2020001926 (P.T.A.B. Nov. 2, 2020)

ID-CON, LLC

Patent Trials and Appeals BoardNov 2, 2020

2020001926 (P.T.A.B. Nov. 2, 2020)

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. 15/158,957 05/19/2016 Roy S. Luoma 12200.2C1 4998 27774 7590 11/02/2020 MAYER & WILLIAMS PC 55 Madison Avenue Suite 400 Morristown, NJ 07960 EXAMINER CICCHINO, PATRICK D ART UNIT PAPER NUMBER 3619 NOTIFICATION DATE DELIVERY MODE 11/02/2020 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): docket@mwpatentlaw.com kwilliams@mwpatentlaw.com mwolf@mwpatentlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ROY S. LUOMA, MARK C. DOYLE, and LINDA S. LUOMA __________ Appeal 2020-001926 Application 15/158,957 Technology Center 3600 __________ Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and ANNETTE R. REIMERS, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–11, 18, 19, 23, 26, 34–36, 54, and 55. Non-Final Act. 1 (Office Action Summary). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE and enter NEW GROUNDS OF REJECTION under 35 U.S.C. § 41.50(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “ID-CON, LLC.” Appeal Br. 1. Appeal 2020-001926 Application 15/158,957 2 CLAIMED SUBJECT MATTER The claimed subject matter “relates to packaging systems, and to methods for making and using customized packages, e.g., single-dose packages provided together, e.g., in a container, strip, and the like.” Spec. 2:7–9. Apparatus claims 1 and 55 and method claim 26 are independent. Claim 1 is illustrative of the claims on appeal and is reproduced below. 1. An apparatus for administering medications to a patient, the medications provided in a strip, the strip comprising a base layer with multiple blisters defined therein and a cover attached to the base, and the strip further comprising a first dispensing end, a second end, and a plurality of blisters aligned in single file generally along a longitudinal axis between the first and second ends and arranged in single-dose packages adjacent one another, at least some of the single-dose packages including a plurality of blisters having different types of medications therein, each blister containing a single tablet, pill, or other medication, the base layer and cover having weakened regions or perforations between adjacent single dose packages, the cover further comprising machine readable features that at least indicate specific locations of items within a single dose package, the apparatus comprising: a housing for receiving the strip therein such that the first dispensing end extends from an outlet of the housing; a drive mechanism within the housing and coupled to the strip for selectively advancing the strip to dispense single-dose packages sequentially from the outlet; a reader adjacent the outlet for reading one or more labels on each of the single-dose packages; and a controller coupled to the reader and the drive mechanism for reading a label on a single-dose package adjacent the outlet and determining a scheduled administration time for medications in the single-dose package and for actuating the drive mechanism to dispense the-single-dose package from the outlet at or about the scheduled administration time, the controller further configured to extend the strip through the first dispensing end a Appeal 2020-001926 Application 15/158,957 3 distance based on the prescription, the distance accommodating a plurality of blisters in a single dose package, at least some of the single-dose packages including different numbers of blisters as between adjacent packages. EVIDENCE Name Reference Date Lewis US 6,681,935 B1 Jan. 27, 2004 Joslyn US 8,135,497 B2 Mar. 13, 2012 Waugh et al. (“Waugh”) US 2012/0083666 A1 Apr. 5, 2012 THE REJECTIONS ON APPEAL Claims 1, 8–11, 18, 19,2 23, 26, 34, 35, 54, and 55 are rejected under 35 U.S.C. § 103 as unpatentable over Waugh and Lewis. Non-Final Act. 2. Claims 2–7 and 363 are rejected under 35 U.S.C. § 103 as unpatentable over Waugh, Lewis, and Joslyn. Non-Final Act. 6. 2 The Examiner does not list claim 19 in the header of this rejection. Non- Final Act. 2. However, claim 19 is discussed in the body of the rejection. Non-Final Act. 5. 