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
Claims 1-23 were previously pending.
Applicant’s election of the invention of group I drawn to a method of making a sterilizable microporous 3D tissue engineering scaffold and the species of natural polymer and polysaccharide in the reply filed on 20 October, 2025 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 § 818.01(a)).
Receipt is acknowledged of the amendments to the claims filed on 20 October, 2025. Claims 1, and 20-22 are amended. Claims 2, 4, 13, and 23 are cancelled. Claims 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, claims 1, 3, 5-12, and 14-18 are pending and under consideration in the present Official Action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/ES2020/070385, filed 12 June, 2020.
Therefore, the earliest possible priority for the instant application is 12 June, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08 December, 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings submitted on 08 December, 2022 are accepted by the Examiner.
Claim Interpretation
Claims 14-18 recite only optional further limitations to independent claim 1 because all further limitations occur after the recitation of “optionally”. These claims are being interpreted consistent with their broadest reasonable interpretation as not requiring any of the limitations occurring after the recitation of “optionally”.
Claim Objections
Claim 1 is objected to because of the following informalities: “comprising” and “freeze” are improperly conjugated. “comprising” should be replaced with “comprises” and “freeze” should be replaced with “freezing”. Appropriate correction is required.
Claims 3, 6, 15-17 are objected to because of the following informalities: clauses reciting “from the list consisting of” in claims 3, 6, 15-17 should be amended to recited their intended Markush groups by reciting ““from the group consisting of”. Appropriate correction is requested.
Clauses (ii) of claims 3, 6 and 16 improperly state their intended Markush groups; the proper format requires the use of the conjunction “and” before the final member of the groups. Appropriate correction is requested.
Claim 14 is objected to because of the following informalities: “comprises” is incorrectly conjugated and “wherein” is not needed. The claim should instead recite “The method according to claim 1, optionally further comprising”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: it appears to be missing words in between “wherein” and “further”. The claim should instead recite “The method according to claim 14, wherein the method further comprises”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “are” is referencing a singular noun. “are” should be replaced with “is”. Also, “inmuglobulin” is not a word. It seems like Applicant may have intended to recite “immunoglobulin” instead. Also, “poly-e-lysine” does not appear to exist. ε-polylysine exists and can be of either L or D chirality. 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 1, 3, 5-12, and 14-18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the at least a biocompatible natural polymer" in the fourth line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “a network of at least an inter-crosslinked biocompatible natural polymer” prior to the recitation of "the at least a biocompatible natural polymer”. To overcome this rejection, it is recommended to amend claim 1 step a) to instead recite “Preparing a dissolution of a biocompatible natural polymer,”.
Claim 1 recites the limitation "the solution of step a)" in the fifth line of the claim and “the solution” in the sixth line of the claim. There is insufficient antecedent basis for these limitations in the claim. Instead of solution, this step should reference “the dissolution” in each respective location since that is what is prepared in step a).
Claim 1 recites the limitation "the scaffold" in the ninth line of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the recitation of “the scaffold” is intended to refer to the lyophilized scaffold or the freeze-scaffold produced in steps prior to step e). Thus, in having multiple possible antecedents, “the scaffold” lacks sufficient antecedent basis.
Claims 3, 5-12, and 14-18 are further rejected for their dependency on a rejected base claim.
Claim 3 depends from cancelled claim 2. Consequently, it is unclear what the intended claim scope of claim 3 is and claim 3 is rejected for being indefinite. Claim 3 should be rewritten in independent form or else be amended to depend from a currently pending claim. For the purpose of compact prosecution, claim 3 is being interpreted as if depending on independent claim 1. In the event Applicant amends claim 3 to depend from claim 1, it is noted that the recitation “the natural polymer or any variant thereof” lacks antecedent basis in claim 1. In the event Applicant amends claim 3 to be in independent form, it is noted that “the natural polymer or any variant thereof” also lacks antecedent basis within claim 3 itself. Thus, in either scenario, claim 3 is further rejected for being indefinite for lacking sufficient antecedent basis.
Claim 5 recites the limitation "the polymer" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim. As discussed above, there are multiple recitations of a polymer in claim 1 from which claim 5 depends, neither of these recitations is directed to “a polymer” but rather “a network of at least an inter-crosslinked biocompatible natural polymer” and “the at least a biocompatible natural polymer”.
Claim 6 recites “the polymer” in the first line of the claim in reference to step a). Neither claim 6 nor claim 1 from which it depends recites “a polymer”. Claim 1 recites “the at least a biocompatible natural polymer” in step a).
Claim 7 recites “the polymer” in the second line of the claim in reference to step a). Neither claim 7 nor claim 1 from which it depends recites “a polymer”. Claim 1 recites “the at least a biocompatible natural polymer” in step a).
Claim 8 recites ”the pH of step a)” There is not proper antecedent bases for the recitation of “the pH of step a)” in the parent claim.
