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 .
Priority
The instant application was received 23 February 2024; it is a national stage application of PCT/CN2022/113195, filed 18 August 2022 and claims foreign priority to CN202110969047.9, filed 23 August 2021. Acknowledgment is made of Applicant’s claim for foreign priority and certified copies of the priority documents have been received.
Status of the Claims
The listing of claims filed 16 July 2024 has been examined.
Claims 11-29 are pending.
Claims 11-29 are newly added.
Claims 1-10 are cancelled.
Claims 11-29 are examined on the merits.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 18 April 2024 is acknowledged and has been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains phrases which can be implied, such as, “The present invention relates to…” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 13, 19-21, and 22-29 are objected to because of the following informalities:
As written, claim 1 contains numerous grammatical errors. For example, claim 1 recites, “A method for preventing and/or treating tumor…” Examiner recommends amending to recite “a tumor” or “tumors,” or similar. Also, claim 1 recites, “…the tumor comprises tumor…”
Claim 13 recites, “…substituted or unsubstituted C3-C8 cycloalky;” This appears to be a typo. Examiner suggests amending to “cycloalkyl.”
Claim 19 recites, “The method of claim 1, the DNA methylase is selected from…” The word “wherein” seems to be missing. Examiner recommends amending to, “The method of claim 1, wherein the DNA methylase is selected from…” Claims 20-21 and 23-29 have similar issues.
Numerous additional grammatical errors are present throughout the claims.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112(a)
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.
Claims 11-15 and 17-29 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 claims contain 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include 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. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Claim 11, upon which claims 12-15 and 17-29 all either directly or indirectly depend, recites, “A method for preventing and/or treating tumor, which comprises administering a compound of formula I…” Formula I is broad and encompasses many distinct compounds. However, the only instantly disclosed compounds of formula I are nifuroxazide and furazolidone (Claim 16; Specification, p. 34, Lines 1-9), shown below:
PNG
media_image1.png
202
426
media_image1.png
Greyscale
PNG
media_image2.png
196
493
media_image2.png
Greyscale
Prior art contains other compounds of formula I, such as nifuroxazide analogues like Compound 3 as disclosed by Masunari (Masunari et al., “A new class of nifuroxazide analogues: Synthesis of 5-nitrothiopene derivatives with antimicrobial activity against multidrug-resistant Staphylococcus aureus,” Bioorg. Med. Chem. 15 (2007) 4229-4236), shown below (p. 4232, Table 2):
PNG
media_image3.png
712
815
media_image3.png
Greyscale
Masunari’s Compound 3 contains Cl and S atoms. No exemplary compounds containing a halogen or wherein W is S are instantly disclosed. Furthermore, Masunari states nifuroxazide is, “…a synthetic antimicrobial agent used as a second or third choice in enteric infection treatments…” Thus, Masunari teaches nifuroxazide analogues as antimicrobial agents, not chemotherapeutics, and Masunari’s teachings fail to suggest or draw a clear line as to which compounds of formula I would be expected to function as anti-tumor agents. Accordingly, a person having ordinary skill in the art (PHOSITA) is not in possession of the knowledge of which structural changes to nifuroxazide and/or furazolidone would yield a compound which would be expected to retain the anti-cancer activity of nifuroxazide and/or furazolidone. Phrased differently, a PHOSITA would not be able to predict which compounds, of the vast number that are claimed, will be active or inactive absent evidence. Additionally, there is no structure/function correlation in the Specification showing which compounds, besides nifuroxazide and furazolidone, would or would not be useful for treating a tumor. There is no structure/function correlation and no representative number of specific examples of compounds to demonstrate which compounds retain chemotherapeutic activity.
Medicinal chemistry is an experimental science with a low predictability level. Small changes in the structure of a compound can lead to large differences in their pharmacological activity.
The Specification provides no exemplary method for making a compound of formula I. Methods of synthesizing compounds are, in general, known to a PHOSITA; however, methods of making the myriad of compounds encompassed by the instant claims is beyond the skill of the artisan. As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in other compounds of formula I, besides nifuroxazide and furazolidone, because the examples illustrated in the experimental section are limited to only nifuroxazide and furazolidone.
