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 .
Claim Status
Claims 1, 4-6, 8-12, 14, 16-20, 22-27, 31-33, 42, and 46 are pending. Claims 2-3, 7, 13, 15, 21, and 28-30 were canceled; no claims were added; and claims 1, 4, 6, 9-12, 14, 16-20, 22-27, 31, 33, 42, and 46 were amended in the Reply filed 8/17/2026. Claims 32-33, 42, and 46 remain withdrawn. Claims 1, 4-6, 8-12, 14, 16-20, 22-27, and 31 are presently considered.
Election/Restriction
Applicant’s election of Group I (products, claims 1-31 and 46 as filed 6/05/2023) and the species of Example 3 wherein SEQ ID NO: 181 is used in a 1:1 ratio with lipoaspirate in the reply filed on 12/23/2025 as shown at Figures 5B-C and as disclosed in the Specification (see, e.g., Spec. filed 12/02/2022 at 33-34 at bridging ¶, Fig. 5B-C) was previously acknowledged. Because applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The originally elected species does not appear in the priority document of US Provisional Application No. 63/035173 (filed 6/05/2020).
Following extensive search and examination, the originally elected species was previously deemed anticipated and/or obvious in view of the prior art of record (see, e.g., Action mailed 3/17/2026 at 12-39). In response, the amendments to claim 1 as filed 8/17/2026 are understood to exclude the originally elected species. Specifically, amended claim 1 recites “and 25% of amino acids of the polypeptide are within structured domains”, wherein the originally elected species is either M[(G[V4:A1]GVP)15-GD(A25)K]4-GWP or M[(G[V4:A1]GVP)15-GD(A25)K]6-GWP (see footnote 1, identifying that SEQ ID NO: 18 was altered in the Sequence listing filed 8/17/2026), wherein G[V4:A1]GVP is the “disordered domain”, wherein “GD(A25)K” is the polyalanine domain and structured domain, and wherein the N-terminal Met and C-terminal GWP residues do not correspond to either the disordered or structured domain. The ambiguity over the proper interpretation of the originally elected species is rendered moot because both interpretations are excluded by the amendment filed 8/17/2026. Critically, M[(G[V4:A1]GVP)15-GD(A25)K]4-GWP is 416 amino acids in length, but comprises a structured domain of 112 amino acids (i.e., [GD(A25)K] repeated four times); and M[(G[V4:A1]GVP)15-GD(A25)K]6-GWP is 622 amino acids in length, but comprises a structured domain of 168 amino acids. Accordingly, the originally elected species either comprises 26.92% (original SEQ ID NO: 18) or 27% (SEQ ID NO: 18 in sequence listing filed 8/17/2026) of amino acids “within structured domains”, and therefore is excluded from the pending claims scope since it does not comprise “25% of amino acids . . . within structured domains” as required by amended claim 1.
Per MPEP § 803.02,
Should applicant, in response to a rejection of a Markush claim, overcome the rejection by amending the Markush claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush claim will be examined again. The examination will be extended to the extent necessary to determine patentability of the Markush claim. In the event prior art is found during this examination that anticipates or renders obvious the amended Markush claim, the claim will be rejected, and the action can be made final….
Here, the “Markush claim” at issue is instant claim 1. Accordingly, examination has been extended to the non-elected subgenus of compositions comprising human lipoaspirate and a polypeptide, wherein the polypeptide comprises a plurality of disordered domains and a plurality of structured domains; wherein the disordered domains comprise [VPGXG]m (m is > 1) wherein X is Val, Ala, or a 1:1 to 1:4 mixture of Ala to Val; wherein the structured domains comprise a polyalanine domain having “at least about 60% of the amino acids in an alpha-helical conformation” and the polyalanine domain is selected from (A)25, K(A)25, and D(A)25K; and wherein about 25% of the polypeptide is structured domains.
Following extensive search and examination, the non-elected subgenus of compositions has been deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A), claims directed to non-examined, non-elected species are held withdrawn.
Claims 32-33 and 42 are 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. Election was made without traverse in the reply filed on 12/23/2025.
Claim 46 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. Election was made without traverse in the reply filed on 12/23/2025.
Claims 1, 4-6, 8-12, 14, 16-20, 22-27, and 31 are presently considered.
Information Disclosure Statement
The IDS filed 8/20/2026, 6/30/2026, and 3/26/2026 are each acknowledged.
Applicant should note that one or more documents disclosed on the IDS form submitted 3/26/2026 and 8/20/2026 were not considered since they did not conform to 37 CFR 1.98(b) by providing either a proper date, title, and or relevant pages of the document. 37 CFR 1.98(b) requires that each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue. See MPEP 609.04(a). Here, the earliest priority claim is to US Provisional Application No. 63/035173, filed 6/05/2020; therefore, all documents published in 2019 or later must be accompanied by both month and date of publication.
References that were not considered have been indicated by strike-though on the attached IDS forms. Although not considered, these documents have been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement, or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Examiner notes that the IDS documents on record currently cite over 1400 documents and exceeds 185 pages in length. Applicant is advised that the MPEP states the following with respect to large information disclosure statements:
Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.
(see MPEP § 609.04(a)(III)).
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant' s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff' d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974).
(see MPEP § 2004 at item 13).
These statements are in accord with Molins PLC v. Textron, Inc. (33 USPQ 2d 1823 (1995); 48 F.3d 1172 (Fed. Cir. 1995)), which stated that “'burying' a particularly material reference in a prior art statement containing a multiplicity of other references can be probative of bad faith” (Id. at 1831), wherein the case presented a situation where the disclosure was in excess of 700 pages and contained more than 50 references. Here, the cumulative IDS cites in excess of 20,000 pages and contains over 1400 references. Furthermore, following review, it is the Examiner’s position that the majority of cited references appear to lack any substantial or material relationship to the presently claimed invention, including those documents cited in the IDS filed 8/20/2026.
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 application, US Provisional Application 63/035173 (filed 6/05/2020) and PCT/US2021/035823 (filed 06/04/2021) 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.
Claims 1, 4-6, 8-12, 14, 16-20, 22-27, and 31 are pending. Claim 1 is representative of the pending claim scope as amended in the Reply filed 8/17/2026.
Lack of Express Support
Amended claim 1 is representative of the pending claim scope. Amended claim 1, as filed 8/17/2026, does not literally appear in Pro’173 or PCT’823, and therefore the claims lack literal support in the Pro’173 or PCT’823. More specifically, the functionally defined genus of claim 1, defined by the combined structural limitations (e.g., “25% of amino acids of the polypeptide are within structured domains”) and functional limitations (e.g., the newly added “wherein” clauses), do not literally appear on record individually or otherwise as an integrated whole2.
Accordingly, Pro’173 and PCT’823 each fail to provide literal support for the pending claim scope that is synonymous or equivalent in scope with the instant claim scope.
Lack of Implicit or Inherent Support
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. In the absence of express support, the relevant issue is whether or not the claimed invention is supported by Pro’171 or PCT’823 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’171 or PCT’823, at least because these priority documents do not literally, implicitly, or inherently teach, disclose, nor identify instant a genus of compositions equivalent or synonymous in scope with instant amended claim 1.
Notably, Pro’171 does not disclose instant SEQ ID NO: 2, 12-18, or 25. Furthermore, neither Pro’171 or PCT’823 implicitly or inherently disclose amended claim 1 as filed 8/17/2026, because the limitation requiring “25% of amino acids of the polypeptide are within structured domains” is literally, implicitly, and inherently absent from the priority documents.
The closest disclosure in Pro’171 is found at pages 13 (see Pro’171 at 13 at 2nd full ¶, stating that “At least about 2%, 3%....75%.... or 95% of the POP may comprise disordered domains”) and page 15 (see Pro’171 at 15 at 2nd full ¶, stating that “At least about 2%, 3%....25%.... or 95% of the POP may comprise structured domains”). However, recitations of approximate minimal percentages is not equivalent or synonymous to the non-variable, static amount of “25% of amino acids of the polypeptide are within structured domains”, wherein such limitation is combined with additional functional limitations (e.g., see the newly added structural and functional “wherein” clauses at amended claim 1). Furthermore, zero examples of any species within the genus of instant amended claim 1 were actually specifically taught or disclosed by Pro’171 (see SEQ ID NOs: 1-39 at pages 31-56 of Pro’171, showing zero disclosed embodiments within the scope of instantly amended claim 1). Furthermore, the limited disclosure of Pro’173, at best, utilizes indefinite language to describe the invention (see, e.g., Pro’173 at claims 3-6, referring to a “%” without identifying if it refers to percent volume, percent mass, percent weight, etc.), and Pro’171 does not disclose instant SEQ ID NO: 2, 12-18, or 25. Accordingly, Pro’171 does not disclose the instantly amended claim scope literally, implicitly, or inherently using synonymous or equivalent language.
The closest disclosure in PCT’823 is found at page 17 (see PCT’823 at 17 at 2nd full ¶, stating that “At least about 2%, 3%....75%.... or 95% of the Fractomer may comprise disordered domains”) and page 18 (see PCT’823 at 18 at 2nd full ¶, stating that “At least about 2%, 3%....25%.... or 95% of the Fractomer may comprise structured domains”). However, recitations of approximate minimal percentages is not equivalent or synonymous to the non-variable, static amount of “25% of amino acids of the polypeptide are within structured domains”, wherein such limitation is combined with additional functional limitations (e.g., see the newly added structural and functional “wherein” clauses at amended claim 1). Furthermore, zero examples of any species within the genus of instant amended claim 1 were actually specifically taught or disclosed by PCT’823 (see, e.g., PCT’823 at SEQ ID NOs: 12-19, noting that zero embodiments reduced to practice actually satisfy the requirement of newly amended claim 1 by having “25% of amino acids of the polypeptide are within structured domains” as required). Accordingly, PCT’823 does not disclose the instantly amended claim scope literally, implicitly, or inherently using synonymous or equivalent language.
Accordingly, the claim language presently claimed is not supported by the priority documents by synonymous or equivalent language.
Accordingly, Pro’173 and PCT’823 each fail 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.
Alleged Support Identified by Applicant
In the response filed 8/17/2026, Applicant alleges that “Support for the claim amendments can be found throughout the application as filed” (see, e.g., Reply filed 8/17/2026 at 11 at § Status of the Claims), and specifically
Applicant attempted to amend the Priority document of Pro’171 to alter an incorporation by reference (see, e.g., Reply filed 8/17/2026 at 12 at 2nd full ¶), and
Applicant alleges that the sequences at issue are “derivable” from SEQ ID NO: 1 of Pro’171 (see, e.g., Reply filed 8/17/2026 at 12 at 2nd full ¶); and
Applicant alleges that other limitations are “derivable” from a different PCT disclosure that was not actually cited in Pro’173 as filed 6/05/2020 (see, e.g., Reply filed 8/17/2026 at 12 at 2nd full ¶).
These arguments are not persuasive because
Per 37 CFR 1.121(k), “Amendments in provisional applications are not usually made”, and here the proposed amendment has not been entered. Therefore, reliance upon the amendment is misplaced.
Arguments that do not deny that something is literally, inherently, or implicitly absent from the priority document, but rather that it is “derivable”, are not persuasive because this is equivalent to arguing that it renders something “obvious”. However, obviousness is not the test for written description support:
[A]n applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention" (see, e.g., Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398, emphasis added).
Therefore, even assuming arguendo that the provisional disclosure were sufficient to render the instant claim scope obvious, “a description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention” (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)).
Accordingly, all arguments regarding support in the provisional disclosure have been fully considered but not found persuasive.
Conclusion
Accordingly, priority to US Provisional Application 63/035173 (filed 6/05/2020) and PCT/US2021/035823 (filed 06/04/2021) is denied for claim 1 and all of the dependents of those claims; these claims have been accorded a priority date of 12/02/2022, which corresponds to the filing date of the instant application.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Amended claim 1, as filed 8/17/2026, is representative of the pending claim scope. Applicable claim interpretations are set forth below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“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)).
“Fractomer” is understood to be a trade name or a mark used in commerce (Serial number 97566233; InSoma Bio, Inc., Filed Aug. 26, 2022; allowed May 07, 2024).
“Amino acids” and “polypeptides” are not limited to naturally occurring proteinogenic amino acids, but include “amino acid derivatives that are not naturally occurring” and “non-native amino acid derivative[s]” (see, e.g., Spec. filed 12/02/2022 at 22 at 1st full ¶).
