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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/13/2026 has been entered.
Response to Arguments
Applicant's arguments filed 3/20/2026 have been fully considered.
Regarding the cancellation of claims 9-19, 28, the examiner agrees that the cancellation overcomes the 112(a) rejection and the rejection is therefore withdrawn.
Regarding the rejection of claims 1, 15, 22 over Poddar in view of Gross, Applicant argues that none of the cited references teaches an orifice having a diameter of about 0.1 mm. Applicant further argues the holes of Poddar have already been optimized and therefore a person of ordinary skill in the art would not have any motivation to optimize them further to be smaller as claimed. This argument is not convincing. However, in an effort to further prosecution, Latere et al (US 9,345,857) is cited herein to teach a hole having a diameter of 0.1 mm.
Applicant further points to fig. 28 which shows the greatest reduction of the injection pressure as compared to a standard needle. The examiner does not find that this example provides support for unintended results for the diameter of the hole specifically, as that parameter does not appear to be isolated in the comparative tests. For example, the comparison needles have similarly sized holes but are not tapered which implies that at least some of the performance benefit comes from the tapered configuration. The standard needle that is not cross drilled and therefore provides no information regarding the size of the holes, only that cross drilled holes provide a benefit. Therefore, this example does not provide unexpected results commensurate in scope with the claimed invention.
The remainder of the arguments appear to hinge on the rejection of claim 1 which has been addressed above.
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 1, 22-27 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 “wherein at least one of the two or more orifices has a diameter of about 0.1 mm.” There is no support for this limitation. Applicant points to example 1 which describes a needle 30 having holes with a diameter or 0.1092 mm. The examiner has found that this specific recitation of one example of a hole having a diameter of 0.1092 mm does not support the generic claim reciting “about 0.1 mm.” According to MPEP 2163.05(I)(B), the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. In this case, only a single species is described to represent the genus and therefore it is not clear to one of ordinary skill in the art that Applicant had possession of the genus. Nor is it clear what “about 0.1 mm” encompasses.
Claims 22-27 inherit the deficiencies of claim 1.
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 Latere et al (US 9,345,857) 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 at least one of the two or more orifices to have a diameter of about 0.1 mm. Applicant has not provided any criticality this parameter by describing any particular purpose or benefit ascribed to the claimed area. Fig. 28 of the instant invention shows injection pressure characteristics of various needles, however, it does not appear that the orifice size is an isolated parameter and therefore, the pressure characteristics of the various example needles could be attributed to a variety of parameters, not specifically the orifice diameter. Latere teaches a needle having an orifice that has a diameter of 0.1 mm (col. 11, lines 39-41: 100 µm). Gross further 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 at least one of the orifices of Poddar to have a diameter of about 0.1 mm as taught by Latere 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 22, Poddar discloses that the increase in inner diameter occurs along the entire length of the cannula (fig. 2).
Claim(s) 1, 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 Latere 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 Poddar in calling for at least one of the two or more orifices to have a diameter of about 0.1 mm. Applicant has not provided any criticality this parameter by describing any particular purpose or benefit ascribed to the claimed area. Fig. 28 of the instant invention shows injection pressure characteristics of various needles, however, it does not appear that the orifice size is an isolated parameter and therefore, the pressure characteristics of the various example needles could be attributed to a variety of parameters, not specifically the orifice diameter. Latere teaches a needle having an orifice that has a diameter of 0.1 mm (col. 11, lines 39-41: 100 µm). Gross further 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 at least one of the orifices of Poddar to have a diameter of about 0.1 mm as taught by Latere 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 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, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Latere 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 differs from Gross in calling for at least one of the two or more orifices to have a diameter of about 0.1 mm. Applicant has not provided any criticality this parameter by describing any particular purpose or benefit ascribed to the claimed area. Fig. 28 of the instant invention shows injection pressure characteristics of various needles, however, it does not appear that the orifice size is an isolated parameter and therefore, the pressure characteristics of the various example needles could be attributed to a variety of parameters, not specifically the orifice diameter. Latere teaches a needle having an orifice that has a diameter of 0.1 mm (col. 11, lines 39-41: 100 µm). Gross further 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 at least one of the orifices of Gross to have a diameter of about 0.1 mm as taught by Latere 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 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 Latere 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.
Conclusion
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.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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