DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 7/24/2024 and 1/26/2026 are acknowledged.
Claim Rejections- 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 35 recites further comprises caffeine or a pharmaceutically acceptable salt, solvate, derivative or metabolite thereof and claim 31 recites natural caffeine extract thus it is not clear if this is the same caffeine or an additional different caffeine is added as the composition of claim 31 already comprised caffeine.
Claim Rejections- 35 USC § 112-Scope of enablement
4. The following is a quotation of the first paragraph of 35 U.S.C. 112:
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 31-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. Claims 11-18 contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification, while being enabled for treating a craving for coffee in an individual or treating caffeine withdrawal or a symptom of caffeine withdrawal, does not reasonably provide enablement for a method of preventing a craving for coffee or preventing caffeine withdrawal or a symptom of caffeine withdrawal.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(A) The nature of the invention (B) Breadth of the claims:
The invention is drawn to a method of treating or preventing a craving for coffee in an individual or treating or preventing caffeine withdrawal or a symptom of caffeine withdrawal in an individual.
Prevention is suggested to include a level of protection against, up to and including complete protection against the development of a disease or condition which is unsupported by the disclosure. Giving the claims their broadest reasonable interpretation the term “prevention” includes any measure taken prior to the onset or occurrence of a disease or condition which precludes its coming into existence, absolutely and in all cases. Therefore, preventing a craving for coffee or preventing caffeine withdrawal or a symptom of caffeine withdrawal renders the scope of the claims unreasonably broad.
(C) The state of the prior art (D) The predictability or unpredictability of the art and (E) The relative skill of those in the art:
The state of the replete in terms of treating a craving for coffee or caffeine withdrawal and symptoms of caffeine withdrawal. There is no evidence in the prior art that the instant composition would be usable as a preventative composition, particularly for preventing a craving for coffee or caffeine withdrawal. MPEP 2141.03 states (in part), “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988).
There is no evidence in the prior art that the instant composition would be usable as a preventative composition, particularly for preventing a craving for coffee or caffeine withdrawal. “Preventing” connotes an absolute absence of a condition which cannot reasonably be achieved with regard to infections, with few exceptions (such as vaccines to prevent the development of pathogen-borne illnesses). In addition, there is no definitive method by which to determine whether a patient will develop a particular condition and, thus, be in need of preventive therapy. This is distinguished from preventing the relapse or recurrence of certain conditions, in which case an objective basis may exist to identify patients at risk of disease or infection, and could reasonably be construed as treatment. Prior to the initial onset or occurrence, however, even if a patient can be identified as having known risk factors for a condition, there is no certainty that the patient would in fact develop the condition. Further, the failure of a disease, infection, or condition to develop cannot reliably be attributed to the claimed active agent(s). The non-development of a condition may be due to other factors such as lifestyle. In this sense, in the context of preventing a condition, the level of unpredictability is extremely high.
(F) The amount of direction or guidance presented:
The specification fails to disclose how to prevent caffeine withdrawal or a craving for coffee. The amount of direction or guidance is minimal or non-existent with regards to preventing caffeine withdrawal or craving for coffee. Thus, with respect to the instant composition, there is a substantial gap between treatment and prevention especially when no working examples are provided. Consequently, it would require undue experimentation for the skilled artisan to discover how to make and use the instant invention in order to prevent a craving for coffee or caffeine withdrawal.
(G) The presence or absence of working examples: The specification does not disclose any evidence that a craving for coffee or caffeine withdrawal can be prevented.
(H) The quantity of experimentation necessary: In the instant case, there is a substantial gap between treatment and prevention. Consequently, a burdensome amount of research would be required by one of ordinary skill in the art to bridge this gap. Because "preventing” a condition by the administration of an active agent cannot be objectively measured or achieved with any certainty, coupled with a lack of guidance and direction provided by the instant disclosure, a skilled artisan could not practice the invention commensurate with the full scope of the claims without undue experimentation. This rejection can be overcome by amending the claims to omit the term “preventing.”
CONCLUSION
Given the complete lack of guidance in applicant's instant disclosure, regarding preventing a craving for coffee or caffeine withdrawal, an undue amount experimentation is required to realize the full scope of claims 31-50 would be required to discover how to use the invention as broadly claimed. Applicant has not described how to prevent a craving for coffee or caffeine withdrawal, with a composition as recited by claims 31-50 of the instant application in such full, clear, concise, and exact terms as to enable any person skilled in the art to do so.
