DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 10/13/2025.
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 .
Status of the Claims
Claims 51 and 55 have been amended. Claims 1-50 and 57 are cancelled. No claims are newly added. Accordingly, claims 51-56 and 58-60 remain pending in the application and are currently under examination.
Withdrawn Objections
Applicant’s amendment renders the objection of claim 55 moot. Specifically, “an implant” has been removed from the claim. Thus, said objection has been withdrawn.
Maintained Rejections
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 51-56 and 58-60 stand rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al. (WO 2016/011387 A1, pub. Jan. 21, 2016, eff. filing date Jul. 17, 2015, hereafter as “Griffin ‘387”) in view of Kim et al. (US 2007/0005140 A1, Jan. 4, 2007, hereafter as “Kim”). It is noted that the Griffin ‘387 reference qualifies as prior art under 102(a)(1) and 102(a)(2).
The instant claims are drawn to a method of treating an orthopedic disorder in a subject, the method comprising: (a) delivering a hydrogel composition to the subject, the hydrogel composition comprising: (i) a plurality of microgel particles, wherein at least one microgel particle of the plurality of microgel particles comprises: (1) a first annealing component comprising a vinyl group, a free cysteine, a thiol, an amine, triethanolamine, a transglutaminase substrate, a substrate of enzyme Factor XIII, a collagen peptide, a K peptide, or a Q peptide; and (2) a backbone polymer; and (ii) a plurality of interconnected pores; (b) treating the orthopedic disorder in the subject; and (c) coupling the first annealing component to a second annealing component to form a stabilized scaffold having interstitial spaces therebetween, wherein the stabilized scaffold has a compressive modulus of about 1,500 Pa to about 200,00 Pa.
Regarding instant claim 51, Griffin ‘387 teaches a microporous gel system for biomedical applications comprising an aqueous solution containing a plurality of microgel particles formed by a reaction of a backbone polymer having one or more cell attachment moieties, one or more annealing components, and a biodegradable network crosslinker component; and methods of treating tissue comprising delivering said gel system to said tissue (Abstract; [0016]-[0017]). Griffin ‘387 teaches that annealing agents allow the microgel particles to anneal to one another and produces an interconnected network of pores/interstitial spaces (abstract; [0025], [0078] and [0088]; Fig. 1). Griffin ‘387 teaches said gels are injectable directly into tissue ([0011]). Griffin ‘387 teaches the particular backbone polymers, poly(ethylene glycol) vinyl sulfone, polyethylene glycol, polyacrylamide, polymethacrylate, polyester, polyamide, polyurethan and heparin ([0021] and [0092]). Griffin ‘387 also teaches that Michael and pseudo-Michael addition reactions, including α,β-unsaturated carbonyl groups (e.g., acrylates, vinyl sulfones, maleimides, and the like) )(i.e., first annealing component) to a nucleophilic group (e.g., thiol, amine, aminoxy) (i.e., second annealing component) may be used to anneal microgel particles which forms a scaffold having interstitial spaces therebetween ([0095]; Fig. 1). Griffin ‘387 further teaches the particular annealing components, K peptide and Q peptide, collagen or a fragment thereof, a substrate of enzyme Factor XIII, a free cysteine, triethanolamine, a transglutaminase substrate ([0021], [0094], [00100], [00122], [00124], [00130], [00144] and [00118]).
Griffin ‘387 is silent to “the stabilized scaffold has a compressive modulus of about 1,500 Pa to about 200,00 Pa”.
However, MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
MPEP 2112.01(II) also states that if the composition is physically the same, it must have the same properties. Griffin ‘387 teaches the same scaffold comprising annealed hydrogel particles as claimed. Accordingly, where the claimed and prior art products are identical or substantially identical in structure or composition, it is reasonable to conclude that the prior art product possesses the same characteristics or properties as that of the claimed product including a compressive modulus of about 1,500 Pa to about 200,000 Pa.
