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 .
Claim Status
Claims 1-21 are pending and under consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at page 21 and 32. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 6-8 are objected to because of the following informalities: claims 6-8 depend from claim 1 which has only three subpart (i)-(iii). Claim 1 does not have subpart (iv) but claim 6 recites subpart (v). In this case, where is subpart (iv)? Same reasoning applies to claims 7-8. It is suggested that Applicant delete “(iv)”, “(v)”, “(vi)”, “(vii)” from claims 5-8. Appropriate correction is required.
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.
Claims 10-20 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to a judicial exception (natural phenomenon), specifically, the claims are drawn to a composition for preventing or treating tumor comprising a bacterial strain, as an active ingredient, wherein the bacterial strain i) belongs to a species Enterococcus faecium; ii) has a lactate production ability compared to microbial growth (lactate/OD600) of 3 g/L or more, when cultured for 48 hours; and iii) exhibits anti-tumor activity. Furthermore, the claims do not integrate said judicial exception into practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The 2019 Patent Subject Matter Eligibility Guidance (“Guidance”) provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101. The Guidance requires an analysis of multiple steps, Steps 1, 2A, and 2B:
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a composition, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because as indicated above, the claims are drawn to a natural phenomenon, specifically, the claims are drawn to a composition for preventing or treating tumor comprising a bacterial strain, as an active ingredient, wherein the bacterial strain i) belongs to a species Enterococcus faecium; ii) has a lactate production ability compared to microbial growth (lactate/OD600) of 3 g/L or more, when cultured for 48 hours; and iii) exhibits anti-tumor activity. This bacterial strain was isolated from natural samples (example 1 of instant specification, page 19), and therefore it is a natural product.
With respect to prong two of Step 2A, the claim does not recite additional elements that integrate the judicial exception into a practical application. Claim 10 recite “for preventing or treating tumor”. However, this limitation is intended use and does not correspond to “additional elements that integrate the judicial exception into a practical application”. See MPEP 2111.02: "If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction." (emphasis added)
In addition to the recited judicial exception, claim 12 recites that the composition is in the form of a capsule or a tablet. However, this limitation relates to general format for a pharmaceutical composition and does not integrate the judicial exception into a practical application. Said limitations do not integrate the recited judicial exception, for example, by applying or using said judicial exception to effect a particular treatment for a disease or medical condition. Therefore, the answer to prong two of the Step 2A analysis is “No.”
With respect to Step 2B, claims 15-19 recite “for co-administering with at least one other therapeutic agent” which is intended use for the claimed composition. Therefore, the composition does not necessarily comprise at least one other therapeutic agent because claims 15-19 do not recite that the composition further comprises another therapeutic agent. Thus, the claimed composition can comprise only a natural product and this claimed natural product is intended to be administered with another therapeutic agent sequentially or simultaneously. These intended use does not amount to additional elements that amount to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
See the 2019 Revised Patent Subject Matter Eligibility Guidance and Federal Register https://www.federalregister.gov/documents/2019/10/18/2019-22782/october-2019-patent-eligibility-guidance-update; and FDsys.gov.
Claim Rejections - 35 USC § 112
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 1-21 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.
Claims 1-2, 10 and 21 recite “(lactate/OD600)” which is exemplary claim language and it is unclear the content in parenthesis is limiting or merely exemplary.
Claims 1-2, 10 and 21 recite “has a lactate production ability compared to microbial growth (lactate/OD600) of 3 g/L or more, when cultured for 48 hours”. One of ordinary skill in the art would not be able to determine whether a specific strain of Enterococcus faecium is encompassed by instant claims because lactate production ability depends on many conditions such as culture time, pH of culture medium, temperature, oxygen content of culture medium, type and concentration of the carbon source or some other factors. Instant claims define only a single condition (i.e. culture time of 48 hours) and do not specify all of these culture conditions. Therefore, when a strain of Enterococcus faecium has lactate production ability of 3 g/L at one culture condition and ability lower than 3 g/L at a different culture condition, one of ordinary skill in the art would not be able to determine whether this strain is encompassed by instant claims. Thus, instant claims fail to particularly point out and distinctly claim the subject matter.