Substantial and undue experimentation would be needed to practice Applicant’s invention because the specification lacks sufficient detail to show how to use compounds beyond nifuroxazide and furazolidone. Further, there is no guarantee that all of the compounds embraced by the scope of the claims would be used in methods for treating a tumor.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. The claim(s) are broad and generic with respect to all possible compounds encompassed by the claims and the possible structural variations are limitless to any compounds of the genus. In the instant case, however, the specification does not disclose a sufficient variety of species to reflect this variance in the genus. The Specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. Furthermore, based on the limited number of examples provided for the claimed genus, a representative number of examples to support the claimed genus is lacking and a PHOSITA would conclude that Applicant is not in possession of the claims, as currently recited.
Claims 11-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claim 11, upon which claims 12-29 all either directly or indirectly depend, recites, “A method for preventing and/or treating tumor, which comprises administering a compound of formula I…to a subject in need…” This is a broad genus and, according to its broadest reasonable interpretation, includes any tumor. While the specification, in view of the prior art, reasonably provides enablement for the treatment of a tumor, specifically lung cancer, renal carcinoma, breast cancer, colon cancer, lymphoma, pancreatic cancer, and glioblastoma (p. 35, Lines 20-28), it does not reasonably provide enablement for the prevention of a tumor or treatment of any tumor.
MPEP § 2164.01(a) explains how enablement for the claimed invention can be analyzed:
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The Wands factors are analyzed with respect to the claimed elements in turn below.
The breadth of the claim and b) the nature of the invention. The claims are directed to a method for treating and/or preventing a tumor by administering a compound of formula I or a pharmaceutically acceptable salt thereof.
The range of cancers that can be associated with a tumor is extensive. While claim 11 recites limitations regarding low or no NNMT gene expression, high DNA methylase expression, high UHRF1 expression, and high NNMT gene methylation, the tumor thereof could be associated with a myriad of distinct cancers having mutually exclusive etiologies. A “tumor” could include cancers which, presently, have uncharacterized NNMT expression levels, DNA methylase expression levels, UHRF1 expression levels, and/or NNMT gene methylation levels. Additionally, a “tumor” could include, currently, undiscovered tumors having low or no NNMT gene expression, high DNA methylase expression, high UHRF1 expression, and high NNMT gene methylation.
The state of the prior art. This can be ascertained by reviewing the Background of the Specification and relevant literature. Currently, no compound has been found to treat all cancers. The Specification states, “Due to the heterogeneity of tumor and individual difference in patient, simply using the same treatment method or medication based on source of pathological characteristic of tumors can easily lead to improper treatment, which can delay valuable treatment time and opportunities for patient. Therefore, it is very necessary to take personalized and precise treatment according to the different conditions of patient.” (p. 1, Lines 9-13).
The Specification defines “prevention” as, “…a method of preventing the occurrence of a disease and/or its accompanying symptoms, or protecting a subject from getting disease.” (p. 27, Lines 1-2). The term “treatment” is defined as, “…delaying and terminating the progression of the disease, or eliminating the disease, and it does not require 100% inhibition, elimination and reversal.” (p. 25, 3-5). While treating particular tumors may be possible, treating and/or preventing all tumors is not.
Furthermore, NIH (National Institutes of Health (US); Biological Sciences Curriculum Study. NIH Curriculum Supplement Series [Internet]. Bethesda (MD): National Institutes of Health (US); 2007.) states, “…cancer is a group of more than 100 diseases… each type of cancer has its unique features…” (p. 1, ¶ 1).
Prior art, Luo (CN 109793729 A; IDS dated 18 April 2024, Cite No. 1), discloses an anti-tumor drug which comprises nifuroxazide and/or nifuroxazide salt in addition to an additional pharmaceutically acceptable component (p. 1, Summary of the Invention) and said drug is used in treating osteosarcoma tumors (p. 2, Line 3). Thus, Luo discloses nifuroxazide has anti-tumor activity (p. 2, Lines 13-15).
The level of one of ordinary skill. This may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
The level of predictability in the art is generally unpredictable. The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. MPEP § 2164.02(II) explains that a correlation between the claimed invention and the evidence provided in an application, along with a correlation between the evidence and the models recognized in the art, are required:
“Correlation” as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a “working example” if that example “correlates” with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute “working examples.” In this regard, the issue of “correlation” is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995) (reversing a USPTO decision based on finding that in vitro data did not support in vivo applications).
