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 .
Support for the amendments is within the instant application specification.
Applicants’ amendment to the claims filed on 9/2/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-20, 24-25 are pending and examined on the merits.
Claims 21-23 are cancelled.
Priority
Acknowledgement is made of this national stage entry of PCT/KR2022/007002 filed on 5/16/2022, which claims domestic priority to U.S. nonprovisional application 18/866,485, filed on 5/16/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/15/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 2/14/2025 are acknowledged and accepted by the Examiner.
Claim Objections
Claim 1, 9 are objected to because of the following informalities: the genus name ‘Bacillus’ needs to be italicized. Appropriate correction is required.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP). Since Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP) is essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. The strain Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP) is not fully disclosed, nor have all the sequences required for their construction been shown to be publicly known and freely available. The enablement requirements of 35 U.S.C. 112 may be satisfied by a deposit of Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP). The specification does not disclose a repeatable process to obtain the SOD and it is not apparent if the DNA sequences are readily available to the public. Accordingly, it is deemed that a deposit Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP) should have been made in accordance with 37 CFR 1.801-1.809.
If a deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be available to the public under the conditions specified in 37 CFR 1.808, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, applicants may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
1. during the pendency of this application , access to the invention will be afforded to the Commissioner upon request;
2. upon granting of the patent the strain will be available to the public under the conditions specified in 37 CFR 1.808;
3. the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer; and
4. the deposit will be replaced if it should ever become inviable.
Written Description
Claims 1-10, 12-20, 24-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claims 1-10, 12-20, 24-25 are drawn to a composition and method for treating, improving or preventing mucositis, comprising a superoxide dismutase (SOD) derived from Bacillus as an active ingredient. Claim 1 and those dependent therefrom claim SOD enzyme “derived from “ Bacillus which encompasses a large number of species. The recitation of “derived from” does not limit the source or the structure of the enzyme and is not a specific limitation. Furthermore, the term “Bacillus” can include all species and strains of Bacillus. In addition, said claims read on SOD enzymes having any structure, derived from any Bacillus species and any source including all mutants and variants of any SOD enzyme. However, the rejection of said claims can be overcome by limiting the SOD to the specific SEQ ID NO: 4.
Claim 10 is drawn to the composition of claim 1, wherein the SOD comprises an amino acid sequence as set forth in SEQ ID NO: 4. Although claim 10 recites the sequence of SEQ ID NO: 4 thereby providing the structure, it does not provide the full structure due to the recitation of “comprises an amino acid sequence of SEQ ID NO: 4” which means any SOD enzyme having any small subsequence of SEQ ID NO: 4 reads on the claimed enzyme irrespective of the SEQ ID NO provided. However, the rejection of claim 10 can be overcome by amending the claim to recite “comprises the amino acid of SEQ ID NO: 4.”
In this case, the specification discloses the following representative species of Bacillus upon which SOD is derived as encompassed by the claims (i.e. derived from Bacillus amyloliquefaciens). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of Bacillus species for which SOD is derived. The breadth of the claims encompass any Bacillus species for the production of SOD, including mutants.
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). Here, the disclosure fails to teach which species of Bacillus is used for the production of SOD.
Accordingly, one of skill in the art would not accept the disclosure of a superoxide dismutase (SOD) derived from Bacillus as being representative of all species for the production of SOD as encompassed by the claims. As such, the specification, taken with the pre-existing knowledge in the art of SOD, fails to satisfy the written description requirement of 35 U.S.C. 112, first paragraph.
Claim Rejections - 35 USC § 112(b)
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 1-20, 24-25 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 (claims 2-20, 24-25 dependent thereof), the recitation of the amended term ‘improving’ is indefinite because it is unclear what the scope of the phrase is intended to encompass structurally and functionally. It is unclear what the term ‘improving’ is intended to encompass as it can encompass an indefinite number of attributing factors that constitute an improvement in mucositis. Specifically, the word “improving” is a subjective term. Without a specific quantitative definition as to what is encompassed in the term “improving” one of skilled cannot determine what is encompassed by the recitation ‘an improvement.’ Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from this term.