Claim 9 recites “the scaffold of step b)” in the first line of the claim. Claim 1 recites no scaffold in step b). Thus, this claim is unclear and a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought. This rejection can be overcome by amending claim 9 to instead recite “the freeze-scaffold obtained in step b)” as it is referenced in instant claim 1.
Claim 9 recites ”the freezing temperature of step b)”. There is not proper antecedent bases for the recitation of “the freezing temperature of step b)” in the parent claim.
Claim 11 recites “at least a period which ranges from 16h to 96h”. This is unclear because it is unclear whether Applicant intends the scope of claim 11 to encompass the range of periods set forth or whether Applicant instead intends for claim 11 to encompass infinitely long periods (as indicated by the “at least”). Thus, claim 11 is unclear and a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought.
Regarding claims 5, 7, 8, 11, and 16, the phrase "preferably" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 14 recites “and/or” in the second and third lines of the claim. It is unclear whether Applicant intends the scope of claim 14 to encompass both of the recitations occurring on either end of each “and/or” or either recitation in the alternative for each respective repetition of “and/or”. Thus, claim 14 is unclear and a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 recites in step b), “pouring out the solution of step a) into molds”. Claim 9 depends from claim 1 and recites “wherein the scaffold of step b) is formed by molding the dissolution via extrusion directly”. Pouring into molds does not encompass “molding” via direct extrusion. Extrusion uses a small opening like at the end of a syringe for example, to shape a high viscosity liquid via forcing the liquid through the opening (See Fig. 2 if the instant disclosure). This is a distinct process from “pouring” a liquid into a mold. Thus, claim 9 fails to further limit claim 1 in its recitation of direct extrusion because such recitation is not encompasses by “pouring” into molds. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 (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 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.
Claims 1, 3, 5-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, et al. Macromolecular research 12.4 (2004): 367-373., hereinafter “Kim” in view of Elsabee, et al., Materials science and engineering: C 33.4 (2013): 1819-1841., hereinafter “Elsabee”, Of Record, Ji, et al. Materials Science and Engineering: C 33.7 (2013): 3780-3785., hereinafter “Ji”, Of Record in the IDS filed: 08 December, 2022, and https://www.sigmaaldrich.com/US/en/product/aldrich/448877?srsltid=AfmBOoqaJSvWXAtguzQX29zonW0BEWT9dSgjGKrMRYdEC4ZxtX41vFyG, Millipore Sigma, Catalog No. 448877, website FAQ, accessed: 20251120, hereinafter “Millipore”.
Regarding independent claim 1, Kim discloses a method for making chitosan scaffolds (Kim, page 368, fourth full paragraph). Kim teaches a method wherein chitosan is dissolved in acetic acid, poured into molds, frozen, lyophilized, then heated in an oven at 110 degrees C (Kim, page 368, fourth and fifth full paragraphs). The step of heating in the oven is interpreted as meeting the instant “curing” limitation because dependent claim 12 specifies that the curing process is a thermal process at a temperature between 30 to 180 degrees C. The scaffolds produced by the method of Kim are tissue engineering scaffolds that are 3-dimmensional and macroporous (See Kim, Figure. 1, Abstract). Further, the chitosan in the scaffolds produced through the method of Kim are inter-crosslinked as a result of the heat treatment (Kim, page 370, second full paragraph). Even further, the chitosan scaffolds of Kim are inherently edible as evidenced by Elsabee who teaches that chitosan is a natural, non-toxic, biodegradable polymer that has a variety of applications, one of which is as an edible food packaging material (Elsabee, page 1839, “Conclusion” heading).
Kim does not teach the sterilization of the scaffolds by hot steam (step “e)” of claim 1) .
Ji teaches the sterilization of chitosan scaffolds by hot steam in an autoclave after lyophilization (Ji, page 3780, last paragraph). Ji teaches that steam autoclave is a common sterilization method for thermal-inert compositions and products in the medical industry (Ji, page 3780, third paragraph), and that, with a melting temperature around 130 to 140 degrees C, chitosan is such a thermal-inert composition (Ji, page 3780, last paragraph). Ji also teaches that the steam sterilization treatment was efficient to sterilize and simultaneously induce intermolecular crosslinking of lyophilized chitosan scaffolds, and that the sterilized scaffolds possessed similar pore diameters and overall porosity with improved homogenous distribution of pore sizes (Ji, page 3785, “Conclusions”). Ji also teaches that the use of autoclave sterilization for chitosan scaffolds eliminates the use of toxic sterilants and that the produced scaffolds are promising for soft tissue engineering applications (Ji, page 3785, “Conclusions”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have added a steam sterilization step as taught by Ji to the method of producing a chitosan scaffold of Kim and to have arrived at the invention claimed in instant claim 1 with a reasonable expectation of success because they would have been motivated to do so to produce chitosan scaffolds which are promising for soft tissue engineering applications with more homogenous pore distribution and without toxic sterilants. There would have been a reasonable expectation of success insofar as Ji teaches that steam autoclave is a common sterilization method for thermal-inert compositions and that chitosan scaffolds are such a thermal-inert composition.
