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 .
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.
Claim Status
Applicant’s arguments dated 2/4/26 have been received and entered in the application.
Claims 93-120 are currently pending.
Claims 114-118 are withdrawn as directed to non-elected inventions without traverse.
Claims 93-113, 119-120 are elected and examined on the merits.
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.
Claim(s) 93-94, 96, 99, 102-104, 106, 108-113 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brahm, T., US Patent No. 10,905,800 (hereinafter Brahm).
Regarding claims 93, 102-104, Brahm disclose ocular grafts fabricated from human birth tissues, and methods of making thereof (Abstract, col 4 ln 43-55). Brahm discloses obtaining human birth tissue material and removing placental globe, umbilical cord, other gelatins, fluids, cells, and extracellular matrix (col 5 ln 46-55). The recovered membrane may be stored in a sterile saline solution comprising about 0.09% to 20% sodium chloride (NaCl) for up to five days (col 6 ln 19-25). In some embodiments, multiple saline rinse cycles may be performed, including two or more separate rinse cycles (col 6 ln 55-62).
Regarding claim 94, Brahm does not explicitly disclose that the unseparated amnion chorion tissue comprises an intermediate layer. However, this is a feature of a naturally occurring placenta. As Brahm discloses utilizing an intact placental membrane comprising an amnion and chorion, it is inherent that the placental membrane of Brahm includes an intermediate layer.
Regarding claim 96, Brahm discloses that excess blood and fluids may be removed from the membrane by stirring or swirling the fluid, or by placing a basin on a shaker (col 6 ln 44-54). Preferably, the container is of a sufficient size to allow the membrane to be spread out in the container (col 6 ln 44-54).
Regarding claims 99, 106, Brahm discloses that the membrane is stored in the saline solution at a temperature of about 1 to 10 °C (col 6 ln 19-25).
Regarding claims 108-109, 111, 113, Brahm discloses that the membrane may be treated with an alcohol solution, air-dried and terminally sterilized (col 2 ln 18-26, col 7 ln 18-col 8 ln15).
Regarding claim 110, Brahm discloses that the membrane may be cut to any desired size (col 7 ln 47-col 8 ln 4). Typically the composition has a thickness of between 0.01 to 0.35 mm (col 7 ln 47- col 8 ln 4).
Regarding claim 112, Brahm discloses that the amniotic and chorionic membranes may be utilized alone or in various combinations to form a layered composition (col 4 ln 63-col 5 ln 10).
Therefore, every limitation of claims 93-94, 96, 99, 102-104, 106, 108-113 is present in Brahm and the subject matter is anticipated.
Claim Rejections - 35 USC § 103
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.
Claim(s) 97-98, 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brahm as applied to claims 93-94, 96, 99, 102-104, 106, 108-113 above.
Regarding claim 97, Brahm does not disclose that the washing comprises at least 3 to 10 washing steps. However, Brahm discloses that at least two washing steps are performed (col 6 ln 55-62). Therefore there is a suggestion present in Brahm that more than two washing steps may be performed.
Regarding claim 98, Brahm does not disclose that the washing media is exchanged at least once between any washing step. However, Brahm discloses that multiple saline rinse cycles may be performed, including two or more separate rinse cycles (col 6 ln 55-62). Therefore, there is a suggestion present that the separation of washing steps would include exchanging the washing media.
Regarding claim 101, Brahm does not disclose that tissue processing is performed at a steady temperature. However, it would be obvious to one of ordinary skill in the art to try performing the processing at a steady temperature as one of a finite number of options for tissue processing (steady temperature or variable temperature), with the predictable result that a placental tissue graft could be successfully prepared.
Claim(s) 95, 100, 105, 107 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brahm as applied to claims 93-94, 96, 99, 102-104, 106, 108-113 above, and in view of Daniel et al., US Patent No. 8,409,626 (cited on IDS dated 7/6/22, hereinafter Daniel).
Brahm does not disclose washing the tissue according to particular protocols.
Daniel discloses therapeutic placental tissue grafts and methods of making thereof (Abstract). Daniel discloses obtaining a human placental and storing in saline solution at a refrigeration temperature (col 3 ln 41-55, col 4 ln 11, 20). The placenta is gently massaged and warmed to room temperature to help separate and remove blood clots (col 4 ln 42-54). In one embodiment, clotted blood is removed and the chorion rinsed in an 18% saline solution for 30 minutes (col 6 ln 30-54). During the first rinse the saline is heated to approximately 48 °C (col 6 ln 30-54). The tissue is then washed in a Triton-X wash solution, rinsed with water, washed with phosphate-buffered saline, and rinsed with water a second time (col 6 ln 30-54). Daniel explains that the disclosed method produces a graft with no evidence of remaining blood (col 6 ln 30-54).
As both Brahm and Daniel disclose methods of preparing placental tissue grafts, one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to utilize the washing protocol of Daniel in the methods of Brahm as use of a known washing technique to better remove blood remnants in the tissue graft.
