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 .
Election/Restrictions
Claims 1, 5, 9-10, 50-53, 62-72 are pending.
Claims 1, 9, and 50-53 are amended.
Claims 62-72 are newly added.
Claims 1, 5, 9-10, 50-53, 62-72 have been examined on their merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection of claims 1, 5, 9, and 50-51 under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Penn et al. (WO2006002152, 2006, on IDS 10/20/2022) is withdrawn due to amendment of the claims and Applicant’s persuasive arguments (see Response to Arguments, below).
The rejection of claims 1 and 10 under 35 U.S.C. 103 as being unpatentable over Penn et al. (WO2006002152, 2006, on IDS 10/20/2022) in view of Arnold et al. (International Journal of Molecular Science, 2018) is withdrawn in order to address the claims as amended.
The rejection of claims 1, 12, 52, and 53 under 35 U.S.C. 103 as being unpatentable over Penn et al. (WO2006002152, 2006, on IDS 10/20/2022) in view of Wang et al. (Cardiovascular Research, 2009, on IDS 10/20/2022) and Lee et al. (International Journal of Molecular Sciences, 2018, on IDS 10/20/2022) as evidenced by SinoBiological (Recombinant Human NAMPT Protein, retrieved from internet 12/04/2025), and NCBI (alignment 10990-H20B with SEQ ID NO: 3, retrieved from internet 12/04/2025, hereafter “NCBI”) is withdrawn in order to address the claims as amended.
Claim Rejections - 35 USC § 112(a)
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, 5, 9-10, 50-53, 62-72 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 encompasses a genus of NAMPT “or any fragment thereof comprising a cytokine finger (cif) motif, or a modified form thereof, or a functional derivative thereof.”
Dependent claims 9, 52-53, 62-64 repeat the limitations of any fragment comprising a cif domain, modified form, or derivative of NAMPT.
Dependent claims 5, 10, 50-51, and 65-72 provide further embodiments of the methods.
According to claim 53, the NAMPT “or fragment thereof, or a modified form thereof, or a functional derivative thereof” can consist of SEQ ID NO:3.
According to claim 62, the NAMPT “or fragment thereof, or a modified form thereof, or a functional derivative thereof” comprises the amino acid sequences in SEQ ID NO: 1, 2, or 5, or can have at least 80% identity with these sequences.
It is noted that SEQ ID NO: 3 contains 491 amino acids, while SEQ ID NO: 1 , 2, and 5 contain 91 amino acids.
While the claimed fragments must have a “cytokine finger (cif) motif”, in regards to the meaning of a cif motif the instant specification states, “the C-terminus of NAMPT was recombinantly reproduced . . . this fragment, which is termed herein a ‘cytokine finger’ (cif) (paragraph [0404]).
Thus, a fragment with a cif motif is any fragment that minimally comprises the C-terminus (which can be the very last amino acid in the polypeptide chain).
Furthermore, because this motif is a natural part of the NAMPT polypeptide, full length wild type NAMPT also has this motif.
Therefore, since SEQ ID NO: 3 contains 491 amino acids, this still results in at least 491 possible fragments (assuming the fragments are contiguous) with a possible fragment being a single amino acid. Likewise, SEQ ID NO: 1 , 2, and 5 result in at least 91 fragments each, including the single amino acid histidine.
In regards to a modified form of the NAMPT or a functional derivative of the NAMPT, these are not defined in the claims or specification and therefore, can refer to any modified form or functional derivative of NAMPT.
Under the written description guidelines (see MPEP 2163) the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
Actual Reduction to Practice
In regards to claims 1, 5, 9-10, 50-53, 62-72, while broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc).
While the instant specification asserts a genus of NAMPT “or any fragment thereof comprising a cytokine finger (cif) motif, or a modified form thereof, or a functional derivative thereof”, the specification only identifies full length recombinant NAMPT (paragraph [0400]) or an unspecified single fragment in vitro (paragraph [0404]), but does not test for modifications, functional derivatives, or other fragments.
Accordingly, Applicant has not demonstrated the full genus of any fragment comprising a cytokine finger (cif) motif, a modified form thereof, or a functional derivative and has not demonstrated identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of compositions.
State of the Art
In regards to claims 1, 5, 9-10, 50-53, 62-72, while as evidenced by SinoBiological (Recombinant Human NAMPT Protein, retrieved from internet 12/04/2025, previously cited), recombinant full length NAMPT was known in the art, the art is silent as to fragments, modifications, functional derivatives of the broad genus as claimed.
