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 .
Note: 37CFR 1.121 (c)4(i) states:
No claim text shall be presented for any claim in the claim listing with the status of "canceled" or "not entered."
Please observe this in future claim listings.
Claims 151, 156, 169, and 170 been canceled. Claims 148-150, 155, 159, 164, 171, 172 and 174 have been amended. Claims 148-150, 152-155, 157-168 and 171-174 are pending and under consideration.
Claim 150 is objected to because of the following informalities: there is an extraneous “_” between “claim” and “148”.
Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 155 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 155 recites at least 90% identical to SEQ ID NO: 1-8 or SEQ ID NO: 10-13. Claim 148 requires that the GAG-binding peptide comprises an amino acid sequence at least 30% positively charged amino acids. It is noted that at least 90% identical includes SEQ ID NO: 4, 5, 11 and 12 which have only 27% positively charged amino acids as arginine and thus do not include the limitation of claim 148 requiring at least 30% positively charged amino acids. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 172 is 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 172 is vague and indefinite because its unclear if it requires, in part, a single factor that inhibits cellular proliferation, angiogenesis, inflammation and immunity, or if it requires, in part, a factor that inhibits cellular proliferation, a factor that inhibits angiogenesis, a factor that inhibits inflammation, or a factor that inhibits immunity.
Claim 172 is rejected for having an improper Markush group format which is “selected from the group consisting of A, B, C and D. In the instant case, the claim has “or” between “tyrosine kinase agonist”, and “tyrosine kinase inhibitor”, and between “tyrosine kinase inhibitor” and “a factor that inhibits…”.
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 148-150, 152-155, 157-168 and 171-174 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.
(A)Claims 148-150, 152-154, 157-168, 171- 174 are reliant on the identity of a genus of GAG-binding peptides wherein each peptide binds to chondroitin sulfate or heparan sulfate, and wherein the GAG-binding peptide comprises an amino acid sequence comprising at least 30% positively charged amino acids. This is a new matter rejection. Claim 148 and 171 have been amended to require that the GAG-binding peptides comprise an amino acid sequence of at least 30% positively charged amino acids. When given the broadest reasonable interpretation this includes at least 30% of the amino acids Arg, Lys and His. The specification has provided a written description of the GAG-binding peptides of SEQ ID NO:1-13 which represent 11-mer GAG-binding peptides having either 27% Arg or 36% Arg. This fails to provide support for the instant claims because the genus of peptide encompassed by claim 148 and 171 include peptide with at least 30% Arg, at least 30% Lys and/or at least 30% His.
(B)This is a written description rejection. Section 2163 of the M.P.E.P. states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). 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. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention.
In the instant case the requirement for a peptide having at least 30% positively charged amino acids fails to provide a correlation between relevant, identifying characteristics, providing for the functional characteristic of binding chondroitin sulfate and/or heparan sulfate and binding GAG in an alpha granule of a platelet. When given the broadest reasonable interpretation, the peptide can range in length and the positively charged amino acids can be located at any position in the peptide, such as contiguously at either terminus, or spread throughout the peptide sequence. There are no teachings in the specification correlating the configuration of the positively charged amino acids within the peptide and the resultant property of binding of the peptide to chondroitin sulfate and/or heparan sulfate and GAG in an alpha granule of a platelet. One of skill in the art would not be able to envisage a required GAG-binding peptide outside of the disclosed SEQ ID NO: 1-13.
Regarding the sufficient number of species that describe the claimed genus, the disclosure of SEQ ID NO: 1-13 fails to describe the claimed genus because the genus only requires the functional characteristic of binding chondroitin sulfate and/or heparan sulfate, and binding GAG in an alpha granule of a platelet. The structural characteristic of being a peptide of indeterminant length having at least 30% positively charged amino acids at any position is broad, encompassing any peptide with 30% positively charged amino acids. Therefore, the genus is highly variant, and the disclosure of SEQ ID NO:1-13 is not representative of the full scope of the genus.