“Structured domains” are recited at amended claim 1, but this component is ill-defined on record. The “structured domain” may “consist[] of . . . oligoalanine amino acid (from 5 to 500, but typically A25) that form perfect α-helices” (see, e.g., Spec. filed 12/02/2022 at 15-16 at bridging ¶), but may “comprise at least one of a polyproline domain and a polyalanine domain” (see, e.g., Spec. filed 12/02/2022 at 17-18 at bridging ¶), wherein the “polyalanine domain” is not limited to oligoalanine sequences, but may comprise non-alanine residues (see, e.g., Spec. filed 12/02/2022 at 18 at 2nd full ¶). Notably, the structured domain need not comprise nor consist of only “perfect α-helices” (see, e.g., Spec. filed 12/02/2022 at 15-16 at bridging ¶), but instead, in some embodiments “at least about 50% of the amino acid” are “in an α-helical conformation” (see, e.g., Spec. filed 12/02/2022 at 18 at 3rd full ¶), wherein “about” is defined in multiple but non-equivalent ways on record (see, e.g., Spec. filed 12/02/2022 at 8 at lines 12-21, noting that “about” is defined as “up to ± 10%” variation, “3 or more standard deviations”, “within an order of magnitude”, “within 5-fold”, or “within 2-fold” of a value). Accordingly, “at least about 50%” may mean as little as 5%. Therefore, the metes and bounds of what does or does not constitute a “structured domain” is ill-defined but highly variable. For purposes of applying prior art, a “structured domain” is understood to include at least prior art moieties consisting of instant SEQ ID NOs: 7, 8, 9, 10, and 11. A “structured domain” is generically understood to be any polypeptide of form (X1)y([polyalanine domain])n(X1)y, wherein X1 is independently any amino acid (natural or non-natural), the [polyalanine domain] comprises “between 5 and 50 alanine residues” in any pattern or order, and wherein each y and n are one or greater, without limitations regarding charge, length, or composition of X1
“Disordered domains” is an ill-defined structure of unknown size, which is understood to be any sequence that “comprises an amino acid sequence of (GXGVP)n (SEQ ID NO: 2), wherein X is any amino acid except proline and n is an integer greater than or equal to 1” (see, e.g., amended claim 1 as filed 8/17/2026). This domain may “comprise” any additional amino acids, have any net charge, and be of any length, wherein “X” may be any amino acid, including non-naturally occurring amino acids (see, e.g., Spec. filed 12/02/2022 at 22 at 1st full ¶). Accordingly, a “disordered domain” as recited at instant claim 1 is understood to generically encompass and “comprise” any polypeptide of form (X1)y(GXGVP)n(X1)y, wherein each X1 is independently selected from any amino acid (natural or non-natural), each X is any amino acid (natural or non-natural) except proline, and each y and n are one or greater, and wherein the sequence selections are not limited by charge, length, or composition of X1 (i.e., X1 may be proline, cysteine, etc.).
“Polyalanine domains” is understood to be a domain of unknown size and length that comprises both oligoalanine sequences, and alanine with non-alanine residues (see, e.g., Spec. filed 12/02/2022 at 18 at 2nd full ¶). Examples of “polyalanine domains” are provided in claim 8 as filed 8/17/2026. Accordingly, a “polyalanine domain” is understood to be any polypeptide, of any charge or composition, “having between 5 and 50 alanine residues” in any pattern or arrangement (i.e., consecutive, non-consecutive, adjacent, non-adjacent), which may be shown as the generic sequence of (X1)n(X2)o(X3)p, wherein each of X1, X2, and X3 may be alanine or any other amino acid (natural or non-natural), and n+o+p is at least 5, wherein (X1)n(X2)o(X3)p must contain “between 5 and 50 alanine residues” (e.g., K50C50A5K50C50 satisfies the literal structural limitations recited at claim 1).
“25% of amino acids of the polypeptide are within structured domains” this phrase has been rejected under 35 USC 112(b), below. For purposes of examination, unless otherwise stated, “the polypeptide” is understood to refer to the complete “recombinant polypeptide”, and therefore includes all structured domains, polyalanine domains, disordered domains, and any additional N- or C-terminal sequences. This is pertinent because it limits the claim scope to structures such as [(G[V4:A1]GVP)3-GD(A2)K]x; [(G[V4:A1]GVP)6-GD(A7)K]x; [(G[V4:A1]GVP)9-GD(A12)K]x; [(G[V4:A1]GVP)12-GD(A17)K]x; [(G[V4:A1]GVP)12-(A20)]x; M[(G[V4:A1]GVP)10-GD(A15)K]1-GWP; etc., etc., wherein the structured domain is exactly 25% of the total number of amino acids within the overall polypeptide.
“Lipoaspirate” is interpreted in view of Example 1, wherein “lipoaspirate” is identified “the processed tissue” in liposuctioned fat, following removal of “excess blood, oil, and non-fat tissue” (see, e.g., Spec. filed 12/02/2022 at 22 at 1st full ¶).
Amended, dependent claims 20 and 22-27 now recite a contingent limitation, namely “when the composition is in an injectable form….”. Contingent limitations are interpreted as described at MPEP § 2111.04(II), which explains that “[t]he broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur.” Accordingly, the recitation of a contingent limitation in a product claim requires that the product comprise the structure required to perform the recited function. Therefore, such contingent limitations act as functional limitations that further limit the structures of the independent claim to a subgenus of structures capable of performing the recited limitation. However, currently the functional limitations fail to correspond to any structure/function relationship of record.
Examiner notes that the interpretation of multiple terms and phrases are set forth below under 35 USC 112(b), and those discussions are incorporated here. For purposes of applying prior art, all functional limitations are presumed to be fully satisfied by the structure of the originally elected species at this time.
Additional claim interpretations are set forth below.
Withdrawn Claim Rejections
The rejections of claims 1-31 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdraw in view of the cancellation of claims 2-3, 7, 13, 15, 21, and 28-30; in view of the updated sequence listing filed 8/17/20263; and in view of the amendments to claims 1, 4, 6, 9-12, 14, 16-20, 22-27, and 31 in the Reply filed 8/17/2026. However, the amendments have necessitated revised rejections, as set forth below.
The rejection of claim 12 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is withdrawn in view of the amendment to claim 12 in the Reply filed 8/17/2026.
The rejection of claims 13-19, 28, and 30-31 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, is withdrawn-in-part in view of the cancellation of claims 2-3, 7, 13, 15, 21, and 28-30; in view of the updated sequence listing filed 8/17/20264; and in view of the amendments to claims 1, 4, 6, 9-12, 14, 16-20, 22-27, and 31 in the Reply filed 8/17/2026. However, these amendments have necessitated a revised rejection, as set forth below.
The rejection of claims 1-8 and 12-31 under 35 U.S.C. 103 as being unpatentable over WO2019006374A1 (filed Jan. 3, 2019) in view of US2018/0133401 (May 17, 2018) is successfully traversed in part in view of the cancellation of claims 2-3, 7, 13, 15, 21, and 28-30; ; in view of the updated sequence listing filed 8/17/20265; and in view of the amendments to claims 1, 4, 6, 12, 14, 16-20, 22-27, and 31 in the Reply filed 8/17/2026. However, the amendments have necessitated a revised rejection, which has been set forth below.
The rejection of claims 9-11 under 35 U.S.C. 103 as being unpatentable over WO2019006374A1 in view of US2018/0133401 as applied to claims 1-8 and 12-31 above, and further in view of Roberts6 and Kowalczyk et al7 is withdraw in view of the cancellation of claims 2-3, 7, 13, 15, 21, and 28-30; in view of the updated sequence listing filed 8/17/20268; and in view of the amendments to claims 1, 4, 6, 9-12, 14, 16-20, 22-27, and 31 in the Reply filed 8/17/2026. Specifically, claims 9-11 are understood to recite embodiments excluded by amended claim 1 as filed 8/17/2026, which has necessitated a rejection under 35 USC §112(d), as set forth below.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claims 12, 14, 16-18-20, 22-27, and 31 would be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. These claims recite “wherein” clauses that do not correspond to structure/function relationships, and therefore do not appear to be unambiguous functional limitations that further limit the scope of instant claim 1 to specific embodiments. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New or Revised Claim 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 1, 4-6, 8-12, 14, 16-20, 22-27, 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 1 now recites the “wherein” clause
…wherein the polypeptide undergoes phase transition and aggregates when heated above a transition temperature of heating (Tt-heating) of the polypeptide…
As an initial matter, it is unclear if this statement is a non-limiting recitation of an intended or expected use, fully satisfied by all possible embodiments that satisfy the positively recited structural limitations set forth in the body of amended claim 1 (see, e.g., MPEP § 2111.04(I)), or if the phrase is intended to be a functional limitation that excludes some, but not all, structures that satisfy the positively recited structural requirements set forth in the body of instant claim 1 (see, e.g., MPEP § 2173.05(g)). Accordingly, because it is unclear in view of the instant record whether or not the phrase is a functional limitation or is non-limiting language, and the claim scope varies depending upon the interpretation, the pending claim scope is rendered indefinite. In addition, if the “wherein” clause is intended to be a functional limitation, the “wherein” clause does not correspond to any structure/function relationship of record, commensurate in scope with the claims. Per MPEP § 2173.05(g),
[T]he 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. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). 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. . .
Here, if the “wherein” clause is a functional limitation, then the clause merely recites a description of functions or results to be achieved by the invention rather than a description of the actual structures capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). This is reasonable because MPEP § 2173 identifies that the primary purpose of the requirement is to inform the public of the boundaries of what constitutes infringement of the patent, but here it is unclear what compounds that satisfy the structural limitations set forth in the body of instant claim 1 actually do or do not infringe upon the scope of claim 1, by satisfying the functional limitation. Zero additional guidance or structure/function teachings are presented identifying any functional sequences satisfying all structural limitations of amended claim 1, wherein “25% of amino acids of the polypeptide are within structured domains” as presently claimed. This is pertinent because the courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
This is problematic because close prior art exists (see discussion under 35 USC 103, below). Accordingly, because (i) it is unclear if the “wherein” clause is a limiting functional limitation, or non-limiting recitation s of intended or expected results, and (ii) if a functional limitation, it is unclear what compounds do or do not satisfy the functional limitations, an artisan would be unable to identify infringing from non-infringing compounds. Accordingly, claim 1 is rejected as indefinite.
Amended claim 1 now recites the “wherein” clause
“wherein the composition is injectable prior to being heated to a temperature above the Tt-heating of the polypeptide”
As an initial matter, it is unclear if this statement is a non-limiting recitation of an intended or expected use, fully satisfied by all possible embodiments that satisfy the positively recited structural limitations set forth in the body of amended claim 1 (see, e.g., MPEP § 2111.04(I)), or if the phrase is intended to be a functional limitation that excludes some, but not all, structures that satisfy the positively recited structural requirements set forth in the body of instant claim 1 (see, e.g., MPEP § 2173.05(g)). Accordingly, because it is unclear in view of the instant record whether or not the phrase is a functional limitation or is non-limiting language, and the claim scope varies depending upon the interpretation, the pending claim scope is rendered indefinite. In addition, if the “wherein” clause is intended to be a functional limitation, the “wherein” clause does not correspond to any structure/function relationship of record, commensurate in scope with the claims. Per MPEP § 2173.05(g),
[T]he 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. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). 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. . .
Here, if the “wherein” clause is a functional limitation, then the clause merely recites a description of functions or results to be achieved by the invention rather than a description of the actual structures capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). This is reasonable because MPEP § 2173 identifies that the primary purpose of the requirement is to inform the public of the boundaries of what constitutes infringement of the patent, but here it is unclear what compounds that satisfy the structural limitations set forth in the body of instant claim 1 actually do or do not infringe upon the scope of claim 1, by satisfying the functional limitation. Zero additional guidance or structure/function teachings are presented identifying any functional sequences satisfying all structural limitations of amended claim 1, wherein “25% of amino acids of the polypeptide are within structured domains” as presently claimed. This is pertinent because the courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
This is problematic because close prior art exists (see discussion under 35 USC 103, below). Accordingly, because (i) it is unclear if the “wherein” clause is a limiting functional limitation, or non-limiting recitation s of intended or expected results, and (ii) if a functional limitation, it is unclear what compounds do or do not satisfy the functional limitations, an artisan would be unable to identify infringing from non-infringing compounds. Accordingly, claim 1 is rejected as indefinite.
Amended claim 1 recites the limitations
“25% of amino acids of the polypeptide are within structured domains”
and
…wherein the polypeptide undergoes phase transition and aggregates when heated above a transition temperature of heating (Tt-heating) of the polypeptide…
at lines 9 and 11-12, respectively, and each renders the claim scope indefinite. There is insufficient antecedent basis for either limitation in the claim. The phrase “the polypeptide” may refer to multiple polypeptides at issue, including the “recombinant polypeptide”, “structured domains”, “plurality of disordered domains”, and “polyalanine domains”, each of which is a polypeptide. For purposes of examination, the reference to “the polypeptide” is understood to refer to the “recombinant polypeptide” (i.e., the total and complete sequence), which is reasonable because the term “polypeptide” is only used literally utilized in the claim with reference to the “recombinant polypeptide”. Clarification is required.
Amended claims 12, 14, 16-18-20, 22-27, and 31 appear to recite functional limitations (i.e., “wherein” clauses)9, but these “wherein” clauses do not unambiguously correspond to any structure/function relationship on record permitting an artisan to reasonably identify what embodiments within the scope of the independent claim are further excluded by such “wherein” clauses. This is pertinent because if such claims have the same, identical scope as amended claim 1, then each claim would be properly objected to as a substantial duplicate upon allowability of instant claim 1 (see, e.g., MPEP § 608.01(m); Form paragraphs 7.05.05 and 7.05.06). If claims 12, 14, 16-18-20, 22-27, and 31 further limit the scope of the independent claim, then the “wherein” clauses must be functional limitations that fail to correspond to an unambiguous structure/function relationship of record. Per MPEP § 2173.05(g),
[T]he 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. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). 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. . .
Here, dependent claims 12, 14, 16-18-20, 22-27, and 31 appear to merely recite a description of a problem to be solved or a function or result that the inventor(s) hope and desire for the invention to achieve, but in view of the complete absence of any structure/function relationship permitting an artisan to reasonably identify embodiments within the scope of the independent claim, but excluded by the functional limitation in the dependent claim, the boundaries of the claim scope of each of claims 12, 14, 16-18-20, 22-27, and 31 is unclear. In the complete absence of any identification of actual structures capable of achieving the hoped-for and desired function or result recited in the “wherein” clause, an artisan would not reasonably understand the metes and bounds of such claim limitations. This issue is further complicated because close prior art exists (see discussion of references applied under 35 USC 103, below; see also discussion of Roberts10, below), and it is unclear what prior art structures do or do not satisfy the functional limitations of these instant claims. Per MPEP § 2173, the primary purpose of 35 USC § 112(b) is “to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement”, and the courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Therefore, because it is unclear and unknown what compounds do or do not satisfy the functional limitations of claims 12, 14, 16-18-20, 22-27, and 31, an artisan would be unable to identify infringing from non-infringing compounds. Accordingly, claims 12, 14, 16-18-20, 22-27, and 31 are rejected as indefinite.
