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 .
The examiner acknowledges receipt of request for extension of time, amendment and remarks filed 05/05/2026.
Claims 1, 6, 14 and 19 are amended.
Claim 18 is canceled.
Claims 1-17 and 19-31 are pending.
Priority
This application claims benefit of 63/435375 filed 12/27/2022.
Response to Arguments
For the rejection under 35 USC 112, the amendment to claims 6, 14 and 15 overcomes the rejection.
For the rejection under 35 USC 102: a) Applicant argues that Yang does not teach the presently claimed structure wherein a “biphasic structure is provided that includes a porous section and citrate based polymer hydrogel section and wherein, when positioned in proximity to an osteochondral defect, the porous section of the biphasic hydrogel section of the biphasic structure supports cartilage regeneration.” An example of applicant’s claimed biphasic structure is provided in Fig. 9. That paragraph [0044] describes Fig.9 as an exemplary embodiment showing scaffold 90 may be biphasic containing a porous section 90 for subchondral bone regeneration and a citrate-based hydrogel 93 for cartilage regeneration. In addition, the citrate-based hydrogel 93 may be blended, e.g. with hyaluronic acid 95. b) Applicant argues that the biphasic structure offers significant clinical benefits in that it is ideally suited to support both subchondral bone regeneration and cartilage regeneration. c) Applicant argues that Yang’s hydrogel teaching would not motivate a skilled practitioner to arrive at applicant’s claimed structure; that Yang fails to appreciate the potential for combining a porous section and a hydrogel section in a single construct to realize the benefit of the two distinct morphologies and that the totality of Yang’s teaching of hydrogel is found in paragraph [0078] as follows:
“In addition, a polymer network described herein can be a hydrogel. A hydrogel, in some cases, comprises an aqueous phase and a polymeric disperse or discontinuous phase. Further, in some embodiments, a cross-linked polymer network described herein is not water soluble.”
Applicant thus submits that, for the reasons presented above, independent claim 1 as amended, patentably distinguishes the teachings of Yang and that claims 2-5, 7-12, 13-18 and 22-31 dependent from claim 1 are also not anticipated or rendered obvious by Yang.
Response: The examiner respectfully disagrees that Yang does not teach independent claim 1 as amended and as such dependent claims 2-5, 7-12, 13-18 and 22-31 are also taught by Yang in view of the following: a) Yang teaches biphasic porous scaffold (paragraphs [0008], [0017], [0091], [0163], [0165]); in paragraph [0091], Yang teaches that the scaffold has two component structure, a porous section and a polymer network section and that the porosity of the polymeric component is measured by determining the bulk volume of the porous sample and subtracting the volume of the polymer network material. Paragraph [0085] teaches that the polymer network is comprised of citrate. The recitation that when the construct is positioned in a proximity to osteochondral defect, the porous section of the biphasic structure supports subchondral bone regeneration and the citrate-based polymer hydrogel section of the biphasic structure supports cartilage regeneration is what would happen when the constrict is positioned in proximity to an osteochondral defect and the recitation does not limit the construct or scaffold. Regarding paragraph [0078] of Yang and hydrogel, a singular teaching is a teaching and paragraph [0078] does not say that the polymer network cannot be a hydrogel. b) Yang teaches biphasic structure and as such would also offer significant clinical benefits in that it would also be ideally suited to support both subchondral bone regeneration and cartilage regeneration. Supporting subchondral bone regeneration and cartilage regeneration are effects of the construct/scaffold and does not structurally limit the construct. c) Yang’s hydrogel teaching is a teaching and motivation is not required to arrive at a teaching that is present in the art because modification is not required.
For the rejection under 35 USC 103: Claims 20 and 21, applicant argues that Hubbell fails to cure the deficiency of Yang discussed above.
Response: Hubbell was relied upon for teaching medical device (paragraphs [0161], [0173]) in the form of a scaffold (paragraphs [0068]-[0069], [0174], [0179]) for bone regeneration (paragraphs [0411]-[0412]) comprising heparin-binding peptide moiety (paragraphs [0035], [0057], [0063], [0077]) and growth factor binding domains to enhance biomimetic nature of the biomaterials (paragraphs [0167]-[0168], [0020], [0053], [0061], [0095]).
For claims 12,19 and 6, applicant argues that claims 12, 19 and 6 are patentable over the cited art because Yang does not teach claim 1.
Response: The examiner has responded above to affirm that Yang teaches claim 1. Therefore, for the reasons presented above, claims 12, 19 and 6 are not patentable over Yang in combination with Panitch and Zhai.
For the rejections under provisional non-statutory double patenting rejection, applicant argues that amended claim 1 distinguishes over the co-pending claims.
