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 .
Election/Restrictions
Applicants’ election without traverse of Group 2, and the species of CD321 being absent (claim 7), CD49e being present (claim 19), hyaluronic acid (claim 24), cartilage (claim 26), hyaline cartilage (claim 27), articular cartilage (claim 28) and arthritis (claim 29), in the reply filed on July 7, 2025 is acknowledged. Applicants did not indicate explicitly whether their election was with or without traverse. Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, a non-elected Group, there being no allowable generic or linking claim. Claims 1-5 and 8-17 have been canceled; no claims have been added. Claim 6 has been amended. Claims 6, 7 and 19-29 are examined on the merits herewith. The restriction requirement is deemed proper and is made final.
Claim Rejections - 35 USC § 112, (b)
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 21-23 and 25 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 claims are indefinite because they are confusing and unclear.
Claim 21 recites that the stem cells are treated as a therapeutic agent. What does this phrase mean? How are the stem cells treated as a therapeutic agent? If the intended meaning is that the stem cells are prepared or formulated as a composition that is administered in a therapeutically effective amount, to repair or regenerate tissue in a subject in need thereof (as claim 6 is a method of making, a method of making the stem cells), claim 21 should be so amended. Clarification and appropriate correction are required.
Claim 22 recites that the therapeutic agent is an injection. Chorionic villi stem cells are not an injection. If the intended meaning is that the therapeutic composition of claim 21 (which comprises these stem cells) is administered via injection, claim 22 should be so amended. Clarification and appropriate correction are required.
Claim 23 recites that the therapeutic agent further includes a hydrogel. If the intended meaning is that the therapeutic composition of claim 21 further comprises a hydrogel (stem cells cannot include a hydrogel), claim 23 should be so amended. Clarification and appropriate correction are required.
Claim 25 recites that the stem cells are treated for tissue generation. How are these stem cells treated; what is the treatment step, or set of steps, to effect tissue generation? Do Applicants mean tissue regeneration, as the composition comprising the stem cells is for wound or tissue repair or regeneration? If such is the intended meaning, claim 25 may be amended to recite the method of claim 6, further comprising the steps of preparing the stem cells obtained in step 2 as a therapeutic composition, and administering a therapeutically effective amount of this composition to a subject in need of tissue repair or tissue regeneration, to effect repair or regeneration of the damaged or missing tissue. Clarification and appropriate correction are required.
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.
Claim(s) 6 and 20-22 and 25-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ha et al. (US 2016/0324901 A). Ha et al. disclose a method of isolating stem cells from the bCT (the basal chorionic trophoblast layer) of the chorionic membrane. The bCT is adjacent to the chorionic membrane on the fetal side and is the lower 25%, or 20 – 30% (see paragraphs 6 and 32) of the tCT (the total chorionic trophoblast layer). See Fig. 1 and paragraphs 1, 6-8, 12, 13, 28, 31, 32, 36 and 63. The lower 30% of the tCT is about the same as, and is not significantly different from, the region adjacent to the chorionic membrane/plate that extends up to a third of the distance to the distal end of the villi (with respect to the native structure around the fetus). In the method of Ha et al., the bCT that includes the villi and the interstices among the villi is isolated as used as the starting material to prepare the stem cells. See claim 6.
The stem cells are fetal, as they are obtained from a placenta that was collected during a cesarean birth. See paragraph 63; see claim 20.
The stem cells are prepared as a composition that is a cellular therapeutic agent. This therapeutic agent can treat diseases and restore the functions of cells and tissues. See paragraph 51. The therapeutic agent can treat damaged or defective cartilage, including the damaged or defective cartilage in arthritis (osteoarthritis is a type of arthritis). See paragraphs 44, 52 and 53. See claims 21, 25, 26 and 29. Regarding claim 25, as noted above, the claim is indefinite, yet has been interpreted to mean that the stem cells are prepared as a therapeutic composition for treating and regenerating tissue. An interpretation is needed to provide Applicants with compact prosecution.
The cartilage treated is hyaline cartilage or articular cartilage. See paragraph 60; see claims 27 and 28.
Regarding claim 22, Ha et al. do not disclose that the therapeutic composition comprising the stem cells is administered via injection. One of ordinary skill in the art at the time that the invention was filed, however, would have known, or would have had every expectation, that if the target site of the therapeutic composition was an arthritic joint (such as a knee or hip or shoulder), this therapeutic composition would have had to be administered via injection, to reach the interior of the joint. This claim does not distinguish the invention over the reference.
The reference does not use the exact same words that Applicants do, yet, it discloses the same subject matter. In view of the foregoing, a holding of obviousness is required.