Amended claim 1 recites the limitations
“25% of amino acids of the polypeptide are within structured domains”
Which renders the claim scope indefinite per MPEP § 2173.05(b), which explains that a claim may be rendered indefinite by reference to an object that is variable, wherein the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. Here, the positively recited structural limitations in the body of claim 1 ostensibly encompass any sequence “comprising” the enumerated portions, in any orientation, including at least the general structures of
[Leader]-(X1)y([polyalanine domain])n(X1)y-[linker]- (X1)y(GXGVP)n(X1)y-[Trailer];
[Leader]-(X1)y(GXGVP)n(X1)y-[linker]-(X1)y([polyalanine domain])n(X1)y [Trailer];
[Leader]-[(X1)y([polyalanine domain])n(X1)y-[linker]-(X1)y(GXGVP)n(X1)y]z-[Trailer]; or
[Leader]-[(X1)y(GXGVP)n(X1)y-[linker]-(X1)y([polyalanine domain])n(X1)y]z-[Trailer];
Wherein [Leader] is an optional leader sequence of unlimited length, charge, and composition; [Trailer] is an optional trailer sequence of unlimited length, charge, and composition; each “X1” is independently selected from any natural or non-natural amino acid; each [Linker] is independently an optional linker sequence of unlimited length, charge, and composition; each “y” is individually and independently selected from any integer of zero or greater; each “n” is one or more with the proviso that each individual “structured domain” comprises a “[polyalanine domain]” that has “between 5 and 50 alanine residues”; wherein z may be an integer of one or greater; and wherein each [polyalanine domain] corresponds to the formula (X2)n(X3)o(X4)p, wherein each of X2, X3, and X4 may be alanine or any other amino acid (natural or non-natural), wherein n+o+p is 5 or greater, and wherein (X1)n(X2)o(X3)p must contain “between 5 and 50 alanine residues”. The issue under MPEP 2173.05(b) is therefore illustrated by noting that any determination that “25% of amino acids of the polypeptide are within structured domains” requires foreknowledge of what amino acids are arbitrarily deemed to be part of the structured domains, and foreknowledge of the total length of the polypeptide. As noted above, open-ended nature of “comprising” means that structures such as [linker/Leader]-(X1)y([polyalanine domain])n(X1)y-[Linker/Trailer] are encompassed by the claim scope. However, the exact determination of what amino acids constitute a Linker/Leader/Trailer sequence, and which amino acids constitute (X1)y (i.e., a portion of the structured domain) is entirely arbitrary and left to the interpretation of artisans (e.g., in a sequence such as GRGRG(AK)25RGRGG, the determination of whether then entire “structured domain” consists of a “polyalanine domain” consisting of (AK)25, RG(AK)25, GRGRG(AK)25RG, GRGRG(AK)25RGRGG, etc. is arbitrary). Accordingly, the same embodiments may be alternatively included or excluded from the pending claim scope by the limitation requiring “25% of amino acids of the polypeptide are within structured domains” depending upon how a particular artisan interprets the exact amino acid boundaries of each component of the claimed invention. Accordingly, in the absence of limitations regarding the definitions of all components that the polypeptide comprises, the regarding an exact percentage of amino acids within a single domain renders the claim scope indefinite.
Claims 4-6, 8-12, 14, 16-20, 22-27, and 31 depend directly or indirectly from an indefinite base claim, and fail to clarify the indefiniteness of the base claim. Accordingly, claims 2-31 are rejected as indefinite for depending upon an indefinite base claim.
Claims 1, 4-6, 8-12, 14, 16-20, 22-27, 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.
Claims 9-11 are 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.
Claims 9-11 depends from claim 1, wherein claim 1 recites and requires that “25% of amino acids of the polypeptide are within structured domains”. At claims 9-10, the “structured domain” is understood to be “GX1(A)25X1” (see instant claim 9), and either “GD(A)25K” or “GK(A)25K” at claims 10-11. However, each of these structures comprises 28 amino acids, and the disordered domain is 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 amino acids in length (see, e.g., instant claims 9-11), but 28 divided by such numbers does not yield 25%. Furthermore, although claims 10-11 recite an additional N-terminal Methionine, and a C-terminal trailer sequence of GWP (see, e.g., instant claims 10-11), the recited compounds have total polyalanine domains of 168 amino acids (28*6) or 112 amino acids (28*4), but the total lengths of the recited amino acid sequence of SEQ ID NOs: 12-19 is 622, 416, 622, 416, 652, 436, 622, and 416, respectively, and therefore such sequences do not have “25% of amino acids of the polypeptide are within structured domains”. Accordingly, claims 9-11 are rejected for failing to include all the limitations of the claim upon which it depends.
Further examination of claims 9-11 in view of the prior art is precluded at this time, as claims 9-11 are understood to be directed to subject matter excluded from the scope of instant claim 1.
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 1, 4-6, 8-12, 14, 16-20, 22-27, 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.
Applicable Case Law
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Regarding narrowing amendments attempting to carve a narrower genus from a broad and highly varied genus and laundry list disclosure, the case law and MPEP guidance states, per MPEP § 2163.05(II), that
The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) . . . . ; Rozbicki v. Chiang, 590 Fed.App’x 990, 996 (Fed. Cir. 2014) (non-precedential) (The court found that patentee, "while attempting to obtain the broadest claim language possible during prosecution, cannot now improperly narrow its language by importing limitations not supported by the claim language or written description."). In Ex parte Ohshiro, 14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989) . . . .
This courts have clearly stated that the mere disclosure of “each ... individual limitations” separately and distinctly, does not evidence possession of all combinations of all such limitations “as an integrated whole” because written description support requires more than the combination of “an amalgam of disclosures plucked selectively from the ... application” (see, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349, 107 U.S.P.Q.2d 1457, 1467, 2013 BL 192990, 14 (Fed. Cir. 2013), explaining that the written description analysis requires “[t]aking each claim . . . as an integrated whole rather than as a collection of independent limitations”).
Lack of literal Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Amended claim 1 as filed 8/17/2026 is representative of the pending claim scope. Amended claim 1 does not literally appear in the originally filed disclosure. For example, zero genera or subgenera are literally disclosed as having the limitations of claim 1 and also having “25% of amino acids of the polypeptide are within structured domains”.
Accordingly, the amended claim scope lacks literal support in the originally filed disclosure.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163. As noted above, the claims are not literally or inherently supported by the originally filed disclosure. Accordingly, the relevant issue is whether or not the new amendments and resulting claim scope is implicitly or inherently supported by the originally filed disclosure.
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 1 and the scope thereof, and no such “obvious error” has been alleged or identified by Applicant. Accordingly, the amendments filed in the recent Reply cannot be said to correct an “obvious error”.
As noted above MPEP § 2163.05(II) explains that the introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species). Therefore, the question is whether or not the narrowed claim scope, considered “as an integrated whole”11, is supported by the as-filed disclosure.
Upon review, the closest supporting disclosure corresponds to instant SEQ ID NOs: 12-19 and 25 (see, e.g., amended claims 9-11 as filed 8/17/2026). For purposes of the instant rejection, “the polypeptide” at claim 1 is understood to refer to the complete “recombinant polypeptide”, and therefore includes all structured domains, polyalanine domains, disordered domains, and any additional N- or C-terminal sequences. This is relevant because, at SEQ ID NOs: 12-19 and 25, the “structured domain” is understood to be “GX1(A)25X1” (see instant claim 9), or otherwise either “GD(A)25K” or “GK(A)25K” (see instant claims 10-11). However, each of these “structured domains” comprises 28 amino acids, meaning that the claimed sequences, regardless of repeats, contains a “structured domain” having a length corresponding to a multiple of 28. This is pertinent because the disordered domain (i.e., “GXGVP”) contains multiples of five amino acids between 50 and 100 (i.e., 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 amino acids; see instant claim 9 when “n” is 10-20). Accordingly, zero embodiments of form [(GXGVP)10-20-GX1(A)25X1]4-8 at claim 9 satisfy the limitation that “25% of amino acids of the polypeptide are within structured domains” (note that “25%” is not synonymous or equivalent to the range of “about 25%”, “at least 25%”, “at most 25%”, etc., because “25%” requires a static, exact value). Similarly, although claims 10-11 recite an additional N-terminal Methionine, and a C-terminal trailer sequence of GWP (see, e.g., instant claims 10-11 and SEQ ID NOs: 12-19), such compounds have total “structured domains” (i.e., polyalanine domains) of 168 amino acids (28*6) or 112 amino acids (28*4), but the total lengths of the recited amino acid sequences of SEQ ID NOs: 12-19 are 622, 416, 622, 416, 652, 436, 622, and 416, respectively. Notably, 168 is 25% of 672 and 112 is 25% of 448, and therefore zero embodiments among SEQ ID NOs: 12-19 satisfy the newly added structural limitation recited at instant claim 1 requiring that “25% of amino acids of the polypeptide are within structured domains”.
Presumably, amended claim 1 now reads upon embodiments having “25% of amino acids of the polypeptide are within structured domains”, which would presumably include structures such as (1) [(G[V4:A1]GVP)6-GD(A7)K]x; (2) [(G[V4:A1]GVP)9-GD(A12)K]x; (3) [(G[V4:A1]GVP)12-GD(A17)K]x; (4) [(G[V4:A1]GVP)12-(A20)]x; (5) M[(G[V4:A1]GVP)10-GD(A15)K]1-GWP; etc., etc., wherein the structured domain is exactly 25% of the total number of amino acids within the overall polypeptide. Critically, zero examples of such species were reduced to practice, and zero guidance to arrive at such embodiments exists on record. Such a combination of limitations could only arise if an artisan improperly “plucked selectively from the ... application” (see, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349, 107 U.S.P.Q.2d 1457, 1467, 2013 BL 192990, 14 (Fed. Cir. 2013)) some disclosures while wholly ignoring other disclosures.
Although inherent and implicit support may be established by a “representative number of species” per MPEP § 2163, MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus (see, e.g., MPEP § 2163(II)(3)(a), MPEP §2163.03(V)). Here, the claim scope is vast and ostensibly encompasses numerous species of compounds (>>trillions in view of “comprising” language and ill-defined references to “structured domain”, “polyalanine domain” and “disordered domain” (see Claim Interpretation section, above). However, zero examples of representative species within the scope of amended claim 1 were reduced to practice. Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. Similarly, here the disclosure of zero examples of the claimed invention of amended claim 1, cannot be reasonably said to be a “representative number of species” sufficient to satisfy the written description requirement for a vast and highly varied genus of structures as instantly claimed genus.
Accordingly, there is no inherent or implicit support for the subgenus of amended claim 1, as the limitation “25% of amino acids of the polypeptide are within structured domains” does not literally appear in the originally filed disclosure, and no inherent or implicit guidance exists that would direct an artisan to arrive at a subgenus defined by such a combination of limitations as recited at instant claim 1.
Consideration of Alleged Supporting Disclosures
Applicant failed to identify any literal, implicit, or inherent supporting disclosures for the amended claim scope, but instead alleged that “Support for the claim amendments can be found throughout the application as originally filed”. This assertion is not persuasive in view of the analysis set forth above.
“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” (see Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323, 1329 (Fed. Cir. 2021). The courts have noted
As Ruschig makes clear, one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree [*1327] must be in the originally filed disclosure. . . . It is "not a question of whether one skilled in the art might be able to construct the patentee's device from the teachings of the disclosure.... Rather, it is a question whether the application necessarily discloses that particular device. . .
Purdue Pharma LP v. Faulding Inc., 230 F.3d 1320, 1327, 56 U.S.P.Q.2d 1481, 1486, 2000 BL 26918, at *7 (Fed. Cir. 2000)
Here, no “blaze marks” have been identified in the originally filed disclosure, and the originally filed disclosure discloses a “forest”, rather than the “tree” presently claimed. Stated alternatively, if the instant disclosure were actually a prior art reference that could be applied against the instantly claimed inventions, the instant disclosure would not be sufficient to establish a 35 USC 102 rejection on any embodiment within the scope of claim 1.
The rationale that limitations can be cobbled together from various portions of the disclosure to formulate a novel subgenus has been rejected by the courts (see, e.g., In re Smith (458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972), noting that “[w]hatever may be the viability of an inductive-deductive approach to arriving at a claimed subgenus, it cannot be said that such a subgenus is necessarily described by a genus encompassing it and a species upon which it reads";
Accordingly, the subgenera recited at the amended claims do not literally, implicitly, or inherently appear in the originally filed disclosure “as an integrated whole”.
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 result in a narrower claim genus which defines a novel subgenus of species that was not inherently, implicitly, or literally supported by the originally filed disclosure.
Although the originally-filed disclosure may render the instant claims obvious, “a description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention” (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)) because “[o]ne shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious” (Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997) at 1572).
Claims 1, 4-6, 8-12, 14, 16-20, 22-27, 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 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 1, 4-6, 8-12, 14, 16-20, 22-27, 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.
Brief Statement of the Issue(s)
Amended claims 1, 12, 14, 16-20, 22-27, and 31 recite functional limitations that fail to correspond to a structure/function relationship of record, or otherwise known in the art, that reasonably permits artisans to differentiate among functional and non-functional embodiments within the scope of instant claim 1 that do or do not satisfy the functional limitations recited at claims 1, 12, 14, 16-20, 22-27, and 31.
