DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-6, 8-12 and 14-22 are pending in the instant invention. According to the Amendments to the Claims, filed May 28, 2026, claims 7, 13 and 23-89 were cancelled.
Status of Priority
This invention claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/494,039, filed April 4, 2023.
Restrictions / Election of Species
The inventor’s or joint inventor’s provisional election of the following, with traverse, in the reply filed on May 28, 2026, is acknowledged: a) Group I - claims 1-6, 8-12 and 14-22; and b) pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water - p. 29, Table 1, Formulation MG1, hereafter referred to as pharmaceutical composition comprising (a) cetyltrimethyl-ammonium chloride (CTAC) surfactant; (b) N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent; (c) a pH modifier; and (d) the solvent, water. Claims 1, 2, 5, 6, 8-12 and 18-22 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the traversal is on the grounds that searching the full scope of the claims would not impose an undue burden on the Office. This is not found persuasive because the multiple inventions in the instant invention are independent or distinct for the reasons disclosed in the Requirement for Restriction / Election of Species, mailed on April 10, 2026.
Likewise, the inventor or joint inventor should further note that there would be a serious burden on the examiner if restriction was not required because the inventions have acquired a separate status in the art due to their divergent subject matter and would require a different field of search.
Next, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Moreover, the inventor or joint inventor should further note that the elected species was found to be free of the prior art. Thus, the examiner has expanded the forthcoming prosecution to include all claims relevant to the genus of Group I, for a first Office action and prosecution on the merits.
Thus, a first Office action and prosecution on the merits of claims 1-6, 8-12 and 14-22 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying the pharmaceutical compositions comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively.
The following title is suggested: BIODEGRADABLE ANTI-INFECTIVE FORMULATIONS COMPRISING A CETYLTRIMETHYLAMMONIUM HALIDE SURFACTANT AND AN N,N-CICARBOXYMETHYL GLUTAMIC ACID (GLDA) CHELATING AGENT.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision, to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), and attain compliance with the Requirement for Restriction/Election of Species, mailed on April 10, 2026, the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising:
(a) a cationic cetyltrimethylammonium (CTA) halide surfactant of the following formula:
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wherein:
X is F, Cl, Br, or I;
(b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent of the following formula:
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or a pharmaceutically acceptable salt thereof;
(c) a pH modifier comprising:
(i) an acid selected from the group consisting of acetic acid, trichloroacetic acid, adipic acid, benzoic acid, butyric acid, caproic acid, citric acid, formic acid, fumaric acid, gluconic acid, glutaric acid, hydrobromic acid, hydrochloric acid, hydroxyacetic (glycolic) acid, itaconic acid, lactic acid, maleic acid, malic acid, malonic acid, nitric acid, oxalic acid, propionic acid, succinic acid, sulfamic acid, methylsulfamic acid, sulfuric acid, tartaric acid, terephthalic acid, urea hydrochloride, and valeric acid, or a mixture thereof; or
(ii) a base selected from the group consisting of an amine, ammonia, ammonium hydroxide, a borate, a carbonate, a hydroxide, and a silicate, or a mixture thereof; and
(d) the solvent, water.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the cationic cetyltrimethylammonium (CTA) halide surfactant is cetyltrimethylammonium chloride (CTAC).
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the cationic cetyltrimethylammonium (CTA) halide surfactant is cetyltrimethylammonium bromide (CTAB).
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the cationic cetyltrimethylammonium (CTA) halide surfactant is cetyltrimethylammonium iodide (CTAI).
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the GLDA chelating agent, or a pharmaceutically acceptable salt thereof, is N,N-dicarboxymethyl glutamic acid (GLDA) tetrasodium salt.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the cationic cetyltrimethylammonium (CTA) halide surfactant at a concentration in the range of from 0.2 mM to 50 mM.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the cationic cetyltrimethylammonium (CTA) halide surfactant at a concentration of 2 mM.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the cationic cetyltrimethylammonium (CTA) halide surfactant at a concentration of 3 mM.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the GLDA chelating agent, or a pharmaceutically acceptable salt thereof, at a concentration in the range of from 1 mM to 200 mM.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the GLDA chelating agent, or a pharmaceutically acceptable salt thereof, at a concentration of 20 mM.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the GLDA chelating agent, or a pharmaceutically acceptable salt thereof, at a concentration of 26 mM.
Appropriate correction is required. See MPEP § 2173.02.
Claim 14 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises a pH modifier comprising acetic acid.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the pH modifier at a concentration in the range of from 1 mM to 150 mM.
