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 § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer (US Pub No. 20140025035 A1).
Regarding claim 1, Fischer discloses an injection needle (100 – Fig.1) that perpendicularly punctures a surface of a target site such as an intramucosal or intradermal site and injects a medicinal solution into the target site (“The tissue-penetrating tip may resemble any tip known to those of ordinary skill in the art to be suitable to penetrate tissue of a human” - Para [0034]), the injection needle comprising:
a bevel-needle-shaped needle body (106 – Fig.1) having a hollow portion (Shown at 122 – Fig.1) through which the medicinal solution is passable (“a fluid supplied by a second syringe… can travel through the connector, through the second lumen” – Para [0036]);
a needle body blade surface which is formed at a distal portion (102 – Fig.1) of the needle body (See annotated Fig.1 below) and enables a puncture of the target site (“tissue-penetrating tip” – Para [0042]); and
a passage hole (126 – Fig.1) which is formed at the distal portion of the needle body (Fig.1) and through which the medicinal solution from the hollow portion passes (“a fluid supplied by a second syringe… can travel through the connector, through the second lumen, and out of the distal opening” – Para [0036]), wherein
the passage hole is disposed biasedly toward a side on which a distal end of the needle body blade surface is positioned (Fig.1, Fig.2), and
a length in an axial direction of the needle body from an edge portion of an opening edge of the passage hole on a side opposite to a biased side of the opening edge to the distal end of the needle body blade surface is set to a dimension.
PNG
media_image1.png
527
1084
media_image1.png
Greyscale
Fischer fails to explicitly disclose the length in the axial direction of the needle body from the edge portion of the opening edge of the passage hole on the side opposite to the biased side of the opening edge to the distal end of the needle body blade surface is set to 0.1 mm or longer and shorter than 2.0 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length in the axial direction of the needle body from the edge portion of the opening edge of the passage hole on the side opposite to the biased side of the opening edge to the distal end of the needle body blade surface to be set to 0.1 mm or longer and shorter than 2.0 mm since it is evident that Fischer recognizes that the length of the needle body would need to be sized for penetration, integrity, and fluid flow characteristics. Determining an appropriate value for such a dimension would have amounted to routine optimization of a result-effective variable. Therefore, it would be obvious to have optimized Fischer’s length in the axial direction of the needle body from the edge portion of the opening edge of the passage hole on the side opposite to the biased side of the opening edge to the distal end of the needle body blade surface to a selected length within the claimed range to render the claimed range obvious. Further, applicant places no criticality on the range claimed, indicating simply that “the length of the needle body in the axial direction from the edge portion of the passage hole to the distal end of the needle body blade surface is set to 0.1 mm or longer and shorter than 2.0 mm” – Para [0008].
Regarding claim 4, Fischer discloses the injection needle as set forth above, wherein
the needle body includes a first bevel needle (109 – Fig.1) having a first lumen (112 – Fig.1) and a first blade surface (See annotated Fig.1 below), and a second bevel needle (119 – Fig.1) that has a second lumen (122 – Fig.1) and a second blade surface (See annotated Fig.1 below) and is accommodated in the first lumen of the first bevel needle (Fig.3),
the hollow portion is formed by the second lumen of the second bevel needle (Fig.1),
the needle body blade surface is formed by the first blade surface of the first bevel needle (See annotated Fig.1 below),
the passage hole (126 – Fig.1) is formed by a discharge outlet of the second lumen of the second bevel needle (Fig.2),
the second bevel needle has the second blade surface that is oriented in the same direction as the first blade surface of the first bevel needle and is disposed biasedly toward a side on which a distal end of the first blade surface of the first bevel needle is positioned (See annotated Fig.1 below, Fig.2),
the first lumen of the first bevel needle is sealed in a state (118 – Fig.1, Para [0043]) where the second bevel needle is disposed in the first lumen (Fig.2), and
a distal end of the second blade surface of the second bevel needle is not disposed beyond the first blade surface of the first bevel needle (See annotated Fig.1 below, Fig.2).
PNG
media_image2.png
527
1053
media_image2.png
Greyscale
Regarding claim 5, Fischer discloses the injection needle as set forth above, wherein the second bevel needle is disposed in contact with an inner circumferential surface of the first lumen of the first bevel needle (Figs. 1-3, “the second sidewall portion of the inner tube is fixedly coupled to the first sidewall portion of the outer tube” – Para [0032]).
Regarding claim 7, Fischer discloses the injection needle as set forth above, wherein the first bevel needle has an outer diameter of a needle tube, an inner diameter, and a bevel length of the first blade surface (Fig.2, Fig.3), and
the second bevel needle has an outer diameter of a needle tube, an inner diameter, and a bevel length of the second blade surface (Fig.2, Fig.3).
