CTNF 19/111,435 CTNF 97104 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 1, 3-5, 7, 11-15 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Pravongviengkham et al (US 8,945,058 B2, herein referred to as ‘058) . Regarding claim 1, ‘058 discloses a trocar sleeve (Figs. 1-2) comprising: a cannula 3 having a distal end and a proximal end (Fig. 2); a housing 11 having a distal end and a proximal end (Figs. 1-2), the proximal end of the housing attached to the distal end of the cannula (Figs. 1-2); and a lumen extending from the distal end of the cannula to the proximal end of the housing (Fig. 4), wherein the cannula and housing are made of a biocompatible material designed to withstand a plurality of sterilization cycles (Col. 8 lines 19-27). Regarding claim 3, ‘058 discloses the trocar sleeve of claim 1. ‘058 also discloses wherein the biocompatible materials is designed to withstand at least two sterilization cycles (Col. 8 lines 19-27 disclose sterilization and re-usability). Regarding claim 4, ‘058 discloses the trocar sleeve of claim 1. ‘058 also discloses wherein the trocar sleeve has a smooth internal surface and external surface that excludes narrow features that trap debris and designed for flow of washing fluids to flow through for removal of debris for sterilization (Figs. 1-2). Regarding claim 5, ‘058 discloses the trocar sleeve of claim 1. ‘058 also discloses wherein a range of an internal diameter of the lumen is 7.1 - 7.3 mm (Col. 5 line 65-Col. 6 line 20) for an obturator or instrument with an external diameter of 5 mm (i.e., Col. 5 lines 65-Col. 6 line 20 discloses obturators to go inside cannula), and 14.1 - 14.3 mm for an obturator or instrument with an external diameter of 12 mm (i.e., Col. 5 lines 65-Col. 6 line 20 discloses obturators to go inside cannula). Regarding claim 7, ‘058 discloses the trocar sleeve of claim 1. ‘058 also discloses wherein a range of an outer diameter of the cannula is 9.45 - 10.6 mm for an obturator or instrument with an external diameter of 5 mm, and 16.75 - 17.7 mm for an obturator or instrument with an external diameter of 12 mm (i.e., Col. 5 lines 65-Col. 6 line 20 discloses obturators to go inside cannula). Regarding claim 11, ‘058 discloses the trocar sleeve of claim 1. ‘058 also discloses further comprising at least one protruding feature designed for securing thread that is stitched to skin of a subject when the trocar sleeve is in use and positioned through the skin (i.e., Col. 5 lines 65-Col. 6 line 20 discloses finger holds or grips and suture tie slots). Regarding claim 12, ‘058 discloses the trocar sleeve of claim 1. ‘058 also discloses wherein the cannula includes a plurality of raised features designed to engage a locking mechanism of a depth limiter that fixes location of the cannula relative to the depth limiter (Col. 7 lines 27-44 discloses raised features (i.e., annular barbs 15) to provide a mechanical lock which prevents the tip from moving proximally or distally and thus limits depth). Regarding claim 13, ‘058 discloses the trocar sleeve of claim 12. ‘058 also discloses wherein a distal end portion of the cannula excludes the raised features (Fig. 9A; note 7 excludes the features). Regarding claim 14, ‘058 discloses the trocar sleeve of claim 12. ‘058 also discloses wherein the plurality of raised features are spaced apart along a long axis of the cannula defining a resolution for fixing the location of the cannula relative to the depth limiter (Fig. 9A; Col. 7 lines 27-44). Regarding claim 15, ‘058 discloses the trocar sleeve of claim 1. ‘058 also discloses wherein an external diameter of the cannula varies across a length of the cannula, the external diameter decreases from the proximal end of the cannula to the distal end of the cannula (i.e., at least because it includes tapered portion 17; see Fig. 10) . 07-15 AIA Claim s 1, 2 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Young et al (US 2019/0099200 A1) . Regarding claim 1, Young discloses a trocar sleeve 100 (Figs. 1-2) comprising: a cannula 104 having a distal end and a proximal end (Fig. 1); a housing 204 having a distal end and a proximal end (Figs. 1-2), the proximal end of the housing attached to the distal end of the cannula (Figs. 1-2); and a lumen extending from the distal end of the cannula to the proximal end of the housing (para. [0029]), wherein the cannula and housing are made of a biocompatible material designed to withstand a plurality of sterilization cycles (para. [0042]). Regarding claim 2, Young discloses the trocar sleeve of claim 1. Young also discloses wherein the biocompatible materials is selected from a group comprising: polyetheretherketone (PEEK) (para. [0042]), and polyphenylsulfone (PPSU) . 