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 .
Priority
The instant application was filed 3/22/2024. This application claims benefit to U.S. Provisional Application Serial Number 63/491,676, filed 3/22/2023. Claims 1-22 are pending.
Election/Restrictions
Applicant’s election without traverse of Group III, claims 19-22, in the reply filed on 5/15/2026 is acknowledged. Claims 1-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/15/2026. Applicant traverses the species election, persuasively arguing that searching the additional species will not unduly burden the Office; hence, the species election requirement is withdrawn. Claims 1-18 are withdrawn and claims 19-22 have been examined on the merits.
Information Disclosure Statement
The information disclosure statements submitted on 3/25/2024 have been considered by the examiner. NPL cite 3 of the 4-page IDS is lined through because the document was not received. NPL cites 14, 17, 22, 36, 39 and 44 of the 8-page IDS are lined through because the documents were not received. NPL cites 17 and 21 of the 9-page IDS are lined through because the documents were not received.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84(i) states "Words must appear in a horizontal, left-to-right fashion when the page is either upright or turned so that the top becomes the right side, except for graphs utilizing standard scientific convention to denote the axis of abscissas (of X) and the axis of ordinates (of Y)." In the instant application, words in Figures 2 (page 3) and 5A (page 7) do not appear in a left-to-right hand fashion.
Additionally, some text in Figs. 1A, 1B, 1C, 3A, 4A and 5A is illegible, specifically the text next to the pregnant mouse in Fig. 1A, axis labels in Fig. 1B, labels in Fig. 1C, scale text in Fig. 3A and 4A and text within the photographs in Fig. 5A are completely illegible. Most of the text in most of the figures appears to be grainy and smeared (see Fig. 1C as an example). Additionally, figures 1C, 4C and 4D have dark smudges in the upper left of the figures. Additionally, figures 3A, 4A, 5A have an extra “A” at the upper left of the figure and 3B has an extra “B” at the upper left of the figure. The extra “A”s or “B” should be removed.
Additionally, in the phenograph in Fig. 1C, the presumed different colors are indistinguishable in black and white; hence, the phenograph is impossible to interpret.
Amendment to make the figures legible is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 drawings will not be held in abeyance.
Claim Objections
Claim 22 is objected to because of the following informalities:
Claim 22, lines 10-12, recites “fetal microchimeric cells or fetal extracellular vesicles that express comprising Lineage-Sea-I +c-kit- (LSK-) phenotype of murine hematopoietic cells called very small embryonic-like (VSEL) cells” which should be “fetal microchimeric cells or fetal extracellular vesicles that express markers comprising Lineage-Sea-I+c-kit- (LSK-) phenotype of murine hematopoietic cells called very small embryonic-like (VSEL) cells” or equivalent language to be grammatically correct.
Claim 22, lines 16-17, recites “fetal microchimeric cells or fetal extracellular vesicles comprising that express both CD4 and CD8, and low T cell receptor, characteristic of double-positive thymocytes” which should be “fetal microchimeric cells or fetal extracellular vesicles.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 19-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a subject in need of regenerating or protecting one or more maternal organs comprising: isolating at least one of: fetal microchimeric cells or fetal extracellular vesicles comprising stem cell-like properties from a pregnant female during pregnancy; and injecting the fetal microchimeric cells or fetal extracellular vesicles into a patient in need thereof in an amount sufficient to regenerate and protect the one or more maternal organs wherein the paternal DNA encodes a fluorescent marker protein (tdTomato) and wherein the fetal microchimeric cells or fetal extracellular vesicles express the paternal marker and are obtained from the pregnant female by killing the female, dissecting the heart, dissociating the cells of the heart and visualizing the fetal cells by flow cytometry or mass spectroscopy, does not reasonably provide enablement for practicing the method without killing the mother and isolating the fetal microchimeric cells from organs of the cadaver.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with claims 19-22.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art; (d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The claims are not overly broad (factor a). The nature of the invention is biotechnology (factor b), i.e., the physiological arts, which are known to be unpredictable (MPEP 2164.03 - factor e); however, the skill of the ordinary artisan in such arts is generally high (usually Ph. D. level - factor d). The prior art does not disclose a non-invasive way of obtaining fetal microchimeric cells from maternal tissues (factor c); hence, a person of ordinary skill in the art at the time of filing would have relied on the working examples and direction provided by the inventor (factors f and g). The instant disclosure does not provide working examples or guidance for obtaining non-genetically-marked fetal microchimeric cells from maternal tissues non-invasively and ONLY discloses isolating genetically-labeled fetal cells by killing the pregnant female, isolating the heart from the cadaver and visualizing and/or isolating the genetically-marked cells by flow cytometry or mass spectroscopy. Hence, a person of ordinary skill in the art at the time of filing would have had to engage in undue experimentation (factor h) to practice the claimed method for the full scope of the invention; therefore, claims 19-22 are rejected under 35 U.S.C. 112(a) for failing to provide enablement commensurate in scope with the invention.
Claim Rejections - 35 USC § 103
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 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, 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 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 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Vadakke-Madathil et al., 2019 (cite U, attached PTO-892; herein “Vadakke-Madathil”).
Vadakke-Madathil teaches isolating fetal microchimeric cells expressing Cdx2 and eGFP from end-gestation placenta, i.e., isolating fetal microchimeric cells comprising stem cell-like properties from a pregnant female during pregnancy, and injecting them into the tail vein of infarcted wild-type male mice which resulted in significant improvement of contractility of the heart of the injected animal, i.e., injecting the fetal microchimeric cells into a patient in need thereof in an amount sufficient to regenerate and protect the heart (Abst.).
Vadakke-Madathil teaches that fetal microchimeric cells naturally migrate to injured maternal heart (Abst.); hence, a person of ordinary skill in the art at the time of filing would have found it obvious to inject the fetal microchimeric cells into a maternal patient in need thereof in an amount sufficient to regenerate and protect the maternal heart; therefore, claims 19-22 are prima facie obvious.
Regarding claim 21, the fetal microchimeric cells were not obtained from a pregnant female subject with a premature birth or preterm pregnancy; thus, claim 21 is prima facie obvious.
Regarding claim 22, Cdx2 is not expressed in hematopoietic cells; hence, the fetal microchimeric cells are non-hematopoietic and do not express CD45; therefore, claim 22 is prima facie obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
Prosecution Insights