Ex Parte 6155485 et alDownload PDFBoard of Patent Appeals and InterferencesSep 17, 201090007995 (B.P.A.I. Sep. 17, 2010) 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. 90/007,995 06/16/2006 6155485 447599 7381 30955 7590 09/17/2010 LATHROP & GAGE LLP 4845 PEARL EAST CIRCLE SUITE 201 BOULDER, CO 80301 EXAMINER TIBBITS, PIA FLORENCE ART UNIT PAPER NUMBER 3992 MAIL DATE DELIVERY MODE 09/17/2010 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 BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte ScriptPro LLC, Patent Owner ____________ Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 Technology Center 3900 ____________ Before ROMULO H. DELMENDO, RICHARD M. LEBOVITZ, and JEFFREY B. ROBERTSON, Administrative Patent Judges. ROBERTSON, Administrative Patent Judge. DECISION ON APPEAL1 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 2 ScriptPro LLC, the owner of the patent under reexamination (hereinafter “the ‘485 Patent”), appeals under 35 U.S.C. §§ 134(b) and 306 from a final rejection of claims 1-41 (Appeal Brief 5 (filed June 12, 2009) (hereinafter “App. Br.”); Final Office Action (mailed November 28, 2008) (hereinafter “Final”)). We have jurisdiction under 35 U.S.C. §§ 134(b) and 306. We AFFIRM. STATEMENT OF THE CASE This reexamination proceeding was initiated by Patent Owner (Corrected Request for Ex Parte Reexamination filed June 16, 2006). We heard Patent Owner’s oral arguments on August 11, 2010, a written transcript of which was entered into the record on August 31, 2010. The ‘485 Patent states that the invention involves a medicament dispensing apparatus that verifies that the correct supply container has been accessed for filling a prescription, provides medicament indicia on the prescription label representative of a physical attribute of the medicament, and enables printing of prescription label in a selected second language. (Col. 1, ll. 48-54.) Claims 1-37 have not been amended during the course of this reexamination proceeding. Claims 38-41 have been added. Claims 1 and 36 on appeal read as follows: 1. A method of filling a prescription for a medicament including a designated amount of the medicament, said method comprising: Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 3 (a) retrieving a supply container of medicament corresponding to the prescription, there being prescription data corresponding to the prescription including the medicament stored in a computer, the container having machine-readable container indicia thereon representative of the medicament therein; (b) using an indicia-reading device coupled with said computer to read said container indicia, to produce container data representative thereof, and to provide said container data to said computer; (c) in said computer, comparing said container data and said prescription data to determine a match therebetween; (d) only if a match in step (c), prompting a printer to print a package label representative of said prescription, said package label including medicament indicia representative of at least one physical attribute of the prescription medicament; (e) removing the designated amount of medicament from said container and placing said designated amount into a package; and (f) applying said package label to said package. 36. A prescription-filling apparatus for filling a prescription for a medicament including a designated amount of the medicament, said apparatus comprising: a language database including language data corresponding to the prescription in a second language; a computer including means for accessing said language database for retrieving language data therefrom corresponding to the prescription to be filled; and a printer coupled with said computer and operable to print a prescription label representative of the prescription, Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 4 said computer including means for activating said printer to print a prescription label with prescription data thereon corresponding to said second language, said computer further includes means for activating said printer to print a first prescription label in a first language and a second prescription label in said second language. (Corrected Claims App’x, App. Br. 21, 27.) The Examiner relied upon the following as evidence of unpatentability (Examiner’s Answer mailed August 4, 2009, hereinafter “Ans.,” 2-3): Baum US 4,918,604 Apr. 17, 1990 Nellhaus ‘937 US 5,031,937 July 16, 1991 Liff US 5,713,485 Feb. 3, 1998 Nellhaus ‘264 US 5,845,264 Dec. 1, 1998 Walker US 5,883,370 Mar. 16, 1999 Ursula Jones, “How to Get More from Your Label” (1998). Carol Ukens, “Oregon Board Pushes New Labels to Cut Rx Errors,” Drug Topics, The Newsmagazine for Pharmacists, WM 001821 (1997). Physicians’ Desk Reference (Medical Economics Data 1991) (hereinafter “Physicians’ Desk Reference PDR 45”). Physicians’ Desk Reference (Medical Economics Data 1995) (hereinafter “Physicians’ Desk Reference PDR 49”). Compendium of Drug Therapy (Edwin S. Geffner ed.), Biomedical Information Company, 1986). Appellant relied on the following (Evidence App’x, App. Br. App’x A): Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 5 Declaration of Michael E. Coughlin, Oct. 30, 2008.2 The Examiner rejected claims 1-41 as follows: I. Claims 