Ex Parte KlemDownload PDFPatent Trial and Appeal BoardSep 27, 201613144222 (P.T.A.B. Sep. 27, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/144,222 08/12/2011 29880 7590 09/29/2016 FOX ROTHSCHILD LLP PRINCETON PIKE CORPORATE CENTER 997 LENOX DRIVE BLDG. #3 LAWRENCEVILLE, NJ 08648 FIRST NAMED INVENTOR Bjorn Klem UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. 16207.50002 3736 EXAMINER SHAY,DAVIDM ART UNIT PAPER NUMBER 3769 NOTIFICATION DATE DELIVERY MODE 09/29/2016 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): ipdocket@foxrothschild.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BJORN KLEM Appeal2015-006059 Application 13/144,222 Technology Center 3700 Before JENNIFER D. BAHR, JAMES P. CALVE, and ARTHUR M. PESLAK, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Bjorn Klem (Appellant) appeals under 35 U.S.C. § 134(a) from the Examiner's decision rejecting claims 1, 2, 4, 5, 9-11, and 13-34, which are the only claims pending in this application. Appeal Br. 31-32. We have jurisdiction under 35 U.S.C. § 6(b ). Appellant filed a Request for Oral Hearing on May 28, 2015, but withdrew that Request in the Petition to Make Special - Expedited Patent Appeal Pilot, submitted May 10, 2016. That Petition was granted on July 28, 2016. We AFFIRM. Appeal2015-006059 Application 13/144,222 THE CLAIMED SUBJECT MATTER Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. An irradiation device for insertion into an orifice of the body of a human selected from the female reproductive tract and the rectum for providing photodynamic therapy to a treatment area in the orifice, the device comprising: a housing adapted to be fully inserted and secured in the orifice, the housing enclosing a light emitting diode ("LED") lamp system and a power source for powering the LED lamp system and the housing including a treatment surface having at least one of (a) a size and (b) a shape adapted for complementary fit with the treatment area and the LED system being arranged to emit, when the device is in use, light at a light intensity in the range of 1-50 m W/cm2 from the treatment surface such that the treatment area is illuminated; wherein the device is independently operational while located in the orifice. REJECTIONS We understand the following rejections to be pending in this application: 1 1 In the Advisory Action, dated June 25, 2014, the Examiner withdrew the rejections under 35 U.S.C. §§ 101, 112, first paragraph, and 112, second paragraph. In the Interview Summary issued with the Advisory Action, the Examiner vacated the stray rejections inserted inadvertently in the Final Action following the Examiner's signature. In the Answer, the Examiner confirmed the withdrawal of the rejection under 35 U.S.C. § 101 and also withdrew the rejections under 35 U.S.C. § 103(a) based in part on Bennett (US 2011/0190689 Al, pub. Aug. 4, 2011). Ans. 3--4. The Examiner also stated that rejections under 35 U.S.C. §§ "101, second paragraph," "112, first paragraph," and 112, second paragraph" have been withdrawn. Id. We understand these statements to mean that the Examiner has withdrawn the rejections under 35 U.S.C. § 112, first paragraph, for failing to comply with the written description and enablement requirements, and the rejection under 35 U.S.C. § 112, second paragraph, as indefinite. 2 Appeal2015-006059 Application 13/144,222 l. Claims 1, 2, 4, 5, 9-11, and 13-34 under 35 U.S.C. § 103(a) as unpatentable over Mayer '008 (US 2009/0319008 Al, pub. Dec. 24, 2009), Chen (US 5,445,608, iss. Aug. 29, 1995), Neuberger (US 8,292,935 B2, iss. Oct. 23, 2012), Zadini (US 5,674,239, iss. Oct. 7, 1997) and Appellant's Admitted Prior Art. II. Claims 1, 2, 4, 5, 9-11, and 13-34 under 35 U.S.C. § 103(a) as unpatentable over Mayer '678 (WO 2006/103678 A2, pub. Oct. 5, 2006), Chen, Neuberger, Zadini, and Appellant's Admitted Prior Art. III. Claims 1, 2, 4, 5, 9-11, and 13-34 under 35 U.S.C. § 103(a) as unpatentable over Mayer '008, Chen, Soergel (Phillip Soergel et al., Photodynamic Therapy of Cervical Intraepithelial Neoplasia With Hexaminolevulinate, Lasers in Surgery and Medicine 40:611- 615 (2008)), Zadini and Appellant's Admitted Prior Art. IV. Claims 1, 2, 4, 5, 9-11, and 13-34 under 35 U.S.C. § 103(a) as unpatentable over Mayer '678, Chen, Soergel, Zadini, and Appellant's Admitted Prior Art. 2, 3 V. Claims 1, 2, 4, 5, 9-11, and 13-34 provisionally under the judicially-created doctrine of obviousness-type double patenting as unpatentable over claims 20-23, 25-34, 37, 38, and 40-48 of co- 2 The inclusion of Neuberger, instead of Soergel, in the statement of the rejection (Final Act. 17) is ostensibly an inadvertent error, as the Examiner mentions Soergel, and not Neuberger, in the detailed explanation of the rejection (id. at 19). 