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 . Applicant should note that the examiner assigned to this case has changed.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 9/25/2025 and the supplemental reply 10/03/2025 have been entered.
Response to Amendments
Applicant's amendments filed 9/25/2025 and 10/03/2025 to claims 57, 59, 68, and 69 have been entered, and the supplemental amendments dated 10/03/2025 supersedes the amendments dated 9/25/2025. Claims 1-56, 60, 62, 65-67, and 74 are canceled. Claims 75-79 have been added. Claims 57-59, 61, 63, 64, 68-70, 72, 73, and 75-79 remain pending, and are being considered on their merits. No claims are withdrawn from consideration at this time. References not included with this Office action can be found in a prior action.
The instant amendments to claim 57 have overcome the 35 U.S.C. § 103 rejections of record and affirmed on appeal over Chen in view of Donndelinger, O’Leary, and Howe. That rejection is withdrawn, and new grounds of rejection are set forth necessitated by the instant claim amendments.
Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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 57-59, 61, 63, 64, 68-70, 72, 73, and 75-79 are rejected under 35 U.S.C. § 103 as unpatentable over Chen et al. (US 2009/0024223; cited in the IDS dated 2/19/2020) in view of Donndelinger (US 2010/0144002; cited in the IDS dated 12/23/2020), Howe et al. (US 7,866,878; of record), and de Sousa et al. (Cell Tissue Bank (published online Dec. 6th, 2014), 16:425-431; Reference U).
Chen teaches methods for producing cartilage tissue grafts where the grafts once prepared from human or animal cartilage (i.e., a tissue matrix) into various shaped and sized tissue matrix grafts, the grafts are then cleaned (Abstract, claims 141-144), reading in-part on claims 57(a), 58, and 72, and 78(a). Chen teaches that the shaped cartilage grafts can be further cleaned and disinfected, where the grafts can be placed into a processing chamber that can incorporate multiple osteochondral plugs, cartilage discs, or slices (paragraph 77; loading a processing vessel with cartilage), reading in-part on claim 57(a), and 72, and 78(a). Chen teaches that cleaning solution may be added from the top of the processing chamber, where under centrifugal force the cleaning solutions can be induced to migrate through the tissues (i.e., facilitate penetration of the fluid into the cartilage graft) and into the bottom of the processing chamber and sonicated for about 5 minutes to about 24 hours and at a frequency of from 1 Hz to about 200 Hz, before the centrifugation process using an ultrasonic cleaner (paragraph 77), reading in-part on time and frequency ranges claims 57(b), 59, 72, 75, and 77, and 78(b). Chen teaches utilizing ultrasonic or infrasonic frequencies having any frequency and amplitude that accelerates or improves a least a portion of tissue processing but does not induce local resonant heating (paragraph 0037), reading in-part on claims 57(b). Chen teaches that the graft can be recellularized in vitro with viable cells (e.g., autologous or allograft chondrocytes isolated from articular cartilage, fibrocartilage, or elastic cartilage) to render the tissue vital before implantation (paragraphs 10 and 62; claim 143), reading on the native and viable cells of claims 57(a). Chen also teaches that the cartilage grafts can be stored in 15-77% glycerol and that suitable storage solutions are well known to those of ordinary skill in the art, where such solutions may be readily selected and employed without undue experimentation (paragraph 88), reading on the embodiment of glycerol for the 5-30% v/v cryoprotectant of claims 57(a) and 63. Chen teaches cryopreserving the processed cartilage grafts at -80 °C (paragraph 0164), reading on the -80 °C storage of claim 57 and step (c) and claim 78 and step (d).
Chen teaches adding a bonding agent to the cartilage grafts such as collagen, gelatin, and/or Matrigel® (paragraph 118), reading on those embodiments of a tissue matrix for claim 58.
