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 1 is objected to because of the following informalities: Since the “catheter assembly” of line 2, “needle safety clip”1 of line 8, “barrel” of line 10, “needle hub” of line 11, “introducer needle” of line 12, “catheter hub slider” of line 14, “guidewire” of line 15 and “guidewire slider” of line 17 are all components of the “catheter system”, each of these should be indented the same amount so that they align. In order to be grammatically correct, the term “and” should be inserted after the semi-colon on lines 16, 23, 30, and 33. On line 20, the term “the” in the phrase “the guidewire slider proximal position” should be replaced with the term “a” since this is the first time this position is being introduced in the claim. On line 21, the term “a” in the phrase “a guidewire slider proximal position” should be replaced with the term “the” since this position has been previously introduced in the claim. On line 25, the term “a” in the phrase “a catheter hub slider proximal position” should be replaced with the term “the” since this position has been previously introduced in the claim. On line 37, the term “a” in the phrase “a catheter hub slider proximal position” should be replaced with the term “the” since this position has been previously introduced in the claim. On line 37, the term “a” in the phrase “a distally-advanced position” should be replaced with the term “the” since this position has been previously introduced in the claim. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: In order to be grammatically correct, the term “and” should be inserted after the second comma on line 2. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: In order to be grammatically correct, the term “and” should be inserted after the semi-colon on line 4. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: In order to be grammatically correct, the term “and” should be inserted after the comma on line 3 and after the semi-colons on lines 7 and 8. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: In order to be grammatically correct, the term “and” should be inserted after the comma on line 3. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: In order to be grammatically correct, the term “and” should be inserted after the comma on line 3. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: In order to be grammatically correct, the term “and” should be inserted after the comma on line 2. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: In order to be grammatically correct, the term “and” should be inserted after the comma on line 5. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: In order to be grammatically correct, the term “and” should be inserted after the comma on line 2. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: In order to be grammatically correct, the term “and” should be inserted after the comma on line 3. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-20 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.
Re claim 1, the format of lines 2-9 and the presence of the term “and” on line 7 renders it unclear if the “needle safety clip” and “safety can” are a part of the “catheter assembly” or not; specifically, the inclusion of the term “and” on line 7 implies that the these are a part of the “catheter assembly” but the same indentation of “a catheter assembly” on line 2 and “a needle safety clip” on line 8 implies that these are not part of the “catheter assembly”. For the sake of examination, claim 1 is interpreted such that the “needle safety clip” and the “safety can” are not a part of the “catheter assembly”. Accordingly, it is suggested to delete the term “and” from line 7. Claims 2-20 are rejected due to their dependence on claim 1.
Re claim 7, the claim defines the “distally-extending arm” as having a “hook” and an “outwardly-extending protrusion”, wherein the “hook” and the “protrusion” perform a method step that is substantially similar to the method step that is performed by the “distally-extending arm” in claim 6. Therefore, it is unclear if claim 7 is defining the “hook” and the “protrusion” as being the elements of the “distally-extending arm” that perform the method step of claim 6 or if the method step of claim 7 is in addition to the method step of claim 6. For the sake of examination, the former is the interpretation applied to the claim. Accordingly, it is suggested to amend claim 7 to recite “wherein the movement of the catheter system from the third position to the fourth position, it is the outwardly-extending protrusion of the distally-extending arm that contacts the inner ramp on the inner surface of the barrel and it is the hook that is removed from the groove of the safety can causes the catheter hub slider [[is]] to be uncoupled from the catheter assembly”. Claim 8 is rejected due to its dependence on claim 7.
Re claim 11, the claim defines the “flexible arm” as having a “fin tapered inwardly”, wherein the “fin” performs a method step that is substantially similar to the method step that is performed by the “flexible arm” in claim 1. Therefore, it is unclear if claim 11 is defining the “fin” the element of the “flexible arm” that performs the method step of claim 1 or if the method step of claim 11 is in addition to the method step of claim 1. For the sake of examination, the former is the interpretation applied to the claim. Accordingly, it is suggested to amend claim 11 to recite “wherein in response to the movement of the catheter system from the first position to the second position, it is the fin that the guidewire slider pushes out on to cause the removal of the flexible arm the contact with the needle hub[[,]] and to cause the sliding of the catheter hub slider
Re claim 12, line 7 recites “the flexible arm” but it is unclear if this was intended to refer to the “first flexible arm” or the “second flexible arm”. For the sake of examination, the latter is the interpretation applied to the claim. Accordingly, it is suggested to amend line 7 to recite “the second flexible arm”.
