Micam Tullous

Patent Trials and Appeals Board

Jan 11, 2022

2021001111 (P.T.A.B. Jan. 11, 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. 13/750,763 01/25/2013 Micam W. Tullous P-8581.15(CIP) 8669 30553 7590 01/11/2022 Gunn, Lee & Cave, P.C. 8023 Vantage Dr. Suite 1500 San Antonio, TX 78230 EXAMINER NGUYEN, CAMTU TRAN ART UNIT PAPER NUMBER 3786 MAIL DATE DELIVERY MODE 01/11/2022 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 MICAM W. TULLOUS Appeal 2021-001111 Application 13/750,763 Technology Center 3700 Before BIBHU R. MOHANTY, JENNIFER MEYER CHAGNON, and ROBERT J. SILVERMAN, Administrative Patent Judges. CHAGNON, 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 1-42. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Micam W. Tullous. Appeal Br. 1. Appeal 2021-001111 Application 13/750,763 2 CLAIMED SUBJECT MATTER The Specification describes “a craniocervical orthosis in which an infant’s cranium is positioned while the infant is sleeping to prevent and correct cranial deformities.” Spec.2 ¶ 4. The Abstract describes: A device and method for preventing and correcting abnormal shaping of an infant’s cranium by applying external forces over time with the growth of an infant to achieve normal shaping of the infant’s head. The device is a cranial orthosis having a depression with a contact surface in the shape of at least a portion of a normal infantile cranium. The orthosis further provides lateral support surfaces creating points of contact to restrict rotation of the infant’s cranium and provide additional external forces for normal shaping of the infant’s cranium. Because the present invention is non-conforming to the shape of an abnormal skull, the exerted forces cause accelerated expansion of the skull in less prominent areas coincident with brain and skull growth. Spec., Abstract. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An orthotic headrest for promoting normal shaping of the cranium of an infant, the headrest comprising: a bottom surface for contact with a resting surface; a top surface; 2 In this Decision, we refer to the Specification filed January 25, 2013 (“Spec.”); Final Office Action dated May 23, 2019 (“Final Act.”); Advisory Action dated August 13, 2019 (“Advisory Act.”); Appeal Brief filed September 20, 2019 (“Appeal Br.”); Examiner’s Answer dated July 22, 2020 (“Ans.”); and Appellant’s Reply Brief filed August 25, 2020 (“Reply Br.”). Appeal 2021-001111 Application 13/750,763 3 a generally hemi-ellipsoidal depression in said top surface, said depression having a nadir; a contact surface in said depression having a shape of at least a portion of a normal infantile cranium; first and second lateral support surfaces having at least a portion positioned anterior of a first coronal plane and superior to a mid-cranial transverse plane; said contact surface comprising at least a portion of said first and second lateral support surfaces. Appeal Br. 39. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Mason US 5,127,120 July 7, 1992 Chang US 6,536,058 B1 Mar. 25, 2003 Grisoni et al. (“Grisoni”) US 6,915,598 B2 July 12, 2005 Sklar et al. (“Sklar”) US 6,939,316 B2 Sept. 6, 2005 REJECTIONS I. Claim 10 stands rejected under 35 U.S.C. § 101 and § 33(a) of the Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat. 340 (2011) as being directed to or encompassing a human organism.3 3 The rejection of claim 8 under 35 U.S.C. § 101 and AIA § 33(a) as being directed to or encompassing a human organism has been withdrawn. See Ans. 3. Appeal 2021-001111 Application 13/750,763 4 II. Claims 1-42 stand rejected under 35 U.S.C. § 112(b) as being indefinite.4 III. Claims 1, 5-27, and 42 stand rejected under 35 U.S.C. § 102(b) as being anticipated by Mason. IV. Claim 31 stands rejected under 35 U.S.C. § 102(b) as being anticipated by Chang. V. Claims 2-4 and 28-30 stand rejected under 35 U.S.C. § 103 as being unpatentable over Mason and Grisoni. VI. Claims 32-41 stand rejected under 35 U.S.C. § 103 as being unpatentable over Chang and Sklar. OPINION We review the appealed rejections for error based upon the issues Appellant identifies, and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections.”)). After considering the argued claims in light of each of Appellant’s arguments, we are persuaded Appellant has identified reversible error in the appealed rejections. Encompassing a Human Organism The Examiner determines that “claim 10 requires the contact surface is shaped and positioned to contact the occipital bone and the parietal bone, 4 The rejection of claims 32-42 under 35 U.S.C. § 112(b) was entered as a new ground of rejection in the Examiner’s Answer. See Ans. 3-4. Appeal 2021-001111 Application 13/750,763 5 such recitation is positively reciting headrest contacting the infant cranium.” Ans. 4. The Examiner suggests “Applicant should utilize ‘adapted to’ or ‘capable of’ language to avoid this rejection.” Final Act. 3. Appellant argues that claim 10 “include[s] language which is effectively the equivalent of the phrases ‘adapted to’ or ‘capable of.’” Appeal Br. 17. In particular, claim 10 recites that “the contact surface is shaped and positioned such that it contacts [the bones].” Id. at 40; see id. at 17. We agree with Appellant that the “such that” recitation in claim 10 is effectively equivalent to the Examiner’s proposed “adapted to” language. See id. at 17. As such, claim 10 merely describes that the contact surface is intended to “contact[ the infant cranium at] the occipital bone and the parietal bone . . . ,” and is not directed to nor does it encompass a human organism. See also Spec. ¶ 84, Fig. 12. We do not sustain the Examiner’s rejection under 35 U.S.C. § 101 and AIA § 33(a). Indefiniteness “As the statutory language of ‘particular[ity]’ and ‘distinct[ness]’ indicates, claims are required to be cast in clear-as opposed to ambiguous, vague, indefinite-terms.” In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014) (citation omitted); see also Ex parte McAward, Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (adopting the approach for assessing indefiniteness approved by the Federal Circuit in Packard). At the same time, this requirement is not a demand for unreasonable precision. The requirement, applied to the real world of modern technology, does not contemplate in every case Appeal 2021-001111 Application 13/750,763 6 a verbal precision of the kind found in mathematics. Nor could it do so in a patent system that actually works, in practice, to provide effective protection for modern-day inventions. Rather, how much clarity is required necessarily invokes some standard of reasonable precision in the use of language in the context of the circumstances. Packard, 751 F.3d at 1313. “[A] claim is indefinite when it contains words or phrases whose meaning is unclear.” Packard, 751 F.3d at 1322 (citing MPEP § 2173.05(e)) (9th ed. 2018). Claims, when read in light of the specification, must “reasonably apprise those skilled in the art both of the utilization and scope of the invention” using language “as precise as the subject matter permits.” Georgia-Pacific Corp. v. U.S. Plywood Corp., 258 F.2d 124, 136 (2d Cir. 1958) (cited in Packard, 751 F.3d at 1313). In determining whether a claim is definite under 35 U.S.C. § 112, “[t]he USPTO, in examining an application, is obliged to test the claims for reasonable precision according to [this principle].” Packard, 751 F.3d at 1313. A “satisfactory response” to an indefiniteness rejection under 35 U.S.C. § 112 “can take the form of a modification of the language identified as unclear, a separate definition of the unclear language, or, in an appropriate case, a persuasive explanation for the record of why the language at issue is not actually unclear.” Id. at 1311. Claims 1-42 are rejected under 35 U.S.C. § 112(b) as being indefinite. The Examiner points to two aspects of the claims as being indefinite.5 See Final Act. 3-6; Ans. 3-5. We address each in turn. 5 Claim 14 also was rejected 35 U.S.C. § 112(b) as having insufficient antecedent basis. Final Act. 4. The Examiner entered an after-final amendment to claim 14 addressing this issue. See Advisory Act. Appeal 2021-001111 Application 13/750,763 7 “normal infantile cranium”; “normal infant cranium” Claim 1 recites “a contact surface in said depression having a shape of at least a portion of a normal infantile cranium.” Appeal Br. 39. Independent claims 21, 31, 32, 34, and 42 each also include similar recitations, insofar as they define a shape of the contact surface relative to the “shape of . . . a normal infantile cranium.” See id. at 43, 45-47, 49. The Examiner finds that this is indefinite “because applicant’s claim is relying on a cranium to define the shape of the depression, of which cranium varies from infant to infant.” Final Act. 4. According to