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 .
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered.
With regard to the drawing objection, Applicant’s arguments are convincing. While not necessarily shown in a single drawing, the examiner agrees that all of the features of the claimed invention are shown in such a manner that the subject matter can be understood. Therefore, the drawing objection is withdrawn.
With regard to the rejections under 112(a), Applicant’s argument have been considered and are not persuasive. Applicant argues that the specification describes “in certain embodiments of the cannula described herein, the inner diameter of the cannula is not constant along the length of the cannula.” The examiner agrees with this characterization of the disclosure. The cited passage further refers to fig. 25 which does indeed show a cannula having a tapered configuration, however a tapered cannula having multiple round orifices. The examiner notes that the disclosure recites “in certain embodiments”, not that the cannula may be tapered in any of the described embodiments. And further the cited passages point specifically to the embodiments having a tapered body – figs. 25-27. Therefore, there is no reason to believe that applicant had possession of the combination of the embodiment having orifices as described in claims 3, 9-19, 28 with a tapered body at the time of invention as these are separate embodiments.
Regarding claim 3, the claim has been cancelled and therefore the 112(d) rejection is moot.
Regarding the claim objections, Applicant’s arguments are convincing. The amendments to the claims overcome the objections and the objections are therefore withdrawn.
Regarding claim 1, Applicant argues that claim 1 has been amended to include recitation of orifice area which is not disclosed by Poddar or Iibuchi. This argument is convincing and those rejection are therefore withdrawn. As noted by Applicant, the amendment to claim 1 was previously recited in claim 20. With regard to the rejection of claim 20, the examiner previously rejected the claim over Gross which supports a rejection of achieving optimum working ranges through routine experimentation. Applicant argues that fig. 28 of the instant application shows that the tapered needle having the claimed hole size achieves the greatest reduction in injection pressure. Applicant further argues that needle 30 has hole size having an inner diameter of 0.0043 in which falls within the claimed range. This argument is not convincing as the graph shows the needles of the instant invention as compared to needle 40 which is a standard 25 gauge needle “Not cross drilled. Open end” according to the disclosure, i.e. not having openings at all. Therefore, this does not appear to show any unexpected results of the particular area of the claimed orifices, a) because the table shows a single data point within a large claimed range ~ 4 orders of magnitude, and b) the table compares needles having orifices to a needle not having orifices and therefore gives no information regarding any unexpected results stemming from the size of the orifices.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-19, 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites that the inner diameter of the cannula wall increases from the distal end of the cannula to the proximal end of the cannula. This feature is not disclosed or described in combination with the elements recited in claims 9-19, 28. Therefore, the combination of features in the listed claims is not supported by the disclosure.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 15, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poddar et al (WO 2014/061030 A2) in view of Gross et al (US 2007/0255230).
Regarding claim 1, Poddar discloses a cannula 1 for subcutaneous dispensing of medicaments comprising a cannula wall comprising a distal end 2 and a proximal end (fig. 2(a)), wherein the inner diameter of the cannula wall increases from the distal end of the cannula to the proximal end (fig. 2(a)) and wherein the cannula wall comprises two or more orifices 6 (fig. 2(a)).
Claim 1 differs from Poddar in calling for the two or more orifices each comprise an area between 0.000001 sq. in to 0 0.015 sq. in. Applicant has not provided any criticality this parameter by describing any particular purpose or benefit ascribed to the claimed area. Gross teaches that the size of the orifices can be chosen to achieve the desired flow rate and distribution along the length of the cannula (page 3, para. 0037). Therefore, it would have been obvious to one of ordinary skill in the art to modify the orifices of Poddar to each comprise an area between 0.000001 sq. in to 0.015 sq. in as doing so would have been a matter of discovering the optimum range by routine experimentation to achieve the desired flow rate through the cannula as taught by Gross.
Regarding claim 15, Poddar discloses that the two or more orifices are oriented at a range of angles from one another, wherein the angles range from 0° to 180⁰ when viewed in cross section along the axis of the cannula (fig. 2(a)).
Regarding claim 22, Poddar discloses that the increase in inner diameter occurs along the entire length of the cannula (fig. 2).
Claim(s) 1, 14, 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iibuchi et al (US 2018/0008513) in view of Gross.