3 The multitude of rejections set forth by the Examiner does not appear to be in compliance with the instructions provided in the Manual of Patent Examining Procedure (MPEP 9th ed., Rev. Nov. 2015) § 706.02 CHOICE OF PRIOR ART; BEST AVAILABLE. 3 Appeal2015-006059 Application 13/144,222 pending Application 13/595,167 in view of Mayer '008, Chen, Neuberger, and Zadini. VI. Claims 1, 2, 4, 5, 9-11, and 13-34 provisionally under the judicially-created doctrine of obviousness-type double patenting as unpatentable over claims 20-23, 25-34, 37, 38, and 40-48 of co- pending Application 13/595,167 in view of Mayer '678, Chen, Neuberger, and Zadini. VII. Claims 1, 2, 4, 5, 9-11, and 13-34 provisionally under the judicially-created doctrine of obviousness-type double patenting as unpatentable over claims 20-23, 25-34, 37, 38, and 40-48 of co- pending Application 13/595,167 in view of Mayer '008 and Bennett. VIII. Claims 1, 2, 4, 5, 9-11, and 13-34 provisionally under the judicially-created doctrine of obviousness-type double patenting as unpatentable over claims 20-23, 25-34, 37, 38, and 40-48 of co- pending Application 13/595,167 in view of Mayer '678 and Bennett. DISCUSSION Rejections I-IV Claims 1, 2, 4, 5, 9-11, and 13-24, and 26--30: In contesting each of the rejections of these claims under 35 U.S.C. § 103(a), Appellant presents the same arguments: 1) Neither Mayer '008 nor Mayer '678 discloses using a light intensity within the claimed range, and Chen's teachings with respect to light intensity are not relevant to Mayer '008 or 4 Appeal2015-006059 Application 13/144,222 Mayer '678, or to the appealed claims, because they concern the use of such light intensity in the context of killing Staphylococcus epidermidis bacteria in a Petri dish, and not to rejuvenation of the vaginal wall, as taught by Mayer '008, for example. Appeal Br. 11-13, 21-22, 26, 27, 30. 2) Neither Mayer '008 nor Mayer '678 discloses a self-contained device, including the lamp system and power supply within a housing adapted to be fully inserted and secured in the orifice, and the other references do not remedy this deficiency. Id. at 14,22-23,26,28,30. Appellant presents arguments with reference to Mayer '008, pointing out that "Mayer '678 and Mayer '008 contain essentially the same disclosure" and, thus, the points made with respect to Mayer '008 apply equally to Mayer '678. Id. at 26, 30. The Examiner does not dispute Appellant's characterization of the two Mayer references, so we restrict our discussion to Mayer '008 as representative of both Mayer references. With respect to the first argument, Appellant points out that Mayer '008 discloses, in paragraphs 23 and 94, the use of light intensities from "about 200 mW I cm2 to less than about 1000 mW I cm2" and, in paragraph 93, the use of a light intensity "substantially not exceeding 1 Watt/cm2." Id. at 12. According to Appellant, "[c]onsidering these disclosures together leads to the conclusion that Mayer '008 teaches that intensities somewhere between 200 mW I cm2 and 1 Watt/ cm2, but not greater than 1 Watt/cm2, should be used." Id. Thus, Appellant submits that "[i]t would be impermissible to consider" the "substantially not exceeding 1 Watt/cm2" teaching of paragraph 93 in isolation and conclude that Mayer 5 Appeal2015-006059 Application 13/144,222 '008 teaches light intensities within the claimed range of 1-50 m W/cm2. Id. Appellant contends that, "[i]f anything Mayer '008's range points away from the claimed ranges (i.e., to much higher intensities) and thus would lead one of ordinary skill in the art away from the claimed ranges," thereby teaching away from the claimed range. Id. at 13. A reference teaches away from a claimed invention if "a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant." In re Kubin, 561 F.3d 1351, 1357 (Fed. Cir. 2009) (citing In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)). Prior art does not teach away from claimed subject matter merely by disclosing a different solution to a similar problem unless the prior art also criticizes, discredits or otherwise discourages the solution claimed. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Mayer '008 explicitly describes the particular process (energy level, pulse period, and pulse duration) referenced by Appellant as a "specific but not limiting example." Mayer '008, para. 23. Similarly, the intensity, pulse period, and pulse duration parameters discussed in paragraphs 93 and 94 of Mayer '008 are by way of "example." Appellant does not point to any disclosure in Mayer '008 that criticizes, discredits, or otherwise discourages operation at any intensity level within the broad range of "substantially not exceeding 1 Watt/cm2" disclosed by Mayer '008 in paragraph 93, for other applications. Overlapping ranges create a case of prima facie obviousness that can be rebutted with evidence of unexpected results. See In re Peterson, 315 F.3d 1325, 1329, 1330-31 (Fed. Cir. 2003). Appellant does not present any evidence of unexpected results achieved by operation within the 6 Appeal2015-006059 Application 13/144,222 particular intensity level range claimed. Moreover, even assuming that Mayer '008's disclosure of "substantially not exceeding 1 Watt/cm2" is not deemed sufficient, alone, to render obvious the claimed range of 1-50 m W/cm2, Chen discloses use of a light intensity of 2.6 m W/cm2, which falls within the claimed range, over relatively long duration, for killing bacteria. Chen, col. 7, 11. 14--45. Appellant does not point to any disclosure in Mayer '008 that criticizes, discredits, or otherwise discourages the use of lower intensities and longer durations, as taught by Chen, for such applications. In support of the contention that Chen's light intensity teachings have no relevance to the claimed invention or to the device of Mayer '008, Appellant asserts that Chen contains no data that would lead one of ordinary skill in the art to consider Chen's teachings directed to in vitro use of light to kill Staphylococcus epidermis bacteria in a Petri dish relevant to a device sized and shaped for use in the human female reproductive tract or rectum. Appeal Br. 21. Appellant adds that "[ n ]othing in the record suggests that killing Staphyloccocus epidermis bacteria in a Petri dish has any relevance to [rejuvenation of the vaginal wall]" as taught by Mayer '008. Id. Appellant's arguments are not persuasive. Although Chen may not provide any data confirming that the bacteria-killing results achieved in the in vitro Petri dish experiment necessarily will carry over to in vivo treatment of human tissue, Chen explicitly conveys the belief that this will be the case. See Chen, col. 7, 11. 46-54. Further, rejuvenation of the vaginal wall is just one possible application of the device of Mayer '008; other treatment applications, including treatment of pathogen (i.e., bacteria) infections, such as those causing vaginitis, are contemplated. Mayer '008, paras. 27, 113- 7 Appeal2015-006059 Application 13/144,222 117 ;4 see also id., para. 92 (disclosing reference data stored in the control unit for setting the operational mode of the LEDs, including intensity of the light, for the patient's treatment program). Chen suggests a relatively low intensity, longer duration alternative to more conventional therapy, in which "the treatment site is exposed to relatively high intensity light for a relatively short period of time." Chen, col. 7, 11. 6-13. For the above reasons, Appellant's contention that teachings directed to killing a particular type of bacteria are not pertinent to rejuvenation of the vaginal wall is unavailing to show that it would not have been obvious to combine the teachings of Mayer '008 and Chen as proposed by the Examiner. Appellant advances similar arguments with respect to Neuberger and Soergel, which Appellant submits are more pertinent to treatment of the human female reproductive tract, and which, according to Appellant, point to the use of light intensities much greater than those claimed. See Appeal Br. 20, 27; Reply Br. 4. These arguments are unpersuasive for the reasons discussed above. While Neuberger and Soergel, like Mayer '008, disclose use of light intensities greater than those claimed for some applications, such as vaginal wall rejuvenation and treatment of cancer and precancerous cells, Appellant does not direct our attention to any disclosure in any of these references that suggests that the use of lower light intensities, within the claimed range, would not be appropriate for other treatment applications, such as treatment of bacterial infections. 4 Mayer '008 does not specify the light intensity to be used for treating vaginitis, but does disclose multiple daily treatments over a prolonged period, e.g., one week. Id., paras. 115-116. 