DETAILED ACTION
Claims 1-5 are pending.
Claim Objections
1.Claims 1 and 4 are objected to because of the following informalities: The claims recite the abbreviation and/or acronym of “SCTAG” which should be spelled out at their first usage followed by the abbreviation/acronym in parenthesis. Appropriate correction is required.
2.Claim 1 is objected to because of the following informalities: Claim 1 is missing punctation after 1 and before “A diagnostic kit”. 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.
3.Claims 1-5 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.
The factors to be considered when analyzing claims for compliance with the written description requirement include: actual reduction to practice; disclosure of drawings or structural chemical formulas; sufficient relevant identifying characteristics (e.g., disclosure of complete or partial structure, physical and/or chemical properties, structure/function correlation); method of making the claimed invention; level of skill and knowledge in the art; and predictability in the art. See MPEP §2163.
Claims 1-5 recite the use of “SCTAG”. The specification teaches that SCTAG stands for super-sensitive Cancer/Testis Antigen for Gut diagnosis (see [0005]). However, the term SCTAG is not a known biomarker in the art. Further, an antibody for SCTAG is unknown. The subgenus of the portions of SCTAG that correlate to gastric cancer diagnosis is also unknown and lacks written description because the specification fails to provide any structure/function correlation.
Regarding the SCTAG antibody, the specification does not disclose a single antibody example. The claims are inclusive to a genus of antibodies which possess the unique capabilities of selectively binding SCTAG. In summary, the claims require a genus of antibody products having (1) the ability to bind SCTAG. However, the claims do not recite any structural features or partial structural features.
The specification does not provide any structural or chemical formulas, structure/function correlations, any physical and/or chemical properties, nor any relevant identifying characteristics for SCTAG nor the SCTAG antibody. Thus, the antibody for SCTAG lacks written description.
The specification does not provide any disclosure of what the SCTAG biomarker actually encompasses. The claimed genus of SCTAG is extremely broad. The specification does not provide any structure/function correlation; therefore, it is unknown how the SCTAG correlates with gastric cancer. Claims 1-5 do not recite the sequence for SCTAG, thus the structure is unknown. Claims 1-5 are drawn to a method of using undefined structures.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), clearly states that
“applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date
sought, he or she was in possession of the invention. The invention is, for purposes of the
‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification
doesnot “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented
what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed chemical structure of the encompassed
claimed agents (if any), and therefore conception is not achieved until reduction to practice has
occurred, regardless of the complexity or simplicity of the method of identification. Adequate
written description requires more than a mere statement that it is part of the invention and
reference to a potential method of isolating it. The compound itself is required. See Fiers v.
Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co.
Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991).
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for
lack of written description support, especially in technology fields that are highly unpredictable,
where it is difficult to establish a correlation between structure and function for the whole genus
or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a
genus using functional language to define a desired result, the specification must demonstrate
that the applicant has made a generic invention that achieves the claimed result and do so by
showing that the applicant has invented species sufficient to support a claim to the functionally-
defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
Therefore, the full breadth of the claims does not meet the written description provision
of 35 U.S.C. §112, first paragraph. Applicants are reminded that Vas-Cath makes clear that the
written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see
page 1115).
4.Claims 1-5 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 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.
Factors to be considered in determining whether a disclosure enables one skilled in the
art to make and use the claimed invention in its full scope without resorting to undue
experimentation include: (1) the quantity of experimentation necessary; (2) the amount of
direction or guidance presented; (3) the presence or absence of working examples; (4) the
nature or complexity of the invention; (5) the state of the prior art; (6) the relative skill of those in
the art; (7) the predictability or unpredictability of the art; and (8) the breadth of the claims. See
In re Wands, 8 USPQ2d. 1400 (Fed. Cir. 1988).
All Wands factors listed above have been considered with regard to the instant claims,
with the relevant factors discussed below.
