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
Status of Claims
Claims 1-16 are pending.
Election/Restrictions
Applicants’ election of Group II and ambroxol hydrochloride as a species for one or more compounds belonging to 8-benzylamine structural class, in the reply filed on 7/13/2026 is acknowledged. The election was made without traverse.
Accordingly, claims 6-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Claims 1-5 are under examination in the instant office action.
Priority
The instant application is a continuation-in-part of U.S. Patent Application No. 17/402,419, filed August 13, 2021, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63/065,401, filed August 13, 2020, and U.S. Provisional Patent Application No. 63/076,936, filed September 11, 2020.
It is noted that U.S. Provisional Patent Application No. 63/065,401 fails to provide adequate support for “one or more compounds belong to benzylamine structural class” including AMB and BHH recited in the instant claims 1-5. Also, while U.S. Provisional Patent Application No. 63/076,936 discloses AMB and BHH, it fails to provide adequate support for the genus of “one or more compounds belong to benzylamine structural class” recited in the instant claims 1-2 and 5.
Accordingly, the instant claims 1-2 and 5 as whole are not entitled for the priority date of U.S. Provisional Patent Applications No. 63/065,401 and No. 63/076,936. The instant claims 3-4 as whole are not entitled for the priority date of U.S. Provisional Patent Applications No. 63/065,401. The earliest effective filing date has been determined to be August 13, 2021 for claims 1-2 and 5 and September 11, 2020 for claims 3-4.
Claim objections
Claim 3 is objected to because of the following informalities: A full name of “AMB”, “BHH” should be given in claim 3 for clarification and then use its acronym thereafter. Also, the recitation of “wherein the one or more compounds belong to the benzylamine structural class and” in line 102 should be deleted as it is already recited in claim 1 and thus redundant.
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.
Claim 1-5 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 pre-AIA the applicant regards as the invention. All dependent claims are included.
Claim 1 is indefinite because it fails to particularly point out to whom the claimed composition is administered. This rejection might be overcome by amending instant claim 1 to recite “to a subject in need of inhibiting or ameliorating a SARS-CoV-2 infection” after “administering” in line 2, provided there is support in the disclosure for such an amendment.
Also, the claim is indefinite because one of ordinary skill in the art could not reasonably determine the metes and bounds of “compounds belonging to 8-benzylamine structural class” as recited in claim 1. It is vague and ambiguous whether the genus of “compounds belonging to 8-benzylamine structural class” encompass any compounds as long as they have benzylamine regardless of the size and nature of additional structures/substituents attached to benzylamine. There is not a single definition or reasonable context or description that allows one to reasonably interpret this limitation in the specification. Thus, one of ordinary skill in the art would not be able to ascertain what compounds are encompassed by “claimed genus of compounds belonging to benzylamine structural class” and those that are not, as currently claimed.
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 1-2 and 5 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention.
This is a written description rejection, rather than an enablement rejection under 35 U.S.C. 112, first paragraph. Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). A review of the language of the claim indicates that the claim recites a generic genus, i.e., generic compounds belonging to benzylamine structural class.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(i), the court states, "An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
The recitation of generic compounds belonging to benzylamine structural class does not provide any information as to the rest parts of the compounds other than the core structure. Such recitation without further structural indication, (e.g., the number and nature of substituents/additional structures attached to benzylamine) can encompass numerous compounds having various substituents and additional functional groups, which vary in size and property and may not exhibit the desired properties. In particular, the specification discloses only two examples for those belonging to benzylamine structural class and the examples are limited to those having specific substituents. There are no examples having other substituents and additional structures. Thus, those examples do not adequately support the claimed genus because they are structurally very close to each other and there are substantial variations within the genus in terms of substitutions for the quinoline ring and additional structures attached to the benzylamine structure. Also, the broad variability in the structures of the genus will require distinct methods of making. However, the specification fails to describe how to make and how to use the remaining scope of the genus other than those specifically disclosed compounds. There is no information about how to make and how to use other compounds. Furthermore, Applicants do not describe the structural features of such genus that would possess the claimed activity.
In the absence of sufficient recitation of distinguishing structural characteristics, the specification does not provide adequate written description of the claimed genus. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0233488.
US 2023/0233488 discloses the use of the modulator of glucosylceramide degradation and pharmaceutical compositions containing the same in the treatment of viral infection such as SARS-CoV-2 infection wherein the modulator of glucosylceramide degradation is ambroxol (trans-4-(2-Amino-3,5-dibromobenzylamino) cyclohexanol hydrochloride) (abstract, [0025], [0026], and claims 24 and 30).
US 2023/0233488 further teaches that ambroxol is able to inhibit viral multiplication by inhibiting glucosylceramide degradation and that ambroxol has a concentration-dependent effect reducing SARS-CoV-2 viral load in A549 cells transfected with angiotensin converting enzyme 2 (ACE2) ([0027] and Example 1).