Further, treatments may be effective for some subjects and ineffective for other subjects. Thus, each candidate for pharmaceutical medicine must be evaluated on its own even when a nexus to an existing drug or class of drugs has been established.
The amount of direction provided by the inventor and g) the existence of working examples. The amount of guidance needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability of the art. The less predictable the nature of the invention, the more information needs to be explicitly stated in the specification. See MPEP 2164.03.
The Specification provides some direction related to compositions comprising a compound of formula I (p. 32, Line 36 – p. 33, Line 16) as well as in vitro data (p. 34, Line 25 – p. 38, Line 13). There are no working examples demonstrating the instantly recited compounds’ efficacy in treating and/or preventing a tumor in a subject. The provided in vitro data pertains to human small cell lung cancer, human renal carcinoma, breast cancer, human colon adenocarcinoma, human diffuse large B-cell lymphoma, human glioblastoma, human pancreatic cancer, human glioblastoma multiforme, and clear cell renal cell adenocarcinoma cell lines. However, this data is insufficient in providing an enabling disclosure for the prevention of tumors or the treatment of tumors in cancers beyond the aforementioned cancers.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure. The treatment or prevention of a tumor would at the very least depend on the cause of said tumor and the subject. The prior art demonstrates that it is not possible for a single pharmaceutical product, and its analogs, to treat or prevent all tumors.
In order to practice the invention commensurate with the full scope of the claims, the skilled artisan would need to undertake experiments to determine (1) whether the compound is, in fact, clinically useful for the treatment or prevention of a tumor; (2) the amount of compound that is to be administered; (3) the frequency of dosing and the manner in which the compound is to be administered; (4) the likely side effects and how they should be mitigated; and (5) the pharmaceutical formulation that is suitable for administration to a patient.
Scope of Enablement Conclusion
In view of the Wands factors discussed above, the disclosure of the instant application does not reasonably enable a PHOSITA to use the full scope of the claimed invention. While the state of the prior art does agree nifuroxazide has chemotherapeutic utility, the claims, as written, capture too broad a scope. Given the level of unpredictability in this technology area, and the relative lack of working examples or other specific guidance or teachings by Applicant, Examiner concludes that one skilled in the art would be burdened with undue experimentation when attempting to practice the full scope of the invention as claimed. Examiner suggests deleting the word “preventing” from claim 1 and limiting the tumors to those supported by the disclosure.
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 11-29 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 claims 1 and 20-25, these claims all recite “high” and/or “low” NNMT gene expression, DNA methylase expression, UHRF1 expression, and/or NNMT gene methylation. The words “high” and “low” are indefinite terms which render the claims indefinite. The terms “high” and “low” are not defined by the claims and the Specification provides no standard for ascertaining the requisite degree and, accordingly, a person having ordinary skill in the art (PHOSITA) would not be reasonably apprised of the scope of the invention. The instant Specification states, “As used herein, ‘the low or no expression of NNMT gene, high expression of DNA methylase, high expression of UHRF1, high methylation level of nucleotide site of NNMT gene, and/or high methylation level of DNA CpG site of NNMT gene’ refers to one or more of the low or no expression of NNMT gene, high expression of DNA methylase, high expression of UHRF1, high methylation level of nucleotide site of NNMT gene and high methylation level of DNA CpG site of NNMT gene.” (p. 22, Lines 17-21). Additionally, some preferred embodiments are disclosed. For example, the Specification states, “In another preferred embodiment, the tumor with low or no expression of NNMT gene means that no NNMT protein can be detected in 1 µg of protein extracted from tumor by using NNMT antibody, preferably in 5 µg of protein extracted from tumor, more preferably in 10 µg of protein extracted from tumor, more preferably in 100 µg of protein extracted from tumor, preferably in 1000 µg of protein extracted from tumor.” (p. 6, Lines 22-26). In light of the Specification, a PHOSITA would be unable to readily ascertain which amount of protein extracted from a tumor would be sufficient to demonstrate “low” NNMT gene expression.
