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 .
Withdrawn Objections/Rejections
The objections to claims 187, 191-192, 194, 196-198, and 201 are withdrawn in view of the claim amendments.
The rejections of claims 188-201 under 35 U.S.C. § 112(b) are withdrawn in view of the claim amendments.
Claim Status
Applicants' amendments and arguments filed on 07/21/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-186 are cancelled.
Claims 202-204 are withdrawn as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 187-201 and 205-207 are under current examination. The claims were read in view of the species elections as detailed in Office Action mailed 03/03/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/21/2026 has been considered by
the Examiner.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 188 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 188 recites the limitation “the one or more fixed dose of liposomal trans-crocetin is administered to the subject in an amount of 25mg to 900mg or any range therein between”. Claim 187, from which claim 188 depends, recites “one or more fixed dose of 50mg to 900mg”. Thus, claim 188 has broadened the range of the administered fixed dose and fails to include all of the limitations of claim 187.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Rejections Maintained, Slightly Modified to Address Amended Claims
Claim Rejections - 35 USC § 112(a)-Scope of Enablement
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.
Claims 187-201 and 207 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for increasing the delivery of oxygen in a subject, does not reasonably provide enablement for treating or preventing any disease or condition. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. MPEP 2164.01(a), citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), sets out the factors to consider whether experimentation is undue, which include:
(A) The breadth of the claims. The claims recite a method of treating or preventing a disease or condition in a patient comprising administering an effective amount of liposomal trans-crocetin; the claims do not limit the disease or condition. Absent a limiting definition in the instant specification, preventing a disease or condition is suggested to include a level of protection against, up to and including complete protection against the development of any disease or condition, which is unsupported by the disclosure. Giving the claims their broadest reasonable interpretation, prevention includes any measure taken prior to the onset or occurrence of which precludes its coming into existence, absolutely and in all cases. Therefore, preventing any disease or condition renders the scope of the claims unreasonably broad.
(B) The nature of the invention. The claims are drawn to a method of treating or preventing a disease or condition in a patient comprising administering an effective amount of liposomal trans-crocetin. The instant specification states, “Terms such as "treating," or "treatment," or "to treat" refer to both (a) therapeutic measures that cure, slow down, attenuate, lessen symptoms of, and/or halt progression of a diagnosed pathologic disorder or condition and (b) prophylactic or preventative measures that prevent and/or slow the development of a targeted disorder or condition” (paragraph [0067]). The claims do not limit the disease or condition, and the instant specification provides a vast and wide-ranging number of conditions including ischemia, infection, diabetes, cancer, asthma, Alzheimer’s disease, etc. (see particularly paragraphs [0067] and [0301]-[0320]).
(C) The state of the prior art. It is known in the prior art that not every condition or disease can be prevented. As just a limited number of examples, the prior art of Lakeridge Health teaches that asthma cannot be prevented from starting (“Asthma Attack Prevention”, pg. 1); the prior art of Harris teaches that “outright prevention of Type 1 diabetes isn’t possible” (“An Experimental Genetic Test Gives Early Warning for Kids at Risk of Type 1 Diabetes”, pg. 2); and the prior art of Park teaches that while we can take measures to protect ourselves from certain cancers, some cancers are hereditary, and “some tumors emerge simply at random” (“Most Cancer is Beyond Your Control, Breakthrough Study Finds”, pg. 1).
(D) The level of one of ordinary skill. The level of ordinary skill in the art is assumed to be that
of one having knowledge and/or experience in the medical field of disease or condition treatment. While the relative skill of those in the art is high, likely that of an MD or Ph.D., that factor is outweighed by the unpredictable nature of the art.
(E) The level of predictability in the art. “Preventing” connotes an absolute absence of a
condition which cannot reasonably be achieved with regard to medicine generally, with few exceptions
(such as vaccines to prevent the development of pathogen-borne illnesses). As noted above, the prior
art teaches that not every disease or condition can be prevented. The prior art further suggests that even when protective measures are taken, some diseases such as cancer occur due to hereditary or even random causes (see Park, “Most Cancer is Beyond Your Control, Breakthrough Study Finds”, pg. 1).
Even if a patient can be identified as having a risk factor for a disease or condition, there is no certainty that failure to develop that disease or condition can reliably be attributed to the claimed administering of a fixed dose of liposomal trans-crocetin. In this sense, in the context of preventing any disease or condition, the level of unpredictability is extremely high.
(F) The amount of direction provided by the inventor. The working examples in the specification demonstrate the treatment of severe grade sepsis and acute respiratory distress syndrome due to COVID-19 (paragraphs [0391]-[0444]). The specification does not provide direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for preventing or treating all diseases or conditions, other than those of the working examples.
(G) The existence of working examples. As noted above, the working examples in the specification demonstrate the treatment of severe grade sepsis and acute respiratory distress syndrome due to COVID-19 (paragraphs [0391]-[0444]). No reasonably specific guidance is provided concerning useful therapeutic protocols for preventing or treating all diseases or conditions, and the results of the working examples are not such that a skilled artisan would understand that these results extend to the prevention or treatment of any disease or condition.
