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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-5, drawn to a method of preparing a population of hematopoietic stem cells (HSC), as classified in C12N5/0647, A61K35/28, C12N2506/28, C12N2506/45, and C12N2506/00.
II. Claims 6-10, drawn to a method of treating a subject who has a blood, bone marrow, metabolic, and immune diseases, as classified in C12N5/0647, A61K35/28, C12N2506/28, C12N2506/45, A61P3/00, and A61P7/00.
Inventions I and II are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions are a method of preparing a population of hematopoietic stem cells (HSC) from hemogenic endothelial (HE) cells vs. a method of treating a subject having a blood, bone marrow, metabolic and immune diseases by administering to the subject an amount of hematopoietic stem cells (HSC) prepared from hemogenic endothelial (HE) cells. They have different designs, modes of operation, and effects. They are drawn to different methods that differ at least in objectives, method steps, reagents and schedules used, doses used, response variables and criteria of success. They have different classifications and require separate search, and the search would not be coextensive. Thus, inventions I and II are not obvious variants and are patentably distinct from each other.
A search for prior art and consideration of patentability of all claims of Groups I and II together does not necessary overlap with one another, thereby generating an undue burden in the examiner. Because these inventions are distinct for the reasons given above a search for the invention of the two groups would not be coextensive because a search indicating the product is novel or unobvious would not extend to a holding that the process itself is novel or unobvious; similarly, a search indicating that the process is known or would have been obvious would not extend to a holding that the product is known or would have been obvious.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification; The inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, the allowable linking claim, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Where a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP §804.01.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
DETAILED ACTION
The following action is in response to the papers filed on December 4, 2024. Pursuant to the claims filed on December 4, 2024, claims 1-10 are pending in the application.
During an email conversation with Meghana Gupta on September 22, 2026 a provisional election was made without traverse to prosecute the invention of Group II, claims 6-10, drawn to a method of treating a subject who has a blood, bone marrow, metabolic, and immune diseases. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-5 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Therefore, claims 6-10 are currently under examination to which the following grounds of rejection are applicable.
Priority
The present application is a Continuation of U.S. Application No. 17/452,511 filed on October 27, 2021 that is now Abandoned. U.S. Application No. 17/452,511 is a Divisional of U.S. Application No. 15/781,034 filed on June 1, 2018 that is now Issued Patent No. 11,162,073. U.S. Application No. 15/781,034 is a 371 of PCT US 2016/064706 filed on December 2, 2016 that claims benefit of the prior-filed parent provisional applications 62/332,853 filed May 6, 2016 and 62/262,464 filed on December 3, 2015 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is December 3, 2015.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 7, 2025, January 13, 2025, September 2, 2025, December 12, 2025, April 8, 2026, and July 9, 2026 were filed. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
Cross-Reference to Related Applications
The disclosure filed on December 4, 2024 is objected to because the cross-reference to related applications on the first page of the specification is not current as U.S. Application No. 17/452,511 is now abandoned. The cross-reference should contain the priority applications listed above in addition to the respective patent numbers.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or an official IDS, they have not been considered. These references are listed on pages 26-33 of the Specification.
Claim Objections
Claim 7 is objected to because the recited abbreviation, “iPSC”, shoullad be spelled out at the first encounter in the claims.
Claim 8 is objected to because the recited abbreviations, “5,6-EET, 8,9-EET, 4a-PDD and 4a-PDH”, should be spelled out at the first encounter in the claims.
Claim Rejections - 35 USC § 112
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 8 and 10 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.
The phrase “e.g., 4α-PDD and 4α-PDH” in line 3 of claim 8 is vague and renders the claim indefinite. It is unclear whether 4α-PDD and 4α-PDH are intended to be in the claim or not. It is also unclear whether 4α-PDD or 4α-PDH, or both compounds are intended to be in the claim.
Claim 10 use parentheses in lines 3-4 to comments on or qualify part of the sentences. It is unclear whether the limitations in parentheses are meant to be limitations in the claims or whether they are only suggestions/examples. As such, the metes and bounds of the claims cannot be determined.
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.
Claims 6-10 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Lemischka et al. (US Pub. No: 2015/0004145 A1).
Claims 6-10 are directed to a method of treating a subject who has a blood, bone marrow, metabolic, and immune diseases, the method comprising administering to the subject a therapeutically effective amount of hematopoietic stem cells (HSCs), then recites a method of producing said HSCs.
The method is directed to a method of treatment using HSC, reciting a product, HSCs, and the method of producing the HSC which is being considered a product-by-process limitation. M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” “Even 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, 111 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Therefore, in the instant case, the method of producing said HSCs need not be taught by the employed prior art reference, but rather the product taught, i.e. HSC, should be used in an identical fashion as claimed herein. Moreover, the limitations recited in claims 7 and 8, are also directed to the method of production.
Lemischka teaches “cells expressing a phenotype for hemogenic endothelium can give rise to HSCs and hematopoietic cells”, and “a method for treating a subject who suffers from a condition or a disease that would benefit from hematopoietic stem cell transplantation. In some aspects, the condition or disease is a type of cancer, a congenital disorder, or a type of vascular disease. In more particular aspects, the condition or disease is selected from the group consisting of multiple myeloma, leukemia, congenital neutropenia with defective stem cells, aplastic anemia, myelodysplastic syndrome, neuroblastoma, lymphoma, Ewing's Sarcoma, Desmoplastic small round cell tumor, chronic granulomatous disease, non-Hodgkin's lymphoma, Hodgkin's disease, acute myeloid leukemia, neuroblastoma, germ cell tumors, systemic lupus erythematosus (SLE), systemic sclerosis, amyloidosis,…” (par 0015). The subject in need of treatment is a human subject (par 0058), and the HSCs are obtained from iPSCs (Example 6).
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.
Claims 6-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,162,073 B2 (hereinafter ‘073). Although the claims at issue are not identical, they are not patentably distinct from each other because, although drawn to different scopes, they encompass the same invention and are obvious variants thereof.
Claims 6 of the instant application is directed to a method of treating a subject who has a blood, bone marrow, metabolic, and immune diseases the method comprising administering to the subject a therapeutically effective amount of hematopoietic stem cells (HSCs) obtained by a method comprising: providing a population comprising hemogenic endothelial (HE) cells, and (i) contacting the HE cells with an amount of an agonist of transient receptor potential cation channel-subfamily vanilloid member 4 (Trpv4); and/or (ii) subjecting the cells to cyclic 2-dimensional stretching, for a time and under conditions sufficient to stimulating endothelial-to-RSC transition. Claim 7 is directed to wherein the HE cells are obtained from iPSC.
Claims 1 of ‘073 is directed to a method of preparing a population of hematopoietic stem cells (HSC), the method comprising providing a cell population ex vivo comprising hemogenic endothelial (HE) cells differentiated from human induced pluripotent stem cells (iPSCs) and provided on a flexible cell culture surface, and subjecting the HE cells to cyclic 2-dimensional stretching by applying cyclic 2-dimensional stretching to the flexible cell culture surface having the HE cells thereon, for a time and under conditions sufficient to stimulate endothelial-to-HSC transition.
The claims are obvious variants based on the recited limitations pertaining to the method of making HSC being identical. The recitation in ‘073 claim 1 of “subjecting the HE cells to cyclic 2-dimensional stretching by applying cyclic 2-dimensional stretching to the flexible cell culture surface having the HE cells thereon” anticipates the phrase “subjecting the cells to cyclic 2-dimensional stretching” in claim 6 of the present invention of which is in the alternative. The only difference being the instant claims are directed to method of treatment as seen in the claim preamble and the limitation “the method comprising administering to the subject a therapeutically effective amount of hematopoietic stem cells (HSCs) obtained by a method…”; however, such limitation of using HSC for treatment of select diseases is considered well-known, and therefore would be an obvious step of applying a known technique of administering HSC for improvement in treatments to yield predictable results of treating select diseases or disorders. Therefore, the subject matter of claims 6-10 of the present invention would be obvious to one of ordinary skill in the art in view of the disclosure of claims 1-3 of ‘073.
Conclusion
Claims 1-10 are subject to a Restriction Requirement.
Claims 6-10 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL A RIGA whose telephone number is (571)270-0984. The examiner can normally be reached Monday-Friday (8AM-6PM).
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, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ANGELO RIGA/Examiner, Art Unit 1634
/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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