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 Objections
Claims 1, 3, 4, 6, 7, 9 and 18 is/are objected to due to the following informalities:
In claim 1, line 4, “the sclera” and “the vitreous” should be corrected to “sclera” and “vitreous” since these terms were not previously introduced.
In claim 3, line 2, “the retina” should be corrected to “retina” since this term was not previously introduced.
In claim 3, line 3, “the outer nuclear layer of the retina” should be corrected to “an outer nuclear layer of the retina” since this phrase was not previously introduced.
In claim 4, lines 4-5, “the site for inserting the microneedle” should be corrected to “a site for inserting the microneedle” since this phrase was not previously introduced.
In claim 6, lines 1, “the site of the insertion” should be corrected to “a site of the insertion” since this phrase was not previously introduced.
In claim 7, lines 2, “the site of the insertion” should be corrected to “a site of the insertion” since this phrase was not previously introduced.
In claim 7, line 3, “the posterior retina” should be corrected to “posterior retina” since this term was not previously introduced.
In claim 9, lines 2, “the site of the insertion” should be corrected to “a site of the insertion” since this phrase was not previously introduced.
In claim 18, lines 1-2, “the microneedle as a length” should be corrected to “the microneedle has a length” for grammatical correctness.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 10, 17 and 18 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase in line 2 are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, it is being interpreted that the limitation after the term “such as” in line 2 is not required.
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase in lines 2-3 are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, it is being interpreted that the limitation after the term “such as” in lines 2-3 is not required.
Regarding claim 18, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase in lines 2-3 are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, it is being interpreted that the limitation after the term “such as” in lines 2-3 is not required.
Claim Rejections - 35 USC § 101
Claim(s) 1-14 is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 is rejected under 35 U.S.C. 101 because in the phrase “the microneedle extends through the sclera and choroid layers” in claim 1, the “sclera” and “choroid layers” are positively recited as part of the invention. To overcome this rejection, “sclera” and “choroid layers” need to be functionally recited. Applicant is suggested to amend claim 1 to recite “the microneedle is configured to extend through sclera and choroid layers” to overcome the rejection of claim 1.
Claims 2-14 is/are rejected by virtue of their dependency on claim 1.
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.
Claim(s) 1-3, 5-6, 11-17, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment (Fig. 12) of Clem et al. (US 11723798 B2, herein Clem), and further in view of the emobodiment (Fig. 5) of Clem and Prausnitz et al. (20100256597 A1, herein Prausnitz).
Regarding claim 1, Clem discloses a method of administering a therapeutic agent to an eye (procedure for subretinal delivery of therapeutic agent [Col. 28, lines 64-65])) of a patient (procedure begins by an operator immobilizing tissue surrounding a patient's eye [Col. 29, lines 25-27]), the method comprising:
inserting a microneedle into the eye of the patient (microneedle 420 inserted into eye in Fig. 52C), wherein the microneedle extends through the sclera (the operator then pierces the sclera 304 [Col. 29, line 44]) and choroid layers (advances needle 420 relative to guidance device 700 such that needle 420 pierces through choroid 306 [Col. 29, lines 45-46]), but not into the vitreous (micro-catheter 460 as it is guided between choroid 306 and retina 308 to the delivery site for the therapeutic agent 774 without traversing a vitreous region of eye 301 [Col. 30, lines 34-37]; micro-catheter 460 is advanced distally from the distal end of needle 420 [Col 30, lines 43-44]; it is interpreted that the catheter 460 is an extension of needle 420), and without a vitrectomy or a retinotomy (it is interpreted that since the vitreous is not accessed, therefore no vitrectomy is required);
injecting a fluid (a therapeutic agent 774 is infused via micro-catheter (460) by actuating a syringe or other fluid delivery device [Col. 30, lines 61-64]; it is interpreted that therapeutic agent is a fluid since a fluid delivery device is used to deliver therapeutic agent 774) comprising a therapeutic agent (therapeutic agent 774 in Fig. 53D) through a lumen of the microneedle (it is interpreted that the needle 420 has a lumen through which microcatheter 460 advances and through which therapeutic agent 774 is delivered) and into a subretinal space (SRS) of the eye (procedure for subretinal delivery of therapeutic agent [Col. 28, lines 64-65]),
Clem however fails to explicitly disclose wherein the microneedle has (i) a beveled tip with a bevel angle from 40° to 70° and (ii) an outer diameter that is less than 150 µm.
