Ex Parte Schraa et alDownload PDFPatent Trial and Appeal BoardJun 6, 201712669895 (P.T.A.B. Jun. 6, 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. 12/669,895 08/31/2010 Olaf Schraa ECC-6801 7945 30452 7590 06/07/2017 EDWARDS T TFFSr’TFNr’FS TORPOR ATTON EXAMINER LEGAL DEPARTMENT AGAHI, PUYA ONE EDWARDS WAY IRVINE, CA 92614 ART UNIT PAPER NUMBER 3735 MAIL DATE DELIVERY MODE 06/07/2017 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte OLAF SCHRAA, BOB SCHRAA, and JOS J.G.M. SETTELS Appeal 2016-001080 Application 12/669,8951 Technology Center 3700 Before ULRIKE W. JENKS, JOHN G. NEW, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to a cuff for determining a physiological parameter. The Examiner entered final rejections that the claims are indefinite and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the Real Party in Interest as BMEYE B.V. App. Br. 2. Appeal 2016-001080 Application 12/669,895 STATEMENT OF THE CASE Background The Specification discloses that a disadvantage of prior art cuffs is that: both the back-layer and the top-layer of the inflatable bladder deform to some extent due to applied cuff pressure. This may result in inaccurate reading of physiological parameters such as blood pressure of the cuff due to a changing angle of reflection for a reflective set-up, or a displacement between, for example, the emitter and detector for a transmissive set-up. Spec. 1: 24—2:2. The Specification discloses: a photoplethysmograph arranged with an emitter for emitting a radiation in a direction of a tissue to be investigated; a detector for detecting the radiation from the tissue; and an inflatable bladder for transferring pressure to the tissue, said inflatable bladder comprising a back-layer and a top-layer, wherein the top-layer is conceived to be brought in contact with the tissue, the top-layer being substantially more flexible than the back-layer. Spec 2:10-18. The Claims Claims 1, 3—7, 9, 14—19, 21, and 22 are pending and on appeal. App. Br. 3. Sole independent claim 1 is illustrative and reads as follows, with the relevant claim language emphasized: 1. A cuff for determining a physiological parameter, comprising: a photoplethysmograph including an emitter configured to emit radiation in a direction of a tissue to be investigated; 2 Appeal 2016-001080 Application 12/669,895 a detector configured to detect the radiation from the tissue; and an inflatable bladder configured to transfer pressure to the tissue, said inflatable bladder comprising a back-layer and a top- layer, wherein the top-layer is configured to be brought into contact with the tissue, wherein the back-layer comprises a flexible substantially non-elastic material which does not undergo deformation under application of a suitable internal cuff pressure and the top layer comprises a flexible substantially elastic material which does undergo deformation under application of the suitable internal cuff pressure, and wherein the back-layer and the top layer have substantially the same thickness. App. Br. 16 (Claims App.). The Issues The following rejections are before us to review: Claims 1, 3—7, 9, 14—19, 21, and 22 are rejected under pre-AIA 35 U.S.C. § 112 (second paragraph), as indefinite. Non-Final Act.2 2. Claims 1, 3—7, 9, 14, and 17—19 are rejected under 35 U.S.C. § 103(a) as obvious over Boehmer3 and Voith.4 Non-Final Act. 4. Claim 15 is rejected under 35 U.S.C. § 103(a) as obvious over Boehmer and Voith in view of Chin.5 Non-Final Act. 6. 2 Examiner’s Non-Final Action, mailed April 21, 2014 (“Non-Final Act.”). 3 US 4,726,382, issued Feb. 23, 1988 (“Boehmer”). 4 US 5,840,036, issued Nov. 24, 1998 (“Voith”). 5 US 2002/0038082 Al, published Mar. 28, 2002 (“Chin”). 3 Appeal 2016-001080 Application 12/669,895 Claim 16 is rejected under 35 U.S.C. § 103(a) as obvious over Boehmer and Voith in view of Banet.6 Non-Final Act. 7. Claims 21 and 22 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Boehmer, Voith, and Chesney.7 Non-Final Act. 8. INDEFINITENESS The Examiner finds that: Claim 1, and all dependent claims thereof, recites “a flexible substantially nonelastic material”, “a flexible substantially elastic material”, and “substantially the same thickness” which renders the claim indefinite. The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Non-Final Act. 2. Issue The issue before us is: Did the Examiner err in concluding that the claim language “a flexible substantially nonelastic material”, “a flexible substantially elastic material”, and “substantially the same thickness” renders claim 1 indefinite? Analysis Appellants argue that “substantially” is a commonly used term in patent parlance that is approved by our reviewing Court for use in the manner employed by Appellants. App. Br. 5—7. We agree that “terms in the 6 US 2007/0276262 Al, published Nov. 29, 2007 (“Banet”). 