DETAILED ACTION
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 .
Claim Status
Claims 1-12 are pending and under current examination.
Drawings
The drawings are objected to because there is only one figure and the drawing refers to it as Figure 1. However, 37 CFR 1.84(u)(1) indicates when there is only one drawing, it must not be numbered and the abbreviation FIG must not appear. Therefore, the figure must be referred to as The Figure. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: paragraphs [0004] and [0013] of the specification refer to Figure 1 but should state The Figure as there is only one figure present.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3 and 7-12 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.
Claims 3 and 9 are indefinite because claims 3 and 9 recite a % (percent) without any units. It is therefore unclear what units are meant to be encompassed by the % claimed, rendering the metes and bounds of claims 3 and 9 indefinite.
Claim 7 recites “the composition of ions”. There is insufficient antecedent basis for this limitation in the claim because there is no earlier recitation of a composition of ions in claim 7. Therefore it is unclear if the composition of ions is referring to the recitation of “applying a composition” recited in line 2 or a different composition.
Claims 8-12 recites “the composition”. It is unclear if this is referring to the application of “a composition” or “the composition of ions”. Thus, there is insufficient antecedent basis for “the composition” in claims 8-12.
Claim Rejections - 35 USC §101
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 1-12 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to laws of nature and natural phenomena without significantly more.
The claims recite laws of nature and natural phenomena. These judicial exceptions are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP §2106:
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Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an
abstract idea?
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP §2106.05(a)
Applying the judicial exception with, or by use of, a particular machine. See MPEP §2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP §2106.05(c)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP §2106.05(d)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP §2106.05(e)
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1): The answer to this step is yes since claims 1-6 are directed to a composition of matter, and claims 8-12 are directed to methods (processes) for using the composition to treat a wound. Both are statutory categories.
Step (2A): The answer to this step is yes because the claimed compositions and methods of their use are directed to laws of nature and natural phenomena, specifically a composition comprising ions, and methods for treating skin with said composition.
Prong 1:
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
Claim Analysis
Independent claim 1 recites a composition of ions configured to increase speed of wound healing, wherein the composition of ions comprises a PDR. Per instant claim 2 the composition of ions is rubidium, calcium, zinc, and potassium.
The scope of the positively recited elements of the composition defines it in terms of naturally-occurring compounds, and as such the composition of ions is defined as comprising naturally-occurring compounds. Therefore, the instant claims recite a product of nature.
Claims 4-6 characterizes the properties of the claimed composition for faster wound healing. Claim 7 requires the method of treating a wound by applying the composition of ions.
There is no evidence within the specification that the compositions or the methods of treatment recited in claims 1-12 contain markedly different characteristics from their naturally-occurring counterparts.
Therefore, the answer to step 2A prong 1 is yes.
Prong 2:
The Prong Two analysis considers the given claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application.
Here, the instant claims do not introduce any additional limitations which transform or improve on the judicial exceptions recited in claims 1-12.
Therefore, the answer to step 2A prong 2 is no.
Step (2B):
Claims 1-12 do not recite any additional elements which require analysis under step 2B.
At most, the claims require a composition what comprises ions and such composition can be used to treat a wound.
The instant claims read on bathing in ocean seawater. According to Mineral Makeup of Seawater, seawater contains calcium, rubidium, zinc and potassium ions. Seawater has a natural mineral makeup of rubidium (0.2ppm), calcium (400ppm), zinc (0.014ppm) and potassium (380ppm), see Mineral Makeup of Seawater, page 1. Ocean water has been touted as a cure for all skin problems due to the many minerals in the water that can benefit skin, see Jillian Wilson, page 2. Laubscher further teaches that sea water has benefits including helping to heal wounds, prevent infections and ease pain, see page 2.
The state of the art recognizes that sea water can impart healing properties due to its minerals.
Therefore, compositions comprising the instantly claimed naturally occurring ingredients, and their methods of use as pharmaceutical compositions, are well-understood as possessing routine, and conventional activity.
Therefore, the answer to step (2B) is no.
Conclusion
Claims 1-12 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. §101.
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.
Claim(s) 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Powers (United States Patent 9351995).
Claim 1 is to a composition of ions configured to increase the speed of wound healing, wherein the composition of ions comprises a protease down regulator (PDR). The instant specification refers to the combination of specific ions of rubidium calcium, zinc, and potassium as a protease down regulator PDR, see paragraph [0006].
Claim 2 recites that the composition comprises rubidium calcium, zinc, and potassium.