Griffin ‘387 is silent to “treating an orthopedic disorder” (instant claim 51), “wherein the orthopedic disorder comprises musculoskeletal trauma, arthritis, a fracture, an infection, osteoporosis, or a ligament injury” (instant claim 52), “further comprising delivering an implantable orthopedic device to a tissue of the subject” (instant claim 54), “wherein the implantable orthopedic device comprises an implant, a biomaterial, a mesh, a fabric, a prosthetic device, an artificial knee, an artificial hip, an artificial meniscus, an artificial elbow, a spinal implant, a screw, a rod, an artificial disc, or a portion thereof (instant claim 55), and “wherein delivering in (a) comprises delivering the hydrogel composition at a location of the subject selected from the group consisting of a skull, a spine, a nasal sinus, a neck, a chest, a shoulder, a hip, a pelvis, a leg, an arm, a knee, an elbow, a hand, and a foot” (instant claim 56).
Kim teaches the fabrication and use of biocompatible polymers (e.g., microgel particles) that are injected percutaneously into the inner portion of a defective region of a spinal disc (musculoskeletal trauma) and swell or expand or subsequently cure in situ to form a disc nucleus prosthesis (abstract; [0017]). Kim teaches osteoarthritis is a common cause of disc degeneration ([0008]). Kim also teaches that the microgel particles can be affixed (annealed) to one another ([0054]). Kim teaches that an implantable balloon device (i.e., a spinal implant) can be used in conjunction with the microgel particles within a spinal disc void ([0061]; Figs. 5A-5E). Kim also teaches closure devices (i.e., a spinal implant or portion thereof) or biocompatible glue (i.e., a biomaterial) to seal the opening within the disc annulus ([0064]; Figs. 8A-D).
Griffin ‘387 and Kim are drawn to a composition comprising affixed or annealed microgel particles for the purpose of biomedical applications, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to administer the microgel composition of Griffin ‘387 to treat an orthopedic disorder such as musculoskeletal trauma or arthritis of the spine in combination with a biomaterial or a spinal implant (or portion thereof) as suggested by Kim with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Kim teaches that such a combination is an effective minimally invasive treatment of the spinal disc that allows for disc cell regeneration and tissue ingrowth ([0010]-[0011]).
Regarding instant claim 53, Griffin ‘387, as discussed above, teaches said gels are injectable directly into tissue ([0011]).
Regarding instant claim 58, Griffin ‘387, as discussed above, teaches a void volume of about 10% to about 50% ([0013]). MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Because the claimed range of about 5% to about 70% overlaps with the range of about 10% to about 50% disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claims 59 and 60, Griffin ‘387, as discussed above, teaches the particular backbone polymers, poly(ethylene glycol) vinyl sulfone, polyethylene glycol, polyacrylamide, polymethacrylate, polyester, polyamide, polyurethan and heparin ([0021] and [0092]).
Thus, the combined teachings of Griffin ‘387 and Kim render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 10/13/2025, regarding the 103 rejection over Griffin ‘387 and Kim have been fully considered but they are not persuasive.
Applicant argues that the cited references do not disclose, at least, “coupling the first annealing component to a second annealing component to form a stabilized scaffold having interstitial spaces therebetween wherein the stabilized scaffold has a compressive modulus of about 1,500 Pascal (Pa) to about 200,000 Pascal (Pa)” as recited in claim 51. Applicant asserts that the cited references do not teach or disclose forming a stabilized scaffold having interstitial spaces therebetween, much less the stabilized scaffold having the recite compressive modulus. Remarks, pages 4-5.
In response, it is respectfully submitted that Griffin ‘387 teaches annealing agents allow the microgel particles to anneal to one another and yields an interconnected network of pores/interstitial spaces (abstract; [0025], [0078] and [0088]; Fig. 1). Griffin ‘387 also teaches that Michael and pseudo-Michael addition reactions, including α,β-unsaturated carbonyl groups (e.g., acrylates, vinyl sulfones, maleimides, and the like)(i.e., first annealing component) to a nucleophilic group (e.g., thiol, amine, aminoxy) (i.e., second annealing component) may be used to anneal microgel particles thereby forming a scaffold having interstitial spaces therebetween ([0095]; Fig. 1). While Griffin ‘387 is silent to “the stabilized scaffold has a compressive modulus of about 1,500 Pa to about 200,00 Pa”, MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
MPEP 2112.01(II) also states that if the composition is physically the same, it must have the same properties. Griffin ‘387 teaches the same scaffold comprising annealed hydrogel particles as claimed. Accordingly, where the claimed and prior art products are identical or substantially identical in structure or composition, it is reasonable to conclude that the prior art product possesses the same characteristics or properties as that of the claimed product including a compressive modulus of about 1,500 Pa to about 200,000 Pa. A prima facie case has been established. Applicant’s argument is unpersuasive.
Applicant also asserts that Griffin ‘387 discusses a storage modulus of about 10-1000 Pa. Applicant asserts that a person of ordinary skill in the art would have understood that in microgel systems, the storage modulus and the compressive modulus probe different deformation modes and are not interchangeable. Applicant asserts that there is no universal correlation between storage and compressive moduli in microgel systems. Applicant further asserts that a person of skill in the art would not have been able to derive the compressive modulus from the storage modulus. Applicant also states that Kim provides no guidance as to selecting a particular compressive modulus for use in a microgel system for treating an orthopedic disorder. Remarks, pages 5-7.
In response, it is respectfully submitted that while Griffin ‘387 does not expressly recite the claimed compressive modulus range, Griffin ‘387, as discussed above, teaches the same scaffold comprising annealed hydrogel particles as claimed. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
MPEP 2112.01(II) also states that if the composition is physically the same, it must have the same properties. Because the claimed and prior art products are identical or substantially identical in structure or composition, it is reasonable to conclude that the prior art product possesses the same characteristics or properties as that of the claimed product including a compressive modulus of about 1,500 Pa to about 200,000 Pa. It is the burden of Applicant to provide evidence that the prior art product does not possess the characteristics of the claimed product. Applicant has not provided any such evidence and, as such, Applicant’s argument is unpersuasive.
Applicant also asserts that the claimed compressive modulus range provides an unexpected technical effect in view of the art. That is, the claimed compressive modulus in a range of stiffnesses that could physically support a hard medical device within a surgical pocket, while still enabling a seamless interface between the “stabilized scaffold” and the surrounding tissue of the “surgical void” of the subject.
In response, it is respectfully submitted that insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) and (e) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims (MPEP 716.02(d)). Arguments presented by the applicant cannot take the place of evidence in the record (MPEP 716.01(c)). As such, the assertion that the claimed compressive modulus range provides an unexpected technical effect constitutes merely as argument and not factually supported by objective evidence which is required to effectively establish unexpected results.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained.
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 51-56 and 58-60 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 are of U.S. Patent No. 10,576,185 in view of Kim et al. (US 2007/0005140 A1, Jan. 4, 2007, hereafter as “Kim”).
The instant invention is described above.
