Prosecution Insights
Last updated: October 25, 2026
Application No. 18/007,076

THERAPEUTIC AGENT FOR NERVE DAMAGE

Non-Final OA §102§103§112
Filed
Jan 27, 2023
Priority
Jul 31, 2020 — JP 2020-130911 +1 more
Examiner
ZHU, JIANJIAN
Art Unit
1631
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Neurotech Medical Co. Ltd.
OA Round
3 (Non-Final)
58%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
50 granted / 86 resolved
-1.9% vs TC avg
Strong +82% interview lift
Without
With
+82.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
86 currently pending
Career history
172
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
38.6%
-1.4% vs TC avg
§102
13.7%
-26.3% vs TC avg
§112
26.1%
-13.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 86 resolved cases

Office Action

§102 §103 §112
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 . DETAILED ACTION Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/18/2026 has been entered. Applicant' s amendment and response filed on 06/18/2026 has been received and entered into the case. Terminal Disclaimers The terminal disclaimer filed on June 18, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No: 12,599,632 has been reviewed and is accepted. The terminal disclaimer has been recorded. The rejections of record are withdrawn. Amendments In the reply filed on 06/18/2026, Applicant has amended claim 1, has newly canceled claim 5, and has added new claims 6-7. Claim Status Claims 1-2 and 6-7 are pending and are considered on the merits. Claim Rejections - 35 USC § 112(a) (Written Description) 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 1-2 and 6-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. SCOPE OF THE INVENTION Independent claim 1 and independent claim 2 encompass a genus of method of treatment for nerve damage comprising intravenously administering a therapeutic agent comprising mesenchymal stem cells and/or cells capable of differentiating into MSCs in combination with stimulation of a nerve of the subject applied to an area of nerve damage, an area near the area of nerve damage or an area capable of compensating for a function of the area of nerve damage, the stimulation is selected from motor stimulation, sensory stimulation, electrical stimulation, magnetic stimulation, language stimulation and higher brain function stimulation, the stimulation being performed during a period from 1 hour before to 6 hours after the administration of the therapeutic agent (this timing is only recited in claim 1), wherein the stimulation is applied to the area such that a blood flow rate and a metabolic rate of the stimulated area increase to a greater degree relative to other areas of the subject. Dependent claims 6-7 encompass the timing of administration of the therapeutic agent is adjusted such that the administration overlaps with a period during which blood flow in the selected area is increased by stimulation, and the stimulation is started during the intravenous administration of the therapeutic agent. Accordingly, the scope of the invention encompasses a genus of combinatory therapy for nerve damage by intravenously administering MSCs (and/or cells capable of differentiating into MSCs) in combination with a genus of stimulation to a genus of areas of the subject at any timing (claim 2 has no requirement on timing of stimulation) such that a blood flow rate and a metabolic rate of the stimulated area increase relative to other areas. It is noted that the genus of stimulation (selected from motor stimulation, sensory stimulation, electrical stimulation, magnetic stimulation, language stimulation and higher brain function stimulation) is extremely broad. For example, “the term "sensory stimulation" means stimulation of any of the senses related to nerve damage (e.g., visual sense, auditory sense, tactile sense)” (see specification, p. 19-22 for 4 pages of exemplary stimulations). Similarly, the genus of areas including an area capable of compensating for a function of the area of nerve damage is also extremely broad. For example, when applying sensory stimulation, “In the case of nerve damage to the right primary sensory area (third-order neurons), the "area capable of compensating for the function of the area of nerve damage” may be the left primary sensory area, the secondary somatosensory area communicating with the primary sensory area, the parietal association area, the motor area, or the visual area” (see specification [0091]). Additionally, claim 2 does not have requirement on the timing of applying stimulation, thus encompasses that the stimulation may be applied at any time before or after the MSC administration. However, the specification only discloses a limited number of species of stimulation type (e.g., exercise as motor stimulation, ice bag cooling as sensory stimulation, auditory stimulation (speaking to the patient) and visual stimulation (patient visually confirming the position of limbs), low-frequency electrical stimulation, intermittent Theta-Burst Stimulation (TBS) as magnetic stimulation, language stimulation using communication task (reading, writing, listening, speaking, calculation), higher brain function by attention process training), a limited number of species of stimulation area (affected left fingers to left shoulder and left foot to left hip