2021003029 (P.T.A.B. Oct. 13, 2021)

Fresenius Kabi AB

Patent Trials and Appeals BoardOct 13, 2021

2021003029 (P.T.A.B. Oct. 13, 2021)

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. 15/572,550 11/08/2017 Lars Karlsson 70015-137US1 2058 69713 7590 10/13/2021 OCCHIUTI & ROHLICEK LLP 50 Congress Street Suite 1000 Boston, MA 02109 EXAMINER DEL PRIORE, ALESSANDRO R ART UNIT PAPER NUMBER 3781 NOTIFICATION DATE DELIVERY MODE 10/13/2021 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): INFO@ORPATENT.COM PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte LARS KARLSSON and TORSTEN BRANDENBURGER Appeal 2021-003029 Application 15/572,550 Technology Center 3700 Before JENNIFER D. BAHR, MICHAEL J. FITZPATRICK, and WILLIAM A. CAPP, Administrative Patent Judges. FITZPATRICK, Administrative Patent Judge. DECISION ON APPEAL Appellant, Fresenius Kabi AB,1 appeals under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 9–30. We have jurisdiction under 35 U.S.C. § 6(b). A telephonic oral hearing was held September 27, 2022. A transcript of the hearing was entered into the record October 5, 2021 (“Tr.”). We affirm in part and enter a new ground of rejection. 1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42. Appellant identifies itself as the sole real party in interest. Appeal Br. 1. Appeal 2021-003029 Application 15/572,550 2 STATEMENT OF THE CASE The Specification The Specification discloses “a connector for a medical container” that includes a “connector element to be attached to the medical container for providing a port to the medical container.” Spec. 1:14–18. “The connector element comprises a head section [202] and a pinch-off section [201] adjoining the head section.” Id. at 1:18–19. After the medical container is filled, the pinch-off section can be temporarily pinched off “such that the fluid path through the connector element is closed and fluid cannot exit from the medical container” before a cap or closure elements is attached. Id. at 2:17. Appellant’s Figures 4A and 4B are reproduced below. Appeal 2021-003029 Application 15/572,550 3 Appellant’s Figures 4A and 4B, reproduced above, show sectional views of “connector 2 compris[ing] a connector element 20, a closure element 21 and a membrane element 22 placed in-between the closure element 21 and the connector element 20.” Spec. 6:1–3. Appellant’s Figure 4A, reproduced above left, shows break-off part 214 attached to attachment section 210 of the closure element. Id. at 6:9–11. Appellant’s Figure 4B, reproduced above right, shows connector with the break-off part having been removed and needle 30 inserted therein, piercing through the membrane, and terminating in inner lumen L of pinch-off section 201. Id. at 7:32–36. Appellant explains: The deflection element 205 in the shape of a cylindrical pipe is formed in one piece with the connector element 20 and has a rigid shape such that a needle 30 pinching onto the inner circumferential face of the guide opening 206 is deflected and guided in the insertion direction I or is stopped such that it cannot come into contact with the outer 5 walls 207 of the pinch-off section 201. Hence, the risk that the walls 207 of the pinch-off section may be damaged by the needle 30 is reduced. Id. at 8:1–6. The Claims Claims 9–30 are rejected. Final Act. 1. Claims 1–8 are cancelled. Appeal Br. 13. No other claims are pending. Id. at 13–16. Claim 9, the sole independent claim, is representative and reproduced below. 9. A connector for a medical container, comprising: a connector element to be attached to the medical container for providing a port to the medical container, the connector element comprising a head section and a pinch-off section adjoining the head section, wherein the head section comprises an opening and the pinch-off section encloses an inner lumen being in fluid connection with the opening of the head Appeal 2021-003029 Application 15/572,550 4 section for providing a fluid path through the connector element, the pinch-off section being flexibly deformable for pinching off the fluid path through the connector element, a deflection element extending from the head section towards the inner lumen of the pinch-off section for deflecting a needle of a delivery device when piercing a membrane element wherein the deflection element reaches into the inner lumen of the pinch-off section. Id. at 13. The Examiner’s Rejections The following rejections are before us: 1. claims 14, 20, and 25, under 35 U.S.C. § 112(b), as indefinite (Final Act. 2); and 2. claims 9–30, under 35 U.S.C. § 103(a), as unpatentable over Brandenburger2 and Herbert3 (id. at 4). DISCUSSION Indefiniteness (Rejection 1 and New Ground of Rejection) Rejection 1 A claim is indefinite if, after applying the broadest reasonable interpretation in light of the specification, the metes and bounds of a claim are not clear because the claim contains words or phrases whose meaning is unclear. In re Packard, 751 F.3d 1307, 1310 (Fed. Cir. 2014) (per curiam); see also Ex parte McAward, No. 