Ex Parte Nagel et al

Patent Trials and Appeals BoardFeb 26, 2019

13392736 - (D) (P.T.A.B. Feb. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/392,736 07/10/2012 26161 7590 02/28/2019 FISH & RICHARDSON P.C. (BO) P.O. BOX 1022 MINNEAPOLIS, MN 55440-1022 FIRST NAMED INVENTOR Thomas Nagel UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. 12-151-WO-US 1393 EXAMINER VU, QUYNH-NHU HOANG ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 02/28/2019 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): P ATDOCTC@fr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte THOMAS NAGEL, RENE RICHTER, and ROBERT WITT 1 Appeal2018-004836 Application 13/392,736 Technology Center 3700 Before STEP AN ST AI CO VICI, MICHAEL L. HOELTER, and JAMES P. CALVE, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE This is a decision on appeal, under 35 U.S.C. Â§ 134(a), from the Examiner's Non-Final rejection of claims 1, 3, 5-7, 12, and 13, which constitute all the claims pending in this application. Reply Br. 2; Non-Final Act. 1 (Office Action Summary). We have jurisdiction under 35 U.S.C. 1 "The real party in interest is Sanofi-Aventis Deutschland GmbH, to which this invention is assigned." App. Br. 2. We thus proceed on the basis that, for purposes of this appeal, Sanofi-Aventis Deutschland GmbH is the "Appellant." Appeal2018-004836 Application 13/392,736 Â§ 6(b ). For the reasons explained below, we do not find error in the Examiner's rejections of these claims. Accordingly, we AFFIRM the Examiner's rejections. CLAIMED SUBJECT MATTER The disclosed subject matter "relates to a medicament container, comprising a bag with an outlet, the bag compressible by a compression means." Spec. 1:5-6. Claim 1, which is the sole independent claim, is illustrative of the claims on appeal, and is reproduced below. 1. An arrangement for administering a liquid medicament comprising a medicament container with a bag, further comprising a compression means for locally compressing the bag, wherein the bag comprises an outlet and two opposing parts of an inner surface, characterized in that the opposing parts of the inner surface are welded together when subjected to the compression means and the bag is kept from returning to its initial shape after having been subjected to the compression means and after the compression means are pulled back, wherein the compression means comprises a wiper pressed against the bag, and wherein the wiper is configured to apply a force on the bag in a direction perpendicular to a longitudinal direction of the bag. REFERENCES RELIED ON BY THE EXAMINER Cunningham US 4,013,073 Mar. 22, 1977 Stevenson US 4,273,258 June 16, 1981 Light US 5,743,434 Apr. 28, 1998 Picard US 6,155,458 Dec. 5, 2000 THE REJECTIONS ON APPEAL Claims 1, 3, 5-7, 12, and 13 are rejected under pre-AIA 35 U.S.C. Â§ 103(a) as unpatentable over Cunningham and Picard. 2 Appeal2018-004836 Application 13/392,736 Claims 1, 3, 5-7, 12, and 13 are rejected under pre-AIA 35 U.S.C. Â§ 103(a) as unpatentable over Cunningham and Light. Claims 1, 3, 5-7, 12, and 13 are rejected under pre-AIA 35 U.S.C. Â§ 103(a) as unpatentable over Cunningham and Stevenson. ANALYSIS All of the claims (i.e., claims 1, 3, 5-7, 12 and 13) are rejected under the combination of Cunningham and Picard, under the combination of Cunningham and Light, and under the combination of Cunningham and Stevenson. See Non-Final Act. 5-11. Appellant argues all these claims and all these rejections together, and also addresses each of Cunningham, Picard, Light, and Stevenson. See App. Br. 2-13. We select claim 1 for review, with the remaining claims standing or falling therewith. See 37 C.F.R. Â§ 4I.37(c)(l)(iv). We also address each of Appellant's arguments regarding the teachings of Cunningham, Picard, Light, and Stevenson. Claim construction Claim 1 includes limitations directed to a "compression means" and "wherein the compression means comprises a wiper pressed against the bag." Appellant's Drawings provide an illustration of a "roller" compression means (Fig. 1 ); a "ram" compression means (Fig. 2); and, a "wiper" compression means (Fig. 3). The illustration of this last "wiper" compression means is replicated below. 