3 The Examiner also lists claim 35, but this claim is not addressed in the body of the rejection and thus, its listing is considered to be an oversight. Appeal 2020-001926 Application 15/158,957 4 ANALYSIS NEW GROUND OF REJECTION OF CLAIMS 1–11, 18, 19, 234 Independent claim 1 recites “[a]n apparatus for administering medications to a patient . . . , the apparatus comprising: a housing . . . ; a drive mechanism . . . ; a reader . . . ; and a controller . . . .” Appeal Br. 9 (Claims App); emphases added. The preamble of claim 1 recites “the medications provided in a strip, . . . the strip further comprising . . . a plurality of blisters aligned in single file . . . and arranged in single-dose packages adjacent one another, at least some of the single-dose packages including a plurality of blisters.” Appeal Br. 9 (Claims App); emphases added. Appellant contends that the cited art fails to disclose the limitations pertaining to the blisters, i.e., “[t]aken together, all the blisters in a single package provide a single dose of medication.” Appeal Br. 5. As discussed above, claim 1 is drawn to an apparatus for administering medications in which the apparatus comprises various components including a housing, a drive mechanism, a reader, and a controller. To be clear, claim 1 recites that the claimed housing is “for receiving the strip;” the claimed driving mechanism is “coupled to the strip for selectively advancing the strip;” the claimed reader is “adjacent [to] the outlet for reading one or more labels on each of the single-dose packages;” 4 Because Appellant’s application was filed after September 16, 2012, the effective date of the amendments to 35 U.S.C. § 112 enacted by the Leahy- Smith America Invents Act (AIA), the AIA version of the statute applies. See AIA, Pub. L. No. 112–29, § 4(e), 125 Stat. 284, 297 (2011). Appeal 2020-001926 Application 15/158,957 5 and, the claimed controller is “for reading a label on a single-dose package.” Emphases added. Regardless, claim 1 does not recite that the apparatus comprises the strip, and more specifically, the particular strip recited in the preamble, i.e., one that has a plurality of blisters forming a single dose. In other words, the strip may be used to help define the claimed combination but we do not read the strip as forming part of the claimed combination for purposes of evaluating patentability and infringement. At best, the components of the apparatus of claim 1 can be used for a strip that contains medication or can be used for a plurality of blisters that form a single dose. Thus, the plurality of blisters forming a single dose does not appear to have any bearing on the claimed apparatus. Yet, Appellant’s contention, reiterated above, suggests otherwise.5 Thus, the record should be clarified to indicate how the components of the apparatus of claim 1 are actually affected by the plurality of blisters that form a single dose, i.e., what structures of the components are influenced by whether the plurality of blisters form a single dose. In its current form, claim 1 does not provide sufficient certainty for the potential infringer to evaluate the possibilities of being held liable for direct and/or contributory infringement. “[T]he claims must make it clear what subject matter they encompass.” In re Hammack, 427 F.2d 1378, 1382 (CCPA 1970). Also, “during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed. . . . [T]his way . . . uncertainties of claim scope [can] be removed, 5 The Examiner also appears to believe that the strip, or the plurality of blisters forming a single dose, has some bearing on the components of the apparatus of claim 1. See Non-Final Act. 3–4; Ans. 10–11. Appeal 2020-001926 Application 15/158,957 6 as much as possible, during the administrative process.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). For these reasons, we enter a new ground of rejection of claim 1 and its dependent claims 2–11, 18, 19, and 23 under 35 U.S.C. § 112(b), in order for this ambiguity to be definitively resolved, one way or another, during prosecution. See Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (precedential); accord In re Packard, 751 F.3d 1307, 1324 (Fed. Cir. 2014) (Plager, J., concurring). NEW GROUND OF REJECTION OF CLAIMS 26, 34–36, AND 54 Independent claim 26 (and hence dependent claims 34–36 and 54) recite “the strip comprising the plurality of blisters aligned in a single file . . . and arranged in single-dose packages adjacent one another.” It is not altogether clear whether the intent of this limitation is to indicate the strip or the blisters as being “aligned in a single file” as well as “arranged” in the manner recited. The wording appears to refer back to limitations not previously set forth. We note that independent claim 55 demonstrates Appellant’s intent with more clarity on these points because claim 55 recites, “the