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, 10, and 15 are objected to because of the following informalities:
-Claim 1, line 1: please correct “human” to “a human”
-Claim 1, line 4: please correct “wherein transdermally delivering” to “wherein the transdermally delivering”
-Claim 1, line 10: please correct “the optional booster dose” to “the booster dose”
-Claim 1, line 11: please correct “the optional booster dose” to “the booster dose”
-Claim 1, line 14: please correct “adjacent layers” to “adjacent layers of the two or more layers”
-Claim 1, line 15: please correct “one of the charged polyelectrolyte layers” to “one of the two or more layers”
-Claim 1, line 18: please correct “the polyelectrolytes that are not the antigenic polyelectrolyte” to “another of the two or more layers”
-Claim 1, line 24: please correct “therefrom” to “from the substrate”
-Claim 10, line 2: please correct “the outermost later” to “an outermost layer of the two or more layers”
-Claim 15, line 7: please correct “the supporting layer and substrate” to “the supporting layer or the substrate”
Appropriate correction is required.
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.
Claims 1-17 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 1, the use of the term "optionally" is unclear. Specifically, the use of the term “optionally” renders the claim indefinite because it is unclear whether the limitations following the word “optionally” are part of the claimed invention. See MPEP § 2173.05(h). The limitation “wherein no dose is given between the optional booster dose and the subsequent dose” in lines 10-11 are further unclear by the use of “optional”. If the booster dose is not delivered, it is unclear whether other doses could be delivered between the initial dose and the subsequent dose. The Examiner interprets that the limitations following “optionally” in lines 7-8 are not required by the claim. The Examiner further interprets that the limitation “wherein no dose is given between the optional booster dose and the subsequent dose” in lines 10-11 is only required if the booster dose is delivered.
Claims 2-17 are rejected by virtue of their dependency on rejected claim 1.
Regarding claim 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the Examiner interprets that the limitations following “such as” are not required by the claim.
Claim 15 introduces “a substrate” in line 2. However, claim 1 previously introduces “a substrate” in line 23. It is unclear whether claim 15 is intended to require a total of two separate substrates, or whether the substrate introduced in claim 15 is intended to refer to the substrate of claim 1. For examination purposes, the Examiner interprets “a substrate” in claim 15 as “the substrate”.
Claim 17 is rejected by virtue of its dependency on rejected claim 15.
Claim 16 recites the limitation "the shearing force" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether claim 16 should be interpreted as dependent upon claim 15 or whether claim 16 is intending to introduce “a shearing force”. For examination purposes, the Examiner interprets “the shearing force” as “a shearing force”.
Claim 17 recites the limitation "the at least one feature" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether claim 17 should be interpreted as dependent upon claim 16 or whether claim 17 is intending to introduce “at least one feature”. For examination purposes, the Examiner interprets “wherein the at least one feature comprises a predefined fracture region” as “further comprising a predefined fracture region”.
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.
Claims 1-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang et al. (US 2016/0120799 A1) in view of Falo, Jr. et al. (US 2023/0145599 A1) and further in view of Powell et al. (US 2016/0166669 A1).
Regarding claim 1, Chiang discloses a method of eliciting an immune response in human subject in need thereof (see par. [0008]-[0009]), comprising:
transdermally delivering to the human subject a composition comprising immunogenic particles by a microneedle patch device (see par. [0009], [0089]), wherein transdermally delivering comprises:
transdermally delivering an initial dose by the microneedle patch device (see par. [0089], [0100], [0104]);
optionally transdermally delivering a booster dose by the microneedle patch device within 3-12 weeks of the initial dose (see par. [0094], [0100], [0104]); and
wherein the microneedle patch device (see Figs. 1 and 3) comprises a substrate comprising an array of microneedles extending therefrom (see Figs. 1 and 3, par. [0129]-[0132], [0136]-[0140]), wherein the microneedles comprise the composition comprising immunogenic particles (see par. [0107], [0113]).
However, Chiang fails to expressly state transdermally delivering a subsequent dose by the microneedle patch device at 1 year or more after delivering the initial dose or the optional booster dose, wherein no dose is given between the optional booster dose and the subsequent dose; wherein the composition comprising immunogenic particles comprises a multilayer film, the multilayer film comprising two or more layers of charged polyelectrolytes, wherein adjacent layers comprise oppositely charged polyelectrolytes, one of the charged polyelectrolyte layers in the multilayer film comprises an antigenic polyelectrolyte comprising a peptide epitope covalently linked to the antigenic polyelectrolyte, wherein the polyelectrolytes that are not the antigenic polyelectrolyte comprise a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule, and wherein the multilayer film is deposited on a core particle or forms a hollow particle to provide the composition.
