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
Applicant’s election without traverse of Group II (claims 14-18) in the reply filed on 10/20/2025 is acknowledged.
Claims 1-13 and 19-20 have been canceled, claims 21-34 are newly added, and claims 14-18 and 21-34 have been considered on the merits.
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.
Claim(s) 14-16, 18, 21-31 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansen et al. (WO2015171142A1; IDS ref.) in view of Mathew et al. (2017, Life Sciences) and Semler et al. (US 10,973,953 B1; filing date of 8/18/2016)
Regarding claims 14, 22-23 and 34, Jansen et al. teach a method of treating any tissue injury or tissue defect using a placental composition comprising manipulated placental tissues (para. 94-95, 188). Jansen et al. teach that the placental tissue is amniotic membrane (para. 75, 79, 95 and 282). Jansen et al. teach that placental tissue such as placental or amniotic membrane can be used for wound healing and it comprises MSCs, epithelial cells or fibroblasts (para. 5, 11, 76, 99; p.72, claim 1; p.74, claim 26).
While Jansen et al. teach that the placental composition is subjected to a hypoxic environment to mimic the hypoxic conditions found in chronic wounds (para. 293), which resulted in the increase of the production of VEGF by 200% (para. 295), however, Jansen et al. do not teach that the placental composition being primed prior to the administration.
Mathew et al. teach that hypoxia primed placental mesenchymal stem cells are utilized for wound healing (see entire document).
Semler et al. teach a method and a composition comprising a primed tissue comprising viable cells using various stimuli including hypoxia useful for treating chronic wounds (col. 54, lines 32-49). Semler et al. teach that the primed and/or conditioned tissue or viable cell population are from placenta, amnion, chorion, umbilical cord, Wharton’s Jelly, etc. (col. 57, line 66 – col. 58, line 7).
It would have been obvious to a person skilled in the art to prime or pretreat the placental composition of Jansen et al. with a hypoxic condition prior to the administration for treating an injury or wound with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the placental composition of Jansen et al. comprises mesenchymal stem cells (see para. 5), and Mathew et al. teach that hypoxia primed placental mesenchymal stem cells are utilized for wound healing and Semler et al. teach that primed placenta tissue with hypoxic conditions is useful for treating chronic wounds.
Regarding claim 15, Jansen et al. teach that the placental composition can provide for improved healing of wounds and the wounds include epidermal wound, chronic wound, acute wound, etc. (para. 95 and 190).
Regarding claim 16, Jansen et al. teach topical administration (para. 189).
Regarding claim 18 and 21, the wherein clause of these claims is directed to a result of the method of claim 14, and the limitation does not require any additional active steps to the method steps of claim 14. While the limitation discloses “determined by a cellular functional assay” in the wherein clause, however, this is not an active step required by the claimed method. Rather this is considered as optional (see MPEP 2111.04). Thus, the wherein clause does not provide any patentable weight in determining patentability of the claimed method. As Jansen et al. in view of Mathew et al. and Semler et al. teach the identical method steps as claim 14, the results of the method taught by the cited reference are expected the same as the claimed results.
Regarding claim 24 directed to a form of a sheet, Jansen et al. teach the use of amniotic membrane and it is considered as a sheet form.
Regarding claim 25, Jansen et al. teach that the chorion membrane was cut into pieces then minced into small pieces (para. 241), and the placental composition is minced to small uniformly-sized pieces (para. 246).
Regarding claim 26, Jansen et al. teach that the placental tissue composition comprises a pharmaceutically acceptable carrier (para. 37 and 163; p.73, claim 17).
Regarding claim 27, Jansen et al. teach that the composition can be formulated into a liquid, a solution, a gel, a slurry or suspension (para. 128).
Regarding claim 28, Jansen et al. teach that the placental composition further comprises a saline solution (para. 128) or albumin (a protein) and/or sugars, electrolyte solution, etc. (para. 130).
Regarding claims 29-31 directed to the composition further comprising one or more bioactive materials including cytokines or growth factors, etc. as a byproduct of a hypoxia priming process, Jansen et al. teach that the priming of the placental composition with hypoxic conditions would increase in VEGF production (i.e. growth factor), and the placental compositions comprise one or more angiogenic factors including VEGF (para. 48, 112 and 116). As VEGF is secreted into a culture condition for the placental composition, the teachings of Jansen et al. would meet the limitations of claims 29-31.