7 US 6,048,318, issued April 11, 2000 (“Chesney”). 4 Appeal 2016-001080 Application 12/669,895 claims such as ‘approach each other,’ ‘close to,’ ‘substantially equal,’ and ‘closely approximate’ ... are ubiquitous in patent claims. Such usages, when serving reasonably to describe the claimed subject matter to those of skill in the field of the invention, and to distinguish the claimed subject matter from the prior art, have been accepted in patent examination and upheld by the courts.” Andrew Corp. v. Gabriel Electronics, Inc., 847 F.2d. 819, 821 (Fed. Cir. 1988). Our reviewing court has held that prior to issuance, the test for indefiniteness under 35 U.S.C. § 112, second paragraph is a “lack of clarity (in its several forms) based on the perspective of one of ordinary skill in the art in view of the entire written description and developing prosecution history.” In re Packard, 751 F.3d 1307, 1312 (Fed. Cir. 2014). The issue then becomes: did Appellants’ use of “substantially” in each case sufficiently describe the claimed subject matter to the skilled artisan and distinguish the claimed subject matter from the prior art? Appellants argue that the first two uses of “substantially” in claim 1 describe the relative performance of materials under stress, e.g.,: “In this patent application, a non-elastic material does not deform appreciably under stresses below the material’s fairly high yield strength. An elastic material, in contrast, deforms readily under even rather moderate stress levels.” App. Br. at 6. Appellants note that the Specification contains specific definitions of “elastic material” (“comprises at least any material having a tensile stress at 50% strain of less than 5 MPa”) and “non-elastic material” (“comprises at least any material having a yield strength of more than 50 MPa”). Id. Appellants further argue that “‘non-elastic’ and ‘elastic’ materials are purely theoretical; no such perfect materials exist anywhere in nature . . . modifying 5 Appeal 2016-001080 Application 12/669,895 those terms with ‘substantially’ in fact provides a somewhat truer representation of the actual physical reality than would use of either term unmodified and alone.” Id. at 7—8. Similarly, Appellants argue that the third use of “substantially” in the claim language “the back-layer and the top layer have substantially the same thickness . . . reflects the true physical reality of the world somewhat better than would the bare unmodified ‘the same[]’ [because] the thicknesses of two different physical items will always be different.” Id. at 9. According to Appellants, this use of “substantially” “conveys the ordinary, everyday sense that the two thicknesses are fundamentally the same, reasonably the same, nearly the same, that the difference between the two layers’ thicknesses are merely minor and thus insubstantial, etc..'’’ Id. at 9—10. The Examiner has the better position. As the Examiner found, Appellants’ Specification does not define “substantially” or provide examples indicating what would or would not constitute “substantially elastic,” “substantially non-elastic,” or “substantially the same thickness.” Thus, the Specification does not satisfy Appellants’ obligation to define their claims with particularity. We acknowledge Appellants’ argument that the Specification informs the skilled artisan that an inelastic material suitable for use with the claimed invention should have a yield strength of close to > 50 MPa, and that the top layer should use elastic material having a tensile stress that is close to 50% strain of less than 5 MPa. App. Br. 6. However, the skilled artisan is without guidance as to how “close” these measurements must be to fall within the claim term “substantially”. In addition, no guidance is provided for how “substantially the same thickness” should be interpreted. 