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 (see notes in Action mailed 10/22/2019 regarding change in AIA status).
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/28/2025 has been entered.
Claim Status
Claims 1-9, 11-12, 15, 17-19, 22-23, 26-29, and 31-32 are pending. Claims 20-21 were canceled; claim 32 was newly added; and claims 12 and 31 were amended in the Reply filed 7/28/2025. Claims 11, 15, 17-19, 22-23, 26-29, and 32 are withdrawn. Claims 12 and 31 are presently examined.
Election/Restriction and Application Notes
Applicant's election with traverse of Group II (original claims 10-20 as filed 1/19/2017) and the species of “Example 2/Figure 1” in the reply filed on 6/30/2020 (see Second Requirement mailed 5/1/2020) was previously acknowledged, and the requirement was deemed proper and made final.
The metes and bounds of the elected species were set forth in a previous Action, which is incorporated herein (see, e.g., Final mailed 8/24/2020 at pages 3-5). The amended claim scope as filed 3/18/2024 excluded the originally elected species at least because claim 12(b) excluded NaOH, additional water, and required the usage of 100% pure H2O2 (see id). The amended claim scope filed 7/28/2025 continues to exclude the originally elected species because the claims exclude methods comprising additional steps, such as freeze/thaw cycles, the addition of 3.5 g 30% H2O2 per gram of dry tissue, the resuspension in additional sterile water following homogenization, etc. Accordingly, the instant claim scope continues to exclude the originally elected species.
Per MPEP § 803.02, examination has been extended to non-elected species within the scope of amended claim 12, namely a species having a functionally defined amount of blood combined with a functionally defined amount of H2O2, consisting only of steps 12(a)-12(h) as filed 7/28/2025. This species has been rejected under 35 USC 112, below.
Claims 1-9 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/9/2019.
Claims 11, 15, 17-19, 22-23, 26-29, and 32 are 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/30/2020.
Accordingly, claims 12 and 31 are examined on the merits.
Claim Interpretation
The claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. Applicant was invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Independent claim 12 is representative of the pending claim scope, and was again substantially amended in the most recent reply.:
12. (Currently Amended) A process for decellularizing human placental tissue comprising blood, said process consisting of the following steps:
(a) suspending pieces of said blood-containing human placental tissue in sterile water wherein the amount of blood in said placental tissue is effective to enable decellularization of the placental tissue using only hydrogen peroxide as the only decellularizing agent and without an adjunctive decellularizing agent;
(b) homogenizing the suspended pieces of placental tissue to form a slurry of the placental tissue;
(c) adjusting the pH of the slurry with HCl and, if necessary, NaOH, with mixing, to a pH of 2.5 to 5;
(d) adding to the slurry, with continued mixing, an amount of 30% by weight aqueous hydrogen peroxide effective to yield a slurry comprising decellularized placental tissue particles and unreacted hydrogen peroxide that continues to decellularize and reduce the particle size of the placental tissue in the slurry throughout the remaining process [[step]] steps;
[[(c)]](e) providing a particle size reduction separation filtering system comprising two filters, F1 and F2, wherein the pore size of each filter is selected to provide at least two filters having sequentially smaller pore sizes and there is produced an F1 filtrate, an F1 retentate, and an F2 filtrate and an F2 retentate, and wherein the pore sizes of the filter F1 ranges from 0.2 to 100 microns, and the pore sizes of the filter F2 ranges from 0.2 microns to 10 Kilo Daltons to yield a filtrate and retentate at each of said filters F1 and F2;
[[(d)]](f) subjecting the placental tissue in the slurry to particle size reduction steps while the unreacted hydrogen peroxide continues to decellularize and reduce the particle size of the placental tissue , wherein the particle size reduction steps comprise:
1) passing the slurry through filter F1 to produce an F1 filter filtrate and retentate;
2) passing the filtrate from the F1 filter through the F2 filter, thereby producing an F2 filter filtrate and retentate; and
3) passing the F2 filter filtrate back to said F1 filter retentate for passage through the F1 filter and further decellularization and particle size reduction ; and
[[(e)]](g) recovering the F2 filter retentate comprising a decellularized tissue product that comprises growth factors, and one or more of collagen, elastin, fibronectin and laminin[[,]]
; and
[[(f)]](h) lyophilizing the F2 filter retentate comprising isolated decellularized tissue particles.
The amended claim scope and meaning of terms has been discussed below.
