Pourang Bral

Patent Trials and Appeals BoardNov 2, 2020

14028500 - (D) (P.T.A.B. Nov. 2, 2020)

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. 14/028,500 09/16/2013 Pourang Bral 3979 7590 11/02/2020 Pourang Bral 155 Albion Street Passaic, NJ 07055 EXAMINER CARPENTER, WILLIAM R ART UNIT PAPER NUMBER 3783 MAIL DATE DELIVERY MODE 11/02/2020 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 POURANG BRAL Appeal 2020-002760 Application 14/028,500 Technology Center 3700 Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. HILL, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 19–24, 29–31, 38–42, and 44–49. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as the sole inventor, Pourang Bral. Appeal Br. 2. Appeal 2020-002760 Application 14/028,500 2 BACKGROUND Appellant’s invention relates to methods to reduce pain of a needle insertion. Claims 19, 39, and 44 are independent. Claims 19 and 39, reproduced below, are illustrative of the claimed subject matter: 19. A method to reduce pain of an injection by a needle comprising: a) applying electric current through a plurality of electrodes at least before, during, or after the injection to an injection site, and b) applying gas to said injection site through a nozzle before and during the injection to said injection site. 39. A method to reduce pain of an injection by a needle comprising: a) applying electric current through a plurality of electrodes at least before, during, or after the injection to an injection site, and b) applying gas to said injection site through a nozzle at least before, during, or after the injection to said injection site, wherein said plurality of electrodes are included in a retaining means and positioned so as to come in contact with the recipient’s skin and apply electric current to the vicinity of an injection site at least before, during, or after the injection, and wherein said nozzle is included in said retaining means and positioned so as to apply gas to the injection site at least before, during, or after the injection. Appeal 2020-002760 Application 14/028,500 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Barrett US 4,243,035 Jan. 6, 1981 Sairenji US 4,725,265 Feb. 16, 1988 Bansemir US 4,900,721 Feb. 13, 1990 Erez US 5,578,014 Nov. 26, 1996 Pope US 6,200,308 B1 Mar. 13, 2001 Leibovici US 8,500,678 B1 Aug. 6, 2013 Coulter US 2004/0015188 A1 Jan. 22, 2004 Hunn US 2006/0030824 A1 Feb. 9, 2006 Vallero US 2008/0188779 A1 Aug. 7, 2008 Knutson US 2009/0004628 A1 Jan. 1, 2009 REJECTIONS I. Claims 30, 38, 40, 42, and 46–482 stand rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. II. Claims 30, 38, and 42 stand rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter III. Claims 19, 23, 24, 31, 44, 45, 47, and 48 stand rejected under 35 U.S.C. § 103 as unpatentable over Coulter, Sairenji, Vallero, Knutson, and Erez. IV. Claims 20–22 stand rejected under 35 U.S.C. § 103 as unpatentable over Coulter, Sairenji, Vallero, Knutson, Erez, and Barrett. 2 Although the Examiner includes “and dependents” in the heading of Rejection I and II, we understand this to be a typographical error in that all claims are listed and there are no additional dependent claims. See Final Act. 3, 5. Appeal 2020-002760 Application 14/028,500 4 V. Claims 20–22 stand rejected under 35 U.S.C. § 103 as unpatentable over Coulter, Sairenji, Vallero, Knutson, Erez, Hunn, and Bansemir. VI. Claims 29, 30, 38, and 49 stand rejected under 35 U.S.C. § 103 as unpatentable over Coulter, Sairenji, Vallero, Knutson, Erez, and Pope. VII. Claim 393 stands rejected under 35 U.S.C. § 103 as unpatentable over Coulter, Sairenji, Vallero, and Knutson. VIII. Claims 40 and 46 stand rejected under 35 U.S.C. § 103 as unpatentable over Coulter, Sairenji, Vallero, Knutson, and Erez. IX. Claims 41 and 42 stand rejected under 35 U.S.C. § 103 as unpatentable over Coulter, Sairenji, Vallero, Knutson, and Pope. X. Claim 45 stands rejected under 35 U.S.C. § 103 as unpatentable over Coulter, Sairenji, Vallero, Knutson, Erez, and optionally Leibovici. ANALYSIS Rejections I and II; Written Description and Indefiniteness The Examiner finds that the limitations “simultaneously,” “predefined,” and “at least partially,” as recited in claims 30, 38, 40, 42, and 46–48 fail to comply with the written description requirement, because these limitations are not supported by the originally filed disclosure. Final Act. 3– 4. The Examiner also finds the limitation “predefined” in claims 38 and 42 is indefinite because it is unclear how this term should be interpreted. Final Act. 5. In addition, the Examiner finds that, because Appellant’s use of 3 The Examiner’s inclusion of claim 43 in the heading of Rejection VII appears to be a typographical error because claim 43 is canceled. See Final Act. 1, 14; see also Appeal Br. 20 (Claims App.). Appeal 2020-002760 Application 14/028,500 5 “consists of” and “comprising” in claims 30, 38, and 42 are incompatible, these claims are indefinite. Although Appellant submitted an Amendment After Final Action in an attempt to address these rejections (see Amendment filed May 3, 2018), the Examiner did not enter the Amendment (see Advisory Action mailed May 21, 2018). Because these rejections are not withdrawn, and because Appellant does not offer arguments for these rejections (see generally Appeal Br.), we summarily sustain Rejections I and II. Rejection III -- Coulter, Sairenji, Vallero, Knutson, and Erez In rejecting independent claim 19, the Examiner finds that Coulter discloses reducing pain at an injection site by applying current through an electrode at least before, during, or after the injection. Final Act. 6. The Examiner finds that Coulter does not apply gas before and during the injection, but that Sairenji reduces injection site pain by applying gas to the injection site through a nozzle. Id. at 6–7. According to the Examiner, it would have been obvious to include a gas application step in Coulter’s method “to provide a combinatorial effect of nerve desensitization and distraction to thereby further diminish the pain response.” Id. at 7. In support of the “combinatorial effect” reasoning, the Examiner explains that, because Vallero and Knutson disclose the advantages of combining distraction techniques to reduce pain, “there is a clear expectation of success and clear motivation for providing a single device configured to supply both electricity and gas application to provide an improved device for reducing or eliminating injection site pain.” Id. The Examiner finds that, although Sairenji does not apply gas “before and during” the injection, Erez discloses Appeal 2020-002760 Application 14/028,500 6 a related method where cooling is provided both “prior to and during piercing of the skin.” Id. (citing Erez, Abstract). The Examiner concludes that it would have been obvious to further modify the method of Coulter to apply gas prior to and during injection, “to better desensitize the pain response associated with the injection.” Id. at 8. Appellant argues that, although Vallero and Knutson disclose combining modalities, these references do not combine blowing gas in combination with electric current. Appeal Br. 10. According to Appellant, blowing gas is not a simple substitute for Knutson’s cold compress at least because blowing gas is more difficult to operate during an injection. Id. at 11. Specifically, Appellant asserts that blowing gas can be performed simultaneously with injection at the injection site, whereas a cold compress is placed on an injection site, and thus, cannot be used simultaneously with an injection. Id. at 10–11. The Examiner responds that Knutson contemplates both spraying gas as well as applying a cold compress. Ans. 15–16 (citing Knutson ¶¶ 11, 145). The Examiner thus asserts that “Knutson clearly does provide for the broad concept of combining cooling modalities (including blowing gas) with other physical stimuli (specially vibration).” Ans. 16 (citing Knutson, Abstract). According to the Examiner, because Vallero combines electrical stimuli and vibrational stimuli, “an ordinary artisan would reasonably recognize and appreciate that cooling via the blowing of gas and TENS stimulation, both being separately combinable with vibration to provide for improved distraction of injection site pain, would logically