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 .
Applicant’s election without traverse of group I, SEQ ID NOs: 1, 2, and 157, and stroke in the reply filed on 9/11/25 is acknowledged.
Claims 36, 43, and 46 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/11/25.
Drawings
The drawings filed on 3/29/24 are objected to because they are not fully legible. There are numbers in the structures of Figures 1 that are small and fuzzy. The graphs in Figures 4-6, 10 are illegible. Correction is required.
Improper Markush Rejection
Claims 27 and 30 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The claims are directed to a large multitude of sequences that have no common searchable core and activity. The sequences do not share the same common activity.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. 134 and 37 CFR 41.31(a)(1).
When the Markush grouping is for alternatives of chemical compounds, they shall be regarded as being of a similar nature where the following criteria are fulfilled:
(A) All alternatives have a common property or activity; and
(B) (1) A common structure is present, i.e., a significant structural element is shared by all of the alternatives; or
(B) (2) In cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.
In paragraph (B)(1), above, the words “significant structural element is shared by all of the alternatives” refer to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity. The structural element may be a single component or a combination of individual components linked together.
In paragraph (B)(2), above, the words “recognized class of chemical compounds” mean that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
In order for the members of the Markush group to belong to “recognized class of chemical compounds” there must be an expectation that the members of the class will behave in the same way in the context of the claimed invention. In other words, each member of the class could be substituted one for the other with the expectation that the same intended result would be achieved. In the instant case, activity of any specific nucleic acid molecule is dependent upon the specific sequence of nucleotides. There is no expectation that any one of the nucleotide sequences as claimed can be substituted for any of the other with a completely different sequence with the expectation of the same activity. Each of the “VWF-targeting agent” sequences and each of the antidote sequences have a different sequence and activity.
As set forth in MPEP2117, “Note that where a Markush group includes only materials from a recognized scientific class of equivalent materials or from an art-recognized class, "the mere existence of such a group in an application tend[s] to prove the equivalence of its members and when one of them [is] anticipated the group [is] therefore rendered unpatentable, in the absence of some convincing evidence of some degree of non-equivalency of one or more of the remaining members." In re Ruff, 256 F.2d 590, 598-99, 118 USPQ 340, 348 (CCPA 1958)("[A]ctual equivalence is not enough to justify refusal of a patent on one member of a group when another member is in the prior art. The equivalence must be disclosed in the prior art or be obvious within the terms of Section 103." Id. at 599, 118 USPQ at 348).”
In the instant case, art against any one aptamer or VFW-targeting agent or antidote would not be evidence against any of the remaining members that have completely different sequences and do not have identical activity.
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 25-30, 33-35, 37-42, 44, and 45 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.
The claims are directed to a method of treating a blood clot in a subject comprising administering any “VWF-targeting agent”, which is a genus of agents that have not been adequately described in the specification.
The specification discloses: As used herein, a "VWF-targeting agent" is any agent capable of partially or fully blocking, inhibiting, or neutralizing one or more of the biological activities of a von Willebrand Factor (VWF) protein including, without limitation, a polypeptide, a polynucleotide, or a small molecule.
In some embodiments, a VWF-targeting agent may include an agent capable of binding to the Al domain of a VWF protein and blocking the VWF protein's binding with a gplb alpha protein. A VWF targeting agent may function in a direct or indirect manner. For example, the VWF-targeting agent may directly bind to a VWF protein, thus partially or fully blocking, inhibiting or neutralizing one or more biological activities of the VWF protein, in vitro or in vivo. The VWF- targeting agent may also function indirectly by (1) interacting with (e.g., activating, inducing, blocking or inhibiting) another molecule that can bind to VWF or (2) modulating or affecting the expression (i.e., transcription or translation) of a VWF protein in a cell.
Therefore, the specification acknowledges that the term “VWF-targeting agent” encompasses agents that do not have any specific structural relationship with any specific VWF sequence, but rather encompass agents that can act in any indirect manner and have the secondary effect of targeting VWF. The specification does not adequately describe the structure required for the function.
The specification discloses aptamers that are specific for a specific VWF sequence, which is a species that is not representative of the entire claimed genus. Without further knowledge of the structure required for the function, one would not be able to readily envision which agents meet the instant limitation of being VWF-targeting.
Even with regards to aptamers, as recited in instant claim 26, the aptamer is not required to have any specific structural relationship with any specific VWF sequence, but rather can be targeted to any possible target that has the secondary effect of VWF-targeting, which is a genus that has not been adequately described in the specification.
With regards to claims 27 and 35, the specification does not adequately describe the genus of polynucleotides of any length that comprise at least 70% sequence identity to SEQ ID NO: 1 or at least 70% sequence identity to SEQ ID NO: 2 that have the required function.
