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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 2/3/2026 has been entered.
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.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 1 is objected to because of the following informalities:
in claim 1, line 4: “and wherein” should be deleted;
in claim 1, line 5: “wherein” should be inserted before “the stylet (21) is”;
in claim 1, line 9: “wherein” should be inserted before “the stylet (21) is”;
in claim 1, line 11: “wherein” should be inserted before “a predetermined needle-stylet”; and
in claim 1, line 14: “wherein” should be inserted before “a value of the predetermined needle-stylet release torque”.
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.
Claim 13 is 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 13 recites “wherein the anesthesia needle (11) is slidably inserted within the stylet (21)” in lines 1-2, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
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.
Claims 1-4, 10, 12-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,743,881 (Demco)(previously cited), in view of U.S. Patent Application Publication No. 2008/0065017 (Racz)(previously cited), and further in view of U.S. Patent No. 5,620,427 (Werschmidt)(previously cited) and JP 2004254789 A (Takehiko). Citations to Takehiko will refer to the machine English translation that accompanies this Office Action.
First Interpretation
Demco teaches a coaxial needle assembly for introduction into and through human tissue, comprising an anesthesia needle (the needle member 16 of Demco), a stylet (the trocar 14 of Demco) and a coaxial cannula (the cannula 12 of Demco), wherein
the anesthesia needle (the needle member 16 of Demco) is inserted in the stylet (the trocar 14 of Demco) and has a distal end (the needle 42 of Demco) that projects out from a distal end (the distal tip 33’ of Demco) of the stylet, and wherein
the stylet (the trocar 14 of Demco) is inserted in the coaxial cannula (the cannula 12 of Demco) and has a distal end (the distal tip 33’ of Demco) of the stylet that projects out from a distal end (the distal tip 18’ of Demco) of the coaxial cannula, such that, during introduction into and through the human tissue, the coaxial needle assembly (the instrument 10 of Demco) acts and is manipulated as an integrated device, and
the stylet (the trocar 14 of Demco) is fixedly but detachably connected to the coaxial cannula (the cannula 12 of Demco) and the anesthesia needle (the needle member 16 of Demco) is fixedly but detachably connected to the stylet (the trocar 14 of Demco).
Demco teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is released from the stylet (the trocar 14 of Demco) since the needle member 16 is released from the trocar 14 via the pins 44 and the channels 46 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of Luer-Lock fittings in the same context (paragraph 0036 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Luer-Lock fittings in place of the pins 44 and the channels 46 since it is a simple substitution of one known element for another to obtain predictable results.
Demco teaches or suggests that the stylet (the trocar 14 of Demco) is released from the coaxial cannula (the cannula 12 of Demco) since the trocar 14 is released from the cannula 12 via the pins 32 and the channels 30 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of Luer-Lock fittings in the same context (paragraphs 0040-0041 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Luer-Lock fittings in place of the pins 32 and the channels 30 since it is a simple substitution of one known element for another to obtain predictable results.
As to the value of the torques relative to each other, there is a need to determine these relative torques for the device to operate. Also, there is a finite number of identified, predictable solutions to this problem because there are three possible solutions: the two torques are the same, the stylet-cannula release torque is greater than the needle-stylet release torque, or the needle-stylet release torque is greater than the stylet-cannula release torque. Further, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success since determining a good fit and good release for the lock mechanisms is a predictable art that a mechanical designer is well versed. Furthermore, of the three possible solutions, the solution of the two torques being the same would be the least likely since equality is very difficult to achieve given real-world manufacturing tolerances and user strength/preferences such that it would have been obvious not to choose or even achieve this potential solution.
Alternatively or additionally, the tightening of the Luer-Lock connections would be subject to optimization depending upon the strength and preference of the user (that is, how tight the user screws the mating components of the Luer-Lock connections to each other (“The relative axial position of the hub 24 with respect to the male luer component 26 is determined by the amount of tightening torque applied thereto, which can differ from operator to operator” (col. 7, lines 10-15 of Werschmidt)). Also, the dimensions of each Luer-Lock connection can be modified to suit the particular needs of any particular use environment (col. 9, lines 40-55 of Werschmidt). For example, a larger-sized Luer-Lock connection with a greater potential release torque would be used for the larger diametrical connection between the trocar 14 and the cannula 12 and a smaller-sized Luer-Lock connection with a lower potential release torque would be used for the smaller diametrical connection between the trocar 14 and the needle member 16 of Demco (See FIG. 2 of Demco for the size disparities between the connections) due to the increased surface area and bulk of the larger-sized Luer-Lock connection relative to the smaller-sized Luer-Lock connection. Further, the amount of release torque can vary over a range of torques for a Luer-Lock. Takehiko teaches, for example, that the release torque for a Luer-Lock connection can range as much as 5 to 50 cN·m (paragraphs 0017 and 0027 of Takehiko). As such, the release torques of the Luer-Lock connections are subject to change, would depend upon the strength and preference of the user (that is, how tight the user attaches the mating components of the connections to each other and the desired dimensions of the Luer-Lock fittings, and are results-effective variables that would have been optimized through routine experimentation based on the strength and preference of the user and the desired dimensions of the Luer-Lock fittings. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the release torques of the Luer-Lock connections, using a larger-sized Luer-Lock connection with a greater potential release torque for the larger diametrical connection between the trocar 14 and the cannula 12 and a smaller-sized Luer-Lock connection with a lower potential release torque for the smaller diametrical connection between the trocar 14 and the needle member 16 of Demco and the range of Takehiko as starting points, so as to obtain the desired user preferences based on their strength and the desired dimensions of the Luer-Lock fittings.
