DETAILED ACTION
Notice of Pre-AIA or AIA Status
Claim(s) 1-18 is/are pending.
Claim(s) 1-2, 4-5, 7, 10-18 is/are rejected.
Claim(s) 3, 6, 8-9 is/are withdrawn from consideration.
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 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.
Response to Election/Restrictions
Applicant's election with traverse of: Species (a)(ii) (claims 4, 11-15); Species (b)(ii) (claim 7); Species (c)(ii) (claim 10, 12-15); in the reply filed on 12/19/2025 is acknowledged. The traversal is on the ground(s) that “examination of all of the claims does not create an undue search burden on the examiner.”
This is not found persuasive because the species have acquired a separate status in the art: (i) in view of their different classification; (ii) due to their recognized divergent subject matter; (iii) because the inventions require a different field of search (see MPEP § 808.02) and/or require material difference in search strategies; (iv) prior art applicable to one invention would not likely be applicable to another invention; and/or (v) because the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 3, 6, 8-9 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/19/2025.
Specification
The disclosure is objected to because of the following informalities:
The specification fails to list Figure 3A in the Brief Description of Drawings.
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.
Claim(s) 12-15 is/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.
Claims 12-13, 15 are vague and indefinite because the use of the term “caprolactone” in the phrase “polymer fiber of caprolactone and chitosan fiber” confusing and unclear. It is unclear whether Applicant intends to require that the polymer fiber is formed of: (i) a blend of non-polymeric “caprolactone” compound mixed with chitosan (which is a natural polymer); or (ii) a blend of “polycaprolactone” polymer (i.e., formed from the polymerization of caprolactone compounds) mixed with chitosan. For the purpose of the present Office Action, phrase “polymer fiber of caprolactone and chitosan fiber” as interpreted as requiring a polymer fiber comprising polycaprolactone and chitosan.
Claim 14 is dependent on one or more of the above claims and therefore incorporate the above-described indefinite subject matter.
Claim Rejections - 35 USC § 103 (AIA )
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-5, 7, 11-14, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• ENGINEERING A POLYMER LAYERED BIO-HYBRID HEART VALVE SCAFFOLD.
ENGINEERING A POLYMER LAYERED BIO-HYBRID HEART VALVE SCAFFOLD discloses a bio-hybrid composite material comprising:
• a decellularized bovine pericardium extracellular matrix (DBPECM) scaffold material (corresponding to the recited “inert substantially non-biodegradable material” of claim 1);
• a coated layer of polycaprolactone-chitosan (PCL-CH) nanofibers (corresponding to the recited “active biodegradable material attracting cells” of claim 1) (e.g., made from a preferred electrospinning composition comprising 10% PCL and 1% CH) (corresponding to the recited “about a 10:1 by weight ratio” of claim 13), wherein the layer has an illustrative thickness of about 0.09 mm (about 90 microns, calculated from the difference between the thickness of uncoated DBPECM and the coated DBPECM bio-hybrid composite).
The bio-hybrid composite exhibits adhesion and proliferation of live cells in the PCL-CH nanofibers, and the presence of said live cells in the scaffold material of the bio-hybrid composite, thereby allowing for remodeling of biological tissue (corresponding to the recited “the inert material attracts cells from the active material providing cells which hone into the inert material providing a remodeled material” of claim 1). The bio-hybrid composite is hemocompatible and can be used as a bioprosthetic heart valve in pediatrics (e.g., for addressing congenital heart valve disease). (entire document, e.g., page 263-264; section 3.6-3.7; page 270; etc.)
Regarding claims 1-2, 4-5, 7, 11-14, 16-18, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the bio-hybrid composite material of ENGINEERING A POLYMER LAYERED BIO-HYBRID HEART VALVE SCAFFOLD as an implantable cardiac bio-prosthetics capable of supporting tissue engineering and tissue remodeling (e.g., to remedy congenital heart valve defects in pediatric patients, etc.).
* * *
Claim(s) 1-2, 4-5, 7, 10-11, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• HODGDON (US 2022/0151619), or
• WO 2020/185851 (HODGDON-WO ‘851).
