Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to applicant’s reply filed on November 11, 2025.
Restrictions/Elections.
Applicant election of the following species:
1- 4-((5-Phenyl-4-(trifluoromethyl)-thiazol-2-yl)-amino)-benzoic acid (IA65) as the SOCE modulator, and
2- melanoma as the disease or disorder associated with reduced levels of Calcium signaling
On November 11, 2025, is acknowledged.
In order to accelerate prosecution, the following SOCE modulator is also under examination:
N-[4-[3,5-bis(trifluoromethyl)-1H-pyrazol-1-yl]-phenyl]-4-methyl-1,2,3-thiadiazole-5-carboxamide (YM58483 or BTP2).
Status of Claims
Claims 1-20 are currently pending and are the subject of this office action.
Claims 1-20 are presently under examination.
Priority
The present application claims priority to provisional application No. 60/492,367 filed on 08/04/2003.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “A method of treating a disease or disorder associated with reduced levels of Calcium signaling in need thereof.”
However, it should say “in a subject need thereof”
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 1-20 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. This is a written description rejection.
Claims 1-20 encompass “SOCE modulators from the group consisting of Orai1, Orai2 and Orai3”.
M.P.E.P. #2163 states: “An applicant shows possession of the claimed invention by describing the claimed invention with all its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated that “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1351. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs, 636 F.3d 1341, 1348 (Fed. Cir. 2011).
The description requirement of the patent statute requires a description of an actual invention, not merely an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984) (holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate’). This matter is of particular importance in the evaluation of claims drawn to a chemical genus which identifies a core compound bearing variable substituents. It has been held that “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification...demonstrates that the applicant has invented species sufficient to support a claim to a genus” with such breadth. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1171 (Fed. Cir. 2010). An adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties of species falling within the genus sufficient to distinguish the genus from other materials. Id., quoting Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997).
However, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Ariad, 94 USPQ2D at 1171. 35 U.S. C. 112, first paragraph, requires a description of the invention that “clearly allow[s] persons of ordinary skill in the art to recognize that the inventor invented what is claimed.” Ariad at 1172, quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (1562-63) (Fed. Cir. 1991) (emphasis added). A sufficient disclosure is one which reasonably conveys to one having ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date of the application in question. Vas-Cath, 935 F.2d at 1563. The description must reasonably describe the invention, not simply indicate a result which one might achieve if one actually made the invention. Eli Lilly, 119 F.3d at 1568. To properly evaluate whether an applicant has complied with the written description requirement therefore requires an analysis of whether the skilled artisan would recognize, from the description provided, the applicants were in possession of sufficient compounds representing the full breadth of diversity of the genus claimed.
A description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the members of the genus, which features constitute substantial portion of the genus. See Univ. of California vs. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under section 112 first, by showing enablement of a representative number of species within the genus. A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus.
Here, applicants have claimed an extraordinarily large genus of chemical compounds encompassed by “SOCE modulators from the group consisting of Orai1, Orai2 and Orai3”. The specification discloses only one compound with such characteristics: IA65.
The size of the genus thus described is phenomenal, against which the applicants have offered evidence of being in possession of only one compound (IA65). This small set of compounds cannot be viewed as being reasonably representative of the genus of compounds of “SOCE modulators from the group consisting of Orai1, Orai2 and Orai3” in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus, and in no way either represent the breadth of variable moieties which applicants have claimed, nor permit the skilled artisan to recognize that such claim breadth was actually in the applicants possession as of the time of filing the instant application.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize that Applicant was in possession of “SOCE modulators from the group consisting of Orai1, Orai2 and Orai3”.
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 1-6 and 12-20 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 melanoma, does not reasonably provide enablement for all other disorders associated with reduced levels of Calcium signaling. 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 a scope of enablement rejection.
To be enabling, the specification of the patent application 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 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 1-6 and 12-20 recite:
A method of treating a disease or disorder associated with reduced levels of Ca2+ signaling in a subject in need thereof, comprising administering the to the subject a composition comprising at least one modulator of store-operated Ca2+ entry (SOCE) in a subject in need thereof.
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D.
The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
The specification lists almost any conceivable type of cancer known to humans that can allegedly be treated with the instant method (see specification pages 19-21).
Regarding one drug or type of drug being effective against any type of cancer, the Examiner refers to: Gura (Science (1997) 278:1041-1042) and Johnson et. al. (British Journal of Cancer (2001) 84:1424-1431).
Both references indicate the difficulties between correlating in vitro models with efficacy in clinical trials. Both references also indicate that when it comes to treating cancer there is no single drug or type of drug that can treat all types of cancer.
4. The breadth of the claims
The breadth of the claims is not commensurate in scope with the disclosure.
The instant claims recite a broad spectrum of disorders which encompasses any type of cancer, despite providing data only for melanoma. It also encompasses any type of SOCE modulator, despite only providing data for IA65.
5. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 cites: “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“Nascent technology, however, must be enabled with a specific and useful teaching.’ The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee’s instruction. Thus, the public’s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.”
The specification only provides data for the treatment of melanoma (see pages 43-66).
