DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed on 03/06/23 has been entered in the case. Claims 1-20 are pending for examination.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-6, 16-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (US 5,536,267) in view of Mathiesen et al. (US 7,328,064) & Cragg et al. (US 6,635,027).
Regarding claims 1 and 16, Edwards discloses an electroporation device, in Figs. 1-21 for delivering a molecule into cells of skeletal muscle tissues,
Note: The recitation, i.e., for delivering a molecule into cells of skeletal muscle tissue, has not been given patentable weight because it has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Robie, 88 USPQ 478 (CCPA 1951).
Edwards discloses the electroporation device comprising:
an electrical power source 40/42 configured to deliver a pulse of energy, col. 10, lines 49-51 and Fig. 21;
a housing 18, Fig. 1; and
an elongate needle electrode 20 extending from the housing and in electrical communication with the electrical power source (via electric wiring being connected at the handle 18 in Fig. 1), the needle electrode 20 having a proximal end (adjacent element 18) and a distal end 24 configured to pierce tissue, see Figs. 13-18,
With respect to the limitation, i.e., distal end configured to pierce through skin tissue and into the skeletal muscle tissue, is a method step into the device claim. Therefore, with broadest interpretation, the method step in the device claim is considered as a functional limitation and only requires performing function. In this case, Edwards discloses that: the invention is to provide an RF tissue ablation apparatus which ablates a desired tissue site, such as a tumor, col. 3, lines 10-13; the electrodes is inserted through tissue, and advancement to the selected tissue site… the delivery catheter can be advanced percutaneously to an internal body organ, or site, which the obturator posited in the delivery catheter, col. 4, lines 37-45. Therefore, the distal end of the elongate needle electrode 20 is capable of piercing through a skin tissue and into the selected tissue site such as skeletal muscle tissue for treating in certain tumor area. In addition, the device in Edward can be used to insert into the skeletal muscle tissue as taught by Mathiesen below.
Edwards also discloses that the needle electrode 20 having an electrically nonconductive portion 28 and an electrically conductive portion (not covered by the nonconductive portion 28, Fig. 8) configured to deliver the pulse of energy to the tissue (i.e., can be delivered the pulse of energy into skeletal muscle tissue), the nonconductive portion (e.g. the insulator sleeve 28) being located between the proximal and distal ends 16 & 24,
wherein the needle electrode 20 defines a plurality of apertures 26 that are positioned on the conductive portion such that approximately 10 to 11 of the conductive portion; as shown in Figs. 8, 15-18,
the apertures 26 are spaced around an entire circumference of the conductive portion, Fig. 17, wherein the aperture positioning, spacing, and diameters are configured to provide even distribution of an injection fluid over an entire length of the conductive portion within the target tissue, col. 8, line 67-col. 9, line5 and Figs. 8, 14-17. It is noted that the target tissue can be in the skeletal muscle tissue.
Mathiesen discloses that electroporation device is used in treatment of cancer or in gene therapy. Electroporation provides a method of delivering [pharmaceuticals or DNA into cell, e.g. skeletal muscle cells.
Giving such a teaching by Mathiesen, a person having ordinary skill in the art would have easily recognizes that applying the elongate needle/catheter electrode device of Edwards into a target tissue, i.e., skeletal muscle tissue, as taught by Mathiesen, would provide the benefit of electrically stimulating a muscle and at the same time that delivering pharmaceutical or DNA into the skeletal muscle cell for treating cancer or in gene therapy.
Edwards does not disclose that a ratio of the apertures being arranged between approximately 10 and approximately 100 apertures per centimeter of length of the conductive portion, the apertures have a diameter in a range of 30 microns to 80 microns.
Cragg discloses an infusion catheter comprising: a plurality of apertures 12 that at positioned on the catheter body portion such that an aperture density in between approximately 32 apertures per centimeter length, col. 7, lines 5-7; or 30-50 apertures per centimeter length or 20-32 apertures per centime length, col. 12, lines 13-18, which is in the requirement range of 10-100 apertures per centimeter of length, as required in the claimed invention; wherein the apertures are spaced around an entire circumference of the catheter body portion.