Regarding claim 34, Jansen et al. teach that the placental tissue composition is cryopreserved (para. 20-21; p.72, claim 1).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansen et al. in view of Mathew et al. and Semler et al. as applied to claim 14 above, and further in view of Morse et al. (WO2012/112410A2; published on 8/23/2012).
Regarding claim 17, Jansen et al. in view of Mathew et al. and Semler et al. do not teach the composition being coated onto the surface of a medical device implant, and implanting the coated device into the subject.
Morse et al. teach micronized placental tissue composition for treating wounds, and can be applied to a medical device such as an implantable medical device (p.32, lines 9-28).
It would have been obvious to a person skilled in the art to use the placenta composition of Jansen et al. in view of Mathew et al. and Semler et al. to coat a medical implant device for the purpose of treating wounds. As Morse et al. teach the micronized placental tissue composition is to treat wounds (p.22, lines 6-24), one skilled in the art would recognize that the implantable medical device is for the same purpose of wound healing.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansen et al. in view of Mathew et al., and Semler et al. as applied to claims 14 and 29 above, and further in view of Sinclair et al. (US2018/0104282 A1)
Regarding claim 32 directed to the one or more bioactive materials comprising TNF-a at an amount of about 5-50 ng/ml, Jansen et al. in view of Mathew et al. and Semler et al. do not teach the limitation.
Sinclair et al. teach that cryopreserved amniotic membranes are known to release higher amounts of VEGF into the supernatant or tissue matrix in response to the combination of hypoxia, TNFa (inflammation), and LPS (bacterial infection) (para. 262). Sinclair et al. teach that the culture medium (stimulation medium) for evaluating angiogenic response (i.e. VEGF secretion) utilizes 2 mL of 100 mg/mL TNF-a into 20 ml of culture medium (para. 215), and this would be 10 ng/ml of TNF-a in the culture medium.
It would have been obvious to a person skilled in the art to use 10 ng/ml of TNFa taught by Sinclair et al. along with the hypoxic condition taught by Jansen et al. to prime the placental composition of Jansen et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because Sinclair et al. teach the combination of TNFa and hypoxia and LPS would increase VEGF secretion from the amniotic membrane.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansen et al. in view of Mathew et al., and Semler et al. as applied to claims 14 and 29 above, and further in view of Bulati et al. (2020, Frontiers in Immunology; published on 2/12/2020), Prasanna et al. (2010, PLOS One), Shi et al. (2010, Cell Research) and as evidenced by Menard et al. (2013, Stem Cells and Development)
Regarding claim 33 directed to the one or more bioactive materials comprising IFN-g at an amount of about 5-50 ng/ml, Jansen et al. in view of Mathew et al. and Semler et al. do not teach the limitation.
Bulati et al. teach that the human amnion-derived mesenchymal stromal/stem cells (hAMSCs) are primed with IFN-g resulting in increased immunomodulatory effect of the hAMSCs (Abstract). Bulati et al. teach that the activation of MSCs by certain pro-inflammatory cytokines including IFN-g and TNF-a is necessary for the manifestation of their immunosuppressive properties (p.2, Introduction).
Prasanna et al. teach that pro-inflammatory cytokines, IFNg and TNFa, influence immune properties of Wharton Jelly derived mesenchymal stem cells (see entire document).
It would have been obvious to a person skilled in the art to utilize IFN-g to prime the placental composition of Jansen et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because it is known in the art that priming MSCs with IFN-g would enhance immunomodulatory properties of MSCs and the enhanced immunosuppressive properties of MSCs would be beneficial for tissue repair/regeneration and wound healing according to Shi et al. (see abstract).
Regarding the concentration, Prasanna et al. teach that WJ-MSCs are primed with IFNg at the concentration of 150 U/ml (p.3, 1st col., MSC Priming). The 150 U/ml of IFNg taught by Prasanna et al. is considered the same as 10 ng/ml according to Menard et al. (p.1790, 2nd col. last para.). As Prasanna et al. teach the overlapping concentrations of IFNg as claimed, and thus, it would have been obvious to one skilled in the art try the concentration taught by Prasanna et al. for the priming of the placental tissue taught by Jansen et al. in view of Mathew et al. and Semler et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631