6 Appeal 2016-001080 Application 12/669,895 Appellants have not met the burden set forth in Packard of either modifying the word substantially, providing a separate definition of the word substantially, or providing a persuasive explanation as to why the word substantially is not unclear in the context of claim 1. Appellants focus on the limited information provided in the Specification regarding single measurement points of tensile stress and yield strength does not address the core question at hand: what does the word “substantially” mean as it is recited in claim 1? Appellants do not answer this question and does not provide any evidence as to how a person of skill would understand “substantially” aside from an implied understanding by one of skill in the art. App. Br. 6—10. We find that the claims, read in light of the Specification, fail to inform the skilled artisan with reasonable certainty as to the metes and bounds of “substantially” in any of the three uses in claim 1 such that the skilled artisan could distinguish their subject matter from the prior art. Accordingly, we affirm the Examiner’s rejection of claims 1, 3—7, 9, 14—19, 21, and 22 as indefinite under 35U.S.C. § 112. OBVIOUSNESS Appellants address the four obviousness rejections together on appeal. See App. Br. 10-14. We agree that the same issues are relevant to all rejections and consider the rejections together.8 In addition, because 8 As we discussed above, we find the limitations of “substantially elastic,” “substantially non-elastic,” and “substantially the same thickness” to be indefinite in the appealed claims. While Steele counsels that a prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning 7 Appeal 2016-001080 Application 12/669,895 Appellants argue only the patentability of claim 1 (App. Br. 15), and do not separately argue the rejections of claims 3—7, 9, 14, and 17—19 under 35 U.S.C. § 103(a) as obvious over Boehmer and Voith, the rejection of claim 15 under 35 U.S.C. § 103(a) as obvious over Boehmer and Voith in view of Chin, or the rejection of claim 16 under 35 U.S.C. 103(a) as obvious over Boehmer and Voith in view of Banet, we focus our analysis on claim 1. Claims 2—5, 10, 13, 25, and 31—61 will stand or fall with claim 1. 37 C.F.R. §41.37 (c)(l)(iv). The Examiner finds that Boehmer teaches: a cuff for determining a physiological parameter . . . , comprising: a photoplethysmograph including an emitter configured to emit a radiation in a direction of a tissue to be investigated . . . ; a detector configured to detect the radiation from the tissue . . . ; an inflatable bladder configured to transfer pressure to the tissue . . . , said inflatable bladder comprising a back-layer and a top-layer, wherein the top-layer is conceived to be brought into contact with the tissue . . . , wherein the back- layer comprises a flexible substantially non-elastic material . . . which does not undergo deformation a suitable internal cuff pressure and the top layer comprises a flexible substantially elastic material which undergoes deformation under application of the suitable internal cuff pressure. Non-Final Act. 4. In short, the Examiner concludes Boehmer discloses all elements of claim 1 except that “Boehmer does not explicitly show the thickness of the coated mylar strip 56 (i.e. back layer), in particular the thickness of the of claim language, see In re Steele, 305 F.2d 859, 862 (CCPA 1962), we address the obviousness rejections with respect to these claims in the interests of compact prosecution. 8 Appeal 2016-001080 Application 12/669,895 mylar strip having substantially the same thickness as the inner urethane film with thickness of about 1-2 mils (i.e. top layer).” Id. at 4—5. The Examiner finds “Voith teaches [a] blood pressure measuring apparatus (title) including a protective layer 34 of film, such as Mylar, and [a thickness of] about 1-2 mils”. Id. at 5. The Examiner concludes that the skilled artisan would have found it obvious “to modify Boehmer’s mylar strip to match the same thickness of Voith’s mylar layer because doing so would provide protection to surrounding layers in a cuff configuration and using 1-2 mils thickness for a mylar strip is known in the art.” Id. We agree with the Examiner that Boehmer and Voith establisha prima facie case of obviousness. Boehmer discloses a “cuff. . . comprised of an inflatable bladder that contacts the patient[’s] finger.” Boehmer, Abstract. Boehmer discloses a light source and light detector