Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-8, 14, 16, 18-19, 21-22, 25-26, and 33-34 are currently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8, 14, 16, 18, and 33, in the reply filed on Feb. 26, 2025 is acknowledged. Also, applicant’s election is acknowledged of the species comprising instant SEQ ID NO: 40. Claims 19, 21-22, and 25-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Claims 1-8, 14, 16, 18, and 33-34 have been considered on the merits.
Previous Rejections
Status of the rejections: the previous claim rejections pursuant to 112(b), 102 and double patenting are withdrawn in view of the claim amendments.
Claim Interpretation
In the claims, the term “equivalent” with regard to a polypeptide amino acid sequence or polypeptide is interpreted as encompassing sequences or polypeptides respectively having more than 60% sequence homology and/or exhibiting over 70% similar biological activity in vivo (see instant [0050], [0062], [0048]). Thus in claim 33, the “equivalent” of the isolated polypeptide of claim 1 potentially encompasses polypeptides with sequences having at least 61% sequence homology to any sequence having at least 90% sequence identity to one of SEQ ID NOs: 40-44, 47, 49-56, 58, and 59.
Claim Rejections - 35 USC § 112(a), Written Description (new)
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 33 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.
M.P.E.P. §2163 states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.”
In the instant case, claim 33 broadly comprises a genus of equivalents of isolated polypeptides comprising an amino acid sequence having at least 90% identity to any one of SEQ ID NOs: 40-44, 47, 49-56, 58 or 59. As noted above, the term “equivalent” with regard to an amino acid sequence structurally encompasses sequences having more than 60% sequence homology. Thus, for a 20-25 -residue polypeptide (SEQ ID NOs: 40-44, 47, and 49-54), 90% allows for 2 non-identical residues and at least 61% of that allows for a total of 9-10 non-identical residues. Thus for just this subset, claim 33 encompasses over 5 x 1011 variants per twelve different SEQ ID NOs.
Instant SEQ ID NOs: 55, 56, 58, and 59 adds > 1 x 1026 more variants
With regard to SEQ ID NO: 55 or 56, claim 30 structurally encompasses equivalents that are 7-resiudes long with only 2 residues invariant, or over 3 million variants per SEQ ID NO.
With regard to SEQ ID NO: 58, claim 30 structurally encompasses equivalents that are 12-residues long with only 4 residues invariant, or over 2.5 x 1010 variants.
With regard to SEQ ID NO: 59, claim 30 structurally encompasses equivalents that are 25-resiudes long with only 5 residues invariant, or over 1 x 1026 variants.
The written description lacks a representative number of species for this broad genus of polypeptide sequence variants (over 1 x 1026). Instead, the instant specification merely describes SEQ ID NOs 40-44, 47, and 49-55 fully, as well as SEQ ID NOs: 56 and 58-59 partially with numerous wildcard positions. To meet the definition of an equivalent, each species must exhibit over 70% similar biological activity in vivo to at least one polypeptide having at least 90% identity to any one of SEQ ID NOs: 40-44, 47, 49-56, and 58-59. Although the application never describes any in vivo functional assay, the instant has adequately described a representative means to determining such functionality for any polypeptide using bleomycin-induced mouse lung fibrosis explant model. However this was only demonstrated with a single species, SEQ ID NO: 45 (FIG. 20). Thus, the description serves merely as an invitation to test over 1 x 1026 variants for a shared level of in vivo function in relation to a specifically disclosed species, some of which are disclosed with a majority of undefined residues.
The instant claims as a whole do not apprise one of ordinary skill in the art of its full scope of variants and, therefore, does not serve the notice function required by 35 U.S.C. 112 of providing clear notice as to what polypeptides are encompassed by the claims, e.g., which polypeptides would be infringing.
Claim Rejections - 35 USC § 112(b) (new)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 14, 16, 18, and 33-34 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.
