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 .
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 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.
Applicant’s reply dated 09/03/2026 has been received. Finality is withdrawn and prosecution is reopened. A new rejection appears below.
Priority
The instant application 17/909,263, filed 09/20/2022, is a 371 national stage entry of International Application No. PCT/US2021/021124, filed 03/05/2021, and claims priority to U.S. Provisional Patent Application No. 62/986,116, filed 03/06/2020.
Status of Application and Claims
Claims 1-3,5, 7, 9, 12, 14-16, 19, 21, 23 are currently pending.
In the reply filed 06/25/2025, Applicant elected dental pulp stem cell as a single species of stem cell, and glial cell derived neurotrophic factor (GDNF) as a single species of neurotrophic factor. These species elections are fully acknowledged.
The restriction and election requirements have been deemed proper and previously made FINAL.
Claims 1-3,5, 7, 9, 12, 14-16,19, 21 and 23 are examined on the merits herein.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3,5, 7, 9, 12, 14-16,19, 21 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for carrying out the claimed method using dental pulp stem cells as stem cells, does not reasonably provide enablement for carryingout the method and obtaining production of neurotrophic factors using anystem cell type other than DPSCs. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
MPEP §2164.01(a), 4th paragraph, provides that, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Nature of the Invention-The nature of the invention relates to scaffold-free nerve conduits made from cultured dental pulp stem cells and the extracellular matrix they produce. The cells in the conduit produce neurotrophic factors that support nerve survival and growth.
Breadth of the claims-The claims broadly encompass using any type of stem cell to make the nerve conduit, including lineage restricted stem cells such as hematopoietic stem cells and cells that have not been directed to form neural cell types such as iPSCs and adipose stem cells.
Guidance in the Specification-The Specification teaches carrying out the invention with cells obtained from dental pulp. The cells can be directly obtained from teeth and contain stem cells of neural origin. The specification does not teach use of any other cell source in carrying out the invention.
State of the Art-The state of the art at the time of filing held that there are many types of stem cells of various origins (see Anitua, Cytotherapy, 2018; 20: 479–49). Stem cells, as a genus, includes mesenchymal, endothelial, hematopoietic, as well as iPSCs which have not been primed along any fate path. Dental pulp stem cells are ectodermally derived and develop from cells that migrate from the neural tube (neural crest cells). Dental pulp stem cells have high plasticity and multilineage differentiation capacity and can give rise to numerous cell types. Other stem cell types, such as hematopoietic stem cells, are not so plastic and do not readily take on neural characteristics and would not be expected to secrete neurotrophic factors.
Level of Experimentation-The amount of experimentation needed to determine how to use non-ectodermally-derived and non-neuronally derived stem cells to take on fate characteristics such that the secret neurotrophic factors would be undue. The person of ordinary skill in the art would need to determine how to alter the fate of other stem cells types to cause them to form a matric, align and secret neurotrophic factors the generate the claimed scaffold-free nerve conduit.
Therefore, it is recommended that claims q and 14 be amended to claim “wherein the cells are dental pulp stem cells or are obtained from a population of dental pulp cells” along with cancelation of certain dependent claims that are more broad than that.
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.
The rejection of claim 5 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 is withdrawn in light of the amendments to claims 1 and 5.
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.
The rejection of claims 14, 16, 19 and 23 under 35 U.S.C. 103 as being unpatentable over Dailey, M. T. et al. (2018). 76(10), Supplement, E74 (cited in PTO-892) in view of Syed-Picard, F. N. et al. (2014J. Dent. Res, 93(3), 250-255 (cited in PTO-892), as evidenced by Pourlak, T. et al. (2021). J. Stomatol. Oral Maxillofac. Surg., 122, 441-452 (cited in PTO-892) is withdrawn. Applicant has submitted that previous arguments regarding Dailey that were directed to a separate rejection, were intended to also address this rejection. These arguments were found persuasive as set froth in the action dated 06/08/2026.
