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 § 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 1-2, 5-14, 20-25, 34-39 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.
The amended language in Claim 1 “such that the length is greater than the width by a factor of at least 6” and Claim 20 “such that the length is greater than the width by a factor of at least 3” is considered new matter not described in the specification as originally filed. It is an open-ended range not described in the specification. In [00109] it is disclosed a closed range.
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 1-2, 5-6, 14, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20060084938 A1) in view of Sällberg et al. (US 20160235928 A1).
Regarding claims 1-2 and 34-36, Zhang discloses an injection device (figs 1 and 9) for in vivo delivery of an agent (abstract), comprising:
a tubular body 910 (fig 9) defining a lumen that extends along a central axis oriented along a longitudinal direction [0029], the tubular body 910 defining at least one side-port (fig 9) extending from the lumen to an outer surface of the tubular body; the at least one side-port having a length and a width that each can be measured along the outer surface.
Zhang fails to disclose a distal end of the lumen of the tubular body is occluded, and the at least one side-port is elongated along the outer surface of the tubular body such that the length is greater than the width by a factor of at least 6, wherein the factor is in a range of 6 to about 80, the factor is in a range of about 15 to about 80, wherein the factor is in a range of about 15 to about 50, or wherein the factor is in a range of about 35 to about 45.
Sällberg teaches an injection device (figs 1f,8a) for in vivo delivery of an agent including a tubular body defining a lumen [0008] where a distal end of the lumen of the tubular body is occluded ([0008] closed end), and the at least one side-port is elongated along the outer surface of the tubular body ([0010] for example oval, slit, ovoid shape, rectangular). In [0088], Sällberg also teaches the side ports can vary in size and shape ([0088,0090-0091] for example rectangular and others elongated shape) to maximize efficient delivery of injected material.
Given the teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang’s with an occluded tubular body at the distal end allowing therapeutic fluid coming through the side ports, and with the teachings of selecting a desired side ports size and shape taught by Sällberg (elongated shape, rectangular) in order to would enhance the flow and distribution of agent at the tissue/ to maximize efficient delivery of injected material.
Furthermore, Zhang /Sällberg do not specifically teach that the at least one elongated side-port length is greater than the width by a factor of at least 6, the factor is in a range of 6 to about 80, the factor is in a range of about 15 to about 80, wherein the factor is in a range of about 15 to about 50, or wherein the factor is in a range of about 35 to about 45. However, these parameters are deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Regarding claim 5, Zhang discloses the at least one side-port comprises a plurality of side-ports (fig 9).
Regarding claim 6, Zhang discloses wherein the plurality of side-ports are arranged into distinct rows spaced from each other along the longitudinal direction (figs 7 and 9).
Regarding claim 14, Zhang discloses wherein the injection device 910 is an injection needle [0029].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20060084938 A1) in view of Sällberg et al. (US 20160235928 A1), and further in view of Kjeken et al. (US 20110009807 A1).
Regarding claim 7, Zhang discloses at least a first one of the rows comprises four side-ports of the plurality of side-ports (fig 9). Sällberg teaches in [0010] that the side apertures can be evenly or unevenly spaced along the length of the tubular body (needle), but both fail to disclose that the four side-ports are evenly angularly spaced from each other about a circumference of the tubular body.
Kjeken teaches, (in figures 11a-11b and [0040]), that the apertures are spaced along the needle length (FIG. 11A) and at 90 degrees with respect to one another around the circumference of the needle shaft (FIG. 11B) for uniform distribution of the injected substance into the tissues [0011]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang/ Sällberg side ports by providing them with the teachings of Kjeken since such modification would enhance the flow and distribution of agent at the tissue.
Claims 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20060084938 A1) in view of Sällberg et al. (US 20160235928 A1), and further in view of Kjeken et al. (US 20110009807 A1), and further in view of Chomas et al. (US 10548659 B2).
Regarding claim 8, Zhang/ Sällberg/ Kjeken discloses at least a second one of the rows comprises four additional side-ports of the plurality of side-ports and the four additional side-ports being evenly angularly spaced from each other about a circumference of the tubular body. However, they do not disclose the four additional side-ports are angularly offset from the four side-ports of the at least first one of the rows by an offset angle of about 45 degrees about the central axis.
Chomas teaches in figure 2c the second one of the rows of the additional side ports are angularly offset from the four side-ports of the at least first one of the rows by an offset angle of about 45 degrees about the central axis.
