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 .
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Status of Application and Claims
US Patent 10,576,106 issued on 3/3/20 from application 16/392,524 with claims 1-28. Reissue application 17/685,202 was filed on 3/2/22 and issued as RE50,313 on 2/25/25 with claims 1-61. This application was filed on 2/24/25 as a continuation of the ’202 reissue application and canceled claims 1-28 while adding new claims 29-46.1 Claims 29-46 are pending.
The application data sheet for this application fails to identify it as a reissue application (see discussion below regarding the reissue declaration submitted with this application). It only indicates that this application is a continuation of the ’202 reissue application.
In general, an application which is a continuing application of a reissue application will be considered a Bauman application when there are no indicia on filing that a continuing reissue application is being filed. MPEP 1451. Here, however, this application contains several indicia of a reissue application:
The specification is in double-column format and presents the ’106 patent;
The application contains a statement under 37 CFR 3.73;
The application contains form PTO/AIA /50 (Reissue Patent Application Transmittal form); and
The reissue declaration is not merely a copy of the declaration supplied in the ’202 reissue application (although it fails to correctly identify any error; see below discussion).
In addition, it appears applicant is using some of the amendment conventions for reissue applications as set forth in 37 CFR 1.173(d) (e.g., new claims are partially underlined); that said, see below regarding claim objections.
Applicant is required to submit an amended application data sheet clearly identifying this application as both a continuation of the ’202 application and a reissue of either the ’106 patent or the RE’313 patent. For this Office action, this application is interpreted as being a reissue application of the ’106 patent because the ’106 patent was provided as the specification in double-column format, and claims 1-28 (not claims 1-61, from RE50,313) were canceled, but that fact does not relieve applicant of the requirement to address all requirements for a reissue application.
Election by Original Presentation
37 CFR 1.176(b) permits the examiner to require restriction in a reissue application between claims newly added in a reissue application and the original patent claims where the added claims are directed to an invention that is separate and distinct from the invention(s) defined by the original patent claims. See MPEP 1450.
Further, in the reissue application, if a restriction requirement is made by the examiner, the original patent claims will be held to be constructively elected.
Where a restriction requirement is made by the examiner, the original patent claims will be held to be constructively elected, except where disclaimer applies. Applicant may file divisional reissue applications directed to the constructively non-elected inventions. See MPEP 1450.
This application contains claims to three independent and distinct inventions:
Claims 29-38, drawn to a musculoskeletal stem cell, classified in A61K 35/34.
Claims 39-44, drawn to a method of preparing a musculoskeletal stem cell by culturing an embryonic stem (ESC) or induced pluripotent stem cell (iPSC), classified in C12N 5/0606.
Claims 45 and 46, drawn to a method of treating a musculoskeletal disease with musculoskeletal stem cells, classified in A61P 21/00.
The inventions are independent or distinct, each from the other, because:
The culture method and the cell are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the active method steps of the culture method can produce a cell with a different expression profile, specifically one that is positive for nestin, Pax7, and [Symbol font/0x61]-SMA but negative for LIN28 and CD90. (See US Patent 10,576,106 at claim 1, reciting the same steps as those recited in Group II.) By contrast, this application claims using the same steps to make a cell that is positive for nestin and LGR5 but negative for NANOG. These cells are two materially different products, as evidenced by their distinct marker-expression profiles.
The cell and the treatment method are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In this case, the cells can be used in in vitro investigations of musculoskeletal differentiation that do not require the administration step of the treatment method.
The culture method and the treatment method are directed to related but distinct processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed recite a method comprising culture steps for ESC or iPSC and a treatment method containing no culture steps and administering a musculoskeletal stem cell. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions 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 have acquired a separate status in the art due to their recognized divergent subject matter; and the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
In addition, the inventions are likely to raise different examination issues such as non-prior art issues under 35 U.S.C. 112(a); issues relevant to one invention are not relevant to the other inventions.
Claims 29-38, 45, and 46 are withdrawn from consideration as being drawn to constructively non-elected inventions. Claims 39-44 are under examination.
