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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 49-60 and 71) in the reply filed on 10/21/2025 is acknowledged. Applicant’s cancellation of non-elected Groups II-III (claims 61-70) is also acknowledged
Accordingly, claims 49-60 and71 are pending and have been examined herein.
Priority
The instant claims herein are examined utilizing the accepted effective filing date of 5/14/2020 for the basis of any prior art rejections.
Claim Objections
Claim 1 and 49 is objected to because of the following informalities:
Claim 1 recites “CD63>average2%, CD36>average80%, CD42b>average95%, or GPVI>average90%”, which should read as “CD63>average2%”, CD36>average80%” CD42b>average95%” or GPVI>average90%” instead.
Claim 49 is missing commas in the phrase “platelet- like cells (PLCs) or derivatives thereof or megakaryocyte-like cells (MLCS) or derivatives thereof, wherein a population of the PLCs or derivatives thereof or the MLCS or derivatives thereof.” This lack of punctuation makes the claim awkward to read.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 49-58, 60, and 71 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.
Claim 49 recites “wherein a population of the PLCs or derivatives thereof or the MLCS or derivatives thereof comprise receptors.” It is unclear whether this population of cells is the same population of cells administered in the administrations or whether the population expressing the receptors are a distinct population of cells. Thus, the claim is indefinite.
Claim 49 recites “as compared to reference resting bone marrow derived platelet cells or megakaryocytes.” It is unclear what Applicant intends to claim in the recitation of “resting bone marrow derived” and the instant specification does not provide clarity on the issue. Thus, the claim is indefinite.
Claim 50 recites “extracellular vesicles or another therapeutic agent or a combination thereof.” The lack of commas at the end of the Markush group makes it unclear what the “combination thereof” as claimed is referring to. Thus, the claim is indefinite.
Per MPEP 2173.05 (p)(II), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. The findings in Katz are instructive. Claim 59 is an instance in which statutory categories -product and process - are mixed. Claim 59, drawn to a composition as described by the method of claim 49 (composition), recites, inter alia, “ . . . locally administered at a sight of or near an injury or a disease.” The step of administration is a process step. Thus, the claim is indefinite.
Claim 60 recites “the formulation is performed in a buffer, diluent, or excipient.” It is unclear what Applicant intends to claim by the language “performed in” and what it means for a formulation to be “performed in” as claimed. Thus, the claim is indefinite.
Claim 71 recites “the composition made according to the method of claim 49” however claim 49 is a method of treating, not a method of making. Thus, there is no nexus between the claim limitations. For the purpose of compact prosecution, the examiner is interpreting claim 71 to be a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (see MPEP 2113). "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Please note that claims 50-58 are included in this rejection for being dependent on indefinite claim 49.
Claim Rejections - 35 USC § 112(a)
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 49-58 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
While determining whether a specification is enabling, one considered whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would have required undue experimentation to make and use the claimed invention and whether working examples have been provided. When determining whether a specification meets the enablement requirement, some of the factors that need to be analyzed are: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and whether the quantity of any necessary experimentation to make or use the invention based on the content of the disclosure is “undue” (In re Wands, 858 F.2d at 737, 8 USPQ2d 1400, 1404 (Fed. Cir.1988)).
Furthermore, the USPTO does not have laboratory facilities to test if an invention with function as claimed when working examples are not disclosed in the specification, therefore, enablement issues are raised and discussed based on the state of knowledge pertinent to an art at the time of the invention, therefore, skepticism raised in the enablement rejection are those raised in the art by artisans of expertise.
Nature of the invention:
A method of treating a condition in a subject, the method comprising: administering to the subject an effective amount of a composition comprising platelet- like cells (PLCs) or derivatives thereof or megakaryocyte-like cells (MLCS) or derivatives thereof, wherein a population of the PLCs or derivatives thereof or the MLCS or derivatives thereof comprise receptors of one or more of CD63>average2%, CD36<average80%,CD42b<average95%, or GPVI<average90% as compared to reference resting bone marrow derived platelet cells or megakaryocytes.
The state of the prior art:
The state of the prior art for using platelet-like cells, megakaryocyte-like cells, or derivatives thereof to treat any condition in a subject was unpredictable before the effective filing date of the claimed invention.
