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/Restrictions
Claims 40-41, 44-48, 50, and 52 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
With the cancellation of claim 8, claims 1-2, 4-6, 9, 11-12, 19, and 30 are pending and have been considered on the merits.
Power of Attorney
It is noted that a Power of Attorney has not yet been submitted.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/10/2025 is in compliance with the provisions of 37 C.F.R. 1.97 and has been fully considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Re: Sequence listing
The sequence listing in Computer Readable Format (CRF) is found defective. It must be re-filed with the title “Sequence Listing” above <110>. In addition, the line length in the <400> field of SEQ ID NOs: 2-10 must be reformatted such that the number of characters (including white space) does not exceed 74 characters.
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Maintained specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – This application contains sequence disclosures (Table 3, pages 44-51), in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Specification
RE: Objection to the specification
All amendments are sufficient to overcome the objection. Thus, the objection to the specification has been withdrawn.
Claim Objections
RE: Objection to the claims
The minor informalities in claims 1-2, 9, 12, and 19 have been corrected. The claim objections have therefore been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
RE: Rejection of claim 9 under 35 U.S.C. 112(a) for lack of enablement
Applicant submitted Viability Statements for the biological deposits made under Budapest Treaty (Appendix A & Appendix B) and a Declaration stating that these deposits will be released to the public upon issuance of a patent and that the deposits will be maintained for a period of 30 years, or 5 years after the most recent request date, whichever is longer. Hence, the rejection has been withdrawn.
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.
RE: Rejection of claims 1-2, 4-6, 8-9, 11-12, 19, and 30 under 35 U.S.C. 112(b) for indefiniteness
The indefinite terms in claims 1, 9, and 12 have been deleted. The rejections have thus been withdrawn.
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.
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.
RE: Rejection of claims 1-2, 4, 8-9, 11-12, 19, and 30 under 35 U.S.C. 103 as being unpatentable over Roizman et al. in view of Yum et al. and Kang et al.
Applicant points out that the claims have been amended to specify that the macular degeneration is “wet macular degeneration” and that the superoxide dismutase (SOD) is “derived from Bacillus species bacterium and binds manganese”. It is argued that the primary reference does not teach these limitations and that the secondary references do not remedy these deficiencies given that Yum et al. is drawn to treating hyperlipidemia while Kang et al. is directed to ameliorating ulcerative colitis. Without impermissible hindsight, there is allegedly no motivation to combine Roizman et al.’s method with the methods of Yum et al. and Kang et al.. Applicant asserts that there would have been no reasonable expectation of success because all cited prior art are directed to unrelated diseases.
All arguments have been fully considered but are found unpersuasive. First, Roizman et al. teaches using therapeutic agents that target underlying factors of AMD such as oxidation, inflammation, neovascularization, and cell death in order to treat or prevent age-related macular degeneration (AMD) like neovascular AMD (also known as “wet macular degeneration”; par. [0003]). Since applicable therapeutic agents include SOD mimetics and apolipoprotein peptide mimetics that overexpress SOD, a person with ordinary skill in the art would have recognized that SOD itself would be effective especially since it is recognized by Roizman et al. as an antioxidant. This position/argument is supported by Yum et al. and Kang et al., both of which show that the SOD produced by Bacillus amyloliquefaciens- GF423 is a manganese-containing extracellular SOD having antioxidant and anti-inflammatory activities. These prior art teach that SOD removes reactive oxygen species that are known to accumulate and cause oxidative stress, as well as inhibit the production of inflammatory inducers. So even though Yum et al. and Kang et al. are not directed to treating the same disease as Roizman et al., they both demonstrate that the disclosed SOD possesses properties that target the underlying factors of wet macular degeneration and so it would have been obvious to use SOD per se for treating or preventing said disease. And since Kang et al. shows that administering the disclosed SOD in combination with B. amyloliquefaciens GF423 or GF424 spores results in the synergistic reduction of oxidative stress and inflammation, one with ordinary skill in the art would have been motivated to not only administer the manganese-binding, Bacillus amyloliquefaciens--produced SOD but also B. amyloliquefaciens GF423 or GF424 spores. It is respectfully submitted that the combined teachings of Roizman et al., Yum et al., and Kang et al. provide a reasonable expectation of success based on the findings that SOD such as the one produced by B. amyloliquefaciens- GF423 exhibits antioxidant and anti-inflammatory effects, which are enhanced by co-administration with B. amyloliquefaciens GF423 or GF424 spores.
