ResMed Limited

Patent Trials and Appeals Board

Mar 30, 2022

2022000889 (P.T.A.B. Mar. 30, 2022)

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. 15/313,788 11/23/2016 Timothy Tsun-Fai Fu RESMED 3.3F-117 (1167) 1047 147311 7590 03/30/2022 Botos Churchill IP Law LLP 430 Mountain Avenue Suite 401 New Providence, NJ 07974 EXAMINER ZIEGLER, MATTHEW D ART UNIT PAPER NUMBER 3785 NOTIFICATION DATE DELIVERY MODE 03/30/2022 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): pto@bciplaw.com rbotos@bciplaw.com rchurchill@bciplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte TIMOTHY TSUN-FAI FU and SAKEENA DE SOUZA ____________ Appeal 2022-000889 Application 15/313,788 Technology Center 3700 ____________ Before EDWARD A. BROWN, WILLIAM A. CAPP, and ARTHUR M. PESLAK, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final rejection of claims 1-17, 20, 21, and 156-163. We have jurisdiction under 35 U.S.C. § 6(b).2 We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies ResMed Limited, as the Applicant and real party in interest. Appeal Br. 2. 2 This case came before the Board for regularly scheduled oral hearing on March 22, 2022. Appeal 2022-000889 Application 15/313,788 2 THE INVENTION Appellant’s invention relates to respiratory masks. Spec. ¶ 2. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A patient interface for sealed delivery of a flow of breathable gas to a patient’s airway, the patient interface comprising: a sealing structure having a seal surface adapted to contact skin on a patient’s face; a positioning structure adapted to secure the sealing structure to the patient’s face; a plurality of sensors at the seal surface arranged at different locations on the sealing structure, each sensor of the plurality of sensors adapted to determine a distance of proximity between the seal surface at the different locations and the patient’s face and generate a sensor signal; and a processor connected with the plurality of sensors, the processor configured to determine a sealing condition between the sealing structure and the patient based on at least one of the generated sensor signals, the processor further configured to generate one or more signals to adjust at least one of the sealing structure and the positioning structure to maintain the sealing structure in sealing contact with the patient, during patient use of the flow of breathable gas, based on the distance of proximity between the seal surface and the patient's face detected by at least one of the plurality of sensors. Appeal 2022-000889 Application 15/313,788 3 THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: NAME REFERENCE DATE Brydon US 6,240,921 B1 June 5, 2001 Kwok US 2008/0192459 A1 Aug. 14, 2008 Lanfermann US 8,162,857 B2 Apr. 24, 2012 Armistead US 2012/0190998 A1 July, 26, 2012 Neely US 2013/0032148 A1 Feb. 7, 2013 Stevens US 2013/0118500 A1 May 16, 2013 Hendriks US 10,046,131 B2 Aug. 14, 2018 The following rejections are before us for review: 1. Claims 1-4, 6, 11, 16, 17, 20, 21, 156-158, and 160-163 are rejected under 35 U.S.C. § 103 as unpatentable over Hendriks and Brydon. 2. Claims 5 and 12-14 are rejected under 35 U.S.C. § 103 as unpatentable over Hendriks, Brydon, and Neely. 3. Claims 7 and 8 are rejected under 35 U.S.C. § 103 as unpatentable over Hendriks, Brydon, and Kwok. 4. Claims 9 and 10 are rejected under 35 U.S.C. § 103 as unpatentable over Hendriks, Brydon, and Stevens. 5. Claim 15 is rejected under 35 U.S.C. § 103 as unpatentable over Hendriks, Brydon, and Armistead. 6. Claim 159 is rejected under 35 U.S.C. § 103 as unpatentable over Hendriks, Brydon, and Lanfermann. Appeal 2022-000889 Application 15/313,788 4 OPINION Unpatentability of Claims 1-4, 6, 11, 16, 17, 20, 21, 156-158, and 160-163 over Hendriks and Brydon Claims 1-4, 6, 11, 16, 17, 20, 21, 157, and 160-163 Appellant argues these claims as a group. Appeal Br. 4-14. Claim 1 is representative. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Hendriks discloses the invention substantially as claimed except for having sensors adapted to determine a distance of proximity between the seal surface of the mask at different locations on the patient’s face and adjustment of the surface accordingly, for which the Examiner relies on Brydon. Final Act. 3-5. