Ex Parte Ellwanger et alDownload PDFPatent Trial and Appeal BoardJun 15, 201713719598 (P.T.A.B. Jun. 15, 2017) 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. 13/719,598 12/19/2012 Colleen Ellwanger CVT-001 5815 51414 7590 06/19/2017 GOODWIN PROOTFR T T P EXAMINER PATENT ADMINISTRATOR TSAI, MICHAEL JASPER 100 Northern Avenue BOSTON, MA 02210 ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 06/19/2017 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): PATENTBOS @GOODWINPROCTER.COM PSOUSA-ATWOOD@GOODWINPROCTER.COM GLENN.WILLIAMS@GOODWINPROCTER.COM PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte COLLEEN ELLWANGER, BRIAN NOBLE, TIM COKER, and SEAN PLUNKETT Appeal 2015-002005 Application 13/719,598 Technology Center 3700 Before LINDA E. HORNER, JASON W. MELVIN, and BRENT M. DOUGAL, Administrative Patent Judges. HORNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Civitas Therapeutics, Inc. (Appellant)1 seeks our review under 35 U.S.C. § 134(a) of the Examiner’s decision, as set forth in the Non-Final Office Action dated February 14, 2014 (hereinafter “Non-Final Act.”), rejecting claims 1, 6, 7, 9-13, 31, and 32.2 Appellant’s representative 1 Civitas Therapeutics, Inc. is the applicant as provided in 37 C.F.R. § 1.46 and the real party in interest. Appeal Brief 2 (June 16, 2014) (hereinafter “Appeal Br.”). 2 Claims 2-5, 8, and 14-30 are canceled. Non-Final Act. 1. Appeal 2015-002005 Application 13/719,598 presented arguments at an oral hearing on May 23, 2017. We have jurisdiction under 35 U.S.C. § 6(b). We affirm and designate our affirmance as a NEW GROUND OF REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). CLAIMED SUBJECT MATTER Appellant’s claimed subject matter relates to “devices ... for puncturing a capsule to release a powdered medicament therefrom.” Spec., para. 2. Claim 1 is the sole independent claim and is reproduced below. 1. A combination of a capsule and a device for puncturing the capsule to release a powdered medicament therefrom, the combination comprising: (a) the capsule comprising: opposing domes; a cylindrical wall portion defined by a capsule wall radius r measured from a central axis of the opposing domes; a volume of at least 0.50 cm3; and a thickness between 0.08 mm and 0.12 mm; and (b) the device comprising: a chamber for receiving the capsule; and a mechanism for puncturing at least one hole in only a single dome of the capsule, a center of each hole located within an annular puncture region bounded and defined in the single dome by 0.4r and 0.8r, and wherein a total surface area of all puncture holes is (i) between 0.5% and 2.2% of a total surface area of the capsule and (ii) between 3% and 15% of a total surface area of the single dome. Appeal Br. 15 (Claims App.). 2 Appeal 2015-002005 Application 13/719,598 EVIDENCE The Examiner relied upon the following evidence in the Non-Final Office Action: Messora US 3,927,195 Dec. 16, 1975 Drizen et al. US 6,007,843 Dec. 28, 1999 (“Drizen”) Edwards et al. US 2003/0150453 Al Aug. 14, 2003 (“Edwards”) Appellant submitted a “Declaration of Dr. Sean Plunkett Under 37 CFR § 1.132” on August 5, 2013 (hereinafter “First Plunkett Declaration”) in response to a Non-Final Office Action. The Examiner entered and considered the First Plunkett Declaration, as set forth in the Final Office Action dated September 13, 2013 (hereinafter “2013 Final Action”). As such, the First Plunkett Declaration is part of the official record and is properly before us in the appeal. Appellant subsequently submitted a “Supplemental Declaration of Dr. Sean Plunkett Under 37 CFR § 1.132” on October 29, 2013 (hereinafter “Supplemental Plunkett Declaration”) in response to the 2013 Final Action. As set forth in an Advisory Action dated November 21, 2013 (hereinafter “Adv. Act.”), the Examiner refused to enter the Supplemental Plunkett Declaration because it was filed after issuance of the 2013 Final Action and Appellant failed to provide a showing of good and sufficient reasons why it was necessary and was not earlier presented. Adv. Act. 1. Appellant subsequently resubmitted the Supplemental Plunkett Declaration along with a Request for Continued Examination on January 9, 2014 (hereinafter “RCE 3 Appeal 2015-002005 Application 13/719,598 filing”). As such, the Supplemental Plunkett Declaration is part of the official record and is properly before us in the appeal. Although the RCE filing was entered, it is not clear from the record that the Examiner considered the Supplemental Plunkett Declaration. Appellant also submitted a “Declaration of Dr. Anthony Hickey Under 37 CFR § 1.132” (hereinafter “Hickey Declaration”) with the RCE filing. The Examiner entered and considered the Hickey Declaration, as set forth in the Non-Final Office Action from which this appeal is taken. As such, the Hickey Declaration is part of the official record and is properly before us in the appeal. REJECTIONS The Non-Final Office Action includes the following rejections: 1. Claims 1, 7, 9-13, 31, and 32 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Edwards and Messora.3 4Non-Final Act. 2-7. 