Response: Amended claim 1 is not distinguishable over the co-pending claims because, a) for 18736005, the biodegradable porous scaffold in a gradient structure comprising citrate component, polyol and anionic moiety and particulate inorganic material in the shape of a rod and protein mimicking peptide and growth factors teaches the claimed construct; b) for 8538772 teaches a biodegradable porous, conformable scaffold in a gradient structure comprising citrate component, polyol and particulate inorganic material in the shape of a rod and peptide conjugated to the scaffold and which swells by 500-1500% and which degrades within 6-12 months teaches the claimed construct; and c) for 18891944 biodegradable porous scaffold in a gradient structure comprising citrate component, polyol and charged moiety which is anionic moiety and particulate inorganic material in the shape of a rod and protein binding peptide conjugated to the surface of the composition and protein mimicking peptide and growth factors teaches the claimed construct.
The rejections are maintained below with a modification to address the amendment to claim 1 in which the limitation of canceled claim 18 has been moved into claim 1. The amendment to claims 6, 14 and 19 does not change the scope of these claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-12, 13-17 and 22-31 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Yang et al., (US 20160199541 A1) for reasons or record and with modification to address the amendment to claim 1.
Yang discloses a composition comprising reaction product of citric acid, citrate, or ester of citric acid with a polyol and a monomer comprising one or more alkyne moieties and/or acid moieties; the reaction product in some embodiments is a polymer; in other aspect, the composition/product is in the form of medical implants/devices and/or scaffold/biphasic scaffold (see the whole document with emphasis the abstract; paragraphs [0007]-[0009], [0016]-[0017]). The composition further comprises particulate inorganic material and the particulate material comprises hydroxyapatite, tricalcium phosphate, biphasic calcium phosphate, bioglass, ceramic, magnesium powder (paragraphs [0013], [0017], [0081], [0095]). The polyol includes butanediol, hexane diol and decanediol; the polyol is also polyethylene glycol or propylene glycol (paragraph [0046]). In some embodiment the polyol is glycerol and the polymer of the composition comprised polyglycerol sebacate (paragraph [0077]). The recitation that when the construct is positioned in a proximity to osteochondral defect, the porous section of the biphasic structure supports subchondral bone regeneration and the citrate-based polymer hydrogel section of the biphasic structure supports cartilage regeneration is what would happen when the constrict is positioned in proximity to an osteochondral defect and the recitation does not limit the construct or scaffold. Yang teaches that its composition is a biphasic scaffold and provides bone regeneration (paragraphs [0008], [0091], [0097], [0098], [0160]). Yang teaches that the scaffold has two component structure, a porous section and a polymer network section and that the porosity of the polymeric component is measured by determining the bulk volume of the porous sample and subtracting the volume of the polymer network material. Paragraph [0085] teaches that the polymer network is comprised of citrate. Yang describes the polymer network as a hydrogel (paragraph [0078]).
A construct given it broadest interpretation is a construct. Composition and scaffold and medical implant are all constructs or meets the limitation of the construct of claim 1.
Thus for claims 1, 2, 3, 4 and 5, the composition of Yang, comprising citric acid, citrate, or ester of citric acid, butanediol, hexane diol or decanediol meeting the limitation of diol, glycerol and/or polyglycerol sebacate meeting the limitation of polyol, and hydroxyapatite, tricalcium phosphate, biphasic calcium phosphate, bioglass, or ceramic particulate inorganic material meeting the limitation of particulate inorganic material, teaches all the elements of claims 1-3 and 5.
For claim 7, the polymer formed from citrate and diol/polyol such as citrate based biodegradable poly(1,8-oactane diol citrate) and others (see paragraphs [0100]-0104]) meets the claims.
For claim 8, the scaffold construct meets the claim.
For claims 9 and 22, a single phase scaffold has a uniform porosity of 70% (paragraph [0149]); for a biphasic scaffold, the internal phase has a porosity of 70% and external phase has a porosity of 50% (paragraph [0152]) and a first porosity of between about 65% and about 75% is disclosed (paragraph [0091]) all of which are species points of the claimed range in claim 9 and the various porosity range, external and internal reads on gradient porous structure of claim 22.
For claims 10 and 11, the biodegradable porous scaffold comprising polymer network (paragraphs [0079], [0100], [0120], [0017], [0091], [0097], [0116], [0117], [0147]) meets claims 10 and 11.
For claim 13, “freeze-dried to produce a porous construct” is the process of making the construct. However, Yang’s scaffold is porous (see at least paragraph [0091]) and Yang also teaches that the product is freeze dried (paragraph [0135], [0142]-[0143]).
For claim 14, the particulate material, which is hydroxyapatite or bioceramic is present at between about 30% and about 50% (paragraph [0083]) and the about 30% to about 50% anticipated the claimed range.
For claim 15, Yang’s construct is formed into nanofibers (paragraph [0090])
For claim 16, the surface of the polymer network is functionalized with one or more peptide (paragraphs [0007], [0015], [0071]) and the scaffold is comprised of polymer network.
For claim 17, the citrate based scaffold is modified by cell binding peptide, growth factors (paragraphs [0007]), growth factor which is a bioactive species functionalizes the polymer (paragraph [0071]) and functionalization is absorption.
For claims 23-25, the recitation that the scaffold conformable, can be cut in the operating room and can swell in liquids 500-1500% is the characteristic of the scaffold of claim 8. Yang teaches that scaffold of claim 8. Therefore, the scaffold of Yang would inherently have the claimed characteristic in claims 23-25.
For claim 26, Yang teaches its scaffold to degrade in 34 weeks (paragraph [0110]) which is 6 plus months meeting claim 26.
For claims 27 and 28, 30 and 31, Yang teaches medical implants/devices and/or scaffold/biphasic scaffold (abstract, paragraphs [0016], [0090]) with the implant comprising core-shell polymeric scaffold (paragraph [0017]) which is biphasic (paragraph [0091]-[0093]) having porous core (paragraph [0017]).
For claim 29, the particulate material, which is hydroxyapatite or bioceramic is present in Yang’s construct at between about 65 wt% (paragraph [0083])
Yang teaches all the elements of claims 1-5, 7-11, 13-17 and 22-31.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 20 and 21 remain rejected under 35 U.S.C. 103 as being unpatentable over Yang et al., (US 20160199541 A1) in view of Hubbell et al. (US 20030220245 A1).
Claims 20 and 21 depend from claim 8. Claims 8 and 18 have been described above to be anticipated by Yang.
For claims 20 and 21, Yang does not teach heparin binding peptide or growth factor mimicking peptide. However, Hubbell teaches medical device (paragraphs [0161], [0173]) in the form of a scaffold (paragraphs [0068]-[0069], [0174], [0179]) for bone regeneration (paragraphs [0411]-[0412]) comprising heparin-binding peptide moiety (paragraphs [0035], [0057], [0063], [0077]) and growth factor binding domains to enhance biomimetic nature of the biomaterials (paragraphs [0167]-[0168], [0020], [0053], [0061], [0095]).
Both Yang and Hubbell are concerned with bone regeneration. Therefore, before the effective date of the invention, the ordinary skilled artisan would include growth factors having growth factor binding domains and heparin binding peptides to the composition of Yang with the expectation of predictably enhancing biomimetics of the biomaterials.
Thus Yang in view of Hubel renders claims 20 and 21 prima facie obvious.
Claim(s) 12 and 19 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al., (US 20160199541 A1) in view of Panitch et al., (US 20030190364 A1) and further in view of Zhai et al., “The application of hyaluronic acid in bone regeneration” in International Journal of Biological Macromolecules, Vol 151, 2020, 1224-1239.
Claim 12 depends on claim 8; claim 19 depends on claim 18 which depends on claim 8. Claims 8 and 18 have been described above to be anticipated by Yang.
For claims 12 and 19, Yang does not teach hyaluronic acid. However, Panitch teaches bone regeneration composition (paragraph [0090]) that comprises hyaluronic acid (paragraphs [0022], [0035], [0054], claims 5 and 15). Zhai teaches that hyaluronic acid promotes bone regeneration (see the whole document with emphasis on the abstract).
Both Yang and Panitch are concerned with bone regeneration. Therefore, before the effective date of the invention, the ordinary skilled artisan would include hyaluronic acid to the composition of Yang with the expectation of predictably promoting bone regeneration (see the abstract of Zhai).
For claim 6, the scaffolds comprising the bioceramics or particulate inorganic materials in Yang are cylindrical (paragraph [0147]). Therefore, it would be reasonable to expect that the inorganic particulate materials of Yang are cylindrical and rods are cylindrical.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 1-17 and 19-31 remain provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim 1-7 and 14-29; 1-9 and 13-24 ; and 1-5 and 8-24 of co-pending Application Nos. 18736005; 18538772; and 18891944 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a) the composition of 18736005 as a biodegradable porous scaffold in a gradient structure comprising citrate component, polyol and anionic moiety and particulate inorganic material in the shape of a rod and protein mimicking peptide and growth factors teaches the claimed construct; b) 8538772 teaches a biodegradable porous, conformable scaffold in a gradient structure comprising citrate component, polyol and particulate inorganic material in the shape of a rod and peptide conjugated to the scaffold and which swells by 500-1500% and which degrades within 6-12 months teaches the claimed construct; and c) 18891944 biodegradable porous scaffold in a gradient structure comprising citrate component, polyol and charged moiety which is anionic moiety and particulate inorganic material in the shape of a rod and protein binding peptide conjugated to the surface of the composition and protein mimicking peptide and growth factors teaches the claimed construct. The recitation that when the construct is positioned in a proximity to osteochondral defect, the porous section of the biphasic structure supports subchondral bone regeneration and the citrate-based polymer hydrogel section of the biphasic structure supports cartilage regeneration is what would happen when the constrict is positioned in proximity to an osteochondral defect and the recitation does not limit the construct or scaffold.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
THIS ACTION IS MADE FINAL. 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. The modification of the rejections is necessitated by the amendment to claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
Prosecution Insights