Instant claim 29 recites the administration of an antidote. However, the specification does not adequately describe the structure for a compound to be an antidote that would have the recited function of neutralization of the aptamer or targeting agent.
The specification discloses specific sequences that function as VWF-aptamer neutralizing agents, which is not representative of the entire claimed genus of any possible antidote that would function as claimed, which includes antidotes that neutralize an unknown genus of targets that have the secondary effect of targeting VWF.
Instant claim 30 requires for the antidote to comprise a polynucleotide that comprises at least 70% identity to instant SEQ ID NO: 157, which is a 16-mer.
In absence of a length limitation for the polynucleotide, the open language of the claims encompass sequences of any length (i.e. thousands of nucleotides) that comprises a sequence that has at least 70% identity to the 16-mer.
The specification discloses a single species within the instant genus, wherein the species consists of instant SEQ ID NO: 157. The single species is not representative of the entire claimed genus.
Additionally, even with regards to sequences that are identical in length to the instantly recited sequences, the specification does not adequately describe sequences that are as little as 70% identical to each that necessarily function as required. The species of the specification are not representative of the entire claimed genus.
For example, Kandimalla et al. (Nucleic Acids Research, 1995, 23, 17, 3578-3584) teach that an antisense oligomer has a minimum length that can hybridize to the target of 11-14 bases and increasing the length may decrease the specificity (page 3578). Kandimalla et al. teach that a short oligomer (9-mer) with one or two mismatches does not bind to the intended site (abstract) whereas 21-mers could tolerate up to two mismatches (page 3580). Kandimalla et al. is evidence that the instant claim breadth would not function specifically.
Claim 45 requires for the aptamer to further comprise a stability agent. The specification does not adequately describe the structure required for an agent to be a “stability agent” and does not adequately describe the structure required between the aptamer and the stability agent for the aptamer to “comprise” the agent.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species for agents within the instant enormous genus that function as claimed. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
Claims 25-30, 33-35, 37-42, 44, and 45 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 a method of platelet inhibition via delivery of 9.14T79vrt7 (specific aptamer targeting VWF) and a method of neutralizing the aptamer via delivery of VWF9.14T79-A02 or A055, specific antidote to 9.14T79vrt7), does not reasonably provide enablement for a method for treating a blood clot via delivery of any VWF-targeting agent or any agent comprising a polynucleotide having at least 70% identity to instant SEQ ID NO: 1 and a polynucleotide having at least 70% identity to instant SEQ ID NO:2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in a determination of lack of enablement include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The instant invention is drawn to a method for treating a blood clot comprising administering any therapeutically effective amount of any VWF-targeting agent.
The specification demonstrates delivery of a specific VWF aptamer (9.14T79vrt7) with resultant dose-dependent platelet inhibition of canine whole blood (page 51). However, this is not enabling for broad systemic delivery of any possible VWF-targeting agent, which encompasses agents that act on other targets and have the secondary effect of VWF-targeting, and the predictable outcome of the treatment of any blood clot in any location of the body in vivo.
Additionally, the specification does not draw an adequate nexus between broad systemic delivery of any agent comprising a polynucleotide having as little as 70% identity to instant SEQ ID NO: 1 and a polynucleotide having as little as 70% identity to instant SEQ ID NO:2 and the predictable outcome of treating any possible blood clot.
The specification does not demonstrate that platelet inhibition in vitro would necessarily result in the predictable treatment of any blood clot. The specification does not demonstrate that platelet inhibition would necessarily treat an any pre-existing blood clot. The blood clot is not required to be located in an artery or any specific location.
There is no guidance in the specification as filed that teaches how to deliver any VWF-targeting agent, which encompasses agents with varying structures and act via various mechanisms, and result in predictable treatment of any blood clot at any location in the body.
For example, Collet et al. (Circulation Research, Volume 90, Issue 4, 8 March 2002; Pages 428-434) teaches that some clots are platelet-rich or platelet-poor, as well as comprise platelet-rich and platelet-poor areas, wherein there are differences in lysis between the areas (pages 431 and 432). Collet et al. is evidence that not all blood clots will respond identically to the same agent.
The scope of the claims in view of the specification as filed together do not reconcile the unpredictability in the art to enable one of skill in the art to make and/or use the claimed invention, namely a broad method of treating any blood clot encompassing in vivo effects.
MPEP 2164.01
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
Also, MPEP 2164.01(a)
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Given the teachings of the specification as discussed above, one skilled in the art could not predict a priori whether introduction of any VWF-targeting agent in vivo by the broadly disclosed methodologies of the instantly claimed invention, would result in successful treatment of any blood clot. To practice the claimed invention, one of skill in the art would have to de novo determine; the stability of the agent molecule in vivo, delivery of the agent to the whole organism, specificity to the target tissue in vivo, dosage and toxicity in vivo, and entry of the molecule into the cell in vivo and the effective action therein. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation (see MPEP 2164.01(a)).
