DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection.Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.Applicant's submission filed on 11/25/25 has been entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 27, 28, 30, 37, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prausnitz et al. (U.S. Patent Application Publication No. 20050137531 A1).
Regarding claim 27, Prausnitz et al. discloses a method of delivering an agent to a subject (para. 0110), comprising:
Placing a chamber (Fig. 13b,device 130) adjacent to tissue at a treatment site of the subject (Fig. 13a, Fig. 13b, para. 108-109, note that the skin is not labeled in Fig. 13b (it is labeled in Fig. 13a), one of ordinary skill in the art can understand that the surface on which rim 139 is placed upon is skin tissue;
injecting a fluid injectate into the tissue (Fig. 13b, para. 0110, a drug flows from reservoir 136 through microneedles 140), wherein the fluid injectate comprises the agent (para.0110);
and applying vacuum pressure to the chamber (para. 0110), thereby drawing the tissue through an opening of the chamber (Fig. 13b, para. 0110, vacuum is induced between inner cylinder 134 and outer cylinder 132) and into contact with an interior surface of the chamber (Fig. 13b, microneedles 140), thereby affixing the tissue to the interior surface (para. 0108) and subjecting the tissue to mechanical stress (see Fig. 13b, one of ordinary skill in the art can appreciate that suctioning the skin into the device 130 stretches the tissue), wherein the application of vacuum pressure to the chamber is performed without electroporating the tissue (para. 0110) and without penetrating the tissue (the vacuum of the skin itself does not penetrate the skin, as shown in Fig. 13b, the microneedles that inject fluid after vacuum is applied is what penetrates the skin, therefore the application of vacuum pressure does not penetrate the skin as this can occur prior to or during insertion of microneedles para. 0108), and the application of vacuum pressure to the chamber causes transfection of the agent into cells of the tissue (para. 0108 the suction deforms the skin thus bring the skin into contact with the microneedles which in turn cause the microneedles to pierce the skin and delivery the agent, thus the vacuum pressure causes transfection of the agent into cells of the tissue).
Regarding claim 28, Prausnitz et al. discloses the method of claim 27, wherein the fluid injectate is injected before or during the application of vacuum pressure to the chamber (para. 0108, the suction can occur after insertion of the microneedles).
Regarding claim 30, Prausnitz et al. discloses the method of claim 27, wherein the tissue is at least one of skin tissue and adipose tissue (para. 0109-para. 0110).
Regarding claim 37, Prausnitz et al. discloses the method of claim 27, wherein the vacuum pressure is in a range of about -0.1 psi to about -14.7 psi (para. 0108, the vacuum is preferably between 50 and 300 mmHg (approximately 0.97 psi to 5.8 psi), one of ordinary skill in the art can appreciate that vacuum pressure is a negative pressure).
Regarding claim 38, Prausnitz et al. discloses the method of claim 37, wherein the vacuum pressure is in a range of about -3 psi to about -14.7 psi (about -155 mmHg to about -760 mmHg) (para. 0108, the vacuum is preferably between 50 and 300 mmHg, one of ordinary skill in the art can appreciate that vacuum pressure is a negative pressure).
Claim Rejections - 35 USC § 103
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.
Claims 29, 31, 32, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (U.S. Patent Application Publication No. 20050137531 A1) in view of Trembly et al. (U.S. Patent Application Publication No. 20180070880 A1).
Regarding claim 29, Prausnitz et al. discloses the method of claim 27. Prausnitz et al. fails to teach wherein the fluid injectate is injected before the chamber is placed adjacent to the tissue.
However, Trembly et al. teaches wherein the fluid injectate (Fig. 1, therapeutic agent 110) is injected before the chamber (Fig. 1, partial enclosure 140) is placed adjacent to the tissue (see Fig. 1, Fig. 5, para. 0021, the step of administering a therapeutic agent to the bloodstream 502 occurs before sealing partial enclosure to a patient at a disease site 512, sealing the partial enclosure 140 consists of interfacing edges 142 to a surface 135 of a patient 130 at a disease site 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Prausnitz et al. to inject a fluid before placing a vacuum chamber adjacent to the tissue as taught by Trembly et al., in order to enhancing uptake of a therapeutic agent into a disease site (para. 0036).