(H) The quantity of experimentation needed to make or use the invention. Because prevention
of every disease or condition cannot be achieved with any certainty, coupled with a lack of evidence in
the working examples that the claimed method is capable of treating or preventing any disease or condition, a skilled artisan could not practice the method of increasing the delivery of oxygen or treating or preventing a disease or condition in a subject commensurate with the full scope of the claims without undue experimentation.
Claim Rejections - 35 USC § 103
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.
Claims 187-191, 193-201, and 205-207 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 2016/0199398 A1, published July 14, 2016, included on IDS submitted 01/21/2026) as evidenced by Li et al. (“Hypoxia-Induced Oxidative Stress in Ischemic Retinopathy” Oxidative Medicine and Cellular Longevity 2012, Article ID 426769; of record), hereafter “Li”, in view of Lockwood et al. (US 2007/0015735 A1, published January 18, 2007; included on IDS submitted 09/22/2023), hereafter “Lockwood”, and Hoarau et al. (US 2004/0076683 A1, published April 22, 2004; included on IDS submitted 01/21/2026), hereafter “Hoarau”.
Regarding instant claims 187 and 205, Gao teaches compositions containing crocetin for prevention and/or treatment of cancers and other conditions and diseases (abstract, claim 1) and a method of preventing, mitigating, or treating a disease or condition in a subject comprising administering an effective amount of the composition to a subject in need thereof (claim 11). Gao exemplifies the structure of alpha-crocetin, which is in the trans configuration (see paragraphs [0005]-[0006]). Gao teaches that compositions may be administered in the form of liposomes (paragraph [0104]) and that crocetin may be in a dose of about 50 mg to about 500 mg per dose (paragraph [0105]). Compositions for oral administration can be prepared in water or other aqueous vehicles (paragraph [0099], and compositions can comprise pharmaceutically acceptable sterile aqueous solution, dispersions, etc. (paragraphs [0100]). Gao teaches that the method improves eye health, increases blood flow to the retina, and prevents ischemic retinopathy (claim 24, paragraph [0037]). As the method of Gao is taught to increase blood flow and prevent an ischemic condition, it is interpreted that the method of Gao increases the delivery of oxygen; per the instant specification, “’Ischemia’ relates to a restriction in blood supply to tissues or organs (tissue hypoperfusion) causing a shortage of oxygen needed for cellular metabolism” (paragraph [0063]).
Regarding instant claims 188-189, as noted above, Gao teaches administering a dose of about 50 mg to about 500 mg (paragraph [0105]), overlapping the claimed ranges. Per MPEP 2144.05 I., “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)”.
Regarding instant claim 190, 193, 195, and 196, as noted as noted above, Gao teaches administering a dose of about 50 mg to about 500 mg (paragraph [0105]), overlapping the claimed ranges. Gao further teaches that in certain embodiments, more than one dose is administered (e.g., two or more doses spaced over time) (paragraph [0094]), and that the dose and dose frequency can vary according to the age, body weight, and conditions of an individual patient (paragraph [0105]). Gao further teaches that daily doses can be in single or divided doses (paragraph [0106]).
Regarding instant claims 198-201, as noted above, Gao teaches administering a dose of about 50 mg to about 500 mg (paragraph [0105]), overlapping the claimed ranges, that more than one dose is administered (e.g., two or more doses spaced over time) (paragraph [0094]), that the dose and dose frequency can vary according to the age, body weight, and conditions of an individual patient (paragraph [0105]), and that daily doses can be in single or divided doses (paragraph [0106]). These daily doses are interpreted to meet the limitation of “fixed maintenance doses”.
Regarding instant claim 206, as the method of Gao is taught to improve eye health, increase blood flow, and prevent an ischemic condition, it is interpreted that the method increases the physical performance of the subject treated and that the subject is in need of increased blood flow (increased oxygen delivery).
Gao does not teach a multivalent cation counterion, as required by instant claim 187.
Lockwood teaches carotenoid derivatives and their administration for reducing a subject’s risk of experiencing diseases associated with reactive oxygen species (abstract) including pharmaceutically acceptable salts such as calcium, magnesium, etc. (paragraphs [0094]-[0095]); the administration can inhibit and/or ameliorate disease conditions associated with inhibition of vision (paragraph [0020]). Compounds may be administered in the form of liposome delivery systems (paragraph [0208]). Carotenoids can be modified to enhance the water solubility (abstract, paragraph [0020], paragraph [0114]), including by transforming into a salt derivative or analog (paragraph [0180]).