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (adopting the approach for assessing indefiniteness approved by the Federal Circuit in Packard). 2 US 8,162,915 B2, issued Apr. 24, 2012 (“Brandenburger”). The Examiner abbreviates “Brandenburger” as “Brand,” (see, e.g., Final Act. 4), but we do not follow suit. 3 US 2003/0075469 A1, published Apr. 24, 2003 (“Herbert”). Appeal 2021-003029 Application 15/572,550 5 The Examiner determined that dependent claims 14, 20, and 25 were indefinite on account of their recitations of the connector element being in the “shape of a ship-shaped conus.” Final Act. 2–3. The Specification does not define ship-shaped conus. Outside of the claims as filed, the Specification mentions this phrase only once, stating: “The connector element may for example have the shape of a ship-shaped conus.” Spec. 4:7. And, although the Specification provides some context for ship- shaped, it does not explain the significance, or elucidate the meaning, of conus. See id. at 4:7–11 (“The connector element hence has a general ship shape and comprises for example a fastening section which can be inserted in-between foils of the medical container such that the connector element via its fastening section can be welded to the foils of the medical container (having the shape of for example a flexible bag).” (emphasis added)). Appellant argues: “The noun ‘conus’ suggests a shape that has the essential features of a cone. The adjective ‘ship-shaped’ modifies this shape so that it also has the profile that is common to ships.” Appeal Br. 3. Appellant then elaborates regarding the individual meaning of ship-shaped and conus. Id. at 3–4. The Examiner responds that, even if ship-shaped and conus are individually definite, their combination is not. Ans. 4. In particular, the Examiner points out that it “is still ambiguous as to what constitutes ‘the essential features of a cone’ and what conical features are lost/gained through the modification with ‘ship-shaped’.” Id. In reply, Appellant argues “the examiner has relied exclusively on dictionary definitions and does not take into consideration construing the term claim ‘in light of the specification.’” Reply Br. 15–16. Appellant, Appeal 2021-003029 Application 15/572,550 6 however, does not elaborate or explain what from the Specification allegedly was ignored by the Examiner in attempting to construe the limitation at issue. Id. Appellant does purport to answer the Examiner’s question regarding what conical features are lost/gained through the modification of the conus by ship-shaped. In that regard, Appellant argues: The answer is obvious. In a “ship-shaped conus,” all properties of a cone are retained except for those properties that would not have been necessary for an ordinary artisan to recognize the structure as having been a cone before it was altered to become a “ship-shaped conus.” The procedure for determining whether a candidate structure is, in fact, a “ship-shaped conus” or not is likewise simple. One shows the candidate structure to a statistically large set of ordinary artisans and asking each one: “Does this structure appear to have been obtained by starting with a cone and making it ship-shaped?” One then compiles the results. If more people say “yes” than “no,” then one will have determined, experimentally, whether the candidate structure is a “ship-shaped conus.” Id. at 15. Appellant’s “procedure” for determining whether a claim or limitation complies with 35 U.S.C. § 112(b) is not supported in law and likely would be unworkable. We have considered Appellant’s arguments but they do not persuade us that the Examiner erred in determining that the recitations of “ship-shaped conus” render claims 14, 20, and 25 indefinite. Accordingly, we affirm the rejection of those claims under 35 U.S.C. § 112(b). New Ground of Rejection Claim 30 ultimately depends from claim 9, and, by law, “shall be construed to incorporate by reference all the limitations of the claim to Appeal 2021-003029 Application 15/572,550 7 which it refers.” 35 U.S.C. § 112(d). Claim 30 refers to claim 12, and claim 12 refers to claim 9. Appeal Br. 13, 16. Thus, claim 30 incorporates all the limitations of claim 12, which includes all limitations of claim 9. Claim 9 recites “wherein the deflection element reaches into the inner lumen of the pinch-off section.” Id. at 13. Claim 30 recites “wherein the deflection element does not extend into the pinch-off section.” Id. at 16 (emphasis added). Thus claim 30 requires that deflection element “reaches into the inner lumen of the pinch-off section” without “extend[ing] into the pinch-off section.” Counsel for Appellant was asked about this clear contradiction at the hearing but could not offer any satisfactory explanation. Tr. 13:17–19 (“Well, you know, it sounded