Regarding claim 31, Prausnitz et al. discloses the method of claim 27. Prausnitz et al. fails to teach wherein the application of vacuum pressure to the chamber increases dispersion of the fluid injectate within the tissue.
However, Trembly et al. teaches wherein the application of vacuum pressure (Fig. 1, partial vacuum 145) to the chamber (Fig. 1, partial enclosure 140) increases dispersion of the fluid injectate (Fig. 1, therapeutic agent 110) within the tissue (para. 0043).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Prausnitz et al. to include administering a therapeutic agent directly to a disease site before application of vacuum pressure, as taught by Trembly et al., in order to help disperse particles within a disease site (see Fig. 5, para. 0043).
Regarding claim 32, the modified method of Prausnitz et al. teaches the method of claim 31, wherein the application of vacuum pressure to the chamber increases delivery of the agent into the cells of the tissue (Prausnitz et al., para. 0065).
Regarding claim 35, the modified method of Prausnitz et al. teaches the method of claim 31, wherein the application of vacuum pressure to the chamber increases infiltration of in vivo fluids at the treatment site (Prausnitz et al., para. 0108).
Claims 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (U.S. Patent Application Publication No. 20050137531 A1) in view of Trembly et al. (U.S. Patent Application Publication No. 20180070880 A1) and further in view of Timnack et al. (U.S. Patent Application Publication No. 20200038248 A1).
Regarding claim 33, the modified method of Prausnitz et al. teaches the method of claim 32.
Prausnitz et al. fails to teach wherein the agent comprises nucleic acid and the application of vacuum pressure elicits an immune response in the subject.
However, Timnack et al. teaches wherein the agent comprises nucleic acid (para. 0038) and the application of vacuum pressure elicits an immune response in the subject (para. 0054- 0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the agent of Prausnitz et al. to comprise a nucleic acid and for the vacuum pressure to be applied following administration of the agent, as taught by Timnack et al., in order to accelerate and facilitate penetration of skin cells (see Fig. 1, para. 0038, para. 0055).
Regarding claim 34, the modified method of Prausnitz et al. teaches the method of claim 32.
The modified method of Prausnitz et al. fails to teach wherein the agent comprises DNA.
However, Timnack et al. teaches wherein the agent comprises DNA (para. 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the agent of Prausnitz et al. to comprise DNA, as taught by Timnack et al., in order to accelerate and facilitate penetration of skin cells (para. 0038, para. 0055).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al (U.S. Patent Application Publication No. 20050137531 A1) in view of Trembly et al. (U.S. Patent Application Publication No. 20180070880 A1) and further in view of Slatkine et al. (U.S. Patent Application Publication No. 20080215039 A1).
Regarding claim 36, the modified method of Prausnitz et al. teaches the method of claim 31.
The modified method of Prausnitz et al. fails to teach wherein the application of vacuum pressure to the chamber increases a concentration of the fluid injectate within the chamber.
However, Slatkine et al. teaches wherein the application of vacuum pressure to the chamber (para. 0125, a single light source and vacuum pump are operable in conjunction) increases a concentration of the fluid injectate within the chamber (para. 0125, vacuum chamber that is suitable for inducing an increase in blood concentration at the application site will also increase the concentration of an agent which was delivered into the subject's blood at the application site).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Prausnitz et al. to apply a vacuum pressure of at least 400 mmHg as taught by Slatkine et al., in order to increase the blood concentration within the tissue (Slatkine et al., para. 0069, para. 0125).
Claims 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (U.S. Patent Application Publication No. 20050137531 A1) in view of Myung et al. (U.S. Patent Application Publication No. 20150305930 A1).
Regarding claim 39, Prausnitz et al. teaches the method of claim 27. Prausnitz et al. fails to teach wherein the application of vacuum pressure comprises applying pulses of varying vacuum pressure to the tissue and varying the duration of the pulses.
However, Myung et al. teaches wherein the application of vacuum pressure comprises applying pulses of varying vacuum pressure to the tissue (para. 0125) and varying the duration of the pulses (para. 0126).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Prausnitz et al. to include applying pulses of varying vacuum pressure to the tissue and varying the duration of the pulses as taught by Myung et al., in order to enable the drug to diffuse into the tissue faster and more uniformly (para. 0125).