Chen teaches that after centrifugation or vacuuming, the waste may be discarded and the osteochondral plugs may be removed from their respective processing chambers and the surface aspects of the plugs may be flushed using pulsatile lavage with isotonic saline to remove residual wash solution from the grafts (paragraph 77). In view of the above, the teachings are interpreted where the processing solution and tissue are evaluated to assess at least one characteristic – the penetrative cleaning quality of the graft via material in the waste, the wash solution and inspection of the graft and reading in-part on claims 59 and 61. Chen teaches a processing (e.g. pre-treatment) solution comprising phosphate buffer saline, RPMI media, balanced Hank’s solution, lactated Ringer’s solution, and/or DMEM/F12 (paragraph 0079), reading on those embodiments of a buffer solution for claim 64. Chen teaches maintaining the tissue processing chamber at a temperature of 4-45 °C and preferably 15-37 °C (paragraph 0080 or 0081), reading on claims 73 and 79. Chen teaches adding osteochondral plugs to a composition comprising inactivated FBS (i.e. fetal bovine serum) or human serum (), reading in-part on claim 78(c)
Regarding claims 57(b), 72, and78(b), Chen does not teach that the sonication is resonant acoustic energy applied to a vessel, that resonant acoustic energy will exert up to 100 times (or up to 60 times) the energy of G-force on the processing vessel. Regarding claim 57, 72, and 78, Chen does not teach wherein the cryopreserved tissue retains at least 70% cell viability following thawing after storage at -80 0C for at least 3 months, and wherein the cell viability is a number of viable cells in the thawed cryopreserved tissue as a percentage of the number of viable cells in the tissue before step (a). Regarding claims 68 and 69, Chen does not teach the claimed cell viability ranges. Regarding claim 70, Chen does not teach freezing the processed tissue at a controlled freezing rate to a temperature of -80 °C. Regarding claim 76, Chen does not teach DMSO.
Regarding claims 57(b), 59, 72, 75, 77, and 78(b), Donndelinger teaches systems and methods for accelerating tissue processing (paragraph 11). Donndelinger teaches that systems and methods include treating tissue samples with infrasonic (low frequency sound) vibrations at one or more stages of tissue processing with a tissue processing agent such as impregnation agents and/or other chemicals that can be used to extend the storage time of the sample (paragraph 11). Donndelinger teaches that the infrasonic vibrations can have any frequency that accelerates one or more stages of tissue processing (paragraph 14), such as from about 5 to about 1,000 Hz; about 10 to about 600 Hz, about 20 to about 100 Hz, about 40 to about 80 Hz, or about 50 to about 70 Hz (paragraphs 14 and 32). Donndelinger teaches that the desired frequency of the infrasonic vibrations may be varied from one processing agent to another (e.g., according to fluid viscosity, density, etc.), from one tissue sample to another (e.g., according to tissue size, weight, density, etc.), from one vibrating mechanism to another (e.g., according to the amplitude of the vibrations produced by the mechanism; paragraphs 14 and 32). Donndelinger teaches that infrasonic vibrations can be used in virtually any tissue processing technique (paragraph 28). Donndelinger teaches that the infrasonic vibrations may be applied to the tissue sample while the sample is in contact with any suitable chemical that diffuses through a tissue sample membrane to preserve the sample (e.g., dimethyl sulfoxide/DMSO and water, buffers, etc.; paragraph 30), reading on the DMSO of claim 76 and 78. Donndelinger teaches that the infrasonic vibrations may be applied to the tissue sample for any portion of tissue processing that allows the vibrations to accelerate or otherwise improve tissue processing (e.g., the infrasonic vibrations may be applied to the sample during a single stage, during multiple stages, or during all stages of a tissue processing technique; paragraph 31). Donndelinger teaches that the infrasonic vibrations are applied to the tissue sample and tissue processing agent (e.g., DMSO, etc.) for substantially constant period of between about thirty seconds and about 1 or more days, 15 minutes and about 3 hours, and from about 30 minutes to about 1 hour (paragraphs 30 and 41), reading on claims 57, 76, and 78.
Regarding claims 57(b), 59, 72, 75, 77, and 78(b), Howe teaches methods for resonant-vibratory mixing (Title; column 1, lines 25-27). Howe teaches that mixing processes are called upon to effect the uniform distribution of such materials as chemical ingredients of pharmaceuticals, and biological specimens (e.g., bacteria), while growing in a nurturing media without incurring physical damage (column 1, lines 31-40), and envisions processing biological tissue ( column 1, lines 59-61). Howe teaches methods where mixing is facilitated by a selected frequency, amplitude or acceleration to cause liquids to migrate into porous solids, cause liquids to migrate through porous solids, as well as to cause liquids to migrate into porous solids and leach out materials (column 4, line 58, to column 5, line 1). Howe teaches employing resonant operation to improve efficiency of mixing (column 5, lines 3-4). Howe also teaches producing low-frequencies of 0-1000 Hertz (Hz), high accelerations of 2-75 accelerations equal to that caused by gravity (g's; i.e., 2-75 times the energy of G-Force applied to the vessel) and large displacement amplitudes of 0.01-0.5 inches (column 5, lines 8-12). Howe teaches that operation is typically within 10 Hz of resonance (column 16, lines 10-11). Howe teaches that ResonantSonic® agitation is different from ultrasonic agitation because the frequency of acoustic energy is lower and the scale of mixing is larger (column 16, lines 50-52), and that the ResonantSonic® devices are simple, mechanically driven agitators that can be made large enough to perform industrial scale tasks at reasonable cost (column 16, lines 52-55 Howe teaches that intrusion or infusion of liquids into a porous solid media is enhanced by placing the porous media in an environment that is operative to vibrate the porous media at a preferred frequency of about 5 Hz to about 1,000 Hz with a preferred amplitude between about 0.02 inch to about 0.5 inch (column 22, lines 29-34; claims 1, 5, 8, 13, 16 and 21).
Regarding claims 57, 68-70, 72, and 78, de Sousa teaches that osteochondral allografts frozen at -70 °C and at a rate -1 °C/min with a composition comprising 10% DMSO and stored for a year and subsequently thawed have percentage of cell death of 20.6% ± 7.6, which equates to a relative cell viability reduction of about 7.6% and so a cell viability of about 92.4% relative to the control osteochondral allograft assayed for cell viability at the time of collection (Abstract; page 427, the paragraph starting “In the group frozen at -70 °C; and, Table 3, “FA” as average ± SD, and wherein the “percentage of cell death” is the inverse of cell viability), reading on the cell viability of claims 57 and 68 and reading in-part on the cell viability of claim 70.
Regarding the resonant acoustic energy of claim 57(b) and 78(b), the penetration of claim 59, the frequency ranges of claims 75 and 77, and the product-by-process limitations of claim 72, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the processing equipment and methods to operate the equipment of Howe for the processing equipment of Chen and combine the cartilage processing and cryopreservation methods of Chen in view of Donndelinger. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Chen and Donndelinger are in-part directed towards methods of treating tissue sample by sonic mixing and at overlapping frequency ranges, Donndelinger as a whole teaches the utility of processing tissue with infrasonic vibrations and would point a person of ordinary skill in the art to the teaches of Howe as analogous art, and Howe teaches known processing equipment that utilizes resonant acoustic energy, where resonant frequencies (i.e., low-frequencies of 0-1000 Hertz (Hz)), high accelerations of 2-75 accelerations equal to that caused by gravity (g's; i.e., 2-75 times the energy of G-Force) and large displacement amplitudes of 0.01-0.5 inches are applied to biological specimens (e.g., bacteria), biological materials, biological tissue or biological cell cultures. The skilled artisan would have been motivated to do so because Howe teaches that the substitution would achieve a high level of uniformity of mixing and because the ResonantSonic® agitation system is mechanically simple and capable of scaling up, and so would predictably improve upon the tissue processing methods of Chen.
