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 1-9 have an effective filing date of 10MAY2022.
Status of Claims
Claims 1-9 are currently pending and presented for examination on the merits.
Claims 1 and 8-9 are amended.
Rejections Withdrawn
The rejection filed under 35 U.S.C. 112(a) for failing to satisfy the enablement provision is withdrawn in view of Applicant’s amendments to claims.
Rejections Maintained
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 1-4 and 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.
In the instant case, the claims are inclusive of a genus of GPR75 agonist. However, the written description in this case only sets forth CCL5 and 20-HETE. The specification does not disclose, and the art does not teach, the genus of GPR75 agonists as broadly encompassed in the claims.
The specification discloses the comparison of GPR75 agonist. However, the written description only reasonably conveys CCL5 and 20-HETE. 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 GPR75 agonist that encompass the genus of GPR75 agonist 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.
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 CCL5 and 20-HETE 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).
Applicant’s Arguments:
….. the instant case, the claims are inclusive of a genus of GPR75 agonist.
the instant case, the claims are inclusive of a genus of GPR75 agonist. However, the written description in this case only sets forth CCL5 and 20-HETE. The specification does not disclose, and the art does not teach, the genus of GPR75 agonists as broadly encompassed in the claims. In response, Applicant has amended the claims to specify that the GPR75 agonist binds directly to GPR75 and is administered in a dose is sufficient to stimulate the proliferation of islet B-cells within the subject. Accordingly, Applicant has limited the claims to a specific genus of GPR75 agonist, i.e., those that bind directly to the GPR75 receptor and stimulate the proliferation of islet B-cells.
Examiner’s Response:
Applicant states, “the GPR75 agonist binds directly to GPR75 and is administered in a dose is sufficient to stimulate the proliferation of islet B-cells within the subject”.
MPEP 2163 – II, 3a
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that inventor was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613 (quoting the Written Description Guidelines, 66 Fed. Reg. at 1106, n. 49, stating that "if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function".). "Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function." Id.
For some biomolecules, examples of identifying characteristics include a sequence, structure, binding affinity, binding specificity, molecular weight, and length. Although structural formulas provide a convenient method of demonstrating possession of specific molecules, other identifying characteristics or combinations of characteristics may demonstrate the requisite possession. As explained by the Federal Circuit, "(1) examples are not necessary to support the adequacy of a written description; (2) the written description standard may be met … even where actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure." Falkner v. Inglis, 448 F.3d 1357, 1366, 79 USPQ2d 1001, 1007 (Fed. Cir. 2006); see also Capon v. Eshhar, 418 F.3d at 1358, 76 USPQ2d at 1084 ("The Board erred in holding that the specifications do not meet the written description requirement because they do not reiterate the structure or formula or chemical name for the nucleotide sequences of the claimed chimeric genes" where the genes were novel combinations of known DNA segments.). However, the claimed invention itself must be adequately described in the written disclosure and/or the drawings. For example, disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)("knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies"); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties).
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described.").
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (The novel chemokine receptor, G-protein-coupled receptor 75, is expressed by islets and is coupled to stimulation of insulin secretion and improved glucose homeostasis, Diabetologia (2013) 56:2467–2476), and further in view of Liu et al (2012) (The CaMK4/CREB/IRS-2 Cascade Stimulates Proliferation and Inhibits Apoptosis of b-Cells, PLOS ONE, Vol. 7, Iss. 9, 2012).
In regards to claims 1 and 8-9, Liu et al teaches chemokine (C-C motif) ligand 5 (CCL5) is an agonist for G-protein-coupled receptor 75 (GPR75) [Abstract]. Liu et al further teaches CCL5 stimulates insulin release [Left column, 2nd Paragraph, pg. 2475]. Liu et al further teaches exogenous CCL5 increases beta cell intracellular [Ca2+] via GPR75 and stimulates insulin secretion in vitro and in vivo; also improves glucose tolerance in vivo [Right column, 1st Paragraph, pg. 2475].
Liu et al does not specifically teach a GPR75 agonist activating the proliferation of islet β-cells. However, this deficiency is made up in the teachings of Liu et al (2012).