Re claim 12, lines 7-9 recite “and the catheter hub slider is configured to slide from a catheter hub slider proximal position to a distally-advanced position”. Since this is already recited in claim 1, it is unclear if this was accidentally repeated in claim 12, if this was intended to be another sliding action, or if claim 12 intended to set forth how the second flexible arm affects this sliding action. For the sake of examination, the third is the interpretation applied to the claim. Accordingly, it is suggested to amend claim 12 to recite “the guidewire slider pushes out on the second flexible arm such that the second flexible arm is removed from contact with the needle hub[[,]] [[and]] to cause the sliding of the catheter hub slider the catheter hub slider proximal position to [[a]] the distally-advanced position”.
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, 2 and 5-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 19/207/081 in view of King (PG PUB 2007/0191777).
Independent claim 1 of the copending application discloses all of the subject matter of independent claim 1 of the present application except that the copending claim 1 recites a “housing” without defining that housing being a “barrel”2 as is required by claim 1 of the present application. King, however, teaches a substantially similar catheter system 10 (Fig 1) having a housing 20 that can be in the form of a barrel (“an elongated, advantageously cylindrical, outer needle guard housing 20”, Para 7) or any other shape (“housing 20 or 22 could be shaped other than cylindrical”, Para 26) and still achieve the same purpose (Para 26). Therefore, it would have been obvious to modify the housing of the copending application to be in the shape of a barrel since King teaches that a housing of any shape – including cylindrical – can achieve the same purpose in a catheter system substantially similar to that of the copending application. Therefore, the subject matter of claims 1, 2 and 5-14 of the present application is fully disclosed by the claims of the copending application and King. The correspondence of the present claims to the copending claims is set forth in the following chart:
Present claim
Copending claim in view of King
1
1
2
2
5
3
6
4
7
5
8
6
9
7
10
8
11
9
12
10
13
11
14
1
This is a provisional nonstatutory double patenting rejection.
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.
Claims 1-5, 11-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ribelin et al. (PG PUB 2016/0256667).
Re claim 1, Ribelin discloses a catheter system 10 (Fig 48A; it is noted that all reference characters cited below refer to the embodiment of Fig 48A-60 unless otherwise noted with Fig 49 showing all of the components in an exploded view), comprising: a catheter assembly 42, comprising: a catheter hub 46, comprising a distal end (to the left in Fig 48A), a proximal end (to the right in Fig 48A), and a lumen (through which guidewire 22 extends, Para 99) extending through the distal end of the catheter hub and the proximal end of the catheter hub (as evidenced by Para 99); and a catheter 44 comprising a distal tip (to the left in Fig 48A) and extending from the distal end of the catheter hub (as seen in Fig 48A); and a needle safety clip 56 disposed within a safety can 54 (Para 197) disposed proximal to the catheter hub (as seen in Fig 52); a barrel 12, comprising a distal end (to the left in Fig 48A) and a proximal end (to the right in Fig 48A); a needle hub 1214 fixed to the barrel; an introducer needle 16 comprising a sharp distal tip 168 and a proximal end (to the right in Fig 48A), wherein the proximal end of the introducer needle is secured within the needle hub (Para 197); a catheter hub slider 1224 comprising a flexible arm 1272 with a distally-extending arm (the portion of arm 1272 including notch 1274 and slatned surface 1276)(it is noted that because the arm 1276 has a length that extends in the longitudinal direction, it extends both distally and proximally and, thus, can be considered a “distally-extending” arm); a guidewire 22 comprising a first end (to the left in Fig 54) and a second end (to the right in Fig 54), wherein the first end is configured to advance distally through the introducer needle (Para 202); a guidewire slider 20; wherein the catheter system is configured to move from a first position (seen in Fig 48A,55,56A) to a second position (between the position of Fig 48A and the position of Fig 54), wherein when the catheter system is in the first position: the guidewire slider is disposed in the guidewire slider proximal position and configured to slide from a guidewire slider proximal position to a distal position to distally advance the guidewire (Para 207, “initial positions […] prior to distal guidewire advancement”); the catheter hub slider is disposed in a catheter hub slider proximal position (Para 207, “initial positions […] prior to […] catheter distal advancement”); the flexible arm of the catheter hub slider contacts the needle hub to prevent the catheter hub slider from sliding from a catheter hub slider proximal position to a distally-advanced position (Para 207); wherein when the catheter system is in the second position: the guidewire slider is disposed in the distal position such that the guidewire is advanced beyond the distal tip of the catheter (Para 208, “distal advancement of the guidewire lever 24”); the catheter hub slider is disposed in the catheter hub slider proximal position (Para 208, advancement of the catheter hub slider is prevented until full distal advancement of the guidewire); the distally-extending arm of the catheter hub slider is coupled to the catheter assembly to prevent distal movement and proximal movement of the catheter hub slider with respect to the catheter hub (Para 208); wherein in response to the movement of the catheter system from the first position to the second position, the guidewire slider pushes out on the flexible arm such that the flexible arm is removed from contact with the needle hub, and the catheter hub slider is configured to slide from a catheter hub slider proximal position to a distally-advanced position (Para 208).
