DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 11/7/2025.
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
Claim 1 has been amended. Claim 6 is cancelled. No claims are newly added. Accordingly, claims 1-5 and 7-20 remain pending in the application and are currently under examination.
Information Disclosure Statement
The IDS filed 9/23/2025 has been considered. A signed copy is enclosed herewith.
Withdrawn Rejections
Applicant’s amendment renders the rejection under 35 USC 103 over Chen moot. Specifically, Chen is silent to the limitation, “wherein said matrix comprises fibers having an average diameter of less than 50 µm”. Thus, said rejection has been withdrawn.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 1-5 and 7-20 stand rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2010/016942 A1, Feb. 11, 2010, hereafter as “Chen”) in view of Francis et al. (US 2019/0054205 A1, Feb. 21, 2019, hereafter as “Francis”).
The instant claims are drawn to a porous osteoinductive composite comprising osteoinductive granules comprised in a porous matrix, wherein more than 5% of the surface area of the osteoinductive granules is exposed from said matrix as determined by scanning electron microscopy (SEM) imaging, wherein said matrix comprises fibers having an average diameter of less than 50 microns; a method of preparing thereof; and a method of using thereof.
Regarding instant claims 1-3, 10-15, 18 and 19, Chen teaches a process for making a tissue repair implant having a porous sponge-like structure to repair bone, cartilage, or soft tissue defects by producing a connective tissue homogenate from one or more connective tissues, mixing the connective tissue homogenate with a carrier solution to produce a connective tissue carrier, optionally mixing one or more natural or synthetic bone fragments with said connective tissue carrier to produce a tissue repair mixture, freezing or freeze-drying (lyophilizing) the tissue repair mixture to produce a porous sponge-like structure and create a three-dimensional framework to entrap the natural or synthetic bone fragments (abstract). Chen teaches that the carrier may comprise one or more polysaccharides including collagen (e.g., native collagen), chitosan, cellulose, etc. as well as natural or synthetic polymers such as polyethylene glycol, polylactic acid, etc. ([0024], [0077] and [0086]). Chen also teaches that the carrier in the tissue repair implant may be no more than 20% in the dry state or no more than 5% in the dry state (i.e., less than 45%) ([0028]). Chen teaches that the natural or synthetic bone fragments may comprise calcium phosphate and may in the form of particles having an average particle size of about 125-2000 microns or about 250-710 microns ([0029]), wherein said natural or synthetic bone fragments is present in an amount of about 0.1 to about 95% in the dry state, or about 10% to about 90% in the dry state ([0031]). Chen also teaches that the porous tissue repair implant is useful for repairing defects in tissue such as bone tissues, cartilage or soft tissues (e.g., tendon, ligament, dermis, rotator cuff ([0048]). Additionally, Chen teaches that the tissue repair implant can be in the form of a sheet ([0020]).
Chen is silent to the limitations, “wherein said matrix comprises fibers having an average diameter of less than 50 microns” (instant claim 1) and “wherein said matrix comprises fibers and sheets in a ratio of more than 1:1, wherein fibers are defined as structures having a thickness and width of less than 50 microns and sheets are defined as structures having a thickness and/or width of more than 50 microns” (instant claim 5). It is noted that fibers having a thickness and width of less than 50 microns is being interpreted as having a diameter of less than 50 microns.
Francis teaches implantable scaffolds/devices for tissue repair (abstract). Francis teaches that collagen fibers can be incorporated into the scaffolds, wherein the fibers more preferably have diameters of about 15-50 microns and most preferably, about 20 microns ([0017]-[0018]). Francis further teaches fibers can be used to form sheet-like scaffolds ([0052]-[0054]). Francis teaches that the sheets can be about 0.2 mm (i.e., more than 50 microns) thick ([0073]). It is noted that Francis’ teachings imply that many fibers are needed to form a single sheet and such reads on the claimed ratio of more than 1:1. Francis also teaches additional oriented fibers can be added to the sheet ([0073]).
Chen and Francis are drawn to tissue repair implants, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include fibers and sheets in a ratio of more than 1:1 in the claimed dimensions into the invention of Chen as suggested by Francis with a reasonable expectation of success. A skilled artisan would have been motivated to do so because both references teaches tissue repair implants in the form of sheets and Francis specifically teaches that fibers in the claimed dimensions and amounts can be used to make sheets in the claimed dimensions and amounts as well as in addition to the sheets to provide reinforcement as suitable for the same purpose of repairing tissue defects.
Chen is silent to the limitations, wherein more than 5%, more than 10%, more than 20% of the surface area of the osteoinductive granules is exposed from said matrix as determined by SEM imaging (instant claims 1-3).
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.
Chen teaches a substantially identical composition and a substantially identical method of making thereof. As such, a skilled artisan would have reasonably expected a substantially identical composition made by a substantially identical method would yield the same composition having the same properties including wherein more than 5%, more than 10%, more than 20% of the surface area of the osteoinductive granules is exposed from said matrix as determined by SEM imaging absent evidence to the contrary.
Regarding the limitations, “the amount of the osteoinductive granules in the composite is more than 55 wt%” (instant claim 13) and the granules have a size in the range of 100 to 2500 microns (instant claim 15), 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 percentage of granules of more than 55% and the claimed particle size of granules of 100-2500 microns overlap/lie inside with the granule percentage range and particle size range disclosed by the prior art, a prima facie case of obviousness exists.
It is noted that any intended use limitation such as “for use in a medical treatment of connective tissue and/or bone loss or defect” (instant claim 19) does not alone show patentable distinction. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In other words, if the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding instant claim 4, Chen teaches the elements discussed above. Chen also teaches a porosity range of about 10% to about 95% or from about 30% to about 80% ([0020]). 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 porosity range of 60-95% overlaps/lies inside the porosity ranges disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 7, Chen teaches the elements discussed above. Chen is silent to the limitation, “exhibiting wicking of more than 50wt%”. Said limitation is considered a property of the composition. A composition and its properties are inseparable (MPEP 2112.01(II)). Additionally, “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” (MPEP 2112.01(I)). Chen teaches a substantially identical composition and a substantially identical method of making thereof. As such, a skilled artisan would have reasonably expected a substantially identical composition made by a substantially identical method would yield the same composition having the same properties including exhibiting wicking of more than 50 wt% absent evidence to the contrary.
Regarding instant claim 8, Chen teaches the elements discussed above. Chen also teaches pore sizes of greater than about 50 microns ([0020]) which is generally larger than mesenchymal stem cells and macrophages.
Regarding instant claim 9, Chen teaches the elements discussed above. Chen also teaches that the implants were explanted after 28 days (i.e., at least 5 days) and imply that the implants still have structural integrity ([0148]-[0149]; Fig. 6).
Regarding instant claim 16, Chen teaches the elements discussed above. Chen is silent to the limitation, “exhibiting a tensile strength in the range of 0.1 MPa to 5 MPa and/or an elastic modulus in the range of 2 to 300 MPa”. Said limitation is considered a property of the composition. A composition and its properties are inseparable (MPEP 2112.01(II)). Additionally, “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” (MPEP 2112.01(I)). Chen teaches a substantially identical composition and a substantially identical method of making thereof. As such, a skilled artisan would have reasonably expected a substantially identical composition made by a substantially identical method would yield the same composition having the same properties including a tensile strength in the range of 0.1 MPa to 5 MPa and/or an elastic modulus in the range of 2 to 300 MPa absent evidence to the contrary.
Regarding instant claim 17, Chen teaches the elements discussed above. Chen also teaches that the tissue repair implant is elastic/flexible and can be in the form of a rod, sheet, cube, tube, particle, sphere, ellipsoid, wedge or ribbon ([0020] and [0059]).
Regarding instant claim 20, Chen teaches the elements discussed above. Chen also teaches incorporating autologous cells into the tissue repair implant and implanting the tissue repair implant into a defect ([0039], [0050] and [0091]-[0093]).
Thus, the combined teachings of Chen and Francis render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 11/7/2025, regarding the 103 rejection over Chen and Francis have been fully considered but they are not persuasive.
Applicant argues that the present inventors found that a fibrous morphology of the matrix positively influences the osteoinductive capacity of the composite. Applicant asserts that it is preferred for good osteoconductivity that the matrix comprises mostly fibers and that the presence of sheets is less preferred because sheets can obstruct both the surface of the granules and passages into the inner part of the composite. Remarks, pages 5-7.
In response, it is respectfully submitted that the claims recite, “wherein said matrix comprises fibers having an average diameter of less than 50 µm”. It is important to note that while applicant asserts that good osteoconductivity is produced when the matrix comprises mostly fibers, the claims do not require any particular amount of fibers. Applicant appears to be arguing limitations that are not required by the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is also important to note that while sheets may be less preferred, sheets are not excluded from the claims. In fact, dependent claim 5 requires sheets. Preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments (MPEP 2123(II)). Furthermore, Francis teaches implantable scaffolds/devices for tissue repair comprising collagen fibers, wherein the fibers more preferably have diameters of about 15-50 microns and most preferably, about 20 microns ([0017]-[0018]). Accordingly, Francis teaches fibers having diameters of less than 50 microns. For these reasons, applicant’s argument is not persuasive.
Applicant argues that the fiber content correlates with increased bone formation, i.e., osteoinduction and is unexpected over the teachings of Chen in view of Francis. Applicant points to Fig. 11 of the instant application which shows an increase in bone formation with increasing percentage of fibers. Applicant further states that a skilled person would not have a reasonable expectation of success that including fibers as suggested by Frances into the material of Chen would lead to an increase in osteoinduction. Applicant also argues that high porosity does not inherently lead to good osteoinduction. Remarks, pages 7-9.