In view of the above, the features of “a value of the predetermined needle-stylet release torque is less than a value of the predetermined stylet-cannula release torque, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque” of claim 1 and “wherein the stylet-cannula release torque is predetermined to be between 0.08 and 0.15 Nm” of claim 12 would have been obvious.
With respect to claim 1, the combination teaches or suggests a coaxial needle assembly for introduction into and through human tissue, comprising an anesthesia needle (the needle member 16 of Demco), a stylet (the trocar 14 of Demco), and a coaxial cannula (the cannula 12 of Demco), wherein
the anesthesia needle (the needle member 16 of Demco) is inserted in the stylet (the trocar 14 of Demco) and has a distal end (the needle 42 of Demco) that projects out from a distal end (the distal tip 33’ of Demco) of the stylet, and wherein
the stylet (the trocar 14 of Demco) is inserted in the coaxial cannula (the cannula 12 of Demco) and has a distal end (the distal tip 33’ of Demco) of the stylet that projects out from a distal end (the distal tip 18’ of Demco) of the coaxial cannula, such that, during introduction into and through the human tissue, the coaxial needle assembly (the instrument 10 of Demco) acts and is manipulated as an integrated device,
the stylet (the trocar 14 of Demco) is fixedly but detachably connected to the coaxial cannula (the cannula 12 of Demco) and the anesthesia needle (the needle member 16 of Demco) is fixedly but detachably connected to the stylet (the trocar 14 of Demco)(via the pair of Luer-Lock connections),
a predetermined needle-stylet release torque is required to release the anesthesia needle (the needle member 16 of Demco) from the stylet (the trocar 14 of Demco), and predetermined stylet-cannula release torque is required to release the stylet (the trocar 14 of Demco) from the coaxial cannula (the cannula 12 of Demco), and a value of the predetermined needle-stylet release torque is less than a value of the predetermined stylet-cannula release torque, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque (see the above obvious reasoning based on the optimization rationale).
With respect to claim 2, the combination teaches or suggests that the anesthesia needle (the needle member 16 of Demco) at its proximal end is provided with a needle handle (the element A in the below annotated FIG. 1 of Demco with a Luer-Lock fitting at the distal end) and at a distal end of the needle handle of the anesthesia needle is a needle-stylet connector (the Luer-Lock fitting at the distal end) provided; the stylet (the trocar 14 of Demco) at its proximal end is provided with a stylet handle (the element B in the below annotated FIG. 1 of Demco with the Luer-Lock fitting at the proximal end and the Luer-Lock fitting at the distal end) and at a distal end of the stylet handle is a stylet-cannula connector (the Luer-Lock fitting at the distal end) provided, and at a proximal end of the stylet handle is a stylet-needle connector (the Luer-Lock fitting at the proximal end) provided; the coaxial cannula (the cannula 12 of Demco) at its proximal end is provided with a cannula handle (the handling portion 20 of Demco) and at a proximal end of the cannula handle (the handling portion 20 of Demco) is a cannula-stylet connector (the Luer-Lock fitting at the proximal end) provided; the needle-stylet connector of the anesthesia needle is engaged with the stylet-needle connector of the stylet, forming a needle-stylet connector pair (the Luer-Lock connection), and the stylet-cannula connector of the stylet is engaged with the cannula-stylet connector forming a stylet-cannula connector pair (the Luer-Lock connection); and the predetermined needle-stylet release torque is provided by the needle-stylet connector being engaged with the stylet-needle connector and the predetermined stylet-cannula release torque is provided by the stylet-cannula connector being engaged with the cannula-stylet connector (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
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Annotated FIG. 1 of Demco
With respect to claim 3, the combination teaches or suggests that the stylet-cannula connector pair is arranged to have a first predetermined friction between the cannula-stylet connector and the stylet-cannula connector (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
With respect to claim 4, the combination teaches or suggests that the needle-stylet connector pair is arranged to have a second predetermined friction between the needle-stylet connector and the stylet-needle connector, and said predetermined friction determines the needle-stylet release torque (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
With respect to claim 10, the combination teaches or suggests that the stylet-cannula connector pair is provided with a breakable fixture, the breakable fixture being arranged to break at the predetermined stylet-cannula release torque and thereby forming a one-time locking arrangement (the frictional arrangement between the fittings of the Luer-Lock connection is breakable and forms a different locking arrangement each time).
With respect to claim 12, see the above obvious reasoning based on the optimization rationale.
With respect to claim 13, the combination teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is slidably inserted within the stylet (the trocar 14 of Demco)(col. 2, lines 35-50 of Demco).
With respect to claim 14, the combination teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is inserted in the stylet (the trocar 14 of Demco) and has a distal end (the needle 42 of Demco) that projects out from a distal end (the distal tip 33’ of Demco) of the stylet. Demco further teaches that the needle 42 may be of various gauges and lengths depending on the patient requirements (col. 5, lines 50-60 of Demco). Thus, Demco teaches that the length of the needle 42 is subject to change depending upon the patient requirements. As such, the length of the needle 42 is a results-effective variable that would have been optimized through routine experimentation based on the patient requirements. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the length of the needle 42 so as to obtain the desired patient requirement. Thus, the feature of “wherein the distal end (the needle 42 of Demco) of the anesthesia needle (the needle member 16 of Demco) projects 10-30 mm out from the distal end (the distal tip 33’ of Demco) of the stylet (the trocar 14 of Demco)” would have been obvious. Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 2144.04).
With respect to claim 16, the combination teaches or suggests that the needle-stylet connector pair is arranged to a have a second predetermined friction between the needle-stylet connector and the stylet-needle connector, and said second predetermined friction determines the needle-stylet release torque (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
Second Interpretation
Demco teaches a coaxial needle assembly for introduction into and through human tissue, comprising an anesthesia needle (the needle member 16 of Demco), a stylet (the trocar 14 of Demco), and a coaxial cannula (the cannula 12 of Demco), wherein
the anesthesia needle (the needle member 16 of Demco) is inserted in the stylet (the trocar 14 of Demco) and has a distal end (the needle 42 of Demco) that projects out from a distal end (the distal tip 33’ of Demco) of the stylet, and wherein
the stylet (the trocar 14 of Demco) is inserted in the coaxial cannula (the cannula 12 of Demco) and has a distal end (the distal tip 33’ of Demco) of the stylet that projects out from a distal end (the distal tip 18’ of Demco) of the coaxial cannula, such that, during introduction into and through the human tissue, the coaxial needle assembly (the instrument 10 of Demco) acts and is manipulated as an integrated device, and
the stylet (the trocar 14 of Demco) is fixedly but detachably connected to the coaxial cannula (the cannula 12 of Demco) and the anesthesia needle (the needle member 16 of Demco) is fixedly but detachably connected to the stylet (the trocar 14 of Demco).
Demco teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is released from the stylet (the trocar 14 of Demco) since the needle member 16 is released from the trocar 14 via the pins 44 and the channels 46 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of Luer-Lock fittings in the same context (paragraph 0036 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Luer-Lock fittings in place of the pins 44 and the channels 46 since it is a simple substitution of one known element for another to obtain predictable results.
Demco teaches or suggests that the stylet (the trocar 14 of Demco) is released from the coaxial cannula (the cannula 12 of Demco) since the trocar 14 is released from the cannula 12 via the pins 32 and the channels 30 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of a frictional arrangement of FIG. 3E of Racz in the same context (paragraphs 0041 and 0046 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the frictional arrangement of FIG. 3E of Racz in place of the pins 32 and the channels 30 since it is a simple substitution of one known element for another to obtain predictable results.
As to the value of the torques relative to each other, there is a need to determine these relative torques for the device to operate. Also, there is a finite number of identified, predictable solutions to this problem because there are three possible solutions: the two torques are the same, the stylet-cannula release torque is greater than the needle-stylet release torque, or the needle-stylet release torque is greater than the stylet-cannula release torque. Further, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success since determining a good fit and good release for the lock mechanisms is a predictable art that a mechanical designer is well versed. Furthermore, of the three possible solutions, the solution of the two torques being the same would be the least likely since equality is very difficult to achieve given real-world manufacturing tolerances and user strength/preferences such that it would have been obvious not to choose or even achieve this potential solution.
Alternatively or additionally, the tightening of the Luer-Lock connection and the frictional arrangement would be subject to optimization depending upon the strength and preference of the user (that is, how tight the user attaches the mating components of the connections to each other (“The relative axial position of the hub 24 with respect to the male luer component 26 is determined by the amount of tightening torque applied thereto, which can differ from operator to operator” (col. 7, lines 10-15 of Werschmidt)). Also, the dimensions of the Luer-Lock fitting can be modified to suit the particular needs of any particular use environment (col. 9, lines 40-55 of Werschmidt). Further, the amount of release torque can vary over a range of torques for a Luer-Lock. Takehiko teaches, for example, that the release torque for a Luer-Lock connection can range as much as 5 to 50 cN·m (paragraphs 0017 and 0027 of Takehiko). As such, the relative release torques of the Luer-Lock connection and the frictional arrangement are subject to change, would depend upon the strength and preference of the user and the desired dimensions of the Luer-Lock fittings and the frictional arrangement, and are results-effective variables that would have been optimized through routine experimentation based on the strength and preference of the user and the desired dimensions of the Luer-Lock fittings and the frictional arrangement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the release torques of the Luer-Lock connection and the frictional arrangement, using the range of Takehiko as a starting point, so as to obtain the desired user preferences based on their strength and the desired dimensions of the Luer-Lock connection and the frictional arrangement.
In view of the above, the features of “a value of the predetermined needle-stylet release torque is less than a value of the predetermined stylet-cannula release torque, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque” of claim 1 and “wherein the stylet-cannula release torque is predetermined to be between 0.08 and 0.15 Nm” of claim 12 would have been obvious.
With respect to claim 1, the combination teaches or suggests a coaxial needle assembly for introduction into and through human tissue, comprising an anesthesia needle (the needle member 16 of Demco), a stylet (the trocar 14 of Demco) and a coaxial cannula (the cannula 12 of Demco), wherein
the anesthesia needle (the needle member 16 of Demco) is inserted in the stylet (the trocar 14 of Demco) and has a distal end (the needle 42 of Demco) that projects out from a distal end (the distal tip 33’ of Demco) of the stylet, and wherein
the stylet (the trocar 14 of Demco) is inserted in the coaxial cannula (the cannula 12 of Demco) and has a distal end (the distal tip 33’ of Demco) of the stylet that projects out from a distal end (the distal tip 18’ of Demco) of the coaxial cannula, such that, during introduction into and through the human tissue, the coaxial needle assembly (the instrument 10 of Demco) acts and is manipulated as an integrated device,
the stylet (the trocar 14 of Demco) is fixedly but detachably connected to the coaxial cannula (the cannula 12 of Demco) and the anesthesia needle (the needle member 16 of Demco) is fixedly but detachably connected to the stylet (the trocar 14 of Demco)(via the Luer-Lock connection and the frictional arrangement),
a predetermined needle-stylet release torque is required to release the anesthesia needle (the needle member 16 of Demco) from the stylet (the trocar 14 of Demco), and predetermined stylet-cannula release torque is required to release the stylet (the trocar 14 of Demco) from the coaxial cannula (the cannula 12 of Demco), and a value of the predetermined needle-stylet release torque is less than a value of the predetermined stylet-cannula release torque, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque (see the above obvious reasoning based on the optimization rationale).
