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
Claims 1-17 are pending and are under consideration in the instant office action
Priority
This application claims benefit of U.S. Provisional Application No. 62/844398 filed on 05/07/2019.
Notice to Applicant
An examination of this application reveals that applicant is unfamiliar with patent prosecution procedure. While an applicant may prosecute the application (except that a juristic entity must be represented by a patent practitioner, 37 C.F.R. §1.31), lack of skill in this field usually acts as a liability in affording the maximum protection for the invention disclosed. Applicant is advised to secure the services of a registered patent attorney or agent to prosecute the application, since the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting an attorney or agent.
A listing of registered patent attorneys and agents is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent attorneys and agents located in their area by writing to the Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Applicant is advised that patent prosecution procedure is governed by the guidance provided in the Manual of Patent Examining Procedure ("MPEP"), which may be accessed online without cost at https://www.uspto.gov/web/offices/pac/mpep/index.html. Applicant is specifically requested to note the guidance provided in Chapters 600 and 2100 of the MPEP, as well as Appendix L (Patent Laws, 35 U.S.C.) and Appendix R (Patent Rules, 37 C.F.R.).
Apparent Use of Trademarks in the Specification
Applicant recites the term PERFOROMIST in the as-filed specification (p.11, para.[0008]), which is a trade name or mark used in commerce as registered under the Live Trademark Registration No.
3352756. The term should be accompanied by the generic terminology, and also should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™ SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required.
Objections to the Claims
Claim 1 is objected to for reciting “[t]he method of use sufficient optic pure R-enantiomer B2 agonists”, which is grammatically awkward. Appropriate correction is required.
Claim 1 is objected to for reciting the phrase “pharmaceutical acceptable salts”, which is grammatically awkward. Appropriate correction is required.
Claim 1 is objected to for reciting the phrase “for treatments of”, which is grammatically awkward. Appropriate correction is required.
Claims 4-8 are objected to for reciting the phrase “Claim1” instead of ---Claim 1---. Appropriate correction is required.
Claim 7 is objected to for improperly capitalizing the term “indacaterol’ at I.3 of the claim. Appropriate correction is required.
Claim 7 is objected to for improperly spelling ”arformoterol” instead of formoterol at 1.3 of the claim. Appropriate correction is required.
Claim 8 is objected to for failing to recite a space between “or” and “metaproterenol’ at 1.3 of the claim. Appropriate correction is required.
Claim 6 is objected to for improperly capitalizing the term “olodaterol’ at 1.5 of the claim. Appropriate correction is required.
Claim 8 is objected to for failing to conclude with a period. Appropriate correction is required.
Claims 9-17 are objected to for improperly reciting a comma following the term “wherein”. Appropriate correction is required.
Claims 13-15 are objected to for reciting “characterized by increasing”, which is grammatically awkward. Appropriate correction is required.
Claim 13 is objected to for failing to define the acronyms “ROS” at their first occurrence in the claims. Appropriate correction is required.
Claim 14 is objected to for failing to define the acronyms “NF-κB” and “MARK” at their first occurrence in the claims. Appropriate correction is required.
Claim 15 is objected to for misspelling the term “lyophilized” as “lyophilizes” at 1.2 of the claim. Appropriate correction is required.
Claim 15 is objected to for misspelling the term “topical” as “topic” in the phrase “ointments or patches for topic use” at 1.2-3 of the claim. Appropriate correction is required.
Claim 17 is objected to for failing to recite a space between “bromide” and “methyl sulphate’ at 1.3 of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 101 — Non-Statutory Subject Matter
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 1-17 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 an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. §101. See, for example, Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F.Supp. 131, 149 USPQ 475 (D.D.C. 1966). Also, MPEP §2173.05(q).
For the purposes of examination, instant claims 1-17 will be interpreted as being directed to a product which is a medicament comprising R-enantiomers of β2-agonists, (since the claims fail to define any positively recited, active steps that would properly define a process claim within the meaning of 35 U.S.C. §101), and the recited limitations directed to any manner of “use” of the product will be interpreted as an intended use of the product per se. Under no circumstances, however, should the rejections set forth in the instant Office Action be construed as having examined the claims as a method of use (or, for that matter, anything other than a product per se).