The rejections of record are therefore considered proper. But to address the claim amendments, the rejections have been modified as set forth below.
Modified rejections
Claims 1-2, 4, 8-9, 11-12, 19, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Roizman et al. (Pub. No. US 2018/0296525 A1) in view of Yum et al. (Pub. No. US 2019/0343928 A1; IDS cited) and Kang et al. (Journal of Crohn’s and Colitis 2018, pages 860-869; IDS cited).
Roizman et al. discloses use of one or more therapeutic agents for the treatment of age-related macular degeneration (AMD) and other eye diseases/disorders. The one or more therapeutic agents can be selected to target different underlying factors of AMD such as oxidation, inflammation, neovascularization, and cell death (par. [0003], [0185]).
Oxidation plays a significant role in the pathogenesis of AMD because peroxidized lipids can result in inflammation and neovascularization. Oxidative stress can also compromise the regulation of the complement system by retinal pigment epithelium (RPE) cells (par. [0233]). Another important contributor to the pathogenesis of AMD is inflammation. Inflammatory responses can upregulate the expression of VEGF and other pro-angiogenic factors that cause neovascularization like choroidal neovascularization (CNV) (par. [0272])
Thus, antioxidants can be administered to delay the onset or slow down the progression of AMD. Antioxidants can also prevent toxicity in the retina or interfere with cell death pathways. Other suitable therapeutic agents for treatment of AMD include anti-inflammatory agents and anti-angiogenic agents (par. [0004]-[0022], [0186]-[0203]).
A therapeutic agent is utilized in a therapeutically effective amount. And when used in combination with another therapeutic agent, they can be administered separately or concurrently, which can be achieved using the same formulation or separate formulations (par. [0205]). The one or more therapeutic agents can be provided as a pharmaceutical composition comprising one or more pharmaceutically acceptable carriers or excipients (par. [0542]). In some embodiments, an antioxidant and/or anti-inflammatory agent are administered at least in the early stage of AMD either systematically such as orally, or locally such as by eye drop (par. [0484], [0510], [0524]).
Roizman et al. is comparable to the instant application’s method for the following reasons:
Regarding claim 1: administering a therapeutically effective amount of one or more therapeutic agents to treat AMD, wherein said therapeutic agents include antioxidants, anti-inflammatory agents, and anti-angiogenic agents, is analogous to “A method of treating or preventing macular degeneration, comprising administering to a subject in need thereof an effective amount of a superoxide dismutase (SOD) enzyme and probiotic Bacillus sp. spores”.
Although SOD and Bacillus spores are not listed as examples of therapeutic agents, Roizman et al. teaches administering apolipoprotein peptide mimetics like apoA-I mimetics that increase the expression of the antioxidant enzyme SOD (par. [0093]) and SOD mimetics (par. [0234]), suggesting that SOD itself is a suitable agent for treatment of AMD. Aside from being an antioxidant, SOD is also known as an anti-inflammatory agent as substantiated by Yum et al. and Kang et al..
Yum et al. discloses an antioxidant, anti-inflammatory pharmaceutical composition comprising a SOD produced by Bacillus amyloliquefaciens GF423 strain (par. [0016]). This composition inhibits the production of inflammatory inducers and reactive oxygen species, as well as the expression of inflammatory mediators and inflammatory inducers during an inflammatory response (par. [0023]). It also has an ability to eliminate superoxide anion radicals and inhibit lipid oxide production (par. [0024]). Thus, the disclosed pharmaceutical composition is useful for preventing or treating inflammation including eye-related inflammatory diseases like scleritis and uveitis (Abstract; par. [0044]).
