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 .
Abstract
The abstract of the disclosure is objected to because the abstract currently recites the limitations of claim 1, but fails to recite the proper content of an abstract of the disclosure. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 4-5 are objected to because they recite “[or 3]” in line 1, which uses singular brackets. Examiner notes that eliminated claim language should be indicated with either double brackets or strikethrough. Therefore, it is unclear as to whether “[or 3]” was meant to be a part of claims 4 and 5, or meant to be eliminated. Appropriate correction is required. For examination purposes, the claim slimitations will be interpreted as eliminated.
Claims 21, 25, and 26 are objected to because of the following informalities:
Claim 21 recites “position completely” in line 2, but should read “position, completely”
Claim 25 recites “comprising the steps” in line 2, but should read “comprising steps”
Claim 26 recites “comprising the steps” in line 3, but should read “comprising steps”
Appropriate correction is required.
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 1-26 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.
The term “target” in claim 1 is a relative term which renders the claim indefinite. The term “target” 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.
Claim 2 recites “that when the insertion sheath is connected with the channel device is aligned with the channel to form a conduit” in lines 5-6. It is unclear as to what exactly this limitation entails, as there seems to be a grammatical error present. Claim 2 seems to recite an incomplete conditional statement of “when the insertion sheath is connected with the channel device”. In this case, it is unclear as to what happens when this specified condition is true, as the claims fail to particularly point out and distinctly complete the conditional statement.
Claim 4 recites “wherein the insertion tube length is selected” in line 2. It is unclear as to how the step of “select[ing]” is incorporated into the current claims, as the current claims are drawn to an apparatus rather than a method. Clarification is requested.
Regarding claim 5, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 recites “a venous catheter having a catheter channel” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “venous catheter” from Claim 2, or a separate element. Clarification is requested.
Regarding claim 8, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 9 recites “wherein the cross section of the receptor part has a non-cylindrical shape” in line 2. It is unclear as to whether the Applicant meant to recite “wherein the cross section of the receptor part has a non-circular shape”, as the cross section of a cylindrical tube is a circle. Clarification is requested.
The term “substantially” in claim 11 is a relative term which renders the claim indefinite. The term “substantially” 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.
The term “substantially” in claim 14 is a relative term which renders the claim indefinite. The term “substantially” 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.
The term “stiff” in claim 17 is a relative term which renders the claim indefinite. The term “stiff” 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.
Claim 19 recites “a proximal end of the channel” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “proximal end” from Claim 1, or a separate element. Clarification is requested.
Claim 20 recites the limitation "the length of the channel" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the total translation of the wire" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites “within a closed space” in line 2. It is unclear as to what the “closed space” entails, as it could be referring to a previously introduced element, or a new separate element. Clarification is requested.
Claim 23 recites “an increased thickness” in lines 2-3. It is unclear as to how the stop surface can have an “increased thickness” if this is the first time “thickness” has been introduced and recited within the claims. Clarification is requested.
Claim 23 further recites “a decreased width” in line 3. It is unclear as to how the stop opening can have a “decreased width” if this is the first time “width” has been introduced and recited within the claims. Clarification is requested.
Claim 25 recites “an intravenous section” in line 4. It is unclear as to whether this limitation is referring to the previously introduced “intravenous section” from Claim 1, or a separate element. Clarification is requested.
The term “desired” in claim 26 is a relative term which renders the claim indefinite. The term “desired” 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.
Claim 26 recites the limitation "the eluting fluid" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites “with compound” in line 6. It is unclear as to whether this limitation is referring to the previously introduced “desired compound”, or a separate element. Clarification is requested.
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.
Claims 1-7, 9, 11-19, 22-23, 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoon et al (WO 2005/062940; cited by Applicant).