With respect to claim 2, the combination teaches or suggests that the anesthesia needle (the needle member 16 of Demco) at its proximal end is provided with a needle handle (the element A in the above annotated FIG. 1 of Demco with a Luer-Lock fitting at the distal end) and at a distal end of the needle handle of the anesthesia needle is a needle- stylet connector (the Luer-Lock fitting at the distal end) provided; the stylet (the trocar 14 of Demco) at its proximal end is provided with a stylet handle (the element B in the above annotated FIG. 1 of Demco with the Luer-Lock fitting at the proximal end and the frictional arrangement at the distal end) and at a distal end of the stylet handle is a stylet-cannula connector (the frictional arrangement at the distal end) provided, and at a proximal end of the stylet handle is a stylet-needle connector (the Luer-Lock fitting at the proximal end) provided; the coaxial cannula (the cannula 12 of Demco) at its proximal end is provided with a cannula handle (the handling portion 20 of Demco) and at a proximal end of the cannula handle (the handling portion 20 of Demco) is a cannula-stylet connector (the frictional arrangement at the proximal end) provided; the needle-stylet connector of the anesthesia needle is engaged with the stylet- needle connector of the stylet, forming a needle-stylet connector pair (the Luer-Lock connection), and the stylet-cannula connector of the stylet is engaged with the cannula-stylet connector forming a stylet-cannula connector pair (the frictional arrangement); and the predetermined needle-stylet release torque is provided by the needle-stylet connector being engaged with the stylet-needle connector and the predetermined stylet-cannula release torque is provided by the stylet-cannula connector being engaged with the cannula-stylet connector (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
With respect to claim 3, the combination teaches or suggests that the stylet-cannula connector pair is arranged to have a first predetermined friction between the cannula-stylet connector and the stylet-cannula connector (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
With respect to claim 4, the combination teaches or suggests that the needle-stylet connector pair is arranged to have a second predetermined friction between the needle-stylet connector and the stylet-needle connector, and said predetermined friction determines the needle-stylet release torque (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
With respect to claim 10, the combination teaches or suggests that the stylet-cannula connector pair is provided with a breakable fixture, the breakable fixture being arranged to break at the predetermined stylet-cannula release torque and thereby forming a one-time locking arrangement (the frictional arrangement is breakable and forms a different locking arrangement each time).
With respect to claim 12, see the above obvious reasoning based on the optimization rationale.
With respect to claim 13, the combination teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is slidably inserted within the stylet (the trocar 14 of Demco)(col. 2, lines 35-50 of Demco).
With respect to claim 14, the combination teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is inserted in the stylet (the trocar 14 of Demco) and has a distal end (the needle 42 of Demco) that projects out from a distal end (the distal tip 33’ of Demco) of the stylet. Demco further teaches that the needle 42 may be of various gauges and lengths depending on the patient requirements (col. 5, lines 50-60 of Demco). Thus, Demco teaches that the length of the needle 42 is subject to change depending upon the patient requirements. As such, the length of the needle 42 is a results-effective variable that would have been optimized through routine experimentation based on the patient requirements. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the length of the needle 42 so as to obtain the desired patient requirement. Thus, the feature of “wherein the distal end (the needle 42 of Demco) of the anesthesia needle (the needle member 16 of Demco) projects 10-30 mm out from the distal end (the distal tip 33’ of Demco) of the stylet (the trocar 14 of Demco)” would have been obvious. Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 2144.04).
With respect to claim 16, the combination teaches or suggests that the needle-stylet connector pair is arranged to a have a second predetermined friction between the needle-stylet connector and the stylet-needle connector, and said second predetermined friction determines the needle-stylet release torque (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
Third Interpretation
Demco teaches a coaxial needle assembly for introduction into and through human tissue, comprising an anesthesia needle (the needle member 16 of Demco), a stylet (the trocar 14 of Demco) and a coaxial cannula (the cannula 12 of Demco), wherein
the anesthesia needle (the needle member 16 of Demco) is inserted in the stylet (the trocar 14 of Demco) and has a distal end (the needle 42 of Demco) that projects out from a distal end (the distal tip 33’ of Demco) of the stylet, and wherein
the stylet (the trocar 14 of Demco) is inserted in the coaxial cannula (the cannula 12 of Demco) and has a distal end (the distal tip 33’ of Demco) of the stylet that projects out from a distal end (the distal tip 18’ of Demco) of the coaxial cannula, such that, during introduction into and through the human tissue, the coaxial needle assembly (the instrument 10 of Demco) acts and is manipulated as an integrated device, and
the stylet (the trocar 14 of Demco) is fixedly but detachably connected to the coaxial cannula (the cannula 12 of Demco) and the anesthesia needle (the needle member 16 of Demco) is fixedly but detachably connected to the stylet (the trocar 14 of Demco).