8 Appeal2015-006059 Application 13/144,222 Turning now to Appellant's second argument, claim 1 requires "a housing adapted to be fully inserted and secured in the orifice, the housing enclosing a light emitting diode ("LED") lamp system and a power source for powering the LED lamp system." Appeal Br. 33 (Claims App.). Appellant contends that Mayer '008 does not disclose a device comprising such a housing. Appeal Br. 13-15. In particular, Appellant argues that Mayer '008's housing comprises a handle which "is not fully inserted into the body cavity but instead must be at least partly outside the body cavity so as to be accessible to the patient's or caregiver's hand (in order to make the device 'hand-held')." Id. at 14 (citing Mayer '008, para. 35). Further, Appellant adds, the handle has a control unit, which includes a battery power source; thus, the power source will not be fully inserted as called for in claim 1. Id. (citing Mayer '008, para. 91). Appellant does not direct our attention to any disclosure in Mayer '008 supporting the contention that handle 13 must remain at least partly outside the body cavity (vagina) to be accessible to a user. Mayer '008 discloses "inserting . . . at least part of the probe member into a body cavity via an orifice of the body cavity such that a part of the probe member is located close to said orifice of said body cavity and is accessible to a user." Mayer '008, para. 40. This suggests that the handle may need to be merely close to the orifice of the body cavity, and not actually outside it, in order to be accessible. Moreover, the Examiner does not rely solely on the teachings of Mayer '008 in addressing the "adapted to be fully inserted" limitation. See Final Act. 10 (citing Zadini' s intra vaginal device and determining that it would have been obvious to configure the device of Mayer '008 to be fully insertable to facilitate "normal daily activities without inconvenience"). 9 Appeal2015-006059 Application 13/144,222 Mayer '008 repeatedly describes the probe member as a "tampon-like probe member." See, e.g., Mayer '008, paras. 83, 100, 104. As evidenced, for example, by Zadini, techniques are well known in the art for adapting tampon-like devices to be fully inserted into the vagina while permitting their removal. See Zadini, Figs. 4, 15; col. 4, 11. 41--42. Thus, modifying the device of Mayer '008, to the extent necessary, to configure it to be fully insertable (including the lamp assembly and the power source) into the body cavity, as proposed by the Examiner, would have been well within the technical grasp of a person having ordinary skill in the art. Appellant submits that Chen's devices are intended for implantation "at a surgically created site in the brain," and not for insertion into a body cavity such as the human female reproductive tract or rectum, and, thus, such a configuration would not satisfy the "adapted to be fully inserted" limitation of claim 1. Reply Br. 4--8. However, the Examiner's rejection does not propose to use a configuration as taught by Chen for the probe device of Mayer '008. Rather, the Examiner relies on Chen's discussion of the advantages and disadvantages of self-contained devices with battery power sources incorporated therein versus devices with connections to external power sources and/or control devices as a teaching or suggestion to fabricate the device of Mayer '008 as a self-contained device. See Ans. 6 (citing Chen, col. 9, 1. 18---col. 10, 1. 45); see Chen, col. 10, 11. 31--45 (specifically discussing these advantages and disadvantages). For the above reasons, Appellant does not apprise us of error in any of the rejections of claims 1, 2, 4, 5, 9-11, 13-24, and 26-30 under 35 U.S.C. § 103(a), all of which we, thus, sustain. 10 Appeal2015-006059 Application 13/144,222 Claim 25: Claim 25 depends from claim 1 and further requires that the LED system be arranged to emit "light at a light intensity in the range of 1-10 mW/cm2." Appeal Br. 35 (Claims App.). In contesting the rejection of this claim, Appellant relies essentially on the arguments set forth above regarding the teachings of the Mayer references and Neuberger with respect to light intensity. Appeal Br. 23-24, 26, 28, 30. Appellant adds that "it could not have been predicted that such a low intensity as recited in claim 25 would be effective, given the art's teaching of much higher light intensities." Id. at 24. These arguments are not persuasive, for the reasons discussed above. As noted above, Chen suggests that use of a light intensity within the claimed range would be effective for treating a bacterial infection, which is one of the treatment applications contemplated by Mayer '008. Accordingly, Appellant fails to apprise us of error in any of the Examiner's rejections of claim 25 under 35 U.S.C. § 103(a), all of which we, thus, sustain. Claim 31: Appellant argues that none of the applied references (i.e., the Mayer references, Chen, Neuberger, Zadini, and Soergel) teaches or suggests a device having "a treatment surface sized and shaped so as to cover, in use, the opening of the cervix." Appeal Br. 24; see also id. at 26, 29, 30; Reply Br. 8-9. Appellant