Claim 4 recites the phrase ‘about at least one effect.’ The phrase ‘about at least one effect’ is a relative phrase which renders the claim indefinite. The phrase ‘about at least one effect’ is a term of degree, and there is no indication what the phrase is being compared. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from the claims. It is suggested that applicant clarify the meaning of the phrase. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7165.
The term “about” in claims 4, 15-16 is a relative term which renders the claim indefinite. The term “about” is not defined by the specification. One is not able to ascertain the limitations of the term ‘about.’ Appropriate correction is suggested.
Claim 4 recites the phrases ‘reduced difficulty eating” and “reduced reactive oxygen species (ROS) level.” The term "reduced" is a relative term which renders the claim indefinite. The term "reduced" is a term of degree, and there is no indication what the percentage is being compared. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from the claims. It is suggested that Applicant clarify the meaning of the claims. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7165.
Regarding claim 4, the recitation of the phrase ‘improved re-epithelialization, improved diarrhea symptoms, improved intestinal villus atrophy’ is indefinite because it is unclear what the scope of the phrase is intended to encompass structurally and functionally. It is unclear what the term ‘improved’ is intended to encompass as it can encompass an indefinite number of attributing factors that constitute an improvement in symptoms related to mucositis. Specifically, the word “improved” is a subjective term. Without a specific quantitative definition as to what is encompassed in the term “improved” one of skilled cannot determine what is an improvement. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from this term.
Claim 13 is indefinite as it does not end in a period. As such, the claim language is unclear as it is open ended. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from the claims. It is suggested that Applicant add a period to the end of the sentences.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20, 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is a naturally occurring microorganism.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is drawn to a composition of matter, which is one of the four statutory categories.
Step 2, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim is directed to a natural phenomenon (product of nature). Said natural phenomenon is superoxide dismutase (SOD) derived from Bacillus.
Claims 1-20, 24 are directed towards a composition for treating, improving or preventing mucositis, comprising a superoxide dismutase (SOD) derived from Bacillus as an active ingredient. In the broadest reasonable interpretation of the claim, said SOD is genetically unmodified and naturally occurring. The claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, the claim recites a "product of nature," which is a judicial exception.
Step 2, Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1-20, 24include the phrase ‘a composition.’ However, Applicant has not defined the material that is within the ‘composition.’ As recited, said composition could include additional nature-based material. As such, it does not integrate the judicial exception into practical application since the claims specify naturally occurring bacteria products.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The judicial exception is recited without additional limitations amounting to significantly more than the exception. All of the signified additional elements to the judicial exception are considered to be native to the bacterium on which the judicial exception is to be performed as noted in Step 2A, Prong 2, and, therefore, do not amount to significantly more than the judicial exception that is claimed.
As the instant claims recite judicial exceptions that are not integrated into practical application, and no elements that amount to significantly more than the judicial exception as recited, the claims were found not to be drawn to eligible subject matter under 35 U.S.C. 101.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 9, 12-14, 17-19, 24-25 are rejected under 35 U.S.C. 102a1 as being anticipated by Kang et al (Date of Publication: March 14, 2018, Journal of Crohn’s and Colitis, cited on IDS dated: 11/15/2024) {herein Kang}.
Claims 1, 4, 9, 12-14, 17-19, 24 are drawn to a composition for treating, improving or preventing mucositis, comprising a superoxide dismutase (SOD) derived from Bacillus as an active ingredient.
Claim 25 is drawn to a method for preventing or treating mucositis, comprising administering to a subject the composition of claim 1 or a superoxide dismutase.
