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 .
Claim Status
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 16 April 2025, in which applicant; amended claim 12; canceled claims 16-22. Therefore, claims 1-15 and 23-25 are pending in the application.
Priority
This application was filed 08/22/2024 and is a 371 application of PCT/EP2023/054575 filed on 02/23/2023, which claims benefit to the foreign priority to EP22158238.0 filed on 02/23/2022.
Filing of a certified translated copy of the EP22158238.0 filed 08/22/2024 is acknowledged (MPEP 2304.01(c)) Therefore, the earliest possible priority for the instant application is 02/23/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/22/2024 and 01/30/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Abstract Objection
The abstract of the disclosure filed 08/22/2024 is objected to because the abstract is only 35 words in length. Therefore, submitted abstract is considered non-compliant.
The instant application is a 371 application of PCT/EP2023/054575, filed on 02/23/2023, which the Office acknowledges on page 2 of the Office Action. The abstract of the instant application appears on the front page of the PCT publication. Accordingly, the abstract is compliant in accordance with MPEP § 608.01(b)(I)(C).
However, MPEP §608.01(b)(I) also sets forth guidelines for the abstract. MPEP § 608.01(b)(I)(C) states that “the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.”
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Therefore, appropriate correction is required.
Title Objection
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. See MPEP 606.01
The following title is suggested:
“Printable Bioinks Comprising Coral Particles and Biocompatible Polymer.”
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-12 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Baranes et al., (US20180303974A1; cited in PTO892; hereinafter “Barnes”),
Claim Interpretation: As per MPEP § 2111 and § 2111.01, “[d]uring patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification’" and the words of a claim must be given their ‘plain meaning’ unless such meaning is inconsistent with the specification, wherein ‘plain meaning’ of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art. Because applicant has the opportunity to amend the claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Yamamoto, 740 F.2d 1569, 1571 (Fed. Cir. 1984).
Below are notes made by the examiner regarding claim interpretation of the most recent set of claims. Applicant is respectfully invited to comment on or dispute any of these statements.
In the present case, the preamble of the claim recites a product “bioink” comprising coral particles and biocompatible polymer. As set forth in the MPEP 2111, whether the preamble gives patentable weight or otherwise limits the claim as a whole is to be determined on a case-by-case basis. In the present application, the examiner interprets the claim to be limiting the claim to a composition (i.e., product) comprising coral particles and biocompatible polymer. Accordingly, the claimed “Bioink” is interpreted as requiring the recited coral particles and biocompatible polymer as components of composition.
Regarding claims 1 and 4, Barnes teaches a composition comprising coral particles and biocompatible polymer, (abstract) and the biologically active molecules (i.e., growth factor betal-3 (TGF-betas), bone morphogenetic proteins (BMPs) [0132]) and/or biological cells (i.e., stem cells), wherein the cell population having affinity with the composition and retained within the composition of the invention is an astrocyte population [0120]. Barnes further teaches that the compositions the invention may, if desired, be presented in a pack or dispenser device, such as an FDA approved kit [0174].
Regarding the concentration of coral particle in claims 1-2, 4-5 and 12, Barnes teaches that the composition comprises said porous crystalline calcium carbonate particles and said biocompatible polymer in a ratio of at least 33 μg calcium carbonate particles per milliliter biocompatible polymer (claim 35 of Barnes). Barnes further teaches that Coral skeleton (coral, coralline, aragonite, hydroxyapatite, etc) is microporous and possesses a high ratio of surface area per volume. Coral scaffolds have been used to support ex-vivo growth of cells [0008]. Accordingly, POSITA at the time of invention would have been motivated to adjust the concentration of coral particle in the composition to facilitate easier pipetting to achieve a desire particle concentration. Such optimization would have involved no more than routine experimentation and the claimed concentration would not have been expected to produce unexpected results. MPEP 2144.05(I) teaches “a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).”
Accordingly, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to prepare said nucleic acid because each of the individual elements of the instant claims are independently presented by Barnes as embodiments and are taught that they can be combined in various embodiments; therefore a combination of all the elements into a single embodiment would be apparent to an artisan skilled in cell therapy in light of the Supreme Court' s KSR decision (see MPEP 2143 Exemplary Rationale (A)). Regarding the rationale for combining prior art elements according to known methods to yield predictable results, all of the claimed elements were known in the prior art and one skilled in the art (POSITA) could have combined the element as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Each of the elements to construct composition comprising coral particles and biocompatible polymer are taught by Barnes and further taught in various combinations of composition construct of bioink. It would be therefore predictably obvious to use a combination of these elements in said coral particles and biocompatible polymer.
Regarding claim 3, Barnes teaches that the coral particles have a mean particle size of greater than 30 μm [0202].
Regarding claim 8, Barnes teaches that the coral particles have a mean particle size of less than 35 μm (e.g. 5-20 microns in diameter) [0096].
Regarding claims 9 and 23, Barnes teaches that the coral particles are of the genus selected from Montipora, Favites, Favia, Porites [0079], [0081].
Regarding claims 10-11 and 24-25, Barnes teaches that the biocompatible polymer comprises a cross-linkable polymer is selected from alginate.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Allowable Subject Matter
In the closed prior art, Barnes teaches a composition comprising coral particles and biocompatible polymer, (abstract) and the biologically active molecules (i.e., growth factor betal-3 (TGF-betas), bone morphogenetic proteins (BMPs) [0132]) and/or biological cells (i.e., stem cells), wherein the cell population having affinity with the composition and retained within the composition of the invention is an astrocyte population [0120]. However, Barnes does not teach or fairly suggest a method of producing a coral scaffold comprising a first portion of the coral scaffold and a second portion of the coral scaffold, and the method further comprising crosslinking the biocompatible polymer in the first portion and/or second portion of the scaffold. Therefore, claims 13-15 are prior art free.
Therefore, the method of producing a coral scaffold according to claims 13-15 represent a novel, non-obvious method and distinct from the prior art.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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