Claim Rejections - 35 USC § 112(b) (Pre-AIA Second Paragraph)
The following is a quotation of 35 U.S.C. 112(b):
(o) 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-AlA), 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 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), 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-AlA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, Applicant provides for “[t]he method of use” of optically pure R-enantiomer β2 agonists and its pharmaceutically acceptable salts “as immune-modulators in manufacture of pharmaceutical medicaments or treatments of sepsis and sepsis induced multiple organ failure and related syndromes”, but since the claim does not set forth any active steps to define the recited “method of use’, it is unclear what implied method or process Applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is practiced. MPEP §2173.05(q). Clarification is required. As claims 2-31 do not remedy this point of ambiguity in claim 1, they must also be rejected.
For the purposes of examination, instant claims 1-17 will be interpreted as being directed to a product (since the claims fail to define any positively recited, active steps that would properly define a process claim within the meaning of 35 U.S.C. §101), and the recited limitations directed to the manner of “use” of the composition will be interpreted as defining an intended use of the composition per se. Under no circumstances, however, should the rejections set forth in the instant Office Action be construed as having examined the claims as a method of use (or, for that matter, anything other than a product per se).
In claim 8, Applicant recites that the R-enantiomer B2 agonist is the long-acting B2 agonist “Perforomist”. PERFOROMIST appears to be a trade name registered with the USPTO under the live Registration No. 3352756 to the owner Mylan Specialty L.P. Dey, Inc. and is described within the registration as “[p]harmaceutical preparations, namely preparations and formulations for the treatment of respiratory disorders, asthma, allergies and allergic emergencies”. MPEP §2173.05(u) states, “It is important to recognize that a trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus a trademark or trade name does not identify or describe the goods associated with the trademark or trade name ... If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. In fact, the value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to identify or describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name.” The use of PERFOROMIST in the claim renders the claim indefinite because it only identifies the source of the product and does not clearly and particularly describe the actual product. A trademark cannot be used to properly identify a product and Applicant’s failure to deliberately identify the product to be employed renders the metes and bounds of the claim indefinite. Moreover, Applicant’s use of the trademark PERFOROMIST in this manner devalues the trademark as clearly explained in MPEP §2173.05(u). Clarification is required.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), 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-AlA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, the phrase “sufficient optic pure R-enantiomer B2 agonists and its pharmaceutically acceptable salts” renders the claim indefinite because it is unclear whether the term “optic pure” refers to “optical purity” or something else. Also, it is unclear for what the R-enantiomer β2 agonists are “sufficient”, as it is unclear if this “sufficiency” refers to a requisite degree of optical purity (in which case the claim is additionally indefinite for failing to clearly set forth what the requisite degree is) or suitability for some other unidentified effect. Clarification is required.
In claim 1, the limitation “R-enantiomer β2 agonists and its pharmaceutical acceptable salts” renders the claim indefinite because it is unclear if the claim requires (i) more than one R-enantiomer B2 agonists and more than one pharmaceutically acceptable salts thereof, (ii) more than one R-enantiomer β2 agonists, or more than one pharmaceutically acceptable salts thereof, (ili) an R-enantiomer β2 agonist and a pharmaceutically acceptable salt thereof, or (iv) an R-enantiomer β2 agonist, or a pharmaceutically acceptable salt thereof. Clarification is required.
In claim 7, Applicant recites that the “β2 agonists’ is “terbutaline, salbutamol, bambuterol, vilanterol, clenterol, salmeterol, formoterol, trantinterol and [i]ndacaterol”, which renders the claim indefinite because it is unclear if all the recited agonists are required, or only at least one from the recited list. Clarification is required.
In claim 8, Applicant recites the conjunction “and” between the recited lists of short-acting β2 agonists, long-acting β2 agonists, and ultra-long-acting β2 agonists, which renders the claim indefinite because it is unclear if Applicant requires (i) at least one short-acting β2 agonist, at least one long-acting β2 agonist, and at least one ultra-long-acting β2 agonist, or (i) at least oneβ2 agonist from the recited lists of short-acting β2 agonists, long-acting β2 agonists, or ultra-long-acting β2 agonists. Clarification is required.