However, Clem teaches in the embodiment of Fig. 5 that beveled distal end 26 of cannula has a bevel angle within the range of approximately 5° to approximately 50° [Col. 9, lines 3-4]. One of ordinary skill in the art teaches microneedle 420 to be configured within this range.
Furthermore, Prausnitz teaches the proximal portion of the microneedle has a maximum width or cross-sectional dimension of about 50 µm to 500 µm [0063]. One of ordinary skill in the art teaches the method of Clem to be modified to enable the microneedle to have a outer diameter less than 150 µm as taught by Prausnitz.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Clem to include the microneedle has an outer diameter that is less than 150 µm as taught by Prausnitz since such a modification enables the method of Clem to have tip end with dimensions suitable for minimally invasive insertion [Prausnitz, 0062].
Regarding claim 2, Clem as modified by Prausnitz disclosed all limitations of claim 1. Clem however failed to explicitly discloses wherein the bevel angle is from 50° to 60° and the outer diameter is from 75 µm to 125 µm.
However, Clem teaches in the embodiment of Fig. 5 that beveled distal end 26 of cannula has a bevel angle within the range of approximately 5° to approximately 50° [Col. 9, lines 3-4]. One of ordinary skill in the art teaches microneedle 420 to be configured within this range.
Furthermore, Prausnitz teaches the proximal portion of the microneedle has a maximum width or cross-sectional dimension of about 50 µm to 500 µm [0063]. One of ordinary skill in the art teaches the method of Clem to be modified to enable the microneedle to have an outer diameter between 75 µm to 125 µm as taught by Prausnitz
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Clem to include the microneedle has an outer diameter from 75 µm to 125 µm as taught by Clem since such a modification enables the method of Clem to have tip end with dimensions suitable for minimally invasive insertion [Prausnitz, 0062].
Regarding claim 3, Clem as modified by Prausnitz disclosed all limitations of claim 3. Clem further discloses wherein the microneedle is inserted such that a tip opening of the microneedle is located at the interface of the retina and retinal pigment epithelium (RPE) layers without penetrating deeper than the outer nuclear layer of the retina (the delivery site is superior to the macula, in the potential space between the neurosensory retina and the retinal pigment epithelium layer [Col. 30, lines 40-42])
Regarding claim 5, Clem as modified by Prausnitz disclosed all limitations of claim 1. Clem further discloses further comprising stabilizing the eye while inserting the microneedle (the procedure begins by an operator immobilizing tissue surrounding a patient's eye 301 (e.g., the eyelids) using a speculum (312) [Col. 29, lines 25-29]).
Regarding claim 6, Clem as modified by Prausnitz disclosed all limitations of claim 1. Clem further discloses wherein the site of the insertion is selected from the peripheral retina, mid-periphery, or posterior retina (the delivery site corresponds to a generally posterior region of eye (301) adjacent to an area of geographic atrophy of retina [Col. 30, lines 37-39])
Regarding claim 11, Clem as modified by Prausnitz disclosed all limitations of claim 1. Clem further discloses wherein the therapeutic agent is effective in the treatment of age- related macular degeneration, macular edema, diabetic retinopathy, Leber's congenital amaurosis, retinitis pigmentosa, or glaucoma (the foregoing procedure is carried out to treat a patient having macular degeneration [Col. 31, lines 29-30]).
