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 .
Claims 1-10, 13, 15, 16, 18, 21, and 22 are pending and currently under consideration.
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 2-6, 7-10, 13, 15, and 22 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.
Claim 2 is rejected because claim 2 recites “The method of claim 1,…said R-spondin….” Claim 1 recites multiple R-spondins. There is insufficient antecedent basis for “said R-spondin” the claims.
Claims 3-6 are rejected because claim 3 recites “The method of claim 1, wherein said inhibitor…said R-spondin….” Claim 1 recites multiple possible inhibitors and multiple R-spondins. There is insufficient antecedent basis for “said inhibitor” and “said R-spondin” the claims.
Claims 3-6 are rejected because claims 3 and 6 recite instances of “preferably” followed by possible limitations. It is unclear how, or if, the limitations following “preferably” limit the claims.
Claim 6 recites “…wherein said immunoglobulin or subdomain thereof specifically binds to the extracellular domain of a BMP receptor specifically….” There is insufficient antecedent basis for “said immunoglobulin or subdomain thereof specifically binds to the extracellular domain of a BMP receptor” in the claim.
Claims 7-8 are rejected because claims 7 and 8 recite instances of “preferably” followed by possible limitations. It is unclear how, or if, the limitations following “preferably” limit the claims.
Claims 9, 10, and 22 are rejected because claim 9 recites “preferably” followed by a possible limitation. It is unclear how, or if, the limitation following “preferably” limit the claims.
Claims 9, 10, and 22 are rejected because claim 9 recites “…based on the result of step (c)…”. There is insufficient antecedent basis for “the result of step (c)” in the claims.
Claim 13 is rejected for reciting instances of “preferably” followed by possible limitations. It is unclear how, or if, the limitations following “preferably” limit the claim.
Claim 15 is rejected for reciting “The method of claim 1, wherein said R-spondin….” Claim 1 recites multiple R-spondins. There is insufficient antecedent basis for “said R-spondin” the claim.
Claim 22 is rejected for reciting “The method of claim 9, wherein said R-spondin….” Claim 9 recites multiple R-spondins. There is insufficient antecedent basis for “said R-spondin” the claim.
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.
Claims 2-6 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. In the instant case, the claims are inclusive of: (i) a genus of immunoglobulins and fragments thereof that specifically bind R-spondin 2 and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, (ii) a genus of immunoglobulins and fragments thereof that specifically bind R-spondin 3 and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, (iii) a genus of immunoglobulins and fragments thereof that specifically bind a BMP receptor and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, (iv) a genus of immunoglobulins and fragments thereof that specifically bind the TSP1 domain of R-spondin 2 and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition; (v) a genus of immunoglobulins and fragments thereof that specifically bind the FU1 domain of R-spondin 2 and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, (vi) a genus of immunoglobulins and fragments thereof that specifically bind the TSP1 domain and FU1 domain of R-spondin 2 and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, (vii) a genus of immunoglobulins and fragments thereof that specifically bind the TSP1 domain of R-spondin 3 and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition; (viii) a genus of immunoglobulins and fragments thereof that specifically bind the FU1 domain of R-spondin 3 and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, (ix) a genus of immunoglobulins and fragments thereof that specifically bind the TSP1 domain and FU1 domain of R-spondin 3 and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, (x) a genus of immunoglobulins and fragments thereof that specifically bind the extracellular domain of BMP receptor 1A and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, (xi) a genus of immunoglobulins and fragments thereof that specifically bind the activin domain of a BMP receptor and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, (xii) a genus of immunoglobulins and fragments thereof that specifically bind an epitope comprised in a peptide corresponding to amino acids 1 to 152 of a human BMP receptor 1A and inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, and (xiii) a genus of immunoglobulins and fragments thereof, domain of R-spondin, domain of BMP receptor, peptide aptamer, polynucleotide aptamer, anticalin, or Designed Ankyrin Repeat Protein that that inhibit R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition. The specification does not disclose, and the art does not teach, the genera as broadly encompassed in the claims.
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).