Demco teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is released from the stylet (the trocar 14 of Demco) since the needle member 16 is released from the trocar 14 via the pins 44 and the channels 46 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of a tab-bay arrangement of FIG. 3G of Racz in the same context (paragraphs 0041 and 0048 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the tab-bay arrangement of FIG. 3G of Racz in place of the pins 44 and the channels 46 since it is a simple substitution of one known element for another to obtain predictable results.
Demco teaches or suggests that the stylet (the trocar 14 of Demco) is released from the coaxial cannula (the cannula 12 of Demco) since the trocar 14 is released from the cannula 12 via the pins 32 and the channels 30 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of Luer-Lock fittings in the same context (paragraphs 0040-0041 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Luer-Lock fittings in place of the pins 32 and the channels 30 since it is a simple substitution of one known element for another to obtain predictable results.
As to the value of the torques relative to each other, there is a need to determine these relative torques for the device to operate. Also, there is a finite number of identified, predictable solutions to this problem because there are three possible solutions: the two torques are the same, the stylet-cannula release torque is greater than the needle-stylet release torque, or the needle-stylet release torque is greater than the stylet-cannula release torque. Further, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success since determining a good fit and good release for the lock mechanisms is a predictable art that a mechanical designer is well versed. Furthermore, of the three possible solutions, the solution of the two torques being the same would be the least likely since equality is very difficult to achieve given real-world manufacturing tolerances and user strength/preferences such that it would have been obvious not to choose or even achieve this potential solution. Furthermore, the tab-bay arrangement has a low release torque, if any, since Racz does not disclose that friction is a primary mechanism for connecting the tab-bay arrangement together.
Alternatively or additionally, the tightening of the Luer-Lock connection and the tab-bay arrangement would be subject to optimization depending upon the strength and preference of the user (that is, how tight the user attaches the mating components of the connections to each other (“The relative axial position of the hub 24 with respect to the male luer component 26 is determined by the amount of tightening torque applied thereto, which can differ from operator to operator” (col. 7, lines 10-15 of Werschmidt)). Also, the dimensions of the Luer-Lock fitting can be modified to suit the particular needs of any particular use environment (col. 9, lines 40-55 of Werschmidt). Further, the amount of release torque can vary over a range of torques for a Luer-Lock. Takehiko teaches, for example, that the release torque for a Luer-Lock connection can range as much as 5 to 50 cN·m (paragraphs 0017 and 0027 of Takehiko). Furthermore, Racz does not disclose that friction is a primary mechanism for connecting the tab-bay arrangement together. As such, the release torques of the Luer-Lock connection and the tab-bay arrangement are subject to change, would depend upon the strength and preference of the user and the desired dimensions of the Luer-Lock fitting and the tab-bay arrangement, and are results-effective variables that would have been optimized through routine experimentation based on the strength and preference of the user and the desired dimensions of the Luer-Lock fitting and the tab-bay arrangement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the release torques of the Luer-Lock connection and the tab-bay arrangement, using that the fact that Racz does not disclose that friction is a primary mechanism for connecting the tab-bay arrangement together and the range of torques suggested by Takehiko as starting points, so as to obtain the desired user preferences based on their strength and the desired dimensions of the Luer-Lock connection and the tab-bay arrangement.
In view of the above, the features of “a value of the predetermined needle-stylet release torque is less than a value of the predetermined stylet-cannula release torque, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque” of claim 1 and “wherein the stylet-cannula release torque is predetermined to be between 0.08 and 0.15 Nm” of claim 12 would have been obvious.
With respect to claim 1, the combination teaches or suggests a coaxial needle assembly for introduction into and through human tissue, comprising an anesthesia needle (the needle member 16 of Demco), a stylet (the trocar 14 of Demco) and a coaxial cannula (the cannula 12 of Demco), wherein
the anesthesia needle (the needle member 16 of Demco) is inserted in the stylet (the trocar 14 of Demco) and has a distal end (the needle 42 of Demco) that projects out from a distal end (the distal tip 33’ of Demco) of the stylet, and wherein
the stylet (the trocar 14 of Demco) is inserted in the coaxial cannula (the cannula 12 of Demco) and has a distal end (the distal tip 33’ of Demco) of the stylet that projects out from a distal end (the distal tip 18’ of Demco) of the coaxial cannula, such that, during introduction into and through the human tissue, the coaxial needle assembly (the instrument 10 of Demco) acts and is manipulated as an integrated device,
the stylet (the trocar 14 of Demco) is fixedly but detachably connected to the coaxial cannula (the cannula 12 of Demco) and the anesthesia needle (the needle member 16 of Demco) is fixedly but detachably connected to the stylet (the trocar 14 of Demco)(via the Luer-Lock connection and tab-bay arrangement),
a predetermined needle-stylet release torque is required to release the anesthesia needle (the needle member 16 of Demco) from the stylet (the trocar 14 of Demco), and predetermined stylet-cannula release torque is required to release the stylet (the trocar 14 of Demco) from the coaxial cannula (the cannula 12 of Demco), and a value of the predetermined needle-stylet release torque is less than a value of the predetermined stylet-cannula release torque, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque (see the above obvious reasoning based on the optimization rationale).
