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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “9” has been used to designate both “the device” and “the ramp face”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 16 is objected to because of the following informalities: the claim should be amended in line 3 to recite “…on a top” in order to provide antecedent basis for the claim terminology. Appropriate correction is required.
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.
Such claim limitation(s) is/are:
“means for gripping a guidewire” in claim 1. This limitation will be interpreted to mean a collet, one or more barbs, a clamp, a clamp ball, a grip washer, a steel insert, a cam lock, an o-ring, a duckbill and a wedge, as set forth in paragraph 20 of the published application, and functional equivalents thereof.
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 1-28 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.
Regarding claim 1, the claim recites that the main body component is located between a Luer hub component. This limitation then ends in a semicolon and proceeds to introduce a locking sleeve component. As such, it is not clear to what the main body component is between since the presence of a semicolon indicates a separate limitation. For examination purposes, the main body component is interpreted to be between the Luer hub component and the locking sleeve component. It is recommended to delete the semicolon as originally drafted.
Regarding claims 6, 11, and 18, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 6, the claim recites a plastics material which is “colourless or clear”. It is unclear what the term “colourless” encompasses and how it is distinguished from a “clear” material.
Claim 10 recites the limitation "the outside profile" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is further unclear to what structure “the outside profile” refers.
Regarding claim 24, the claim recites the gripper “effectively locks” the guidewire. It is unclear what the scope of the term “effectively locks” is and how the term is differentiated from a gripper which “locks” the guidewire.
Regarding claim 28, the claim recites “a gripper” in line 2. It is unclear if this gripper is the same as the “means for gripping” set forth in claim 1 or if this gripper is a separate structure. For examination purposes, the gripper of claim 28 is considered the same as the means recited in claim 1.
Further regarding claim 28, the claim is drawn to a lumen comprising a plurality of fenestrations, which are interpreted to mean “openings”. The lumen is the space which extends through the components and is defined by the device as a whole (claim 26) so that it does not appear to have structure on its own. As such, it is unclear how this lumen could have a plurality of fenestrations as it does not appear that a “lumen” could provide the structure for having a plurality of fenestrations.
Claims 2-5, 7-9, 12-17, 19-23, and 25-27 are also rejected by virtue of being dependent on claim 1.
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.
Claim(s) 1, 2, 5, 15, 16, 22, and 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chu (US 20020062106).
Regarding claim 1, Chu discloses a guide wire safety device, comprising: which comprises a main body component (distal body member 4 in fig. 3) located between a Luer hub component for connection to a Luer hub (proximal body portion 12 in fig. 3); and a locking sleeve component for connection to a catheter (hub 7 in fig. 2), wherein the main body component houses a means for gripping a guidewire (this limitation is being interpreted to mean a clamp, as discussed above; fig. 3-4B shows that distal body member 4 houses tubing member 22 entirely and partially houses compression member 24 within aperture 26; the tubing member 22 and the compression member 24 form a clamp).
Regarding claim 2, Chu discloses the means for gripping a guidewire includes a gripper (tube 22 and compression member 24 in fig. 3 form the “gripper”).
Regarding claim 5, Chu discloses the gripper is selected from a collet, one or more barbs, a clamp, a clamp ball, a grip washer, a steel insert, a cam lock, an o-ring, a duckbill and a wedge (compression member 24 is a clamp ball).
Regarding claim 15, Chu discloses the Luer hub component has an end for connection to a syringe (fig. 6D shows an end of proximal body member 12 receiving a syringe 54).
Regarding claim 16, Chu discloses the Luer hub component has an internal taper feature that allows connection to a standard syringe (see below).
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Regarding claim 22, Chu discloses the locking sleeve component moves freely in a rotational direction around the main body component (fig. 2 shows the flanged end of hub 7 screwed onto the female threads of distal body member 4 so that the hub can is capable of rotating around the distal body member).
Regarding claim 25, Chu discloses the gripper is capable of releasing a lock on the guidewire (fig. 2 and 2B shows that the compression ball 24 is capable of being moved to a position in fig. 2 which releases the lock shown in fig. 2B).
Regarding claim 26, Chu discloses defining at least one lumen which extends through the main body component, Luer hub component and locking sleeve component for allowing flushing fluid through the device (fig. 2).
Regarding claim 27, Chu discloses the lumen allows free passage of fluids through the device (fig. 2).
Claim(s) 1, 2, 5, 14-16, and 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brandt (US 4243034).
