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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a glue or a local deformation caused by an indentation or melting within the stylet-cannula connection pair (412) or one of a tape or plastic film provided on the outside of the stylet-cannula connection pair (412)” of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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 20: “wherein” should be inserted before “said breakable fixture”; and
in claim 1, line 22: “an outside” should be “an outside”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 and 12-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the stylet-cannula connection pair” in line 17 in which there is insufficient antecedent basis for this limitation in the claim. Also, it is not clear what relationship the stylet-cannula connection pair has with the other physical structures of claim 1.
Claim 1 recites “said breakable fixture is one of a glue or a local deformation caused by an indentation or melting within the stylet-cannula connection pair (412) or one of a tape or plastic film provided on the outside of the stylet-cannula connection pair (412)” in lines 20-22 which is so grammatically awkward that its meaning is not clear. For example, the recitation raises the following questions:
(1) is said breakable fixture one of a glue; a local deformation caused by an indentation or melting within the stylet-cannula connection pair (412); a tape; or a plastic film provided on the outside of the stylet-cannula connection pair (412)?
(2) is said breakable fixture one of a glue within the stylet-cannula connection pair (412); a local deformation caused by an indentation or melting within the stylet-cannula connection pair (412); a tape provided on the outside of the stylet-cannula connection pair (412); or a plastic film provided on the outside of the stylet-cannula connection pair (412)?
(3) what is meant by a local deformation caused by an indentation? A local deformation of what? An indentation in what?
(4) what is meant by a local deformation caused by melting ? A local deformation of what? A melting of what?
These questions render claim 1 indefinite.
Claims 2-4 and 14-16 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “a stylet-cannula connector pair” in line 13, but it is not clear if this recitation is the same as, related to, or different from “the stylet-cannula connection pair” of claim 1, line 17. If they are the same, “a stylet-cannula connector pair” in claim 2 should be “the stylet-cannula connector pair”. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation should make it clear which recitation is being referred to.
Claims 3-4 and 16 are rejected by virtue of their dependence from claim 2.
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, 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 WO 2007/027830 (Lavelle), and further in view of JP 2004254789 A (Takehiko)(previous cited). Citations to Takehiko will refer to the machine English translation that accompanies the Office Action mailed on 4/20/2026.
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,
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
wherein 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.
Demco teaches the release of the needle member 16 from the trocar 14 before the release of the trocar 14 from the cannula 12 since the trocar 14 and the cannula 12 are locked together when they are slowly advanced along needle member 16 to penetrate the patient's abdomen (col. 6, lines 10-60 of Demco). Lavelle teaches the use of an adhesive between male and female members of a first Luer-Lock connection to prevent easy breaking of the first Luer-Lock connection when a second Luer-Lock connection is to be released so as to make and break the second Luer-Lock connection easier (paragraph 0032-0033 of Lavelle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply an adhesive to the Luer-Lock connection between the trocar 14 and the cannula 12 so as to prevent the easy breaking of the connection between the trocar 14 and the cannula 12 when the Luer-Lock connection between the needle member 16 and the trocar 14 is released and to make and break the Luer-Lock connection between the needle member 16 and the trocar 14 easier.
Lavelle does not teach a particular strength of a Luer-Lock connection with an adhesive versus a Luer-Lock connection without an adhesive. However, the strength of the Luer-Lock connections would be subject to optimization depending upon the strength and preference of the user. Also, the amount of release torque can vary over a range of torques for a Luer-Lock connection. 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 with and without adhesive are subject to change, would depend upon the strength and preference of the user, and are results-effective variables that would have been optimized through routine experimentation based on the strength and preference of the user. 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 so as to obtain the desired user preferences based on their strength.
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,
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,
wherein 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),
wherein 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 a 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
wherein a value of the predetermined needle-stylet release torque is less than a value of the predetermined stylet-cannula release torque (the release torque of the Luer-Lock connection between the needle 16 and the trocar 14 is less than the release torque of the Luer-Lock connection with adhesive between the trocar 14 and the cannula 12 of Demco), 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),
wherein the stylet-cannula connection pair (the Luer-Lock connection with adhesive between the trocar 14 and the cannula 12 of Demco) is provided with a breakable fixture (the adhesive of Lavelle), the breakable fixture being arranged to break at the predetermined stylet-cannula release torque and thereby forming a one-time locking arrangement, and
said breakable fixture is one of a glue or a local deformation caused by an indentation or melting within the stylet-cannula connection pair or one of a tape or plastic film provided on the outside of the stylet-cannula connection pair (the adhesive of Lavelle).
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).
PNG
media_image1.png
838
583
media_image1.png
Greyscale
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).
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).
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 insertable within the stylet (the trocar 14 of Demco)(col. 2, lines 35-50 of Demco; col. 6, lines 10-60 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).
Claim 15 is 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 WO 2007/027830 (Lavelle), and further in view of JP 2004254789 A (Takehiko)(previous cited), 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 8/11/2026 have been fully considered.
Claim objections
In view of the claim amendments submitted on 8/11/2026, the claim objections are withdrawn. However, there are new grounds of claim objections that were necessitated by the claim amendments filed on 8/11/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments submitted on 8/11/2026, 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, that were necessitated by the claim amendments filed on 8/11/2026.
Prior art rejection
The Applicant’s arguments with respect to the rejection of claims 1-4 and 12-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of claim rejection that were necessitated by the claim amendments filed on 8/11/2026.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
