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 .
Detailed Action
This action is in response to the papers filed July 9, 2025.
Claim Amendments
Applicant’s amendment to the claims filed 07/09/2025 is acknowledged.
Claims 2-3 and 11-40 have been canceled.
Claims 1, 4-10 and 41-50 are pending and under examination.
Priority
The instant application 18854936 was filed on 10/07/2024. This application is a national stage of international application PCT/BR2023/050115 filed 04/06/2023, claiming priority based on Brazilian Patent Application BR1020220067597 filed 04/07/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. While a certified copy of the foreign patent application is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
Information Disclosure Statement
The information disclosure statement (IDS) filed 10/07/2024 does not comply with the provisions of 37 CFR 1.97, 1.98 and MPEP 609 for the following reasons. 37 CFR 1.98(b) requires that each item of information in an IDS be identified properly. Each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. In this case, Cite No. 3 of the Foreign Patent Documents lacks the country code, kind code, publication date and the name of patentee or applicant of the cited document. The Examiner respectfully submits that the information would need be printed on any patent, should the claims proceed to issue.
Besides Cite No. 3 of the Foreign Patent Documents, the other documents cited in the IDS filed 10/07/2024 have been considered.
English-language summary abstracts for Cite Nos. 1-3 of the Foreign Patent Documents have been provided by Applicant in the Transmittal Letter filed on 10/07/2024.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, or by applicant in an information disclosure statement (IDS), they have not been considered.
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, 4-10 and 41-50 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. The following is Examiner' s attempt to identify the points of informality in the instant claims which render unclear the subject matter Applicant intends to claim. Applicant's cooperation is requested in correcting any errors which may be found in the claims and placing the claim language in conformity with current U.S. practice.
The pronoun “it” appears repeatedly throughout the claims, including at least claim 1 (line 3), claim 46 (lines 3, 12, 14 and 17), claim 47 (line 4), claim 48 (line 10), claim 49 (lines 9, 12, 19 and 26). The recitation is found to be indefinite because use of the pronoun “it” raises uncertainty regarding the which limitations are being referred to by the pronoun.
The limitation “the isolated extracellular matrix” in claim 1 (line 4) and claim 4 (line 6) lacks antecedent basis, rendering the claims indefinite. Changing the phrase to “an isolated extracellular matrix” would be remedial.
The limitation “the solution” in claim 1 (line 8) and claim 4 (line 8) lacks antecedent basis, rendering the claims indefinite. The claims do not previously refer to any solution.
The limitation “the lyophilized material” in claim 5 lacks antecedent basis, rendering the claim indefinite. Changing the phrase to “the lyophilized isolated extracellular matrix” would be remedial.
In claim 6 (line 3), there is a missing conjunction statement immediately before the term “resolubilizing,” which renders the claim indefinite by raising uncertainty whether the method steps are claimed in conjunction (“and” statement) or in the alternative (“or” statement).
Exemplary language is repeatedly utilized throughout the claims, including at least “preferably” (claims 6, 8, 9, 43 and 44), “more preferably” (claims 8 and 44) and “such as” (claims 10, 45, 46 and 49). Use of exemplary language renders the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP 2173.05(d).
Claims 7 and 42 contain the trademark/trade name Triton™. 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 a detergent for decellularization and, accordingly, the identification/description is indefinite. For these reasons, the trademark/trade name Triton™ renders the clams indefinite.
As a matter of formality, in claims 7 and 42, the phrase “sodium lauroyl sarcosinate (sarcosyl)” should be changed to either “sodium lauroyl sarcosinate, sarcosyl” or “sodium lauroyl sarcosinate” because sarcosyl is a synonym and not an abbreviation of sodium lauroyl sarcosinate.
As a matter of formality, in claims 9 and 44, the phrase “HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid), MES (2-(N-morpholino)ethanesulfonic acid), and MOPS (3-(N-morpholino)propanesulfonic acid)” should be “4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid (HEPES), 2-(N-morpholino)ethanesulfonic acid (MES), and 3-(N-morpholino)propanesulfonic acid (MOPS)” instead because each element should be spelled out first and then followed by the abbreviation in parentheses.
In claim 46 (line 11), the limitation “other chemical groups” is found to be indefinite regarding which chemical groups are excluded by the phrase. Changing the phrase to “chemical groups” would be remedial.
In claim 48, lines 4-5, the limitations “the said solution” and “the said tissue-specific hydrogel” and “the said product derived from the tissue-specific extracellular matrix solution” lack antecedent basis, rendering the claim indefinite.
In claim 48, line 8-9, the limitation “the target tissue” lacks antecedent basis, rendering the claim indefinite.
In claim 48, line 13, the language “in combinations of such solution with other biomaterials” is found to be indefinite regarding which biomaterials are excluded by the phrase “other biomaterials” and regarding what the phrase “such solution” refers to.
In claim 48, line 14, the language “the mixture described in item (a)” is found to be indefinite because the phrase “the mixture” lacks antecedent basis, and it is unclear which “item (a)” is being referred to.
In claim 48, line 16, the limitation “the 3D printing steps” lacks antecedent basis, rendering the claim indefinite.
In claim 49, lines 3-4, the limitations “the said solution” and “the said product derived from the tissue-specific extracellular matrix solution” lack antecedent basis, rendering the claim indefinite.
In claim 49, lines 7-8, the limitation “the target tissue” lacks antecedent basis, rendering the claim indefinite.
In claim 49, lines 28-29, the language “in combinations of such hydrogels with other biomaterials” is found to be indefinite regarding which biomaterials are excluded by the phrase “other biomaterials” and regarding what the phrase “such hydrogels” refers to.
In claim 49, line 30, the language “the mixture described in item (a)” is found to be indefinite because the phrase “the mixture” lacks antecedent basis, and it is unclear which “item (a)” is being referred to.
In claim 49, line 32, the limitation “the 3D printing steps” lacks antecedent basis, rendering the claim indefinite.
As a matter of formality, the phrase “Process of claim 1” should be “The process of claim 1” in claim 50.
In claim 50, line 10, the limitation “the 3D printing steps” lacks antecedent basis, rendering the claim indefinite.
For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, 8-10, 41 and 43-50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/122351 A1 to Frenguelli et al.
As discussed above, the instant claims are generally narrative and indefinite, failing to conform to current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. In an effort to advance compact prosecution, the following rejection applies what is presently considered the closest prior art to the claimed invention as best understood. The burden is on the Applicant to revise the claims to render them in proper form for examination on the merits. See MPEP 702.01.
Frenguelli relates to the combination of two biomaterials, human tissue-specific extracellular matrix (ECM) and a cellulose-based bioink, with or without cells, in the 3D bioprinting of human tissues and scaffolds. See Abstract and page 3, lines 15-28.
The ECM material is obtained from decellularized tissues, including healthy or pathological liver, intestine, pancreas, lung, kidney, heart, brain, muscle, skin, vessel, bile duct, adipose, corneal, bone spleen, thymus, placenta, peritoneum, stomach prostate, breast or cartilage. See page 5, lines 24-29, and page 23, lines 16-21.
In the working examples, decellularized human ECM was obtained, lyophilized and then milled to create a powder. The ECM powder was solubilized in a solution of acetic acid and then mixed with sodium hydroxide (NaOH) for pH neutralization. The neutralized ECM solution was then formulated into a bioink and used in 3D bioprinting. See page 34.
Frenguelli’s process, particularly the solubilization step, is free of proteases (i.e., proteolytic enzymes), such as pepsin. See page 4, lines 24-25, and page 38, lines 17-19. The process is also compared to the prior art using pepsin, which limits translation toward good-manufacturing practices (GMP) and clinical applications due to its xenogenic origin and down-breaking effects. See pages 1-2 and page 23, lines 26-28.
For these reasons, the invention as claimed in claim 1 is anticipated by Frenguelli.