Regarding claim 1, Brandt discloses a guide wire safety device, comprising: which comprises a main body component (connecting housing 4 and flanges 13 in fig. 1) located between a Luer hub component for connection to a Luer hub (head 15 in fig. 1); and a locking sleeve component for connection to a catheter (socket 2 in fig. 1), wherein the main body component houses a means for gripping a guidewire (this limitation is being interpreted to mean a clamp, as discussed above; the hose section 7 and pressure bodies 9 form a clamp in fig. 1 and are capable of gripping a guidewire since the guidewire is only functionally recited).
Regarding claim 2, Brandt discloses the means for gripping a guidewire includes a gripper (hose section 7 and pressure bodies 9 in fig. 1 form the “gripper”).
Regarding claim 5, Brandt discloses the gripper is selected from a collet, one or more barbs, a clamp, a clamp ball, a grip washer, a steel insert, a cam lock, an o-ring, a duckbill and a wedge (fig. 1 shows pressure bodies 9 as “clamp balls”).
Regarding claim 14, Brandt discloses the Luer hub component is bonded to the main body component by either press fit retention, or using one or more bonding adhesives (fig. 1 shows head 15 retained by being pressed into sleeve 6).
Regarding claim 15, Brandt discloses the Luer hub component has an end for connection to a syringe (see below).
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Regarding claim 16, Brandt discloses the Luer hub component has an internal taper feature that allows connection to a standard syringe (see below).
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Regarding claim 25, Brandt discloses the gripper is capable of releasing a lock on the guidewire (3:53-4:3).
Regarding claim 26, Brandt discloses defining at least one lumen which extends through the main body component, Luer hub component and locking sleeve component for allowing flushing fluid through the device (cannula 16 in fig. 1 forms a lumen which extends through all components).
Regarding claim 27, Chu discloses the lumen allows free passage of fluids through the device (fluid can be introduced through cannula 16).
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu, as applied to claims 1 and 2 above, and further in view of Gallacher (US 20140100552).
Regarding claim 3, Chu discloses all of the claimed limitations set forth in claims 1 and 2, as discussed above, but does not teach or disclose the gripper allows free movement of a guidewire outwards towards the Luer hub component from the locking sleeve component and grips the guidewire to prevent movement of the guidewire through the device in an opposite direction away from the Luer hub component.
Gallacher is directed towards a guidewire safety device comprising a gripper (arms 104 in fig. 3) which allows free movement of a guidewire outwards towards the Luer hub component from the locking sleeve component and grips the guidewire to prevent movement of the guidewire through the device in an opposite direction away from the Luer hub component (paragraph 42). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the gripper of Chu to be the gripper of Gallacher so that the gripper allows free movement of a guidewire outwards towards the Luer hub component from the locking sleeve component and grips the guidewire to prevent movement of the guidewire through the device in an opposite direction away from the Luer hub component. This modification prevents migration of the guidewire into the body (paragraph 41).
Regarding claim 4, Chu discloses all of the claimed limitations set forth in claims 1 and 2, as discussed above, but does not teach or disclose the gripper is biased to grip a guidewire without requiring operator intervention if the guidewire is pulled or pushed through the device from the Luer hub towards the locking sleeve component.
As discussed above, Gallacher teaches a gripper configured to grip a guidewire (arms 104 in fig. 3) which is biased to grip a guidewire without requiring operator intervention if the guidewire is pulled or pushed through the device from the Luer hub towards the locking sleeve component (paragraph 42 discloses that spring 102 is biases arms to grip the guidewire). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the gripper of Chu to be the gripper of Gallacher instead with the arms and the spring. Gallacher teaches that this modification prevents guidewire migration into the body lumen (paragraph 41).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu, as applied to claim 1 above, and further in view of Thorne (US 5352215).
Regarding claim 6, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the main body component is manufactured by injection moulding or ultrasonic welding of a plastics material.
Thorne is directed towards a similarly configured main body component (male luer 3 in fig. 1) which is made of a plastic material (3:65-66). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the main body component of Chu to be made from a plastics material, as taught by Thorne, since Thorne teaches that this a moldable material (3:65-66).
It is noted by the examiner that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself and does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 227 USPQ 964. Therefore, as the step of injecting moulding does not impart a physical limitation which differentiates over the prior art, Chu modified with the teaching of Thorne is considered as reading on the limitation "main body component manufactured by injection moulding plastic materials" since the resulting structure is the same, namely a main body component comprised of plastic.
Claim(s) 7, 8, 9, 12 ,13, 17, 20, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu.