connected to the inner surface of a flexible circuit {id. at 3:41—43) with the component wires of the circuit connected “to the electronic circuitry used with the blood pressure monitoring equipment.” Id. at 3:64-4:2. The circuit is adhered to the inflatable bladder with a double-sided adhesive mylar strip, and “which covers entirely the metalized layer 14 of inflatable bladder 12, thus providing an adhesive as well as electrical insulation.” Id. at 4:5—8. Voith also discloses an “inflatable bladder 12 [that] comprises two pieces of material such as urethane film of the same general dimensions and which are heat sealed together about their periphery forming there between an inflatable chamber.” Id. at 2:65—3:1. The inner urethane film that faces the patient[’s] finger “preferably . . . has a thickness of about 1—2 mils.” Id. at 3:4—5. 9 Appeal 2016-001080 Application 12/669,895 Voith discloses a blood pressure monitoring system comprising a cuff placed around the arm. Voith, Abstract. Voith discloses that the cuff includes a transducer for measuring blood pressure (a physiological parameter). Id. at 4:14—19. Voith discloses that “[a] protective layer 34 of film, such as Mylar, and about 1-2 mils, thick is laminated to the film 30 above the electrodes”. Id. at 4:34—36. Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that Boehmer and Voith suggest the subject matter of claim 1. Analysis We adopt and incorporate by reference the Examiner’s findings and conclusions with respect to these references as presented in the Non-Final Action and Answer. Non-Final Act. 4—9; Ans. 5—7. The findings of fact included in the analysis below are provided only to highlight certain evidence of record relevant to our analysis. We agree with the Examiner that the cuff of claim 1 would have been obvious based on Boehmer and Voith. Boehmer suggests a cuff that meets all of the limitations of claim 1 except that it does not expressly disclose that the film above the electrodes (the “back-layer” of claim 1) is “substantially the same thickness” as that of the “front-layer”. However, Voith describes a cuff for measuring a physiological parameter (blood pressure) that employs a mylar film of the exact dimensions used by Boehmer, 1—2 mils. Thus, we agree with the Examiner that it would have been obvious to the skilled artisan to use a back-layer of the same dimension as the front-layer, as taught by Voith. 10 Appeal 2016-001080 Application 12/669,895 Appellants concede that Boehmer and Voith are analogous art (App. Br. 12) but argue that because the cuffs are used on different body parts (fingers in Boehmer and arms in Voith) the teachings are not combinable. Specifically, the locations and flows of blood through the vessels in these body parts differ substantially [,] [tjhere is thus no reason to assume that a configuration - and in particular a detailed parts dimension - useful or optimal in one type of device will necessarily be optimal or even applicable in the other. App. Br. 11-12. Appellants’ argument on this point is not persuasive. The cuffs of Boehmer and Voith are both used on cylindrical body parts to measure a physiological parameter. Appellants do not provide evidence that the configuration in Voith, specifically the use of a mylar film of 1—2 mils as a back-layer, would not work in Boehmer, particularly as Boehmer discloses use of urethane film of precisely the same dimension. Appellants’ arguments without more do not meet this requirement. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“[Attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness”). See also Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (finding appealed claims unpatentable because Appellant provided no evidence that the claimed difference in size was “uniquely challenging or difficult for one of ordinary skill in the art” as it pertained to modifying the prior art as suggested the Examiner). Appellants also argue: 11 Appeal 2016-001080 Application 12/669,895 the operations of the inflatable bladders in the two types of device [s] are substantially different [because i]n Boehmer’s device — and in the device described in the current application - pressure is applied via the inflatable bladder and varied continuously, so that a dynamic trace can be taken of the patient’s blood pressure as it varies over the complete cardiac cycle. App. Br. 12. Appellants argue