DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 12-20 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.
In claim 9, Applicant does not list a year for the ISO-80369 standard, such that it is unclear which standard is meant to apply.
In claims 12, 13 and 19, Applicant requires “a standard pen needle”, “a standard female luer” and/or “a standard-gauge needle”, but it is unclear what would encompass “standard”. For example, “a standard female luer” does that mean as long as a luer taper is present the standard is met? Or does it require threads? Is the collar expected to be monolithic with the taper or movable with respect to the taper? And what other features would or would not be considered standard.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 8 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okihara (US 2022/0354747).
Regarding claim 1, Okihara discloses a male needless connector comprising: an elongate tip 38 having a distal end and a proximal base, a tapered outer surface and a lumen extending through the elongate tip, the proximal base having a diameter greater than a diameter of the distal end the lumen defining an inner sidewall (fig 4A); and, a collar 36 having a substantially cylindrical shape (fig 4A) and a distal end, the collar partially surrounding the elongate tip (fig 4A), the collar having a cavity forming an inner sidewall surface 36b and an outer sidewall surface 36a, the inner sidewall surface having a diameter greater than the proximal base of the elongate tip (fig 4A), the outer sidewall surface including a plurality of threads 42 for connection to corresponding inner threads of a pen needle (intended use, capable of such), wherein the inner sidewall surface of the collar includes inner threads 44 for connection to corresponding threads of a female luer connector (intended use, capable of such).
Regarding claim 2, wherein a female luer connector is inserted in between the elongate tip and inner sidewall surface (fig 8).
Regarding claim 3, further comprising a taper between the inner sidewall of the elongate tip and the distal end of the elongate tip (fig 4A).
Regarding claim 4, wherein the taper has a flat surface (surface of elongate tip).
Regarding claim 6, wherein the taper has an angle θ relative to a central axis Z of the male needleless connector (fig 4A).
Regarding claim 8, wherein the taper is configured to create a seal with a post of a pen needle (capable of such).
Regarding claim 12, wherein the plurality of threads are configured to create more than 2 turns with inner threads of a standard pen needle (fig 4A; in some ways this is intended use as a user can twist/turn almost any number of chosen times to fully attach the two together).
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.
Claim(s) 5, 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okihara (US 2022/0354747) in view of Di Ubaldi et al (US 2018/0289941).
Regarding claim 5, while Okihara substantially discloses the invention as claimed, it does not disclose the taper has a flat surface with rounded edges.
Di Ubaldi disclose a syringe where the elongated tip has rounded edges as the distal end 108 (figs 1 and 2).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Okihara such that the taper has a flat surface with rounded edges as taught by Di Ubaldi to make attaching the various hubs easier (initially inserted over smaller end then fully seats as moved fully onto elongate tip).
Regarding claim 7, while Okihara substantially discloses the invention as claimed, it does not disclose wherein the angle θ is in the range of 26 degrees to 28.5 degrees.
See claim 5 above.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to determine through routine experimentation a working range for the angle to make attachment of various hubs easier.
Regarding claim 9, while Okihara substantially discloses the invention as claimed, it does not disclose wherein the male needless connector is compatible with ISO-80369 standards for Male Luer Locks with Fixed Collars.
Di Ubaldi discloses using an ISO 80369 standard to prevent errors from connections between unrelated delivery systems (¶2).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Okihara such that the male needless connector is compatible with ISO-80369 standards for Male Luer Locks with Fixed Collars as taught by Di Ubaldi to prevent erroneous connections with the wrong connectors.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okihara (US 2022/0354747).
Regarding claim 10, while Okihara substantially discloses the invention as claimed, it does not disclose wherein a projection distance G’ of the distal end of the elongate tip from the proximal base is 7.5 mm and a projection distance M’ of the distal end of the elongate tip from the distal end of the collar is 2.1mm.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to discover appropriate dimensions through routine experimentation to achieve both fluid transfer and delivery (as Okihara discloses as desirable).
Regarding claim 11, while Okihara substantially discloses the invention as claimed, it does not disclose wherein a projection distance G’ of the distal end of the elongate tip from the proximal base is 7.5 mm and a projection distance M’ of the distal end of the elongate tip from the distal end of the collar is in the range of 4.00 mm to 4.80 mm.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to discover appropriate dimensions through routine experimentation to achieve both fluid transfer and delivery (as Okihara discloses as desirable).
Claim(s) 13-15 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okihara (US 2022/0354747) in view of Rini et al (US 2020/0384210).
Regarding claim 13, Okihara discloses a kit comprising: a syringe having a barrel 22 with an open proximal end, a distal end and a cavity 32, the male needless connector of claim 1, the male needless connector integrally molded to the distal end of the barrel (fig 4A); and, a standard female luer needle 16 having a needle hub 16b and a cannula 16a, the needle hub having a proximal end and a distal end, the cannula extending through the distal end (fig 8).
While Okihara substantially discloses the invention as claimed, it does not disclose a pen needle hub having a double-ended cannula for coupling to a standard pen needle assembly, the pen needle having a body and side wall forming an open end, the side wall having inner threads for coupling to a standard pen needle assembly.
Rini discloses a pen needle hub which allows the needle to consistently penetrate to a desired target depth (¶7). Said pen needle hub has a double-ended cannula 20 for coupling to a standard pen needle assembly, the pen needle having a body 12 and side wall 16 forming an open end (fig 5), the side wall having inner threads for coupling to a standard pen needle assembly (fig 5).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Okihara with a pen needle hub having a double-ended cannula for coupling to a standard pen needle assembly, the pen needle having a body and side wall forming an open end, the side wall having inner threads for coupling to a standard pen needle assembly as taught by Rini to allow for subcutaneous injection with a needle which consistently penetrates to a desired depth.
Regarding claim 14, wherein the body has a distal face with a peripheral edge forming a shoulder, from the shoulder extends a tower away from the open end, the shoulder having a shoulder sidewall and a distal end wall (see combination in claim 13 and shoulder 18 fig 5 of Rini).
Regarding claim 15, wherein a post projects proximally from an inner face of the end wall of the pen needle for supporting the double-ended cannula, the post having a conical shaped base portion (see combination in claim 13 and post 50 in fig 5 of Rini).
Regarding claim 18, wherein the plurality of threads of the outer sidewall surface of the collar are configured to interdigitate with the inner threads of the pen needle until an inner surface of the shoulder abuts the distal end of the collar (see combination in claim 13, it would have been obvious to design the pen needle hub to fully seat on the syringe).
Regarding claim 19, wherein the cannula of the standard female luer needle is a standard-gauge needle and the double-ended needle cannula of the pen needle is a small-gauge needle (see combination in claim 13 with a double-ended needle cannula; also Okihara shows a needle 16a which can be considered a small-gauge needle compared one that introduces solid pellets).
Regarding claim 20, while Okihara and Rini substantially disclose the invention as claimed, they do not disclose a method of use of the kit of claim 13 comprising the steps of: attaching the needle hub to the male needless connector; inserting the cannula into a stopper of a vial; aspirating medicine from a vial by withdrawing a plunger rod of the barrel; removing the needle hub from the male needless connector; and, attaching the pen needle to the male needless connector; wherein the pen needle is attached to the male needless connector by threading the inner threads of the pen needle to the plurality of threads of the outer sidewall surface of the collar of the male needless connector.
Okihara discloses it is known to prepare the injection by withdrawal of fluid from a vial (¶4).
It is within the skill of one of ordinary skill in the art to choose how prepare a syringe for injection, including the claimed steps.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Okinara and Rini such that it includes a method of use of the kit of claim 13 comprising the steps of: attaching the needle hub to the male needless connector; inserting the cannula into a stopper of a vial; aspirating medicine from a vial by withdrawing a plunger rod of the barrel; removing the needle hub from the male needless connector; and, attaching the pen needle to the male needless connector; wherein the pen needle is attached to the male needless connector by threading the inner threads of the pen needle to the plurality of threads of the outer sidewall surface of the collar of the male needless connector to allow a user to quickly fill the syringe for use and then dispense via subcutaneous injection with a needle which consistently penetrates to a desired depth.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okihara (US 2022/0354747) in view of Rini et al (US 2020/0384210) and Knapp et al (US 2018/0169350).
Regarding claim 17, while Okihara substantially discloses the invention as claimed, it does not disclose wherein the conical shaped base portion of the post is at least partially inserted within the lumen of the elongate tip creating a seal.
Knapp discloses a pen needle which attaches to a syringe and the the conical shaped base portion of the post is at least partially inserted within the lumen of the elongate tip creating a seal (fig 6).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Okihara and Rini such that the conical shaped base portion of the post is at least partially inserted within the lumen of the elongate tip creating a seal as taught by Knapp to prevent wastage of the fluid.
Allowable Subject Matter
Claim 16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The examiner did not find a teaching or suggestion for modifying Okihara and Rini such that a taper between the inner sidewall of the elongate tip and the distal end of the elongate tip is configured to create a seal with the conical shaped base portion of the post, absent impermissible hindsight. While Rini teaches a taper and there is suggestion for adding a taper to Okihara, the examiner did not find a teaching to make the taper of Rini specifically match that of Okihara to create a seal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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