plurality of blisters is aligned in a single file . . . and arranged in single- dose packages adjacent one another.” Such precision and clarity is missing in claim 26. Additionally, it is noted that the body of claim 26 recites “comprising: reading one or more labels on a single-dose package,” whereas the preamble refers to “single-dose packages” and also “at least some of the single-dose packages.” Thus, it is not evident whether the body of claim 26, which recites “a single-dose package,” refers to one of the aforesaid packages or to Appeal 2020-001926 Application 15/158,957 7 yet another package. As indicated above, it is “during patent prosecution when claims can be amended[ that] ambiguities should be recognized . . . and clarification imposed.” Zletz, 893 F.2d at 321. Accordingly, and in view of the above new grounds of rejection, we do not reach the merits of the art rejections of claims 1–11, 18, 19, 23, 26, 34–36, and 54 because we are unable to review them without having to make speculative assumptions about the meaning of the language of the rejected claims. Consequently, we are constrained to reverse the prior art rejections (see Non-Final Act. 2–7). See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language.). THE REJECTION OF CLAIM 55 AS BEING UNPATENTABLE OVER WAUGH AND LEWIS Independent claim 55 recites “wherein at least one pair of adjacent single-dose packages has a different number of blisters contained within the adjacent single-dose packages.”6 Appeal Br. 13 (Claims App.) (emphasis added). Claim 55 additionally recites, “each blister containing a single tablet or pill of the medication.” Id. Appellant acknowledges that paragraph 72 of Waugh teaches that “[e]ach container may contain, for example, a single pill,” which is consistent with the latter limitation above.7 Appeal Br. 6. 6 We note that similar “different number of blisters” limitations can be found in independent claims 1 and 26. 7 Of interest is Appellant’s contention “that Waugh fails to show a single dose package with a plurality of blisters.” Appeal Br. 6. But Appellant does not explain if, as noted above, Waugh’s dose is a “single pill,” why there would be a need for multiple blisters. Appeal 2020-001926 Application 15/158,957 8 However, the Examiner is silent as to the former requirement that “at least one pair of adjacent single-dose packages has a different number of blisters.” Lewis is not cited for this reason. Non-Final Act. 3. Appellant contends that there is no reason to combine Lewis with that of Waugh to obtain the claimed invention. See Appeal Br. 7. There is merit to Appellant’s contention. We have been instructed that as set forth in MPEP § 2143.03, “all words in a claim must be considered in judging the patentability of that claim against the prior art.” In re Wilson, 424 F.2d l382, l385 (CCPA 1970). There is no indication the Examiner addressed the above limitation concerning a different number of blisters in adjacent pairs of single-dose packages. Lacking same, it cannot be said that the rejection of claim 55 is supported by “articulated reasoning with some rational underpinning” as required by the Supreme Court. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Accordingly, the rejection of claim 55 is not sustained. CONCLUSION For the above reasons, we REVERSE the decision of the Examiner to reject claims 1–11, 18, 19, 23, 26, 34–36, 54, and 55. We enter NEW GROUNDS OF REJECTION of claims 1–11, 18, 19, and 23, 26, 34–36, 54 under 35 U.S.C. § 112(b), as indefinite. Appeal 2020-001926 Application 15/158,957 9 DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed New Ground 1, 8–11, 18, 19, 23, 26, 34, 35, 54, 55 103 Waugh, Lewis 1, 8–11, 18, 19, 23, 26, 34, 35, 54, 55 2–7, 36 103 Waugh, Lewis, Joslyn 2–7, 36 1–11, 18, 19, 23, 26, 34– 36, 54 112(b) Indefiniteness 1–11, 18, 19, 23, 26, 34–36, 54 Overall Outcome 1–11, 18, 19, 23, 26, 34–36, 54, 55 1–11, 18, 19, 23, 26, 34–36, 54 This decision contains new grounds of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides: When the Board enters such a non-final decision, [Appellant], within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection Appeal 2020-001926 Application 15/158,957 10 designated in the decision. Should the examiner reject the claims, [A]ppellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under §41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01 (9th Ed., Rev. 10.2019, June 2020). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). REVERSED; 37 C.F.R. § 41.50(b)