the Examiner, “it is unclear what is considered normal infantile cranium.” Id. (emphasis Examiner’s). Appellant responds that “simply because an application refers in a claim to a human body part which may vary in size to define the shape or size of a device, this, in and of itself, does not render the claim indefinite.” Appeal Br. 19. We agree. See Warsaw Orthopedic, Inc. v. NuVasive, Inc., 778 F.3d 1365, 1370-71 (Fed. Cir. 2015), cert. granted, judgment vacated sub nom. Medtronic Sofamor Danek USA, Inc. v. NuVasive, Inc., 136 S. Ct. 893 (2016), and opinion reinstated in part, 824 F.3d 1344 (Fed. Cir. 2016) (finding the term “vertebra” sufficiently definite to define the size of the length of the claimed spinal implant device, despite the fact that the dimensions of vertebra can vary from patient to patient). Appellant further argues that “even though there can be some slight variance, the shape and size of a ‘normal’ infantile cranium is readily Appeal 2021-001111 Application 13/750,763 8 ascertainable by those of skill in the art.” Appeal Br. 20 (citing Tullous Decl.6 ¶¶ 3, 13). First, we agree with Appellant that the person of ordinary skill in the art is “a practitioner in the[] subspecialties [of pediatric neurosurgery and craniofacial plastic surgery] as opposed to a general practitioner or pediatrician.” Appeal Br. 22. See Daiichi Sankyo Co., Ltd v. Apotex, Inc., 501 F.3d 1254, 1256-7 (Fed. Cir. 2007) (disagreeing with the District Court that a person of ordinary skill in the art would be a general practitioner, and instead finding that the level of skill in the art is that of a specialist in the relevant medical field). Second, we agree with Appellant that “pediatric neurosurgeons, cranial facial plastic surgeons, and others knowledgeable in this field readily understand and know what the shape of a normal infantile cranium is and this shape is easily determined by clinical exam through radiographic imaging study.” Appeal Br. 22; see Spec. ¶¶ 5-27 (describing normal and abnormal growth of an infant’s cranium, and prior methods of prevention/correction of deformity). Dr. Tullous’s testimony further confirms this understanding. See Tullous Decl. ¶ 14 (testifying that persons of skill in the art would “readily understand and know what the shape of a normal infantile cranium is” and that “[t]he shape is easily determined by clinical exam or radiographic imaging study”); see also id. ¶¶ 7-12 (providing a specific written description of the “normal shape” of the head of an “average infant, born full term, with a head circumference of 44.0 cm and a cephalic index of 75”). 6 Declaration under 37 C.F.R. § 1.132 of Micam W. Tullous, M.D. (“Tullous Decl.”) filed October 7, 2015. Appeal Br., Appx. B. Appeal 2021-001111 Application 13/750,763 9 We note, further, that the claims do not recite anything about the size of a normal infantile cranium, but rather the shape thereof. Cf. Ans. 5 (indicating that the “normal” head circumference discussed at Tullous Decl. ¶ 7 is not recited in the claims). As confirmed by Dr. Tullous, “the relative shape of a normal infantile cranium is the same no matter the size of the cranium’s circumference. . . . [T]his normal shape does not vary from infant- to-infant or from smaller head size to larger head size.” Tullous Decl. ¶ 13; see also Spec. ¶¶ 73, 92-93. Accordingly, we do not sustain the rejection of any of the claims as being indefinite on the basis that “a shape of . . . a normal infantile cranium” is unclear. recitation of various reference planes The claims recite various reference planes-”a first coronal plane” (e.g., claim 1); “a second coronal plane” (e.g., claim 6); “a third coronal plane” (e.g., claim 26); and “a mid-cranial transverse plane” (e.g., claim 1). See Appeal Br. 39-49. The Examiner finds that the recitation of these reference planes is indefinite because they vary from infant to infant. Final Act. 5-6; see also Ans. 5 (“such recitations are deemed indefinite as these recitations do not specify what these planes are in reference to”). Appellant argues that the Examiner is incorrect in the assertion that “these coronal planes are defined by reference to the size of an infant’s head,” but that instead “[t]he position of these reference planes fall within a specified range defined and set out in the specification and which are based on specific infant head sizes.” Appeal Br. 23-24. These reference planes