3 Appeal2018-004836 Application 13/392,736 f' 0 Ir 3.1 \f V ~ FIG 3 2 ,~Â·"-----."'i 7 3 4 a i \ "' .L "Figure 3 is a schematic view of another embodiment of the arrangement 1 which differs from the embodiments shown in Figures 1 and 2 by the compression means having the shape of a wiper. The wiper 6 is pressed against the bag 3." Amendment to Specification dated May 10, 2017. Appellant's Specification fails to provide any detailed description of a "wiper" other than to state, "[t]he roller may alternatively be replaced by a shoe or wiper or ram pressed against the bag." Spec. 3: 1-2; see also id. at 5: 19. Lacking such guidance, the Examiner provides examples of dictionary definitions of both the term "wipe" and "wiper." See Non-Final Act. 2--4; Ans. 2--4, 13. "Therefore, for examining purpose, Examiner interprets the term 'wiper' broadly such as: an object/element/component (such as a piece of block or something equivalent) is used for wiping (e.g. rubbing or friction action by sliding) on a surface of the object; or a projecting cam or a cam as defined above." Non-Final Act. 4; Ans. 4, 13. Appellant disagrees stating, "Appellant respectfully asserts that one of ordinary skill in the art would interpret the term 'wiper' to be similar to a windshield wiper blade, as shown in Figure 3." App. Br. 5; see also id. at 8, 10; Reply Br. 2--4. Appellant's more narrow definition is not supported by 4 Appeal2018-004836 Application 13/392,736 the language of claim 1. 2 A windshield wiper blade is readily understood to move along an arc about a pivot point whereas claim 1 recites, "wherein the wiper is configured to apply a force on the bag in a direction perpendicular to a longitudinal direction of the bag." Emphasis added. Appellant does not explain how the claimed requirement of the wiper moving "in a direction perpendicular to a longitudinal direction of the bag" is satisfied by the arc- like pivoting motion of a windshield wiper blade. Appellant also states, "[t]he Examiner is interpreting 'wiper' in a way that would also encompass 'a shoe' and 'a ram."' Reply Br. 4. Regarding how "a shoe" might operate, Appellant's Specification is silent on this point (see Spec. 3:1-2, 5:19), and we decline to speculate in this matter without further guidance. Regarding the operation of "a ram," Appellant's Specification states that "a ram" is "used to consecutively compress[]" the tube as shown in Fig. 2. Spec. 5:10-17. We understand from such teachings that upon completion of the downward tube compression stroke (F), the ram is lifted and moved over an uncompressed portion of the tube before the ram again compresses downwardly (i.e., "consecutively compressing"). This is unlike the operation of a "wiper" which is understood to involve the action of sliding on a surface. See supra. Thus, in view of the above, we do not find fault with the Examiner's definition of the term "wiper" because it is consistent with an ordinary meaning of the term and the Specification. See Non-Final Act. 4; Ans. 4, 13. 2 The Examiner further states, "[ n Jo where in the original specification discloses that the term 'wiper' is to be treated similar to a windshield wiper blade." Ans. 12; see also Ans. 13 ("The original specification does not provide any specific structure of the wiper 6."). 5 Appeal2018-004836 Application 13/392,736 Cunningham The Examiner primarily relies on the teachings of Cunningham for disclosing the recited limitations, and even addresses Cunningham's teaching of using the thumb and forefinger of a user to squeeze material out of the tube. 3 See Non-Final Act. 5; Ans. 13. The Examiner states that this disclosure of squeezing is similar to "rubbing/wiping on the surface of the bag 20 to expel the fluid." Non-Final Act. 5. "In other words, the thumb, forefinger or any fingers are equivalent as the wiper of the claimed invention." Non-Final Act. 5. Appellant does not dispute Cunningham's disclosure of squeezing or flattening the walls of the tube together ( Cunningham 1: 60-68) which suggests the application of "force on the bag in a direction perpendicular to a longitudinal direction of the bag" as recited. Instead, Appellant addresses Cunningham's reliance on the user's thumb/finger stating "[o]ne skilled in the