In regards to claims to a product defined by function, without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 at1568 USPQ2d at 1406 (“definition by function…does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genera. That is, the specification provides neither a representative number of immunoglobulins or fragments thereof that encompass the genera nor does it provide a description of structural features that are common to the genera so that one of skill in the art can ‘visualize or recognize’ the members of the genera. “[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 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 genera, and because the genera are highly variant, the disclosure of is insufficient to describe the genera. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genera 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 genera, the skilled artisan cannot envision the detailed chemical structure of the encompassed genera, 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).
Claim Rejections - 35 USC § 112
Claims 1-8, 15, 16, and 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” leukemia in a subject comprising administering an inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, does not reasonably provide enablement for “preventing” leukemia in a subject comprising administering an inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986). They include 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.
The instant claims are drawn to treating and/or preventing leukemia in a subject comprising administering an inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition. This includes prophylactic methods of preventing a healthy subject from developing leukemia by administering an inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The specification prophetically discloses methods of preventing leukemia by administering an inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition. However, the specification does not demonstrate preventing leukemia by administering an inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition. Further, the specification does not disclose any inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition that prevents leukemia.
Reasonable guidance with respect to preventing any cancer (not just leukemia) relies on quantitative analysis from defined populations which have been successfully pre-screened and are predisposed to particular types of cancer. This type of data might be derived from widespread genetic analysis, cancer clusters, or family histories. The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of clinical cancer and link those results with subsequent histological confirmation of the presence or absence of disease. This irrefutable link between antecedent drug and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent.
One cannot extrapolate the teachings of the specification to the scope of the claims because the claims are broadly drawn to methods of treating and/or preventing leukemia by administering an inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition, and Applicant has not enabled methods of preventing leukemia by administering an inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition because it has not been shown that administering an inhibitor of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition prevents leukemia. Further, undue experimentation would be required to determine which (if any) inhibitors of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition prevent leukemia in order to perform the method as claimed.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as claimed.
Claim Rejections - 35 USC § 112
Claims 9, 10, and 22 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 undue experimentation is required, are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 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 include, but are not limited to: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See also Ex parte Forman, 230 USPQ 546 (BPAI 1986).
The claims are broadly drawn to identifying a subject benefiting from treatment with an inhibitor of R-spondin 2 and/or R-spondin 3 medicated BMP inhibition based, in just any way, on a comparison of amounts of BMP receptor, pSMAD1, ID1, CD14, and/or CD11B in leukemia cells from the subject contacted with an inhibitor of R-spondin 3 and/or R-spondin 2 to a reference. This includes highly-unpredictable contradictory methods wherein, for example, elevated levels of ID1 and decreased levels of ID1 are equally indicative of a subject benefiting from a recited treatment.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The specification prophetically discloses methods of identifying a subject benefiting from treatment with an inhibitor of R-spondin 2 and/or R-spondin 3 medicated BMP inhibition based on a comparison of amounts of BMP receptor, pSMAD1, ID1, CD14, and/or CD11B in leukemia cells from the subject contacted with an inhibitor of R-spondin 3 and/or R-spondin 2 to a reference.
Further, undue experimentation would be required to determine which results of a comparison of amounts of recited markers (BMP receptor, pSMAD1, ID1, CD14, and/or CD11B) in leukemia cells from the subject contacted with an inhibitor of R-spondin 3 and/or R-spondin 2 to a reference are, or are not, indicative of a subject benefiting from treatment with an inhibitor of R-spondin 2 and/or R-spondin 3 medicated BMP inhibition in order to perform the method as claimed.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as claimed.
Claim Rejections - 35 USC § 112
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not reasonably provide enablement for identifying a compound for treating and/or “preventing” leukemia based, in just any way, on an amount of BMP receptor, SMAD1, ID1, CD14, CD11B, R-spondin 2, and/or R-spondin 3 in leukemia cells contacted with the compound. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with the claim.
Factors to be considered in determining whether undue experimentation is required are summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986). They include 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.