Claim Scope
Claim 1 is representative of the pending claims scope and ostensibly appears to encompass an infinitely large genus of compounds defined by ambiguous terminology (see claim interpretation section and discussions under 35 USC §112(b) above, noting the ambiguous definitions of “structured domain”, “disordered domain”, and the usage of “comprising” in the absence of any limitations regarding charge, molecular weight, structures, composition of additional components, or overall length).
Amended claim 1 recites ill-defined and highly variable terms, including “structured domains”, “disordered domains”, and “polyalanine domain”.
In view of the positively recited recitations set forth in amended claim 1, a “structured domain” is generically understood to any polypeptide of form (X1)y([polyalanine domain])n(X1)y, wherein X1 is independently any amino acid (natural or non-natural), the [polyalanine domain] comprises “between 5 and 50 alanine residues” in any pattern or order, and wherein each y and n are one or greater, without limitations regarding charge, length, or composition of X1.
Each individual “polyalanine domain” present is understood to be any polypeptide, of any charge or composition, “having between 5 and 50 alanine residues” in any pattern or arrangement (i.e., consecutive, non-consecutive, adjacent, non-adjacent), which may be shown as the generic sequence of (X2)n(X3)o(X4)p, wherein each of X2, X3, and X4 may be alanine or any other amino acid (natural or non-natural), wherein n+o+p is 5 or greater, and wherein (X2)n(X3)o(X4)p must contain “between 5 and 50 alanine residues”
Each “disordered domain” is of unspecified length, charge, and variable composition so long as it “comprises an amino acid sequence of (GXGVP)n (SEQ ID NO: 2), wherein X is any amino acid except proline and n is an integer greater than or equal to 1” (see, e.g., amended claim 1 as filed 8/17/2026). Accordingly, a “disordered domain” generically includes any sequence of form (X1)y(GXGVP)n(X1)y, wherein X1 is independently any amino acid (natural or non-natural), X is any amino acid (natural or non-natural) except proline, and each y and n are one or greater, without limitations regarding charge, length, or composition of X1.
Amended claim 1 does not exclude the presence of additional domains or components, such as leader sequences, linkers, and trailer sequences. Accordingly, the positively recited structural limitations set forth at the body of amended claim 1 encompass at least any polypeptide having the general structures of
[Leader]-(X1)y([polyalanine domain])n(X1)y-[linker]- (X1)y(GXGVP)n(X1)y-[Trailer];
[Leader]-(X1)y(GXGVP)n(X1)y-[linker]-(X1)y([polyalanine domain])n(X1)y [Trailer];
[Leader]-[(X1)y([polyalanine domain])n(X1)y-[linker]-(X1)y(GXGVP)n(X1)y]z-[Trailer]; or
[Leader]-[(X1)y(GXGVP)n(X1)y-[linker]-(X1)y([polyalanine domain])n(X1)y]z-[Trailer];
Wherein [Leader] is an optional leader sequence of unlimited length, charge, and composition; [Trailer] is an optional trailer sequence of unlimited length, charge, and composition; each “X1” is independently selected from any natural or non-natural amino acid (i.e., thousands of possibilities per amino acid); each [Linker] is independently an optional linker sequence of unlimited length, charge, and composition; each “y” is individually and independently selected from any integer of zero or greater; each “n” is one or more with the proviso that each individual “structured domain” comprises a “[polyalanine domain]” that has “between 5 and 50 alanine residues”; wherein z may be an integer of one or greater; and wherein each [polyalanine domain] corresponds to the formula (X2)n(X3)o(X4)p, wherein each of X2, X3, and X4 may be alanine or any other amino acid (natural or non-natural), wherein n+o+p is 5 or greater, and wherein (X1)n(X2)o(X3)p must contain “between 5 and 50 alanine residues”. Accordingly, the pending claim scope is vast, highly varied, and the positively recited structural limitations encompasses an essentially infinitely large number of polypeptides differing in length (10 amino acid minimum – GXGVPAAAAA, to one thousand or more amino acids), charge (i.e., each X1 may be Lys, Arg, His, a non-natural charged amino acid, etc.), and composition.
However, this infinitely large and highly diverse genus of polypeptides is ostensibly limited by an indefinite structural limitation requiring that “25% of amino acids of the polypeptide are within structured domains” (see rejection under 35 USC 112(b), that discussion is incorporated herein), and further limited by functional limitations at claim 1 requiring
…wherein the polypeptide undergoes phase transition and aggregates when heated above a transition temperature of heating (Tt-heating) of the polypeptide…
and
“wherein the composition is injectable prior to being heated to a temperature above the Tt-heating of the polypeptide”.
The claim scope is ostensibly further narrowed by additional functional limitations recited at amended claims 12, 14, 16-20, 22-27, and 31 (i.e., “wherein” clauses)12. Although such functional limitations presumably exclude some structures defined by the positively recited structural limitations of claim 1, none of the functional limitations actually correspond to any structure/function relationship commensurate in scope with the instantly pending claim scope.
Therefore, the pending claim scope may be vast and highly varied, reading upon >>trillions of species, or the pending claim scope may read upon five or fewer species having unknown structures.
Actual Reduction to Practice
The disclosure reduces to practice zero species reading upon the instant claim scope, because zero species satisfying the limitation requiring that “25% of amino acids of the polypeptide are within structured domains” were reduced to practice (note that “25%” is not synonymous or equivalent to the range of “about 25%”, “at least 25%”, “at most 25%”, etc., because “25%” requires a static, exact value), as discussed in preceding rejections (see New matter rejection, above, discussing calculations utilized).
Accordingly, zero embodiments of form [(GXGVP)10-20-GX1(A)25X1]4-8 (see claim 9) satisfy the limitation that “25% of amino acids of the polypeptide are within structured domains” at amended claim 1 (note that “25%” is not synonymous or equivalent to the range of “about 25%”, “at least 25%”, “at most 25%”, etc., because “25%” requires a static, exact value).
Similarly, zero embodiments of form M[(GXGVP)15-16-GX1(A)25X1]4 or 6-GWP (see claims 10-11) satisfy the limitation that “25% of amino acids of the polypeptide are within structured domains” as recited at amended claim 1.
Accordingly, zero embodiments satisfying the structural limitations of amended claim 1 were reduced to practice, which means zero embodiments satisfying both the structural and functional limitations of claims 1, 12, 14, 16-20, 22-27, and 31 were reduced to practice.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus (see, e.g., MPEP § 2163(II)(3)(a), MPEP §2163.03(V)). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated that the disclosure of zero species within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. Similarly, the disclosure of zero species reading upon the amended claim scope does not provide sufficient disclosure to satisfy the written description requirement for the instantly claimed genus.
Therefore, zero species within the scope of claims 1, 12, 14, 16-20, 22-27, and 31 were unambiguously disclosed and reduced to practice on record.
Identifying characteristics of the Genus
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
The originally filed disclosure provides a laundry list disclosure. For example, the term “structured domain” lacks an unambiguous structural definition because although a “structured domain” may “consist[] of . . . oligoalanine amino acid (from 5 to 500, but typically A25) that form perfect α-helices” (see, e.g., Spec. filed 12/02/2022 at 15-16 at bridging ¶), the “structured domain” may also “comprise at least one of a polyproline domain and a polyalanine domain” (see, e.g., Spec. filed 12/02/2022 at 17-18 at bridging ¶). Critically, a “polyalanine domain” is not limited to literal poly(Ala) sequences, but instead may comprise an unlimited number of non-alanine residues (see, e.g., Spec. filed 12/02/2022 at 18 at 2nd full ¶). Furthermore, neither the structured domain nor the “polyalanine domain” needs to comprise nor consist of only “perfect α-helices” (see, e.g., Spec. filed 12/02/2022 at 15-16 at bridging ¶), but instead, in some embodiments only “at least about 50% of the amino acids” are “in an α-helical conformation” (see, e.g., Spec. filed 12/02/2022 at 18 at 3rd full ¶). The usage of “about” in such instances is worth noting because “about” is defined in multiple but non-equivalent ways on record (see, e.g., Spec. filed 12/02/2022 at 8 at lines 12-21, noting that “about” is defined as “up to ± 10%” variation, “3 or more standard deviations”, “within an order of magnitude”, “within 5-fold”, or “within 2-fold” of a value). Accordingly, the phrase “at least about 50%” presumably includes a structured domain (or polyalanine domain) having as little as 5% α-helices when “about” is “within an order of magnitude” (see, e.g., Spec. filed 12/02/2022 at 8 at lines 12-21). Therefore a “structured domain” is generically understood to any polypeptide of form (X1)y([polyalanine domain])n(X1)y, wherein X1 is independently any amino acid (natural or non-natural), the [polyalanine domain] comprises “between 5 and 50 alanine residues” in any pattern or order, and wherein each y and n are one or greater, without limitations regarding charge, length, or composition of X1.
A “polyalanine domain” is understood to be any polypeptide, of any charge or composition, “having between 5 and 50 alanine residues” in any pattern or arrangement (i.e., consecutive, non-consecutive, adjacent, non-adjacent), which may be shown as the generic sequence of (X1)n(X2)o(X3)p, wherein each of X1, X2, and X3 may be alanine or any other amino acid (natural or non-natural), wherein n+o+p is 5 or greater, and wherein (X1)n(X2)o(X3)p must contain “between 5 and 50 alanine residues” (e.g., K100C50A5K50C100 satisfies the literal structural limitations for a “polyalanine domain” or “structured domain” as recited at claim 1). Accordingly, trillions of highly varied sequences qualify as a “polyalanine domain”.
Similarly, “disordered domains” are ill-defined structures of unknown size, but are understood to be any sequence that “comprises an amino acid sequence of (GXGVP)n (SEQ ID NO: 2), wherein X is any amino acid except proline and n is an integer greater than or equal to 1” (see, e.g., amended claim 1 as filed 8/17/2026). Accordingly, a “disordered domain” presumably encompasses even sequences such as P10(GXGVP)P10, C20W20GXGVPC20W20, or more generically (X1)y(GXGVP)n(X1)y, wherein X1 is independently any amino acid (natural or non-natural), X is any amino acid (natural or non-natural) except proline, and each y and n are one or greater, without limitations regarding charge, length, or composition of X1.
Accordingly, the claim scope is vast and highly varied. The scope is broadened in view of the definitions of “amino acid” and “polypeptide”, which are not limited to naturally occurring proteinogenic amino acids, but instead broadly include “amino acid derivatives that are not naturally occurring” and “non-native amino acid derivative[s]” (see, e.g., Spec. filed 12/02/2022 at 22 at 1st full ¶). This is pertinent because there are substantial numbers of natural and non-natural amino acids (See, e.g., US2008/0139481 A1 at title, abs, at claims, disclosing subgenera of non-natural amino acids; see, e.g., US 6,858,396 B2 at title, abs, claims, disclosing thousands of amino acids). Although this may be reasonably limited by the preamble reciting a “recombinant polypeptide”, it is noted that insertion of non-natural amino acids using amber codon technologies has been available in the art for years.
In view of the disclosure, an artisan would not be reasonably made aware of what structural components were required, necessary, sufficient, or related to the functionality recited in each functional limitation at issue. Rather, the original disclosure fails to provide clear structural requirements necessary to satisfy the functional limitations, but instead repeatedly equivocates or otherwise utilizes hedging language to provide even vague guidance; for example, the specification informs artisans that “The phase transition behavior of the Fractomer may derive from the phase transition behavior of the disordered domains of the Fractomer” (see, e.g., Spec. filed 12/02/2022 at 22 at 3rd full ¶, emphasis added), that “Tt-cooling may be primarily determined by the structured domains” (see, e.g., Spec. filed 12/02/2022 at 22 at 3rd full ¶, emphasis added); and that “TT-heating may be primarily determined by the disordered domains” (see, e.g., Spec. filed 12/02/2022 at 22 at final ¶, emphasis added). However, such language does not actually inform artisans of what exact structures are required to satisfy the functional limitations set forth in the pending claims.
Accordingly, the functional limitations amount to a recitation of what the Inventor(s) hoped, desired, or wanted the invention to achieve, but without providing clear guidance of actual chemical structures necessary and sufficient to achieve the functional limitations.
Therefore, the limited guidance in the originally filed disclosure does not reasonably inform artisans of any structure/function relationships commensurate in scope with the amended claim scope and functional limitations at issue. For example, in view of the originally filed disclosure, an artisan would be unaware if a particular sequence infringed upon claims 1, 12, 14, 16-20, 22-27, and 31, or not. Furthermore, an artisan would be unable to reasonably identify, a priori, any structures that satisfied the functional limitations of instant claim 1, but did not also satisfy the functional limitations of claim 12, 14, 16-20, 22-27, or 31 (i.e., no narrower, functionally defined subgenera exist on record corresponding to the functional limitations).
Predictability in the Art
Although the level of skill in the art is high, the predictability in the art is low due to the complexity of biological systems, biochemistry, and molecular and cellular biophysics. Specifically, an artisan would not be able to predict or identify, a priori, and in the absence of any guidance or consensus structures exactly what compounds would be capable of reading upon instant claim 1, or other read upon instant claim 1 but be excluded from the scope of claims 12, 14, 16-20, 22-27, or 31.
Notably, amended claims 22-24 refer to set ranges of a percent volume of a composition “when the composition is in an injectable form”. This is a contingent limitation, and is interpreted as described at MPEP § 2111.04(II), which explains that “[t]he broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur.” Accordingly, the recitation of a contingent limitation in a product claim requires that the product comprise the structure required to perform the recited function. This raises a substantial and material concern because the prior art reasonably informs artisans that the volume of elastin-containing substances are known to vary with changes in temperature (see, e.g., Wilharm et al.13 at title, abs, Fig. 1, 6 at § Summary, referring to “reversible volume contractions as large as 90%” and showing variations of gel size) swelling conditions (see, e.g., WO2019/006374 at ¶[000120]), and volume contraction due to external forces (see, e.g., WO2019/006374 at ¶[000137]). Accordingly, this raises the issue of “what structure is required to achieve the contingent functional limitations at claims 22-24?”. No guidance identifying what the metes and bounds of the structure(s) required to achieve the recited functional limitations is provided on record or in the prior art, and therefore such limitations could not be identified, a priori, without making and infringing such claims. Furthermore, since volume is temperature dependent, but no temperature is recited at claims 22-24, it is unclear if the claim scope encompasses all species that might satisfy the limitation at least at one temperature even if it does not satisfy the limitations at all temperatures, or if the claim scope encompasses only species that satisfy the limitations at all temperatures relevant to injectable forms of the composition.