art would not reasonably interpret a finger or thumb to be the 'wiper' of claim 1" and that "Cunningham does not show such 'compression means' as part of its device." App. Br. 6. There is merit to Appellant's assertion regarding the Examiner's correlation of the user's digits to the recited "compression means." However, the Examiner also states, "[t]here is another way to" proceed, i.e., by combining the teachings of Cunningham with (a) Picard (Non-Final Act. 5-6); (b) Light (Non-Final Act. 7-8); and/or, (c) Stevenson (Non-Final Act. 3 Cunningham teaches "[a]s the walls are further squeezed together by moving generally one's thumb and forefinger toward the discharge end of the syringe, along the tube, the complete expression across the tube is then completed throughout the entire length of the tube." Cunningham 1:65-2:2. 6 Appeal2018-004836 Application 13/392,736 10). See also Ans. 13. Each of these three additional references are addressed below. Picard Appellant contends, "[t]he Examiner asserts that upper pressure plate 3 is the 'wiper' of claim 1" and that "Appellant disagrees that the upper pressure plate 3 could be characterized as a wiper." App. Br. 8. This is because Picard's upper plate 3 is "an expeller" having one purpose being to "not allow contents to flow backwards into the tube." App. Br. 8 (referencing Picard 1 :65---67). Appellant contends this purpose is redundant because Cunningham already prevents such backflow (referencing Cunningham 3 :46-48), and as such, there would be "no reason to modify the device in Cunningham to include the upper pressure plate of Picard." App. Br. 8; see also Reply Br. 4--5. Regarding Picard's "expeller," another stated purpose of this item (not addressed by Appellant) is to "slide along the length of a collapsible tube in order to aid in expelling its content" and in doing so, "much less pressure is required." Picard 1 :63---65. Picard also states that the invention "described herein offers a much simpler and efficient way of performing" the operation of expressing contents from a tube. Picard 2: 1--4. Thus, in view of Picard's teachings, the Examiner deemed it obvious for a person of ordinary skill in the art to have combined Cunningham and Picard. 4 See Non-Final Act. 6; see also Ans. 14--15. Consequently, Appellant's focus on Picard's expeller 4 The Examiner states that adding "wiper (3) of Picard would serve to provide an alternative way of achieving the same result ... and additionally would be beneficial for one unable to compress the bag with their thumb and forefinger." Ans. 15. 7 Appeal2018-004836 Application 13/392,736 being for preventing backflow is not a full and complete description of the purpose of Picard' s expeller and as such, we do not fault the reasons expressed by the Examiner for combining these references. See supra. Appellant also describes Cunningham's device as being disposable and that, "one would not want to add an additional mechanical feature to a disposable device." App. Br. 8; see also Reply Br. 5. However, Picard's device is described as being "reusable" and that it "can easily be removed and installed onto another tube." Picard 2: 14--18. Hence, Appellant's contention regarding the disposability of Cunningham's device is not persuasive that the Examiner erred in combining Cunningham's disposable device with Picard's re-usable device. Accordingly, and based on the record presented, we are not persuaded the Examiner erred in rejecting claims 1, 3, 5-7, 12, and 13 as being unpatentable over Cunningham and Picard. Light The Examiner states, "the compression means 24 in Light is fair enough to call as a 'wiper." Non-Final Act. 8; see also Ans. 15. Appellant contends that even if this were the case, there would be "no reason to modify the device in Cunningham to include the lever member of Light." App. Br. IO; see also Reply Br. 4. This is because the problems solved by Light are those already addressed by Cunningham. App. Br. 1 O; see also Reply Br. 5. This is not a true understanding of both Cunningham and Light, and the Examiner's reliance thereon. See Ans. 16. Cunningham, as disclosed above, teaches using a thumb and forefinger to squeeze material from a tube. See Cunningham 1:65-67. Light