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 25, 26, 28, 33, 34, 40-42, and 45 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gilbert et al. (WO 2008/150495 A2).
Gilbert et al. teaches VWF aptamers and teaches that the aptamers are used in methods to prevent vWF-meditated platelet aggregation and eliminate blood clots. Gilbert et al. teaches that the aptamers are used in a method of treating human patients with acute coronary syndrome (Example 4) (instant claims 25 and 26).
Gilbert et al. teach that the aptamer formulations provided herein are administered to subjects, particularly, human subjects, in an amount effective to inhibit, reduce, block or otherwise modulate vWF- mediated platelet aggregation (instant claims 33 and 34).
Gilbert et al. teaches that the aptamers are used to treat stroke ()(instant claim 28).
Gilbert et al. teach that the aptamer can be RNA or DNA (instant claim 41). Gilbert et al. teach a 39-mer aptamer on page 8 (instant claim 40).
Gilbert et al. teaches that intravenous formulations may comprise any amount of pharmaceutically acceptable solvent. Various embodiments of the formulations may, optionally, include one or more of the following: buffer, pH adjuster, tonicity agent, cosolvent or pharmaceutically acceptable carrier, Alternatively, intravenous formulations may comprise any amount of pharmaceutically acceptable solvent. Various embodiments of the formulations may, optionally, include one or more of the following: buffer, pH adjuster, tonicity agent, cosolvent or pharmaceutically acceptable carrier. (instant claim 45).
Gilbert et al. teach incorporation of 2’-O-methyl and phosphorothioate modifications, as well as conjugation to PEG, which meets the instant limitation of a stability agent (instant claim 45).
Therefore, the claims are anticipated by Gilbert et al.
Claim Rejections - 35 USC § 103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 29, 37-39, and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert et al. (WO 2008/150495 A2), in view of Oney et al. (Oligonucleotides, 17, 2007, 265-274), and Rusconi (AU 2012244176 B8).
Gilbert et al. teaches VWF aptamers and teaches that the aptamers are used in methods to prevent vWF-meditated platelet aggregation and eliminate blood clots. Gilbert et al. teaches that the aptamers are used in a method of treating human patients with acute coronary syndrome (Example 4) (instant claims 25 and 26).
Gilbert et al. teach that the aptamer formulations provided herein are administered to subjects, particularly, human subjects, in an amount effective to inhibit, reduce, block or otherwise modulate vWF- mediated platelet aggregation (instant claims 33 and 34).
Gilbert et al. teaches that the aptamers are used to treat stroke ()(instant claim 28).
Gilbert et al. teach that the aptamer can be RNA or DNA (instant claim 41). Gilbert et al. teach a 39-mer aptamer on page 8 (instant claim 40).
Gilbert et al. teaches that intravenous formulations may comprise any amount of pharmaceutically acceptable solvent. Various embodiments of the formulations may, optionally, include one or more of the following: buffer, pH adjuster, tonicity agent, cosolvent or pharmaceutically acceptable carrier, Alternatively, intravenous formulations may comprise any amount of pharmaceutically acceptable solvent. Various embodiments of the formulations may, optionally, include one or more of the following: buffer, pH adjuster, tonicity agent, cosolvent or pharmaceutically acceptable carrier. (instant claim 45).
Gilbert et al. teach incorporation of 2’-O-methyl and phosphorothioate modifications, as well as conjugation to PEG, which meets the instant limitation of a stability agent (instant claim 45).
Gilbert et al. does not teach incorporation of an antidote to neutralize the aptamer.
However, it would have been obvious to incorporate an antidote to neutralize the aptamer because Oney et al. teach that an RNA aptamer (instant claim 41) targeting von Willebrand factor (VWF) can potently inhibit VWF-mediated platelet adhesion and aggregation and that a rationally designed antidote molecule can reverse the effects of the aptamer molecule, restoring platelet function quickly and effectively over a clinically relevant period (abstract) (instant claim 29). Therefore, there would have been a reasonable expectation of success that incorporation of the antidote of Oney et al. would result in restoration of platelet function.
Gilbert et al. does not teach that the KD of the aptamer is less than 100 nM for the human VWF protein. However, it would have been obvious for the an antidote to neutralize the aptamer because Oney et al. teach VWF aptamers that inhibited clot formation wherein the Kd of the VWF aptamers R9.3 and R9.14 were 1.2 and 12 nM, respectively (Table 1) (instant claim 37).