Close prior art exists. The lack of description and guidance regarding what structures do or do not read upon the pending claims is problematic because close prior art exists, including Roberts14 (see discussion below), unstructured Recombinant Proteins (URPS) as taught and claimed by US 7,846,445 B2 (see, e.g., US’445 at claims 1-10), XTENylated sequences comprising XTEN between structured protein domains (see, e.g., US10138291B2 at abs, claims, Figures), etc. Accordingly, substantial prior art structures exist that ostensibly comprise “a recombinant partially ordered polypeptide” having a “plurality of disordered domains” and a “plurality of structured domains” as recited at claim 1. Accordingly, the relevant issue is “what actual structures satisfy the functional limitations of amended claim 1?”, and “what actual structures within the scope of instant claim 1 do or do not satisfy the functional limitations recited at claims 12, 14, 16-20, 22-27, or 31?” 15 No clarification permitting an artisan to distinguish, a prior, functional embodiments from non-functional embodiments has been identified in the prior art or on the instant record, commensurate in scope with these claims.
Accordingly, basic identifying characteristics pertinent to the claimed genus are left unanswered, and the functional limitations at the amended claims amount to an attempt merely describe results and effects the Inventor hopes and desires for the invention to achieve, but fails to describe and define actual structures capable of achieving such functionality.
Applicant Admissions and Statements
Examiner notes that in the arguments filed 8/17/2026, the Applicant provides statements weighing in favor of the instant rejection, and specifically alleges that
The elastin-inspired polymer literature shows that relatively modest changes in these solution conditions, including buffer composition, salt content, pH, or local hydrophobic/charged environment can markedly shift the transition temperature and aggregation profile of elastin-inspired polymers, and that introducing a lipid-rich, multiphasic material such as lipoaspirate, with emulsified and structural lipids, lipid droplets, and associated proteins, would be expected to alter solvent quality and effective hydrophobicity in a manner that could disrupt the cooperative hydrophobic interactions responsible for ordered collapse and assembly.
(see, e.g., Reply filed 8/17/20226 at 19-20 at bridging ¶).
This is pertinent because zero embodiments of the claimed invention were reduced to practice, zero structure/function relationships corresponding to “marked[] shifts” caused by “relatively modest changes in these solution conditions, including buffer composition, salt content, pH, or local hydrophobic/charged environment” were discussed on record; and zero guidance regarding “buffer composition, salt content, pH, or local hydrophobic/charged environment” commensurate in scope with the instant claims exists in the originally filed disclosure. Accordingly, if such admissions are correct, then the functional limitations recited at instant claims 1, 12, 14, 16-20, 22-27, and 31 are reasonably understood to be highly convoluted limitations that depend upon more than concentration and temperature, but also upon solution conditions, buffer compositions, salt content, pH, and local hydrophobic/charged environments in a manner that is not identified in the originally filed disclosure. Accordingly, such statements by the Applicant weigh in favor of a determination that the requirements of 35 USC 112 have not been met in the absence of guidance regarding how the functional limitations at issue depend upon such parameters commensurate in scope with the instant claims.
Conclusion
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). The courts have stated that “merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus” (see, e.g., AbbVie v. Janssen, 111 USPQ2d 1780 (Fed. Cir. 2014) at 1789). In addition, the Courts have stated
“[r]egardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
This is pertinent because, in the instant case, Applicants have claimed a broad and highly varied genus comprising an unknown number of species defined by reference to one or more functional limitations; however, the originally filed disclosure has failed to identify any common structure/function relationship sufficient to permit an artisan to identify what structures are included or excluded by the functional limitations of the amended claims. This also means that it is prima facie unclear what structures infringe or do not infringe upon the pending claim scope of these claims.
In conclusion, for the reasons discussed above, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-6, 8, 12, 14, 16-20, 22-27, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019006374A1 (filed Jan. 3, 2019; cited in previous action) in view of US2018/0133401 (May 17, 2018).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding the instant claims, generally, WO’374 teaches, claims and discloses injectable, cellular scaffolds that may comprise (i) human tissue cells, and (ii) one or more POP (“partially ordered polypeptide”) that contains a plurality of disordered domains and a plurality of structured domains (see, e.g., WO’374 at ¶¶[0005], [0007]-[00011], [00093]-[00095], [000102]-[000107], [000148], [000180]-[000190], [000192], claims 1-11 and 14-40), wherein such scaffolds are usable to treat diseases and facilitate wound healing (see, e.g., WO’374 at ¶¶[000108]-[000111]). Regarding instant claim 1 and compositions comprising human tissue and a recombinant polypeptide comprising a plurality of both disordered and structured domains, WO’374 explicitly teaches and discloses compositions (i.e., cellular scaffolds) that may comprise (i) any type of human tissue cells and (ii) any POP (“partially ordered polypeptide”) (see, e.g., WO’374 at claims 1, 11, 26-27, ¶¶[0007], [00011], [00068]-[00070], [00075], [00093]-[00095], [000155]). WO’374 discloses that the scaffolds comprise “POPs” (see, e.g., WO’374 at ¶[00093], claims 26-30), wherein a “POP” is described as a “partially ordered polypeptide” that contains a plurality of disordered domains and a plurality of structured domains (see, e.g., WO’374 at claim 1, 11, ¶¶[00068]-[00070], [00075], [000155]). Regarding instant claims 1, 4-6, and a disordered domain comprising (GXGVP)1-50, wherein X is Ala or Val at a ratio of 1:1 or 1:4, WO’375 teaches that POPs comprise a disordered domain comprising [VPGXG]1-100, wherein X may be Ala, Val, or a mixture of Ala and Val at a ratio of Ala:Val including 1:1 and 1:4 (see, e.g., WO’374 at claims 1-5, ¶¶[00072], [000157]-[000159]). Although “GXGVP” and “VPGXG” are non-identical, it is noted that upon extending the repeats disclosed by the prior art, the prior art sequence of [VPGXG]1-100 may be rewritten in a synonymous and equivalent manner as VP(GXGVP)1-99GXG; therefore, it is evident that the prior art POP fully comprises the pentapeptide domain of “GXGVP” as instantly claimed (see also WO’374 at Fig. 1E, showing “GVGVP” was tested and reported). Regarding instant claims 1, 8, and a “structured domain” comprising a “polyalanine domain” comprising (A)25, K(A)25, D(A)25K, or GD(A)25K, WO’375 teaches that POPs comprise a structured polyalanine domain (see, e.g., WO’374 at claims 1, 6-8, and 10), including (A)25, K(A)25, and D(A)25K (see, e.g., WO’374 at claim 10; see also WO’374 at ¶¶[0006], [00077], [000163]-[000164]). Regarding GD(A)25K, WO’375 teaches, discloses, and exemplifies this sequence at Fig. 1A, where it is identified as “Helix 5” (e.g., “H5”) (see, e.g., WO’374 at Fig. 1A, image at abs, ¶¶[00019], [000129]16, Table 1 on 39). Regarding amended claim 1 and the requirement that “25% of amino acids of the polypeptide are within structured domains”, this phrase has been identified as indefinite (see rejections under 35 USC 112(b), above, and those discussions are incorporated herein). For purposes of the instant rejection, it is noted that WO’374 teaches, discloses, and claims overlapping polypeptide structures comprising a plurality of disordered domains and a plurality of structured domains (see, e.g., WO’374 at claim 1); wherein the disordered domains comprise [VPGXG]m (m is ≥ 1) wherein X is Val, Ala, or a 1:1 to 1:4 mixture of Ala to Val (see, e.g., WO’374 at claims 1, 2(i), 3-6 ); wherein the structured domains comprises a polyalanine domain having “at least about 60% of the amino acids in an alpha-helical conformation” and the structure of (A)25, K(A)25, and D(A)25K (see, e.g., WO’374 at claims 1, 2(i), 3-10); and wherein “about 4% to about 75% of the POP comprises structured domains” (see, e.g., WO’374 at claim 12). Accordingly, the prior art teaches and directs artisans to utilize polypeptides having 4% to 75% of the amino acids within structured domains, which overlaps in scope with the amount recited and required by instant claim 1. Per MPEP § 2144.05(I), “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”, and here 25% lies inside the ranges taught by the prior art. Regarding instant claims 1, 12, 14, 16-18, and temperature of heating and cooling limitations, it is noted that these claims have been rejected under 35 USC §112 above. For purposes of the instant rejection, it is noted that WO’374 explicitly teaches that the disclosed POP structures are understood to have “a transition temperature of heating (Tt-heating) and a transition temperature of cooling (Tt-cooling)” (compare WO’374 at claim 14 with instant claim 12), wherein the “transition temperature of cooling (Tt-cooling) is concentration-independent” (of any domain) (compare WO’374 at claim 18 with instant claim 13), wherein the transition temperature of heating and cooling range from “about 10°C to about 45°C”17 (compare WO’374 at ¶¶[00029], [000131]-[000133], Figs. 2C-2E, 10, 11A-D with instant claim 14), wherein the POP forms a solid aggregate above the Tt-heating (compare WO’374 at claim 18 with instant claim 15), and wherein the solid aggregate resolubilizes when cooled to below the Tt-cooling (compare WO’374 at claim 21 with instant claim 16). Accordingly, the specific “POP” structures taught and disclosed by WO’374 are reasonably understood to all satisfy the limitations at instant claims 1, 12, 14, 16-18. Regarding the formation of a stable three-dimensional matrix, WO’374 explicitly teaches that the disclosed POP structures are understood to form “a stable three-dimensional matrix” (compare WO’374 at claim 20-22 and 26-27). Regarding instant claims 18-19, and a “plurality of pores” that range in size from 1 µm to 150 µm, it is noted that these claims have been rejected under 35 USC §112 above. For purposes of the instant rejection, it is noted that WO’374 explicitly teaches and claims that the aggregate, when formed, is “porous with a void volume” that “is tunable” (see, e.g., WO’374 at claims 24-25), and further identifies that such pores may have a diameter of “about 1 µm to about 100 µm” (see, e.g., WO’374 at ¶¶[00046], [00090], Fig. 28A-B), and POP networks having “~3-5µm pores” were exemplified (see, e.g., WO’374 at ¶[00142], Fig. 5 and 27). Per MPEP § 2144.05(I), “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”, and here the claimed range is reasonably inferred to lie within the ranges taught by the prior art. Regarding instant claims 1, 20, and “injectable” compositions comprising “between 200 µM and 2 mM” of the recombinant polypeptide, it is noted that these claims have been rejected under 35 USC §112 above. For purposes of the instant rejection, it is noted that WO’374 explicitly exemplifies the usage of 250µM injections of a POP injected to a subject, which formed a cellular scaffold in vivo, wherein the explant was subsequently removed (see, e.g., WO’374 at ¶¶[00024], Figs. 6A-6J). Accordingly, an artisan would readily appreciate that cellular scaffolds could be made using at least 250µM injections of a POP (see, e.g., MPEP § 2144.05(I), noting that “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”). Regarding a “shapeable liquid or semisolid” that may be “moldable” into “3-dimensional shapes”, WO’374 explicitly teaches that the disclosed POP structures are understood to form “a stable three-dimensional matrix” (see WO’374 at claim 20-22 and 26-27). In addition, WO’374 explicitly teaches that the compounds have “solid-like” and “liquid-like” behavior, wherein the “POPs exhibit plastic, frequency dependent viscosity” and show “an increase in elastic moduli as the polymer aggregates” (see, e.g., WO’374 at ¶¶[00031], [00089]), wherein the elastic moduli may “span 2-3 orders of magnitude” (see, e.g., WO’374 at ¶¶[000142]), and exemplifies embodiments wherein a POP is liquid enough to inject into subjects, but is capable of “retaining the shape and volume of the initial injection” (see, e.g., WO’374 at ¶¶[00024], Figs. 6A-6J). Accordingly, the prior art compositions are understood to reasonably be a semisolid that can be shaped into 3 dimensional shapes. Regarding instant claims 1, 20, 22-27, and compositions that are “in an injectable form”, it is noted that these claims have been rejected under 35 USC §112 above. For purposes of the instant rejection, it is noted that WO’374 explicitly teaches that the POPs may be injected into subjects (see, e.g., WO’374 at ¶¶[00024], Figs. 6A-6J), and WO’374 explicitly identifies that cellular scaffolds may be implanted into subjects (see, e.g., WO’374 at ¶[000102], claims 28-29) or injected (see, e.g., WO’374 at ¶[000103], claim 30). Regarding instant claims 1, 31, and compositions “wherein the polypeptide permits cell infiltration and vascularization of the” the human tissue, it is noted that these claims have been rejected under 35 USC §112 above. For purposes of the instant rejection, it is noted that WO’374 explicitly teaches that “POP depots supports . . . extensive cellular infiltration” and a “high degree of vascularization” (see, e.g., WO’374 at ¶[000147]), wherein the POPs permit “migration of cells within the scaffold, followed by proliferation and vascularization, indicating that POPs promote wound healing and tissue growth” (see, e.g., WO’374 at ¶[000149]; see also id. at ¶¶[00011], [00024], [000189], [000199], claims 35, 45). Accordingly, it is reasonably inferred that the POP comprising cellular scaffolds permit cell infiltration and vascularization.