Nature of the invention: The invention is a kit for diagnosing gastric cancer that includes an antibody against SCTAG.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: The specification does not teach nor mention any defining characteristics of the SCTAG biomarker. The biomarker SCTAG is not a known biomarker in the art. The specification does not enable any person skilled in the art to which it pertains, or with which it is most connected, to use the invention commensurate in scope with these claims. Specifically, the chemical and or physical makeup of SCTAG is unknown and is not well supported by the specification.
The working examples and guidance provided: The specification fails to provide any working examples on the physical or chemical makeup of SCTAG. The specification recites that SCTAG is an abbreviation for super-sensitive Cancer/Testis Antigen for Gut diagnosis (see [0005]). However, the specification does not provide any guidance on the actual SCTAG biomarker. The specification does not provide any guidance on what the makeup of SCTAG is.
The specification does not enable any person skilled in the art to which it pertains, or
with which it is most connected, to use the invention commensurate in scope with these claims. Biomarkers and diseases are complex and thus the inventor needs to show how the method of the instant application will enable a skilled artisan to use the SCTAG biomarker to diagnose gastric cancer. One of skill in the art would not know the chemical and physical make up of an unknown biomarker. The method of using SCTAG is not well supported by the specification.
Absent specific guidance, one skilled in the art before the effective filing date of the
claimed invention would not know how to practice the claimed invention and would require
undue experimentation to practice over the full scope of the invention claimed.
The state and unpredictable nature of the prior art: The state of the prior art for using a biomarker to diagnose gastric cancer was unpredictable before the effective filing date of the claimed invention. The nature of this invention is complex and unpredictable, involving the effects of an unknown biomarker. SCTAG is not a known biomarker in the art.
Furthermore, in re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991),
the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved,
and the lack of a reasonable correlation between the narrow disclosure in the specification and
the broad scope of protection sought in the claims.
The SEQ ID for SCTAG is provided in the specification, which is identical to the sequence of protein PRM1. MyBioScource “Enzyme-linked Immunosorbent Assay Kit For Protamine 1 (PRM1)” Instruction manual 11th edition. 07/2013. https://www.mybiosource.com/human-elisa-kits/protamine-1-prm1/2020722 teaches an ELISA kit for detecting PRM1. However, the instant claims do not recite the SEQ ID for SCTAG. Such is the case here where there is a
relatively incomplete understanding in the biotechnological field involved, and the lack of a
reasonable correlation between the narrow disclosure in the specification and the broad scope
of protection sought in the claims of the instant application.
The level of one of ordinary skill: Based on the complexity and unpredictability of biomarkers and diseases, the level of a person having ordinary skill in the art is not high enough to determine use of an unknown biomarker for cancer.
The breadth of the claims: The claims are drawn to kit for diagnosing gastric cancer that includes an antibody against SCTAG. SCTAG is not a known biomarker in the art.
Due to the large quantity of experimentation necessary to determine the chemical and/or physical structure of SCTAG, the lack of direction/guidance presented in the specification regarding SCTAG, the complex nature of the invention, and the breadth of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
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.
5.Claims 1-5 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 1-5 recite “SCTAG”. While the specification teaches that “SCTAG” stands for super-sensitive Cancer/Testis Antigen for Gut diagnosis (see [0005]), it does not provide specific elements that “SCTAG” must contain. Further, the claims do not recite a sequence for SCTAG, thus the metes and bounds of the SCTAG protein is not defined completely and one would not know what would qualify an SCTAG protein. Examiner recommends incorporating the SEQ ID NO into the claim to provide a clear definition of a SCTAG protein.
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.
6.Claims 1-5 are rejected under 35 U.S.C. 101 because the claimed product and method are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The ju1dicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03.
In the instant application, claims 1-5 recite the marker SCTAG which is a protein. Because proteins are composed of matter, the marker SCTAG is a composition of matter, which is a statutory category of invention. As explained in the MPEP, it is not necessary to identify a single category into which a claim falls, so long as it is clear that the claim falls into at least one category. MPEP 2106.03(I). Here, because the marker SCTAG is a composition of matter, the claim is to at least one category of invention (Step 1: YES).
Step 2A Prong 1: Does the claim recite a judicial exception?
