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Claims 26, 34, 42, and 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-V, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/25/2026.
Applicant’s election without traverse of Group I, claims 1-21 in the reply filed on 08/25/2026 is acknowledged.
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, 3, 18 and its dependents 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.
The term “an elongate tubular member” in claim 1, line 5 is indefinite since it is unclear if the claim limitation “an elongate tubular member” in claim 1, line 5 is the same “an elongate tubular member” recited in claim 1, line 1. For the purposes of examination, the claim limitation “an elongate tubular member” in claim 1, line 5 is the same component as “an elongate tubular member” of claim 1, line 1.
The term “resistant to puncture by a needle at typical forces exerted manually by a user” in claim 3 is a relative term which renders the claim indefinite. The term “resistant to puncture by a needle at typical forces exerted manually by a user” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to what extent a material is considered to be resistant to puncture by a needle at typical forces exerted manually by the user since it is not quantitatively measurable. The specification of the instant application does not further define the extent of resistance to the typical forces applied (see paragraph 000114 of instant application).
The term “resistant to puncture” in claim 18 is a relative term which renders the claim indefinite. The term “resistant to puncture” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to what extent a material is considered to be resistant to puncture since it is not quantitatively measurable. The specification of the instant application does not further define the extent of resistance to the typical forces applied (see paragraph 000114 of instant application).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 7-8, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karapetian (Publication No. US 2022/0008188 A1).
Regarding claim 1, Karapetian discloses a device for supporting an elongate tubular member (device comprising stent 100 to support blood vessel 112; Paragraph 0108-0109; Figures 16A-16D), the device comprising:
a support member having an interior surface defining a receiving cavity (stent 100 is a support member that has an interior surface that has a receiving cavity; Paragraph 0108-0109; Figures 16-16D), the support member further defining a circumferential opening (side opening 106; Figures 16A-16B; Paragraph 0108), wherein the receiving cavity is operable to receive an elongate tubular member therein (receiving cavity of stent 100 is to receive a blood vessel 112 therein; Figures 16A-16D; Paragraphs 0108-0109), the support member operable to place the elongate tubular member into a state of compression about the circumference (stent 100 compresses blood vessel 112 about the circumference; Figures 16A-16D; Paragraphs 0108-0109).
Regarding claim 3, Karapetian discloses the device of claim 1. Karapetian further discloses wherein the support member comprises a material resistant to puncture by a needle at typical forces exerted manually by a user (stent is made of shape-memory nitinol; Paragraph 0077).
Regarding claim 7, Karapetian discloses the device of claim 1. Karapetian further discloses wherein the interior surface of the support member presents a circular cross-section (C-shaped cross-section is circular; Paragraph 0108; Figures 16A-16B).
Regarding claim 8, Karapetian discloses the device of claim 1. Karapetian further discloses wherein the support member is operable to retain the same cross-sectional area of the elongate tubular member within the receiving cavity and external of the receiving cavity (stent 100 conforms to maintain the same cross-sectional area of the elongate tubular member within and external of the receiving cavity; Figure 16D; Paragraph 0109).
Regarding claim 19, Karapetian discloses the device of claim 1. Karapetian further discloses wherein the support member is operable to place the tubular member into the state of compression (stent 100 compresses blood vessel 112; Paragraph 0108-0109; Figures 16A-16D).
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) 2 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Karapetian (Publication No. US 2022/0008188 A1) in view of Hong et al. (Publication No. US 2017/0304092 A1), hereby referred to as “Hong ‘092”.
Regarding claim 2, Karapetian discloses the device of claim 1. Karapetian does not teach wherein the receiving cavity is adhesively coupled to the elongate tubular member.
However, Hong ‘092 further teaches wherein the receiving cavity is adhesively coupled to the elongate tubular member (reinforcement elements 22/40 adhere to the elongated tubular member 12; Paragraph 0056; Figure 2A-2B and 3).
Karapetian and Hong ‘092 are considered to be analogous to the claimed invention because they are in the same field of grafts/stents. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karapetian to incorporate the teachings of Hong ‘092 to have the receiving cavity to be adhered to the elongated tubular member, as taught by Hong ‘092. This allows for the reinforcement elements to be attached securely onto the outer surface of the tubular member (Hong; Paragraph 0056).
Regarding claim 14, Karapetian discloses the device of claim 1. Karapetian does not teach wherein the support member includes a plurality of segments along a longitudinal length operable to facilitate flexion of the elongate tubular member when positioned with the support member.
