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 .
This action is in response to the non-provisional application filed on 06/20/2024. Claims 1-10 are pending. Claim 1 is independent.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
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 1-10 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 recites the limitation "the guide wire" in line 3 of the claim. Lines 2-3 of the claim recites that each of the first occluder and second occluder comprises a guide wire. It is unclear which of the guide wires that “the guide wire" in line 3 of the claim is referring.
Claim 1 recites the limitation "the catheter" in each of lines 3-4, 4, 5, 6, and 7 of the claim. Lines 2-3 of the claim recites that each of the first occluder and second occluder comprises a catheter. It is unclear which of the catheters that “the catheter" in each lines 3-4, 4, 5, 6, and 7 of the claim is referring.
Claim 1 recites the limitation "the balloon" in each of lines 4 and 5 of the claim. Lines 2-3 of the claim recites that each of the first occluder and second occluder comprises a balloon. It is unclear which of the balloons that “the balloon" in each of lines 4 and 5 of the claim is referring.
Claim 1 recites the limitation "the handle part" in line 4 of the claim. Lines 2-3 of the claim recites that each of the first occluder and second occluder comprises a handle part. It is unclear which of the handle parts that “the handle part" in lines 4 of the claim is referring.
The same 35 U.S.C. 112(b) rejection also applies to “the catheter,” “the guide wire,” “the balloon,” and/or “the handle part” in each of claims 2-10 and also apply to components of each of the catheter,” “the guide wire,” “the balloon,” and/or “the handle part,” such as “the first chamber,” “the second chamber,” “the third chamber,” “the balloon openings,” “the handle,” “the balloon part,” and “the guide wire inlet” and etc.
The art rejection below is/are made as best understood by the examiner because of the 35 U.S.C. 112(b) issues stated above.
Claim Rejections - 35 USC § 103
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 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agah et al. (US Pub. No.: 2022/0111184) in view of Gerrans et al. (US Pub. No.: 2012/0259215).
Regarding claim 1, Agah discloses an occluder (200, Fig. 4; the occluder catheter 200 is fully capable to serve as a venous occluder because it is configured to be inserted in a blood vessel, Para. [0062]), comprising a first occluder (combination of 243, 270, and 278, Figs. 4 and 5), and a second occluder (combination of 228, 260, and 268, Figs. 4 and 5), wherein each of the first occluder and the second occluder comprises a catheter (270/260, Fig. 4), a guide wire (Para. [0130], guidewire, such as 280 and guidewire lumen in each of 260 and 270), a balloon (278/268, Fig. 4), and a handle part (243/228, Fig. 4); the guide wire is arranged inside the catheter (Para. [0130]), and the balloon and the handle part are arranged outside the catheter (Fig. 4); the balloon is arranged at a front end of the catheter (Fig. 4), and the handle part is arranged at a rear end of the catheter (Fig. 4). However, Agah does not specifically disclose that a diameter of the second occluder, except for the handle part, is smaller than that of the catheter of the first occluder.
Gerrans teaches, (in the same field of endeavor (catheter occluder), a diameter of a second occluder (combination of 26, 30, and 81, Fig. 1), except for a handle part (proximal handle part, 83/86), is smaller than that of a catheter of the first occluder (combination of 24, 28, and 81, Fig. 1 and Para. [0066]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the occluder Agah to include a diameter of the second occluder, except for the handle part, is smaller than that of the catheter of the first occluder as taught by Gerrans in order to provide the option of having only the outer/first occluder to be initially inserted into the body vessel and subsequently to insert the inner/inner occluder through the outer/first occluder (Gerrans, Para. [0066]).
Claim(s) 2, 3, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agah et al. (US Pub. No.: 2022/0111184) in view of Gerrans et al. (US Pub. No.: 2012/0259215) as applied to claim 1 above, and further in view of Levine et al. (US Pub. No.: 2021/0308422).
Regarding claim 2, Agah in view of Gerrans discloses all the limitations of claim 1 as taught above. Agah further discloses the catheter is a cylindrical hollow catheter (Fig. 4, 5, and 7). However neither Agah nor Gerrans discloses that the catheter comprises a bent part and a horizontal part; the bent part is located at the front end of the catheter, and the remaining part of the catheter, except for the bent part, is the horizontal part; the balloon is arranged at one end, adjacent to the bent part, of the horizontal part, and the handle part is arranged at one end, away from the bent part, of the horizontal part.
