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 as failing to comply with 37 CFR 1.84(p)(4) because of the following:
Reference character “10” has been used to designate different embodiments in Figs. 5, 9 and 19.
Reference character “100” has been used to designate parts in different embodiments in Figs. 5, 9 and 19.
Reference character “110” has been used to designate parts in different embodiments in both Fig. 10 and 21.
Reference character “116” has been used to designate parts in different embodiments in both Fig. 11 and 21.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Cannula is identified as 122 in Fig. 1-8, however it is misidentified as 120 in specification in paragraph 75, which refers to Fig. 1-8.
Appropriate correction is required.
Claim Objections
Claim 24 is objected to because of the following informalities:
In claim 24, “a cannula including” in line 8 should be corrected to “the cannula including” since this feature was introduced previously in line 3.
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 3,4, 9 and 10 is/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 3 recites “wherein the cannula includes an end protruding from the needle base tip bevel”. Claim 3 is dependent on claim 1 and there is insufficient antecedent basis for this limitation in the claim. The Examiner is unsure if the Applicant intended to use “needle base tip bevel” from claim 3 to refer to “needle base bevel” in claim 1 or introduce a new limitation in claim 3. For the sake of examination, the Examiner is interpreting claim 1 as “needle base tip bevel” in light of specification and rest of claims. Applicant is therefore suggested to amend claim 1 to recite “needle base tip bevel” to overcome rejection of claim 3.
Claim 4 is rejected by virtue of its dependency on claim 3.
Claim 9 recites “wherein the end of the needle base includes a surface forming a predetermined angle with the needle base tip bevel”, and therefore suffers the same issues as claim 3. In light of suggestions made regarding the interpretation of claim 1 with respect to claim 3, claim 9 would not need to be amended (amending claim 1 to recite “needle base tip bevel” would solve the issues in claim 9).
Claim 9 also recites “the slope needle set”. Claim 9 is dependent on claim 1 and there is insufficient antecedent basis for this claim. For the sake of examination, the Examiner is interpreting claim 9 as “the slope needle” in light of claim 1. Applicant is therefore suggested to amend claim 9 to recite “the slope needle” to overcome rejection of claim 9.
Claim 10 recites the limitation “an end of the cannula is disposed on the plane surface of the end of the needle base” It is unclear how the end of the cannula is configured to be disposed on the plane surface of the end of the needle base as per Fig. 3 and Fig. 4. (end of cannula 126 does not interact with base needle end 119). For the sake of examination, the Examiner is interpreting in light of the specification that the Applicant intended for the cannula end to not protrude more than the needle base end. Applicant is therefore suggested to amend claim 10 to recite “an end of cannula does not protrude more than the end of the needle base” to overcome rejection of claim 10.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 3 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being
anticipated by Kim (US20110160612A1, herein Kim).
Regarding Claim 1, Kim discloses a slope needle (101 in Fig. 1) comprising:
a needle base having a predetermined length (106 and 120 in Fig. 1), and accommodating a cannula therein with a portion of the cannula protruded to an outside (102 in Fig. 1);
and a slope hub (105 in Fig. 1) configured to be coupled to a syringe (back of needle hub has an opening [109 in Figs. 4, which is a rearview of Fig. 1] for receiving a syringe [0035]), the slope hub being extended from the needle base (105 shown extending from 120 in Fig. 1),
wherein the needle base includes a needle base bevel (106 in Fig. 2) formed at an end of the needle base from which the cannula protrudes (cannula 102 protruding from 106 in Fig. 2).
Regarding claim 2, Kim discloses all limitations of claim 1. Kim further discloses the slope needle slope hub includes a hub hole (109 in Figs. 4, which is a rearview of Fig. 1) into which one end of the syringe is inserted to be coupled (back of needle hub has an opening [108 in Figs. 1 and 2] for receiving a syringe [0035]), and
wherein the cannula includes a micro hole (exit opening 104 in Fig. 1) for injecting one of a drug and a functional substance into a skin of a patient (to inject a drug substance, needle 102 is jabbed into a cleansed skin surface [0048], see also annotated Fig. 5, which is a cross-sectional view of Fig. 1), the micro hole communicating with the hub hole (see annotated Fig. 5 below).