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the temperature sensors of Hendricks to be proximity measuring capacitive plates as taught by Brydon. Id. at 5. According to the Examiner, a person of ordinary skill in the art would have done this as a simple substitution of one type of leak-detecting sensor for another to achieve a predictable result. Id. Appellant argues that Brydon’s sensors do not determine “a distance of proximity” as claimed. Appeal Br. 7. Appellant concedes that Brydon’s sensors detect contact with, or close proximity of, a mask to patient’s face, however, Appellant argues that Brydon does not teach that its sensors distinguish between “contact” and “close proximity.” Id. Furthermore, Appellant argues that Brydon does not determine a “distance” between the mask and a patient’s face. Id. Appellant interprets Brydon as being limited to detecting “contact with, or close proximity” as a single state that is used to determine whether a patient is wearing the mask. Id. at 8-9. “To be sure, Appeal 2022-000889 Application 15/313,788 5 Brydon suggests merely a single change in the electrical circuit formed by plates 5, 6, when the mask 1 is brought in close proximity to or in contact with the patient’s face.” Id. at 8. Next, Appellant argues that the prior art fails to disclose a processor that is configured to determine a sealing condition based on sensor data that is adapted to determine a distance of proximity between the seal surface and a patient’s face. Id. Furthermore, Appellant argues that the prior art fails to teach a processor that is configured to generate signals to adjust the sealing structure or positioning structure that is based on the distance of proximity between the seal surface and the patient’s face. Id. at 9. In that regard, Appellant argues that Hendriks does not generate adjustment signals based on “distance measurements.” Id. Finally, Appellant argues that Hendriks and Brydon are not combinable in the manner proposed by the Examiner. Id. at 10. In this regard, Appellant argues that Brydon’s capacitive plates are not used for leak detection. Id. Appellant further argues that Hendriks does not explicitly disclose that it has the capability to detect leaks based on signals from Brydon’s capacitive plates. Id. Appellant further contends that using capacitive plates, as taught by Brydon, in the device of Hendriks would render Hendriks unsatisfactory for its intended purpose of sealing leaks, as there is no disclosure that Brydon’s plates are capable of deforming to fit a patient’s face. Id. at 12. In response, the Examiner points out that Appellant fails to provide an operational definition of “distance of proximity.” Ans. 16. The Examiner further explains that “distance” and “proximity” can be measured in relative Appeal 2022-000889 Application 15/313,788 6 terms and that Appellant’s disclosure provides no underlying basis for requiring the use of discrete units of measurement. Id. The Examiner finds that Brydon’s sensors detect more than an “on/off” state and, instead, detect at least three different proximity states. Id. [T]here are at least three detectable states from the capacitive proximity sensors of Brydon: 1) the sensor being in contact with the patient (and thus detecting the bioelectricity through the skin), 2) the sensor being in partial contact/close proximity (thus detecting a reduced amount of bioelectricity), and 3) the sensor having no contact with the patient (thus being far enough from the skin to not detect any bioelectricity). Id. at 16-17 (paragraph indentation added). With respect to Appellant’s arguments directed to a processor, the Examiner explains that both Hendriks and Brydon employ processors and a person of ordinary skill in the art would have been able to re-program a processor to adapt to data originating from a different type of sensor. Id. at 18. [T]he Hendriks device has a controller which reads data related to a leakage/sealing condition in order to adjust the fit of the patient interface, and the modification in light of Brydon does measure a “distance of proximity,” and would include necessary changes to the controller of Hendriks to respond to the capacitive sensors of the modification. Id. The Examiner states the combined teachings of Hendriks and Brydon suggest using proximity sensors in a leak detection system. [T]he Hendriks device uses temperature sensors to detect a leak, make a determination with a controller based on the leak, and adjust the sealing between the mask and the user (Col. 14 lines 1-28). Brydon likewise discloses using a controller to Appeal 2022-000889 Application 15/313,788 7 read the sensed proximity data from the sensors (Col. 4 lines 59-62). It is clear to one of ordinary skill in the art that swapping out one type of sensor for another includes the required electrical components and processing components that read and interpret the sensor data. As such, the Hendriks device has a controller which reads data related to a leakage/sealing condition in order to adjust the fit of the patient interface, and the modification in light of Brydon does measure a “distance of proximity,” and would include necessary changes to the controller of Hendriks to respond to the capacitive sensors of the modification. Ans. 18. The Examiner further explains that the modified device still relies on the disclosure of Hendriks that uses data of a leakage condition to adjust the fit of the patient interface, and merely uses different data to make that determination. Id. at 19. With respect to Appellant’s argument regarding deformation of the mask, the