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 .
Response to Amendment
In light of Applicant’s amendment, claim(s) 1 and 3-6 is/are amended. Claims 1-6 are now pending examination.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 1-6 is/are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 6/2/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant amended to include the limitations “wherein the internal carotid artery inserter and the common carotid artery inserter are respectively assembled with and disassembled from the connector, and wherein opening/closing operations of the blood flow opening/closing cock of the internal carotid artery inserter and the blood flow opening/closing cock of the common carotid artery inserter are performed independently”; however, the claim as written is a product claim and the additional claim components are directed to method steps of manufacturing and using the product. As such, the claim is rejected under Xu as being directed to a product by process and the resulting product being fully capable of performing the claimed function. Although the device of Xu does not explicitly disclose wherein the internal carotid artery inserter and the common carotid artery inserter are respectively assembled with and disassembled from the connector, and wherein opening/closing operations of the blood flow opening/closing cock of the internal carotid artery inserter and the blood flow opening/closing cock of the common carotid artery inserter are performed independently, Xu does state “the term "connection" or similar designation indicating the connection relationship between components should be interpreted broadly. For example, it can be a fixed connection, a detachable connection, or an integral part”, thus the respective inserters are fully capable of being respectively assembled and disassembled with the connector or being integrally formed, or a combination of the two (Paragraph 0029). Further, there is no teaching away from the reference that would not allow for such a configuration to be possible. The device is fully capable of being made and used as claimed. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. As such, the rejection under U.S.C 102 under Xu is maintained.
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.
Claim 6 is 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.
Claim 6 recites the limitation "the other" in 20-21. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “the other of the internal carotid artery inserter and the common carotid artery inserter”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 5-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (CN 115700108 A) (noted on IDS) (in text citations correspond with attached Espacenet translation) (previously of record).
Regarding claim 1, Xu discloses a hybrid shunt system for carotid endarterectomy ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.) comprising:
an internal carotid artery inserter (11) having an internal carotid artery occlusion balloon (12) contracting/expanding with entry and exit of a working fluid (liquid) and provided at one end (end of tube connected to the balloon) of a first tube (11) (Figure 1, 3; Paragraph 0024), and a hub (13) having a blood flow opening/closing port (lumen connected to 13) with a blood flow opening/closing cock (13) and a working fluid entry/exit port (side hole) at the other end (end of tube near 13) of the first tube (Figure 1; Paragraph 0024);
a common carotid artery inserter (21) having a common carotid artery occlusion balloon (22) contracting/expanding with the entry and exit of the working fluid at one end (end located near balloon) of a second tube (21) (Figure 1, 3; Paragraph 0024), and a hub (23) having a blood flow opening/closing port (lumen connected to 23) with a blood flow opening/closing cock (23) and a working fluid entry/exit port (side hole) at other end (end of tube near 23) of the second tube (Figure 1; Paragraph 0024); and
a connector (portion of tubing containing 31) connecting the blood flow opening/closing port of the common carotid artery inserter and the blood flow opening/closing port of the internal carotid artery inserter (Figure 1; Paragraph 0024), which is fully capable of bypassing a blood flow during a carotid endarterectomy (CEA) procedure,
wherein the internal carotid artery inserter and the common carotid artery inserter are respectively assembled with and disassembled from the connector (Paragraph 0029) (Xu states “the term "connection" or similar designation indicating the connection relationship between components should be interpreted broadly. For example, it can be a fixed connection, a detachable connection, or an integral part”, thus the respective inserters are fully capable of being respectively assembled and disassembled with the connector.), and
wherein opening/closing operations of the blood flow opening/closing cock of the internal carotid artery inserter and the blood flow opening/closing cock of the common carotid artery inserter are fully capable of being performed independently as desired by the user as there is no disclosed structure requiring the actions to occur simultaneously ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
Regarding claim 2, Xu further discloses wherein the connector is a three-way cock (Paragraph 0025).