The prior art of WO’374 differs from the instant claims as follows: WO’374 differs from the scope of instant claims 1, 4-6, 8, 12, 14, 16-20, 22-27, and 31 because WO’374 teaches injectable, cellular scaffolds comprising any type of human tissue cells and one or more POP (“partially ordered polypeptide”), but the instant claims are directed to a narrow subgenus of the prior art embodiments explicitly limited to lipoaspirate. Accordingly, the relevant issue is whether or not it would have been obvious in view of the prior art, to practice the invention of WO’374 using adipose tissue, such as lipoaspirate.
In view of the teachings and guidance of WO’374, an artisan would readily appreciate that the WO’374 cellular composition comprised POPs, but would also recognize that POPs were derived from elastin-like polypeptides (ELPs) (see, e.g., WO’374 at ¶¶[00048], [000113], [000128]), and that the disclosed POPs included elements of tropoelastin “that make elastin an important component”, with the hypothesis that the POPs would mimic tropoelastin, but advantageously exhibit “tunable properties” (see, e.g., WO’374 at ¶[000128]), and that POPs are compared to elastin (see, e.g., WO’374 at ¶[000140], [000143]). However, an artisan would reasonably understand that POPs represent an improvement over elastin because POPs have tunable properties (see, e.g., WO’374 at ¶¶[000144]-[00145], [000149]). Accordingly, an artisan would readily appreciate that POPs could be advantageously utilized in place of elastin, tropoelastin, or ELPs in prior art applications.
US’401 pertains to injectable adipose tissue compositions (see, e.g., US’401 at title, abs, ¶¶[0037], [0140]). Regarding instant claims 1, 4-6, 8, 12, 14, 16-20, 22-27, 31, generally regarding adipose tissues, including human lipoaspirate, US’401 teaches and discloses injectable, adipose tissue compositions usable in autografts or allografts (see, e.g., US’401 at ¶¶[0037], [0067], [0140]), which may be utilized in wound healing (see, e.g., US’401 at ¶[0043]), wherein the adipose tissue may be combined with additives (see, e.g., US’401 at ¶¶[0055], [0137]) including elastin (see, e.g., US’401 at ¶[0137]), wherein the adipose tissue may be “human lipoaspirate” (see, e.g., US’401 at ¶¶[0059]). Regarding instant claims 1, 21, and the usage of lipoaspirate, US’401 explicitly teaches that the adipose tissue includes “human lipoaspirate” (see, e.g., US’401 at ¶¶[0005]-[0006], [0008], [0059], [0194]). Accordingly, injectable combinations of human lipoaspirate and elastin polypeptides was already known in the prior art. Regarding instant claims 22-27 and ratios and volumes of lipoaspirate relative to an additive, it is noted that these claims have been rejected under 35 USC §112 above. For purposes of the instant rejection, it is noted that US’401 identifies that adipose tissue includes “human lipoaspirate” (see, e.g., US’401 at ¶¶[0005]-[0006], [0008], [0059], [0194]), and explicitly teaches and discloses “the volume ratio of fat to additive can vary” from at least “about 10:1” to “about 5:1”, including a 1:1 ratio of volumes (see, e.g., US’401 at ¶[0139]). (see, e.g., MPEP § 2144.05(I), noting that “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”). In sum, US’401 teaches and discloses that compositions comprising adipose tissue (e.g., lipoaspirate) and an additive (such as elastin), at a volume ratio of 1:1, were contemplated by the prior art and had known and expected utility, including in wound healing applications.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
First, the claimed invention is the obvious combination of prior art elements (i.e., POPs as taught by WO’374, the human tissue of lipoaspirate as taught by US’401) according to known methods of forming cellular scaffold compositions by combining POPs with human tissue (i.e., lipoaspirate) to yield predictable results, namely a cellular scaffold usable in the applications taught and disclosed by WO’374 (see, e.g., MPEP § 2143(I)(A), (G)). Furthermore, each prior art element would merely perform its art-recognized function in combination as it does separately.
Second, or alternatively, the claimed invention is the obvious simple substitution of one known element (i.e., the POPs disclosed by WO’374) for another known element (i.e., the additives, such as elastin, used in combination with lipoaspirates as taught by US’401), wherein such simple substitution would predictably result in a lipoaspirate/POP composition usable as an injectable substance in the applications taught and disclosed by US’401 (e.g., wound healing), and wherein the usage of POPs would be expected to predictably and expectedly impart the advantageous tunable properties and temperature-based transitions disclosed by WO’374 and attributed to POPs (see, e.g., MPEP § 2143(I)(B), (C), (D)).
Accordingly, the invention is the combination of known elements, wherein such combinations would produce only the predicted and expected results disclosed by the prior art, and would have the utility and therapeutic benefits explicitly taught by the prior art.
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to combine known compounds (e.g., POPs) with known human tissue (e.g., adipose tissue, lipoaspirate) to arrive at a cellular scaffold having known utility and applications, exactly as taught and disclosed by the prior art.
Accordingly, claims 1, 4-6, 8, 12, 14, 16-20, 22-27, and 31 are rejected.
Response to Arguments
Applicant arguments with respect to amended claims filed 8/17/2026 have been considered but are substantially rendered moot in view of the new and revised grounds of rejection, necessitated by Applicant’s amendments. Remaining applicable arguments are addressed below.
Priority
At pages 11-12, Applicant traverses the denial of priority based upon the allegation that “Support for the claim amendments can be found throughout the application as filed” (see, e.g., Reply filed 8/17/2026 at 11 at § Status of the Claims), and Examiner acknowledges that
Applicant attempted to amend the Priority document of Pro’171 to alter an incorporation by reference (see, e.g., Reply filed 8/17/2026 at 12 at 2nd full ¶), and
Applicant alleges that the sequences at issue are “derivable” from SEQ ID NO: 1 of Pro’171 (see, e.g., Reply filed 8/17/2026 at 12 at 2nd full ¶), without identification of how the pending claim scope could be “derived” as presently claimed; and
Applicant alleges that other limitations are “derivable” from a different PCT disclosure that was not actually cited in Pro’173 as filed 6/05/2020 (see, e.g., Reply filed 8/17/2026 at 12 at 2nd full ¶).
These arguments have been fully considered but are not persuasive because
Per 37 CFR 1.121(k), “Amendments in provisional applications are not usually made”, and here the proposed amendment has not been entered. Therefore, reliance upon the amendment is misplaced.
Arguments that do not deny that something is literally, inherently, or implicitly absent from the priority document, but rather that it is “derivable”, are not persuasive because this is equivalent to arguing that it renders something “obvious”. However, obviousness is not the test for written description support:
[A]n applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention" (see, e.g., Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398, emphasis added).
Therefore, even assuming arguendo that the provisional disclosure were sufficient to render the instant claim scope obvious, “a description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention” (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)).
Accordingly, all arguments regarding support in the provisional disclosure have been fully considered but not found persuasive. No literal, inherent, or implicit support for the amended claim scope exists in the provisional document.
35 USC 112(a), (b), and (d)
At page 14, it is the Examiner’s understanding that Applicant jointly addresses and traverses all prior rejections under 35 USC 112 (see, e.g., Reply filed 8/17/2026 at 14 at § Claim Rejections – 35 U.S.C. § 112). Notably, no arguments or explanations are raised, but rather Applicant addresses the prior rejections by asserting, without objective supporting evidence or explanation, that the claims “are not indefinite”, that the rejection “under 35 U.S.C. § 112(d) moot”, and that the written description rejection “is mooted” (see, e.g., Reply filed 8/17/2026 at 14 at § Claim Rejections – 35 U.S.C. § 112).
Accordingly, no arguments were raised, and no explanation was provided. It is the Examiner’s position that Applicant has not specifically disputed that the recitations at issue under 35 USC 112(a) are functional limitations that do not correspond to any known structure/function relationship on record or in the prior art, reasonably permitting an artisan to identify, a priori, functional from non-functional embodiments.
Accordingly, the rejections under 35 USC 112 are maintained as revised above, wherein all revisions were necessitated by Applicant amendment.
35 USC 103
At pages 14-20, Applicant traverses the obviousness rejection made in view of WO2019006374A1 and US2018/0133401, which has been revised above as necessitated by Applicant’s amendments (see, e.g., Reply filed 8/17/2026 at 14 at § “Claim Rejections – 35 U.S.C. § 103” to page 20 at final ¶).
As an initial matter, arguments directed to the withdrawn rejection, previously addressing the originally elected species and claims 9-11, are moot because the rejection is withdrawn in view of the amendments filed 8/17/2026. As explained above, claim 1 excludes the originally elected species and claims 9-11 are rejected under 35 USC §112(d).
Applicant addresses prior art individually: It is the Examiner’s understanding that Applicant is attempting to rebut a rejection based upon two references by addressing elements that were not taught by an individual reference (see, e.g., Reply filed 8/17/20226 at 16-17 at bridging ¶, alleging that WO’374 alone “does not disclose or suggest combining its polypeptide with lipoaspirate”; see also id. at 16-17 at bridging ¶, alleging that US’401 alone does not teach the Elastin-based polymer of WO’374; see also id. at 17 at 2nd full ¶, alleging that “Schwab does not suggest a thermally responsive polymer as a suitable additive”; see also id. at 16-17 at bridging ¶, alleging that US’401 alone discloses “a laundry list of dozens of unrelated biomaterials”; see also id. at 15-16 at bridging ¶, alleging that US’401 alone discloses “laundry list of possible additives”; see also id. at 17-18 at bridging ¶, alleging that US’401 alone discloses “one item in a laundry list of possible biocompatible additives”; see also id. at 19 at 1st full ¶, referring to US’401 alone and “Schwab’s undifferentiated mention of elastin in a laundry list”; this listing is not exhaustive). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is neither disputed nor dispositive of obviousness that a single reference does not render the claims obvious, because the rejection is based upon a combination of references.
Unclaimed limitations do not distinguish the claimed invention relative to the closest prior art of record: It is the Examiner’s understanding that Applicant repeatedly refers to unclaimed limitations (see, e.g., Reply filed 8/17/20226 at 20 at 1st partial ¶ referring to “ordered, hydrophobic collapse and phase transition behavior”, “reproducible across patients and lipoaspirate processing methods”; id. at 19 at final ¶ referring to “buffer composition, salt content, pH, or local hydrophobic/charged environment” and “aggregation profile”; id at 19 at 1st full ¶ referring to “thermal responsiveness, phase transition, or in situ solidification”; id. at 18 at final ¶ referring to “reversible solution-to-aggregate transitions” and “LCST behavior. . . smart interfaces. . . bio-interactive domains, enzyme-mediated crosslinking sites”; this is not an exhaustive listing). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (e.g., those identified above) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Accordingly, arguments premised that the rejection does not address unclaimed limitations are not persuasive.
Applicant alleges that there is no motivation or rationale to combine the prior art references to arrive at the claimed invention: In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references (see, e.g., Reply filed 8/17/20226 at 16-20, generally; see esp. id. at 15 at 2nd full ¶, 17 at 1st to 3rd full ¶¶, 18 at 1st full ¶, 19 at 1st full ¶), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner has explicitly supported a determination of obviousness for the exemplary rationales set forth at MPEP §§ 2143(I)(A), (B), (C), (D), and (G). Accordingly, clear rationales supporting a determination of obviousness were placed on record.
Applicant allegation that there is no motivation to specifically select “elastin” within the list of additives taught by the secondary reference because it allegedly amounts to a “laundry list” of possibilities: It is the Examiner’s understanding that Applicant is suggesting that an artisan would not reasonably select the additive of “elastin” from the “laundry list” of additives in the secondary reference (see, e.g., Reply filed 8/17/20226 at 16-17 at bridging ¶, referring to “a laundry list of dozens of unrelated biomaterials”; see also id. at 15-16 at bridging ¶ referring to “laundry list of possible additives”; see also id. at 17-18 at bridging ¶ referring to “one item in a laundry list of possible biocompatible additives”; see also id. at 19 at 1st full ¶ referring to “Schwab’s undifferentiated mention of elastin in a laundry list”). As an initial matter, Examiner acknowledges that the rationales used to support a determination of obviousness in the rejection included the exemplary rationales set forth at MPEP § 2143(I)(A), (B), (C), (D), and (G); and it is reasonably understood that the alleged “laundry list” arguments (see, e.g., Reply filed 8/17/20226 at 15-16 at bridging ¶, 16-17 at bridging ¶, 17-18 at bridging ¶, 19 at 1st full ¶) are relied upon to attempt to rebut the “simple substitution” rationale (MPEP § 2143(B)). In patent law, a “laundry list” disclosure occurs when a prior art reference lists dozens or hundreds of compounds, materials, or method steps without highlighting or giving preference to any specific option. Whether or not such a “laundry list” renders a claimed invention obvious under 35 USC § 103 depends upon how one of ordinary skill in the art would view the list in combination with the rest of the reference, additional teachings from other references, and the general knowledge in the field. According, an analysis of a “laundry list” argument requires consideration of the an artisan; per MPEP § 2141.03(I), "[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton", and "in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle"; critically, “Office personnel may also take into account ‘the inferences and creative steps that a person of ordinary skill in the art would employ’” (see, e.g., MPEP § 2141.03(I), see discussion of factors (A)-(E)). In the instant case, the ordinary level of education in the field is high (i.e., PhD or masters level). Furthermore, the problem faced by an artisan in view of the primary reference is addressed at the difference statement of the rejection, which identifies that
WO’374 teaches a genus of injectable cellular scaffolds comprising any type of human tissue cells and one or more POP (“partially ordered polypeptide”), but the instant claims are directed to a narrow subgenus of the prior art embodiments explicitly limited to lipoaspirate.
