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 .
Priority
U.S. Pat. Appln. Ser. No. 17/757,572, Filed: June 17, 2022 is a 371 Nat.’ l Stage Entry of WO2021127517A1 (i.e., PCT/US2020/066138, Intern.’l Filing Date: December 18, 2020, Intern.’l Pub. Date: June 24, 2021), which claims priority from U.S. Prov. Appln.: 62/949,483, Filed: December 18, 2019.
Status
The present Non-Final Office Action is in responsive to November 26, 2025 Amendment and Request for Reconsideration.
Claims 1, 7 and 10-14 are pending, 1-2 are original, claims 12-14 are new and claims 2-6 and 8-9 are cancelled in the above-identified application.
WITHDRAWN REJECTIONS
Rejection of claims 1, 10 and11 (i.e., claims 2, 5, 6, 8 and 9 cancelled) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd para. is WITHDRAWN, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. (Note: Original rejection inadvertently included claim 7 which was not rejected.)
Rejection of claims 1, 7,10 and11 (i.e., claims 2, 5, 6, 8 and 9 cancelled) are rejected under 35 U.S.C. 112(a) for lack of enablement of the present invention is WITHDRAWN (i.e., in favor of New Rejection Necessitated by Amendments)
Rejection of U.S. Patents identified as A to E on the ground of non-statutory
obviousness-type double patenting as being unpatentable over the identified claims below are WITHDRAWN:
Claims
Directed To
Miscellaneous
Transition Phrase
U.S. Spenser. No.
Corresp. To
U.S Pat. No
Assignee
Granted
A
1-6
Trmt Methods
Admin. PDE1 Inhibitors
Comprising
US17/336,798
12,364,695
Intra-Cellular Therapies, Inc.
2025-07-22
B
1-3 & 18
Trmt Methods
Admin. PDE1 Inhibitors
Comprising
US16/892,206
11,759,465
Intra-Cellular Therapies, Inc.
2023-09-19
C
1-3
Trmt Methods
Admin. PDE1 Inhibitors
Comprising
US16/966,818
11,839,614
Intra-Cellular Therapies, Inc.
2023-12-12
D
1,3,7,14,16-17, 20 & 22-26
Trmt Methods
Admin. PDE1 Inhibitors
Comprising
US16/090,142
10,682,354
Intra-Cellular Therapies, Inc.
2020-06-16
; and
Provisional Rejection of U.S. Patent Applications identified as F and G on the ground of non-statutory obviousness-type double patenting as being unpatentable over the following claims are WITHDRAWN:
Claims
Directed To
Miscellaneous
Transition Phrase
U.S Appln.
Ser. No.
Corresp.To
U.S Pat. Pub. No.
Assignee
371 Filing
Date
E
1,2, 4-5, 8,15-16, & 19
Trmt Methods
Admin. PDE1 Inhibitors
Comprising
US17/279,518
US 2021/0338679
Intra-Cellular Therapies, Inc.
2021-03-24
F
1-3 & 18-20
Trmt Methods
Admin. PDE1 Inhibitors
Comprising
US18/344,406
US 2023/0338385
Intra-Cellular Therapies, Inc.
2023-11-03
REJECTIONS
OBJECTIONS
Objections to Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
It is suggested that the title of the instant application be amended to recite:
“Methods For Treatment Of Neurodegenerative Diseases With A Combination Of
Cyclopent [4,5]Imidazo[L,2-A]Pyrazolo[4,3-E]Pyrimidin-4(2h)-One Phosphodiesterase 1 ( Pde-1) Inhibitor Derivatives And Adamantan-Yl Ureido Soluble Epoxide Hydrolase (SEH) Inhibitor Derivatives”.
Objections to Claims
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 7 can also be maintained upon amendments to claim 1.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Updates and Comments
[1] In the August 27, 2025 Office Action, the issued 103 Rejection therein inadvertently misidentifies this journal reference cite as:
“Kim et al, Bioorg. Med, Chem. 2006 Sep 29; 15(1);312-323. Doi.: 10.106/j.bmc.2006.09.057”,
when the correct reference cite should be identified as:
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However, the substance of this reference recited in the text or body of the 103 rejection was substantively correct, thus the substantive content associated with the KIM reference is is maintained.