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Annotated Fig. 5 from Kim
Regarding claim 3, Kim discloses all limitations of claim 1. Kim further discloses the slope needle cannula includes an end protruding from the needle base tip bevel (103 in Fig.1), and the end includes a cannula tip bevel (distal end 103 of the needle 102 is beveled [0035]).
Regarding claim 4, Kim discloses all limitations of claim 3. Kim further discloses the slope needle cannula tip bevel is inclined in the same direction as the needle base tip bevel (bevel of 106 and bevel of 102 are slanted from the top left corner to the bottom right corner in Fig. 2).
Claim(s) 5, 6 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sefi et al. (US20110238038A1, herein Sefi)
Regarding Claim 5, Sefi discloses a slope needle set (112 and 113 in Fig. 11A) comprising:
a slope needle having a predetermined length (112 in Fig. 11A), and including a cannula therein with a portion of the cannula protruded to an outside (hypodermic needle 12 is part of 112 [0094], see annotated Fig. 11A below); and
an adjustment adapter (113) configured to be detachably coupled to the slope needle (113 coupled to 112 in Fig. 11C) to adjust a degree to which the cannula protrudes to an outside (12a protrudes out of 113 in Fig. 11C),
wherein the slope needle includes:
a needle base having a predetermined length (not characterized in Fig.11A-11C, see annotated Fig. 11A below), and including the cannula therein with the portion of the cannula protruded to an outside (hypodermic needle protruding out of needle base, see annotated Fig. 11A below); and
a slope hub configured to be coupled to a syringe, the slope hub being extended from the needle base (hub not characterized in Fig. 11A, see annotated Fig. 11A below), and
wherein the adjustment adapter includes an adapter tip bevel (bevel 18 in Fig. 11B) formed at an end of the adjustment adapter from which the cannula protrudes (hole 115 partially on bevel 18, which allows needle 12a to protrude from bevel 18).
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Annotated Fig. 11A from Sefi
Regarding claim 6, Sefi discloses all limitations from claim 5. Sefi further discloses the slope needle adjustment adapter includes an adjustment hole (hole 115 in Fig. 11B) formed therein in a longitudinal direction of the adjustment adapter, and wherein the cannula is exposed to an outside through the adjustment hole (12a protruding out of hole 115 in Fig. 11C).
Regarding Claim 24, Sefi discloses a slope needle set (112 and 113 in Fig. 11A) comprising:
a hub coupled to a syringe (112 interact with syringe in Fig 11A);
a slope needle coupled to the hub (113 with 12a forms the slope needle, 113 coupled to 112 in Fig. 11C), the slope needle including a cannula disposed therein and protruding to an outside (12a protruding out of 113 in Fig. 11C),
wherein the slope needle includes:
a fixing adapter having a predetermined length to be coupled to the hub (113 coupled to 112 in Fig. 11C) and having an adapter tip bevel formed at one end of the fixing adapter (bevel 18 in Fig. 11B); and
a cannula including a cannula tip (12A in Fig. C) disposed in the slope needle and partially protruding from the adapter tip bevel (hole 115 is partially on bevel 18 in Fig. 11B, which allows 12a to protrude partially from bevel 18).
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) 7 and 8, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sefi et al. (US20110238038A1, herein Sefi) as applied in claim 5 above.
Regarding claim 7, Sefi discloses all the limitations of claim 5. However, Sefi fails to explicitly disclose the slope needle set, wherein the needle base includes a needle base tip bevel formed at an end of the needle base from which the cannula protrudes, and wherein the adjustment adapter is coupled to the slope needle so that the needle base tip bevel and the adapter tip bevel are inclined in the same direction.
It would have been obvious to one of ordinary skill in the art, prior to the effective
filing date of the claimed invention, to modify the needle base of Sefi (see annotated Fig. 11A above) to include a needle base tip bevel corresponding to the bevel of adapter 113 in order to facilitate guiding and insertion between the needle base and the adapter 113. Changes in shape to achieve predictable improvements in performance is recognized as an obvious design choice (see MPEP 2144.04.IV.B; In re Dailey).
Regarding claim 8, Sefi as modified discloses the slope needle set of claim 7. Sefi also teaches wherein the adjustment adapter is coupled to the slope needle (113 coupled to 112 in Fig. 11C) so that a length of the cannula protruding from the adapter tip bevel is shorter (hollow hypodermic needle 12 having beveled penetrating portion 12a protruding no more than 3mm from 16a [0060]) than a length of the cannula protruding from the needle base tip bevel (exposed needle length from 112 is greater than 3mm and typically in excess of 10mm [0094]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the slope needle set taught by Sefi to include wherein the adjustment adapter is coupled to the slope needle so that a length of the cannula protruding from the adapter tip bevel is shorter than a length of the cannula protruding from the needle base tip bevel to improve structural protection of the cannula by protecting majority of the cannula inside the adjustment adapter.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US20110160612A1, herein Kim) as applied in claim 1 above, and further in view of Sefi et al. (US 20110238038 A1, herein Sefi).
Regarding claim 9, Kim discloses all limitations of claim 1. However, Kim failed to explicitly disclose wherein the end of the needle base includes a surface forming a predetermined angle with the needle base tip bevel.
However Sefi teaches wherein the end of the needle base (intradermal mini needle interface 50 in Fig. 5) includes a surface (16b in Fig. 5) forming a predetermined angle with the needle base tip bevel (16b and 16 forms an angle with 18 in Fig. 5). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the slope needle set of Kim with the intradermal mini needle interface of Sefi to include a surface forming a predetermined angle with the needle base tip bevel to provide a skin contact edge (a penetration limiter 16 providing a skin contact edge 16a).
Regarding claim 10, Kim as modified discloses all limitations of claim 9. However, Kim fails to explicitly disclose slope needle set wherein the end of the needle base includes a plane surface, and
wherein an end of the cannula is disposed on the plane surface of the end of the needle base.
However, Sefi teaches wherein the end of the needle base (intradermal mini needle interface 50 in Fig. 5) includes a plane surface (16b forming a plane surface denoted by the dashed line in Fig. 5), and
wherein an end of the cannula is disposed on the plane surface of the end of the needle base (cannula 12a does not exceed passed the dashed line in Fig.5).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the slope needle set of Kim with the intradermal mini needle interface of Sefi to include wherein the end of the needle base includes a plane surface, and wherein an end of the cannula is disposed on the plane surface of the end of the needle base to limit depth of penetration of the cannula (perpendicular approach of the needle to the skin is blocked by the forward projection 16b [0082])
Claim(s) 11, 12, 13, 14, 15 16, 25, 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sefi et al. (US20110238038A1, herein Sefi) and further in view of Ooyauchi et al. (US 20160184532 A1, herein Ooyauchi).
Regarding claim 11, Sefi discloses a slope needle (mini needle interface of Fig. 5) comprising:
a fixing adapter (50 in Fig. 5) having a length and including an adapter tip bevel (16 in Fig. 5) at one end of the fixing adapter;
and a cannula (12a in Fig. 5) coupled to the fixing adapter,
a cannula tip partially protruding from the adapter tip bevel (12a protruding from 16);
Sefi fails to explicitly disclose a blunt cannula body extending from the cannula tip and having an outer diameter greater than an outer diameter of the cannula tip.
However Ooyauchi teaches and a blunt cannula body (3a in Fig. 2, see also Fig.4 which is an enlarged schematic of Fig. 2) extending from the cannula tip (3b in Fig. 2) and having an outer diameter greater than an outer diameter of the cannula tip (3b formed to have a constant outer diameter smaller than that of the larger diameter portion 3a [0054]).
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the slope needle of Sefi to include a blunt cannula body extending from the cannula tip and having an outer diameter greater than an outer diameter of the cannula tip since such a modification can prevent the movement of cannula in the adapter (hollow needle is locked to the inner cylindrical body to be prevented from being moved in a removal direction [0065]). Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Regarding claim 12, Sefi as modified discloses all limitations of claim 11. However, Sefi further discloses wherein the fixing adapter includes an adapter hole formed therein in a longitudinal direction of the fixing adapter (hole not shown in Fig.5, see annotated Fig. 1B below; it is noted that line 4 of [0082] sets forth that the interface 50 of Fig. 5 is structurally and functionally similar to interface 10 of Fig.1B), and
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Annotated Fig. 1B from Sefi
wherein the cannula is inserted into the adapter hole to be coupled to the fixing adapter (fully inserted position of needle 12 for precise and reliable assembly [0075], see also annotated Fig. 1B).