discloses problems with this digital method of squeezing, including leaving "corrugated deformations" in the 8 Appeal2018-004836 Application 13/392,736 tube and that "[ n Jot infrequently, such corrugations cause tube wall fractures and spilled contents." Light 1:18-25. Light resolves these problems and does so via a portable/reusable device. Light 1 :56-60; 6:30-32 ("slide in a fresh tube."). We thus do not find fault with the Examiner's assessment that "Light would serve to provide an alternative way of achieving the same result of expelling all the contents from the bag and additionally would be beneficial for one unable to compress the bag with their thumb and forefinger." 5 Ans. 16. Appellant also describes Cunningham's device as being disposable and that, "one would not want to add an additional mechanical feature to a disposable device." App. Br. 10-11; see also Reply Br. 5. However, Light's device is described as being "portable" and that it "is easy to operate, and which is amenable to low cost, high volume unit production that will lead to widespread adoption." Light 1 :56-60. Hence, Appellant's contention regarding the disposability of Cunningham's device is not persuasive that the Examiner erred in combining Cunningham's disposable device with Light's "portable" device. Accordingly, we are not persuaded the Examiner erred in concluding that it would have been obvious to combine Cunningham and Light. See supra. We sustain the Examiner's rejection of claims 1, 3, 5-7, 12, and 13 as being unpatentable over Cunningham and Light. 5 The Examiner also states that it would have been obvious "to modify the device of Cunningham with providing compression means as a wiper/rotating pressure plate, as taught by Light, in order to apply a force on the bag in a perpendicular direction to expel small amount of medicament." Non-Final Act. 8-9. 9 Appeal2018-004836 Application 13/392,736 Stevenson The Examiner states that, as regarding Stevenson, "the compression means 56 is being as a block used for wiping/rubbing on a surface of the tube 20." Non-Final Act. 10; see also Ans. 17. Appellant responds that there is "no reason to modify the device in Cunningham to include the foot member of Stevenson." App. Br. 12; see also Reply Br. 4. Appellant contrasts Cunningham's teaching of complete expression with Stevenson disclosure of only expressing a desired amount. See App. Br. 12. Consequently, Appellant contends that the teachings of Cunningham and Stevenson are not combinable "because they are directed to different solutions." App. Br. 12. Appellant also contends, "[o]ne would not want to add an additional mechanical feature to a disposable device when it already works as intended." App. Br. 13; see also Reply Br. 5. First, it is noted that whether the amount expressed is "complete" (Cunningham) or partial (Stevenson), such feature is not recited in claim 1. Further, Appellant does not make clear how Stevenson's disclosure of partial expression is not also performed by Cunningham's device up until the time of Cunningham's "complete" expression. Additionally, the fact that Cunningham's device may be disposable, is not to say that Stevenson's device is also a one-time-use product. Instead, Stevenson's device is directed for use with a variety of different tubes "longitudinally disposed within the recess 18." Stevenson 2:49-50. 10 Appeal2018-004836 Application 13/392,736 Further, we do not find fault with the Examiner's assessment to the effect that Stevenson6 "would serve to provide an alternative way of achieving the same result of expelling all the contents from the bag and additionally would be beneficial for one unable to compress the bag with their thumb and forefinger." Ans. 16. Hence, based on the record presented, we are not persuaded the Examiner erred in combining Cunningham and Stevenson. We sustain the Examiner's rejection of claims 1, 3, 5-7, 12, and 13 as being unpatentable over Cunningham and Stevenson. DECISION The Examiner's art rejections of claims 1, 3, 5-7, 12, and 13 under 35 U.S.C. Â§ 103(a) are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 6 The Examiner referenced "Light" but we understand the Examiner to be discussing Stevenson instead. See Ans. 18. 11