Re claim 2, Ribelin discloses that the second end of the guidewire is fixed within the barrel (“attachment point on the top housing portion 12A”, Para 194), wherein the guidewire slider comprises a U-shaped slot (formed by surfaces 980, as seen in Fig 53A) therethrough, wherein when the catheter system is in the first position, the guidewire is disposed in the U-shaped slot in a double-throw configuration (as seen in Fig 53A) such that there is a 2:1 advancement ratio between the first end of the guidewire and the guidewire slider (Para 194).
Re claim 3, Ribelin discloses that the U-shaped slot is oriented vertically within the barrel (as seen in Fig 53A).
Re claim 4, Ribelin discloses that the U-shaped slot is asymmetric (as seen in Fig 53A).
Re claim 5, Ribelin discloses that the catheter is configured to move from the second position to a third position (seen in Fig 54), wherein when the catheter system is in the third position: the guidewire slider is disposed in the distal position such that the guidewire is advanced beyond the distal tip of the catheter; the catheter hub slider is disposed in the distally-advanced position, wherein distal advancement of the catheter hub slider advances the catheter assembly (Para 203).
Re claim 11, Ribelin discloses that the flexible arm comprises a fin tapered inwardly in a distal direction (as seen in Fig 55, as the portion proximal to the cutout 1274), wherein in response to the movement of the catheter system from the first position to the second position, the guidewire slider pushes out on the fin such that the flexible arm is removed from contact with the needle hub, and the catheter hub slider is configured to slide from the catheter hub slider proximal position to the distally-advanced position (Para 208).
Re claim 12, Ribelin discloses that the flexible arm is a first flexible arm (on the left in Fig 55), wherein the catheter hub slider comprises a second flexible arm 1272 (on the right in Fig 55) opposite the first flexible arm, wherein the second flexible arm of the catheter hub slider contacts the needle hub to prevent the catheter hub slider from sliding from the catheter hub slider proximal position to the distally-advanced position (Para 202), wherein in response to the movement of the catheter system from the first position to the second position, the guidewire slider pushes out on the second flexible arm such that the flexible arm is removed from contact with the needle hub, and the catheter hub slider is configured to slide from a catheter hub slider proximal position to a distally-advanced position (Para 208).
Re claim 13, Ribelin discloses that the catheter assembly further comprises another safety clip 1008 disposed within the safety can (Para 197) and configured to trap the sharp distal tip of the introducer needle in response to proximal withdrawal of the introducer needle (as seen in Fig 59, Para 180).
Re claim 14, Ribelin discloses that the barrel further comprises a slot 1236 disposed between the distal end of the barrel and the proximal end of the barrel (as seen in Fig 48A), wherein when the catheter system is in the first position (as seen in Fig 48A), the guidewire slider extends through the slot and is configured to slide along the slot from the guidewire slider proximal position to the distal position to distally advance the guidewire (Para 194).
Re claim 15, Ribelin discloses that when the catheter system is in the second position, the guidewire slider extends through the slot and is configured to slide along the slot from the guidewire slider distal position to the catheter hub proximal position (Para 194).