be combinable with one another to provide for a superior treatment effect.” Id. Appeal 2020-002760 Application 14/028,500 7 Appellant replies that even if blowing gas were considered to be a simple substitution for a cold compress prior to injection, this is not the case during an injection. Reply Br. 4. Appellant asserts that Knutson sprays prior to injection to “avoid introducing aerosols into the injection hole during an injection.” Id. Appellant has the better position. Although we appreciate that Knutson and Vallero contemplate combining two types of stimuli to reduce injection pain, the Examiner has not adequately established that applying gas to the injection site during injection in conjunction with applying an electric current would have been obvious. Notwithstanding that paragraph 11 of Knutson, upon which the Examiner relies, describes the prior art, this paragraph discloses a single modality by “directing a vapocoolant aerosol spray onto the puncture area prior to a puncture” or “applying the cold side of a Peltier electrode to the puncture area prior to a puncture.” Knutson ¶ 11 (emphasis added). Thus, this disclosure is similar to that of Sairenji, which only uses a cooling gas prior to injection. The Examiner also relies on paragraph 145 of Knutson, which is part of Example 5 of Knutson. See Knutson ¶¶ 144–146. There, Knutson discloses that “absorbent surface of cap 44 is sprayed with a refrigerant. Needle device 78 is oriented perpendicularly over a tissues puncture area and cap 44 is pressed into contact with the tissues.” Knutson ¶ 144. Knutson then discloses that “device 78 is turned on. Actuator 18 vibrates cap 44, and cap 44 vibrates the tissues of the puncture area. The refrigerant spray cools the tissue.” Knutson ¶ 145. We do not understand that spraying a gas on a cap, pressing the cap into tissue so that the already applied spray cools the tissue, to be applying gas to the injection site as required by claim 19. Appeal 2020-002760 Application 14/028,500 8 Thus, the Examiner has not established adequately that blowing of gas is combined with a second pain distraction method. For these reasons, the Examiner’s findings that “cooling via the blowing of gas and TENS stimulation, [are] both [] separately combinable with vibration to provide for improved distraction of injection site pain,” is not supported by a preponderance of the evidence. Thus, the Examiner’s assertion that blowing of gas and TENS stimulation “would logically be combinable with one another to provide for a superior treatment effect” is not sufficiently supported by evidence. Although the Examiner also relies on Erez to disclose cooling both “prior to and during piercing of the skin,” Erez uses a cooled contact plate that is in contact with the skin. Erez, 5:65–6:6, 6:29–33; Figs. 5A, 5B. Thus, Erez does not suggest applying gas to an injection site prior to and during injection. Because claim 19 is a method claim that requires the step of applying gas during injection, and because none of the references suggest this step, the record as a whole does not support “the legal conclusion that the invention would have been obvious.” In re Oetiker, 977 F.2d 1443, 1449 (Fed. Cir. 1992). For these reasons, we do not sustain the rejection of claim 19, and claims 23, 24, and 31, which depend from claim 19. The Examiner relies on the same finding for independent claim 44. See Final Act. 6–8. For the same reasons, we do not sustain the rejection of claim 44, and claims 45, 47, and 48, which depend from claim 44. Appeal 2020-002760 Application 14/028,500 9 Rejections IV–VI -- Coulter, Sairenji, Vallero, Knutson, Erez, Barrett, Hunn, Bansemir, and Pope Rejections IV–VI rely on the same proposed combination of Coulter, Sairenji, Vallero, Knutson, and Erez, with additional disclosure of Barrett, Hunn, Bansemir, and Pope. The Examiner does not rely on the additional disclosures of Barrett, Hunn, Bansemir, and Pope in any manner that would remedy the conclusion set forth in the rejection based on Coulter, Sairenji, Vallero, Knutson, and Erez. We do not sustain Rejections IV–VI for the same reasons set forth above. Rejection VII -- Coulter, Sairenji, Vallero, and Knutson Independent claim 39 differs from claim 19 in that it does not require applying gas to said injection site through a nozzle during the injection. Rather, the applying gas step can be before, during or after injection. Claim 39 does, however, include the additional requirement that both the plurality of electrodes and the nozzle are included in a (same) retaining means. In rejecting claim 39 as obvious, the Examiner finds that Coulter discloses many of the limitations of the injection method of claim 39 including providing electrodes in a retaining means. Final Act. 14. The Examiner finds that Coulter does not discloses a nozzle in the retaining means but that Sairenji’s injection device includes a nozzle. Id. The Examiner considers that it would have been obvious to include a nozzle in Coulter’s retaining means “to provide combined means for reducing the pain response particularly useful in treating patients with sensitive nociceptors.” Id. at 15. To support the reasoning for the proposed combination of Coulter and Sairenji, the Examiner determines that, because Vallero and Knutson Appeal 2020-002760 Application 14/028,500 10 disclose using “nerve distraction techniques” in combination to reduce pain, “there is a clear expectation of success and clear motivation for providing a single device configured to supply both electricity and gas application to provide an improved device for reducing or eliminating injection site pain.” Id. Stabilization Appellant argues that the claimed device “cannot be replicated by prior art” because the positional relation of the nozzle and the electrode eliminates hand tremor by including a stabilizing means. Appeal Br. 13. According to Appellant, such a design is needed only when gas is applied for several seconds, which is not done in the art. Id. at 13–14. Specifically, Appellant argues that there is no reason to add a nozzle to Coulter because “the prior art is not concerned with stabilizing the gas flow.” Id. at 14. The Examiner responds that Coulter discloses a retaining means consistent with Appellant’s Specification, and that Coulter’s retaining means would incorporate Sairenji’s nozzle. Ans. 22. According to the Examiner, the resultant structure would provide “stabilization.” Id. The Examiner notes that, in any event, stabilization is not recited in claim 39, and Appellant’s Specification does not disclosed how stabilization is obtained by the claimed retaining means. Id. at 23. Appellant replies that one of ordinary skill in the art would not have modified Coulter’s device to include a nozzle. Reply Br. 6. Specifically, Appellant asserts that such combination is bulky and cumbersome to use, restricts the angle with which the user holds and positions the syringe, and Coulter’s shoe restricts access to the syringe. Id. According to Appellant, the discomfort associated with such combination outweighs its benefits. Id. Appeal 2020-002760 Application 14/028,500 11 Appellant asserts that the combination also presents an assembling and disassembling burden. Id. Appellant also asserts that, although the term “stabilization” is not used in the Specification, because the present application relates to “physical stimulation by air friction sensation . . . it is apparent that the structures of Figs. 9 and 9a are intended, among other aims, to stabilize the flow of air/gas to the injection site.” Id. at 7. Appellant’s arguments are not persuasive. The Examiner finds that Coulter’s elements 1, 7, and 8, in combination, are a “retaining means.” See Final Act. 14. Indeed, Coulter’s element 7 is labeled as a “Retainer.” Coulter ¶ 9; Figure. Coulter’s retainer 7 and shoe 8 are U-shaped and together substantially surround the syringe. Id., Figure. As the Examiner correctly finds, shoe 8 contains electrodes 10 that provide nerve stimulation “before during and after an injection.” Id. ¶ 6; see also Final Act. 14. As the Examiner correctly notes, the claims do not require “stabilization.” Appellant’s argument regarding stabilization does not address the Examiner’s proposed combination. To Coulter’s device, the Examiner proposes to add a nozzle