this differs from Voith’s cuff, “in which a relatively high pressure is applied at the start to occlude blood flow through the vessel [and] is then released slowly while characteristic sounds are listened for, until the pressure drops to a point where blood flow can resume in the vessel.” Id. at 12—13. According to Appellants, because the pressure in Voith’s cuff is “driven, controlled, and applied much less dynamically and continuously than in cuffs of the type described in Boehmer or the present application”, one cannot assume the materials and parts of Voith could be compatible. Id. at 13. Appellants’ argument on this point is not persuasive. Appellants do not provide evidence to show or persuasively explain why different mechanisms of operating of the bladder would prevent the skilled artisan from using a back-layer of the same dimension as the front layer. The claimed bladder must only be “configured to transfer pressure to the tissue,” which both bladders disclosed in Boehmer and Voith accomplish. We conclude that one of ordinary skill in the art would have had a reasonable expectation of success in using a back-layer of the same thickness as the front layer based on the combined disclosures of Boehmer and Voith. “Obviousness does not require absolute predictability of success. ... For 12 Appeal 2016-001080 Application 12/669,895 obviousness under § 103, all that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). Appellants further argue that Boehmer’s cuff already has a mylar layer, thus “there is no reason to believe that making the thickness 1—2 mils as it is in Voith would provide any improvement to Boehmer.” App. Br. 13. Appellants further speculate that the existing layer could already be thicker or need to be thinner than 1—2 mils, and that modifying it could be detrimental to operation of the cuff. Id. As Boehmer is silent about the thickness of the mylar layer on the back of the cuff and states no thickness requirement tied to bladder performance (notably, claim 1 also lacks this element), we are not persuaded that this a reason the skilled artisan would find the absence of Boehmer’s disclosure to be a reason to avoid using a layer of the thickness taught in Voith. Finally, Appellants argue that “nowhere in the art cited thus far is it taught that those [the thicknesses of Boehmer and Voith] should correspond. Nowhere, that is, outside of the current applicants’ own specification and claims” and assert that the Examiner’s rejection is based on impermissible hindsight. App. Br. 14. We are not persuaded. While we are fully aware that hindsight bias may plague determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1,36 (1966), we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. In the instant case, Appellants point to no evidence that any of the Examiner’s findings were beyond the level of ordinary skill at the time of the invention or could have been taken only 13 Appeal 2016-001080 Application 12/669,895 from Appellants’ Specification. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Accordingly, we affirm the rejection of claim 1 as obvious. Having not been argued separately, we likewise affirm the rejection of claims 3—7, 9, 14—19, 21, and 22. As discussed above, Appellants have waived arguments directed to Chin, Banet, and Chesney. We therefore also affirm the rejection of claims 15, 16, 21, and 22 over the combination of those references with Boehmer and Voith. See Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“In the event of such a waiver, the PTO may affirm the rejection of the group of claims that the examiner rejected on that ground without considering the merits of those rejections.”). SUMMARY We affirm the rejection of claims 1, 3—7, 9, 14—19, 21, and 22 as indefinite under 35U.S.C. § 112. We affirm the rejection of claims 1, 3—7, 9, 14, and 17—19 under 35 U.S.C. § 103(a) as obvious over Boehmer and Voith. We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as obvious over Boehmer and Voith in view of Chin. We affirm the rejection of claim 16 under 35 U.S.C. § 103(a) as obvious over Boehmer and Voith in view of Banet. We affirm the rejection of claims 21 and 22 under 35 U.S.C. § 103(a) as obvious over Boehmer, Voith, and Chesney. 14 Appeal 2016-001080 Application 12/669,895 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 15 Copy with citationCopy as parenthetical citation