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 submission filed on June 24, 2026 has been entered and considered. Rejections and/or objections not reiterated from the previous action mailed March 24, 2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-3, 5-7, 10, 12, and 19-20 drawn to a method of preparing a fetal support tissue product and species election of umbilical cord amniotic membrane (claim 5) in the reply filed on February 12, 2026 is acknowledged.
Claims 21, 23-26, 31, and 45-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 4, 8-9, 11, 13-18, 22, 27-30, and 32-44 were previously canceled. Claims 6, 21, 23-26, 31, and 45-46 have been withdrawn. In view of the prior art, the species of placental amniotic membrane (claim 5) has been rejoined.
Claims 1, 2, 5-6, 10, 12, and 19 have been amended. Claim 3 has been canceled.
Claims 1-2, 5, 7, 10, 12, and 19-20 are examined on the merits.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/US2021/056518, filed on October 25, 2021. The instant application claims benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) to U.S. provisional applications 63/105770, filed on October 26, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 24, 2026 are in compliance with the provisions of 37 CFR 1.97 based on submission of the filing fee. The IDSs submitted August 2, 2023; October 9, 2024; and February 12, 2026 are in compliance with the provisions of 37 CFR 1.97 and were previously considered by the examiner.
Claim Interpretation
Applicant has amended claims 1, 5-6, 10, 12, and 19 to include limitations that the fetal support tissue is cryopreserved. Applicant’s instant specification does not specifically recite that the fetal support tissue is cryopreserved but does disclose that the fetal support tissue may be frozen prior to homogenizing (Para. [0042], [0054]) by exposing the fetal support tissue to liquid nitrogen (Para. [0054]). Therefore, based on Applicant’s instant specification, a cryopreserved fetal support tissue is considered to be fetal support tissue which has been frozen.
Claim Rejections - 35 USC § 103
Claims 1-2, 5, 7, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tseng et al. (US 9,682,044, found in IDS dated 08/02/2023, hereafter “US ‘044”) in view of Corning Filtration Guide (2009, retrieved 07/31/2025, https://web.archive.org/web/20200929003355/https://www.corn ing.com/catalog/cls/document s/selection-guides/t_filterselectionguide.pdf, pp. 1-20; found in IDS dated 02/12/2026).
This is a new rejection necessitated by Applicant’s amendment. However, this rejection shares substantial similarity to the rejection as previously set forth in the office action dated March 24, 2026. The following new rejection provides additional interpretation of the claims which is necessitated by Applicant’s amendment in the response filed on June 24, 2026. Any aspect of Applicant’s traversal that pertains to the rejection as newly set forth will be provided following the new statement of rejection.
With regard to claims 1 and 2, US ‘044 teaches generation of a fetal support tissue product (Abstract) comprising “grinding” of fetal support tissue (Col. 30, lines 57-58) which can include homogenizing (Col. 24, lines 5-8) and include use of a freezer/mill (Col. 31, line 6) as instantly disclosed in Para. [00220] of the specification. US ‘044 teaches that the fetal support tissue can be frozen, which is considered to reasonably read on a cryopreserved fetal support tissue, prior to homogenizing (Col. 28, lines 16-22). US ‘044 teaches that grinding the fetal support tissue can include be accomplished by a pulverizer (e.g. Corvaris Cryoprep) (Col. 30, line 66) and performed while continuously freezing the fetal support tissue (Col. 31, lines 30-37), which is considered to reasonably read on cryopulverizing a cryopreserved fetal support tissue to obtain a cryopulverized cryopreserved homogenized fetal support tissue. US ‘044 teaches that a buffer or water can be mixed with the resultant ground fetal support tissue (i.e., cryopulverized cryopreserved homogenized fetal support tissue) (Col. 33, lines 38-40) in order to form a solution (Col. 37, line 36), which is considered to reasonably read generating an extract of fetal support tissue via mixture with an excipient (see also Example 9).
US ‘044 teaches that the fetal tissue support product can be terminally sterilized via any medically acceptable method (Col. 35, lines 45-47) and provides several examples of treatment using fetal support tissue product where the fetal support tissue is in a liquid formulation (e.g., See Examples 12, 13, 14, 15, and 24). However, despite the fact that sterilization by filtration is a technique widely known in the art, US ‘044 is silent as to sterilization via filtering for a liquid fetal support tissue product.
Corning Filtration Guide teaches that sterilization of biological fluids can be done using a filter having a pore size of 0.2 µm or 0.22 µm as recited in claim 2 (Pg. 3, Step 1 and Table 1) and that clarification and prefiltration of solutions can be done to improve filter performance using a filter having pore size of 0.45 µm or larger and (Pg. 3, Step 1 and Table 1). Thus, the Corning Filtration Guide teaches that sterilization of biological fluids can be performed via prefiltration using a filter membrane of 0.45 µm or greater, which is considered to reasonably read on a membrane having a pore size of 0.7 µm or less followed by use of a filter membrane having a pore size of 0.2 µm or 0.22 µm, which is considered to reasonably read on a membrane having a pore size of 0.4 µm or less as recited in claim 1.
