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 1-33, 42, and 46 are pending. Claims 32-33, 42, and 46. Claims 1-31 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: 18 is used in a 1:1 ratio with lipoaspirate in the reply filed on 12/23/2025 is acknowledged. Because applicant 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 is understood to be a 1:1 ratio of lipoaspirate to SEQ ID NO: 181, 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). The originally elected species does not appear in the priority document of US Provisional Application No. 63/035173 (filed 6/05/2020). The originally elected species as disclosed at Example 3 does not appear to read upon all pending claims of Group I. For example, the originally elected species does not read upon instant claim 46 because the product of Example 3 is not disclosed as a kit comprising molds for specific volumetric dimensions or “means for adipose tissue aspiration”. Although the originally elected species does not appear to read upon instant claims 22-24, these claims have been rejected as indefinite at this time, and as a courtesy to the Applicant; however, upon clarification in subsequent replies, claims 22-24 may be withdrawn.
Following extensive search and examination, the originally elected species has been deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
Accordingly, claims 1-31 are rejected in view of the originally elected species and claims that do not read upon the originally elected species are 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 1-31 are presently considered.
Information Disclosure Statement
The IDS filed 2/03/2023 (188 pages), 4/30/2023; 7/20/2023; 3/29/2024; 7/03/2024; 10/02/2024; 02/17/2025; 8/04/2025; 10/28/2025; and 1/02/2026 are each acknowledged.
Applicant should note that one or more documents disclosed on the IDS form submitted on 2/03/2023, 7/03/2024, 10/02/2024, 02/17/2025, 8/04/2025, and 3/29/2024 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 filed 2/03/2023 cites 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 instant 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.
Priority
Although claims 1-3, 7, 12, 21, 29, and 31 appear to be supported by the priority document of US Provisional Application 63/035173 (filed 6/05/2020), instant claims 4-6, 8-11, 13-20, 22-28, and 30 are not. Priority to Pro’ 173 for claims 4-6, 8-11, 13-20, 22-28, and 30 is denied as set forth below.
Denial of Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, US Provisional Application 63/035173 (filed 6/05/2020) fails 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.
Lack of Express Support
Claims 4-6, 8-11, 13-20, 22-28, and 30 are representative of the pending claim scope. These claims do not literally appear in Pro’173, and therefore the claims lack literal support in the Pro’173.
Accordingly, Pro’173 fails to provide literal support for the pending claim scope that is synonymous or equivalent in scope with instant claims 4-6, 8-11, 13-20, 22-28, and 30.
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 through implicit or inherent disclosures.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims 4-6, 8-11, 13-20, 22-28, and 30 is found in Pro’171, at least because Pro’173 does not literally, implicitly, or inherently teach, disclose, nor identify instant SEQ ID NOs: 3-6, 10-11, 12-18, the structure shown at instant claim 10 erroneously called SEQ ID NO: 18, “micropores”, structure/function relationships commensurate in scope with instant claims 13-18, the ranges at claims 19-20 and 22-27, “semisolid”, “shapeable liquid”, “micropores”, etc., etc. 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 such language does not clearly and unambiguously provide support for the instant claims because such descriptions are not synonymous or equivalent in scope with the instant claims. Accordingly, the claim language presently claimed is not supported by the provisional document by synonymous or equivalent language.
Accordingly, Pro’173 fails to provide implicit or inherent support for the pending claim scope that synonymous or equivalent in scope, or otherwise commensurate in scope with the pending claims.
Conclusion
Accordingly, priority to US Provisional Application 63/035173 (filed 6/05/2020) is denied for claims 4-6, 8-11, 13-20, 22-28, and 30 and all of the dependents of those claims; these claims have been accorded a priority date of 6/04/2021, which corresponds to the filing date of PCT/US2021/035823 (filed 6/04/2021).
Objection to Specification
The use of the term “Fractomer” (Serial number 97566233; InSoma Bio, Inc., Filed Aug. 26, 2022; allowed May 07, 2024), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Sequence Listing: The instant disclosure is objected to for not complying with 37 C.F.R. 1.821 as detailed in MPEP §§ 2421–2424. Specifically, the instant application does not comply with 37 C.F.R. 1.821(b)-(e). The instant claims and/or disclosure contain references or disclosures of amino acid sequences that should be accompanied by a sequence listing and identified using "SEQ ID NOs” as prescribed (see, e.g., MPEP §§ 2421–2424). Specifically, the instant application discloses sequences at page 1 at line 24, page 2 at line 9 line 16, page 2 at line 23-34, page 19 at lines 8 and 18, page 29 at line 1 and line 12, page 2 at line 9 that do not satisfy the sequence requirements (For example, at pages 1 at line 24, 19 at line 8 and 29 at line 1, the structure lacks a SEQ ID NO; At pages 2 at line 9, 19 at line 18 and 29 at line 12, the structure(s) does not match the SEQ ID NO on file). This listing is not exhaustive, and Applicant’s help is requested in identifying similar and repeated issues throughout the originally filed disclosure.
