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 .
Current Status
This action is responsive to the amended claims of 01/08/2024. Claims 1-10 are pending and have been examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 07/06/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/08/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-9 are objected to because of the following informalities: claim 1 contains a typo “manufacturer”. Please replace with “manufacture”. Dependent claims 2-9 are objected to since they do not rectify the issue. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed recitation of a “use,” without setting forth any steps involved in the process, results in a claim which is not a proper process claim. See MPEP 2173.05(q): "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967). Thus, the “use” claims are directed to non-statutory subject matter.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (chlorogenic acid) without significantly more. The claims recite chlorogenic acid, intended uses thereof, and a medicament/dosage form comprising chlorogenic acid. This judicial exception (JE) is not integrated into a practical application because the “for use” clauses which constitute “intended use” limitations, do not limit the scope of the claims because such statements do no more than define a context in which the invention can operate. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it is well-understood, routine, and conventional in the art to mix an active pharmaceutical ingredient, such as chlorogenic acid, with excipients to produce dosage forms thereof. Regarding the intended use language recited in the claims, these uses do not convey any structural limitation to the claimed chlorogenic acid.
Step 1: Is the claim drawn to a process, machine, manufacture, or composition of matter?
Yes, the broadest reasonable interpretation (BRI) of the claims as a whole are drawn to a composition of matter comprising chlorogenic acid. Note, claims 2-9 are drafted as “use” claims, but due to their dependence on claim 1 and under the BRI, Examiner interprets them as composition claims for purposes of examination.
Revised Step 2A:
Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claims are drawn to a natural phenomenon – chlorogenic acid which is a product of nature. The instant specification admits chlorogenic acid “is an organic acid widely present in plants” (Pg. 2 Line 8-9). Further, HADLEY (Hadley, M., Journal of Nutritional Biochemistry, 2002, 13, 717-726) discloses chlorogenic acid is ubiquitously found in plants (Pg. 717 Abstract).
The chlorogenic acid, as claimed, is not markedly different from naturally occurring chlorogenic acid. The claims 1-10 do not recite any structural differences made to the chemical structure of the compound. Further, for claims 1-9, the intended use “for manufacturer of a medicament” does not recite any positive steps taken to change the form of the chlorogenic acid, so as to make it structurally or chemically different from the natural form. The further definition of the intended use by claims 2-9 similarly does not introduce any markedly different characteristics of the chlorogenic acid itself. For claim 10, the intended use “for treating” CNS tumors similarly does not structurally change the chlorogenic acid since it is only providing a context in which the chlorogenic acid may act. Further, while claim 10 recites the chlorogenic acid is mixed with a pharmaceutically acceptable excipient, mixing a natural product with an excipient does not make the natural product any less natural. The chlorogenic acid is not altered by the mixing.
Note, even if the chlorogenic acid is synthetically made, the structure of the compound is the same as that of the natural product. A natural product is not made markedly different by virtue of synthetic preparation since the natural product is not structurally or chemically altered.
Prong Two: Does the Claim Recite Additional Elements that Integrate the Judicial Exception (JE) into a Practical Application?
No, the BRI of claims 1-10 contain no additional elements which would integrate the JE into practical applications. Claims 1 and 10 are drafted as product/composition of matter claims and do not recite any positive steps which would limit the way in which the chlorogenic acid is used. The intended use clauses of these claims merely provide a suggestion to “apply it” (see MPEP 2106.05(f)). The claims fail to recite details of how a solution to a problem is accomplished. Similarly, claims 2-9 are drafted as “use” claims and fail to recite any positive method steps which would utilize the chlorogenic acid in a process/application. Thus, none of the intended use clauses integrate the JE into a practical application, such as treatment for a disease.
The addition of a pharmaceutically acceptable excipient to the chlorogenic acid to form a medicament/dosage form is extra-solution activity to the JE and merely provides the artisan with a suggestion to apply the JE to the field of pharmacology/medicine.
Step 2B: Does the claim recite additional elements that amount to significantly more than the JE?