Examiner states that Hendriks incorporates dielectric elastomeric actuators (“DEA”) that cause the patient interface to change shape in response to detection of a leak. Id. at 19. The Examiner notes that Brydon’s capacitive plates can be disposed within the mask so that the mask retains its character of having a cushioning member. Id. at 20. According to the Examiner, modifying Hendriks with the capacitive plates of Brydon does not affect the ability to re-shape the sealing surface of the mask. Id. at 19-20. With respect to Appellant’s argument that Brydon’s sensors are capable of only an “off/on” determination, but not relative proximity, the Examiner explains that a capacitive sensor will inherently fluctuate its readings based on a distance between the sensor and the skin and, therefore, detects a spectrum of values that correspond to proximity. Id. at 20. In reply, Appellant argues that “distance of proximity” as used in claim 1 is understood to mean the amount of space between two surfaces Appeal 2022-000889 Application 15/313,788 8 (i.e., the mask and the face). Reply Br. 3. Appellant reiterates that Brydon does not disclose determination of a “distance of proximity” as such term is construed by Appellant. Id. at 4. Appellant also disputes the Examiner’s finding that Brydon discloses three detectable states. Id. at 5. In that regard, Appellant accuses the Examiner of reading subject matter into Brydon that is not present. Id. Moreover, Appellant disputes the Examiner’s finding that Brydon discloses a spectrum of values corresponding to proximity. Id. Appellant raises an issue of claim construction regarding the meaning of “distance of proximity.” During patent examination, pending claims are given their broadest reasonable construction consistent with the specification. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under the broadest reasonable interpretation standard, claim terms are given their ordinary and customary meaning as would be understood by one of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). We have reviewed Appellant’s Specification and are unable to determine that a “distance of proximity” must be realized in terms of discrete units of measurement. See generally Spec. Indeed, Appellant does not direct us to any language in the Specification that supports such a narrow interpretation of the term. Under the circumstances, the Examiner’s construction that “distance of proximity” may mean relative distance such as near or far comports with the broadest reasonable construction of the term. Hendriks discloses a CPAP mask that is worn during sleep and used to alleviate sleep apnea. Hendricks col. 1, ll. 34-47; col. 2, ll. 52-67. Hendriks’s mask contains features for leak detection and correction. Id. at col. 8, ll. 6-17. Hendriks employs a controller that is coupled to a plurality Appeal 2022-000889 Application 15/313,788 9 of temperature sensors. Id. Hendriks detects changes in temperature in the cushion element of the mask and interprets cooler temperatures as leaks. Id. When a leak is detected, the controller selectively applies electrical voltage to certain dielectric elastomer actuators (“DEA”) in the mask to close the leak. Id. Brydon is directed to a system for automatically starting and stopping a CPAP mask in connection with determining whether the mask is placed on or off the face of the patient. Brydon col. 2, ll. 7-19. Brydon determines whether the mask is being worn based on electrical circuit means mounted in the mask whose electrical characteristics change in response to proximity with the patient’s face. Id. at col. 2, ll. 58-67. Brydon uses sensors that detect a change in capacitance in an electrical field that is attributable to proximity with a patient’s face. Id. at col. 4, ll. 54-67, Fig. 3a. Appellant’s argument that modifying Hendriks with capacitive proximity sensors as taught by Brydon would render Hendriks unsatisfactory for its intended purpose is not persuasive. Hendriks discloses a self- adjusting CPAP mask. Hendriks accomplishes this purpose through sensing leak detection and using a controller in conjunction with DEA technology to close leaks. DEAs can be easily applied for the applications of the present invention . . . deformation of the electroactive polymer material can be monitored by measuring the material’s electrical capacitance. Dependent on the determined deformation, an electrical voltage is applied to the electroactive polymer material in order to bend the material and to close the air leaks. Hendriks, col. 6, ll. 1-11. Hendriks’s purpose would remain intact if its mask were modified by merely substituting one type of leak detection sensor with another. Appeal 2022-000889 Application 15/313,788 10 Appellant’s argument that Brydon’s sensors do not determine a “distance of proximity” between the mask and face is unpersuasive. Brydon’s sensor operates under the principle that, as mask 1 is brought: (1) in