For these reasons, the claims fail to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AlA second paragraph) and are, thus, properly rejected.
For the purposes of examination, Applicant’s claimed product of claim 1 will be interpreted as providing for an R-enantiomer β2 agonist, or a pharmaceutically acceptable salt thereof, for the intended use as recited therein. Dependent claims defining further physical and/or structural limitations of this product will be interpreted as further defining this product of claim 1.
Claim Rejections - 35 USC § 112(d) (Pre-AIA Fourth Paragraph)
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 9-14 are rejected under 35 U.S.C. 112(d) or pre-AlA 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.
In claims 2-4 and 9-14, Applicant defines limitations relevant to the intended use of the claimed product of an R-enantiomer β2 agonist (or a pharmaceutically acceptable salt thereof), which fails to properly further limit the product of claim 1 from which such claims ultimately depend, as they fail to introduce any additional physical and/or structural limitations to the product already defined in claim 1. As the limitations of claims 9-14 seeks to define the intended use of the product, rather than any specific feature of the product itself, such claims fail to constitute a proper further limitation of the subject matter claimed within the meaning of 35 U.S.C. §112(d) (pre-AlA fourth paragraph). Clarification is required.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abert et al. (US 2008/0161411)
Instant claims 1-17 are drawn to the pharmaceutical medicaments comprising (R)-enantiomers of β2 agonists for treatments of sepsis and sepsis induced multiple organ failure and related syndromes.
Aberg et al. discloses composition comprising pure (R,R) isomer of formoterol or the pharmaceutically acceptable salt of the same as a bronchodialator, which uses the highly potent β-adreneregic effects of the (R,R) isomer of formoterol, while substantially limiting the advers effects (abstract, [0047] [0049]). They disclose their composition to have at leasdt 99% by weigh of the (R,R) formoterol and less than 1% by weight of the (S,S) formoterol [0059-0060]. The disclose dosage forms to include tablets, troches, dispersions, suspensions, solutions, capsules and patches and routes of administration including oral, parenteral, transdermal inhalation [0068] [0071] . They further disclose that the pharmaceutically acceptable salts of their (R,R) formoterol to include fumaric hydrobromic, hydrochloric, isethionic, lactic, malefic, malic, mandelic, methanesulfonic, mucic, nitric, pamoic, pantothenic, phosphoric, succinic, tartaric, p-toluenesulfonic, sulfuric etc. [0069].
Applicant’s limitations of claims 2-4 and 9-14, define an intended use of the product recited in claim 1 —in this case, a product of R-enantiomer or β2 agonist or a pharmaceutically acceptable salt thereof. A recitation of an intended use of the claimed product must result in a structural difference between the claimed invention and the prior art to patentably distinguish the claimed invention from the prior art’.
In the instant application, Applicant’s recited intended use does not impart any physical or material characteristics to the claimed product that are not already present in the prior art of Aberg et al. As a result, the statements of intended use as recited in claims 2-4 and 9-14 do not patentably distinguish the claimed product from the prior art product. Moreover, the prior art product of Aberg et al. must be capable of being used in the same manner as that instantly claimed because products of identical chemical composition must be capable of being used in the same manner. MPEP §2112.
Therefore, instant claims 1-17 are properly anticipated by Aberg et al. under AIA 35 U.S.C. §102(a}(1).
Claims 1-7 and 9-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheng et al. (WO 2004/014290 A2: 2004).
Instant claims are as recited above.
Cheng et al. teaches optically pure (R)-bambuterol and salts thereof (p.3, para.2-4; p.20, claim 1). Cheng et al. teaches that there is at least 80% by weight (R)-enantiomer and not more than 20% by weight (S)-enantiomer, or at least 98.5% by weight (R)-enantiomer and not more than 1.5% by weight (S)- enantiomer (p.20, claims 2-3). Cheng et al. describes optically pure (R)-bambuterol, in which there is at least 80% (R)- enantiomer and no more than 20% (S)-enantiomer (i.e., an enantiomeric excess of 60%,), or in which there is at least 98.5% (R)-enantiomer and no more than 1.5% (S)- enantiomer (i.e., an enantiomeric excess of 97%,). They disclose Pharmaceutical preparation comprising R-Bambuterol is administered orally, by injection or by inhalation ( claim 20, page 7. Last para). They discloses suitable salts of the compound to include sulfates, hydrochlorides ,mesylates, fumarates, tartrates, citrates, maleates, succinates and benzoates (page 7, 4th para).
