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
The text of those sections of Title 35, U.S. Code not included in this action can be found
in a prior Office action.
This Action is in response to the papers filed on January 20, 2026 for a Request for Continued Examination. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 20, 2026 has been entered.
Pursuant to the amendment filed on January 20, 2026, claims 1-7, 22, 25-26, 30, 34-36, 39-41, 44-45, 48, 56, 60-67, 69, 73, 76,78, 81-83, and 86-91 are currently pending of which claim 1 has been amended, and claims 86-91 are newly added. No claims have been cancelled.
Claims 2-12, 14-15, 17, 19-21, 25-26, 30, 34-36, 39-41, 44-45, 48, 56, 60-67, 69, 73, 76, 78 and 81-83 were previously withdrawn in the Office Action dated December 2, 2024. The restriction requirement between Groups I-IV was previously made FINAL. In view of new claims 86-91 that are directed to Group I, they are examined herein.
Therefore, claims 1, 22, and 86-91are currently under examination to which the following grounds of rejection are applicable.
Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or an official IDS, they have not been considered.
Response to Arguments
Withdrawn Objections/Rejections in response to Applicants’ arguments or amendments:
Claim Rejections - 35 USC § 112
In view of Applicants’ amendment to the claims dated January 20, 2026, wherein claim 1 has been amended, the rejection to claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite has been withdrawn.
Claim Rejections - 35 USC § 103
In view of Applicants’ amendment to the claims dated January 20, 2026, wherein claim 1 has been amended, the rejection to claims 1 and 22 rejected under 35 U.S.C. 103 as being obvious over Shi et al. in view of Denu and Lin, are withdrawn.
The withdrawn rejections are in view of the amended claim 1, and in view of the corresponding Remarks filed.
Applicants' arguments are moot in view of the withdrawn rejection. A response to any argument pertaining to a new or maintained rejection can be found below.
Response to Applicants' Arguments as they apply to rejection of claims 1 and 22 rejected under 35 USC § 103 as being obvious in view of Shi et al. 2019 (The Spine Journal 2019, 19, 171-181) ("Shi") in view of Lin et al 2017 (J Orthop. Trans/at. 2017, 9, 19-27) ("Lin") and Denu et al 2016 (Acta Haematologica 2016, 136, 85-97) ("Denu")
Starting on page 12 of the remarks filed on January 20, 2026, Applicants essentially argue the following:
Fibroblasts and MSCs are distinguishable, and points to Lin as referring to fibroblasts as different from MSCs, Denu describing select fibroblasts as incapable of differentiating into select cell lines for which MSCs can differentiate into.
The references do not teach the gene markers that are recited in the claim.
Applicants’ response has been fully considered, but is not persuasive due to the following reasons:
Regarding the first argument presented, the new grounds of rejection employ Shi et al. in view of Denu et al., Nitzsche et al., How et al., and evidenced by Page et al. The rejections no longer employ the Lin reference, and therefore the argument pertaining to Lin as described in the Remarks is considered moot. The fibroblasts of Shi remain to be taught as similar, or rather indistinguishable from MSCs because Shi explicitly states this.. The Nitzsche reference fills the gap of teaching the homing ability of MSCs.
In reference to Denu describing select studies showing fibroblasts as incapable of differentiating in certain cell lines, the reference then explores if such outcomes are accurate, and states, “We provide evidence that fibroblasts and MSCs could not be distinguished phenotypically, based on their morphology, cell surface markers, differentiation potential and immunomodulatory properties. We demonstrate that 4 well-established fibroblast strains express all the cell surface markers of the ISCT consensus criteria that are used to define MSCs [10], and that they are also capable of differentiating into adipocytes, chondrocytes and osteoblasts. Additionally, we show that the extracellular matrix secreted by MSCs is similar to that secreted by fibroblasts [40,41]” (Discussion, emphasis added). Therefore, Denu’s own experimental findings clarify any uncertainty, concluding the cell types are highly similar, and not distinguishable.
Moreover, despite this argument that connects the homing ability characteristic of MSC to fibroblasts, the claim remains anticipated or obvious based on the new 102/103 rejection that is not dependent on the fibroblasts = MSC reasoning. This is because the active method step and composition used are taught by Shi with fibroblasts. Despite the reference not describing the outcomes of regeneration at the first tissue site as opposed to the second site (site of administration), this outcome is expected since the steps and compositions are the same, in particular this outcome would naturally stem from the teachings of Shi. Furthermore, the scope of the tissue sites remain broad, and there is an expectation that the first site would be stimulated when it is next to the site second site.
