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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3-6, 8, 11 and 16 in the reply filed on 1/9/26 is acknowledged.
Claims 12-14 and 17-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/9/25.
Claim Status
Claims 2, 7, 9, 10, and 15 are cancelled.
Claims 1, 3-6, 8, 11-14 and 16-25 are pending.
Claims 12-14 and 17-25 are withdrawn.
Claims 1, 3-6, 8, 11 and 16 are presented for examination on the merits.
Priority
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Claim 1 has the limitation: “the solid form of magnesium is dispersed or embedded below an external surface in the polymer matrix”. This appears to introduce a new concept. A text search of provisional application 62385363 for the term “dispersed” did not find support. Nor could the Examiner reasonable derive disclosure that would support the term “dispersed”. Consequently, it is a new concept not supported in the provisional application and the effective filing date for all claims dependent upon claim 1 is the international fling date of 09/11/2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/18/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(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, 3-4, 8, 11 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sfeir et al. (WO2015142631, published 9/24/2015, cited on 892 mailed 12/9/25) and, in the event that Applicant corrects the priority benefit to the provisional application, claim(s) 1, 3-4, 8, 11 and 16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sfeir et al. (WO2015142631).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Instant claim 1 is directed to:
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Claim interpretation: Claim 1 is directed to a “temporomandibular joint medical implant device”. MPEP 2111.02(II) states: “The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." After careful consideration, the term “temporomandibular joint” does not appear to add any further components to the implant device and is being considered as an intended use of the medical implant device. See MPEP 2111.02(II): “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). An intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). While the limitation has been considered, it is not given patentable weight. Even if it could be construed that “temporomandibular joint” provides some structure and is limiting, the medical implant device of Sfeir et al. is capable of performing such an intended use. See MPEP 2111.02(II): “To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim.”
Also note that the limitations of “is applied or deposited” and “is dispersed or embedded” are reasonably interpreted as present passive voice describing a state resulting from a completed action and not an active step to be taken.
Regarding claims 1, 3-4 and 11, Sfeir et al. disclose a medical implant device (Claim 12), such as a joint replacement device (Claim 13), which the Examiner interprets as reading on the claimed temporomandibular joint medical device, comprising a magnesium-polymer composite comprising magnesium particles embedded in the polymer matrix (Claim 1) where the magnesium particles include pure magnesium particles and powder, magnesium alloy particles and powder, metallic magnesium, magnesium salt particles and powder (Claim 2), hence solid forms of magnesium, and the polymer matrix is made of a biodegradable polymer such as gelatin or poly(glycerol sebacate) (Claim 3). Consequently, a single composite biphasic implant material is disclosed by Sfeir et al. with a first phase being the biodegradable polymer and the second phase being the solid form of magnesium. Sfeir et al. disclose that the medical implant device provides sustained delivery of magnesium particles to an implant area in a body of a patient (Claim 16), which is controlled by polymer degradation (Claims 4-7), and since the same component are disclosed by Sfeir et al. as claimed by Applicant then the medical device of Sfeir et al. also is effective to simultaneously regenerate fibrocartilage and restore bone when implanted.
Regarding claim 1, Sfeir et al. disclose temporomandibular joint medical implant devices [0036] and that: “it is believed that the release of magnesium, for example, into a bone environment is effective to trigger hone growth and/or regeneration.” [0025] Sfier et al. disclose attaching to the surface or encapsulating within the medical implant device an active substance such as cells [0037].
Sfeir et al. disclose that the implant is in the form of plates and meshes (Claim 13; [0034, 0036]).Regarding claim 8, the joint replacement medical device of Sfeir et al. naturally serves as a scaffold.
Regarding claim 16, the limitation of “wherein the implanted medical implant” is a past tense action of a user that has implanted the medical implant and thus reads on an intended use of the implant. The medical device implant of Sfeir et al. is also capable of performing such an action.
Claim(s) 1, 3-4, 8, 11 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. (Acta Biomaterialia 11 (2015) 543–553).
Regarding claims 1, 3, 4 and 8, Brown et al. disclose a metallic magnesium particle/PLGA composite scaffold that enhance osteogenesis (Abstract; Table 1) produced by solvent casting to make a single composite material (Page 544, 2.1. Synthesis of scaffolds; page 547, Figure 1; page 548, Figure 2C). Thus, Brown et al. disclose a medical implant device comprising a single composite material with biodegradable PLGA polymer matrix and a solid form of metallic magnesium particles dispersed in the polymer matrix. The same composite of Brown et al. made of the same materials claimed will also be effective in simultaneously regenerating fibrocartilage and restore bone. As discussed above and incorporated by reference, the claim preamble of temporomandibular joint medical device is an intended use of the implant. The implant of Brown et al. is also capable of performing such an action.
