DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-2, 8, 10-13, 17-20, 23-24, 31-33, 35, 38, and 61 are pending (claim set as filed on 02/26/2026).
Priority
This application is a PCT/US2021/063645 filed on 12/15/2021, which has a PRO 63/289,868 filed on 12/15/2021 and foreign applications to: (a) AU 2020904675 filed on 12/15/2020; (b) AU 2021900059 filed on 01/12/2021; (c) AU 2021902941 filed on 09/10/2021; and (d) AU 2021903365 filed on 10/20/2021.
Withdrawal of Rejections
The response and amendments filed on 02/26/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Maintained Rejections
Claim Rejections - 35 USC §103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 8, 13, 17-20, 23-24, 31-33, 35, 38, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Itescu (US 2017/0340674 A1) in view of Stumpf (C-reactive protein levels predict systolic heart failure and outcome in patients with first ST-elevation myocardial infarction treated with coronary angioplasty, 2017) - both references cited by the ISA and in the IDS filed on 02/23/2024.
Itescu’s general disclosure relates to stem cell therapy for subjects with cardiovascular events (see ¶ [0006], [0009]).
Itescu teaches “methods for preventing progressive heart failure in subjects with persistent left ventricular (LV) dysfunction. Such methods may also be used for treating or preventing progressive heart failure in subjects with a proximal left anterior descending (LAD) lesion and persistent left ventricular dysfunction” (see abstract & ¶ [0001]). Itescu teaches “administering to the subject a population of mesenchymal lineage precursor or stem cells and/or progeny thereof and/or soluble factors derived therefrom” (see ¶ [0010]-[0013], [0153]).
Regarding claims 1-2, 8, 18, 38, and 61’s limitations pertaining to the New York Heart Association (NYHA) classification scale, Itescu teaches the method comprises the step of selecting a subject (see ¶ [0011]) and further teaches “the methods of the present disclosure can be used to treat progressive heart failure in a MI [myocardial infarction] subject with various stages or classifications of heart failure. For example, the subject can have stage A, B, C or D heart failure. In an example, the subject has stage B or C heart failure. In these examples, heart failure staging is based on the American College of Cardiology (ACC) and the American Heart Association (AHA) staging criteria. In another example, the subject can have Class I, II, III or IV heart failure. In an example, the subject has Class II or III heart failure. In these examples, heart failure classification is based on the New York Heart Association (NYHA) classification scale” (see ¶ [0101]-[0102]).
Regarding claim 13 pertaining to the subject’s conditions, Itescu teaches “the subject has a proximal left anterior descending (LAD) arterial lesion. In these examples, the subject can have persistent left ventricular dysfunction. For example, the subject can have a LVEF of less than about 55%. In another example, the subject has a LVEF of less than about 45%. In another example, the subject has a LVEF of less than about 40%” (see ¶ [0031]).
Regarding claims 17-19 and 61 pertaining to the intended outcome of the treatment, claim interpretation: a wherein or whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited (MPEP 2111.04(I)). Therefore, these dependent claims merely describe the effect or outcome of the treatment after it is performed and since the prior art teaches the same active steps and conditions as required by the claims, then the results should be inherently present.
Regarding claim 20 pertaining to the route of administration, Itescu teaches the population of mesenchymal lineage precursor or stem cells and/or progeny thereof and/or soluble factors derived therefrom can be administered intravenously (see ¶ [0025]).
Regarding claims 23-24 and 32-33 pertaining to the mesenchymal stem cells, Itescu teaches the composition comprising the mesenchymal lineage precursor or stem cells and/or progeny cells thereof (see ¶ [0030], [0049]-[0051]). Itescu teaches the population of cells and/or progeny cells are autogeneic or allogeneic and/or the soluble factors are derived from autogeneic or allogeneic cells (see ¶ [0028]). Mesenchymal lineage precursor or stem cells reside primarily in the bone marrow (see ¶ [0052]). The population of cells and/or progeny thereof have been culture expanded prior to administration and/or prior to obtaining the soluble factors (see ¶ [0029]). The composition may comprise a cryopreservative (see ¶ [0030]). The population may be enriched from cells expression STRO-3 (TNAP) (see ¶ [0056]-[0061).