The breadth of the claims:
The claims encompass a method of treating any condition by administering PLCs or derivatives thereof or megakaryocyte-like cells or derivatives thereof via various administration routes. Various conditions include back pain, fertility loss, various cancers (leukemia, lymphoma, melanoma, prostate cancer, breast cancer, ovarian cancer, mesothelioma, renal cell carcinoma, pancreatic cancer, lung cancer, etc.) various bacterial infections, various fungal infections, various viral infections, autoimmune disorders, idiopathic disorders, hair loss, wounds, heart disease, diabetes, neurodegenerative diseases, etc. Various administration routes include direct injection, subcutaneous, oral, intravenous, intramuscular, intrathecal, intraperitoneal, topical administration, intracorporeal injection, etc.
The level of skill in the art:
The level of skill is high that requires a researcher with a PhD degree.
The working examples and guidance provided:
The specification discloses working examples in which PLCs are administered to osteoarthritis model leading to reduced pain cessation (example 1). It also describes only prophetic examples of utilizing PLCs for diabetic wound healing, and hair growth (examples 2 and 3).
The specification fails to provide any working examples in which any PLC, PLC derivatives, MLC, or MLC derivatives is administered to ameliorate various pathological symptoms of the various conditions embraced by the claims.
The unpredictable nature of the art:
The art does not recognize PLCs or PLC derivative nor MLC or MLC derivatives with Applicant’s instantly claimed receptor profile to be an “end-all be-all” treatment for the various conditions, diseases, and disorders encompassed by the instant claims.
Treating any disease with the same modality: Diseases such as cancer, infections, cardiovascular diseases, etc., are multifactorial in their etiology and treatment modalities. While there can be overlap between diseases (e.g., a viral infection leading to an increased likelihood of having a certain type of cancer), there are still many factors at play to how a disease can be treated. Infectious diseases, cancers, and other disease populations are not treated the same way nor are they treated the same at different points of disease progression.
Cancer therapy is highly unpredictable, and no example exists for the efficacy of a single product against all cancers generally. The National Cancer Institute, in their webpage about cancer treatment, states that the types of treatment for cancer depends on the type of cancer you have and how advanced it is. Some people with cancer only have one treatment, but most people require a combination of treatments, including chemotherapy, surgery, radiation therapy, immunotherapy, targeted therapy, and hormone therapy. This shows that a singular treatment cannot be the “end-all, be-all” for cancer.
Treatment of an infectious disease depends on the severity of infection. Kaye (“Cytomegalovirus (CMV) Infection”, 8 Oct 2018) teaches that CMV is a common herpesvirus infection with a wide range of symptoms ranging from no symptoms to severe symptoms (p.1). It also states that, mild CMV infection is usually not treated, but if the infection is severe, antiviral drugs (such as valganciclovir, ganciclovir, cidofovir, foscarnet, or a combination) may be given (p. 3, “Treatment”). There is no indication for the use of CAR or T cell receptor immunotherapy to treat CMV successfully. These references show that a singular treatment cannot be an “end all, be all” treatment for all disease populations.
Cell therapy: There are various barriers before a cell can reach its target site, for example, layers of dermal cells, blood vessel wall, cell membranes, extracellular matrix between cells, gastrointestinal digestive acids, and blood-brain barrier for reaching cells in the brain and vice versa. Whether the cell can reach target sites in vivo or not depends on the administration route of said cell. How the claimed cell is administered to a subject will determine the efficiency of the cell to reach the target site in the subject and whether sufficient cell can reach target sites to exert therapeutic effects to provide various cell replacement therapies so as to treat various diseases or disorders in a subject.
Mouse model translation to humans: The example disclosed in the specification uses mice models. While mice models are common to study human diseases and drug development, the results do not always translate to humans as it relates to treatment.
Sellers et al (Toxicol Pathol. 2017 Jan; 45(1):134-145; Epub 4 Nov 2016) states that translation of beneficial responses to therapeutics from mice to humans has not always been successful and that these differences may be attributed to variations in the alignment of protein expression and signaling in the immune systems between mice and humans (abstract). Although genetically engineered mice (GEM) have allowed phenotypic evaluation of individual genes and gene mutations as well as the development of mouse models of human diseases such as UC or CD, they do not exactly replicate the spectrum of human disease (Mouse Model Enigma, para 1). Simply replicating the underlying genetic predispositions to human disease in mice may not be adequate for disease expression, as they cannot recapitulate the myriad influences that drive the pathogeneses (same para). While underlying genetic polymorphisms in the human population may predispose to disease, manifestation of disease typically also requires additional environmental, microbial, or physiological triggers that often cannot be easily captured in the animal model (same para).