The preamble of claim 12 (“for decellularizing....”) has been interpreted in view of MPEP § 2111.02(II), and has been reasonably identified as reciting an intended purpose or use that is fully satisfied by all embodiments that satisfy the positively recited method steps in the body of claim 12 (see, e.g., MPEP § 2111.02, §2111.02(II)).
“Consisting of” excludes any elements, step, or ingredient not specified (see, e.g., MPEP § 2111.03(II)). When the phrase "consists of" appears in a clause of the body of a claim, rather than immediately following the preamble, the "consisting of" phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole (see, e.g., MPEP § 2111.03(II)).
“Blood-containing” is understood to be equivalent to the previously utilized claim term “blood-laden”. The Examiner’s prior interpretation of “blood-laden” was set forth on record in a previous action (see, e.g., Action mailed 5/22/2024 at 6). The original disclosure states that “[t]he term ‘blood-laden’ is meant to be descriptive of any tissue which retains a residual amount of blood as part of the tissue” (see, e.g., Spec. filed 2/23/2021 at ¶[0024]), but also may encompass “a significant amount of blood” (see, e.g., Spec. filed 2/23/2021 at ¶[0011]). The specification identifies that tissue may be “rendered blood-laden” by “supplying exogenous blood thereto”, wherein the total amount of blood is unspecified, but presumably “can be varied over a wide range to yield suitable results” (see, e.g., Spec. filed 2/23/2021 at ¶[0011]). Accordingly, the amount of blood implied by “blood-containing” is understood to range from less than 0.001 µL1 to over 1 L, and to be equivalent to the prior art usage of partially exsanguinated tissues2.
Amended claim 12 now limits blood present in the method to an amount defined by the following functional limitation:
….wherein the amount of blood in said placental tissue is effective to enable decellularization of the placental tissue using only hydrogen peroxide as the only decellularizing agent and without an adjunctive decellularizing agent;
This “wherein” clause is understood to be a functional limitation that attempts to functionally define the amount of blood present and utilized in the claimed process. This limitation does not literally appear in the originally filed disclosure, and has raised issues under 35 USC § 112, as discussed in the new and revised rejections set forth below.
Amended claim 12 now limits the “30% by weight aqueous hydrogen peroxide” utilized in the method to an amount defined by the following functional limitation:
…an amount of 30% by weight aqueous hydrogen peroxide effective to yield a slurry comprising decellularized placental tissue particles and unreacted hydrogen peroxide that continues to decellularize and reduce the particle size of the placental tissue in the slurry throughout the remaining process [[step]] steps;
This “wherein” clause is understood to be a functional limitation that attempts to functionally define the amount of “30% by weight aqueous hydrogen peroxide” present and utilized in the claimed process. However, this functional limitation does not literally appear in the originally filed disclosure, and has raised issues under 35 USC § 112, as discussed in the new and revised rejections set forth below.
“Retentate”: One of ordinary skill in the fractionation and separation arts would understand that retentate is the portion of the sample that does not pass through a membrane/filter, and may also be called the concentrate. In tangential-flow filtration, the retentate is recirculated (see, e.g., US2004/0167320A1 at ¶¶[0098]-[0099], cited in previous action).
“Filtrate” (or “permeate”): One of ordinary skill in the fractionation and separation arts would understand that a filtrate (or permeate) is the portion of the sample that does pass through a membrane/filter (see, e.g., US2004/0167320A1 at ¶¶[0101]-[0099], cited in previous action).
“About”: The term “about” is undefined on record. The term “about” is given its ordinary meaning in view of the biochemical arts, and is understood to mean “within 20 percent” (see, e.g., US 2009/0028832 A13 at ¶[0111]; see also US 2009/0105341 A14 at ¶[0049]; see also US 2012/01786765, at ¶[0277]). Accordingly, with respect to the instant disclosure and with prior art of record, unless the term “about” is otherwise clearly defined, the term is reasonably inferred to indicate a range either “within 20 percent” of a recited number.
Amended claim 12 now recites “said process consisting of the following steps”. Accordingly, claim 12 is limited to a process consisting of steps (a)-(h). As such additional steps, such as those recited at amended claim 31 are excluded from the scope of instant claim 12 (see Rejection under 35 USC 112(d), below).
Regarding additional decellularization steps: Amended claim 12 is now limited to a method “consisting of” only steps 12(a)-12(h), and is therefore understood to fully exclude any additional “decellularizing agents”, non-oxidizing decellularizing agents6, or non-chemical decellularization processes7 to facilitate decellularization (e.g., sonication, freeze/thaw cycles, etc) that are not inherently or implicitly present in the claimed invention.