Regarding claim 155, requiring, in part, that the GAG-binding peptide comprises an amino acid sequence that is at least 90% identical to one of SEQ ID NO:1-10, such as a 50-mer peptide comprising SEQ ID NO: 1-8 and 10-13, one of skill in the art confronted with a peptide of any length having the required sequence identity, but not one of the peptides consisting of SEQ ID NO:1-8 and 10-13, wherein the peptide had at least 30% positively charged amino acids, would not be able to determine if said peptide was part of the required genus in terms of the functional binding requirements.
One of skill in the art would reasonably conclude that applicant was not in possession of the genus of broadly claimed GAG binding peptides, or the genus of GAG-binding peptide variants of SEQ ID NO:1-13 at the time of filing.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 148-150, 152-155, 157-161, 163 and 163-164 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 13, 22, 25-28, 33, 34, 36 and 38-40 of copending Application No. 18/356,688 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over or anticipated by the claims of the ‘688 application.
Claims 1-7, 25, 38 and 39 of the ‘688 application anticipate instant claims 148-150, 157 and 163 to the extent that the GAG-binding peptide of ‘688 comprise SEQ ID NO:1-3, 6-10 and 13 which comprise 36% arginine. Claims 8 and 13 anticipate instant claims 154 and 155 to the extent that the ‘688 peptides are SEQ ID NO:1-3, 6-10 and 13 which comprise 36% arginine. Claims 26-28 and 33 anticipate instant claim 158. Claim 34 anticipates instant claim 159. Claim 36 anticipate instant claim 160. Claim 161 and 163 are rendered obvious by claim 40 of the ‘688 application because “1 to 1000 copies” is obvious over “at least one copy” as claimed in claim 161. Instant claim 164 is obvious over claim 40 in light of claim 34 which teaches the specific second agents.
Regarding instant claims 152 and 153, Section 804 IIb of the M.P.E.P. states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).
In the instant case the ‘688 specification defines the inventive GAG-binding peptides as:
remaining bound to a CS-containing column when exposed to about 1N NaCl; remains bound to a CS-containing column when exposed to about 2N NaCl and becoming unbound to a CS-containing column when exposed to about 3N NaCl (paragraph [0155]);
being unbound to an HS-containing column, a serglycin-containing column, perlecan-containing column, dermatan sulfate-containing column, keratan sulfate-containing column, and/or GPIIb/IIIa-containing column when exposed to NaCl of between about 0.001N and about 0.01N.; being unbound to an HS-containing column, a serglycin-containing column, perlecan-containing column, dermatan sulfate-containing column, keratan sulfate-containing column, and/or GPIIb/IIIa-containing column when exposed to NaCl of at least about 0.1N; being unbound to an HS-containing column, a serglycin-containing column, perlecan-containing column, dermatan sulfate-containing column, keratan sulfate-containing column, and/or GPIIb/IIIa-containing column when exposed to NaCl of at least about 1N (paragraph [0156]).
Thus, instant claims 152 and 153 are obvious over claims 13 and 22 of the ‘688 application
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 148-150, 152-155, 157-161, and 163-166 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8, 13, 22, 25-28, 33, 34, 36 and 38-40 of copending Application No. 18/356,688 in view of Chen et al (Advanced Healthcare Materials, 2018, article 1800424, 11 pages).
Regarding claims 165 and 166, Chen et al teach the administration of anti-PD-L1 antibodies conjugated to the surface of platelets, wherein the platelets were delivered to the tumor resection site.
Claim 34 of the ‘688 application teaches that the first agent and/or the second agent is, in part, an immune checkpoint inhibitor.
Thus, it would have been prima facie obvious to loa the composition of claim 34 as pertaining to the immune checkpoint inhibitor into the isolated platelet of claim 40 to make a pharmaceutical composition comprising the loaded platelet thus meets the limitation of instant claims 165 and 166, and further to administer the loaded platelets in the mouse model of Chen et al, thus fulfilling the limitations of claims 167 and 168
This is a provisional nonstatutory double patenting rejection.
All claims are rejected.
All other rejections and/or objections as set forth or maintained in the prior Office action are withdrawn.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643