No, the BRI of the claims does not recite additional elements amounting to significantly more. The various intended use clauses cannot amount to significantly more since they are mere suggestions of the context in which the JE can operate. They do not actually limit the application of the JE or the structure of the JE. Furthermore, it is well-understood, routine, and conventional (“WURC”) in the art to mix an active ingredient with pharmaceutical excipients to form pharmaceutical preparations thereof. As evidenced by NAVEED (Naveed, M. et al., Biomedicine & Pharmacotherapy, 2018, 97, 67-74), chlorogenic acid is known to be biologically active and have therapeutic roles in a variety of applications (Pg. 67 Abstract). Further, as evidenced by CHAUDHARI (Chaudhari, S.P. & Patil, P.S., Internation Journal of Advances in Pharmacy, Biology, and Chemistry, 2012, 1(1), 21-34), pharmaceutical excipients play an important role in formulating a dosage form of an active pharmaceutical ingredient (Pg. 21 Abstract & Intro P1). CHAUDHARI further provides a general review of standardization and safety evaluation procedures used in preparation of pharmaceutical dosage forms (Pg. 28-33 Tables 1-9). Thus, the additional elements of claim 10 are understood as WURC techniques.
Note, while claim 10 also provides for specific amounts of the JE in the dosage form, having more or less of a natural product does not suddenly make the natural product more than just that. At most, a specified amount in a WURC dosage form merely provides a suggestion to apply the composition to the field of medicine.
Thus, claims 1-10 are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of central nervous system (CNS) tumors, does not reasonably provide enablement for prevention of CNS tumors. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Wands Factors used in a scope of enablement rejection include (per MPEP 2164.01(a)):
The breadth of the claims:
The claims 1-9 are drawn to the compound chlorogenic acid intended for use in preparation of a medicament which is intended for treating or preventing a CNS tumor. The claims are narrow in the compound which is intended for treatment/prevention of a CNS tumor. Claim 1 is broadly drawn to an intended treatment of any CNS tumor while claims 2-5 narrow the scope of the intended CNS tumor to various types of CNS lymphomas.
The nature of the invention:
The invention belongs to pharmaceutical technology, more specifically, tumor therapy involving pharmaceutical compositions comprising: chlorogenic acid (claims 1-6) and a pharmaceutically acceptable excipient (claims 7-9). The invention, as put forth in the specification, also entails administering said pharmaceutical compositions to treat or prevent CNS tumors (e.g., Pg. 9 Experimental example 2). While the claims are drafted as composition of matter claims (not method), the intended use for prevention of CNS tumors reflects the disclosure of the specification.
The state of the prior art & predictability of the art:
Examiner cites HUANG (Huang, S. et al., Theranostics, 2019, 9(23), 6745-6763), LI (Li, W. et al., Journal of Clinical Oncology, June 2018, 36(15), 1-2), BISPO (Bispo et al., Cold Harbor Spring Perspectives in Medicine, 2020. 10, 1-23), and KUNNUMAKKARA (Kunnumakkara et al., Experimental Biology and Medicine, 2019, 244, 663-689) as representative of the state of the prior art and predictability thereof.
HUANG teaches cancer cells treated with chlorogenic acid showed reduced proliferation rate, migration/invasion ability, and mitochondrial ATP production; chlorogenic acid increased expression of differentiation biomarkers to induce differentiation (Pg. 6745 Abstract Results). Further, the chlorogenic acid altered the expression of differentiation-related genes only in cancer cells, not in normal cells (Pg. 6745 Abstract Results). The chlorogenic acid was detectable in the blood and brain when administered intraperitoneally in animals (Pg. 6745 Abstract Results). Based on this disclosure, the artisan would expect chlorogenic acid to be a viable therapy for treatment of cancer/tumors. Since the chlorogenic acid was found in both the blood and the brain, treatment of cancers throughout the body (including the CNS) would have a reasonable expectation of success (i.e., predictability). However, since the chlorogenic acid only has an effect on cancer cells and not normal cells, the artisan would not expect the therapy to achieve prevention of the development of cancer.
LI teaches chlorogenic acid administration to patients with glioma (i.e., a CNS tumor) was safe and well tolerated with potential antitumor activity (Pg. 1-2 Conclusions). LI’s disclosure further supports the use of chlorogenic acid for treatment of CNS tumors.
BISPO teaches most lymphomas are sporadic and the specific etiology remains elusive; these malignancies often develop in the context of genetic abnormalities, immunosuppression, and exposure to various risk factors (Pg. 1 Abstract). Thus, BISPO establishes the unpredictable nature of the development of lymphoma. Further, BISPO stresses specific prevention efforts targeting these malignancies are nonexistent (Pg. 1 Abstract).