Claim Rejections- 35 USC § 102
5. 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 31, 33, 35 and 43-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wenig et al. (WO 1998004929).
Wenig et al. (WO 1998004929) (hereinafter Wenig et al.) disclose methods of nasally administering caffeine via an aqueous composition of caffeine extract (abstract, claims 1-12). With regards to claim 33, and maintaining a nil by mouth status, the composition of Wenig et al. is not meant to be administered orally. The composition includes preservatives. The active method steps of claim 1 have been met where an individual is administered via intranasal delivery an aqueous pharmaceutical composition comprising a natural caffeine extract and at least one pharmaceutically acceptable excipient. Wenig et al. disclose the term "caffeine" as used herein is intended to encompass not only caffeine as the anhydrous powder, but any salt or derivative of caffeine having caffeine like activity which is non-toxic and pharmaceutically acceptable.
Claim Rejections- 35 USC § 103
6. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 31-50 are rejected under 35 U.S.C. 103 as being unpatentable Wenig et al. (WO 1998004929) in view of Gizurarson (US Patent 6647980), Benjamin et al. (US Patent 4,983,595), Ching-Yin Ho et al. “In vitro effects of preservatives in nasal sprays on human nasal epithelial cells”, Abraham et al. (US 2020/0009179), Kushwaha et al. “Advances in nasal trans-mucosal drug delivery”, Gizurarson et al. (US 2004/0005275), Gizurarson et al. (US 2008/0275030), Bonfour et al. (US 20070031343), Born et al. (US 2009/0230013), Moreira et al. “Anti-inflammatory effect of aqueous extracts of roasted and green Coffea arabica L” Ozaki et al. (US 20120076907), Merkus et al. (US 2016/0271135), Wang et al. (US 20130190349) and Weber et al. “Prophylactic Intravenous Administration of Caffeine and Recovery After Ambulatory Surgical Procedures” as evidenced by Shammary et al. “Naproxen”.
Wenig et al. (WO 1988004929) (hereinafter Wenig et al.) disclose nasal administration of caffeine (abstract) and that caffeine containing compositions can be usefully administered to mammals in novel nasal compositions at low dosage levels to elicit systemic therapeutic response and provide enhanced bioavailability, rapid onset of activity, ease of administration and reduced side effects compared to most current methods of administration (see 3rd paragraph of page 3). The concentration of the caffeine may vary with the condition to be treated and age and size of the patient (last paragraph of page 4). The desired isotonicity can be accomplished using inorganic or organic solutes (page 5). The viscosity is maintained at the selected level using therapeutically acceptable thickening agent which include hydroxypropyl methyl cellulose (HPMC) (i.e., Hypromellose). The concentrations vary depending on the agent but it important to use an amount which will achieve the selected viscosity (see page 5 second full paragraph). The composition includes a humectant to inhibit drying of the mucous membrane and prevent irritation. These include glycerol. A therapeutically acceptable preservative is generally employed to increase the shelf life of the compositions and suitable concentrations are from 0.02-2 %. (see page 6, first full paragraph). The compositions can include 1-20 grams per 100ml composition (page 7).
Wenig et al. disclose compositions of inhalation that include caffeine and further teach that the compositions of the invention may contain other therapeutically active agents together with the caffeine. These may include, for example, analgesics, anti-inflammatory and antipyretic agents such as aspirin, acetaminophen, or other therapeutic agents normally employed with caffeine. These drugs include bitter drugs such as naproxen (see evidence reference Shammary et al. “Naproxen”).
Wenig et al. does not disclose a coffee extract v/v, potassium sorbate at 0.05-0.2 % w/v, 0.5-2 % v/v glycerol, Hypromellose (hydroxypropylmethylcellulose) 0.01-1 % w/v and PBS to 100 %.
With regards to HPMC and potassium sorbate, Wenig et al. does disclose using HPMC as thickening agent to achieve desired viscosity. Gizurarson (US Patent 6647980) (hereinafter Gizurarson ) disclose nasal sprays containing viscosity enhancing agent (abstract). The viscosity enhancing agents may be HPMC (i.e., hypromellose) and are present within the range of 0.01-10 % w/v (col. 8, lines 19-65). Preservatives such as potassium sorbate are taught but Gizurarson does not disclose w/v % of preservative.