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Given the teaching, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang/ Sällberg/ Kjeken with Chomas teaching since such modification as taught old and well known in the art, and it is deemed matter of design choice, and recognized by Sällberg/ Kjeken/Chomas, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results in order to improve and/or control the distribution and flow of agent at the tissue.
Regarding claim 9, Sällberg teaches the four side-ports and the four additional side-ports are each elongated along the longitudinal direction [0010,0022, 0088].
Regarding claim 10, Sällberg teaches wherein the four side-ports and the four additional side-ports are each rectangular [0010,0022, 0088].
Regarding claim 11, Zhang/ Sällberg/ Kjeken/Chomas fail to disclose at least a third one of the rows comprises four yet additional side-ports of the plurality of side-ports, the four yet additional side- ports being evenly angularly spaced from each other about a circumference of the tubular body, and wherein the four yet additional side-ports are angularly aligned from the four side-ports of the at least first one of the rows.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang/ Sällberg/ Kjeken/Chomas with the claimed limitations since such modification would have been a mere duplication of essential working parts of the tubular body in order to complete the side ports around the circumference of the tubular body (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claims 12-13, Kjeken teaches in ([0011] .1 to 1.5cm falling the range) the plurality of side-ports are arranged in a side-port array that is bounded within a region of the tubular body (see fig 8), the side-port array having an infusion length that can be measured along the longitudinal direction from a proximal end of the side-port array to a distal end of the side-port array, wherein and wherein the region has a length in a range of about 3.0 mm to about 12.0 mm (3cm to about 1.2cm); and (claim 13) wherein the length of the region is in a range of about 4.0 mm to about 6.0 mm (.4cm to about .6cm). Moreover, Zhang (fig1) and Sällberg (figs 1A, 2A-2C, 3-4, 5C-5D) also teach the plurality of side-ports are arranged in a side-port array that is bounded within a region of the tubular body, the side-port array having an infusion length that can be measured along the longitudinal direction from a proximal end of the side-port array to a distal end of the side-port array.
Claims 20-25, and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Draghia-Akli et al. (US 20040167458 A1) in view of Sällberg et al. (US 20160235928 A1).
Regarding claim 20, Draghia-Akli discloses an assembly for in vivo delivery of an agent [0061], comprising:
an electroporation device (figs 3-4) having an electrode array that includes a plurality of needle electrodes 3 configured for delivering one or more electroporation pulses to tissue;
at least one injection needle 2 attachable to the electroporation device [0021] so as to extend substantially parallel with at least one of the plurality of needle electrodes, the at least one injection needle 2 defining a lumen that extends along a central axis oriented along a longitudinal direction.
Draghia-Akli fails to disclose a distal end of the lumen is occluded, the at least one injection needle 2 defining at least one side-port extending from the lumen to an outer surface of the at least one injection needle, the at least one side-port having a length and a width each measured along the outer surface, wherein the at least one side-port is elongated along the outer surface of the injection needle, such that the length is greater than the width by a factor of at least 3, the factor is in a range of about 15 to about 80, the factor is in a range of about 15 to about 50, or the factor is in a range of about 35 to about 45.
Sällberg teaches an injection device (figs 1f,8a) for in vivo delivery of an agent including a tubular body defining a lumen [0008] where a distal end of the lumen of the tubular body is occluded ([0008] closed end), and side ports where the at least one side-port is elongated along the outer surface of the tubular body ([0010] for example oval, slit, ovoid shape, rectangular). In [0088], the at least one side-port having a length and a width can be measured along the outer surface. Sällberg also teaches the side ports can vary in size and shape ([0088,0090-0091] for example rectangular and others elongated shape) to maximize efficient delivery of injected material.
Given the teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Draghia-Akli with an occluded tubular body at the distal end allowing therapeutic fluid coming through the side ports, and with the teachings of selecting a desired side ports size and shape taught by Sällberg (elongated shape, rectangular) in order to would enhance the flow and distribution of agent at the tissue/ to maximize efficient delivery of injected material.