2. Claim 6 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Edwards, Messora, and Drizen. Id. at 7. 3 Although the statement of the first ground of rejection lists only claims 1, 7, and 9-13, the discussion of the rejection also includes an analysis of claims 31 and 32. Non-Final Act. 2, 6-7. We understand claims 31 and 32 to be subject to the first ground of rejection. 4 Appeal 2015-002005 Application 13/719,598 ANALYSIS First Ground of Rejection Appellant argues claims 1, 7, and 9-13 as a first subgroup, and argues claims 31 and 32 as a second subgroup. Appeal Br. 5-13. We select claim 1 as representative of the first subgroup and claim 31 as representative of the second subgroup. Claims 7 and 9-13 stand or fall with claim 1, and claim 32 stands or falls with claim 31. 37 C.F.R. § 41.37(c)(l)(iv). Claims 1, 7, and 9-13 Appellant contends the inventors discovered that the claimed combination of puncture hole location and puncture hole surface area “advantageously avoids the capsule collapsing upon itself when punctured” and the “puncture hole surface areas reliably and repeatably allow for a full dose of a low-density powder to be emitted from a large capsule at a sufficient volumetric flow rate and an achievable magnitude of volumetric flux so as to be consumed in a single breath by a typical adult patient.” Appeal Br. 5. Appellant argues the Examiner improperly determined that the claimed surface area limitations would have been obvious and improperly disregarded the rebuttal evidence presented by Appellant, including three sworn inventor and expert declarations. Id. at 6. Appellant asserts that the evidence presented in the Supplemental Plunkett Declaration rebuts the Examiner’s determination of obviousness of the claimed size and location of the puncture holes. Appeal Br. 7 (arguing that this declaration shows the combination of the surface area and the location bound for the puncture holes optimizes release of the powdered 5 Appeal 2015-002005 Application 13/719,598 medicament and that the particular location bound claimed for the puncture holes was unexpected). Appellant’s argument further cites to certain paragraphs of the Specification and the Figures in support thereof. Id. n.12 (citing Spec., paras. 50-53, 55-58, Figs. 6-9). We do not find the evidence presented in the Declaration and the cited paragraphs and Figures from the Specification to be persuasive of error in the Examiner’s rejection of claim l.4 Paragraphs 4 through 6 of the Supplemental Plunkett Declaration and paragraphs 50 through 53 of the Specification address the total surface area of the puncture holes in claim 1. The Supplemental Plunkett Declaration states that Dr. Plunkett, together with his co-inventors, discovered that for large volume capsules having a particular thickness, the combined total surface area of the puncture holes must be at least 0.5% of the total surface area of the capsule to allow an acceptable percentage of powder to be emitted in a single patient breath. Supplemental Plunkett Declaration, para. 4. Dr. Plunkett further states that, together he and his co-inventors discovered that it is undesirable for the combined total surface area of the puncture holes to be greater than 2.2% because the puncture force that results from producing puncture holes greater than that size can approach or exceed the loading limits for typical capsule materials. Id. at para. 5. Dr. 4 Because we find no indication in the record that the Examiner considered the Supplemental Plunkett Declaration, and because we address this Declaration herein in the first instance, we designate our affirmance as a new ground of rejection to afford Appellant a full and fair opportunity to respond. 6 Appeal 2015-002005 Application 13/719,598 Plunkett also states that “the percentage of powder emitted from the capsule approaches 100% generally asymptotically and little to no appreciable benefit (in terms of the percentage of powder emitted from the capsule) exists for puncture hole areas beyond that size.” Id. Thus, Dr. Plunkett characterizes the claimed upper and lower bounds in the total surface area of all puncture holes as “critical.” Id. at para. 6 (citing Spec, paras. 