Dependent claims are also rejected because they depend from claims 1 or 10, and therefore contain same claim limitation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 21 depends from claim 1 and repeats claim limitation of claim 1. Therefore, claim 21 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 9 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 novel biological materials, specifically bacterial strains LMT17-62, LMT17-74, LMT17-25, LMT15-24 and LMT15-4 as claimed by instant claim 9. Since the biological materials are essential to the claimed invention, they must be obtainable by a reproducible method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
The specification does not disclose a repeatable process to obtain the biological materials and it is not apparent if the biological materials are readily available to the public. It is noted that Applicant has deposited Enterococcus faecium LMT17-62 (accession number: KCTC 14284BP), Enterococcus faecium LMT17-74 (accession number: KCTC 14285BP), Enterococcus faecium LMT15-24 (accession number: KCTC 14289BP), Enterococcus faecium LMT17-25 (accession number: KCTC 14288BP), Enterococcus faecium LMT15-4 (accession number: KCTC 14290BP), Enterococcus faecium LMT17-43 (accession number: KCTC 14286BP), Enterococcus faecium LMT17-40 (accession number: KCTC 14287BP) and Enterococcus faecium LMT2-17 (accession number: KCTC 14291 BP) at Korean Collection for Type Cultures (KCTC) at the Korea Research Institute of Bioscience and Biotechnology on August 26, 2020 (page 21 of instant specification), but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, 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 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of 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:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Claims 1-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating tumor using the bacterial strain of Enterococcus faecium, does not reasonably provide enablement for preventing tumor using the bacterial strain of Enterococcus faecium. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors, which have been outlined in the Federal Circuit decision of In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), include, but are not limited to, the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, the breadth of the claims, and the quantity of experimentation which would be required in order to practice the invention as claimed. See also Ex parte Forman, 230 USPQ 546 (BPAI 1986).
Instant claims are directed to a method of preventing or treating tumor in a subject, comprising administrating a bacterial strain to a subject in need of prevention or treatment of tumor, wherein the bacterial strain i) belongs to a species Enterococcus faecium; ii) has a lactate production ability compared to microbial growth (lactate/OD600) of 3 g/L or more, when cultured for 48 hours; and iii) exhibits anti-tumor activity; or a composition for preventing or treating tumor comprising a bacterial strain, as an active ingredient, wherein the bacterial strain i) belongs to a species Enterococcus faecium; ii) has a lactate production ability compared to microbial growth (lactate/OD600) of 3 g/L or more, when cultured for 48 hours; and iii) exhibits anti-tumor activity. Claims 1 and 10 recite claim limitation “preventing tumor”.
With respect to preventing tumor, it is noted that the prevention of hyperproliferative disorders, including cancers and tumors, i.e., keeping individuals free of any such disorders indefinitely, is an intractable proposition, if not now wholly impossible, given, for example, that cancers are widely heterogeneous diseases, having widely varying pathologies and etiologies, and with causes that are multifactorial and as yet only partially characterized and poorly understood. It is generally recognized that a disease cannot be prevented unless and until its causes are fully appreciated and understood to a degree that it becomes possible to intercede effectively to block its onset or development by any cause. There are effective treatments for tumor using bacterial strain of Enterococcus faecium known in the art, but prophylactic administration to prevent tumor has not been described in the art. For example, Mulder et al (WO2017/085518; 2/27/2023 IDS) teaches composition comprising Enterococcus faecium for use in a method of treating cancer (claims 1-2 and 5).
Notably, in the instant case, the specification does not present any working example in which bacterial strain of Enterococcus faecium can be used to prevent tumor while it presents an example in which bacterial strain of Enterococcus faecium can be used to treat cancer (e.g., example 2 of instant specification, page 21). As such, the specification, which lacks any specific non-general guidance, direction, and exemplification that is reasonably commensurate in scope with the intended use of preventing a cancer, would not reasonably enable the artisan to prevent cancer without undue and/or unreasonable experimentation.
Applicant is reminded that reasonable correlation must exist between the scope of the claims and scope of enablement set forth.
In deciding In re Fisher, 166 USPQ 18, 24 (CCPA 1970), the Court indicated the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. “Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC 1997).
In conclusion, upon careful consideration of the factors used to determine whether undue experimentation is required, in accordance with the Federal Circuit decision of In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988), the amount of guidance, direction, and exemplification disclosed in the specification, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue and/or unreasonable experimentation.
Claims 1-8 and 10-21 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Regents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., binding to antigen, high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. For antibodies, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor, 97 USPQ2d at 1875 (“[T]he application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common. However, the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims.”). A chimeric antibody shares the full heavy and light chain variable regions with the corresponding mouse antibody; that is, the structure shared between a mouse and chimeric antibody would generally be expected to conserve the antigen binding activity.
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Additionally, “An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.” Amgen Inc v. Sanofi 124 USPQ2d 1354, 1361 (Fed. Cir. 2017). “Further, the “newly characterized antigen” test flouts basic legal principles of the written description requirement. Section 112 requires a “written description of the invention.” But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory “quid pro quo” of the patent system where “one describes an invention, and, if the law's other requirements are met, one obtains a patent.” Ariad, 598 F.3d at 1345.” Amgen at 1362.
Claim Analysis
Instant claims are directed to a method of preventing or treating tumor in a subject, comprising administrating a bacterial strain to a subject in need of prevention or treatment of tumor, wherein the bacterial strain i) belongs to a species Enterococcus faecium; ii) has a lactate production ability compared to microbial growth (lactate/OD600) of 3 g/L or more, when cultured for 48 hours; and iii) exhibits anti-tumor activity; or a composition for preventing or treating tumor comprising a bacterial strain, as an active ingredient, wherein the bacterial strain i) belongs to a species Enterococcus faecium; ii) has a lactate production ability compared to microbial growth (lactate/OD600) of 3 g/L or more, when cultured for 48 hours; and iii) exhibits anti-tumor activity.
