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 .
Priority
Instant application 18/036,673 filed on 05/12/2023 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1-3, 9-11 and 18-21 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/12/2023 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of compound 2 and peripheral neuropathy in the reply filed on 12/19/2025 is acknowledged.
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Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' combination of elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping
Species Election
A careful review of the prior art has indicated that combination of elected species is free of the prior art. A claim directed to the elected species in independent form would be free of the prior art.
The examiner has moved onto alternative species embodied within the general formula I and recited in the instant claims 11 and 21:
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The subsequent examination is based on this species expansion.
Claim Interpretation
The instant claims recite methods comprising administering an SARM1 enzyme activity inhibitor. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See also MPEP 2111.03.
Claim Rejections - 35 USC § 112
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 1-3, 9-11 and 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating specific neurodegenerative diseases or specific neurological diseases, does not reasonably provide enablement for preventing any disease. Further, the specification not reasonably provide enablement for a treatment or prevention of all diseases or conditions related to axonal degeneration. It should be noted that the claims cover 'diseases' that are known to exist and those that may be discovered in the future, for which there is no enablement provided.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is scope of enablement rejection.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed more recently in Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill;(E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure (MPEP 2164).
The instant claims are very broad, directed to a method for the treatment or prevention of a neurodegenerative disease or a neurological disease with SARM1 enzyme activity inhibitor and to a method for the treatment or prevention of a disease or condition related to axonal degeneration.
First, the claims cover “diseases or condition related to axonal degeneration” that are known to exist and those that may be discovered in the future, for which there is no enablement provided.
Further, the instants claim appears to be a 'reach through' claims. Reach through claims, in general have a format drawn to mechanistic, receptor binding or enzymatic functionality and thereby reach through to the corresponding therapeutic method of any or all diseases, disorders or conditions, for which they lack written description and enabling disclosure in the specification thereby requiring undue experimentation for one of skill in the art to practice the invention.
Loring (Heather S. Loring et al., Bioorg Med Chem. 2020 September 15; 28(18): 115644) teaches that “Sterile Alpha and Toll Interleukin Receptor Motif–containing protein 1 (SARM1) is a key therapeutic target for diseases that exhibit Wallerian–like degeneration; Wallerian degeneration is characterized by degeneration of the axon distal to the site of injury. These diseases include traumatic brain injury, peripheral neuropathy, and neurodegenerative diseases. SARM1 promotes neurodegeneration by catalyzing the hydrolysis of NAD+ to form a mixture of ADPR and cADPR” (see abstract).
Further, Loring teaches “Progressive axonal and neuronal degeneration (i.e., Wallerian degeneration) underlie many diseases, including traumatic brain injury, peripheral neuropathy and neurodegenerative diseases (e.g., Alzheimer’s disease, Parkinson’s disease, and Amyotrophic Lateral Sclerosis)” (see Introduction, page 2, first paragraph).
It should be noted that compounds of instant Formula I are known for modulation of axon degradation.
For example, WO 2011/050192 teaches inhibitors of neuron or axon degeneration (see Table 2):
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The above compound listed in Table 2 and Table 5 of WO 2011/050192 falls under instant Formula I wherein R1 is C1 alkyl (methyl) and R3 is phenyl substituted by methyl.
It should be noted that the above compound is the same as instant compound 1 (see the first compound recited in instant claims 11 and 21).
Further, WO 2011/050192 teaches (see page 1, lines 10- 13):
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With respect to the definition of “prevention”, the claims are given their broadest reasonable interpretation.
The Oxford English Dictionary defines the verb “to prevent” as “to preclude the occurrence of (an anticipated event, state, etc.); to render (an intended, possible, or likely action or event) impractical or impossible by anticipatory action; to put a stop to” (definition II.9.a). “Preventing” as recited in the instant claims, is interpreted to mean the complete and total blocking of all symptoms of a muscle disease for an indefinite period of time. Merely making the disease less likely would not render the disease impossible and thus not qualify as preventing.