Regarding the second presented argument, the new grounds of rejection employ Page et al. that supports fibroblasts express the following cell markers: Nanog and Oct-4, and therefore an expectation that Shi’s fibroblasts express such genes.
Claim Rejections - 35 USC § 102/ 103
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.
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.
Claims 1 and 22 are newly rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Shi et al. (The Spine Journal 19.1 (2019): 171-181; of record ) as evidenced by Page et al. (Cloning and stem cells 11.3 (2009): 417).
Shi teaches the administration of dermal fibroblasts (neonatal human dermal fibroblasts (nHDFs) and rabbit dermal fibroblasts (RDFs)) into degenerated rabbit intervertebral discs (IVDs), wherein the outcomes observed were increased disc height, increased expression of collagen types I and II, and increased proteoglycan content, these outcomes were observed at higher rates with using nHDFs than RDFs. Altogether, “This study showed that cell transplantation with nHDF into degenerated IVDs can significantly increase markers of disc regeneration (disc height, collagen type I and II gene expression, and proteoglycan contents).” (Abstract; p 9, par 2). Shi further teaches that MSCs have been shown to have similar outcomes to that of the fibroblasts in rabbits; and that in treatments in humans, patients reported improvements in pain and function (Discussion). Shi then describes “Based on the current definition of MSCs by the International Society for Cell Therapy, researchers have found that MSCs are not distinguishable from fibroblasts.”, which means the scope of the claim may take into account therapies that employ mesenchymal stem cells (p 9, col 2, par 3).
In reference to the cell markers limitation recited Shi is silent on, “wherein the (i) fibroblasts, (ii) dedifferentiated fibroblasts, or (iii) fibroblasts and dedifferentiated fibroblasts express at least one marker selected from the group consisting of NANOG, OCT-4, SSEA-4, stem cell factor receptor, and a combination thereof,” however, fibroblasts inherently express Nanog and Oct-4 as evidenced by Page et al. (abstract). Regarding dedifferentiated cells, of which the instant specification describes as encompassing precursor or progenitor cells, multipotent stem cells, e.g. MSCs, and pluripotent stem cells (0028), Page describes the activation of OCT4, SOX2, NANOG, and LIN28 leads to pluripotent state, and therefore Nanog and Oct-4 are inherently expressed by dedifferentiated cells that are stem cells (Introduction).
Lastly, in reference to the limitation of administration of fibroblasts and/or dedifferentiated fibroblast cells to a second tissue site in order to stimulate regeneration in a first tissue site, the method describes degeneration as occurring across the ventral surface of four consecutive lumbar IVDs (L2/L3, L3/L4, L4/L5, and L5/L6) in which fibroblasts were then administered to these IVDs four weeks later in which regeneration characteristics were then observed (p 3 col 1, par 3-4). Based on the broad scope of claim 1, that recites administration of a composition to a single site with (i) fibroblasts, (ii) dedifferentiated fibroblasts, or (iii) fibroblasts and dedifferentiated, and wherein there is no limitation regarding the proximity of the tissue sites and/or viability/health of the first tissue site, it can be understood that Shi teaches this claim. In particular, since the active steps are the same and the compositions are the same, there is an expectation the outcomes related to this step would be similar, that is of stimulating regeneration in the first tissue site. For this reason, the claim is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shi as evidenced by Page.
However, even if Shi’s teachings in relation to the administration with corresponding outcomes and the regenerative composition comprising fibroblasts are not one and the same with the claimed method recited in claim 1, and there is, in fact, no anticipation, Shi as evidenced by Page would, nevertheless, have rendered to one of ordinary skill in the art at the time of the invention to have claimed the fibroblasts expressing Oct-4 and/or Nanog based on these genes being known to inherently be expressed in fibroblasts. Thus, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the references, especially in the absence of evidence to the contrary.
When the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention a basis for shifting the burden of proof to applicant is present, as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). See MPEP §§ 2112 - 2112.02.