In claims 1, 4-5, and 33, each recites the term “equivalent” of a polypeptide or amino acid sequence thereof which is described in the instant specification as encompassing sequences exhibiting over 70% similar biological activity in vivo to the reference polypeptide (see instant [0050], [0062], [0048]). A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)). Here, the determination of the scope of “equivalent” depends on an indefinite variable (e.g., an unrecited biological activity of a reference polypeptide), and thus claims 1, 4-5 and 33 are indefinite. Claims 6-8, 14, 16, and 18 are included in this rejection for being dependent on indefinite claim 1.
Claims 1-3 and 34 each recites amino acid sequences with some positions limited to hydrophobic amino acids, which is indefinite without a definition of the genus of hydrophobic amino acids. For example, hydrophobic amino acids may or may not include glycine, proline, tryptophan, alloleucine, desmosine, isodesmosine, methylisoleucine, methylvaline, norleucine, etc. Note, a patent claim should not unnecessarily incorporate information from the specification, i.e., <223> in a sequence listing denoting “any hydrophobic amino acid,” but instead should be self-contained to particularly point out and distinctly claim the invention with its own language. See MPEP § 2422(I). Claims 6-8, 14, 16, 18 and 33 are included in this rejection for being dependent on indefinite claim 1.
Claim Rejections - 35 USC § 102 (new)
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-8, 14, 16, 18, and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (US20160176936A1).
The claims are interpreted as provided in a previous section.
Regarding claims 1-3 and 34, Wu discloses an isolated polypeptide comprising or consisting of instant SEQ ID NO: 59 (SEQ ID NO: 10; claims 1-4), as shown below.
Query Match 100.0%; Length 25;
wherein * is hydrophobic
Qy 1 XXXXXR*A*XXA*XLAG*A*XXNXX 25
:::::||||::||:||||||::|::
Db 1 KKKKKRFAFKKAFKLAGFAFKKNKK 25
Regarding claims 6-7, Wu discloses wherein the polypeptide comprises only 25 amino acids or is no more than 35 amino acids (id.; claim 3).
Regarding claim 8, Laukkanen discloses the polypeptide comprises additional polypeptide sequences that confer stability, e.g., antibody fragment, Fv domain and surrounding conserved antibody structural sequences ([0088]).
Regarding claim 14, Wu discloses a host cell comprising one or more of these polypeptides ([0171]).
Regarding claim 16, Wu discloses a composition comprising a carrier and one or more of these polypeptides ([0206]).
Regarding claim 18, Wu discloses wherein the polypeptide is conjugated to a drug (targeting antibody or antibody conjugated to a drug) ([0088]; [0196]).
Regarding claim 33, Wu discloses a kit comprising the polypeptide and instructions (claim 32; [0015]).
Thus, Wu anticipates the claimed invention.
Double Patenting (new)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35 of U.S. Patent No. 10,314,889. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 35 is directed to an isolated polypeptide consisting of SEQ ID NO: 13, which is identical to instant SEQ ID NO: 45.
Instant claim 33 is interpreted as provided in a previous section. As instant SEQ ID NO: 45 has over 60% sequence homology with instant SEQ ID NOs: 42, 47, 49-56, 58, and 59 (as shown in one example below) or an equivalent having at least 90% sequence identity thereto, the patent SEQ ID NO: 13 is structurally encompassed by instant claim 33 and functionally has at least 71% activity to at least one species of the genus of sequences at least 90% identical to SEQ ID NOs: 42, 47, 49-56, 58, and 59 absent evidence to the contrary.
80.0% identity in 25 residues overlap; Score: 109.0; Gap frequency: 0.0%
SEQ ID NO 50 1 KKKKKRFSFAKSFKLSGFSFKKNKK
Seq13 1 KKKKKRFAFKKAFKLAGFAFKKNKK
******* * * *** ** ******
Presence of Patentable Subject Matter
It is noted that an isolated polypeptide comprising or consisting of any one of SEQ ID NOs: 40-44 and 47, or any amino acid sequence having at least 95% sequence identity thereto, constitutes patentable subject matter in view of the art of record.
Conclusion
No claim is allowed.
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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC J ROGERS whose telephone number is (571)272-8338. The examiner can normally be reached Monday - Friday 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore, can be reached on 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J ROGERS/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638