With respect to claim 2, the combination teaches or suggests that the anesthesia needle (the needle member 16 of Demco) at its proximal end is provided with a needle handle (the element A in the above annotated FIG. 1 of Demco with the tags for the tag-bay arrangement at the distal end) and at a distal end of the needle handle of the anesthesia needle is a needle-stylet connector (the tags for the tag-bay arrangement at the distal end) provided; the stylet (the trocar 14 of Demco) at its proximal end is provided with a stylet handle (the element B in the above annotated FIG. 1 of Demco with the bays for the tag-bay arrangement at the proximal end and the Luer-Lock fitting at the distal end) and at a distal end of the stylet handle is a stylet-cannula connector (the Luer-Lock fitting at the distal end) provided, and at a proximal end of the stylet handle is a stylet-needle connector (the bays for the tag-bay arrangement at the proximal end) provided; the coaxial cannula (the cannula 12 of Demco) at its proximal end is provided with a cannula handle (the handling portion 20 of Demco) and at a proximal end of the cannula handle (the handling portion 20 of Demco) is a cannula-stylet connector (the Luer-Lock fitting at the proximal end) provided; the needle-stylet connector of the anesthesia needle is engaged with the stylet-needle connector of the stylet, forming a needle-stylet connector pair (the tag-bay arrangement), and the stylet-cannula connector of the stylet is engaged with the cannula-stylet connector forming a stylet-cannula connector pair (the Luer-Lock connection); and the predetermined needle-stylet release torque is provided by the needle-stylet connector being engaged with the stylet-needle connector and the predetermined stylet-cannula release torque is provided by the stylet-cannula connector being engaged with the cannula-stylet connector (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
With respect to claim 3, the combination teaches or suggests that the stylet-cannula connector pair is arranged to have a first predetermined friction between the cannula-stylet connector and the stylet-cannula connector (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
With respect to claim 4, the combination teaches or suggests that the needle-stylet connector pair is arranged to have a second predetermined friction between the needle-stylet connector and the stylet-needle connector, and said predetermined friction determines the needle-stylet release torque (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
With respect to claim 10, the combination teaches or suggests that the stylet-cannula connector pair is provided with a breakable fixture, the breakable fixture being arranged to break at the predetermined stylet-cannula release torque and thereby forming a one-time locking arrangement (the fittings of the Luer-Lock connection are breakable and forms a different locking arrangement each time).
With respect to claim 12, see the above obvious reasoning based on the optimization rationale.
With respect to claim 13, the combination teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is slidably inserted within the stylet (the trocar 14 of Demco)(col. 2, lines 35-50 of Demco).
With respect to claim 14, the combination teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is inserted in the stylet (the trocar 14 of Demco) and has a distal end (the needle 42 of Demco) that projects out from a distal end (the distal tip 33’ of Demco) of the stylet. Demco further teaches that the needle 42 may be of various gauges and lengths depending on the patient requirements (col. 5, lines 50-60 of Demco). Thus, Demco teaches that the length of the needle 42 is subject to change depending upon the patient requirements. As such, the length of the needle 42 is a results-effective variable that would have been optimized through routine experimentation based on the patient requirements. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the length of the needle 42 so as to obtain the desired patient requirement. Thus, the feature of “wherein the distal end (the needle 42 of Demco) of the anesthesia needle (the needle member 16 of Demco) projects 10-30 mm out from the distal end (the distal tip 33’ of Demco) of the stylet (the trocar 14 of Demco)” would have been obvious. Alternatively or additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 2144.04).
With respect to claim 16, the combination teaches or suggests that the needle-stylet connector pair is arranged to a have a second predetermined friction between the needle-stylet connector and the stylet-needle connector, and said second predetermined friction determines the needle-stylet release torque (col. 4, line 60 to col. 5, line 60 of Demco; see the above obvious reasoning based on the optimization rationale).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Demco, in view of Racz, and further in view of Werschmidt and Takehiko, and further in view of U.S. Patent Application Publication No. 2017/0049993 (Cosman)(previously cited).
Cosman teaches the use of echogenic markers on needles (including anesthetic needles) so as to enhance visibility when viewed with ultrasound imaging (paragraphs 0048 and 0051-0052 of Cosman). Such markers are provided along the shaft of the needle including the distal end portion (FIG. 1 of Cosman). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide echogenic markings along the length of the anesthesia needle including the distal end portion of the anesthesia needle since it enhances visibility when viewed with ultrasound imaging so as to ensure proper position of the needle.
With respect to claim 15, the combination teaches or suggests that a distal end portion of the anesthesia needle (the needle member 16 of Demco) is provided with at least one echogenic marking (the echogenic markings of Cosman).
Response to Arguments
The Applicant’s arguments filed 2/3/2026 have been fully considered.
Claim objections
In view of the claim amendments submitted on 2/3/2026, the claim objections are withdrawn. However, there are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments submitted on 2/3/2026, the claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
However, there are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Prior art rejection
With respect to the prior art rejections based on Demco, the Applicant asserts:
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This argument is not persuasive. In response to the Applicant’s argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The Applicant’s arguments with respect to the First Interpretation
Demco teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is released from the stylet (the trocar 14 of Demco) since the needle member 16 is released from the trocar 14 via the pins 44 and the channels 46 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of Luer-Lock fittings in the same context (paragraph 0036 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Luer-Lock fittings in place of the pins 44 and the channels 46 since it is a simple substitution of one known element for another to obtain predictable results. Also, Demco teaches or suggests that the stylet (the trocar 14 of Demco) is released from the coaxial cannula (the cannula 12 of Demco) since the trocar 14 is released from the cannula 12 via the pins 32 and the channels 30 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of Luer-Lock fittings in the same context (paragraphs 0041 and 0046 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Luer-Lock fittings in place of the pins 32 and the channels 30 since it is a simple substitution of one known element for another to obtain predictable results.