Since Edwards and Cragg are both from the same field of endeavor (e.g. using infusion apertures for delivering a drug into a target tissue), the purpose disclosed by Cragg would have been recognized in the pertinent art of Edwards.
Giving such a teaching by Cragg, a person having ordinary skill in the art would have easily recognizes that modifying the elongate needle/catheter electrode device of Edwards (or Edwards in view of Mathiesen) with providing an aperture density in range of 10-100 apertures per centimeter of length of the insertion portion (the conductive portion), as taught by Cragg, would provide the benefit of enhancing a drug distribution evenly around the circumference of the insertion catheter body portion (or the conductive portion) at the target size, i.e., skeletal muscle tissue.
With regarding the limitation of the apertures have a diameter in a range of 30 microns to 80 microns, Edwards also states that the size of fluid distribution ports 26 can vary, depending on the size and shape of the electrode 20, col. 9, lines 19-13. In other words, the size of the apertures 26 can have in a range of 30-80 microns, as considered that discovering an optimum value of a result effective variable involves only routine skill in the art. Cragg discloses the size of the infusion apertures are about 0.01 cm (= 100 microns). Meanwhile, the claimed invention requires the diameter being in the range of 30-80 microns. Although the aperture dimension of the prior art ranges does not overlap but are close enough (80 micron compares with 100 microns) that one skilled in the art would have expected them to have the similar outcomes. It is noted that the outflow rate of the drug depends on the numbers and size of the apertures. Meanwhile, the number of the apertures are in the required ranged of the claimed invention, but the size of the apertures is a very close (80 micron compares with 100 microns). As mentioned in the above, Edwards states that the size of the size of fluid distribution ports 26 can vary, depending on the size and shape of the electrode 20, col. 9, lines 19-13.
Evidence: Applicant clearly states in the PGPub 2020/0289818 (equivalent to the current application 16/804717) that the apertures can be between 20 and 120 microns in diameter, paras [0042, 0057]; the specific diameters of the apertures include 20, 25, ...90 and 100 microns. Meanwhile, the size of the apertures in Cragg is about 0.01 cm (100 micron) is within the range that Applicant discussed in the para [0042]. Therefore, the size of 80 microns to 100 microns values are close enough that can be treated in certain disease.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the diameter of the apertures in a range of 30-80 micron, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. For example: one wish to using the size of 30-80 micron for delivering a drug into the target tissue, i.e., skeletal muscle tissue for certain dosage in certain treatment.
Furthermore, the instant disclosure describes these parameters of the diameter of the apertures as being merely preferable and does not describe it as contributing any unexpected result to the needle electrode. As such, these parameters are deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. See also In re Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) where the Federal Circuit held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claims 2-3 and 17, Edwards in view of Mathiesen and Cragg discloses all claimed subject matter as required in the claim 1 above. Edwards also states in col. 9, lines 12-28 that the insulator sleeve 28 is adjustable, slidable along an exterior surface of the electrode 20. The insulator sleeve 28 is advanced and retracted along electrode 20 in order to define the size of a conductive surface of electrode 20. In other words, the nonconductive position is spaced from the distal end being adjusted by the insulator sleeve 28, and a length of the conductive portion is also adjustable as the advancing or retracting of the insulator sleeve.
Thus, one of ordinary skill in the art would understand that it would be necessary to modify said distance of the nonconductive portion being spaced from the distal end (by adjusting the insulator sleeve) in between about 2.5 and at least 0.1 cm; or the length of the conducive portion is between 0.01 cm and 2.5 cm (by adjusting the insulator sleeve) are considered as a discovering these parameters are deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. For example: the desired ablation volume is defined by deployed electrodes 20, as well as the positioning of insulator sleeve 28 on each electrode in a manner of very precise ablation volume being created, col. 9, lines 26-30.
Regarding claims 4 and 18, wherein the nonconductive portion 28 (insulator sleeve 28) comprises an insulation coating, col. 9, line 13.
Regarding claim 5, Edwards shows tin Fig. 8 hat wherein the elongate needle electrode does not have an aperture at a tip at the distal end of the needle.