Based on the Shi reference teaching all the limitations of the claim except the properties pertaining to the gene markers of the employed fibroblasts and the outcome of using these cells which are considered inherent properties of the fibroblasts, it is clear Shi anticipates or renders obvious the claimed invention.
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.
Claims 1, 22, and 86-91 are newly rejected under 35 U.S.C. 103 as obvious over Shi et al. (The Spine Journal 19.1 (2019): 171-181; of record ) in view of Denu et al. (Acta haematologica 136.2 (2016): 85-97; of record), Nitzsche et al. (Stem Cells, Volume 35, Issue 6, June 2017, Pages 1446–1460), and How et al. (Journal of Trauma and Acute Care Surgery 79.4 (2015): 592-601), as evidenced by Page et al. (Cloning and stem cells 11.3 (2009): 417).
As described in the 35 USC 102/103 rejection, Shi teaches the entirety of claim 1, but does not teach the employed fibroblasts express the claimed gene markers, and secondly, does not teach the outcomes at the first tissue site (different than site of administration). However, the claim is anticipated or would be obvious based on fibroblasts inherently expressing a subset of these markers as evidenced by Page, and the outcome related to tissue regeneration is to be expected since the method steps and compositions taught by Shi are similar to that claimed. Secondly, the rejection describes that MSCs are indistinguishable from fibroblasts, and outcomes related to their use are also similar.
The rejection below is directed to the regenerative composition comprising (i) fibroblasts that are comparable to mesenchymal stem cells (MSC), (ii) dedifferentiated fibroblasts, or A (iii) combination thereof.
Regarding claim 1, Shi teaches the administration of dermal fibroblasts (neonatal human dermal fibroblasts (nHDFs) and rabbit dermal fibroblasts (RDFs)) into degenerated rabbit intervertebral discs (IVDs), wherein the outcomes observed were increased disc height, increased expression of collagen types I and II, and increased proteoglycan content, these outcomes were observed at higher rates with using nHDFs than RDFs. Altogether, “This study showed that cell transplantation with nHDF into degenerated IVDs can significantly increase markers of disc regeneration (disc height, collagen type I and II gene expression, and proteoglycan contents).” (Abstract; p 9, par 2).
In reference to MSC, Shi teaches MSCs have been shown to have similar outcomes to that of the fibroblasts in rabbits; and that in treatments in humans, patients reported improvements in pain and function (Discussion). Furthermore, Shi describes “Based on the current definition of MSCs by the International Society for Cell Therapy, researchers have found that MSCs are not distinguishable from fibroblasts.” The expression of cell surface markers are the same, both cell types demonstrating multipotency, and preventing T cell activation and proliferation and inhibit in vitro graft versus host reaction, and concluding “Our results suggest that the therapeutic effects of nHDF in the rabbit degenerated discs are similar to those reported in animal studies that tested MSC intradiscal treatment” (p 9, col 2, par 3).
In further support of the similarity between fibroblasts and MSCs, Denu states “Fibroblast strains had a similar morphology to MSCs, expressed the same cell surface markers as MSCs and could also differentiate into adipocytes, chondrocytes and osteoblasts. Also, similar to MSCs, these fibroblasts were capable of suppressing T cell proliferation and modulating the immunophenotype of macrophages. We also show that MSCs deposit extracellular matrices of collagen type I and fibronectin, and express FSP1 in patterns similar to fibroblasts…Based on currently accepted definitions for cultured human MSCs and fibroblasts, we could not find any immunophenotypic property that could make a characteristic distinction between MSCs and fibroblasts.” (Abstract).
In reference to the cell markers limitation recited, Shi is silent on , “wherein the (i) fibroblasts, (ii) dedifferentiated fibroblasts, or (iii) fibroblasts and dedifferentiated fibroblasts express at least one marker selected from the group consisting of NANOG, OCT-4, SSEA-4, stem cell factor receptor, and a combination thereof,” however, fibroblasts inherently express Nanog and Oct-4 as evidenced by Page et al. (abstract). Regarding dedifferentiated cells, of which the instant specification describes as encompassing precursor or progenitor cells, multipotent stem cells, e.g. MSCs, and pluripotent stem cells (0028), Page describes the activation of OCT4, SOX2, NANOG, and LIN28 leads to pluripotent state, and therefore Nanog and Oct-4 are inherently expressed by dedifferentiated cells that are stem cells (Introduction).
