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 .
Election/Restrictions
Claims 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/26/2026.
Applicant's election with traverse of Group I in the reply filed on 8/26/2026 is acknowledged. The traversal is on the ground(s) that "there is more than likely a corresponding method of how to both make and use the apparatus", thus would not be a search burden. This is not found persuasive because searching for the apparatus and the corresponding method of manufacture and method of use would require a number of different searches using different text-limiters in different subclasses. Further, it is not guaranteed that a reference containing the claimed apparatus would disclose either or both claimed method. For example, a number of different methods may be used to manufacture such a device, so it need not be disclosed as claimed in the present invention and would require further search and/or consideration. Likewise, a device similar to the claimed device need not be directed to deploying an intravascular treatment device and could be used in a materially different process, such as deploying a medical device into a luminal organ or perhaps not in the medical field, such as deploying a device into a plumbing pipe. Thus, the three inventions are independent and distinct.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 recites the limitation “wherein the extendable section of the intermediate hypotube is positioned within the lumen of the delivery tube”, however, claim 6, from which thus claim depends includes the same limitation “wherein the intermediate hypotube comprises an extendable section, and wherein the extendable section is positioned within the lumen of the delivery tube”. Thus, claim 7 fails to further limit the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-2, 4-5, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keren (US 20180280667 A1) (noted on IDS) in view of Bardsley et al. (US 20200229957 A1) (noted on IDS).
Regarding claim 1, Keren discloses an intravascular delivery system (Figure 1-3C, Paragraphs 0013; 0035; 0052-0056; 0059; 0061-0067) comprising:
a delivery tube (46) sized to be delivered through a patient to a treatment site (Paragraph 0059);
an intermediate hypotube (31) affixed to the delivery tube and extending in a proximal direction from a proximal end (proximal end of 46) of the delivery tube (Figure. 1 and 3A; Paragraph 0052; 0066);
a pull wire (36) extending through a lumen (lumen of 31) of the intermediate hypotube and through a lumen (lumen of 46) of the delivery tube (Figure 3A; Paragraph 0066),
a sheath (34) attached to the intermediate hypotube (Figure 3A; Paragraph 0066),
wherein the pull wire comprises an engagement bump (52) affixed thereto and positioned in the proximal direction in relation to a proximal end (proximal end of 31) of the intermediate hypotube (Figure 3A-3C; Paragraphs 0013; 0035; 0066-67), and wherein the engagement bump is sized to inhibit movement of the engagement bump into the lumen of the intermediate hypotube (Figure 3A-3C; Paragraphs 0013; 0035; 0066-67).
Keren fails to explicitly disclose wherein a proximal portion of the intermediate hypotube comprising a breakable attachment is positioned within a lumen of the sheath.
However, Bardsley is directed to an intravascular delivery system and teaches wherein a proximal portion (1260) of the intermediate hypotube (1262) comprising a breakable attachment (1264) is positioned within a lumen of the sheath (1265) (Figure 117A-C; Paragraph 0189; 0216).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Keren such that wherein a proximal portion of the intermediate hypotube comprising a breakable attachment is positioned within a lumen of the sheath, as taught by Bardsley, as both references and the claimed invention are directed to implant delivery devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Keren with the teachings of Bardsley by incorporating wherein a proximal portion of the intermediate hypotube comprising a breakable attachment is positioned within a lumen of the sheath in order to disengage the shaft to release an implant (Bardsley Paragraph 0186).
Regarding claim 2, the combination of Keren and Bardsley further teaches wherein the breakable attachment is movable in a distal direction in relation to the proximal end of the intermediate hypotube (the present breakable attachment is a welding and Bardsley states the weakened portion can comprise two shafts connected via welding, thus the breakable attachment would be fully capable of being movable in a distal direction since it has the same structure as the breakable attachment of the present disclosure) (Bardsley Paragraph 0189).
Regarding claim 4, Keren further discloses wherein an intravascular treatment device (26) is positioned approximate a distal end of the intravascular delivery system (Figure 3A-C; Paragraph 0062; 0064), and wherein the pull wire is movable to deploy the intravascular treatment device (Figure 3A; Paragraph 0052; 0064).
Regarding claim 5, Keren further discloses wherein a distal end of the intermediate hypotube is positioned within the lumen of the delivery tube (Figure 3A-C; Paragraph 0065).
Regarding claim 10, Keren further discloses wherein a distal end of the intermediate hypotube is affixed within the lumen of the delivery tube (Figure 3A; Paragraph 0065).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keren and Bardsley as applied to claim 1 above, and further in view of Johnson et al. (US 20090270877 A1) (noted on IDS) and Chou et al. (US 20200015876 A1) (noted on IDS).
Regarding claim 3, Keren as modified by Bardsley discloses the intravascular delivery system of claim 1 but fails to explicitly disclose wherein the intermediate hypotube can be attached with a second breakable attachment to the delivery tube on a proximal side of an extendable section of the intermediate hypotube, the extendable section located near the proximal end of the delivery tube.