Claims 2-19 and 26-29, which all depend on claim 1 either directly or indirectly, do not resolve the aforementioned issues of indefiniteness and are therefore included in this rejection.
Regarding claims 20, 23, and 25, the phrases "for example" and “preferably” render the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11-16 and 18-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luo (CN 109793729 A; IDS dated 18 April 2024, Cite No. 1).
Regarding claims 11-16 and 18-26, Luo teaches the use of nifuratone, or a salt thereof, in the treatment of osteosarcoma (p. 1, Technical Field). Nifuratone (Drawings, p. 1/3, Fig. 1), shown below, is structurally identical to nifuroxazide:
PNG
media_image4.png
111
329
media_image4.png
Greyscale
Relative to instantly recited formula I, in nifuroxazide R1 is nitro, R2 is H, R3 is H, R4 is C6 aryl having a hydroxyl substitution, R5 is H, R6 is H, and W1 is O. Luo discloses an anti-tumor drug which comprises nifuroxazide and/or nifuroxazide salt in addition to an additional pharmaceutically acceptable component (p. 1, Summary of the Invention) and said drug is used in treating osteosarcoma tumors (p. 2, Line 3). Luo discloses nifuroxazide has anti-tumor activity in vivo (p. 2, Lines 13-15).
Luo is silent regarding NNMT gene expression levels, DNA methylase expression levels, UHRF1 expression levels, and NNMT gene methylation levels. However, treating a tumor having these limitations will inevitably flow from Luo’s teachings, since the same compound (i.e., nifuroxazide) is being administered to the same subjects (i.e., cancer cells). Phrased differently, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding the NNMT gene expression levels, DNA methylase expression levels, UHFR1 expression levels, and NNMT gene methylation levels, by practicing the method taught by Luo (i.e., treating a tumor using nifuroxazide), a PHOSITA would have been treating tumors meeting one or more of the instantly recited limitations regarding NNMT gene expression levels, DNA methylase expression levels, UHFR1 expression levels, and/or NNMT gene methylation levels, even though said limitations failed to be explicitly recognized by the prior art.
MPEP 2112(I) states, “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’ Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that ‘just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.’”
Claim Rejections - 35 USC § 103
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.
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.
Claims 11-16 and 18-29 are rejected under 35 U.S.C. 103 as being unpatentable over Luo (CN 109793729 A; IDS dated 18 April 2024, Cite No. 1) in view of Karamanakos (Karamanakos, “Possible role for furazolidone in the treatment of glioblastoma multiforme,” JBUON 2013; 18(4): 1097-1100).
Regarding claims 11-16 and 18-29, Luo teaches all of the claimed elements as stated above.
Luo does not explicitly teach a method of using nifuroxazide in treating other cancers aside from osteosarcoma.
Karamanakos suggests furazolidone be investigated as a possible treatment for glioblastoma multiforme (p. 1, Col. 2).
Karamanakos does not present data regarding the in vivo or in vitro efficacy of treating a tumor using furazolidone.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Luo would have found it prima facie obvious to treat glioblastoma multiforme by administering a compound of formula I based on the teachings of Karamanakos because Karamanakos suggests furazolidone may be useful for treating glioblastoma multiforme. Like nifuroxazide, furazolidone is also a compound of formula I. A skilled artisan would have recognized both nifuroxazide and furazolidone are nitrofuran-class antimicrobial drugs. Because Luo discloses nifuroxazide functions as a chemotherapeutic, specifically in regard to osteosarcoma, and Karamanakos suggests furazolidone as a potential treatment for glioblastoma multiforme, a PHOSITA would have been motivated to try applying the method taught by Luo in treating glioblastoma multiforme instead of osteosarcoma.
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Luo (CN 109793729 A).
Regarding claim 17, Luo teaches all of the claimed elements as stated above. Furthermore, Luo indicates nifuroxazide and salts thereof have anti-tumor activity (p. 1, Technical Field).
Luo does not explicitly teach specific nifuroxazide salts.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Luo would have found it prima facie obvious to treat a tumor by administering a pharmaceutically acceptable salt of a compound of formula I because Luo teaches nifuroxazide salts and a PHOSITA would have recognized forming a salt can improve pharmaceutical characteristics by, for example, increasing aqueous solubility.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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, ADAM C MILLIGAN can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights