Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Preliminary amendment filed on 03/22/2023 is acknowledged. Claims 1-10 were amended and claims 11-19 were newly added. Claims 1-19 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/IB2021/058670, filed on 09/23/2021 and claims foreign priority to ITALY 1020000022471 filed on 09/23/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 03/22/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS document has been placed in the application file and the information therein has been considered as to the merits.
Claim Objections
Claim 6 is objected to because of the following informalities: “[H:CS]” on line 3 should be “[HA:CS]”. Appropriate correction is required.
Claim Interpretation
Claim 8 recites “…said chondroitin of plant origin or said vegetable chondroitin sulfate or said a salt thereof (CS)…”. The examiner will interpret (CS) as referring to all of said chondroitin of plant origin or said vegetable chondroitin sulfate or said a salt thereof.
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 1-9 and 11-18 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.
Regarding claim 1, the phrase “an analogue of a chondroitin or a vegetable chondroitin as a compound that comprises a mixture comprising an extract of at least one alga” is confusing as a compound is a single entity and cannot be a mixture. The examiner will interpret the phrase as “a mixture comprising an extract of at least one alga that comprises an analogue of a chondroitin or a vegetable chondroitin as a compound”. Claims 2-3, 5, 7-9, and 11-18 are rejected for being dependent from a rejected base claim.
Regarding claims 1, 4 and 6, the phrase “a hyaluronic acid” is listed twice and it is unclear if the two “a hyaluronic acid” are the same or different. The examiner will interpret the composition as comprising just one hyaluronic acid. Claims 2-3, 5, 7-9, and 11-18 are rejected for being dependent from a rejected base claim.
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.
Claim 10 is rejected under 35 U.S.C. 112(a), because the specification, while being enabling for treating gastroesophageal reflux disease (GERD) by administering to an individual in need with a composition comprising chondroitin, hyaluronic acid, and a pharmaceutical grade additive and/or excipient, it does not reasonably provide enablement for preventing GERD, laryngopharyngeal reflux disease (LPR), lesions or ulcers in the mucosa or tissues of the oral cavity, lesions or ulcers in the mucosa or tissues of the pharyngolaryngeal tract, lesions or ulcers in the mucosa or tissues of the oesophageal tract, oesophageal ulcers, deepithelialization of the oesophageal mucosa, peptic ulcers, gastric ulcers, mucositis, aphthous, aphthoid lesions, acute or chronic inflammations of the mucous membrane or tissues of the oral cavity, acute or chronic inflammations of the mucous membrane or tissues of the pharyngolaryngeal tract, acute or chronic inflammations of the mucous membrane or tissues of the oesophageal tract, oesophagitis or acute or chronic inflammation of the oesophageal mucosa, acid regurgitation, heartburn, feeling of gastric fullness, epigastric pain, dyspepsia, nausea, chronic cough, bronchospasm, inflamed throat, laryngitis, globus sensation or hypopharyngeal bolus, pyrosis, dysphonia, nasopharyngeal inflammation, laryngospasm, raucousness, excessive throat clearing, throat pain or burning, postnasal drip, pharyngitis and/or other symptoms of the upper respiratory tract.. 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.
With respect to the claimed method, attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered and those most relevant to the cited claims are discussed below.