joint, brain, or in a control patient a full body workout, or unaffected limbs), and a limited number of species of stimulation timing (6 hours or 1 hour before administration, during administration, and 3, 6, or 12 hours after administration) (see e.g., [0107], [0108], [0109], [0110], [0111], [0112], [0113]). Furthermore, although specification discloses changes in blood flow and oxygen metabolism may be determined by functional magnetic resonance imaging (functional MRI), single photon emission CT (SPECT), optical topography, positron emission tomography (PET) or other inspection techniques ([0077]-[0078]), the specification does not provide any factually supported objective evidence demonstrating that any of the cited species of stimulation applied to the cited species of area at the cited species of timing would result in a higher blood flow rate and a higher metabolic rate in the stimulated area relative to other areas. Thus, the specification only discloses a much limited scope compared to the extremely broad scope encompassed by the claims, and further lacks any objective evidence or working example demonstrating the stimulation would have had the claimed functionality. ACTUAL REDUCTION TO PRACTICE As stated supra, the independent claims and dependent claims have a much broader scope compared to what is disclosed in the specification. Specifically, the specification only discloses a limited number of species of stimulation type to a limited number of species of area at a limited number of species of timing. Furthermore, Applicant does not disclose any factually supported objective evidence demonstrating that any of the cited stimulation application would result in a higher blood flow rate and a higher metabolic rate in the stimulated area relative to other areas. Thus, Applicant fails to show actual reduction to practice the broad scope as being claimed. DISCLOSURE OF STRUCTURE The Applicant has provided a combinatory method of treatment for nerve damage by administering MSCs in combination with a limited number of stimulations applied at 6 timing points to limited areas of the subjects, without any objective evidence or working example demonstrating the stimulation would result in a higher blood flow rate and a higher metabolic rate in the stimulated area. Certainly, a skilled artisan could apply any stimulation at any time before or after the MSC administration to any area capable of compensating the function of the area of nerve damage. However, neither the specification nor the art indicates a relationship between the structure of the claimed genus of stimulation and the ability to increase a blood flow rate and a metabolic rate of the stimulated area. While applications of stimulations are known, it is not routine in the art to screen for multiple substitutions or multiple combinations of the stimulations applied at multiple timing points before or after the MSC administration to multiple areas, as encompassed by the instant claims, and the outcome to increase a blood flow rate and a metabolic rate of the stimulated area is unpredictable. As stated supra, the specification does not support the broad scope of the claims by only disclosing a limited number of species of stimulation but lacking any factually supported objective evidence or working example demonstrating the cited stimulation would have the claimed function. Thus, applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims. Without sufficient guidance, increasing blood flow rate and metabolic rate of the stimulated area by any stimulation to any area at any timing points is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731,8 USPQ2nd 1400 (Fed. Cir, 1988). SUFFICIENT RELEVANT IDENTIFYING CHARACTERISTICS As mentioned in above, applying stimulations are known. Accordingly, if the skilled artisan sought to use the claimed genus of method for treating nerve damage to increase the blood flow rate and metabolic rate of the stimulated area, they would first need to know how to choose the type of stimulations, the area for the stimulation to apply to, and the timing point of applying the stimulation, and still be able to predicably result in increase in the blood flow rate and metabolic rate of the stimulated area. Hence, based on the new written description guidelines, the Examiner should conclude that the applicant was not in possession of the claimed genus of method. The breath of the claims encompasses a very broad genus of method for treating nerve damage by administering MSCs in combination with any stimulation to any area of the subject at any timing points before or after the administration such that the blood flow rate and the metabolic rate of the stimulated area increase. However, the present specification provides no guidance nor description to any rationale in how to choose the type of stimulations, the area for the stimulation to apply to, or the timing point of applying the stimulation, therefore the skilled artisan would not know what rational approach to take to make modifications with any predictable outcome on increased blood flow rate and metabolic rate of the stimulated area. Therefore, it is incumbent on the applicant to provide this nexus between structure and function, in order to be given credit for possession of a larger genus of method related to those