[2] The 103 rejection of record reiterated below has been modified to reflect amended or cancelled claims.
[3] Modified Rejection
Claims 1, 10 and 11 (i.e., claims 2 and 8-9 cancelled) are rejected under 35 U.S.C. 103 as being unpatentable over:
U.S. Pat. Pub. No. 2017/0226117 A1 to Intra-cellular Therapies, Inc. (Filed: February 6, 2017, Pub. Date: August 10, 2017). (“U.S. ‘117 Pat. Pub.”),
alone, in combination with and/or further in view of:
U.S. Pat. Pub. No. 2017/0240526 A1 to X-Chem, Inc. (Filed: February 15, 2017, Pub. Date: August 24, 2017). (“U.S. ‘526 Pat. Pub.”); and
Kim et al., J. Med. Chem, 2007, October 18
The present invention relates to:
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In general, the U.S. ‘117 Pat. Pub. relates to:
[a1] methods of treatment of diseases or disorders characterized by disruption of/ damage to/ameliorated or modulating certain cGMP/PKG mediated dependent signaling pathways (e.g., in cardiac tissue or in vascular smooth muscle); and
[a2] methods of treatment of cardiovascular disease and related disorders (e.g., congestive heart disease, atherosclerosis, myocardial infarction, and stroke), respectively,
which comprises administration of novel PDE1 (phosphodiesterase 1) inhibitor of Formula (I):
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corresponding pharmaceutical compositions to a patient in need thereof (i.e., see paras. [0110] to [0111] therein);
where:
phosphodiesterases (PDEs) are in Family I or Ca2+-calmodulin-activated dependent phosphodiesterases (CaM-PDEs), respectively, shown to be mediated by calcium and cyclic nucleotide (i.e., e.g. cAMP and cGMP) signaling pathways. (i.e., see [0031 therein]);
“selective PDE1 inhibitors regulate cGMP/PKG in cardiac hypertrophy. accordingly, without being bound by any theory, it is believed that inhibition of PDE1A could, for example, reverse or prevent the attenuation of cGMP/PKG signaling. etc. . . . administration of a PDE1 inhibitor as described herein could provide a potential means to regulate cardiac hypertrophy, and by extension provide a treatment for various cardiovascular diseases and disorders. (i.e., see [0110 therein]”
[b] a combination (combination therapy), which comprises:
a PDE1 inhibitor compound of Formula I (or any of formulae 1.1-1.39 defined therein), in free or pharmaceutically acceptable salt form, may be used:
as a sole therapeutic agent or
as a secondary agent which may be used in combination or for co-administration with other active agents. ([0205]
e.g., for selected from angiotensin II receptor antagonist, angiotensin-converting-enzyme (ACE) inhibitor, neutral endopeptidase (NEP or Neprilysin) inhibitor and/or phosphodiesterase 5 (PDE5) inhibitor, in free or pharmaceutically acceptable salt form;
[c]Disruption of cGMP/PKG mediated signaling pathways is associated with diseases and disorders also are known in the art to include additional diseases (i.e., other than those defined infra) associated with the aforementioned pathway conventionally known in the art since the late 1970’s include neurodegenerative disease, a neurological condition, trauma, a mental disorder, a respiratory and inflammatory disorder, a neuroinflammatory disorder, a cancer, a tumor, or pain.
Next while U.S. ‘117 Pat. Pub. may be used as a secondary agent in combination or for co-administration with other active agents. ([0205] defined supra, it does not teach administering a PDE1 inhibitor or free form or a pharmaceutically acceptable salt thereof and a soluble hydrolase inhibitor.