proximity to; or (2) in contact with, the patient’s face, the electrical state of the sensing circuit within the controller 8 will change. As the mask 1 is brought in proximity to, or in contact with, the patient’s face, the electrical state of the sensing circuit within the controller 8 will change. The detectable change is for the reason that a conductive (albeit high resistance) path is provided by the surface of the patient’s face. The change will either be as . . . a change in capacitance (FIG. 3b). Brydon, col. 4, ll. 54-67 (emphasis added). The Examiner finds that a capacitive sensor, such as in Brydon, will inherently produce a spectrum of values corresponding to its proximity to skin. Ans. 20. Although Appellant argues that Brydon does not explicitly disclose that its capacitive sensor is capable of producing a spectrum of values corresponding to proximity (Reply Br. 5), Appellant never addresses, much less refutes, the Examiner’s position (Ans. 20) that Brydon’s sensor inherently produces such a spectrum of values. See generally Appeal Br., Reply Br. It is settled law that where the claimed and prior art product are substantially identical, the PTO can require an applicant to prove that the prior art product does not inherently possess the characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). The Examiner’s finding that Brydon’s capacitive sensor inherently produces a spectrum of values, which finding is supported by sound technical reasoning, is sufficient to shift the burden to Appellant to come forward with persuasive contrary evidence. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“when the PTO shows sound basis for believing that the products Appeal 2022-000889 Application 15/313,788 11 of the applicant and the prior art are the same, the applicant has the burden of showing that they are not”). Appellant presents neither evidence nor persuasive technical reasoning to carry its burden to refute the Examiner’s position on inherent disclosure of a spectrum of values. In view of Appellant’s failure to refute the Examiner’s position on inherent disclosure related to Brydon’s capacitive sensor, we are not apprised of error in the Examiner’s findings in this regard. Appellant’s argument regarding the modification to Hendriks’s processor is not persuasive. The use of sensors and processors in a control system is ubiquitous in our current technological environment. Hendriks and Brydon both employ processing technology to process data input from sensors and direct output signals to actuators and other equipment. In our view, re-programing Hendrik’s processor to process signal input data from capacitive sensors instead of temperature sensors would have required no more than ordinary skill. Appellant’s arguments that the teachings of Hendriks and Brydon cannot be combined is not persuasive. “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 416, United States v. Adams, 383 U.S. 39, 50-51 (1966). Furthermore, when a patent “simply arranges old elements with each performing the same function it had been known to perform” and yields no more than one would expect from such an arrangement, the combination is obvious. KSR at 417, quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976). Here, the Appeal 2022-000889 Application 15/313,788 12 Examiner proposes to substitute Brydon’s sensors for Hendrik’s sensors. This is little more than a substitution or rearrangement of known parts. Appellant’s arguments the Brydon does not explicitly disclose that its capacitive sensors are capable of deforming is not persuasive. Appeal Br. 12. Figure 3b of Brydon illustrates sensors 6 as being at or near the point of contact between the mask and the patient’s skin. Brydon Fig. 3b. What a reference teaches a person of ordinary skill is not limited to what a reference specifically “talks about” or what is specifically “mentioned” or “written” in the reference. Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005). A person of ordinary skill in the art would understand that Brydon’s sensors are sufficiently pliable, flexible, and deformable that they can be disposed at or near skin so as to permit sealing contact between the mask and the patient’s face. We have considered Appellant’s remaining arguments and find them to be without merit. In view of the foregoing, we sustain the Examiner’s rejection of claims 1-4, 6, 11, 16, 17, 20, 21, 157, and 160-163. Claim 156 Claim 156 depends from claim 1 and adds the limitation: wherein the processor is configured to detect at least one state from a plurality of states by evaluation of the at least one generated sensor signal, the plurality of states comprising a first state indicating that the patient interface is being worn, a second state indicating that the patient interface is ill-fit, and a third state indicating that the patient interface is not being worn. Claims App. Appellant argues that neither Hendriks nor Brydon, alone or