Regarding claim 1, Iibuchi discloses a cannula 1 for subcutaneous dispensing of medicaments (page 5, para. 0065) comprising a cannula wall comprising a distal end 2a and a proximal end 8a (figs. 1, 2) wherein the inner diameter of the cannula wall increases from the distal end of the cannula to the proximal end (figs. 2, 6) and wherein the cannula wall comprises two or more orifices 7a-c (figs. 1, 2).
Claim 1 differs from Iibuchi in calling for the two or more orifices each comprise an area between 0.000001 sq. in to 0 0.015 sq. in. Applicant has not provided any criticality this parameter by describing any particular purpose or benefit ascribed to the claimed area. Gross teaches that the size of the orifices can be chosen to achieve the desired flow rate and distribution along the length of the cannula (page 3, para. 0037). Therefore, it would have been obvious to one of ordinary skill in the art to modify the orifices of Iibuchi to each comprise an area between 0.000001 sq. in to 0.015 sq. in as doing so would have been a matter of discovering the optimum range by routine experimentation to achieve the desired flow rate through the cannula as taught by Gross.
Regarding claim 14, Iibuchi discloses that the two or more orifices are not closed such that a portion of the perimeter of the opening of the orifice or two or more orifices intersects with the distal end of the cannula (figs. 1,2: a portion of the perimeter of the orifices intersect with channels that intersect with the distal end of the cannula; page 3, para. 0049).
Regarding claim 23, Iibuchi discloses that the increase in inner diameter occurs along one or more discrete portions of the length of the cannula (fig. 6).
Claim(s) 1, 9-13, 16-19, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Poddar.
Regarding claim 1, Gross discloses a cannula (figs. 2-12). The limitation “for subcutaneous dispensing of medicaments” is interpreted to be an intended use limitation. The cannula of Gross is capable of dispensing medicament into whatever tissue in which it is inserted, including subcutaneous tissue. Gross discloses that the cannula comprises a cannula wall comprising a distal end and a proximal end (various embodiments shown in figs. 2-12), and wherein the cannula wall comprises two or more orifices (figs. 2-12: various orifice configurations).
Claim 1 further calls for the inner diameter of the cannula wall increases from the distal end of the cannula to the proximal end. Poddar teaches a cannula for fluid delivery wherein the cannula has an inner diameter increasing from the distal end of the cannula to the proximal end in order to maintain a constant fluid delivery pressure throughout the length of the needle (page 5, lines 24-28; fig. 2(a)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of Gross to have a diameter that increases from the distal end to the proximal end as taught by Poddar to provide constant fluid delivery pressure along the length of the cannula to ensure that the fluid is delivered as desired.
Claim 1 further calls for the two or more orifices each comprise an area between 0.000001 sq. in to 0 0.015 sq. in. Applicant has not provided any criticality this parameter by describing any particular purpose or benefit ascribed to the claimed area. Gross teaches that the size of the orifices can be chosen to achieve the desired flow rate and distribution along the length of the cannula (page 3, para. 0037). Therefore, it would have been obvious to one of ordinary skill in the art to modify the orifices of Gross to each comprise an area between 0.000001 sq. in to 0.015 sq. in as doing so would have been a matter of discovering the optimum range by routine experimentation to achieve the desired flow rate through the cannula as taught by Gross.
Regarding claim 9, Gross discloses that the two or more orifices are in the shape of an ellipse, wherein the ellipse comprises a long axis and a short axis (fig. 6).
Regarding claim 10, Gross discloses that the two or more orifices are in the shape of a polygon (fig. 8).
Regarding claim 11, Gross discloses that the polygon is an elongated polygon (fig. 11: elongated polygon (rectangle) is one of the shapes shown).
Claim 12 calls for the length of the elongated polygon spans range between 1% and 80% of the length of the cannula. Gross does not specifically disclose this feature. However, Applicant has not provided any criticality to this range and Gross recognizes the length of the openings to be a result effective variable. Gross teaches that the length of the opening and their distribution along the length of the cannula can be chosen to control the flow rate and distribution pattern of the material along the length of the cannula (page 3, para. 0037). Therefore, it would have been obvious to one of ordinary skill in the art to modify the orifices of Gross to span a range between 1% or 80% as doing so would have been a matter of discovering the optimum range by routine experimentation to achieve the desired flow rate through the cannula as taught by Gross.
