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 .
In light of the amendments to the claims filed 10/15/2024 in which claims 6, 8, 13, 15, 20-24, 28-33 were cancelled, claims 1-5, 7, 9-12, 14, 16-19, 25-27, and 34-35 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims priority to U.S. Provisional App. no. 63/529,851 filed on 07/31/2023.
Claims 1-5, 7, 9-12, 14, 16-19, 25-27, and 34-35 receive priority to the prior-filed application, filed on 07/31/2023.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 312 (Fig. 4). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because the abstract comprises phrases which can be implied (e.g. “Disclosed is…”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 2-3 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 2-3 recite the limitation "a…Tuohy-Borst valve coupled to the proximal end of the…proximal arm" in ln. 1-2. These limitations are indefinite in that it is unclear if these valves are the same or different from the hemostasis valves as recited in claim 1, which claims 2-3 are dependent upon. For the sake of compact prosecution, the examiner is treating the claim as though the Tuohy-Borst valves are a part of the hemostasis valves.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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Ex. Fig. 1 of Fantuzzi Fig. 20
Claims 1, 7, 16-19, 25, and 35 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by US/2017/0312492 A1 to Fantuzzi.
Regarding claim 1, Fantuzzi discloses an access device (Ex. Fig. 1; Fig. 20, access device 1110; para. 0074-0081; para. 0086; access device 1110 is similar in feature and function to access device 610; access device 610 is similar in feature and function to access device 710), comprising:
a body defining:
a common arm with a common lumen extending from a distal end of the common arm to a proximal end of the common arm, the distal end of the common arm configured to be attached to a graft (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0075; para. 0081, barbs 740 engage inner surface of graft 110; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices, access device 1110 comprises barbs 1140 which are similar to those of access device 710; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise a lumen);
a first proximal arm with a first lumen extending from a proximal end of the first proximal arm to the common lumen (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0081; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise lumens); and
a second proximal arm with a second lumen extending from a proximal end of the second proximal arm to the common lumen (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0081; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise lumens); and
a plurality of hemostasis valves including a first hemostasis valve being disposed at the proximal end of the first proximal arm and a second hemostasis valve being disposed at the proximal end of the second proximal arm (Ex. Fig. 1; Fig. 20, first hemostasis valve 1111 and second hemostasis valve 1112; para. 0086).
Regarding claim 4-5, the cited prior art discloses the invention of claim 1. Fantuzzi further discloses (Claim 4) wherein the common lumen has a circular cross-section and (Claim 5) wherein the common lumen has an elliptical cross-section (Ex. Fig. 1; Fig. 8, access device 610 comprising a lumen with a circular cross-section; Fig. 20, access device 1110; para. 0074-0081; para. 0086; access device 1110 is similar in feature and function to access device 610; access device 610 is similar in feature and function to access device 710; circle is a special type of ellipse).
Regarding claim 7, the cited prior art discloses the invention of claim 1. Fantuzzi further discloses wherein the distal end of the common arm is configured to be coupled directly to a vascular graft (Ex. Fig. 1; Fig. 14; para. 0075; para. 0081, barbs 740 engage inner surface of graft 110; para. 0086, access device 1110 comprises barbs 1140 which are similar to those of access device 710).
Regarding claim 16, the cited prior art discloses the invention of claim 1. Fantuzzi further discloses an adapter configured to be removably coupled to a distal end of the body (Fig. 13; para. 0071, clamp 210 can act as an adapter; para. 0075-0077; para. 0080-0081; para. 0086).
Regarding claim 17, the cited prior art discloses the invention of claim 1. Fantuzzi further discloses wherein the common arm includes at least one notch on an external surface configured for coupling to the graft (Ex. Fig. 1; Fig. 14; para. 0075; para. 0081, barbs 740 engage inner surface of graft 110; para. 0086, access device 1110 comprises barbs 1140 which are similar to those of access device 710).
Regarding claim 18, the cited prior art discloses the invention of claim 1. Fantuzzi further discloses a system, comprising: the access device of claim 1 (as explained above); and a vascular graft operably coupled to a distal end of the access device (Ex. Fig. 1; Fig. 14; para. 0075; para. 0081, barbs 740 engage inner surface of graft 110; para. 0086, access device 1110 comprises barbs 1140 which are similar to those of access device 710).
Regarding claim 19, the cited prior art discloses the invention of claim 18. Fantuzzi further discloses a first medical device slidably inserted through the first lumen, the common lumen, and the vascular graft (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0075; para. 0081, barbs 740 engage inner surface of graft 110; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices, access device 1110 comprises barbs 1140 which are similar to those of access device 710; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise a lumen).
Regarding claim 25, the cited prior art discloses the invention of claim 1. Fantuzzi further discloses a kit comprising, an access device of claim 1 (as explained above); and one or more adapters configured to be removably coupled to a distal end of the access device (Fig. 13; para. 0071, clamp 210 can act as an adapter; para. 0075-0077; para. 0080-0081; para. 0086).
Regarding claim 35, Fantuzzi discloses a method, comprising:
operably coupling a graft to an access device, the access device comprising a body (Ex. Fig. 1; Fig. 20, access device 1110; para. 0074-0081; para. 0086; access device 1110 is similar in feature and function to access device 610; access device 610 is similar in feature and function to access device 710) defining:
a common arm with a common lumen extending from a distal end of the common arm to a proximal end of the common arm, the distal end of the common arm configured to be attached to a graft (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0075; para. 0081, barbs 740 engage inner surface of graft 110; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices, access device 1110 comprises barbs 1140 which are similar to those of access device 710; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise a lumen);
a first proximal arm with a first lumen extending from a proximal end of the first proximal arm to the common lumen (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0081; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise lumens); and
a second proximal arm with a second lumen extending from a proximal end of the second proximal arm to the common lumen (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0081; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise lumens);
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi (hereinafter referred to as Fantuzzi ‘492) as applied above, and further in view of US/2021/0085923 A1 to Fantuzzi (hereinafter referred to as Fantuzzi ‘923).
Regarding claims 2-3, the cited prior art discloses the invention of claim 1.
Fantuzzi ‘492 differs from the instantly claimed invention in that Fantuzzi ‘492 fails to disclose first and second Tuohy-Borst valves coupled to the proximal end of the first and second proximal arms, respectively.
Fantuzzi ‘923 teaches an access device comprising Tuohy-Borst mechanisms located at hemostasis valves to secure the position of the medical device (Fig. 4; Fig. 5A-5B; para. 0039-0041).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the hemostasis valves of Fantuzzi ‘492 (para. 0086) that firmly grip the medical devices, for the Tuohy-Borst mechanisms as taught in Fantuzzi ‘923 since these mechanisms perform the same functions of forming a tight connection between a medical device and the access device (Fantuzzi ‘492: para. 0086; Fantuzzi ‘923: para. 0039-0041). Simply substituting one locking means for another would yield the predicable result of forming a tight connection. See MPEP 2143.
Claims 9-12, 14, 26-27, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi ‘492 as applied above.
Regarding claim 9, the cited prior art discloses the invention of claim 1.
Fantuzzi ‘492 differs from the instantly claimed invention in that Fantuzzi ‘492 fails to explicitly disclose wherein the first lumen and the second lumen each have an inner diameter of at least 6 mm.
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 device of the prior art such that the first lumen and the second lumen each have an inner diameter of at least 6 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of the prior art would not operate differently with the claimed dimensions as the device need only be sized to allow for parallel and independent insertion and manipulation of two medical devices in a graft and since Fantuzzi ‘492 discloses different embodiments of the device comprising different configurations of the valves and sheath, it seems that the device would function appropriately having the claimed dimensions. Further, it appears that applicant places no criticality on the dimensions claimed, indicating simply that the dimensions “may” be the claimed values (specification para. 0012-0013).
Regarding claim 10-11, the cited prior art discloses the invention of claim 1.
Fantuzzi ‘492 differs from the instantly claimed invention in that Fantuzzi ‘492 fails to explicitly disclose wherein (Claim 10) an axial length of the common lumen is greater than or equal to an axial length of the first lumen or (Claim 11) an axial length of the common lumen is shorter than an axial length of the first lumen.
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 device of the prior art such that (Claim 10) an axial length of the common lumen is greater than or equal to an axial length of the first lumen or (Claim 11) an axial length of the common lumen is shorter than an axial length of the first lumen since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of the prior art would not operate differently with the claimed dimensions as the device need only be sized to allow for parallel and independent insertion and manipulation of two medical devices in a graft and since Fantuzzi ‘492 discloses different embodiments of the device comprising different configurations of the valves and sheath, it seems that the device would function appropriately having the claimed dimensions. Further, it appears that applicant places no criticality on the dimensions claimed, indicating simply that the dimensions “may” be the claimed values (specification para. 0029).