in combination, disclose this limitation. Appeal Br. 15-16. In response, the Examiner states that Brydon determines whether a mask is being worn, which is a type of leak detection. Ans. 21. The Appeal 2022-000889 Application 15/313,788 13 Examiner finds that the sensors of Brydon detect the closeness of the mask to the user, including states of partial contact and no contract. Id. at 21-22 (“the Brydon capacitive sensors do determine a second state whereby the seal surface is ‘close to the patient’s face and not contacting the patient’s face.’”). Furthermore, according to the Examiner, a person of ordinary skill in the art would recognize that a mask that is not in full contact with a face will have some amount of leak, proportional to how much of the mask is not touching the face. Id. Moreover, the Examiner explains that Hendriks has a controller that reads data related to a leakage/sealing condition and does so in order to adjust the fit of the mask. Id. The Examiner further explains that the rejection contemplates modifying the controller of Hendriks to accommodate data derived from the capacitive sensors of Brydon. Id. (“[M]odifying the controller of Hendriks to read the capacitive proximity sensors of Brydon requires minimal modification, and is routine in the art”). Finally, the Examiner finds that the capacitive sensor of Brydon is configured to detect a middling state between full contact and no contact, and that such aligns with known properties and interactions between capacitive sensors and the skin of a user. Id. In reply, Appellant argues that the Examiner’s Answer falls short of establishing that Hendriks and Brydon detect the “second state” of claim 156. Reply Br. 12. Appellant, furthermore, argues that the Examiner fails to cite evidence in the prior art that a processor determines that a patient interface is ill-fit. Id. As discussed in more detail above with respect to the rejection of claim 1, the Examiner’s finding that Brydon’s sensors are capable of Appeal 2022-000889 Application 15/313,788 14 determining the three states at issue is supported by a preponderance of the evidence. Ans. 16-17, 22 (“[T]his is how a capacitive sensor works”). We also agree with the Examiner that programming Hendriks’s processor to differentiate between and among the three states and direct control signals to the mask accordingly requires no more than ordinary skill. Ans. 18 (“It is clear to one of ordinary skill in the art that swapping out one type of sensor for another includes the required electrical components and processing components that read and interpret the sensor data”). We are not apprised of error and, therefore, sustain the Examiner’s rejection of claim 156. Claim 158 Claim 158 depends directly from claim 157 and indirectly from claims 1 and 156 and adds the limitation: wherein the processor is configured to determine the first state if the processor determines the seal surface is contacting the patient’s face, the second state if the processor determines that at least a portion of the seal surface is close to the patient’s face and not contacting the patient's face, and the third state if the processor determines that the seal surface is not contacting the patient's face and not close to the patient’s face. Claims App. Appellant argues that neither Hendriks nor Brydon, alone or in combination, disclose this limitation. Appeal Br. 16-18. In response, the Examiner explains that Hendriks has a controller that reads data related to a leakage condition to adjust the fit of the mask, and that the modification in light of Brydon would include changes to Hendriks’s controller to respond to the capacitive sensors of the modification. Ans. 21. Appellant’s arguments are not persuasive for reasons that we have previously discussed in connection with the rejection of claims 1 and 156. Appeal 2022-000889 Application 15/313,788 15 Hendriks teaches an auto-fit mask that is modified by using capacitive sensors as taught by Brydon. We sustain the rejection of claim 158. Unpatentability of Claims 5, 7-10, 12-14, 15, and 159 over Combinations based on Hendriks and Brydon These claims are rejected over Hendriks and Brydon in combination with various other references and are not separately argued. See generally Appeal Br. We sustain the Examiner’s rejection of claims 5, 7-10, 12-15 and 159. See 37 C.F.R. § 41.37(c)(1)(iv) (failure to separately argue claims constitutes a waiver of arguments for separate patentability). CONCLUSION Claims Rejected 35 U.S.C. § References Affirmed Rev’d 1-4, 6, 11, 16, 17, 20, 21, 156-158, 160-163 103 Hendriks, Brydon 1-4, 6, 11, 16, 17, 20, 21, 156-158, 160-163 5, 12-14 103 Hendriks, Brydon, Neely 5, 12-14 7, 8 103 Hendriks, Brydon, Kwok 7, 8 9, 10 103 Hendriks, Brydon, Stevens 9, 10 15 103 Hendriks, Brydon, Armistead 15 159 103 Hendriks, Brydon, Lanfermann 159 Overall Outcome 1-17, 20-21, 156-163 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED