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 13 is objected to because of the following informalities: “a second opening” should recite - - a second opening[s]] - -. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 1-3, 5-7, 13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Avneri et al (US 2016/0346002).
Averni et al discloses the following limitations:
Claim 1. A medical device (Figs. 1-4) comprising:
a rim (each one of tube loops 18 combined together forms the claimed ‘rim’; for example in Fig. 2A the rim is formed and define by the four tube loops 18 which forms a rim around the distal opening of sheath 12) defining a loop (one of tube loop 18; as the claim recites “comprising” and is open ended and may have more than one loop; therefore, the claim only requires the rim to define at least one loop and does not preclude additional loops) and having two openings (each one of 23 on a tube loop 18; or the two discrete openings in Fig. 4H) at a distal end (end furthest from user) of the rim (each opening 23 as seen in Fig. 2A for example is disposed on a distal end of the rim which is defined as all the tube loops 18); and
a wire (24) coupled to the distal end of the rim and extending proximally from the distal end to a proximal end (end closest to user) of the rim, wherein the wire extends through the two openings such that a first portion (portion proximal of opening 23) of the wire is proximal to the distal end of the rim and a second portion (portion distal to opening 23) of the wire is distal to the distal end of the rim (see annotated figure below; a single wire 24 extends through the two labeled openings, wherein all the tube loops 18 together were interpreted as the claimed rim and therefore the wire extends through the two openings at the distal end of the rim).
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Claim 2. The medical device of claim 1, wherein the first portion of the wire extends radially outward relative to a longitudinal axis of the rim (Figs. 1B, 2A, 2B; [0101], [0133]; wire 18 is disposed within tube loops 18, wherein tube loops 18 are arched and therefore the wire follows the arch of the tube loops and extends radially outward as seen in the figures).
Claim 3. The medical device of claim 1, wherein a cross-sectional dimension of the wire is smaller than a cross-sectional dimension of the rim (Fig. 1B, 2A).
Claim 5. The medical device of claim 1, wherein the first portion of the wire includes a first curvature extending proximally from a first opening (top opening 23 in annotated figure of claim 1) of the two openings (Fig. 1B; see annotated figure from claim 1).
Claim 6. The medical device of claim 5, wherein first portion of the wire includes a second curvature extending proximally from a second opening (bottom opening 23 in annotated figure of claim 1) of the two openings (Fig. 1B).
Claim 7. The medical device of claim 6, wherein the first curvature and the second curvature extend radially outward relative to a longitudinal axis of the rim (Fig. 1B).
Claim 13. The medical device of claim 1, wherein the rim includes a first side (radially exterior) and a second side (radially interior), wherein the first portion of the wire includes a first curvature and a second curvature extending proximally from a first opening (top opening 23) and a second opening (bottom opening 23) of the two openings, respectively, wherein, the first curvature and the second curvature each extend radially outward from the first side (see annotated figure from claim 1).
Claim 15. The medical device of claim 1, wherein the wire is coupled to the proximal end of the rim (Fig. 1B).
Claim(s) 1, 3, 5, 6, 8, 9, 11 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parihar et al (US 2011/0184431).
Parihar et al discloses the following limitations:
Claim 1. A medical device (Figs. 12-16) comprising:
a rim (312) defining a loop (Figs. 13, 16) and having two openings (356) at a distal end (end furthest from user) of the rim ([0078]); and
a wire (310) coupled to the distal end of the rim and extending proximally from the distal end to a proximal end (end closest to user) of the rim, wherein the wire extends through the two openings such that a first portion of the wire is proximal to the distal end of the rim and a second portion (352) of the wire is distal to the distal end of the rim ([0078]; Figs. 12, 13, 15, 16).
Claim 3. The medical device of claim 1, wherein a cross-sectional dimension of the wire is smaller than a cross-sectional dimension of the rim (Fig. 14).
Claim 5. The medical device of claim 1, wherein the first portion of the wire includes a first curvature (outer surface of rod 309 of arm 310; wherein arm 310 is a rounded wire and thus the exterior surface of rod 309 is considered a first curvature) extending proximally from a first opening of the two openings (Fig. 12-14).
Claim 6. The medical device of claim 5, wherein first portion of the wire includes a second curvature (outer surface of rod 311 of arm 310; wherein arm 310 is a rounded wire and thus the exterior surface of rod 311 is considered a second curvature) extending proximally from a second opening of the two openings (Figs. 12-14).
Claim 8. The medical device of claim 1, wherein the rim includes a nickel-titanium alloy ([0079]).
Claim 9. The medical device of claim 1, wherein the rim has a substantially rectangular cross-section (Fig. 14).
Claim 11. The medical device of claim 1, wherein an inner surface (radially inner surface) of the rim is roughened (the rim is provided with openings 356 which extend through the thickness of the rim and therefore causes a discontinuity in the inner surface. Therefore, the inner surface is considered roughened due to the discontinuity of the surface at this location).
Claim 15. The medical device of claim 1, wherein the wire is coupled to the proximal end of the rim (Figs. 12-13).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dostal et al (US 9101383).