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the treatment of any type “disorder associated with reduced levels of Calcium signaling, including any type of cancer”, is required for practice of the claimed invention.
6. The Quantity of experimentation necessary
Because of the known unpredictability of the art (see section 3) and in the absence of experimental evidence commensurate with the claims (see section 5), the skilled in the art will not accept that the administration of a composition any SOCE modulator can treat any type of disorder associated with reduced levels of Calcium signaling, including any type of cancer (except for melanoma) as inferred by the claims and contemplated by the specification.
7. Conclusion
Accordingly, the inventions of claims 1-6 and 12-20 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention, a person of ordinary skill in the art would have to engage in undue experimentation with no reasonable expectation of success.
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 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.
1) Claim(s) 1-3 and 5-13 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Umemura et. al. (PLOS ONE (2014) 9:1-11, cited by Applicant).
For claims 1-3, 5-7 and 12-13, Umemura teaches a method of treating melanoma in vitro, comprising administering to melanoma cells a composition comprising the compound YM58483 (BTP2, a modulator (inhibitor) of SOCE and Orai, see instant specification on paragraph bridging pages 51-52) (see Figure 4 B, page 7 under “inhibition of SOCE suppresses melanoma cell proliferation”, and page 8 under “inhibition of SOCE suppresses melanoma cell migration/metastasis”).
Umemura does not teach the treatment of a subject in need thereof. However, Umemura teaches that “SOCE is a potential target for the treatment of melanoma” (see page 10, left column, last paragraph).
Since there is a presumption of a correlation between in vitro and in vivo assays, before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat melanoma (a disease associated with reduced levels of Calcium) in a subject suffering from melanoma comprising the administration of the SOCE modulator YM58483 that has already proven to be effective in vitro, thus resulting in the practice of claims 1-3, 5-7 and 12-13 with a reasonable expectation of success.
Regarding claim 8 The prior art is silent regarding the statement: “wherein administering the composition to the subject downregulates anabolic metabolic pathways in cancerous cells”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating melanoma comprising administering to a subject in need thereof a composition comprising a SOCE modulator".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein administering the composition to the subject downregulates anabolic metabolic pathways in cancerous cells” appears to be the result of the process made obvious by the prior art: “a method of treating melanoma comprising administering to a subject in need thereof a composition comprising a SOCE modulator", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
Similar arguments can be made for the “wherein” clauses in claims 9-11 and 15-20.
All this will result in the practice of claims 8-11 and 15-20.
2) Claim(s) 1, 5-7 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et. al. (Advances in Cancer Research (2020) 148:233-317, cited by Applicant).
For claim 1 and 5-7, Gross teaches that: “some melanomas utilize Wnt5a/PKC and suppressed SOCE for progression. This necessitates discovering and generating novel drugs that enhance SOCE to combat melanoma in some contexts” (see page 282, last paragraph).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat melanoma comprising the administration of a SOCE enhancer (i.e. a SOCE modulator), thus resulting in the practice of claim 1 and 5-7 with a reasonable expectation of success.
Regarding claim 10 The prior art is silent regarding the statement: “wherein administering the composition to the subject reduces migration of the melanoma”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating melanoma comprising administering to a subject in need thereof a composition comprising a SOCE modulator".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein administering the composition to the subject reduces migration of the melanoma” appears to be the result of the process made obvious by the prior art: “a method of treating melanoma comprising administering to a subject in need thereof a composition comprising a SOCE modulator", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
Similar arguments can be made for the “wherein” clause in claim 11.
All this will result in the practice of claims 10-11.
3) Claim(s) 2-4, 8-9 and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et. al. (Advances in Cancer Research (2020) 148:233-317, cited by Applicant) as applied to claims 1, 5-7 and 10-11 above, further in view of Azimi et. al. (Pharmacology and Translational Science (2020) 3:135-147, cited by Applicant).
Gross teaches all the limitations of claims 2-4 and 12-14, except for the SOCE modulators being IA65. However, Azimi teaches that IA65 is a selective pharmacological enhancer of Orai1 Ca channel (and hence SOCE) (see title and page 141 under discussion, first two paragraphs).
Since Gross teaches a method of treating melanoma comprising the administration of a composition a SOCE enhancer, and since Azimi teaches that IA65 is a SOCE enhancer, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (a SOCE enhancer) for another (IA65) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claims 2-4 and 12-14, with a reasonable expectation of success.
Regarding claim 8 The prior art is silent regarding the statement: “wherein administering the composition to the subject downregulates anabolic metabolic pathways in cancerous cells”.
However, the above statements do not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating melanoma comprising administering to a subject in need thereof a composition comprising a SOCE modulator".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein administering the composition to the subject downregulates anabolic metabolic pathways in cancerous cells” appears to be the result of the process made obvious by the prior art: “a method of treating melanoma comprising administering to a subject in need thereof a composition comprising a SOCE modulator", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
Similar arguments can be made for the “wherein” clauses in claims 9 and 15-20.
All this will result in the practice of claims 8-9 and 15-20.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 15, 2025.