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 1-25 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 “a portion between the first end and the second end” in line 10. The phrase “a portion” renders the claim indefinite because it is unclear what of the limitation following the phrase is part of the claimed invention. See MPEP § 2173.05(d). The Examiner believes this is a typographical mistake and that the Applicant meant to recite “portion of the cable between the first end and the second end” as in line 12.
Claims 2-25 are similarly rejected by virtue of their dependency upon claim 1.
Claim 17 recites “the second distal part”. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 is similarly rejected by virtue of their dependency upon claim 17.
Claim 18 recites “said second distal portion”. There is insufficient antecedent basis for this limitation in the claim.
Claims 19 and 20 both recite “bevel”. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 is similarly rejected by virtue of their dependency upon claim 19.
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.
Claims 1-6, 8, 14-16, 19-22, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn et al. (U.S. Patent No. 9888881), hereinafter Hulvershorn.
Regarding claim 1, Hulvershorn a needle (needle 20; Figs. 2A,2G, and 4A-B) for a syringe (syringe 50), the needle comprising:
a shaft (shaft 202) having a tip (tip 204) at one end of the shaft, the tip adapted to penetrate a body tissue during usage of the syringe (see Col 20 Line 64 – Col 21 Line 4);
a hub (structure 28) attached at another end of the shaft, to attach the needle to a tube or to the syringe;
a pressure sensor (sensing elements 210) in the shaft to measure pressure of fluid in the shaft.
However, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state a cable including a first end optically or electrically connected to the pressure sensor in the shaft, a second end outside the needle suitable for connection to a control unit, a portion between the first end and the second end, wherein said portion of the cable between the first end and the second end pass through a hole in a structure of the hub, wherein said hole is filled and blocks said portion in the structure of hub, the pressure sensor is at the tip of the shaft or at a predetermined distance from the tip of the shaft in a direction along a longitudinal axis of the shaft.
Hulvershorn teaches an embodiment seen in FIG. 5B comprising a cable (optical fibers and/or electrical leads 410) including a first end optically or electrically connected to the pressure sensor (sensing devices 412) in the shaft, a second end outside the needle (see FIG. 5B) suitable for connection to a control unit (“A remote or external end of the sensing guidewire 400 can be coupled to a remote or external computer system or medical device 90, 92”, Col 22 Lines 5-7), a portion between the first end and the second end, wherein
said portion of the cable between the first end and the second end pass through a hole in a structure of the hub (see opening of needle 20 and structure 28 in FIG. 5B), wherein
said hole is filled and blocks said portion in the structure of hub (see FIG. 5B, the hole is filled with the wire),
the pressure sensor is at the tip of the shaft or at a predetermined distance from the tip of the shaft in a direction along a longitudinal axis of the shaft (“A given optical fiber, optical element, electrical lead, and/or sensing element can be retained or secured at a predetermined position within the probe or needle 20”, Col 21 Lines 51-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to combine the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B with that of FIG. 5B. Hulvershorn teaches numerous different combinations of embodiments described herein are possible, and such combinations are considered part of the present invention (see Col 39 Lines 62-64). Further, Applicant may wish to note that the Federal Circuit has held that it is permissible to combine two different embodiments disclosed in the same piece of prior art and noted that such a combination does not require “a leap of inventiveness.” Boston Scientific Scimed, Inc. v. Cordis Corp., 554 F.3d 982, 991 (Fed. Cir. 2009).
Regarding claim 2, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, and Hulvershorn further teaches wherein a lumen of the shaft (lumen of needle 20) is a space delimited by a continuous surface inside the shaft, the pressure sensor is not in contact with said continuous surface (see FIG. 5B).
Regarding claim 3, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, and Hulvershorn further teaches wherein the pressure sensor (sensing devices 412) is maintained by the cable (optical fibers and/or electrical leads 410) in a floating position inside the shaft (see FIG. 5B).
Regarding claim 4, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiments of Hulvershorn FIGS. 2A,2G, 4A-B and 5B do not expressly state wherein the cable avoids fluctuation of the pressure sensor in the shaft.
Hulvershorn teaches an embodiment seen in FIGS. 16A and 16B wherein the cable avoids fluctuation of the pressure sensor in the shaft (“a pressure relief/buffer system of a device can include a reservoir disposed in the device to function as a sort of buffer or capacitor to accommodate small volume fluctuations in the fluid channel 1514 that result in pressure changes from factors other than tissue/target pressure monitoring.” Col 31 Lines 21-26.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to combine the embodiments of Hulvershorn FIGS. 2A,2G, 4A-B, and 5B with that of FIGS. 16A-16B. Hulvershorn teaches numerous different combinations of embodiments described herein are possible, and such combinations are considered part of the present invention (see Col 39 Lines 62-64). Further, Applicant may wish to note that the Federal Circuit has held that it is permissible to combine two different embodiments disclosed in the same piece of prior art and noted that such a combination does not require “a leap of inventiveness.” Boston Scientific Scimed, Inc. v. Cordis Corp., 554 F.3d 982, 991 (Fed. Cir. 2009).
