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 .
Status of Claims
Claims 1-6 are pending and under examination.
Sequence Requirements
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 C.F.R. § § 1.821-1.825 for the reason(s) set forth below.
In the instant case the specification pages 7, 8, 9 and 10 and Figures 1 and 2 recite sequences that are not followed by a sequence identifier.
Full compliance with the sequence rules is required in response to this office action.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi et al (KR20230062390A, published 5-9-2023).
Choi et al teach a pharmaceutical composition for alleviation, treating and preventing of sarcopenia containing a microorganism transformed with a vector expressing myostatin and activin A on the cell surface as an active ingredient (see abstract and description). Choi et al teach the L. paracasei surface display expression vector comprising pKV_Pald-psgA-Activin A- linker – Myostatin (Example 1, Example 2 and Table 3). Choi et al anticipates the instantly claimed invention. The gene sequences are inherent to the display vector.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Gromada et al (US2015/003739) in view of Halkier et al (WO 01/05820 January 25, 2001), Sung et al (Int. J. Mol. Sci. 23:9059 pages 1-15, published August 13, 2022), KR20210081196A (published 7-1-2021) and GenBank inhibin βA nucleotide sequence M13436.1; 1995.
Gromada et al teach anti-activin A antibodies in combination with anti-GDF8 (myostatin)-specific antibodies can be sued for treating preventing and/or ameliorating a disease or disorder characterized by decreased muscle mass or strength. Diseases or disorders characterized by decreased muscle mass include sarcopenia (see page 4, paragraph [0034]). Gromada et al teach that ani-activin A is also known as inhibin βA; page 1, [0005]. Gromada et al teach that anti-activin A antibodies can be made by immunizing with activin A (see page 18, Example 1). Gromada et al differ by not teaching expression by display vector on the surface of the microorganism, wherein the vector includes the pgsA gene, the microorganism is a lactic acid bacterium, and the lactic acid bacterium is Lactobacillus paracasei. Gromada et al also do not teach immunization with activin A gene to produce neutralizing anti-activin A antibodies.
Halkier et al teaches methods of immunization with myostatin ( aka:GDF-8) produces neutralizing antibodies that antagonize myostatin and result in an increase in muscle mass in an animal (see page 63, claims 29 to page 66, claim 49). Halkier et al teach administration of the protein, nucleic acid or non-pathogenic transformed cell expressing the nucleic acid as a means to produce antagonizing antibodies (see claims 29-49; specification pages 39-43).
Sung et al teach inhibition of myostatin in vivo by oral administration of Lactobacillus casei expression myostatin protein on the surface and the generation of antibodies thereto in vivo. Sung et al teach expression by means of surface display using psgA fusion with myostatin (see Figure 1a) on the surface of Lactobacillus.
KR20210081196A teaches simultaneous surface display vector of dual antigen using promoters from Lactobacillus casei and methods of using vectors to express target proteins on the surface of a microorganism (see claims, page 2 of translation). KR20210081196A teaches the microorganism is preferably from the genus Lactobacillus (see page 5 of translation, 6th paragraph). KR20210081196A exemplifies a surface expression vector comprising pKV-pald-pgsa-HPV16E7 (antigen 1)-pgm-pgsa-EGFP (antigen 2) at Figure 2 (page 6 of translation).
GenBank M13436.1l teaches the nucleotide sequence of activin A, also known as inhibin βA was known to the art in 1995.
It would have been prima facie obvious at the time the invention was filed to substitute activin A gene sequence of GenBank and myostatin gene sequence of Sung et for the HPF16E7 and EGFP antigens in the display vector and host cell of KR20210081196A and transform any Lactobacillus for surface display for administration because Gromada et al teaches the combination of antibodies to activin A and myostatin are useful for treatment of sarcopenia and other diseases characterized by decreased muscle mass, Halkier et al teach the methods to generate antibodies to myostatin by means of nucleic acid expression in a transformed cell for administration, Sung et al teach the effectiveness of Lactobacillus surface display for the generation of antibodies in vivo and KR20210081196A teach a conventional means for displaying dual antigens for generation of an immune response in a Lactobacillus display vector. One skilled in the art would have reasonable expectation of success given the success of Sung et al in a Lactobacillus display vector comprising pKV-plad-pgsa-myostatin. As to claim 6, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to express the modified dual antigen expression vector as set forth above in Lactobacillus paracasei because Lactobacillus paracasei is a well-established member of the Lactobacillus casei group of lactobacilli known in the art and KR20210081196A teaches that any Lactobacillus is useful and is preferred.
Conclusion
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/Patricia Duffy/Primary Examiner, Art Unit 1645