Regarding Claim 1, Hoon discloses a medical sampling device for capturing bioanalytes (Method and apparatus for in vivo collection and surveillance of circulating biological components; Abstract), comprising:
a wire (probe 10) having a receptor part (distal binding zone 34), the receptor part having receptors to bind target bioanalytes (The distal zone of the probe is provided with a binding zone, having a binding partner for binding with a marker of interest…the surface area of the binding zone may be configured by one skilled in the art depending upon the expected release pattern, degradation and metabolization pathways and binding kinetics of the CMCs of interest; Pages 26-27),
a channel device (These devices include but are not limited to centrally or peripherally inserted intravenous catheters, pacemakers and their leads, automatic internal converter defibrillators, hemodialysis catheters, peritoneal catheters and prosthetic grafts. One example of the proposed device is a coated catheter, guidewire or filament, chip, biomaterial and/or matrix that can be inserted through a centrally or peripherally placed intravenous catheter or implantable device into body fluids such as peritoneal cavity, pleural cavity, bone marrow, cerebrospinal fluid, etc.; Pages 8-9;
Catheter-based probes; Pages 22-23) defining a channel to receive the wire, the channel having a proximal end and a distal end, wherein the wire is movable with respect to the channel between at least an extended position in which at least an intravenous section of the receptor part extends from the distal end of the channel and a retracted position in which the intravenous section of the receptor part is retracted into the channel (Probe body 16 should also have sufficient stiuctural integrity (e.g., column strength or "pushability") to permit the probe to be advanced to a desired target site without buckling or undesirable bending…the distal end 14 of the probe 10 may be provided with an atraumatic distal tip 25 which may include a guidewire exit port 26 in a guidewire lumen embodiment as is known in the art. A radiopaque marker (not illustrated) may be provided on the probe body 16 in the case of relatively long probes to facilitate positioning of the probe as is known in the art. Page 25; Examiner’s Note: The Examiner notes wherein the limitation “wherein the wire is movable with respect to the channel between at least an extended position in which at least an intravenous section of the receptor part extends from the distal end of the channel and a retracted position in which the intravenous section of the receptor part is retracted into the channel” is a recitation of the intended use of the invention. It has been held that 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 satisfying the claimed structural limitations),
wherein the channel device comprises a liquid inlet (infusion port 22) arranged proximally with respect to at least a part of the intravenous section of the receptor part when the wire is arranged in the retracted position (Manifold 18 may be provided with a guidewire port 20 in an embodiment where over-the-wire navigation of the probe may be desired. An infusion port 22 may be provided with or without the guidewire port. The infusion port is in fluid communication with the binding zone through an infusion lumen. This allows periodic or continuous infusion of saline, heparin or other media to prevent "clogging" or coating of the binding zone over time, by natural clotting or other processes which may interfere with the efficacy of the binding chemistry. Additional access ports may be provided as needed, depending upon the desired capabilities of the catheter; Page 25; Figure 2).
Regarding Claim 2, Hoon discloses wherein the sampling device comprises an insertion sheath comprising an insertion tube and a connector, wherein the connector is arranged to connect the insertion sheath to the distal end of the channel, wherein the insertion tube is arranged to be inserted into a venous catheter, and wherein the insertion tube comprises an inner channel that when the insertion sheath is connected with the channel device is aligned with the channel to form a conduit (Although the probe 10 will be described primarily in terms of an insert to be temporarily placed down an existing access port or sheath into the cardiovascular system, for retrieving a marker from blood, the present inventors contemplate broader applicability as will be apparent to those of skill in the art in view of the disclosure herein. Existing access ports or sheaths include but are not limited to Hickman catheters, Portacath catheters, peripherally inserted central catheter (PICC) lines, femoral, jugular, or subclavian central venous lines, radial arterial catheters and peripheral venous lines. Furthermore, additional procedures, such as transseptal puncture and transjugular intrahepatic puncture, may be used to access other body sites such as the arterial chambers of the heart or the portal vein, respectively. For example, the probe may be adapted for direct access to a target site, without the use of a distinct tubular access catheter, hi general, whether used with an access sheath or as a stand alone device, the dimensions of the probe can be optimized by persons of skill in the art in view of the present disclosure to suit any of a wide variety of target sites; Pages 22-23).
Regarding Claim 3, Hoon discloses wherein the connecter is configured to provide a releasable connection (the cap is provided with a complementary surface structure to allow a removable connection between the cap and the proximal end of the TV catheter or other device through which the probe 10 will achieve contact with blood or other body fluid. Removable attachment may be accomplished by using any of a wide variety of clips, twist fasteners such as Luer connectors, interlocking snap fit connectors, or friction fit connectors as will be appreciated by those of skill in the art in view of the disclosure herein; Page 25).