Regarding claim 5, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state wherein the cable is rigid or semirigid.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the cable of Hulvershorn to be rigid or semirigid since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 6, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state wherein the hole has a diameter corresponding to a diameter of the cable.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the diameter of the hole of Hulvershorn to correspond to the cables diameter, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 8, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state wherein the hole has a diameter greater than a diameter of the cable.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the diameter of the hole of Hulvershorn to be greater than the cables diameter, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 14, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, and Hulvershorn further teaches wherein the hub (structure 28) is constituted by a single body, the body including a first port attached to said another end of the shaft (end 26), a second port for attachment of said tube or syringe (proximal opening of structure 28), and said hole.
Regarding claim 15, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 14, and Hulvershorn further teaches wherein said body (body of structure 28) includes no further ports other than said first and second ports (proximal and distal openings of 28 for coupling to needle and syringe; see FIG. 5B).
Regarding claim 16, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 14, and Hulvershorn further teaches wherein said body (structure 28) includes a cylindrical portion having diameter greater than the diameter of the shaft (shaft 22), a first distal part connecting one end of the cylindrical portion to said another end of the shaft (see Examiner annotated FIG. 5B below), the first distal part being tapered (the Examiner notes taper of structure 28) from the cylindrical part towards the needle, a second distal part (see Examiner annotated FIG. 5B below) for connecting the syringe or tube to the cylindrical portion, wherein said hole is in the cylindrical portion, in the first distal part or in the second distal part.
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Regarding claim 19, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, and Hulvershorn further teaches wherein said predetermined distance from the tip or bevel is from 1% to 20% of a length of the shaft (“A given optical fiber, optical element, electrical lead, and/or sensing element can be retained or secured at a predetermined position within the probe or needle 20”, Col 21 Lines 51-54).
Hulvershorn discloses the claimed invention except for wherein the predetermined distance is 1% to 20% of a length of the shaft. It would have been obvious to one having ordinary skill in the art at the time the invention was made to predetermine the distance to be 1% to 20% of a length of the shaft since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 20, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, and Hulvershorn further teaches wherein the sensor (sensing elements 210) includes a sensing surface arranged to be contacted by a fluid to be injected with the syringe, and being adapted to measure a pressure of the fluid around the bevel, and/or a variation of the fluid pressure around the bevel (“bodily fluid can flow or be drawn into the AECD 100, 102, 104 for sensing or analysis, and/or into a syringe 50 that is coupled to the AECD 100, 102, 104.” Col 21 Lines 1-5.
Regarding claim 21, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 19, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state wherein the sensing surface includes at least a portion perpendicular to the longitudinal axis of the shaft, said portion being towards the tip of the shaft.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to orient a portion of the sensing surface proximally, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 22, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, and Hulvershorn further teaches wherein the second end of the cable includes a wireless interface to transmit wirelessly the pressure value to a device outside the needle (“In one embodiment, a device of the present invention can be coupled wirelessly to one or more graphical displays positioned remotely from the device, thereby enabling wireless monitoring of signal detection with the device.”, Col 38 Lines 40-43).
Regarding claim 23, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, and Hulvershorn further teaches wherein the cable is an optical fibre (optical fibers and/or electrical leads 410).
Regarding claim 25, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 2, and Hulvershorn further teaches wherein the pressure sensor (sensing elements 210) comprises an external surface and a surface of the cable (optical fibers and/or electrical leads 410) and the external surface of the pressure sensor directly oppose the continuous surface of the shaft (the Examiner notes that due to the optical fibers/leads 410 of sensing wire 400 is located along the length of the shaft axially along the central axis, disposed between the circumference of the shaft. The Examiner is of the position that this is sufficient disclosure to teach or suggest wherein the sensor directly opposes the continuous surface of the shaft).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn et al. (U.S. Patent No. 9888881), hereinafter Hulvershorn, and further in view of Hendriks et al. (U.S. Patent Pub. 20140121538), hereinafter Hendriks.
Regarding claim 7, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state wherein the hub is thermomoulded on said portion of the cable.
Hendriks teaches a needle with integrated fibers (see [0001]) wherein the hub is thermomoulded on said portion of the cable (“The needle tip might also be made of a ceramic material. This has the advantage of being mouldable in various shapes while still allowing for a sharp and robust needle tip. On the other end, the holder part might be made by plastic injection moulding.”, [0030]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the hub of Hulvershorn to be thermomoulded on said portion of the cable. Doing so allows for various shapes to be chosen to mold the hub in while permitting a needle to pass through for fluid flow, as taught by Hendriks (see [0030]).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn et al. (U.S. Patent No. 9888881), hereinafter Hulvershorn, and further in view of Shih et al. (U.S. Patent Pub. 20070073245) hereinafter Shih.
Regarding claim 9, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state
Regarding claim 9, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 8, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state a stopper arranged in the hole, the stopper being formed in elastic and/or compressible material and has a diameter slightly larger than a diameter of the hole at rest, when free from the hub, so as it is forcedly fitted into the hole, the stopper further including an inner hole and said portion of the cable pass through said inner hole of the stopper and is blocked in the inner hole.
