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 .
1. Claim 1 is pending and under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 04/23/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Withdrawn Specification Objection
3. The objection to the specification for improper trade name or marker usage is withdrawn in view of Applicant’s amendment to the specification.
Withdrawn Claim Rejections
4. The rejections of claims 2 and 3 under 35 U.S.C. 112(b) are rendered moot in view of Applicant’s cancellation of these claims.
5. The rejection of claim 2 under 35 U.S.C. 101 is rendered moot in view of Applicant’s amendment to the claim.
6. The rejections of claims 2 and 3 under 35 U.S.C. 102(a)(1) is rendered moot in view of Applicant’s cancellation of these claims.
Rejections Necessitated by Amendment
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.
7. Claim 1 is 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.
8. Claim 1 contains the trademark/trade name Triton X-100. 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 and, accordingly, the identification/description is indefinite.
Maintained Claim Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
9. Claim 1 remains rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring pancreas extracellular matrix without significantly more. The claim(s) recite(s) pancreas extracellular matrix which is not shown to differ from that in nature. Although maintained, the rejection is revised in view of Applicant’s amendment to claim 1.
The Office published Office's new guidance document entitled 2019 Revised Patent Subject Matter Eligibility Guidance, published January 7, 2019. Applicant is directed to the Federal Register, Volume 4, No. 4, pages 50-57 at page 74621.
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Step 1 of the USPTO' s eligibility analysis entails considering whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: Process, machine, manufacture, or composition of matter. The claims are directed to a composition of matter (step 1, Yes).
Step 2A of the 2019 Revised Patent Subject Matter Eligibility Guidance is a two-prong inquiry. In Step 2A Prong One, examiners evaluate whether the claim recites a judicial exception. The composition of matter (pancreas extracellular matrix) is directed to a natural phenomenon (Step 2A, prong 1, Yes). Because the claim recites a nature-based product limitation (pancreas extracellular matrix), the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. The claim also recites “scaffold” and “decellularized by treating a pancreatic tissue with a mixed solution of detergent (sold under the trademark Triton X-100) and ammonium hydroxide”, however, the Applicant’s specification teaches that the pancreas extracellular matrix is a scaffold and “extracellular matrix” is defined as a natural scaffold for cell growth that is prepared by decellularization of tissue found in mammals (page 6, para. 24; page 8, para. 46; page 13, para. 72; page 14, para. 76). Therefore, the claim recites a natural product. The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. Here, the closest natural counterpart is naturally occurring pancreas extracellular matrix. When the claimed pancreas extracellular matrix is compared to this counterpart, the comparison indicates that there are no differences in structure, function or other characteristics. Further, the claimed pancreas extracellular matrix is not markedly different from the natural counterpart as a result of decellularization with a mixed solution of detergent and ammonium hydroxide as Wan (Wan, Jian, et al. BioMed research international 2017.1 (2017): 4276928; previously cited) teaches decellularized pancreas maintained its original shape and the integrity of the microstructure were largely preserved with the decellularized pancreas possessing a microstructure similar to the native pancreas (page 2, right col. para. 1; page 4, left col. last para and right col. para. 2; Figure 1 and 4). Wan teaches the decellularized pancreas scaffold were implanted into animals where they retained their appearance and texture and cells permeated through the scaffold (page 4, right col. last para.). Therefore, the claimed pancreas extracellular matrix is a product of nature exception and recites a judicial exception.
In Step 2A Prong Two, examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the judicial exception, the claim recites the judicial exception is “for culture and transplantation of a pancreatic organoid” and product-by-process limitations for the production of the judicial exception and a concentration of the judicial exception. An evaluation of whether these limitations are insignificant extra-solution activity is then performed. Note that because Step 2A Prong Two analysis excludes consideration of whether a limitation is well-understood, routine, conventional activity, this evaluation does not take into account whether or not the limitation is well-known. When so evaluated, these additional elements are insignificant extra-solution activity because the “for culture and transplantation of a pancreatic organoid” limitation is an intended use of the judicial exception and Wan teaches transplantation of a decellularized pancreas scaffold where cells permeated in the scaffold (page 4, right col. last para.). and Recitation of how the judicial exception is obtained does not Applicant defines “extracellular matrix” as a natural scaffold for cell growth that is prepared by decellularization of tissue found in mammals and multicellular organisms (page 8, para. 46). Recitation of how the judicial exception is obtained and “a concentration from 2 mg/ml to 4 mg/ml” do not integrate the judicial exception into a practical application because the claim is to a product and not a method of producing or method of using. The claim does not recite any specific form of the pancreas extracellular matrix or any additional components that distinguish the claimed pancreas extracellular matrix from its naturally occurring counterpart. Therefore, the intended use of the claimed pancreas extracellular matrix fails to meaningfully limit the claim because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the intended use does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception (Step 2A, prong 2, No).