Appropriate correction is required.
Claim Objections
Claims 4 and 9-10 are objected to because of the following informalities:
Sequence Listing: The instant disclosure is objected to for not complying with 37 C.F.R. 1.821 as detailed in MPEP §§ 2421–2424. Specifically, the instant claims does not comply with 37 C.F.R. 1.821(b)-(e). The instant claims contain references or disclosures of amino acid sequences that should be accompanied by a sequence listing and identified using "SEQ ID NOs” as prescribed (see, e.g., MPEP §§ 2421–2424). Claim 9 recites a sequence lacking a proper SEQ ID NO, and claims 4 (at SEQ ID NOs: 3 and 4) and 10 (at SEQ ID NO: 19) recite sequence identifiers that are not associated with the structures set forth in the claims.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show colors as described in the specification (e.g., Spec. filed 12/02/2022 at 5 at lines 10-15 and page 33 at lines 25-30 refer “blue” and “red” at Fig. 5). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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).
Claim 1 is representative of the pending claim scope. Applicable claim interpretations are set forth below.
“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).
Examiner notes that the interpretation of multiple terms 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.
Claim Rejections
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 1-31 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.
Claims 1, 2, 12, 15, 25-27, and 31 recite “Fractomer” which is understood to be a trademark (Serial number 97566233; InSoma Bio, Inc., Filed Aug. 26, 2022; allowed May 07, 2024). Per MPEP § 2173.05(u), if the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Here, the trademark is used to identify a particular genus of ill-defined polypeptides, and therefore this usage does not comply with the requirements of 35 USC 112(b).
Claim 1 recites “partially ordered”. The term “partially” in claim 1 is a relative term which renders the claim indefinite. The term “partially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 1 recites “recombinant partially ordered polypeptide (Fractomer)” renders the claim scope indefinite because it is unclear if the parenthetical is being used to exemplify a particular type of “recombinant partially ordered polypeptide”, or if the parenthetical is being used to simply define an alternative term, “Fractomer”, that is being used as a synonym for all products within the scope of the genus of “recombinant partially ordered polypeptides”. Because “Fractomer” is functionally defined (see, e.g., Spec. filed 12/02/2022 at 15 at lines 23-30, explaining that “Fractomer” refers “to the class of recombinant, artificial proteins designed to mimic native elastin that are thermally responsive, allowing them to be injected as a liquid, yet rapidly form a porous, solid network at body temperature”, without giving structural metes and bounds), and the term “recombinant partially ordered polypeptide” appears to generically refer to numerous other proteins other than mimics of native elastin (e.g., XTENS, URPs, etc.), then it is reasonably inferred that the parenthetical in this context is being utilized to exemplify “Fractomer” (e.g., the parenthetical appears equivalent to “such as” or “like” in view of the instant context). Accordingly, in this context, the usage of a parenthetical renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 4 recites “wherein X is Val (SEQ ID NO: 3), or Ala (SEQ ID NO: 4)”, wherein SEQ ID NO: 3 and 4 are polypeptides rather than the single amino acids of either valine or alanine. This raises substantial and material concerns regarding the pending claim scope, and clarification is required. For purposes of applying prior art, claim 4 is interpreted as “…wherein X is Val
Claim 6 recites “wherein X is an alternating iteration of Ala and Val in a ratio of ….1:4 (SEQ ID NO: 6)” renders the claim scope indefinite because it is unclear if the parenthetical is being used to exemplify a preferred structure (e.g., “Like” or “such as”), or if the parenthetical is being used to limit and require the specific structure of SEQ ID NO: 6. This difference in interpretations alters the pending claim scope because SEQ ID NO: 6 is limited to the exact sequence of GVGVPGVGVPGVGVPGVGVPGAGVP, wherein “X” is V except wherein X is A in the 5th repeat of the (GXGVP) motif, which would therefore exclude alternative variants such as sequences wherein Ala is in the 3rd or 4th repeat from the pending claim scope. Alternatively, if the parenthetical is meant to be exemplary only, then presumably the claim might read upon variants such as wherein A is in the 3rd, 4th, or 5th repeat. Accordingly, in context, there are two distinct plausible claim constructions, which renders the claim scope indefinite because it is unclear whether the parenthetical is a limitation further limiting the structure of the claimed invention or not. See MPEP § 2173.05(d). Applicant could clarify the claim scope by, for example, (i) not reciting “SEQ ID NO: 6” after “1:4” or (ii) amending the claim to simply require that the “disordered domain of claim 3” comprises SEQ ID NO: 6.