50-53, Figs. 6-7). The cited portions of the Specification describe results from testing of size 00 capsules punctured to create holes with a total combined surface area ranging from 0.027 cm2 to 0.066 cm2 (i.e., 0.0042 in2 to 0.0102 in2). Spec., para. 50. “The percentage of the filled powder mass emitted during a simulated breath was then measured for each hole area configuration.” Id. The results of the study are shown in table 600 of Figure 6 and graph 700 of Figure 7. Id. The results led to the conclusion that “the average fraction of powder emitted in a single breath increases asymptotically towards 100% with increasing puncture hole area. Id. at para. 51. Appellant’s Specification describes that when a combined total surface area of all the puncture holes is about 0.5% of the total surface area of the entire capsule, 48% of the capsule’s powder is emitted, on average, in a single breath of a patient. Id. at para. 52. “This represents the lower bound on an acceptable percentage of powder to be emitted in a single breath of a pediatric patient.” Id. The Specification further describes: It has been found that it is undesirable for the combined total surface area of all the puncture holes to be greater than about 2.2% of the total surface area of the entire capsule, because the 7 Appeal 2015-002005 Application 13/719,598 puncturing force that results from producing puncture holes greater than that size can approach or exceed the loading limits for typical capsule materials. . . . [T]he percentage of powder emitted from the capsule approaches 100% generally asymptotically and little to no appreciable benefit (in terms of the percentage of powder emitted from the capsule) exists for puncture hole areas beyond that size. Id. at para. 53. As seen in Figures 6 and 7, however, the chart shows the results of emitted powder testing on capsules in which the combined surface area of all puncture holes was 0.5% to 1.3% of the total capsule surface area. The testing does not show any data points above 1.3% of the total capsule surface area. Further, at 1.3%, the testing shows that 98% of the powder was emitted from the capsule. As the percentage of powder emitted from the capsule approaches 100% generally asymptotically, it is difficult to discern from these test results an appreciable benefit in terms of the percentage of powder emitted from the capsule for combined total surface area puncture holes greater than 1.3% and up to the upper bound of 2.2%. Further, we see no evidence that the testing described in the Specification included any testing of a capsule with a combined total surface area of puncture holes of 2.2%. We find very little evidence to support a criticality to the upper end of the range of 2.2%. Further, the upper end of the range appears to be the result of routine experimentation to discern an upper limit of combined puncture hole surface area that would not cause collapse of the capsule. 8 Appeal 2015-002005 Application 13/719,598 Paragraphs 7 through 11 of the Supplemental Plunkett Declaration and paragraphs 55 through 58 of the Specification address the location of the puncture holes as recited in claim 1. The Supplemental Plunkett Declaration states that Dr. Plunkett, together with his co-inventors, discovered that for large volume capsules having a particular thickness, if the centers of the puncture holes in a capsule’s dome are located below 0.4r, the rate of dome collapse increases dramatically. Supplemental Plunkett Declaration, para. 7. Dr. Plunkett further states that, together with his co-inventors, they discovered if the centers of the puncture holes are located at greater than 0.8r, the puncturing mechanism can tear down the cylindrical wall of the capsule or create a side load on the capsule that might deflect or crush the capsule. Id. at para. 8. Thus, Dr. Plunkett characterizes the claimed upper and lower bounds in the puncture hole location as “critical.” Id. at para. 9 (citing Spec, paras. 