In reference to the limitation of administration of fibroblasts and/or dedifferentiated fibroblast cells to a second tissue site in order to stimulate regeneration in a first tissue site, Shi teaches describes degeneration as occurring across the ventral surface of four consecutive lumbar IVDs (L2/L3, L3/L4, L4/L5, and L5/L6) in which fibroblasts were then administered to these IVDs four weeks later in which regeneration characteristics were then observed (p 3 col 1, par 3-4). Based on the broad scope of claim 1, that recites administration of a composition to a single site with (i) fibroblasts, (ii) dedifferentiated fibroblasts, or (iii) fibroblasts and dedifferentiated, and wherein there is no limitation regarding the proximity of the tissue sites and/or viability/health of the first tissue site, it can be understood that Shi teaches this claim. In particular, since the active steps are the same and the compositions are the same, there is an expectation the outcomes related to this step would be similar, that is of stimulating regeneration in the first tissue site.
Shi in view of Denu does not teach the limitation of stimulating regeneration in a first tissue site in an individual, despite this outcome being expected as described above.
Nitzsche teaches using MSC in cellular therapies for regenerative medicine, wherein MSC home towards lesion sites, particularly sites of injury and inflammation (abstract). MSC administration can be conducted either systemically or locally, wherein the homing in site-specific/local transplantation follows chemotactic principles whereas systemic transplantation also involves travel in coordination with the vascular system (Fig. 1); further stating, “This distinct homing capability enables application of minimally invasive systemic delivery strategies in clinical practice, facilitating a widespread implementation of novel MSC-based treatment protocols.” (Introduction).
Therefore, since the understanding of MSC and fibroblasts are similar as described by Shi and Denu, Shi’s teaching of administering fibroblasts/MSC is expected to provide treatment to more than the site of administration based on Nitzsche’s teaching.
Shi in view of Denu and Nitzsche teach in relation to the regenerative composition comprising (i) fibroblasts or mesenchymal stem cells, but does not teach in relation to (ii) dedifferentiated fibroblasts, or (iii) a combination of both.
How et al. teaches the dedifferentiation of fibroblasts wherein Oct4, Sox2, and Klf4 were introduced into mouse embryonic fibroblasts (MEFs) via retroviral transfection to obtain induced pluripotent stem cells (iPSCs). In a mice model of mesenteric ischemia-reperfusion injury, iPSC were administered intravenously, and engrafted to the lungs and the ileum in response the injury. The iPSCs were seen to decrease the intensity of acute lung injury 24 hours after the induced injury, furthermore the transplantation significantly reduced the expression of proinflammatory cytokines, oxidative stress markers, and apoptotic factors in injured lung tissue and remarkably enhanced endogenous alveolar cell proliferation. The treatments with just the iPSC-conditioned medium treatment exerted a partial effect compared with iPSC treatment (abstract). The obtained iPSC expressed Nanog and Oct-4 amongst other stem cell gene markers (p 593, col 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have been motivated to describe fibroblasts as stimulating regeneration in different tissues based on fibroblasts being similar to mesenchymal stem cells (MSC), and the known capacity of MSCs to migrate towards inflammation/ wounds and facilitate regeneration as described by Nitzsche. Regardless on the particular degree of likeness between these cell groups, it would remain obvious to substitute MSC with fibroblasts based on the similarities between these groups in relation to both function and morphology as described by Shi and Denu, and the known capabilities MSC have in relation to homing and tissue regeneration at site of injury as described by Nitzsche.
Furthermore, in the instance the regenerative composition comprises (ii) dedifferentiated fibroblasts, it would be obvious to substitute the fibroblasts of Shi in view of Denu and Nitzsche with the iPSCs that are derived from fibroblasts as taught by How. The teachings of How describe therapeutic outcomes when using these iPSCs for treatment of mesenteric ischemia-reperfusion injury, and therefore it would be obvious to use these iPSC as they display similar properties in treatment of injuries, and moreover comprise the same gene markers as evidenced by Page and further taught by Nitzsche.