It would have prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the trans-crocetin in the method of Gao with the multivalent cation counterion suggested by Lockwood. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to improve the water solubility of trans-crocetin, a carotenoid (see Gao, paragraph [0005]), for use in liposomal formulations for reducing a subject’s risk of experiencing diseases associated with reactive oxygen species, such as those associated by inhibition of vision, as suggested by Lockwood. There is a reasonable expectation of success as Gao teaches administration of aqueous and liposomal formulations of trans-crocetin for increasing blood flow to the retina and preventing ischemic retinopathy. As evidenced by Li, oxidative stress, or the imbalance between the production of reactive oxygen species and the ability to scavenge these, plays a crucial role in the pathogenesis of retinal ischemia (see entire document, particularly abstract).
Gao does not teach that the liposome is pegylated or a has a diameter of 20 nm to 200 nm, as required by instant claim 187, nor the diameters of instant claims 191, 194, 197, and 201.
Hoarau teaches stealth lipid nanocapsules used as a carrier for active principles including carotenoids (abstract, claims 1 and 33-35). The nanocapsules include at least one amphiphilic derivative of poly(ethylene glycol) (abstract) such as pegylated phospholipids (paragraphs [0086]-[0093]); the “pegylated” derivative confers a stealth aspect which allows the nanocapsules to not be detected and then sequestered and/or degraded by the immune system of the host to which they are administered (see paragraphs [0001]-[0002], [0006], and [0011]-[0012]). Hoarau teaches diameters between 80 and 120 nm in diameter (claims 26-27) and that sizes less than 200 nm avoid extravasation at the level of cells of the liver, avoid filtration in the spleen, and increase the amount of time in blood circulation (paragraph [0065]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the liposomes in the method of Gao with the pegylation and diameter of 80 nm-120 nm, overlapping the ranges of the instant claims, suggested by Hoarau. One of ordinary skill in the art would have been motivated to do so in order to achieve a carrier for the delivery of a carotenoid active agent with stealth properties which avoids immune detection and degradation, and which is in a size that increases the amount of time in blood circulation, as suggested by Hoarau. There is a reasonable expectation of success as Gao teaches liposomal formulations for the delivery of trans-crocetin, a carotenoid, (see Gao, paragraph [0005]), and suggests that the liposomes can comprise physiologically acceptable phospholipids known in the art (paragraph [0104]).
Regarding instant claim 207, the limitation “liposomes in at least one administered dose of liposomal trans-crocetin are prepared according to a method comprising…” is a product-by-process limitation. Per MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Here, the liposome defined by the process of claim 207 is that which is structurally defined in claim 187; that is, a pegylated liposome encapsulating trans-crocetin having the formula Q-trans-crocetin-Q, wherein, Q is a multivalent cation counterion, and the liposome diameter is 20 nm to 200 nm, or any range therein between. As set forth above, the prior art of Gao in view of Lockwood and Hoarau renders obvious the method of claim 187 and structural limitations of the liposome of claim 187, and thus renders obvious the method of administering the liposome made by the process of the instant claim.
Claim 192 is rejected under 35 U.S.C. 103 as being unpatentable over Gao, as evidenced by Li, in view of Lockwood and Hoarau as applied to claims 187-191, 193-201, and 205-207 above, and further in view of de Sousa Martins (US 2017/0231920 A1, published August 17th, 2017; of record).
The teachings of the modified Gao are set forth above. Regarding the elected species of claim 192, as set forth above, the modified Gao teaches a multivalent cation counterion including calcium, and the elected 80 nm to 120 nm liposome diameter. Regarding the elected species that the liposome comprises HSPC, Hoarau further teaches the inclusion of HSPC to obtain benefits such as better rigidity and stealth properties (paragraph [0073]), rendering the inclusion of HSPC in the liposomes of Gao prima facie obvious to one of ordinary skill in the art, particularly as Gao suggests that the liposomes can comprise physiologically acceptable phospholipids known in the art (paragraph [0104]). Regarding the trans-crocetin/lipid ratio recited in “[e]” of claim 192, Gao teaches administering an effective amount of trans-crocetin (paragraph [0094]) in a dose consistent with that of the instant invention, and administration via liposomes comprising lipids (paragraph [0104]). Gao further suggests modifying the dose of crocetin according to the individual needs of a patient (paragraph [0105]). Thus, one of ordinary skill in the art would have been motivated to routinely optimize the concentration of trans-crocetin, and thus the corresponding ratio of trans-crocetin to lipid, in order to achieve a dosage that is effective for the age, body weight, and condition of an individual patient. Per MPEP 2144.05 II. A., “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
The combination of Gao, Lockwood, and Hoarau do not teach the elected species limitation of a zeta potential of 25 to 0 mV.
de Sousa Martins teaches positively charged liposome vesicles for use as carriers of lipophilic molecules, particularly carotenoids (abstract, claims 1 and 3). The liposomes are capable of transporting the lipophilic molecules through the cornea and sclera cells for delivery to the eye (paragraphs [0002] and [0005]). de Sousa Martins exemplifies a cationic liposomal formulation with a zeta potential of +3.64 mV) (paragraph [0033], Fig. 9).
