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 .
Applicant’s amendment and response filed on 5/4/2026 has been received and entered into the case.
Claims 1-13, 19-20, 25 and 33 have been canceled, claims 35-36 are newly added, and claims 14-18, 21-24, 26-32 and 34-36 have been considered on the merits. All arguments have been considered.
Response to Amendment
The claim rejection under 35 USC 103 has been withdrawn due to the instant amendment and replaced with new 103 rejections to address the new limitations and claims.
Claim Rejections - 35 USC § 103 (New Rejection)
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, 21-24, 26-31 and 34-35 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; of record) and Semler et al. (US 10,973,953 B1; filing date of 8/18/2016; of record)
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 the newly added limitation of the wherein clause of claim 14; the wherein clause of claim 18 as amended; the wherein clause of claim 21 as amended; and the newly added claim 35, Jansen et al. in view of Mathew et al. and Semler et al. do not particularly teach the limitations.
However, these limitations are directed to the characteristics of hypoxia primed placental tissue or the results of priming placental tissue with hypoxic conditions. These limitations do not require any additional active step to be performed for the claimed method other than the active step of priming placental tissue with hypoxic condition as disclosed in claim 14. Thus, it is considered that they are directed to the inherent characteristics/results of the hypoxia primed placental tissue. As the combined teachings of Jansen et al. in view of Mathew et al. and Semler et al. teach the identical step of priming placental tissue as claimed, the primed placental tissue of Jansen et al. in view of Mathew et al. and Semler et al. would inherently secrete IL-1RA as claimed.
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02.
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 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; of record)
It is noted that claim 32 has been amended. However, the newly added limitation is disclosed alternatively using “and/or”. Thus, the claim is interpreted as directed to TNF-alpha.
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) 36 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 Triaud et al. (2003, JALA)
Regarding claim 36 directed to the parameters for the priming step directed to incubating the placental tissue for 1-96 hours at about 37°C, 1-5% O2, 1-10% CO2 and 90-96% relative humidity in a culture medium comprising 1-3% serum, Jansen et al. teach that the hypoxia is induced by incubating the placental composition under hypoxic conditions which is at 37°C, 5% CO2 and 1% O2 (para. 294). Jansen et al. also teach the use of 1% FBS for culturing placental composition (para. 333).
However, Jansen et al. do not teach the relative humidity as claimed.
Triaud et al. teach that an automated cell culture incubator would be maintained the relative humidity at around 95% (p.3, 1st col.).
While Jansen et al. teach the use of cell culture incubator, however, a person skilled in the art would have at once envisaged that Jansen et al.’s cell culture incubator would be an automated cell culture incubator.
It would therefore have been obvious to a person skilled in the art to use the relative humidity at around 95% used for mammalian cell culture condition by automatically controlled incubator as taught by Triaud et al. for the priming step of Jansen et al. in view of Mathew et al. and Semler et al. with a reasonable expectation of success.
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.
Response to Arguments
Applicant's arguments filed 5/4/2026 have been fully considered but they are not persuasive.
It is noted that the claim rejections presented above have been modified to address the new limitations and claims.
Regarding the teaching of Jansen et al., applicant argued that Jansen’s process is a wound-mimic response experiment, not administering ex vivo hypoxia primed viable placental tissue composition having the claimed IL-1RA secretion profile. The claim rejection has acknowledged that Jansen et al. do not use hypoxic conditions prior to the administration, and Mathew et al. and Semler et al. have been introduced to address the deficiency.
Applicant alleged that the missing IL-1RA limitation cannot be supplied by inherency. The Examiner respectfully disagrees with this allegation. The increased secretion of IL-1RA is considered as a result of the step priming the placental tissue with hypoxic conditions. Thus, the same process step of priming a placental tissue using a hypoxic condition should inherently produce the same results unless proven otherwise. Applicant has not been successfully shown that the increased IL-1RA secretion is not due to the priming of the placental tissue.
Applicant asserted that the cited references do not disclose identical method steps. The examiner disagrees. The claimed step of claim 14 is to administer a composition comprising hypoxia primed viable placental tissue. There is no other specific detailed method steps than just “priming” a viable placental tissue with “hypoxia”. The combined teaching of Jansen et al. in view of Mathew et al. and Semler et al. teach the identical step of priming placental compositions.
Applicant argued that claim 36 is independently patentable. A newly added claim 36 has been addressed under a separate 103 rejection above, and for the reason disclosed in the rejection, claim 36 is obvious over the combined teachings of the cited references.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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