55-58, Figs. 8-9). Dr. Plunkett further states that throughout the course of developing the claimed invention, the inventors experimented with known prior puncturing approaches, e.g., puncturing the sidewall, both domes, or the centralized tip of the capsule’s dome(s). Id. at para. 10. Dr. Plunkett attested: Only after extensive effort did we unexpectedly discover that, in order to achieve our intended objective (i.e., to release the correct amount of powder medicament from the capsule in a single patient breath without collapsing the capsule itself), it is critical to puncture only a single dome of the capsule such that the center of each hole is located within an annular puncture region bounded and defined in the single dome by 0.4r and 0.8r and such that a total surface area of all puncture holes is between 0.5% and 2.2% of a total surface area of the capsule. The fact 9 Appeal 2015-002005 Application 13/719,598 that the release of powdered medicament from a capsule is optimized by a combination of all of that particular surface area and that particular location bound and solely one dome was unexpected. In fact, contrary to the suggestion of the many prior approaches described above, it was only confirmed after the extensive analysis and testing described above and in paragraphs [0050]—[0053] and [0055]—[0058] of our originally-filed specification (with reference to FIGS. 6-9 thereof). Id. at para. 11. The burden of showing unexpected results rests on the person who asserts them by establishing that the difference between the claimed invention and the closest prior art was an unexpected difference. See In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). Further, it is well established that “any superior property must be unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (2007). Dr. Plunkett’s declaration does not explain the factual basis for concluding that a person having ordinary skill in the art would have considered the results as set forth in the Tables in the Specification to be unexpected. See In re Freeman, 474 F.2d 1318, 1324 (CCPA 1973). Further, the declaration fails to compare the results to the closest prior art, i.e., Edwards, in which punctures holes are located on one of the capsule’s domes and in a location that is distanced from the centralized tip. In re Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.”). 10 Appeal 2015-002005 Application 13/719,598 Paragraphs 55 and 56 of Appellant’s Specification describe a simulation of the capsule material’s response to a constant force loading at different positions along the radius of the capsule’s dome using finite element analysis and the mechanical properties of the capsule material. Spec., para. 55. The results of that analysis are shown in table 800 of Figure 8 and in graph 900 of Figure 9. Id. According to the Specification, “[t]he analysis predicts, as can be observed from FIGS. 8 and 9, that a change in degree of deflection in response to a constant loading force similar to that imparted to the capsule material during puncturing will occur between 40% to 50% of the dome radius.” Id. at para. 56. Paragraph 57 describes a separate laboratory study that was conducted to confirm the simulation results. Id. at para. 57. “The study showed that once the centers of the puncture holes reached values below 0.4r the rate of dome collapse increased dramatically.” Id. As such, the preferred location for the center of each puncture hole is in the annular region of the capsule dome that is no less than 0.4r. Id. at para. 58. The outer boundary of the puncture region is described to be about 0.8r because attempting to puncture the capsule dome in a region greater than 0.8r might lead to the puncturing mechanism slipping off the capsule’s dome and/or tearing down the cylindrical wall portion of the capsule, and/or creating a side load on the capsule, causing it to detrimentally deflect within the inhaler chamber. Id. Dr. Plunkett’s characterization of the claimed invention as an “unexpected” discovery is not sufficient to demonstrate unexpected results. Further, the Specification does not demonstrate a connection between the 11 Appeal 2015-002005 Application 13/719,598 location of the puncture holes and the ability to release a correct amount of the powder medicament in a single breath. Rather, the location of the puncture holes is described in the Specification as being relevant only to preventing collapse of the capsule when the puncture holes are made. There is no evidence that the claimed ranges for location of the punctures holes was unexpected, but rather the evidence shows that it was simply unknown until a finite element analysis was run. The Specification does not tie together the claimed location of the puncture holes and the claimed total surface area of the puncture holes to evidence a combined effect of these two parameters. Rather, as detailed above, the Specification describes the need for placement of the puncture holes within a certain range of locations to avoid collapse of the capsule during puncturing, and the Specification describes the total surface area of the puncture holes being between a certain range to optimize delivery of the medicament in a single breath. In conclusion, although the simulations and studies described in the Specification may demonstrate the reasons for the claimed ranges, it does not provide evidence that either the location of the punctures hole or the total surface area of the puncture holes, or their combination, provided unexpected results. Appellant asserts the prior art fails to evince it was known in the art that the location and surface area of the puncture holes are result effective variables. Appeal Br. 7-10 (arguing the prior art teaches either puncturing a sidewall, or both domes, or a centralized tip of one or both domes). Appellant argues that none of the prior art references of record teach 12 Appeal 2015-002005 Application 13/719,598 puncturing a single one of the capsule’s domes. Id. This argument, however, fails to account for the fact that Edwards, the primary reference relied on in the rejection of claim 1, teaches puncturing a single one of the capsule’s domes at a position that is not at the centralized tip of the dome. Edwards, Fig. 2; Non-Final Act. 4 (Examiner finding that Edwards “appears to disclose the puncturing mechanism being configured such that the center of each hole is located within an annular puncture region bounded and defined in the at least one dome by 0.4r and 0.8r as shown in FIG. 8, but does not specifically disclose such a region being between about 0.4r and 0.8r”). The Examiner determined that situating the puncture region between about 0.4r and 0.8r would have been obvious because it “would be dependent upon the capsule size and dimensions.” Non-Final Act. 4. The Examiner further explains: Edwards clearly discloses a . . . pair of prongs for puncturing a single capsule dome (as seen in FIG. 8 and 9b of Edwards) and also provides that the device as disclosed is able to accommodate capsules of differing sizes (capsule size 2, 1, 0, 00, or 000) (Edwards, para. 0091). With such evidence that [the] chamber of the device of Edwards is able to accommodate capsules of differing sizes[,] one of ordinary skill in the art at the time the invention was made would have found the optimization of the location through routine experimentation. Ans. 9. In response, Appellant provides expert testimony from Dr. Anthony Hickey opining that the claimed location bounds for the puncturing holes in large capsules “would not have been obvious to me, nor to others having an 13 Appeal 2015-002005 Application 13/719,598 ordinary level of skill in my professional field, at the time of the invention.” Hickey Declaration, para. 13 (declarant attesting that he “would have pursued the strategy employed in industry to pierce small capsules5 containing solid, dense particles, and would have assumed that methodology would also work for large capsules that contain a large volume of a low density powder”). The problem with this testimony is that it fails to address the fact that Edwards teaches the claimed piercing strategy of piercing holes in a single one of the capsule’s domes at a position that is not at the centralized tip of the dome for use with large capsules. Edwards, Fig. 2 (showing U-shaped staple having two prongs 232 configured to puncture one dome of the capsule at a distance removed from O.Or), para. 91 (describing that the apparatus can be used to puncture capsule sizes 0 and 00 (e.g., having volumes of 0.67 cm3 and 0.95 cm3, respectively). According to Appellant’s Specification, these capsule sizes are “large” capsules. Spec., para. 8 (describing size 0 and size 00 capsules, having volumes of 0.68 cm3 and 0.95 cm3, respectively, as “larger capsules”). Further, Appellant argues that Edwards “teaches away” from the claimed puncture location range because Edwards teaches using the same chamber size for different size capsules, which would result in a puncture hole location falling outside of the claimed range for a size 2 capsule. Reply 5 Dr. Hickey attests that the piercing strategy employed in industry to pierce small capsules “is to either: (a) pierce the centralized tip(s) of the capsule’s dome(s) (i.e., pierce the capsule’s dome(s) at about O.Or ... or (b) pierce the sidewall of the capsule . . . .” Hickey Declaration, para. 11. 14 Appeal 2015-002005 Application 13/719,598 Br. 8-11. Appellant’s calculations, however, are based upon the convenient starting assumption that the prongs of Edwards are sized to puncture a size 0 capsule at 0.6r. Id. at 9. Thus, the calculations are based on a starting premise that conveniently proves Appellant’s point. For instance, Appellant does not calculate the puncture hole location on a size 2 capsule in the event the prongs are designed to puncture a size 0 capsule at the lower end of the claimed range, i.e., 0.4r. Using Appellant’s rendering (Reply Br. 10) and calculations provided in the Reply Brief, were one to design Edward’s prongs to puncture a size 0 capsule at 0.4r, then the corresponding punctures to a size 2 capsule within the same chamber and with the same prongs would be at 0.59r and at 0.68r, which locations are within the claimed range. As such, we do not agree that Edwards teaches away from the claimed range. Appellant further argues that Edwards “does not recognize the problem — i.e., that piercing a large hole through a large capsule requires a relatively high force loading which will, if the capsule is punctured in an incorrect region, collapse the capsule before the puncture is created.” Reply Br. 7. Edwards, however, is well aware of the possibility of capsule collapse due to the force applied while puncturing a capsule. See, e.g., Edwards, para. 140 (describing testing of various staple designs (e.g., sharp edge staples, circular section staples, and square section staples) to discern the effort required to puncture the capsule with each design and the recognizing the possibility of crushing the capsule during puncturing). Thus, we agree with the Examiner that based on Edward’s disclosure of a two-pronged staple that is used to puncture the dome of a capsule in an area of the capsule 15 Appeal 2015-002005 Application 13/719,598 removed from the center point of the dome, it would have been a matter of routine optimization for a person skilled in the art to determine the optimized annular range for the location of the puncture holes to avoid crushing the capsule during puncturing. Further, the arguments in the Appeal Brief as to result effective variable focus only on the location of the puncture holes. There is no argument or evidence specifically challenging the Examiner’s position that the total surface area of the puncture holes was known in the art to be a result effective variable.6 Rather, Appellant argues only that the combination of surface area and location was not appreciated in the art. Yet, as we noted supra, the Specification does not support Appellant’s assertion of a synergy in the combination of the claimed surface area (which relates to the amount of medicament released) and puncture location (which relates to the ability to puncture the capsule without damaging it). Appellant further argues that the Examiner erred in reasoning that the claimed location bounds of the puncture holes would have been obvious in view of Edwards, as modified by Messora, because it is based on “a non- 6 The prior art recognizes the total surface area of the puncture holes as a result effective variable. In particular, Edwards explicitly recognizes that “larger longitudinal prongs of the present invention can create larger openings in the receptacles than conventional piercing devices, which allows for higher emitted doses at low peak inspiratory flow rates, low volumes, and high dosage quantities” and that increasing the size of the holes in the receptacle improves the powder flow from the receptacle. Edwards, paras. 44, 45. 16 Appeal 2015-002005 Application 13/719,598 existent capsule sized to the Examiner’s whim and fancy.” Appeal Br. 11- 12. The Examiner specifically found that Edwards discloses a puncture apparatus for use with large capsules (as discussed supra). We agree with this finding. See Edwards, para. 91 (describing capsules of size 0 (volume of 0.67 cm3) and size 00 (volume of 0.95 cm3)), id. at paras. 116-117 (describing experiments performed using size 00 capsules), Spec. Fig. 3 (chart of standard capsule sizes). Appellant further argues that “Edwards teaches away from the surface area claim limitations and, thus, Appellant’s claimed invention.” Reply Br. 5 (citing Edwards, paras. 116, 117). Specifically, Appellant asserts that Edwards discloses a single fixed capsule hole surface area of 0.013 square inches, which translates to approximately 1.325% of a total surface area of a size 00 capsule. Id. Appellant argues that because Edwards teaches that the disclosed hole surface area is the “maximum” and Appellant’s claimed range exceeds that maximum, Edwards teaches away from the claimed range. Edwards teaches: Initially, it was discovered that it is always desirable to maximize the capsule hole area. Accordingly, the capsule hole area was fixed at 0.013 square inches. It should be understood that the present invention encompasses other capsule hole areas, especially when used with different sized capsules. It was also determined that the total area of the holes in the mouthpiece was an important factor but that the number of holes in the mouthpiece did not effect the results. Edwards, para. 117. 17 Appeal 2015-002005 Application 13/719,598 We do not agree with Appellant that this disclosure in Edwards constitutes a teaching away. Although Edwards teaches a total puncture hole surface area of 1.3% in order to “maximize the capsule hole area,” this disclosure would not have discredited or led one having ordinary skill in the art away from experimenting to see if a larger surface area would be possible. Instead, Edwards encourages such experimentation by indicating the desirability to maximize this parameter. Notably, the upper limit of the puncture hole area tested in Figures 6 and 7 of Appellant’s Specification is 1.3%, which matches the total surface area disclosed in Edwards. Further, because the percentage of powder emitted from the capsule approaches 100% generally asymptotically, it is difficult to discern from the test results provided in Appellant’s Specification an appreciable benefit in terms of the percentage of powder emitted from the capsule for combined total surface area puncture holes greater than 1.3% and up to the upper bound of 2.2%. The upper end of the range appears to be the result of routine experimentation to discern an upper limit of combined puncture hole surface area that would not cause collapse of the capsule. For these reasons, and considering all of the evidence presented in support of both the obviousness and nonobviousness of the claimed invention, we find that Appellant has not demonstrated error in the Examiner’s rejection of claim 1. Accordingly, we sustain the rejection of claim 1, and claims 7 and 9-13 which fall with claim 1, under 35 U.S.C. § 103(a) as unpatentable over Edwards and Messora. We designate our affirmance as a new ground of rejection. 18 Appeal 2015-002005 Application 13/719,598 Claims 31 and 32 Dependent claims 31 and 32 recite narrower limitations of the location boundary of the puncture holes and the total surface area of all puncture holes.7 Appeal Br. 16 (Claims App.). Appellant states that the “arguments above regarding the patentability of independent claim 1 apply similarly here to the narrower limitations of dependent claims 31 and 32.” Id. at 13. For the same reasons discussed supra in our analysis of claim 1, and considering all of the evidence presented in support of both the obviousness and nonobviousness of the claimed invention, we find that Appellant has not demonstrated error in the Examiner’s rejection of claim 31. Accordingly, we sustain the rejection of claim 31, and claim 32 which falls with claim 31, under 35 U.S.C. § 103(a) as unpatentable over Edwards and Messora. We designate our affirmance as a new ground of rejection. Second Ground of Rejection Appellant does not present any additional arguments for dependent claim 6 apart from the arguments presented in support of independent claim 1, from which claim 6 depends. Appeal Br. 13 (arguing Drizen does not cure the deficiencies of Edwards and Messora with regard to claim 1). Accordingly, for the same reasons discussed supra, we sustain the rejection 7 Claim 31 recites “the center of each hole is located with an annular puncture region bounded and defined in the single dome by 0.5r and 0.8r.” Appeal Br. 16 (Claims App.). Claim 32 recites “the total surface area of all puncture holes is between 1.1% and 1.6% of the total surface area of the capsule.” Id. 19 Appeal 2015-002005 Application 13/719,598 of claim 6 under 35 U.S.C. § 103(a) as unpatentable over Edwards, Messora, and Drizen. We designate our affirmance as a new ground of rejection DECISION The rejection of claims 1, 7, 9-13, 31, and 32 under 35 U.S.C. § 103(a) as unpatentable over Edwards and Messora is affirmed. The rejection of claim 6 under 35 U.S.C. § 103(a) as unpatentable over Edwards, Messora, and Drizen is affirmed. As explained supra, because our affirmance of each ground of rejection relies on consideration of the Supplemental Plunkett Declaration in the first instance, and relies on a more thorough consideration of the Hickey Declaration than that provided by the Examiner, we designate our affirmance of each rejection as a NEW GROUND 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, the 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: 20 Appeal 2015-002005 Application 13/719,598 (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 designated in the decision. Should the examiner reject the claims, appellant 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. 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)(l)(iv). AFFIRMED; 37 C.F.R, $ 41.50(b) 21 Copy with citationCopy as parenthetical citation