However, U.S. ‘526 Pat. Pub. teaches that:
PDE1 inhibitor compounds of the invention can be combined with one or more therapeutic agents that have sEH-inhibiting activity, i.e., e.g., where such compounds having soluble epoxide hydrolase inhibitory activity are conventionally known in the art;
where:
such combinations can be used for other types of treatment (which may or may not inhibit sEH) to treat, prevent, and/or reduce the risk of any disorders that benefit from sEH inhibition and used for various medical conditions or treatments, which may include, but are not limited to cardiovascular diseases, respiratory diseases, inflammation, and diabetes.(i.e., see Abstract therein); and
the dosages of one or more of the therapeutic compounds in such combinations may be reduced from standard dosages when administered alone.
While the U.S. ‘526 Pat. teaches sEH inhibitors, it does not teach the sEH inhibitors recites in claim 10 of the claimed invention.
However, (“U.S. ‘910 Pat.”) teaches each of the conventional sEH inhibitors taught in the claimed invention (i.e., see Kim reference)
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Based on the foregoing and the teachings of the art, a person of ordinary skill in the art would have combined the teachings of would meet with an expectation of success in designing a method for treatment or prophylaxis of a disease or disorder:
to administer a PDE1 inhibitor in combination with a soluble epoxide hydrolase inhibitor by routine experimentation to enhance the efficacy and attain greater therapeutic benefit than inhibition of either enzyme alone, eliminate side effects known for use of PDE1 inhibitors and reduce dosing to yield better treatment methods for a wide range of diseases, neurological disorders, inflammatory conditions, and cancer.
Moreover, the ordinary artisan would have been motivated to combine PDE1 inhibitor in combination with a soluble epoxide hydrolase inhibitor for treatment of associated diseases,
because PDE1 inhibitors and soluble epoxide hydrolase (sEH) inhibitors complementary or interconnected signaling pathway/mechanisms of action and additive synergistic effects result in successful use in combination therapies necessitated by unmet medical needs.
Based on the foregoing, claimed invention is rendered obvious over U.S. ‘117 Pat. Pub.” alone, in combination with and/or further in view of “U.S. ‘526 Pat. Pub.
DISCUSSION OF THE 103 REJECTION
Applicants November 26, 2025 Arguments
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Examiner’s Response
The Examiner disagrees with the Applicants arguments that 35 U.S.C. § 103 references neither teach nor suggest the claimed invention individually and cannot be combined as it is generally not considered reasonable if the combination relies on the ordinary knowledge of a person having ordinary skill in the art (PHOSITA) to solve a common problem, or if the references are from the same or analogous fields.
The law permits combining multiple references, even a large number, if there is a teaching, suggestion, or motivation to combine such references. "Reasonable Expectation of Success": The test is not whether the combination is perfect, but whether it is a reasonable, predictable variation of existing technology to a PHOSITA.
Based on the foregoing and the teachings of the art, a person of ordinary skill in the art would have combined the teachings of would meet with an expectation of success in designing a method for treatment or prophylaxis of a disease or disorder:
to administer a PDE1 inhibitor in combination with a soluble epoxide hydrolase inhibitor by routine experimentation to enhance the efficacy and attain greater therapeutic benefit than inhibition of either enzyme alone, eliminate side effects known for use of PDE1 inhibitors and reduce dosing to yield better treatment methods for a wide range of diseases, neurological disorders, inflammatory conditions, and cancer.
Support for this rejection is provided by the "Obvious to Try" Rationale (see MPEP 2143); i.e., e.g.,
where consideration for the combination of PDE1 inhibitors as taught by US ’711 Pub. and soluble epoxide hydrolase (sEH) inhibitors as taught by US ’526 Pat. Pub. leads to an obvious to try use of the aforementioned combination for improved treatment methods for specific/related diseases or disorders, in light of known synergy between associated pathways (sEH and PDE1) in complementary therapeutic areas.
While US ‘526 Pat. Pub. states :
“A [sEH inhibitor] compound of the invention can be used alone or in combination with other agents that have sEH-inhibiting activity, or in combination with other types of [agents in] treatment (which may or may not inhibit sEH) to treat, prevent, and/or reduce the risk of any disorders that benefit from sEH inhibition. . .”
it does not literally state that
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However, a distinction is to be made between language cited in US ‘526 Pat. Pub. vs Examiner’s interpretation of that literal language as set forth in the August 26, 2025 Office Action as it relates to the definition of “a combination phosphodiesterase 1 (PDE1) inhibitor and a soluble epoxide hydrolase (sEH) compound”):
Section From August 26, 2025 FAOM
Copied Section From US ‘526 Pat. Pub.