It would have prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the liposome in the method of the modified Gao with the zeta potential consistent with the elected species suggested by de Sousa Martins. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to achieve a positively charged liposome capable of delivering carotenoids to ocular tissue, as suggested by de Sousa Martins. There is a reasonable expectation of success as Gao teaches administration of liposomal formulations of trans-crocetin, a carotenoid (see Gao, paragraph [0005]), for increasing blood flow to the retina (an ocular tissue) and preventing ischemic retinopathy.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 187-201 and 205-207 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 187, 189-190, 193-199, and 203-207 of copending Application No. 18/018,132 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Both the instant claims and those of copending Application No. 18/018,132 are directed to a method of increasing the delivery of oxygen comprising administering one or more fixed dose of liposomal trans-crocetin in an aqueous solution. Both sets of claims recite Q-trans-crocetin-Q, wherein Q is a multivalent cation counterion, and recite a pegylated liposome. Both sets of claims recite dosage amounts, liposome diameters, zeta potentials, trans-crocetin/lipid ratios, and times of dosage administration in overlapping amounts. Both sets of claims recite the same subject population (compare instant claim 206 to copending claim 204), and that the liposomes are made via the same method (compare instant claim 207 to copending claim 205).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 187-201 and 205-207 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 188-205, and 209-211 of copending Application No. 17/917,792 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Both the instant claims and those of copending Application No. 17/917,792 are directed to a method of increasing the delivery of oxygen comprising administering one or more fixed dose of liposomal trans-crocetin in an aqueous solution. Both sets of claims recite Q-trans-crocetin-Q, wherein Q is a multivalent cation counterion, and recite a pegylated liposome. Both sets of claims recite dosage amounts, liposome diameters, zeta potentials, trans-crocetin/lipid ratios, and times of dosage administration in overlapping amounts. Both sets of claims recite the same subject population (compare instant claim 206 to copending claim 210), and that the liposomes are made via the same method (compare instant claim 207 to copending claim 211).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 187-201 and 205-207 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 20-25 of U.S. Patent No. 12,622,874 B2 (previously claims 188-198, 200-206, 213, and 215-219 of copending Application No. 17/917,908) in view of Gao (US 2016/0199398 A1, published July 14, 2016, included on IDS submitted 01/21/2026).
Both the instant claims and those of U.S. Patent No. 12,622,874 B2 are directed to a method of increasing the delivery of oxygen comprising administering one or more fixed dose of liposomal trans-crocetin. Both sets of claims recite Q-trans-crocetin-Q, wherein Q is a multivalent cation, and recite a pegylated liposome. Both sets of claims recite liposome diameters, zeta potentials, trans-crocetin/lipid ratios, and times of dosage administration in overlapping amounts. Both sets of claims recite the same subject population. While the copending claims do not teach that the liposomes are made by the method recited in instant claim 207, this is a product-by-process limitation that does not structurally limit the liposomes administered in the method.
The claims of US Patent No. 12,622,874 B2 recite dosage amounts in mg/kg, while the instant claims recite dosage amounts in mg (50mg to 900mg in instant independent claim 187). The claims of U.S. Patent No. 12,622,874 B2 do not recite that the liposomes are in an aqueous solution.
Gao teaches compositions containing crocetin for prevention and/or treatment of cancers and other conditions and diseases (abstract, claim 1) and a method of preventing, mitigating, or treating a disease or condition in a subject comprising administering an effective amount of the composition to a subject in need thereof (claim 11). Gao exemplifies the structure of alpha-crocetin, which is in the trans configuration (see paragraphs [0005]-[0006]). Gao teaches that compositions may be administered in the form of liposomes (paragraph [0104]) and that crocetin may be in a dose of about 50 mg to about 500 mg per dose (paragraph [0105]). Gao further teaches the dose and dose frequency can vary according to the age, body weight, and conditions of an individual patient (paragraph [0105]). Compositions for oral administration can be prepared in water or other aqueous vehicles (paragraph [0099], and compositions can comprise pharmaceutically acceptable sterile aqueous solution, dispersions, etc. (paragraphs [0100]). Gao teaches that the method improves eye health, increases blood flow to the retina, and prevents ischemic retinopathy (claim 24, paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the doses of trans-crocetin recited in U.S. Patent No. 12,622,874 B2 with the dose suggested by Gao, overlapping that of the instant claims, in order to optimize the dose to one that is suitable for the age, weight, and condition of the individual patient. It would further have been prima facie obvious to incorporate the liposomes into an aqueous solution, as suggested by Gao, in order to use a pharmaceutically acceptable solvent that can deliver the liposomal formulation by a desired route.