Regarding Claim 4, Hoon discloses wherein the insertion tube has an insertion tube length, wherein the insertion tube length is selected to extend completely through the venous catheter used to introduce the sampling device at least partially into a blood vessel of a patient (The axial length of the probe 10 is preferably precisely calibrated to match the particular access catheter with which it is to be used, to provide a reproducible length of the binding zone to be exposed to the sample of interest; Page 25).
Regarding Claim 5, Hoon discloses wherein the insertion tube has an insertion tube length, wherein the insertion tube length is 10 to 300 mm, for example 30 to 100 mm (The probe 10 generally comprises an elongate body 16 extending between a proximal end 12 and a distal functional end 14. The length of the body 16 depends upon the desired access site and the desired placement site for the distal end 14. For example, lengths in the area of from about 1 cm to about 20 or 30 cm may be useful in applications that require the catheter to be advanced down a relatively short tubular access sheath. Longer lengths may be used as desired, such as on the order of from about 120 cm to about 140 cm for use in percutaneous access at the femoral artery for placement of the distal end 14 in the vicinity of the coronary artery; Page 23).
Regarding Claim 6, Hoon discloses wherein the sampling device comprises a venous catheter having a catheter channel (Although the probe 10 will be described primarily in terms of an insert to be temporarily placed down an existing access port or sheath into the cardiovascular system, for retrieving a marker from blood, the present inventors contemplate broader applicability as will be apparent to those of skill in the art in view of the disclosure herein. Existing access ports or sheaths include but are not limited to Hickman catheters, Portacath catheters, peripherally inserted central catheter (PICC) lines, femoral, jugular, or subclavian central venous lines, radial arterial catheters and peripheral venous lines. Furthermore, additional procedures, such as transseptal puncture and transjugular intrahepatic puncture, may be used to access other body sites such as the arterial chambers of the heart or the portal vein, respectively. For example, the probe may be adapted for direct access to a target site, without the use of a distinct tubular access catheter, hi general, whether used with an access sheath or as a stand alone device, the dimensions of the probe can be optimized by persons of skill in the art in view of the present disclosure to suit any of a wide variety of target sites; Pages 22-23).
Regarding Claim 7, Hoon discloses wherein the insertion tube fully extends through the catheter channel (The axial length of the probe 10 is preferably precisely calibrated to match the particular access catheter with which it is to be used, to provide a reproducible length of the binding zone to be exposed to the sample of interest; Page 25).
Regarding Claim 9, Hoon discloses wherein the cross section of the receptor part has a non-cylindrical shape (the body 16 may be hollow or solid depending upon the nature of the binding system and other desired capabilities. In one cardiovascular example, the body 16 is provided with an approximately circular cross-sectional configuration having an external diameter within the range of from about 0.025 inches to about 0.100 inches, hi accordance with one embodiment of the invention, the body 16 has an average external diameter of about 0.042 inches (4.2 f) throughout most of its length. Alternatively, generally rectangular, oval or triangular cross- sectional configurations can also be used, as well as other noncircular configurations, depending upon the method of manufacture, desired surface area, flexibility, access pathway and other design considerations that may be relevant for a particular application; Page 24).
Regarding Claim 11, Hoon discloses wherein the guiding surfaces extend partially along a cylindrical shape having substantially a diameter that is substantially the same or slightly smaller than the diameter of the channel (the body 16 may be hollow or solid depending upon the nature of the binding system and other desired capabilities. In one cardiovascular example, the body 16 is provided with an approximately circular cross-sectional configuration having an external diameter within the range of from about 0.025 inches to about 0.100 inches, hi accordance with one embodiment of the invention, the body 16 has an average external diameter of about 0.042 inches (4.2 f) throughout most of its length. Alternatively, generally rectangular, oval or triangular cross- sectional configurations can also be used, as well as other noncircular configurations, depending upon the method of manufacture, desired surface area, flexibility, access pathway and other design considerations that may be relevant for a particular application; Page 24).