Decellularization agents present in the claimed process of amended claim 12: Instant claim 12 inherently comprises multiple “decellularization agents”.
First, the claim explicitly recites and requires “30% by weight aqueous hydrogen peroxide”.
Second, routine pH adjusting agents such as chemical agents acting as acids and bases are common decellularizing agents (see, e.g., Crapo8 at 3234 at col I at §§ 3.1.1, 3235 at Table 2), and such agents are recited at amended claim 12(c).
Third, “blood” naturally contains decellularizing agents as evidenced by Tamkovich9, which identifies that blood contains DNase and other hydrolyzing enzymes capable of degrading DNA (see, e.g., Tamkovich at abs, 191 at 1st ¶ to 192 at 1st partial ¶); nucleases are art-recognized decellularizing agents (see, e.g., Crapo at 3236 at col I-II at §§ 3.2.1, 3235 at Table 2).
Fourth, “blood” naturally contains approximately 400 ng/mL of trypsin (see, e.g., Temler et al.10 at abstract).
Accordingly, an artisan would readily appreciate that the claimed method would inherently and necessarily utilize at least the decellularizing agents of (i) hydrogen peroxide, (ii) chemical agents such as acids and/or bases, (iii) nucleases and other enzymes present in blood, and (iv) trypsin present in blood.
Additional claim interpretations are discussed below.
Denial of Priority
Applicant’s claim for the 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) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications Provisional Application No. 61/630,561 (filed 12/14/2011); Application No. 13/694,586 (filed 12/14/2012); and Application No. 13/986,970 (filed 6/20/2013) each fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
Claim 12 is representative and the applicable claim interpretation for instant claim 12 has been set forth above in a separate section entitled “Claim Interpretation” or otherwise discussed in rejections set forth under 35 USC 112(b), herein. Those discussions and interpretations pertaining to the pending claim scope are incorporated herein.
Lack of Express Support
Claim 12 is representative of the pending claim scope and does not literally appear in Pro’561 (filed 12/14/2011); App’586 (filed 12/14/2012); and App’970, and therefore the claims lack literal support in these prior filed applications.
As a non-exhaustive example, amended claim 12 now limits blood present in the method to an amount defined by the following functional limitation:
….wherein the amount of blood in said placental tissue is effective to enable decellularization of the placental tissue using only hydrogen peroxide as the only decellularizing agent and without an adjunctive decellularizing agent;
This “wherein” clause is understood to be a functional limitation that attempts to functionally define the amount of blood present and utilized in the claimed process, but this functional limitation does not literally appear in Pro’561, App’586, or App’970.
Second, as a non-exhaustive example, the applications fail to literally teach or disclose any example that “consists of” instant steps 12(a)-12(h) as presently claimed (i.e., relative to Example 2 of record, instant claim 12 excludes freeze/thaw cycles, the step of resuspension in sterile water following homogenization of tissue to a slurry, the step of pH to between 6.5 and 7 following filtering, etc.).
Accordingly, Pro’561, App’586, and App’970 fail to provide literal support for the pending claim scope as filed 3/18/2024.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirement, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
In the absence of express support, the relevant issue is whether or not the claimed invention is supported by Pro’561, App’586, or App’970 through implicit or inherent disclosures.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims is found in Pro’561, App’586, or App’970, at least because amended claim 12 was not implicitly or inherently disclosed, as an integrated whole11, in any priority application of record. Accordingly, even if such language was even present in a priority document, no guidance to selectively pick and choose some limitations, while ignoring others, to retroactively create an invention having the metes and bounds now claimed, exists in such documents (see Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000), stating that "[t]here is therefore no force to Purdue’s argument that the written description requirement was satisfied because the disclosure revealed a broad invention from which the [later-filed] claims carved out a patentable portion"; ” see Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323, 1329 (Fed. Cir. 2021), noting that “[a] written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention”).
Furthermore, multiple limitations appear to be completely novel and fail to correspond to any equivalent or synonymous language of record. For example, amended claim 12 now limits blood present in the method to an amount defined by the following functional limitation:
….wherein the amount of blood in said placental tissue is effective to enable decellularization of the placental tissue using only hydrogen peroxide as the only decellularizing agent and without an adjunctive decellularizing agent;
However, no structure/function relationship corresponding to this limitation appears literally, inherently, or implicitly in Pro’561, App’586, or App’970. Critically, zero examples of decellularization methods using “hydrogen peroxide as the only decellularizing agent” were actually disclosed on record because the disclosed methods rely upon routine pH adjusting using acids and bases, which are common decellularizing agents (see, e.g., Crapo12 at 3234 at col I at §§ 3.1.1, 3235 at Table 2), and such agents are recited at amended claim 12(c). Furthermore, “blood” naturally contains decellularizing agents as evidenced by Tamkovich13, which identifies that blood contains DNase and other hydrolyzing enzymes capable of degrading DNA (see, e.g., Tamkovich at abs, 191 at 1st ¶ to 192 at 1st partial ¶); nucleases are art-recognized decellularizing agents (see, e.g., Crapo at 3236 at col I-II at §§ 3.2.1, 3235 at Table 2). In addition, “blood” naturally contains approximately 400 ng/mL of trypsin (see, e.g., Temler et al.14 at abstract), and trypsin is an art-recognized decellularizing agent (see, e.g., Crapo at 3236 at col II at §§ 3.2.1, 3235 at Table 2). Furthermore, the originally elected example includes a freeze-thaw cycle (see, e.g., US’150 at ¶¶[0080]-[0081]), and “ice crystals” and freeze-thaw cycles are disclosed in the art as “physical and miscellaneous agents” for decellularization (see, e.g., Crapo at 3237 at col I at §§ 3.3.1, 3235 at Table 2). Accordingly, zero methods or descriptions of methods of record actually exist describing the functional limitation regarding “the amount of blood” recited in amended claim 12. Accordingly, such limitation is not supported literally, implicitly, or inherently by Pro’561, App’586, or App’970.
Amended claim 12 also attempts to limit the amount of “30% by weight aqueous hydrogen peroxide” utilized in the method to an amount defined by the following functional limitation:
…an amount of 30% by weight aqueous hydrogen peroxide effective to yield a slurry comprising decellularized placental tissue particles and unreacted hydrogen peroxide that continues to decellularize and reduce the particle size of the placental tissue in the slurry throughout the remaining process [[step]] steps;
This functional limitation does not literally appear in the originally filed disclosure. Although Applicant directs the Examiner to disclosures at ¶¶[0015], [0029], and [0062] (see, e.g., Remarks filed 7/28/2025 at 9 at 1st partial ¶ to first full ¶). However, the disclosures at ¶¶[0015], [0029], and [0062] do not even recite nor refer to “30% hydrogen peroxide” or placental tissue at all, and fail to provide any structure/function relationship permitting an artisan to reasonably determine how much “30% hydrogen peroxide” is “effective” to achieve the desired results set forth in the functional limitation. Accordingly, such limitation is not supported literally, implicitly, or inherently by Pro’561, App’586, or App’970.
Accordingly, Pro’561, App’586, and App’970 each fails to provide implicit or inherent support for the pending claim scope that synonymous or equivalent in scope, or otherwise commensurate in scope with the pending claims.
Conclusion
Accordingly, priority to Provisional Application No. 61/630,561 (filed 12/14/2011); Application No. 13/694,586 (filed 12/14/2012); and Application No. 13/986,970 (filed 6/20/2013) is denied for claim 12 and all of the dependents of claim 12; these claims have been accorded a priority date of 1/19/2017, which corresponds to the filing date of US Application No. 15/530,465 (filed 1/19/2017).
Specification
The disclosure is objected to because of the following informalities: A sole inventor is listed on the present Application, however, the specification repeatedly utilizes the plural pronoun “we” (see, e.g., Spec. filed 2/23/2021 at [0009] reciting “we utilize”, “we term”; [0010] reciting “we have found…”, [0012] reciting “we have discovered”, etc.; please note these examples are not exhaustive). This raises questions regarding inventorship and whether or not another should be listed as an inventor. Unless one or more inventors are not properly listed, the Specification should be revised to remove plural pronouns and either use “I”, “The inventor”, etc.
Appropriate correction is required.
Withdrawn Rejections
All prior rejections are withdrawn in view of the amendments filed 7/28/2025, which amended claim 12 to not exclude the connective tissue of blood; however, the amendments have necessitated new or revised rejections, which are set forth on the record below.
New or Revised Rejections Necessitated by Applicant Amendment
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Amended claim 12 now limits the amount of blood present in the method to an amount defined by the following functional limitation:
….wherein the amount of blood in said placental tissue is effective to enable decellularization of the placental tissue using only hydrogen peroxide as the only decellularizing agent and without an adjunctive decellularizing agent;
This renders the claim scope indefinite because it is unknown what “amount” of blood is capable of satisfying the functional limitation because no corresponding structure/function relationship is disclosed on record. Per MPEP § 2173.05(g), the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite, for example when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. MPEP § 2173.05(g) explains that “a vice of functional claiming occurs ‘when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty’”. First, the functional limitation was not literally, inherently, or explicitly disclosed, discussed or exemplified on record: Notably, zero examples or scientifically accurate discussions of any decellularization methods using “hydrogen peroxide as the only decellularizing agent” were actually disclosed on record because all disclosed and described methods relied upon multiple decellularization agents and techniques. Specifically, the methods, including the originally elected species utilized chemical agents acting as pH adjusting agents (i.e., acids and bases) which are art-recognized decellularizing agents (see, e.g., Crapo15 at 3234 at col I at §§ 3.1.1, 3235 at Table 2), which are even recited in the instant claim (see, e.g., amended claim 12(c)). Furthermore, “blood” naturally contains decellularizing agents as evidenced by Tamkovich16, which identifies that blood contains DNase and other hydrolyzing enzymes capable of degrading DNA (see, e.g., Tamkovich at abs, 191 at 1st ¶ to 192 at 1st partial ¶); nucleases are art-recognized decellularizing agents (see, e.g., Crapo at 3236 at col I-II at §§ 3.2.1, 3235 at Table 2). In addition, “blood” naturally contains approximately 400 ng/mL of trypsin (see, e.g., Temler et al.17 at abstract), and trypsin is an art-recognized decellularizing agent (see, e.g., Crapo at 3236 at col II at §§ 3.2.1, 3235 at Table 2). Furthermore, the originally elected example includes a freeze-thaw cycle (see, e.g., US’150 at ¶¶[0080]-[0081]), and “ice crystals” and freeze-thaw cycles are disclosed in the art as “physical and miscellaneous agents” for decellularization (see, e.g., Crapo at 3237 at col I at §§ 3.3.1, 3235 at Table 2). Furthermore, water18, 19 and NaOH20,21 are understood to be “decellularizing agents”. Accordingly, zero methods or descriptions of methods of record actually exist describing the functional limitation regarding “the amount of blood” defined in a method that “only” utilizes hydrogen peroxide as recited in amended claim 12(a). Second, the amount of blood utilized is critical to claimed invention as averred by the Inventor and as stated by the Applicant: The Applicant and Declarant have repeatedly emphasized the “importance of the blood” (see, e.g., Reply filed 3/18/2024 at 21 at 1st full ¶; see Dec. filed 3/18/2024 at ¶6), alleged that a “significant amount of blood” is used (see, e.g., Reply filed 3/18/2024 at 21 at 1st full ¶), and alleged that a “residual amount” excludes small amounts such as “one drop” of blood (see, e.g., Reply filed 3/18/2024 at 22 at 1st full ¶). In addition, the sole inventor has expressly averred the following:
I assert that the claimed process only works when using the appreciable amount of H2O2 that we used, in solution with the blood of the tissue and at low pH . . .
(see, e.g., Dec. filed 3/18/2024 at 5 at 1st full ¶, emphasis added).
In addition, the Applicant has previously referred to the combination of an unknown amount of blood with an unknown amount of hydrogen peroxide as
“….the ‘special sauce’ ”
(see, e.g., Reply filed 2/27/2023 at 10 at 1st full ¶, emphasis added).
The sole Inventor has averred that
“The claimed invention achieves these beneficial outcomes only with the addition of H2O2 and blood…”
(see, e.g., Dec. filed 11/22/2024 at 8 at final ¶, emphasis added).
Accordingly, the amount of blood utilized and the ratio of blood to H2O2 present is critical to the invention, which “only works” if the ‘special sauce’ is present (see, e.g., Reply filed 2/27/2023 at 10 at 1st full ¶, see, e.g., Dec. filed 3/18/2024 at 5 at 1st full ¶, Dec. filed 11/22/2024 at 8 at final ¶). Third, close prior art exists: Close prior art exists as evidenced by the record (see, e.g., Action mailed 8/24/2020 at rejection under 35 USC 103 starting on 38; see also Action mailed 5/25/2021 at rejection under 35 USC 103 starting on 32; see also Action mailed 3/02/2022 at rejection under 35 USC 103 starting on 11 and 17; see also Action mailed 9/20/2023 at rejection under 35 USC 103 starting on 15). In fact, Applicant’s own earlier application is available, close prior art (see, e.g., US20130165384 at claims, abs, ¶¶[0022]-[0040]). Accordingly, the functional limitational limitation renders claim 12 indefinite in view of MPEP § 2173.05(g), because it fails to provide “a clear-cut indication of the scope of the subject matter embraced by the claim", merely recites a description of a problem to be solved or a function or result achieved by the invention, and therefore the boundaries of the claim scope may be unclear. Close prior art exists, and an artisan would not be reasonably able to distinguish infringing from non-infringing inventions.