Nature of the invention: The invention is drawn a method for preventing GERD, laryngopharyngeal reflux disease (LPR), lesions or ulcers in the mucosa or tissues of the oral cavity, lesions or ulcers in the mucosa or tissues of the pharyngolaryngeal tract, lesions or ulcers in the mucosa or tissues of the oesophageal tract, oesophageal ulcers, deepithelialization of the oesophageal mucosa, peptic ulcers, gastric ulcers, mucositis, aphthous, aphthoid lesions, acute or chronic inflammations of the mucous membrane or tissues of the oral cavity, acute or chronic inflammations of the mucous membrane or tissues of the pharyngolaryngeal tract, acute or chronic inflammations of the mucous membrane or tissues of the oesophageal tract, oesophagitis or acute or chronic inflammation of the oesophageal mucosa, acid regurgitation, heartburn, feeling of gastric fullness, epigastric pain, dyspepsia, nausea, chronic cough, bronchospasm, inflamed throat, laryngitis, globus sensation or hypopharyngeal bolus, pyrosis, dysphonia, nasopharyngeal inflammation, laryngospasm, raucousness, excessive throat clearing, throat pain or burning, postnasal drip, pharyngitis and/or other symptoms of the upper respiratory tract.. by treating a subject in need with a composition comprising chondroitin, hyaluronic acid, and a pharmaceutical grade additive and/or excipient.
Relative skill of those in the art: The relevant art is pharmaceutical formulations, which is a mature art where practitioners receive specialized training and earn advanced degrees during the course of their study. There is a voluminous amount of published material describing research, best practices and practical application of compositions and techniques to the medical field. The relative skill of those in the art is high.
Breadth of claims: The claims are broad with respect to the concept of prevention. The full scope of the instant claims covers the entire definition of treatment and prevention as well any adverse effect from GERD, laryngopharyngeal reflux disease (LPR), lesions or ulcers in the mucosa or tissues of the oral cavity, lesions or ulcers in the mucosa or tissues of the pharyngolaryngeal tract, lesions or ulcers in the mucosa or tissues of the oesophageal tract, oesophageal ulcers, deepithelialization of the oesophageal mucosa, peptic ulcers, gastric ulcers, mucositis, aphthous, aphthoid lesions, acute or chronic inflammations of the mucous membrane or tissues of the oral cavity, acute or chronic inflammations of the mucous membrane or tissues of the pharyngolaryngeal tract, acute or chronic inflammations of the mucous membrane or tissues of the oesophageal tract, oesophagitis or acute or chronic inflammation of the oesophageal mucosa, acid regurgitation, heartburn, feeling of gastric fullness, epigastric pain, dyspepsia, nausea, chronic cough, bronchospasm, inflamed throat, laryngitis, globus sensation or hypopharyngeal bolus, pyrosis, dysphonia, nasopharyngeal inflammation, laryngospasm, raucousness, excessive throat clearing, throat pain or burning, postnasal drip, pharyngitis and/or other symptoms of the upper respiratory tract. The specification defines “prevention” to include treatment of delaying, or impeding or preventing the onset of a condition, or a disease and/or the symptoms associated there with; preventing a patient from contracting a condition or a disease; or reducing the risk of a patient's contracting a given disease or a condition; or reducing the risk of a patient's contracting a given disease or a condition (specification page 19). The full scope of the claims encompasses the entire definition of tertiary prevention, which covers reducing the occurrence of or eliminating a symptom or condition. The term “prevention” is assumed to take on the customary meaning known to those skilled in the art. Specifically, “prevention” is defined according to the Institute for International Medical Education (Wojtczak, 2002) as: the goals within the field of medicine to promote health, to preserve health, to restore health when it is impaired, and to minimize suffering and distress. Customarily prevention is sub-classified as primary (the protection of health by personal and community wide effects), secondary (the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health) and tertiary (the measures available to reduce or eliminate long-term impairments and disabilities, minimize suffering caused by existing departures from good health, and to promote the patient's adjustment to irremediable conditions). Tertiary prevention is most relevant as used in the context of the instant invention. Thus, the intent of the method, as interpreted by a skilled practitioner of the medical or pharmaceutical arts, would include that which reduces the occurrence of, or eliminates, GERD, laryngopharyngeal reflux disease (LPR), lesions or ulcers in the mucosa or tissues of the oral cavity, lesions or ulcers in the mucosa or tissues of the pharyngolaryngeal tract, lesions or ulcers in the mucosa or tissues of the oesophageal tract, oesophageal ulcers, deepithelialization of the oesophageal mucosa, peptic ulcers, gastric ulcers, mucositis, aphthous, aphthoid lesions, acute or chronic inflammations of the mucous membrane or tissues of the oral cavity, acute or chronic inflammations of the mucous membrane or tissues of the pharyngolaryngeal tract, acute or chronic inflammations of the mucous membrane or tissues of the oesophageal tract, oesophagitis or acute or chronic inflammation of the oesophageal mucosa, acid regurgitation, heartburn, feeling of gastric fullness, epigastric pain, dyspepsia, nausea, chronic cough, bronchospasm, inflamed throat, laryngitis, globus sensation or hypopharyngeal bolus, pyrosis, dysphonia, nasopharyngeal inflammation, laryngospasm, raucousness, excessive throat clearing, throat pain or burning, postnasal drip, pharyngitis and/or other symptoms of the upper respiratory tract in an individual.