individual species. Otherwise, the Written Description guidelines suggest that the applicant is entitled to only the species specifically recited as having this activity. Moreover, even when several species are disclosed, these are not necessarily representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613. STATE OF THE ART & QUANTITY OF EXPERIMENTATION The method of using the claimed invention is not well established. Although combining MSCs with neurorehabilitation is known, one of skill in the art would neither expect nor predict the increase of blood flow rate and metabolic rate of the stimulated area by any stimulation to any area of the subject at any timing points before or after MSC administration according to the claimed genus of method as broadly as is claimed. As stated supra, the specification only discloses a limited number of species of stimulation, but does not provide any factually supported objective evidence or working example demonstrating that any of the cited species of stimulation applied to the cited species of area at the cited species of timing would result in a higher blood flow rate and a higher metabolic rate in the stimulated area relative to other areas. For example, the specification discloses a working example using ice bag cooling stimulation to the paralyzed limbs as sensory stimulation (see [0108]). One of ordinary skill in the art would have immediately expected that the application of an ice bag cooling stimulation to the paralyzed limbs would have resulted in decreased blood flow rate and metabolic rate of the stimulated area relative to other areas of the subject. Furthermore, Ito et al., (Int. J. Mol. Sci. 2020, 21, 3135; p. 1-21. IDS 01/27/2023) summarizes the cell therapy and neurorehabilitation on motor function for stroke recovery and evidences that “[a]s improper stimulation conditions can lead to negative effects, it will be essential to optimize stimulation parameters and consider factors such as injury site, transplanted cell type, and the timing and conditions of stimulation” (p. 12, last para). Therefore, both the instant specification and prior art demonstrate that applying any stimulation to any area of the subject at any timing points before or after MSC administration to increase blood flow rate and metabolic rate of the stimulated area is highly unpredictable. Applicant has claimed a genus of method for treating nerve damage by intravenously administering MSCs in combination with a genus of stimulation to a genus of areas of the subject at any timing points before or after MSC administration, yet the specification has only disclosed a limited number of species of stimulation, area or timing but lacks any factually supported objective evidence or working example demonstrating that any of the cited species of stimulation would result in a higher blood flow rate and a higher metabolic rate in the stimulated area relative to other areas. Independent of how these specific conditions were arrived upon by Applicant, applying any stimulation to any area of the subject at any timing points before or after cell administration cannot predicably increase the blood flow rate and metabolic rate in the stimulated area. Because Applicant has no manner a priori to predict what combination/modification can be done and still be able to increase the blood flow rate and metabolic rate, the genus of method claimed by Applicant cannot be predictably made or used by the ordinary artisan. CONCLUSION The Examiner concludes that there is insufficient written description of the instantly claimed genus of method of treating nerve damage. Specifically, Applicant has only provided limited numbers of species of stimulation type, stimulation area and stimulation timing, and has not provided any factually supported objective evidence or working example demonstrating that any of the cited species of stimulation would result in a higher blood flow rate and a higher metabolic rate in the stimulated area, thus does not provide sufficient number of species to represent the entire scope of the claimed extremely broad genus of method. Therefore, the Examiner concludes that there is insufficient written description to show that Applicant was in possession of the claimed genus of method for treating nerve damage by intravenously administering MSCs in combination with a genus of stimulation to a genus of area of the subject at any timing points before or after MSC administration such that a blood flow rate and a metabolic rate of the stimulated area increase relative to other areas. 