With respect to claims 1, 4, 9, 12-14, 17-18, 25, Kang teaches a novel therapeutic alternative to fight IBD and mucositis via the administration of probiotic bacteria such as Bacillus that produces superoxide dismutase (SOD) as a dietary supplement or powder (page 861, column 2, para 3; page 862, column 1, para 2; page 866, column 2, para 1; page 867, column 1, para 1). The SOD is mixed with shellac solution and ethanol, then lyophilized before administering to a subject (page 862, column 1, para 2). Since said SOD is being used as a therapeutic supplement, it is the Examiner’s position that it would also serve as a pharmaceutical composition since it is a mixture of active medical ingredients and inactive substances designed to be safely and effectively administered to a human or animal. Said SOD is from the sodA gene encoding manganese-containing SODs [Mn-SOD] in B. amyloliquefaciens (abstract) and found extracellularly in liquid culture (page 867, column 2, para 1). The SOD is isolated from said strain (page 865, column 2, para 2) and orally administered (abstract). It is the Examiner’s position that the teaching of ‘a novel therapeutic alternative’ by Kang is the same as the recitation ‘treating, improving mucositis’ within the instant application claim 1 since it is well-understood in the art that the term ‘therapeutic’ means having a healing, curative, or calming effect that helps restore physical or mental health. Additionally, it is the Examiner’s position that the SOD taught by Kang would necessarily be an ‘active ingredient’ since Kang teaches said SOD has the activity of promoting antioxidant defenses in the body (fig. 5), thereby providing a medical effect. Kang further teaches said treatment resulted in improved diarrhea symptoms (fig. 3).
With respect to claims 19, 24, Kang teaches the instructions wherein mice were randomly separated into nine groups and administered SOD for 10 days in PBS for the treatment of oxidative stress (page 862, column 2, para 2). It is the Examiner’s position that said teaching is the same as an instruction manual since said teaching contains detailed directions that tell one how to do, make, and use the SOD in live animals. Furthermore, it is the Examiner’s position that said composition is a veterinary composition since the SOD is a formulated mixture of active pharmaceutical ingredients and excipients designed to treat oxidative stress in mice.
For the reasons stated herein, the teachings of Kang anticipate claims 1, 4, 9, 12-14, 17-19, 24-25.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-3, 5-8, 11, 15-16, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al (Date of Publication: March 14, 2018, Journal of Crohn’s and Colitis, cited on IDS dated: 11/15/2024) {herein Kang} in view of Mapsukar et al (Date of Publication: 2019 January, HHS Public Access, Examiner cited) {herein Mapsukar} and Justia (Date of Publication: Mar 7, 2018, PDF nexus, Examiner cited) {herein Justia}.
Claims 2 is drawn to the composition of claim 1, wherein the mucositis is caused by chemotherapy, radiotherapy, or a combination thereof.
Claim 3 is drawn to the composition of claim 1, wherein the mucositis comprises oral mucositis, esophageal mucositis, gastrointestinal mucositis, rectal mucositis, or a combination thereof.
Claim 5 is drawn to the composition of claim 1, wherein the composition is administered to a subject before, after, or both before and after receiving radiotherapy.
Claim 6 is drawn to the composition of claim 1, wherein the composition is administered to a subject before, after, or both before and after receiving chemotherapy.
Claim 7 is drawn to the composition of claim 1, wherein the composition is administered to a subject who is undergoing anticancer treatment.
Claim 8 is drawn to the composition of claim 6, wherein an anticancer agent used in the chemotherapy comprises at least one selected from cytotoxic anticancer agents, targeted anticancer agents, immune anticancer agents, or a combination thereof.
Claim 11 is drawn to the composition of claim 1, wherein the SOD is derived from Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP).
Claim 15 is drawn to the composition of claim 1, wherein the SOD is administered or applied at a dose of about 50 units/kg/day to about 2500 units/kg/day based on a subject's weight.
Claim 16 is drawn to the composition of claim 1, wherein the SOD is administered or applied at a dose of about 125 units/kg/day to about 1000 units/kg/day based on a subject's weight.
Claim 20 is drawn to the kit of claim 19, wherein the instruction manual comprises instructions directing to use the composition in combination with radiotherapy and/or chemotherapy, or in combination with an anticancer agent.
The teachings of Kang as applied to claims 1, 4, 9, 12-14, 17-19, 24-25 are set forth in the 102a1 rejection above.