Claims 187-201 and 205-207 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 20, 33-34, 39, and 66-67 of copending Application No. 18/559,680 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of copending Application No. 18/559,680 are directed to a method of treating a chronic disease in a subject, including chronic hypoxia; thus, the method is interpreted as increasing the delivery of oxygen and that the subject is in need of increased oxygen delivery. Both the method of the instant claims and that of copending Application No. 18/559,680 recite administering one or more fixed dose of liposomal trans-crocetin in an aqueous solution. Both sets of claims recite Q-trans-crocetin-Q, wherein Q is a multivalent cation counterion, and a pegylated liposome. Both sets of claims recite dosage amounts, liposome diameters, zeta potentials, trans-crocetin/lipid ratios, and times of dosage administration in overlapping amounts. While the copending claims do not teach that the liposomes are made by the method recited in instant claim 207, this is a product-by-process limitation that does not structurally limit the liposomes administered in the method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 187-201 and 205-207 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 123-135 and 138-139 of copending Application No. 19/333,941 in view of Gao (US 2016/0199398 A1, published July 14, 2016, included on IDS submitted 01/21/2026).
The claims of copending Application No. 19/333,941 are directed to a method of treating a disease or condition characterized by ischemia or hypoxia (see copending claims 138-139); thus, the method is interpreted as increasing the delivery of oxygen and that the subject is in need of increased oxygen delivery. Both the instant claims and those of copending Application No. 19/333,941 recite administering a pegylated liposome encapsulating Q-trans-crocetin-Q, wherein Q is a multivalent cation counterion, with overlapping diameters of liposome. The claims of copending Application No. 19/333,941 further recite liposomes that have zeta potentials and trans-crocetin/lipid ratios in overlapping amounts. While the copending claims do not teach that the liposomes are made by the method recited in instant claim 207, this is a product-by-process limitation that does not structurally limit the liposomes administered in the method.
The claims of copending Application 19/333,941 do not recite the fixed dose amounts (50mg to 900mg in instant independent claim 187) nor dosing times recited by the instant claims. The claims of copending Application 19/333,941 do not recite that the liposomes are in an aqueous solution.
Gao teaches compositions containing crocetin for prevention and/or treatment of cancers and other conditions and diseases (abstract, claim 1) and a method of preventing, mitigating, or treating a disease or condition in a subject comprising administering an effective amount of the composition to a subject in need thereof (claim 11). Gao exemplifies the structure of alpha-crocetin, which is in the trans configuration (see paragraphs [0005]-[0006]). Gao teaches that compositions may be administered in the form of liposomes (paragraph [0104]) and that crocetin may be in a dose of about 50 mg to about 500 mg per dose (paragraph [0105]). Gao further teaches that in certain embodiments, more than one dose is administered (e.g., two or more doses spaced over time) (paragraph [0094]), and that the dose and dose frequency can vary according to the age, body weight, and conditions of an individual patient (paragraph [0105]). Gao further teaches that daily doses can be in single or divided doses (paragraph [0106]). Compositions for oral administration can be prepared in water or other aqueous vehicles (paragraph [0099], and compositions can comprise pharmaceutically acceptable sterile aqueous solution, dispersions, etc. (paragraphs [0100]). Gao teaches that the method improves eye health, increases blood flow to the retina, and prevents ischemic retinopathy (claim 24, paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the method of administering liposomal trans-crocetin recited in copending Application No. 19/333,941 with the dose and dose frequency suggested by Gao, overlapping that of the instant claims. One of ordinary skill in the art would have been motivated to do so in order to optimize the dose and frequency to one that is suitable for treating ischemic conditions and which is suitable for the age, weight, and condition of the individual patient. It would further have been prima facie obvious to incorporate the liposomes into an aqueous solution, as suggested by Gao, in order to use a pharmaceutically acceptable solvent that can deliver the liposomal formulation by a desired route.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 19/333,941, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
Claims 187-201 and 205-207 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8-10, 29, 31, 35, 45, 50-51, 58-59, and 80-81 of copending Application No. 19/339,809 in view of Gao (US 2016/0199398 A1, published July 14, 2016, included on IDS submitted 01/21/2026).
The claims of copending Application No. 19/339,809 are directed to a method of treating a disease or condition characterized by ischemia or hypoxia (see copending claims 80-81); thus, the method is interpreted as increasing the delivery of oxygen and that the subject is in need of increased oxygen delivery. Both the instant claims and those of copending Application No. 19/339,809 recite administering a liposome encapsulating Q-Polyene Carotenoid-Q, wherein Q is a multivalent cation counterion, with overlapping diameters of liposome. The claims of copending Application No. 19/339,809 further recite that the liposome encapsulates Q-trans-crocetin-Q, that the liposome comprises pegylated lipids, that the liposome is in an aqueous pharmaceutically acceptable carrier, and liposomes that have zeta potentials, diameter, and carotenoid/lipid ratios in overlapping amounts with those of the instant claims. While the copending claims do not teach that the liposomes are made by the method recited in instant claim 207, this is a product-by-process limitation that does not structurally limit the liposomes administered in the method.
The claims of copending Application 19/339,809 do not recite the fixed dose amounts (50mg to 900mg in instant independent claim 187) nor dosing times recited by the instant claims.