Mouse strain-specific immunological peculiarities have been exploited to generate mouse models of disease (Examples of immune variation impacting mouse models, para 1). Susceptibility of various strains to infectious or immune disease induction, due to immune deficits or polymorphisms that may or may not be associated with disease susceptibility in humans, is useful: these models tend to be consistent and reproducible in certain strains (same para). For example, one of the most common strains of mice used for induction of experimental autoimmune encephalitis, a model of multiple sclerosis, is the SJL/J strain. These mice have a wide assortment of immune abnormalities, including hyperresponsive IL-12 and hyporesponsive IL-4 and abnormalities in T cell receptor (TCR)β-V8 receptor function as well as factors associated with SJL/J sub-strain variation. In addition, strains may have different biases in T helper (TH)-type responses. For example, C57BL/6 mice have been demonstrated to have a TH1-type bias to pathogens, whereas strains such as BALB/c, A/J, and DBA/2 mice have TH2-biased responses. This does have an impact on how mice respond to infectious diseases, induction of autoimmune disease, and clearance of materials, such as nanoparticles used in immunotherapies (same para).
The extremely broad scope of the claims and lack of guidance in the specification exacerbates a highly unpredictable art. While the results presented in the art do not necessarily preclude Applicant’s hypothesis, they certainly fail to support it in its totality that PLC (or derivatives) or MLCs (or derivatives) treat all conditions on its own. Consequently, the prior and post-filing art, when combined with the lack of any disclosed direct experimental test of Applicant’s hypothesis, shows that one of ordinary skill would have no basis to reasonably predict or conclude that PLCs, MLCs, or derivatives thereof can treat any and all conditions. Though not controlling, the lack of working examples is, nevertheless, a factor to be considered in a case involving both physiological activity and an underdeveloped art. When a patent applicant chooses to forego exemplification and bases utility on broad terminology and general allegations, they run the risk that unless one of ordinary skill in the art would accept the allegations as obviously valid and correct, the PTO may, properly, ask for evidence to substantiate them. Ex parte Suilosky, 21 USPQ2d 1702, 1705 (BPAI 1991); In re Novak, 134 USPA 335 (CCPA 1962); In re Fouche, 169 USPQ 429 (CCPA 1971).
In essence, the specification merely presents an idea of, and leaves it entirely up to the practitioner to determine whether the method would produce a therapeutically relevant effect, and if so, how to carry out the claimed method. It has been established by legal decision that a patent is not a hunting license. It is not a reward for a search, but compensation for its successful conclusion. Tossing out the germ of an idea does not constitute an enabling disclosure. While every aspect of a generic claim need not have been carried out by an inventor or exemplified in the specification, reasonable detail must be provided in order to enable one of ordinary skill to understand and carry out the invention. It is true that a specification need not disclose what is well known in the art. However, that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement under 35 USC 112(a) or 35 USC 112, first paragraph.
The amount of experimentation necessary:
One of ordinary skill in the art could not reasonably take these working examples and readily or immediately apply the data generated in the working examples (prophetic or otherwise) to the instantly claimed method of treating conditions. Outside of the speculative and prophetic embodiments within the instant disclosure, Applicant has provided no empirical evidence on the record that adequately substantiates that the broad genus of PLC and MLC cells can treat all known and unknown conditions as embraced by the instant claims in comparison with the known teachings of prior and post-dated art regarding different disorders.
For the reasons set forth above, one skilled in the art before the effective filing date of the claimed invention would not be able to make and/or use the invention as claimed. This is particularly true given the nature of the invention, the state of the prior art, the breadth of the claims, the amount of experimentation necessary, the level of skill which is high, the working examples provided and scarcity of guidance in the specification, and the unpredictable nature of the art.
Examiner’s Note
Claim 59 recites “implanted on an implantable device . . . locally administered at a sight of or near an injury or a disease.” The examiner is interpreting these limitations as intended uses of the claimed composition (see MPEP 2111.04).
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 and 71 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Feng et al (US20150313944A1, 12/21/2013; published 11/5/2015).