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Thus, an ordinary artisan would understand from the US ‘526 Pat. Pub. definition noted above that sEH inhibitors can or may be used in combination with other agents (i.e., which inc. PDE-1 inhibitors to treat diseases for which chemical and physical properties of sEH inhibitors may be beneficial).
In particular,
while US ’526 Pat. Pub. might not explicitly say "combine with a PDE1 inhibitor," it teaches that:
sEH inhibitors can or may be used in combination with other agents (i.e., which inc. PDE-1 inhibitors) to treat diseases for which chemical and physical properties of sEH inhibitors may be beneficial);
i.e. e.g., where used in combination it appears that there is a reduction of one or both of the individual standard dosages (than when each is administered alone)
combined should provide a therapeutic effect” In combination treatments, the dosages of one or more of the therapeutic compounds may be.
sEH inhibitors are used to treat a specific, finite list of disorders (e.g., inflammation, hypertension, neurodegeneration). Ref 1 teaches that PDE1 inhibitors are also used to treat these same, or similar, disorders.
PDE1 inhibitors of US ’711 Pub. treat same, or similar, disorders (i.e., neurodegenerative disease, a neurological condition, trauma, a mental disorder, a circulatory and cardiovascular disorder, a respiratory and inflammatory disorder, a neuroinflammatory disorder, a cancer, a tumor, or pain) as that defined for sEH inhibitors of US ’526 Pat. Pub. (i.e., e.g., (e.g., inflammation, hypertension, neurodegeneration)
c. Known Synergistic Effect: these two drug types (PDE1 and sEH inhibitors) have already been shown individually to treat a particular conditions (like a neurological disease) to see if they work better together is a predictable, routine optimization of a combination therapy, not a new invention.
d. Combination Effect of PDE-1 and sEH inhibitors:
create a potent, synergistic anti-inflammatory and analgesic (pain-reducing) effect. The combination allows for lower doses of each drug while achieving greater therapeutic results, specifically by sustaining the signaling of epoxy fatty acids that rely on cyclic nucleotide messengers.
e. the conventional art since early to mid 2010’s has long described synergistic pharmacological and complementary effects associated with two pathways in treating similar diseases (e.g., cardiovascular, CNS, inflammatory diseases, cancers, diabetes etc.).
as influenced by Mechanism of Action and Convergent Pathways
sEH Inhibitors (sEH): Block the enzyme sEH, which converts epoxy fatty acids (EpFAs)—such as EpETrEs (EETs)—into less active diols (DHETs). By inhibiting sEH, these agents increase the levels of anti-inflammatory and anti-hypertensive epoxy fatty acids.
PDE1 Inhibitors: Block the PDE1 enzyme, which breaks down cyclic nucleotides (cAMP and cGMP) in vascular smooth muscle and nerve cells, particularly under high-calcium conditions.
Synergy (Convergent Mechanism): sEHs increase the levels of EETs, which increase cAMP/cGMP. PDE1 inhibitors prevent the degradation of that cAMP/cGMP.
Moreover, the ordinary artisan would have been motivated to combine PDE1 inhibitor in combination with a soluble epoxide hydrolase inhibitor for treatment of associated diseases,
because PDE1 inhibitors and soluble epoxide hydrolase (sEH) inhibitors complementary or interconnected signaling pathway/mechanisms of action and additive synergistic effects result in successful use in combination therapies necessitated by unmet medical needs.
Therefore. it would have been obvious to a person of ordinary skill in the art (PHOSITA) to combine the PDE1 inhibitors of U.S. ‘711 Pat. Pub. with the sEH inhibitors of U.S. ‘526 Pat. Pub. to treat the identified list of diseases, because both classes of compounds are known in the art to treat such via distinct, but compatible, mechanisms, providing a reasonable expectation of improved therapeutic efficacy."