Similarly, Kang et al. demonstrates that dietary supplementation of enteric-coated SOD produced by B. amyloliquefaciens GF423 not only promoted antioxidant defenses as indicated by increased SOD, catalase, and GPx activities, but also improved cell resistance to oxidative stress in oxidative models of mice. And when said SOD was co-administered with spores of B. amyloliquefaciens GF423 (wild-type strain) or GF424 (high producer of SOD), they were found to work synergistically together in decreasing oxidative stress and inflammatory response. It was also determined that the effect of the B. amyloliquefaciens GF423 spores was proportional to the SOD productivity of the strain (Abstract; left col., page 865; Figure 6, page 866). Furthermore, Kang et al. teaches that B. amyloliquefaciens GF423’s SOD activity is due to the extracellular SOD encoded by the gene sodA that contains manganese (i.e., binds manganese) (Results 3.1, page 863).
Based on the teachings of Yum et al. and Kang et al., it would have been obvious to modify Roizman et al.’s method by administering the manganese-containing SOD produced by B. amyloliquefaciens GF423 and B. amyloliquefaciens spores as the one or more therapeutic agents to a subject with AMD with reasonable expectation that they would synergistically decrease oxidative stress and inflammation, thereby successfully treating AMD. It can also be predicted that providing said SOD as an enteric-coated formulation and B. amyloliquefaciens as spores gives the benefit of conveniently administering these therapeutic agents via the oral route. Obviousness is based on the rationale that some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Claim 1 is therefore obvious over Roizman et al. in view of Yum et al. and Kang et al..
Regarding claim 2: the modified method’s SOD is an isolated manganese-containing enzyme secreted by B. amyloliquefaciens and coated with shellac prior to oral administration, which reads on “(a) the SOD enzyme is an isolated enzyme and/or is a recombinant enzyme; (b) the SOD enzyme is coated with shellac; or (c) the SOD enzyme and/or the Bacillus sp. spores are administered orally, intravenously, intraocularly, or intramuscularly, optionally orally”.
Regarding claim 4: the disclosed SOD shares 98% identity with SEQ ID NO: 1 (see sequence alignment below), which meets the limitation “the SOD enzyme comprises: (a) the amino acid sequence with at least or about 85% sequence identity to the sequence set forth in SEQ ID NO: 1”.
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Regarding claim 9: the SOD being derived from B. amyloliquefaciens GF423 or GF424 is identical to “the SOD enzyme is from Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP) or from GF424 strain (KCTC 13227BP)”.
Regarding claim 11: the modified method reduces inflammation in the retina, which is expected to inhibit upregulation in the expression of VEGF and other pro-angiogenic factors that cause choroidal neovascularization. This teaching fulfills “the method (i) decreases choroidal neovascularization (CNV); (ii) decreases cell death in the retina; (iii) decreases inflammation in the retina; (iv) decreases hypoxia in the retina; (v) decreases the expression of vascular endothelial growth factor (VEGF) in the retina; and/or (vi) increases retinal function”.
Regarding claim 12: the modified method aims to treat AMD in a subject such as a human (par. [0077]), which corresponds to “the wet macular degeneration is a wet age-related macular degeneration (AMD)” and meets “the subject is a mammal”.
Roizman et al. teaches administering the one or more therapeutic agents (SOD and SOD-producing B. amyloliquefaciens spores) separately such as one therapeutic agent being administered prior to or subsequent to administration of the other therapeutic agent, or concurrently in the same formulation (par. [0205]). These teachings are analogous to “the SOD enzyme and the probiotic Bacillus sp. spores are administered to the subject sequentially” and “the SOD enzyme and the probiotic Bacillus sp. spores are administered to the subject, optionally wherein the subject is administered with or the retina is contacted with a composition comprising the SOD enzyme and the probiotic Bacillus sp. spores” (interpreted to mean that the enzyme and spores are administered together).
The embodiment of administering the one or more therapeutic agents as a pharmaceutical composition satisfies “the SOD enzyme and/or the Bacillus sp. spores are in a pharmaceutical composition or a nutraceutical composition”.