Applicant’s limitations of claims 2-4 and 9-14, define an intended use of the product recited in claim 1 —in this case, a product of R-enantiomer or β2 agonist or a pharmaceutically acceptable salt thereof. A recitation of an intended use of the claimed product must result in a structural difference between the claimed invention and the prior art to patentably distinguish the claimed invention from the prior art’.
In the instant application, Applicant’s recited intended use does not impart any physical or material characteristics to the claimed product that are not already present in the prior art of Cheng et al. As a result, the statements of intended use as recited in claims 2-4 and 9-14 do not patentably distinguish the claimed product from the prior art product. Moreover, the prior art product of Cheng et al. must be capable of being used in the same manner as that instantly claimed because products of identical chemical composition must be capable of being used in the same manner. MPEP §2112.
Therefore, instant claims 1-7 and 9-17 are properly anticipated by Cheng et al. under AIA 35 U.S.C. §102(a}(1).
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morley (US 2004/0192783)
Instant claims are as recited above.
Morley discloses an inhalable terbutaline composition comprising greater than 98% R-terbutaline and a pharmaceutically acceptable carrier (claim 15) and its use in the treatment of inflammatory or obstructive airway disease while avoiding side effects associated with the administration of racemic terbutaline (claim 11) . They also disclose that the selective β2 sympathomimetic bronchodilator drugs of group 1.3 include a) TERBUTALINE, b) ALBUTEROL (also known as SALBUTAMOL), c) FENOTEROL, d) HEXOPRENALINE, e) RIMITEROL, f) ISOETHARINE, g) METAPROTERENOL, h) REPROTEROL, i) CLENBUTEROL, j) PROCATEROL, k) CARBUTEROL, l) TULOBUTEROL, m) PIRBUTEROL, n) BITOLTEROL and, more recently, the so-called "long acting selective .beta..sub.2 sympathomimetic bronchodilator drug substances" o) FORMOTEROL, p) BAMBUTEROL and q) SALMETEROL [(R,S)-1-(4-hydroxy-3-hydroxymethylphenyl)-2- -[6-(4-phenylbutoxy)hexylamino]ethanol] as free base or in the pharmaceutically acceptable salt form, e.g. as the sulphate , hydrobromide, hydrochloride, dihydrochloride, fumarate , methanesulfonate or hydroxynaphthoate [0013]. They also disclose that In the case of GROUP 1.3 DRUGS having a single asymmetric carbon atom BRONCHODILATOR ENANTIOMER will thus be the (R) enantiomer and in the case of GROUP 1.3 DRUGS having two asymmetric carbon atoms BRONCHODILATOR ENANTIOMER will thus usually be the (R,R) enantiomer which is atleast greater than 98% pure.[0044-0045].
Applicant’s limitations of claims 2-4 and 9-14, define an intended use of the product recited in claim 1 —in this case, a product of R-enantiomer or β2 agonist or a pharmaceutically acceptable salt thereof. A recitation of an intended use of the claimed product must result in a structural difference between the claimed invention and the prior art to patentably distinguish the claimed invention from the prior art’.
In the instant application, Applicant’s recited intended use does not impart any physical or material characteristics to the claimed product that are not already present in the prior art of Morley. As a result, the statements of intended use as recited in claims 2-4 and 9-14 do not patentably distinguish the claimed product from the prior art product. Moreover, the prior art product of Morley et al. must be capable of being used in the same manner as that instantly claimed because products of identical chemical composition must be capable of being used in the same manner. MPEP §2112.
Therefore, instant claims 1-17 are properly anticipated by Morley under AIA 35 U.S.C. §102(a}(1).
Conclusion
Claims 1-17 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691