Regarding the cell viabilities of claims 57, 68, and the product-by-process limitations of 72, and 78, and the controlled rate freezing of claim 70 it would have been obvious to a person of ordinary skill in the art before the invention was filed to combine the methods of Chen, Donndelinger, and Howe that utilizes low frequency Hertz resonant acoustic energy to get known penetrating cryopreservants into the cartilage matrix with the assay techniques that assess cell viability from de Sousa. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Chen and de Sousa are both in-part directed towards processing of cartilage grafts for medical purposes, where Chen, Donndelinger, and Howe teach known cryopreservation techniques, and how to penetrate cartilage matrices within known penetrants and equipment utilizing resonant acoustic energy, while de Sousa teaches known cryopreservation techniques and assays to assess and achieve cell viabilities greater than 80% after the cartilage samples they have been thawed post freezing. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the methods of Chen, Donndelinger, and Howe with de Sousa since all the references teach the processing of cartilage grafts for medical purposes, and by the combination provides and advantage to the Chen, Donndelinger, and Howe method by providing additional assays and techniques to assess viability of tissue grafts to ensure cryopreservation is optimally performed.
Regarding claim 69 and the cell viability is at least 95%, as noted above, de Sousa teaches osteochondral allografts having a cell viability of about 92.4% when thawed after a year of storage at -70 °C and when stored in a composition comprising 10% DMSO. As such, MPEP § 2144.05(I) sets forth 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). In the instant case, it would have been within the purview of one of ordinary skill in the art to utilize the techniques, materials and equipment provided within the teachings of Chen, Donndelinger, Howe and de Sousa and adjust the protocols, penetrants, mixing times, freezing rates, etc., to increase the cell viability rates to at least 95% and so that the produced cartilage tissue is a high value product with a long shelf life and a product with higher chance of cell proliferation within the patient. Therefore, the burden is shifted back to Applicant to show the criticality of the claimed range.
Regarding the DMSO of claims 76 and 78, a person of ordinary skill in the art would have had a reasonable expectation of success in substituting the DMSO of Donndelinger for the glycerol and at the concentrations taught by Chen because DMSO and glycerol are both explicitly taught as being useful for THE SAME PURPOSE as cryoprotectants in the context of tissue processing. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”). Alternatively, the skilled artisan would have been motivated to do so because de Sousa teaches that DMSO is predictably advantageous to improve the viability of cells in osteochondral allografts when frozen and so the substitution would predictably improve upon the cell viability of the cells in Chen’s cryopreserved cartilage tissue.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim 72 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over de Sousa et al. (Cell Tissue Bank (published online Dec. 6th, 2014), 16:425-431; Reference U).
de Sousa teaches that osteochondral allografts frozen at -70 °C and at a rate -1 °C/min with a composition comprising 10% DMSO and stored for a year and subsequently thawed have percentage of cell death of 20.6 ± 7.6 (Abstract; page 427, the paragraph starting “In the group frozen at -70 °C; and, Table 3, “FA” as average ± SD, and wherein the “percentage of cell death” is the inverse of cell viability). Cetinkaya teaches that adult primary cartilage cells ACC) possess of about 80% viability when previously slow frozen at 1°C/min or 2°C/min to -80 °C and thawed after 3 weeks (Fig. 2, page 293, subheading “Slow freezing of cell and tissue samples”), anticipating or reading on claim 72.
