DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 recites: the proximal end of the housing attached to the distal end of the cannula. Examiner believes Applicant intended to recite that the distal end of the housing is attached to the proximal end of the cannula.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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 –
(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.
Claims 1, 3-5, 7, 12-15, 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muthuchidambaram et al. (US 20210338272 A1).
Regarding claim 1, Muthuchidambaram discloses a trocar sleeve 110 comprising: a cannula 120 having a distal end and a proximal end (Fig. 6); a housing (i.e., 150) having a distal end (i.e., at 122) and a proximal end (i.e., at 116 of Fig. 6), the proximal end of the housing attached to the distal end of the cannula (i.e., as shown in Fig. 6); and a lumen 114 extending from the distal end of the cannula to the proximal end of the housing (Fig. 6; para. [0078]), wherein the cannula and housing are made of a biocompatible material designed to withstand a plurality of sterilization cycles (para. [0072], [0075]), and wherein an external surface of the cannula includes a first guide element configured for engaging a corresponding second guide element of a depth limiter (para. [0090] discloses that the depth limiter has a first and second effective diameter such that the second effective diameter is actuated to couple the depth limiter to the cannula tube and as such the external surface of the distal tip of the cannula is the first guide element and the second effective diameter of the depth limiter is the second guide element via 256, 258), the cannula being insertable into a limiter lumen of the depth limiter only when the first guide element is engaged with the second guide element (Fig. 6; para. [0090]).
Regarding claim 3, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram also discloses wherein the biocompatible materials is designed to withstand at least two sterilization cycles (para. [0075] discloses multiple sterilization procedures).
Regarding claim 4, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram 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 (para. [0207] discloses various techniques for sterilization including ethylene oxide and steam which would both require that the sleeve has external surfaces that excludes narrow features that trap debris and designed for flow of washing fluids to flow through for removal of debris for sterilization).
Regarding claim 5, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram also discloses wherein a range of an internal diameter of the lumen is 7.1 - 7.3 mm for an obturator or instrument with an external diameter of 5 mm, and 14.1 - 14.3 mm for an obturator or instrument with an external diameter of 12 mm (para. [0084] discloses various cannula sizes including 5mm, 8mm, 10mm, and 15mm such that the obturator would have to have a diameter compatible with the cannula in the corresponding sizes such that the obturator diameters would fall within the claimed range).
Regarding claim 7, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram 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 (para. [0084]).
Regarding claim 12, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram also discloses wherein the cannula includes a plurality of raised features 128 designed to engage a locking mechanism of a depth limiter that fixes location of the cannula relative to the depth limiter (para. [0088]).
Regarding claim 13, Muthuchidambaram discloses the trocar sleeve of claim 12. Muthuchidambaram also discloses wherein a distal end portion of the cannula excludes the raised features (Figs. 1-2).
Regarding claim 14, Muthuchidambaram discloses the trocar sleeve of claim 12. Muthuchidambaram 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 (Figs. 1-2; para. [0088]).
Regarding claim 15, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram 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 (Fig. 1; i.e., at least at 24).
Regarding claim 17, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram also discloses wherein the first guide element engaging the second guide element prevents rotation of the cannula within the limiter lumen (para. [0088]; i.e., at least because the limiter is engaged such that the diameter clamps onto the cannula).
Regarding claim 18, Muthuchidambaram discloses a trocar assembly (Fig 1) comprising: a trocar sleeve 110 comprising a cannula 120 having a distal end and a proximal end (Fig. 6); a housing 150 having a distal end (i.e., at 122) and a proximal end (i.e., at 116 of Fig. 6), the distal end of the housing attached to the proximal end of the cannula (Fig. 1), and a lumen 114 extending from the distal end of the cannula to the proximal end of the housing (Fig. 1; para. [0078]), wherein the cannula and the housing are made of a biocompatible material configured to withstand a plurality of sterilization cycles (paras. [0072], [0075]); and a depth limiter 210 comprising a limiter lumen (Fig. 7) configured to accommodate the cannula (Fig. 6), and a locking mechanism (i.e., features to lock as described in para. [0088]) that sets the cannula in a fixed position within the limiter lumen (para. [0088]), wherein an external surface of the cannula includes a first guide element and the limiter lumen includes a corresponding second guide element (para. [0090] discloses that the depth limiter has a first and second effective diameter such that the second effective diameter is actuated to couple the depth limiter to the cannula tube and as such the external surface of the distal tip of the cannula is the first guide element and the second effective diameter of the depth limiter is the second guide element via 256, 258), the cannula being insertable into a limiter lumen of the depth limiter only when the first guide element is engaged with the second guide element (Fig. 6; para. [0090]).