Regarding claim 3, Xu further discloses wherein both of the tubes are a multi-lumen tube including a first flow path (111) through which blood may flow and a second flow path (112) through which the working fluid may flow (Figure 2; Paragraph 0024).
Regarding claim 5, Xu further discloses wherein one end of the first flow path passes through the occlusion balloon and one end of the second flow path communicates with the occlusion balloon (the lumens extend through tube 11, which is in communication with balloon 12) (Paragraph 0024).
Regarding claim 6, Xu discloses a hybrid shunt system for carotid endarterectomy ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.) comprising:
an internal carotid artery inserter (11) having an internal carotid artery occlusion balloon (12) contracting/expanding with entry and exit of a working fluid (liquid) and provided at one end (end of tube connected to the balloon) of a first tube (11) (Figure 1, 3; Paragraph 0024), and a hub (13) having a blood flow opening/closing port (lumen connected to 13) with a blood flow opening/closing cock (13) and a working fluid entry/exit port (side hole) at the other end (end of tube near 13) of the first tube (Figure 1; Paragraph 0024);
a common carotid artery inserter (21) having a common carotid artery occlusion balloon (22) contracting/expanding with the entry and exit of the working fluid at one end (end located near balloon) of a second tube (21) (Figure 1, 3; Paragraph 0024), and a hub (23) having a blood flow opening/closing port (lumen connected to 23) with a blood flow opening/closing cock (23) and a working fluid entry/exit port (side hole) at other end (end of tube near 23) of the second tube (Figure 1; Paragraph 0024); and
a connector (portion of tubing containing 31) connecting the blood flow opening/closing port of the common carotid artery inserter and the blood flow opening/closing port of the internal carotid artery inserter (Figure 1; Paragraph 0024), which is fully capable of bypassing a blood flow during a carotid endarterectomy (CEA) procedure;
wherein the connector is integrally formed or assembled with any one of the blood flow opening/closing port of the internal carotid artery inserter or the blood flow opening/closing port of the common carotid artery inserter (Figure 1; Paragraph 0024); and
wherein one of the internal carotid artery inserter and the common carotid artery inserter is respectively assembled with and disassembled with respect to the connector and one of the internal carotid artery inserter and the common carotid artery inserter is integrally formed with the connector (Figure 1; Paragraph 0024; 0029) (Xu states “the term "connection" or similar designation indicating the connection relationship between components should be interpreted broadly. For example, it can be a fixed connection, a detachable connection, or an integral part”, thus the respective inserters are fully capable of being respectively assembled and disassembled with the connector or being integrally connected, or a combination of both.);
wherein opening/closing operations of the blood flow opening/closing cock of the internal carotid artery inserter and the blood flow opening/closing cock of the common carotid artery inserter are fully capable of being performed independently as desired by the user as there is no disclosed structure requiring the actions to occur simultaneously ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Hayman et al. (US 20030060756 A1) (previously of record).
Regarding claim 4, Xu discloses the hybrid shunt system of claim 3 but fails to explicitly disclose wherein both of the tubes have a concentric structure where the first flow path passes inside the second flow path.
However, Hayman is directed to a balloon occlusion catheter and teaches wherein two tubes (44 and 48) are a multi-lumen tube including a first flow path (40 or 46) through which blood may flow and a second flow path (42 or 47) through which the working fluid may flow (Figure 3A-3B; Paragraph 0058), and further wherein the tube (44) has a concentric structure where the first flow path (40) passes inside the second flow path (42).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the flow paths of Xu such that wherein both of the tubes have a concentric structure where the first flow path passes inside the second flow path, as taught by Hayman, as both references and the claimed invention are directed to balloon occlusion 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 Xu with the teachings of Hayman by incorporating wherein both of the tubes have a concentric structure where the first flow path passes inside the second flow path as a known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art and/or a simple substitution of one known element for another to obtain predictable results, as Hayman discloses both adjacent lumens as provided in Xu along with concentric lumens as claimed by the present invention and teaches the two configurations to be known equivalents of one another. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
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