Regarding claim 12, Clem as modified by Prausnitz disclosed all limitations of claim 1. Clem further discloses wherein the therapeutic agent comprises stem cells, differentiated cells, viruses, phages, gene vectors, nanoparticles, microparticles, antibodies, proteins,small molecules, retinal prosthetics, and/or artificial retina (therapeutic agents includes, but are not necessarily limited to, drugs having smaller or large molecules, therapeutic cell solutions, certain gene therapy solutions [Col. 30, line 65- Col. 31 line 3]).
Regarding claim 13, Clem as modified by Prausnitz disclosed all limitations of claim 1. However Clem failed to explicitly disclose wherein an inserted portion of the microneedle has a length of between about 500 µm and 1.5 mm.
However, Prausnitz teaches microneedle has a length of about 150 µm to about 1500 µm [0063]. One of ordinary skill in the art teaches the microneedle of Clem to be configured according to the range of length taught by Prausnitz.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Clem to include wherein wherein an inserted portion of the microneedle has a length of between about 500 µm and 1.5 mm as taught by Prausnitz since such a modification enables the method of Clem to have tip end with dimensions suitable for minimally invasive insertion [Prausnitz, 0062].
Regarding claim 14, Clem as modified by Prausnitz disclosed all limitations of claim 1. Clem further discloses further comprising, before the inserting, selecting a length of the microneedle such that the beveled tip of the microneedle is configured to be positioned within the SRS upon complete insertion of the microneedle (the delivery site is superior to the macula, in the potential space between the neurosensory retina and the retinal pigment epithelium layer [Col. 30, lines 40-42]; it is interpreted that the microneedle reaches the subretinal space since delivery site is the potential space between the neurosensory retina and the retinal pigment epithelium layer)
Regarding claim 15, Clem discloses an injection apparatus (instrument 400 in Fig. 12) for administering a therapeutic agent (administration of a therapeutic agent [Col. 18, line 40-41]) into a subretinal space (SRS) of an eye of a patient (configured for use in a procedure for the subretinal administration of a therapeutic agent to an eye of a patient [Col. 18, line 40-41]), the apparatus comprising:
a microneedle (needle 420 in Fig. 12) which extends from a needle hub (see needle hub in annotated Fig. 12 below) and is configured to be inserted through the sclera (the operator then pierces the sclera 304 [Col. 29, line 44]) and choroid layers (advances needle 420 relative to guidance device 700 such that needle 420 pierces through choroid 306 [Col. 29, lines 45-46]), but not into the vitreous (micro-catheter 460 as it is guided between choroid 306 and retina 308 to the delivery site for the therapeutic agent 774 without traversing a vitreous region of eye 301 [Col. 30, lines 34-37]; micro-catheter 460 is advanced distally from the distal end of needle 420 [Col 30, lines 43-44]; it is interpreted that the catheter 460 is an extension of needle 420) ; and
an injector (fluid port 442 in Fig. 12) configured to inject a fluid (it is interpreted that fluid port in connection with fluid supply line 444 provides fluid access to interior of body via which fluid is injected [Col.19, lines 21-23]) comprising a therapeutic agent (therapeutic agent 774 in Fig. 53D) through a lumen of the microneedle (it is interpreted that the needle 420 has a lumen through which microcatheter 460 advances and through which therapeutic agent 774 is delivered) and into the SRS following insertion of the microneedle procedure for subretinal delivery of therapeutic agent [Col. 28, lines 64-65];
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Annotated Fig. 12 of Clem
However, Clem failed to explicitly disclose wherein the microneedle has (i) a beveled tip with a bevel angle from 400 to 70° and (ii) an outer diameter that is less than 150 pm.
However, Clem teaches in the embodiment of Fig. 5 that beveled distal end 26 of cannula has a bevel angle within the range of approximately 5° to approximately 50° [Col. 9, lines 3-4]. One of ordinary skill in the art teaches microneedle 420 to be configured within this range.
Furthermore, Prausnitz teaches the proximal portion of the microneedle has a maximum width or cross-sectional dimension of about 50 µm to 500 µm [0063]. One of ordinary skill in the art teaches the device of Clem to be modified to enable the microneedle to have a width less than 150 µm as taught by Prausnitz.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection apparatus of Clem to include the microneedle has an outer diameter that is less than 150 pm as taught by Prausnitz since such a modification enables the device of Clem to have tip end with dimensions suitable for minimally invasive insertion [Prausnitz, 0062].