Amended claim 12 attempts to limit the amount of “30% by weight aqueous hydrogen peroxide” utilized in the method to an amount defined by the following functional limitation:
…an amount of 30% by weight aqueous hydrogen peroxide effective to yield a slurry comprising decellularized placental tissue particles and unreacted hydrogen peroxide that continues to decellularize and reduce the particle size of the placental tissue in the slurry throughout the remaining process [[step]] steps;
This functional limitation renders the pending claims scope indefinite. Per MPEP § 2173.05(g), the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite, for example when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. MPEP § 2173.05(g) explains that “a vice of functional claiming occurs ‘when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty’”. First, the functional limitation was not literally, inherently, or explicitly disclosed, discussed or exemplified on record: The original disclosure fails to define what amount of “30% hydrogen peroxide” is an “effective” amount suitable to achieve the desired outcome set forth in the functional limitation. Although Applicant directs the Examiner to disclosures at ¶¶[0015], [0029], and [0062] (see, e.g., Remarks filed 7/28/2025 at 9 at 1st partial ¶ to first full ¶), the disclosures at ¶¶[0015], [0029], and [0062] do not even recite nor refer to “30% hydrogen peroxide” or placental tissue at all, and fail to provide any structure/function relationship permitting an artisan to reasonably determine how much “30% hydrogen peroxide” is “effective” to achieve the desired results set forth in the functional limitation. In addition, the originally filed disclosure only mentions and recite “30% hydrogen peroxide” at the single paragraph corresponding to ¶[0082] of the published application, in combination with a pH of “about 3.2” and relative to a 10 minute mix prior to resuspension of water (see, e.g., US’ 150 at ¶[0082]). At no point is a general structure/function relationship for determining an “effective” amount of “30% hydrogen peroxide” for a pH range of 2.5 to 5, having variable steps and step durations discussed or disclosed on record. Second, the amount of hydrogen peroxide utilized is critical to claimed invention as averred by the Inventor and as stated by the Applicant: The sole inventor has expressly averred the following:
I assert that the claimed process only works when using the appreciable amount of H2O2 that we used, in solution with the blood of the tissue and at low pH . . .
(see, e.g., Dec. filed 3/18/2024 at 5 at 1st full ¶, emphasis added).
In addition, the Applicant has previously referred to the combination of an unknown amount of blood with an unknown amount of hydrogen peroxide as
“….the ‘special sauce’ ”
(see, e.g., Reply filed 2/27/2023 at 10 at 1st full ¶, emphasis added).
The sole Inventor has averred that
“The claimed invention achieves these beneficial outcomes only with the addition of H2O2 and blood…”
(see, e.g., Dec. filed 11/22/2024 at 8 at final ¶, emphasis added).
Accordingly, the amount of H2O2 and its ratio to the amount of blood present is critical to the invention, which “only works” if the ‘special sauce’ is present (see, e.g., Reply filed 2/27/2023 at 10 at 1st full ¶, see, e.g., Dec. filed 3/18/2024 at 5 at 1st full ¶, Dec. filed 11/22/2024 at 8 at final ¶). Third, close prior art exists: Close prior art exists as evidenced by the record (see, e.g., Action mailed 8/24/2020 at rejection under 35 USC 103 starting on 38; see also Action mailed 5/25/2021 at rejection under 35 USC 103 starting on 32; see also Action mailed 3/02/2022 at rejection under 35 USC 103 starting on 11 and 17; see also Action mailed 9/20/2023 at rejection under 35 USC 103 starting on 15). In fact, Applicant’s own earlier application is available, close prior art (see, e.g., US20130165384 at claims, abs, ¶¶[0022]-[0040]; see also US2013/0288973 at claims, Example 2). Accordingly, the functional limitational limitation regarding H2O2 renders claim 12 indefinite in view of MPEP § 2173.05(g), because it fails to provide “a clear-cut indication of the scope of the subject matter embraced by the claim", merely recites a description of a problem to be solved or a function or result achieved by the invention, and therefore the boundaries of the claim scope may be unclear. Close prior art exists, and an artisan would not be reasonably able to distinguish infringing from non-infringing inventions.