Regarding claim 11, the composite of Brown et al. has a phase of solid metallic magnesium particles and a phase of biodegradable polymer matrix and is thus biphasic.
Regarding claim 16, the limitation of “wherein the implanted medical implant” is a past tense action of a user that has implanted the medical implant and thus reads on an intended use of the implant. The implant of Brown et al. is also capable of performing such an action.
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.
Claim(s) 1, 3-5, 8, 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sfeir et al. (WO2015142631) in view of Athanasiou et al. (US20090142307).
The applied reference (Sfeir et al) has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1) and 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant claims:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical implant research scientist, as is the case here, then one can assume comfortably that such an educated artisan will have knowledge of implant biomaterials such as metals, ceramics and polymers to design and construct the implant, tissue engineering to regenerate tissue as well as experience with biomechanics and relevant laboratory techniques. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
It is well settled that “a disclosure that anticipates under § 102 also renders the claim invalid under §103, for anticipation is the epitome of obviousness. See MPEP 1207.03(a)(II) states: “"lack of novelty is the epitome of obviousness." May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))”. Accordingly, the claims rejected under §102 above are also invalid under §103.
The reference of Sfeir et al. is discussed in detail above and that discussion is incorporated by reference.
Regarding claim 5, Athanasiou et al. teach that in tissue engineering for temporomandibular joints (Claims 1 and 6) the artisan selects fibrochondrocytes and chondrocytes to seed in the mold (Claims 1 and 9-11).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Sfier et al. is that Sfier et al. do not expressly teach wherein the solid form of magnesium is combined with seeding cells selected from the group consisting of fibrochondrocyte and chondrocyte cells. This deficiency in Sfier et al. is cured by the teachings of Athanasiou et al.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to seed fibrochondrocyte and chondrocyte cells, as suggested by Athanasiou et al., in the biphasic medical device of Sfier et al. and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Sfier et al. suggest adding cells and Athanasiou et al. teach seeding fibrochondrocyte and chondrocyte cells in implants for temporomandibular joints. The ordinary artisan would have a reasonable expectation of success in so doing.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sfeir et al. (WO2015142631) as applied to claims 1, 3-4, 8, 11 and 16 above. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1) and 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant claims:
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Determination of the scope and content of the prior art
(MPEP 2141.01)
It is well settled that “a disclosure that anticipates under § 102 also renders the claim invalid under §103, for anticipation is the epitome of obviousness. See MPEP 1207.03(a)(II) states: “"lack of novelty is the epitome of obviousness." May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))”. Accordingly, the claims rejected under §102 above are also invalid under §103.
The reference of Sfeir et al. is discussed in detail above and that discussion is incorporated by reference.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Sfier et al. is that Sfier et al. do not expressly teach wherein the metallic magnesium is selected from the group consisting of a sheet and a mesh. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the metallic magnesium in a sheet and/or a mesh in the biphasic medical device of Sfeir et al. and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Sfeir et al. teach metallic magnesium (Claims 1 and 11) and the form of the device is a plate or mesh (Claim 13). In terms of shape, both a plate and a sheet are generally flat materials where a plate can be considered a thick sheet. Thus, disclosure of a plate would render obvious a sheet to the ordinary artisan in this art. It is then obvious to have the metallic magnesium in a similar form as the implant for ease of construction, which is in the form of a plate (sheet) or a mesh for the corresponding medical device form. The ordinary artisan would do so with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
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 1, 3-6, 8, 11 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12023418 (parent application with the same inventive entity and assignee) Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses:
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The tri-magnesium phosphate powder is a solid particulate form of magnesium that when absorbed or soaked into the sponge reads on being dispersed or embedded below an external surface in the biodegradable polymer matrix. Since a sheet or mesh is also taught by the patent (Claim 3), then a biphasic device is taught with a biodegradable polymer matrix as one phase and the solid form of magnesium as the other phase. Consequently, the mandibular condyle bone-cartilage interface metical implant of the patent reads upon the instantly claimed subject matter.
The patent does not expressly teach adding fibrochondrocyte and chondrocyte seeding cells. However, the patent teaches that the implant is to effect regeneration of bone and cartilage (Claim 5). It is then obvious to add fibrochondrocyte and chondrocyte seeding cells to the implant, which then serves as a scaffold, to effect simultaneous regeneration of fibrocartilage on a cartilage portion and restoration of bone on a bone portion of the bone-cartilage interface.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613