Additionally, as above, the claimed sequences in SEQ IDs: 3 and 1/2/5 amount to at least 491 and 91 fragments comprising a cif, respectively. Indeed, as above, this can be the single amino acid histidine.
Therefore, the was not well established with a representative number of the genus of “any fragment thereof comprising a cytokine finger (cif) motif, or a modified form thereof, or a functional derivative thereof” as claimed. This would require undue experimentation, and one of skill in the art would neither expect nor predict the genus of any fragment thereof comprising a cytokine finger (cif) motif, or a modified form thereof, or a functional derivative thereof.
Conclusion
In regards to claims 1, 5, 9-10, 50-53, 62-72, the claims require any fragment thereof comprising a cytokine finger (cif) motif, or a modified form thereof, or a functional derivative thereof, yet the instant specification guidance for full length NAMPT and one unspecified fragment.
Indeed, as a fragment, even a fragment that comprises a cif motif can comprise a single amino acid (such as histidine) and the specification does not disclose identifying these fragments from the fragments of other proteins. While full-length NAMPT itself was known in the art, the art is not well established as to the genus of possible fragments.
As above, neither the specification nor the art describes the broad genus of modified forms or functional derivatives.
Therefore, the Examiner concludes that there is insufficient written description of the instantly claimed genus of any fragment thereof comprising a cytokine finger (cif) motif, or a modified form thereof, or a functional derivative thereof. Specifically, there no description of any fragment thereof comprising a cytokine finger (cif) motif, or a modified form thereof, or a functional derivative thereof, the art does not adequately describe the genus of possible fragment thereof comprising a cytokine finger (cif) motif, modified forms thereof, or functional derivatives thereof, and a person of ordinary skill in the art would find that the specification inadequately described the claimed genus of compositions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 9, 50-53, 62-64, 67, 69, 70, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Penn et al. (WO2006002152, 2006, on IDS 10/20/2022, previously cited) in view of Frederick et al. (Cell Metabolism, 2016) and Lee et al. (International Journal of Molecular Sciences, 2018, on IDS 10/20/2022, previously cited) as evidenced by SinoBiological (Recombinant Human NAMPT Protein, retrieved from internet 12/04/2025, previously cited), NCBI (alignment 10990-H20B with SEQ ID NO: 3, retrieved from internet 12/04/2025, hereafter “NCBI”, previously cited), and NCBI (alignment 10990-H20B with SEQ ID NO: 1, retrieved from internet 05/15/2026, hereafter “NCBI 2”).
In regards to claim 1, Penn teaches methods for regenerating skeletal muscle comprising administering a CCR5 ligand to a subject (claim 1; p30, lines 03-12).
Penn does not explicitly teach that the CCR5 ligand is NAMPT specifically (it is noted that NAMPT is a well-known species of CCR5 ligand).
However, a person of ordinary skill in the art would have been motivated to use NAMPT as a CCR5 ligand because Frederick teaches that exposure to NAMPT prevents age-related decline in muscle function in subjects (Summary, p269; Gain of Nampt Function Maintains Exercise Capacity into Old Age; p275-276).
Furthermore, because Lee teaches that recombinant visfatin (NAMPT) can be administered to subjects in vivo to improve wound healing (Abstract, p1; Fig. 5, p8), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 5, Applicant should note that this is a property or natural consequence of the method of claim 1. Since the method of Penn results in treatment of muscle tissue, and carries out the method steps as in claim 5, it would be expected to do so without fibrosis.
In regards to claim 9, Penn teaches that the composition can be a cellular composition comprising cells that express the CCR5 (i.e., NAMPT (claim 1; p16, lines 1-30).
In regards to claim 50, Penn teaches that the composition is administered to skeletal muscle (p30, lines 03-12).
In regards to claims 51 and 72, Penn teaches that additives that enhance the stability (which would promote delivery) of the composition may be added (p15, lines 16-19).
In regards to claims 52-53 and 62, in regards to a “cytokine finger (cif) motif” the instant specification states, “the C-terminus of NAMPT was recombinantly reproduced . . . this fragment, which is termed herein a ‘cytokine finger’ (cif) (paragraph [0404]). Thus, the “cytokine finger (cif) motif” is a natural part of the NAMPT protein. Thus, claim 52 allows for any fragment of the NAMPT protein as long as it comprises the “cytokine finger (cif) motif” of the NAMPT protein.
Additionally, in regards to what the disclosure considers a NAMPT fragment, the specification states, “In one embodiment, NAMPT or a part thereof comprising a cytokine finger (cif) motif or a derivative thereof comprising a cytokine finger (cif) motif, comprises the amino acid sequence set out in one of SEQ ID NO: 1 to 4”.
