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 Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “channel part arranged to removable receive a syringe body” in line 5-6. The word removable appears to be a misspelling and should recite –removably--. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1 and all dependents thereof 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 “a cannula” in line 7. However, a cannula is already recited in line 2. Therefore it is unclear whether or not the cannula in line 7 is the same as the cannula in line 2. For purposes of examination the cannula in line 7 is the same as the cannula in line 2.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 8-9, 14-16, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawamoto et al. (US 2012/0083749 A1).
With regard to claim 1, Kawamoto discloses a needle assembly (fig. 1) comprising: a cannula (2) and a hub (3) arranged for removable connection to a syringe body, and having a proximal end (inherent and located within the hub 3) and a distal end (at 4a), wherein the hub is provided with a channel (at 6a) for establishing a fluid connection between the proximal end and the distal end, wherein the channel comprises includes a cannula channel part (see in part 8 of the hub that holds the cannula and the lumen that holds the cannula for a cannula channel) in which a proximal end of the cannula is mounted (see Fig. 1) and a syringe channel part (at 6a) arranged to removably receive a syringe body (9), the needle assembly further comprising including a cannula (4) received in the cannula channel part (as shown in Fig. 1 at part 8 of the hub), wherein the cannula is received in the cannula channel part such that the proximal end of the cannula extends at least partly out of the cannula channel part (see Fig. 1 the proximal end of the cannula 4 extends partly out of the cannula channel into the syringe channel 6a), wherein the cannula has a gauge of at least 18 ([0021], gauge ranges from 10 to 36).
With regard to claim 2, Kawamoto discloses wherein the cannula is a thin wall cannula (Fig. 1, the close up shows the wall of the cannula 4 and is considered thin walled).
With regard to claim 8, Kawamoto discloses wherein the syringe channel part (6a) is a tapered channel (Fig. 1 shows the channel tapering from a proximal end at 7 towards part 8), such that an inner diameter of the syringe channel part near the distal end of the hub (towards 8) is smaller than an inner diameter of the syringe channel part near the proximal end of the hub (at 7).
With regard to claim 9, Kawamoto discloses wherein the syringe channel part (6a) has a length such that, when a syringe body is removably connected to the hub (as shown with element 9 placed in 6a in Fig. 1), a dead space (see annotated Fig below) is formed in the tapered channel between a distal end of the syringe channel part and a distal end of a syringe body.
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With regard to claim 14, Kawamoto discloses wherein the hub is of a polycarbonate ([0024]).
With regard to claim 15, Kawamoto discloses wherein the hub (3) is manufactured by injection-moulding (this is considered a product-by-process limitation, therefore only the structure of the hub needs to be taught by the prior art).
With regard to claim 16, Kawamoto discloses wherein the cannula is fixedly connected to the hub with a glue cone ([0004], [0006], [0046]).
With regard to claim 20, Kawamoto discloses a syringe (9, Fig. 1) comprising a syringe body for containing a solution ([0020]).
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto et al. (US 2012/0083749 A1).
With regard to claim 3 and 4, Kawamoto discloses wherein the proximal end of the cannula extends at least partly out of the cannula channel part (as shown in fig. 1, the proximal end of the cannula extends out of 8 and into the syringe channel part 6a).
Kawamoto does not explicitly disclose the exact distance.
However it would be prima facie obvious for one of ordinary skill in the art to optimize the specific distance to be over a distance of between 0.5 mm to 2 mm or extending over a length of 1mm because doing so would not alter the overall function of the device and the claims do not currently recite any specific significance to this distance.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto et al. (US 2012/0083749 A1) in view of King (US 2015/0359975 A1).
With regard to claim 5, Kawamoto discloses wherein the cannula has a gauge of at most 34 ([0021], gauge ranges from 10 to 36).
However, Kawamoto does not explicitly disclose an external diameter.
King teaches the cannula with an external diameter of at mot 1.2 mm or at least 2mm ([0022], outer diameter of part 32 approximately 0.72mm, outer diameter of part 48 to be approximately 0.41mm).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of Kawamoto with the specific outer diameter as taught by King for the purpose of allowing use of a standard easily available needle size ([0022]).
With regard to claim 6 and 7, Kawamoto discloses the claimed invention except for the proximal end having a beveled end.
King teaches a similar needle assembly (Fig. 3) having a cannula (46) and a hub (60). The cannula having a proximal end (at 22) that is beveled (24).
While King does not explicitly disclose the exact angle of the bevel it would be prima facie obvious for one of ordinary skill in the art at the time of the invention to optimize the angle to be between about 10 degrees and about 70 degrees and more specifically about 45 degrees as doing so would not alter the overall function of the device.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of Kawamoto with the proximal bevel as taught by King for the purpose of aiding the end to be inserted into a cartridge ([0020]).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto et al. (US 2012/0083749 A1) in view of Ryan (US 2021/0260304 A1).
With regard to claim 10, Kawamoto discloses the claimed invention except for a specific length.
