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, 6-28, and 30-32 are pending.
Claims 1, 6-28, and 30-32 are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 08-Aug-2024 has been considered by the examiner.
Abstract
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 56, A, tigrinum should be “A. tigrinum”.
Paragraph 58, EMC proteins should be “ECM proteins”.
Paragraph 58, “Examples of various types of collagens, such as one or more…” is a sentence fragment.
Appropriate correction is required.
The use of the term “Triton X-100”, which is a trade name or a mark used in commerce, has been noted in this application (Paragraph 15, 17, 64, 88, 138). 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. 15 17 63 64 69 88 138
The use of the term “Tween” and Tween 20, 40, 60, or 80, which is a trade name or a mark used in commerce, has been noted in this application (Paragraph 63). 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.
The use of the term “Azure Biosystems c150”, which is a trade name or a mark used in commerce, has been noted in this application (Paragraph 25). 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.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 17 is objected to because of the following informalities: “Tween, 20, 40, 60, or 80” reads as Tween plus separate numbers. Should correct to “Tween 20, Tween 40, Tween 60, or Tween 80” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 6-13, 15-20, and 22-26 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “greater than 70%”, and the claim also recites “80% to 90%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “1% to 10%”, and the claim also recites “2%-10%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “less than 300 bases (bps)”, and the claim also recites “50 bps to 300 bps” and “less than 250 bps” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 6 and 7 recites the limitation "the ECM". There is insufficient antecedent basis for this limitation in the claim. Claim 6 and 7 depend on claim 1, and claim 1 recites two ECMs, namely “a gelatinized ECM” and “an isolated amphibian ECM” therefore lacking antecedent clarity.
Claim 15 recites the limitation "The method of claim 15". The claim depends from itself, which does not provide ascertainable basis from which the metes and bounds of claim 15 can be determined. For the purposes of compact prosecution, claim 15 is interpreted as dependent on claim 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 contains the trademark/trade name “Tween”. Where a 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 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe polyoxyethylene (20) sorbitan monolaurate and, accordingly, the identification/description is indefinite.
Claim 19 contains the trademark/trade name “pulmozyme”. Where a 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 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe dornase alfa and, accordingly, the identification/description is indefinite.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1, 6-28, and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Early (US10617790B2, Published 14-Apr-2020, Filed: 09-Jan-2014), and further in view of Sun (WO2013163186A1, Published 31-Oct-2013) and Sigurjonsson et al. (US20110244054A1, Published: 06-Oct-2011, Filed: 06-Oct-2010).
In regards to Claims 1, 6-13, and 24-28 Early teaches a biological scaffold biomaterial obtained from a neotenic urodele (Col 4, line 11-19), wherein the tissue sample comprising extracellular matrix is subjected to a decellularization process that maintains the structural and functional integrity of the extracellular matrix, while removing sufficient cellular components to reduce or eliminate antigenicity and immunogenicity for xenograft purposes (Abstract). Early further teaches the post decellularization process preserved ECM architecture with an absence of cells or cellular debris (Col 18, line 14-19 and Fig. 5). Early further teaches DNA quantification, demonstrating an 89.8-92.8% DNA reduction post-decellularization (Col 19, line 41-49 and Fig. 6). Early further teaches the resultant biomaterial can be produced into a gel form (Col 7, line 1-4), disclosing pharmaceutical formulations comprising of the ECM and pharmaceutically acceptable excipients such as solvents, dispersion media, diluents (Col 17, line 39-45). Early teaches adding agents xenogenic to the ECM, such as cytokines, chemokines, emollients, retinoids, steroids (Col 13, line 5-7). Early further teaches the urodele ECM can be combined with polymers such as polylactic-glycolic acid microparticles, agarose, poly(ester urethane) urea elastomer and poly(ether ester urethane) urea elastomer (Col 13, line 58-62). Early teaches the tissue for decellularization can include fibrous connective tissue such as cartilage, tendon, bone, dura mater and fascia (Col 5, line 46-47). Early teaches dissolving acellular urodele connective tissue matrix in aqueous 1M glacial acetic acid in Example 3 (Col 18, line 52-53)
In regards to Claims 14-23, Early teaches decellularizing urodele tissue samples using chemical decontamination such as hyperisotonic saline washes, alkaline treatments, antibiotic solutions, solvent dehydration, and various physical and enzymatic approaches (Col 9–10 and Col 17, Example 1). Early specifically discloses anionic detergents, nucleases, and proteases as suitable techniques for decellularization (Col 6, line 4-16). Early further teaches washing with 18% NaCl, antibiotic solutions, and sterile saline in a sequential multi-step process (cols. 9–10).
In regards to Claims 30-32, Early teaches the composition can be used to treat burns, grafts, split-thickness graft coverings, ulcers, or used for cosmetic purposes such as breast, lip or buttock augmentation (Col 16, line 1-5).