1-4, 7, 11-19, 23-26, and 41 under 35 U.S.C. § 103(a) as unpatentable over Walker in view of Baum or Liff (Ans. 4); II. Claim 8 under 35 U.S.C. § 103(a) as unpatentable over Walker in view of Baum or Liff, and further in view of Jones (Ans. 162); III. Claims 21, 22, 36, and 37 under 35 U.S.C. § 103(a) as unpatentable over Walker in view of Baum or Liff, further in view of Jones and Nellhaus ‘264 (Ans. 183); IV. Claims 9, 10, 20, and 38 under 35 U.S.C. § 103(a) as unpatentable over Walker in view of Baum or Liff, further in view of Nellhaus ‘937, Ukens, and the combination of Physicians’ Desk Reference PDR 45, Physicians’ Desk Reference PDR 49, and Compendium (Ans. 163); V. Claim 5 under 35 U.S.C. § 103(a) as unpatentable over Walker in view of Baum or Liff, further in view of Nellhaus ‘937, and the combination of Physicians’ Desk Reference PDR 45, Physicians’ Desk Reference PDR 49, and Compendium (Ans, 101; 2 Appellant also attempts to rely on an additional Declaration of Michael E. Coughlin, filed with the Notice of Appeal on December 29, 2008. However, Appellant did not petition the Examiner’s decision not to consider the Declaration because Appellant had not presented good and sufficient reasons why the Declaration was not presented earlier. (Ans. 228.) See 37 C.F.R. § 1.181. Accordingly, the additional Declaration is not before us on appeal. Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 6 VI. Claims 6 and 27-35 under 35 U.S.C. § 103(a) as unpatentable over Walker in view of Baum or Liff, further in view of Nellhaus ‘937, and the combination of Physicians’ Desk Reference PDR 45, Physicians’ Desk Reference PDR 49, and Compendium, and further in view of Nellhaus ‘264 and Ukens (Ans. 103); and VII. Claims 39 and 40 under 35 U.S.C. § 103(a) as unpatentable over Walker in view of Baum or Liff, further in view of Nellhaus ‘937, the combination of Physicians’ Desk Reference PDR 45, Physicians’ Desk Reference PDR 49, and Compendium, Nellhaus ‘264, and Ukens, and further in view of Jones (Ans. 210). ISSUES Consistent with both the Examiner’s and Appellant’s Briefs, the majority of our discussion will focus on Rejections I and III, which include representative independent claims 1 and 36. We address Rejections II and IV-VII, each which involves the same primary references as in Rejections I and III, as necessary in view of Appellant’s specific arguments in the Briefs. The Examiner found that Walker discloses all of the limitations of claim 1, except for the printing of a physical attribute on a package label as recited in step (d). (Ans. 15; Final 21.) The Examiner found that Baum and Liff both disclose printing a graphic illustration of a drug obtained from a data file on a package label. (Ans. 19-21; Final 21, 22.) The Examiner determined that it would have been obvious to modify Walker’s system to Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 7 include a graphic illustration, such as a color illustration or printed picture of a prescribed drug, and print it on a package label to provide for a better educated consumer/patient and increased security. (Ans. 19-21; Final 23- 24.) Regarding claim 36, the Examiner found that the combined teachings of Walker, Baum, and Liff, fail to disclose printing a second language on a package label. (Ans. 199-202; Final 35-36.) The Examiner found that Jones discloses that it is old and well known in the art to print one label having multiple languages to meet multilingual requirements as well as to eliminate the need for individual single language labels. (Ans. 202; Final 35.) The Examiner also found that Nellhaus ‘264 discloses the used of a text database and an extended database containing textual information about the drug. (Ans. 202; Final 36-37.) The Examiner determined that it would have been obvious to have printed labels with multiple languages in order to meet multilingual requirements and that one would have turned to Nellhaus ‘264 in order to find a solution for storage of multilingual textual information. (Ans. 202-203; Final 37.) Appellant contends that the rejection fails to show conditional printing of a medicament attribute on the basis of computer matching that is traceable back to the supply container. (App. Br. 18.) Specifically, Appellant argues that none of Walker, Baum, and Liff provides a database to facilitate the matching step. (App. Br. 19, 30.) Appellant also contends that there was no database in existence at the time of the invention and that the combination would have been impossible due to lack of technical feasibility to make the combination. (App. Br. 19, 22-23.) Appellant points to Ukens and the Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 8 Coughlin Declaration as evidence that at the time of the invention, one of ordinary skill could not have developed a pharmacy dispensing system operable to print a prescription label with an attribute of a medicament. (App. Br. 22-23.) Appellant argues that secondary considerations such as long felt need, commercial success, and copying by Wal-Mart outweigh the Examiner’s evidence of obviousness. (App. Br. 25-29.) Thus, the principal issues in this appeal are: Did the Examiner err in concluding that a person of ordinary skill in the art would have found it obvious to modify the system of Walker to include printing a physical attribute of a prescription medicament on a package label as disclosed by Baum or Liff, or printing a label with multiple languages as disclosed by Jones and Nellhaus ‘264? Does Appellant’s evidence of secondary considerations outweigh the Examiner’s evidence of obviousness? FINDINGS OF FACT (“FF”) 1. The ‘485 Patent discloses that a computer used in the medicament dispensing station includes a prescription database, an attribute database, a medicament database, and a language translation database, which “may stored locally such as on the hard drive of computer 16 or may be stored remotely such as on a server computer or central pharmacy computer.” (Col. 2, ll. 34-39.) 