contends that Neuberger's disclosure that its photonic device is shaped to provide uniform illumination to treatment areas in and around the cervix means that it cannot be sized and shaped to cover, in use, the opening of the cervix. Appeal Br. 24; Reply Br. 9. According to Appellant, ifNeuberger's devices were "to cover the opening of the cervix, 11 Appeal2015-006059 Application 13/144,222 illumination would not reach areas around the cervix." Appeal Br. 24. It is not immediately apparent, and Appellant does not adequately explain, why illumination of areas around the cervix is inconsistent with the treatment surface being sized and shaped to cover the cervix opening. Moreover, to the extent that Neuberger's treatment surface is not so sized and shaped, Appellant fails to apprise us of error in the Examiner's position that it would have been obvious, and within the technical grasp of a person having ordinary skill in the art, to so modify the treatment surface of the device of either of the Mayer references in order to treat the cervix, as taught by Neuberger or Soergel. See Final Act. 10-11, 13-14, 16-17, 19-20; Ans. 8. Accordingly, for the above reasons, Appellant fails to apprise us of error in any of the rejections of claim 31 under 35 U.S.C. § 103(a), all of which, we, thus, sustain. Claim 32: The Examiner relies on Neuberger or Soergel for a suggestion to provide a treatment surface having a ring-shaped contact surface and a concave portion sized and shaped to cover, in use, the opening of the cervix. Final Act. 10-11, 13-14, 16-17, 19-20; Ans. 8 (alluding to the "cup shaped portion of the instant applicator"). Appellant contends that Neuberger's device has a disk, "indicated by a solid vertical line in Figure 1," and, thus, "cannot meet the 'concave' portion limitation of claims 32-34." Appeal Br. 25. We find no support for this contention. Appellant does not direct our attention to any disclosure in Neuberger indicating that there is a disk at this location; rather, the solid line to which Appellant refers appears to depict the edge of semi spherical reflector 105. See Neuberger, col. 5, 11. 12-15. 12 Appeal2015-006059 Application 13/144,222 Appellant also contends that "Soergel's devices are simply catheters without ring-shaped or concave portions or any other features sized and shaped to cover the opening of the cervix." Appeal Br. 29. Appellant does not make any attempt to explain why the device pictured in Figure 1 of Soergel lacks a ring-shaped or concave portion. See Final Act. 16, 19 (pointing to Soergel, Fig. 1 ). For the above reasons, Appellant fails to apprise us of error in any of the rejections of claim 32 under 35 U.S.C. § 103(a), all of which we, therefore, sustain. Claims 33 and 34: Appellant's argument contesting the rejections of claims 33 and 34 is predicated on their position that none of the prior art applied in the rejection teaches or suggests a treatment surface sized and shaped to cover the opening of the cervix in use or a ring-shaped contact surface. Appeal Br. 25, 2 7, 2 9, 31. For the reasons discussed above, this line of argument is not persuasive, and fails to apprise us of error in any of the Examiner's rejections of claims 33 and 34 under 35 U.S.C. § 103(a), all of which we, thus, sustain. Rejections V and VI Appellant does not present any arguments contesting these rejections. See Appeal Br., passim. Appellant has waived any argument of error, and, thus, we summarily sustain these rejections. See In re Berger, 279 F.3d 975, 984, 985 (Fed. Cir. 2002) (holding that the Board did not err in sustaining a rejection when the applicant failed to contest the rejection on appeal); Manual of Patent Examining Procedure (MPEP) § 1205.02, 9th ed., Rev. Nov. 2015 ("If a ground of rejection stated by the examiner is not addressed 13 Appeal2015-006059 Application 13/144,222 in the appellant's briet: appellant has waived any challenge to that ground of rejection and the Board may summarily sustain it, unless the examiner subsequently withdrew the rejection in the examiner's answer."). Re} ections VII and VIII In light of the Examiner's decision withdrawing the rejections under 35 U.S.C. § 103(a) relying on Bennett (Ans. 4), we decline to review the rejections under the doctrine of obviousness-type double patenting relying on Bennett. Rather, we leave it to the Examiner to clarify the status of these rejections upon return of jurisdiction of this application to the Examiner. DECISION The Examiner's decision rejecting claims 1, 2, 4, 5, 9-11, and 13-34 pursuant to Rejections I-VI is AFFIRMED. 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 14 Copy with citationCopy as parenthetical citation