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the instant invention to choose sterilization via filtration as taught by the Corning Filtration Guide for use in the method of producing a fetal support tissue product comprising homogenizing fetal support tissue and generating an extract via addition of an excipient as taught by US ‘044 with a reasonable expectation of success. US ‘044 teaches that for sterilization of a fetal tissue support product can be via any suitable method (Col. 35, lines 46-47), that the fetal support tissue product can be in a “syringeable” aqueous form (Col. 37, lines 29-34), and examples where the fetal support tissue product is administered via injection (Ex. 12-15). Sterilization by filtration is a technique widely known and used in the art, and which can be performed fairly quickly, easily, and inexpensively. Thus, a skilled artisan would have been motivated to choose sterilization by filtration using filters having pore sizes as taught by the Corning Filtration Guide in order to produce a fetal support tissue product in aqueous form which is sterile and can be safely administered to a subject for treatment.
Additionally, it is noted that the instant specification does not provide a definition for what is to be considered “about” related to the pore sizes in the membrane used for sterilization by filtering. As such, the broadest reasonable interpretation of “about” 0.7 µm includes sizes from 0.07 µm to 7 µm, the broadest reasonable interpretation of “about” 0.4 µm includes sizes from 0.04 µm to 4 µm, and the broadest reasonable interpretation of “about” 0.2-0.3 µm includes sizes from 0.02-0.03 µm to 2-3 µm.
With regard to claim 5, US ‘044 teaches that the cryopreserved fetal support tissue can be placental amniotic membrane (Col. 1, line 44) and/or umbilical cord amniotic membrane (Col. 27, line 67; see also Col. 32, lines 57-59).
With regard to claim 7, US ‘044 teaches that the cryopreserved fetal support tissue product can be mixed with saline (Col. 33, line 44).
With regard to claim 20, US ‘044 teaches that the fetal support tissue product is anti-inflammatory (Col. 3, line 21).
Claims 10, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US ‘044 and Corning Filtration Guide as applied to claim 1 above, and further in view of Tseng et al (US 8,153,162, found in IDS dated 08/02/2023, hereafter “US ‘162’).
With regard to claim 10, as detailed above, the combination of US ‘044 and Corning Filtration Guide teaches a method of preparing a fetal support tissue product comprising homogenizing a cryopreserved fetal support tissue in order to generate a cryopulverized cryopreserved fetal support tissue, adding an excipient in order to make a fetal support tissue extract, and sterilizing by filtration using a filter membrane having a pore size of 0.7 µm or less followed by a filter membrane having a pore size of 0.4 µm or less.
The combination of ‘044 and Corning Filtration Guide is silent regarding centrifuging the cryopulverized cryopreserved fetal support tissue extract.
US ‘162 teaches an extract of amniotic membrane (Col. 13, line 63) derived from the placenta (Col. 13, line 64), which is considered to reasonably read on a fetal support tissue product, prepared by pulverizing amniotic membrane in liquid nitrogen (Col. 14, lines 1-4), which is considered to reasonably read on homogenizing a cryopreserved fetal support tissue; and adding PBS (Col. 14, line 4), which is considered to reasonably read on adding an excipient; in order to form an amniotic membrane extract (Col. 14, lines 12-13). US ‘162 teaches that the amniotic membrane extract can be centrifuged (Col. 14, lines 15-16) and that centrifugation can be used to remove large particles from the fetal support tissue extract (Col. 11, line 64-65).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to apply a method step comprising centrifuging after adding an excipient as taught by US ‘162 to the method of preparing a fetal support tissue product comprising homogenizing a cryopreserved fetal support tissue, adding an excipient to produce an extract, and sterilization by filtration as taught by the combined teachings of US ‘044 and Corning Filtration Guide. A skilled artisan would have recognized that centrifuging the extract prior to filtration could be used to remove any large particles of fetal tissue which would help reduce clogging of the membrane during the filtration/sterilization process. A skilled artisan would have had a reasonable expectation of success as both US ‘044 and US ‘162 teach production of a cryopreserved fetal support tissue product comprising homogenization and addition of an excipient and centrifugation is a commonly used technique well known to those having ordinary skill in the art.
With regard to claim 12, as detailed above, the combination of US ‘044 and Corning Filtration Guide teaches a method of preparing a fetal support tissue product comprising homogenizing a cryopreserved fetal support tissue, adding an excipient in order to make a fetal support tissue extract, and sterilizing by filtration using a filter membrane having a pore size of 0.7 µm or less followed by a filter membrane having a pore size of 0.4 µm or less.