Ryan teaches a needle assembly (Fig. 3a) similar to Kawamoto. Ryan teaches the hub (200) is made to ISO 80369-7:2016 standards ([0057]) which accordingly has a length of at most 7.5mm ([0044], length of the male standard luer taper is between 7.5mm to 10.5mm).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawamoto with the length as taught by Ryan for the purpose of using standard sizing that would accommodate a variety of syringes to be used with the needle assembly ([0044]).
With regard to claim 11, Kawamoto discloses the claimed invention except for the ISO compliance.
Ryan teaches wherein the hub is compliant to ISO 80369-7:2016 ([0044], [0057]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawamoto with the ISO compliance as taught by Ryan for the purpose of using standard sizing that would accommodate a variety of syringes to be used with the needle assembly ([0044]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto et al. (US 2012/0083749 A1) in view of Akhavi (US 4,240,423).
With regard to claim 12, Kawamoto discloses the claimed invention including a flanged proximal end (7).
However, Kawamoto does not explicitly disclose threads.
Akhavi teaches a similar needle assembly (fig.1) having a cannula (1) and hub( 4) that includes a proximal flange that can be threaded and arranged fro removable threaded connection to a syringe body (6)(Col 2, lines 26-28).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawamoto with the threads as taught by Akhavi for the purpose of helping hold the needle assembly with the syringe (Col 2, lines 26-28).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto et al. (US 2012/0083749 A1) in view of Moulton (US 2006/0264833 A1).
With regard to claim 13, Kawamoto discloses the claimed invention except for an indicator.
Moulton teaches a needle assembly (Fig. 2) wherein the hub (10) further includes an indicator (arrow 15, [0040]) arranged to indicate an orientation of a distal end of the cannula ([0040], arrow points towards distal end of needle).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawamoto with the indicator as taught by Moulton for the purpose of guiding the caregiver ([0040]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto et al. (US 2012/0083749 A1) in view of Oshida et al. (US 2017/0135720 A1).
With regard to claim 17, Kawamoto discloses a method for manufacturing a needle assembly as defined in any of the claims 1, the method comprising:
- providing a hub (fig. 1, hub 3) having a proximal end (7) and a distal end (at 8) wherein the hub comprises includes a channel (generally at 6a and within the channel of 8) for establishing a fluid connection between the proximal end and the distal end, wherein the channel comprises a cannula channel part (the channel in part 8 holding the cannula 4) arranged to receive a cannula (4) and a syringe channel part (6a) arranged to removable receive a syringe body (9);
- inserting a cannula (4) into the cannula channel part from the distal end of the hub;
- fixedly connecting the cannula to the hub (via adhesive, [0004], [0006], [0046]).
However, Kawamoto does not disclose an insert.
Oshida teaches a needle assembly (Fig. 1) similar to that of Kawamoto. Oshida further teaches a method of manufacturing the hub (Fig. 2) including inserting an insert (38) in the syringe channel part (generally at 40) of the hub such that there is a distance between the distal surface of the insert (60) and the proximal opening of the cannula (at 48). Oshida teaches removing the insert from the syringe channel part ([0008], removing the core pin, [0044]. The male mold moves forward and backward).
While Oshida does not explicitly disclose the specific distance of about 0.5mm to 2mm, it would be prima facie obvious for one of ordinary skill in the art at the time of the art to optimize the distance to be between 0.5mm to 2mm because doing so would not alter the overall function of the device.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawamoto with insert as taught by Oshida for the purpose of creating the shape of the hub ([0037]).
With regard to claim 18, Kawamoto discloses wherein the cannula is fixedly connected to the hub with a glue cone ([0004], [0006], [0046]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto et al. (US 2012/0083749 A1) in view of Oshida et al. (US 2017/0135720 A1) and in further view of Leeflang et al. (US 2015/0320971 A1).
With regard to claim 19, Kawamoto/Oshida teach the claimed invention except for a metal insert.
Leeflang teaches wherein a mandrel (50 [0086], [0087], [0091]) that can be inserted into a medical device for shaping similar to that of the insert in Oshida can be made of metal ([0087]).
Claim(s) 21, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto et al. (US 2012/0083749 A1) in view of Masi et al. (US 2009/0270814 A1).
With regard to claim 21 and 22, Kawamoto discloses the claimed invention except for a dermal filler.
Masi teaches a similar needle assembly (fig. 5a, element 20) that is used with a syringe (21) containing a solution that is a dermal filler ([0006]) and therefore is used for dermal injections.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawamoto with for delivering dermal filler as taught by Masi because the substation of one known agent for another is well-known in the art and does not affect the overall function of the device ([0006]).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto et al. (US 2012/0083749 A1) in view of Tachikawa et al. (US 2013/0174518 A1).
With regard to claim 23, Kawamoto discloses the claimed invention except for the ISO.
Tachikawa teaches the used of cannulas that are ultra-thin wall according to
ISO 9626:2016 ([0037]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawamoto with ISO specific cannula as taught by Tachikawa because the substation of one needle size standard for another is well-known in that art and would not alter the overall function of the device and provides standardized needle cannula that is commonly used in the art ([0037]).
Conclusion
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/Lauren P Farrar/Primary Examiner, Art Unit 3783