Regarding claim 16, Clem as modified by Prausnitz disclosed all limitations of claim 15. However, Clem failed to explicitly disclose wherein the microneedle has an outer diameter between 50 µm and 120 µm and the bevel angle is from 50° to 60°.
However, Clem teaches in the embodiment of Fig. 5 that beveled distal end 26 of cannula has a bevel angle within the range of approximately 5° to approximately 50° [Col. 9, lines 3-4]. One of ordinary skill in the art teaches microneedle 420 to be configured within this range.
Furthermore, Prausnitz teaches the proximal portion of the microneedle has a maximum width or cross-sectional dimension of about 50 µm to 500 µm [0063]. One of ordinary skill in the art teaches the device of Clem to be modified to enable the microneedle to have a diameter between 50 µm and 120 µm as taught by Prausnitz.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection apparatus of Clem to include the microneedle has an outer diameter between 50 µm and 120 µm as taught by Prausnitz since such a modification enables the device of Clem to have tip end with dimensions suitable for minimally invasive insertion [Prausnitz, 0062].
Regarding claim 17, Clem as modified by Prausnitz disclosed all limitations of claim 15. However, Clem failed to explicitly disclose wherein an inserted portion of the microneedle has a length of between about 500 µm and 1.5 mm.
However, Prausnitz teaches microneedle has a length of about 150 µm to about 1500 µm [0063]. One of ordinary skill in the art teaches the microneedle of Clem to be configured according to the range of length taught by Prausnitz.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection apparatus of Clem to include wherein wherein an inserted portion of the microneedle has a length of between about 500 µm and 1.5 mm as taught by Prausnitz since such a modification enables the device of Clem to have tip end with dimensions suitable for minimally invasive insertion [Prausnitz, 0062].
Regarding claim 19, Clem as modified by Prausnitz disclosed all limitations of claim 15. Clem discloses a fluid provided via fluid supply line 444 is communicated to the distal end of needle 420 [Col. 19, lines 24-28], but failed to explicitly disclose:
wherein the injector comprises: a reservoir for the fluid; and
means for driving the fluid from the reservoir into and through the microneedle.
However, Prausnitz teaches the microneedle device includes a fluid reservoir for containing the fluid drug formulation, the fluid drug reservoir being in operable communication with the bore of the microneedle at a location distal to the tip end of the microneedle. The fluid reservoir is integral with the microneedle, integral with the elongated body, or separate from both the microneedle and elongated body [0073].
Prausnitz further teaches the base portion 115 of the elongated body is operably connected to an actuator 120 in Fig. 4 for controlled infusion of the fluid drug formulation through the microneedle.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection apparatus of Clem to include the injector comprises: a reservoir for the fluid; and means for driving the fluid from the reservoir into and through the microneedle as taught by Prausnitz since such a modification enables the device of Clem to control infusion of the fluid through the microneedle [Prausnitz, 0072].
Regarding claim 20, Clem as modified by Prausnitz disclosed all limitations of claim 15. Clem further discloses wherein the injection apparatus further comprises:
means for stabilizing a position of the microneedle relative to a target site in an eye of a patient (the procedure begins by an operator immobilizing tissue surrounding a patient's eye 301 (e.g., the eyelids) using a speculum (312) [Col. 29, lines 25-29]); and/or
an imaging system configured to image a target site for a microneedle insertion path in which no large conjunctival, choroidal and retinal blood vessels exist (imaging system is not required by claim 20 due to the use of and/or).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment (Fig. 12) of Clem et al. (US 11723798 B2, herein Clem), and further in view of the embodiment (Fig. 5) of Clem, Prausnitz et al. (20100256597 A1, herein Prausnitz) and Loerner (US 11615526 B2, herein Loerner).