The combination has two Luer-Lock connections, both of which have release torques. One of ordinary skill in the art would have understood that the respective release torques would have been different. In particular, the solution of the two torques being the same would be the least likely possibility of the relative release torques between the two Luer-Lock connections since equality is very difficult to achieve given real-world manufacturing tolerances and user strength/preferences. Thus, one torque would be greater than the other. Also, the tightening of the Luer-Lock connections would be subject to optimization depending upon the strength and preference of the user (that is, how tight the user attaches the mating components of the connections to each other (“The relative axial position of the hub 24 with respect to the male luer component 26 is determined by the amount of tightening torque applied thereto, which can differ from operator to operator” (col. 7, lines 10-15 of Werschmidt)) and the dimensions of each Luer-Lock fitting can be modified to suit the particular needs of any particular use (col. 9, lines 40-55 of Werschmidt). For example, a larger-sized Luer-Lock connection with a greater potential release torque would be used for the larger diametrical connection between the trocar 14 and the cannula 12 and a smaller-sized Luer-Lock connection with a lower potential release torque would be used for the smaller diametrical connection between the trocar 14 and the needle member 16 of Demco (See FIG. 2 of Demco for the size disparities between the connections). Further, the amount of release torque can vary over a range of torques for a Luer-Lock. Takehiko teaches, for example, that the release torque for a Luer-Lock connection can range as much as 5 to 50 cN·m (paragraphs 0017 and 0027 of Takehiko). As such, the release torques of the pair of Luer-Lock connections are subject to change, would depend upon the strength and preference of the user and the desired dimensions of the Luer-Lock fittings, and are results-effective variables that would have been optimized through routine experimentation based on the strength and preference of the user (that is, how tight the user attaches the mating components of the connections to each other and the desired dimensions of the Luer-Lock fittings. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the release torques of the pair of Luer-Lock connections, using a larger-sized Luer-Lock connection with a greater potential release torque for the larger diametrical connection between the trocar 14 and the cannula 12 and a smaller-sized Luer-Lock connection with a lower potential release torque for the smaller diametrical connection between the trocar 14 and the needle member 16 of Demco and the range of torques suggested by Takehiko as starting points, so as to obtain the desired user preferences based on their strength and the desired dimensions of the Luer-Lock fittings.
With respect to the assertion that one of ordinary skill in the art would not intentionally create different release torques for the two Luer-Lock connections and that the release torques would be for all practical purposes the same, these arguments are not persuasive for the reasons provided above. That is, the combination uses two Luer-Lock connections: a larger-sized Luer-Lock connection with a greater potential release torque for the larger diametrical connection between the trocar 14 and the cannula 12 and a smaller-sized Luer-Lock connection with a lower potential release torque for the smaller diametrical connection. The combination suggests that the sizes and the release torques between the two connections would be different since FIG. 2 of Demco shows the size disparity between the connections such that one of ordinary skill in the art would not conclude that the sizes and the release torques of the Luer-Lock connections are the same and would conclude that the larger-dimensioned connection would have the greater potential release torque due to the increase surface area and bulk of the connection. Additionally, the release torques of the Luer-Lock connections have a variable component during use with respect to how tight the user attaches the mating components of the connections to each other (“The relative axial position of the hub 24 with respect to the male luer component 26 is determined by the amount of tightening torque applied thereto, which can differ from operator to operator” (col. 7, lines 10-15 of Werschmidt)). This operation variability based on the strength and preference of the user is an optimization component.
With respect to the arguments that the surgeon would be provided with a practically indistinguishable “feel” with the two connections and that there is no reason for the designer to “abandon the simple path of using identical parts”, these arguments are not persuasive for the reasons provided above. That is, the combination uses two Luer-Lock connections: a larger-sized Luer-Lock connection with a greater potential release torque for the larger diametrical connection between the trocar 14 and the cannula 12 and a smaller-sized Luer-Lock connection with a lower potential release torque for the smaller diametrical connection. The combination suggests that the sizes and the release torques between the two connections would be different since FIG. 2 of Demco shows the size disparity between the connections such that one of ordinary skill in the art would not conclude that the sizes and the release torques of the Luer-Lock connections are the same and would concluded the larger-dimensioned connection would have the greater potential release torque due to the increase surface area and bulk of the connection. Additionally, the release torques of the Luer-Lock connections have a variable component during use with respect to how tight the user attaches the mating components of the connections to each other (“The relative axial position of the hub 24 with respect to the male luer component 26 is determined by the amount of tightening torque applied thereto, which can differ from operator to operator” (col. 7, lines 10-15 of Werschmidt). This operation variability based on the strength and preference of the user is an optimization component.
The Applicant asserts:
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This argument is not persuasive. The combination uses two Luer-Lock connections: a larger-sized Luer-Lock connection with a greater potential release torque for the larger diametrical connection between the trocar 14 and the cannula 12 and a smaller-sized Luer-Lock connection with a lower potential release torque for the smaller diametrical connection. The combination suggests that the sizes and the release torques between the two connections would be different since FIG. 2 of Demco shows the size disparity between the connections such that one of ordinary skill in the art would not conclude that the sizes and the release torques of the Luer-Lock connections are the same and would conclude that the larger-dimensioned connection would have the greater potential release torque due to the increase surface area and bulk of the connection.
