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 The following Office Action is in response to Applicant’s communication dated 8/8/2024 . Claims 13-32 are pending. Claim Rejections - 35 USC § 102 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 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 30-32 are rejected under 35 U.S.C. 102 (A)(1) as being anticipated by : Al-Hezaimi, Khalid, et al. "A hybrid approach to direct pulp capping by using emdogain with a capping material." Journal of endodontics 37.5 (2011): 667-672. (Provided in IDS of 8/8/2024) Regarding claim 30 , Al-Hezaimi teaches the claimed method. Al-Hezaimi teaches the use of both an EMD-MTA and an EMD-Calcium Hydroxide hybrid composition for direct pulp capping, where the EMD is first applied, and the capping material (MTA or Calcium Hydroxide) is placed over the EMD. (AL-Hezaimi, Abstract, Pulp Exposure section) Regarding claim 3 1 , Al-Hezaimi teaches that after pulp capping, the damaged teeth were given an amalgam restoration (i.e., a dental filling). (Al-Hezaimi pg 669, first paragraph) Regarding claim 32 , Al-Hezaimi teaches that t he designated pulp-capping material was then mixed and carefully placed over the EMD-containing exposure site and the adjacent dentin . (i.e., in contact with dentin at the periphery of the site of exposed vital pulp). (Al-Hezaimi, pulp exposure section). Allowable Subject Matter Claims 13-29 are allowed. The following is an examiner’s statement of reasons for allowance in view of the closest prior art: Pellegrini, G., et al. "Human pulps capped with PDGF: A pilot study." JOURNAL OF ORAL SCIENCE & REHABILITATION 2.3 (2016): 34-41 , (Provided in IDS of 8/8/2024) and Al-Hezaimi, Khalid, et al. "A hybrid approach to direct pulp capping by using emdogain with a capping material." Journal of endodontics 37.5 (2011): 667-672 (Provided in IDS of 8/8/2024). Pellegrini teaches a method of pulp capping exposed vital pulp in a tooth, comprising the administration of PDGF directly to the exposed vital pulp. (Pellegrini, Abstract-Materials and Methods section). After administering Specifically, the pulp was capped with sterile cotton embedded in a PDGF BB solution and covered with zinc oxide cement (CAVIT, 3M ESPE, Seefeld, Germany) (Pellegrini, pg. 36, “Procedures Employed”). Regarding the calcium hydroxide step, CAVIT zinc oxide cement is a temporary filling material, and does not consist of calcium hydroxide. Pellegrini is aware of the method of pulp-capping with calcium hydroxide, but appears to offer using a PDGF pulp cap in place of a calcium hydroxide cap, and not as a layered combination as claimed. Pellegrini teaches that “ Although calcium hydroxide is the most widely used pulp capping agent to encourage hard-tissue bridging, the material is not able to effectively induce new tissue formation . Bridge formation remains unpredictable, with varying thickness and numerous tunnel defects, suggesting that it may be of insufficient quality to protect the pulp against bacterial microleakage along the restoration margins .“ ( Pellegrini , Introduction). Then, Pellegrini offers a PDGF pulp cap as an improved replacement capping material for a calcium hydroxide cap. “ Within its limitations, this study suggests that PDGF-BB appears to be a safe pulp capping agent ”. ( Pellegrini , Conclusion) Pellegrini is the closest prior art that teaches a method of pulp capping exposed vital pulp in a tooth with the direct application of rhPDGF. But Pelligrini does not teach placing calcium hydroxide over the PDGF. Pelligrini instead disparages the use of calcium hydroxide for the purpose of pulp capping for various reasons , and offers their PDGF pulp cap as an improvement. The closest teaching in the prior art for placing calcium hydroxide over an initial growth factor substance appears to be the inventor’s own work (Al-Hezaimi). Al-Hezaimi teaches a method of direct pulp capping by first applying Emdogain, then applying a capping material which may include calcium hydroxide over the previously administered Emdogain. (Al-Hezaimi, “Pulp Exposure” section.). Emdogain does not consist of PDGF, but instead is a composition of various enamel matrix derivatives that promote the growth and maturation of pulp cells. Al-Hezami appears to be more concerned with optimizing the EMD-capping material hybrid composition, and is silent on whether or not the EMD composition could be swapped out for a different composition that would promote healing instead. There appears to be no suggestion in the prior art that would lead a skilled artisan to have an expectation that PDGF could be swapped in for EMD in Al-Hezami’s method, because it is unclear what effects calcium hydroxide would have on the PDGF, and the eventual healing of the tooth itself. Claims 13-29 are free of the art . Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” Conclusion Claims 13-29 are allowed. Claims 30-32 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT THOMAS RUSSE AMICK whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-5474 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 7:30-5 M-F . 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, FILLIN "SPE Name?" \* MERGEFORMAT Tracy Vivlemore can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-2914 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /THOMAS R. AMICK/ Examiner, Art Unit 1638 /Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638