Lastly, in the instance the regenerative composition comprises (iii) dedifferentiated fibroblasts and fibroblasts, it would be obvious to try based on the respective groups being shown as effective in treatments, and therefore the combination of cell groups are expected to have a similar outcome. In further support, Shi describes “Rabbit discs that were treated with a combination of cells (MSCs or human umbilical cord derived cells), different carriers, scaffolds or proteins resulted in higher MRI signals had lesser signs of disc degeneration than the injured untreated groups.” (p 179, col 1) The combination of different cell groups has been used prior, and has led to improved outcomes, and therefore, using both the taught fibroblasts and dedifferentiated fibroblasts would be an obvious choice
Regarding claim 22, dependent on claim 1, Shi teaches administering two different fibroblasts, nHDFs and RDFs, wherein the respective dosage were nHDFs (1×107, 5×107, and 1×108 cells/mL) or RDFs (1×107 cells/mL) (p 3 col 1, par 3-4).
Regarding claim 86, the rejection above to claim 1 describes the teachings of How teaching using iPSCs for treatments, and moreover Shi teaches outcomes in relation to MSC, and therefore the prior art teachings above adequately describe the composition as comprising stem cells. It is also described above, that the prior art references of Shi and Denu, considers fibroblasts as MSCs, a type of stem cell.
Regarding claim 87, the claim is similar to claim 1, but recites the additional steps of determining, or having determined, tissue functionality of a tissue at a first site as seen in steps (i) and (iii), and then limits the scope of the tissue functionality to select conditions. The rejection above to claim 1 is applied herein, and in relation to steps (i) and (iii), Shi describes that X-rays were taken before and after treatments, “To determine whether the nHDF or RDF transplantation could help regenerate the disc and increase the disc height, X-rays were taken before injury, 4 weeks after injury, and 8 weeks after transplantation (n=21–27).” The images were used to calculate disc height indexes (DHI) and intervertebral disc (IVD) heights to then be compared before and after treatments (p 174, col 1). Therefore, Shi teaches steps (i) and (iii), and moreover determining tissue functionality in view of degeneration via X-Ray imaging. In respect to the difference between the first and second tissue sites, the rejection to claim 1 describes broadness of the scope encompassing nearby regions to the site of administration. The imaging conducted by Shi is expected to encompass the first tissue site.
Regarding claims 88, dependent on claim 1, and claim 89, dependent on claim 87, the rejection of Shi in view of Denu, Nitzsche, and How describe the homing abilities of MSC, similar to that of fibroblasts, when administered systemically. Therefore, there is an expectation that a site of injury can be reached if contralateral to the site of systemic administration. Moreover, it is acknowledging that the scope remains broad as there is no limitation regarding the specific site of administration for which the other site is contralateral. The Example in the Specification describes administering to the knee and the other site being contralateral, yet the instant claims are not identical.
Regarding claims 90, dependent on claim 1, and claim 91, dependent on claim 87, the rejection above is applied herein when systemic delivery is employed, as there would an expectation that a tissue site that is a bilateral tissue on a different part of the body would be reached as the cells would be traveling via vascular system as described by Nitzsche (Fig. 1 and 2).
Maintained Objections/Rejections in response to Applicants’ arguments or amendments:
Double Patenting
Claims 1, 22 remain provisionally rejected and claim 86 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11-13, 21-23 of copending Application No. 17/052,859 as per claims filed on August 27, 2025 (hereinafter ‘859) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420; of record) because:
The provisional rejection of claims 1, 22, and 86 on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7, 11-13, and 21-23 of copending Application No. 17/052,859 as per claims filed on August 27, 2025 (hereinafter ‘859) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420) is maintained. Applicants offer to provide a terminal disclaimer upon indication by the Examiner of allowable claims. However, Applicant’s request is not a proper response to the rejections of record as it neither traverses the grounds of rejection by providing specific arguments, nor indicates that a terminal disclaimer has been filed to overcome the rejection. As such, the rejections of record stand.
Claims 1, 22 remain provisionally rejected and claim 86 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10-11, 13, 36-38, 41-45 of copending Application No. 18/042,323 as per claims filed on February 24, 2026 (hereinafter ‘323) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420) because:
The provisional rejection of claims 1, 22, and 86 on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5, 10-11, 13, 36-38, 41-45 of copending Application No. 18/042,323 as per claims filed on February 24, 2026 (hereinafter ‘323) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420) is maintained. Applicants offer to provide a terminal disclaimer upon indication by the Examiner of allowable claims. However, Applicant’s request is not a proper response to the rejections of record as it neither traverses the grounds of rejection by providing specific arguments, nor indicates that a terminal disclaimer has been filed to overcome the rejection. As such, the rejections of record stand.