Re claim 16, Ribelin discloses that the proximal end of the barrel comprises an opening (the opening being the interior of the housing, surrounded by upper and lower portions 12A,12B), wherein the catheter hub slider is configured to slide within the opening from the proximal catheter hub slider position to the distally-advanced position, wherein the guidewire slider is configured to slide within the opening from the guidewire slider proximal position to the distal position (as seen in Fig 49, Para 194).
Re claim 17, Ribelin discloses that the guidewire slider wraps around the catheter hub slider (as seen in Fig 55, the flexible arm 1272 of the catheter hub slider 1224 is aligned with and surrounds posts 1264 of the needle hub 1214; as seen in Fig 53A, block 1258 and guidewire lever 24 of the guidewire slider 20 wraps around posts 1264; therefore, block 1258 and guidewire lever 24 of the guidewire slider 20 warps around the catheter hub slider 1224).
Re claim 19, Ribelin discloses that the second end of the guidewire is fixed within the needle hub (as seen in Fig 53B, the guidewire extends through the needle hub and cannot be removed therefrom due to it being attached to the housing, Para 194).
Re claim 20, Ribelin discloses that when the catheter system is in the second position, the guidewire slider is configured to slide back and forth between the guidewire slider proximal position and the distal position (prior to the protrusion 1254 and depression 1252 mating as described in Para 204).
Allowable Subject Matter
Claims 6-10 and 18 depend on claim 1 and, therefore, are rejected under 112(b) as set forth above. Additionally, claims 6-10 are objected to and rejected under double patenting. However, if the claims were rewritten to overcome the rejections and objections and claim 6 (upon which claims 7-10 depend) and/or claim 18 were rewritten in independent form including all of the limitations of their respective base claims and any intervening claims, claims 6-10 and 18 would be allowable.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of dependent claim 6 (in combination with claims 1 and 5 upon which it depends) and the subject matter of dependent claim 18 (in combination with claims 1, 16 and 17 upon which it depends) could not be found nor was suggested in the prior art of record.
Claim 6 (upon which claims 7-10 depend) requires the safety can to comprise a groove and the barrel to comprise an inner ramp on its inner surface such that when the catheter system is moved from the third position to a fourth position, the distally-extending arm of the catheter hub slider contacts the inner ramp to remove the distally-extending arm from the groove of the safety can so that the catheter hub slider is uncoupled from the catheter assembly. Ribelin does not disclose either the groove nor the inner ramp, nor are the components of Ribelin’s catheter system arranged such that the safety can and the catheter hub slider directly contact each other or such that the barrel and the distally-extending arm of the catheter hub slider directly contact each other. Therefore, it would not have been obvious to one of ordinary skill in the art to modify the safety can, the barrel, and the catheter hub slider to be structured and arranged to meet this limitation as doing so would require substantial redesign and may render the catheter system inoperable. Additionally, a catheter system comprising the features of claim 6 could not be found elsewhere in the prior art of record.
Claim 18 requires the guidewire slider to wrap completely around the catheter hub slider. As set forth above, Ribelin’s guidewire slider (specifically lever 24 and block 1258) wraps around the catheter hub slider. However, the guidewire slider does not wrap completely around the catheter hub slider and it would not have been obvious to one of ordinary skill in the art to modify the shape of the guidewire slider and/or the shape of the catheter slider to meet this limitation as doing so would render the catheter system inoperable. Additionally, a catheter system arranged in the manner recited in claim 18 could not be found elsewhere in the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2011/0282285 and PG PUB 2014/0094774 to Blanchard et al., PG PUB 2016/0045715 to Galgano et al., PG PUB 2018/0133438 to Hulvershorn et al., PG PUB 2018/0296799 to Horst et al., and PG PUB 2018/0369540 to Asai, PG PUB 2019/0275303 to Tran et al., and PG PUB 2020/0170559 to Burkholz et al. each disclose a catheter system relevant to that of the present invention including at least a catheter assembly, a needle assembly and a guidewire assembly that move relative to each other.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 See the interpretation applied due to the 112(b) rejection below.
2 The term “barrel” is interpreted under broadest reasonable interpretation as meaning “a cylindrical part” as per the Merriam Webster Dictionary. https://www.merriam-webster.com/dictionary/barrel
Prosecution Insights