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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5, 15, and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 15 recite “the inlet port of the body extending toward the recessed portion.” [emphasis added] According to the elected embodiment which corresponds to Fig. 5 of the present application, in paragraph [0064] of the original specification, the recessed portion has been described as extending from the second end toward the first end, but there is no “toward” language pertaining to the inlet port. Additionally, according to paragraph [0062], the difference between the prior art of Fig. 3 and the present invention of Fig. 4 is the additional material on the stabilizer at the second end to prevent rocking, which is shown as a clear separation between the stabilizer/wing and the inlet port. Therefore, even if the stabilizer or wing of Fig. 4 had a recess, the inlet port would not point “toward” the recess, especially since the inlet port is in line with the longitudinal axis L and the wing in angled away from line L. Paragraph [0064] describes the recessed portions as providing clearance for the inlet port, but it is unclear if that means providing space below the inlet port or if the inlet port is actually positioned within the recess itself. If it is the latter, then such language should be specified in the claims and a clear figure showing such a feature should be provided. It is noted that in Fig. 5, it is unclear if the inlet port is positioned within the wing or sits on top of the wing, but as disclosed in light of Fig. 4, it appears that the inlet port only sits on the top of the wing. For examination purposes, the limitation of the inlet port extending “toward” the recessed portion will be interpreted as any generally angled proximal direction (from the first end towards the second end) as consistent with the direction shown in Fig. 5.
All remaining claims are rejected under 112(a) by virtue of being dependent on a rejected base claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5, 15, and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 15 recite “the first wing member defining a recessed portion adjacent to the inlet port of the body, the inlet port of the body extending toward the recessed portion.” Given the new limitation of the recess and the inlet port extending thereto, it is unclear how the limitation “a portion of the stabilizer extending beyond the inlet port of the body extending along the longitudinal axis” can still be true. As can be seen in Fig. 5, due to the recess, no part of the stabilizer extends “beyond” the inlet port, conversely, at least a portion of the inlet port now appears to extend beyond the stabilizer in the longitudinal direction. For examination purposes, since the new limitation, which is consistent with the elected embodiment, appears to make the limitation regarding the stabilizer extending beyond the inlet port contradictory, the limitation regarding the stabilizer extending beyond the inlet port will not be considered.
All remaining claims are rejected under 112(b) by virtue of being dependent on a rejected base claim.
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.
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.
Claims 1, 3, 5, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2020/0094026 to Isaacson et al. (“Isaacson”) in view of U.S. Patent No. 5,676,656 to Brimhall.
Regarding claim 1, Isaacson teaches a catheter adapter (Figs. 11A-D) comprising a body (313) having a first end and a second end positioned opposite the first end (left and right ends of 313), the body comprising an inlet port (walls surrounding 304 in Fig. 11A, not including the cap indicated at 302) positioned between the first end and the second end (Fig. 11A), the body defining a longitudinal axis extending between the first end and the second end of the body (longitudinal axis of 313), a catheter (15, as labeled in other embodiments) configured to be inserted into a patient's vasculature, the catheter positioned at the first end of the body (left end of Fig. 11A), and a stabilizer comprising a first wing member and a second wing member (wings as best shown in Figs. 11B & D),
However, although Isaacson does not disclose the inlet port extending towards the recessed portion, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inlet from extending upward to extending proximally on the side, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed arrangement would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and/or such a placement of the inlet port would be an obvious matter of design choice In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
In any case, Brimhall has been cited to teach a proximally extending inlet (22, Fig. 1, also see 112a rejection above for interpretation) on a similar type of device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inlet of Issacson to extending proximally as taught by Brimhall to yield the predictable result of providing an inlet on a catheter to receive medicament. Both Isaacson and Brimhall show an inlet port, Brimhall merely shows an obvious art-recognized alternative port configuration which may benefit and/or be better suited for certain applications. Once combined, the inlet would extend towards the recess given the broadest reasonable interpretation in light of the 112 rejections above.
Regarding claim 3, Isaacson and Brimhall teach the catheter adapter of claim 1 as shown above, Isaacson further teaching the stabilizer is symmetric with respect to the longitudinal axis (Fig. 11B).
Regarding claim 5, and Brimhall teach the catheter adapter of claim 1 as shown above, Isaacson further teaching the recessed portion of the first wing member extends from the second end of the first wing member toward the first end of the first wing member (the recess extends from the right side to the left side of the wing in Fig. 11B).
Regarding claim 15, Isaacson teaches a vascular access device comprising a catheter adapter (Figs. 11A-D) comprising a body (313) having a first end and a second end positioned opposite the first end (left and right ends of 313), the body comprising an inlet port (walls surrounding 304 in Fig. 11A, not including the cap indicated at 302) positioned between the first end and the second end (Fig. 11A), the body defining a longitudinal axis (longitudinal axis of 313) extending between the first end and the second end of the body, a catheter (15, as labeled in other embodiments) configured to be inserted into a patient's vasculature, the catheter positioned at the first end of the body (left end of Fig. 11A), a stabilizer comprising a first wing member and a second wing member (wings as best shown in Figs. 11B & D), but does not explicitly show the claimed position of the inlet port, and a needle hub assembly connected to the body of the catheter adapter (needle hub assembly is on the far right of Figs. 11A-D).
However, although Isaacson does not disclose the inlet port extending towards the recessed portion, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inlet from extending upward to extending proximally on the side, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed arrangement would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and/or such a placement of the inlet port would be an obvious matter of design choice In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
In any case, Brimhall has been cited to teach a proximally extending inlet (22, Fig. 1, also see 112a rejection above for interpretation) on a similar type of device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inlet of Issacson to extending proximally as taught by Brimhall to yield the predictable result of providing an inlet on a catheter to receive medicament. Both Isaacson and Brimhall show an inlet port, Brimhall merely shows an obvious art-recognized alternative port configuration which may benefit and/or be better suited for certain applications. Once combined, the inlet would extend towards the recess given the broadest reasonable interpretation in light of the 112 rejections above.
Regarding claim 16, Isaacson and Brimhall teach the vascular access device of claim 15 as shown above, Isaacson further teaching the stabilizer is spaced from the needle hub assembly (Fig. 11B, the wings are spaced from the needle hub assembly as defined above).
Response to Arguments
Applicant's arguments and amendments with respect to art rejections have been fully considered but they are not persuasive. As shown above, the inlet port extending towards the recess would be considered an obvious rearrangement of parts and/or design choice. In any case, a new rejection has been made over Isaacson alternatively or additionally in view of Brimhall in response to the new amendments.
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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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