Regarding claim 31 pertaining to the amount of cells, Itescu teaches “administering between 1x106 to 8x108 cells. In an example, the methods of the present disclosure comprise
administering between 1.2x108 to 4x108 cells. In an example, the methods of the present disclosure comprise administering at least about 1.5x108 cells” (see ¶ [0027], [0113]-[0115]).
However, Itescu does not teach: wherein the subject’s C-reactive protein (CRP) level is ≥ 2 mg/L (claims 1-2, 8, and 33’s limitations).
Stumpf discloses that “there is growing evidence that inflammation plays a pivotal role in the etiology and progression of atherosclerosis. High C-reactive protein (CRP) levels have been associated with high mortality in patients with acute myocardial infarction (AMI). Furthermore, in animal models CRP has been found to significantly increase infarct size. So, there is growing evidence that CRP is not only a marker for cardiovascular disease but also might be pathogenic. The aim of our study was to test the hypothesis that peak CRP levels could predict heart failure (HF) in ST-elevation myocardial infarction (STEMI) patients” (see page 1086: Abstract’s introduction). CRP strongly and independently predicts adverse cardiovascular events, including myocardial infarction, ischemic stroke, and sudden cardiac death in individuals (see page 1087, left col.). Stumpf teaches patients having a CRP measurement of 15.1 ± 27.7 mg/L (see page 1090, left col.). Stumpf discloses the “concept could in part explain our results that patients with high CRP levels developed post-infarction heart failure. Large infarct size, thus resulting in heart failure, is furthermore a major determinant of morbidity and mortality following STEMI” (see page 1091, right col.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a subject with an elevated C-reactive protein (CRP) level such as taught by Stumpf in the treatment method of Itescu. The ordinary artisan would have been motivated to do so is because Stumpf suggests that CRP strongly and independently predicts adverse cardiovascular events, including heart failure, myocardial infarction, ischemic stroke, and sudden cardiac death in individuals (see Stumpf at abstract & at page 1087, left col.). Thus, it would have been readily apparent to use elevated CRP levels as a diagnostic predictor or criteria in patients or subjects suffering from a cardiovascular event in Itescu’s stem cell treatment methodology to reduce risk and mortality in patients.
Claims 1-2, 8, 13, 17-20, 23-24, 31-33, 35, 38, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Itescu (US 2017/0340674 A1 - cited by the ISA and in the IDS filed on 02/23/2024) in view of Ichim (US 2016/0067213 A1) as evidenced by Gotto (Role of C-Reactive Protein in Coronary Risk Reduction: Focus on Primary Prevention).
Itescu’s general disclosure relates to stem cell therapy for subjects with cardiovascular events (see ¶ [0006], [0009]).
Itescu teaches “methods for preventing progressive heart failure in subjects with persistent left ventricular (LV) dysfunction. Such methods may also be used for treating or preventing progressive heart failure in subjects with a proximal left anterior descending (LAD) lesion and persistent left ventricular dysfunction” (see abstract & ¶ [0001]). Itescu teaches “administering to the subject a population of mesenchymal lineage precursor or stem cells and/or progeny thereof and/or soluble factors derived therefrom” (see ¶ [0010]-[0013], [0153]).
Regarding claims 1-2, 8, 18, 38, and 61’s limitations pertaining to the New York Heart Association (NYHA) classification scale, Itescu teaches the method comprises the step of selecting a subject (see ¶ [0011]) and further teaches “the methods of the present disclosure can be used to treat progressive heart failure in a MI [myocardial infarction] subject with various stages or classifications of heart failure. For example, the subject can have stage A, B, C or D heart failure. In an example, the subject has stage B or C heart failure. In these examples, heart failure staging is based on the American College of Cardiology (ACC) and the American Heart Association (AHA) staging criteria. In another example, the subject can have Class I, II, III or IV heart failure. In an example, the subject has Class II or III heart failure. In these examples, heart failure classification is based on the New York Heart Association (NYHA) classification scale” (see ¶ [0101]-[0102]).
Regarding claim 13 pertaining to the subject’s conditions, Itescu teaches “the subject has a proximal left anterior descending (LAD) arterial lesion. In these examples, the subject can have persistent left ventricular dysfunction. For example, the subject can have a LVEF of less than about 55%. In another example, the subject has a LVEF of less than about 45%. In another example, the subject has a LVEF of less than about 40%” (see ¶ [0031]).