based on the teachings of Sairenji. In Sairenji, gas cylinder 10 is removably clamped to the exterior of syringe 1 using clamping pieces 9. Sairenji, 2:53–59; Figs. 1, 2. Sairenji discloses that gas cylinder 10 is connected to gas injection nozzle 18 by flexible hose 12. Id., Figs. 1, 2. Given that Sairenji removably clamps the gas cylinder to the exterior of a curved syringe, Appellant does not provide persuasive arguments why attaching a similar cylinder to Coulter’s syringe or to Coulter’s U-shaped (curved) retainer or shoe would deter one of ordinary skill in the art from the proposed modification. Appeal 2020-002760 Application 14/028,500 12 Appellant’s arguments regarding the angle with which the user holds and positions the syringe are not persuasive, because the gas injection nozzle of Sairenji is Z-shaped and is connected by a flexible hose, and one of ordinary skill in the art using a similar nozzle in the device if Coulter would readily adjust the angles of the “Z” or the position of the hose to locate the nozzle with respect to the injection site. In addition, because Coulter discloses that the retainer allows “easy removal and replacement of the syringe and needle” (Coulter ¶ 9) and because Sairenji discloses a removably clamped gas cylinder (Sairenji, 2:57–59), Appellant’s assertion that the combination presents an assembling and disassembling burden is unfounded. Appellant includes claim 39 in the arguments presented for claims 19 and 44 (see Appeal Br. 8–12); however, because claim 39 does not require blowing during injection, we do not find these arguments persuasive, as set forth below. Space for Nozzle Appellant’s argument, that Coulter’s device does not have enough space to permit a nozzle within Coulter’s shoe (see Appeal Br. 8), relies on blowing being required during injection. Because blowing in claim 39 could be performed prior to or after injection, placing the nozzle external to the shoe, as in Sairenji, would enable blowing prior to or subsequent to injection. Thus, Appellant’s argument is not persuasive of Examiner error. Teaching Away Appellant’s argument that Sairenji teaches away (see Appeal Br. 9– 10) is not persuasive because this argument relies on “cooling the injection site simultaneously with an injection,” which is not required by claim 39. Appeal 2020-002760 Application 14/028,500 13 Two Modalities Appellant’s argument that no reference uses two modalities that include blowing (see Appeal Br. 10–11) is not persuasive because this argument relies on blowing “at the same time as giving an injection” which, as explained above, is not required by claim 39. Compatibility Appellant argues that, because the operating principle of Erez is incompatible with that of Sairenji, a skilled artisan “will not combine Erez’s device with Sairneji’s.” See Appeal Br. 11–12. This argument is not persuasive because the Examiner does not propose such a combination. Rather, Coulter’s device is the device being modified. See Final Act. 14–15. Moreover, the rejection of claim 39 does not include Erez. Appellant’s additional arguments about “gate control theory” (see Appeal Br. 12) are not persuasive, because these arguments rely on stimulation “during an injection,” which is not required by claim 39. Rejection VIII -- Coulter, Sairenji, Vallero, Knutson, and Erez Claim 40 depends from claim 39 and further requires that the gas is applied to the injection site before and during the injection. Rejection VIII relies on the same proposed combination of Coulter, Sairenji, Vallero, Knutson, and Erez discussed above in Rejection III. Because claim 40 includes blowing during injection, we do not sustain Rejection VIII for the same reasons set forth above in Rejection III. Claim 46 depends from claim 40 and the rejection thereof is not sustained for the same reason. Appeal 2020-002760 Application 14/028,500 14 Rejection IX -- Coulter, Sairenji, Vallero, Knutson, and Pope The Examiner finds that Coulter, Sairenji, Vallero, and Knutson do not disclose a plurality of discrete bursts, as claimed in claims 41 and 42. Final Act. 17. The Examiner finds that Pope reduces pain response by suppling a