In Step 2B, the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements adds an inventive concept into the claim. As discussed with respect to Step 2A Prong Two, the claim recites an intended use, which is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept. The claim also recites “a scaffold” containing the judicial exception but Applicant’s specification teaches the judicial exception is a scaffold and Wan teaches the naturally occurring decellularized pancreas is a scaffold for cells (page 4, right col. last para.; page 3, right col. last para.; page 7, left col. last para. and right col. para. 1). At Step 2B, the evaluation of the insignificant extra-solution activity consideration takes into account whether or not the extra-solution activity is well-known. Here, recitation of “scaffold” and “pancreas extracellular matrix” is recited at a high level of generality with no additional components recited or recitation of the judicial exception in a form that distinguishes it from the natural counterpart. Thus, recitation of “scaffold” and the intended use does not amount to significantly more and does not provide an inventive concept (Step 2B: No).
Markedly different characteristics can be expressed as the product' s structure, function, and/or other properties. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product' s naturally occurring counterpart. If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a ‘‘product of nature” exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception.
Limitations that were found not to be enough to qualify as ‘‘significantly more” when recited in a claim with a judicial exception include: Adding the words ‘‘apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer; simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry; adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or generally linking the use of the judicial exception to a particular technological environment or field of use.
In the instant case, the limitations of the claim does not impose limits on the claim scope such that they are not markedly different in structure from a naturally occurring product.
Claim Interpretation
10. For the purpose of applying prior art, claim 1 is interpreted as decellularized PEM because Applicant’s specification defines “extracellular matrix” as “a natural scaffold for cell growth that is prepared by decellularization of tissue found in mammals and multicellular organisms” (page 8, para. 46). The limitation “by treating a pancreatic tissue with a mixed solution of Triton X-100 and ammonium hydroxide” is interpreted as a product-by-process limitation in which determination of patentability is based on the product itself and does not depend on its method of production (see MPEP 2113). The limitation of “a concentration from 2 mg/ml to 4 mg/ml” is not given patentable weight because the concentration range is interpreted as a preference for an intended use of the claimed PEM for culture and transplantation of a pancreatic organoid rather than a patentable distinction, and because the claim is drawn to a product and not a method.
Claim Rejections - 35 USC § 102
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 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.
11. Claim(s) 1 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang (Jiang, K., et al. "Biomaterials 198 (2019): 37-48; previously cited), hereinafter Jiang.
Claim 1 is drawn to a scaffold for culture and transplantation of a pancreatic organoid, containing a pancreas extracellular matrix (PEM), wherein: the PEM is decellularized by treating a pancreatic tissue with a mixed solution of detergent (sold under the trademark Triton X-100®) and ammonium hydroxide; the scaffold comprises the PEM at a concentration from 2 mg/ml to 4 mg/ml.
Jiang teaches a scaffold for culturing islets comprising porcine decellularized pancreas ECM that was prepared by treating pancreas tissue with Triton X-100 and ammonium hydroxide (page 38, left col. last para. and right col. para. 1 – 3; page 39, right col. para. 2; Figure 3, 5, 7).
Therefore, Jiang anticipates claim 1.
12. Claim(s) 1 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orlando (US-20220305175-A1; Filed 05/08/2020; Published 09/29/2022; previously cited), hereinafter Orlando.
Claim 1 is drawn to a scaffold for culture and transplantation of a pancreatic organoid, containing a pancreas extracellular matrix (PEM), wherein: the PEM is decellularized by treating a pancreatic tissue with a mixed solution of detergent (sold under the trademark Triton X-100®) and ammonium hydroxide; the scaffold comprises the PEM at a concentration from 2 mg/ml to 4 mg/ml.