In order to prevent a disease: one would need to precisely identify those subjects likely to acquire such a disease, administer Applicant’s claimed invention, and demonstrate that the patient did not develop the disease as a result of the administration of the claim invention. The instant specification does not provide any guidance for selecting a population.
A disclosure should contain representative examples which provide reasonable assurance to one skilled in the art that ensure that the inventor had possession, as of the filling date of the application, of the specific subject matter claimed by him.
The instant claims recite treatment or prevention of disease or condition related to axonal degeneration is selected from the group consisting of Alzheimer's disease, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis and peripheral neuropathy. (see instant claim 18).
Regarding the elected peripheral neuropathy, as evidenced by NIH (www.ninds.nih.gov/health-information/disorders/peripheral-neuropathy, printed 03/23/2026) there are several types of peripheral neuropathies. For example, inherited peripheral neuropathies are caused by genetic mutations rather than external factors, making them impossible to prevent.
Inherited peripheral neuropathies include: Charcot-Marie-Tooth disease, which affects both sensory and motor nerves (nerves that trigger an impulse for a muscle to contract) in the arms, hands, legs, and feet; Friedreich ataxia, which causes progressive damage to the nervous system and movement problems; Giant axonal neuropathy (GAN), which happens when the GAN1 gene is changed and causes the axons, or the message sender of the nerve cell, to become larger than normal and eventually break down, causing movement and sensation problems. GAN is progressive, meaning that it worsens over time. Most children will begin showing signs of GAN before five years of age and will need to use a wheelchair in the second decade of life. Some children with GAN survive into early adulthood. Currently there is no cure or treatment to stop the progression of this rare disorder (see page 2, first paragraph).
Further, regarding amyotrophic lateral sclerosis (ALS), prior art teaches “several drugs such as dexpramipexole, pioglitazone, lithium, and many others have been tested in large multicenter trials, albeit with disappointing results” (Dorst et al., Ther Adv Neurol Disord 2018, Vol. 11: 1–16). Moreover, prior art fails to teach ALS prevention. Unfortunately, there is currently no way to prevent most neuromuscular disorders.
As evidenced by NIH (NIH: Inflammatory Myopathies National Institute of Neurological Disorders and Stroke and as evidenced by NIH: Amyotrophic Lateral Sclerosis, printed 3/24/2026) “Nearly all cases of ALS are considered sporadic, meaning the disorder seems to happen at random with no clearly associated risk factors and no family history. Although family members of people with ALS are at an increased risk for the disorder the overall risk is very low—most won’t develop ALS.” (page 2, second paragraph).
Further, prevention of a disease is a significant challenge, most individuals eligible for the preventive treatment will be healthy and asymptomatic, and the use of medicines with side effects will need to be justify in terms of the risk–benefit ratio.
The instant specification has provided no working examples of preventing any diseases. The only information in the specification are data related to inhibiting SARM1 enzyme activity (see instant specification, Tables 1-3).
Further, the specification does not provide any guidance for selecting a population or any data about risk-benefit ratio for treatments of healthy subjects.
Furthermore, the specification does not provide directions about the length of the preventive treatment. Prevention of a disease is not the same as treatment. In order to prevent a disease, as opposed to merely delaying or reducing symptoms, a method must either render the subject completely resistant to said disease after a limited number of treatments, or, when continued indefinitely, continue to suppress the occurrence of that disease.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. The specification does not enable any skilled in the art to which it pertains, or with it is most nearly connected, to use the invention commensurate in scope with the claim. Considering the lack of guidance in the specification, one of ordinary skill in the art would be burden with undue experimentation to practice the invention commensurate in the scope of the instant claims.
The examiner suggests limiting the instant claims to methods of treating specific diseases or conditions.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 9-11 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2011/151359-A1.
WO 2011/151359-A1 teaches and claims a thiadiazolidinedione derivative of formula (I):
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and of at least one cholinesterase inhibitor.