Regarding claim 12 and 14, the cited prior art discloses the invention of claim 1.
Fantuzzi ‘492 differs from the instantly claimed invention in that Fantuzzi ‘492 fails to explicitly disclose wherein (Claim 12) a smallest angle A formed between a central axis of the common lumen and a central axis of the first lumen is
0
<
A
<
45
°
or (Claim 14) a smallest angle B formed between a central axis of the common lumen and a central axis of the first lumen is
0
<
B
<
45
°
.
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 device of the prior art such that (Claim 12) a smallest angle A formed between a central axis of the common lumen and a central axis of the first lumen is
0
<
A
<
45
°
or (Claim 14) a smallest angle B formed between a central axis of the common lumen and a central axis of the first lumen is
0
<
B
<
45
°
since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of the prior art would not operate differently with the claimed dimensions as the device need only be sized to allow for parallel and independent insertion and manipulation of two medical devices in a graft and since Fantuzzi ‘492 discloses different embodiments of the device comprising different configurations of the valves and sheath, it seems that the device would function appropriately having the claimed dimensions. Further, it appears that applicant places no criticality on the dimensions claimed, indicating simply that the dimensions “may” be the claimed values (specification para. 0030).
Regarding claim 26, Fantuzzi ‘492 discloses an access device (Ex. Fig. 1; Fig. 20, access device 1110; para. 0074-0081; para. 0086; access device 1110 is similar in feature and function to access device 610; access device 610 is similar in feature and function to access device 710), comprising:
a body defining:
a common arm with a common lumen extending from a distal end of the common arm to a proximal end of the common arm, the distal end of the common arm configured to be attached to a graft (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0075; para. 0081, barbs 740 engage inner surface of graft 110; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices, access device 1110 comprises barbs 1140 which are similar to those of access device 710; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise a lumen);
a first proximal arm with a first lumen extending from a proximal end of the first proximal arm to the common lumen (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0081; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise lumens); and
a second proximal arm with a second lumen extending from a proximal end of the second proximal arm to the common lumen (Ex. Fig. 1; Fig. 12-14 showing catheter 810 passing through lumen of access device 610; para. 0081; para. 0086, access device 1110 allows for insertion and manipulation of two different medical devices; as access device 610 has a lumen to allow a medical device to pass through, access device 1110 is considered to comprise lumens).
Fantuzzi ‘492 differs from the instantly claimed invention in that Fantuzzi ‘492 fails to explicitly disclose wherein the common arm has a length that is 0.5 to 3 times the length of each proximal arm.
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 device of the prior art such that the common arm has a length that is 0.5 to 3 times the length of each proximal arm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of the prior art would not operate differently with the claimed dimensions as the device need only be sized to allow for parallel and independent insertion and manipulation of two medical devices in a graft and since Fantuzzi ‘492 discloses different embodiments of the device comprising different configurations of the valves and sheath, it seems that the device would function appropriately having the claimed dimensions. Further, it appears that applicant places no criticality on the dimensions claimed, indicating simply that the dimensions “may” be the claimed values (specification para. 0029).
Regarding claim 27, the cited prior art suggests the invention of claim 26. Fantuzzi ‘492 further discloses a system, comprising: the access device of claim 26 (as explained above); and a vascular graft operably coupled to a distal end of the access device (Ex. Fig. 1; Fig. 14; para. 0075; para. 0081, barbs 740 engage inner surface of graft 110; para. 0086, access device 1110 comprises barbs 1140 which are similar to those of access device 710).
Regarding claim 34, the cited prior art suggests the invention of claim 27. Fantuzzi ‘492 further discloses a kit comprising, an access device of claim 27 (as explained above); and one or more adapters configured to be removably coupled to a distal end of the access device (Fig. 13; para. 0071, clamp 210 can act as an adapter; para. 0075-0077; para. 0080-0081; para. 0086).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US/2021/0228855 A1 to Glowczwski US/2004/0122346 A1 to Kawamura each disclose vascular access devices comprising two channels.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 3 September 2026
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