Regarding claim 6, Edwards discloses an actuator 22 (or other actuating device) for driving the elongate needle electrode in a linear movement (i.e. advance and retract), col. 7, lines 59-65.
It is noted that the limitation “for driving the elongate needle electrode in a linear movement having a travel length between 0.5 cm and 4.0 cm” is a functional limitation and only requires to perform of function. In this case, Edwards discloses that the extent of electrode 20 fan like travel is dependent on the strength of the material from which it is made, col 8, lines 20-31. In addition, Edwards further states that different electrodes 20 will have various degrees of deployment (linear movement in travel length) based on type of electrode material, the level of prespringing of the electrodes and the geometric configuration of the electrodes in their deployed states, col 10, lines 8-14. Based on these statements above, a person skilled in the art would recognize that the travel length of the needle electrode depends on the material of the needle electrode to achieve the various degrees of deployment in linear movement. In addition, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the actuator for driving the needle electrode in a liner movement of the needle electrode having a travel length between 0.5-4.0 cm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Furthermore, the instant disclosure describes these parameters as being merely preferable, and does not describe it as contributing any unexpected result to the insertion of the needle electrode. As such, these parameters are deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. See also In re Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) where the Federal Circuit held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
With regarding the limitation “wherein the actuator creates a pressure that allows the injection fluid to pass through each of the plurality of apertures at equivalent flow dynamics”, it is a result of actuator perform of a function and considered as a functional limitation. In this case, the actuator uses to advance and retract the electrodes 20 in and out of delivery catheter; wherein the ports 26 are able to distribution the fluid to a desired tissue site. Therefore, the actuator is capable of creating a pressure that allows the injection fluid to pass through each of the plurality of apertures at equivalent flow dynamics.
Claims 1-6, 16-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Simon et al. (US 2005/0154434) in view of Mathiesen et al. (US 7,328,064) &Cragg et al. (US 6,635,027).
Regarding claims 1 and 16, Simon discloses an electroporation device, in Figs. 4-8, 10-13 & 15 for delivering a molecule into cells of tissue, i.e., skeletal muscle tissue,
Note: The recitation, i.e., for delivering a molecule into cells of skeletal muscle tissue, has not been given patentable weight because it has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Robie, 88 USPQ 478 (CCPA 1951).
Simon discloses that the electroporation device comprising:
an electrical power source 82 configured to deliver a pulse of energy, similar shown in Fig. 1;
a housing 66 (Figs. 6-10) or 202 (Fig. 21), or 208 (Fig. 23) or 212 (Fig. 24);
an elongate needle electrode 34 extending from the housing and in electrical communication with the electrical power source 82, the needle electrode 34 having a proximal end and a distal end configured to pierce skin tissue 52 (and capable of inserting into the skeletal muscle tissue), the needle electrode 34 having an electrically nonconductive portion 104, in Fig. 15, and an electrically conductive portion 105 configured to deliver the pulse of energy to the tissue (e.g., can be the skeletal muscle tissue), the nonconductive portion being located between the proximal and distal ends, see Fig. 15,
With respect to the limitation, i.e., distal end configured to pierce through skin tissue and into the skeletal muscle tissue, is a method step into the device claim. Therefore, with broadest interpretation, the method step in the device claim is considered as a functional limitation and only requires performing function. In this case, Simon discloses that: a treatment device is provided for applying electrical energy to biological tissue in conjunction with injection a composition that diffuses through the tissue 50, see abstract, also see Fig. 1. Therefore, the distal end of the elongate needle electrode 34 is capable of piercing through a skin tissue and into the selected tissue site such as skeletal muscle tissue for treating in unhealthy area. In addition, the device in Simon can be used to insert into the skeletal muscle tissue as taught by Mathiesen below.
Simon further discloses that wherein the needle electrode defines a plurality of apertures 52 that are positioned on the conductive portion, see Fig. 19. Note: the apertures 52 of the needle electrode in Fig. 19 is different embodiment with the needle electrode in Fig. 15; however, a person skilled in the art would recognize the apertures 52 can be provided in the needle electrode 34 in Fig. 15 for spreading or distribution the drug into the tissue area; wherein the apertures 52 are spaced around a circumference of the conductive portion; wherein the aperture positioning, spacing, and diameters are configured to provide even distribution of an injection fluid over an entire length of the conductive portion, Fig. 19.