Regarding claim 40, Prausnitz et al. teaches the method of claim 27. Prausnitz et al. fails to teach wherein the application of vacuum pressure comprises applying varying vacuum pressure to the tissue, discontinuing the application of vacuum pressure to the tissue, and reapplying vacuum pressure to the tissue.
However, Myung et al. teaches wherein the application of vacuum pressure comprises applying varying vacuum pressure to the tissue, discontinuing the application of vacuum pressure to the tissue, and reapplying vacuum pressure to the tissue (para. 0125, para. 0126).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Prausnitz et al. such that the vacuum pressure is discontinued and reapplied to the tissue as taught by Myung et al., in order to enables the drug to diffuse into the tissue faster and more uniformly (para. 0125).
Claims 41 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (U.S. Patent Application Publication No. 20050137531 A1) in view of Mikszta et al. (U.S. Patent Application Publication No. 20040120964 A1).
With regard to claim 41, Prausnitz et al. discloses a method of delivering an agent to a subject (para. 0110), comprising:
Placing a chamber (Fig. 13b,device 130) adjacent to tissue at a treatment site of the subject (Fig. 13a, Fig. 13b, para. 108-109, note that the skin is not labeled in Fig. 13b (it is labeled in Fig. 13a), one of ordinary skill in the art can understand that the surface on which rim 139 is placed upon is skin tissue;
injecting a fluid injectate into the tissue (Fig. 13b, para. 0110, a drug flows from reservoir 136 through microneedles 140), wherein the fluid injectate comprises the agent (para.0110);
and applying vacuum pressure to the chamber (para. 0110), thereby drawing the tissue through an opening of the chamber (Fig. 13b, para. 0110, vacuum is induced between inner cylinder 134 and outer cylinder 132) and into contact with an interior surface of the chamber (Fig. 13b, microneedles 140), thereby affixing the tissue to the interior surface (para. 0108) and subjecting the tissue to mechanical stress (see Fig. 13b, one of ordinary skill in the art can appreciate that suctioning the skin into the device 130 stretches the tissue), wherein the application of vacuum pressure to the chamber is performed without electroporating the tissue (para. 0110) and without penetrating the tissue (the vacuum of the skin itself does not penetrate the skin, as shown in Fig. 13b, the microneedles that inject fluid after vacuum is applied is what penetrates the skin, therefore the application of vacuum pressure does not penetrate the skin as this can occur prior to or during insertion of microneedles para. 0108), and the application of vacuum pressure to the chamber causes transfection of the agent into cells of the tissue (para. 0108 the suction deforms the skin thus bring the skin into contact with the microneedles which in turn cause the microneedles to pierce the skin and delivery the agent, thus the vacuum pressure causes transfection of the agent into cells of the tissue).
However, Prausnitz does not explicitly disclose the treatment site encompassing a previous injection site.
Mikszta teaches that microneedles can be used a same treatment site multiple times ([0149], [0150]) thus the treatment site encompasses a previous injection site on the skin in order to enhance administration of the agent.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Prausnitz et al. with the treatment site encompassing a previous injection site as taught by Mikszta for the purpose of enhancing administration of the agent ([0150]).
Claims 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (U.S. Patent Application Publication No. 20050137531 A1) in view of Mikszta et al. (U.S. Patent Application Publication No. 20040120964 A1) and in further view of Timnack et al. (U.S. Patent Application Publication No. 20200038248 A1).
Regarding claim 42, the modified method of Prausnitz et al./Mikszta teaches the method of claim 41.
Prausnitz et al./Mikszta fails to teach wherein the agent comprises nucleic acid and the application of vacuum pressure elicits an immune response in the subject.
However, Timnack et al. teaches wherein the agent comprises nucleic acid (para. 0038) and the application of vacuum pressure elicits an immune response in the subject (para. 0054- 0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the agent of Prausnitz et al./Mikszta to comprise a nucleic acid and for the vacuum pressure to be applied following administration of the agent, as taught by Timnack et al., in order to accelerate and facilitate penetration of skin cells (see Fig. 1, para. 0038, para. 0055).
Regarding claim 43, the modified method of Prausnitz et al. teaches the method of claim 41.
The modified method of Prausnitz et al./Mikszta fails to teach wherein the agent comprises DNA.
However, Timnack et al. teaches wherein the agent comprises DNA (para. 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the agent of Prausnitz et al./Mikszta to comprise DNA, as taught by Timnack et al., in order to accelerate and facilitate penetration of skin cells (para. 0038, para. 0055).