Regarding further comprising, before inserting:
imaging tissue of the eye to identify one or more target sites which have a needle path in which no large conjunctival, choroidal and retinal blood vessels exist; and
selecting one of the one or more targets sites as the site for inserting the microneedle.
Loerner teaches system 110 include at least one computer system configured to generate an image presented on at least one of displays 116A, 250A, 116B, and 250B. Computer systems 112A and 112B is coupled to observational devices, such as a microscope, a camera, an optical coherence tomography (OCT) device or display, or another device able to measure the position of the eye undergoing surgery [Col. 8, lines 15-26]. One of ordinary skill in the art teaches the method of Clem as modified by Prausnitz to be configured to work in conjunction with the device of Loerner to locate a needle path to avoid blood vessels prior to insertion of microneedle.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Clem as modified by Prausnitz to include imaging tissue of the eye to identify one or more target sites which have a needle path in which no large conjunctival, choroidal and retinal blood vessels exist; and selecting one of the one or more targets sites as the site for inserting the microneedle as taught by Loerner since such a modification enables the method of Clem to locate position of the eye undergoing surgery [Lorner, Col. 8, lines 20-25].
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment (Fig. 12) of Clem et al. (US 11723798 B2, herein Clem), and further in view of the embodiment (Fig. 5) of Clem, Prausnitz et al. (20100256597 A1, herein Prausnitz) and Albrecht et al. (US 20230277374 A1, herein Albrecht).
Regarding claim 7, Clem as modified by Prausnitz disclosed all limitations of claim 1. Clem further discloses wherein the injecting is done in manner that guides the fluid away from the site of the insertion (form a leading bleb 770 ahead of needle 420 [Col. 30, lines 18-19]; it is interpreted that the fluid is being guide away from the site of injection since the bleb forms ahead of needle), and optionally toward the posterior retina and/or macula (leading bleb 770 provides a barrier between needle 420 and retina 308 once needle 420 has penetrated choroid [Col. 30, lines 23-24]; it is interpreted that the bleb makes contact with the retina in order to form a barrier between the needle and retina), but fails to explicitly disclose the injecting is done in manner that suppresses subretinal bleb growth.
However, Albrecht teaches the presence of a device for recording a current value of the at least one parameter, that is to say in particular an apparatus for generating an image of the injection site and a pressure sensor, is advantageous in that this allows determination of the current point on a predetermined curve of the increasing injection flow rate as a function of at least one parameter. This makes it possible to ensure in a particularly effective manner that the volume flow caused by the increasing injection flow rate does not exceed the maximum rate at which the volume of the bleb can change [0025]. One of ordinary skill in the art teaches bleb growth is regulated by controlling the flow rate of the injection.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Clem as modified by Prausnitz to include the injecting is done in manner that suppresses subretinal bleb growth as taught by Albrecht since such a modification enables the method of Clem to actively control bleb growth during subretinal injection [Albrecht, 0025].
Regarding claim 10, Clem as modified by Prausnitz and Albrecht disclosed all limitations of claim 7. However, Clem as modified by Prausnitz failed to explicitly disclose wherein the fluid is injected at a flowrate from 0.5 μL/s to 20 μL/s, such as from 2 μL/s /s to 10 μL/s /s.
However, Albrecht teaches the maximum injection flow rate reached during the injection is in the range between 5 μl/s and 100 μl/s [0014].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Clem as modified by Prausnitz to include the fluid is injected at a flowrate from 0.5 μL/s to 20 μL/s, such as from 2 μL/s /s to 10 μL/s /s as taught by Albrecht since such a modification enables the method of Clem to actively control bleb growth during subretinal injection [Albrecht, 0025].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment (Fig. 12) of Clem et al. (US 11723798 B2, herein Clem), and further in view of the embodiment (Fig. 5) of Clem, Prausnitz et al. (20100256597 A1, herein Prausnitz), Albrecht et al. (US 20230277374 A1, herein Albrecht) and Price et al. (US 20180256394 A1, herein Price).