Regarding claim 13, Gross discloses that the long axis of the elongated polygon is oriented at an angle to the axis of the cannula between 0⁰ and 45° (fig. 11: rectangular orifice oriented at an angle of 0⁰).
Regarding claim 16, Gross discloses that the two or more orifices are spaced an unequal distance apart along the axis of the cannula (figs. 5-7).
Regarding claim 17, Gross discloses that the two or more orifices are spaced at increasing distances apart in the distal direction along the axis of the cannula (figs. 6, 9).
Regarding claim 18, Gross discloses that the two or more orifices are spaced at decreasing distances apart in the distal direction along the axis of the cannula (figs, 7, 8).
Regarding claim 19, Gross discloses that the the two or more orifices comprise a combination of elliptical and polygonal shapes (fig. 11).
Regarding claim 27, Gross discloses that the two or more orifices are in the shape of a circle (fig. 2).
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poddar in view of Gross as applied to claim 1 above, and further in view of Hillios et al (US 7,789,856).
Claim 24 differs from Poddar in calling for the cannula to further comprises a guide for controlling the angle and depth of insertion of the cannula. Hillios teaches a cannula including a guide 2 for controlling the angle and depth of insertion of the cannula (figs. 1-3) to increase ease of use of the cannula as the user does not need to find the proper angle and depth for the desired injection (col. 3, lines 31-41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of Poddar to include a guide for controlling the depth and angle of insertion as taught by Hillios to increase ease of use as the user can be sure the injection is being given at the proper depth and angle.
Regarding claim 25, Hillios teaches the injection guide as discussed above with regard to claim 42. Claim 25 further calls for the cannula is limited to a range of insertion depths of the distal end of the cannula between 1/4 inch and 3 inches. Hillios does not explicitly teach this length, however, Hillios teaches that the set length is chosen for proper subcutaneous injection depth (col. 3, lines 37-38). Subcutaneous injections are typically given at 8mm (1/3 in). therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Poddar in view of Hillios to include the cannula limited to a depth of about 1/3 of an inch as this is the appropriate depth for a subcutaneous injection and Hillios teaches that the guide is intended to deliver the injection cannula to the proper depth for subcutaneous delivery.
Regarding claim 26, Hillios teaches that the cannula is limited to an insertion angle between the axis of the cannula and the surface of the patient's skin ranging from 5° to 90⁰ (fig. 1: 90 degree angle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include this feature in the combination described above with regard to claim 24 so that desired injection depth is reached and to increase ease of use of the device.
Claim(s) 28, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Poddar as applied to claim 9 above, and further in view of Latere et al (US 9,345,857).
Regarding claim 28, Gross discloses that the two or more orifices are in the shape of an ellipse(fig. 7), wherein the ellipse comprises a long axis and a short axis (fig. 7), but fails to disclose that the long axes of each of the two or more orifices are not parallel to the axis of the cannula. Applicant has not provided any criticality to this feature as the disclosure does not describe any benefit or particular purpose to having the elliptical orifices arranged at an angle. A person of ordinary skill in the art would expect the orifices of Gross and the claimed invention to work equally well for delivering fluid at the desired rate while having any orientation. Therefore, this is interpreted to be a matter of obvious design choice. Additionally, providing a cannula having multiple elongate orifices, the orifices arranged at an angle is a known configuration in the art as taught by Latere (fig. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elliptical orifices of Gross to be oriented at an angle as recited in claim 28 because doing so would have been a matter of obvious design choice.
Claim 29 calls for the long axes of the two or more orifices to be oriented at an angle to the axis of the cannula between 50 and 90⁰. Gross discloses the elliptical orifices as discussed above with regard to claim 9, but fails to disclose the axis at an angle. Applicant has not provided any criticality to this feature as the disclosure does not describe any benefit or particular purpose to having the elliptical orifices arranged at the claimed angle. A person of ordinary skill in the art would expect the orifices of Gross and the claimed invention to work equally well for delivering fluid at the desired rate while having any orientation. Therefore, this is interpreted to be a matter of obvious design choice. Additionally, providing a cannula having multiple elongate orifices, the orifices arranged at an angle between 5 and 90⁰ degrees is a known configuration in the art as taught by Latere (fig. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elliptical orifices of Gross to be oriented at an angle as recited in claim 3 because doing so would have been a matter of obvious design choice.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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.
LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
Prosecution Insights