The combination of ‘044 and Corning Filtration Guide is silent regarding centrifuging the cryopulverized cryopreserved fetal support tissue and dilution after centrifuging.
US ‘162 teaches that the fetal support tissue extract can be centrifuged (Col. 14, lines 15-16) after addition of the excipient in order to remove any remaining large particles (Col. 11, line 64-65) and lyophilized (Col. 14, line 23). Additionally, US ‘162 teaches that lyophilized fetal support tissue can be reconstituted in a suitable buffer prior to use (Col. 12, lines 58-60), that the concentration of the fetal support tissue can be varied as needed (Col. 12, lines 61-62), and that additional compounds (including buffers) can be added to the reconstituted fetal support tissue in order to reach the desired concentration (Col. 12, lines 65-67 and Col. 13, lines 1-4).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to apply addition of buffers to reconstituted lyophilized fetal support tissue product (i.e., dilution) after the fetal support tissue product has been centrifuged as taught by US ‘162 to the method of preparing a fetal support tissue product as taught by the combination of US ‘044 and Corning Filtration Guide with a reasonable expectation of success. A skilled artisan would be motivated to apply dilution of a fetal support tissue product because US ‘162 teaches that the desired amount of fetal support tissue in a preparation can vary based on the intended use of the product and that lower concentrations of fetal support tissue in a preparation is desired for some procedures (Col. 12, lines 62-64). A skilled artisan would have had a reasonable expectation of success as both US ‘044 and US ‘162 teach compositions comprising fetal support tissue produced by homogenization and addition of an excipient which have therapeutic uses. Additionally, dilution of solutions in order to modify concentrations is a commonly used technique well-known to those having ordinary skill in the art.
With regard to claim 19, as detailed above, the combination of US ‘044 and Corning Filtration Guide teaches a method of preparing a fetal support tissue product comprising homogenizing a cryopreserved fetal support tissue, adding an excipient in order to make a fetal support tissue extract, and sterilizing by filtration using a filter membrane having a pore size of 0.7 µm or less followed by a filter membrane having a pore size of 0.4 µm or less. US ‘162 teaches that the fetal support tissue extract can be centrifuged (Col. 14, lines 15-16) after addition of the excipient in order to remove any remaining large particles (Col. 11, line 64-65) and lyophilized (Col. 14, line 23).
US ‘044 teaches that fetal support tissue comprises hyaluronic acid (i.e., hyaluronan) (Col. 45, line 43) which can diffuse out of the fetal support tissue product (Col. 45, lines 50-51), but is silent as to the specific amount of HA in the fetal support tissue.
US ‘162 teaches that the fetal support tissue product comprises hyaluronan (HA) (Col. 9, line 47) and that fetal support tissue extracts prepared with a 1:1 ml/g ratio of PBS and fetal support tissue, centrifuged, lyophilized, and reconstituted with water (See “Amniotic Membrane Extract Preparations, starting at Col. 13, line 63) comprise 44-75 µg/ml of HA (Table 1). US ‘162 also teaches that the amount of HA can be assayed with a HA Quantitative Test Kit (Example 2).
Therefore, as US ‘162 teaches a fetal support tissue comprising a target final concentration of 44-75 µg/ml of HA, it would have been obvious to one having ordinary skill in the art as an intermediate HA target concentration for dilution of fetal support tissue, for example to be able to assay the diluted fractions for therapeutic benefit at various points in the purification process.
Additionally, it is noted that the instant specification does not provide a definition for what is to be considered “about” related to the concentration of HA in a diluted fetal support tissue. As such, the broadest reasonable interpretation of “about” 1 µg/mL to about 150 µg/mL includes ranges of HA amounts from about 0.1 µg/ml to about 1.5 mg/ml.
Response to Arguments
Applicant's arguments filed June 24, 2026 are acknowledged and have been fully considered but they are not persuasive.
Claims 1-2, 5-7, 10 and 20 were rejected under 35 U.S.C 103 as being unpatentable over Tseng et al. (US ‘044) in view of Corning Filtration Guide (Corning). Claims 10, 12, and 19 were rejected under 35 U.S.C 103 as being unpatentable over US ‘044 and Corning in further view of Tseng (US ‘162).
Claim 3 has been canceled, rendering any traversal of the rejection of claim 3 moot.
Applicant asserts that the combination of US ‘044 and Corning fail to teach each element of the instant invention, specifically that US ‘044 is silent as to “cryopulverization” and does not disclose any benefit to cryopulverization in fetal support tissue production and further that Corning does not cure the deficiencies of US ‘044 (Pg. 9). Specifically, Applicant traverses that a skilled artisan would not be motivated to arrive at the instant claims based on the various processing steps disclosed in US ‘044 as US ‘044 does not disclose cryopreservation or cryopulverization nor any advantages of those processes and that the instant specification discloses that cryopulverization produced a fetal support tissue of higher potency compared to methods of production using other homogenization techniques (Pg. 10, 1st & 2nd paras.). Applicant further asserts that Corning does not teach or suggest any benefits of filtering the extract with a membrane having a pore size of about 0.7 microns or less followed by filtering the extract with a membrane having a pore size of about 0.4 microns or less which Applicant discloses results in less degradation of proteins of interest. Applicant asserts that a skilled artisan would not be motivated to apply two filtering steps using different sized membranes if sterilization were the motivation (Pg. 10, 3rd para.).
Applicant’s traversal has been fully considered but is not persuasive.
Regarding Applicant’s assertion that US ‘044 provides a “laundry list of potential processing steps”, Applicant is reminded that patents are relevant as prior art for all they contain and all they would have reasonably suggested to one having ordinary skill in the art (See MPEP 2123(I)).
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005).
In the instant case, Applicant has amended the instant claims to recite cryopulverization of a cryopreserved fetal support tissue. Based on the instant specification, cryopreservation appears to refer to fetal support tissue which has been frozen prior to pulverizing, thereby producing a cryopreserved cryopulverized fetal support tissue. As detailed supra, US ‘044 discloses that the fetal support tissue can be frozen (Col. 28, lines 16-22) prior to grinding via various methods including using a freezer/mill as instantly disclosed (Col. 31, lines 5-7), which is considered to reasonably read on a cryopreserved cryopulverized fetal support tissue. US ‘044 discloses that freezing the fetal support tissue prior to grinding results in a fetal support tissue product which has greater potency compared to a fetal support tissue product which is not frozen prior to grinding (Col. 28, lines 22-28). Thus, a skilled artisan would understand that the disclosure of US ‘044 discloses freezing of fetal support tissue prior to grinding as well as provides motivation for freezing by disclosing that freezing the tissue results in increased potency. Additionally, one of ordinary skill would expect frozen homogenized fetal support tissue to exhibit higher potency compared to room temperature homogenization because degrading enzymes and proteases are inactive during cryopulverization.
Although Applicant asserts that Corning does not teach or suggest any benefits of multiple filtering steps using membranes of different sizes and that a skilled artisan would not be motivated to apply two filtering steps using different sized membranes for sterilization, as detailed supra, Corning discloses prefiltration with a membrane larger than 0.45 microns in order to clarify solutions and improve filter performance and that routine sterilization is done with 0.2 - 0.22 micron filters (Pg. 3, Step 1). Therefore, Corning both discloses and provides motivation to use a two-part filtration step in order to sterilize solutions. MPEP 2144 (IV) states that the reason or motivation to modify a reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by Applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). In instant case, the prior art teaches to a two step filtrations process to improve the filter sterilization process. The fact that Applicant has potentially recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Additionally, Applicant’s traversal appears to rely on features of the fetal support tissue extract produced by the instant method including increased potency compared to other processing techniques (Pg. 10, 2nd para.) and reduced degradation of HC-HA/PTX3, HA, and other proteins based on use of filtering for sterilization (Pg. 10, 3rd para.).
As detailed supra, increased potency of a fetal support tissue due to freezing prior to homogenization is disclosed in the prior art of US ‘044. Although the cited prior art is silent as to sterilization by filtration limiting protein degradation, a skilled artisan would understand that use of filtration would prevent protein denaturation that could occur by using other sterilization methods such as heat and gamma, X-ray, or UV radiation.
Regarding the rejection of claims 10, 12, and 19, Applicant asserts that the improvements of the instant invention over US ‘044 and Corning and the deficiencies of US ‘162 overcome the obvious rejection (Pg. 11, 1st para.).
Applicant’s traversal has been fully considered but is not persuasive.
As addressed supra, US ‘044 discloses the method steps of the instant invention and provides reason for one having ordinary skill in the art to freeze fetal support tissue prior to homogenization and Corning discloses the instantly claimed filtration steps rendering the instant invention obvious. Although Applicant’s traversal references deficiencies of US ‘162, no specific remarks regarding the alleged deficiencies of US ‘162 could be found.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Liu et al. (US 8,071,135 and PG Pub US 20080181967, found in IDS dated 08/02/2023) teaches compositions comprising fetal support tissue and methods of making compositions comprising fetal support tissue including disrupting the fetal support tissue by homogenizing in an aqueous solution (Para. [0057]). Liu et al. further teach that compositions of the invention can be sterilized by any means known in the art, including filtration using a pore size less than about 0.45 microns or less than about 20 nanometers (Para. [0094]).
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 ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
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