The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 10-1-2025 is acknowledged. Claim 61 has been amended. Claims 62-65, 67-68 and 73-74 have been cancelled. Claims 57-59, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 60-61, 66, 69-72 and 75 are currently under examination.
Claim Objections
Claims 60, 69-70 are objected to for reciting claim language drawn to non-elected inventions.
Claim Rejections Withdrawn
The rejection of claims 60, 66, 68-72 under 35 U.S.C. 102(a)(2) as being anticipated by Martyn et al. (U.S. Patent Application Publication US 2021/0299187) is withdrawn in light of the statement of common ownership filed on 10-1-2025.
The rejection of claims 60-61, 66-72 and 75 under 35 U.S.C. 103 as being unpatentable over Martyn et al. (U.S. Patent Application Publication US 2021/0299187) is withdrawn in light of the statement of common ownership filed on 10-1-2025.
The rejection of claims 60-61, 66-72 and 75 under 35 U.S.C. 103 as being unpatentable over Akle et al. (Wo 2015/092382 – IDS filed on 6-29-2022) and Levin et al. (Human Vaccines & Immunotherapeutics, Vol. 11 No. 4, pages 991-997 – IDS filed on 6-29-2022) is withdrawn in light of the amendment thereto.
New Grounds of Rejection
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 60-61, 66, 69-72 and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Akle et al. (WO 2015/092382 – IDS filed on 6-29-2022) and Henderson (U.S. Patent Application Publication US 2017/0196966 – IDS filed on 6-29-2022).
Akle et al. disclose the administration of a Mycobacterium species to treat tumors (see abstract and Figure 1 for example). Akle et al. further disclose that said Mycobacterium species can be Mycobacterium obuense (see abstract for example); that said Mycobacterium is a non-viable, whole cell rough variant (see page 11, lines 23-24 and page 12, lines 1-6 and claim 10); that said Mycobacterium can be prepared as either a suspension or dry preparation (see page 12, lines 20-22); that said preparations can be administered intradermally or subdermally (see page 25, lines 7-17); and that said cancer can be melanoma which can be metastatic (see page 13, line 1 and page 15, line 11-13, for example).
Akle et al. differs from the instant invention in that don’t explicitly disclose the use of said Mycobacterium can be delivered intradermally by a microneedle device to intradermally administer said Mycobacterium; that said the microneedles are arrayed in a patch; that said microneedles are at least partially coated or embedded with said Mycobacterium; and that said coating or microneedle is dissolvable or hydratable upon contact with the skin in order to provide immediate or sustained release of the Mycobacterium.
Henderson discloses the use of microneedle devices for the delivery of exogenous materials (e.g. polypeptides or alphaviruses) to an individual. Henderson et al. further disclose that the exogenous material can be coated on embedded into the microneedles (see paragraph [0006]; that the microneedles can be dissolvable, biosoluble or biodegradable (see paragraph [0007]); that said exogenous material can be an antigen associated with an infectious agent (see paragraph [0008] and that said infectious agent can be a Mycobacterium (see paragraph [0073]); that the microneedles can be arrayed on a patch (see paragraph [0044]) and that the exogenous material can be dissolved in the skin compartment or injected into the skin (see paragraph [0043]); and that the benefits of their microneedle arrays include: the ability to deliver material directly to the immune cells in the skin, a reduction in the amount of material needed which reduces production cost and time; the material can be self-administered; increased stability of the exogenous material at room temperature and that they are painless (which makes their use more tolerable for the patient) (see paragraph [0042]).
It would have been obvious for one ordinary skill in the art to utilize the microneedle devices of Henderson in the methods of Akle et al. in order to take advantage of the many benefits associated with said microneedle arrays including reduced dosages (and associated costs) as well as the ability to target the immune cells (dendritic and Langerhans) within the skin.
One would have had a reasonable expectation of success as Henderson discloses the use of microneedle devices with Mycobacterium based vaccines and Akle et al. disclose that their Mycobacterium preparations can be administered intradermally.
Moreover, the KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Akle et al. disclose the effective use of non-infectious, non-viable whole cell Mycobacterium preparations in the treatment of cancers such as melanomas and the use of microneedle arrays are well established in the art, the use of microneedle arrays in the methods of Akle et al. is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
Claims 60-61, 66, 69-72 and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Akle et al. (WO 2015/092382 – IDS filed on 6-29-2022) and Junger et al. (U.S. Patent Application Publication US 2020/0246450).
Akle et al. disclose the administration of a Mycobacterium species to treat tumors (see abstract and Figure 1 for example). Akle et al. further disclose that said Mycobacterium species can be Mycobacterium obuense (see abstract for example); that said Mycobacterium is a non-viable, whole cell rough variant (see page 11, lines 23-24 and page 12, lines 1-6 and claim 10); that said Mycobacterium can be prepared as either a suspension or dry preparation (see page 12, lines 20-22); that said preparations can be administered intradermally or subdermally (see page 25, lines 7-17); and that said cancer can be melanoma which can be metastatic (see page 13, line 1 and page 15, line 11-13, for example).
Akle et al. differs from the instant invention in that don’t explicitly disclose the use of said Mycobacterium can be delivered intradermally by a microneedle device to intradermally administer said Mycobacterium; that said the microneedles are arrayed in a patch; that said microneedles are at least partially coated or embedded with said Mycobacterium; and that said coating or microneedle is dissolvable or hydratable upon contact with the skin in order to provide immediate or sustained release of the Mycobacterium.
Junger et al. discloses the use of microneedle devices for the transdermal delivery of vaccine compositions to an individual (see paragraph [0130]). Henderson et al. further disclose that the microprojections can solid, non-porous, non-hollow, porous or hollow (see paragraph [0132]); that the microprojections can be arrayed in a patch (see paragraph [0133] and that the exogenous material can be dissolved in the skin compartment or injected into the skin (see paragraph [0130] and [0132]); that said exogenous material can be whole cell bacteria (see paragraph [0144] and [0147]) and that said bacteria can be a Mycobacterium (see paragraph [0150]); and that the benefits of their microneedle arrays include the increased stability of vaccine formulations (see paragraph [0154]), the ability to deliver material directly to the immune cells in the skin, and a reduction in the amount of material needed which reduces production cost and time.
It would have been obvious for one ordinary skill in the art to utilize the microneedle devices of Junger et al. in the methods of Akle et al. in order to take advantage of the many benefits associated with said microneedle arrays including increased stability, reduced dosages (and associated costs) as well as the ability to target the immune cells (dendritic and Langerhans) within the skin.
One would have had a reasonable expectation of success as Junger et al. disclose the use of microneedle devices with Mycobacterium based vaccines and Akle et al. disclose that their Mycobacterium preparations can be administered intradermally.
Moreover, the KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Akle et al. disclose the effective use of non-infectious, non-viable whole cell Mycobacterium preparations in the treatment of cancers such as melanomas and the use of microneedle arrays are well established in the art, the use of microneedle arrays in the methods of Akle et al. is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 January 27, 2026