Benjamin et al. (US Patent 4,983,595) (hereinafter Benjamin et al.) disclose non-stinging aqueous compositions for intranasal administration (abstract). The formulations should contain an effective amount of preservative which is preferably between about 0.02-0.08 % w/v (col. 1, lines 41-56). Benjamin et al. disclose the term preservative refers to a compound or mixture used in a formulation which is useful for reducing or eliminating microbial growth in a formulation. Examples include benzalkonium chloride and potassium sorbate (see col. 3, line 65- col. 4, line 13).
Ching-Yin Ho et al. “In vitro effects of preservatives in nasal sprays on human nasal epithelial cells” (hereinafter Ching-Yin Ho) discloses that potassium sorbate appears to be safer preservative than benzalkonium chloride for use in nasal sprays and drops.
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 substitute the preservative benzalkonium chloride of Wenig et al. for potassium sorbate and optimize the amounts for the intended purpose of reducing or eliminating microbial growth in nasal spray formulations.
It would have further been prima facie obvious to one of ordinary skill in the art before the effective filing date to optimize the amount of viscosity enhancer HPMC to achieve desired viscosity. Gizurarson discloses HPMC may be present in nasal formulations in overlapping amounts . 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).
With regards to the concentration of humectant, Wenig et al. disclose the humectant of glycerol but does not disclose the v/v however, Abraham et al. (US 2020/0009179) (hereinafter Abraham et al.) disclose intranasal compositions that contain humectant from about 1-5 % w/v (abstract and para 0055-0056 and 0058). The humectant may be glycerin (also known as glycerol) (see para 0058).
In calculating the v/v from 1-5 % m/v of glycerin (glycerol) using the density of glycerin which is 1.26 g/cm3, assuming 100 mL of solution then 1 % =1g of glycerol. 1 g/1.26 g/ml=0.79 mL of glycerol. 0.79 mL glycerol/100 mL solution x 100 % =0.79 % v/v. Now for the upper range 5%=5g of glycerol. 5 g/1.26 g/ml=3.97 mL. 3.97 mL glycerol/100 mL solution x 100 %=3.97 % v/v. These are ranges that overlap with the instant claimed amounts.
Kushwaha et al. “Advances in nasal trans-mucosal drug delivery” disclose humectants are added to avoid nasal irritation and are not likely to affect drug absorption and common examples are glycerin (glycerol). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to optimize the amount of humectant such as glycerol. One would have been motivated to do so for the purpose of avoiding nasal irritation. 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).
Wenig et al. disclose the carriers include water (see Examples) but does not disclose saline or phosphate buffered saline v/v.
Gizurarson et al. (US 2004/0005275) (hereinafter ‘275) disclose intranasal administration of compositions which contain physiologically acceptable vehicles (carriers) such as phosphate buffered saline or water (para 0050). The amount v/v is not disclosed however, Gizurarson et al. (US 2008/0275030) (‘030) disclose compositions for intranasal administration (abstract). The preferred amount of vehicle (i.e., water) can be from 2 % v/v to about 99 % v/v (para 0063). 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 have the pharmaceutically acceptable vehicle (i.e., water) for the intranasal composition of Wenig et al. contain from about 2 % v/v to about 99 % v/v the composition of the vehicle. It would have further been prima facie obvious to one of ordinary skill in the art to substitute the water for phosphate buffered saline as both are art recognized equivalent vehicles suitable for nasal administration.
With regards to the coffee extract and v/v, Bonfour, III et al. (US 20070031343) (hereinafter Bonfour et al.) disclose flavored medicinal inhalant (abstract). The composition may comprise extract of coffee (para 0009). The extracts (coffee) are flavoring agents (flavorants) and may be present from 0.0001-10 % by volume (para 0015). Bonfour et al. disclose as those skilled in the art will appreciate, many conventional methods and apparatus are available for administering precisely metered doses of medicinal inhalant. Delivery may be achieved by any of various inhalant approaches, including liquid nebulizers, pump or squeeze-actuated nebulized or atomized spray dispensers, aerosol-based metered dose inhalers, and any other systems suitable for delivery of medicinal inhalants (para 0011). Thus, administration of a metered dose would have been within the purview of one of ordinary skill in the art as it allows for administering precisely metered dosages of medicinal inhalant. Balfour provides motivation to include flavorants such as coffee extracts for improving the palatability of the inhalants. Balfour et al. disclose a flavorant that is compatible with medicinal inhalants and substantially improves the palatability of the inhalant (para 0007).