Orlando teaches a scaffold comprising decellularized pancreatic extracellular matrix and pancreatic cells (page 7, 0104 – 0111; page 8, 0121; Figure 2, 3, 6).
Therefore, Orlando anticipates claim 1.
13. Claim(s) 1 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frenguelli (WO2019122351; Filed 12/21/2018; Published 06/27/2019; previously cited), hereinafter Frenguelli, which is cited on the IDS filed 10/30/2025.
Claim 1 is drawn to a scaffold for culture and transplantation of a pancreatic organoid, containing a pancreas extracellular matrix (PEM), wherein: the PEM is decellularized by treating a pancreatic tissue with a mixed solution of detergent (sold under the trademark Triton X-100®) and ammonium hydroxide; the scaffold comprises the PEM at a concentration from 2 mg/ml to 4 mg/ml.
Frenguelli teaches a scaffold comprising decellularized pancreas extracellular matrix, a cellulose-based bioink and pancreatic cancer cells for culturing pancreatic cancer cells (page 40, lines 15 – 28; Figure 18).
Therefore, Frenguelli anticipates claim 1.
14. Claim(s) 1 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jin (US-20180282699-A1; Filed 12/13/2017; Published 10/04/2018; previously cited), hereinafter Jin, which is cited on the IDS filed 08/30/2024.
Claim 1 is drawn to a scaffold for culture and transplantation of a pancreatic organoid, containing a pancreas extracellular matrix (PEM), wherein: the PEM is decellularized by treating a pancreatic tissue with a mixed solution of detergent (sold under the trademark Triton X-100®) and ammonium hydroxide; the scaffold comprises the PEM at a concentration from 2 mg/ml to 4 mg/ml.
Jin teaches a scaffold comprising decellularized pancreas extracellular matrix for culturing pancreatic organoids (page 15, 0092 – 0093; page 16, 0097, 0102; page 20, 0137 – 0139; page 22, 0158; Figure 2A, 3A, 3B, 3C, 6B).
Therefore, Jin anticipates claim 1.
Applicant’s Arguments/Response to Arguments
15. Applicant Argues: Applicant asserts that amended claim 1 is directed to a man-made (decellularized matrix) which is not a product of nature and the presence of living cells fundamentally distinguishes native tissue from it decellularized ECM counterpart, rendering the latter a qualitatively different entity. Applicant asserts that decellularization leaves behind only a preserved but static structural scaffold and the decellularized product is a re-engineered construct. Applicant asserts that the removal of living cells constitutes a transformative manufacturing step that yields a material with its own profile. Applicant provides Figure 9B showing that PEM along with other extracellular matrices can support increasing in gene expression markers of pancreatic cells
Response to Argument: This is not found persuasive because claim 1 is drawn to a product and not a method of preparing PEM or culturing pancreatic organoids with PEM and Applicant defines extracellular matrix as a natural scaffold for cell growth prepared by decellularization of tissue found in mammals. Therefore, based on Applicant’s definition and Figure 9B, the claimed product of decellularized PEM is a natural product that supports cell growth. Further, as cited above, Wan teaches decellularized pancreas maintained its original shape and the integrity of the microstructure were largely preserved with the decellularized pancreas possessing a microstructure similar to the native pancreas and when implanted into animals, cells permeated through the scaffold. Therefore, absent any markedly different characteristics (other than lack of living cells) from naturally occurring pancreas extracellular matrix, Applicant’s PEM is a product of nature exception and recites a judicial exception.
Applicant Argues: Applicant asserts none of the cited references teach “at a concentration from 2 mg/ml to 4 mg/ml”.
Response to Argument: This is not found persuasive because the recited concentration is interpreted as a preference for an intended use of the PEM and not a patentable distinction over prior art. Nevertheless, each of Jiang’s, Orlando’s, Fregueli’s, and Jin’s decellularized pancreas extracellular matrix for culturing cells would be capable of fulfilling the intended use of culture and transplantation of a pancreatic organoid where the concentration of the PEM is from 2 mg/mL to 4 mg/mL.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZANNA M BEHARRY whose telephone number is (571)270-0411. The examiner can normally be reached Monday - Friday 8:45 am - 5:45 pm.
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/Z.M.B./Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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