Claim 10 recites “M[(G[V4:A1]GVP)15-GD(A25)K]4-GWP (SEQ ID NO: 19)”, which renders the claim scope indefinite because SEQ ID NO: 19 is “PXXXXXXXXXXXXXXXG”, wherein X can be any amino acid and all but one may be absent (see, e.g., sequence listing for SEQ ID NO: 19, <220> to <223>). Accordingly, the claim scope is prima facie indefinite because the structure shown is inconsistent with the sequence identifier set forth in the claim, and therefore it is unclear if claim 10 encompasses “M[(G[V4:A1]GVP)15-GD(A25)K]4-GWP” or SEQ ID NO: 19 (“PXXXXXXXXXXXXXXXG”) as actually filed. Clarification is required.
Claims 13-19, 28, and 30-31 appear to recite functional limitations (i.e., “wherein” clauses)2, but these “wherein” clauses do not unambiguously correspond to a structure/function relationship on record permitting an artisan to reasonably identify what embodiments within the scope of the independent claim are excluded or included in the scope of dependent claims 13-19. Per MPEP § 2173.05(g), the use of functional language in a claim may fail to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. 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. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008). Likewise, each “wherein” clause merely recites a description of a function or result achieved by the invention, but in the complete absence of any identification of actual structures capable of achieving the function or result recited. This is problematic because close prior art exists (see discussion of Roberts3, below), and it is unclear what prior art “Fractomer” 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 here, an artisan would not know what structural metes and bounds were included or excluded by the functional “wherein” clauses of instant claims 13-19. This is consistent with available caselaw, wherein courts have stated that “[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).
Claims 14, 19, and 20 recite the term “about”, which is rendered indefinite on the instant record because the Applicant has defined it in multiple, non-synonymous ways. Specifically, the term “about” is defined in multiple, alternative, but non-equivalent ways on record (see, e.g., Spec. filed 12/02/2022 at 8 at lines 12-21, noting that it 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). This renders the claim scope indefinite because it is unclear which definition for “about” to apply, and the claim scope varies substantially depending upon the definition utilized. For example, “about 150” at claim 19 may be interpreted as
(i) “± 10%” and be interpreted as equivalent to the range of 135-1654;
(ii) “within an order of magnitude” and be interpreted as equivalent to the range of 15-15005;
(iii) “within 5-fold” and be interpreted as equivalent to the range of 30 to 7506;
(iv) “within 2-fold” and be interpreted as equivalent to the range of 75 to 3007;
This is exemplary in nature and non-exhaustive, but may be extended to all instances of “about”. Accordingly, because Applicant has provided multiple, non-equivalent definitions for the term “about”, the metes and bounds of the claim scope at each instance of “about” are rendered indefinite because multiple plausible constructions simultaneously exist, and it is unclear what embodiments do or do not satisfy the pending claim scope. For purposes of applying prior art, “about” is given the broadest reasonable interpretation (e.g., either “within 5-fold” or “within an order of magnitude”).
Claim 22 depends upon claim 21, wherein claim 21 recites that “the adipose tissue comprises lipoaspirate”, and wherein claim 22 recites “a range of lipoaspirate from about 10% to about 90% by volume”. It is unclear if “by volume” refers the total volume of the complete composition of claim 1, or if “by volume” refers to the relative amount of lipoaspirate to other adipose tissues “comprised by” the adipose tissue. Because different components each may have a volume, this phrase at claim 22 is indefinite due to insufficient antecedent basis for the limitation referring to “volume”.
Claims 22-24 refer to percent volume of a composition comprising a “recombinant partially ordered polypeptide (Fractomer)” and adipose tissue comprising lipoaspirate (see, e.g., instant claims 22-24). This is problematic 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.8 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, the reference to limitations of volumes renders the claim scope indefinite per MPEP § 2173.05(b), which explains that references to a variable object (i.e., here the volume of the compositions) may render the claim scope indefinite when claims may have two or more plausible constructions. Here, it is unclear if claims 22-24 include only embodiments that satisfy the volume ranges at any temperature (narrower scope), or if claims 22-24 include all embodiments that might fall within the volume ranges at least at one temperature within the range, even if it might not satisfy the volume requirements at another temperature (broader scope). Accordingly, “wherein” limitations directed to volume are indefinite in the absence of further clarification. For purposes of applying prior art, any volume disclosed by the prior art falling within the disclosed ranges is understood to satisfy the claim limitations.
Claims 25-27 refer to “a mixture of Fractomer and lipoaspirate in a ratio” (see, e.g., claims 25-27). Critically, the total amount of adipose tissue is unknown, because the adipose tissue “comprises” an unknown amount of lipoaspirate (see claim 21), but may “comprise” additional types of adipose tissue. The “ratio” is not specified in the claim, and a ratio may be made by volume, weight, concentration, etc. (e.g., a ratio of volume is not equivalent to a ratio of weights or concentrations, and a ratio of volume to weight, volume to concentration, etc. is also possible). Accordingly, the metes and bounds of claims 25-27 are prima facie unknown because a “ratio” may be interpreted in multiple but non-equivalent ways, and it is unclear what the metes and bounds of the claims might be in the absence of clarification. For purposes of applying prior art, any property within the ratio ranges (e.g., volume) disclosed by the prior art is understood to satisfy the claim limitations.
Claim 28 refers to a “shapeable liquid”, which is not defined on record. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “shapeable liquid” in claim 28 is presumably used by the claim to mean a non-liquid that is shapeable, while the accepted meaning of “liquid” in the art is a free -flowing substance having a constant volume but no fixed shape. The term is indefinite because the specification does not clearly redefine the term. If Applicant means that the “liquid” can take the shape of a container, then such property is inherent in “liquid” and the term “shapeable” is redundant and unnecessary. For purposes of applying prior art, the term is reasonably inferred to mean a gel, foam, hydrogel, or the like.
Claims 2-31 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 1-31 are rejected.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 depends from claim 1, and does not recite a limitation that functionally or structurally limits the scope of the products of claim 1. The “wherein” clause appears to only recite inherent properties of the compositions of claim 1 in the absence of any additional structural limitations. Accordingly, claim 12 is rejected as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
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 13-19, 28, and 30-31 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)
Claims 13-19, 28, and 30-31 are understood recite a functional limitation further limiting the scope of claim 1 or the claim upon which it depends. Claims 13-20, 25-28, and 30-31 are presumed to fully satisfy the requirements of 35 USC §112(d) by further limiting the scope of the claim upon which it depends. However, it is prima facie unclear what exact structures of “Fractomers”, “recombinant partially ordered polypeptides”, or compositions thereof are actually included or excluded by the limitations recited at these dependent claims because the recited limitations fail to reasonably identify what structures do or do not satisfy the functional limitations.
Claim Scope
Claims 1 and 12-13 are representative of the pending claims scope and ostensibly appear to encompass an infinitely large genus of compounds defined by ambiguous terminology (see claim interpretation section and discussions under 35 USC §112(b) above).
Actual Reduction to Practice
The disclosure appears to reduce to practice the species shown at claim 10 (e.g., SEQ ID NOs: 12-18 and the structure shown adjacent to “SEQ ID NO: 19”), which is a total of 8 different species. All disclosed species of record are highly similar and share an initial Met and a trailer sequence of GWP, as well as a GX(A)25K motif (where “X” is D or K), and comprise GXGVP repeats (where “X” is limited to either valine and/or alanine). Zero structures having any other “structured domains”, “disordered domains”, or alternative amino acids at “X” are explicitly reduced to practice or otherwise discussed with specificity on record.
It is reasonably inferred that the exact structures at claim 10 satisfy the functional limitations of claims 13-19, 28, and 30-31, but it is unclear what other embodiments are either included or excluded from the scope of each claim.
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.
As an initial matter, zero examples lacking an initial Met, a trailer sequence of GWP, a “structured domain” of GX(A)25K motif (where “X” is D or K), and a “disordered domain” comprising GXGVP repeats (where “X” is only valine and/or alanine) were reduced to practice, and therefore zero species of any other genus or subgenus within the scope of claim 1 was actually reduced to practice or otherwise discussed with specificity on record.