Furthermore, with regard to unpredictability, KUNNUMAKKARA teaches cancer is a group of more than 200 neoplastic diseases caused by diverse deregulated cell signaling cascades (Pg. 633 Left ¶1); cancer occurs as a result of the dysregulation of as many as 500 different genes which may happen over a very long duration of time (20–30 years) till the symptoms become apparent (Pg. 633 Right last ¶). Therefore, the art is unpredictable regarding how and when the development of cancers is triggered.
In view of the relevant prior art, the artisan would be enabled to use chlorogenic acid to treat cancers, including those of the CNS. However, since there is a lack of predictability surrounding the development of cancers and since there are no known preventative techniques for lymphoma (as specifically recited in instant claims 2-6), the art does not provide enablement for prevention of CNS tumors, including lymphoma, by administration of chlorogenic acid.
The level of one of ordinary skill:
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. This factor is outweighed, however, by the unpredictable nature of the art (established above). It is well established that "the scope of enablement varies with the degree of unpredictability of the factors involved" and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved).
The level of one of ordinary skill includes the knowledge/skill to engage in a reasonable amount of experimentation to make the pharmaceutical compositions as intended by claims 1-9 based on the disclosure in the Specification (see Pg. 2-18 Examples 1-2 & Experimental Examples 1-3). The Specification discloses making a composition of chlorogenic acid and administering said composition to treat a CNS tumor, exemplified by lymphoma. The art cited above further provides support for the artisan to engage in treatment of other CNS tumors (see HUANG & LI). However, the skill of the artisan, especially in view of the relevant prior art, does not overcome the undue burdensome level of experimentation required to provide enablement for preventing CNS tumors by administration of chlorogenic acid.
The amount of direction provided by the inventor and the existence of working examples:
Inventors have provided direction as to making pharmaceutical compositions comprising chlorogenic acid (see Pg. 2-4 Examples 1-2 of the instant Specification) and administering said compositions to treat CNS lymphomas (see Pg. 4-18 Experimental Examples 1-3 of the instant Specification).
The results of these working examples are summarized in tables on Pg. 12 (Table 2) and Pg. 16 (Table 3) of the instant Specification. In vivo treatment with chlorogenic acid resulted in tumor inhibition rates of about 20-60%. Notably, administration with chlorogenic acid did not result in 100% inhibition of tumor growth and Inventors have not provided any working examples wherein prevention of tumor development is shown.
Thus, Applicants have guidance/enablement in their Specification (Experimental Example 1-3) for treating lymphoma by administering pharmaceutical compositions of chlorogenic acid. In view of the relevant prior art, this guidance provides support for treating CNS tumors. However, this guidance does not support preventing CNS tumors, especially in view of the relevant prior art.
The quantity of experimentation needed to make or use the invention:
Applicants’ tumor therapy invention comprising chlorogenic acid requires a high level/quantity of experimentation to use the invention for the intended use of preventing CNS tumors. While Applicants have provided guidance in their Specification for making pharmaceutical compositions of the claimed chlorogenic acid, they have not provided enough evidence that said pharmaceutical composition can be used to prevent the scope of CNS tumors per the BRI of instant claims 1-9. At best, the Specification does provide enablement/guidance for using the instantly claimed compound in pharmaceutical compositions to treat (not prevent) CNS tumors (see Specification Pg. 4-18 Experimental Examples 1-3).
Therefore, claims 1-9 are rejected under 35 USC 112(a) for lacking scope of enablement for preventing a CNS tumor. Claim 10 is not rejected here since the claim only intends to treat CNS tumors with the medicament of chlorogenic acid.
To render moot this scope of enablement rejection: Applicants should delete “prevent” and/or “prevention”/”preventing” from the claims.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2-9 recite “The use” of chlorogenic acid without any active, positively recited steps delimiting how the use is actually practiced. See MPEP 2173.05(q): “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness.” Since no steps are recited, the metes and bounds of the claims are undefined rendering the claims indefinite.
Further, these claims depend from claim 1 – a product claim. This dependence and the recitation of “The use of claim 1” makes it unclear whether claims 2-9 are meant to be product or process claims. Thus, the metes and bounds of the claims are undefined rendering the claims indefinite.
