significantly different than prescription labeling.” Id. Thus, Appellant focuses on the content of the container disclosed de la Huerga (allegedly, blood). Appellant also contends that de la Huerga’s label information is used internally, by same entity that orders the test tubes from the manufacturer, and this information is used differently than the information used on pharmaceutical containers. Id. We find this argument unavailing. We do not agree that the intended audience for the information written on the container, or the content of the Appeal 2017-011642 Application 13/875,785 10 container (pharmaceuticals or blood samples) separates the containers recited in claim 4 from the containers recited in de la Huerga to such an extent that de la Huerga is not in Appellant’s field of endeavor. Like Appellant’s claimed method, de la Huerga labels small containers at the manufacturer, and then further labels these small containers at a medical facility. The similarity in these methods is strong, and the fact that both methods deal with containers in the medical industry confirms that de la Huerga is in the field of labeling of containers. Even assuming, for the purpose of argument, that the field of endeavor required some connection to pharmaceutical containers, and not merely containers, de la Huerga discloses this specific application as well. “There are also a variety of other containers in healthcare that need to be carefully labeled, for example medication containers or vials.” de la Huerga 2:59–61; see also Ans. 5.6 Thus, Appellant’s argument regarding the content and purpose of the containers disclosed by de la Huerga misses important facts regarding the wider applicability of de la Huerga’s disclosure. Accordingly, de la Huerga satisfies the first prong of the test for analogous art, and, therefore, qualifies as analogous art. See Klein, 647 F.3d at 1348. The Selection Step Appellant next argues neither Gear nor de la Huerga discloses or suggests a prescription labeling process in which the manufacture of the prescription container “receiv[es] from the pharmacy a selection of generic information independent from a patient or prescription medicine to be dispensed to the patient at the pharmacy” and then ships empty prescription containers with 6 de la Huerga also indicates that its method can be applied even more generally. “Problems such as these can go far beyond the medical field. In the manufacturing industry, for instance, it is often important to keep adequate records of individual components.” de la Huerga 4:26–28. Appeal 2017-011642 Application 13/875,785 11 a pre-applied label containing the selected generic information for subsequent labeling at the pharmacy. Appeal Br. 8–9. Thus, Appellant contends that the portion of the method recited in claim 4 requiring a selection is missing from Gear and de la Huerga. Specifically, Appellant argues that Gear “has nothing to do with labeling or dispensing of any type of container and the information of Huerga’s pre-applied manufacturer label is chosen/selected by the manufacturer of the test tube instead of the collection facility out of necessity (i.e., to identify the purpose/reagents of the particular test tube and to provide a bar code for tracking the test tube).” Id. at 9. The Examiner characterizes Appellant’s argument on this point as an attack on the references individually rather than on the combination proposed in the rejection, and notes that Miceli is relied on to teach that generic information is selected by a pharmacist using a computer. Ans. 7 (citing Miceli ¶ 36). The Final Office Action refers to paragraphs 34–36 of Miceli for this disclosure. See Final Act. 5. The Examiner also states “[t]here is no ‘selecting’ step recited in the claim at issue.” Id. Appellant replies that in claim 4, “the selection limitation is provided in the claimed step where the manufacture of the prescription container ‘receiv[es] from the pharmacy a selection of generic information independent from a patient or prescription medicine to be dispensed to the patient at the pharmacy.’” Reply Br. 3. Appellant then reiterates “none of the references disclose or suggest a manufacture of a prescription container receiving a selection of generic information from a pharmacy and then shipping a container with the generic information on a pre-printed label applied to the shipped container.” Reply Br. 3. Appeal 2017-011642 Application 13/875,785 12 Although we agree with Appellant that claim 4 implicitly7 requires that a selection of generic information has to have occurred prior to execution of the recited method, this requirement is accounted for by the Examiner’s rejection (see Final Act. 5), and Appellant’s argument amounts to an attack on Gear and de la Huerga, individually, whereas the rejection of claim 4 relies on a combination of the teachings of Miceli, Gear, and de la Huerga. Appellant does not dispute that Miceli “teaches applying secondary advertising labels 30 to a medicine container separately from a primary pharmaceutical label 18” and “that the advertisements may be selected based on criteria independent from the patient and medicine.” Final Act. 5 (citing Miceli ¶¶ 11, 13, 16, 34–36, Figs. 1, 2, 6) (emphasis added). Paragraph 36 of Miceli explains how the advertisements are selected by a computer operated by a pharmacist. The Examiner correctly finds that Gear discloses a method for producing multiple-section documentation that includes sections that are pre-printed in bulk off-site and then combined with a customized section that is separately printed. Id. at 6. The Examiner modifies the process in Miceli to print Miceli’s advertisements (which are selected by a computer operated by a pharmacist) off-site. Id. Thus, the advertisements that are printed off- site are based on a selection received from the pharmacy. Appellant merely recites a portion of claim 4 that the Examiner addresses with the 7 We understand the Examiner statement that “[t]here is no selecting step recited in the claim at issue” (Ans. 7) to mean that there is no requirement for the entity practicing the claimed invention to be the one who actively “selects.” Rather, a selection is made by an actor, at some prior time to occurrence of at least a portion of the steps recited in claim 4, and claim 4 recites “receiving from the pharmacy [the] selection.” Appeal Br. 11 (Claims App.). Appeal 2017-011642 Application 13/875,785 13 combination of the three cited references and asserts that none of the references, taken individually, discloses that entire portion of the claim. Accordingly, Appellant’s comments on this point are not persuasive. Appellant, in the Reply Brief, attacks the Examiner’s reasoning for the proposed modification to Miceli. Reply Br. 2–3. Specifically, Appellant states: Without recognition of the problem that labeling of prescription containers entirely at the pharmacy is inefficient for at least some labels and/or pharmacies, the prior art references cannot be combined as suggested by the Examiner as there is no motivation or reason to make such modification contained within the record. Id. at 2. Thus, Appellant contends that the prior art did not recognize the problem addressed by Appellant’s invention. First, we disagree with Appellant’s argument because the reason for making the proposed modification does not have to be the same reason as Appellant’s. See In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996). Moreover, “neither the particular motivation nor the avowed purpose of the [Appellant] controls” in an obviousness analysis. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). Thus, it is not necessary that any of the prior art recognize “the problem that labeling of prescription containers entirely at the pharmacy is inefficient for at least some labels and/or pharmacies.” Reply Br. 2. Second, the rationales articulated by the Examiner on page 6 of the Final Office Action are supported by the disclosures of Gear (improved economy and efficiency) and de la Huerga (improved efficiency and precision).8 See Gear ¶¶ 21, 167; de la Huerga 1:64–69. Further, Appellant, 8 Notwithstanding the fact that the Examiner’s rationale does not have to be the same as Appellant’s in order to be adequate, it would appear that the Appeal 2017-011642 Application 13/875,785 14 in the attack on the Examiner’s reason for making the proposed modification, does not dispute that the benefits of the proposed combination of references touted by the Examiner would occur. See Reply Br. 1–3. The fact that the proposed modifications to the process disclosed by Miceli would result in an improvement (which is uncontested by Appellant), is sufficient underpinning for the Examiner’s stated reasoning. We sustain the Examiner’s rejection of claim 4 as unpatentable over Miceli, Gear, and de la Huerga. Claims 5–14, which are not argued separately, fall with claim 4. DECISION The Examiner’s rejection of claims 4–14 is affirmed. 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 Examiner’s reasons for making the proposed combination of teachings align with the benefits Appellant’s disclose as resulting from the claimed invention. See Spec. ¶ 34.