Falo, Jr. teaches a method of eliciting an immune response in human subject in need thereof (see par. [0146]), comprising transdermally delivering a subsequent dose by the microneedle patch device at 1 year or more after delivering the initial dose or the optional booster dose (see par. [0086], [0146]-[0148]), wherein no dose is given between the optional booster dose and the subsequent dose (see par. [0146]-[0148]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Chiang to include transdermally delivering a subsequent dose by the microneedle patch device at 1 year or more after delivering the initial dose or the optional booster dose, wherein no dose is given between the optional booster dose and the subsequent dose, as taught by Falo, Jr., in order to provide the appropriate immune response and maintain the desired levels of protective immunity in the subject depending on the immunization protocol of the particular composition (see Falo, Jr. par. [0147]-[0148]).
However, modified Chiang still fails to expressly state wherein the composition comprising immunogenic particles comprises a multilayer film, the multilayer film comprising two or more layers of charged polyelectrolytes, wherein adjacent layers comprise oppositely charged polyelectrolytes, one of the charged polyelectrolyte layers in the multilayer film comprises an antigenic polyelectrolyte comprising a peptide epitope covalently linked to the antigenic polyelectrolyte, wherein the polyelectrolytes that are not the antigenic polyelectrolyte comprise a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule, and wherein the multilayer film is deposited on a core particle or forms a hollow particle to provide the composition.
Powell teaches a method of eliciting an immune response in a subject in need thereof (see par. [0021]) comprising delivering a composition comprising immunogenic particles (see par. [0021]), the composition comprising immunogenic particles comprising a multilayer film (see par. [0021]), the multilayer film comprising two or more layers of charged polyelectrolytes (see par. [0022]), wherein adjacent layers comprise oppositely charged polyelectrolytes (see par. [0022]), one of the charged polyelectrolyte layers in the multilayer film comprises an antigenic polyelectrolyte comprising a peptide epitope covalently linked to the antigenic polyelectrolyte (see par. [0022], [0024], [0039]), wherein the polyelectrolytes that are not the antigenic polyelectrolyte comprise a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule (see par. [0012], [0024]), and wherein the multilayer film is deposited on a core particle or forms a hollow particle to provide the composition (see par. [0022], [0027], [0085]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Chiang to include wherein the composition comprising immunogenic particles comprises a multilayer film, the multilayer film comprising two or more layers of charged polyelectrolytes, wherein adjacent layers comprise oppositely charged polyelectrolytes, one of the charged polyelectrolyte layers in the multilayer film comprises an antigenic polyelectrolyte comprising a peptide epitope covalently linked to the antigenic polyelectrolyte, wherein the polyelectrolytes that are not the antigenic polyelectrolyte comprise a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule, and wherein the multilayer film is deposited on a core particle or forms a hollow particle to provide the composition, as taught by Powell, in order to incorporate different types of compositions for eliciting different immune responses in the subject in a manner that improves the immune response in an effective and convenient manner (see Powell par. [0021]).
Regarding claim 2, modified Chiang teaches the method of claim 1 substantially as claimed. Chiang further teaches wherein the microneedles are bioerodible microneedles (see par. [0008], [0107], [0109]-[0110], [0129]).
Regarding claim 3, modified Chiang teaches the method of claim 1 substantially as claimed. Chiang further teaches wherein the microneedles comprise a matrix material, such as polyvinyl alcohol, carboxymethylcellulose, sucrose, trehalose, or a combination thereof (see par. [0006], [0129], [0144]).
Regarding claim 4, modified Chiang teaches the method of claim 1 substantially as claimed. Modified Chiang further teaches delivering the subsequent dose at more than two years after delivering the booster dose (see previous modifications in view of Falo, Jr. in rejection of claim 1 above, see Falo, Jr. par. [0086], [0146]-[0148]).
Regarding claim 5, modified Chiang teaches the method of claim 1 substantially as claimed. Modified Chiang further teaches delivering the subsequent dose at more than three years after delivering the booster dose (see previous modifications in view of Falo, Jr. in rejection of claim 1 above, see Falo, Jr. par. [0086], [0146]-[0148]).