Mathiesen discloses that electroporation device is used in treatment of cancer or in gene therapy. Electroporation provides a method of delivering [pharmaceuticals or DNA into cell, e.g. skeletal muscle cells.
Giving such a teaching by Mathiesen, a person having ordinary skill in the art would have easily recognizes that applying the elongate needle/catheter electrode device of Edwards into a target tissue, i.e., skeletal muscle tissue, as taught by Mathiesen, would provide the benefit of electrically stimulating a muscle and at the same time that delivering pharmaceutical or DNA into the skeletal muscle cell for treating cancer or in gene therapy.
Simon does not disclose that the plurality of apertures are in between approximately 10 and approximately 100 apertures per centimeter of length of the conductive portion, and the apertures are spaced around an entire circumference of the conductive portion and have a diameter in a range of 30 microns to 80 microns.
Cragg discloses an infusion catheter comprising: a plurality of apertures 12 that at positioned on the catheter body portion such that an aperture density in between approximately 32 apertures per centimeter length, col. 7, lines 5-7; or 30-50 apertures per centimeter length or 20-32 apertures per centime length, col. 12, lines 13-18, which is in the requirement range of 10-100 apertures per centimeter of length, as required in the claimed invention; wherein the apertures are spaced around an entire circumference of the catheter body portion; wherein the aperture positioning, spacing, and diameters are configured to provide even distribution of an injection fluid over an entire length of the catheter body portion.
Since Simon and Cragg are both from the same field of endeavor (e.g. using infusion apertures for delivering a drug into a target tissue), the purpose disclosed by Cragg would have been recognized in the pertinent art of Simon.
Giving such a teaching by Cragg, a person having ordinary skill in the art would have easily recognizes that modifying the elongate needle/catheter electrode device of Simon with providing an aperture density in range of 10-100 apertures per centimeter of length of the insertion portion (the conductive portion), as taught by Cragg, would provide the benefit of enhancing a drug distribution evenly around the circumference of the insertion catheter body portion (or the conductive portion) at the target size.
With regarding the limitation of “the apertures have a diameter in a range of 30 microns to 80 microns”, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the diameter of the apertures in a range of 30-80 micron, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. For example: one wish to control the velocity or flow rate of the drug during delivery into the target tissue for certain dosage in certain treatment for each patient.
Furthermore, the instant disclosure describes these parameters of the diameter of the apertures as being merely preferable, and does not describe it as contributing any unexpected result to the needle electrode. As such, these parameters are deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. See also In re Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) where the Federal Circuit held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Note: for claim 16, the claim 1 contains all the limitations of claim 16. Therefore, the claim 16 is being rejected as using same analysis as discussed in the claim 1.
Regarding claims 2-3 and 17, Simon discloses that the nonconductive portion (insulation layer) is spaced from the distal end and the conductive portion makes electrical contact with tissue 50. Simon does not disclose a distance being spaced from the nonconductive portion to the distal end of the electrode is in between 0.1-2.5 cm; or the length of the conductive portion is between 0.01-2.5 cm.
It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain values as required in the claims 2-3, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. For example: the exposed conductive portion is directly contact to the tissue 50, therefore, the length of the nonconductive portion (or the space in between the nonconductive portion to the distal end of the needle electrode) is variable if one wishes to use insert shallow or deep in the target treatment tissue.
Regarding claims 4 and 18, Simon discloses that wherein the nonconductive portion 104 comprises an insulation coating.
Regarding claims 5 and 19, Simon in view of Mathiesen & Cragg disclose all claim subject matter except the limitation of the elongate needle electrode does not have an aperture at a tip at the distal end of the needle. It is noted that the plurality of apertures located around the conductive portion of the elongate needle electrode. Therefore, a person skilled in the art would recognize that provide a closed-end at the distal tip (i.e. no aperture at a tip at the distal end of the needle), instead of providing the apertures around the conductive portion of the needle to concentrate the drug delivery at small area and eliminate to spread out the drug at the distal end of the needle.