However, Fischer does not explicitly disclose wherein the first bevel needle has a 27G (outer diameter of 0.40 mm) needle tube having an inner diameter of 0.22 mm (less than 27G) and a bevel length of the first blade surface of 1.85 mm, and
the second bevel needle has a 36G (outer diameter of 0.10 mm) needle tube having an inner diameter of 0.04 mm (less than 30G) and a bevel length of the second blade surface of 0.15 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the first and second bevel needles and their blades since it is evident that Fischer recognizes that the dimensions of the needle bodies and their blades would need to be sized for penetration, integrity, and fluid flow characteristics. Therefore, It would have been obvious to optimize such dimensions through routine experimentation to achieve desired performance characteristics and render the claimed dimensions obvious.
Claims 2-3 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer in view of Kern (US Pub No. 20090216202 A1).
Regarding claim 2, Fischer discloses the injection needle as set forth above, but Fischer does not explicitly disclose wherein the distal end of the needle body blade surface has an angle of 30° or smaller.
Kern teaches a distal end of a needle body blade surface having an angle of 30° or smaller (See annotated Fig.2 below, “about 30 degrees” – Para [0033]).
PNG
media_image3.png
513
1518
media_image3.png
Greyscale
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the needle body blade surface of Fischer to have an angle of 30 degrees as taught by Kern since Kern teaches that 30 degrees is a well-known angle for a needle body blade surface.
Regarding claim 3, Fischer discloses the injection needle as set forth above, wherein the needle body has an outer diameter (Fig.3) but Fischer does not disclose wherein the needle body has an outer diameter of at least 0.20 mm or larger.
Kern teaches a needle body (20 – Fig.2) with an outer diameter of at least 0.20 mm or larger (“a diameter of about 1 millimeter (mm) to about 4 mm” - Para [0037]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the outer diameter of the needle body of Fischer to be at least 0.20 mm or larger as taught by Kern since kern teaches that an outer dimension larger than 0.20 mm, is a well-known suitable dimension for a needle body (Kern, Para [0037]).
Regarding claim 8, Fischer discloses the injection needle as set forth above, wherein the needle body is made of a metal material (“stainless and/or surgical steel” – Para [0068]),
the hollow portion and the passage hole are formed by a lumen (122 – Fig.1) parallel to the axial direction of the needle body (Fig.1),
the needle body has a thick region having a thick wall and a thin region having a thin wall, the thick region and the thin region being formed by disposing the lumen biasedly (Fig.1, Fig.2).
However, Fischer fails to explicitly disclose wherein the needle body has a wall thickness in the thin region that is set to at least 0.02 mm or more.
Kern teaches a needle body (20 – Fig.2) with a wall thickness in the thin region (23 – Fig.2) that is set to at least 0.02 mm or more (“0.1 mm to about 0.5 mm thick” – Para [0037]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the wall thickness in the thin region of Fischer to be set to at least 0.02 mm or more as taught by Kern since Kern teaches that wall thickness larger than 0.02 mm is a well-known suitable dimension for a thin region on a needle body (Kern, Para [0037]).
Regarding claim 9, Fischer discloses the injection needle as set forth above, wherein the needle body is made of a metal material (“stainless and/or surgical steel” – Para [0068]),
the hollow portion is formed by a lumen (122 – Fig.1) concentric to an axial center of the needle body (Fig.3).
However, Fischer fails to explicitly disclose a wall thickness of the needle body set to at least 0.02 mm or more.
Kern teaches a wall (23 – Fig.2) thickness of the needle body (20 – Fig.2) that is set to at least 0.02 mm or more (“0.1 mm to about 0.5 mm thick” – Para [0037]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the wall thickness of the needle body of Fischer to be set to at least 0.02 mm or more as taught by Kern since Kern teaches that a wall thickness larger than 0.02 mm is a well-known suitable dimension for a wall thickness on a needle body (Kern, Para [0037]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer in view of Lindenberg (WO 2010054660 A1).
Regarding claim 6, Fischer discloses the injection needle as set forth above, wherein an angle of the distal end of the first blade surface of the first bevel needle is the same angle of the distal end of the second blade surface of the second bevel needle, but Fischer does not explicitly disclose wherein an angle of the distal end of the first blade surface of the first bevel needle is more acute than an angle of the distal end of the second blade surface of the second bevel needle.
Lindenberg teaches an angle of a distal end of a first blade surface of a first bevel needle (1 – Fig.1) that is more acute than an angle of a distal end of a second blade surface of a second bevel needle (2 – Fig.1)(“the tip of the inner cannula has an angle which is larger than the tip of the outer cannula” – Page 6, lines 23-24).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the angles of the distal ends of the first and second blade surface of Fischer to wherein the first blade surface of the first bevel needle is more acute than the angle of the second blade surface of the second bevel needle as taught by Lindenberg since Lindenberg teaches that is well known for a tip of an inner cannula to have an angle which is larger than the tip of the outer cannula in a double needle system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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, Bhisma Mehta can be reached at (571) 272-3383. 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.
/MARISSA TAYLOR/ Examiner, Art Unit 3783
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights