Prosecution Insights
Last updated: October 04, 2026
Application No. 18/019,210

METHODS FOR MAINTAINING MICROVASCULAR INTEGRITY

Non-Final OA §102§103§112
Filed
Feb 01, 2023
Priority
Aug 03, 2020 — provisional 63/060,245 +1 more
Examiner
SZNAIDMAN, MARCOS L
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Neurothera Labs Inc.
OA Round
1 (Non-Final)
37%
Grant Probability
At Risk
1-2
OA Rounds
0m
Est. Remaining
54%
With Interview

Examiner Intelligence

Grants only 37% of cases
37%
Career Allowance Rate
475 granted / 1273 resolved
-22.7% vs TC avg
Strong +16% interview lift
Without
With
+16.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
83 currently pending
Career history
1346
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
38.4%
-1.6% vs TC avg
§102
17.8%
-22.2% vs TC avg
§112
27.8%
-12.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1273 resolved cases

Office Action

§102 §103 §112
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 April 27, 2026. Election/Restrictions Applicant’s election of the following species: 1- Tetrahydrocannabinol (THC, dronabinol) as the cannabinoid, 2- Treating damage to microvascular integrity, and 3- Traumatic Brain Injury (TBI) as the specific type of microvascular integrity, is acknowledged. NOTE: In the response dated 04/27/2026, Applicant elected THC. However, the structure depicted was of tetrahydrocannbinoic acid (THCA): PNG media_image1.png 108 196 media_image1.png Greyscale (see page 5 of the response dated 04/27/2026). The real structure of THC is: PNG media_image2.png 150 304 media_image2.png Greyscale Status of Claims Claims 1-17 and 35-38 are currently pending and are the subject of this office action. Claims 36-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being non-elected species. Claims 1-17 and 35 are presently under examination. 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. NOTE: for the purpose of enablement rejection the word “prevention” is being interpreted as 100% success (i.e. “keeping from happening”, see specification paragraph [0086]). The “subjects in need of prevention of damage to microvascular integrity due to TBI” are being considered individuals that suffer from TBI that do not yet suffer from microvascular integrity. Since according to the specification, the word treatment also encompasses the word prevention (see [0087]), this rejection also applies for methods of “treatment”. Claims 1-17 and 35 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an 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 1-17 and 35 recite: A method for preventing (100% success) damage to microvascular integrity, comprising administering to a subject in need thereof (a subject suffering from TBI, not yet suffering from damage to microvascular integrity), a composition comprising one or more cannabinoids. 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 First, the term prevention is synonymous with the term curing, and both circumscribe methods of treatment having absolute success (100% success). Humans in need of prevention of damage to microvascular integrity are humans that do not yet suffer from damage to microvascular integrity, and if they were to be administer cannabinoids, according to the instant claims, they will never ever suffer from damage to microvascular integrity (100% success). The general knowledge of the prior art clearly indicates that the art of preventing (100% success) any diseases including damage to microvascular integrity, is highly unpredictable. Second, an extensive search of the prior art reveals that there are no references disclosing any type of prevention of damage to microvascular integrity with any drug, including cannabinoids. 4. 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 teaches (see Example 1) that in animal models of TBI (not yet suffering from damage to microvascular integrity), those TBI animals exposed to THC suffered less damage to microvascular integrity than in TBI untreated animals (see for example specification, paragraph [00111]). Thus, while the specification provides a procedure for decreasing the damage (less damage, less than 100% success) to microvascular integrity in animals suffering from TBI (not yet suffering from damage to microvascular integrity) when treated with THC, the specification appears to be silent on a nexus between: decreasing the damage to microvascular integrity (less than 100% success) in subjects that suffer from TBI, that do not yet suffer from damage from microvascular integrity and were administered THC, and preventing (100% success) damage to microvascular integrity, in subjects that suffer from TBI, that do not yet suffer from damage to microvascular integrity and were administer THC. As such, if there is no correlation then the examples do not constitute working examples. 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 prevention (100% success) of damage to microvascular integrity due to TBI, is required for practice of the claimed invention. 5. 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 4), the skilled in the art will not accept that the administration of a composition comprising THC or any cannabinoid, can prevent (100% success) damage to microvascular integrity as inferred by the claims and contemplated by the specification. 6. Conclusion Accordingly, the inventions of claims 1-17 and 35 do not comply with the 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 § 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 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. (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. NOTE: for the purpose of anticipatory rejection the word “prevention” is being interpreted as less than 100% success (“averting, countering, hampering arresting”, see specification paragraph [0086]) which is equivalent to “reducing the risk of” damage to microvascular integrity. The “subjects in need of prevention (i.e. reducing the risk) of damage to microvascular integrity due to TBI” are being considered individuals that suffer from TBI that do not yet suffer from microvascular integrity. Since according to the specification, the word treatment also encompasses the word prevention (see [0087]), this rejection also applies for methods of “treatment”. Claim(s) 1-8, 10, 12, 14, 16-17 and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jha (WO 2018/145213, August 16, 2018). For claims 1-2, 5, 8, 12 and 35, Jha teaches a method of treating TBI comprising the administration of a composition comprising the cannabinoids THC and CBD to subjects suffering from TBI (see abstract and claim 18). The prior art is silent regarding “prevention (reducing the risk of) damage to microvascular integrity due to TBI”. However: “prevention (reducing the risk of) damage to microvascular integrity due to TBI” will inevitably flow from the teachings of Jha, since the same compounds (a composition comprising the cannabinoids THC and CBD) is being