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 . 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.
Election/Restrictions
Applicant's election with traverse of group I and crosslinked elastin in the replies filed on 11 March, 2026 and 22 May, 2026 is acknowledged. The traversal is on the ground(s) that as the two groups are related, they are not independent and distinct. This is not found persuasive because the restriction requirement showed that the tissue scaffold can be made with a method patentably distinct from the one that applicant has claimed; a showing of independence and distinctness.
The requirement is still deemed proper and is therefore made FINAL.
Applicants have elected cross linked elastin. A search was conducted for this invention, and a reference was found that anticipated it. As a result, claims 1 and 2 were examined, and claims 3, 4, 10, 12-18, and 75-80 have been withdrawn from consideration. Applicants state that they believe claims 77-79 read on the elected species, but those claims discuss fractions of elastin, which were not elected. Thus, these claims are properly withdrawn.
Information Disclosure Statement
The information disclosure statements filed 18 Oct, 2024 and 10 July, 2023 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Both information disclosure statements list references that were not submitted with the statements or found with the parent application. Thus, those references were not considered.
Claims Status
Claims 1-4, 10, 12-18, and 75-80 are pending.
Claims 4, 10, 12-18, and 75-80 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the replies filed on 11 March and 22 May, 2026.
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 and 2 are rejected under 35 U.S.C. 101 because they read on a judicial exception (natural phenomenon).
The Supreme Court has given a two part test for eligibility under this statute:
1) Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there anything beyond the judicial exception?
Applying the test:
1) The claims are drawn to crosslinked elastin, a composition of matter, passing the first test.
2a) Schrader et al (J. Biol. Chem. (2018) 293(39) p15107-15119, previously cited) states that elastin is naturally crosslinked (abstract). The limitation of lyophilization is not considered to make a difference in terms of eligibility, as it does not make the substance materially different. Alternatively, Clark (Nova episode of 24 Nov, 1998) discusses mummies of the Incas (title). Almost all of these mummies were naturally freeze dried (7th page, 3d paragraph). As they reasonably comprise elastin, which, as noted by Schrader et al, is naturally crosslinked, a naturally occurring material anticipates applicant’s claims.
2b) As this is the same material, there can be nothing beyond the judicial exception. Thus, the claims lack patent eligibility.
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.
Claim(s) 1 and 2 are rejected under 35 U.S.C. 102(2)(a) as being anticipated by Daamen et al (US 20090274734).
Daamen et al discuss hollow nanoparticles (title), which can be used for, among other purposes, tissue engineering (paragraph 112), interpreted as suitable for use as tissue scaffold. Elastin was made into particles by freezing droplets of 20% (w/v) elastin in dilute acetic acid, followed by lyophilization (paragraph 129). These particles were then crosslinked with glutaraldehyde/formaldehyde vapor (paragraph 132), and, optionally, further crosslinked with glutaraldehyde in solution (paragraph 133). Note that these particles are crosslinked and lyophilized elastin, which are suitable for use as a tissue scaffold, anticipating claims 1 and 2.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 11,738,112. Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 1 describes a method of making a tissue scaffold, comprising crosslinking a composition comprising elastin. Competing claim 12 describes lyophilizing the resulting material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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