However, Hong ‘092 teaches wherein the support member includes a plurality of segments along a longitudinal length operable to facilitate flexion of the elongate tubular member when positioned with the support member (sealing cannulation regions 30 along the longitudinal length to allow flexion of elongate tubular member 12; Figure 2A; Paragraph 0042-0043, 0047-0048, and 0053-0054).
Karapetian and Hong ‘092 are considered to be analogous to the claimed invention because they are in the same field of grafts/stents. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karapetian to incorporate the teachings of Hong ‘092 to have the support member of Karapetian be made of the reinforcement elements comprising a plurality of segments, as taught by Hong ‘092, and placed over the elongated tubular member of Karapetian. This allows for the intermediate loop regions to bend while the cannulation regions allow for needles to penetrate the tubular member (Hong; Paragraph 0042 and 0053-0054).
Regarding claim 15, Karapetian in view of Hong ‘092 teaches the device of claim 14. The combination of Karapetian in view of Hong ‘092 further teaches wherein the plurality of segments are discrete elements (Hong ‘092; reinforcement elements 40 are located in cannulation regions 30 and are discrete/separate; Figure 2A-2B; Paragraph 0042-0043, 0047-0048, 0053-0054).
Regarding claim 16, Karapetian in view of Hong ‘092 teaches the device of claim 14. The combination of Karapetian in view of Hong ‘092 further teaches wherein the plurality of segments are an integral member forming the support member (Hong ‘092; elements 40 are integral to form regions 30/support member; Figure 2A; Paragraphs 0047-0050), the support member including an extension portion extending between adjacent segments, the extension portion including a thinned profile operable to facilitate flexion (Hong ‘092; support member/regions 30 has extension portions 20 between the regions 30 that are thinner and allow for flexion; Paragraph 0053-0057).
Regarding claim 17, Karapetian in view of Hong ‘092 teaches the device of claim 14. The combination of Karapetian in view of Hong ‘092 further teaches wherein the plurality of segments facilitates flexion of the elongate tubular member (Hong ‘092; reinforcement elements 22/40 extend through intermediate loop regions 20 and sealing cannulation regions 30 along the longitudinal length to allow flexion of elongate tubular member 12; Figure 2A; Paragraph 0042-0043, 0047-0048, and 0053-0054).
Regarding claim 18, Karapetian in view of Hong ‘092 teaches the device of claim 14. The combination of Karapetian in view of Hong ‘092 further teaches wherein the support member is resistant to puncture (Hong ‘092; elements 40/22 are made of nitinol; Paragraph 0046 and 0055).
Claim(s) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Karapetian (Publication No. US 2022/0008188 A1).
Regarding claim 4, Karapetian discloses the device of claim 3. The embodiment of Figures 16A-16D of Karapetian does not teach where the support member comprises a bioabsorbable material.
However, the embodiment of Figures 18A-18B of Karapetian teaches where the support member comprises a bioabsorbable material (tension element 134 can dissolve over time/bioabsorbable; Paragraph 0112; Figures 18A-18B).
Karapetian is considered to be analogous to the claimed invention because they are in the same field of grafts/stents. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Figures 16A-16D of Karapetian to incorporate the teachings of the embodiment of Figures 18A-18B to have the tension element of Figures 18A-18B of Karapetian to be a part of the stent/support member of the embodiment of Figures 16A-16D of Karapetian. This allows for the stent to enable the tissue of the blood vessel to overgrow into the stent wall (Karapetian; Paragraph 0112).
Regarding claim 5, Karapetian discloses the device of claim 1. Karapetian does not expressly teach wherein the circumferential opening of the support member is from about 10% to about 90% of a circumference of the elongate tubular member.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the circumferential opening of the support member is from about 10% to about 90% of a circumference of the elongate tubular member 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) (MPEP 2144.04(IV)(A)). In the instant case, the support member would not operate differently with the claimed range of the circumferential opening since the device is constructed with similar components and structure (see disclosed above) and is intended to support an elongate tubular member. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the amount is “about” the given range (specification; paragraph 000113).
Regarding claim 6, Karapetian discloses the device of claim 1. The embodiment of Figures 16A-16D of Karapetian does not teach wherein the interior surface of the support member presents an oval cross-section.
However, the embodiment of Figures 18A-18B of Karapetian teaches wherein the interior surface of the support member presents an oval cross-section (stent 130 had an oval cross-section in the interior surface; Figures 18A-18B; Paragraph 0112).
Karapetian is considered to be analogous to the claimed invention because they are in the same field of grafts/stents. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Figures 16A-16D of Karapetian to incorporate the teachings of the embodiment of Figures 18A-18B to have the oval cross-section shape of the embodiment of Figures 18A-18B on the stent/support member of Karapetian. This allows for the stent to have the blood vessel to assume a more oval shape (Karapetian; Paragraph 0112).