With respect to claim 11, Kang teaches a composition comprised of Bacillus amyloliquefaciens for the production of SOD (abstract). It would be obvious to one of ordinary skill in the art to use the specific strain Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP) for the production of SOD as it is well-known in the art to produce high-levels of SOD. Kang would be motivated to utilize said strain since Justia teaches said strain produces very high levels of SOD which is advantageous for the production of a wide range of materials including: foods, health supplement foods, pharmaceutical drugs, etc (page 4, para 8). Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 15-16, Kang discloses the administration of the claimed SOD except at a dose of about 50 units/kg/day to about 2500 units/kg/day (instant application claim 15) and at a dose of about 125 units/kg/day to about 1000 units/kg/day (instant application claim 16) based on a subject's weight. However, Examiner takes the position that it would have been obvious to one having ordinary skill in the art at the time the invention was made to find the most appropriate amount of SOD, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
However, Kang does not teach wherein the mucositis is caused by chemotherapy, radiotherapy, or a combination thereof (claim 2). Kang does not teach wherein the mucositis comprises oral mucositis, esophageal mucositis, gastrointestinal mucositis, rectal mucositis, or a combination thereof (claim 3). Kang does not teach wherein the composition is administered to a subject before, after, or both before and after receiving radiotherapy (claim 5). Kang does not teach wherein the composition is administered to a subject before, after, or both before and after receiving chemotherapy (claim 6). Kang does not teach wherein the composition is administered to a subject who is undergoing anticancer treatment (claim 7). Kang does not teach wherein an anticancer agent used in the chemotherapy comprises at least one selected from cytotoxic anticancer agents, targeted anticancer agents, immune anticancer agents, or a combination thereof (claim 8). Kang does not teach Kang does not teach wherein the instruction manual comprises instructions directing to use the composition in combination with radiotherapy and/or chemotherapy, or in combination with an anticancer agent (claim 20).
With respect to claims 2-3, 5-8, Mapsukar teaches a composition comprising GC4419 for the treatment of severe oral mucositis (SOM) in patients undergoing (after) chemoradiation (page 3, para 1, 3; page 4, para 1). Said SOM negatively affects swallowing (page 3, para 1). GC4419 is a member of the pentaaza-macrocyclic Mn(II) class of SOD mimetics that catalyzes the dismutation of O2•− into H2O2 at a rate constant of 2 × 107 M−1 s−1, which is comparable to the native SOD enzyme (2 × 109 M−1 s−1) (page 2, para 4). Mapsukar further teaches the administration of GC4419 improved SOM in patients (page 4, para 2). It is the Examiner’s position that since the administration of GC4419 improved SOM, then it will necessarily improve the ability of patients with SOM to eat. Furthermore, it is the Examiner’s position that patients undergoing chemoradiation are necessarily undergoing anti-cancer treatment since chemotherapy is by definition an anti-cancer treatment that uses powerful drugs to destroy cancer cells or slow their growth of which is a cytotoxic anti-cancer agent since it results in cellular death.
With respect to claim 20, Mapuskar teaches phase 1b/2a trial tested GC4419 in combination with intensity-modulated radiation/m2 (IMRT) and concurrent cisplatin (either 100 mg/m2 every three weeks or 30–40 mg weekly) in patients with American Joint Committee on Cancer version 7 Stage IIIIVb oral cavity and oropharynx squamous cell carcinoma (page 3, para 3). The IMRT plan had to include at least 2 oral mucosal sites (right or left buccal mucosa, right or left ventral/lateral oral tongue, floor of mouth, or soft palate) within the 50 Gy cumulative isodose line (page 3, para 3). GC4419 was delivered as a 60-min IV infusion, ending within 60 minutes prior to each radiation fraction (page 3, para 3). It is the Examiner’s position that said teaching is the same as an instruction manual since said teaching contains detailed directions that tell one how to do, make, and use the GC4419 in combination with chemotherapy in patients.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Kang et al of a novel therapeutic alternative to fight IBD and mucositis via the administration of probiotic bacteria such as Bacillus that produces superoxide dismutase (SOD) as a dietary supplement or powder (page 861, column 2, para 3; page 862, column 1, para 2; page 866, column 2, para 1; page 867, column 1, para 1) or combine the teaching of Mapsukar because Mapsukar teaches a composition comprising GC4419 for the treatment of severe oral mucositis (SOM) in patients undergoing (after) chemoradiation (page 3, para 1, 3; page 4, para 1).