HODGDON ‘619 and HODGDON-WO ‘851 disclose implantable composites comprising:
• an internal frame component (e.g., comprising an inert material and/or a biological material -- for example, mammalian (e.g., porcine, bovine, human, etc.) tissue, pericardium collagen, etc.) (corresponding to the recited “inert substantially non-biodegradable material” of claim 1);
• an external casing component (e.g., comprising a biocompatible, biodegradable material -- e.g., synthetic or natural polymer, etc.) (corresponding to the recited “active biodegradable material attracting cells” of claim 1), wherein biocompatibility refers to a material which does not induce immunological or inflammatory response;
wherein the external casing component can be present on any or all sides (including the inner surface) of the internal frame;
wherein the components (i.e., internal frame and/or external casing) of the composite can be in the form of combined fibers or strands (e.g., braided, knit, mesh, woven, non-woven, etc.).,
The composite can have a dissolution period exceeding 1 month (e.g., 2 months, 3 months, 6 months, more than 6 months, etc.). The composite can be configured as a bio-scaffold for supporting viable cells (i.e., cells that are alive and capable of growth, proliferation, migration, and/or differentiation; living cells), wherein the composite is implanted within a subject, wherein the implanted composite can facilitate in-growth and remodeling of tissue. (HODGDON ‘619, entire document, e.g., paragraph 0005, 0008, 0016, 0018, 0020, 0022, 0030-0031, 0033, 0037, 0089, 0096-0104, etc.) (see corresponding portions of HODGDON-WO ‘851)
Regarding claims 1-2, 4-5, 7, 10-11, 16, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce multi-component implantable composites in accordance with HODGDON ‘619 and HODGDON-WO ‘851 which are capable of supporting and attaching living cells and aiding in the proliferation (e.g., in-growth) of said cells throughout the composite, thereby facilitating tissue remodeling (corresponding to the recited “the inert material attracts cells from the active material providing cells which hone into the inert material providing a remodeled material” of claim 1).
Further regarding claim 1, one of ordinary skill in the art would have utilized an inert material with a relatively slow biodegradation rate (e.g., greater than 1 month) (corresponding to the recited “substantially non-biodegradable material” of claim 1) as the internal frame component of HODGDON ‘619 and HODGDON-WO ‘851 in order to provide the composite with sufficient structural stability over an extended period as required for specific applications (e.g., composites with a desired extended use-life exceeding 1, 2, 3, or 6 months).
Regarding claim 10, one of ordinary skill in the art would have intermingled fibers or strands of the internal frame component and the external casing component (e.g., by weaving, etc.) in order to promote attachment, infiltration, and proliferation (e.g., in-growth) of said cells throughout the composite, and thereby facilitate controlled remodeling of tissue.
Allowable Subject Matter
Claim(s) 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record fails to disclose or suggest an implantable composite material formed from the application of fiber comprising caprolactone and chitosan on an aldehyde-functionalized decellularized pericardium material (claim 15), wherein the recitation of “the process of contacting the decellularized pericardium with a dialdehyde” is a product-by-process limitation and is not further limiting in as so far as the structure of the product is concerned.
ENGINEERING A POLYMER LAYERED BIO-HYBRID HEART VALVE SCAFFOLD and HODGDON ‘619 and HODGDON-WO ‘851 fail to specifically disclose multi-component compositions comprising aldehyde-functionalized decellularized pericardium material.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following references disclose polycaprolactone / chitosan nanofibers for implantable materials for tissue engineering:
• “New poly(ε-caprolactone)/chitosan blend fibers for tissue engineering applications”;
• “Polycaprolactone/ chitosan electrospun scaffolds for tissue engineering applications”;
• “Fibers for hearts: A critical review on electrospinning for cardiac tissue engineering”.
SAINT-PIERRE ET AL (US 2015/0246157) and JOHNSON ET AL (US 2017/0319742) disclose polycaprolactone / chitosan nanofibers for implantable materials for tissue engineering.
“Pericardial Processing: Challenges, Outcomes and Future Prospects” disclose process of pericardium tissues.
“Biological and mechanical evaluation of a Bio-Hybrid scaffold for autologous valve tissue engineering” disclose composite implantable materials for heart valves.
WEBER ET AL (US 2017/0333185) disclose prosthetic heart valves containing components comprising composite nanofibers.
MATHENY ET AL (US 2022/0128465) disclose multi-component implantable bio-prosthetics.
BOTHWELL (US 3,093,439) disclose collagen-based materials treated with dialdehyde compounds.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vivian Chen (Vivian.chen@uspto.gov) whose telephone number is (571) 272-1506. The examiner can normally be reached on Monday through Thursday from 8:30 AM to 6 PM. The examiner can also be reached on alternate Fridays.
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January 24, 2026
/Vivian Chen/
Primary Examiner, Art Unit 1787