Gao teaches compositions containing crocetin for prevention and/or treatment of cancers and other conditions and diseases (abstract, claim 1) and a method of preventing, mitigating, or treating a disease or condition in a subject comprising administering an effective amount of the composition to a subject in need thereof (claim 11). Gao exemplifies the structure of alpha-crocetin, which is in the trans configuration (see paragraphs [0005]-[0006]). Gao teaches that compositions may be administered in the form of liposomes (paragraph [0104]) and that crocetin may be in a dose of about 50 mg to about 500 mg per dose (paragraph [0105]). Gao further teaches that in certain embodiments, more than one dose is administered (e.g., two or more doses spaced over time) (paragraph [0094]), and that the dose and dose frequency can vary according to the age, body weight, and conditions of an individual patient (paragraph [0105]). Gao further teaches that daily doses can be in single or divided doses (paragraph [0106]). Gao teaches that the method improves eye health, increases blood flow to the retina, and prevents ischemic retinopathy (claim 24, paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the method of administering liposomal trans-crocetin recited in copending Application No. 19/339,809 with the dose and dose frequency suggested by Gao, overlapping that of the instant claims. One of ordinary skill in the art would have been motivated to do so in order to optimize the dose and frequency to one that is suitable for treating ischemic conditions and which is suitable for the age, weight, and condition of the individual patient. It would further have been prima facie obvious to incorporate the liposomes into an aqueous solution, as suggested by Gao, in order to use a pharmaceutically acceptable solvent that can deliver the liposomal formulation by a desired route.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 19/339,809, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
Claims 187-201 and 205-207 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-15, 21, 25, 34-37, and 39 of U.S. Patent No. US 12,458,597 B2 in view of Gao (US 2016/0199398 A1, published July 14, 2016, included on IDS submitted 01/21/2026).
The claims of copending U.S. Patent No. US 12,458,597 B2 are directed to a method of treating a disease or condition characterized by ischemia or hypoxia (see claims 21 and 25); thus, the method is interpreted as increasing the delivery of oxygen and that the subject is in need of increased oxygen delivery. Both the instant claims and those of U.S. Patent No. US 12,458,597 B2 recite administering a pegylated liposome encapsulating Q-trans-crocetin-Q, wherein Q is a multivalent cation counterion. The claims of U.S. Patent No. US 12,458,597 B2 further recite liposomes that have diameters, zeta potentials and trans-crocetin/lipid ratios in overlapping amounts, and the presence of a pharmaceutically acceptable carrier. While the copending claims do not teach that the liposomes are made by the method recited in instant claim 207, this is a product-by-process limitation that does not structurally limit the liposomes administered in the method.
The claims of U.S. Patent No. US 12,458,597 B2 do not recite the fixed dose amounts (50mg to 900mg in instant independent claim 187) nor dosing times recited by the instant claims. The claims of copending Application 19/333,941 do not explicitly recite that the liposomes are in an aqueous solution.
Gao teaches compositions containing crocetin for prevention and/or treatment of cancers and other conditions and diseases (abstract, claim 1) and a method of preventing, mitigating, or treating a disease or condition in a subject comprising administering an effective amount of the composition to a subject in need thereof (claim 11). Gao exemplifies the structure of alpha-crocetin, which is in the trans configuration (see paragraphs [0005]-[0006]). Gao teaches that compositions may be administered in the form of liposomes (paragraph [0104]) and that crocetin may be in a dose of about 50 mg to about 500 mg per dose (paragraph [0105]). Gao further teaches that in certain embodiments, more than one dose is administered (e.g., two or more doses spaced over time) (paragraph [0094]), and that the dose and dose frequency can vary according to the age, body weight, and conditions of an individual patient (paragraph [0105]). Gao further teaches that daily doses can be in single or divided doses (paragraph [0106]). Compositions for oral administration can be prepared in water or other aqueous vehicles (paragraph [0099], and compositions can comprise pharmaceutically acceptable sterile aqueous solution, dispersions, etc. (paragraphs [0100]). Gao teaches that the method improves eye health, increases blood flow to the retina, and prevents ischemic retinopathy (claim 24, paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the method of administering liposomal trans-crocetin recited in U.S. Patent No. US 12,458,597 B2 with the dose and dose frequency suggested by Gao, overlapping that of the instant claims. One of ordinary skill in the art would have been motivated to do so in order to optimize the dose and frequency to one that is suitable for treating ischemic conditions and which is suitable for the age, weight, and condition of the individual patient. It would further have been prima facie obvious to incorporate the liposomes into an aqueous solution, as suggested by Gao, in order to use a pharmaceutically acceptable solvent that can deliver the liposomal formulation by a desired route.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of U.S. Patent No. US 12,458,597 B2, the instant claims are rejected on the ground of nonstatutory double patenting.
Response to Arguments
Applicant’s arguments filed 07/21/2026 have been fully considered.
Regarding the claim rejections under 35 USC § 112(a), Applicant argues that the rejection misapplies the In re Wands factors, fails to ground its predictability analysis in the mechanism of action of the claimed method, and improperly elevates the legal definition of "prevention" to an absolute standard that is contrary to the specification and established legal precedent. Particularly, Applicant argues that the Office concedes that the specification enables the mechanism of increasing delivery of oxygen to a tissue, but treats the broad list of downstream clinical conditions as if they are entirely disconnected from this underlying mechanism; hypoxia and oxygen deprivation are universally recognized, foundational pathologies underlying a wide array of ischemic, infectious, metabolic, proliferative, and inflammatory disorders, and a person skilled in the art possesses the requisite scientific framework to expect success when treating the underlying hypoxic component of the claimed conditions. Applicant further argues that the Office committed a clear legal error by applying an absolute definition to the term “preventing” or “prevention”, and this violate the requirement to accord claim terms their BRI in view of the specification, citing to paragraph [0067] of the specification which defines prophylactic or preventative measures as actions that "prevent and/or slow the development of a targeted disorder or condition". Applicant further argues that a person skilled in the art would readily appreciate that a therapeutic agent capable of successfully reversing hypoxia and delivering oxygen under the severe, systemic crisis of the working examples would successfully function in localized or less severe hypoxic and ischemic disorders, and no "undue" experimentation is required to practice the full scope of the claimed invention.
These arguments are unpersuasive. The Examiner respectfully maintains the position that the specification does not reasonably provide enablement for treating or preventing any disease or condition, and that the In re Wands have been appropriately applied. The claims recite an unreasonably broad method of “treating or preventing a disease or condition in a patient” comprising administering an effective amount of liposomal trans-crocetin. While, as noted by Applicant hypoxia and oxygen deprivation are known as pathologies underlying multiple conditions, the specification does not provide evidence that it is an underlying pathology in any disease or condition, and does not provide reasonably guidance to one of ordinary skill in the art that the claimed method is capable of preventing any disease or condition. Paragraph [0067] of the specification, cited to by Applicant states (emphasis added), “[t]erms such as "treating," or "treatment," or "to treat" refer to both (a) therapeutic measures that cure, slow down, attenuate, lessen symptoms of, and/or halt progression of a diagnosed pathologic disorder or condition and (b) prophylactic or preventative measures that prevent and/or slow the development of a targeted disorder or condition”. No limiting definition of the term “prevent” or “preventing” is supplied by the specification, and the Examiner therefore disagrees that the BRI of the term “preventing” has been applied in error.
Regarding the argument that a person skilled in the art would recognized that that the working examples would extend to localized or less severe hypoxic and ischemic disorders, the Examiner respectfully maintains that the evidence does not support the overly broad recitation “treating or preventing a disease or condition in a patient” particularly in view of the knowledge of the prior art that not every disease or condition can be prevented, and the known unpredictability of the pharmaceutical sciences.
Regarding the claim rejections under 35 USC § 103, Applicant argues that The Office's proposed combination fails to establish a prima facie case of obviousness because it fails to establish every claimed element, relies on impermissible hindsight reconstruction, and completely overlooks critical physical, chemical, and structural incompatibilities detailed within the cited references themselves. Particularly, Applicant argues that Gao fails to disclose the isolation or purification of trans-crocetin; Gao uses the phrase “crocin and/or crocetin” loosely throughout the text, but when executing the actual production method, isolates crocin, not trans-crocetin. Further, Gao generically references liposomes with no specific recipe, example or experimental data, and Gao does not disclose or suggest a pegylated liposome encapsulating a trans-crocetin salt, nor does it teach a trans-crocetin salt having the formula Q -trans-crocetin-Q (where Q is a multivalent cation counterion). As the secondary references do not disclose or suggest a clinical method comprising administering a fixed dose of such a liposome, they cannot cure the threshold deficiencies of Gao.
Applicant further argues that Lockwood and Gao have fundamentally incompatible chemical structures as Lockwood is strictly directed to water-soluble or water-dispersible xanthophylls that necessarily comprise more than 9 conjugated double bonds while the chemical structure of trans-crocetin contains only 7. Lockwood addresses the low water solubility of long-chain C40 xanthophyll carotenoids by executing a direct covalent modification of the native molecule while trans-crocetin is a dicarboxylic carotenoid containing a carboxyl group at each end of its chemical structure and forms an insoluble precipitate when reacted with a multivalent metal ion, as documented in paragraph [0070] of the present specification.
Applicant further argues that the physical incompatibility and structural fragility of the Hoarau lipid vehicles predicates an expectation of failure. Hoarau underscores that the cohesion of its lipid envelopes depends entirely on highly sensitive, non-covalent intermolecular forces that they have fragile surface components prone to rapid disassembly under environmental shifts and altered pegylated phospholipid content (paragraphs [0080], [0081] and [0206]). Introducing multivalent cations from Lockwood's counterion disclosure into the lipid vehicle preparations of Hoarau would likely alter the stability Hoarau's fragile fluid lipid envelope matrices and trigger premature matrix breakdown. Applicant further argues that de Sousa Martins does not cure the deficiencies of these references.
These arguments are unpersuasive. Regarding the arguments that Gao does not exemplify the isolation or purification of trans-crocetin and provides no specific recipe, example or experimental data of liposome preparation, per MPEP 2123 I., “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)”. Here, Gao reasonably suggests to the ordinary skilled artisan the use of trans-crocetin by consistently describing the use of crocin and/or crocetin, and by demonstrating the structure of trans (alpha) crocetin at paragraph [0006]. Gao further reasonably suggests administration in the form of liposomes, and that methods known in the art for forming liposomes are suitable (paragraph [0104]).
In response to applicant's argument regarding the combination of Lockwood and Gao, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, Gao suggests the use of liposomal trans-crocetin (a carotenoid) for increasing blood flow and preventing an ischemic condition. Lockwood reasonably suggests carotenoid salts (including calcium) can be administered in liposomal delivery systems for the same purpose. Lockwood teaches that “[a] carotenoid may be transformed into an ionic salt derivative or analog by reacting the carotenoid with a base” (paragraph [0180]) and suggest that this can enhance solubility, motivating the skilled artisan to modify the trans-crocetin carotenoid of Gao to its salt form. Further, the Examiner notes that paragraph [0070] of the specification, cited to in Applicant’s remarks, does not appear to show any data regarding the precipitation of calcium trans-crocetin.
Regarding the argument that multivalent cations from Lockwood’s disclosure would “likely alter the stability Hoarau's fragile fluid lipid envelope matrices and trigger premature matrix breakdown”, the Examiner notes that this is purely conjecture and no evidence is provided or cited to in support of this theory. Per MPEP 2145, “arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984)”. Hoarau in fact suggests that “sufficient fragility” of lipid nanoparticles is required to ensure rapid biodegradability (paragraph [0080]), and that managing the amount of pegylated lipid can be used to avoid instability (paragraph [0206]). Nowhere does Hoarau suggest that multivalent cations would result in premature breakdown.
Applicant further argue that the invention demonstrates objective indicia of unexpected, non-linear synergistic results that go far beyond the predictable results required under MPEP § 2143(1)(A). Applicant argues that free trans-crocetin possesses an incredibly short clinical half-life and that the claimed method achieves a sustained half-life of 5.12 hours, citing to Examples 3 and 4 and Table 3 of the specification. More profoundly, the total systemic drug exposure (AUC) scales from a baseline of 0.21 h·μg/ml for the free drug to 8.36 h·μg/ml for the liposomal Q-trans-crocetin-Q administered according to the claimed method, which represents a substantial, non-linear, 40-fold increase in total drug exposure. Neither Gao, Li, Lockwood, nor Hoarau provides any baseline hint, suggestion, or expectation that locking a multivalent cation salt of trans-crocetin into a sub-200 nm pegylated liposome core would safely yield a 40-fold exposure enhancement without triggering formulation collapse. Because the claimed combination yields unpredictable synergistic properties that directly resolve the systemic stability limitations of the prior art, the combination is nonobvious. Applicant further argues that the proposed combination represents an impermissible hindsight reconstruction that is directly contradicted by the teachings of the cited art.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As set forth in the above rejections, the teachings of the prior art were within the level of ordinary skill before the effective filing date of the instant invention, and the rejections do not rely on any knowledge gleaned only from the Applicant’s disclosure.
Regarding the allegations of unexpected results, the Examiner notes that per MPEP 716.02(e), “[a]n affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979)” and per MPEP 716.02(b), “[t]he evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)”. In the present instance, Applicant compares results of free trans-crocetin to calcium trans-crocetin encapsulated in liposomes. However, liposomal carotenoid formulations are known in the art, and Hoarau teaches that lipid nanoparticles can achieve a plasmatic half-life of 3 to 10 hours (paragraph [0085]), consistent with the sustained half-life of the present invention. Per MPEP 716.02(c) "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”. From the evidence relied on, the Examiner cannot conclude that the instant invention has achieved results that are unexpected and of both statistical and practical significance over the teachings of the prior art.
Regarding the provisional double patenting rejections over copending Application Nos. 18/018,132, 17/917,792, and 18/559,680, Applicant requests that the rejections be formally held in abeyance.
In response, the Examiner notes that a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). Thus, the double patenting rejections of record have been maintained as no action regarding these rejections has been taken by applicants at this time.
Regarding the double patenting rejections over the claims of copending Application Nos. 17/917,908, 19/333,941, and 19/339,809 and U.S. Patent No. 12,458,597 B2 in view of Gao, Applicant argues that the Patent Office's reliance on Gao to bridge any structural or metric gaps in the claims of the reference issued patent and reference copending applications is misplaced, for the reasons argued in the response to the 35 U.S.C. § 103 rejections.
The arguments regarding Gao are addressed above. For these reasons and those set forth in the above rejection, the Examiner respectfully maintains that the instant claims are unpatentable over the claims co-pending Application Nos. 19/333,941 and 19/339,809 and U.S. Patent Nos. 12,458,597 B2 and 12,622,874 B2 (previously copending Application No. 17/917,908) in view of Gao.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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