MATERNA MEDICAL, INC.

Patent Trials and Appeals Board

Feb 14, 2022

2021003618 (P.T.A.B. Feb. 14, 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. 15/050,287 02/22/2016 Mark JURAVIC 10799-702.301 5292 66854 7590 02/14/2022 SHAY GLENN LLP 2929 CAMPUS DRIVE SUITE 225 SAN MATEO, CA 94403 EXAMINER KREMER, MATTHEW ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 02/14/2022 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): info@shayglenn.com shayglenn_pair@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MARK JURAVIC and MICHAEL STEWART ____________ Appeal 2021-003618 Application 15/050,287 Technology Center 3700 ____________ Before MURRIEL E. CRAWFORD, BIBHU R. MOHANTY, and AMEE A. SHAH, Administrative Patent Judges. SHAH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s final decision to reject claims 1-3 and 5-9.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as Materna Medical, Inc. Appeal Br. 2. 2 Claim 4 has been withdrawn. Appeal 2021-003618 Application 15/050,287 2 CLAIMED SUBJECT MATTER The Appellant’s invention relates generally to “preparing tissue for childbirth” and more specifically, to “prepare and dilate vaginal tissue during labor so as to prevent pelvic floor damage, and vaginal and perineal lacerations.” Spec. ¶ 3. Claim 1 is the only independent claims on appeal, is representative of the subject matter on appeal, and is reproduced below (with added bracketed notations for reference): 1. A method of dilating a vagina of a patient during labor, comprising: [(a)] inserting a dilation device into the vagina of the patient; [(b) measuring a diameter of the dilation device with a diameter sensor; [(c)] dilating the vagina with the dilation device; [(d)] providing an indication of the measured diameter of the dilation device; and [(e)] stopping dilating the vagina when the dilation device reaches a target diameter. Appeal Br. 9, Claims App. REFERENCES The prior art references relied upon by the Examiner are: Name Reference Date Tomer US 5,876,357 A Mar. 2, 1999 Sorensen US 2008/0058604 A1 Mar. 6, 2008 Mashimo et al. (“Mashimo”) US 2010/0113939 A1 May 6, 2010 Jianying et al. (“Jianying”) CN 2262410 Y Sept. 17, 1997 Appeal 2021-003618 Application 15/050,287 3 REJECTIONS I. Claims 1, 2, and 5-8 stand rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable Sorensen and Tomer. II. Claims 1-3 and 5-9 stand rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable Jianying and Tomer. III. Claims 1, 2, and 5-8 stand rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable Sorensen and Mashimo. IV. Claims 1-3 and 5-9 stand rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable Jianying and Mashimo. OPINION Rejection I - Sorenson and Tomer The Examiner finds that Sorenson teaches the method of claim 1 comprising steps (a), (c), and (e) of inserting a dilation device, dilating the vagina using the device, and stopping the dilation when the device reaches a certain diameter. Final Act. 5. Acknowledging that Sorenson does not teach steps (b) and (d) of measuring the diameter of the device and providing an indication of the measured diameter, the Examiner relies on Tomer to cure those deficiencies. Id.; see also Ans. 3-4. The Examiner determines: It would have been obvious to one of ordinary skill in the art at the time of invention to use the sensor of Tomer on the dilation device of Sorenson and use the computer processing and display of Tomer with the sensor so that the actual size of the vagina during delivery can be delivered to the health professional so they can accurate[ly] judge the size of the vagina. Final Act. 4-5. The Examiner also determines that a health professional knowing the actual dimension of Sorenson’s device diameter “will ensure Appeal 2021-003618 Application 15/050,287 4 the device is suitably open so as to fulfill its function that it is opened to a dimension that is larger than the dimension of the baby’s head.” Ans. 3-4. We are not persuaded of error by the Appellant’s argument that the Examiner’s rejection is in error because “[t]he Examiner has provided no articulated reasoning with some rational underpinning to support the legal conclusion of the obviousness of combining Sorensen and Tomer,” and because “the Examiner’s reasoning for combining Sorensen and Tomer amounts to a mere conclusory statement in which the Examiner simply recites the benefits achieved and described only by the Appellant’s specification and claims.” Appeal Br. 4; Reply Br. 2. Sorenson discloses “a less painful and faster device and method for delivering a baby, which gently and safely opens the birth canal and cervix,” increasing the diameter for an “easier, quicker childbirth.” Sorenson Abstr. Sorenson discusses existing problems of painful childbirths, such as those requiring episiotomies and forceps, and the side effects