However, Early does not teach a gelatinized ECM, residual DNA fragment length in base pairs, characterize cell removal as a percentage, or endopeptidase of claims 1, 6-13 and 24-28.
Early does not teach the specific sequential decellularization method steps recited of harvesting a sample, washing with a N-lauryl sarcosine detergent solution, digesting the sample with dispase II, rinsing with DPBS for 5 minutes, treating with benzonuclease, and dehydrating with vacuum at 150°C and 360 Torr, and Early does not teach dispase II or benzonuclease as specific reagents for amphibian ECM decellularization, and does not recite the particular ordered sequence of these steps with the specific reagents and conditions claimed of claims 14-23.
Early does not teach the use of a gelatinized ECM composition for treating skin conditions such as fine lines, wrinkles, aging, razor bumps, uneven skin tone, stretch marks, hyperpigmentation, and does not teach protection from UV rays or environmental pollution of claims 30-32. For this reason, Sun and Sigurjonsson are added.
Sun teaches a method of gelatinization, wherein the decellularized tissue is suspended in an aqueous solution that is homogenized to produce a gelatin (Paragraph 63), and the ECM can be derived from a broad range of animals such as pigs, sheep, goats, cows, rabbits, or monkeys (Paragraph 30). Sun further teaches the gelatin gel comprises homogenized acellular or partially decellularized tissue in an aqueous solution at a concentration of about 0.1–10.0% w/v (Paragraph 40) and the gelatin form provides improved flowability, moldability, and surgical deliverability compared to sheet or powder forms (Paragraph 24). Sun further teaches the tissue composition comprising further of therapeutic agents such as growth factors, cytokines, chemokines, anti-inflammatory agents, and analgesics (Paragraph 38). Sun teaches decellularizing tissue by placing it in a decellularization solution containing detergents such as TRITON X-100, sodium deoxycholate, and SDS, treating with a DNase solution overnight, and washing with PBS (Paragraph 53-55). Furthermore, Sun teaches the use of Type I collagenase to digest the ECM (Paragraph 90).
Sigurjonsson that ECM from non-mammalian vertebrates can be successfully decellularized to yield functional scaffolds to support cell migration, adherence and proliferation (Page 1, paragraph 7). Sigurjonsson teaches that chemical and enzymatic decellularization methods such as using anionic detergents, proteases such as dispase II or trypsin, and nucleases degrade and fragment cellular DNA as part of the removal process (Page 2, paragraph 17), which would have reasonably resulted in fragmented residual DNA less than 300 bp. Sigurjonsson teaches that decellularized fish skin ECM is used as a wound dressing for cuts, abrasions, burns, ulcers, chronic wounds, Dermatitis, pressure wounds, and other wound types (Page 4, paragraph 0037).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the decellularized ECM scaffold of Early with the gelatinized and enzymatic ECM processing methods taught by Sun and the non-mammalian decellularization techniques taught by Sigurjonsson to arrive at the claimed gelatinized ECM compositions and methods. Early teaches the decellularized urodele ECM scaffolds, gel forms, pharmaceutical compositions, ECM connective tissue sources, and the preservation of the ECM structure after decellularization, while Sun teaches the homogenization and gelatinization of decellularized ECM into a flowable gel composition, and Sigurjonsson teaches the sequential detergent, protease, and nuclease based decellularization process. A person having ordinary skill in the arts would have been motivated to combine these teachings because they are directed to the closely related ECM scaffolding technologies for tissue regeneration and wound healing, representing a combination of known ECM materials to a known ECM processing technique to obtain predictable results of a biocompatible gelatinized ECM scaffold with attenuated cellular content.
Further, it would have been obvious to apply the specific sequential decellularization approach taught by Sigurjonsson to the ECM of Early because Sigurjonsson demonstrates that such techniques are effective for non-mammalian vertebrate derived ECM. The selection of specific detergents, proteases, nucleases, rinse duration, washing times, vacuum and drying times, and process order represents routine optimization of result-effective variables and the selection of known equivalent reagents commonly used in ECM decellularization processes. A person having ordinary skill in the arts would have a reasonable expectation of success because the teachings present a preservation of the ECM structure while removing extraneous cellular mater using substantially similar processing techniques.
Furthermore, it would have been obvious to use the claimed gelatinized ECM composition for the treatment of wounds, burns, abrasions, skin repair, cosmetic skin conditions, or protection of damaged skin because Early and Sigurjonsson both teach the use of decellularized ECN scaffolds for wound healing, tissue regeneration, dermal repair, anti-scarring, and cosmetic tissue augmentation, while Sun teaches therapeutic ECM formulations for topical and surgical administration. This is an obvious application of ECM material functions and represents the predictable use of ECM compositions according to their established properties. For the forgoing reasons, Claims 1, 6-28, and 30-32 are rendered obvious by the teachings of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENHAN LI whose telephone number is (571)272-9143. The examiner can normally be reached Monday-Friday 7:30 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.L./Examiner, Art Unit 1614
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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