The Applicant asserts:
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This argument is not persuasive since the amount of torque necessary to unscrew a Luer-Lock connection is a variable property that is a function of user strength/preference and size of the connection itself. For example, the combination uses two Luer-Lock connections: a larger-sized Luer-Lock connection with a greater potential release torque for the larger diametrical connection between the trocar 14 and the cannula 12 and a smaller-sized Luer-Lock connection with a lower potential release torque for the smaller diametrical connection. The combination suggests that the sizes and the release torques between the two connections would be different since FIG. 2 of Demco shows the size disparity between the connections such that one of ordinary skill in the art would not conclude that the sizes and the release torques of the Luer-Lock connections are the same and the larger-dimensioned connection would have the greater potential release torque due to the increase surface area and bulk of the connection. Since the release torque for the Luer-Lock connection is driven in part by the connection’s own dimensions, it is a matter of a change in the amount of force application by the user and the relative values of these forces are simply a matter of optimization.
In view of the above, the rejections of claim 1 and its dependent claims are proper.
The Applicant’s arguments with respect to the Second Interpretation
Demco teaches or suggests that the anesthesia needle (the needle member 16 of Demco) is released from the stylet (the trocar 14 of Demco) since the needle member 16 is released from the trocar 14 via the pins 44 and the channels 46 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of Luer-Lock fittings in the same context (paragraph 0036 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Luer-Lock fittings in place of the pins 44 and the channels 46 since it is a simple substitution of one known element for another to obtain predictable results. Demco teaches or suggests that the stylet (the trocar 14 of Demco) is released from the coaxial cannula (the cannula 12 of Demco) since the trocar 14 is released from the cannula 12 via the pins 32 and the channels 30 (col. 4, line 60 to col. 5, line 60 of Demco). Racz teaches the use of a frictional arrangement of FIG. 3E of Racz in the same context (paragraphs 0041 and 0046 of Racz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the frictional arrangement of FIG. 3E of Racz in place of the pins 32 and the channels 30 since it is a simple substitution of one known element for another to obtain predictable results.
The combination has one Luer-Lock connection and one frictional arrangement, both of which have release torques. One of ordinary skill in the art would have understood that the respective release torques would have been different given their different structures. In particular, the solution of the two torques being the same would be the least likely possibility of the relative release torques between the two different structures since equality is very difficult to achieve given real-world manufacturing tolerances and user strength/preferences . Thus, one torque would be greater than the other. Also, the tightening of the Luer-Lock connection and the frictional arrangement would be subject to optimization depending upon the strength and preference of the user (that is, how tight the user attaches the mating components of the connections to each other (“The relative axial position of the hub 24 with respect to the male luer component 26 is determined by the amount of tightening torque applied thereto, which can differ from operator to operator” (col. 7, lines 10-15 of Werschmidt)) and the dimensions of each of the Luer-Lock connection and the frictional arrangement. Further, the amount of release torque can vary over a range of torques for a Luer-Lock. Takehiko teaches, for example, that the release torque for a Luer-Lock connection can range as much as 5 to 50 cN·m (paragraphs 0017 and 0027 of Takehiko). As such, the release torques of the Luer-Lock connection and the frictional arrangement are subject to change, would depend upon the strength and preference of the user and the desired dimensions of the Luer-Lock fitting, and are results-effective variables that would have been optimized through routine experimentation based on the strength and preference of the user (that is, how tight the user attaches the mating components of the connections to each other) and the desired dimensions of the Luer-Lock fitting. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the release torques of the Luer-Lock connection and the frictional arrangement so as to obtain the desired user preferences based on their strength and the desired dimensions of the Luer-Lock fitting.
With respect to the assertion that one of ordinary skill in the art would not intentionally create different release torques for the Luer-Lock connection and the frictional arrangement and that the release torques would be for all practical purposes the same, this argument is not persuasive for the reasons provided above. That is, the combination uses the Luer-Lock connection and the frictional arrangement. Different arrangements would have different release torques. Additionally, the release torques of the Luer-Lock connection and the frictional arrangement have a variable component during use with respect to how tight the user attaches the mating components of the connections to each other (“The relative axial position of the hub 24 with respect to the male luer component 26 is determined by the amount of tightening torque applied thereto, which can differ from operator to operator” (col. 7, lines 10-15 of Werschmidt). This operation variability based on the strength and preference of the user is an optimization component.
With respect to the arguments that the surgeon would be provided with a practically indistinguishable “feel” with the two connections and that there is no reason for the designer to “abandon the simple path of using identical parts”, these arguments are not persuasive for the reasons provided above. Further, Racz teaches the use of different combinations of connections. In this case, the combination uses the Luer-Lock connection and the frictional arrangement. Different connections would have different release torques. Additionally, the release torque of the Luer-Lock connections have a variable component during use with respect to how tight the user attaches the mating components of the connections to each other (“The relative axial position of the hub 24 with respect to the male luer component 26 is determined by the amount of tightening torque applied thereto, which can differ from operator to operator” (col. 7, lines 10-15 of Werschmidt). This operation variability based on the strength and preference of the user is an optimization component.
The Applicant asserts:
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This argument is not persuasive. The combination uses the Luer-Lock connection and the frictional arrangement. Different arrangements would have different release torques.
The Applicant asserts:
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This argument is not persuasive since the amounts of torque necessary to unscrew a Luer-Lock connection and unlock the frictional arrangement are variable properties that are a function of user strength/preference and sizes of the connections themselves. Since the release torques are driven in part by the connection’s nature, the relative values of release torque is simply a matter of optimization.
In view of the above, the rejections of claim 1 and its dependent claims are proper.
The Applicant’s arguments with respect to the Third Interpretation
There is a new grounds of rejection based on the teachings of Demco and FIG. 3G of Racz.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights