KCI Licensing, Inc.

Patent Trials and Appeals BoardMay 7, 2021

2020005323 (P.T.A.B. May. 7, 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. 14/882,403 10/13/2015 Gregory Phillips P001339US02SEC 6290 60402 7590 05/07/2021 KINETIC CONCEPTS, INC. c/o Harness Dickey & Pierce 5445 Corporate Drive Suite 200 Troy, MI 48098 EXAMINER TREYGER, ILYA Y ART UNIT PAPER NUMBER 3781 NOTIFICATION DATE DELIVERY MODE 05/07/2021 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): dgodzisz@hdp.com troymailroom@hdp.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte GREGORY PHILLIPS and BRIAN ROBEY ____________ Appeal 2020-005323 Application 14/882,403 Technology Center 3700 ____________ Before MICHAEL C. ASTORINO, BRADLEY B. BAYAT, and AMEE A. SHAH, Administrative Patent Judges. SHAH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s final decision to reject claims 1–6, 8–28, 30–32, and 34–53. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART and enter a NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as KCI Licensing, Inc. Appeal Br. 2. Appeal 2020-005323 Application 14/882,403 2 CLAIMED SUBJECT MATTER The Appellant’s invention “relates generally to medical treatment systems for treating tissue sites and monitoring the usage of such systems,” and more particularly “to a system for monitoring the compliant usage of negative-pressure wound therapy systems.” Spec. ¶ 1. Claims 1, 14, 27, 43, 47, and 50 are the independent claims on appeal. Claim 1 is illustrative of the subject matter on appeal and is reproduced below (with added bracketed lettering for reference): 1. A system for monitoring negative-pressure treatment of a tissue site, comprising: [(a)] a negative-pressure source; [(b)] a dressing fluidly coupled to the negative-pressure source and adapted to be disposed on the tissue site for distributing negative pressure; and [(c)] a communication device coupled to the negative- pressure source and configured to transmit operational data of the negative-pressure source, wherein the operational data indicates whether a usage time of the negative-pressure source meets a threshold value, and wherein the threshold value is in a range of 16 hours/day to 19 hours/day. Appeal Br. 14 (Claims App.) (emphasis added). REFERENCES The prior art references relied upon by the Examiner are: Name Reference Date Karpowicz et al. (“Karpowicz”) US 2010/0022990 A1 Jan. 28, 2010 Duesterhoft et al. (“Duesterhoft”) US 2014/0298928 A1 Oct. 9, 2014 Appeal 2020-005323 Application 14/882,403 3 REJECTIONS Claims 1–6, 8–15, 17–28, 30–32, and 34–53 stand rejected under 35 U.S.C. § 103 as unpatentable over Karpowicz. Claim 16 stands rejected under 35 U.S.C. § 103 as unpatentable over Karpowicz and Duesterhoft. OPINION Claims 1–6, 8–28, 30–32, and 34–42 We find unpersuasive the Appellant’s arguments that the Examiner has not adequately established that Karpowicz renders obvious the operational data indicating whether a usage time meets a threshold value being in a range of 16 hours/day to 19 hours/day, as highlighted above in limitation (c) of claim 1 and similarly recited in independent claims 14 and 27. See Appeal Br. 7–12. The difficulty with the Appellant’s argument is that it seeks to distinguish the claimed subject matter over that of Karpowicz based on the difference in the content of the information (indication of a usage time meeting a threshold value in the range of 16 to 19 hours per day) to be transmitted. However, there is insufficient evidence on the record showing a functional relationship between the information and the system claimed. Claim 1 merely recites transmitting such information; there is nothing claimed regarding the origin of the information nor is there anything regarding the use of such information. Absent such evidence of a functional relationship, it is reasonable to characterize the type of information communicated to be transmitted as descriptive, falling under the category of patentably-inconsequential subject matter. See Ex parte Curry, 84 USPQ2d Appeal 2020-005323 Application 14/882,403 4 1272, 1275 (BPAI 2005) (informative). “Nonfunctional descriptive material cannot render nonobvious an invention that would have otherwise been obvious.” Id. at 1274 (citing In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004). Cf. In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (when descriptive material is not functionally related to the substrate, the descriptive material will not distinguish the invention from the prior art in terms of patentability). See also In re Xiao, 462 F. App’x 947, 950–52 (Fed. Cir. 2011) (non-precedential): [T]he Board did not create a new “mental distinctions” rule in denying patentable weight . . . . On the contrary, the Board simply expressed the above-described functional relationship standard in an alternative formulation—consistent with our precedents—when it concluded that any given position label’s function . . . is a distinction “discernable only to the human mind.” . . . ; see In re Lowry, 32 F.3d 1579, 1583 (Fed. Cir. 1994) (describing printed matter as “useful and intelligible only to the human mind”) (quoting In re Bernhart, 417 F.2d 1395, 1399 (CCPA 1969)). Xiao, 462 F. App’x at 951–52. “Thus non-functional descriptive material, being useful and intelligible only to the human mind, is given no patentable weight.” Ex parte Graff, Appeal 2012-003941, 2013 WL 3873066, *4 (PTAB July 23, 2013) (non-precedential), aff’d, In re Graff, 585 F. App’x 1012 (Fed. Cir. 2014) (non-precedential). “The rationale behind this line of cases is preventing the indefinite patenting of known products by the simple inclusion of novel, yet functionally unrelated limitations.” King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010). We recognize that the Examiner’s reasoning in support of the obviousness determination differs from ours. The Examiner finds Karpowicz discloses a communication device configured to transmit Appeal 2020-005323 Application 14/882,403 5 operational data. Final Act. 4, 6, 8. The Appellant does not contest this finding. The Examiner acknowledges “Karpowicz does not expressly disclose the particular parameter of the therapeutic procedure time period range” and finds “[s]ince the particular parameter of the therapeutic procedure time period range affects the particular procedure protocol, it is the matter of optimization as being result effective variable.” Id. at 4; see also id. at 6–8. We agree that Karpowicz alone is sufficient to address the content of the information transmitted as claimed, but not for the reason provided by the Examiner. Claim 1 is directed to a system, that is, an apparatus, comprising (a) “a negative-pressure source”; (b) “a dressing fluidly coupled to the negative- pressure source”; and (c) “a communication device coupled to the negative- pressure source and configured to transmit operational data of the negative- pressure source.” Appeal Br. 14 (Claims App.). Claim 14 similarly recites a device, i.e., an apparatus, comprising a negative-pressure source and a communication device coupled thereto and configured to transmit operational data. Id. at 16. Claim 27 recites a method comprising a step of transmitting operational data. Id. at 18. The communication device reasonably broadly covers any device capable of transmitting information (see Spec. ¶ 17), and in the case of claim 27, may not even require a device. The systems and method of claims 1, 14, and 27 are distinguished from that of Karpowicz in the type of information, i.e., operational data of usage time within a threshold, transmitted. But a difference in type of information is a difference in nonfunctional descriptive material and, as such, is not one that is patentably consequential. Appeal 2020-005323 Application 14/882,403 6 Our reasoning departs from that of the Examiner, amounting to an articulation of a new rationale. Consequently, albeit we affirm the rejection of independent claims 1, 14, and 27 and their dependent claims 2–6, 8–13, 15, 17–26, 28, 30–32, and 34–42 (against which the Appellant presents no separate argument), the affirmed rejection is denominated as a new ground of rejection. We also affirm the Examiner’s rejection under 35 U.S.C. § 103 of dependent claim 16, against which the Appellant presents no separate argument. Claims 43–46 The Appellant presents the same arguments against independent claim 43 and its dependent claims 44–46 as for claim 1. See Appeal Br. 4, 9, 12. Independent claim 43 recites: A method for treating a tissue site, comprising: activating a negative-pressure source configured to provide negative pressure to the tissue site; transmitting data related to a usage time of the negative- pressure source to a remote user; determining that the usage time is less than a threshold value, wherein the threshold value is in a range of 16 hours/day to 19 hours/day; generating an alert to signal that the usage time is less than the threshold value and to prompt the remote user to contact a user of the negative-pressure source. Appeal Br. 20 (Claims App.). The Examiner finds Karpowicz discloses “determining that the usage time is less than a threshold value” and “generating an alert to signal that the usage time is less than the threshold value” (Final Act. 9–10), which the Appeal 2020-005323 Application 14/882,403 7 Appellant does not contest. As with claim 1, the Examiner acknowledges that “Karpowicz does not expressly disclose the particular parameter of the therapeutic procedure time period range,” and that it would have been a “matter of optimization” to have the claimed range. Id. at 10. Contrary to claim 1, claim 43 requires a use of the threshold range — a determination based on the threshold range and an alert based on that determination. Thus, there is a functional relationship between the information determined and the method claimed. The Examiner incorporates the “rationale of obviousness” of claim 1’s rejection (Final Act. 10): Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the particular parameter of the therapeutic procedure time period range in order to provide the desired therapeutic protocol, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233(MPEP 2144.05 (II-A)).[2] Id. at 4. Section 2144.05(II)(A) of the MPEP discusses “Optimization Within Prior Art Conditions or Through Routine Experimentation.” Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 . . . (CCPA 1955). 2 Manual of Patent Examining Procedure (9th ed., rev. 10.2019, June 2020). Appeal 2020-005323 Application 14/882,403 8 Id. § 2144.05(II)(A). The court in Aller established two conditions for a conclusion of obviousness based on optimization of ranges: one, the general conditions of the claim must be disclosed in the prior art; and two, discovery of the optimum value or workable range must be a matter of routine experimentation for a person of ordinary skill in the art. See Aller, 220 F.2d at 456. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” Aller, 220 F.2d at 456. This rule is limited to cases in which the optimized variable is a “result-effective variable.” In re Antonie, 559 F.2d 618, 620 (CCPA 1977); see Boesch, 617 F.2d at 276 (“[D]iscovery of an optimum value of a result effective variable . . . is ordinarily within the skill of the art.”). In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (brackets in original). Here, the Examiner has not adequately established that the usage time threshold was known to be a result-effective variable rendering its optimization within the ordinary skill in the art. Karpowicz discloses that its “invention preferably uses a time based dimensionless number based in part on the overall patient compliance with therapy” that may be shown to the patient in a fractional format such as 21/24 or as a color indicator to show acceptable, marginal, or unacceptable compliance, such as ratio greater than 21/24 hours, greater than 15/25 hours, or less than 15/25 hours, respectively. Karpowicz ¶ 79. However, Karpowicz is silent as to how the usage time compliance threshold/recited acceptable compliance ratio affects the negative-pressure treatment or any particular result. The Examiner finds that “[i]t appears to be a [sic] common sense that by increasing the time of the exposure to therapeutic modality, the better result is achieved” (Ans. 3) and Appeal 2020-005323 Application 14/882,403 9 that the “claimed therapeutic procedure time period range is interpreted as achieving expected result, and because the therapeutic procedure time range regarded by both Appellant and Karpowicz as affecting the therapeutic result, the particular parameter of the therapeutic procedure time is indeed a result effective variable” (id. at 5) (emphasis omitted). However, this reasoning does not explain how Karpowicz’s compliance example from 15 to 21 hours per day affects its “clinically effective level[] of suction.” Karpowicz ¶ 78. The Specification discusses that compliance thresholds may be set based on therapeutic factors and wound conditions. Spec. ¶ 58. For example, the threshold may be set to 18 hours per day “if the compliance team decides that the present therapy is generating high amounts of wound exudate volumes may be impeding the healing process,” while another patient may have a threshold “set at 16 hours/day to accommodate the administration of fluid instillation therapy.” Id. Thus, “[w]hile often it is preferred that patients are administered negative-pressure therapy to a wound for as close to 24 hours/day as possible, usage compliance thresholds, such as those discussed above, may be set based on empirical data indicating that usage time is critical for wound healing progression.” Id. ¶ 59. As can be seen from the data in Table 1, one critical threshold may exist between the 60-69% usage percentage range (approximately 14.5 to 16.5 hours per day) and the 70-79% usage percentage range (approximately 17 to 19 hours per day). Thus, based on this data, in order to achieve a desired wound volume reduction per day of greater than about 1.5%, a user should adhere to a negative-pressure therapy compliance threshold of at least about 70%, or about 17 hours per day, to avoid an alarm warning of non-compliance. Spec. ¶ 60, Table 1. Appeal 2020-005323 Application 14/882,403 10 “The controlling question is simply whether the differences (namely the value of [usage time] and its property) between the prior art and appellant’s invention as a whole are such that appellant’s invention as a whole would have been obvious.” In re Antonie, 559 F.2d at 620. We agree with the Appellant that the Examiner has not shown that it would have been obvious. See Appeal Br. 11–12. At best, Karpowicz discusses determining that the usage time is less than a threshold value, such as 15/25 hours, but the Examiner has not shown how Karpowicz discusses how the set usage time compliance threshold effects, or is relevant to achieve, a particular, desired result. Cf. Applied Materials, 692 F.2d at 1296 (finding that prior art showed that the width and depth of grooves affected the desired polishing pad properties and were thus result-effective variables). For the above reason, we do not sustain the Examiner’s rejection under 35 U.S.C. § 103 of independent claim 43 and its dependent claims 44–46. Claims 47–49 The Appellant presents the same arguments against independent claim 47 and its dependent claims 48 and 49 as for claim 1. See Appeal Br. 4, 9, 11, 12. Independent claim 47 recites: A method for treating a tissue site, comprising: activating a negative-pressure source; transmitting data related to a usage time of the negative- pressure source to a remote user; and Appeal 2020-005323 Application 14/882,403 11 generating a threshold value based on the data related to the usage time, wherein the threshold value is in a range of 16 hours/day to 19 hours/day. Appeal Br. 20 (Claims App.). The Examiner finds Karpowicz discloses “determining that the usage time is less than a threshold value” and “generating an alert to signal that the usage time is less than the threshold value” (Final Act. 9–10), which the Appellant does not contest. Although the Examiner does not explicitly address the threshold within the claimed range, the Appellant admits “claim 47 recites elements similar or analogous to those of claim 1.” Appeal Br. 9, 10, 12. Thus, we consider the Examiner’s omission regarding the threshold values as harmless error. As with claim 1, we agree that Karpowicz alone is sufficient to address the content of the information generated as claimed. We note that the step of generating is recited functionally without any details on how, technologically or by what algorithm, the alert is generated and without any particular device or structure performing the generating. Further, the method does not recite that, or how, the generated data is used. The method of claim 43 is distinguished from that of Karpowicz in the type of data threshold data generated, i.e., within a certain range. But a difference in type of data is a difference in nonfunctional descriptive material and, as such, is not one that is patentably consequential. Our reasoning departs from that of the Examiner, amounting to an articulation of a new rationale. Consequently, albeit we affirm the rejection of independent claim 47 and its dependent claims 48 and 49 (against which the Appellant presents no separate argument), the affirmed rejection is denominated as a new ground of rejection. Appeal 2020-005323 Application 14/882,403 12 Claims 50–53 The Appellant presents the same arguments against independent claim 50 and its dependent claims 51–53 as for claim 1. See Appeal Br. 4, 9, 12. Independent claim 50 recites: A system for monitoring negative-pressure therapy, comprising: a negative-pressure therapy unit; a dressing fluidly coupled to the negative-pressure therapy unit; a communication device coupled to the negative-pressure therapy unit and configured to transmit operational data of the negative-pressure therapy unit; and a receiving unit configured to receive operational data transmitted from the communication device, wherein the receiving unit comprises a processor configured to process the operational data to provide an output determination of whether a usage time of the negative-pressure therapy unit meets a threshold value, wherein the threshold value is in a range of 16 hours/day to 19 hours/day. Appeal Br. 21 (Claims App.). The Examiner finds Karpowicz discloses a receiving unit as claimed, but for “the particular parameter of the therapeutic procedure time period range.” Final Act. 11. The Appellant does not contest these findings. As with claim 43, the Examiner finds that it would have been a “matter of optimization” to have the claimed range and incorporates the “rationale of obviousness” of claim 1’s rejection. Id. Claim 50’s processing of operational data and providing of an output determination requires the processor to make some determination of whether the usage time meets a threshold value of a certain range. As with claim 43, Appeal 2020-005323 Application 14/882,403 13 claim 50 requires a use of the threshold range — a determination based on the threshold range and an output based on that determination. Thus, there is a functional relationship between the information determined and the method claimed. As discussed above with reference to claim 43, the Examiner has not adequately established that the usage time threshold was known to be a result-effective variable rendering its optimization within the ordinary skill in the art such that the subject matter of claim 50 would have been obvious. For the above reason, we do not sustain the Examiner’s rejection under 35 U.S.C. § 103 of independent claim 50 and its dependent claims 51–53. CONCLUSION The Examiner’s decision to reject claims 1–6, 8–28, 30–32, 34–42, and 47–49 under 35 U.S.C. § 103 is affirmed, but the affirmed rejections under § 103 are denominated as new grounds of rejection. The Examiner’s decision to reject claims 43–46 and 50–53 under 35 U.S.C. § 103 is reversed. In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed New Ground 1–6, 8–15, 17–28, 30–32, 34–53 103 Karpowicz 1–6, 8–15, 17–28, 30–32, 34–42, 47–49 43–46, 50–53 1–6, 8–15, 17–28, 30– 32, 34–42, 47–49 16 103 Karpowicz, Duesterhoft 16 16 Appeal 2020-005323 Application 14/882,403 14 Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed New Ground Overall Outcome 1–6, 8–28, 30–32, 34–42, 47–49 43–46, 50–53 1–6, 8–28, 30–32, 34– 42, 47–49 TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that 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: (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. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. . . . Further guidance on responding to a new ground of rejection can be found in MPEP § 1214.01. AFFIRMED IN PART; 37 C.F.R. § 41.50(b)