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 .
Election/Restriction
Inventor’s election, without traverse, of the claims of Group I and Lacticaseibacillus rhamnosus as the Group and species, respectively, elected to begin prosecution is acknowledged.
The election/restriction is hereby made FINAL.
Markush Search
All elected claims have been examined with respect to formal matters.
The elected species has been examined and is deemed free of the prior art. The search was, therefore, expanded as called for under Markush examination practice to include a single additional species. That species is: Mycobacterium smegmatis.
All claimed but as yet unexamined subject matter which does not read on the above species is hereby withdrawn from consideration, for purposes of this Office Action, as being drawn to non-elected subject matter. This subject matter will be rejoined as appropriate as the Markush examination progresses.
Claim Rejections - 35 USC § 102
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 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 1-3, 14, 15, 22, 24, 25, 27, 28, 38-40, 43-47, 52, 56, 58 and 59, in so far as they read on the species defined above, are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2011/0045079 A1, cited in the IDS.
The reference teaches a spray dried viable bacterial cellular material, for example, Mycobacterium smegmatis bacteria with leucine as an excipient, formulated for administration by inhalation and useful as a vaccine (abstract; page 1, [0005], [0007], Example 3). Cryoprotectants (i.e. “stabilizers”) may be added during spray drying in order to reduce osmotic stress during the spray drying process (non-limiting examples of which are dimethyl sulfoxide, ethylene glycol, propylene glycol, and glycerol) (page 7, [0084]). Surfactants may be added, for example the non-ionic surfactant Pluronic F68 (page 20 Example 11). The spray dried composition may comprise rod-like spray dried particles having a length of about 1-4 µm and diameter of about 200-400 nm and sphere-like spray dried particles having a mean geometric diameter of about 1-4 µm (page 1, [0007], [0011]). The spray dried powder has a MMAD of about 2-3 µm (page 1, [0007]). When live cells, e.g. bacteria, comprise the spray dried powder they may be 1%, 2%, 4%, 5%, 6%, 8%, 10%, 12%, 15%, 18%, 20%, 25% or greater (page 3, [0020]). The spray dried powder contains less than 10% water, as determined by any means known in the art (page 2, [0018]; page 7, [0078]). The spray dried powder may be formulated as a capsule or cartridge (page 11, [0117]). The spray dried powder may be delivered by a dry powder inhaler (page 17, [0198]).
Claim 47 is included in this rejection because its limitation, that the target tissue is distal to the lungs, is intrinsic to the vaccination method of the cited art.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 57, in so far as it reads on the species defined above, is rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0045079 A1, cited in the IDS.
Inventor teaches a spray dried biotherapeutic matrix composition comprising a bacterial preparation wherein the composition is formulated for administration by inhalation via a capsule which contains at least 10 mg of the spray dried composition.
US 2011/0045079 A1 has been outlined above.
Inventor principally distinguishes over the cited art in that a particular amount of the spray dried composition is specified in the capsule. However, one of ordinary skill in the art, before the effective filing date of the instant invention, would have found it obvious, and with a reasonable expectation of success, to optimize a results-effective variable such as the capsule loading. One of ordinary skill in the art would have been motivated to do so by ordinary clinical considerations (efficacy, dosage control, etc.).
Allowable Subject Matter
The elected species being free of the prior art, any claim, or portion of a claim, drawn exclusively to this species constitutes allowable subject matter. That being the case, claims 4, 12, 13, 20, 21, 29, 31, 35, 36, 41, 48 and 50 are objected to because they are drawn to both allowable subject matter (the elected species) as well as subject matter which has not yet been completely searched.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 8/2/2026
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