2. Walker describes an automated drug prescription filling system that uses bar codes to confirm a match between the prescribed Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 9 medicament and the pharmacy container before printing a label for the prescription container. (Col. 1, ll. 49-67.) 3. Walker discloses that the doctor’s computer system may include detailed information on the prescription drug including standard directions for use of the drug, which “may be outputted upon entry and used by the doctor to advise the patient or to consider when prescribing and/or printed out and provided to the patient.” (Col. 5, ll. 39-47.) 4. Baum discloses a computer program for digitally representing a depiction of a pill or capsule, which is retrieved from a computer file of data and printed on a label. (Col. 1, ll. 18-27; Abstract.) Baum also discloses a “multiplicity of files of data,” where “each file of data represent[s] in color a graphic illustration of a different prescription drug.” (Abstract.) 5. Baum discloses: “the system of the present invention is readily adapted for dispensing of prescription drugs by retail pharmacies.” (Col. 1, ll. 51-54.) 6. Baum discloses that in response to a request for a prescription, a main frame computer finds the prescription data packet in its memory and sends the data to a microcomputer, where “[u]pon confirming that the display data conforms with that on the prescription itself, the dispensing pharmacist then actuates a transmit key 27 which causes a printer 19 to print prescription labels.” (Col. 2, ll. 24-53.) Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 10 7. Baum further discloses: [t]he program routines for depicting pictures of each different pill or drug capsule can either be provided by using computer graphics to paint a picture of each different pill or capsule to be prescribed by the system or, alternatively, a video camera can be employed to take a video picture of each pill or capsule which is digitized as a routine to generate the pill or capsule illustration when applied to the printer 19. (Col. 3, ll. 39-46.) 8. Liff discloses a drug dispensing system that includes a host computer and a printer capable of printing packaging labels with pharmaceutical information such as a printed picture of the pharmaceutical, in order to provide additional security. (Col. 6, ll. 36-48.) 9. Liff discloses “[u]pon validating the bar-code 98 of the dispensed package 74, the computer generates a label 58 containing prescription information at a label printer 54.” (Col. 5, ll. 26-28.) 10. Nellhaus ‘264 discloses bar code identification of drugs, where drug information is provided through interaction of a bar code and a drug identification database and extended drug identification database. (Col. 5, l. 25 – col. 6, l. 16.) 11. Jones discloses that one label may be printed in twelve languages due to multilingual requirements. (Jones, p. 1.) 12. Ukens discloses packaging labels containing a description or picture of the drug “could also be printed out in the pharmacy Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 11 when the prescription is entered into the computer system, but . . . not all operating systems will work with the available database.” (Ukens, col. 1, 3.) 13. Ukens also quotes Steven Schulte, R.Ph.-pharmacy inspector: “‘[w]e tried to show drug manufacturers the benefits of accuracy labels for themselves and the public, but we didn’t get very far in that fishing expedition,’ added Shulte. ‘The reaction from the pharmacy profession has been very favorable.’” (Ukens, col. 3.) 14. Nellhaus ‘937 discloses that visual depictions of medication can be reproduced from the Physicians’ Desk Reference (PDR) or Compendium of Drug Therapy. (Col. 2, ll. 9-14.) 15. Mr. Coughlin declared that he was invited to attend a meeting of the Oregon Board of Pharmacy (“The Board”) by Mr. Schulte where the Board planned to propose a requirement to print drug descriptive information on prescription labels. (Coughlin Decl., paras. 7-8.) 16. The other participants at the Board meeting including representatives from chain pharmacies and representatives from software companies objected to including drug descriptive information on labels because “they had no way to do it” and it would drive up the costs of prescriptions/software, and “there was no source of drug description information for them to use.” (Coughlin Decl., para. 10.) Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 12 17. Mr. Coughlin declared that there were a number of technical difficulties involved in placing an image on a prescription label including the lack of necessary permissions to obtain and/or modify data from the Physicians’ Desk Reference, lack of a single database that contained the necessary information about the drugs, and lack of multi-language capability. (Coughlin Decl., para. 12.) 18. Mr. Coughlin declared that Ukens confirms that the combination of Walker, Baum, Liff, and the other references of record would have produced an inoperable result. (Coughlin Decl., para. 12.) PRINCIPLES OF LAW In KSR, the Supreme Court explained, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. “Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instruments v. LKB Produkter AB, 892 F.2d 1547, 1551, (Fed. Cir. 1989); Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991) (“a non-enabling reference may qualify as prior art for the purpose of determining obviousness under § 103.”) Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 13 ANALYSIS While Appellant has separately grouped each of the seven grounds of rejection, as mentioned above, the majority of Appellant’s arguments focus on Rejections I and III. Accordingly, we confine the majority of our discussion to appealed claims 1 and 36, which contain claim limitations representative of the arguments made by Appellants, and address other claims only to the extent that Appellants have argued them separately pursuant to 37 C.F.R. § 41.37(c)(1)(vii). Specifically, our comments with respect to Rejection I apply equally to Rejection VI. Our comments with respect to Rejection III apply equally to Rejections II and VII, and we separately address Rejections IV and V. Rejection I Viewing the prior art as a whole, we are unpersuaded by Appellant’s argument that Walker in view of Baum or Liff fails to show conditional printing of a medicament attribute on the basis of computer matching that is traceable back to the supply container. Walker discloses that a prescription for a medicament is matched with the corresponding pharmacy container via a bar code scan and that in order for processing to continue, such as printing of a label, there must be a match. (FF 2 & 3.) Both Baum and Liff disclose a system for printing an image of a medicament on a prescription label, where each contains a verification step before dispensing a package label. (FF 4-6, 8, & 9.) Baum in particular discloses that the medicament information is present in a data packet that is retrieved from the computer. (FF 6.) Thus, when combined, the evidence supports the Examiner’s determination that the attribute data such as the images of medicaments Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 14 disclosed in Baum and Liff would have been traceable back to the supply container in accordance with the matching step disclosed in Walker. While Appellant contends that providing a database with the recited physical attribute data was not feasible at the time of the invention, we are not persuaded that the evidence on the record is sufficient to support Appellant’s arguments. Initially, we note that claim 1 does not specifically require an attribute database, and that Appellant argues claims 6 and 27-35 (Rejection VI) separately as reciting databases. (App. Br. 33.) Accordingly Appellant’s arguments are not commensurate in scope with the claims not specifically reciting databases as represented by claim 1. For claims 6 and 27-35, Baum expressly discloses that physical attribute data is retrieved from a file of data and provides direction as to how images of medicaments may be added to the data file. (FF 6 & 7.) Moreover, rather than providing evidence that databases including physical attributes of medicaments were not feasible at the time of the invention, Ukens discloses the existence of an “available database.” (FF 12.) Although Ukens discloses that the not all operating systems will work with the available database, the implication of this statement is that at least some operating systems were compatible with the available database. (FF 12.) In light of the prior art discussed above, we are not persuaded by the general statements in the Coughlin Declaration that with respect to including drug descriptive information on labels, the statements that the chain pharmacy and software company representatives “had no way to do it” (FF 16) necessarily means that providing the requisite databases would have been impossible to one of ordinary skill in the art at the time of the Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 15 invention. The chain pharmacies and software companies were also concerned over the cost of prescriptions and software. (FF 16.) Thus, given the opposition to a rule that would increase the costs experienced by pharmacies and software companies, we are not persuaded that one of ordinary skill in the art would have been unable to implement the proposed rule. Importantly, Appellant has provided no direct statements from the representatives of chain pharmacies or software companies to support Appellant’s position. In addition, although the Coughlin Declaration states that there was no source of drug descriptive information to use, there is insufficient evidence, particularly in light of Baum and Ukens, that designing and