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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 21-29, drawn to a catheter system, classified in A61B17/3421.
II. Claims 30-39, drawn to an obturator, classified in A61B1/3132.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination of group I specifies a distal cannula region but does not require that the distal cannula engagement region is proximal to the tapered distal end of the elongate body and distally adjacent to a second region of the elongate body as in group II. The subcombination of group II has separate utility such as using an obturator without the need for a catheter as in group I.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have different elements/steps which require examination and searching in alternate classes/subclasses as noted above. Due to the variance in scope, it would be necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Richard Shoop on 8 January 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 21-29. Affirmation of this election must be made by applicant in replying to this Office action. Claims 30-39 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04.
Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Parvongviengkham et al. (US 2010/0100045; hereinafter “Parvongviengkham”) in view of Buckman et al. (US 2004/0133226; hereinafter “Buckman”).
Regarding claim 21, Parvongviengkham discloses a system comprising: a catheter having a distal end region having a first stiffness (e.g. ¶¶ 37 – “atraumatic tip 7 has a flexural modulus that is about 1,500 psi”); and an obturator having a distal cannula engagement region having a stiffness that is matched to the first stiffness within +/- 5% of the first stiffness (e.g. ¶¶ 37 – “ensures that tip deflects or does not otherwise interfere with a surgical instrument, e.g., a laparoscope, obturator and others, having a tubular portion or shaft with properties similar to the remaining portions of the cannula inserted through the cannula and moved off-axis or portions of the instrument articulated off-axis.”), wherein the stiffness of the distal cannula engagement region is different from the stiffness of a tapered region distal to the distal cannula engagement region (i.e. where the examiner notes that the distal cannula engagement region of the obturator is clearly defined in the above section ¶¶ 37 as sharing flexural modules properties similar to the body of the cannula, which is different than the tapered tip region); wherein the obturator and catheter are configured to engage to form a combined structure with each other proximally so that the distal cannula engagement region is aligned with the distal end region of the catheter to prevent forming a gap between the obturator and the catheter when the combined structure is bent or curved (e.g. ¶¶ 36 – “The flexible joint, e.g., bellows, would enable the distal tip or portion of the cannula to pivot in response to contact with body tissue or inserted instrumentation “; ¶¶ 41-42 – “The smooth transition between the distal tip of the cannula and the obturator can decrease the possibility for body tissue to wedge between the cannula and the obturator during insertion through the abdominal wall and can therefore reduce the insertion force required to place the trocar through the abdominal wall. The interference fit can also serve to create a seal between the distal tip of the obturator 31 and the cannula 3.”).
Parvongviengkham fails to expressly disclose the stiffness of the distal cannula engagement region of the obturator is different from a region of the obturator proximally adjacent to the distal cannula engagement region. In the same field of endeavor, Buckman discloses an obturator which can have different regions of stiffness – specifically where the stiffness of the distal cannula engagement region of the obturator is different from a region of the obturator proximally adjacent to the distal cannula engagement region (e.g. ¶¶ 82 – “It is preferred that the obturator control rod 30 is more flexible toward the distal end and less flexible toward the proximal end”) in order to permit insertion and bending while minimizing organ damage. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of differing stiffness characteristics of an obturator where the stiffness of the distal cannula engagement region of the obturator is different from a region of the obturator proximally adjacent to the distal cannula engagement region, as taught by Buckman, to improve the similar device of Parvongviengkham, by allowing appropriate insertion and avoiding damage to internal regions and organs of the patient.
Regarding claim 22, Parvongviengkham discloses the distal cannula engagement region comprises a stiffening component (e.g. ¶¶ 30 – “This length enables the cannula 3 to be disposed across the abdominal wall such that the rigid portion 5 of the cannula 3 is positioned within the abdominal wall to hold the abdominal wall in a retracted position.”).
Regarding claim 23, Parvongviengkham discloses the stiffening component comprises a tubular member within the distal cannula engagement region (e.g. ¶¶ 37 – “having a tubular portion or shaft with properties similar”).
Regarding claim 24, Parvongviengkham discloses the stiffening component comprises a material having a higher stiffness than a material forming the tapered region distal and/or the region of the obturator proximally adjacent to the distal cannula engagement region (e.g. ¶¶ 47 – “internal wire form 19 to provide greater rigidity and column strength as compared to a cannula tip without an internal wire form”).
Regarding claim 25, Parvongviengkham discloses the stiffening component comprises an internal frame (e.g. ¶¶ 47 – “internal wire form 19 to provide greater rigidity and column strength as compared to a cannula tip without an internal wire form”).
Regarding claim 26, Parvongviengkham discloses the distal cannula engagement region comprises a length that is between 1 mm and 40 mm (e.g. ¶¶ 30 – 025” = 6.35mm).
Regarding claim 27, Parvongviengkham discloses the distal cannula engagement region comprises a length that is greater than 5 mm (e.g. ¶¶ 30 – 025” = 6.35mm).
Regarding claim 28, Parvongviengkham discloses the obturator comprises an elongate guidewire channel extending down a length of the obturator (e.g. ¶¶ 47 – “wire form in one aspect also comprises a series of wires radially spaced and embedded within the atraumatic elastomeric cannula tip”).
Regarding claim 29, Parvongviengkham discloses the distal cannula engagement region comprises a stiffening insert within the distal cannula engagement region (e.g. ¶¶ 47 – “internal wire form 19 to provide greater rigidity and column strength as compared to a cannula tip without an internal wire form”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796