This part of the eligibility analysis evaluates whether the claim recites a judicial
exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a
judicial exception when the judicial exception is “set forth” or “described” in the claim.
Regarding instant claims 1-5, Example 44 of the “2019 PEG” shows a similar fact
pattern. Claim 1 in example 44 is drawn to denveric acid. The markedly different characteristics
analysis is used to determine if the nature-based product limitation is a product of nature
exception. MPEP 2106.04(c)(I). Although the claim also recites a non-nature based product
limitation (the container), the markedly different characteristics analysis should be applied only
to the nature- based product limitation. MPEP 2106.04(c)(I)(A). The markedly different
characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart
is naturally occurring denveric acid. When the claimed denveric acid is compared to this
counterpart, the comparison indicates that there are no differences in structure, function, or
other characteristics. Therefore, the claimed denveric acid is a product of nature exception.
Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013)
(naturally occurring things are “products of nature” which cannot be patented).”
Similarly, instant claims 1-5 recite the use of marker SCTAG. The closest natural
counterpart to SCTAG is naturally occurring SCTAG. When the claimed markers are compared
to this counterpart, the comparison indicates that there are no differences in structure, function,
or other characteristics.
Accordingly, instant claims 1-5 recite a judicial exception (a product of nature and an
abstract idea), and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong 2: Does the claim recite additional elements that integrate the exception into a practical application?
Regarding instant claims 1-5, Example 44 of the “2019 PEG” shows a similar fact
pattern. In claim 1 of example 44 of the “2019 PEG” and per Step2A, Prong two, the evaluation
is performed by (a) identifying whether there are any additional elements recited in the claim
beyond the judicial exception, and (b) evaluating those additional elements individually and in
combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Claim 1 recites an additional
element (the container). Although this limitation indicates that the denveric acid is held in the
container, it does not provide any information as to how the denveric acid is contained, or what
the container is, but instead covers any possible container that a doctor or pharmacist decides
to use. Because denveric acid must be placed in a container in order to store and use it, merely
reciting a generic “container” thus fails to meaningfully limit the claim because it is at best the
equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the
container does not integrate the recited judicial exception into a practical application and the
claim is therefore directed to the judicial exception (Step 2A: YES)”.
While example 44 recites a container which still was not deemed sufficient, instant
claims 1-5 do not even recite any container and contains no more than the biomarker, SCTAG
(the natural product). Example 44 did not pass Step 2A prong 2 with an additional element (the
container). Accordingly, instant claims 1-5 do not have additional elements that would integrate
the judicial exceptions cited above into a practical application.
Therefore, instant claims 1-5 do not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
Regarding instant claims 1-5, this part of the eligibility analysis evaluates whether the
claim as a whole amounts to significantly more than the recited exception, i.e., whether any
additional element, or combination of additional elements, adds an inventive concept to the
claim. MPEP 2106.05 As discussed with respect to Step 2A Prong Two, the claims do not even recite a container or any additional elements. (Step 2B: NO). The claims are not eligible.
Thus, instant claims 1-5 are rejected under 35 USC 101.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. MyBioScource “Enzyme-linked Immunosorbent Assay Kit For Protamine 1 (PRM1)” Instruction manual 11th edition. 07/2013. https://www.mybiosource.com/human-elisa-kits/protamine-1-prm1/2020722.
The sequence of PRM1 and SCTAG are identical.
MyBioSource teaches an ELISA kit for detecting PRM1 and the quality control standard is PRM1 (see page 5 under test principle).
MyBioSource does not teach that the PRM1 ELISA kit is for detecting gastric cancer.
Schneider et al., Re-visiting the Protamine-2 locus: deletion, but not haploinsufficiency, renders male mice infertile. Sci Rep. 2016 Nov 11;6:36764. doi: 10.1038/srep36764. PMID: 27833122; PMCID: PMC5105070.
Schneider teaches immunohistochemical staining of PRM1 (see figure 5, see page 10 under immunohistochemistry).
Schneider does not teach immunohistochemical staining of PRM1 to diagnose gastric cancer.
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/MCKENZIE A DUNN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
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