DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of Group II, claims 14, 16, 17, 26, and 34, and the species of Wharton’s Jelly Perinatal Stromal Cells, lung or pulmonary fibrosis, embodiment (i) in claim 17, and embodiment (iii) in claim 34, in the reply filed on 16 April 2026 is acknowledged. However, upon further search and consideration, the species of amnion perinatal stromal cells, placenta proper stromal cells, whole chorion derived stromal cells, and/or chorionic villi-derived stromal cells (claim 14); skin fibrosis (claim 16), skin and scar tissue in (i), and embodiments (ii)-(v) (claim 17), and embodiments (i), (ii), (iv), and (v) (claim 34), have been rejoined and examined on the merits.
Claims 1, 2, 6, 15, 25, and 29-33, and the non-elected and not rejoined species, have been withdrawn. Claims 14, 16, 17, 26, and 34 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/US2022/018108, filed 28 February 2022, which claims priority to U.S. Provisional Application No. 63/154027, filed 26 February 2021.
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 14, 16, 17, 26, and 34 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.
Claim 14 refers to claim 1, which is a non-elected and withdrawn claim. As such the dependency is unclear. For the purposes of examination, reference to the composition of claim 1 is interpreted to include: a perinatal stromal cell (PSC) composition comprising at least one of the following cell types: (i) amnion perinatal stromal cells (APSCs), (ii) placenta proper stromal cells (PPSCs), (iii) Wharton's jelly perinatal stromal cells (WPSCs), (iv) whole chorion derived stromal cells (CSCs), and (v) chorionic villi-derived stromal cells (CVCs), and a pharmaceutically acceptable carrier.
Regarding claim 16, the phrase "e.g." (abbreviation of “for example”) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding claim16, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 34, the phrase "e.g." (abbreviation of “for example”) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 17 and 26 are included in this rejection, as these claims depend from above rejected claims and fails to remedy the noted deficiencies.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 14, 16, 17, 26, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jansen et al. (IDS; WO 2015/171142, Published 2015).
Regarding claims 14, 16, and 17, Jansen et al. teach administration of a perinatal stromal cell composition to a subject, the composition comprising: amnion perinatal stromal cells, placenta proper stromal cells, Wharton's jelly perinatal stromal cells, whole chorion derived stromal cells, and/or chorionic villi-derived stromal cells, with a pharmaceutically acceptable carrier (Abs.; para. 36, 75-76, 93). Administration is effective for treating a wound or tissue defect, including a skin wound, chronic or acute wound, a tunnel wound developed due to prolonged inflammation of a chronic wound, and for reducing fibrosis at a wound site (Para. 6, 190, 204), wherein administration to human skin stimulates tissue regeneration (Para. 205), and reduces or prevents the formation of scar tissue (Para. 118). Which is administration to a subject in need of reducing chronic inflammation and consequent tissue fibrosis, including skin fibrosis, and scar tissue.
Jansen et al. teach the method as claimed, including the composition as claimed. As such, the results of reducing collagen content/deposit in the tissue; decreasing a fibrotic score in the tissue including an Ashcroft or Ishak score; decreasing a molecular marker of fibrosis, including αv-integrin expression, MMP-2 activity, pAKT/AKT expression ratio, and miR199 expression; and increasing an anti-fibrotic molecular marker, including Caveolin-1 expression, would naturally flow from performance of the method as taught by Jansen et al.
With regard to claim 26, Jansen et al. teach the method as claimed, including the composition as claimed. As such, the result of decreasing a molecular marker of inflammation in a tissue as compared to the molecular marker in the tissue before administration of the composition, the molecular marker including TNFα expression, INFγ expression, or a combination thereof; and/or the result of decreasing CD45+ T-cell infiltration in a tissue as compared to before administration, would naturally flow from performance of the method as taught.
With regard to claim 34, the composition comprises chorionic villi-derived stromal cells and a pharmaceutically acceptable carrier (Abs.; Para. 36, 93). Additionally, the subject to be treated with the composition has a tunnel wound (Para. 6), wherein a tunnel wound puts a subject at risk for sepsis (see Art of Record: Net Health). Thus, a subject with a tunnel wound is at risk of developing sepsis. Further, treatment is effective for a subject with a tunnel wound developed due to prolonged inflammation of a chronic wound (Para. 6, 190, 204), which is a subject with tissue inflammation.
Conclusion
No claims are allowable.
Art of Record:
Net Health, Tunneling Wounds 101: Essential Tips for Practitioners, Nov. 4, 2024, Available online at: www.nethealth.com/blog/tunneling-wounds-101-essential-tips/ (tunneling wounds can cause sepsis).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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