Regarding claim 6, modified Chiang teaches the method of claim 1 substantially as claimed. Chiang further teaches wherein the microneedles have a height between 100 µm and 2 mm (see par. [0135]).
Regarding claim 7, modified Chiang teaches the method of claim 1 substantially as claimed. Chiang further teaches wherein the microneedles are solid microneedles (see Figs. 1 and 3, par. [0006], [0129]).
Regarding claim 8, modified Chiang teaches the method of claim 1 substantially as claimed. Modified Chiang further teaches wherein the antigenic polyelectrolyte is an antigenic polypeptide (see previous modifications in view of Powell in rejection of claim 1 above, see Powell par. [0022], [0024], [0039]).
Regarding claim 9, modified Chiang teaches the method of claim 1 substantially as claimed. Modified Chiang further teaches wherein the antigenic polyelectrolyte further comprises a covalently linked TLR ligand (see previous modifications in view of Powell in rejection of claim 1 above, see Powell par. [0021]-[0022], [0024], [0039]).
Regarding claim 10, modified Chiang teaches the method of claim 1 substantially as claimed. Modified Chiang further teaches wherein the antigenic polyelectrolyte is in the outermost layer of the multilayer film (see previous modifications in view of Powell in rejection of claim 1 above, see Powell par. [0021]-[0022], [0024], [0039], [0091]).
Regarding claim 11, modified Chiang teaches the method of claim 1 substantially as claimed. Modified Chiang further teaches wherein the peptide epitope is a viral, bacterial, fungal, or parasite epitope (see previous modifications in view of Powell in rejection of claim 1 above, see Powell par. [0006], [0021]).
Regarding claim 12, modified Chiang teaches the method of claim 1 substantially as claimed. Modified Chiang further teaches wherein the peptide epitope is a Plasmodium falciparum circumsporozoite protein T1, B, T8 epitope, or a combination thereof (see previous modifications in view of Powell in rejection of claim 1 above, see Powell par. [0031]-[0034]).
Regarding claim 14, modified Chiang teaches the method of claim 1 substantially as claimed. Modified Chiang further teaches wherein the peptide epitope is an RSV-G, RSV-F, RSV-M2 epitope, or a combination thereof (see previous modifications in view of Powell in rejection of claim 1 above, see Powell par. [0029]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang et al. (US 2016/0120799 A1) in view of Falo, Jr. et al. (US 2023/0145599 A1) and further in view of Powell et al. (US 2016/0166669 A1), as applied to claim 1 above, and further in view of Birkett (WO 02/13765 A2).
Regarding claim 13, modified Chiang teaches the method of claim 1 substantially as claimed. However, modified Chang fails to expressly state wherein the peptide epitope comprises a modified Plasmodium falciparum T* epitope of SEQ ID NO: 4 or SEQ ID NO: 5.
Birkett teaches delivering a peptide epitope comprising a modified Plasmodium falciparum T* epitope of SEQ ID NO: 5 (see claim 25 – SEQ ID NO: 148 or 25 (aa 1-20) comprises 100% sequence identity with a modified Plasmodium falciparum T* epitope of SEQ ID NO: 5 of the instant claim).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Chaing to include wherein the peptide epitope comprises a modified Plasmodium falciparum T* epitope of SEQ ID NO: 5, as taught by Birkett, in order to form a deliverable composition effective in the prevention of malaria infections (see Birkett, page 1 under “Technical Field”).
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang et al. (US 2016/0120799 A1) in view of Falo, Jr. et al. (US 2023/0145599 A1) and further in view of Powell et al. (US 2016/0166669 A1), as applied to claim 1 above, and further in view of McAllister et al. (US 2021/0196937 A1).
Regarding claim 15, modified Chiang teaches the method of claim 1 substantially as claimed. However, modified Chiang fails to expressly state wherein the microneedle patch device comprises a housing having a depressible portion; a substrate having a microneedle side and an opposing back side; the array of microneedles extending from the microneedle side of the substrate, wherein the microneedles comprise the immunogenic particles; and a supporting layer arranged on the opposing back side of the substrate, and movably mounted within the housing; wherein the depressible portion is configured to apply or activate upon depression a shearing force to at least one of the supporting layer and substrate effective to separate the array of microneedles from the substrate.