populating attribute databases, even if expensive, would have beyond the level of one of ordinary skill in the art. In re Farenkopf, 713 F.2d 714, 718 (Fed. Cir. 1983) (reference does not teach away from addition of inhibitor to an Angiotensin I standard solution or composition, where reference indicated that adding inhibitor “can be costly”). Indeed, Baum specifically discloses a “multiplicity of files of data” of drug illustrations (FF 4). Appellant has not provided any evidence that such database lacks enablement. Accordingly, Appellant’s arguments are not persuasive. Rejection III Regarding claim 36, Appellant again relies on the Coughlin Declaration for the proposition that linking multiple languages to other system data was not possible at the time of the invention. (App. Br. 30 & 34.) However, as discussed above, Appellant has not provided sufficient evidence that the “lack of multi-language capability” was a problem that would have been beyond a person having ordinary skill in the art. Indeed, Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 16 Jones discloses that one label may be printed in twelve languages, and Nellhaus ‘264 discloses databases that contain drug information. (FF 10 & 11.) In the absence of a description of the specific problems that would have prevented one of ordinary skill in the art from including drug information in different languages in the databases disclosed by Nellhaus ‘264, the general statements in the Coughlin Declaration do not outweigh the Examiner’s evidence of obviousness. Rejections IV and V Regarding claims 5 and 9, which are representative of the claims subject to Rejections IV and V, we are not persuaded by Appellant’s argument that Nellhaus ‘937 incorrectly stated that visual depictions can be directly reproduced from the Physicians’ Desk Reference. (App. Br. 30-33.) Specifically, the Coughlin Declaration does not explain why the PDR images could not be reproduced as a matter of routine in the art, particularly when Baum discloses that a video camera can be used to take pictures of pills or capsules, which then may be digitized as a routine. (FF 7.) In addition, whether the PDR images had been licensed as of 1997, does not provide any information as to whether the use of the images would have been impossible. Further, the Coughlin Declaration provides insufficient facts to support the statement that no one had licensed the PDR data. Nonetheless, Baul specifically refers to drug illustrations in a multiplicity of files (FF 4). Thus, Appellant’s arguments are unconvincing. Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 17 Secondary Considerations Once a prima facie case of obviousness has been established, objective evidence of secondary considerations, when present, must be considered in making an obviousness decision. See Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538-39 (Fed. Cir. 1983). Any initial obviousness determination is reconsidered anew in view of the proffered evidence of nonobviousness. See In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976); In re Eli Lilly & Co., 902 F.2d 943, 945 (Fed. Cir. 1990); Ex Parte Quist, No. 2008-001183, at 10-11 (BPAI June 2, 2010) (Precedential) (available at http://www.uspto.gov/ip/boards/bpai/decisions/prec/fd08001183.pdf). The ultimate determination of whether a claimed invention would have been obvious or non-obvious is a legal conclusion, which is made based on considering and weighing all of the facts in evidence. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). A “nexus” must be established between the merits of the claimed invention and the evidence of secondary considerations in order for the evidence to be given substantial weight. See In re GPAC, Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). The scope of the “objective evidence of non- obviousness must be commensurate in scope with the claims which the evidence is offered to support.” In re Tiffin, 448 F.2d 791, 792 (CCPA 1971); see also In re Peterson, 315 F.3d 1325, 1329-31 (Fed. Cir. 2003). The objective evidence is not commensurate in scope (coextensive) with the claimed subject matter if the claims are unreasonably broader in scope than the scope of the objective evidence, e.g., if the product included Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 18 elements or features not recited in the claims which may be responsible for the commercial success or praise. See Joy Techs., Inc. v. Manbeck, 751 F. Supp. 225, 229-30 (D.D.C. 1990), aff'd, 959 F.2d 226 (Fed. Cir. 1992). Long-Felt Need Establishing long-felt need requires objective evidence showing existence of a persistent problem recognized by those of ordinary skill in the art for which a solution was not known. In re Gershon, 372 F.2d 535, 539 (CCPA 1967). In addition, the long-felt need must not have been satisfied by another before the invention by applicant. Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988). Hence, the appellant must present affidavits or other factual evidence of “a failure of others to provide a feasible solution to [a] long-standing problem” and evidence “that experts did not foresee” the solution claimed. See In re Piasecki, 745 F.2d 1468, 1475 (Fed. Cir. 1984). Finally, the invention must satisfy the long-felt need. In re Cavanagh, 436 F.2d 491, 496 (CCPA 1971). Appellant contends that there was a long felt need for a pharmacy dispensing system that included the capability to print an attribute such as an image or descriptive text on a prescription label to help reduce pharmacy dispensing errors. (App. Br. 25.) Appellant acknowledges that Baum and Nellhaus ‘937 disclose showing images of pills on prescription labels, but argues that because of technical problems in printing pill images the need was unmet at the time of the invention. (App. Br. 25-26.) Appellant contends that had such printing been feasible, Appellant would not have been approached in order to help persuade the attendees of the Board Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 19 meeting that a requirement for prescription labels to include images of pills would be feasible. (App. Br. 26.) Appellant again points to the Coughlin Declaration where industry members stated that they had no way to implement the proposed requirement. (App. Br. 26.) However, in view of Baum and Liff, which both disclose images of pills on prescription labels, we are not persuaded that there was a long felt need that was unsatisfied by others. In addition, as discussed above, in view of the prior art, the Coughlin Declaration is not sufficient to establish that that printing labels with physical attributes of a medicament would not have been feasible. Commercial Success/Copying If evidence of commercial success is relied upon, the Appellant must offer proof “that the sales were a direct result of the unique characteristics of the claimed invention—as opposed to other economic and commercial factors unrelated to the quality of the patented subject matter.” In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996). The evidence must also demonstrate commercial success in the relevant market. See Id. In addition, there must be a nexus between the commercial success and merits of the claimed invention. Cable Elec. Prods., Inc. v. Genmark, Inc., 770 F.2d 1015, 1026 (Fed. Cir. 1985). The mere fact of copying is insufficient to make the action significant in an obviousness analysis. Cable Elec. Prods., Inc. v. Genmark, Inc., 770 F.2d 1015, 1027 (Fed. Cir. 1985), overruled on other grounds by, Midwest Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 20 Indus., Inc. v. Karavan Trailers, Inc., 175 F.3d 1356, 1359 (Fed. Cir. 1999) (en banc). Appellant contends that commercial success has been demonstrated because Appellant’s systems operate in thousands of pharmacies in over 10 countries. (App. Br. 27.) Appellant also argues that commercial success has been shown because Wal-Mart copied Appellant’s systems and methods. (App. Br. 27-28.) Appellant contends that a nexus between the claims and the commercial success is shown by Wal-Mart’s actions as well as laws requiring accuracy labels. (App. Br. 28.) Appellant provides insufficient evidence to establish a nexus between the claims and the alleged commercial success. Although Appellant’s systems may operate in a large number of pharmacies, Appellant has provided no sales data, evidence of market share, or other data which would establish commercial success of a system within the scope of the claims. In addition, the existence of laws in some States requiring accuracy labels is a regulatory factor that is unrelated to the merits of the invention. Regarding Appellant’s allegations of copying, Appellant does not provide sufficient details correlating the systems employed by Wal-Mart to the present claims. Moreover, Appellant’s argument that Wal-Mart emphasized an invalidity/unenforceability defense (App. Br. 28), provides evidence that Wal-Mart’s copying may be attributed to other factors, such as lack of concern for patent property or contempt for the patentees ability to enforce the patent. Cable Elec. Prods., 770 F.2d at 1028. Thus, Appellant’s Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 21 evidence of commercial success is not sufficient to outweigh the Examiner’s evidence of obviousness.3 CONCLUSION On this record, Appellant has failed to demonstrate any error in the Examiner’s factual findings and conclusions that: a person of ordinary skill in the art would have found it obvious to modify the system of Walker to include printing a physical attribute of a prescription medicament on a package label as disclosed by Baum or Liff or printing a label with multiple languages as disclosed by Jones and Nellhaus ‘264; Appellant’s evidence of secondary considerations outweigh the Examiner’s evidence of obviousness. DECISION The Examiner’s decision to reject claims 1-41 under 35 U.S.C. § 103(a) is affirmed. Requests for extensions of time in this ex parte reexamination proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f). AFFIRMED 3 To the extent that Appellant’s arguments rely on evidence presented in the second Coughlin Declarations, e.g., for professional approval (App. Br. 29), such arguments are not persuasive as they are insufficiently supported by evidence in the record. See n.2 infra. Appeal 2010-007567 Reexamination Control 90/007,995 Patent 6,155,485 22 KMF LATHROP & GAGE LLP 4845 Pearl East Circle, Suite 201 Boulder, CO 80301 Copy with citationCopy as parenthetical citation