DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1,3,5-12 and 14-22 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 was previously 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 25 March, 2026. Claims 1, 3, 5-11, and 14-18 are amended. Claim 12 is cancelled. Claims 19-22 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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, 5-11, 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.
Claim Interpretation
Claim 18 recites only optional further limitations to independent claim 1 because all further limitations occur after the recitation of “optionally”. This claim is being interpreted consistent with its broadest reasonable interpretation as not requiring any of the limitations occurring after the recitation of “optionally”.
Claim Objections
The objections to claims 1, 3, 6, and 15-18 are withdrawn in view of Applicant’s amendments to the claims. Applicant has corrected previously-identified issues of grammar.
Claim 14 remains objected to because of the following informalities: The recited list is missing either “and” or “or” to specify whether the list is in the alternative or not. There should be either an “and” or an “or” between “adhesion molecule,” and “at least a cross-linker agent”. Appropriate correction is required.
Withdrawn Rejections in view of Applicant’s Amendments/Arguments
The rejection of claim 9 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 is withdrawn in view of Applicant’s amendments to the claims. Applicant has amended claim 9 to limit step b) of claim 1 to molds of different shapes and sizes.
Maintained Rejections in view of Applicant’s Amendments/Arguments
Claim Rejections - 35 USC § 112
The rejection of claims 1, 3, 5-12, and 14-18 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 is withdrawn over claims 1, 3, and 5-12 and maintained over claims 14-18 in view of Applicant’s amendments to the claims.
Applicant has amended claims 1,3, and 5-12 to overcome previously-identified issues of indefiniteness. Applicant has removed all recitations of “preferably”, corrected antecedent basis issues, and clarified “and/or” recitations.
However, amended claim 14 now reads “The method according to claim 1 , further comprising the addition of at least an additive, at least an adhesion molecule, at least a cross-linker agent, in any combination, which may be added in step a) in an additional step between steps c) and d), or in both”. This recitation is unclear for a multitude of reasons. First, it is unclear whether Applicant intends the scope of claim 14 to encompass the addition of at least an additive, at least an adhesion molecule, and at least a cross-linker agent or whether Applicant instead intends to encompass these in the alternative. This issue is confounded by the recitation of “in any combination” as it is unclear whether Applicant intends the claim to encompass a combination of the three recited additions or of combinations of just two of the three and which combinations are required to be within the scope of the claim. Second, the phrase "may be added" 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). Third, the final recitation of “or in both” is unclear insofar as the claim does not state what “both” is referring to. The prior recitation to “or in both” recites “an additional step” which is singular. Accordingly, claim 14 as amended remains rejected for being indefinite.
Claims 15-18 remain rejected for their dependency on a rejected base claim.
Claim Rejections - 35 USC § 103
Claims 1, 3, 5-11, and 14-18 remain 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, https://www.sigmaaldrich.com/US/en/product/aldrich/448877?srsltid=AfmBOoqaJSvWXAtguzQX29zonW0BEWT9dSgjGKrMRYdEC4ZxtX41vFyG, Millipore Sigma, Catalog No. 448877, website FAQ, accessed: 20251120, hereinafter “Millipore”, https://sterilizers.com/autoclave-time-temperature-pressure-chart.html?srsltid=AfmBOoq6bJ_fOrMYR4U0u9svZyv8uDP8obTa6vW7yiez9aEhbzJo1NGG, ALFA Autoclave Temperature and Time Pressure Chart, accessed: 20260518, hereinafter “Alfa”, Kuo, et al., Materials Science and Engineering: C 78 (2017): 265-277, hereinafter “Kuo”, and Hyldgaard, et al. Applied and environmental microbiology 80.24 (2014): 7758-7770, hereinafter “Hyldgaard”. This rejection has been modified as necessitated by Applicant’s amendments to the claims.