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 1-2 and 6 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Choi et al., (Biotechnol. Prog. 2017;33:201-211. Cited in IDS 10/23/2024). With respect to claims 1 and 2, it is noted that the specification discloses that the sensory stimulation is preferably selected from auditory stimulation ([0049]) and the term “auditory stimulation” means stimulation provided by sound ([0057]). Choi teaches a combined therapy to treat a mouse cerebral ischemia model (e.g., see abstract), thus teaches a method of treatment for nerve damage of a subject in need thereof in claims 1 and 2. Choi teaches “At 24 h following completion of the ischemic surgery, hBM-MSCs suspended in saline were intravenously transplanted” (see e.g., p. 202, right col, section “Cerebral ischemic mouse model and groups”, para 2), thus teaches intravenously administering to the subject (i.e., the ischemic model) a therapeutic agent comprising mesenchymal stem cells (i.e., hBM-MSCs) in claims 1 and 2. Choi teaches “The mice were exposed to pulsed electromagnetic fields (PEMFs) and sound waves after transplantation of the hBM-MSCs in vivo” (e.g., p. 204, para 1), thus teaches the therapeutic agent (i.e., hBM-MSCs) being administered to the subject in combination with stimulation of a nerve of the subject, wherein the stimulation is selected from sensory stimulation (e.g., an auditory stimulation of sound waves) and magnetic stimulation (e.g., pulsed electromagnetic fields) in claims 1 and 2. PNG media_image1.png 381 649 media_image1.png Greyscale Choi teaches when applying PEMFs, “the mice cage was located between two solenoid coils” and “PEMF was generated uniformly in the region between the two coils” (see Figure 1 and legend), thus teaches the stimulation is applied to at least an area of nerve damage and an area near the area of nerve damage (since the whole mouse is exposed to PEMF). Choi teaches “To stimulate sound waves, the mice were put into chamber and a sound generating emitter was placed in the ischemic lesion site on the brain” (e.g., p. 204, para 1 and see Fig 2B attached), thus teaches the stimulation is applied to, or is preferentially applied to at least an area of nerve damage and an area adjacent to the area of nerve damage in claims 1 and 2. Choi teaches “The mice were exposed to PEMFs and sound waves after transplantation of the hBM-MSCs in vivo” (e.g., p. 204, para 1) and “24 h after the in vivo induction of ischemia, human BM-MSCs were injected, and the mice were exposed to combined waves for 8 days” (e.g., p. 207, left col, para “Combined wave reduce infarction volume”). Thus, Choi implicitly teaches the stimulation (i.e., combined waves) is performed immediately after the administration of the therapeutic agent (the hBM-MSCs) in claim 1. Regarding the blood flow rate and metabolic rate increase in claims 1 and 2, it must be noted that these wherein clauses do not recite an active step in the claimed method, but only the results of applying the stimulation to the selected area or a given area as taught by Choi. MPEP 2111.04 I states a whereby clause (or a wherein clause) “in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore, these wherein clauses do not provide any patentable weight in determining patentability of the claimed method. Nevertheless, Choi indeed teaches “after stimulation with combined wave, we observed a significant decrease in infarct size and the ischemic zone became smaller and shallower” (p. 207, left col, para “Combined wave reduce infarction volume” and see Fig 6), thus teaches when the stimulation (i.e., combined waves) is applied to the at least one selected area or a given area (i.e., the ischemic lesion site on the brain), a blood flow rate and a metabolic rate of the stimulated area increase to a greater degree relative to other areas of the subject (evidenced by a significant decrease in infarct size and a smaller and shallower ischemic zone), recited in claims 1 and 2. With respect to claim 6, directed to the timing of the administration of the therapeutic agent being adjusted to overlap with a period when blood flow is increased by the stimulation, the specification recites that “the timing of the administration of the therapeutic agent is preferably adjusted to overlap when the affected area has a larger blood flow. Specifically, the time taken for the application of stimulation to increase the blood flow to the affected area tends to be longer in a case where the stimulation is sensory or language stimulation than in a case where the stimulation is electrical or magnetic stimulation. Therefore, in a case where the stimulation is sensory or language stimulation, … the period from the administration of the therapeutic agent to the application of the stimulation is preferably set relatively short (preferably within 3 hours after the administration, more preferably within 1 hour after the administration). In a case where the stimulation is electrical or magnetic stimulation, … the period from the administration of the therapeutic agent to the application of the stimulation may be set relatively long (within 6 hours after the administration, preferably within 3 hours after the administration).” (specification, [0081], page 29). Accordingly, the instant specification discloses that the period from the administration of the therapeutic agent to the application of the sensory or magnetic stimulation being set within 6 hours, within 3 hours or within 1 hour after the administration of the therapeutic agent would result in the administration of the therapeutic agent overlapping with a period during which blood flow in the selected area is increased by the stimulation. As stated supra, Choi teaches “The mice were exposed to PEMFs and sound waves after transplantation of the hBM-MSCs in vivo” (e.g., p. 204, para 1) and “24 h after the in vivo induction of ischemia, human BM-MSCs were injected, and the mice were exposed to combined waves for 8 days” (e.g., p. 207, left col, para “Combined wave reduce infarction volume”). Thus, Choi