Claim(s) 7 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ha et al. (US 2016/0324901 A), in view of Ferreira et al. (“Comprehensive characterization of chorionic villi-derived mesenchymal stromal cells from human placenta,” Stem Cell Research and Therapy 9(28):1-17, 2018), cited in Applicant’s PCT application and IDS; and Muench et al. (“The human chorion contains definitive hematopoietic stem cells from the the fifteenth week of gestation,” Development 144:1399-1411, 2017). The teachings of Ha et al. are discussed above. Ha et al. disclose that the stem cells from the bCT display the cell surface/marker proteins CD44, CD73, CD90 and CD105, and that they lack the cell surface/ marker proteins CD31, CD34, CD45 and HLA-DR. See paragraphs 37, 42 and 43. The reference is silent as to other cell surface markers/proteins. Ferreira et al. disclose that the stem cells from the bCT (or chorionic villi) lack the cell surface/ marker protein CD275, and that they display and lack the same cell surface/marker proteins disclosed by Ha et al. See p. 9 and Table 3. See claims 7 and 19. Muench et al. disclose that human chorionic stem cells display relatively high levels of the cell surface marker/protein CD49e, and that this marker/protein is a β1 integrin adhesion molecule (type α5β1) that regulates homing and retention of the stem cell. See pp. 1406 and 1408. See claim 19. Thus, these claims do not distinguish the invention over the prior art.
Claim(s) 7 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ha et al. (US 2016/0324901 A), in view of Ferreira et al. (“Comprehensive characterization of chorionic villi-derived mesenchymal stromal cells from human placenta,” Stem Cell Research and Therapy 9(28):1-17, 2018), cited in Applicant’s PCT application and IDS; Muench et al. (“The human chorion contains definitive hematopoietic stem cells from the the fifteenth week of gestation,” Development 144:1399-1411, 2017); Sugano et al. (“Junctional adhesion molecule-A, JAM-A, is a novel cell-surface marker for long-term repopulating hematopoietic stem cells,” Hematopoiesis 111(3):1167-1172, 2008); and Denk et al. (“Early detection of Junctional adhesion molecule-1 (JAM-1) in the circulation after experimental and clinical polytrauma,” 2015(id no. 463950):1-7, 2015).
. The teachings of Ha et al., Ferreira et al. and Muench et al. are discussed above. Ha et al. disclose that the stem cells from the bCT display the cell surface/marker proteins CD44, CD73, CD90 and CD105, and that they lack the cell surface/ marker proteins CD31, CD34, CD45 and HLA-DR. See paragraphs 37, 42 and 43. The reference is silent as to other cell surface markers/proteins. Ferreira et al. disclose that the stem cells from the bCT (or chorionic villi) lack the cell surface/ marker protein CD275, and that they display and lack the same cell surface/marker proteins disclosed by Ha et al. See p. 9 and Table 3. See claims 7 and 19. Muench et al. disclose that human chorionic stem cells display relatively high levels of the cell surface marker/protein CD49e, and that this marker/protein is a β1 integrin adhesion molecule (type α5β1) that regulates homing and retention of the stem cell. See pp. 1406 and 1408. See claim 19. None of these references disclose that the stem cells from the bCT (or chorionic villi) lack the marker/protein CD321. Denk et al. disclose that CD321 is commonly referred to as JAM-1 or JAM-A, junction adhesion molecule-1 or junction adhesion molecule-A, and that this marker/protein is expressed on hematopoietic stem cells that facilitate the long-term repopulation and re-endothelialization of injured blood vessel walls. See pp. 1-2. Sugano et al. disclose that JAM-A/CD321 is expressed on hematopoietic cells, such as leukocytes, platelets and erythrocytes. See p. 1167. In view of these teachings, the artisan of ordinary skill at the time that the invention was filed would not have expected CD321 to be present on the stem cells of the bCT (chorionic villi), because these stem cells do not go on to form blood cells. They are MSCs (mesenchymal stem cells); see Ferreira et al., Abstract, i.a. Thus, these claims do not distinguish the invention over the prior art.
Claims 23 and 24, although indefinite as discussed above, are free of the prior art. Ha et al., discussed above, do not disclose that their therapeutic composition is formulated as a hydrogel, or a hydrogel comprising one of the polymers listed in claim 24.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROSANNE KOSSON whose telephone number is (571)272-2923. The examiner can normally be reached M, T, Th- 9-6; W- 9-2.
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/ROSANNE KOSSON/Primary Examiner, Art Unit 1759 2025-07-14
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