Further, WO 2011/151359-A1 teaches and claims:
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It should be noted that 4-benzyl-2-methyl-[1,2,4]thiadiazolidine-3,5-dione:
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falls under instant Formula I wherein R1 is C1 alkyl (methyl) and R3 is phenyl substituted by methyl.
Further, WO 2011/151359-A1 teaches and claims the above compound treatment of Alzheimer's disease (see claim 13):
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Regarding instant claims 11 and 21, it should be noted that the above compound is the same as instant compound 1 (the first compound recited in instant claims 11 and 21).
MPEP 2131.02 states “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). “
Since WO 2011/151359-A1 teaches and claims 4-benzyl-2-methyl-[1,2,4]thiadiazolidine-3,5-dione (instant compound 1) and treats Alzheimer's disease, thus, a person of skill in the art, reading the reference, would ‘at once envisage’ combining the said compound to treat Alzheimer’s disease in a subject in need.
Further, as discussed above under claim interpretation, it should be noted that the instant claims recite methods comprising administering compound represented by formula I and allow for additional, unrecited elements. Therefore the combination of 4-benzyl-2-methyl-[1,2,4]thiadiazolidine-3,5-dione with cholinesterase inhibitor for treatments of Alzheimer's disease meets the limitations of the instant claims. See also MPEP 2111.03.
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 1-3, 9-11 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2011/151359-A1.
WO 2011/151359-A1 teaches and claims a combination of at least one thiadiazolidinedione derivative of formula (I):
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and of at least one cholinesterase inhibitor.
Further, WO 2011/151359-A1 teaches and claims:
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It should be noted that 4-benzyl-2-methyl-[1,2,4]thiadiazolidine-3,5-dione:
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falls under instant Formula I wherein R1 is C1 alkyl (methyl) and R3 is phenyl substituted by methyl.
Regarding instant claims 11 and 21, it should be noted that the above compound is the same as instant compound 1 (the first compound recited in instant claim 11 and 21).
Regarding instant claim 18, WO 2011/151359-A1 teaches treatments of Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis (ALS) (see claims 12, 13 and page 27):
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Further, WO 2011/151359-A1 teaches and claims (see claim 13):
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WO 2011/151359-A1 does not teach that the above compound is a SARM1 enzyme activity inhibitor. In other words, WO 2011/151359-A1 does not teach the recited mechanism of action.
However, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947(Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed.Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art
plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily
possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the
discovery of properties of a known material does not make it novel, the identification and
characterization of a prior art material also does not make it novel." (see MPEP 2112).
In addition, invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP § 2112). In the instant case, the inhibition of SARM1 enzyme activity is inherent feature of the compound disclosed by WO 2011/151359-A1.
Further, "where the Patent Office has reason to believe that a functional limitation asserted to
be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the characteristics relied on"); In
re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (indicating that the burden of proof can be shifted
to the applicant to show that the subject matter of the prior art does not possess the characteristic
relied on whether the rejection is based on inherency under 35 U.S.C. 102 or obviousness under 35
U.S.C. 103 (MPEP 2183).
Furthermore, MPEP 2144.07 states: “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.)”
In the instant case, WO 2011/151359-A1 teaches 4-benzyl-2-methyl-[1,2,4]thiadiazolidine-3,5-dione is suitable for treatment of Alzheimer's disease, Parkinson's disease and/or amyotrophic lateral sclerosis (ALS), therefore, Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, 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 combine 4-benzyl-2-methyl-[1,2,4]thiadiazolidine-3,5-dione (instant compound 1) and Alzheimer's disease, Parkinson's disease and/or amyotrophic lateral sclerosis (ALS) with a reasonable expectation of success. A skilled artisan would have been motivated to use the compound disclosed by WO 2011/151359-A1 for treatments of all diseases recited in WO 2011/151359-A1.
Furthermore, it should also be noted that MPEP states: A REJECTION UNDER 35 U.S.C. 102 AND 103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC.
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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