Powers teaches a composition comprising:
a therapeutically effective amount of potassium ions;
a therapeutically effective amount of rubidium ions;
a therapeutically effective amount of calcium ions;
a therapeutically effective amount of zinc ions;
a therapeutically effective amount of magnesium ions;
a therapeutically effective amount of bromide ions;
a therapeutically effective amount of counterions wherein the counterions are selected from the group consisting of citrate, chloride, bromide, sulfate, hydroxide, bicarbonate, carbonate, phosphate, lactate, glutamate, acetate and combinations thereof; and a pharmaceutically acceptable carrier, see claims 1-8. The amount of potassium ions is between about 0.02% to about 3.0% (w/v), see claim 3. The amount of rubidium ions is between about 0.0001% to about 4.0% (w/v), see claim 4. The amount of calcium ions is between about 0.0000055 to about 1.3% (w/v). The amount of zinc ions is between about 0.0000057% to about 2.12% (w/v). The composition results in no edema so is configured to reduce edema, see Table 4. The composition enhances wound healing, see claims 17-29. The composition can be applied topically, see example 3, examples 4-5 and column 12, lines 16-21. Powers teaches a method for enhancing wound healing by administering a composition comprising rubidium, calcium, zinc and Potassium. Administration of Solution 2 increased wound healing, see Table 10 and Example 2. Solution 2 contains between about 0.02-3.0% (w/v) of K+; from between about 0.0001-4.0% (w/v) of Rb+; from between about 0.000005-1.3% (w/v) of Ca2+; and from between about 0.0000057-2.12% (w/v) of Zn2+. A beneficial amount of K+ is about 0.924% (w/v). A beneficial amount of Rb+ is about 0.007068% (w/v). A beneficial amount of Ca2+ is about 0.0002568% (w/v). A beneficial amount of Zn2+ is about 0.0000554% (w/v). Solution 2 may also contain citrate (C6H5O7 3) in a range from between about 0.03-4.7% (w/v). A beneficial amount of C6H5O7 3− is about 1.57% (w/v). Solution 2 may also contain citric acid (C6H5O7) in a range from between about 0.01-0.1% (w/v). Solution 2 may be administered at least once per day. The composition reduces inflammation, see column 6, lines 16-35 and column 11, line 43.
Regarding instant claims 4-5, that the composition regulates an ability to heal the wound faster by increasing epithelization and granulation or reduces edema, inflammation and exudate accumulation, from MPEP 2112.01, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
From MPEP 2112.02, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). Here, claims 10-11 merely recite results of using the ions on the wound.
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9-11 and 20 of copending Application No. 18/123226 (reference application) in view of Powers (United States Patent 9351995).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of ‘226 recite a composition comprising rubidium, calcium and potassium.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The difference between the instant claims and that of Application ‘226 is the recitation of zinc and the amount of the ions present and topical application as Application ‘226 is nasal application.
However, Powers teaches a composition comprising: a therapeutically effective amount of potassium ions; a therapeutically effective amount of rubidium ions; a therapeutically effective amount of calcium ions; a therapeutically effective amount of zinc ions; a therapeutically effective amount of magnesium ions; a therapeutically effective amount of bromide ions; a therapeutically effective amount of counterions wherein the counterions are selected from the group consisting of citrate, chloride, bromide, sulfate, hydroxide, bicarbonate, carbonate, phosphate, lactate, glutamate, acetate and combinations thereof; and a pharmaceutically acceptable carrier. The amount of potassium ions is between about 0.02% to about 3.0% (w/v), see claim 3. The amount of rubidium ions is between about 0.0001% to about 4.0% (w/v), see claim 4. The amount of calcium ions is between about 0.0000055 to about 1.3% (w/v). The amount of zinc ions is between about 0.0000057% to about 2.12% (w/v). The composition results in no edema so is configured to reduce edema, see Table 4. The composition enhances wound healing, see claims 17-29. The composition can be applied topically, see example 3, examples 4-5 and column 12, lines 16-21. Powers teaches a method for enhancing wound healing by administering a composition comprising rubidium, calcium, zinc and Potassium. Administration of Solution 2 increased wound healing, see Table 10 and Example 2. Solution 2 contains between about 0.02-3.0% (w/v) of K+; from between about 0.0001-4.0% (w/v) of Rb+; from between about 0.000005-1.3% (w/v) of Ca2+; and from between about 0.0000057-2.12% (w/v) of Zn2+. A beneficial amount of K+ is about 0.924% (w/v). A beneficial amount of Rb+ is about 0.007068% (w/v). A beneficial amount of Ca2+ is about 0.0002568% (w/v). A beneficial amount of Zn2+ is about 0.0000554% (w/v). Solution 2 may also contain citrate (C6H5O7 3) in a range from between about 0.03-4.7% (w/v). A beneficial amount of C6H5O7 3− is about 1.57% (w/v). Solution 2 may also contain citric acid (C6H5O7) in a range from between about 0.01-0.1% (w/v). Solution 2 may be administered at least once per day. The composition reduces inflammation, see column 6, lines 16-35 and column 11, line 43. Such compositions can be administered either topically or nasally.
It would have been obvious to provide the ions of claim 20 in Application ‘226 with zinc and to provide the ions in amounts suggested by Powers because Powers teaches that such compositions of ions can be used nasally or topically to enhance wound healing.
Conclusion
Currently, claims 1-12 are rejected and no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619