Based on the foregoing, claimed invention is rendered obvious over U.S. ‘117 Pat. Pub.” alone, in combination with and/or further in view of “U.S. ‘526 Pat. Pub.
Appropriate action is required accordingly.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and 10-14 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.
[1] Claim 1 is rejected for lack of clarity and for being vague, ambiguous and indefinite for recitation of a prodrug of a PDE1 inhibitor compound of Formula (Ia), given that it is unclear what the prodrug is, or what components it is formed from as per lack of definition in the claimed invention such that the metes and bound of the scope of the claimed invention is indeterminate.
[2] Claim 11 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or joint inventor regards as the invention.
Claim 11 depends from claim 1. Claim 1 is directed to a method of treatment, whereas claim 11 is directed to a pharmaceutical composition. A dependent claim must further limit the subject matter of the claim from which it depends without changing the statutory class of the claim. See 37 CFR 1.75(c).
Because claim 11 changes the statutory class from a method to a composition, the scope of claim 11 is unclear. It is uncertain whether claim 11 is intended to be a composition per se, a composition for use in the method of claim 1, or some other relationship. This ambiguity prevents one of ordinary skill in the art from determining the metes and bounds of the claimed invention with reasonable certainty.
Applicant is advised to amend claim 11 so that it is consistent in statutory class with the claim from which it depends, or to rewrite it in independent form to clearly define the intended subject matter.
[3] Claims 12-14 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or joint inventor regards as the invention.
Independent method claim 1 refers to broad disease categories recited in claim 1, which recites the phrase:
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Dependent claims 13 and 14 do not refer back, identify or incorporate the broader disease state “neurodegenerative or neurological condition” defined in independent claim 1 that the narrower or specific disease limitations, Parkinson’s disease (i.e., in claim 13) and Alzheimer’s disease (i.e., in claim 14), respectively, should refer back to.
For example, claim 13 should be amended to (likewise for claim 14):
“The method of claim 1, wherein the condition, disease or disorder is a neurological condition or a neufrodegenerative disease which is Parkinson’s disease”.
Appropriate claim amendments are required accordingly.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 and dependent claims10-14 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.
In particular, the specification at paras [0104] to [0105] set forth limited information on prodrug formation as it pertains to related to PDE-1 inhibitors and corresponding pro-drugs of the claimed invention:
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Thus, the subject matter as it pertains to or a prodrug thereof not properly described in the application as filed, because:
Applicants claim a broad genus of prodrugs as in claims based on a generalized description of substituting active hydrogens on urea or carbamate compounds.
However, the application fails to provide any specific exemplified examples of these prodrug compounds or their preparation; i.e., e.g.,
without at least one or more specific examples (e.g., urea derivative, carbamate derivative), it is difficult to show "possession" of a broad class of prodrugs, even if the general concept of substituting active hydrogens is known in the art.
While the application cites several references, these do not provide the necessary, specific disclosure of the claimed compounds; i.e., e.g.,
because incorporation by reference by merely citing references does not substitute for describing the specific compounds of the invention within the specification and is insufficient, as it does not guide one of ordinary skill in the art to the specific, actionable compounds within the scope of the claims.
Without structural details, or representative examples detailing the specific chemical structure of the claimed prodrugs, the specification constitutes a mere invitation to experiment rather than a description of the invention.
Therefore, one skilled in the art would not recognize specific claimed prodrug compounds urea/carbamate derivatives at the time of filing, given general idea of making prodrugs given lack of examples, combined with the broad, functional language, fails to show that the inventor had possession of the claimed subject matter.
Appropriate actions and claim amendments are required accordingly.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the Examiner
should be directed to GRACE C HSU whose telephone number is (571) 270-1689. The
Examiner can normally be reached Monday-Friday 7:30 am - 6 pm.
Examiner interviews are available via telephone, in-person, and video conferencing
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encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s
supervisor, Kortney L. Klinkel can be reached on 571-270-5239.
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/G.C.H./
Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627 [AltContent: roundedrect][AltContent: roundedrect][AltContent: roundedrect]