.
Claims 44 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (U.S. Patent Application Publication No. 20050137531 A1) in view of Mikszta et al. (U.S. Patent Application Publication No. 20040120964 A1) and in further view of Slatkine et al. (U.S. Patent Application Publication No. 20080215039 A1).
Regarding claim 44, the modified method of Prausnitz et al. teaches the method of claim 31, wherein the application of vacuum pressure to the chamber increases infiltration of in vivo fluids at the treatment site (Prausnitz et al., para. 0108).
The modified method of Prausnitz et al. fails to teach wherein the application of vacuum pressure to the chamber increases a concentration of the fluid injectate within the chamber.
However, Slatkine et al. teaches wherein the application of vacuum pressure to the chamber (para. 0125, a single light source and vacuum pump are operable in conjunction) increases a concentration of the fluid injectate within the chamber (para. 0125, vacuum chamber that is suitable for inducing an increase in blood concentration at the application site will also increase the concentration of an agent which was delivered into the subject's blood at the application site).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Prausnitz et al./Mikszta to apply a vacuum pressure of at least 400 mmHg as taught by Slatkine et al., in order to increase the blood concentration within the tissue (Slatkine et al., para. 0069, para. 0125).
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (U.S. Patent Application Publication No. 20050137531 A1) in view of Mikszta et al. (U.S. Patent Application Publication No. 20040120964 A1) and in further view of Myung et al. (U.S. Patent Application Publication No. 20150305930 A1).
Regarding claim 45, Prausnitz et al. discloses the method of claim 37, wherein the vacuum pressure is in a range of about -3 psi to about -14.7 psi (about -155 mmHg to about -760 mmHg) (para. 0108, the vacuum is preferably between 50 and 300 mmHg, one of ordinary skill in the art can appreciate that vacuum pressure is a negative pressure).
Prausnitz et al./Mikzsta fails to teach wherein the application of vacuum pressure comprises applying pulses of varying vacuum pressure to the tissue and varying the duration of the pulses.
However, Myung et al. teaches wherein the application of vacuum pressure comprises applying pulses of varying vacuum pressure to the tissue (para. 0125) and varying the duration of the pulses (para. 0126).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Prausnitz et al./Mikszta to include applying pulses of varying vacuum pressure to the tissue and varying the duration of the pulses as taught by Myung et al., in order to enable the drug to diffuse into the tissue faster and more uniformly (para. 0125).
Regarding claim 46, Prausnitz et al. discloses the method of claim 37, wherein the vacuum pressure is in a range of about -3 psi to about -14.7 psi (about -155 mmHg to about -760 mmHg) (para. 0108, the vacuum is preferably between 50 and 300 mmHg, one of ordinary skill in the art can appreciate that vacuum pressure is a negative pressure).
Prausnitz et al./Mikszta fails to teach wherein the application of vacuum pressure comprises applying varying vacuum pressure to the tissue, discontinuing the application of vacuum pressure to the tissue, and reapplying vacuum pressure to the tissue.
However, Myung et al. teaches wherein the application of vacuum pressure comprises applying varying vacuum pressure to the tissue, discontinuing the application of vacuum pressure to the tissue, and reapplying vacuum pressure to the tissue (para. 0125, para. 0126).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Prausnitz et al./Mikszta such that the vacuum pressure is discontinued and reapplied to the tissue as taught by Myung et al., in order to enables the drug to diffuse into the tissue faster and more uniformly (para. 0125).
Response to Arguments
Applicant’s arguments with respect to claim(s) 27-40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Prausnitz teaches the amended claim limitation of applying vacuum pressure without penetrating the tissue because the vacuum pressure itself does not penetrate the tissue. Para 108 describes that vacuum pressure can be present prior to microneedles puncturing the skin thus the vacuum pressure itself does not penetrate the tissue but rather microneedles are used to penetrate the skin. Further, the vacuum pressure is considered to cause the transfection of the agent because the vacuum pressure deforms the skin such that the microneedles may then puncture the skin and deliver the agent. Thus without the vacuum pressure the skin is not brought into contact with the microneedles. Claims would need to further define the vacuum pressure and the injecting of the fluid into the tissue in order to overcome the current rejection.
Conclusion
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/Lauren P Farrar/Primary Examiner, Art Unit 3783