Feng teaches production of platelets from pluripotent stem cells (abstract). The pharmaceutical preparation that is suitable for use in a human patient comprising at least 108 platelets, wherein the preparation is substantially free of leukocytes and wherein substantially all of the platelets are functional (claim 1 of Feng). The reference teaches that the platelets are positive for CD42b (claim 4 of Feng). This anticipates “composition as described by the method of claim 49, wherein the composition is one or more of: formulated for application to a site of injury for therapeutic use” as in instant claim 59 and “a composition for treating a condition in a subject, the composition made according to the method of claim 49.” as in instant claim 71. The MLPs are suspended in phosphate buffered saline (para 392) (“wherein the formulation is performed in a buffer, diluent, or excipient or a combination thereof” as in instant claim 60).
Thus, Feng anticipates the instant invention of claims 59-60 and 71.
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.
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.
Claim 50 and 71 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 12403161 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method as claimed in the ‘576 patent would necessarily produce the composition as claimed.
Claim 1 recites “method for differentiating induced pluripotent stem cells (iPSC) to prepare a composition, the method comprising expanding induced pluripotent cells in a matrix independent culture using single cell passaging; dissociating the expanded pluripotent cells into a single cell suspension;
differentiating the dissociated 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 in a third culture medium into megakaryocytes; and lysing the megakaryocytes so as to obtain a lysate composition comprising one or more of Interleukin 1-beta, Interleukin 16, Interleukin 12P40, TNF-beta, BCA-1, IP-30, Fractalkine, GCkine, MCP-4, MIP-1alpha, MIP-1beta, SDF-1alpha, SDF-1beta, or a combination thereof.” Claim 12 recites “A method for differentiating induced pluripotent stem cells (iPSC) to prepare a composition, the method comprising: differentiating induced pluripotent cells in a first culture medium into hemogenic endothelial cells, the first culture medium comprising BMP4 for a first time period and bFGF and VEGF for a second time period after the first time period; differentiating the hemogenic endothelial cells in a second culture medium into megakaryocytic progenitors; differentiating the megakaryocytic progenitors in a third culture medium into megakaryocytes; and lysing the megakaryocytes so as to obtain a lysate composition comprising one or more of Interleukin 1-beta, Interleukin 16, Interleukin 12P40, TNF-beta, BCA-1, IP-30, Fractalkine, GCkine, MCP-4, MIP-1alpha, MIP-1beta, SDF-1alpha, SDF-1beta, or a combination thereof.” This would read on “A composition as described by the method of claim 49, wherein the composition is one or more of: formulated for application to a site of injury for therapeutic use, lyophilized” as in instant claim 50 and “A composition for treating a condition in a subject, the composition made according to the method of claim 49” as in instant claim 71 if it were available as prior art.
Claim 50 and 71 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 12060576 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method as claimed in the ‘576 patent would necessarily produce the composition as claimed.
Claim 1 recites “method for megakaryocyte production comprising:
culturing dissociated pluripotent stem cells in a matrix-independent culture and under continuous agitation such that the pluripotent stem cells form self-aggregating pluripotent cell spheroids;
differentiating, under continuous agitation, the self-aggregating pluripotent cell spheroids in a first culture medium into hemogenic endothelial cell spheroids; and differentiating, under continuous agitation, the hemogenic endothelial cell spheroids in a second culture medium to produce megakaryocytic progenitors, causing the hemogenic endothelial cell spheroids to release the megakaryocytic progenitors into suspension while maintaining the hemogenic endothelial cell spheroids for subsequent production and release of the megakaryocytic progenitors.” Claim 8 recites “method for megakaryocyte production comprising: differentiating, in a matrix-independent culture, pluripotent stem cells in a first culture medium into hemogenic endothelial cells; and differentiating the hemogenic endothelial cells in a second culture medium into megakaryocytic progenitors, wherein each of the differentiating the pluripotent stem cells and the differentiating the hemogenic endothelial cells is carried out under continuous agitation to enable the pluripotent stem cells to self-aggregate and differentiate into hemogenic endothelial cell spheroids and the hemogenic endothelial cells in the hemogenic endothelial cell spheroids to differentiate into megakaryocyte progenitors, causing the hemogenic endothelial cell spheroids to release the megakaryocytic progenitors into suspension while maintaining the hemogenic endothelial cell spheroids for subsequent production and release of additional megakaryocytic progenitors.” This would read on “A composition as described by the method of claim 49, wherein the composition is one or more of: formulated for application to a site of injury for therapeutic use” as in instant claim 50 and “A composition for treating a condition in a subject, the composition made according to the method of claim 49” as in instant claim 71 if it were available as prior art.
