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 .
Receipt is acknowledged of Applicant’s Amendment filed on 02/20/2026.
Claims 1, 9, 14 have been amended.
Claims 1-5, 7-15, 26-27 are pending in the instant application.
Claims 8, 10, 13-15, 26-27 have been previously withdrawn consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112, 4th paragraph
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 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 2 is rejected under 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. Dependent claim 2 recites the same limitation as recited in claim 1. 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.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claim(s) 1-5, 7, 9, 11-12 is/are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over INGBER et al (US 2013/0295012).
INGBER teaches a composition comprised of therapeutic compounds encapsulated in red blood cells (see [0062]), such as red blood cell-derived vesicle (see [0067]), which reads on a red blood cell-derived vesicle comprising an encapsulated active agent, for treating thrombolytic therapies (see title), which would include blood clot (see [0062]).
Additional disclosures include: Red blood cells are biocompatible carriers and most of their volume is available for the encapsulation of drugs (see [0066]); “in some embodiments of this and other aspects of the invention described herein, one or more compounds, e.g., a compound to be delivered, can be associated with the aggregate. As used herein, with respect to aggregates, the phrase "associated with" means entangled, embedded, incorporated, encapsulated, bound to the surface, or otherwise associated with the aggregate or a nanoparticle constituent of the aggregate (see [0036]); compounds of interest (see [0103]), such as thrombolytic agents, such as tissue-type plasminogen activator (t-PA; see [0019]), and/or anticoagulant, such as aspirin (see [0120]).
INGBER further teaches coupling ligand to the nanoparticle/red blood cells to provide enhanced affinity for a selected target (see [0148]-[0149), which is a targeting ligands and would be on the surface to bind with a target molecule (see [0149]), such targeting ligands include RGD peptide (see [0151]), which is the same platelet targeting moiety used by Applicant (see Applicant’s specification at [0269]), which is arginine-glycine-aspartic acid (see Applicant’s specification at [0039]) and is also SEQ ID No. 1 (see Applicant’s pg. 19 at SEQ ID No. 1); and would have the same functional properties as recited in Applicant’s claims 3-4.
INGBER does not have a specific example using Applicant’s specific targeting ligands, such as SEQ ID No. 1, and specific active agent, such as tPA and aspirin. However, the teaching of INGBER is not limited to the examples, especially when these ingredients are used for thrombolytic therapies, such as blood clot.
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.
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) 1-5, 7, 9, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over INGBER et al (US 2013/0295012) in view of HUANG et al (Affinity Manipulation of Surface-conjugated RGD-peptide to Modulate Binding of Liposomes to Activated Platelets. Biomaterials. 2008 April; 29(11): 1676–1685) and GRAVANIS et al (tPA as a therapeutic target in stroke. Expert Opin Ther Targets. 2008 February; 12(2). Pg. 1-18).
As discussed above, INGBER teaches Applicant’s invention.
INGBER does not have a specific example using Applicant’s targeting ligand, such as SEQ ID No. 1; or a specific example using active agents, such as tPA and aspirin.
HUANG teaches the prior art had known of treating thrombosis/blood clot (see abstract) by using surface-conjugated RGD peptides (see title) that can selectively target and bind on activated platelets (see title and abstract). Additional disclosures include: delivery system that can carry thrombolytics selectively to the sites of active platelet aggregation (see abstract), such as tissue-plasminogen activator (see pg. 9, reference #29).
Note, RGD peptide is the same platelet targeting moiety used by Applicant (see Applicant’s specification at [0269]), which is arginine-glycine-aspartic acid (see Applicant’s specification at [0039]) and is also SEQ ID No. 1 (see Applicant’s pg. 19 at SEQ ID No. 1); and would have the same functional properties as recited in Applicant’s claims 3-4.
GRAVIS teaches the prior art had known of treating stroke, which is a blood clot (see Title; and pg. 1 under Introduction) by using active agents, such as tissue plasminogen activator (“tPA”; see title and abstract). Other drugs for treating blood clot includes aspirin (see pg. 6).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate targeting ligands, such as RDG peptide, which is SEQ ID No. 1. The person of ordinary skill in the art would have been motivated to make those modifications, because the targeting ligand would selectively target blood clots, and reasonably would have expected success because the primary reference INGBER teaches RDG peptide can be used.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate active agents, such as tPA and aspirin. The person of ordinary skill in the art would have been motivated to make those modifications, because these active agents would treat the blood clot, and reasonably would have expected success because the primary reference INGBER teaches these active agents can be used.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over HUANG (US 2009/0274630) in view of INGBER et al (US 2013/0295012).
HUANG teaches using red blood cell-derived vesicles (RDV) as a nanoparticle drug delivery system (see title and abstract) comprised of: encapsulated therapeutic agents (see abstract), which reads on active agent.
HUNAG does not teach using a targeting agent.
INGBER teaches the prior art had known of coupling ligand to the nanoparticle/ red blood cells to provide enhanced affinity for a selected target (see [0148]-[0149), which is a targeting ligands and would be on the surface to bind with a target molecule (see [0149]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate targeting agent. The person of ordinary skill in the art would have been motivated to make those modifications, because to provide enhanced affinity for a selected target for treatment, and reasonably would have expected success because targeting ligands/agents are well-known in the field of pharmaceutical drugs.
Response to Arguments
Applicant argues that Ingber discloses microparticles that use the increased shear stress that occurs in the context of a stenosis to disrupt/break down the microparticles into nanoparticles and deposit therapeutics in close proximity to the clot site.
The Examiner finds this argument unpersuasive, because INGBER’s microparticle composition include red blood cell derived vesicles and targeting agents, which is the same composition as claimed by Applicant.
Applicant argues that in contrast to the claimed red blood cell-derived vesicles, which are naturally derived, the nanoparticles from which Ingber' s microparticles are derived are synthetic. Therefore, Ingber' s vesicles rely on physical disruption, whereas the claimed vesicles rely on the integrin interaction between RGD and activated platelets.
The Examiner finds this argument unpersuasive, because INGBER teaches red blood cell-derived vesicles could also be used.
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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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