Regarding claims 17-19 and 61 pertaining to the intended outcome of the treatment, claim interpretation: a wherein or whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited (MPEP 2111.04(I)). Therefore, these dependent claims merely describe the effect or outcome of the treatment after it is performed and since the prior art teaches the same active steps and conditions as required by the claims, then the results should be inherently present.
Regarding claim 20 pertaining to the route of administration, Itescu teaches the population of mesenchymal lineage precursor or stem cells and/or progeny thereof and/or soluble factors derived therefrom can be administered intravenously (see ¶ [0025]).
Regarding claims 23-24 and 32-33 pertaining to the mesenchymal stem cells, Itescu teaches the composition comprising the mesenchymal lineage precursor or stem cells and/or progeny cells thereof (see ¶ [0030], [0049]-[0051]). Itescu teaches the population of cells and/or progeny cells are autogeneic or allogeneic and/or the soluble factors are derived from autogeneic or allogeneic cells (see ¶ [0028]). Mesenchymal lineage precursor or stem cells reside primarily in the bone marrow (see ¶ [0052]). The population of cells and/or progeny thereof have been culture expanded prior to administration and/or prior to obtaining the soluble factors (see ¶ [0029]). The composition may comprise a cryopreservative (see ¶ [0030]). The population may be enriched from cells expression STRO-3 (TNAP) (see ¶ [0056]-[0061).
Regarding claim 31 pertaining to the amount of cells, Itescu teaches “administering between 1x106 to 8x108 cells. In an example, the methods of the present disclosure comprise
administering between 1.2x108 to 4x108 cells. In an example, the methods of the present disclosure comprise administering at least about 1.5x108 cells” (see ¶ [0027], [0113]-[0115]).
However, Itescu does not teach: wherein the subject’s C-reactive protein (CRP) level is ≥ 2 mg/L (claims 1-2, 8, and 33’s limitations).
Ichim’s general disclosure relates to the treatment of cardiovascular disease (see ¶ [0002]). Ichim teaches a “method of treating cardiovascular disease can include: a) identifying a subject suffering from cardiovascular disease; b) administering a mesenchymal stem cell population to said subject; b) administering a CD34 positive stem cell population to said subject; and c) administering ascorbic acid intravenously to said subject in a combined amount sufficient to ameliorate said cardiovascular disease” (see ¶ [0007], [0014]-[0016]).
Regarding the heart condition, Ichim teaches “the term cardiovascular disease, as used herein can non-exclusively be selected from a group consisting of: cardiomyopathy, post myocardial infarction scarring, myocardial ischemia, coronary artery disease, peripheral vascular
disease, CNS vascular disease, congestive heart failure” (see ¶ [0008], [0022], & Example 1).
Regarding the C-reactive protein (CRP), Ichim discloses “It is known that numerous cardiovascular conditions are associated with increased levels of oxidative stress and inflammatory changes. For example, circulating levels of C-reactive protein (CRP), a marker of inflammation are associated with extent of atherosclerosis (9). Elevated levels of CRP are also predictive of coronary heart disease and found increased in valvular heart disease (10, 11). It is believed that causes of inflammation are associated with increased oxidative stress, and in some cases said oxidative stress is actually causative of inflammation. For example, an inverse correlation has been demonstrated between plasma ascorbic acid and CRP levels in patients with peripheral artery disease” (see ¶ [0019]). Gotto (citation reference #9 used by Ichim at ¶ [0019] & [0040]) discloses that “in response to inflammation induced by trauma or metabolic, immunologic, infective, or other processes anywhere in the body. During the acute-phase response, CRP levels increase to > 10 mg/L” (see page 718, right col.). Gotto also discloses “Those with CRP levels > 4 mg/L may be reclassified as “high risk,” a shift that would require more aggressive intervention” (see Gotto at page 719, right col.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a subject with an elevated C-reactive protein (CRP) level such as > 4 mg/L as taught by Ichim in the treatment method of Itescu. The ordinary artisan would have been motivated to do so is because Ichim suggests that elevated levels of CRP are also predictive of coronary heart disease and Gotto discloses “Those with CRP levels > 4 mg/L may be reclassified as “high risk,” a shift that would require more aggressive intervention” (see Gotto at page 719, right col.). Thus, it would have been readily apparent to select a patient with elevated CRP levels as a diagnostic predictor or criteria in patients or subjects suffering from a cardiovascular event in Itescu’s stem cell treatment methodology to reduce risk and mortality in patients.