(see Rejection above, at difference statement). Therefore, in view of the primary reference, the issue faced by one of ordinary skill in the art was the selection of the specific tissue of human lipoaspirate from among all human tissues, but not the specific selection of “elastin” from an alleged “laundry list”. Accordingly, Applicant’s arguments are not persuasive because they rely upon mischaracterizing the selection issue faced by one of ordinary skill in the art, because artisans faced a tissue selection issue, not the issue of selecting “elastin” from a list. In addition, such arguments are not persuasive because Applicant’s arguments effectively ignore the substantial additional guidance and teachings of the primary reference, and the teachings of US’401 cannot be considered in isolation, because one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner notes that Applicant’s arguments also appear to stem from a mischaracterization of the obviousness rationale set forth in the rejection under MPEP § 2143(I)(B), because Applicant’s arguments appear to assume the rationale relies upon a specific selection of elastin, but this is incorrect because the rejection rationale clearly states
…the obvious simple substitution of one known element (i.e., the POPs disclosed by WO’374 for another known element (i.e., the additives, such as elastin, used in combination with lipoaspirates as taught by US’401”)….
(see, e.g., Rejection above; see also Action mailed 3/17/2026 at 33). This distinction is important because the rationale does not rely upon selection of a single, specific additive, but rather upon the fact that an artisan, in view of the disclosure regarding additives in general by the secondary reference, would readily appreciate that the specific additive(s) utilized would not materially or substantially alter the predicted and expected results and applications taught by US’401 (i.e., no selection is required, because an artisan would appreciate that any additive could be utilized or substituted freely). Accordingly, a “laundry list” of possible additives reasonably informs artisans that the particulars of specific “additives” used would not be predicted and expected to substantially alter the utility of such formulations, but would reasonably inform artisans that “additives” could be generally present, while still yielding predicted and expected results. Accordingly, the arguments regarding a “laundry list” and specific selection of “elastin” are not persuasive because the rationales supporting a determination of obviousness depend upon substitution of any additive, and does not require the specific selection and substitution of the single additive of elastin. Accordingly, the mere existence of a “laundry list” of alternative additives in US’401 alone does not eliminate (or justify ignoring or dimissing) the substantial guidance provided by WO’374, because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses or suggests, including non-preferred and alternative embodiments (see, e.g., MPEP §§ 2123(I)-(II)); and here, each prior art component of the claimed invention was already known in the art, and each component would perform the same function in combination as they do individually; accordingly, in the absence of any unexpected results, the outcomes remains predictable and expected, regardless of the total number of alternatives and regardless of the particular “additive” selected and substituted by the POPs of the primary reference. Therefore a determination of obviousness is consistent the Court’s guidance, which explains that
"[W]hen a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious."
KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 , 417 , 127 S. Ct. 1727 , 167 L. Ed. 2d 705 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273 , 282 , 96 S. Ct. 1532 , 47 L. Ed. 2d 784 (1976)).
Likewise, the Supreme Court has rejected rigid tests for obviousness and has emphasized that
[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 416.
And has also emphasized that
“If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 417.
Here, all aspects of the claimed method were already known in the art, including (i) POP (“partially ordered polypeptide”) containing a plurality of disordered domains and a plurality of structured domains18; (ii) formulations for injectable, cellular scaffolds comprising any human tissue cells and one or more POP19; (iii) predicted and expected utility of such injectable POP/tissue formulations in methods of treating diseases and facilitate wound healing20; (iv) that human lipoaspirate was a known human tissue composition usable in injectable compositions for use in wound healing21; and (v) that such injectable human lipoaspirate compositions could be formulated with a vast number of additives, while yielding predictable and expected results, including compositions for use in wound healing22. Accordingly, one of ordinary skill in the wound-healing arts would readily appreciate that lipoaspirate could be utilized in combination with POPs to predictably form an injectable composition for use in wound healing, wherein the use of POPs would convey the additional benefits taught and disclosed by the primary reference. Accordingly, arguments premised upon a “laundry list” selection of “elastin” have been fully considered but not found persuasive for the reasons discussed above, including the fact that such a selection does not reflect the issues faced by one of ordinary skill in the art, that such arguments dismiss the additional guidance of the primary reference, and that the rejection rationales do not require or rely upon a specific selection of “elastin” specifically from a “laundry list” of additives.
The existence of alternatives does not “teach away” from the claimed inventions: It is the Examiner’s understanding that Applicant is suggesting that the disclosure of additional “additives” in an alleged “laundry list” of additives “teaches away” from the claimed invention (see, e.g., Reply filed 8/17/20226 at 16-17 at bridging ¶, referring to “a laundry list of dozens of unrelated biomaterials”; see also id. at 15-16 at bridging ¶ referring to “laundry list of possible additives”; see also id. at 17-18 at bridging ¶ referring to “one item in a laundry list of possible biocompatible additives”; see also id. at 19 at 1st full ¶ referring to “Schwab’s undifferentiated mention of elastin in a laundry list”). This is not persuasive because the existence of alternatives in an alleged “laundry list” does not constitute a “teaching away” from a broader disclosure or non-preferred embodiments (see also MPEP §§ 2143(I)), and the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses or suggests, including non-preferred and alternative embodiments (see, e.g., MPEP §§ 2123(I)-(II)).
Allegations suggesting “lack of predictability” or “lack of reasonable expectation of success”: It is the Examiner’s understanding that Applicant is alleging a lack of predictability or otherwise a lack of reasonable expectation of success (see, e.g., Reply filed 8/17/20226 at 15-16 at bridging ¶, 17-18 at bridging ¶, 17 at 1st full ¶ to 19 at 1st full ¶). These arguments have been fully considered but are not persuasive because the Applicant’s assertions do not reflect the proper legal standards for evaluating predictability. MPEP § 2143.02(II) explains that “[o]bviousness does not require absolute predictability”, but instead clarifies that only “at least some degree of predictability is required” (see, e.g., MPEP § 2143.02(II)). Here, the rejection explicitly addresses predictability and reasonable expectation of success, but Applicant fails to address the explicitly identified predicted and expected results set forth in the rejection. Here, the Examiner’s basis for “predictability” is merely based upon the presumption that the prior art is fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). As explained at MPEP § 2143.02, predictability and reasonable expectation of success are satisfied when “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art”. Here zero evidence of unexpected results commensurate in scope with the requirements of MPEP 716.02 have been set forth on record, all elements of the claimed invention were known in the prior art, one of ordinary skill was fully enabled to combined each component using routine methods in the biochemical arts per the guidance of the primary reference, and the elements would have merely performed their art-recognized, respective functions (see Rejection, above). Accordingly, such arguments are not persuasive.
Allegations suggesting “skepticism of experts”: It is the Examiner’s understanding that Applicant’s statements amount to a suggestion that the Examiner’s position would be met with skepticism of experts, by repeatedly alleging what an artisan would have thought, done, or concluded (see, e.g., Reply filed 8/17/20226 at 16 at 1st full ¶, alleging that “lipoaspirate is not a mere collection of cells” and that “Elastin as disclosed in Schwab, however, is …insoluble, animal-derived extracellular matrix elastin”; see also id. at 17 at 3rd full ¶, alleging that “A skilled artisan would not have equated Chilkoti’s defined cell populations with lipoaspirate” and alleging that “nor would such an artisan have been motivated . . without specific guidance to do so”; see also id. at 18-19 at bridging ¶, alleging that an artisan would not consider “elastin” as disclosed by the secondary reference to be equivalent to POPs; see also id. at 19 at bridging ¶, alleging that “a person of ordinary skill in the art would not view them as ‘better elastin’”; see also id. at 19-20 at bridging ¶ alleging that even “modest changes in … solution conditions… can markedly shift the transition temperature and aggregation profile of elastin-inspired polymers”; this is not an exhaustive listing). If Applicant means to suggest the existence of skepticism of experts, such evidence should be filed per MPEP § 716.05 as evidence is required to establish skepticism of experts. In the absence of any supporting, objective evidence, such statements are understood to be unsupported conjecture of counsel. Critically, the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), and no objective evidence rebutting this presumption has been placed on record to date. Accordingly, such assertions are not persuasive.
Allegations suggesting “inoperability” or lack of enabling disclosure regarding a prior art reference: It is the Examiner’s understanding that Applicant’s statements amount to a suggestion that the prior art is not fully enabled or operable for combinations of POPs with lipoaspirate or otherwise lipoaspirate in combination with an “additive” of a POP, wherein such combinations are understood to yield injectable compositions suitable for use in wound healing applications (see, e.g., Reply filed 8/17/20226 at 16 at 1st full ¶, alleging that “lipoaspirate is not a mere collection of cells” and that “Elastin as disclosed in Schwab, however, is …insoluble, animal-derived extracellular matrix elastin”; see also id. at 17 at 3rd full ¶, alleging that “A skilled artisan would not have equated Chilkoti’s defined cell populations with lipoaspirate” and alleging that “nor would such an artisan have been motivated . . without specific guidance to do so”; see also id. at 18-19 at bridging ¶, alleging that an artisan would not consider “elastin” as disclosed by the secondary reference to be equivalent to POPs; see also id. at 18-19 at bridging ¶, alleging that “a person of ordinary skill in the art would not view them as ‘better elastin’”; see also id. at 19-20 at bridging ¶ alleging that even “modest changes in … solution conditions… can markedly shift the transition temperature and aggregation profile of elastin-inspired polymers”; this is not an exhaustive listing). If Applicant is attempting to allege that the prior art is not enabling or inoperable Applicant is directed to MPEP § 2121(I), which notes that the prior art is presumed fully enabled for all that it discloses, and the burden is on the Applicant to rebut the presumption of operability (see, e.g., MPEP § 2121(I); MPEP § 716.07). No evidence of inoperability commensurate in scope with the requirements of MPEP § 716.07 have been placed on record at this time; critically, arguments of counsel cannot take the place of evidence in the record (see, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965), and evidence is required to rebut the presumption of operability. The Examiner’s position is that the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)). Accordingly, the Applicant has not satisfied their burden to rebut the presumption of operability of the prior art at this time (see, e.g., MPEP § 2121(I); MPEP § 716.07).
Arguments alleging that “evidence of record” is required to identify working embodiments weighs in favor of a determination that the instant disclosure is not enabling and has not provided requisite description commensurate with the requirements of 35 USC 112: It is the Examiner’s understanding that Applicant is alleging a lack of predictability or otherwise a lack of reasonable expectation of success (see, e.g., Reply filed 8/17/20226 at 15-16 at bridging ¶, 17-18 at bridging ¶, 17 at 1st full ¶ to 19 at 1st full ¶), including the specific allegation that
The elastin-inspired polymer literature shows that relatively modest changes in these solution conditions, including buffer composition, salt content, pH, or local hydrophobic/charged environment can markedly shift the transition temperature and aggregation profile of elastin-inspired polymers, and that introducing a lipid-rich, multiphasic material such as lipoaspirate, with emulsified and structural lipids, lipid droplets, and associated proteins, would be expected to alter solvent quality and effective hydrophobicity in a manner that could disrupt the cooperative hydrophobic interactions responsible for ordered collapse and assembly.
(see, e.g., Reply filed 8/17/20226 at 19-20 at bridging ¶).
Examiner notes that zero embodiments of the claimed invention were reduced to practice, zero structure/function relationships corresponding to “marked[] shifts” caused by “relatively modest changes in these solution conditions, including buffer composition, salt content, pH, or local hydrophobic/charged environment”, and zero guidance regarding “buffer composition, salt content, pH, or local hydrophobic/charged environment” commensurate in scope with the instant claims exists in the originally filed disclosure. Accordingly, if such admissions were correct, and a high degree of evidence was required for predictability in the instant art, such admissions would not weigh in favor of allowability of the claimed invention, but instead weigh in favor of a determination that the requirements of 35 USC 112 had not been met. Accordingly, Applicant is advised that such admission, if presented on record with supporting evidence, would be weighed in view of the originally filed disclosure. For purposes of examination, the Examiner’s position is that the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), wherein the full scope of POPs in combination with any tissue materials is fully enabled, and similarly wherein the full scope of lipoaspirates in combination with any additive is fully enabled.
Allegations suggesting improper or impermissible hindsight: It is the Examiner’s understanding that Applicant is suggesting that the Examiner’s position fails to establish a prima facie case of obviousness because the prior art does not lead an artisan to the instant invention (see, e.g., Reply filed 8/17/20226 at 15 at 2nd full ¶; see also id. at 18 at 1st full ¶ alleging that the rejection “uses the claimed invention as a blueprint for selecting and combining prior art elements”). If Applicant means to suggest that the Examiner arrived at the instantly claimed invention via the use of improper hindsight, this is not persuasive because any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Here, Applicant fails to identify a single aspect of the claimed invention that was not taught, disclosed, or suggested by the prior art relied upon by the Examiner.