Regarding claims 7 and 12 , Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not explicitly teach or disclose the main body component has length of about 20mm to about 25mm [claim 7] and the luer hub component has a length of about 10mm to about 15 mm [claim 12].
There is no evidence of record that establishes that changing the length of the main body/luer hub component would result in a difference in function of the device of Chu. Further, a person having ordinary skill in the art, being faced with modifying the main body/luer hub component of Chu, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the claimed range is merely “preferable” (paragraphs 25 and 28 of the published application) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the length of the main body portion of Chu to be between 20mm-25mm and the length of the luer hub component of Chu to be between 10mm-15mm as an obvious matter of design choice within the skill of the art.
Regarding claims 8 and 13, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the main body component and the Luer hub component has a maximum outside diameter of about 8mm.
There is no evidence of record that establishes that changing the maximum outside diameters of the main body/luer hub component would result in a difference in function of the device of Chu. Further, a person having ordinary skill in the art, being faced with modifying the main body/luer hub component of Chu, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameters. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the claimed range (the examiner notes that the term “about” implies a range as the diameter can be slightly below 8mm and above 8mm) is merely “preferable” (paragraphs 24 and 29 of the published application) and the specification provides example diameters which are outside the range (paragraphs 83 and 91 of the published application disclose the maximum outside diameter can be about 10mm) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the maximum outside diameter of the main body component and the Luer hub component of Chu to be about 8mm as an obvious matter of design choice within the skill of the art.
Regarding claim 9, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the main body component has an internal empty volume of about 20mm3 to about 136mm3.
There is no evidence of record that establishes that changing the internal empty volume of the main body component would result in a difference in function of the device of Chu. Further, a person having ordinary skill in the art, being faced with modifying the main body component of Chu, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed volumes. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the claimed range is merely “preferable” (paragraph 25 of the published application) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the internal empty volume of the main body component of Chu to be between 20mm3 to about 136mm3 as an obvious matter of design choice within the skill of the art.
Regarding claim 17, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the Luer hub component has a lumen having a diameter of about 0.8mm to about 1mm.
There is no evidence of record that establishes that changing the lumen diameter of the luer hub component would result in a difference in function of the device of Chu. Further, a person having ordinary skill in the art, being faced with modifying the luer hub component of Chu, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameters. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the claimed range is merely “preferable” (paragraph 32 of the published application) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the lumen diameter of the luer hub component of Chu to be between 0.8mm-1mm as an obvious matter of design choice within the skill of the art.
The examiner notes that once modified, the luer hub diameter is greater than that of a guide wire which allows for free unrestricted movement of the guide wire through the Luer hub component since the guidewire is a functional element of the claim and the luer hub of modified Chu would be capable of being used with a guidewire having a diameter less than the luer hub diameter.
Regarding claim 20, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the locking sleeve component has a maximum outside diameter of about 10 mm to about 12 mm.
There is no evidence of record that establishes that changing the maximum outside diameter of the locking sleeve component would result in a difference in function of the device of Chu. Further, a person having ordinary skill in the art, being faced with modifying the locking sleeve component of Chu, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed maximum outside diameters. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the claimed range is merely “preferable” (paragraph 35 of the published application) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the maximum lumen diameter of the locking sleeve component of Chu to be between 10mm-12mm as an obvious matter of design choice within the skill of the art.
Regarding claim 28, Chu discloses all of the claimed limitations set forth in claims 1 and 26, as discussed above, and further discloses a fenestration between a gripper and an inner wall of the main body component (aperture 26 in fig. 3 is positioned between a portion of the inner wall below and an outer portion of the gripper), as best understood by the examiner. However, in this embodiment Chu does not teach a plurality of fenestrations.
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In a separate embodiment (fig. 23), Chu teaches a plurality of fenestrations (fig. 23). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the first embodiment of Chu to comprise two fenestrations with two compression balls, as taught by the second embodiment of Chu, as teaches that this is an alternative configuration to the first embodiment (paragraph 60) and which may assist in imparting even compression along the guidewire.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu, as applied to claim 1 above, and further in view of Windischiman (US 3752510).
Regarding claim 10, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, and further discloses an end of the main body component adjacent to the locking sleeve component has a shallow external inclusive angle (distal end 6 is shown to be tapered in fig. 2 and is adjacent a portion of locking sleeve component 7). However, Chu does not explicitly teach or disclose the angle being about 3.4 degrees.
