DETAILED ACTION
Claim Status
As of the Non-Final Office Action mailed 1/14/2026, claims 49-60 and 71 were pending.
In Applicant's Response filed on 5/14/2026, claims 49-50 and 59-60 were amended, claim 72 was newly added, and claim 71 was canceled.
As such, claims 49-60 and 72 are pending and have been examined herein.
Withdrawn Objections/Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection of record of claims 49-58 under 35 USC § 112(a) have been withdrawn in view of Applicant’s amendment to claim 49 to specify the condition treated as osteoarthritis.
The rejection of claim 59-60 under 35 USC § 102 as anticipated over Feng et al (US20150313944A1) has been withdrawn in view of Applicant’s amendment to claim 59. The rejection of claim 71 is moot in view of its cancelation.
The rejections of claim 49 on the grounds of nonstatutory double patenting over copending 17985641 has been withdrawn in view of Applicant’s amendment to claim 49.
The rejection of claim 59 and 71 on the grounds of nonstatutory double patenting over US patent 12403161 B2 has been withdrawn in view of Applicant’s amendment to claim 59 and cancelation of claim 71.
The rejection of claim 59 and 71 on the ground of nonstatutory double patenting over US patent 12060576 B2 has been withdrawn in view of Applicant’s amendment to claim 59 and cancelation of claim 71.
New Grounds of Rejections Necessitated by Amendments
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.
Claims 53-55 are 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 53 recites “wherein the composition is administered to treat . . ., a wound healing or wound-healing related disorders, or a dry eye disease”. Claim 54 recites “wherein the composition is administered to treat osteoarthritis”. Claim 55 recites “wherein the composition is administered to treat dry eye disease. These limitations do not specify a further limitation to the subject matter being claimed in claim 49. The recitation of “a wound healing or wound-healing related disorders, or a dry eye disease” broadens the scope of disease to be treated via the method of independent claim 49 beyond osteoarthritis. Moreover, claim 54 states that the composition is administered to treat osteoarthritis, which is the same as instant claim 49. Accordingly, these claims do not further limit claim 49. 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 Interpretation
Claim 49 recites, inter alia, “A method of treating osteoarthritis in a subject, . . . administering to a subject suffering from osteoarthritis and effective amount, . . . wherein the effective amount is sufficient to treat osteoarthritis.” Absent evidence to the contrary, the examiner is interpreting that any amount, including de minimis amounts of platelet-like cells or megakaryocyte like cells would be sufficient to treat osteoarthritis.
Furthermore, osteoarthritis is the most common form of arthritis. As such, the examiner is interpreting that, absent evidence to the contrary, treating arthritis encompasses treating osteoarthritis.
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) 59-60 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Matsubara et al (US20190269732A1, 10/17/2018; published 9/5/2019).
Regarding claim 59, Matsubara teaches a platelet-like cell population where the proportion of CD42b-positive cells is 5% or more; the proportion of CD63-positive cells is 60% or more, the proportion of CD36-positive cells is 40% or less (see para 18).
Matsubara continues to teach that the cells are a liquid agent for external use (liniment, etc.), a spray (in the form of mist, powder, foam or paste), a patch (matrix tape, reserver tape, poultice, etc.), an ointment, a cream, a gel (collagen gel agent, CMC gel (sodium salt of carboxymethylcellulose or potassium salt of carboxymethylcellulose) agent, thermally responsive gel agent (e.g., an agent that is gelled by body temperature), etc.), and a solid agent for external use (liniment, powder, etc.), and even more preferably include a liquid agent for external use, a spray, a patch, and a gel (i.e., formulated for therapeutic use and formulated for local administration; para 105).
Regarding claim 60, Matsubara teaches that the population is in a pharmaceutical composition supplemented with a physiologically acceptable buffer solution such as an aqueous solution, preferably a Hank's balanced salt solution, a Ringer's solution and a physiological salt buffer solution. Examples of optional components other than the pharmacologically and pharmaceutically acceptable carrier include a diluent, a solubilizer or a dissolution aid, a tonicity agent, a pH adjuster, a stabilizer, an antiseptic, a preservative, a dispersant, an emulsifier, a gelling agent, a thickener, a pressure-sensitive adhesive, and a dye (para 104).