Instant specification disclosed five selected strains with anti-tumor activity and three selected strains without anti-tumor activity (figure 2A; example 1-2, page 19-22). However, the genus of instant claim1 and 10 encompasses any possible strains of Enterococcus faecium with anti-tumor activity and lactate production ability as claimed by instant claims 1 and 10. As shown in example 1, Applicant selected the five anti-tumor strains from natural samples. Therefore, we cannot conclude that these five selected strains are only possible strains with anti-tumor activity and lactate producing ability. Thus, only five strains with anti-tumor activity disclosed by instant specification cannot be considered as a representative number of species falling within the scope of genus encompassing any possible strains as claimed by instant claims.
Claims 2-8 recite functional property of the bacterial strains. Specifically, claim 2 recites “the bacterial strain has lactate production ability (lactate/OD600) compared to microbial growth that is greater than 2.5 g/L, when the bacterial strain is cultured for 24 hours.” Claim 3 recites “the bacterial strain exhibits a tumor inhibition rate of 10% or more.” Claim 4 recites “the bacterial strain exhibits a tumor inhibition rate of 20% or more.” Claim 5 recites “the bacterial strain has β-galactosidase activity.” Claim 6 recites “the bacterial strain has a D-sorbitol decomposition ability.” Claim 7 recites “the bacterial strain has a D-tagatose decomposition ability.” Claim 8 recites “the bacterial strain has a methyl-aD-mannopyranoside decomposition ability.” As discussed above, for a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Regents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members.
The disclosure therefore does not show that applicant was in possession of the necessary common attributes or features possessed by the members of the claimed genus. Accordingly, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
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.
Claim(s) 1-2 and 10-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mulder et al (WO2017/085518; 2/27/2023 IDS).
Regarding claims 1-2, 10, and 21, Mulder teaches composition comprising Enterococcus faecium for use in a method of treating cancer (claims 1-2 and 5). Although Mulder is silent about lactate production ability (subpart (ii) of instant claims 1 and 10), the bacterial strain of Enterococcus faecium taught by Mulder must have lactate production ability greater than 3 g/L for 48 hour culture and greater than 2.5 g/L for 24 hour culture because the bacterial strain of Mulder has anti-tumor activity. As evidenced by instant specification (figure 3C and page 24 of instant specification), lactate production ability and anti-tumor activity is correlated and the border line between anti-tumor strain and non-anti-tumor strain is 3 g/L for 48 hour culture and about 2.5 g/L for 24 hour culture as shown in Figure 3C. Therefore, the bacterial strain of Enterococcus faecium taught by Mulder must have lactate production ability greater than 3 g/L for 48 hour culture and greater than 2.5 g/L for 24 hour culture because the bacterial strain of Mulder has anti-tumor activity.
In this case, the Office does not have the facilities for examining and comparing Applicant's products with the products of the prior art in order to establish that the products of the prior art possess the same material, structural, and functional characteristics as Applicant’s products. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the products to which the claims are directed are different than that taught by the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA, 1977) and Ex parte Gray, 10 USPQ2d 1922 1923 (PTO Board of Patent Appeals and Interferences, 1988 and 1989).
Regarding claim 11, Mulder teaches “In certain embodiments, the composition of the invention comprises a bacterial strain that has been lyophilised.”
Regarding claim 12, Mulder teaches “The composition may be administered orally and may be in the form of a tablet, capsule or powder.”
Regarding claim 13, Mulder teaches that the composition is for use in a method of treating cancer, such as lung cancer, breast cancer or liver cancer which are solid tumors (claim 5).
Regarding claim 14, Mulder teaches “A suitable daily dose of the bacteria, for example for an adult human, may be from about 1 x 103 to about 1 x 1011 colony forming units (CFU); for example, from about 1 x 107 to about 1 x 1010 CFU; in another example from about 1 x 106 to about 1 x 1010 CFU. In certain embodiments, the composition contains the bacterial strain in an amount of from about 1 x 106 to about 1 x 1011 CFU/g, respect to the weight of the composition; for example, from about 1 x 108 to about 1 x 1010 CFU/g. The dose may be, for example, 1 g, 3g, 5g, and 10g.”
Regarding claim 15-20, Mulder teaches “The compositions of the invention may be particularly effective when used in combination with further therapeutic agents … In preferred embodiments the anticancer agent is an immune checkpoint inhibitor, a targeted antibody immunotherapy, a CAR-T cell therapy, an oncolytic virus, or a cytostatic drug. In preferred embodiments, the composition comprises an anti-cancer agent selected from the group consisting of: Yervoy (ipilimumab, BMS); Keytruda (pembrolizumab, Merck)”. The pembrolizumab is anti-PD-1 antibody.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674