Regarding claim 13, Sefi as modified discloses all limitations of claim 12. Sefi further disclosed further comprising a bonding part (not shown in Fig. 5, see 21 in annotated Fig. 1B above; it is noted that line 4 of [0082] sets forth that the interface 50 of Fig. 5 is structurally and functionally similar to interface 10 of Fig.1B) for fixing the cannula to the adapter hole (small step 21 against which needle 12 abuts to accurately define a fully inserted position of needle 12 for precise and reliable assembly [0075]).
Regarding claim 14, Sefi as modified discloses all limitations of claim 11. Sefi further disclosed wherein the cannula tip includes a micro hole (hollow hypodermic needle 12 [0060]) for injecting one of a drug and a functional substance into a skin of a patient (intradermal mini-needle interface [0082]).
Regarding claim 15, Sefi as modified discloses all limitations of claim 11. Sefi further disclosed wherein the cannula tip includes a cannula tip bevel (12a in Fig. 5) at an end protruding from the adapter tip bevel (12a protruding from 16 in Fig. 5).
Regarding claim 16, Sefi as modified discloses all limitations of claim 15. However, Sefi fails to explicitly disclose wherein the cannula tip bevel is inclined in the same direction as the adapter tip bevel (Sefi discloses an obtuse angle alpha between bevel surfaces 16 and 18 [0083] and Fig. 5, which appears in similar orientation as the bevel of 12a, but fails to disclose if it is in same direction).
Regarding claim 25, Sefi discloses all limitations of claim 24. However, Sefi fails to explicitly disclose wherein the cannula further includes a blunt cannula body extending from the cannula tip and having an outer diameter greater than an outer diameter of the cannula tip,
and wherein the hub includes a hub hole therein, and when the slope needle is coupled to the hub, the blunt cannula body is coupled to the hub hole.
However, Ooyauchi teaches wherein the cannula further includes a blunt cannula body (3a in Fig. 2) extending from the cannula tip (3a extending from 3b via 3c in Fig. 2) and having an outer diameter greater than an outer diameter of the cannula tip (3b formed to have a constant outer diameter smaller than that of the larger diameter portion 3a [0054]),
and wherein the hub includes a hub hole (7c in Fig. 2) therein, and when the slope needle is coupled to the hub, the blunt cannula body is coupled to the hub hole (3a inside 7c in Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to
the effective filing date of the claimed invention, to modify the slope needle set of Sefi with Ooyauchi to include wherein the cannula further includes a blunt cannula body extending from the cannula tip and having an outer diameter greater than an outer diameter of the cannula tip,
and wherein the hub includes a hub hole therein, and when the slope needle is coupled to the hub, the blunt cannula body is coupled to the hub hole since such a modification may prevent the movement of the cannula by locking the blunt body of the cannula in the hub hole (the hollow needle 3 is locked to the inner cylindrical body 7 to be prevented from being moved in a removal direction [0065]). Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03)
Regarding claim 27, Sefi as modified discloses all limitations of claim 25. Sefi further disclosed wherein the fixing adapter includes: a cannula coupling portion (part of the adapter 113 which has hole 115 and bevel 18 in Fig.11C, with passage for cannula not shown in Fig. 11C, see annotated Fig. 6, it is noted that line [0094] sets forth that the adapter 113 of Fig. 11C is functionally similar to interfaces of Fig.1-8, which also includes 60 of Fig. 6) having the adapter tip bevel formed at one end of the cannula coupling portion (hole 115, which is the opening of the cannula coupling portion is partially on bevel 18 in Fig. 11C); and a hub coupling portion extending from the cannula coupling portion and coupled to the hub (cannula coupling portion and hub coupling portion is connected, not shown in Fig. 11C, see annotated Fig. 6 below).
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Annotated Fig. 6 from Sefi
Regarding claim 28, Sefi as modified disclosed all limitations of claim 27. However, Sefi does not disclose wherein the blunt cannula body protrudes from the cannula coupling portion toward the hub, and wherein the slope needle further includes a bonding part for fixing the cannula to the fixing adapter.
As the slope needle set of Sefi previously modified to include the cannula with blunt body previously taught by Ooyauchi, a person of ordinary skill in the art would recognize that the diameter of the cannula blunt body (3a in Fig. 2) is larger than the diameter of the cannula (3b in Fig. 2). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date to recognize that the hole or passageway of the cannula in the cannula coupling portion (see annotated Fig. 6 above) could predictably prevent movement of the cannula blunt body due to its larger diameter, thereby restricting overall movement of the cannula. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Conclusion
Any inquiry concerning this communication or earlier communications from the
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783