Regarding claim 4, Frenguelli further discloses a step of crosslinking the neutralized ECM solution for transition to a hydrogel. See page 5, lines 15-17; page 7, lines 5-6; page 27, lines 13-15.
Regarding dependent claims 5 and 41, Frenguelli discloses the lyophilization step occurs after decellularization and before solubilization. See page 34.
Regarding dependent claims 8 and 43, Frenguelli discloses the acid is acetic acid. See page 34.
Regarding dependent claims 9 and 44, Frenguelli discloses neutralization is performed with a basic solution comprising NaOH.
Regarding dependent claims 10 and 45, Frenguelli discloses the ECM material is obtained from decellularized tissues, including healthy or pathological liver, intestine, pancreas, lung, kidney, heart, brain, muscle, skin, vessel, bile duct, adipose, corneal, bone spleen, thymus, placenta, peritoneum, stomach prostate, breast or cartilage. See page 5, lines 24-29, and page 23, lines 16-21.
Dependent claims 46-50 are directed to intended use limitations of the claimed invention. As instructed by MPEP 2111.04, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In this case, the language of claims 46-50 indicates the intended use of the claimed ECM material without positively limiting the ECM material to a particular structure, or the production process to a particular manipulative action. A recitation of an intended use of the claimed invention must result in a structural or manipulative difference between the claimed invention and the cited prior art in order to patentably distinguish the claimed invention from the cited prior art. If the prior art structure is capable of performing the intended use, then the cited prior art reads on the intended use or functional property recitation. There is no requirement that the cited prior art expressly teach or suggest the intended use recitation. For these reasons, the intended use limitations of dependent claims 46-50 are not found to patentably distinguish the claimed invention from the cited prior art.
Claim Rejections - 35 USC § 103
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.
Claims 6-7 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Frenguelli, as applied above; in view of Ali et al. (2019) “A photo‐crosslinkable kidney ECM‐derived bioink accelerates renal tissue formation” Advanced healthcare materials, 8(7), 1800992, 10 pages.
Regarding dependent claim 6, Frenguelli does not teach a lyophilization step after the neutralization step and before the crosslinking step, as claimed.
Ali is relevant prior art for teaching 3D bioprinting strategies in tissue engineering aim to fabricate clinically applicable tissue constructs that can replace the damaged or diseased tissues and organs. A photo-crosslinkable kidney, decellularized extracellular matrix- (dECM-) derived bioink, termed “KdECMMA,” is produced by decellularizing whole porcine kidneys via a perfusion method, dissolving in an acidic solution, chemically-modifying by methacrylation and formulating into a bioink for 3D bioprinting. See, Abstract. The Experimental Section, on pages 7-9, describe obtaining whole porcine kidneys, decellularizing the kidneys via heparin treatment followed by detergent treatment, solubilizing the decellularized kidney matrix via lyophilization followed by digestion in an acetic acid solution comprising pepsin, neutralizing the solubilized kidney dECM via dialysis, and chemically-modified by methacrylation for structural integrity after bioprinting.
After the neutralization step, the neutralized dECM is freeze-dried (lyophilized) for storage and then, at a later time, resolubilized in acetic acid with pH adjustment for methacrylation. See page 8, right column
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify Frenguelli and include lyophilization and resolubilization steps after the neutralization step and before the crosslinking step, in view of Ali, with a reasonable expectation of success because such process steps provide a means of storing the neutralized dECM material until ready for use or application.
Regarding dependent claims 7 and 42, Frenguelli does not teach that decellularization is performed with a detergent such as Triton™ X-100, as claimed.
However, Ali performed decellularized with the detergent Triton™ X-100. See page 8, left column.
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify Frenguelli and perform decellularization with the detergent Triton™ X-100, in view of Ali, with a reasonable expectation of success because Frenguelli is silent to the means of decellularization, and therefore one of ordinary skill in the art would have sought the known decellularization techniques of the prior art, as found in Ali.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James D Schultz can be reached at (571)272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
