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 .
DETAILED ACTION
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-12 have an effective filing date of 10 DEC 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/7/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
Claims 1-12 are currently pending and presented for examination on the merits.
Claims 1-7 are amended.
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 1-4, and 7 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. In the instant case the claims are drawn to a natural phenomenon, specifically, the relationship between asprosin levels and a diagnosis of pancreatic cancer. Furthermore the claims do not integrate said judicial exception in to practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
6. 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:
7. 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.
8. 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.
9. 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.
10. With respect to Step 1, the claims are drawn to a process, so the answer to Step 1 is “Yes.”
11. With respect to prong one of Step 2A, the answer is “Yes,” because the claims are drawn to a natural phenomenon, specifically, the relationship between asprosin levels and a diagnosis of pancreatic cancer
12. With respect to prong two of Step 2A, the claims do not recite additional elements that integrate the judicial exception into a practical application. In addition to the recited judicial exception, the claims recite obtaining a sample from the subject suspected of having the pancreatic cancer, contacting the sample with a biomarker composition, measuring and comparing a level of the asprosin with a control, and diagnosing the subject having the pancreatic cancer if the level of the asprosin is higher than the control; however these steps primarily relate to routine laboratory practices involving detecting protein expression. As such these steps do not integrate the judicial exception into a practical application. The claims also do not recite any additional method steps that would integrate the recited judicial exception, for example, by applying or using said judicial exception as an indicator to determine whether a particular treatment or prophylaxis for a disease or medical condition should be administered. It is further noted that the claims include an “comparing” and “diagnosing” step, see claim 1, and this step is an abstract idea, which involves steps that may be carried out by the human mind. Therefore the answer to prong two of the Step 2A analysis is “No.”.
With respect to Step 2B, as indicated above, the claims recite steps related to routine laboratory practices involving detecting protein expression; however these steps were well-understood, routine, and conventional data gathering steps that were practiced by investigators prior to Applicant’s invention. These steps, alone or in combination, fail to qualify as 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.
Claims 5-6 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. In the instant case the claims are drawn to a natural phenomenon, specifically, the relationship between asprosin levels and a diagnosis of pancreatic cancer. Furthermore the claims do not integrate said judicial exception in to 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.
With respect to Step 1, the claims are drawn to a process, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because the claims are drawn to a natural phenomenon, specifically, the relationship between asprosin levels and a diagnosis of pancreatic cancer.
With respect to prong two of Step 2A, the claims do not recite additional elements that integrate the judicial exception into a practical application. In addition to the recited judicial exception, the claims recite obtaining a sample from the subject suspected of having the pancreatic cancer, measuring a level of the asprosin by a preparation for measuring the level of the asprosin, and comparing the expression level of the asprosin with a control; however these steps primarily relate to routine laboratory practices involving detecting protein expression. As such these steps do not integrate the judicial exception into a practical application. The claims also do not recite any additional method steps that would integrate the recited judicial exception, for example, by applying or using said judicial exception as an indicator to determine whether a particular treatment or prophylaxis for a disease or medical condition should be administered. It is further noted that the claims include an “comparing” step, see claim 5, and this step is an abstract idea, which involves steps that may be carried out by the human mind. Therefore the answer to prong two of the Step 2A analysis is “No.”.
With respect to Step 2B, as indicated above, the claims recite steps related to routine laboratory practices involving detecting protein expression; however these steps were well-understood, routine, and conventional data gathering steps that were practiced by investigators prior to Applicant’s invention. These steps, alone or in combination, fail to qualify as 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.
Claims 8-12 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. In the instant case the claims are drawn to a natural phenomenon, specifically, the relationship between asprosin levels and a diagnosis of pancreatic cancer. Furthermore the claims do not integrate said judicial exception in to 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.
With respect to Step 1, the claims are drawn to a process, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because the claims are drawn to a natural phenomenon, specifically, the relationship between asprosin levels and a diagnosis of pancreatic cancer.
With respect to prong two of Step 2A, the claims do not recite additional elements that integrate the judicial exception into a practical application. In addition to the recited judicial exception, the claims recite measuring a level of asprosin in a biological sample derived from a subject, determining if the level of asprosin is higher than that of a healthy control group, that pancreatic cancer has developed or is likely to develop; however these steps primarily relate to routine laboratory practices involving detecting protein expression. As such these steps do not integrate the judicial exception into a practical application. The claims also do not recite any additional method steps that would integrate the recited judicial exception, for example, by applying or using said judicial exception as an indicator to determine whether a particular treatment or prophylaxis for a disease or medical condition should be administered. It is further noted that the claims include an “determining” step, see claim 8, and this step is an abstract idea, which involves steps that may be carried out by the human mind. Therefore the answer to prong two of the Step 2A analysis is “No.”.
With respect to Step 2B, as indicated above, the claims recite steps related to routine laboratory practices involving detecting protein expression; however these steps were well-understood, routine, and conventional data gathering steps that were practiced by investigators prior to Applicant’s invention. These steps, alone or in combination, fail to qualify as 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.
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 5 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 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.
In the instant case, the claims are inclusive of a genus of a preparation. However, the written description in this case only sets forth an antibody that specifically binds to the asprosin, and specifically, an antibody of Asprosin (ASPROSIN), ELISA Kit (MBS167434) from Mybiosource (CA, USA). The specification does not disclose, and the art does not teach, the genus of a preparation as broadly encompassed in the claims.
The specification discloses a preparation that specifically binds asprosin with an antibody. However, the written description only reasonably conveys an antibody that specifically binds to the asprosin, and specifically, an antibody of Asprosin (ASPROSIN), ELISA Kit (MBS167434) from Mybiosource (CA, USA). A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number of preparations that encompass the genus of preparations nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus. “[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. Further, in view of Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) and the Office’s February 2018 memo clarifying written description guidance for claims drawn to antibodies, the 2008 Written Description Training Materials are outdated and should not be relied upon as reflecting the current state of law regarding 35 U.S.C. 112. Further, a “newly characterized antigen” test flouts basic legal principles of the written description requirement (Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017)). Adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that newly characterized antigen. Where an antibody binds to an antigen tells one nothing about the structure of any other antibody. Also, see the Board’s recent decision in Appeal 2017-010877 (claims to “A monoclonal antibody that binds a conformational epitope formed by amino acids 42-66 of SEQ ID NO:1”).
The functional requirements of the claimed antibodies is the sort of wish list of properties which fails to satisfy the written description requirement because “antibodies with those properties have not been adequately described.” Centocor, 636 F.3d at 1352.
The “claims merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad Pharmaceuticals, Inc. v. EliLilly and Co.,598 F.3d 1336, 1353 (Fed. Cir. 2010).
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure of an antibody that specifically binds to the asprosin, and specifically, an antibody of Asprosin (ASPROSIN), ELISA Kit (MBS167434) from Mybiosource (CA, USA), is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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 does not “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). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. 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. See Ariad, 94 USPQ2d at 1161; 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.”)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicant is 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642