Wenig et al. does not teach a metered dose. With regards to providing a metered dose, Born et al. (US 2009/0230013) disclose dosage unit that has indicia that enables a user to select a system and one or more dosage units and actives appropriate to a user’s needs (abstract). The compositions may be in liquid form and the inhaled compositions include nasal spray para 0274). The compositions may contain 0.1-90 % coffee extract by weight of the dosage unit which may be liquid (para 0232 and 0274). The main constituent in coffee extract is caffeic acid which is believed to display antioxidant activity (para 0231). As taught by Moreira et al. “Anti-inflammatory effect of aqueous extracts of roasted and green Coffea arabica L” (hereinafter Moreira et al.) disclose aqueous extracts of coffee beans (Coffea arabica L) (ARCa) and that these contain caffeic acid.
Bonfour et al. does not disclose the coffee extract is an aqueous extract of roasted coffee beans or that caffeine is present from the extract from 2 mg/mL to 10 mg/mL.
With regards to the aqueous extract of roasted coffee beans, Ozaki et al. (US 20120076907) disclose aqueous extract from roasted coffee beans (abstract, claim 1) and disclose that roasted coffee extract has potent antioxidant properties and shows a highly favorable balance with the flavor of coffee (para 0007). Thus, not only is the aqueous extract from coffee beans to make the coffee extract beneficial for its flavorant properties but it is also a potent antioxidant. Additionally, Bonfour disclose increasing palpability of medicaments and the compositions of Weing et al. may include medicaments such as aspirin or naproxen which are known bitter tasting drugs.
Weing et al., Bonfour et al. and Ozaki et al. do not disclose the caffeine in the coffee extract is from 2 mg/mL to 10 mg/mL. Merkus et al. (US 2016/0271135) (hereinafter Merkus et al.) disclose caffeine in nasal compositions can be provided from coffee (e.g., Coffea arabica and Coffea robusta) (para 0052). The nasal compositions can contain an aqueous extract containing caffeine from 1-50 v/v (para 0052). Merkus et al. teach the caffeine may be up toto 5 mg/ml and may be from coffee beans (paras 0030- 0031). One of ordinary skill in the art understands that the amount of caffeine in the extract is dependent on the source of the coffee beans and as taught by Moreira et al., coffee is a rich source of caffeine and that extracts of coffee bean (ARca) contain caffeine (Table 1). The contents of caffeine, trigonelline, CGA, caffeine and caffeic acid in commercial coffee may be greatly influenced by the coffee species, variety, geographical origin and roasting conditions (see discussion). It would have been prima facie obvious to one of ordinary skill in the art to select coffee beans to extract coffee and vary the amount of the desired caffeine for the extract. Caffeine presents a characteristic bitter taste that important to coffee flavor and roasting does not affect the caffeine contents. 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). 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 further add aqueous coffee extracts from roasted coffee beans to the compositions of Wenig et al. for its flavoring effects as well as antioxidant activity. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical (MPEP 2144.05 II). [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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, not only is the aqueous extract from coffee beans to make the coffee extract beneficial for its flavorant properties but it is also a potent antioxidant. Additionally, Bonfour et al. disclose increasing palpability of medicaments and the compositions of Weing et al. may include medicaments such as aspirin or naproxen which are known bitter tasting drugs (see the evidence reference Shammary et al. “Naproxen”).
The modified Weing et al. does not disclose how much caffeine per 0.1 mL actuation however, Wang et al. (US 20130190349) (hereinafter Wang et al.) disclose spray volumes include 0.05 to about 0.15 per actuation (claim 20) and the prior art discloses drugs can be included in a nasal dispersion that delivery a quantity comprising 1.8 mg per actuation 0.1 mL (para 0147). 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 administer about 1.8 mg of caffeine per 0.1 ml actuation. One of ordinary skill in the art would adjust the desired dosage per actuation as shown by Wang.
Weber et al. “Prophylactic Intravenous Administration of Caffeine and Recovery After Ambulatory Surgical Procedures”” (hereinafter Weber et al.) disclose that caffeine has shown a role in prophylaxis and treatment of postoperative headache and that the desired outcome would be to prevent postoperative headaches. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to administer the composition of the Weing et al. prior to a medical procedure such as surgery would prevent postoperative caffeine withdrawal.
CORRESPONDENCE
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
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