Claim 6 recites “the brain, eye, or spinal cord”. There is insufficient antecedent basis for this limitation in the claim. This is the first time these elements are introduced and the claims do not recite a subject which would inherently introduce these elements. Thus, it is unclear what brain, eye, or spinal cord claim 6 is referring to. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 9 recites “the pharmaceutical formulation”. There is insufficient antecedent basis for this limitation in the claims. Parent claim 8 recites a “pharmaceutical preparation”, but not a formulation. Since the words used after “pharmaceutical” are different, it is unclear what “formulation” claim 9 is drawn to. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claims 9 and 10 both recite “the unit dosage form”. There is insufficient antecedent basis for this limitation in the claims. This is the first time a unit dosage form is introduced in either claim tree. Thus, it is unclear what unit dosage form either of the claims is referring to. Therefore, the metes and bounds of the claims are undefined rendering the claims indefinite.
Claims 9 and 10 both recite “preferably” and “more preferably”. It is unclear whether the limitations following preferably are required or are merely exemplary embodiments. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 6 and 9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. Claims 6 and 9 recite limitations which are not supported by the scope of their parent claims (see ¶15-17 above). Thus, the claims do not properly further limit their parent claims. 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.
Examiner recommends to use “a” to introduce limitations in both claims and replacing “formulation” with “preparation” in claim 9.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HADLEY (Hadley, M., Journal of Nutritional Biochemistry, 2002, 13, 717-726).
Regarding claim 1, Examiner understands the claim as a product claim drawn to the compound chlorogenic acid wherein the phrase “for use in manufacturer of medicaments for the prevention and/or treatment of central nervous system tumors” is an intended use (see MPEP 2111.02(II)). HADLEY teaches chlorogenic acid in an infusion (injectable) dosage form of 5mg/kg (Pg. 719 Left Col. ¶3). The instant intended use does not structurally limit the chlorogenic acid and nothing precludes the use of the chlorogenic acid for the intended purpose. Thus, HALDEY anticipates claim 1.
Regarding claims 2-6, these claims only further define the tumor which the medicament is intended to treat, wherein the claimed chlorogenic acid is intended for use in preparation of said medicament. The instant intended use does not structurally limit the chlorogenic acid and nothing precludes the use of the chlorogenic acid for the intended purpose. Thus, HALDEY anticipates claims 2-6.
Regarding claims 7-9, these claims define the intended medicament. While these are further intended uses, HADLEY does teach treatment of rats with chlorogenic acid as an infusion of 5mg/kg in phosphate buffer (Pg. 719 Left Col. ¶3). Thus, HADLEY teaches chlorogenic acid as an active ingredient in an injectable pharmaceutical preparation with pharmaceutically acceptable excipient (i.e., buffer) wherein the unit dosage form contains 1.6 mg chlorogenic acid (5mg/kg for 327g rats (Pg. 718 sect. 2.1)). Thus, nothing precludes the use of the chlorogenic acid for the intended purpose and HALDEY anticipates claims 7-9.
Regarding claim 10, the recitation of “for treating central nervous system tumors” is an intended use (MPEP 2111.02(II)) which does not structurally limit the claimed medicament comprising chlorogenic acid. Since HALDEY teaches a chlorogenic acid dosage form of 1.6 mg in phosphate buffer (Pg. 719 Left Col. ¶3 & Pg. 718 sect. 2.1), the structural limitations of the claim are met (i.e., medicament, active ingredient, excipient, and amount in mg). The dosage amount of 1.6 mg anticipates the claimed range of 0.5-5.5 mg and 1.1-3.3 mg. Thus, nothing precludes the use of the chlorogenic acid for the intended purpose and HALDEY anticipates claim 10.
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 1-9 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/262,969 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a pharmaceutical composition comprising chlorogenic acid (1-7) and uses thereof (8-10). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference use, the practitioner would have to be in possession of the chlorogenic acid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 11-17 of copending Application No. 18/556,818 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a pharmaceutical composition comprising chlorogenic acid (1-3, 5-6, 11-15) and methods of use thereof (16-17). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/577,127 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a pharmaceutical composition comprising chlorogenic acid (1-8) and uses thereof (9). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference use, the practitioner would have to be in possession of the chlorogenic acid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 19/071,026 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treatment comprising administering a pharmaceutical preparation of chlorogenic acid (1-9). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,884,036. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating psoriasis comprising administering a pharmaceutical preparation of chlorogenic acid (1-6). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-5 and 10-14 of U.S. Patent No. 9,918,956. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a composition comprising chlorogenic acid (1-5 and 10-14). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,058,525. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating lupus comprising administering a pharmaceutical composition of chlorogenic acid (1-8). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,004,713 Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating oligodendroglioma (i.e., a CNS tumor) comprising administering a pharmaceutical composition of chlorogenic acid (1-5). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claim 10 is rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,004,713 further in view of ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53).