Shih teaches a needle-retractable safety hypodermic syringe (Abstract) comprising a stopper (stopper 25) arranged in the hole (opening of barrel 1), the stopper being formed in elastic and/or compressible material (rubber stopper 25; see claim 9), the stopper further including an inner hole and said portion of the cable pass through said inner hole of the stopper and is blocked in the inner hole (the Examiner notes the fibers of Hulvershorn going through needle 20 in combination with the needle 31 and stopper 25 would be teach the stopper further including an inner hole and said portion of the cable pass through said inner hole of the stopper).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the device of Hulvershorn to a stopper arranged in the hole, the stopper being formed in elastic and/or compressible material, the stopper further including an inner hole and said portion of the cable pass through said inner hole of the stopper and is blocked in the inner hole. Doing so allows for control of fluid flow, as taught by Shih (see [0017]).
However, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B in view of Shih does not expressly state a stopper that has a diameter slightly larger than a diameter of the hole at rest, when free from the hub, so as it is forcedly fitted into the hole.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the diameter of the Stopper of Hulvershorn in view of Shih to slightly larger than a diameter of the hole at rest, when free from the hub, so as it is forcedly fitted into the hole, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 10, Hulvershorn’s combination of embodiments in view of Shih teaches the claimed invention as discussed above concerning the rejection of claim 9, and Hulvershorn further teaches wherein the portion of the cable (optical fibers and/or electrical leads 410) closes the inner hole of the stopper (the Examiner notes the fibers of Hulvershorn going through needle 20 in combination with the needle 31 and stopper 25 would be teach wherein the portion of the cable closes the inner hole of the stopper should only the hole and the cable were made to be the same diameter as to create a friction fit. Such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955)).
Regarding claim 11, Hulvershorn’s combination of embodiments in view of Shih teaches the claimed invention as discussed above concerning the rejection of claim 9, and Hulvershorn further teaches wherein said hole (opening of structure 28) includes a first portion of a first diameter (see opening by second distal part in Examiner annotated FIG. 5B below) and a second portion of a second diameter (see opening by first distal part in Examiner annotated FIG. 5B below), smaller than the first diameter.
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However, the embodiments of Hulvershorn FIGS. 2A,2G, 4A-B, and 5B does not expressly state wherein the stopper is in the first portion.
Shih teaches a needle-retractable safety hypodermic syringe (Abstract) comprising a stopper (stopper 25).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Hulvershorn in view of Shih to include the stopper is in the first portion, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn et al. (U.S. Patent No. 9888881), hereinafter Hochman, and further in view of Hendriks et al. (U.S. Patent Pub. 20140012226), hereinafter Hochman.
Regarding claim 12, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state a glue or resin filling the hole, the glue or resin adhering to said portion of the cable inside the hole.
Hochman teaches an automatic injection apparatus (Abstract) including a glue or resin filling the hole, the glue or resin adhering to said portion of the cable inside the hole (“The ID-Connector also ensures the proper selection of the disposable components. In the preferred embodiment the ID-Connector is rigidly connected to as many disposable components as possible, i.e. by glue, heat or chemical bonding to the in-line pressure sensor and tubing set.”, [0134]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the device of Hulvershorn to include a glue or resin filling the hole, the glue or resin adhering to said portion of the cable inside the hole. Doing so allows the device made of separate components to be used together as a single component, as taught by Hochman (see [0087;0091]).
Regarding claim 13, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state wherein said portion of the cable is not slidable in said hole.
Hochman teaches an automatic injection apparatus (Abstract) wherein said portion of the cable is not slidable in said hole (“Connector is rigidly connected to as many disposable components as possible, i.e. by glue, heat or chemical bonding to the in-line pressure sensor and tubing set.”, [0134]; the Examiner notes when bonded, at bonded portion, the cable will not be slidable).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the cable of Hulvershorn to be not slidable in said hole. Doing so allows the device made of separate components to be used together as a single component, as taught by Hochman (see [0087;0091]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn et al. (U.S. Patent No. 9888881), hereinafter Hulvershorn, and further in view of Reich et al. (U.S. Patent No. 6057911), hereinafter Reich.
Regarding claim 24, Hulvershorn’s combination of embodiments teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiments of Hulvershorn FIGS. 2A,2G, and 4A-B do not expressly state wherein the pressure sensor is a Fabry-Perot optical fibre sensor.
Reich teaches optical strain gauges and sensors wherein the pressure sensor is a Fabry-Perot optical fibre sensor (first 10 and second 12 optical fibers thus define a Fabry-Perot interferometer).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the pressure sensor of Hulvershorn to be a Fabry-Perot optical fibre sensor. The use of such a fiber optic Fabry-Perot sensor to measure strain is particularly advantageous in those situations where it is not desirable to have an electrical signal, as taught by Reich (see Col 4 Lines 31-33).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
09/05/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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