Regarding claim 19: since the one or more therapeutic agents include anti-angiogenic agents like ranibizumab (LUCENTIS®) and aflibercept (EYLEA®), which can be administered along with an anti-inflammatory agent (par. [0294], [0325]), it would have been obvious for a person with ordinary skill before the effective filing date of the claimed invention to also administer an anti-angiogenic agent such as ranibizumab and aflibercept. This meets “further comprising administering to the subject an effective amount of at least one additional agent that treats macular degeneration, optionally wherein the at least one additional agent is ranibizumab or aflibercept”.
Regarding claim 30: the one or more therapeutic agents being used to treat AMD in a subject necessitates that the subject has macular degeneration, which satisfies “the subject is afflicted with a wet macular degeneration”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
RE: Nonstatutory double patenting rejections
Applicant traverses the nonstatutory double patenting rejections because:
(i) co-pending application 18/723214 is drawn to treating or preventing dry macular degeneration (i.e., not wet macular degeneration); and (ii) co-pending application 17/173324 does not teach using SOD in combination with Bacillus spores and Kang et al. does not cure this deficiency as it discloses an unrelated method.
The traversal has been fully considered and is found partly persuasive. It is conceded that the method of 18/723214 no longer reads on the instant application since the instant claims have been amended to specifically treat or prevent wet macular degeneration, or to decrease or inhibit choroidal neovascularization. However, 17/173324 is drawn to a method of treating or preventing wet AMD by administering a composition comprising an antioxidant enzyme such as a Bacillus-derived SOD that binds manganese, which is similar to the claimed method. Although said co-pending application’s method does not entail using Bacillus spores, Kang et al. teaches that co-administering B. amyloliquefaciens GF423 or GF424 spores Kang et al. provides the motivation to modify the co-pending application’s method and administer them in addition to the manganese-binding, Bacillus-derived SOD.
Accordingly, only the double patenting rejections over co-pending Application No. 18/723214 have been withdrawn. The rejections over 17/173324, on the other hand, are considered proper but have been modified due to claim amendments.
Modified rejections
Claims 1-2, 4-6, 9, 11-12, 19, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 9, 12-13, 15, 52-53, and 56-58 of co-pending Application No. 17/173324 in view of Kang et al. (Journal of Crohn’s and Colitis 2018, pages 860-869; IDS cited).
The co-pending application is directed to a method of treating or preventing wet age-related macular degeneration (AMD), comprising administering to a subject in need thereof an effective amount of a composition comprising an antioxidant enzyme. The method can further comprise administering at least one additional agent that treats wet AMD, or decreases or inhibits CNV, wherein the at least one additional agent is not an antioxidant enzyme such as ranibizumab or aflibercept. The antioxidant enzyme consists of a superoxide dismutase (SOD) and is required to be derived from a Bacillus and binds manganese. In addition, the composition is administered orally and decreases or inhibits choroidal neovascularization (CNV).
Some embodiments further define the SOD as comprising: an amino acid sequence with at least or about 85% sequence identity to the sequence set forth in SEQ ID NO: 1; the amino acid sequence set forth in SEQ ID NO: 1; or the amino acid sequence set forth in SEQ ID NO: 1, wherein the amino acid residue Met1 is deleted. In another embodiment, the SOD is an isolated enzyme and/or coated with shellac, or is from Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP).
The co-pending application is different from the claims of the instant application in that the composition being administered does not contain Bacillus spores.
Nonetheless, Kang et al. shows that co-administering SOD with spores of B. amyloliquefaciens GF423 (wild-type strain) or GF424 (high producer of SOD) reduced oxidative stress and inflammatory response in a synergistic manner. A person with ordinary skill in the art before the effective filing date of the claimed invention would have therefore been motivated by Kang et al. to incorporate B. amyloliquefaciens GF423 or GF424 spores to the composition. It can be expected that the presence of SOD-producing B. amyloliquefaciens spores would facilitate the reduction of oxidative stress and inflammation. The conclusion of obviousness is based on some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
This is a provisional nonstatutory double patenting rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651