implicitly teaches the stimulation is performed immediately after the BM-MSCs injection, i.e., the period from the administration of the therapeutic agent (the hBM-MSCs) to the application of the stimulation (electromagnetic fields and sound waves) being set within 6 hours, within 3 hours or within 1 hour after the administration of the MSCs, and thus it would result in the administration of the therapeutic agent overlapping with a period during which blood flow in the selected area is increased by the stimulation in claim 6. Accordingly, Choi anticipates instant claims. Response to Traversal: Applicant’s arguments filed on 06/18/2026 are acknowledged. Applicant's arguments regarding Zhao (Remarks, p. 1) and Mu (Remarks, p. 1-4) become moot because the new ground of rejection does not rely on Zhao or Mu for any teaching or matter specifically challenged in the argument. Regarding the argument on the amended limitation of a blood flow rate and a metabolic rate of the stimulated area increase (Remarks, p. 3), Applicant is reminded that this limitation does not recite an active step in the claimed method, but only the results of applying the stimulation to the selected area, thus does not provide any patentable weight in determining patentability of the claimed method. See MPEP 2111.04 I. 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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Choi et al., (Biotechnol. Prog. 2017;33:201-211. Cited in IDS 10/23/2024). Claim 7 is directed to the stimulation being started during the intravenous administration of the therapeutic agent. As stated supra, Choi teaches the stimulation (PEMFs and sound waves) is started after the intravenous administration of the therapeutic agent (hBM-MSCs) (see e.g., p. 204, para 1 and p. 207, left col), but is silent on the stimulation being started during the intravenous administration of the therapeutic agent. However, Choi clearly contemplates protocols to optimize the stimulation conditions, such as “First, we identified the optimal range for PEMFs (10 mT, 60 Hz) and sound waves (1 kHz, 81 dB) to exert neurogenic effects and performed analysis via RT-PCR and Western blotting (data not shown). To find the optimal conditions and protocol for exposure to combined wave, various conditions with PEMFs and sound waves were conducted in vitro.” (e.g., p. 208, para 1). Furthermore, Choi teaches “the combined wave greatly enhanced the endogenous neural differentiation of hBM-MSCs in vivo” (p. 209, para 1). Thus, Choi teaches the stimulation (the combined wave) has effect on the therapeutic agent (the hBM-MSCs). Accordingly, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combinatory method of treating nerve damage by starting PEMF and sound wave stimulation after the intravenous administration of hBM-MSCs, by substituting with a protocol of starting PEMF and sound wave stimulation during the intravenous administration of hBM-MSCs with a reasonable expectation of success. Since Choi contemplates protocols to optimize the stimulation exposure and teaches the combined wave greatly enhanced the endogenous neural differentiation of hBM-MSCs in vivo, one of ordinary skill in the art would have had a reason to substitute with starting PEMF and sound wave stimulation during the intravenous administration of hBM-MSCs, instead of after the MSC administration, in order to elongate the effect time of the stimulation on the MSCs to obtain enhanced neural differentiation of MSCs by the stimulation. Furthermore, because the timing of administering MSCs and stimulation is a results effective variable (see e.g., Fig 6 for applying stimulation and MSCs in different protocols), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to apply the claimed protocol to start the stimulation during administration of MSCs, since it has been held that discovering an optimum value/protocol of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary. Response to Traversal: Applicant’s arguments filed on 06/18/2026 are acknowledged and have been discussed above. Withdrawn Double Patenting Rejections The prior rejection of claims 1-2 on the ground of nonstatutory double patenting as being unpatentable over claims of US Patent No. 12,599,632 is withdrawn in light of Applicant’s filing of the terminal disclaimer filed on June 18, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No: 12,599,632. Conclusion No claims are allowed. Examiner Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST). 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, James Douglas (Doug) Schultz can be reached on (571) 272-0763. 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. /JIANJIAN ZHU/Examiner, Art Unit 1631
Read full office action

Prosecution Timeline

Jan 27, 2023
Application Filed
Oct 08, 2025
Non-Final Rejection mailed — §102, §103, §112
Jan 02, 2026
Response Filed
May 04, 2026
Final Rejection mailed — §102, §103, §112
Jun 18, 2026
Request for Continued Examination
Jun 22, 2026
Response after Non-Final Action
Oct 16, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
58%
Grant Probability
99%
With Interview (+82.5%)
3y 8m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 86 resolved cases by this examiner. Grant probability derived from career allowance rate.

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