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 lacking the common consensus motifs shared by all disclosed species of record does not provide sufficient disclosure to satisfy the written description requirement for the instantly claimed genus.
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.
Although claims 13-19, 28, and 30-31 appear to recite functional limitations (i.e., “wherein” clauses)9, these “wherein” clauses do not unambiguously correspond to a structure/function relationship on record permitting an artisan to reasonably identify what embodiments within the scope of the independent claim are excluded or included in the scope of dependent these claims.
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 Roberts10 (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 claims 1-2. Accordingly, the relevant issue is what actual structures within the scope of instant claim 1 are actually required and necessary to achieve the functional outcomes recited at dependent claims 13-19, 28, and 30-31? What sequences within the scope of claim 1 are excluded by dependent claim 13, claim 14, claim 15 . . . or claim 31? 11 No clarification permitting an artisan to distinguish the scope of claim 1 (or the prior art) from structures required to achieve the functional limitations of claims 13-19, 28, and 30-31 appear on record commensurate in scope with these claims.
This is pertinent because it is unclear what structures within the scope of instant claim 1 are excluded by the functional limitation at each of claims 13-19, 28, and 30-31, and 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).
Likewise, here, the recitation of functional limitations that do not correspond to specific structures raise substantial written description issues, because it is unclear what compounds do or do not satisfy the recited claim limitations. Accordingly, an artisan would be unaware of what compounds did or did not infringe upon these claims in view of the instant description.
Accordingly, the functional limitations at claims 13-19, 28, and 30-31 are only utilized as a vague attempt to capture unknown and undisclosed structures, sufficient to achieve some functional result that Applicant hopes and desires that the disclosed invention is able to achieve. However, the disclosure but does not meaningfully disclose an unambiguous structure/function relationship permitting an artisan to identify, a priori, which exact structures do or do not satisfy the functional limitations at issue.
Accordingly, basic identifying characteristics pertinent to the claimed genus are left unanswered, including “which compounds within the scope of the independent claim do or do not actually read upon each of claims 13-19, 28, and 30-31?”.
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, but be excluded from the scope of claims 13-19, 28, and 30-31.
Accordingly, in the absence of sufficient structure/function teachings identifying particular compounds capable of satisfying the functional “wherein” limitations at claims 13-19, 28, and 30-31, as required to practice the full scope of the claims, an artisan would not reasonably conclude that Applicant possessed the full scope of the broad and highly varied claim scope.
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 claims 13-19, 28, and 30-31. 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 1-8 and 12-31 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019006374A1 (filed Jan. 3, 2019) 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 FRACTOMER, 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 26-27, ¶¶[0007], [00011], [00093]-[00095]). Regarding instant claims 1-2 and compositions wherein the FRACTOMER comprises a plurality of both disordered and structured domains, 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 1-6 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 1-3, 7-8, and 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]12, Table 1 on 39). Regarding instant claims 1, 12-16, 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” (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”13 (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 12-16. Regarding instant claims 1, 17, and the formation of a stable three-dimensional matrix, 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 form “a stable three-dimensional matrix” (compare WO’374 at claim 20-22 and 26-27 with instant claim 17). Regarding instant claims 1, 12, 15, 18-19, and a “plurality of micropores ranging in size from about 1 µm to about 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). Regarding instant claims 1, 20, and compositions comprising “between about 200 µM and about 2 mM” of “Fractomer”, 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. Regarding instant claim 1, 28, 30, and a “shapeable liquid or semisolid” that may be “moldable” into “3-dimensional shapes”, 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 form “a stable three-dimensional matrix” (compare WO’374 at claim 20-22 and 26-27 with instant claims 17, 28, 30). 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, 29, and compositions that are injectable or implantable, 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 and implanted 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 Fractomer permits cell infiltration and vascularization of” 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 1-8, 12-20, and 28-31 because WO’374 teaches injectable, cellular scaffolds comprising (i) any type of human tissue cells and (ii) 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 adipose tissue, such as 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 1-8, 12-12, and 28-31, generally regarding adipose tissues, 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]). 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]). 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, lipoaspirate as taught by US’401) according to known methods of forming cellular scaffold compositions by combining POPs with human tissue 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 1-8 and 12-31 are rejected.
Claims 9-11 are rejected 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 Roberts14 and Kowalczyk et al15.
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.
The teachings of WO’374 in view of US’401 as applied to instant claims 1-8 and 12-31 have been discussed above, and those discussions are incorporated into the instant rejection.