One of ordinary skill in the art would be motivated to either use the teachings of Kang et al. by itself or combine the teachings of Mapuskar because Mapuskar provides Kang the motivation to administer the SOD to patients undergoing chemoradiation because Kang teaches (GC4419), a member of the pentaaza-macrocyclic Mn(II) class of SOD mimetics SOD minimizes radiation and chemotherapy-induced normal tissue injury, resulting in enhanced patient outcomes (abstract; page 2, para 4). One of ordinary skill in the art would have a reasonable expectation of success that administering SOD to patients undergoing chemoradiation would reduce mucositis because Mapuskar teaches patients administered said combination experience reduced tissue injury and enhanced patient outcomes (abstract).
One of skill in the art would have a reasonable expectation of success to make and use the claimed composition because Kang provides the basic composition of SOD derived for Bacillus for the treatment of mucositis. Whereas, Mapsukar provides the teachings of a composition comprising GC4419 for the treatment of severe oral mucositis (SOM) in patients undergoing (after) chemoradiation (page 3, para 1, 3; page 4, para 1). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 9, 11-20, 24-25 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 8-10, 13, 16, 18-20, 25 of prior U.S. Patent Application No. 18866521 {herein 521} which are commonly owned and have common inventors and filed before the instant application. This is a statutory double patenting rejection.
Independent claim 1 of 521 is not patentable distinct from claims 1, 15-16, 19-20 of the instant application because claim 1 of 521 recites a composition for treating, improving or preventing mucositis, comprising a superoxide dismutase (SOD) as an active ingredient, which is not patentably distinct from the instant application claims 1, 15-16, 19-20.
Dependent claim 8 of 521 is not patentable distinct from claim 12 of the instant application because claim 8 of 521 recites the composition of claim 1, wherein the SOD is an isolated or purified enzyme, which is not patentably distinct from the instant application claim 12.
Dependent claim 9 of 521 is not patentable distinct from claim 13 of the instant application because claim 9 of 521 recites the composition of claim 1, wherein the SOD is included in a form of a strain lysate, a strain culture, a strain culture concentrate, a strain culture extract, or a dried form thereof, which is not patentably distinct from the instant application claim 13.
Dependent claim 10 of 521 is not patentable distinct from claim 9 of the instant application because claim 10 of 521 recites the composition of claim 1, wherein the SOD is a Mn-SOD, which is not patentably distinct from the instant application claim 9.
Dependent claim 13 of 521 is not patentable distinct from claim 11 of the instant application because claim 13 of 521 recites the composition of claim 1, wherein the SOD is derived from Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP), which is not patentably distinct from the instant application claim 11.
Dependent claim 16 of 521 is not patentable distinct from claim 14 of the instant application because claim 16 of 521 recites the composition of claim 1, wherein the composition is for oral administration, which is not patentably distinct from the instant application claim 16.
Dependent claim 18 of 521 is not patentable distinct from claim 17 of the instant application because claim 18 of 521 recites the composition of claim 1, wherein the composition is a pharmaceutical composition, which is not patentably distinct from the instant application claim 18.
Dependent claim 19 of 521 is not patentable distinct from claim 24 of the instant application because claim 19 of 521 recites the composition of claim 1, wherein the composition is a veterinary composition, which is not patentably distinct from the instant application claim 24.
Dependent claim 20 of 521 is not patentable distinct from claim 18 of the instant application because claim 20 of 521 recites the composition of claim 1, wherein the composition is a food composition, which is not patentably distinct from the instant application claim 18.
Dependent claim 25 of 521 is not patentable distinct from claim 25 of the instant application because claim 25 of 521 recites a method for treating, improving or preventing diabetic retinopathy or uveitis, comprising administering to a subject the composition of claim 1 or a superoxide dismutase (SOD), which is not patentably distinct from the instant application claim 25.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Status of claims
Claims 1-20, 24-25 are pending and examined on the merits.
Claims 21-23 are cancelled.
Claims 1-20, 24-25 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