Liu et al (2012) teaches methods of stimulating β-cell proliferation [Abstract]. Liu et al (2012) further teaches CaMK4 stimulates β-cell proliferation [Right column, 3rd paragraph, pg. 2]. Liu et al (2012) further teaches that β-cells CaMK4 is activated by elevated glucose levels and increase in intracellular Ca2+ [Right column, 2nd paragraph, pg. 1].
One of ordinary skill, before the effective filing date, would have been motivated to use Liu’s method of improving glucose tolerance comprising exogenous administration of CCL5 an agonist for GPR75 and mobilizes the internalization of Ca2+, with Liu’s (2012) method of activating β-cell proliferation by increasing intracellular Ca2+ via to activate CaMK4. It would have been prima facie obvious to use the methods of Liu and Liu (2012) for a method of activating the proliferation of islet β-cells within a subject for treating diabetes comprising administering a GPR75 agonist, because Liu teaches CCL5, an GPR75 agonist, stimulates insulin secretion, improves glucose tolerance, and increases intracellular Ca2+, and Liu (2012) teaches than increases to intracellular Ca2+ activates CaMK4 stimulating β-cell proliferation.
In regards to claim 2, Liu et al teaches CCL5 is present in islets from individual with type I diabetes [Left column, 1st Paragraph, pg. 2468]. Liu et al further teaches exogenous CCL5 increases beta cell intracellular [Ca2+] via GPR75 and stimulates insulin secretion in vitro and in vivo; also improves glucose tolerance in vivo [Right column, 1st Paragraph, pg. 2475].
In regards to claim 3, Liu et al further teaches agents that stimulate insulin secretion in vivo can reduce hyperglycemia by promoting glucose uptake and storage [Left column, 3rd Paragraph, pg. 2475]. Liu et al further teaches CCL5 improved glucose tolerance and increased insulin secretion [Left column, 3rd Paragraph, pg. 2475].
In regards to claim 5, Liu et al teaches the GPR75 agonist is recombinant CCL5 [Right column, 3rd Paragraph, pg. 2469].
In regards to claim 7, Liu et al further teaches the administration of DPP4 inhibitor to treat diabetes [Left column, 3rd Paragraph, pg. 2475].
Applicant’s Arguments:
First, it is noteworthy that the claims have been amended to recite a method of activating the proliferation of islet β -cells within a subject for treatment of diabetes in a subject in need thereof
Second, a review of Liu finds that the reference fails to disclose, or even suggest, that GPR75 agonists possess the ability to stimulate the proliferation of islet B-cells.
Examiner’s Response:
Liu et al and Liu et al (2012) are discussed above.
Liu et al teaches chemokine (C-C motif) ligand 5 (CCL5) is an agonist for G-protein-coupled receptor 75 (GPR75) [Abstract]. Liu et al further teaches exogenous CCL5 increases beta cell intracellular [Ca2+] via GPR75 and stimulates insulin secretion in vitro and in vivo; also improves glucose tolerance in vivo [Right column, 1st Paragraph, pg. 2475].
Liu et al (2012) teaches methods of stimulating β-cell proliferation [Abstract]. Liu et al (2012) further teaches CaMK4 stimulates β-cell proliferation [Right column, 3rd paragraph, pg. 2]. Liu et al (2012) further teaches that β-cells CaMK4 is activated by elevated glucose levels and increase in intracellular Ca2+ [Right column, 2nd paragraph, pg. 1].
One of ordinary of ordinary skill in the art, before the effective filing date, would have been motivated to use Liu’s method of improving glucose tolerance comprising exogenous administration of CCL5 an agonist for GPR75 and mobilizes the internalization of Ca2+, with Liu’s (2012) method of activating β-cell proliferation by increasing intracellular Ca2+ via to activate CaMK4. It would have been prima facie obvious to use the methods of Liu and Liu (2012) for a method of activating the proliferation of islet β-cells within a subject for treating diabetes comprising administering a GPR75 agonist, because Liu teaches CCL5, an GPR75 agonist, stimulates insulin secretion, improves glucose tolerance, and increases intracellular Ca2+, and Liu (2012) teaches than increases to intracellular Ca2+ activates CaMK4 stimulating β-cell proliferation.
Furthermore given that the claimed invention and that of the prior art include the same method steps, both methods would be expected to have the same functional characteristics, such as stimulating the proliferation of islet β-cells in a subject.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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