Regarding Claim 12, Hoon discloses wherein the cross section of the receptor part has a central portion about a longitudinal axis and at least three prongs extending from the central portion (the body 16 may be hollow or solid depending upon the nature of the binding system and other desired capabilities. In one cardiovascular example, the body 16 is provided with an approximately circular cross-sectional configuration having an external diameter within the range of from about 0.025 inches to about 0.100 inches, hi accordance with one embodiment of the invention, the body 16 has an average external diameter of about 0.042 inches (4.2 f) throughout most of its length. Alternatively, generally rectangular, oval or triangular cross- sectional configurations can also be used, as well as other noncircular configurations, depending upon the method of manufacture, desired surface area, flexibility, access pathway and other design considerations that may be relevant for a particular application; Page 24).
Regarding Claim 13, Hoon discloses wherein the cross section of the wire has a central portion about a longitudinal axis and at least three prongs extending from the central portion (the body 16 may be hollow or solid depending upon the nature of the binding system and other desired capabilities. In one cardiovascular example, the body 16 is provided with an approximately circular cross-sectional configuration having an external diameter within the range of from about 0.025 inches to about 0.100 inches, hi accordance with one embodiment of the invention, the body 16 has an average external diameter of about 0.042 inches (4.2 f) throughout most of its length. Alternatively, generally rectangular, oval or triangular cross- sectional configurations can also be used, as well as other noncircular configurations, depending upon the method of manufacture, desired surface area, flexibility, access pathway and other design considerations that may be relevant for a particular application; Page 24).
Regarding Claim 14, Hoon discloses wherein the cross section of the receptor part has a substantially polygonal main shape (the body 16 may be hollow or solid depending upon the nature of the binding system and other desired capabilities. In one cardiovascular example, the body 16 is provided with an approximately circular cross-sectional configuration having an external diameter within the range of from about 0.025 inches to about 0.100 inches, hi accordance with one embodiment of the invention, the body 16 has an average external diameter of about 0.042 inches (4.2 f) throughout most of its length. Alternatively, generally rectangular, oval or triangular cross- sectional configurations can also be used, as well as other noncircular configurations, depending upon the method of manufacture, desired surface area, flexibility, access pathway and other design considerations that may be relevant for a particular application; Page 24).
Regarding Claim 15, Hoon discloses wherein a cross section area of the receptor part of the wire fills at least 40% of a cross section area of the channel (the body 16 may be hollow or solid depending upon the nature of the binding system and other desired capabilities. In one cardiovascular example, the body 16 is provided with an approximately circular cross-sectional configuration having an external diameter within the range of from about 0.025 inches to about 0.100 inches, hi accordance with one embodiment of the invention, the body 16 has an average external diameter of about 0.042 inches (4.2 f) throughout most of its length. Alternatively, generally rectangular, oval or triangular cross- sectional configurations can also be used, as well as other noncircular configurations, depending upon the method of manufacture, desired surface area, flexibility, access pathway and other design considerations that may be relevant for a particular application. Dimensions outside of the ranges identified above may also be used, provided that the functional consequences of the dimensions are acceptable for the intended purpose of the catheter; Page 24).
Regarding Claim 16, Hoon discloses wherein the receptor part is provided at least partially with a coating comprising the receptors (The wire may optionally have a Teflon or polyimide insulation coating, generally about 10 micron to about 100 micron in average thickness; Page 33).
Regarding Claim 17, Hoon discloses wherein the wire comprises a stiff core wire (A metallic core may be included in proximal section 33 and/or distal zone 34 to provide sufficient column strength or pushability; Page 28) and at least at the receptor part a polymer material provided on the core wire (The wire may optionally have a Teflon or polyimide insulation coating, generally about 10 micron to about 100 micron in average thickness; Page 33).
Regarding Claim 18, Hoon discloses wherein the core wire is made of a metal (A metallic core may be included in proximal section 33 and/or distal zone 34 to provide sufficient column strength or pushability; Page 28).
