DETAILED ACTION
This action is in reply to papers filed 8/14/2025.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20220305061A1, Published 9/29/2022.
Election by Original Presentation
Newly submitted independent claim 12 is directed to an acellular human amnion-derived composition, comprising: a plurality of tissue-remodeling biomolecules comprising; cystatin C (CST3), plasminogen activator inhibitor-1 (PAI-1), matrix metallopeptidase 1 (MMP1), nidogen-1 (NID1), cathepsin L (CTSL), clusterin (CLU), TIMP metallopeptidase inhibitor 1 (TIMP1), TIMP metallopeptidase inhibitor 2 (TIMP2), tumor necrosis factor superfamily member 11A (TNFRS11A), and transforming growth factor beta-induced protein ig-h3 (BIGH3);
one or more proliferation biomolecules comprising macrophage-colony stimulating factor (MCSF); a plurality of angiogenic biomolecules comprising pentraxin 3 (PTX3), angiogenin (ANG) thrombospondin 1 (THBS1), transforming growth factor beta induced (TGFBJ), and angiopoietin 1 (ANG1); a plurality of migration biomolecules comprising syndecan 4 (SDC4) and dickkopf WNT signaling pathway inhibitor 3 (DKK3); a plurality of anti-inflammatory biomolecules comprising follistatin like 1 (FSTL1), galectin 1 (LGALS1), and c-x-c motif chemokine 14 (CXCL14); and one or more anti-microbial biomolecules comprising beta-2-microglobulin (B2M). Claims 13-20 are dependent upon on new claim 12.
However, newly submitted claim 12 (and its dependents) are distinct from independent claim 1. This is because independent claim 1 is drawn to an acellular human amnion-derived composition comprising biomolecules selected from groups consisting of specific biomolecules. This is in contrast to new claim 12 which is drawn an acellular human amnion-derived composition comprising biomolecules selected from groups comprising specific biomolecules. In U.S. patent law, "comprising" indicates an open-ended claim, allowing for additional, unrecited components, while "consisting of" signifies a closed claim, limiting the invention to only the specified components. The choice between these terms determines the scope of the patent protection, with "comprising" offering broader protection and "consisting of" providing a narrower, more restrictive scope. Accordingly, the two products are distinct. See MPEP 806.06.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 12-20 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Withdrawn Rejection(s)
The 112(b) rejection of claims 1-3 is withdrawn in view of amendments made to the claims.
Maintained Rejection(s)
Claim(s) 1, 3, 8 and 11 remain rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.). Applicant’s arguments will be considered following maintained rejection.
Claims 2 and 4 remain rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3, 8 and 11 and further in view of Grillari et al. (WO2015052345A1, Published 4/16/2015). Applicant’s arguments will be considered following maintained rejection.
Claim 5 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3, 8 and 11 and further in view of Gimbel et al. (Arch Surg. 2001 Mar;136(3):311-7. Applicant’s arguments will be considered following maintained rejection.
Claim 6 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3, 8 and 11 and further in view of Cappuzzello et al. (J Invest Dermatol. 2016 Jan;136(1):293-300..). Applicant’s arguments will be considered following maintained rejection.
Claim 7 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3, 8 and 11 and further in view of Neuss et al. (Stem Cells, Volume 22, Issue 3, May 2004, Pages 405–414). Applicant’s arguments will be considered following maintained rejection.
Claim 9 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598 and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3 8, and 11 and further in view of Li et al. (Biomed Pharmacother. 2017 Jul:91:174-180.). Applicant’s arguments will be considered following maintained rejection.
Claim 10 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017),Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3 8, and 11 and further in view of Li et al. (J Ocul Pharmacol Ther. 2012 Apr;28(2):179-85.). Applicant’s arguments will be considered following maintained rejection.
Claims 1-11 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-9 and 12-16 of copending Application No. 17290662 (reference application). Applicant’s arguments will be considered following maintained rejection.
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.
Prior Art Rejection 1
Claim(s) 1, 3, 8 and 11 remain rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.).
Prior Art Rejection 2
Claims 2 and 4 remain rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3, 8 and 11 and further in view of Grillari et al. (WO2015052345A1, Published 4/16/2015).
Prior Art Rejection 3
Claim 5 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3, 8 and 11 and further in view of Gimbel et al. (Arch Surg. 2001 Mar;136(3):311-7.
Prior Art Rejection 4
Claim 6 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3, 8 and 11 and further in view of Cappuzzello et al. (J Invest Dermatol. 2016 Jan;136(1):293-300..).
Prior Art Rejection 5
Claim 7 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3, 8 and 11 and further in view of Neuss et al. (Stem Cells, Volume 22, Issue 3, May 2004, Pages 405–414).
Prior Art Rejection 6
Claim 9 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017), Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598 and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3 8, and 11 and further in view of Li et al. (Biomed Pharmacother. 2017 Jul:91:174-180.).
Prior Art Rejection 7
Claim 10 remains rejected under 35 U.S.C. 103 as being unpatentable over Matheny, R. (PgPub US20140335046A1, Published 11/13/2014) in view of Baker et al. (US20170189479A1, Filed 7/6/2017),Sheets et al. (PLoS One. 2016 Jul 26;11(7):e0159598) and Rajasekaran et al. (Biochim Biophys Acta Biomembr. 2019 Jan;1861(1):256-267.) as applied to claims 1, 3 8, and 11 and further in view of Li et al. (J Ocul Pharmacol Ther. 2012 Apr;28(2):179-85.).
Applicant’s Arguments/Response to Arguments
Applicant argues: An amnion derived fluid has a biological synergy that work
together to produce a greater effect than the sum of the individual effects. Furthermore, using the amnion derived fluid preserves the functional ratios between the biomolecules that cannot be achieved by artificial supplementation. The synergistic combination of the claimed invention is not shown in the prior art.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. At the outset, it is unclear what “synergy” Applicant refers to as the claims do not require such. Moreover, no ratio of the biomolecules is claimed. It is further noted that the breadth of the claims embraces many permutations of an acellular human amnion-derived composition and no working example is provided that teaches each of these permutations provides a synergy. For example, an acellular human amnion-derived composition comprising CSTB, DPP4, FLT1, TGFB1, AXL, LGALS1, B2M- which is encompassed by the breadth of claim 1- is not identified by the specification as having synergy.
Applicant argues: Furthermore, Matheny's ECM comprising an acellular amniotic membrane differs fundamentally from conditioned media in composition, preparation, and potential applications. Matheny is a solid, sheet-like biomaterial in comparison to conditioned media which is a liquid medium. Applicant's conditioned media contains factors secreted by the cells but has no physical ECM structure. Acellular amniotic membrane does not comprise the secreted cytokines as conditioned media does. Acellular amniotic membrane mechanism of action is a biological scaffold to provide a mechanical coverage and barrier as opposed to conditioned media which works through paracrine signaling. Acellular amniotic membrane has a limited profile of growth factors compared to conditioned media. Many factors in an acellular amniotic membrane are not bioavailable unless liberated. In comparison to conditioned media where the factors are secreted into liquid, readily available.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. Para. 91 of Matheny makes clear that a disclosed sterilized acellular ECM composition can also be produced in any suitable form, including, for example and without limitation, a solid, liquid, gel, particulate, emulsion, or suspension form similar to cosmetic compounds or lotions. Thus, Applicant’s argument that Matheny’s ECM is a “solid, sheet-like biomaterial” is incorrect.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Double Patenting
Claims 1-11 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-9 and 12-16 of copending Application No. 17290662 (reference application).
Applicant’s Arguments/Response to Arguments
Applicant’s arguments: In response to the nonstatutory double patenting rejection, a timely filed terminal disclaimer is being included with this response.
In Response: The terminal disclaimer was disapproved because the person who signed the terminal disclaimer is not the applicant, patentee or an attorney or agent of record.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632