07-15 AIA Claim s 1, 6, 8, 10 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Yaffe et al. (US 20190343552 A1) . Regarding claim 1, Yaffe discloses a trocar sleeve (Figs. 2H-2L) comprising: a cannula 220 having a distal end and a proximal end (Fig. 2H-2L); a housing 270 having a distal end and a proximal end (Figs.2H-2L), the proximal end of the housing attached to the distal end of the cannula (Figs. 2H-2L); and a lumen extending from the distal end of the cannula to the proximal end of the housing (Figs. 2H-2L), wherein the cannula and housing are made of a biocompatible material designed to withstand a plurality of sterilization cycles (para. [0070]). Regarding claim 6, Yaffe discloses the trocar sleeve of claim 1. Yaffe also discloses wherein an internal diameter of the lumen is selected to provide a clearance of about 0.3 mm from an outer diameter of an obturator placed within the lumen (para. [0077]). Regarding claim 8, Yaffe discloses the trocar sleeve of claim 1. Yaffe also discloses wherein an outer diameter of the housing ranges from 44.8 - 47.0 mm (para. [0077]). Regarding claim 10, Yaffe discloses the trocar sleeve of claim 1. Yaffe also discloses wherein a working length of the trocar sleeve ranges from 60 - 150 mm (para. [0077]) . 07-15 AIA Claim s 1 and 9 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Hart et al (US 20160051281 A1) . Regarding claim 1, Hart discloses a trocar sleeve (Figs. 1-2) comprising: a cannula 12 having a distal end and a proximal end (Figs. 1-2); a housing 18 having a distal end and a proximal end (Figs. 1-2), the proximal end of the housing attached to the distal end of the cannula (Figs. 1-2); and a lumen 13 extending from the distal end of the cannula to the proximal end of the housing (para. [0060]), wherein the cannula and housing are made of a biocompatible material designed to withstand a plurality of sterilization cycles (para. [0062]). Regarding claim 9, Hart discloses the trocar sleeve of claim 1. Hart also discloses wherein a working length of the trocar sleeve ranges from about 45 mm to 65 mm for pediatric use (para. [0062]) . 07-15 AIA Claim s 1, 16-17 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Muthuchidambaram et al (US 20210338272 A1 herein referred to as ‘272) . Regarding claim 1, ‘272 discloses a trocar sleeve (Fig. 6) comprising: a cannula 120 having a distal end and a proximal end (Fig. 6); a housing 150 having a distal end and a proximal end (Fig. 6), the proximal end of the housing attached to the distal end of the cannula (Fig. 6); and a lumen extending from the distal end of the cannula to the proximal end of the housing (Fig. 6), wherein the cannula and housing are made of a biocompatible material designed to withstand a plurality of sterilization cycles (para. [075], [0080]). Regarding claim 16, ‘272 discloses the trocar sleeve of claim 1. ‘272 also discloses wherein an external surface of the cannula includes a first guide element 128 set for engaging a corresponding second guide element of a depth limiter 210 (para. [0088], wherein the cannula is insertable into a lumen of the depth limiter by engaging the first guide element with the second guide element (Fig. 6, para. [0084]), and the trocar cannula is prevented from being inserted into the lumen of the depth limiter when the first guide element does not engage the second guide element (para. [0088]). Regarding claim 17, ‘272 discloses the trocar sleeve of claim 16. ‘272 also discloses wherein the first guide element engaging the second guide element prevent rotation of the cannula within the depth limiter (para. [0088]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RACHAEL L GEIGER/ Examiner, Art Unit 3771 /BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771 Application/Control Number: 19/111,435 Page 2 Art Unit: 3771 Application/Control Number: 19/111,435 Page 3 Art Unit: 3771 Application/Control Number: 19/111,435 Page 4 Art Unit: 3771 Application/Control Number: 19/111,435 Page 5 Art Unit: 3771 Application/Control Number: 19/111,435 Page 6 Art Unit: 3771 Application/Control Number: 19/111,435 Page 7 Art Unit: 3771
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