a little indefinite to me as well but I didn’t get a 112(b) rejection or anything so I thought well, I guess it does make some sense that there’s a difference between the two.”). Counsel merely pointed out that the Examiner did not reject claim 30 as indefinite and speculated that the competing claim requirements could be harmonized by interpreting “reaches into” differently than “extend into.” Id. at 14:10–12 (“So reaching into means you get there and extending into means you push a little forward and that’s, you know, what I’m going with in interpreting this.”). Counsel’s statements are insufficient to clarify what seems to us to be a clear contradiction. Accordingly, we enter a new ground of rejection of claim 30 as indefinite in violation of 35 U.S.C. § 112(b). Obviousness (Rejection 2) The Examiner rejected all pending claims as unpatentable over Brandenburger and Herbert. Final Act. 4. Appellant presents arguments for Appeal 2021-003029 Application 15/572,550 8 independent claim 9 (Appeal Br. 5–9), dependent claim 14 (id. at 9–10), and dependent claim 30 (id. at 10–11). We consider these claims first. Claim 9 The Examiner found that Brandenburger teaches the subject matter of claim 9 save for a deflection element. Final Act. 4 (citing Brandenburger 3:1–4, 3:23–25, 1:66–2:5, Fig. 1). The Examiner found that Herbert discloses a withdrawal and injection system for use with a medical container for providing a port to the medical container and teaches a deflection element (tube section 16) for deflecting a needle that has pierced membrane 11. Id. at 4–5 (citing Herbert Abstract, ¶¶36, 37, 39, Fig. 1). The Examiner determined: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brand[enburger] to comprise a deflection element as taught by Herbert as the tube of Herbert serves to guide a needle (or spike) and prevent puncturing of the surrounding material, as recognized by Herbert. Id. at 5 (citing Herbert ¶39); see also id. (further determining and explaining why it would have been obvious “to incorporate the tube of Herbert below the membrane of Brand in the same manner as shown in Fig. 1 of Herbert”). Appellant argues that the proposed modification would destroy the function of Brandenburger’s pinch-off section, thus rendering Brandenburger unsatisfactory for its intended purpose. Appeal Br. 5 (“If a tube’s function depends on its flexibility, then obviously one should not reinforce it with a rigid tube. Doing so would make it rigid, thus making it lose the very quality that it requires to carry out its function.”), 6 (“[I]f one were to insert a rigid tube into the pinch-off tube, the resulting combination of tubes could no longer be pinched.”), 6 (“Applicant submits that an Appeal 2021-003029 Application 15/572,550 9 ordinary artisan would have agreed that such protection [from accidental needle puncture] would occur, but only at the cost of making it impossible for the press elements to pinch the tube.”), 7 (“If such a [circular cross section] tube were to be inserted into [Brandenburger’s] pinch-off section, the pinch-off tube would no longer have the desired [non-circular] cross- section [and thus] make it more difficult to pinch off the tube.”). Appellant’s argument is a straw man argument. The Examiner has not proposed a modification in which Herbert’s deflection element (rigid tube) would extend the entire axis of Brandernburger’s pinch-off section. The Examiner made this clear in the Final Action by annotating Brandenburger’s Figure 1 to show the proposed modification. Final Act. 7. The Examiner’s annotated Figure 1 of Brandenburger is reproduced below. Appeal 2021-003029 Application 15/572,550 10 Final Act. 7. The Examiner’s annotated Figure 1 of Brandenburger, reproduced above, shows “connecting part 1 [having] elastically deformable pinching-off part 4 designed with a noncircular cross section.” Brandenburger 3:9–11. As can be seen above, the Examiner’s proposed modification incorporates Herbert’s deflection element extending through only a portion of Brandenburger’s pinch-off section 4. Final Act. 7. The Final Action further explained: [I]t would have been obvious to a person of ordinary skill in the art before the effective filling date that when combining Brand and Herbert to maintain the function of the pinch-off section, particularly as there is no reason to remove said function. In the case that the preservation of the function of the pinch-off section was in question, this would easily be achievable by changing the proportions of the relevant sections (namely the head section, the pinch-off section, and the deflection element itself; i.e. changing the lengths of the head section and deflection element such that the deflection element can direct the needle away from the pinch off section without blocking the pinch-off section), and would require only routine skill in the art as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. Final