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 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 1-6 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.
Claim 1 line 8-9 recites the limitation “a common carotid artery occlusion balloon contracting/expanding with the entry and exit of the working fluid at one end of the tube”. However, the claim earlier recites “an internal carotid artery occlusion balloon contracting/expanding with entry and exit of a working fluid (liquid) and provided at one end of a tube”, thus it is unclear if the one end of the tube is the same with respect to both balloons. Similarly, “at another end of the tube” is recited twice but based on the claim, there is only one tube thus it is unclear as to how one tube has two “one ends” and two “another ends”. For examination purposes, the limitation will be seen as one tube corresponding to the common carotid artery occlusion balloon and a separate tube corresponding to the internal carotid artery occlusion balloon.
Claim 5 recites “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” which is indefinite as claim 1 from which this claim depends introduces two different occlusion balloons, an internal carotid artery occlusion balloon and a common carotid artery occlusion balloon. Thus, it is unclear which of the occlusion balloons are being referred to, or whether “the occlusion balloon” refers to the same or different of the two balloons. For examination purposes, the limitation will be seen as either one and/or both of the occlusion balloons.
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).
Regarding claim 1, as best understood in view of the 112(b) issues above, 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 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 another end (end of tube near 13) of the 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 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 another end (end of tube near 23) of the 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.
Regarding claim 2, Xu further discloses wherein the connector is a three-way cock (Paragraph 0025).
Regarding claim 3, Xu further discloses wherein the tube is 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).
As best understood in view of the 112(b) issues above, 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 further discloses 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).
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).
Regarding claim 4, Xu discloses the hybrid shunt system of claim 3, but fails to explicitly disclose wherein the tube has 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 a tube (44 or 48) is 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 the tube has 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 the tube has 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 4731055 A; US 20130041305 A1
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771