Regarding claim 8, Clem as modified by Prausnitz and Albrecht disclosed all limitations of claim 7. However, Clem as modified by Prausnitz and Albrecht failed to explicitly disclose wherein from 25% to 75% of the injected fluid forms a subretinal bleb.
However, Price teaches fluid delivery system 80 is actuated to drive bleb fluid from bleb fluid source 82, thereby delivering a substantial volume of bleb fluid (90) to the subretinal space in the range of approximately 50 μL and approximately 700 μL [0064].
Price further teaches the volume of therapeutic agent 92 delivered to the subretinal space is in the range of approximately 15 μL to approximately 300 μL [0066]. One of ordinary skill in the art teaches the method of Clem as modified by Prausnitz and Albrecht to be modified according to the bleb and therapeutic agent volume ranges as taught by Price to inject from 25% to 75% of bleb fluid.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Clem as modified by Prausnitz and Albrecht to include 25% to 75% of the injected fluid forms a subretinal bleb as taught by Price since such a modification enables the method of Clem to create space between tissue layers for injection of therapeutic agent [Price, 0056].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment (Fig. 12) of Clem et al. (US 11723798 B2, herein Clem), and further in view of the embodiment (Fig. 5) of Clem, Prausnitz et al. (20100256597 A1, herein Prausnitz), Albrecht et al. (US 20230277374 A1, herein Albrecht) and VanTassel et al. (US 7252654 B2, herein VanTassel).
Regarding claim 9, Clem as modified by Prausnitz and Albrecht disclosed all limitations of claim 7. However, Clem as modified by Prausnitz and Albrecht disclosed wherein the injecting produces formation of intricate tree-like bifurcating patterns that spread circumferentially from the site of the injection.
However, VanTassel teaches surgical assemblage comprises a needle with a sharp distal point with or without flow-through, and a catheter with a porous distal portion attached to the distal end of the needle, wherein the porous distal portion of the catheter is adapted to cause a liquid injectate to weep or ooze multidirectionally therefrom into surrounding tissue under injection pressure [Col. 3, lines 8-15]. One of ordinary skill in the teaches the method of Clem as modified by Prausnitz and Albrecht to be modified to inject in a multidirectional pattern.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Clem as modified by Prausnitz and Albrecht to include the injecting produces formation of intricate tree-like bifurcating patterns that spread circumferentially from the site of the injection as taught by VanTassel since such a modification enables the method of Clem to inject multidirectionally to reach surrounding tissue [VanTassel, Col. 3, lines 8-15].
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment (Fig. 12) of Clem et al. (US 11723798 B2, herein Clem), and further in view of the embodiment (Fig. 5) of Clem, Prausnitz et al. (20100256597 A1, herein Prausnitz) and Rini et al. (US 20200384210 A1, herein Rini).
Regarding claim 18, Clem as modified by Prausnitz disclosed all limitations of claim 15. However, Clem as modified by Prausnitz failed to explicitly disclose wherein the needle hub has a width (W), the microneedle as a length (L), and the ratio of W:L is between 0.1 and 10, such as between 0.2 and 5, between 0.5 and 3, between 0.7 and 2, between 0.8 and 1.5, or about 1.
However, Rini teaches the needle hub has an axial height of about 0.5 to 2.0 mm and width of about 5.0 to 8.0 mm [0019].
Rini further teaches the cannula has a length of about 3.5 to about 8.0 mm [0038]. One of ordinary skill in the art teaches the width of needle hub and needle length of Clem to be configured to have a ratio of W:L between 0.1 and 10 according to the dimensions taught by Rini.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection apparatus of Clem as modified by Prausnitz to include the needle hub has a width (W), the microneedle as a length (L), and the ratio of W:L is between 0.1 and 10, such as between 0.2 and 5, between 0.5 and 3, between 0.7 and 2, between 0.8 and 1.5, or about 1 as taught by Rini since such a modification enables the device of Clem to consistently insert to a desired target depth [Rini, 0007].
Conclusion
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/M.F./Patent Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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