Claim(s) 119-120 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brahm as applied to claims 93-94, 96, 99, 102-104, 106, 108-113 above, and in view of Koob, T., US Publication No. 2016/0199537 (hereinafter Koob).
Brahm does not disclose that the tissue is powderized.
Koob discloses multi-layered tissue grafts comprising placental tissues (Abstract). Koob discloses preparing tissue grafts comprising amnion and chorion ([0038]-[0050]). In some embodiments, the tissue graft may be further micronized into particles ([0009], [0077]-[0078]). Koob explains that the micronized composition may be molded, formulated for systemic, local, or topical treatments ([0092]-[0094]). Koob further explains that the topical application is particularly well suited for treatment of burns, psoriatic sores, dermatitis, and wrinkles ([0094]).
As both Brahm and Koob disclose methods of preparing placental tissue grafts, one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to micronize the graft of Brahm for increased administration modalities as suggested by Koob.
Response to Arguments
Applicant's arguments dated 2/4/26 have been fully considered but are not persuasive as explained in detail below.
Claim(s) 93-94, 96, 99, 102-104, 106, 108-113 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brahm.
Applicant argues that step (b) requires “washing” for 12 to 36 hours or overnight; applicant argues that the specification distinguishes between storage and washing (Response p7). Applicant argues that Brahm fails to disclose “washing” for 12 to 36 hours or overnight such that Brahm cannot anticipate the present claims (Response p7-8).
In response, applicants have not specifically defined the term “washing”. Further, applicants at paragraph [0033] indicate that washing may be performed “by soaking” the tissue. Therefore, under a broadest reasonable interpretation the term “washing” is interpreted to encompass any action by which the tissue is subjected to a fluid (e.g., soaking, rinsing, flushing, etc.). As Brahm discloses an initial processing of dissecting the amnion/chorion tissue away from the placental disc followed by soaking in a sterile saline solution comprising about 0.09% to 20% sodium chloride (NaCl) for up to five days Brahm is deemed to anticipate the claims as presented.
Applicant argues that the word “intact” recited in Brahm is not synonymous with “unseparated” as per the present invention (Response p8-9). Applicant indicates that Brahm’s use of “amnion and/or chorion” indicates that Brahm differentiates between the amnion and chorion, and that Brahm only teaches a separated amnion (Response p7-8).
The term “intact” is commonly understood to refer to something that is integral, whole or complete. Brahm discloses utilizing an “intact amnion and/or chorion” (emphasis added). This indicates that, at least in some embodiments, Brahm contemplates using an integral amnion and chorion membrane. Further, under MPEP § 2123 a prior art reference may be relied upon for all that it contains and reasonably suggests to one of ordinary skill in the art, including nonpreferred embodiments. Preferred embodiments do not constitute a teaching away from a broader disclosure or a nonpreferred embodiment. That Brahm discloses that a preferred embodiment is composed of a separated amnion, does not constitute a teaching away from utilizing an intact amnion and chorion.
Claim(s) 97-98, 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brahm.
Applicant argues that throughout Brahm teaches processing a separated amniotic membrane (Response p9-10). Applicant argues that one of ordinary skill in the art would not have a reasonable expectation for processing an unseparated amnion/chorion (Response p9-10).
As noted above, under MPEP § 2123 a prior art reference may be relied upon for all that it contains and reasonably suggests to one of ordinary skill in the art, including nonpreferred embodiments. Preferred embodiments do not constitute a teaching away from a broader disclosure or a nonpreferred embodiment. Brahm explicitly discloses that the tissue may comprise “both a chorionic and an amniotic membrane” (See e.g., col 4 ln 56-col 5 ln 19).
Applicant argues that one of ordinary skill in the art would not have a reasonable expectation of successfully cleaning an unseparated amnion/chorion tissue using the methods of Brahm (Response p10-11). Applicant points to the Griffiths Declaration filed 10/18/21 in parent application 15/760,757 in support of this position (Response p10-11).
As per MPEP 201.06(c) where applicants desire to rely on an earlier filed affidavit or declaration, applicant should file the affidavit or declaration in the current application. Additionally, the Griffiths declaration is not commensurate in scope with the claims currently presented. The Griffiths declaration indicates that to achieve the low hemoglobin levels claimed in the prior application, multiple washing and cleansing steps are required. The present claims do not require a certain hemoglobin level, nor do the claims require the additional steps described in the Griffiths declaration. Therefore, applicant’s arguments are considered spurious.
Claim(s) 95, 100, 105, 107 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brahm in view of Daniel. Claim(s) 119-120 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brahm in view of Koob.
Applicant argues that neither Daniel nor Koob cure the deficiencies noted in Brahm (Response p11-13).
As discussed supra, the examiner disagrees that Brahm fails to anticipate the claims as presented. 2/4/26
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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