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.
Claim 20 is 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. Claim 20 calls for the first portion of the handle to include a barrel having a plurality of ridges thereon, and wherein the barrel is proximal of both the first flange and the second flange. The disclosure describes the first flange and second flange 134, 136 as being at the proximal end of the first body 130 (fig. 1B), and therefore fails to provide written description support for the barrel to be proximal to both the first flange and the second flange.
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.
Claim(s) 1, 2, 5, 8, 13, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ralph (US 10,945,714).
Regarding claim 1, Ralph discloses a medical device handle comprising: a first body 26 defining a lumen 100 (figs. 1-1, 2); and a second body 28 having a portion 36 that is movably received within the lumen (fig. 2), wherein the second body includes a grip 38, wherein the grip includes a proximal portion, a distal portion, and a middle portion between the proximal portion and the distal portion, and wherein the middle portion has a greater cross-sectional width than the proximal portion and the distal portion (see fig. 1-1 annotated below); wherein the second body is configured to move proximally and distally along a longitudinal axis of the second body in order to actuate a needle of a medical device (figs. 1-1, 1-2, 2).
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Regarding claim 2, Ralph discloses that the grip includes a plurality of ridges (fig. 1-1).
Regarding claim 5, Ralph discloses that the first body 26 includes a flange at a proximal end thereof (see fig. 1-1 annotated below).
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Claim 8 calls for a proximal end of the second body includes an adapter for coupling to a fluid source. The limitation “for coupling to a fluid source” is interpreted to be an intended use limitation. Ralph discloses that the proximal end of the second body 28 is connected to a luer connector (col. 3, lines 17-19). A luer connector is capable of being coupled to a fluid source.
Regarding claim 13, Ralph discloses that the first body includes a barrel having a plurality of ridges thereon (see fig. 1-1 annotated below).
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Regarding claim 15, Ralph discloses that the second body 28 includes a shank 36 that extends distally from the grip to be movably received within the lumen of the first body, and wherein a tapered surface extends between the grip and the shank (see fig. 1-1 annotated below).
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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) 5, 6, 12, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ralph.
Claim 5 differs from Ralph in calling for the flange to a first flange, and wherein the first body includes a second flange that is proximal of the first flange. Ralph discloses a first flange as discussed above, but fails to disclose a second flange that is proximal to the first flange. The court has held that mere duplication of parts has no patentably significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)). In this case, no unexpected result is achieved by providing as second flange on the body and therefore claim 5 is not patentably distinct from Ralph.
Claim 6 further calls for the first flange has a curved surface that faces distally and the second flange has a curved surface that faces proximally. Applicant has not described that this particular shape serves a particular purpose or provides a stated benefit. A person of ordinary skill in the art would expect the flanges of Ralph and the instant invention to perform equally well with a flat shape of a curved surface. Therefore, 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 flanges of Ralph as discussed above to be curved as described in claim 6 because doing so would have been a matter of obvious design choice.
Claim 12 calls for the adapter to include a concave proximal surface. Applicant has not described that this particular shape serves a particular purpose or provides a stated benefit. A person of ordinary skill in the art would expect the adapter of Ralph and the instant invention to perform equally well with a flat shape of a curved surface. Therefore, 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 adapter of Ralph as discussed above to have a concave proximal surface as described in claim 12 because doing so would have been a matter of obvious design choice.
Regarding claim 19, Ralph discloses a medical device handle comprising: a first body 26 defining a lumen (fig. 2), wherein the first body includes: a first flange (fig. 2: flange at proximal end of handle 26); and a second body 28 having a portion 36 that is movably received within the lumen (figs. 1-1, 1-2, 2); wherein the second body is configured to move proximally and distally along a longitudinal axis of the second body in order to actuate an element of a medical device (figs 1-1, 1-2).
Claim 19 differs from Ralph in calling for the first flange to have a first concave surface, wherein the first concave surface faces at least partially distally; and a second flange proximal of the first flange and having a second concave surface, wherein the second concave surface faces at least partially proximally. The court has held that mere duplication of parts has no patentably significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)). In this case, no unexpected result is achieved by providing as second flange on the body and therefore claim 5 is not patentably distinct from Ralph. Further, Applicant has not described that this particular shape of the flanges serves a particular purpose or provides a stated benefit. A person of ordinary skill in the art would expect the flanges of Ralph and the instant invention to perform equally well with a flat shape of a curved surface. Therefore, 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 flanges of Ralph as discussed above to be curved as described in claim 6 because doing so would have been a matter of obvious design choice.
Allowable Subject Matter
Claims 3, 4, 9, 10, 11, 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 16-18 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the prior art fails to teach or fairly suggest that the ridges extend at a non-zero angle to the longitudinal axis, and wherein the ridges are non-perpendicular to the longitudinal axis, in combination with the features of the invention, substantially as claimed.
Regarding claim 4, the prior art fails to teach or fairly suggest a first ridge of the plurality of ridges has a first portion that extends a first radial distance from the central longitudinal axis, and wherein the first ridge has a second portion that extends a second radial distance from the central longitudinal axis, wherein the second radial distance differs from the first radial distance, in combination with the features of the invention, substantially as claimed.
Regarding claim 9, the prior art fails to teach or fairly suggest the adapter includes an opening defined by a first wall, a second wall surrounding the first wall, and at least one fin extending between the first wall and the second wall, in combination with the features of the invention, substantially as claimed.
Regarding claim 14, the prior art fails to teach or fairly suggest the ridges extend at a non-zero angle to the longitudinal axis, and wherein the ridges are non-perpendicular to the longitudinal axis, in combination with the features of the invention, substantially as claimed.
Regarding claim 16, the prior art fails to teach or fairly suggest a medical device handle comprising: a first body defining a lumen; and a second body having a portion that is movably received within the lumen, wherein the second body includes a grip, wherein the grip includes a plurality of ridges, wherein the ridges extend at a non-zero angle to a longitudinal axis of the second body, and wherein the ridges are non-perpendicular to the longitudinal axis; wherein the second body is configured to move proximally and distally along a longitudinal axis of the second body in order to actuate an element of a medical device, in combination with the features of the invention, substantially as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Marler (US 8,591,480) teaches a handle having ridges of different lengths (fig. 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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