Regarding claims 6 and 20, Simon discloses in para [0110] that retraction of an elongated sharp structure or deployment of a sheath to confine the sharp structure, can be triggered automatically by operations. In other words, the device system in Simon further comprising: an actuator (for triggered automatically) for driving the elongate needle electrode in a linear movement, i.e. retraction and deployment having a travel length in certain cm.
It is noted that the limitation “for driving the elongate needle electrode in a linear movement having a travel length between 0.5 cm and 4.0 cm” is a functional limitation and only requires to perform of function. In this case, as mentioned above, the elongate needle electrode is moving in a linear movement. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain a travel length of the elongate needle electrode in between 0.5 to 4.0 cm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Furthermore, the instant disclosure describes these parameters as being merely preferable, and does not describe it as contributing any unexpected result to the insertion of the needle electrode. As such, these parameters are deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. See also In re Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) where the Federal Circuit held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
With regarding the limitation “wherein the actuator creates a pressure that allows the injection fluid to pass through each of the plurality of apertures at equivalent flow dynamics”, it is a result of actuator perform of a function and considered as a functional limitation. In this case, the actuator uses to advance and retract the electrodes 20 in and out of delivery catheter; wherein the ports 26 are able to distribution the fluid to a desired tissue site. Therefore, the actuator is capable of creating a pressure that allows the injection fluid to pass through each of the plurality of apertures at equivalent flow dynamics.
Claims 7- 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Simon et al. (US 2005/0154434) in view of Mathiesen et al. (US 7,328,064) & Cragg et al. (US 6,635,027) and further in view of Gilbert et al. (US 6,314,316).
Regarding claim 7, Simon in view of Mathiesen & Cragg discloses all claimed subject matter as required in the claim 1. Simon discloses a ring electrode 132/136/162 (Figs. 4-5, 8, 10-13 & 15). Simon (or Simon in view of Cragg) fails to disclose that the ring electrode is electrically isolatable into two electrically conductive halves.
Gilbert teaches a device for electroporation wherein a planar ring support is provided with a plurality of electrode posts 126/22/220/32 in Figs. 3-7 capable of individual axial or angular movement to facilitate electrical contact with nonplanar surface, col. 5, lines 36-56. Gilbert also teaches that electrodes are electrically isolated and activated in oppositely charged pairs, col. 5, lines 14-21, Fig. 4 in order to create the desired electromagnetic field to rive fluid particles and permeabilize target cell membrane, col. 5, lines 8-13. Therefore, the arrangement of multiple of electrically conductive projects is divided the ring electrode (planar ring support) is electrically isolatable into two electrically conductive halves, see Figs. 3-7.
Giving such a teaching by Gilbert, a person having ordinary skill in the art would have easily recognizes that modifying the device of Simon in view of Mathiesen & Cragg with obtaining a ring electrode (includes plurality of electrode post) and the electrode are electrically isolated and activated in oppositely charge pairs, as taught by Gilbert, would provide the benefits of increasing the effectiveness of the Simon in view of Cragg device for use on irregular surface and to more effectively deliver a composition to a target tissue region.
In addition, it would have been an obvious matter of design choice to provide a geometric and planar of the ring electrode being electrically isolatable into two electrically conductive halves, since applicant has not disclosed that the electrically being isolated into two electrically conductive halves of the ring electrode solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the standard ring electrode as shown in the prior art Simon.
Regarding claims 8-10. Simon in view of Mathiesen & Cragg discloses all claimed subject matter as required in the claims 1 & 7 above but fail to discloses that the ring electrode has a surface area of between 1 cm2 and 100 cm2; an electrically conductive surface area of the conductive portion in between 0.06-0.86 cm2; a surface area ratio between the ring electrode and the elongate needle electrode is in a range between 1000:1 and 5:1. It would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the surface area of the ring electrode, the electrically conductive surface area of the conductive portion, the surface area ration between the ring electrode and the elongate needle electrode that would be dependent on the actual application and dependent on each treatment of each patient, thus the optimum value determined for the specific application would fall within the range of the values listed above as claimed depending on the specific application.
Furthermore, the instant disclosure describes these parameters as being merely preferable, and does not describe it as contributing any unexpected result to the ring electrode, the conductive portion or the surface area ratio between the ring electrode and the elongate needle electrode. As such, these parameters are deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. See also In re Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) where the Federal Circuit held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claim 11, Simon in view of Mathiesen & Cragg discloses all claimed subject matter as required in the claimed invention. It is noted that the tissue at or near the needle electrode is a target tissue for injection drug. Meanwhile, the tissue at or near the ring electrode is located outer face and far distance from the targeted injection site. Simon also states that the electrical signal applied to the tissue site is sufficient to affect a stimulation response in the tissue at the site or in a reaction in the composition that is infused into the tissue via needle, para [0078]. Therefore, when the variable current density electrode system is activated by providing the pulse of energy in the body tissue, i.e., skeletal muscle tissue, electric current density in the body tissue at or near the elongate needle electrode is higher (e.g. higher density for stimulation the target tissue) than current density in the body tissue at or near the ring electrode.
Regarding claim 12, Simon in view of Mathiesen & Cragg and further in view of Gilbert discloses all claimed subject matter as required in the claims 1, 7-11 above. Gilbert further discloses that wherein: the ring electrode has a multiplicity of electrically conductive projections 22/220/32 thereon, in Figs. 6-7; the multiplicity of electrically conductive projections have respective tips that collectively define a total tip surface area for conducting current proportional to a surface area of the conductive portion of the elongate needle electrode, and the surface area ratio is measured between the total tip surface area of the ring electrode and the surface area of the conductive portion.
Regarding claims 13-14, Simon in view of Mathiesen & Cragg and further in view of Gilbert discloses all claimed subject matter as required in the claims 1, 7-11 above. It is noted that the device system in Simon (or Simon in view of Mathiesen & Cragg and Gilbert) is electrical stimulation, i.e. electrophoresis that generally applying a direct current electric field in order to drive migration of positive and negative ions, para [0007]. Simon further teaches that the polarity of the electrodes is adjusted by the driving unit based on user selections, para [0077, 0079]). Thus, one skilled in the art would furthermore find it obvious to modify treatment parameters such as electrode polarity, insertion depth and electrode surface area based on the requirement of a particular treatment. Simon further shows in Fig. 16 that the elongated electrode 34 can be either positive or negative charge. For example: if the elongated electrode is negative charge, then it would be obvious that the ring electrode must be positive charge that opposite charge with respect to the elongated electrode.
Since the elongated needle electrode can be a negative charged, and therefore, will bring the result of negligible shedding of metal ions from the elongate needle electrode into the body tissue, i.e., skeletal muscle tissue upon discharge of the at least one pulse of energy into the body tissue.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Simon et al. (US 2005/0154434) in view of Mathiesen et al. (US 7,328,064) & Cragg et al. (US 6,635,027) and further in view of Kon et al. (US 7,904,172).
Regarding claim 15, Simon in view of Mathiesen & Cragg discloses all claimed subject matter as required in the claim 1. Simon discloses at least one capacitor (e.g. a voltage source 96 is provided, which preferably comprises an on-board battery as opposed to a formidable-appearing AC wall plug cord, para [0077]) in electrical communication with the electronic circuitry; wherein the housing 66/202/208 covers the electronic circuitry.
For example: para [0093], In FIGS. 6 and 8, a conventional syringe is received in a carrier 66 that facilitates certain of the electrical connections and signal requirements needed to effect a treatment procedure. The syringe 32 is received in the carrier 66, for example being snap fit into the carrier, at a position at which the electrical connections are made by contact or can readily be made by making necessary connections. Having said in the para [0093], the housing 66 covers the electronic circuitry. In addition, the Figs. 21-23 also show that the housing 202/208 covers (partially) the electronic circuitry
a charging unit 96 for charging the at least one capacitor (e.g. voltage source 96 includes an AC wall plug cord);
and a computer 82 in electrical communication with the charging unit, wherein the computer comprises software capable of performing programming functions for the variable current density electrode system, (para [0077], driving unit 82 acts as a controller and programmed with “adaptive features, as described).
Simon does not disclose that the housing covers the at least one capacitor.