The disclosure of general guidance to any human “tissue” in combination with POPs does not “teach away” from the usage of lipoaspirate: It is the Examiner’s understanding that Applicant is suggesting that WO’374 “teaches away” from lipoaspirate because lipoaspirate is not “a mere collection of cells” (see, e.g., Reply filed 8/17/20226 at 16 at 1st full ¶), and that “[a] skilled artisan would not have equated Chilkoti’s defined cell populations with lipoaspirate” (see also id. at 17 at 3rd full ¶). This is not persuasive because no objective citation is provided wherein the primary reference “teaches away” from the usage of lipoaspirate, because the primary reference does not actually “criticize, discredit, or otherwise discourage the solution claimed” (see, e.g., MPEP § 2141.02(VI)). Rather, WO’374 is not limited to a “defined cell population”, but rather WO’374 identifies that a POP may be present in “any biological fluid or tissue” (see, e.g., WO’374 at ¶[00061]), wherein the such tissue sample comprising POP “can be used directly as obtained from a patient or can be pre-treated, such as by filtration, distillation, extraction, concentration, centrifugation, inactivation of interfering components, addition of reagents, and the like, to modify the character of the sample in some manner as discussed herein or otherwise as is known in the art” (see, e.g., WO’374 at ¶[00061]), and wherein a “cellular scaffold” may include a variety of human cell types (see id. at ¶[00094]), so long as is “suitable for … tissue regeneration” and “promote[s] the formation of vasculature, wound healing, or a combination thereof (see id. at ¶[00094], claims 27-31, 38-40). Accordingly, WO’374 does not “teach away” from the usage of a lipoaspirate, and the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses or suggests, including non-preferred and alternative embodiments (see, e.g., MPEP §§ 2123(I)-(II)), including all types of biological tissues and cellular scaffolds.
The disclosure of “elastin” does not “teach away” from the usage of a POP: It is the Examiner’s understanding that Applicant is suggesting that US’401 “teaches away” from utilizing a POP because a POP is not the same as “elastin” (see, e.g., Reply filed 8/17/20226 at 16 at 1st full ¶, alleging that “Elastin as disclosed in Schwab, however, is …insoluble, animal-derived extracellular matrix elastin”; see also id. at 18-19 at bridging ¶, alleging that an artisan would not consider “elastin” as disclosed by the secondary reference to be equivalent to POPs; see also id. at 18-19 at bridging ¶, alleging that “a person of ordinary skill in the art would not view POPs as ‘better elastin’”). This is not persuasive because the relevant issues and facts underlying the rationales supporting a determination of obviousness do not actually depend upon an assumption of equivalency of elastin and POPs, and no objective citation is provided wherein the primary reference “teaches away” from the usage of a POP in the lipoaspirate formulations of the secondary reference, because neither the primary nor secondary references “criticize, discredit, or otherwise discourage the solution claimed” (see, e.g., MPEP § 2141.02(VI)). In addition, Examiner notes that Applicant’s arguments rest upon an unsubstantiated premise, namely that “elastin” as used by the secondary reference should be limited to the proffered interpretation provided by the Applicant; this reasoning improperly imports definitions and limiting interpretations that simply are not present in US’401. However, the guidance provided by the secondary reference is clear, namely that “additives” in lipoaspirate compositions disclosed by US’401 may include any type of “biocompatible materials”, including hydrogels, elastinc, “bioactive agents”, fillers, etc., etc. (see, e.g., US’401 at ¶¶[0137]-[0138], claims 14 and 19). Accordingly, no “teaching away” exists, and Examiner’s position is that the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)). Accordingly, the Examiner’s position is that (i) the full scope of POPs in combination with any tissue materials is fully enabled, (ii) the full scope of lipoaspirates in combination with any additive is fully enabled; (iii) injectable tissue compositions comprising POPs and tissue were known in the art; (iv) injectable tissue compositions comprising lipoaspirate and any “biocompatible” additives were known in the art; and (v) that the predicted and expected utilize of such injectable compositions were known in art, wherein both were taught for wound healing applications.
No unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, or 716.02 exists on record or has otherwise been identified by Applicant: Upon review of the arguments set forth in the response, Examiner notes that zero evidence of unexpected results have been identified on record. To establish unexpected results commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02, the allegations must be timely and supported by objective evidence (see, e.g., 37 C.F.R. 1.132; see MPEP §§ 716.01, 716.01(a), 716.01(c)); to be of probative value the proffered evidence must be related to the claimed invention (see MPEP §§ 716.01(b), discussing nexus requirement and noting that "[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention"); the evidence must establish that the expected results occur to an unexpected extent (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein a comparison of the claimed invention with the closest prior art of record is provided (see, e.g., MPEP § 716.02(e)). Furthermore, even if evidence satisfying MPEP §§ 716.02, 716.02(a), 716.02(b), 716.02(d), and 716.02(e) is set forth on record, such evidence may not be sufficient to rebut prima facie obviousness because the evidence of expected and unexpected results must be weighed (see, e.g., MPEP § 716.02(c)(I)) and the totality of the record considered (see, e.g., MPEP §§ 716.01(d), 716.02(f)), including teachings in the prior art and evidence of expected results which weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)). Here, zero examples of the claimed invention were disclosed on record, tested relative to the closest existing prior art, or shown to exhibit any unexpected results of practical and statistical significance. Accordingly, the claimed invention appears to be a combination of prior art elements, according to prior art methods, wherein the combination merely yields the expected and predicted results, which weighs in favor of a determination of obviousness.
Accordingly, all applicable arguments have been fully considered and weighed against the evidence of record supporting a determination of obviousness, but the arguments are not persuasive for reasons set forth above, and therefore the claimed invention continues to be rejected as obvious in view of the revised rejection set forth above.
Summary
All applicable arguments have been fully considered and weighed against the evidence of record, but the arguments are not persuasive for reasons set forth above, and therefore the claimed invention continues to be rejected in view of the new or revised rejection set forth above. All new or revised rejections were necessitated by Applicant’s amendments.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20030161816A123 identifies that fat grafts are well-known in the prior art (see, e.g., US20030161816A1 at title, abs, claims).
US9662422B224 teaches that such fat grafts can be improved if combined with a hydrogel-forming component (e.g., a scaffold) (see, e.g., US9662422B2 at title, abs, claim 1).
Roberts25 is cited here as a publication corresponding to WO’374, which explicitly and unambiguously identifies the tested compounds of WO’375 at Table 2 (see, e.g., WO’374 at ¶[000116]) and Table 1 (see, e.g., WO’374 at ¶[000129]), and in view of Roberts it is understood that E2-H5-25% of WO’375 has the structure of
M[(VPG[A1/V4]G)15-GD(A)25K]4GWP
And that E3-H5-25% has the structure of
M[(VPG[A1/V1]G)15-GD(A)25K]4GWP
(see, e.g., Roberts at Supp. Table 1 on Supp page 34, reproduced in part below; compare id. with WO’374 at Table 1 at ¶[000129]):
PNG
media_image1.png
213
554
media_image1.png
Greyscale
Note that “Try” is understood to be a grammatical error caused autocorrection of “Trp” for tryptophan (see, e.g., Roberts at Supp. Table 1 on Supp page 34 at asterisk).
Kowalczyk et al26 pertains to structures recite the repeating pentapeptide of GXGVP rather than VPGXG, and informs artisans that both of these pentapeptides are recognized in the art as functionally equivalent ELP subunits (see, e.g., Kowalczyk at Table 1 on 2142, referring to “VPGXG”, and “GVGXP” as ELP, ELP blocks, or “elastin subunits”; see also id. at 2143 at col. II at 1st full ¶, 2147 at col II at 1st full ¶; see also id. at 2143 at col I-II at bridging ¶, defining any sequence containing VPGXG repeats to be an Elastin-like polypeptide), and have the same, art-recognized physical properties ascribed to ELPs (see, e.g., Kowalczyk at 2143 at final ¶ to 2144 at col I at final ¶). Accordingly, both (GXGVP)n and (VPGXG)n are art-recognized ELP subunits having equivalent properties, and therefore these pentapeptide repeats are art-recognized equivalents.
US20200148724A1 (published 5/14/2020) pertains to partially ordered polypeptides (POPs) (see, e.g., US’724 at title, abs, claims).
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 RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 SEQ ID NO: 18 was set forth in the Sequence listing filed 12/02/2022 as having the following sequence: MGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGDAAAAAAAAAAAAAAAAAAAAAAAAAKGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGDAAAAAAAAAAAAAAAAAAAAAAAAAKGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGDAAAAAAAAAAAAAAAAAAAAAAAAAKGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGDAAAAAAAAAAAAAAAAAAAAAAAAAKGWP, but this was identified as M[(G[V4:A1]GVP)15-GD(A25)K]6-GWP. The species is actually M[(G[V4:A1]GVP)15-GD(A25)K]4-GWP in the Sequence listing version 1.0 and 1.1 filed 12/02/2022, but the sequence was updated and redefined in the Sequence listing filed 8/17/2026 such that SEQ ID NO: 18 was M[(G[V4:A1]GVP)15-GD(A25)K]6-GWP.
2 See, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349, 107 U.S.P.Q.2d 1457, 1467, 2013 BL 192990, 14 (Fed. Cir. 2013), explaining that the written description analysis requires “[t]aking each claim . . . as an integrated whole rather than as a collection of independent limitations”.
3 Regarding the sequence listing, definitions of multiple sequences were altered in the 8/17/2026 version of the sequence listing. For example, SEQ ID NO: 19 was previously “PXXXXXXXXXXXXXXXG”, but in the most recent sequence listing was altered to a sequence of form M[(G[V4:A1]GVP)15-GD(A25)K]4-GWP (SEQ ID NO: 19). Other changes, including to the definition of SEQ ID NO: 18, was made relative to the Sequence listing filed 12/02/2022.
4See prior footnote.
5See prior footnote.
6 Roberts et al., Injectable tissue integrating networks from recombinant polypeptides with tunable order. Nat Mater. 2018 Dec;17(12):1154-1163, and Supp. pages 1-39. doi: 10.1038/s41563-018-0182-6. Epub 2018 Oct 15 (hereafter “Roberts”); cited in Requirement mailed 10/24/2025.
7 Kowalczyk et al., Elastin-like polypeptides as a promising family of genetically-engineered protein based polymers. World J Microbiol Biotechnol. 2014 Aug;30(8):2141-52. doi: 10.1007/s11274-014-1649-5. Epub 2014 Apr 4. PMID: 24699809; PMCID: PMC4072924.
8See Footnotes 3-4 above.
9 If such clauses are non-limiting, then these claims would be properly rejected under 35 USC 112(d). At this time, the “wherein” clauses are presumed to be functional limitations deemed to be satisfied by compounds satisfying the structural limitations of claims 3-8.
10 Roberts et al., Injectable tissue integrating networks from recombinant polypeptides with tunable order. Nat Mater. 2018 Dec;17(12):1154-1163, and Supp. pages 1-39. doi: 10.1038/s41563-018-0182-6. Epub 2018 Oct 15 (hereafter “Roberts”); cited in Requirement mailed 10/24/2025.
11 See, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349, 107 U.S.P.Q.2d 1457, 1467, 2013 BL 192990, 14 (Fed. Cir. 2013), explaining that the written description analysis requires “[t]aking each claim . . . as an integrated whole rather than as a collection of independent limitations”.
12 If such clauses are non-limiting, then these claims would be properly rejected under 35 USC 112(d). At this time, the “wherein” clauses are presumed to be functional limitations deemed to be satisfied by compounds satisfying the structural limitations of claims 3-8.
13 Wilharm et al. Energetic electron assisted synthesis of highly tunable temperature-responsive collagen/elastin gels for cyclic actuation: macroscopic switching and molecular origins. Sci Rep 9, 12363 (2019). https://doi.org/10.1038/s41598-019-48830-w (hereafter “Wilharm”); cited in previous action.
14 Roberts et al., Injectable tissue integrating networks from recombinant polypeptides with tunable order. Nat Mater. 2018 Dec;17(12):1154-1163, and Supp. pages 1-39. doi: 10.1038/s41563-018-0182-6. Epub 2018 Oct 15 (hereafter “Roberts”); cited in Requirement mailed 10/24/2025.
15 If the clauses at dependent claims are non-limiting, then these claims would be properly rejected under 35 USC 112(d). At this time, these “wherein” clauses are presumed to be functional limitations further limiting the scope of the independent claim, but it is prima facie unclear what structures encompassed by the independent claim are included or excluded from the scope of the dependent claims, because the functional limitations fail to correspond to any structure/function relationship of record.
16 WO’375 at ¶[000129] discloses the naming convention of the exemplified embodiments, Fig. 1 discloses the sequences utilizes at each portion, and Table 1 identifies that each tested sequence included a “Met leader” and a “Gly-Try-Pro” trailer (wherein “Try” is understood to be an erroneous autocorrection meant to be “Trp” or otherwise a grammatical error meant to refer to “Tryptophan”). In combination, this implies that the prior art disclosed and tested the sequences of M[(VPGVG)n-GD(A)25K]mGWP; M[(VPG[A1/V4]G)n-GD(A)25K]mGWP, and M[(VPG[A1/V1]G)n-GD(A)25K]mGWP. The portions would be repeated within the claimed and disclosed amounts.
17 See definition and interpretation of “about”, discussed under 35 USC 112(b).
18 See rejection above; see also WO’374 at ¶¶[0005], [0007]-[00011], [00093]-[00095], [000102]-[000111], [000148], [000180]-[000190], [000192], claims 1-11 and 14-40.
19 See previous footnote.
20 See previous footnote.
21 See rejection above; see also US’401 at ¶¶[0005]-[0006], [0008], [0037], [0043], [0055], [0059], [0067], [00137], [0194].
22 See previous footnote.
23 Cited in Requirement mailed 10/24/2025.
24 Cited in Requirement mailed 10/24/2025.
25 Roberts et al., Injectable tissue integrating networks from recombinant polypeptides with tunable order. Nat Mater. 2018 Dec;17(12):1154-1163, and Supp. pages 1-39. doi: 10.1038/s41563-018-0182-6. Epub 2018 Oct 15 (hereafter “Roberts”); cited in Requirement mailed 10/24/2025.
26 Kowalczyk et al., Elastin-like polypeptides as a promising family of genetically-engineered protein based polymers. World J Microbiol Biotechnol. 2014 Aug;30(8):2141-52. doi: 10.1007/s11274-014-1649-5. Epub 2014 Apr 4. PMID: 24699809; PMCID: PMC4072924; cited in previous action.
Prosecution Insights