US 2023/0233488 also teaches the compositions may be in the dosage form of solid, semi-solid or liquid such as, e.g., tablets, pills, powders, capsules, gels, ointments, liquids, or suspensions and suitable liquid or solid pharmaceutical preparation forms are aqueous or saline solutions for inhalation, microencapsulated, encochleated, coated onto microscopic gold particles, contained in liposomes, nebulized, aerosols, or pellets ([0060] and [0071]).
As to claims 2 and 4, which recite intended results of administering the claimed compound, since the prior art teach the administration of the same compound (e.g., ambroxol hydrochloride) to the same patient (subject with SARS-CoV-2 infection), the claimed intended results necessarily occur, whether expressly recognized by prior art or not. It should be noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. Though mechanisms of action of chemical entities are not doubt important contributions to scientific and pharmaceutical development, the assessment of patentability under 35 U.S.C. 102/103 is based upon the therapeutic applications and therapeutic effects of the compounds, not the mechanism by which they exert such a therapeutic effect. Furthermore, it is generally well settled in the courts that a mechanistic property of a chemical compound, or combination of chemical compounds, when administered under identical conditions, is necessarily present, despite the fact that such a property may not have been readily apparent to, or recognized by, one of ordinary skill in the art. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Also see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
As such, the instant claims are anticipated by US 2023/0233488.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ID 2020SID01459 (its English translation cited).
ID 2020SID01459 teaches a formulation of ambroxol hydrochloride in liquid inhalation device for the treatment of respiratory disorders such as SARS and COVID-19 (abstract and p1, Para 1).
ID 2020SID01459 further teaches COVID-19 or coronavirus 2019 is an infectious disease caused by acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (p5, para 11).
ID 2020SID01459 also teaches that COVID-19 enters the body because it attaches to the lung receptors and ambroxol hydrochloride functions as a receptor blocker to prevent the COVID-19 virus from attaching to the respiratory tract (p5, last para-p6, para 1).
In addition, ID 2020SID01459 teaches a liquid formulation containing ambroxol hydrochloride with additional ingredients of propylene glycol, and vegetable glycerin which is applied to inhalation devices by producing aerosols to produce vapors that will enter the respiratory tract by blocking ACE2 receptors (Angiotensin Converting Enzyme) in the lungs, which can prevent the virus from entering the respiratory tract (p6, para 2).
As such, the instant claims are anticipated by ID 2020SID01459.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gissen (Peak Sciences Group (HK) Ltd., April 28, 2020).
Gissen teaches the use of ambroxol (ambroxol hydrochloride) for prevention and treatment of respiratory virus, including influenza viruses, rhinoviruses, coronavirus, and SARS-CoV-2 (abstract and p2, para 3-p2, para 1). Ambroxol has demonstrated properties that go beyond its potential ability to prevent infection by enhancing passive mucosal defenses, because it may also be able to directly interfere with the SARS-CoV-2 life-cycle as has been demonstrated with influenza A and rhinovirus (p2, para 1). Ambroxol (trans-4-(2-amino-3,5-dibromobenzylamino)-cyclohexanol hydrochloride, CAS 18683-91-5) is used as a mucolytic, mucokinetic, expectorant, and secretolytic drug (p2, para 1). Ambroxol has been studied and utilized in various forms including syrups, tablets, lozenges, time-release capsules, intravenous, and inhalable presentations (p2, para 1).
Gissen teaches and suggests that ambroxol or bromhexine are safe and effective for the prevention or treatment of SARS-CoV-2 infection and COVID-19 and Ambroxol may have the unique ability to be utilized as a prophylactic (prephylactic) to prevent infection by respiratory viruses, due to its well-balanced and favorable benefit-risk profile (p4, conclusion).
In addition, Gissen teaches that ambroxol lowered the production of inflammatory cytokines in the lung , corrected the imbalance of antioxidant protection and had a beneficial effect on the incidence of severe lung injuries (p3, last para-p4, para 1).
As to claims 2 and 4, which recite intended results of administering the claimed compound, since the prior art teach the administration of the same compound (e.g., ambroxol hydrochloride) to the same patient (patient with SARS-CoV-2 infection), the claimed intended results necessarily occur, whether expressly recognized by prior art or not. It should be noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. Though mechanisms of action of chemical entities are not doubt important contributions to scientific and pharmaceutical development, the assessment of patentability under 35 U.S.C. 102/103 is based upon the therapeutic applications and therapeutic effects of the compounds, not the mechanism by which they exert such a therapeutic effect. Furthermore, it is generally well settled in the courts that a mechanistic property of a chemical compound, or combination of chemical compounds, when administered under identical conditions, is necessarily present, despite the fact that such a property may not have been readily apparent to, or recognized by, one of ordinary skill in the art. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Also see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
As such, the instant claims are anticipated by Gissen.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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