However, Johnson is directed to a medical device deployment system and teaches a tube (34) attached with a breakable attachment (42) to a delivery tube (36) on the proximal side of the tube (Figure 4; Paragraph 0031).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Keren as modified by Bardsley such that wherein the intermediate hypotube can be attached with a second breakable attachment to the delivery tube on a proximal side of the intermediate hypotube, as taught by Johnson, as both references and the claimed invention are directed to deployment catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Keren as modified by Bardsley with the teachings of Johnson by incorporating wherein the intermediate hypotube can be attached with a second breakable attachment to the delivery tube on a proximal side of the intermediate hypotube in order to allow the user control of the tubes separately (Johnson Paragraph 0031).
Further, Chou is directed to a medical device and teaches wherein a shaft (110) comprises an extendable section (114) (Figure 3A; Paragraph 0516). Since the intermediate hypotube of Keren is proximal the delivery tube, when combined, the extendable section would be located near the proximal end of the delivery tube.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Keren to include an extendable section of the intermediate hypotube, as taught by Chou, as both references and the claimed invention are directed to medical catheter devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Keren with the teachings of Chou by incorporating an extendable section of the intermediate hypotube in order to provide variable force to the tube and increase range of motion (Chou Paragraph 0517).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keren and Bardsley as applied to claim 1 above, and further in view of Chou et al. (US 20200015876 A1) (noted on IDS).
Regarding claims 6-7, Keren as modified by Bardsley discloses the intravascular delivery system of claim 1 but fails to explicitly disclose wherein the intermediate hypotube comprises an extendable section, and wherein the extendable section is positioned within the lumen of the delivery tube.
However, Chou is directed to a medical device and teaches wherein a shaft (110) comprises an extendable section (114) (Figure 3A; Paragraph 0516). Since the intermediate hypotube of Keren is located inside the delivery tube, when combined, the extendable section would be positioned within the lumen of the delivery tube.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Keren as modified by Bardsley such that wherein the intermediate hypotube comprises an extendable section, as taught by Chou, as both references and the claimed invention are directed to medical catheter devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Keren as modified by Bardsley with the teachings of Chou by incorporating wherein the intermediate hypotube comprises an extendable section in order to provide variable force to the tube and increase range of motion (Chou Paragraph 0517).
Regarding claim 8, the combination of Keren and Chou further teaches wherein a distal end of the intermediate hypotube is in a distal direction relative to the extendable section, as the flexible/compressible section 114 of Chou is located between a distal and a proximal end (Chou Figure 3A).
Regarding claim 9, the combination of Keren and Chou further teaches wherein the proximal portion of the intermediate hypotube is in a proximal direction relative to the extendable section as the flexible/compressible section 114 of Chou is located between a distal and a proximal end (Chou Figure 3A).
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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US 12419645 B2 in view of Bardsley et al.
Regarding claim 1, claim 1 of US 12419645 B2 claims an intravascular delivery system (Col 11, line 59) comprising:
a delivery tube sized to be delivered through a patient to a treatment site (Col 11, line 60-61);
an intermediate hypotube affixed to the delivery tube and extending in a proximal direction from a proximal end of the delivery tube (Col 11, line 62-64);
a pull wire extending through a lumen of the intermediate hypotube and through a lumen of the delivery tube (Col 11, line 65-66); and
a sheath attached to the intermediate hypotube (Col 11, line 67),
wherein the pull wire comprises an engagement bump affixed thereto and positioned in the proximal direction in relation to a proximal end of the intermediate hypotube (Col 12, line 1-4), and
wherein the engagement bump is sized to inhibit movement of the engagement bump into the lumen of the intermediate hypotube (Col 11 line 5-7).
US 12419645 B2 fails to claim wherein a proximal portion of the intermediate hypotube comprising a breakable attachment is positioned within a lumen of the sheath.
However, Bardsley is directed to an intravascular delivery system and teaches wherein a proximal portion (1260) of the intermediate hypotube (1262) comprising a breakable attachment (1264) is positioned within a lumen of the sheath (1265) (Figure 117A-C; Paragraph 0189; 0216).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify US 12419645 B2 such that wherein a proximal portion of the intermediate hypotube comprising a breakable attachment is positioned within a lumen of the sheath, as taught by Bardsley, as both references and the claimed invention are directed to implant delivery devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 12419645 B2 with the teachings of Bardlsey by incorporating wherein a proximal portion of the intermediate hypotube comprising a breakable attachment is positioned within a lumen of the sheath in order to disengage the shaft to release an implant (Bardsley Paragraph 0186).
Regarding claim 2, see claim 2 of US 12419645 B2.
Regarding claim 3, see claim 3 of US 12419645 B2.
Regarding claim 4, see claim 4 of US 12419645 B2.
Regarding claim 5, see claim 5 of US 12419645 B2.
Regarding claim 6, see claim 6 of US 12419645 B2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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