Claims 1, 22 remain provisionally rejected and claim 86 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 20-22, 28-30, 35-36, 43-46, 51-52, 63, and 75 of copending Application No. 17/996, 033 as per claims filed on January 12, 2026 (hereinafter ‘033) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420) because:
The provisional rejection of claims 1, 22, and 86 on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 20-22, 28-30, 35-36, 43-46, 51-52, 63, and 75 of copending Application No. 17/996, 033 as per claims filed on January 12, 2026 (hereinafter ‘033) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420) is maintained. Applicants offer to provide a terminal disclaimer upon indication by the Examiner of allowable claims. However, Applicant’s request is not a proper response to the rejections of record as it neither traverses the grounds of rejection by providing specific arguments, nor indicates that a terminal disclaimer has been filed to overcome the rejection. As such, the rejections of record stand.
Claims 1, 22 remain provisionally rejected and claim 86 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, and 15 of copending Application No. 17/309,177 as per claims filed on August 6, 2025 (hereinafter ‘177) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420) because:
The provisional rejection of claims 1, 22, and 86 on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12, and 15 of copending Application No. 17/309,177 as per claims filed on August 6, 2025 (hereinafter ‘177) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420) is maintained. Applicants offer to provide a terminal disclaimer upon indication by the Examiner of allowable claims. However, Applicant’s request is not a proper response to the rejections of record as it neither traverses the grounds of rejection by providing specific arguments, nor indicates that a terminal disclaimer has been filed to overcome the rejection. As such, the rejections of record stand.
Claims 1, 22 remain provisionally rejected and claim 86 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-13, and 16-28 of copending Application No. 17/309,178 as per claims filed on January 20, 2026 (hereinafter ‘178) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420) because:
The provisional rejection of claims 1, 22, and 86 on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 5-13, and 16-28 of copending Application No. 17/309,178 as per claims filed on January 20, 2026 (hereinafter ‘178) in view of Lefevre at al. (Nature medicine 15.12 (2009): 1414-1420) is maintained. Applicants offer to provide a terminal disclaimer upon indication by the Examiner of allowable claims. However, Applicant’s request is not a proper response to the rejections of record as it neither traverses the grounds of rejection by providing specific arguments, nor indicates that a terminal disclaimer has been filed to overcome the rejection. As such, the rejections of record stand.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
Claims 86-91 are newly 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.
Claim 87 is indefinite in reference to the method steps listed in (i), (ii), and (iii) where it states the following steps: “or having determined”, “or having administered”, and “or having determined”, respectively, as it is unclear if these are active steps for which the method requires. Specifically, the claim is currently written in which no active steps may be required to carry out the method of the claimed invention when using the tense “having…”. With this said, the claim is directed to an outcome as opposed a method.
Claim 87 recites the limitation "the individual" in lines 11-12, and 13 (twice). There is insufficient antecedent basis for this limitation in the claim. In particular, there is no introduction of “an individual” prior to this recitation.
Regarding claim 87, the limitation recited below appears to be incorrectly recited as it appears a comparison is being made between the outcomes at the first site versus the second site, however, the limitation does not complete this comparison as seen at the end of the following phase:
“wherein the cell death, tissue necrosis, atrophy, fibrosis, inflammation, fat deposition, generation of degenerative molecules, loss of elasticity, neurodegeneration, autoimmunity, complement activation, cartilage loss, ligament tears, muscle tears, loss of connective tissue, neoplasms, or a combination thereof, of the tissue at a first site according to (iii) is less than the cell death, tissue necrosis, atrophy, fibrosis, inflammation, fat deposition, generation of degenerative molecules, loss of elasticity, neurodegeneration, autoimmunity, complement activation, cartilage loss, ligament tears, muscle tears, loss of connective tissue, neoplasms, or a combination thereof step (i).”
Conclusion
Claims 1, 22, and 86-91 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL A RIGA whose telephone number is (571)270-0984. The examiner can normally be reached Monday-Friday (8AM-6PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ANGELO RIGA/ Examiner, Art Unit 1634
/TERESA E KNIGHT/ Primary Examiner, Art Unit 1634