plurality of discrete bursts of variable sequence, duration, and strength. Id. (citing Pope, 1:36–2:21; 4:58–5:10; 7:15–39; 8:1–16). The Examiner considers that it would have been obvious to configure the device of Coulter to control a sequence, duration, and strength of a plurality of cooling pulses/bursts “to reduce the amount of time that the coolant must be applied to achieve the desired skin cooling as well as preventing the risk of damaging the skin based on the application of excessive coolants.” Id. at 18. Appellant argues that Pope removes the cause of the pain (heat) rather than alleviating pain after it is caused. Appeal Br. 16 (citing Pope, 1:33–35). Appellant also argues that, because injections do not generate heat, one skilled in the art would not rely on Pope’s heat reduction removal to reduce an injection pain. Id. The Examiner responds that one of ordinary skill would understand that over-cooling of the skin could be damaging by causing frostbite, and that limiting over-cooling by using bursts as in Pope would be beneficial. Ans. 25. The Examiner notes that Pope is not being relied upon for using cooling energy to reduce injection pain, but is relied upon for applying cooling energy in discrete bursts. Ans. 25–26. Appellant replies that over-cooling is preventable by using already available products. Reply Br. 8. Appellant’s arguments are not persuasive. Appellant does not contest the Examiner’s finding that cooling energy is used to reduce pain. Final Act. Appeal 2020-002760 Application 14/028,500 15 17. We discern no error in this finding. Each of the references rely on cooling to reduce pain, and the Examiner determines that cooling in pulses would reduce the amount of coolant and lessen the risk of damaging the skin. Although we appreciate that overcooling can be achieved in different ways, Appellant has not provided factually-supported reasoning persuading us that a skilled artisan would not consider teachings that relieve pain by cooling prior to, during or after the pain is introduced. In the Reply Brief, Appellant argues for the first time that Pope uses bursts to “prevent light flashes from occurring” that are “much more slow paced,” which is limited to Pope’s laser treatment. Reply Br. 8–9. This argument was not raised in the Appeal Brief, is not responsive to any argument raised in the Examiner’s Answer, and good cause has not been shown for its late inclusion. See 37 C.F.R. § 41.41(b)(2). We will not consider this argument because it was not timely raised, and we have not received the Examiner’s position. For these reasons, we sustain the rejection of claims 41 and 42. Rejection X -- Coulter, Sairenji, Vallero, Knutson, Erez, and Leibovici Rejection X relies on the same proposed combination of Coulter, Sairenji, Vallero, Knutson, and Erez discussed above in Rejection III, with additional disclosure of Leibovici. The Examiner does not rely on the additional disclosure of Leibovici in any manner that would remedy the conclusion set forth in the rejection based on Coulter, Sairenji, Vallero, Knutson, and Erez. We do not sustain Rejection X for the same reasons set forth above. Appeal 2020-002760 Application 14/028,500 16 CONCLUSION The Examiner’s rejections are affirmed in part. More specifically, DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 30, 38, 40, 42, 46–48 112(a) Written description 30, 38, 40, 42, 46–48 30, 38, 42 112(b) Indefiniteness 30, 38, 42 19, 23, 24, 31, 44, 45, 47, 48 103 Coulter, Sairenji, Vallero, Knutson, Erez 19, 23, 24, 31, 44, 45, 47, 48 20–22 103 Coulter, Sairenji, Vallero, Knutson, Erez, Barrett 20–22 20–22 103 Coulter, Sairenji, Vallero, Knutson, Erez, Hunn, Bansemir 20–22 29, 30, 38, 49 103 Coulter, Sairenji, Vallero, Knutson, Erez, Pope 29, 30, 38, 49 39 103 Coulter, Sairenji, Vallero, Knutson, 39 40, 46 103 Coulter, Sairenji, Vallero, Knutson, Erez 40, 46 41, 42 103 Coulter, Sairenji, Vallero, Knutson, Pope 41, 42 45 103 Coulter, Sairenji, Vallero, Knutson, Erez, Leibovici 45 Overall Outcome 30, 38–42, 46–48 19–24, 29, 31, 44, 45, 49 Appeal 2020-002760 Application 14/028,500 17 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED IN PART