Amount of guidance/Existence of working examples: The instant specification provides experimental results on the film forming ability on 3D reconstructed esophageal epithelium (instant specification page 29) and show Lucifer Yellow (LY) results that evaluate the tissue permeability of the compositions (instant specification page 32 and Figure 1). The results showed that the compositions could form a film and did not permeate the tissues beyond baseline. However, there are no working examples that show results that the recited composition is effective at preventing GERD, laryngopharyngeal reflux disease (LPR), lesions or ulcers in the mucosa or tissues of the oral cavity, lesions or ulcers in the mucosa or tissues of the pharyngolaryngeal tract, lesions or ulcers in the mucosa or tissues of the oesophageal tract, oesophageal ulcers, deepithelialization of the oesophageal mucosa, peptic ulcers, gastric ulcers, mucositis, aphthous, aphthoid lesions, acute or chronic inflammations of the mucous membrane or tissues of the oral cavity, acute or chronic inflammations of the mucous membrane or tissues of the pharyngolaryngeal tract, acute or chronic inflammations of the mucous membrane or tissues of the oesophageal tract, oesophagitis or acute or chronic inflammation of the oesophageal mucosa, acid regurgitation, heartburn, feeling of gastric fullness, epigastric pain, dyspepsia, nausea, chronic cough, bronchospasm, inflamed throat, laryngitis, globus sensation or hypopharyngeal bolus, pyrosis, dysphonia, nasopharyngeal inflammation, laryngospasm, raucousness, excessive throat clearing, throat pain or burning, postnasal drip, pharyngitis and/or other symptoms of the upper respiratory tract in a patient with the full scope of the claim.
State of the prior art/Predictability or unpredictability of the art: Jaroz et al. (the Prz Gastroenterol, published 10/19/2014, pages 297–301) is drawn to the study of the risk factors for gastroesophageal reflux disease (GERD) and the role of diet (title).GERD is a chronic gastrointestinal disease that significantly reduces quality of life and, in some patients, leads to serious complications, such as oesophageal stricture, gastrointestinal bleeding, or Barrett’s oesophagus. The typical symptoms of this disease are heartburn, discomfort in the upper abdomen, and acid eructation (abstract). Jaroz teaches that GERD symptoms are experienced up to weekly by 10-30% of the adult population in Western countries and that there are many factors that can contribute to the development of the disease, including lifestyle and nutrition, but relevant studies often provide contradictory results (abstract).
Vaezi et al. (Clinical Gastroenterology and Hepatology, published 09/2003, see PTO-892) is drawn to the study of the cause and effect association between laryngeal signs and symptoms and GERD (title). Vaezi teaches that GERD causes laryngeal signs and symptoms and that GERD is a significant causative agent in the development of contact ulcers of the larynx. GERD causes hoarseness, chronic cough, globus sensation (page 332).
