DETAILED ACTION
This action is in reply to papers filed 4/24/2026.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240042102A1, Published 2/8/2024.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 16-34, in the reply filed on 4/24/2026 is acknowledged. Claim 35 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/24/2026.
Drawings
The drawings are objected to because Fig. 7 depicts ‘A’, ‘B’ and ‘C’. However, none of ‘A’, ‘B’, and ‘C’ are described in the specification under ‘BRIEF DESCRIPTION OF THE DRAWINGS.’ Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 30 is objected to because of the following informalities: Claim 30 recites, inter alia, “…scaffold of claims 20, wherein….”. The term ‘claim’ is misspelled. 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 22 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.
Regarding claim 22, the phrase “e.g.” or "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Appropriate correction is requested.
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.
Prior Art Rejection 1
Claim(s) 16-19 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Kim et al. (KR101541249B1, Published 8/3/2015, English translation and Original Disclosure are attached). Note the citations of Kim below, unless otherwise noted, are from the English translation.
Kim et al. is drawn to a three-dimensional porous cell carrier containing cells and a preparing method thereof (Abstract). Regarding claim 18(a), Kim discloses a) depositing a first frozen polymeric layer on a refrigerated support (stage) kept below 0°C temperature (Pg. 6 of 18, Col. 2, step (a) –(b); Pg. 7, Col. 2, para. 8 “…..cooled bottom may have a temperature range of 0 to -40° C.”); b) depositing a plurality of subsequent polymeric layers by modulating the below 0°C temperature of the refrigerated support, said first frozen polymeric layer and said plurality of subsequent polymeric layers forming a stack of polymeric layers (Pg. 6 of 18, Col. 2, step (c) –(e)) (as in claim 19 (b)) and c) bringing the stack of polymeric layers formed in step b) to a temperature above 0°C (Pg. 7 of 18, Col. 2, ‘…… the macromolecular solution in which the cell is mixed is maintained by 0 through 37℃) (as in claim 16(c)); wherein each of the plurality of subsequent layers is: i) deposited on a previously deposited layer after freezing of said previously deposited layer (Pg. 10 of 18, Col. 2, ‘….. cooling the bottom surface in which the cell carrier is manufactured at the ultralow temperature and it can manufacture the cell carrier consisting of the pillar of three dimension pore type and is then cooled) (~ stack of frozen polymeric layers as in claim 16(c) and claim 19(b)); ii) deposited on said previously deposited layer before complete polymerization of said previously deposited layer (Pg. 10 of 18, Col. 2, ‘….it is distributed on the cooled bottom surface and the pillar layer is formed …..for 5 minutes to 12 hours) (as in claim 17); and iii) deposited at a temperature higher than a freezing temperature of said previously deposited layer (Pg. 10 of 18, Col. 2, ’….the temperature range of ….0 through 37 ℃ (the room temperature) that the macromolecular solution in which the cell is mixed regularly maintains the temperature it distributes) (as further in claim 19(b)).Kim teaches the polymeric layers comprise crosslinked polymer matrix (Pg. 10, Col. 2, para. 1) had the polymeric layers have pores with a mean pore size between 1 and 500 µm (as further in claim 1(c)) (Fig. 2 of Pg. 13 of Original Disclosure).
Accordingly, Kim anticipates the claimed invention.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Prior Art Rejection 2
Claim(s) 20-34 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR101541249B1, Published 8/3/2015, English translation attached) as applied to claims 16-19 and further in view of Everland et al. (PgPub US20120165957A1, Published 6/28/2012) and Guelcher et al. (PgPub US20100112032A1, Published 5/6/2010).
The teachings of Kim et al. are relied upon as detailed above. And although Kim teaches a multicompartment three-dimensional scaffold comprising a stack of polymeric layers, wherein the scaffold is porous and non-porous (Fig. 2 of Pg. 13 of Original Disclosure) (as in claim 30) and a second liquid comprising encapsulated cells (as in claim 24 and claim 34) (Pg. 6 of 18, Col. 2, step (c) –(e)).
Kim et al. fails to teach the stack of layers that comprise the multicompartment three-dimensional scaffold are mechanically connected by a built-in intermediate layer, having a thickness smaller than those of its adjacent layers (as in claim 20).
Before the effective filing date of the claimed invention, Everland teach reinforced biodegradable (as in claim 27) scaffolds for soft tissue regeneration, as well as methods for support and for augmentation and regeneration of living tissue, wherein a reinforced biodegradable scaffold is used for the treatment of indications, where increased strength and stability is required besides the need for regeneration of living tissue within a patient (Abstract). Everland teaches the scaffold may be reinforced to be easily handled by doctors in the operating room (Pg. 9, para. 198). In one example, Everland teaches the scaffold may be reinforced by attaching the scaffold to a non-woven membrane. Everland teaches the membrane would be significantly thinner than the scaffold and in the centre of the scaffold (as in claim 20) (Pg. 9,para. 199).
