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 .
Claim status
In the reply on 01 September 2023, Examiner is pursuing the claims filed on 01 September 2023, wherein Applicant disclosed claims 1-10. Therefore, claims 1-10 are herein pending.
Accordingly, claims 1-10 are under current examination.
Priority
This application was filed 09/01/2023 and is a 371 application of PCT/CL2022/050020 filed on 03/02/2022, which claims benefit to the Provisional Application 63155725 filed on 03/02/2021. Thus, the earliest possible priority for the instant application is 03/02/2021.
Thus, the earliest possible priority for the instant application is 03/02/2021.
Information Disclosure Statement
Applicant has not disclosed all information material to patentability. See MPEP §2001.04 and 37 C.F.R. § 1.56. Applicant is respectfully reminded the individuals covered by 37 C.F.R. § 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question. As set forth by the court in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). See MPEP §2001.06(b).
Applicant is also 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: abbreviations such as "Pacer" should be spelled out in full at the first encounter in the claims. Appropriate correction is required.
Specification and Drawing Objection
The specification of the disclosure filed 01 September 2023 is objected because it discloses “Large intestine and cecum were extracted from the peritoneal cavity of mice. To determine if MSC-hPacer treatment affected overall colon physiology/morphology we measured the colon length (Figure 8C and 8D). MSC-hPacer treated mice had a similar colon length compared to healthy control mice and improved colon length compared to MSC-EV treated mice. These results suggest that MSC-hPacer show improved capabilities to alleviate DSS-induced inflammatory colon injury compared to non-modified MSC,” however, applicant filed the drawing on 01 September 2023 do not includes Figure 8C and 8D. Therefore, the Specification do not conform to standards as “readable and reproducible for publication purposes” as set forth in MPEP § 507 (see also 37 CFR 1.84(b)).
Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the specification and drawings will not be held in abeyance.
Therefore, 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 7-8 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 pre-AIA the applicant regards as the invention.
Claims 7-8 provide for the use of Mesenchymal Stem Cells genetically modified for overexpressing Pacer (MSChPacer), however, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
Claim Rejections – 35 U.S.C. 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 7-8 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). See MPEP 2173.05(q).
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 1-6 and 9-10are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (Mol Cell Biochem 476, 1135–1149, Published 16 November 2020; cited in PTO892; hereinafter “Deng”), in view of Cheng et al. (Molecular cell, 65(6), pp.1029-1043, 2017; cited in PTO892; hereinafter “Cheng” with evidentiary reference Lu et al. (US20200171093A; cited in PTO892; hereinafter “Lu”).
Claim interpretation: From the wording thereof, it is understood that a genetically modified MSC is later transformed with a vector containing genetic information to express human Pacer as discloses in claim 1. However, the description shows that MSCs are genetically modified with a vector containing genetic information to express Pacer (see SPEC p. 7 last ¶). Therefore, for the sole purpose of expediting prosecution the search and analysis of this claim, it is interpreted that MSC is genetically modified with a vector containing genetic information to express human Pacer.
Regarding claim 1-3, Deng discloses that the biological activity of human MSCs (Table 2) allows for the therapeutic use thereof in the treatment of diverse inflammatory conditions, autoimmune disorders and degenerative disorders and more specifically teaches the macroautophagy as a promising regulatory target for improving MSC based therapeutic efficacy (hereafter referred to as autophagy) (abstract and p. 1137 right-col. 2nd ¶, Fig. 1-2). These MSC cells can be obtained from different organs and tissues, such as bone marrow, muscle, fatty tissue, dental pulp, placenta, hair follicles, cerebral periosteum and umbilical cord (p. 1137 left-col. 2nd ¶).
Although Deng mentions that autophagy plays an important role in the biological function of MSCs and that it could be a promising target for improving the therapeutic efficiency of these cells. Still, Deng does not mention modifying the autophagy process by transforming the MSCs with a vector that allows for Pacer overexpression. However, such was known in the prior art.
Regarding claim 1, Cheng discloses the 293T cells were treated with vector containing genetic information to express human Pacer (Figure 1A of Cheng) and teaches the overexpression of Pacer in 293T cells increases autophagy (Fig. 2 and p. 1031 right col. 1and 2nd ¶ of Cheng).
MPEP 2143 (A) states that combining prior art elements according to known methods to yield predictable results. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395. Accordingly, it would have been obvious to practice the autophagy regulated MSCs of Deng and include the vector containing genetic information to express human Pacer as taught by Cheng with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Cheng because overexpression of Pacer in the cells increases autophagy (Fig. 2 and p. 1031 right col. 1and 2nd ¶ of Cheng). Therefore, a person skilled in the art who wants to intervene in the autophagy in MSCs appears to consider genetically modifying them in the same way that the 293T cells were modified by Cheng. In regard to the reasonable expectation of success in doing so, include the Pacer gene in the vector of Cheng had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Regarding claim 4, Deng discloses that the MSC is a bone merrow derive human MSCs (Table 2 of Deng). Although Deng does not specifically MSC are CD73+, CD90+, CD105+ and CD166+, however it is the inherent property of the bone marrow derived human MSC. Supported by the evidentiary reference Lu et al. (US202001710 93A; cited in PTO892) (see [0015] ¶ of Lu). See MPEP 2131.01 (III) for case law on inherency.
Regarding claims 5-6, since document Deng is explicit with respect to the therapeutic use of MSCs and, therefore, pharmaceutical formulations comprising MSCs are already known. Accordingly, Deng in combination with Cheng teaching it would be obvious that POSITA can prepare the pharmaceutical formulations comprising MSC-hPacer. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969). The invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made as evidenced by the teachings of Deng et al. in view of Cheng especially in the absence of unexpected results.
Regarding claims 9-10, the recitation of “A method of treating an individual having or at risk of developing a disease of inflammatory origin” is not given patentable weight as it is an intended used of the product that does not limit a claim to a particular structure (see MPEP 2111.02).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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, Christopher Babic can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684