Quantity of experimentation: One of ordinary skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of the claimed compositions to both healthy individuals and individuals with GERD laryngopharyngeal reflux disease (LPR), lesions or ulcers in the mucosa or tissues of the oral cavity, lesions or ulcers in the mucosa or tissues of the pharyngolaryngeal tract, lesions or ulcers in the mucosa or tissues of the oesophageal tract, oesophageal ulcers, deepithelialization of the oesophageal mucosa, peptic ulcers, gastric ulcers, mucositis, aphthous, aphthoid lesions, acute or chronic inflammations of the mucous membrane or tissues of the oral cavity, acute or chronic inflammations of the mucous membrane or tissues of the pharyngolaryngeal tract, acute or chronic inflammations of the mucous membrane or tissues of the oesophageal tract, oesophagitis or acute or chronic inflammation of the oesophageal mucosa, acid regurgitation, heartburn, feeling of gastric fullness, epigastric pain, dyspepsia, nausea, chronic cough, bronchospasm, inflamed throat, laryngitis, globus sensation or hypopharyngeal bolus, pyrosis, dysphonia, nasopharyngeal inflammation, laryngospasm, raucousness, excessive throat clearing, throat pain or burning, postnasal drip, pharyngitis and/or other symptoms of the upper respiratory tract to determine if the claimed compositions can be used in the fully claimed scope to treat and prevent GERD. Genetech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors as discussed above, e.g., the breadth of the claims, the amount of guidance provided, the state/unpredictability of the art and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Biffi (US 2019/0125665 Al, published 05/02/2019, see IDS dated 03/22/2023, hereinafter referred to as Biffi ‘665) and Biffi et al. (IT 201600101413 A1, published 04/10/2018, see PTO-890, hereinafter referred to as Biffi ‘413).
Biffi ‘665 is drawn to a chewable and/or melt-in-mouth tablet based on hyaluronic acid and chondroitin sulphate and/or salts thereof (abstract). Biffi ‘665 teaches a composition for oral use in the solid form of a chewable and/or suckable and/or melt-in-mouth tablet, comprising a mixture including: a hyaluronic acid, or a salt thereof, and a chondroitin, or a salt thereof and, optionally, a basic substance with antacid properties wherein the basic substance is a salt in the form of an oxide, a hydroxide, a carbonate, a bicarbonate, a silicate, a trisilicate, a sulphate or a citrate of a cation, the cation being an alkali metal cation, or an alkaline earth metal cation or a metal (III) cation; and, optionally, a proton pump inhibitor (PPI) compound selected from the group consisting of: omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole sodium, ilaprazole and tenatoprazole; and, optionally, at least one food or pharmaceutical grade excipient or additive. The composition is for use in the treatment of subjects with disorders or symptoms caused or provoked by gastroesophageal reflux (GERD), or in the treatment of subjects with extraesophageal disorders or symptoms caused by the upflow of gastric contents and/or gastric vapors from the stomach along the oral cavity (also known as refluxate, which comprises pepsin, acid and/or mildly acidic or non-acidic but irritating contents), or in the treatment of subjects with ulcers or lacerations provoked in the gastric mucosa (stomach lining), in the esophageal and laryngopharyngeal mucosa or the tissues lining the oral cavity, so as to protect the mucosa and the tissues of the various anatomical regions from the damage provoked
thereto (claim 1). The chondroitin, or a salt thereof, is chondroitin or a chondroitin sulphate or a chondroitin sulphate sodium (claim 7). The chondroitin may have an average molecular weight comprised from greater than about 1 kDa to less than about 1,000 kDa (claim 2). The composition may include a salt wherein said salt is aluminum hydroxide, magnesium hydroxide, magnesium trisilicate, or mixtures thereof (claim 11). Biffi ‘665 teaches that the hyaluronic acid may be in an amount compromised from 0.1 % by weight to 5% by weight, the antacid substance (i.e. aluminum hydroxide or magnesium trisilicate) is in an amount comprised from 10% by weight to 50% by weight, and the chondroitin is in an amount comprised from 20% by weight to 80% by weight, relative to the total weight of the mixture (claim 13). The hyaluronic acid may be in the form of sodium hyaluronate (paragraph 0038).