Regarding Claim 19, Hoon discloses wherein the wire extends proximally from a proximal end of the channel (The probe 10 generally comprises an elongate body 16 extending between a proximal end 12 and a distal functional end 14. The length of the body 16 depends upon the desired access site and the desired placement site for the distal end 14. For example, lengths in the area of from about 1 cm to about 20 or 30 cm may be useful in applications that require the catheter to be advanced down a relatively short tubular access sheath. Longer lengths may be used as desired, such as on the order of from about 120 cm to about 140 cm for use in percutaneous access at the femoral artery for placement of the distal end 14 in the vicinity of the coronary artery; Page 23).
Regarding Claim 22, Hoon discloses wherein the sampling device comprises one or more stops to block movement of the wire from the retracted position in proximal direction of the channel and/or to block movement of the wire from the extended position in distal direction of the channel (The soft or atraumatic tip 54 has a length of about 2 mm to about 6 mm and is joined at its proximal end 56; Page 29).
Regarding Claim 23, Hoon discloses wherein the stop comprises a stop surface of the wire and a stop opening in the channel, wherein the stop surface of the wire has an increased thickness that is not able to pass the stop opening in the channel that has a decreased width (The soft or atraumatic tip 54 has a length of about 2 mm to about 6 mm and is joined at its proximal end 56 to a porous segment 52 at a joint area 50 using an adhesive such as a polyurethane adhesive, an epoxy, fast setting glue, UV cure adhesive or other adhesives known in the art. The porous segment has a length of about 1 mm to about 10 mm and an average diameter of about 0.5 mm to about 2 mm or more; Page 29; Examiner’s Note: As best understood in view of the 112(b) rejections above, the stop surface of the wire is not able to pass through the proximal end 56).
Regarding Claim 25, Hoon discloses a method of using the sampling device of claim 1, to carry out a flow biopsy, comprising the steps of: moving the wire with respect to the channel from the retracted position to the extended position such that at least an intravenous section of the receptor part extends from the distal end of the channel into a blood vessel, and after a certain time period moving the wire back to the retracted position in which the intravenous section of the receptor part is retracted into the channel (The device can be removed after insertion into the blood stream to be monitored for biomarkers or cells it can capture. The insertion device can be a catheter, array chip, capture vessel, capture filter, and/or entrapment device. The device can be inserted for 1, 2, 3, 4...24 hrs or days or weeks; Page 15).
Regarding Claim 26, Hoon discloses a method of using the sampling device of claim 1 to carry out a solid phase extraction, while the wire is in the retracted position, comprising the steps of: injecting an eluting liquid into the liquid inlet to recover a desired compound from the receptors, and collecting the eluting fluid with compound in a collector (the introducing step may be performed by injecting the binding agent into the bloodstream, eluting the binding agent from an implant within the body or ingestion of the binding agent into the body. In some embodiments, the assessing step is performed by impedance- based detection of the binding agent or by optical detection of the binding agent; Page 4; The method involves introducing a binding agent into the body that is capable of binding to one or more CMC of interest. The binding agent is typically injected into the body, but diffusion from an eluting component of the probe or a separate eluting implant, ingestion, or transfer into the body transdermally or by suppository may also be used; Page 9; The probe may further comprise an optional elution zone capable of retaining and releasing one or more substances such as drug compounds, reagents, anti-reagents or other substances; Page 39).
Claims 1, 21, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pawliszyn (U.S. Publication No. 2005/276727; cited by Applicant).
Regarding Claim 1, Pawliszyn discloses a medical sampling device for capturing bioanalytes (Multiple sampling device and method for investigating biological systems; Abstract), comprising:
a wire (wire 2) having a receptor part (extraction phase 4), the receptor part having receptors to bind target bioanalytes (The extraction phase 4 could be a polymeric layer prepared on the wire surface, particulate adsorptive or absorptive material glued or otherwise affixed to the wire surface, or immobilized biorecognition agents such as antibodies nucleotides or protein receptors; [0141]),
a channel device (medical catheter 10) defining a channel to receive the wire (Figure 2), the channel having a proximal end and a distal end, wherein the wire is movable with respect to the channel between at least an extended position in which at least an intravenous section of the receptor part extends from the distal end of the channel (FIG. 5, part B shows the extraction device supported in a thick tubing 6 for opening up the leaves of the needle end to allow exposure of extraction phase for sampling; [0150]) and a retracted position in which the intravenous section of the receptor part is retracted into the channel (When the device is in the retracted position the housing as seen in FIG. 5, part A; [0150]; Examiner’s Note: The Examiner notes wherein the limitation “wherein the wire is movable with respect to the channel between at least an extended position in which at least an intravenous section of the receptor part extends from the distal end of the channel and a retracted position in which the intravenous section of the receptor part is retracted into the channel” is a recitation of the intended use of the invention. It has been held that 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 satisfying the claimed structural limitations),
wherein the channel device comprises a liquid inlet (sealing septum 12 (PRN)) arranged proximally with respect to at least a part of the intravenous section of the receptor part when the wire is arranged in the retracted position ([0142-0144]).