Determining the Scope and Contents of the Prior Art:
The reference claims are drawn to a method of treating oligodendroglioma (i.e., a CNS tumor) by administering a pharmaceutical preparation comprising an effective amount of chlorogenic acid (ref. claims 1-5) wherein the preparation comprises 1-3000 mg of chlorogenic acid per unit (ref. claim 2).
ANSEL teaches the safe and effective dose of a drug depends on a number of factors including characteristics of the drug, the dosage form, and a variety of patient factors (Pg. 48 Left Col. para 2) and the effective dose may be different for different patients (Pg. 48 Left Col. para 4).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
U.S. Patent No. 10,004,713 does not teach the unit dosage form contains 0.5-5.5, 1.1-3.3, or 3.3 mg of the chlorogenic acid.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a unit dosage form of chlorogenic acid useful for treatment of a CNS tumor and possesses the technical knowledge necessary to make adjustments to the dosage form to optimize/enhance the dosage. Said artisan has also reviewed the problems in the art regarding optimization of dosages and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references U.S. Patent No. 10,004,713 in view of ANSEL.
Regarding claim 10, the artisan would have been motivated to optimize the unit dosage amount of chlorogenic acid in the pharmaceutical preparation. Since the intended use of the instant claim does not structurally limit the claimed medicament/dosage form, nothing precludes the reference composition from the instant intended use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid composition.
MPEP 2144.05(II)(A) provides guidance about the routine optimization of prior art conditions: "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 normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").”
Furthermore, MPEP 2144.05(I) provides guidance about overlapping ranges: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists…Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”
In the instant case, U.S. Patent ‘713 teaches a unit dosage form contains 1-3000 mg (ref. claim 2). This dosage overlaps with/approaches the instantly claimed 0.5-5.5, 1.1-3.3, and 3.3 mg. Since ANSEL the safe and effective dose of a drug depends on various factors (Pg. 48 Left Col. para 2) and may be different for different patients (Pg. 48 Left Col. para 4), the artisan would recognize the dosage of chlorogenic acid as a result-effective variable, i.e., a variable that achieves a recognized result. Thus, the dosage is analogous to the “concentration or temperature” recited in the MPEP and may be optimized by routine experimentation. Therefore, the determination of the optimum or workable dosage regimen of chlorogenic would have been well within the practice of the artisan. Furthermore, absent any evidence demonstrating a patentable difference between the instant and prior art compositions and the criticality of the claimed dosage regimen, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the artisan.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,265,289. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating melanoma comprising administering a medicament comprising chlorogenic acid (1-10). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-2 and 11 of U.S. Patent No. 10,246,401. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a crystalline form of chlorogenic acid (1-2 and 11). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,238,702. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a pharmaceutical composition comprising chlorogenic acid (1-5). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,314,806. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a pharmaceutical preparation comprising chlorogenic acid (1-8 and 10-15) and a method of treating a brain glioma (i.e., a CNS tumor) comprising administering the preparation (9). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,547,715. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating chordoma comprising administering a composition of chlorogenic acid (1-7). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,376,267. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a pharmaceutical preparation comprising chlorogenic acid (1-4). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-4 and 6-9 of U.S. Patent No. 11,596,598. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to an anti-tumor composition comprising chlorogenic acid (1-4) and a drug comprising said composition (6-9). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,135,160. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to methods of administering a composition of chlorogenic acid (1-4). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,156,861. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a pharmaceutical composition comprising chlorogenic acid (1-7) and a method of treating a kidney cancer comprising administering the preparation (8). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,628,199. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a pharmaceutical preparation comprising chlorogenic acid (1-3). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,150,926. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating sarcoma comprising administering a composition of chlorogenic acid (1-8). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,178,792. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating drug-resistant tumor by administering chlorogenic acid (1-11). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,364,677. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating ocular inflammation comprising administering chlorogenic acid (1-8). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Claims 1-9 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,194,013. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating squamous cell carcinoma comprising administering a composition of chlorogenic acid (1-6). Since the intended uses of the instant claims do not structurally limit the claims, the reference claims anticipate the instant claims which are drawn to chlorogenic acid. Nothing precludes the reference claims from the instant use. Further, to practice the reference method, the practitioner would have to be in possession of the chlorogenic acid.
Conclusion
Claims 1-10 are rejected.
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/S.E.B./
Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625