Kon discloses an electroporation device for delivering a molecule into cells of the tissue 30 (capable of target tissue, i.e. skeletal muscle tissue), comprising: a housing 1; an elongate needle electrode 5 (Note: Kon discusses in the Background of the invention that: needle electrodes are employed to secure the tissue of interest in place, col. 1, lines 44-46. Therefore, a person skilled in the art would recognize that the electrode 5 (including electrical conductor 22 being connected to the electrode 5, in Fig. 1) is to be used as an elongate needle electrode for introducing a molecule/drug into cells of the target tissue); wherein the elongate needle electrode extending from the housing an in electrical communication with the electrical power source 1 (inside the power module 1, see Figs. 1-2); wherein the housing 1 of the electrical power source 1 covers the electronic circuitry 22 and the at least one capacitor 12 (e.g., the capacitor 12 located inside the housing/power module 1, see Fig. 2).
Since Simon and Kon are both from the same field of endeavor (e.g. using the housing covers a capacitor in electroporation device. Note: the housing 66/202/208 in Simon is equivalent to the housing 1 in Kon), the purpose disclosed by Kon would have been recognized in the pertinent art of Simon.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Simon in view of Mathiesen & Cragg with rearrange parts in the electroporation device system such as providing a housing/power module that covers the electronic circuitry and the at least one capacitor, as taught by Kon, in order to obtain multiple component in one unitary unit for compact size purpose.
Response to Arguments
Applicant's arguments filed 11/20/25 have been fully considered but they are not persuasive.
1) Applicant states on page 7 of the Remarks 11/20/25 that Craggs fails to disclose the aperture diameters of 100 microns that do not overlap with the recited range of 30-80 microns.
In response, this claimed features had been discussed in the Examiner’s Answer and affirmed by Patent Board Decision 09/19/25. Therefore, Examiner does not need to provide any further explanation. Please re-read the Patent Board Decision 09/19/25 for more details.
2) Applicant states that neither Edwards nor Cragg discloses delivering an injection fluid within skeletal muscle tissue.
In response, this limitation, i.e., delivering an injection fluid within skeletal muscle tissue is a method step in the device claim. Therefore, with broadest interpretation, the limitation above is treated as functional limitation. In this case, Edwards discloses that: the invention is to provide an RF tissue ablation apparatus which ablates a desired tissue site, such as a tumor, col. 3, lines 10-13; the electrodes is inserted through tissue, and advancement to the selected tissue site… the delivery catheter can be advanced percutaneously to an internal body organ, or site, which the obturator posited in the delivery catheter, col. 4, lines 37-45. Therefore, the distal end of the elongate needle electrode 20 is capable of piercing through a skin tissue and into the selected tissue site such as skeletal muscle tissue for treating in certain tumor area. In addition, the device in Edward can be used to insert into the skeletal muscle tissue as taught by Mathiesen. Please see the rejection in the claim 1 above for more details.
3) Applicant argues that that the modifying the diameter’s of Simon’s aperture down to a range of 30-80 microns would been routine or even desirable “ for delivering a molecule into cells of skeletal muscle tissue, especially, wherein the aperture positioning, spacing, and diameters are configured to provide even distribution of an injection fluid over an entire length of the conductive portion within the skeletal muscle tissue, are recited in amended claim 1.
In response, this claimed features, i.e., diameter’s apertures had been discussed in the Examiner’s Answer and affirmed by Patent Board Decision 09/19/25. Therefore, Examiner does not need to provide any further explanation. Please re-read the Patent Board Decision 09/19/25 for more details.
With respect to the limitation, i.e., delivering an injection fluid within skeletal muscle tissue is a method step in the device claim and therefore, it is considered as functional limitation. The limitation, the apertures positioning, spacing, and diameter are configured to provide even distribution of an injection fluid over an entire length of the conductive portion within the skeletal muscle tissue, is a result of providing even distribution… to the target tissue, i.e., skeletal muscle tissue. In other words, it is considered as functional limitation and only require performing a function. Examiner also provide a new reference Mathiesen with a teaching of using electroporation device for delivering a molecule into a skeletal muscle tissue. Please see the rejection in the claim1 above for more details.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783