Regarding claim 19, Muthuchidambaram discloses the trocar assembly of claim 18. Muthuchidambaram also discloses wherein the locking mechanism prevents the cannula from moving proximally and distally within the limiter lumen, whereby the depth limiter sets a maximum depth of the cannula (para. [0088]).
Regarding claim 20, Muthuchidambaram discloses the trocar assembly of claim 18. Muthuchidambaram also discloses wherein the first guide element engaging the second guide element prevents rotation of the cannula within the limiter lumen (para. [0087]-[0090]).
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Muthuchidambaram.
Regarding claim 2, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram doesn’t directly disclose wherein the biocompatible materials is selected from a group comprising: polyetheretherketone (PEEK), and polyphenylsulfone (PPSU), however Muthuchidambaram does disclose a biocompatible material that is made out of a robust material (para. [0080]) and also discloses using a polymeric material (para. [0115]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of the biocompatible materials is selected from a group comprising: polyetheretherketone (PEEK), and polyphenylsulfone (PPSU) such that the material is robust and biocompatible. As such, there a limited number of materials to be used in the body that are robust and polymeric (as described in para. [0115]) apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at the biocompatible materials is selected from a group comprising: polyetheretherketone (PEEK), and polyphenylsulfone (PPSU).
Regarding claim 6, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram doesn’t directly disclose 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.
Muthuchidambaram discloses (para. [0084]) that various sizes of cannulas may be used and that the cannula inner diameters and clearances need to be optimized to guide the obturator through into the cannula. As shown in Fig. 1, the obturator protrudes from the cannula such that the obturator is inserted into the cannula and the clearance between the cannula and the obturator is disclosed to be a result effective variable in that changing the clearance would affect the ability and ease of the obturator to be placed into the cannula shaft. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Smith et al. device to have a length within the claimed range, as it involves only adjusting the dimension of a component disclosedtorequire adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Muthuchidambaram by making the clearance of about 0.3mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Muthuchidambaram in view of Yaffe et al. (US 20190343552 A1—previously presented).
Regarding claim 8, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram doesn’t directly disclose wherein an outer diameter of the housing ranges from 44.8 - 47.0 mm.
In the same field of endeavor, namely surgical laparoscopic ports for implanting medical systems, Yaffe discloses an outer diameter of the housing ranges from 44.8 - 47.0 mm (para. [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Muthuchidambaram with the housing range of Yaffe for purposes of connecting the obturator to the housing and for ease of use (para. [0036]).
Regarding claim 10, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram doesn’t directly disclose wherein a working length of the trocar sleeve ranges from 60 - 150 mm.
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]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Muthuchidambaram to have a working length of the trocar sleeve ranges from 60 - 150 mm for purposes of accommodating different patients with different anatomies (para. [0077]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Muthuchidambaram in view of Hart et al. (US 20160051281 A1—previously presented).
Regarding claim 9, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram doesn’t directly disclose wherein a working length of the trocar sleeve ranges from about 45 mm to 65 mm for pediatric use.
In the same field of endeavor, namely highly responsive instrument seal, Hart discloses 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]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Muthuchidambaram with the working length of Hart for purposes of having the device be used in different patients with varied anatomies including pediatric patients (para. [0062]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Muthuchidambaram in view of Pravongviengkham et al (US 8,945,058 B2, herein referred to as ‘058).
Regarding claim 11, Muthuchidambaram discloses the trocar sleeve of claim 1. Muthuchidambaram doesn’t directly disclose 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.
In the same field of endeavor namely trocar cannula with atraumatic tip, Pravongviengkham discloses (i.e., Col. 5 lines 65-Col. 6 line 20 discloses finger holds or grips and suture tie slots).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Muthuchidambaram to have 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 for purposes of accommodating suture slots (Col. 5 lines 65-Col. 6 line 20)
Response to Arguments
Applicant’s arguments with respect to claims 1-15, 17-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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