Amended claim 12 attempts to limit the amount of “30% by weight aqueous hydrogen peroxide” utilized in the method to an amount defined by the following functional limitation:
…an amount of 30% by weight aqueous hydrogen peroxide effective to yield a slurry comprising decellularized placental tissue particles and unreacted hydrogen peroxide that continues to decellularize and reduce the particle size of the placental tissue in the slurry throughout the remaining process [[step]] steps;
This functional limitation renders the pending claims scope indefinite because the “effective” amount presumably requires prior knowledge about the total “remaining process steps”, but such steps may vary (see, e.g., amended claim 12(d), dependent claim 32). Accordingly, the “effective” amount of 30% by weight aqueous hydrogen peroxide depends upon the length, duration, and number of “remaining process steps” and the total amount of starting material. However, per MPEP § 2173.05(b)(II), reference to variable objects may render a claim indefinite when the relationship between the limitation and the variable object is not sufficiently defined. Here, the relationship between what is an “effective” amount per step, per unit of duration, and per unit of starting material is unknown and therefore not sufficiently defined. Accordingly, the limitation at issue is indefinite because the amount “effective” to achieve the required result depends upon unknown and variable parameters, including the total “remaining process steps”. Accordingly, claim 12 is rejected as indefinite.
Claim 31 depends from claim 12 and fails to rectify the indefiniteness of the base claim. Accordingly, claim 31 is rejected as indefinite for the reasons applied to claim 12 above.
Claims 12 and 31 are rejected.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 31 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 31 depends upon claim 12, and recites an additional step. However, claim 12 is limited to methods that “consist of” only the steps of Claim 12(a)-(h), which do not include a step of adding additional blood. Accordingly, claim 31 is rejected for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a), New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12 and 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The applicable claim interpretation has been set forth in separate sections in the instant action, under 35 USC 112(b) and also in a separate section entitled “claim interpretation”, and those interpretations are incorporated herein.
The MPEP states that "[w]hile there is no in haec verba requirement, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
Lack of Express Support
Claim 12 is representative of the pending claim scope and does not literally appear in the originally filed disclosure. Therefore, the claims lack literal support in these prior filed applications.
As a non-exhaustive example, amended claim 12(a) now limits blood present in the method to an amount defined by the following functional limitation:
….wherein the amount of blood in said placental tissue is effective to enable decellularization of the placental tissue using only hydrogen peroxide as the only decellularizing agent and without an adjunctive decellularizing agent;
This “wherein” clause is understood to be a functional limitation that attempts to functionally define the amount of blood present and utilized in the claimed process, but this functional limitation does not literally appear the originally filed disclosure.
As a second non-exhaustive example, amended claim 12(d) also attempts to limit the amount of “30% by weight aqueous hydrogen peroxide” utilized in the method to an amount defined by the following functional limitation:
…an amount of 30% by weight aqueous hydrogen peroxide effective to yield a slurry comprising decellularized placental tissue particles and unreacted hydrogen peroxide that continues to decellularize and reduce the particle size of the placental tissue in the slurry throughout the remaining process [[step]] steps;
This functional limitation does not literally appear in the originally filed disclosure.
Accordingly, the originally filed disclosure fails to provide literal support for the most recently amended claim scope.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirement, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
In the absence of express support, the relevant issue is whether or not the claimed invention is supported by the originally filed disclosure through implicit or inherent disclosures.
Per MPEP § 2163(I)(B), “[a]n amendment to correct an obvious error does not constitute new matter where the ordinary artisan would not only recognize the existence of the error in the specification, but also recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971)”. Here, no allegation that the amendments correct an obvious error has been made. Furthermore, upon inspection, Examiner is unable to identify any single “obvious error” that would lead to instantly amended claim 12 and the scope thereof. Accordingly, the amendments cannot be said to merely correct an obvious error.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims is found in the originally filed disclosure, at least because claim 12 was not implicitly or inherently disclosed, as an integrated whole22. Accordingly, even if portions of such language was even present within the originally filed application, no guidance to selectively pick and choose some limitations, while ignoring others, as necessary to retroactively create an invention having the metes and bounds now claimed, exists in such documents (see Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000), stating that "[t]here is therefore no force to Purdue’s argument that the written description requirement was satisfied because the disclosure revealed a broad invention from which the [later-filed] claims carved out a patentable portion"; ” see Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323, 1329 (Fed. Cir. 2021), noting that “[a] written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention”).