Biffi ‘665 does not teach that the chondroitin is of a plant origin or chondroitin sulfate of plant origin. Biffi ‘665 does not teach the composition in liquid form such as a water-based liquid or hydroalcoholic-based liquid to meet the limitation of claim 7. Biffi ‘665 does not teach that the composition may additionally comprise honey and an aloe vera gel.
Biffi ‘413 is drawn to liquid composition for use in the treatment of gastroesophageal reflux disease (abstract). The liquid composition may comprise aloevera gel, hyaluronic acid or a salt thereof, honey and a chondroitin salt such as chondroitin sulfate (claim 1 and claim 3). Biffi ‘413 teaches that the chondroitin sulfate may be derived from plant origin (page 5). Biffi ‘413 teaches that the composition may be in the form of a syrup and exemplifies the composition with a water base (page 7).
It would have been prima facie obvious to modify the teachings of Biffi ‘665 and Biffi ‘413 before the effective filing date of the claimed invention by substituting the plant derived chondroitin sulfate as taught by Biffi ‘413 for the animal derived chondroitin sulfate in the composition taught by Biffi ‘665 to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to substitute the plant derived chondroitin sulfate taught by Biffi ‘413 for the composition taught by Biffi ‘665 because Biffi ‘413 teaches a similar composition for the use of treating GERD and teaches that the chondroitin sulfate may be plant derived. One of ordinary skill in the art would have a reasonable expectation of success because Biffi ‘413 teaches a similar composition for the use of treating GERD and teaches that the chondroitin sulfate may be plant derived.
Regarding claims 6, 7, and 17, it would have been prima facie obvious to combine the teachings of Biffi ‘665 and Biffi ‘413 before the effective filing date of the claimed invention by modifying the composition taught by Biffi ‘665 to be in a liquid water-based syrup form and contain honey and aloe vera as taught by Biffi ‘413 to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to modify the composition containing hyaluronic acid, chondroitin and a basic substance for treating GERD as taught by Biffi ‘665 to be in a liquid water-based form and add aloe vera and honey because Biffi ‘413 teaches a similar composition for the use of treating GERD and teaches that composition in a liquid form with a water base and further comprising aloe vera and honey. One of ordinary skill in the art would have a reasonable expectation of success because Biffi ‘413 teaches a similar composition for the use of treating GERD and teaches that composition in a liquid form with a water base and further comprising aloe vera and honey.
Regarding claims 5, 8, 15, 16, 18, and 19 it would have been prima facie obvious to one of ordinary skill in the art to optimize the ratio of the hyaluronic acid, the basic substance, and the chondroitin as taught by Biffi ‘413 in the composition comprising a plant derived chondroitin as taught by Biffi ‘665 to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to optimize the ratio of the hyaluronic acid, basic substance and the chondroitin because Biffi ‘665 teaches that in the composition the hyaluronic acid may be in an amount compromised from 0.1 % by weight to 5% by weight, the antacid substance (i.e. aluminum hydroxide or magnesium trisilicate) is in an amount comprised from 10% by weight to 50% by weight, and the chondroitin is in an amount comprised from 20% by weight to 80% by weight, relative to the total weight of the mixture. 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). (MPEP § 2144.05(I)) Moreover, 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). (MPEP § 2144.05(II)) “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.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
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 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/246,222 (amended claim set filed 03/22/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and copending claims are directed to a composition and method for treating a subject with GERD comprising an extract of at least one alga, wherein said at least one alga comprises or, alternatively, consists of an alga belonging to the species Ulva Lactuca (L.) and/or an alga belonging to the genus Fucus (L.), and - a hyaluronic acid or a salt thereof and wherein said composition further comprises at least one food or pharmaceutical grade additive and/or excipient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693