Appropriate correction is required. See MPEP § 2173.02.
Claim 16 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the pH modifier at a concentration of 10 mM.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the pH modifier at a concentration of 15.6 mM.
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), 35 U.S.C. § 112(d), and/or attain compliance with the Requirement for Restriction/Election of Species, mailed on April 10, 2026, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises the solvent, water, in an amount in the range of from 96 wt% to 98.9 wt%.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 1-6, 8-12 and 15-22 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, pH modifier, in claim 1, with is a relative phrase which renders the claim indefinite. The phrase, pH modifier, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification, on page 11, uses open language, such as non-limiting examples, to define the phrase, pH modifier, as hydroxyacetic (glycolic) acid, etc.; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the phrase, pH modifier.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 6 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 8 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 9 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 10 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 11 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 12 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 15 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 16 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 17 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 18 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 19 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, substantially, is a relative term which renders the claim indefinite. The term, substantially, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, substantially. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, substantially. {See In re Nehrenberg, 280 F.2d 161, 126 USPQ 383 (CCPA 1960); In re Mattison, 509 F.2d 563, 184 USPQ484 (CCPA 1975); Andrew Corp. v. Gabriel Electronics, 847 F.2d 819, 6 USPQ2d 2010 (Fed. Cir.1988); and MPEP § 2173.05(b)}.
The examiner suggests amending or cancelling the claim, to overcome this rejection.
Claim 20 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, substantially, is a relative term which renders the claim indefinite. The term, substantially, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, substantially. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, substantially. {See In re Nehrenberg, 280 F.2d 161, 126 USPQ 383 (CCPA 1960); In re Mattison, 509 F.2d 563, 184 USPQ484 (CCPA 1975); Andrew Corp. v. Gabriel Electronics, 847 F.2d 819, 6 USPQ2d 2010 (Fed. Cir.1988); and MPEP § 2173.05(b)}.
The examiner suggests amending or cancelling the claim, to overcome this rejection.
Claim 21 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, substantially, is a relative term which renders the claim indefinite. The term, substantially, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, substantially. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, has been rendered indefinite by the use of the term, substantially. {See In re Nehrenberg, 280 F.2d 161, 126 USPQ 383 (CCPA 1960); In re Mattison, 509 F.2d 563, 184 USPQ484 (CCPA 1975); Andrew Corp. v. Gabriel Electronics, 847 F.2d 819, 6 USPQ2d 2010 (Fed. Cir.1988); and MPEP § 2173.05(b)}.
The examiner suggests amending or cancelling the claim, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 112(d)
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
(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.
Claim 19 is rejected under 35 U.S.C. § 112(d) 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.
The inventor or joint inventor should note that claim 19 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property for a pharmaceutical composition must result in a further structural limitation in the pharmaceutical composition, in order to be further limiting. In the instant dependent claim, the pharmaceutical composition comprising (a) a cationic cetyl-trimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, is substantially free of enzymes. Consequently, since the physicochemical property of the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, whereby the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water is substantially free of enzymes, fails to result in a further structural limitation to the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, and/or fails to include all the limitations of the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 20 is rejected under 35 U.S.C. § 112(d) 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.
The inventor or joint inventor should note that claim 20 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property for a pharmaceutical composition must result in a further structural limitation in the pharmaceutical composition, in order to be further limiting. In the instant dependent claim, the pharmaceutical composition comprising (a) a cationic cetyl-trimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, is substantially free of oxidant. Consequently, since the physicochemical property of the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, whereby the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water is substantially free of oxidant, fails to result in a further structural limitation to the pharmaceutical composition comprising (a) a cationic cetyltrimethyl-ammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, and/or fails to include all the limitations of the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 21 is rejected under 35 U.S.C. § 112(d) 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.
The inventor or joint inventor should note that claim 21 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property for a pharmaceutical composition must result in a further structural limitation in the pharmaceutical composition, in order to be further limiting. In the instant dependent claim, the pharmaceutical composition comprising (a) a cationic cetyl-trimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, is substantially free of water soluble film forming polymers. Consequently, since the physicochemical property of the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, whereby the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water is substantially free of water soluble film forming polymers, fails to result in a further structural limitation to the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, and/or fails to include all the limitations of the pharmaceutical composition comprising (a) a cationic cetyltrimethylammonium halide surfactant; (b) an N,N-dicarboxymethyl glutamic acid (GLDA) chelating agent, or a pharmaceutically acceptable salt thereof; (c) a pH modifier; and (d) the solvent, water, respectively, as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights