DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-11 are pending and under current examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Both of claims 2 and 6 recite "...a total weight of the 3D printing photo-curing composition...". This language renders the claim indefinite because it suggests that there could be greater than one total weight of the 3D printing photo-curing composition, raising the question of whether the entire amount of each substance that is present is included in calculating the ratio. Amending the claim to recite "the total weight of the 3D printing photo-curing composition " would obviate the rejection. This will not raise concerns over antecedent basis because any composition of matter inherently has a total weight.
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 1-4 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mashiach (WO2023/073711; publication date: 05/04/2023).
With regard to claim 1, Mashiach discloses a curable composition comprising collagen having a plurality of photocurable groups (i.e. a photocrosslinkable hydrogel forming material) and a photoinitiator (abstract). The composition may further comprise nanoclay (page 21) and contains a photo absorbing dye (i.e. a photoresist; see e.g. page 62-63). Mashiach teaches in some of any of the embodiments described herein the conjugate-containing curable formulation further comprises a gel-forming agent. The hydrogel forming agents may be GelMA (page 41) or HA methacrylate (i.e. photocrosslinkable hydrogels; page 38). The compositions are used for 3D printing (page 1). The photoabsorber or photoblocker of Mashiach’s invention includes the same substances as the instant invention, e.g. Sudan I (page 63). Thus, Mashiach teaches compositions comprising nanoclay, photocrosslinking hydrogel, a photoinitiator, and a photoresist. In the closest example Mashiach discloses a composition comprising rhCollagen functionalized with methacrylic acid, the photoinitiator, LAP, and minocycline as a photoabsorber (i.e. photoresist). The closest example composition does not contain a nanoclay. The claims are considered prima facie obvious because although Mashiach does not disclose a single example composition containing all four substances, in practicing the full scope of the invention, one having ordinary skill would simply add a nanoclay, as needed, to the compositions comprising the photocrosslinking hydrogel, a photoinitiator, and a photoresist, according to the teaching of Mashiach. With regard to the preamble of claim 1, Mashiach teaches that the object formed is implantable and may be an artificial tissue, including bone tissue (page 60). As such, the examiner considers the composition taught by Mashiach to be suitable for 3D printing photocuring skull repair.
With regard to claim 2, Mashiach teaches a range of from 0.01 to 5% for the dye substance (i.e. the photoresist; page 64); 0.1 to 10 % of the photoinitiator (page 47); at least 2 mg/mL of the photocrosslinkable collagen (pages 36-36). These ranges overlap with the ranges required by the instant claims, see MPEP 2144.05(I). Mashiach does not particularly limit the amount of nanoclay in the composition, and describes the nanoclay as becoming a hardened material. The examiner considers it a matter of routine testing for one of ordinary skill, e.g. an individual with a Ph.D. in biomedical materials engineering, to test the quantity of nanoclay to provide the requisite hardness for any given application (see MPEP 2144.05(II)(A)).
With regard to claims 3 and 11, the curable material may be GelMA (page 41) or HA methacrylate (page 38).
With regard to claim 4, the composition may contain hydroxyapatite sized sufficiently as not to block the printer nozzles. This disclosure in addition to teaching nanoclay in general renders obvious including hydroxyapatite nanoclay in the composition as it would have been obvious to optimize the size of the particles and nanoclay is taught as suitable.
With regard to claim 7, Mashiach discloses benzoin alkyl ethers (page 46).
With regard to claim 8, as noted above, Mashiach discloses Sudan I (page 63).
With regard to claims 9 and 10, Mashiach discloses adding vascular endothelial growth factor (i.e. VEGF, a chemokine per the instant invention; page 43).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Mashiach (WO2023/073711; publication date: 05/04/2023) as applied to claims 1-4 and 7-11 above, and further in view of Park et al. (KR 101935381; publication date: 01/04/2019; citing the English abstract).
The relevant disclosure of Mashiach is set forth above. As noted in the rejection supra, Mashiach teaches forming bone tissue from the photocrosslinkable composition; however, Mashiach does not disclose adding a green tea polyphenol to the composition.
Park teaches that adding the tea polyphenol epigallocatechin gallate (EGCG) to bone grafts can reduce the occurrence of infection that may occur during bone grafting (abstract).
With regard to claim 5, it would have been prima facie obvious to add EGCG to the composition taught by Mashiach. The artisan of ordinary skill would have been motivated to do so in order to reduce the chance of infection and had reasonable expectation of success because this would merely require including the EGCG in the 3D printed composition, which is processed under mild conditions (e.g. room temperature for the printing process, see e.g. Mashiach, page 2).
With regard to claim 6, it would have been obvious to optimize the quantity of EGCG to obtain reduced risk of infection, as taught in the prior art. See MPEP 2144.05(II)(A).
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 1-4 and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18811750 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims.
Inter alia the claims of the ‘750 application embrace a method of 3D printing a skull flap using a composition suitable to do so that comprises a photocrosslinking hydrogel, a nanoclay, an photoinitiator, and a photoresist in amounts overlapping with those required by the instant claims; wherein the hydrogel can be GelMA, HAMA, or AlgMA; and the nanoclay can be hydroxyapatite, tricalcium phosphate, or lithium magnesium silicate; the composition further comprises a chemokine that may be CNTF, VEGF, or BMP-2.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18811750 (reference application) as applied to claims 1-4 and 9-11 above, and further in view of Park et al. (KR 101935381; publication date: 01/04/2019; citing the English abstract).
The relevant limitations of the ‘750 application are set forth above. As noted in the rejection supra, the claims are directed to a method of forming bone tissue from the photocrosslinkable composition; however, the claims do not recite any limitation regarding green tea polyphenol in the composition.
Park teaches that adding the green tea polyphenol epigallocatechin gallate (EGCG) to bone grafts can reduce the occurrence of infection that may occur during bone grafting (abstract).
It would have been prima facie obvious to add EGCG to the composition embraced by the ‘750 claims. The artisan of ordinary skill would have been motivated to do so in order to reduce the chance of infection and had reasonable expectation of success because this would merely require including the EGCG in the 3D printed composition. With regard to claim 6, it would have been obvious to optimize the quantity of EGCG to obtain reduced risk of infection, as taught in the prior art. See MPEP 2144.05(II)(A).
Claims 7 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18811750 (reference application) as applied to claims 1-4 and 9-11 above, and further in view of Park et al. (KR 101935381; publication date: 01/04/2019; citing the English abstract).
The relevant limitations of the ‘750 application are set forth above. As noted in the rejection supra, the claims are directed to a method of forming bone tissue from the photocrosslinkable composition comprising a photoinitiator and a photoresist; however, the claims do not recite any limitation regarding the specific substances serving these purposes.
Mashiach, in the analogous art of photocrosslinkable hydrogel artificial tissue replacement teaches that alkyl ethers (page 46) and Sudan I (page 63) were a recognized photoinitiator and a known photoabsorbing dye (i.e. photoresist) as of the instant effective filing date. It would have been prima facie obvious to use these substances for the purposes they were known for in the art because one having ordinary skill would have recognized them a suitable (MPEP 2144.07).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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