Appeal 2021-001111 Application 13/750,763 10 are defined in the Specification (Spec. ¶ 75), and do not change depending on the size of the infant using the orthotic. See, e.g., Spec. ¶ 73 (“[A] preferred embodiment of an orthosis having the features of the present invention is configured to address, at a minimum, head circumferences within a range of 36.5 cm to 46.5 cm in circumference.”), ¶ 74 (describing that the coronal planes are “predetermined . . . relative to the orthosis” (emphasis added)). In the Specification, a “first coronal plane” is “defined as a coronal (i.e., horizontal) plane[7] positioned approximately at forty percent (40%) of the anterior-posterior distance[8] APD1, a position which approximates the height of the earhole 52 for an infant having [a 46.5 cm circumference] head size.” Spec. ¶ 75; Fig. 9A. “With respect to the orthosis 10, the first coronal plane 51 is positioned approximately 6.2 to 6.7 cm above the nadir 23 (i.e., lowest point) of the depression 18.” Spec. ¶ 75. In the Specification, a “second coronal plane” is “defined as a coronal plane positioned at approximately seventy percent (70%) of APD2 for an infant having [a 36.5 cm circumference] head size.” Spec. ¶ 75; Fig. 9B. “With respect to the orthosis 10, the second coronal plane is positioned approximately 8.8 and 9.3 cm above the nadir 23 of the depression.” Spec. ¶ 75. 7 The Specification indicates that “standard anatomical terms of location are used” and that a “coronal plane divides the body into posterior and anterior portions.” Spec. ¶ 66. 8 Anterior-posterior distance “is the distance between the most posterior point 54 on the infant’s head and the most anterior point 57 on the infant’s forehead.” Spec. ¶ 75; Fig. 9A. Appeal 2021-001111 Application 13/750,763 11 In the Specification, a “third coronal plane” is “defined as a coronal plane positioned at the most anterior contact point 27 between the infant’s cranium 49 and the headrest 10.” Spec. ¶ 75; Fig. 9A. “With respect to the headrest 10, the third coronal plane 21 is positioned approximately 8.0 to 8.6 cm from the bottom surface.” Spec. ¶ 75. In the Specification, a “mid-cranial transverse plane” is defined as “the transverse plane intersecting the nadir 23 of the depression 18,” of the orthosis 10. Spec. ¶ 77; Figs. 5, 6. We agree with Appellant that these reference plane terms are specifically defined in the Specification, and, contrary to the Examiner’s position, do not vary from infant to infant as they are used in the claims. See In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989) (“When the applicant states the meaning that the claim terms are intended to have, the claims are examined with that meaning, in order to achieve a complete exploration of the applicant’s invention and its relation to the prior art.”); MPEP § 2173.05(a)(I). Accordingly, we do not sustain the rejection of any of the claims as being indefinite on the basis of reciting these reference planes. Conclusion as to Indefiniteness For these reasons, we do not sustain the rejection of claims 1-42 under 35 U.S.C. § 112(b) as being indefinite. Appeal 2021-001111 Application 13/750,763 12 Rejections in view of Mason Anticipation of Claims 1, 5-27, and 42 Claim 1 recites, inter alia, “a contact surface in said depression having a shape of at least a portion of a normal infantile cranium.” Appeal Br. 39. Independent claims 21 and 42 each also include similar recitations. See id. at 43, 49. The Examiner relies on cup-shaped head-receiving cavity 14 of Mason as disclosing the claimed depression. Final Act. 7; Mason 2:19, Fig. 1. Appellant argues “the normal shape of an infant’s cranium is much more than simply ‘cup-shaped.’” Appeal Br. 28 (citing Tullous Decl. ¶ 12); see also id. at 28-30 (expanding upon this argument). We agree. There is nothing in Mason that discloses that the contact surface therein has the shape of a normal infantile cranium, as claimed. Id. at 30. Mason relates to an “infant support pad” configured “to restrain the infant’s head and neck from involuntary movement.” Mason, 1:34-39. There is no discussion in Mason about promoting the normal shaping and growth of a normal infantile cranium. For these reasons, we do not sustain the rejection of claims 1, 5-27, and 42 as being anticipated by Mason. Obviousness of Claims 2-4 and 28-30 in further view of Grisoni Claims 2-4 and 28-30 depend from claims 1 and 