Levine teaches, in the same field of endeavor (catheter occluder), a catheter comprises a bent part (32, Fig. 1C) and a horizontal part (straight/horizontal part of 26, Fig. 1C. Also see Fig. 1A); the bent part is located at the front end of the catheter (Fig. 1A and 1C), and the remaining part of the catheter, except for the bent part, is the horizontal part (Fig. 1A and 1C); the balloon is arranged at one end, adjacent to the bent part, of the horizontal part, and the handle part is arranged at one end, away from the bent part, of the horizontal part (Fig. 1C).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the catheter of Agah in view of Gerrans to include a bent part and a horizontal part; the bent part is located at the front end of the catheter, and the remaining part of the catheter, except for the bent part, is the horizontal part; the balloon is arranged at one end, adjacent to the bent part, of the horizontal part, and the handle part is arranged at one end, away from the bent part, of the horizontal part in order as taught by Levine to facilitate the manipulation and deployment of the catheter within the body (Levine, Abstract and Para. [0008]).
Regarding claim 3, Agah further discloses that the catheter is internally provided with a first chamber (273, Fig. 6 ; or guidewire lumen, Para. [0130]) which is an access channel of the guidewire (Paras. [0130]), and a second chamber (274, Fig. 6) which communicates with the balloon (Para. [0068]). Levine further discloses that the catheter is internally provided with a first chamber (55, Fig. 2C/2D), a second chamber (42, Fig. 2C/2D), and a third chamber (lumen through which 62 extends, Fig. 2C/2D); the first chamber is located in a middle part of the catheter and is an access channel of the guide wire, the second chamber is located at a bottom of the catheter and communicates with the balloon, and the third chamber is located at a top of the catheter (Fig. 2C/2D, when the catheter is rotated 180 degrees of what is shown in Fig. 2C/2D, the first chamber is located in a middle part of the catheter and is an access channel of the guide wire, the second chamber is located at a bottom of the catheter and communicates with the balloon, and the third chamber is located at a top of the catheter).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the catheter of Agah in view of Gerrans to be internally provided with a first chamber, a second chamber, and a third chamber; the first chamber is located in a middle part of the catheter and is an access channel of the guide wire, the second chamber is located at a bottom of the catheter and communicates with the balloon, and the third chamber is located at a top of the catheter as taught by Levine in order to protect a pull wire for the bent part and facilitate the deflection of the catheter (Levine, Para. [0046]).
Regarding claim 9, Agah further discloses that the handle part comprises a handle (distal cylindrical part of 243, Fig. 4), a balloon port (235, Para. [0068]), and a guide wire inlet (inlet of guidewire lumen, such as at 230, Para. [0130] and Fig. 4); the handle is arranged at a periphery of the horizontal part, and is located at one end, away from the bent part, of the horizontal part, and the balloon port and the guide wire inlet are both located at a rear end of the handle (Fig. 4, also see Fig. 30 for the distal bent part).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agah et al. (US Pub. No.: 2022/0111184) in view of Gerrans et al. (US Pub. No.: 2012/0259215) and Levine et al. (US Pub. No.: 2021/0308422) as applied to claim 3 above, and further in view of Fischer, JR. et al. (US Pub. No.: 2017/0189644).
Regarding claim 4, Agah in view of Gerrans and Levine discloses all the limitations of claim 3 as taught above. Levine further discloses that a steel wire (62, Fig. 2C/2D and Para. [0072]) located in the third chamber (Fig. 2C/2D) for manipulating the bending of the bending part. However, none of Agah, Gerrans, and Levine disclose that a rotary hub, wherein the steel wire is fixedly connected to the third chamber; the rotary hub is arranged outside the horizontal part, and located at a position, adjacent to the handle part, of the horizontal part, the steel wire is connected to the rotary hub, and the rotary hub is of a collar structure.