Act. 17. Thus, Appellant’s argument that the proposed modification would destroy the function of Brandenburger’s pinch-off section, thus rendering Brandenburger unsatisfactory for its intended purpose, is based on a false premise and consequently does not persuade us of Examiner error. Appellant also argues “there would have been no motivation to insert [Herbert’s] rigid tube into [Brandenburger’s] pinch-off tube” because “one of ordinary skill in the art would have had no reason to think that piercing [Brandenburger’s] pinch-off tube with a needle would have been a significant risk.” Appeal Br. 7–8 (emphasis added). This is so, Appellant Appeal 2021-003029 Application 15/572,550 11 argues, because needle piercing is a higher risk event in Herbert than in Brandenburger. Id. But, even assuming that were true, it would not support Appellant’s assertion that “there would have been no motivation” for the modification. Appeal Br. 8 (emphasis added). As the Examiner responds, “Appellant’s arguments regarding the relative risks between piercing the films of Herbert and the tube of Brandenburger are irrelevant [or at least unpersuasive] as an alleged lower risk of puncturing does not indicate there is no risk of puncturing.” Ans. 8; see Dystar Textilfarben GmBH & Co, v. C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006) (“the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical”). In any event, and as the Examiner also points out, Herbert explicitly teaches that its deflection element (tube 16) “serves to guide the needle and prevent puncturing of the surrounding material.” Id. (citing Herbert ¶39); see also Herbert ¶39 (“When the membrane 11 of the withdrawal piece 3 is pierced by the spike, the tube section 16 serves, on the one hand, as a guide for the spike and, on the other hand, as a covering which prevents puncture of the film bag.”). We have considered Appellant’s arguments but they are not persuasive. Accordingly, we affirm the rejection of claim 9. Claim 14 Claim 14 depends from 9 and, as discussed above in the indefiniteness rejection, recites “wherein the connector element has the shape of a ship- shaped conus.” Appeal Br. 14. The Examiner finds that Brandenburger teaches a “connector element having a general ship shape.” Final Act. 9 (citing Brandenburger 2:43–46, 3:23–27, Fig. 5a). The Examiner finds that it “also has conical elements (illustrated in the sloping up from the base 5 of Appeal 2021-003029 Application 15/572,550 12 the connector element, up along the side walls of the connector element in Fig. 1).” Appellant argues “only the base portion [of Brandenburger] is shaped like a conus. This is contrary to the claim, which requires the ‘connector element’ as a whole have the relevant shape.” Appeal Br. 9. The indefinite scope of “ship-shaped conus,” precludes meaningful review of the Examiner’s prior art rejection. Consequently, we reverse the rejection of claim 14.4 See In re Steele, 305 F.2d 859, 862–63 (CCPA 1962). Claim 30 As discussed above in the Board’s new ground of rejection, claim 30 is indefinite such that meaningful review of the Examiner’s prior art rejection cannot be achieved. Consequently, we reverse the rejection of claim 30. See Steele, 305 F.2d at 862–63. Claims 10–13 and 15–29 Appellant argues that “[c]laims 10–13 stand or fall with claim 9.” Appeal Br. 9. We affirm the obviousness rejection of claim 9 above, and, thus, claims 10–13 fall. Appellant argues that “[c]laims 15–28 stand or fall with the claims from which they depend.” Id. at 10. We affirm the obviousness rejection of all such claims above, and, thus, claims 15–28 fall. 4 As discussed above in the indefiniteness rejection, claims 20 and 25 also recite “wherein the connector element has the shape of a ship-shaped conus.” However, Appellant argues against the rejection of claims 20 and 25 solely based on their dependency, collectively from claims 9, 10, and 12. See Appeal Br. 10 (“Claims 15–28 stand or fall with the claims from which they depend.”). Appeal 2021-003029 Application 15/572,550 13 Appellant argues “[c]laim 29 stands or falls with claim 30.” Id. at 10. Although we pro forma reverse the obviousness rejection of claim 30 above, we nonetheless affirm the rejection of claim 29. This is so because claim 29 does not depend from claim 30. SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 14, 20, 25, 30 112(b) Indefiniteness 14, 20, 25 30 9–30 103 Brandenburger, Herbert 9–13, 15– 29 14, 30 Overall Outcome 9–29 30 TIME PERIOD FOR RESPONSE 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 that 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 proceeding will be remanded to the examiner. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. Appeal 2021-003029 Application 15/572,550 14 Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. 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 IN PART; 37 C.F.R. § 41.50(b)