of drugs to alleviate this pain. Id. ¶¶ 3-10. Sorenson’s birth tunnel forming device assists childbirth by enlarging the diameter of the birth canal to a dimension larger than that of the baby’s head to allow the baby to safely and effortlessly slide out. Id. ¶¶ 98-101. Tomer discloses “[a] system and method for monitoring uterine cervical dilation, effacement, and consistency during labor.” Tomer Abstr. Tomer discusses that monitoring of cervical dilation and effacement is important for a safe delivery. See id. at col. 1, l. 10-col. 2, l. 4, col. 10, ll. 28-37. Tomer’s probe has a flexible membrane that is attached to a circle, such as the inner surface of the cervix or vagina, whereby the deflection of the membrane to fit the circumference of the cervix is Appeal 2021-003618 Application 15/050,287 5 measured by a sensor. Id. at col. 7, ll. 19-37, col. 10, ll. 38-49. The sensor output is processed, relayed to a computer, and displayed. Id. at col. 3, ll. 50-55; col. 7, ll. 37-41. Based on the above, we find the Examiner’s reasoning, i.e., that adding to the method of Sorenson the steps of measuring Sorenson’s tunnel forming device diameter and displaying that data would provide a benefit of allowing a health professional to accurately judge the size of the vagina so as to ensure the device is suitably open, has rational underpinning. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The Appellant further contends “it is unclear why one of skill in the art would be motivated to modify Sorensen to include a diameter sensor,” because “[k]nowledge of the diameter of the Sorensen device would not change the way that it is used, as the Sorensen specification simply teaches expanding the device until the baby slides out.” Appeal Br. 4; Reply Br. 2. We disagree. Knowledge of the diameter of the Sorenson device would aid the health professional to determine the stage of the labor and if there are issues requiring attention without requiring repeated manual examinations, and would help ensure the canal is opened enough to ensure the baby will slide through. See Ans. 4-5; Tomer, col. 3, l. 50-col. 4, l. 21, col. 10, ll. 48-33. We disagree with the Appellant’s contention that “[t]he Examiner’s combination of Sorensen and Tomer is no more than improper hindsight analysis.” Appeal Br. 3; Reply Br. 3. As discussed above, we find the Examiner has articulated reasoning with rational underpinning. The Appellant does not provide support or reasoning to show that the Examiner’s Appeal 2021-003618 Application 15/050,287 6 reasoning is based only on information gleaned from the Appellant’s disclosure. Thus, we sustain the Examiner’s rejection under 35 U.S.C. § 103 as obvious over Sorenson and Tomer of independent claim 1 and dependent claims 2 and 5-8, for which the Appellant provides no separate argument. Rejection II - Jianying and Tomer The Examiner finds that Jianying teaches the method of claim 1 comprising steps (a), (c), and (e) of inserting a dilation device, dilating the vagina using the device, and stopping dilation when the device reaches a target diameter. Final Act. 6-7. Acknowledging that Jianying does not teach steps (b) and (d) of measuring the diameter of the device and providing an indication of the measured diameter, the Examiner relies on Tomer to cure those deficiencies. Id.; see also Ans. 7-8. The Examiner determines: It would have been obvious to one of ordinary skill in the art at the time of invention to use the sensor of Tomer on the balloon of Jianying and use the computer processing and display of Tomer with the sensor so that the actual size of the birth canal (including vagina) during delivery can be delivered to the health professional so they can accurate[ly] judge the size of the birth canal (including vagina). Final Act. 7. The Examiner also determines “it would have been obvious to one of ordinary skill in the art at the time of the invention to monitor the diameter of the balloon and stop the inflation upon reaching the fetal head size of 6-8 cm so as to prevent cervical or vaginal laceration.” Ans. 10. We are not persuaded of error by the Appellant’s argument that the Examiner’s rejection is in error because “[t]he Examiner has provided no articulated reasoning with some rational underpinning to support the legal conclusion of the obviousness of combining Jianying and Tomer,” and Appeal 2021-003618 Application 15/050,287 7 because “the Examiner’s reasoning for combining Jianying and Tomer amounts to a mere conclusory statement in which the Examiner simply recites the benefits achieved and described only by the Appellant’s specification and claims.” Appeal Br. 5-6; Reply Br. 3. Jianying discloses “an airbag midwifery device which can effectively shorten the parturition process and dilates the cervix and the birth canal to the size of a fetal