Fischer, JR. teaches, in the same field of endeavor (catheter occluder), an occluder comprising a rotary hub (96A and/or 96B, Figs. 8 and 9 and Para. [0073]), wherein a steel wire (362, Fig. 16 and Para. [0096]) is fixedly connected to a third chamber (360, Fig. 16); the rotary hub is arranged outside the horizontal part (Figs. 8 and 9), and located at a position, adjacent to the handle part, of the horizontal part, the steel wire is connected to the rotary hub, and the rotary hub is of a collar structure (Figs. 8 and 9).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the catheter of Agah in view of Gerrans and Levine to include a rotary hub, wherein the steel wire is fixedly connected to the third chamber; the rotary hub is arranged outside the horizontal part, and located at a position, adjacent to the handle part, of the horizontal part, the steel wire is connected to the rotary hub, and the rotary hub is of a collar structure as taught by Fischer, JR. in order to facilitate the deflection of the bent part (Fischer, JR., Para. [0074]).
Regarding claim 5, Levine further discloses that the bent part is made of an elastic material (super-elastic alloy, Para. [0056]), and has a smooth outer wall (Figs. 1C and 3D); the bent part is able to form an angle with the horizontal part under traction of the steel wire (Fig. 1C and Para. [0073] and [0096]), and the bent part is able to automatically reset when no traction force exists (Para. [0056], the bent part is able to automatically reset when no traction force exists because the support of the bent part is formed of super-elastic alloy).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the catheter of Agah in view of Gerrans and Fischer, JR., to include that the bent part is made of an elastic material, and has a smooth outer wall; the bent part is able to form an angle with the horizontal part under traction of the steel wire, and the bent part is able to automatically reset when no traction force exists as taught by Levine in order to facilitate the manipulation of the bent part (Levine, at least Para. [0056]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agah et al. (US Pub. No.: 2022/0111184) in view of Gerrans et al. (US Pub. No.: 2012/0259215) and Levine et al. (US Pub. No.: 2021/0308422) as applied to claim 3 above, and further in view of Samson et al. (US Pat. No.: 6,186,978).
Regarding claim 6, Agah in view of Gerrans and Levine discloses all the limitations of claim 3 as taught above but fails to disclose that an outer wall of the second chamber at a joint of the second chamber and the balloon is provided with a plurality of balloon openings, the balloon openings are circular, the plurality of balloon openings are uniformly arranged in a length direction of the first chamber, so that normal saline is able to enter the balloon from the second chamber through the balloon openings.
Samson teaches, in the same field of endeavor (catheter occluder), a catheter occluder comprising an outer wall of a second chamber (244, Fig. 6) at a joint of the second chamber and a balloon (312, Fig. 6) is provided with a plurality of balloon openings (316, Figs. 6 and 11A-11C), the balloon openings are circular (Figs. 6 and 11A-11C), the plurality of balloon openings are uniformly arranged in a length direction of a first chamber (central lumen shown in Fig. 6), so that normal saline is able to enter the balloon from the second chamber through the balloon openings (normal saline is able to enter the balloon from the second chamber through the balloon openings, Fig. 6).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the catheter occluder of Agah in view of Gerrans and Levine to include that an outer wall of the second chamber at a joint of the second chamber and the balloon is provided with a plurality of balloon openings, the balloon openings are circular, the plurality of balloon openings are uniformly arranged in a length direction of the first chamber, so that normal saline is able to enter the balloon from the second chamber through the balloon openings as taught by Samson in order to facilitate the expansion of the balloon.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agah et al. (US Pub. No.: 2022/0111184) in view of Gerrans et al. (US Pub. No.: 2012/0259215) as applied to claim 1 above, and further in view of van Sloten et al. (US Pub. No.: 2007/0100280) and Lin et al. (US Pub. No.: 2009/0041923).
Regarding claim 7, Agah in view of Gerrans discloses all the limitations of claim 1 as taught above but fails to disclose that each of a top end and a bottom end of the balloon is provided with an X-ray marker for determining a position of the balloon, and an outside of the balloon is coated with an anticoagulant drug coating for preventing blood coagulation.
van Sloten teaches, in the same field of endeavor (catheter balloon), each of a top end and a bottom end of a balloon is provided with an X-ray marker (X-ray marker 48 /46 at each of a top end and a bottom end of a balloon, Figs. 3 and 7 and Para. [0020])) for determining a position of the balloon.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the balloon of Agah in view of Gerrans to include an X-ray marker provided at a top end and a bottom end of the balloon for determining a position of the balloon as taught by van Sloten in order to obtain the advantage of indicating the proximal and distal extend of a working portion of the balloon (van Sloten. Para. [0045]).