Regarding claim 3, the methods of Ji and Kim both use chitosan as the natural polymer.
Regarding claim 5, the chitosan of Ji is medium molecular weight chitosan with a catalog No. 448877. This chitosan has a molecular weight of between 190,000 to 310,000 Da as evidenced by Millipore (Millipore, page 11).
Regarding claim 6, Kim teaches a method wherein chitosan is dissolved in acetic acid, poured into molds, frozen, lyophilized, then heated in an oven at 110 degrees C (Kim, page 368, fourth and fifth full paragraphs). It is known in the art that acetic acid is an organic solvent.
Regarding claim 7, the solutions of both Kim and Ji are 1.5 wt% (Kim, page 368, fourth paragraph; Ji, page 3780, “Materials”).
Regarding claim 8, Kim uses 1% acetic acid which has a pH of around 2.8 (Kim, page 368, fourth paragraph). Millipore teaches the viscosity of 1 wt% chitosan in 1% acetic acid at 25 degrees C (Millipore, page 3). Thus, a person having ordinary skill in the art would have understood 25 degrees C to be sufficient to dissolve chitosan in 1% acetic acid.
Regarding claim 9, the molds of Kim are 99cm2 (equaling a diameter of around 11cm) and the molds of Ji are “custom made” molds which produce a scaffold of around 1cm diameter (Kim, page 368, fourth paragraph; Ji, Fig. 1, page 3780, last paragraph). Thus, a person having ordinary skill in the art would have understood that the chitosan solution generated in the first step of both Kim and Ji could be put into molds of different shapes and sizes to produce the predictable result of chitosan scaffolds having different shapes and sizes.
Regarding claim 10, the freezing temperature of Kim is -80 degrees C (Kim, page 368, fourth paragraph).
Regarding claim 11, the lyophilization of Kim is at -55 degrees C, at 0.2torr for 24 hours (Kim, page 368, fourth paragraph). 0.2torr equals 0.266645 mbar.
Regarding claim 12, the scaffold of Kim is heated at 110 degrees C for between 1-3 days (Kim, page 368, fifth paragraph).
Regarding claims 14-18, all further limitations occur after the recitation of “optionally”. These claims are being interpreted consistent with their broadest reasonable interpretation as not requiring any of the limitations occurring after the recitation of “optionally” (see claim interpretation above). In rendering prima facie obvious, claim 1, Kim, Elsabee, and Ji render prima facie obvious claims 14-18.
Nonstatutory 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, 3, 5-12, and 14-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-13 and 19-28 of copending Application No. 18/001159 as evidenced by Elsabee, et al., (Materials science and engineering: C 33.4 (2013): 1819-1841), hereinafter “Elsabee”. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the cited claims of Application 18/001159.
Claim 1 of 18/001159 is directed to: edible and sterilizable by hot steam macroporous three-dimensional tissue engineering scaffold comprising a biocompatible polymer from natural synthetic origin or any variant thereof.
Claim 1 of the invention is directed to
A method for obtaining a sterilizable macroporous three
Dimensional (3D) tissue engineering scaffold which comprising a network of at least an inter crosslinked biocompatible natural polymer, wherein the method comprises the following steps:
a) Preparing a dissolution of the at least a biocompatible natural polymer,
b) Pouring out the solution of step a) into molds and freeze, preferably at a temperature
lower than the freezing temperature of the solution;
c) Lyophilizing the freeze-scaffold obtained in step b)
d) Curing the lyophilized scaffold of step c), and
e) Sterilization of the scaffold by hot steam.
Claim 19 of the invention is directed to sterilizable by hot steam and edible macroporous 3D tissue engineering scaffold which comprising a network of at least a biocompatible polymer obtained by the method according to claim 1.
Claim 1 of the invention does not claim an edible and sterilizable by hot steam macroporous three-dimensional tissue engineering scaffold.
Elsabee teaches that natural polymers such as chitosan is a natural, non-toxic, biodegradable polymer that has a variety of applications, one of which is as an edible food packaging material (Elsabee, page 1839, “Conclusion” heading).
It would have been obvious that the claimed 3D scaffold of the instant invention comprising a at least a biocompatible natural polymer including chitosan would have been edible in view of the teachings of Elsabee et al.,
The present claims at issue are encompassed by, and are a species of, claims 1, 2, 4-13 and 19-28 of copending Application No. 18/001159. Claim 1 is generic to that which is recited in claims 1, 3, 5-12, and 14-21 of the instant specification. Thus the instant claims are anticipated by claims 1, 2, 4-13 and 19-28 of copending Application No. 18/001159
The 18/001159 application claims methods and compositions, but double-patenting rejections of claims to a method of making based on a claimed composition are proper. This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA G LEAVITT can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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