Regarding claim 21 and claim 22, Everland teaches the crosslinked polymer matrix comprises alginate (Pg. 4,para. 99). Regarding claim 23, Everland teaches the crosslinked polymer matrix comprises hyaluronic acid (Pg. 5,para. 128), Regarding claim 24, Everland teaches the scaffold matrix comprises cells (Pg. 4,para. 82). Regarding claim 25, K Everland teaches the scaffold is suitable for cell transplantation (Pg. 2, para. 37). Regarding claim 26, Everland teaches the scaffold may be a custom made three dimensional construct of desired shape fitted for implantation into the site of defect or site requiring implantation (Pg. 5, para. 105). Regarding claim 31, Everland teaches the scaffold is patterned on a medical device (Pg. 17,para. 400). Regarding claim 33, Everland teaches the scaffold's internal organization is close to the architecture of native tissues or organs (Pg. 4,para. 96).
However, neither Kim nor Everland teach the scaffold is permanent (as in claim 28) or parts thereof are permanent (as in claim 29). Furthermore, neither of these references teach the scaffold is flowable and injectable (as in claim 32).
Before the effective filing date of the claimed invention, Guelcher et al. teach a composition that is either naturally moldable and/or injectable, or it can be made moldable and/or injectable (as in claim 32) (Abstract). Guelcher adds that after implantation or injection, the composition may be set to form a porous composite that provides mechanical strength and supports the in-growth of cells. Guelcher notes that the inventive composites have the advantage of being able to fill irregularly shape implantation site while at the same time being settable to provide the mechanical strength for most orthopedic applications (Pg. 1, para. 9). Guelcher teaches as the bone particles and polymers used in the present invention are resorbed, these non-biodegradable materials may be removed from tissue sites by natural metabolic processes, allowing degradation of the polymers and resorption of the bone particles to be tracked using standard medical diagnostic techniques (as in claim 28 and claim 29) (Pg. 10, para. 96).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Kim et al., wherein Kim teaches a three-dimensional porous cell carrier containing cells and a preparing method thereof, with the teachings of Everland et al., wherein Everland teaches a method of reinforced biodegradable scaffolds for soft tissue regeneration wherein a membrane is inserted in the center of the scaffold, with a reasonable expectation of arriving at the claimed invention. That is, one of ordinary skill in the art would have found it prima facie obvious to insert a thin membrane, as set forth in Everland, in the center of the 3D scaffold of Kim et al., such that the scaffold is Kim is reinforced prior to in vivo implantation. Moreover, one of ordinary skill in the art would have found it prima facie obvious to make scaffold injectable, as set forth in Guelcher et al., because Guelcher teaches this allows for the scaffold to be able to fill irregularly shape implantation site while at the same time being settable to provide the mechanical strength for most orthopedic applications.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the claimed invention, as a whole, was clearly prima facie obvious
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 16-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11724006B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Instant claims are drawn to a method of producing a multicompartment three-dimensional scaffold, said method comprising: c) raising the temperature of a stack of frozen polymeric layers from a temperature below 0° C. to a temperature above 0° C., wherein the stack of frozen polymeric layers comprises crosslinked polymers, wherein following step (c), the stack comprises a crosslinked polymer matrix in one or more of the polymeric layers having pores with a mean pore size between 1 μm and 500 μm. Claim 16 is drawn to a multicompartment three-dimensional scaffold produced by the method of claim 16, wherein the stack of layers that comprise the multicompartment three-dimensional scaffold are mechanically connected by a built-in intermediate layer, having a thickness smaller than those of its adjacent layers.
Claim 1 of U.S. ‘006 is drawn to a method of producing a cryogel-based multicompartment three-dimensional scaffold, said method comprising steps of: a) depositing a first liquid comprising a first precursor of a first polymeric material to form a first frozen polymeric layer on a refrigerated support kept below 0° C. temperature; b) repeatedly depositing a second liquid comprising a second precursor of a second polymeric material to form a plurality of subsequent polymeric layers on the refrigerated support at below 0° C., said first frozen polymeric layer and said plurality of subsequent polymeric layers forming a stack of polymeric layers, wherein step (b) further comprises polymerizing the first and/or second precursor, wherein the first precursor and the second precursor are the same or different; and c) bringing the stack of polymeric layers formed in step b) to a temperature above 0° C.; wherein following step (c), the stack comprises a crosslinked polymer matrix in one or more of the polymeric layers having pores with a mean pore size between 1 μm and 500 μm, wherein each of the plurality of subsequent layers is: i) deposited on a previously deposited layer after freezing of said previously deposited layer; ii) deposited on said previously deposited layer before complete polymerization of said previously deposited layer; and iii) deposited at a temperature higher than a freezing temperature of said previously deposited layer.
It is clear that all the elements of the application claims are to be found in patent claims (as the application claims fully encompasses patent claims). The difference between the application claims and the patent claims lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the patent, it is not patentably distinct from claims of the patent.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
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