2’) The rejection of claim 15 under 35 U.S.C. 103 as being unpatentable over Dailey, M. T. et al. (2018). “Scaffold-Free Dental Pulp Cell Sheets to Enhance Facial Nerve Regeneration.” Journal of Oral and Maxillofacial Surgery, 76(10), Supplement, E74 (cited in PTO-892) and Syed-Picard, F. N. et al. (2014). "Scaffoldless tissue-engineered dental pulp cell constructs for endodontic therapy." J. Dent. Res, 93(3), 250-255 (cited in PTO-892), as applied to claims 14, 16, 18-19 and 23 above, and further in view of Fan, et al. (2020). “A prevascularized nerve conduit based on a stem cell sheet effectively promotes the repair of transected spinal cord injury.” Acta Biomaterialia, 101, 304-313 (cited in IDS 10/20/2022), as evidenced by Pourlak, T. et al. (2021). “Usage of stem cells in oral and maxillofacial region.” J. Stomatol. Oral Maxillofac. Surg., 122, 441-452 (cited in PTO-892) is withdrawn in light of Applicant’s arguments.
2”) The rejection of claim 21 under 35 U.S.C. 103 as being unpatentable over Dailey, M. T. et al. (2018). “Scaffold-Free Dental Pulp Cell Sheets to Enhance Facial Nerve Regeneration.” Journal of Oral and Maxillofacial Surgery, 76(10), Supplement, E74 (cited in PTO-892) and Syed-Picard, F. N. et al. (2014). "Scaffoldless tissue-engineered dental pulp cell constructs for endodontic therapy." J. Dent. Res, 93(3), 250-255 (cited in PTO-892), as applied to claims 14, 16, 19 and 23 above, and further in view of Sharma, A. D. et al. (2016). “Oriented growth and transdifferentiation of mesenchymal stem cells towards a Schwann cell fate on micropatterned substrates.” J. Biosci. Bioeng., 121(3), 325-335 (cited in PTO-892), as evidenced by Pourlak, T. et al. (2021). “Usage of stem cells in oral and maxillofacial region.” J. Stomatol. Oral Maxillofac. Surg., 122, 441-452 (cited in PTO-892) is withdrawn in light of Applicant’s arguments.
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.
1) The provisional rejection of claims 1-3,5, 7, 9 and 12 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 10 of copending Application No. 16/976,821 in view of Sharma, A. D. et al. (2016). “Oriented growth and transdifferentiation of mesenchymal stem cells towards a Schwann cell fate on micropatterned substrates.” J. Biosci. Bioeng., 121(3), 325-335 (cited in PTO-892), Rutowski, G. E. et al. (2004). “Synergistic effects of micropatterned biodegradable conduits and Schwann cells on sciatic nerve regeneration.” J. Neural Eng., 1, 151 (cited in PTO-892), and Fan, et al. (2020). “A prevascularized nerve conduit based on a stem cell sheet effectively promotes the repair of transected spinal cord injury.” Acta Biomaterialia, 101, 304-313 (cited in IDS 10/20/2022), as evidenced by Dailey, M. T. et al. (2018). “Scaffold-Free Dental Pulp Cell Sheets to Enhance Facial Nerve Regeneration.” Journal of Oral and Maxillofacial Surgery, 76(10), Supplement, E74 (cited in PTO-892) and Pourlak, T. et al. (2021). “Usage of stem cells in oral and maxillofacial region.” J. Stomatol. Oral Maxillofac. Surg., 122, 441-452 (cited in PTO-892) is withdrawn in view of the filing of a Terminal Disclaimer.
2)The provisional rejection of claims 14-16, 18-19, 21 and 23 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 10 of copending Application No. 16/976,821 in view of Syed-Picard, F. N. et al. (2014). "Scaffoldless tissue-engineered dental pulp cell constructs for endodontic therapy." J. Dent. Res, 93(3), 250-255 (cited in PTO-892), Fan, et al. (2020). “A prevascularized nerve conduit based on a stem cell sheet effectively promotes the repair of transected spinal cord injury.” Acta Biomaterialia, 101, 304-313 (cited in IDS 10/20/2022), and Sharma, A. D. et al. (2016). “Oriented growth and transdifferentiation of mesenchymal stem cells towards a Schwann cell fate on micropatterned substrates.” J. Biosci. Bioeng., 121(3), 325-335 (cited in PTO-892), as evidenced by Dailey, M. T. et al. (2018). “Scaffold-Free Dental Pulp Cell Sheets to Enhance Facial Nerve Regeneration.” Journal of Oral and Maxillofacial Surgery, 76(10), Supplement, E74 (cited in PTO-892) and Pourlak, T. et al. (2021). “Usage of stem cells in oral and maxillofacial region.” J. Stomatol. Oral Maxillofac. Surg., 122, 441-452 (cited in PTO-892) is withdrawn in view of the filing of a Terminal Disclaimer.
Conclusion
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/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