Thus, a NAMPT that comprises SEQ ID: 3 (as in claim 53), is considered a NAMPT fragment per the specification.
To this end, Lee teaches that the recombinant NAMPT, is a commercial product (Reagents and Antibody, p10; SinoBiologcal 10990-H20B). As evidenced by SinoBiological, recombinant NAMPT 10990-H20B, comprises has the amino acid sequences of accession number P43490 (first page). As further evidenced by NCBI, NAMPT P43490 (Query 1) has 100% hit identity with SEQ ID: 3 (Subject 1), and therefore, is a NAMPT fragment comprising a cytokine finger (cif) motif. As further evidenced by NCBI 2, NAMPT P43490 (Query 1) also has 100% identity with SEQ ID NO: 1 (Subject 1).
A person of ordinary skill in the art would have been motivated to use this NAMPT fragment comprising a cytokine finger (cif) motif because as above, Lee teaches that this particular recombinant NAMPT can be administered to subjects in vivo to improve wound healing (Abstract, p1; Fig. 5, p8). Furthermore, because Lee teaches that the specific recombinant NAMPT can be administered to patients, it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 63, the recombinant NAMPT protein as taught Lee, as evidenced by SinoBiological is a single polypeptide chain (Protein Construction, first page) and therefore a monomeric protein.
In regards to claim 64, the recombinant NAMPT protein as taught Lee, as evidenced by SinoBiological comprises a GST tag which is a type of label moiety.
In regards to claim 67, Penn teaches that that stem cells can be included with the composition (claim 2; p3, lines 117; p4, lines 27-30).
In regards to claims 69 and 70, Penn teaches that the composition can be administered with a pharmaceutically acceptable carrier such as saline (p26, lines 14-10) which is a species of “retentive material” or with gelatin (p15, lines 23-25), which is a species of hydrogel scaffold.
Therefore, the combined teachings of Penn, Frederick, and Lee renders the invention unpatentable as claimed.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Penn et al. (WO2006002152, 2006, on IDS 10/20/2022, previously cited) in view of Frederick et al. (Cell Metabolism, 2016) and Lee et al. (International Journal of Molecular Sciences, 2018, on IDS 10/20/2022, previously cited), as applied to claims 1 and 9 above, and further in view of Arnold et al. (International Journal of Molecular Science, 2018, previously cited).
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Penn et al. (WO2006002152, 2006, on IDS 10/20/2022, previously cited) in view of Frederick et al. (Cell Metabolism, 2016) and Lee et al. (International Journal of Molecular Sciences, 2018, on IDS 10/20/2022, previously cited), as applied to claim 1 above, and further in view of Arnold et al. (International Journal of Molecular Science, 2018, previously cited).
In regards to claims 10 and 68, Penn does not explicitly teach that the cell is a macrophage.
However, a person of ordinary skill in the art would have been motivated to use a macrophage specifically because Arnold teaches that macrophages are important for muscle regeneration and stimulate myogenesis and fiber growth (Abstract, p1057; MO/MP presence is mandatory for skeletal muscle regeneration, p1061-1062).
Furthermore, because Arnold teaches that macrophages are found in muscle during regeneration (Fig. 1, p1058), because Penn teaches that transplanted cells can be different from the tissue being treated (p16, lines 13-16), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Penn, Frederick, Lee, and Arnold renders the invention unpatentable as claimed.
Claims 65-66 are rejected under 35 U.S.C. 103 as being unpatentable over Penn et al. (WO2006002152, 2006, on IDS 10/20/2022, previously cited) in view of Frederick et al. (Cell Metabolism, 2016) and Lee et al. (International Journal of Molecular Sciences, 2018, on IDS 10/20/2022, previously cited), as applied to claims 1 and 64 above, and further in view of Mochizuki et al. (Nature Biomedical Engineering, 2019, on IDS 03/17/2026).
In regards to claims 65-66, Penn does not explicitly teach an enhanced signaling moiety such as a heparin binding sulfate moiety which is a syndecan binding moiety specifically. However, Mochizuki teaches that for tissue regeneration growth factors (e.g., NAMPT) can stimulate regeneration but that side effects and low effectiveness have impeded their use in translational regenerative medicine (Abstract, p1). To address this, Mochizuki teaches that the inclusion of syndecan-binding moieties triggers sustained tonic signaling, reduces desensitization of growth factor receptors, and therefore, induces greater tissue repair (Abstract, p1). Therefore, a person of ordinary skill in the art would have been motivated to include an enhanced signaling moiety such as a heparin binding sulfate moiety which is a syndecan binding moiety to promote the effectiveness of the growth factor (NAMPT) and improve wound healing. Furthermore, because Mochizuki demonstrates that the inclusion of enhanced signaling moieties such as a heparin binding sulfate moiety which is a syndecan binding moiety specifically improves wound healing (Abstract, p1; Fig. 6, p8), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Penn, Frederick, Lee, and Mochizuki renders the invention unpatentable as claimed.
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Penn et al. (WO2006002152, 2006, on IDS 10/20/2022, previously cited) in view of Frederick et al. (Cell Metabolism, 2016) and Lee et al. (International Journal of Molecular Sciences, 2018, on IDS 10/20/2022, previously cited), as applied to claims 1 and 69-70 above, and further in view of Roura et al. (Journal of Tissue Engineering and Regeneration Medicine, 2017).
In regards to claim 71, while as above, Penn teaches that the composition may comprise a scaffold such as a hydrogel (i.e., gelatin), Penn does not explicitly teach a fibrin hydrogel.
However, the use of fibrin hydrogels for medical application is long-known in the art. In particular, a person of ordinary skill in the art would have been motivated to use a fibrin hydrogel because Roura teaches that in the context of transplanting cells, fibrin maintains cell adherence at the site of injury, where cells are required for tissue repair, and offers a nurturing environment that protects implanted cells without interfering with their expected benefit (Abstract, p2304). Furthermore, because Roura teaches that fibrin has broad medical and research use (Abstract, p2304) and teaches that it can be applied to tissues including muscular tissues (Fig. 1, p2306; Fig. 2, p2308), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Penn, Frederick, Lee, and Mochizuki renders the invention unpatentable as claimed.
Therefore, the combined teachings of Penn, Frederick, Lee, and Roura renders the invention unpatentable as claimed.
Response to Arguments
Applicant argues that Penn does not anticipate the claims under 35 USC 102 as amended (Remarks, p6).
Applicant’s arguments, see p6, filed 03/16/2026, with respect to the rejection of the claims under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, due to amendment of the claims, a new ground of rejection is made under 35 USC 103 over Penn et al. (WO2006002152, 2006, on IDS 10/20/2022) in view of Frederick et al. (Cell Metabolism, 2016) and Lee et al. (International Journal of Molecular Sciences, 2018, on IDS 10/20/2022), etc., as discussed above.
Applicant also argues that the claims as amended are not prima facie obvious under 35 USC 103 over Penn (Remarks, p7).
Specifically, Applicant argues that Penn does not teach anything about using NAMPT to treat skeletal muscle, skeletal muscle tissue regeneration, or a musculoskeletal deficiency, disorder, or injury (Remarks, p8).
Applicant’s arguments, filed 03/16/2026, have been fully considered but are not persuasive.
In regards to skeletal muscle, Penn explicitly teaches that a CCR5 ligand can be administered to a subject for regenerating skeletal muscle (claim 1; p30, lines 03-12).
While Penn does not explicitly teach NAMPT as a specific CCR5 ligand, as above, a person of ordinary skill in the art would have been motivated to use NAMPT as a CCR5 ligand because Frederick teaches that overexposure of NAMPT prevents age-related decline in skeletal muscle function in subjects (Summary, p269; Gain of Nampt Function Maintains Exercise Capacity into Old Age; p275-276).
Furthermore, because Lee teaches that recombinant visfatin (NAMPT) can be administered to subjects in vivo to improve wound healing (Abstract, p1; Fig. 5, p8), it could have been done with predictable results and a reasonable expectation of success.
Applicant argues that the prior art is in the context of smooth muscle, myocardial infarction, and skin healing, which the Applicant argues is very different from skeletal muscle (Remarks, p7).
Applicant’s arguments, filed 03/16/2026, have been fully considered but are not persuasive.
Penn explicitly teaches that not only can both cardiac and skeletal muscle be treated (p30, lines 3-12), but that skeletal myoblasts, smooth muscles cells, and fibroblasts can be transplanted into an infarcted myocardium (p16, lines 13-30), suggesting broad applicability to a variety of tissues and cell types.
Furthermore, as taught by Frederick above, CCR5 ligand NAMPT is known to promote skeletal regeneration, as taught by Lee, NAMPT is known to promote broadly, and as evidenced by Wang et al. (Cardiovascular Research, 2009, on IDS 10/20/2022, cited 11/16/2025) NAMPT (visfatin) promotes aortic smoot muscle proliferation (Abstract, p370; Fig. 2, p373).
Thus, a person of ordinary skill in the art would have recognized that NAMPT has broad applicability to different tissues and cell.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638