Claim 72, which incorporates the method of claim 57, is a product-by-process claim. See M.P.E.P. § 2113; product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Furthermore, alternate grounds of rejection under both 102 and 103 is permissible given the lack of physical description of product-by-process claims and the inability of the USPTO to manufacture and compare products. See M.P.E.P. § 2113 (III). Once a product appearing to be substantially identical is found and an art rejection made, the burden shifts to the applicant to show an unobvious difference. In this case, the burden is shifted to Applicant to show that the manufacturing process steps of the product-by-process claims impart any novel and/or non-obvious structural characteristics to the claimed product as compared to the substantially identical composition taught by de Sousa, as de Sousa teaches a cartilage tissue cryopreserved in 10% has at least 70% viability (i.e. the inverse of the % cell death) when thawed after 1 year of storage at -70 °C but is not further processed by resonant acoustic energy as set forth in method claim 57. Particularly, if the product-by process limitations of claim 72 impart no structural difference then the claims are anticipated. If the product-by process limitations of claim 72 impart a structural difference, then Applicant must clearly set forth why any structural difference between the claimed composition and the composition of de Sousa is non-obvious.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
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 57, 59, 61, 63, 68-70, 72, 73, and 75-78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10-14, 22, 23, and 25 of copending Application No. 16/249,689 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 11 of the ‘689 Application is coextensive to claim 1 and reads on a method of cryopreserving a tissue, the method comprising: (a) loading a processing vessel with a tissue and a cryopreservation solution comprising 5% to 30% of a cryoprotectant (vol/vol) a processing solution comprising a cryoprotectant, thereby providing a combination comprising the tissue and the processing solution disposed in the processing vessel, wherein the tissue comprises cartilage, and wherein the tissue contains native, viable cells; (b) applying resonant acoustic energy to the processing vessel and the combination disposed therein for 10 minutes to 60 minutes, the resonant acoustic energy having a frequency between 15 Hertz and 60 Hertz and exerting 20 to 50 times the energy of G-force (20-50 G), thereby vibrating the processing vessel and the combination disposed therein to form a processed tissue comprising the tissue penetrated with the cryoprotectant; and (c) freezing the processed tissue to form a cryopreserved tissue comprising native, viable cells; wherein the cryopreserved tissue retains at least 70% cell viability following thawing after storage at -80 °C for at least 3 months, and wherein the cell viability is a number of viable cells in the thawed cryopreserved tissue as a percentage of the number of viable cells in the tissue before step (a).
Claim 2 of the ‘689 Application reads on instant claim 64. Claim 2-5, 12, and 13 of the ‘689 Application reads on instant claim 63 and 64 and the DMSO and DMSO concentrations of claims 76 and 77. Claim 10 of the ‘689 Application reads on instant claim 61. Claim 14 of the ‘689 Application reads on instant claim 72. Claims 22 and 23 of the ‘689 Application reads on instant claims 68 and 69. Claims 11 and 25 of the ‘689 Application reads on instant claims 70 and 73.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Affidavit/Declaration
The Declaration under 37 CFR 1.132 filed 9/25/2025 is insufficient to overcome the rejection of claims 57-74 based upon Chen in view of Donndelinger, O’Leary, and Howe as set forth in the last Office action because: the instant claim amendments have necessitated new grounds of rejection over Chen in view of Donndelinger, Howe, and de Sousa. Particularly, the Declaration is not persuasive as the addition de Sousa to the rejection of claim 57, 68, 69, and new claim 78 fully addresses the limitations to cell viability of at least 70% as set forth in the claims.
As such, the Declaration is not persuasive of nonobviousness at this time because it only include(s) statements which amount to an affirmation that the claimed subject matter functions as it was intended to function. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. See MPEP § 716. Furthermore, the Declaration is not persuasive because the data set forth therein refers to osteochondral plugs, but claims 57 and 78 are directed towards the broader embodiment of cryopreserved cartilage tissue. Thus, there is no showing that the objective evidence of nonobviousness is commensurate in scope with the claims. See MPEP § 716.
Response to Arguments
Applicant's arguments on in the replies dated 9/25/2025 and 10/03/2025 have been fully considered, but not found persuasive of error over the new grounds of rejection set forth above and necessitated by the instant claim amendments. Briefly restated, the addition de Sousa to the rejection of claim 57, 68, 69, and new claim 78 fully addresses the limitations to cell viability of at least 70% as set forth in the claims.
Any arguments regarding the instant Declaration are fully addressed above.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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