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 .
DETAILED ACTION
Claim status
Claims 1-15, 25, 31, and 34-36 are pending
Claims 7, 8, 15, 25, 31, and 34-36 are withdrawn
Claims 1-6, 9-14 are under examination
Election/Restrictions
Applicant’s election of the following invention without traverse in the reply filed on 3/16/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 1-14, drawn to a methods of identifying, isolating, enriching skeletal stem cells.
Claims 15, 25, 31, and 34-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Applicant’s election of the following species is acknowledged.
Claims 5 and 6, drawn to anti-BMPR1A antibodies.
Claims 7 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/22/2023 and 2/18/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
However, Applicant is reminded that 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, they have not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: instant claim uses the abbreviation of BMPR1A for bone morphogenetic protein receptor 1A. Abbreviations should be spell-out upon first use unless they are immediately apparent to one who has not read the specification. Appropriate correction is required.
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 4-5, and 9 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 4 recites “the cells” in regard to Claim 1. Claim 5 recites “or cells” in regard to Claim 2. Claim 9 recites “or cells” in regard to Claim 1. There is insufficient antecedent basis for the limitations in the claims because it is unclear which “cells: the claims encompass (i.e., the start cell or BMPR1A+ cell). Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, and 10-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 1, 4, and 10-14 are directed to identifying cells based on a mental process. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they are not substantially more.
Briefly summarized here, the guidance for patent subject matter eligibility is a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
In regard to Step 1, Claims 1, 4, and 10-14 are drawn to a process, a method for identifying a skeletal stem cell.
In regard to Step 2A prong one, this part of the eligibility analysis evaluates whether the claim recites a judicial exception. Claim 1 recites that the method requires the step of “identifying from the start cell population a cell expressing a BMPR1A”. Claim 4 states the cell co-expresses naturally occurring markers, and Claims 10-14 state that cell starting population is one of several natural sources. Under its broadest reasonable interpretation consistent with the specification, the plain and ordinary meaning of this limitation requires an evaluation of a cell from a population of cells. As this step simply requires comparing a cell against some population of cells, the limitation falls into the “mental process” grouping of abstract ideas because the evaluation can be practically performed in the human mind. Thus, the claim(s) are directed to the judicial exception of (a mathematical concept-type abstract idea, a mental process-type abstract idea, and a law of nature) (Step 2A, Prong One: YES).
In regard to Step 2A, prong two: this part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. In the present situation, although the claims recite the active method step of “identifying” a cell expressing a BMPR1A as an attempt to generally link the judicial exception to a field of use, this attempt amounts to a generic instruction for applying the mental process (i.e., identifying a cell based on expression). Furthermore, Claim 4 does not explicitly include step of evaluating other cell markers, and Claims 10-14 are directed comparing different start cell populations; however, these steps amount to insignificant extra-solution activity that merely reflect the cell sources that are incidental to the mental step. Thus, even when considering the elements in combination, the claim(s) as a whole do not meaningfully integrate the recited exception into a practical application (Step 2A, prong two: No).
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As stated supra, additional elements such as the source of cells are considered insignificant extra-solution activities in Step 2A, prong two. Furthermore, the element of “identifying” the cell as determined by or based on the expression of BMPR1A is at most a generic instruction to apply the abstract idea. Consequently, for the reasons discussed above, the additional elements individually or in combination with the judicial exception do not provide an inventive concept; so, the claim as a whole does not amount to significantly more than a generic instruction to “apply” the judicial exception. (Step 2B: NO).
For the reasons set forth above, the claims are not considered to recite something significantly different than a judicial exception and thereby are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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)(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 1, 4, and 10-11, and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chan et al., (US 11,083,755, filed 1/06/2016, patented 8/10/2021).
(Mouse Bone Embodiment)
With respect to claim 1, Chang teaches a method for identifying mouse skeletal stem cells (mSSCs) comprising
Obtaining a start cell population from a mouse bone;
Identifying from the start cell population a cell expressing BMPR1A by single cell RNA sequencing (col 8, last para., col 52, 1st para., Fig. 3, see Fig. 3A excerpt below).
PNG
media_image1.png
258
1129
media_image1.png
Greyscale
[AltContent: textbox ([img-media_image2.png])]In regard to claim 4, Chan teaches the mSSC expresses BMP2 (see Fig. 3C excerpt adjacent).
In regard to claims 10-11 and 13, the starting cell population is from mouse tissue comprising bone marrow (see Fig. 3A above).
Accordingly, Chan anticipates instant claims.
Claims 1-3, 5-6, and 9-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chan et al., (US 11,083,755, filed 1/06/2016, patented 8/10/2021).
(Human Adipose Embodiment)
With respect to claim 1, Chang teaches a method for identifying, isolating, and enriching mouse skeletal stem cells (mSSCs) comprising
Obtaining a start cell population from human adipose stromal cells (hASCs);
Identifying from the start cell population a cell expressing BMPR1A by FACS with antibodies (Example 4, cols 73-74).
In regard to claims 2-3, Chan teaches steps of isolating the a plurality of BMPR1A+ cells (col 74, 3rd para.).
In regard to claims 5-6, and 9, as stated supra, Chan teaches using an BMPR1a antibody to FACS isolate hASCs expressing BMPR1A.
In regard to claims 10-13, as stated supra, the starting cell population is from human adipose comprising stromal cells (i.e., MSC).
Accordingly, Chan anticipates instant claims.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al., (US 11,083,755, filed 1/06/2016, patented 8/10/2021), in view of Guo et al. (Bone Res 6, 30 (2018).
As discussed previously, Chan teaches methods for identifying BMPR1A+ stem cells from a various of start populations.
However, although Chan teaches the skeletal stem cells are in bone material such as crainum (col 50, lines 29), they are silent with respect to cranial bone suture material.
With respect to instant claims, Guo teaches BMPR1A positive osteoprogenitors in cranial bone sutures (p. 2, Results, 1st para., see Fig. 1), and demonstrates that cells from suture material can be collected for FACs analysis (p.9, Materials & Methods, 5th para.).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have practice the method of identifying or isolating or enriching skeletal stem cells from bone comprising identifying BMPR1A expressing cells as taught by Chan, and choose bone sutures as taught by Guo with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Guo because the MSCs from sutures give rise to osteoprogenitors that show active BMP signaling (Abstract of Guo), which would enable the desired “autocrine signaling” as disclosed by Chan that positively regulates the expansion of the skeletal stem cells (col 52, 1st para., see also Fig. 3C).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-5 and 10-14 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/835,928. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for identifying, isolating, or enriching skeletal stem cells comprising identifying BMPR1A of cited application anticipates the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific with respect to other markers. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Claim 6 and 9 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/835,925, in view of Chan et al., (US 11,083,755, filed 1/06/2016, patented 8/10/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for identifying, isolating, or enriching skeletal stem cells comprising identifying BMPR1A of cited application using a polypeptide makes obvious the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the instant application claims are more specific with respect to the polypeptide being an antibody and using FACs.
Nevertheless, using an anti-BMPR1A antibody to FACS isolate BMPR1A+ stem cells was well known in the art (Example 4, col 74 of Chan).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have practice the method of identifying or isolating or enriching skeletal stem cells comprising identifying BMPR1A expressing cells claimed by cited application, and do so with a FACS antibody method as taught by Chan with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so because this was an effective means to identify, isolate, or enrich cells.
Since the instant application claims are obvious over cited application claims in view of Chan, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARTHUR S LEONARD/Examiner, Art Unit 1631
Prosecution Insights