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 claim 1 specifies that the curing process is a thermal process at a temperature between 30 to 180 degrees C for a period of 30min to 8 hours. The scaffold of Kim is heated at 110 degrees C for between 1-3 days (Kim, page 368, fifth paragraph). It is noted that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Heating in an oven for 1 day is so close to heating in an oven for 8 hours in the context of thermal curing of chitosan scaffolds that in the absence of any evidence of criticality of a thermal curing step with a duration of 30 minutes to 8 hours, this recitation is prima facie obvious in view of the 1 to 3-day thermal curing step taught in Kim. 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. 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”). The steam sterilization of Ji was performed at 121 degrees C for 30 minutes (Ji, page 3780, “2.2.” subheading). An autoclave operated at 121 degrees C necessarily has a pressure of 15 psi as evidenced by Alfa which teaches this inherent property of steam saturation at 121 degrees C (Alfa, whole document). 15 psi equals 1.03421 bar. 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 the similar but not overlapping ranges for the pressure of the lyophilization step claimed and the pressure of the lyophilization step of Kim, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Lyophilization at 1 to 0.4 mbar is so close to lyophilization at 0.266645 mbar in the context of lyophilization of chitosan scaffolds that in the absence of any evidence of criticality of a pressure of 1 to 0.4 mbar during lyophilization, this recitation is prima facie obvious in view of the 0.266645 mbar pressure taught in Kim.
Regarding claim 14, neither Kim, Ji, Elsabee, Millipore, nor Alfa teach to add an additive, an adhesion molecule, and a cross-linker agent after lyophilization.
Kuo teaches chitosan/γ-poly(glutamic acid) scaffolds surface modified with elastin, poly-L-lysine, and albumin (Kuo, Title). Kuo specifically teaches to add solutions of elastin, albumin, and poly-L-lysine to lyophilized chitosan scaffolds followed by a second lyophilization step (Kuo, page 267, “2.1.” and “2.2.” subheadings). Kuo also specifically teaches to add genipin simultaneously to facilitate cross-linking of the chitosan with the other components (Kuo, page 267, “2.1.” and “2.2.” subheadings). Kuo also teaches that the surface modified chitosan scaffolds effectively promote the growth of chondrocytes, and improve the regenerative ability of cartilaginous tissues (Kuo, Abstract).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have surface modified the chitosan scaffolds of Kim and Ji by adding solutions containing a cross-linker agent (genipin), an adhesion molecule (poly-L-lysine), and an additive (elastin) as taught by Kuo following lyophilization and to have arrived at the invention claimed in instant claim 14 with a reasonable expectation of success because they would have been motivated to do so to improve the regenerative ability of cartilaginous tissues cultured on the scaffolds. There would have been a reasonable expectation of success in combining the teachings of Kuo, Kim, and Ji insofar as Kim and Ji teach a method of making chitosan scaffolds generally while Kuo teaches that specific solutions added following lyophilization of chitosan scaffolds functionalize the scaffolds for a particular purpose by producing scaffolds which effectively promote the growth of chondrocytes, and improve the regenerative ability of cartilaginous tissues.
Regarding claim 15, the elastin of Kuo is dissolved in NaOH prior to being added (Kuo, page 267, “2.2.” subheading). NaOH is an acidity regulator.
Regarding claim 16, neither Kim, Ji, Elsabee, Millipore, Alfa, nor Kuo teach ε-poly-L-lysine.
However, Hyldgaard teaches that ε-poly-L-lysine is a natural antimicrobial peptide which is generally regarded as safe as a food preservative (Hyldgaard, Abstract). Hyldgaard teaches that ε-poly-L-lysine is a promising natural antimicrobial that has a broad spectrum of activity against food spoilage and food-poisoning bacteria in complex food matrices (Hyldgaard, page 7758, first paragraph). Thus, a person having ordinary skill in the art as far back as 2014 understood ε-poly-L-lysine to be an alternative to traditional poly-L-lysine and that ε-poly-L-lysine possesses antimicrobial properties which make it advantageous to use in place of poly-L-lysine.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have substituted ε-poly-L-lysine for the poly-L-lysine taught by Kuo in the scaffolds of Kim, Ji and Kuo and to have arrived at the invention claimed in instant claim 16 because Hyldgaard teaches ε-poly-L-lysine as a beneficial alternative to poly-L-lysine, a person having ordinary skill in the art could have made the substitution before the effective filing date of the claimed invention, and the results of substituting ε-poly-L-lysine for poly-L-lysine would have been predictable insofar as the ε-poly-L-lysine would be performing the same functions as the poly-L-lysine in the chitosan scaffolds of Kuo, Kim, and Ji.
Regarding claim 17, the genipin of Kuo crosslinks chitosan through a carboxyl group.
Regarding claim 18, Ji teaches to wash the scaffolds in PBS (rinsed extensively) following lyophilization (Ji, page 3780, “2.2.” subheading).
Response to Arguments
Applicant argues (1) the cited references do not disclose or suggest Applicant’s specific and functionally interdependent sequence (Remarks, page 8), (2) Kim does not disclose sterilization or thermal curing “in the sense of the present invention” (Remarks, page 8), (3) Ji relies on the steam sterilization to sterilize and induce cross linking and does not disclose thermal curing in a prior step so a person having ordinary skill in the art would have understood a separate curing step to be unnecessary (Remarks, page 9), (4) that the claimed sequence of steps provides a specific and non-obvious technical effect insofar as it results in a scaffold that withstands steam sterilization, retains macroporous structure, and “maintains functional properties for cell proliferation” which Kim and Ji do not teach (Remarks, page 10), (5) Ji is silent as to the effect of applying steam sterilization to a scaffold that has already been thermally cured so there would not have been a reasonable expectation of success (Remarks, page 11), and (6) conventional sterilization methods other than steam sterilization are impractical at industrial scale and neither Kim nor Ji addresses this problem (Remarks, page 12). Applicant’s arguments against the obviousness of the instant invention have been fully considered but have not been found persuasive for the following reasons.
(1) Applicant’s invention differs from the method of Kim only in that it utilizes a steam sterilization step after thermal curing as the final step of the method. Kim teaches a method of making chitosan scaffolds for tissue engineering applications. Ji teaches to steam sterilize chitosan scaffolds in an autoclave to avoid the use of toxic sterilants to produce scaffolds which are promising for soft tissue engineering applications. Thus, a person having ordinary skill in the art would have been motivated to steam sterilize the scaffolds of Kim to avoid the use of toxic sterilants while producing scaffolds for tissue engineering applications. The fact that Kim does not explicitly teach the final step of steam sterilization does not defeat the prima facie case of obviousness here because the rejection is based upon a combination of references where Ji provides both the teaching of steam sterilization and the motivation to use steam sterilization in an identical context (producing chitosan scaffolds for tissue engineering applications).
(2) It is unclear what Applicant means by “in the sense of the present invention”. Kim teaches to heat chitosan scaffolds in an oven at 110 degrees C under in vacuo. “thermal curing” as recited in the instant invention plainly encompasses heating chitosan scaffolds in an oven in vacuo. Applicant’s supporting disclosure even states that the scaffolds are “cured in ovens” (Specification, page 15, line 26).
(3) While Ji teaches that the temperature treatment during autoclaving in itself is sufficient to induce crosslinking, this does not undermine Ji’s teaching of autoclaving as an effective sterilization method nor Ji’s teaching of a motivation to use steam sterilization for chitosan scaffolds in soft tissue engineering applications. Ji teaches multiple benefits to autoclaving lyophilized chitosan scaffolds and one of these is to sterilize which a person having ordinary skill in the art would be motivated to do to the scaffolds of Kim to produce chitosan scaffolds which are promising for soft tissue engineering applications without toxic sterilants.