The disclosures of WO’374 in view of US’401 differ from instant claims 9-11 as follows: Although WO’374 in view of US’401 directs artisans to compositions of cellular scaffolds comprising human tissue (e.g., lipoaspirate) and POPs16 comprising (VPGXG)1-100GD(A25)K, this prior art differs from the structures recited at instant claims 9-11, because the pentapeptide repeat presently claimed is GXGVP rather than VPGXG.
As an initial matter, WO’375 discloses partially identified sequences, which were reduced to practice (see, e.g., WO’374 at Fig. 1A, image at abs, ¶¶[00019], [000129], Table 1 on 39). More specifically, 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 “Tryptophan”) (see, e.g., WO’374 at Fig. 1, Table 1 at ¶[000129], ¶[00069]). Accordingly, WO’374 is understood to teach and exemplify at least the sequences of M[(VPG[A1/V4]G)n-GD(A)25K]mGWP, and M[(VPG[A1/V1]G)n-GD(A)25K]mGWP. It is unclear what the n and m for these species would be in view of WO’374; however, Roberts 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). It is reasonably inferred that the alternating unstructured and structured portions of each of these exemplified embodiments could be repeated less than or more than four times (see, e.g., WO’374 at ¶[00069]17), and the other embodiments at Supplementary Table 1 of Roberts shows that the alternating domains could be repeated at least 2, 4 or 6 times (see, e.g., Roberts at Supp. Table 1 on Supp page 34; see also, WO’374 at Table 1 at ¶[000129]). In sum, in view of Roberts and WO’374, structures such as
M[(VPG[A1/V4]G)15-GD(A)25K]mGWP
or
M[(VPG[A1/V1]G)15-GD(A)25K]mGWP
Wherein “m” is at least 2, 4, or 6 would be obvious to one of ordinary skill in the art.
These prior art POPs are highly similar to the originally elected species18 and the embodiments recited at instant claims 9-11. However, these structures differ from the instant claim scope because the instantly claimed structures recite the repeating pentapeptide of GXGVP rather than VPGXG. However, Kowalczyk 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.
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):
The claimed invention is the obvious and simple substitution of one art-recognized, equivalent ELP pentapeptide in place of another (e.g., (GXGVP)n in place of (VPGXG)n), wherein such substitution would yield predictable and expected results, namely compounds of form M[(G[A1/V4]GVP)15-GD(A)25K]4-6GWP and M[(G[A1/V1]GVP)15-GD(A)25K]4-6GWP, which would readily understood to be functional equivalents to M[(VPG[A1/V4]G)15-GD(A)25K]4-6GWP and M[(VPG[A1/V1]G)15-GD(A)25K]4-6GWP in view of Kowalczyk, and predicted and expected to have the same functionality, properties, and utility in the cellular scaffold compositions of WO’374 (see, e.g., MPEP §§ 2143(I)(B), (F), 2144.06(II), noting that substituting equivalents for the same purpose is obvious).
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), comprising known “disordered” and “ordered” structures, including known ELP pentapeptide subunits, 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.
Claims 9-11 are rejected.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20030161816A119 identifies that fat grafts are well-known in the prior art (see, e.g., US20030161816A1 at title, abs, claims).
US9662422B220 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).
Conclusion
No claims are allowed.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 SEQ ID NO: 18 has the following sequence: MGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGDAAAAAAAAAAAAAAAAAAAAAAAAAKGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGDAAAAAAAAAAAAAAAAAAAAAAAAAKGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGDAAAAAAAAAAAAAAAAAAAAAAAAAKGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGVGVPGVGVPGVGVPGVGVPGAGVPGDAAAAAAAAAAAAAAAAAAAAAAAAAKGWP, which may also be written as M[(G[V4:A1]GVP)15-GD(A25)K]6-GWP.
2 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.
3 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.
4 See, e.g., Spec. filed 12/02/2022 at 8 at lines 12-21
5 See prior footnote.
6 See prior footnote.
7 See prior footnote.
8 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”).
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.
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 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.
12 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.
13 See definition and interpretation of “about”, discussed under 35 USC 112(b).
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 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.
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 “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 The disclosure at [00069] is simplified for purposes of the instant action, but are consistent with structures shown at Fig. 1 and at Table 1.
18 M[(G[V4:A1]GVP)15-GD(A25)K]6-GWP.
19 Cited in Requirement mailed 10/24/2025.
20 Cited in Requirement mailed 10/24/2025.