Examiner’s Response to Arguments
Applicant’s amendments and arguments filed on 02/26/2026 have been fully considered but they are not persuasive and deemed insufficient to overcome the prior arts of record.
In response to Applicant’s argument (addressing page 8 of the remarks) that “the inventors surprisingly identified that MLPSC administration to patients with Class II heart failure and CRP > 2mg/L significantly decreased risk [of cardiac death] … these findings were not observed in subjects with Class III heart failure”: this argument is not persuasive because the MPEP 716.02(d) states that “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected”. The determination of obviousness also takes into account the understanding of the ordinary artisan where it would have been reasonable to expect that patients with Class II heart failure to have a better prognosis than patients with Class III heart failure because Class III would be considered the more severe, advanced or late form of the disease or disorder. Said differently, patients with Class II diagnosis would be predicted or expected to have better survival outcomes after therapeutic intervention than Class III analogous to higher success rate in early stages of cancer than later stages. Therefore, Applicant alleging that “patients with Class III heart failure may have progressed too far along the disease continuum for MLPSC therapy to improve their survival” is an expected theory or concept rather than surprising.
In response to Applicant’s argument (addressing page 9 of the remarks) that “Itescu contains generic references/description … there is no specific direction to select a patient that has NYHA Class II heart failure and CRP > 2 mg/L”: this argument is not persuasive because even if Itescu does not teach an embodiment or specifically pinpoint out NYHA Class II heart failure, the MPEP 2123(I) states that “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including non-preferred embodiments” and that the disclosure of Itescu cannot be limited to a particular disclosed example. Moreover, Itescu does provide a small enough genus to select from wherein “the subject can have Class I, II, III or IV heart failure. In an example, the subject has Class II or III heart failure. In these examples, heart failure classification is based on the New York Heart Association (NYHA) classification scale” (see ¶ [0102]). Thus, an explicit specific direction or a teaching-suggestion-motivation from the prior art is not necessary when there is a finite number option to choose from or reasonably envisage within a small genus (MPEP 2141).
In response to Applicant’s argument (addressing page 10 of the remarks) that “Itescu is completely silent on patients having the requisite elevated CRP levels defined by the claims. Therefore, a person of ordinary skill in the art would have no reason to select patients on this basis”: this argument is not persuasive because one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references (MPEP 2145). The secondary references provided a suggested teaching to select patients with elevated CRP levels. In particular, Stumpf teaches patients having a CRP measurement of 15.1 ± 27.7 mg/L (see page 1090, left col.) and patients with high CRP levels developed post-infarction heart failure. Large infarct size, thus resulting in heart failure, is furthermore a major determinant of morbidity and mortality following STEMI” (see page 1091, right col.).
In response to Applicant’s argument (addressing pages 10-11 of the remarks) that “Importantly, Stumpf provides no teaching towards a threshold level of CRP as an inclusion criterion for MLPSC therapy”: this argument is not persuasive because Stumpf’s teaching of a CRP measurement of 15.1 mg/L would read on the base claims’ starting value. As discussed above, Stumpf was relied upon for the general teaching of pathological and diagnostic values in patients with cardiovascular conditions including the relationship between elevated CRP and heart failure and thereby, providing a nexus with the primary reference of Itescu for a reason to include patients with higher levels of CRP.
In response to Applicant’s argument (addressing page 12 of the remarks) that “neither Ichim nor Gotto remedies the deficiencies of Itescu … neither document teaches towards a threshold level of CRP as an inclusion criterion for MLPSC therapy”: this argument is not persuasive because the secondary reference of Ichim does provide sufficient guidance to include CRP as a predictive measure of heart failure. As discussed in the prior office action, Ichim teaches identifying a subject suffering from a cardiovascular disease including heart failure and administering mesenchymal stem cells to ameliorate the disease. Ichim further teaches elevated levels of CRP is associated with adverse cardiovascular conditions and “Those with CRP levels > 4 mg/L may be reclassified as “high risk,” a shift that would require more aggressive intervention” (see Gotto at page 719, right col.). Thus, Ichim’s teaching of elevated CRP levels associated with cardiovascular diseases including heart failure and treating with stem cells provides the nexus with Itescu which is also directed to treating heart failure with mesenchymal stem cells.