Claim(s) 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Karapetian (Publication No. US 2022/0008188 A1) in view of Hong et al. (Patent No. US 9,427,218 B2), hereby referred to as “Hong ‘218”.
Regarding claim 9, Karapetian discloses the device of claim 1. Karapetian further teaches wherein the support member has two opposing arms defining the circumferential opening (outer arms of C-shape defines the opening 106; Figures 16A-16B; Paragraph 0108), the two opposing arms being interconnected by a body (middle portion of C-shape is the body; Figures 16A-16B; Paragraph 0108). Karapetian does not teach the two opposing arms including a material having a durometer that is lower than a durometer of the body.
However, Hong ‘218 teaches the two opposing arms including a material having a durometer that is lower than a durometer of the body (end regions of port 330 have a softer durometer material and smaller thickness compared to the central region; Figures 13A-13B; Column 17, lines 14-21).
Karapetian and Hong ‘218 are considered to be analogous to the claimed invention because they are in the same field of grafts/stents. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karapetian to incorporate the teachings of Hong ‘218 to have the support member of Karapetian to have the two opposing arms of Karapetian be made of a softer durometer and smaller thickness compared to the body, as taught by Hong ‘218. This allows for the body of the device to self-seal or close for the securement of the device to a tubular member (Hong ‘218; Column 17, line 1-21).
Regarding claim 10, Karapetian and Hong ‘218 teaches the device of claim 9. The combination of Karapetian and Hong ‘218 further teaches wherein the two opposing arms impart a compressive force to the elongate tubular member (two opposing arms of Karapetian in view of Hong applies compressive force to elongate tubular member; Karapetian; Figures 16A-16D; Paragraph 0108; see rejection of claim 9 above).
Regarding claim 11, Karapetian in view of Hong ‘218 teaches the device of claim 9. The combination of Karapetian and Hong ‘218 further teaches wherein the two opposing arms are formed from a shape memory material (stent with two opposing arms of Karapetian in view of Hong ‘218 are made of shape-memory nitinol; Karapetian; Paragraph 0077; see rejection of claim 9 above).
Regarding claim 12, Karapetian in view of Hong ‘218 teaches the device of claim 11. The combination of Karapetian and Hong ‘218 further teaches wherein the shape memory material is nitinol (stent with two opposing arms of Karapetian in view of Hong ‘218 are made of shape-memory nitinol; Karapetian; Paragraph 0077; see rejection of claim 9 above).
Regarding claim 13, Karapetian in view of Hong ‘218 teaches the device of claim 9. The combination of Karapetian in view of Hong ‘218 further teaches wherein the body is thicker than the two opposing arms (Hong ‘218; end regions of port 330 have a softer durometer material and smaller thickness compared to the central region; Figures 13A-13B; Column 17, lines 14-21).
Claim(s) 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Karapetian (Publication No. US 2022/0008188 A1) in view of Singh et al. (Publication No. US 2020/0061337 A1).
Regarding claim 20, Karapetian teaches the device of claim 1. Karapetian does not teach further comprising a location device operable to be magnetically coupled to the support member, the location device forming a donut hole through which a needle may be inserted.
However, Singh teaches further comprising a location device operable to be magnetically coupled to the support member (magnetic guide 364 that is magnetically coupled to metallic ring 362; Paragraph 0102; Figure 26), the location device forming a donut hole through which a needle may be inserted (guide 364 is a donut hole shape to allow for needle to be inserted; Paragraph 0010 and 0102; Figure 26).
Karapetian and Singh are considered to be analogous to the claimed invention because they are in the same field of needle access devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karapetian to incorporate the teachings of Singh to have the locating device/guide of Singh and the metallic ring on the support member of Karapetian, as taught by Singh. This allows for the user to identify the location of the septum for needle access to the port (Singh; Paragraph 0010).
Regarding claim 21, Karapetian in view of Singh teaches the device of claim 20. The combination of Karapetian in view of Singh further teaches wherein the location device includes indicators about a periphery of the donut hole indicating different positions for needle insertion (Singh; inner periphery and outer periphery of magnetic guide 364 are indicators that indicates the possible insertion points of the needle to the port; Figure 26; Paragraph 0010 and 0102).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burd (Patent No. US 4,184,489) discusses a supporting member attached to an elongated tubular member;
Silverman et al. (Patent No. US 5,931,865 A) discusses a supporting member attached to an elongated tubular member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