Furthermore, Draghia-Akli /Sällberg do not specifically teach that the at least one elongated side-port length is greater than the width by a factor of at least 3, the factor is in a range of about 15 to about 80, the factor is in a range of about 15 to about 50, or the factor is in a range of about 35 to about 45. However, these parameters are deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Regarding claims 21-22, Draghia-Akli/ Sällberg discloses wherein the at least one side-port comprises a plurality of side-ports, and the plurality of side-ports are configured to expel injectate from the at least one injection needle along respective directions that extend radially outward from the central axis, such that the plurality of side-ports are configured to disperse injectate through muscle tissue (Draghia-Akli); and wherein the plurality of side-ports are configured to disperse injectate through both muscle tissue and adipose tissue (Sällberg).
Regarding claim 23, Draghia-Akli discloses the at least one injection needle is located intermediate the plurality of needle electrodes (fig 3), and Draghia-Akli /Sällberg teaches the at least one side-port is configured to eject fluid from the lumen into tissue intermediate the plurality of needle electrodes.
Regarding claim 24, Draghia-Akli discloses the plurality of needle electrodes are carried by a support member (figs 3-4) that also defines at least one injection channel for receiving the at least one injection needle.
Regarding claim 25, Draghia-Akli discloses wherein the plurality of needle electrodes are arranged in a circular pattern, and the at least one injection needle is centrally disposed in the circular pattern when attached to the electroporation device (figs 3 and 5).
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
In response to applicant's first argument (pages 7-8 in the Remarks) to the rejection of claim 1 over Zhang et al in view of Sällberg et al, and argument on pages 10-11 to the rejection of claim 20 over Draghia-Akl et al in view of Sällberg et al,
Pages 8-9: “to modify Zhang's side ports shape with the ones taught by Sallberg (elongated shape) in order to improve and/or control the distribution and flow of agent at the tissue." Office Action, pg. 8 (emphasis added). But the Office Action does not identify any disclosure in either Zhang or Sällberg teaching or suggesting that modifying "side port[] shape" can "improve and/or control the distribution and flow of agent at the tissue." This deficiency fails to set forth a prima facie rejection of claim 1 because a § 103 rejection "must be reached on the basis of the facts gleaned from the prior art" and not "hindsight" based upon applicant's disclosure." MPEP 2142 (titled the "Legal Concept of Prima Facie Obviousness") (emphasis added).”, and
Pages 10-11: “The Office Action then alleges that Sällberg teaches an injection device having a tubular body with a "closed end" and side ports where "the at least one side-port is elongated along the outer surface of the tubular body," citing Sällberg's disclosure of "oval, slit, ovoid shape." Id. But the Office Action does not identify any disclosure in either Draghia-Akli or Sällberg teaching or suggesting that modifying Draghia-Akli based on Sällberg "would have enhanced the distribution and flow of agent at the tissue." Id. Accordingly, as with claim 1, the rejection of claim 20 fails to set forth a prima facie case because a § 103 rejection "must be reached on the basis of the facts gleaned from the prior art" and not "hindsight" based upon applicant's disclosure." MPEP § 2142.”,
the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Furthermore, applicant is advised that the whole disclosure of the cited references should be considered not only the sections that the examiner pointed out. It is noted the examiner previously cited in the rejection filed on 02/23/2026, that Sällberg teaches in [0008 and 0010] the advantages of having a closed end to increase pressure of delivery when the side ports have a small diameter or other shape, or having a length and a width with similar results.
It is also noted that in [0008-0010, 0022, 0027, 0087-0088, 0090] Sällberg discloses the advantages of having an open and close end needle, that the needle can comprise more or less side ports, and smaller or larger size side ports to maximize efficient delivery of the injected fluid, knowledge also gleaning from applicant’s disclosure. It is also noted Zhang, in [0107-0109] discloses that additional side ports (holes) are used to deliver of the agent in the tissue.
In response to applicant's second argument with respect to the amendments to claims 1 and 20, it seems applicant’s argument, on pages 8-9 and 11-12, is trying to argue unexpected results pointing out the specification test results in [0144] as being surprising and unexpected in view of obviousness rejection over Sällberg. The argument is not convincing.
“Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).”. MPEP 2145(II).
“Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).”. MPEP 716.02(c)(I).
Based on the entire record, the examiner has concluded that applicant’s arguments are not convincing to overcome the obviousness rejection on Sällberg for the abovementioned reasons in first argument above, when Sällberg teaches clearly that modifying size and shape are obvious and within the skill of one of ordinary skilled in the art to attain a desirable result as stated by Sällberg.
Conclusion
THIS ACTION IS MADE FINAL. 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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
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