Gilbert et al. does not teach that the aptamer comprises a 5’ or 3’ linker. It would have been obvious to incorporate a 5’ or 3’ linker because Rusconi teaches the incorporation of 2’-dexy, 2’-O-methyl, and 5’ linkers. One would have had a reasonable expectation of success to incorporate a 5’ linker to attach PEG into the aptamer of Gilbert et al. with reasonable expectation of successful delivery (instant claim 44).
Gilbert et al. does not teach incorporation of a tail sequence. However, it would have been obvious to incorporate a tail sequence into the aptamer of Gilbert et al. because Rusconi teaches the benefits thereof. Rusconi teaches aptamers and antidotes thereof to reverse the effects of the aptamer. Rusconi teaches incorporation of a single stranded tail at the end of the aptamer (Example 4, page 73). Rusconi teaches that incorporation of the single-stranded tail added to the end of the aptamer promotes association of an antidote oligonucleotide with the aptamer. Rusconi teaches incorporation of a 3 nucleotide 2’-O-methyl modified RNA tail. The tail sequence was designed to reduce secondary structures within the complementary antidote oligonucleotide. Rusconi teaches that the addition of the tail increased the efficiency of reversal by an antidote oligonucleotide (pages 73-74) (instant claim 38). It would have been obvious for the sequence to be UUU or TTT because these sequences would meet the criteria of to reduce secondary structures within the complementary antidote oligonucleotide as taught by Rusconi.
Double Patenting
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.
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Claims 25-30, 33, 34, 37-42, 44, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,965,160 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US ‘160 B2 are directed to a method for preventing blood clot formation comprising delivering an aptamer comprising SEQ ID NO: 3 (claim 9), which is a species of the instant claim 27 (instant claims 25-27 and 36) and is a RNA sequence (instant claim 41); wherein the subject suffers from the same conditions as recited in instant claim 28 (claim 10); and delivery of an antidote comprising SEQ ID NO: 157 (claims 1-3 and 20) (instant claims 29 and 30); wherein the subject is mammal, more specifically human (claims 6, 7, 11, 12, 17, and 18) (instant claims 33 and 34). The specification of US ‘160 B2 further defines the structural characteristics of the recited aptamer including the KD of the aptamer for the human VWF protein being less than 100 nanomolar (instant claim 37), the presence of the terminal tail consisting of 2-12 nucleotides (instant claim 38), wherein the tail consists of (U/T) (U/T) (U/T) (U/T) (U/T) (instant claim 39), and the aptamer being no more than 39 nucleotides in length (instant claim 40), each being limitations of the previously patented aptamer that could have been recited in the patented claims. The claims are obvious variations of each other.
Claims 25-30, 33-35, 37-42, 44, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,889,816 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US ‘816 B2 are directed to a method for preventing blood clot formation comprising delivering an aptamer comprising SEQ ID NOs: 1 and 2 (claims 1 and 16, which is a species of the instant claim 27 (instant claims 25-27, and 35) and is a RNA sequence (instant claim 41); wherein the subject suffers from the same conditions as recited in instant claim 28 (claim 17); incorporation of a stability agent (claim 11) (instant claim 45); the instantly recited chemical modifications (claim 8)(instant claim 42); and delivery of an antidote (claim 18), wherein the specification discloses that the antidote comprises SEQ ID NO: 157 (claims 1-3 and 20) (instant claims 29 and 30); wherein the subject is mammal (claim 19) (instant claims 33 and 34). US ‘816 B2 recites that the KD of the aptamer for the human VWF protein being less than 100 nanomolar (claim 4)(instant claim 37), the presence of the terminal tail consisting of 2-12 nucleotides (claim 5)(instant claim 38), wherein the tail consists of (U/T) (U/T) (U/T) (U/T) (U/T) (claim 6)(instant claim 39), and the aptamer being no more than 39 nucleotides in length (claim 7)(instant claim 40). The claims are obvious variations of each other.
Claims 25-28, 33, 34, 37, 38, 40-42, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,790,924 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US ‘924 B2 are directed to a method of inhibiting platelet aggregation in a subject comprising delivering a VWF aptamer comprising SEQ ID NO: 56, which is a species in the genus of instant claim 27 (claims 1 and 6) (instant claims 25-27) and is a RNA sequence (instant claim 41); wherein the specification discloses that the subject suffers from the same conditions as recited in instant claim 28. US ‘942 B2 defines the aptamer as the KD of the aptamer for the human VWF protein being less than 100 nanomolar (instant claim 37), incorporation of the instant modifications (instant claim 42), the presence of the terminal tail consisting of 2-12 nucleotides (instant claim 38), and the aptamer being no more than 39 nucleotides in length (SEQ ID NO: 56) (claim 1)(instant claim 40). The carrier of claim 5 meets the instant limitation of a stability agent (instant claim 45). The claims are obvious variations of each other.
Conclusion
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636