DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-16 are currently pending.
Election/Restrictions
Applicant’s election of Group I, Claims 1-9, and of species nitrooxidative and nitrocysteine, in the reply filed on 7/7/2026 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 § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 3, 5 and 10-16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 1-2, 4 and 6-9 are being examined in this application, insofar as they read on the elected species of nitrooxidative and nitrocysteine.
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 1-2, 4 and 6-9 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 pre-AIA the applicant regards as the invention.
Claim 1, line 2, the recitation of “modifications” is indefinite as it is unclear what has changed to what, in other words, the starting material is unknown and changes are unknown.
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.
Claims 1-2, 4 and 6-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to an extracellular matrix (ECM) product comprising nitroxidative or oxidative modifications. It was well-known that ECM naturally develop nitroxidative modifications, and that natural oxidative modifications occur routinely in ECM. There is no indication in the instant specification that the claimed ECM comprises nitroxidative or oxidative modifications has any characteristics that are different from the naturally occurring ECM comprises nitroxidative or oxidative modifications. Thus, the ECM comprises nitroxidative or oxidative modifications does not have markedly different characteristics from its natural counterparts in its natural state, and is a “product of nature” exception. Claim 1 also recites a preparation method, which is regarded as a product-by-process limitation. A product-by-process limitation is not limited to manipulations of the recited steps, but instead is only limited to the structure implied by the steps. As noted above, the claimed ECM comprises nitroxidative or oxidative modifications does not have markedly different characteristics from its natural counterparts in its natural state. Accordingly, claim 1 is directed to an exception. Claim 1 does not include any additional features that could add significantly more to the exception. Therefore, claim 1 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claims 2, 4 and 6 recite a characterization or conclusion of the results of process step positively recited. These limitations are regarded as product by process type limitations. A product-by-process limitation is not limited to manipulations of the recited steps, but instead is only limited to the structure implied by the steps. These product by process type limitations do not include any additional features that could add significantly more to the exception. Therefore, claims 2, 4 and 6 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claims 7-8 recite the ECM further comprises nanovesicles and its preparation steps. It was well-known that ECM naturally contains nanovesicles. There is no indication in the instant specification that the claimed ECM comprises nanovesicles has any characteristics that are different from the naturally occurring ECM comprises nanovesicles. Thus, the ECM comprises nanovesicles does not have markedly different characteristics from its natural counterparts in its natural state, and is a “product of nature” exception. Claims 7-8 also recite a preparation method, which is regarded as a product-by-process limitation. A product-by-process limitation is not limited to manipulations of the recited steps, but instead is only limited to the structure implied by the steps. As noted above, the claimed ECM comprises nanovesicles does not have markedly different characteristics from its natural counterparts in its natural state. Claims 7-8 do not include any additional features that could add significantly more to the exception. Therefore, claims 7-8 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 9 recites a mesh or matrix of a synthetic polymer composition. The instant specification discloses the polymer can be collagen (para 0018). It was well-known that collagen naturally forms mesh-like networks and structural scaffolds. The ECM comprises collagen does not include any additional features that could add significantly more to the exception. Therefore, claim 9 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
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 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.
(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 1-2, 4 and 6-9 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Kennett et al (Free Radical Biology & Medicine. 2008;45:716-725.) as evidenced by Badylak et al (WO 2017/151862 A1; 9/8/2017. Cited on IDS).
The instant claims recite an extracellular matrix (ECM) product comprising nitroxidative or oxidative modifications, prepared by a method comprising contacting tissue or an ECM material with a reactive oxygen species (ROS) or a reactive nitrogen species (RNS) to produce the ECM product having nitroxidative or oxidative modifications.
Kennett teaches an extracellular matrix (ECM) product comprising nitroxidative or oxidative modifications (p.718 col right – para 1-2). Kennett teaches ECM comprises collagen (a mesh or matrix) (p.716 col right – para 3, p.722 col right – para 4). Before the effective filing date of the claimed invention, it was well-known in the art that ECM contains embedded nanovesicles. Badylak teaches matrix bound nanovesicles are embedded in any type of ECM (p.24 line 13-14).
Limitations of “prepared by a method …” in claim 1, “comprising at least a two-fold increase …” in claims 2, 4 & 6, “prepared from …” in claim 7, “wherein the nanovesicles are prepared from …” in claim 8, and “a synthetic polymer composition” in claim 9 are regarded as product by process type limitations. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113)
Therefore the reference anticipates the claimed subject matter.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Lynn Y Fan/
Primary Examiner, Art Unit 1759
Prosecution Insights