Dostal et al discloses the following limitations:
Claim 16. A medical device comprising:
a rim (61a + 61b + 63) defining a loop (Figs. 1-4) and having a first opening (65c) and a second opening (65d) at a distal end (end furthest from user) of the rim (Figs. 4a, 4b);
a wire (61c + 61d; disclosed as one continuous wire in col. 6, ll. 31-33) coupled to the distal end of the rim and extending proximally from the distal end to a proximal end of the rim, wherein a first curvature (61c) of the wire extends proximally from the first opening and a second curvature (61d) of the wire extends proximally from the second opening (col. 6, ll. 21 – col. 7 ll. 55); and
a shaft (50) configured to cover a portion of the rim and a portion of the wire (Fig. 3; col. 8, ll. 32 – col. 10, ll. 3).
Claim 17. The medical device of claim 16 further comprising: a plurality of actuators (24, 31) coupled to the proximal end of the rim or a proximal end of the wire (Figs. 1, 2; col. 10, ll. 4-21).
Claim 18. The medical device of claim 16, wherein the distal end of the rim includes an atraumatic distal tip (Fig. 3a; the distal face of hub 63 is flat and not sharpened or pointed with a traumatic tip and is therefore considered an atraumatic distal tip).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Avneri et al in view of Cheng (US 2007/0225729).
Claim 4. Averni et al discloses the invention substantially as claimed above, including a width of the wire is less than a cross-sectional dimension of each of the two openings (Figs. 4A-4H) but fails to explicitly disclose a cross-sectional dimension of the wire is rectangular. Instead, Averni et al discloses the wire may have any cross-sectional shape ([0132]).
In a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely surgical removal of unwanted elements from the body, Cheng teaches a medical device (2) comprising wires (30) for capturing stones (34) for removal (Fig. 9), wherein the wires include any cross-sectional shape known in the art, such as rectangular for allowing capture ([0033]).
There is no evidence of record that establishes that changing the cross-sectional dimension of the at least one wire to be rectangular would result in a difference in function of the Averni et al device. Further, a person having ordinary skill in the art, being faced with modifying the at least one wire of Averni et al, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed shapes. Lastly, Applicant has not disclosed that the claimed cross-sectional shape solves any stated problem, indicating that the shape "may" have a substantially circular cross-section, and that the wire (20) "is not limited" to the rectangular cross-sectional dimension ([0033]). Thus, there appears to be no criticality placed on the shape as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cross-sectional dimension of the at least one wire in Averni et al to be rectangular based upon the teachings of Cheng as an obvious matter of design choice within the skill of the art.
Claim(s) 11, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Averni et al in view of Que et al (US 7169154).
Claim 11. Averni et al discloses the invention substantially as claimed above, but fails to disclose an inner surface of the rim is roughened.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely surgical removal of unwanted elements from the body, Que et al teaches a medical device (10) comprising a rim (12) having a roughened inner surface (col. 7, ll. 53-61). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the rim of Averni et al to have a roughened surface based upon the teachings of Que et al to improve the grip on the material for removal (col. 7, ll. 53-61).
Claims 12 and 14. Averni et al discloses the invention substantially as claimed above, but fails to disclose an edge of the rim includes serrations or scallops (as per claim 12) or an edge of the second side of the rim includes serrations or scallops (as per claim 14).
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely surgical removal of unwanted elements from the body, Que et al teaches a medical device (10) comprising a rim (12) having serrations (11) on a second side (radially interior) of the rim (Fig. 3A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Averni et al with serrations on the edge of the second side of the rim as taught by Que et al to maximize the grip on the material for removal (col. 7, ll. 53-61).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9, 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12357331 (parent application U.S. Serial No. 17/756,207).
Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of claims 1-9, 11-18 of the instant application are to be found in claims 1-19 of the patent. Thus the difference between claims 1-9, 11-18 of the instant application and claims 1-19 of the patent lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of claims 1-19 of the patent is in effect a “species” of the “generic” invention of claims 1-9, 11-18 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-9, 11-18 are anticipated by claims 1-19 of the patent, it is not patentably distinct from claims 1-19 of the patent.
.
Allowable Subject Matter
Claims 19 and 20 are allowed.
Claim 10 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 10, the closest prior art of record, Averni et al and Parihar et al, each discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed medical device comprising, inter alia, the rim includes a curved outer surface, wherein the second portion of the wire extends along and contacts the curved outer surface of the rim.
In regard to claim 19, the closest prior art of record, Gerard (US 2004/0122444), discloses a medical device (1) comprising: a rim (4) defining a loop (Fig. 1) and having a first opening and a second opening (each one of cutting lines 11, 12 form an opening) at a distal end of the rim ([0034], [0035]), wherein the rim includes a first side (top side) and a second side (bottom side) opposite to the first side relative to a longitudinal axis of the rim; and a wire (5) coupled to the distal end of the rim and extending proximally from the distal end to a proximal end of the rim, wherein a first portion of the rim extends proximal to the first or second opening and curves radially outward from the first side (Fig. 1). The prior art of record does not disclose or fairly suggest either singly or in combination the claimed medical device comprising, inter alia, a second portion is positioned distal to the distal end of the rim and extends along a curved outer surface of the rim between the first opening and the second opening.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
