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 .
Status of Claims
Claims 1-20 are pending and currently under consideration for patentability.
Claims 1 and 10 have been amended.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Foley (US 20150320970 A1) in view of Barrish (US 20170157363 A1) in view of Burkholz (US 20200023166 A1).
Regarding Claim 1, Foley teaches a catheter assembly (20) comprising:
a catheter member (34a) having a proximal portion and an outer surface (figure 2);
an introducer (22) having a cap member (proximal insertion portion 138a), a handle member (125), and a lumen (22) configured to receive the proximal portion of the catheter member (figure 2).
and a sleeve (30) having a compressed portion (opposite of extended position, paragraph 0061) housed in the lumen of the introducer (paragraph [0052])the sleeve being configured to evert over the outer surface as the catheter member is inserted through the lumen of the introducer (paragraph [0065]]);
and wherein the proximal portion of the sleeve is secured to the introducer between the handle (125) member and the cap member.
Foley fails to teach wherein the cap member and the handle member being configured to be detachably connected . Barrish teaches a catheter comprising an introducer. Barrish teaches a catheter with an introducer member where the handle for the catheter is configured to be detachably connected (paragraph [0060]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Foley to include a removeable handle, similar to Barrish, so that the interface of the handle may be reused with other catheters (as motivated by Barrish, Paragraph [0060]).
Foley and Barrish fails to teach wherein the proximal portion of the sleeve is secured to the introducer between an external surface of the handle member and an internal surface of the cap member. Burkholz teaches a cannula wherein the proximal portion of the sleeve is secured to the introducer between an external surface of the handle member and an internal surface of the cap member (paragraph [0072])(Figure 3A). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Foley wherein the proximal portion of the sleeve is secured to the introducer between an external surface of the handle member and an internal surface of the cap member, similar to Burkholz, so that the sleeve is controlled by the introducer.
Regarding Claim 2, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 1. Foley further teaches wherein the proximal portion of the catheter member is configured to push a distal portion of the sleeve proximally (figure 2 and 3) , and the compressed portion of the sleeve forms a soft proximal tip (proximal insertion end 38) of the catheter assembly as the catheter member exits a proximal opening of the introducer (paragraph [0068]).
Regarding Claim 3, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 1. Foley further teaches wherein the sleeve (30) is not secured to the catheter member (figure 3A, 3B) (paragraph [0052]).
Regarding Claim 4, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 1. Foley further teaches wherein the cap member (138) having an enlarged proximal surface (figure 2) .
Regarding Claim 5, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 4. Foley further teaches wherein the cap member has a retaining member (34b) (figure 2) that covers the sleeve when contained in the introducer and deflects as the catheter member is advanced proximally from the introducer (paragraph [0073]).
Regarding Claim 6, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 5. Foley further teaches wherein the retaining member comprises a plurality of flaps (42) (figure 1) .
Regarding Claim 7, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 5. Foley further teaches wherein the retaining member forms a projection extending proximally (30a) from the enlarged proximal surface (figure 2) .
Regarding Claim 8, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 1. Foley further teaches wherein the handle member (handle of Barrish) having a surface configured to be gripped by a user (paragraph [0070]).
Regarding Claim 9, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 8. Foley further teaches wherein the surface of the handle member includes a concave surface (hand gripping member) and/or one or more ridges (paragraph [0070]).
Regarding Claim 10, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 1. Foley further teaches wherein the proximal portion of the sleeve (30) has a folded portion secured to the introducer by being sandwiched between the handle member and the cap member (paragraph [0068] (as motivated by Barrish, see Claim 1).
Foley and Barrish fails to teach wherein the proximal portion of the sleeve is secured to the introducer between an external surface of the handle member and an internal surface of the cap member. Burkholz teaches a cannula wherein the proximal portion of the sleeve is secured to the introducer between an external surface of the handle member and an internal surface of the cap member (paragraph [0072])(Figure 3A). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Foley wherein the proximal portion of the sleeve is secured to the introducer between an external surface of the handle member and an internal surface of the cap member, similar to Burkholz, so that the sleeve is controlled by the introducer.
Regarding Claim 11, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 8. Foley further teaches wherein the cap member and the handle member are in a mating configuration (paragraph [0070]).
Regarding Claim 12, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 1. Foley further teaches wherein the distal portion of the sleeve is releasably engaged by an internal shoulder of the introducer (paragraph [0081]).
Regarding Claim 14, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 1. Foley further teaches wherein the proximal portion of the catheter member (34a) is open, and the catheter member has a lumen (33) therethrough.
Regarding Claim 15, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 1. Foley further teaches wherein the catheter member includes a funnel member (38a) on a distal portion (figure 4).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Foley (US 20150320970 A1) in view of Barrish (US 20170157363 A1) in view of Burkholz (US 20200023166 A1) in view of House (US 20100312227 A1).
Regarding Claim 13, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 8. Foley fails to teach wherein the handle member includes a plurality of elongated guide members extending from a distal portion.
In a similar field of endeavor, namely catheter advancement, House teaches wherein the handle member includes a plurality of elongated guide members extending from a distal portion (Claim 8). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Foley so the handle member includes a plurality of elongated guide members extending from a distal portion similar to House to prevent damage to the bladder while still maintaining efficacy (as motivated by House, paragraph [0014])..
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Foley (US 20150320970 A1) in view of Barrish (US 20170157363 A1) in view of Burkholz (US 20200023166 A1) in view of Hunter (US 20100312227 A1).
Regarding Claim 16, Foley in view of Barrish and Burkholz teaches the catheter assembly of claim 1. Foley fails to explicitly teach wherein the catheter assembly is non-lubricated. However Foley never once mentions the need for a lubricant and mentions the elongated introducer and flexible material are adapted for ease of insertion into urethra, therefore anyone of ordinary skilled in the art would find it obvious that the assembly is non-lubricated. In addition, Hunter teaches a urinary catheter assembly and cites “any users are happy to perform this procedure without lubrication, “ (paragraph [0028]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Foley as many catheters do not require lubrication (Hunter, paragraph [0028]).
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foley (US 20150320970 A1) in view of Barrish (US 20170157363 A1) in view of Burkholz (US 20200023166 A1) in view of Sarna (US 20190126010 A1).
Regarding Claim 17, Foley in view of Barrish and Burkholz teaches method of inserting a catheter assembly of claim 1 (paragraph [0071]) into a bodily lumen, the method comprising:
inserting the catheter member into the lumen of the introducer containing the compressed portion of the sleeve (paragraph [0074]); and
Foley fails to explicitly teach everting the sleeve over the catheter member as the catheter member is inserted into the bodily lumen. In the same field of endeavor, namely a method of inserting a catheter, Sarna teaches everting the sleeve over the catheter member as the catheter member is inserted into the bodily lumen (paragraph [0054]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sleave of Foley to evert the sleeve over the catheter member as the catheter member is inserted into the bodily lumen similar to Sarna so that the inner lumen is not occluded (As motivated by Sarna, paragraph [0054]).
Regarding Claim 18, Foley in view of Barrish and Burkholz and Sarna teaches the method of claim 17. Foley further teaches pushing a distal portion of the sleeve proximally (paragraph [0052]); and
forming a soft proximal tip of the catheter assembly with the compressed portion of the sleeve as the catheter member is inserted into the bodily lumen (paragraph [0052]).
Regarding Claim 19, Foley in view of Barrish and Burkholz and Sarna teaches the method of claim 17. Foley further teaches inserting a projection of the introducer into the bodily lumen (paragraph [0076]).
Regarding Claim 20, Foley in view of Barrish and Burkholz and Sarna teaches the method of claim 17. Foley further teaches retaining the sleeve in the introducer with a retaining member (paragraph [0076]); and deflecting the retaining member as the sleeve is advanced proximally from the introducer (paragraph [0073] and [0080]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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