Regarding Claim 21, Pawliszyn discloses wherein the wire is, in its retracted position completely housed within a closed space (When the device is in the retracted position the housing as seen in FIG. 5, part A, is constructed of a rigid tube 40 with a handle 46 and has a sealed tip 44 for penetrating soft tissue; [0150]).
Regarding Claim 24, Pawliszyn discloses wherein the sampling device comprises a seal arranged proximal of the liquid inlet, at least when the wire is in the retracted position, wherein the seal prevents at the seal liquid flow through the channel (sealing septum 12 (PRN). PRN is the commonly used term for an i.v. adapter to seal a catheter; [0142-0144]).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pison et al (U.S. Publication No. 2013/261373; cited by Applicant).
Regarding Claim 1, Pison discloses a medical sampling device for capturing bioanalytes, comprising:
a wire (guide element 1) having a receptor part (magnetic element 4), the receptor part having receptors to bind target bioanalytes (The magnetic element 4 in FIG. 2 may additionally have binding molecules on its surface which react with specific cells and/or molecules in the body of humans and animals and thereby permit an improved enrichment of specimen material in situ; [0117]),
a channel device (cannula 9) defining a channel to receive the wire, the channel having a proximal end and a distal end, wherein the wire is movable with respect to the channel between at least an extended position in which at least an intravenous section of the receptor part extends from the distal end of the channel and a retracted position in which the intravenous section of the receptor part is retracted into the channel (Figure 9; Examiner’s Note: The Examiner notes wherein the limitation “wherein the wire is movable with respect to the channel between at least an extended position in which at least an intravenous section of the receptor part extends from the distal end of the channel and a retracted position in which the intravenous section of the receptor part is retracted into the channel” is a recitation of the intended use of the invention. It has been held that 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 satisfying the claimed structural limitations),
wherein the channel device comprises a liquid inlet (iii. a port which is designed preferably on the adaptor and by means of which an infusion solution can be administered during the dwell time of the instrument in the patient's body; [0073]) arranged proximally with respect to at least a part of the intravenous section of the receptor part when the wire is arranged in the retracted position ([0073-0076]).
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.
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hoon et al.
Regarding Claim 8, Hoon fails to explicitly disclose wherein a length of the channel between the liquid inlet and the distal end of the channel is 0.5 to 2 times a length of the intravenous section, for example 1 to 1.5 times the length of the intravenous section.
However, there is no evidence of record that establishes that changing the length of the channel between the liquid inlet and the distal end of the channel would result in a difference in function of the device of Hoon. Further, a person having ordinary skill in the art, being faced with modifying the device of Hoon, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the length. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the channel between the liquid inlet and the distal end of the channel to be 0.5 to 2 times a length of the intravenous section as an obvious matter of design choice within the skill of the art.
Regarding Claim 20, Hoon fails to explicitly disclose wherein the length of the channel between the liquid inlet and the proximal end of the channel is more than the total translation of the wire between the retracted position and the extended position.
However, there is no evidence of record that establishes that changing the length of the channel between the liquid inlet and the proximal end of the channel would result in a difference in function of the device of Hoon. Further, a person having ordinary skill in the art, being faced with modifying the device of Hoon, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the length. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the channel between the liquid inlet and the proximal end of the channel to be more than the total translation of the wire between the retracted position and the extended position as an obvious matter of design choice within the skill of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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