Claims 49 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 48, 50-53, 60, 64, and 67 of copending Application No. 17985641 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because it would anticipate the instant claims if it were available as prior art.
Claim 48 of ‘641 recites “method for generating megakaryocytes from progenitor stem cells comprising at least two stages: (i) performing a stage zero (0) comprising an expansion and maintenance stage of the progenitor stem cells; and, (ii) performing a stage one (I) comprising a differentiation phase wherein the differentiation phase comprises differentiating the progenitor stem cells in step (i) for a period sufficient to generate matured megakaryocytes, wherein the matured megakaryocytes are positive for one or more of CD61, CD42a, and CD42.”
Claim 50 of ‘641 recites “culturing the matured megakaryocytes in a bioreactor subject to one or more of shear stress, mechanical strain and pulsed electromagnetic field.”
Claim 51 of ‘641 recites “differentiating the matured megakaryocytes to pro-platelets or platelets.”
Claim 52 of ‘641 recites “A composition comprising platelets produced by the method of claim 48, wherein the platelets are used in treating a disease or a disorder in subject.”
Claim 53 of ‘641 recites “wherein the disease or disorder is selected from one or more of an immunoinflammatory disorder, a metabolic disorder, a neoplastic disorder, an autoimmune disorder, viral or bacterial-induced disorder.”
Claim 60 of ‘641 recites “method for generating platelet variants from progenitor stem cells comprising at least: (i) performing an expansion and maintenance stage of the progenitor stem cells comprising culturing the progenitor stem cells; (ii) performing a differentiation stage wherein the differentiation stage comprises differentiating the progenitor stem cells in step (i) for a period sufficient to generate matured megakaryocytes, wherein the matured megakaryocytes are positive for one or more of CD61, CD42a, and CD42b; and (iii) passaging said matured megakaryocytes through a bioreactor wherein the matured megakaryocytes generate platelet variants”
Claim 64 recites “A method for generating platelet variants from progenitor stem cells for administration into a subject in need thereof comprising passaging megakaryocytes through a bioreactor, wherein the megakaryocytes are positive for one or more of CD61,CD42a,andCD42b”
Claim 67 of ‘641 recites “method for generating genetically engineered platelet variants from progenitor stem cells for administration into a subject in need thereof comprising: (i) genetically engineering the progenitor stem cells and differentiating to produce genetically engineered megakaryocytes. wherein the genetically engineered megakaryocytes are positive for one or more of CD61. CD42a. and CD42b: and,(ii) passaging the genetically engineered megakaryocytes through a bioreactor subject to one or more of shear stress, mechanical strain and pulsed electromagnetic field.”
If available as prior art, these claims would anticipate “A method of treating a condition in a subject, the method comprising: administering to the subject an effective amount of a composition comprising platelet- like cells (PLCs) or derivatives thereof or megakaryocyte-like cells (MLCS) or derivatives thereof, wherein a population of the PLCs or derivatives thereof or the MLCS or derivatives thereof comprise receptors of one or more of CD63>average2%, CD36<average80%, CD42b<average95%, or GPVI<average90% as compared to reference resting bone marrow derived platelet cells or megakaryocytes” as in instant claim 48, “wherein the PLCs, MLCs, or derivatives thereof are free of red blood cells or hemoglobin content or white blood cells” as in instant claim 56, “wherein the PLCs, MLCs, or derivatives thereof are generated by exposure of induced pluripotent stem cells (iPSCs) with one or more of shear stress, mechanical strain, or a pulsed electromagnetic field” as in instant claim 58, “A composition as described by the method of claim 49, wherein the composition is one or more of: formulated for application to a site of injury for therapeutic use, lyophilized, implanted on an implantable device, cryopreserved, locally administered at a sight of or near an injury or a disease” as in instant claim 59, “wherein the formulation is performed in a buffer, diluent, or excipient or a combination thereof” as in instant claim 60, and “A composition for treating a condition in a subject, the composition made according to the method of claim 49” as in instant claim 71.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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 7-3.
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/G.R./Examiner, Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632