In response to Applicant’s argument (addressing bridging ¶ of pages 12-13 of the remarks) that Ichim’s teachings includes ascorbic acid and does not teach administering MLPSCs to subjects having elevated CRP: this argument is not persuasive because note that the claim’s transitional phrase of “comprising” is open-ended and does not exclude additional, unrecited elements or method steps (MPEP 2111.03). Therefore, the claim does not exclude the prior art’s use of ascorbic acid in the treatment methodology. Nonetheless, Ichim does teach administering a mesenchymal stem cell population to said subject suffering from a cardiovascular disease to ameliorate said disease (see Ichim at ¶ [0007], [0014]-[0016]).
In response to Applicant’s argument (addressing of page 13 of the remarks) that Gotto fails to provide any suggestion that subjects with high CRP levels who were administered MLPSCs would benefit from improved outcomes: this argument is not persuasive because the primary reference of Itescu already taught the limitation of MLPSCs administration and the secondary references were primarily relied upon to address the elevated CRP levels. If it was required that the secondary reference also teach MLPSCs in addition to CRP, then the rejection would have been an anticipation. However, the proposed rejection was based upon an obviousness rationale where one of ordinary skill in the art would have found the claimed invention readily apparent after following the guidance of the cited arts.
Maintained Rejections - Double Patenting
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 8, 10-13, 17-20, 23-24, 31-33, 35, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-3, 6, 9, 11, 16, 19-20, 23, 29, 31, 35, and 43 (claim set as filed on 12/09/2024) of co-pending Application no. 18/711,167. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1-2 and 8, co-pending ‘167 teaches a method for treating or preventing progressive heart failure in a subject, the method comprising administering to the subject a composition comprising mesenchymal lineage precursor or stem cells, wherein the subject’s CRP level is ≥ 2 mg/L (see claims 1 and 3 of co-pending ‘167). Co-pending ‘167 teaches wherein the subject has Class II or Class III heart failure according to the New York Heart Association (NYHA) classification scale (see claim 9 of co-pending ‘167).
Regarding claims 10-12, co-pending ‘167 teaches wherein the subject’s level of N-terminal pro-B-type natriuretic peptide is between 1000 - 2000 pg/ml; and the CRP level is < 5 mg/L (see claim 11 of co-pending ‘167).
Regarding claim 13, co-pending ‘167 teaches the subject has a LVEF less than 45% or 40% (see claim 6 of co-pending ‘167).
Regarding claims 17-19, co-pending ‘167 teaches wherein the subject has a reduced risk of cardiac death after treatment, wherein the reduced risk is relative to risk of cardiac death in a subject that has not been administered mesenchymal lineage precursor or stem cells; or wherein the subject has a reduced risk of ischaemic MACE after treatment, wherein the MACE is MI or stroke (see claims 2 and 16 of co-pending ‘167).
Regarding claim 20, co-pending ‘167 teaches wherein the composition is administered transendocardially and/or intravenously (see claim 19 of co-pending ‘167).
Regarding claim 23, co-pending ‘167 teaches wherein the mesenchymal lineage precursor or stem cells are mesenchymal precursor cells (MPCs) or wherein the mesenchymal lineage precursor or stem cells are mesenchymal stem cells (MSCs) (see claim 20 of co-pending ‘167).
Regarding claim 24, co-pending ‘167 teaches wherein the cells are allogeneic (see claim 23 of co-pending ‘167).
Regarding claim 32, co-pending ‘167 teaches the cells are culture expanded; the cells are isolated from bone mononuclear cells with an anti-STRO-3 antibody; the cells are STRO-3+ before they are culture expanded; and/or the cells have been cryopreserved (see claims 23 and 31 of co-pending ‘167).
Regarding claim 31, co-pending ‘167 teaches wherein the composition further comprises Plasma-Lyte A (70%), DMSO (10%), HSA (25%) solution, the HSA solution comprising 5% HSA and 15% buffer, wherein the composition comprises greater than 6.68x106 viable cells/mL (see claim 29 of co-pending ‘167).
Regarding claims 33, 35, and 38, co-pending ‘167 teaches wherein the ischemic events formation of an arterial occlusion; a cerebrovascular occlusion; a cardiac occlusion; stroke; or myocardial infarction (see claims 35 and 43 of co-pending ‘167).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Examiner’s note: the non-statutory double patenting rejection has been maintained in light of Applicant’s request for the rejection to be held in abeyance until allowable subject matter has been identified.
Conclusion
No claims were allowed.
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 extension fee 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 date of this final action.
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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