Furthermore, multiple limitations appear to be completely novel and fail to correspond to any equivalent or synonymous language of record. For example, amended claim 12 now limits blood present in the method to an amount defined by the following functional limitation:
….wherein the amount of blood in said placental tissue is effective to enable decellularization of the placental tissue using only hydrogen peroxide as the only decellularizing agent and without an adjunctive decellularizing agent;
However, this functional limitation was not literally, inherently, or explicitly disclosed, discussed or exemplified on record: Zero examples or scientifically accurate discussions of any decellularization methods using “hydrogen peroxide as the only decellularizing agent” were actually disclosed on record because all disclosed and described methods rely upon multiple art-recognized decellularization agents and techniques. Specifically, all exemplified methods, including the originally elected species utilized chemical agents acting as pH adjusting agents (i.e., acids and bases) which are art-recognized decellularizing agents (see, e.g., Crapo23 at 3234 at col I at §§ 3.1.1, 3235 at Table 2), which are even recited in the instant claim (see, e.g., amended claim 12(c)). Furthermore, “blood” naturally contains decellularizing agents as evidenced by Tamkovich24, which identifies that blood contains DNase and other hydrolyzing enzymes capable of degrading DNA (see, e.g., Tamkovich at abs, 191 at 1st ¶ to 192 at 1st partial ¶); nucleases are art-recognized decellularizing agents (see, e.g., Crapo at 3236 at col I-II at §§ 3.2.1, 3235 at Table 2). In addition, “blood” naturally contains approximately 400 ng/mL of trypsin (see, e.g., Temler et al.25 at abstract), and trypsin is an art-recognized decellularizing agent (see, e.g., Crapo at 3236 at col II at §§ 3.2.1, 3235 at Table 2). Furthermore, the originally elected example includes a freeze-thaw cycle (see, e.g., US’150 at ¶¶[0080]-[0081]), and “ice crystals” and freeze-thaw cycles are disclosed in the art as “physical and miscellaneous agents” for decellularization (see, e.g., Crapo at 3237 at col I at §§ 3.3.1, 3235 at Table 2). Furthermore, water26, 27 and NaOH28,29 are understood to be “decellularizing agents”. Accordingly, zero methods or scientifically accurate descriptions of any decellularization methods of record actually exist describing the functional limitation regarding “the amount of blood” defined in instant claim 12(a), wherein the method uses “only hydrogen peroxide as the only decellularizing agent”.
As an additional example, amended claim 12 also attempts to limit the amount of “30% by weight aqueous hydrogen peroxide” utilized in the method to an amount defined by the following functional limitation:
…an amount of 30% by weight aqueous hydrogen peroxide effective to yield a slurry comprising decellularized placental tissue particles and unreacted hydrogen peroxide that continues to decellularize and reduce the particle size of the placental tissue in the slurry throughout the remaining process [[step]] steps;
This functional limitation does not literally appear in the originally filed disclosure. Although Applicant directs the Examiner to disclosures at ¶¶[0015], [0029], and [0062] (see, e.g., Remarks filed 7/28/2025 at 9 at 1st partial ¶ to first full ¶), these disclosures do not actually recite nor refer to “30% hydrogen peroxide” or placental tissue at all, and therefore such disclosures fail to provide any structure/function relationship permitting an artisan to reasonably determine how much “30% hydrogen peroxide” is “effective” to achieve the desired results set forth in the functional limitation. It is therefore prima facie unclear if 1 mL of H2O2 per gram of tissue is “effective” when present with 1 mL of “blood”; or if 3 mL of H2O2 per gram of tissue is “effective” when present with 0.01 mL of “blood”; or if the “remaining steps” are repeated (see claim 12(d) and dependent claim 32) if the “effective” amount must be substantially higher than when the steps aren’t repeated. No corresponding explanation is provided. Accordingly, such limitation is not supported literally, implicitly, or inherently by the originally filed disclosure.
Accordingly, the originally filed disclosure fails to provide literal, implicit, or inherent support for the pending claim scope that is synonymous or equivalent in scope, or otherwise commensurate in scope, with the pending claims.
Conclusion
Per MPEP § 2163, new or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement (see, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971)). Here, the newly added claim limitations are not inherently, implicitly, or literally supported by the originally filed disclosure, and therefore violate the written description requirement as explained above.
Accordingly, claims 12 and 31 are rejected.
Claim Rejections - 35 USC § 112(a), Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to whi