Thus, absent evidence to the contrary, Matsubara anticipates the invention of instant claims 59-60.
Claim(s) 49-54, 56-60, and 72 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Thon et al (WO2020006539A1, 6/29/2019; published 1/2/2020).
Regarding claim 49-50 and 58, Thon teaches a method of treating a subject comprising administering a therapeutically effective amount of a composition comprising a IPSC-derived cell, such as pre-megakaryocyte, megakaryocyte, proplatelets, pre-platelets or platelets, comprising a therapeutic agent (Summary, para 6; claim 59 of Thon). The therapeutic agent is a chemokine, a cytokine, a growth factor, a polypeptide, a polynucleotide, or a small molecule (claim 53 of Thon). Platelets and pre-platelets are produced from iPSC-derived megakaryocytes, in some iterations, by subjecting the MKs to shear stresses.
Thon continues to teach that the megakaryocytes are CD42b+, CD61+, and DNA+ (claim 21 of Thon).
Thon continues to teach that the cells are CD42b+ and GPVI- (i.e, GPVI<avergage90%; claims 39 and 42 of Thon). Human iPSC derived platelets described herein are distinguished from primary, human donor derived platelets with respect to their lack of GPVI expression and greater thrombin generation over a more acute timeframe (FIGs. 46C-47).
Thon continues to teach that the administration of suitable dose and dose regimen may be determined based on subject age, sex, weight, general medical condition, and the specific condition for which the composition is being administered.
Regarding claim 51, Thon teaches that the pharmaceutical compositions described herein comprise a pharmaceutically acceptable carrier or excipient, such as sterile water, aqueous saline solution, aqueous buffered saline solutions, aqueous dextrose solutions, aqueous glycerol solutions, ethanol, or combinations thereof. The preparation of such solutions ensuring sterility, pH, isotonicity, and stability is affected according to protocols established in the art (“Pharmaceutical compositions” para 2).
Regarding claim 52, Thon teaches the megakaryocytes produced by the methods can uptake fibrinogen, serotonin, and LDL when incubated with plasma.
Regarding claim 49 and 53-54, Thon teaches that the diseases to be treated include ischemic injury, such as stroke, myocardial infarction, or any other ischemic event that causes tissue damage, peripheral vascular disease, wounds, burns, fractures, blunt trauma, arthritis, and inflammatory diseases.
Regarding claim 56, Thon does not state that there are red blood cells, hemoglobin, or white blood cells in the composition (i.e., absent from the composition).
Regarding claim 57, the reference teaches that the iPSC-derived megakaryocytes contain microparticles (i.e., type of extracellular vesicle; Fig. 37A-D).
Regarding claim 59, Thon teaches a composition comprising a megakaryocytic progenitor, a megakaryocyte, or a platelet produced by comprising a therapeutic agent, the method comprising: differentiating the pluripotent cells in a first culture medium into hemogenic endothelial cells; differentiating the hemogenic endothelial cells in a second culture medium into megakaryocytic progenitors; differentiating the megakaryocytic progenitors into mature megakaryocytes; differentiating the mature megakaryocytes under conditions sufficient to produce a platelets; and loading one of the platelets, megakaryocytes, megakaryocytic progenitors, or combinations thereof with a therapeutic agent (see claims 1 and 39 of Thon).
Regarding claim 59 and 60, Thon continues to teach that the composition further comprises a pharmaceutically acceptable excipient (claim 45 of Thon). The carrier can be a diluent, an adjuvant, a preservative, an anti-oxidant, a solubilizer, an emulsifier, a buffer, water, an aqueous solution, oil, an excipient, an auxiliary agent or vehicle or combinations thereof (“Administration” para 1). The cells may be administered by any method. In some embodiments, the instant megakaryocytic progenitors, megakaryocytes, proplatelets, pre-platelets, or platelets can be administered by direct injection, for example intravenous injection (i.e., formulated for therapeutic use and local administration; “Administration” para 4).
Regarding claim 72, Thon also teaches that CD42b expression of the mature megakaryocytes can reach levels above 90%.
Thus, absent evidence to the contrary, Thon anticipates the invention of instant claims 49 59-60.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras Jr can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.R./Examiner, Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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