Reissue Oath/Declaration
The reissue oath/declaration filed with this application is defective because it fails to identify at least one error which is relied upon to support the reissue application. See 37 CFR 1.175 and MPEP § 1414.
As discussed above, this application was filed with a copy of the ’106 patent and instructions to cancel claims 1-28, and the 2/24/25 remarks pertain to changes being made to the ’106 patent. These filings are consistent with this application being a reissue of the ’106 patent. The reissue declaration, however, purports to identify errors in the RE’313 patent, not the ’106 patent. (See 7/15/25 submission.) The declaration is therefore incompatible with the other filings in this application, which, again, is being treated as a reissue application of the ’106 patent.
A replacement declaration properly identifying a correctable error within the ’106 patent is required.
Claim Rejections—35 U.S.C. 251
Claims 39-44 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action.
Claim Objections
All new claims in a reissue must be underlined in their entirety throughout prosecution; see 37 CFR 1.173(b) and (d). A compliant claim listing is required in response to this Office action. Only one copy of the claim listing should be submitted (compare the 2/24/25 preliminary amendment, which was submitted three times).
Claim 39 is objected to because it depends from a withdrawn claim. Claim 39 should be amended so that it is self-contained.
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.
Claim 42 is 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 42 recites the limitation “the TGF-3/activin/nodal signaling inhibitor” at lines 1-2. There is insufficient antecedent basis in claim 39 for this limitation because claim 39 recites a TGF-[Symbol font/0x62]/activin/nodal signaling inhibitor. Clarification is required.
Relevant Prior Art
Claim 39 is drawn to a method that cultures either ESCs or iPSCs in medium comprising noggin, LIF, and bFGF along with inhibitors of Wnt signaling, ERK signaling, and TGF-[Symbol font/0x62]/nodal/activin signaling.
Varum et al. (2009, Stem Cell Research 3: 142-156; reference U) teach culturing ESCs with bFGF. (Abstract; page 153, column 1.) Varum teaches that LIF maintains ESC self-renewal but is not sufficient to maintain pluripotency and that combined activities of noggin and bFGF maintain ESC self-renewal. (Page 143, column 1.) Varum further teaches that activin/nodal signaling cooperates with bFGF to maintain ESC pluripotency in chemically defined medium. (Page 143, column 1.) Varum does not, however, culture ESCs in medium containing all six required components.
Bian et al. (2016, PLoS ONE 11: e0155227; reference V) teach culturing ESCs with noggin and CHIR99021 (a Wnt signaling inhibitor; see claim 40). (Page 3/15.) Bian teaches, however, that the culturing differentiates ESCs into neuroepithelial-like stem cells, not musculoskeletal stem cells. (Page 3/15.) Bian also does not culture ESCs in medium containing all six required components.
Hsieh et al. (2011, Cellular Reprogramming 13: 241-255; reference W) teach culturing ESCs with LIF and bFGF. (Abstract and page 243, column 2.) Hsieh teaches, however, that this combination maintains ESC “stemness” (pluripotency) rather than stimulating differentiation. (Page 253, column 2; Figure 8.) Hsieh does not culture ESCs in medium containing all six required components.
Quattrocelli et al. (2015, Journal of Clinical Investigation 125: 4463-4482; 6-page IDS NPL reference 12) teaches culturing iPSCs with LIF to generate cells that can differentiate into muscle cells. (Page 4478, column 1.) Quattrocelli does not culture iPSCs in medium containing all six required components.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lora Barnhart Driscoll, whose telephone number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m. ET.
Applicant is encouraged to contact the examiner via telephone for any necessary assistance in preparing a replacement declaration and amended ADS.
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, Patricia Engle, can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lora E Barnhart Driscoll/Patent Reexamination Specialist, Art Unit 3991
Conferees:
/KSO/
Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
1 The 2/24/25 preliminary amendment to the claims erroneously instructs the Office to “amend Claims 16-17 and add new Claims 29-46 as below.” (Claim listing at 1.) The claim listing speaks for itself and shows claims 1-28 as canceled. The 2/24/25 remarks likewise indicate that claims 1-28 are canceled. (Remarks at 7.)
Prosecution Insights