head for the fetus to successfully pass through.” Jianying Abstr. Jianying discusses existing problems of painful and traumatic childbirths, such as those requiring episiotomies, vacuum extractions, forceps, and cesarean sections, and that the method of using abdominal compressions can increase the perineal laceration rate. Id. at 1. Jianying’s airbag device can be applied in the vagina, comprises a balloon, pipes, pressure gauge, tee, valve regulating plug, and inflator, and expands the size of the cervix and birth canal to avoid resistance and create a smooth fetal output. Id. The pressure is measured to ensure a gradual rate of inflation so as to avoid cervical or vaginal laceration. Id. As discussed above, Tomer discusses that monitoring of cervical dilation and effacement is important for a safe delivery and discloses a device that measures a diameter and displays that measurement. See supra. Based on the above, we find the Examiner’s reasoning, i.e., that adding to the method of Jianying the steps of measuring the airbag device diameter and displaying that data would provide a benefit of allowing a health profession to accurately judge the size of the birth canal so as to ensure the device is suitably open and to avoid laceration, has rational underpinning. Appeal 2021-003618 Application 15/050,287 8 The Appellant further contends “it is unclear why one of skill in the art would be motivated to modify Jianying to include a diameter sensor,” because “the Examiner[s] . . . suggest[ion] that operating the device based on inflation pressure be abandoned in favor of operating the device based on a measured diameter . . . fundamentally changes the operation of the Jianying device.” Appeal Br. 6; see also Reply Br. 3-4. We disagree. The Appellant speculates but does not provide evidence or reasoning why Jianying’s device would not still be inflated to specific pressure ranges with the addition of a measurement of the diameter, i.e., how measuring a diameter fundamentally changes the ability to inflate to specific pressure ranges, or what “technical challenges” (Reply Br. 4) would arise that would prevent adding to Jianying’s method the steps of Toomer’s measuring of Jianying’s device with a sensor and displaying the resulting diameter. And, the Examiner does not “integrate” Toomer’s sensor “within or attached” to Jianying’s airbag device. Reply Br. 4. Rather, the Examiner adds the steps of measuring and displaying to Jianying’s method. We agree with the Examiner that knowledge of the diameter of Jianying’s device would aid the health professional to determine the stage of the labor and if there are issues requiring attention without requiring repeated manual examinations, would help ensure the canal is opened enough to ensure the baby will slide through, and would help prevent lacerations. See Ans. 7-11; Tomer, col. 3, l. 50-col. 4, l. 21, col. 10, ll. 48-33; Jianying 1. We disagree with the Appellant’s contention that “[t]he Examiner’s combination of Jianying and Tomer is no more than improper hindsight analysis.” Appeal Br. 6; Reply Br. 4. As discussed above, we find the Examiner has articulated reasoning with rational underpinning. The Appeal 2021-003618 Application 15/050,287 9 Appellant does not provide support or reasoning to show that the Examiner’s reasoning is based only on information gleaned from the Appellant’s disclosure. Thus, we sustain the Examiner’s rejection under 35 U.S.C. § 103 as obvious over Jianying and Tomer of independent claim 1 and dependent claims 2, 3, and 5-9, for which the Appellant provides no separate argument. Rejections III and IV - Sorenson or Jianying and Mashimo We decline to reach the remainder of the rejections and issues related to these rejections, such as the substantial new question of patentability issue related to the obviousness rejections in view of Mashimo, because the rejections of claims 1, 2, and 5-8 as obvious over Sorenson in view of Tomer and of claims 1-3 and 5-9 as obvious over Jianying in view of Tomer encompass all of the pending claims. As such, our affirmance of these rejections results in the rejection of all claims and renders the remaining rejections merely cumulative. CONCLUSION The Examiner’s decision to reject claims 1-3 and 5-9 is affirmed. In summary: Claim(s) Rejected 35 U.S.C. § References/ Basis Affirmed Reversed 1, 2, 5-8 103 Sorenson, Toomer 1, 2, 5-8 1-3, 5-9 103 Jianying, Toomer 1-3, 5-9 1, 2, 5-8 1033 Sorenson, Moshimo 3 As explained above, we do not reach this rejection as it is cumulative. Appeal 2021-003618 Application 15/050,287 10 Claim(s) Rejected 35 U.S.C. § References/ Basis Affirmed Reversed 1-3, 5-9 1034 Jianying, Moshimo Overall Outcome 1-3, 5-9 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 4 As explained above, we do not reach this rejection as it is cumulative.