The patent is drawn to a method of delivering a hydrogel system to an in vivo site of an implanted medical device in a subject, the method comprising: (a) implanting a medical device in an in vivo site of a subject; (b) delivering a hydrogel into the in vivo site of the implanted medical device by injection, the hydrogel comprising: (1) a network of microgel particles, each microgel particle having a median diameter of about 10 micrometers to about 500 and comprising: (i) annealing components, wherein an annealing component is configured to bond to an adjacent annealing component; and (ii) a backbone polymer; and (2) a plurality of interconnected pores, the plurality of interconnected pores having a median size of at least 10 microns; (c) delivering an annealing agent to the in vivo site of the implanted medical device; and (d) exposing the hydrogel and the annealing agent to light causing the annealing components to bond to adjacent annealing components to stabilize the network of microgel particles comprising the plurality of interconnected pores, the stabilized hydrogel comprising: (1) an inner surface molded to a shape of the implanted medical device; (2) an outer surface molded to a shape of the in vivo site of the implanted medical device in the subject; and (3) a compressive modulus of between 1,500 and 200,000 Pascal (Pa). The patent additionally recites that the annealing component is a functional group selected from a vinyl sulfone, thiol, amine, imidazole, aldehyde, ketone, hydroxyl, azide, alkyne, vinyl, alkene, maleimide, carboxyl, N-hydroxysuccinimide (NHS) ester, isocyanate, isothiocyanate, hydroxylamine, thione, catechol, sialic acid, boronic acid, molecular cage, adamantane, biotin, and streptavidin; the backbone polymer comprises poly(ethylene glycol); and the annealing component is coupled/covalently bonded to an adjacent annealing component.
The patent does not explicitly teaches that the method is for the purpose of treating an orthopedic disorder (instant claim 51), “wherein the orthopedic disorder comprises musculoskeletal trauma, arthritis, a fracture, an infection, osteoporosis, or a ligament injury” (instant claim 52), “further comprising delivering an implantable orthopedic device to a tissue of the subject” (instant claim 54), “wherein the implantable orthopedic device comprises an implant, a biomaterial, a mesh, a fabric, a prosthetic device, an artificial knee, an artificial hip, an artificial meniscus, an artificial elbow, a spinal implant, a screw, a rod, an artificial disc, or a portion thereof (instant claim 55), and “wherein delivering in (a) comprises delivering the hydrogel composition at a location of the subject selected from the group consisting of a skull, a spine, a nasal sinus, a neck, a chest, a shoulder, a hip, a pelvis, a leg, an arm, a knee, an elbow, a hand, and a foot” (instant claim 56).
Kim teaches the fabrication and use of biocompatible polymers (e.g., microgel particles) that are injected percutaneously into the inner portion of a defective region of a spinal disc (musculoskeletal trauma) and swell or expand or subsequently cure in situ to form a disc nucleus prosthesis (abstract; [0017]). Kim teaches osteoarthritis is a common cause of disc degeneration ([0008]). Kim also teaches that the microgel particles can be affixed (annealed) to one another ([0054]). Kim teaches that an implantable balloon device (i.e., a spinal implant) can be used in conjunction with the microgel particles within a spinal disc void ([0061]; Figs. 5A-5E). Kim also teaches closure devices (i.e., a spinal implant or portion thereof) or biocompatible glue (i.e., a biomaterial) to seal the opening within the disc annulus ([0064]; Figs. 8A-D).
The patent and Kim are drawn to a composition comprising affixed or annealed microgel particles for the purpose of biomedical applications, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to administer the patented microgel composition to treat an orthopedic disorder such as musculoskeletal trauma or arthritis of the spine in combination with a biomaterial or a spinal implant (or portion thereof) as suggested by Kim with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Kim teaches that such a combination is an effective minimally invasive treatment of the spinal disc that allows for disc cell regeneration and tissue ingrowth ([0010]-[0011]).
Thus, the instant claims are unpatentable over the patented claims in view of the teachings of Kim.
Response to Arguments
Applicant's arguments, filed 10/13/2025, regarding the double patenting rejection have been fully considered but they are not persuasive.
Applicant states that claim 51 has been amended and requests the rejection be held in abeyance. Remarks, pages 7-8.
In response, it is respectfully submitted that the rejection has been reconsidered in light of the claim amendments. As explained in the rejection, the patent recites the newly added limitations. Accordingly, the rejection is still applicable to the currently amended claims. Applicant’s request to hold the rejection in abeyance is acknowledged.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained.
Conclusion
All claims have been rejected; no claims are 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617