(4) In response to applicant’s argument that the claimed sequence of steps provides a specific and non-obvious technical effect insofar as it results in a scaffold that withstands steam sterilization, retains macroporous structure, and “maintains functional properties for cell proliferation” which Kim and Ji do not teach, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In particular, Ji teaches that one can autoclave a lyophilized chitosan scaffold without any thermal curing, so it is unclear how it is non-obvious that a thermally cured chitosan scaffold would withstand steam sterilization as a person having ordinary skill in the art would expect this from Ji. Further, thermal curing induces crosslinking to essentially lock the structure of the chitosan scaffold and Ji teaches that autoclaving provides enough thermal energy to do just that, so it is unclear how it is non-obvious that the macroporous structure of the chitosan scaffolds following thermal curing would be preserved through steam sterilization as a person having ordinary skill in the art would have also expected this from Ji. Lastly, Applicant is not specific with regard to how their method “maintains functional properties for cell proliferation” in any way which would not be inherent to the combination of Kim and Ji.
(5) In response to Applicant’s argument that there would not have been any reasonable expectation of success in adding a steam sterilization step as taught by Ji to the method of making chitosan scaffolds as taught by Kim, it is noted that obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). A person having ordinary skill in the art would have reasonably expected the chitosan scaffolds obtained through the combination of Kim and Ji to have obtained similar properties insofar as they would have reasonably expected to sterilize the scaffolds without the use of toxic sterilants and without affecting the macroporous structure of the scaffolds. It is worth noting that throughout Applicant’s arguments there is an underlying assumption that autoclaving a thermally cured chitosan scaffold would somehow undo the crosslinking or otherwise reorganize the scaffolds in a manner inconsistent with their intended function. Applicant does not support this notion with any evidentiary or argumentative support nor does Applicant attempt to directly address it. Ji teaches that autoclaving induces crosslinking to produce stable chitosan scaffolds, Kim teaches that thermal curing in an oven does the same. Why then would doing either of these after the other undo the work done by the former? In any event, the combination of Ji and Kim rests on the sterilization ends rather than the crosslinking ends to the autoclaving means, so it is immaterial that autoclaving is sufficient to induce crosslinking outside of this underlying assumption.
(6) Applicant’s final argument concedes the point argued previously that one would want to sterilize chitosan scaffolds and instead argues that neither Kim nor Ji addresses the lack of scalability of conventional methods that aren’t steam sterilization. The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In this case, Ji teaches why one would want to steam sterilize chitosan scaffolds for soft tissue engineering applications. It does not matter that Ji is silent as to the reasons why one would want to use steam sterilization over other forms of sterilization.
Accordingly, Applicant’s arguments have been fully considered but are not found to be persuasive.
Nonstatutory Double Patenting
Claims 1, 3, 5-12, and 14-22 remain 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 a biocompatible natural polymer,
b) pouring out the dissolution of step a) into molds and freezing at a temperature lower than the freezing temperature of the dissolution, thereby obtaining a freeze-scaffold;
c) lyophilizing the freeze-scaffold obtained in step b) for a period that ranges from 16h to 96h, at a pressure which ranges from 1 to 2.6 x 10-4 mbar, and at a temperature which ranges from 25 °C to -100 °C, thereby obtaining a lyophilized scaffold;
d) curing the lyophilized scaffold of step c) by a thermal curing process performed at a temperature which ranges from 30 °C to 180 °C for a period of time that ranges from 30 min to 8h, thereby obtaining a cured scaffold; and
e) sterilizing the cured scaffold by hot steam at a temperature which ranges from 121 °C to 134 °C; at a pressure which ranges from 0.5 to 1.05 bar and for a period of time from 10 to 60 minutes.
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.
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).
Thus, the claimed 3D scaffold of the instant invention comprising at least a biocompatible natural polymer including chitosan is necessarily 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 obvious variants of 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.
Response to Arguments
Applicant’s request to hold the nonstatutory double patenting rejection in abeyance is acknowledged. Until the claims are amended such that they do not read on the copending claims or vice versa, or until the filing of a terminal disclaimer in the instant application, the rejection will be maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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