Windischiman teaches a similarly configured male luer tip (surface 20 in in fig. 1) which comprises a taper angle of about 3.4 degrees (2:39-42 discloses a three degree angle). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the angle of the main body component and the internal angle of the locking sleeve component to be about 3.4 degrees, as taught by Windischiman, as it appears that Chu would operate equally well with this angle since Windischiman teaches that this angle provides a desired locking (2:33-37).
Regarding claim 11, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the Luer hub component is manufactured by injection moulding plastics.
Windischiman teaches a similar luer hub component (connector 12 in fig. 1) which is made from a plastic material (4:6-11). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the luer hub component of Chu to be made from a plastic material, as taught by Windischiman, in order to render the component moldable (4:6-11).
It is noted by the examiner that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself and does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 227 USPQ 964. Therefore, as the step of injecting moulding does not impart a physical limitation which differentiates over the prior art, Chu modified with the teaching of Windischman is considered as reading on the limitation "a luer hub component manufactured by injection moulding plastic materials" since the resulting structure is the same, namely a luer hub component comprised of plastic.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu, as applied to claim 1 above, and further in view of Gandras (US 20050113801).
Regarding claim 18, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose locking sleeve component is manufactured by injection moulding plastic materials.
Gandras teaches a similar locking sleeve component (hub 106 in fig. 1) which connects to a catheter (fig. 1) and which is made from a plastic material (paragraph 25 discloses a “hard plastic”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the locking sleeve component of Chu to be made from a plastic material, as taught by Gandras, as Gandras teaches that this type of material is a commonly known material in the art to manufacture catheter hubs.
It is noted by the examiner that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself and does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 227 USPQ 964. Therefore, as the step of injecting moulding does not impart a physical limitation which differentiates over the prior art, Chu modified with the teaching of Gandras is considered as reading on the limitation "a locking sleeve component manufactured by injection moulding plastic materials" since the resulting structure is the same, namely a locking sleeve component comprised of plastic.
Regarding claim 19, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the locking sleeve component has a length of about 10mm to about 15mm.
As discussed above, Gandras teaches a similar locking sleeve component (hub 106 in fig. 1) which comprises a length from about 10mm to 15mm (paragraph 25 discloses a length between 1-2 cm which equates to 10-20mm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the length of the locking sleeve component of Chu to comprise a length of about 10mm to about 15mm, as taught by Gandras, since Gandras teaches this length is effective as connecting to a catheter and it appears that the locking sleeve component of Chu would operate equally well with the claimed length.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu, as applied to claim 1 above, and further in view of Kugo (US 5304140).
Regarding claim 21, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the locking sleeve component is press fitted on to the main body component.
Kugo teaches a locking sleeve component (hub 4 in fig. 4) which is press fitted onto a main body component (hub 2 in fig. 4). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the connection between the locking sleeve and the main body component to be a press fit connection, as taught by Kugo, since Kugo teaches this connection is a suitable type of connection to couple guidewire and catheter hubs (fig. 4).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu, as applied to claim 1 above, and further in view of Graham (US 11458285).
Regarding claim 23, Chu discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose an internal thread is present in an internal bore of the locking sleeve component which allows for a secure screw connection to the catheter.
Graham teaches a locking sleeve component (luer lock connector 34 in fig. 5) which is connected to a catheter (catheter 14 in fig. 5) and which has an internal thread present on an internal bore (fig. 5; 4:55-58) which allows for a main body component (connector 36 in fig. 5) to have a secure screw connection to the catheter (fig. 5). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the locking sleeve component and the main body component of Chu to comprise an internal thread present on an internal bore and a mating external thread, respectively, as taught by Graham, as an alternative method of connecting the locking sleeve component and main body component which is equally effective and releasable.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu, as applied to claims 1 and 2 above, and further in view of Alokaili (US 20160008587 ).
Regarding claim 24, Chu discloses all of the claimed limitations set forth in claim 1, as discussed. While it appears that the device of Chu is fully capable of effectively locking the guidewire even if the guidewire is coated in body fluids, Chu does not explicitly teach or disclose this function.
Alokaili teaches a gripper (surface 30 in fig. 1A) which is coated with a material having a high coefficient of friction so to further limit or preclude any slipping of the guidewire (paragraph 26). It is the examiner’s opinion that this gripper coated with the coating would “effectively lock”, as best understood by the examiner, the guidewire when the guidewire is coated in body fluids. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the tube (22) of Chu to be coated with a coating having a high coefficient of friction, as taught by Alokaili, so to preclude any slippage of the guidewire (paragraph 26).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783