administered to the same subjects (subjects that suffer from TBI, that do not yet suffer from damage to microvascular integrity). In other words, products of identical composition cannot exert mutually exclusive properties when administered under the same circumstances. In other words, even though the prior art is silent regarding “prevention (reducing the risk of) damage to microvascular integrity due to TBI”, by practicing the method of Jha: “the administration of a composition comprising the cannabinoids THC and CBD to individuals who suffer from TBI, but don’t yet suffer from damage to microvascular integrity", one will also be “preventing (reducing the risk of) damage to microvascular integrity due to TBI”, even though the prior art was not aware of it. Apparently, Applicant has discovered a new property or advantage ("preventing (reducing the risk of) damage to microvascular integrity due to TBI”) of the method disclosed by Jha (“the administration of a composition comprising the cannabinoids THC and CBD to individuals who suffer from TBI, but don’t yet suffer from damage to microvascular integrity "). MPEP 2112 I states: “The 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).” For claim 3, Jha teaches the administration of 25 to 50 mg of CBD and 1.5 to 3.0 mg of THC (see [0026]), both anticipate the claimed range of 0.01 mg to 600 mg. For claim 4, Jha teaches that the cannabinoids can be administered via an oral, rectal, nasal, parenteral, sublingual route of administration (see [0038]). For claims 6-7 and 16, Jha teaches that the cannabinoids can be derived from plants (see [0031], see claim 64). Jha further teaches that the cannabinoids can be derived from Cannabis sativa or Cannabis indica plants (see claim 65). For claim 10, Jha teaches the administration of 2.0 mg to 2.5 mg of THC (see claim 77) which anticipates the range of claim 10 (0.5 mg to about 2.5 mg). For claim 14, Jha teaches the administration of 25 mg to 50 mg of CBD (see claim 73), which anticipates the range of claim 14 (from about 10 mg to about 100 mg) For claim 17, Jha teaches that the subjects are human (see [0059] and claim 72). 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. Claim(s) 9, 11, 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jha (WO 2018/145213, August 16, 2018). Jha teaches all the limitations of claims 9 and 11 (see 102(a)(1) above), except for the claimed amounts of THC. However, Jha teaches the administration of 1.5 mg to 3.0 mg of THC (see claim 76 and 2.0 mg to 2.5 mg of THC (see claim 77), which either overlap or are very close to the claimed ranges. MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). "A prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005). MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).” All this will result in the practice of claims 9 and 11 with a reasonable expectation of success. Jha teaches all the limitations of claims 13 and 15 (see 102(a)(1) above), except for the claimed amounts of CBD. However, Jha teaches the administration of 25 to 50 mg of CBD (see claim 73), 30 to 45 mg of CBF (see claim 74) and 35 to 45 mg of CBD (see claim 75), which either overlap or are very close to the claimed ranges. MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). "A prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005). MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).” All this will result in the practice of claims 13 and 15 with a reasonable expectation of success. 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. NOTE: for the purpose of enablement rejection the word “treatment” is being interpreted as: “ameliorating”, “inhibiting”, “attenuating”, “reducing” (see specification paragraph [0087]). The “subjects in need of “treatment” of damage to microvascular integrity due to TBI” are being considered individuals that already suffer from microvascular integrity due to TBI. Claims 1-17 and 35 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an 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 1-17 and 35 recite: A method for treating damage to microvascular integrity due to TBI, comprising administering to a subject in need thereof (a subject suffering from suffering from damage to microvascular integrity due to TBI), a composition comprising one or more cannabinoids. 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 prior art is silent regarding the treatment of damage to microvascular integrity comprising the administration of cannabinoids to subjects already suffering from damage to microvascular integrity. 4. 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 teaches (see Example 1) that in animal models of TBI (not yet suffering from damage to microvascular integrity), those exposed to THC suffered less damage to microvascular integrity than in TBI untreated animals (see for example specification, paragraph [00111]). Thus, while the specification provides a procedure for decreasing the damage to microvascular integrity in animals suffering from TBI (not yet suffering from damage to microvascular integrity) by administering THC, the specification appears to be silent on a nexus between: decreasing the damage to microvascular integrity in subjects that suffer from TBI, that do not yet suffer from damage from microvascular integrity and were administered THC, and treating damage to microvascular integrity, in subjects that suffer from damage to microvascular integrity due to TBI and were administered THC. As such, if there is no correlation then the examples do not constitute working examples. 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 damage to microvascular integrity in patients already suffering from damage to microvascular integrity due to TBI comprising the administration of cannabinoids, is required for practice of the claimed invention. 5. 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 4), the skilled in the art will not accept that the administration of a composition comprising THC or any cannabinoid, can treat damage to microvascular integrity in an individual already suffering from damage to microvascular integrity due to TBI, as inferred by the claims and contemplated by the specification. 6. Conclusion Accordingly, the inventions of claims 1-17 and 35 do not comply with the 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. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is 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, 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MARCOS L SZNAIDMAN/ Primary Examiner, Art Unit 1628 May 20, 2026.
Read full office action

Prosecution Timeline

Feb 01, 2023
Application Filed
Aug 12, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
37%
Grant Probability
54%
With Interview (+16.2%)
3y 6m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1273 resolved cases by this examiner. Grant probability derived from career allowance rate.

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