21, respectively. The Examiner relies on Grisoni for teaching the recited material hardness, and does not rely on Grisoni for any limitations of the independent claims. See Final Act. 16. We do not sustain the rejection of claims 2-4 and 28-30 Appeal 2021-001111 Application 13/750,763 13 for the same reasons discussed above regarding independent claims 1 and 21. Rejections in view of Chang Anticipation of Claim 31 Claim 31 recites, inter alia, “a contact surface comprising at least a portion of first and second lateral support surfaces,” where the “first and second lateral support surfaces [are positioned] anterior to a first coronal plane and posterior to a second coronal plane.” Appeal Br. 45. The Examiner relies on portions of concave area 200 of Chang’s headrest as disclosing the claimed first and second lateral support surfaces. Final Act. 15; Chang, Figs. 9A, 9B. The Examiner’s annotated version of Figure 9B of Chang is reproduced below. The annotated figure, above, illustrates the Examiner’s interpretation of the first and second lateral support surfaces in the headrest of Chang. Appeal 2021-001111 Application 13/750,763 14 Appellant argues that Chang does not disclose the claimed first and second lateral support surfaces positioned anterior (i.e., toward the front side of the body) of a first coronal plane. Appeal Br. 32. As previously discussed, the “first coronal plane” is “defined as a coronal (i.e., horizontal) plane positioned approximately at forty percent (40%) of the anterior- posterior distance APD1, a position which approximates the height of the earhole 52 for an infant having [a 46.5 cm circumference] head size.” Spec. ¶ 75; Fig. 9A; see Appeal Br. 32. As discussed in the Specification, the first coronal plane is positioned at “approximately 6.2 to 6.7 cm above the nadir.” Spec. ¶ 75; Appeal Br. 32. Appellant argues that Chang “fails to provide any dimensions concerning the height of the lateral sides.” Appeal Br. 32. We agree. See also Hockerson-Halberstadt, Inc. v. Avia Group Int’l, Inc., 222 F.3d 951, 956 (Fed. Cir. 2000) (“[I]t is well established that patent drawings do not define a precise proportion of the elements and may not be relied upon to show particular sizes if the specification is completely silent on the issue.”); In re Wright, 569 F.2d 1124, 1127 (CCPA 1977) (“Absent any written description in the specification of quantitative values, arguments based on measurement of a drawing are of little value.”). Further, as Appellant notes, Figure 11B of Chang clearly shows that the earholes of the baby positioned in the headrest are above the portion identified by the Examiner as the claimed first and second lateral support surfaces. Appeal Br. 33-34. The Examiner does not address this discrepancy. For these reasons, we do not sustain the rejection of claim 31 as being anticipated by Chang. Appeal 2021-001111 Application 13/750,763 15 Obviousness of Claims 32-41 in further view of Sklar Similar to claim 31, independent claims 32 and 34 each recite, inter alia, “a contact surface comprising at least a portion of first and second lateral support surfaces,” where the “first and second lateral support surfaces [are positioned] anterior to a first coronal plane and posterior to a second coronal plane.” Appeal Br. 45-47. The Examiner relies on the same portions of Chang discussed above with respect to claim 31 as teaching these limitations. See Final Act. 17-19. As discussed above, we do not agree with the Examiner’s determinations as to these limitations. The Examiner relies on Sklar for teaching “claimed limitations promoting growth of areas of cranial flattening by eliminating contact between said contact surface and the areas of cranial flattening.” Id. at 17- 20. The Examiner does not rely on Sklar as teaching any positioning of the first and second lateral support surfaces. See id. Claim 33 depends from claim 32. Claims 35-41 depend from claim 34. We do not sustain the rejection of claims 32-41 for the same reasons discussed above regarding independent claim 31. CONCLUSION The Examiner’s rejections of claims 1-42 are reversed. In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 10 101 Eligibility 10 1-42 112(b) Indefiniteness 1-42 1, 5-27, 42 102(b) Mason 1, 5-27, 42 31 102(b) Chang 31 2-4, 28-30 103 Mason, Grisoni 2-4, 28-30 Appeal 2021-001111 Application 13/750,763 16 32-41 103 Chang, Sklar 32-41 Overall Outcome 1-42 REVERSED