McAllister teaches a method of eliciting an immune response in a human subject in need thereof comprising transdermally delivering to the human subject a composition by a microneedle patch device (drug delivery device 400) (see Fig. 4, par. [0075]-[0080], [0137]-[0141]), wherein the microneedle patch device (drug delivery device 400) comprises a housing (housing 420) having a depressible portion (depressible portion 410) (see Fig. 4, par. [0079]); a substrate (substrate 440) having a microneedle side (bottom side of substrate 440 in Fig. 4) and an opposing back side (top side of substrate 440 in Fig. 4) (see Fig. 4, par. [0079]); the array of microneedles (array of microneedles 450) extending from the microneedle side (bottom side of substrate 440 in Fig. 4) of the substrate (substrate 440) (see Fig. 4, par. [0079]), wherein the microneedles (microneedles 490) comprise the immunogenic particles (see par. [0075]-[0080], [0137]-[0141]); and a supporting layer (supporting layer 430) arranged on the opposing back side (top side of substrate 440 in Fig. 4) of the substrate (substrate 440) (see Fig. 4, par. [0079]), and movably mounted within the housing (housing 420) (see Fig. 4, par. [0079]); wherein the depressible portion (depressible portion 410) is configured to apply or activate upon depression a shearing force to at least one of the supporting layer (supporting layer 430) and substrate (substrate 440) effective to separate the array of microneedles (array of microneedles 450) from the substrate (substrate 440) (see Fig. 4, par. [0075]-[0080]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Chiang to include wherein the microneedle patch device comprises a housing having a depressible portion; a substrate having a microneedle side and an opposing back side; the array of microneedles extending from the microneedle side of the substrate, wherein the microneedles comprise the immunogenic particles; and a supporting layer arranged on the opposing back side of the substrate, and movably mounted within the housing; wherein the depressible portion is configured to apply or activate upon depression a shearing force to at least one of the supporting layer and substrate effective to separate the array of microneedles from the substrate, in order to provide the structure for the microneedle patch device to serve as an applicator for delivering the microneedles comprising the composition into the subject (see McAllister par. [0075]-[0080]).
Regarding claim 16, modified Chiang teaches the method of claim 1 substantially as claimed. However, modified Chiang fails to expressly state wherein one or more of the microneedles of the array of microneedles comprises at least one feature configured to separate the one or more microneedles from the substrate upon application of the shearing force.
McAllister teaches a method of eliciting an immune response in a human subject in need thereof comprising transdermally delivering to the human subject a composition by a microneedle patch device (drug delivery device 100) (see Fig. 1, par. [0040], [0137]-[0141]), wherein one or more of the microneedles (microneedles 130) of the array of microneedles (array of microneedles 130) comprises at least one feature (predefined fracture region 140) configured to separate the one or more microneedles (microneedles 130) from the substrate (substrate 120) upon application of the shearing force (see Figs. 1A-C, par. [0038]-[0040], [0051]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Chiang to include wherein one or more of the microneedles of the array of microneedles comprises at least one feature configured to separate the one or more microneedles from the substrate upon application of the shearing force, in order to provide the structure for the microneedles comprising the composition to fracture such that they can be delivered into the subject and increase the likelihood that the microneedles separate at the desired location (see McAllister par. [0040], [0051]).
Regarding claim 17, modified Chiang teaches the method of claim 15 substantially as claimed. However, modified Chiang fails to expressly state further comprising a predefined fracture region at a proximal end of one or more microneedles of the array of microneedles and/or the substrate located about each of the one or more microneedles of the array of microneedles (see 112b rejection/interpretation of claim 17 above).
McAllister teaches a method of eliciting an immune response in a human subject in need thereof comprising transdermally delivering to the human subject a composition by a microneedle patch device (drug delivery device 100) (see Fig. 1, par. [0040], [0137]-[0141]), further comprising a predefined fracture region (predefined fracture region 140) at a proximal end of one or more microneedles (microneedles 130) of the array of microneedles (array of microneedles 130) and/or the substrate (substrate 120) located about each of the one or more microneedles (microneedles 130) of the array of microneedles (array of microneedles 130) (see Figs. 1A-C, par. [0038]-[0040], [0051]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Chiang to include a predefined fracture region at a proximal end of one or more microneedles of the array of microneedles and/or the substrate located about each of the one or more microneedles of the array of microneedles, in order to provide the structure for the microneedles comprising the composition to fracture such that they can be delivered into the subject and increase the likelihood that the microneedles separate at the desired location (see McAllister par. [0040], [0051]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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