In response, it is respectfully submitted that the claims are drawn to an osteoinductive composite. Chen teaches a tissue repair implant that induces tissue formation or regeneration including bone ([0090] and [0099]). While the references do not explicitly teach that the inclusion of fibers increases bone formation, Chen does meet the osteoinductive limitation. In terms of unexpected increased osteoinduction due to fibers, Fig. 11 demonstrates that a composition having 5% fibers yielded about 1% bone formation and a composition containing about 90% yielded about 7.5% bone formation. It is important to note that there is no particular fiber amount or particular degree of osteoinduction required by the claims. It is also important to note that unexpected results must be commensurate in scope with the claimed invention (MPEP 716.02(d)). The data relied upon is based on a very particular formulation whereas the claims are much broader in scope. Thus, the data is not commensurate in scope with the claimed invention. For these reasons, applicant’s argument is unpersuasive.
Applicant also argues that incorporating the fibers of Francis in the composition of Chen is not prima facie obvious because the methods of Chen and Francis are incompatible with one another. Chen utilizes mixing and freezing or freeze-frying whereas Francis prepares fibers by electrospinning, melt electrospinning, electrowriting, extrusion, and 3D-printing. Applicant asserts that the natural or synthetic bone fragments of Chen cannot be processed by electrospinning or the like. Remarks, pages 9-10.
In response, it is respectfully submitted that arguments presented by applicant cannot replace evidence where evidence is necessary. MPEP 2145 states, “An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness”. Contrary to applicant’s assertion, natural or synthetic bone fragments (e.g., calcium phosphate, hydroxyapatite) was known to be included in fiber processes such as electrospinning as evidenced by Kasuga et al. (US 2016/0121024 A1, see [0012]) and Wei et al. (US 2007/0255422, see [0150]). Thus, applicant’s argument that the natural or synthetic bone fragments of Chen cannot be processed by electrospinning or the like is unpersuasive.
For these reasons, said rejection is maintained.
New Rejections
In light of the IDS filed 9/23/2025, the following rejections have been newly added:
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 9, 14, 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dias et al. (CN 111867642 A, Oct. 30, 2020) or equivalent document WO 2019/170769 A1, Sep. 12, 2019, hereafter as “Dias”. It is noted that the citations referenced in the rejection are from the WO document as the Chinese document is not in the English language.
The claimed invention is described above.
Regarding instant claims 1 and 14, Dias teaches a medical implant comprising osteoconductive fibers, wherein the fibers comprise bioceramic particles and the particles are exposed at the fiber surface (abstract). Dias teaches that the fibers are composed of one or more filaments, wherein a filament has a diameter of less than 50 microns (page 8, lines 1-9). Figures 1A-1C, 2A-2B and 9A-9F illustrate a porous matrix having more than 5% of the surface area of the particles exposed from the fibers/matrix. Dias teaches that osteogenesis is the formation of bone tissue or development of bones, while osteoinduction refers to the act or process of stimulating osteogenesis (page 8, lines 29-30). Dias also teaches that tricalcium phosphate (TCP) stimulates osteogenesis and further that the compositions comprising TCP demonstrated osteogenesis which implies that the composition is osteoinductive (page 11, lines 1-11; page 36, lines 1-8).
Regarding instant claim 2, Dias teaches the elements above. Figures 1A-1C and 2A-2B of Dias illustrate more than 10% of the surface area of the particles exposed from the fibers/matrix.
Regarding instant claim 3, Dias teaches the elements above. Figures 1A-1C and 2A-2B of Dias illustrate more than 20% of the surface area of the particles exposed from the fibers/matrix.
Regarding instant claim 9, Dias teaches the elements above. Dias also teaches that the fibers are high-strength polyolefin such as ultra-high molecular weight polyethylene (UHMWPE) which is not biodegradable (i.e., biostable) (abstract; page 2, lines 16-20; page 6, lines 19-21). Fig. 9 also shows SEM images of fiber samples cultured with hMSCs for 28 days which exhibit structural integrity. Based on the nondegradable characteristics of the fibers and the SEM images, a skilled artisan would reasonably expect the composite to exhibit structural integrity for at least 5 days under PBS solution at 37°C. It is important to note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants' composition differs and, if so, to what extent, from that of the discussed reference. Additionally, 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.
Dias, as discussed above, teaches a substantially identical composition to that of the claimed composition and further reasoning based on the non-degradability of the fibers as well as the SEM images, provide a reasonable basis that the prior art product possesses the claimed structural integrity property. Thus, a prima facie case exists.
Regarding instant claim 17, Dias teaches the elements above. Dias also teaches that the fiber may be a long continuous thread with different cross-sectional shapes, like a ribbon, a tape or a filament. Dias also teaches a fibrous construction or fibrous articles having a knitted, braided, woven or non-woven construction such as sutures, cables, tapes (strip), textiles or fabrics (sheet) (page 8, lines 1-17).
Regarding instant claim 19, Dias teaches the elements above. Dias teaches that the fibrous devices are useful for repairing bone fractures, torn ligaments or tendons, bone voids, etc. (paragraph bridging pages 18-19).
Regarding instant claim 20, Dias teaches the elements above. Dias teaches that the fibrous devices are useful for repairing bone fractures, torn ligaments or tendons, bone voids, etc. (paragraph bridging pages 18-19). Dias also teaches implantation of said fibrous devices (page 1, lines 6-13; page 5, lines 28-37).
Thus, the teachings of Dias render the instant claims anticipated.
Conclusion
All claims have been rejected; no claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 9/23/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617