Lin further teaches, in the same field of endeavor (catheter balloon), an outside of a balloon is coated with an anticoagulant drug coating for preventing blood coagulation (Para. [0034]).
Fefore the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the an outside of the balloon of Agah in view of Gerrans to be coated with an anticoagulant drug coating for preventing blood coagulation in order to obtain the advantage of local drug delivery for achieving anticoagulating effect.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agah et al. (US Pub. No.: 2022/0111184) in view of Gerrans et al. (US Pub. No.: 2012/0259215) and Levine et al. (US Pub. No.: 2021/0308422) as applied to claim 3 above, and further in view of Ravikumar (US Pub. No.: 2024/0090901)
Regarding claim 8, Agah in view of Gerrans and Levine discloses all the limitations of claim 3 as taught above but fails to specifically disclose that the guide wire is made of a medical titanium alloy material, and has a length greater than that of the catheter, and the guide wire is able to enter the first chamber from the handle part.
Ravikumar teaches, in the same field of endeavor (catheter occluder), an occluder comprising a guide wire (107, Fig. 12B) is made of a medical titanium alloy material (Para. [0017]), and has a length greater than that of a catheter (Fig. 12B), and the guide wire is able to enter the first chamber from a handle part (Fig. 12B).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the guidewire of Agah in view of Gerrans and Levine to be made of a medical titanium alloy material, and have a length greater than that of the catheter, and able to enter the first chamber from the handle part as taught by Ravikumar in order to prevent migration of the distal end of the catheter during use (Ravikumar, at least Para. [0007]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agah et al. (US Pub. No.: 2022/0111184) in view of Gerrans et al. (US Pub. No.: 2012/0259215) and Levine et al. (US Pub. No.: 2021/0308422) as applied to claim 9 above, and further in view of Schaeffer et al. (US Pub. No.: 2015/0039014).
Regarding claim 10, Agah in view of Gerrans and Levine discloses all the limitations of claim 9 as taught above. Agah further discloses that the balloon port communicates with the second chamber (Fig. 4 and Para. [0068]) and the guide wire inlet communicates with the first chamber and is configured for allowing the guide wire and the second occluder to enter (Fig. 4 and Para. [0130]). However, none of Agah, Gerrans, and Levine disclose the balloon port is externally provided with a screw cap, the screw cap is configured for being connected to a nipple of a syringe; the guide wire inlet is externally provided with a further screw cap.
Schaeffer teaches, in the same field of endeavor (catheter occluder), an occluder comprising a balloon port (631, Fig.7) externally provided with a screw cap (threaded connector / Tuohy Borst adapter, Para. [0139], also see connector 1120 in Fig. 12 and Para. [0169]), the screw cap is fully capable for being connected to a nipple of a syringe (Para. [0139]); and a guide wire inlet (633, Fig. 7 and Para. [0139] and [0048]) externally provided with a further screw cap (threaded connector / Tuohy Borst adapter, Para. [0139], also see connector 1120 in Fig. 12 and Para. [0169]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the catheter of Agah in view of Gerrans and Levine to include that the balloon port is externally provided with a screw cap, the screw cap is configured for being connected to a nipple of a syringe; and that the guide wire inlet is externally provided with a further screw cap as taught by Schaeffer in order assisting attaching one or more devices to the handle (Schaeffer, Para. [0139]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20060200075 A1 Zadno-Azizi; Gholam-Reza discloses an occluder system comprising an inner balloon catheter and an outer balloon catheter.
US 20140214002 A1 LIEBER; GLEN et al. discloses a bifurcated occluder system comprising two inner balloon catheters and an outer balloon catheter.
US 4327736 A Inoue; Kanji discloses a balloon catheter having multiple circular inflating ports for inflating the balloon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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