The instant claims are drawn to identifying a compound for treating and/or preventing leukemia based, in just any way, on an amount of BMP receptor, SMAD1, ID1, CD14, CD11B, R-spondin 2, and/or R-spondin 3 in leukemia cells contacted with the compound. This includes contradictory methods wherein just any amount (including a decreased amount and an increased amount) of BMP receptor, SMAD1, ID1, CD14, CD11B, R-spondin 2, and/or R-spondin 3 in leukemia cells contacted with a compound identifies the compound as a compound that prevents leukemia in healthy patients.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The specification does not demonstrate, and the art does not teach, just any amount (including a decreased amount and an increased amount) of BMP receptor, SMAD1, ID1, CD14, CD11B, R-spondin 2, and/or R-spondin 3 in leukemia cells contacted with a compound identifies the compound as a compound that both treats leukemia and prevents leukemia in healthy patients.
One cannot extrapolate the teachings of the specification to the scope of the claims because the claims are broadly drawn to identifying a compound for treating and/or preventing leukemia based on an amount of BMP receptor, SMAD1, ID1, CD14, CD11B, R-spondin 2, and/or R-spondin 3 in leukemia cells contacted with the compound, and Applicant has not enabled said method because it has not been shown that just any amount (including a decreased amount and an increased amount) of BMP receptor, SMAD1, ID1, CD14, CD11B, R-spondin 2, and/or R-spondin 3 in leukemia cells contacted with a compound identifies the compound as a compound that treats leukemia and prevents leukemia in healthy patients.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as claimed.
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.
Claim(s) 1, 7, 8, 15, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meng-er et al (Blood, 1988, 72(2): 567-572).
Meng-er et al teaches a method of treating leukemia comprising administering all-trans retinoic acid to subjects with leukemia (Abstract, in particular). Said subjects are equivalent to those identified as benefiting from treatment with all-trans-retinoic acid. Meng-er et al teaches said method further comprising administering to the subject the antiproliferative agent ara-c (left column on page 569, in particular).
Claim Rejections - 35 USC § 102
Claim(s) 1-7, 16, 18, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gurney et al (US 9,598,497 B2; 3/21/17).
Gurney et al teaches a method of treating cancer in subjects comprising administering antibodies (same as “immunoglobulin”) (including an antibody comprising SEQ ID NOs:78-80, 81, 84, and 14) that specifically binds R-spondin 3 to the subjects (claims 1-2, in particular). Gurney et al further teaches said method wherein the cancer is leukemia (line 60 of column 19, in particular). Gurney et al further teaches said method wherein a chemotherapeutic, such as the antiproliferative agent irinotecan, is administered to the subjects (claim 13, in particular). Gurney et al further teaches said method wherein the subjects have elevated expression of R-spondin 3 (claim 20, in particular). Such subjects are equivalent to subjects identified as benefiting from treatment with an R-spondin 3 inhibitor. Gurney et al further teaches said method wherein the antibodies are combined preparations comprising the antibody conjugated to a chemotherapeutic, such as the antiproliferative agent methotrexate (lines 16-19 of column 68, in particular).
Gurney et al does not specifically point-out that the antibodies of Gurney et al that bind R-spondin 3 are inhibitors of R-spondin 2 and/or R-spondin 3 mediated BMP receptor inhibition or that the antibodies bind TSP1 and/or FU1 domains of R-spondin 3; however, the method of Gurney et al appears to be the same as that claimed because both the instant claims and the method of Gurney et al are directed to treating cancers by administering antibodies that specifically bind R-spondin 3. The claimed method appears to be the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the method of the prior art does not possess the same material, structural and steps-like characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed method is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Claim Rejections - 35 USC § 102
Claim(s) 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toofan et al (Cell Death and Disease, 2018, 9(927): 1-19).
Toofan et al teaches expression of inhibitor of differentiation/binding (ID) family of early response genes, which includes ID1, is necessary for re-entry of quiescent cells into the cell cycle and G1-S progression (right column on page 3, in particular). Toofan et al further teaches a method comprising contacting leukemia cells with compounds suspected to be compounds for treating leukemia, determining the amount of ID1 in said leukemia cells, and identifying compounds for treating leukemia as compounds that inhibit amounts of ID1 (Figure 2 and Figure 3B, in particular).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E AEDER whose telephone number is (571)272-8787. The examiner can normally be reached M-F 9am-6pm ET.
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, Samira Jean-Louis can be reached at (571)270-3503. 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.
/SEAN E AEDER/Primary Examiner, Art Unit 1642