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 1-20 are pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1 and 3-20, and the species of zinc salts, integration inhibitors, and glycerol in the reply filed on 3/27/2026 is acknowledged. The traversal is on the ground that Wei teaches polyhexamethylene guanidine hydrochloride rather than Poly-N1-hydrazino (imino) methyl-1,6-hexanediamine. This is not found persuasive because the method of claim 2 does not require M4, so this is not the shared technical feature between the groups.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2 and 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention (claim 2 is drawn to the method rather than the product) or species (claims 13-14 are drawn to the species of a protease inhibitor rather than the elected species of an integration inhibitor), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/27/2026.
Claims 1, 3-12, and 15-20 are examined herein.
Claim Objections
Claims 1, 5-8, 10-11, and 15-20 are objected to because of the following informalities:
In claim 1, there is no closing parenthesis for Poly-N1-hydrazino (imino) methyl-1,6-hexanediamine.
In claim 1, Sodium in lines 3 and 4 should not be capitalized.
In claim 5, commas are missing between zinc salts, glycerol, and sorbitol, as well as between salts of dihydrophosphates and salts of manganese.
Also in claim 5, “Oil” is unnecessarily capitalized.
In claim 7, “a fern, moss and, a green algae” has a misplaced comma. Also, in line 2 the word “of” should be removed from “of selected from the group.”
In claim 10, “ofM4” in line 1 should be “of M4” and “toincrease” should be two separate words.
In claim 15, there is space missing in “from0.001” (line 2).
In claims 15 and 17-20 there is an erroneous double comma after RNAse (from 0.1 μg/ml to 500.0 μg/ml).
In claims 5-6, 8, 10-11, 16-17, and 19, “10e5” should be corrected to 1×105, which is a more formal way of expressing scientific notation.
Appropriate correction is required.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See [0081], [0121], [0128], [0150], [0158]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure is objected to because of the following informalities: “Example 11. Bioactive effect of products on the vegetative In some embodiments plant” on page 24.
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 1, 3-12, and 15-20 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.
Claim 1 is indefinite for the preamble “A product to be used in agriculture veterinary, medicine including M4 (Poly-N1-hydrazino (imino) methyl-1,6-hexanediamine.” The placement of the comma leads to multiple reasonable interpretations of the claim. In one interpretation, the intended use of the product is agriculture or veterinary medicine and the product includes M4. In a second interpretation, the product is to be used in agriculture, veterinary sciences, or medicine that includes M4.
In claim 1, line 5, the slash separating integration and recombination makes it unclear whether the claim scope encompasses inhibitors of integration, inhibitors of recombination, or inhibitors of both integration and recombination. It is further unclear whether “inhibitors” applies to proteases, DNAse, RNAse, and VTL or only to reverse transcription and integration/ recombination.
In claim 1, the acronym VTL is not defined and there is no special definition provided in the specification. There is no plain and ordinary meaning for VTL.
In claim 1, it is unclear whether “having a bioactive effect and/or the ability to control the activity of cells and/or to act on the properties of cells and/or group of cells controlled by DNA and/or RNA receptors of cells to improve the properties of plants and/or animals and/or the properties of water and/or soil, as well as the prevention and/or treatment of diseases of plants, animals and humans” modifies VTL, compositions of the M4, or a product.
Claim 3 is indefinite for “fry forms,” which cannot be interpreted due to lack of definition in the specification or in the art, as well as for the limitation “including lightly crosslinked acrylic polymers, and/or lipophilic hydrocarbon, fatty, silicone and other components.” The person of ordinary skill in the art cannot determine the extent of “lightly crosslinked.” It is further unclear what “other components” are within the scope of the claim. In addition, “fatty” is an adjective without an accompanying noun. Claim 3 is further indefinite for requiring narrow limitations, “additionally including hydrophilic ointment bases including crosslinked acrylic polymers and/or lipophilic hydrocarbon,” and broad limitations “powders, solutions, gels, and/or emulsions, and/or ointments” within the same claim. It is unclear whether the product is required to include the hydrophilic ointment bases, the lightly crosslinked acrylic polymers, lipophilic hydrocarbon, fatty, silicone and other components.
Claim 4 is further indefinite for the parentheses surrounding each of the numerical ranges because it is unclear whether these limitations are part of the claimed invention. Claim 4 is also indefinite for the placement of “complex” because it is unclear whether “complex” modifies only DNAse or whether the word complex also modifies DNase, RNase, and the inhibitors. Claim 4 is also indefinite for the limitation of “integration/recombination inhibitors” since it is unclear whether the claim scope is integration inhibitors, recombination inhibitors, or integration and recombination inhibitors. Claim 4 is further indefinite for “intended for the prevention and treatment of animals and humans.” It is unclear what is being prevented.
Claim 5 is indefinite because there is no conjunction separating salts of manganese and glutamic acid salts (line bridging pages 2-3).
Claim 5 is also indefinite for “integration/ recombination.” It is unclear whether the claim scope is inhibitors of these processes because the claim only recites “integration/ recombination” and does not recite inhibitors except in relation to reverse transcription. If the claim scope is inhibitors of these processes, it is further unclear whether the claim scope is integration inhibitors, recombination inhibitors, or integration and recombination inhibitors.
Claim 5 recites the limitation "complexes of the above products" in lines 4-5 on page 3. There is insufficient antecedent basis for this limitation in the claim. Claim 5 recites a single product, which is M4.
Claim 5 is further indefinite for “which are used to increase the productivity of agricultural and/ and whether ornamental and/or forest and/or domestic plants and/or aquaculture are used for the regulation of the plants.” The significance of the “and/ and whether” is unclear and the sentence seems to combine two different limitations “increasing productivity of agricultural, ornamental, forest, and/or domestic plants and/or aquaculture” as well as “used for the regulation of the plants.” It is further unclear what “used for the regulation of the plants” is modifying: M4, compositions of M4, complexes, or aquaculture. The claim is further indefinite for the “non-limiting examples” because the person of ordinary skill in the art would have been unable to determine whether the claim scope is limited to the examples. The claim is further indefinite for the combination of “increasing and/or decreasing,” which encompasses both increasing and decreasing the duration of flowering at the same time. The claim is further indefinite for increasing “vigor” because this is a subjective term. The claim is further indefinite for “safety of crops in plants” which cannot be interpreted. Claim 5 is further indefinite for “more early and sprouting and fruiting” because it is unclear what is “more early.” Claim 5 also recites “increased/or altered” and the significance of the slash is unclear. “Fiber length modulate senescence” also renders the claim indefinite because this limitation can either be interpreted as the complex of M4 increases or alters fiber length or modulates senescence or the M4 increases or alters fiber length, which modulates senescence.
Claim 5 is indefinite for “increasing number of plants capable of growing in a given area ameliorates negative effects of hypoxia” because it is unclear whether these are separate limitations or whether increasing the number of plants is what ameliorates the negative effects of hypoxia.
Claim 5 is further indefinite for the parentheses surrounding each of the numerical ranges because it is unclear whether these limitations are part of the claimed invention. Claim 5 is further indefinite for the parenthetical limitation acceleration and/or delaying the time to flowering because it is unclear whether this limitation is part of the claim scope. Claim 7 is indefinite because of the parenthetical limitation “including vertical farms” because it is unclear whether the limitation is part of the claimed invention or not. Claims 5-20 are indefinite for the limitations in parentheses because it is unclear whether they are part of the claimed invention.
Claim 6 is indefinite because the claim includes two separate claims as part of the same claim. The claim is further indefinite for the parenthetical limitations because it is unclear whether these are part of the claimed invention. Furthermore, it is unclear whether the limitation “which is used to increase the productivity of agriculture and/or forest and/or domestic plants and/or ornamental and/or aquaculture is modifying gluconic acid soda or the product M4. Additionally, ornamental (second to last line of claim 6) is an adjective without an accompanying noun. The limitation “due to seed dressing and/or treatment of roots and/or vegetative parts of the plant” further renders the claim indefinite because it is unclear whether this limitation is further modifying the intended use of the product, composition of M4, or aquaculture.
Claim 7 is further indefinite for ending with “etc.” since the person of ordinary skill in the art cannot determine the metes and bounds of the claim. Furthermore, the claim recites the narrow limitation “including wheat, soy, rice…” with the broad limitation “dicotyledonous plant” in the same claim.
Claim 9 recites “the product is a complex of M4, zinc salts, and RNase. Claim 9 depends from claim 1, which is drawn to a composition of M4 and zinc salts and RNase. Complex in biology signifies a high degree of structural organization (e.g. multi-subunit molecules such as hemoglobin). However, complex can also mean “having many layers or parts.” It is unclear which definition applies here. Thus, claim 9 is indefinite.
Claims 5, 15 and 19-20 are further indefinite for “zinc salts of glycerol in lines 2-3,” which could reasonably be interpreted as a typographical error (“of” instead of “or”). Alternatively, the limitation could be interpreted as a zinc in a salt with glycerol.
In addition, claims 15-20 are indefinite because it is unclear which components are part of the claimed composition with M4. There is a large list of components with no conjunctions separating any of the components.
Claims 15 and 17-20 are indefinite for “integration/ recombination.” It is unclear whether the claim scope is inhibitors of these processes because the claim only recites “integration/ recombination” and does not recite inhibitors except in relation to reverse transcription. If the claim scope is inhibitors of these processes, it is further unclear whether the claim scope is integration inhibitors, recombination inhibitors, or integration and recombination inhibitors.
Claims 15-20 each recite the limitation "complexes of the listed products." There is insufficient antecedent basis for this limitation in the claim. Claims 15-20 recites a single product, which is M4.
Claim 16 is indefinite for “other vital and commercially important characteristics of animals and aquaplankton” because the person of ordinary skill in the art cannot discern the metes and bounds of the claim based on this limitation.
Claim 17 is indefinite for “sol bore” because this is not an art-recognized term and there is no special definition provided within the specification, nor is there are a plain and ordinary meaning of this term.
Claim 17 is further indefinite for “DNAse + RNAse of the complexes of the listed products, as well as their forms, which are gels and/or emulsions and/or ointments and/or sol bores that are used to prevent and treat hoof rot and/or animal skin diseases.” Due to the convoluted structure of the claim, it is unclear which products are part of the complex, which products have what forms, and which products and forms prevent and treat hoof rot and/or animal skin diseases.
Claim 18 is similarly indefinite for “DNAse + RNAse (from 0.1 μg/ml to 500.0 μg/ml) of the complexes of the listed products, as well as their forms, which are gels and/or emulsions and/or ointments and/or sol ora, which is used to treat eye diseases with conjunctivitis and dacryocystitis” because it is unclear which products are part of the complex, which products have what forms, and which products and forms treat eye diseases with conjunctivitis and dacryocystitis. Claim 18 is also indefinite for “sol ora” because this is not an art-recognized term and there is no special definition provided within the specification, nor is there are a plain and ordinary meaning of this term.
Claims 19-20 recite the limitation "the condition of the oral cavity" in the second to last line of each claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 19-20 are indefinite for the limitation “complexes of the listed products, which are gels and/or emulsions and/or ointments and/or solutions that are used is used to correct the condition of the oral cavity, including periodontal and endodontic mucosa, as well as cysts and granulomas” because it is unclear which products are part of the complexes, which products have what forms, and which products and forms correct what conditions. The combination of both plural and singular verb tense (are used and is used) leads to further ambiguity in the claim scope.
Claims 3-12 and 15-20 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
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 4, 7, and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 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.
Claims 4 and 12 fail to include all the limitations of independent claim 1, from which they depend. Claims 4 and 12 recite the product is “a complex of DNase…” and do not recite M4. However, claim 1 is drawn to a product including M4 or a composition of M4 and DNase.
Claim 7 does not further limit the structure of the claimed product because it merely recites intended use of the claimed product.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies 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-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, and 7 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ashkinazi et al. (US 20170013838 A1).
Regarding claim 1, Ashkinazi teaches the antiviral agent poly-N1-hydrazino(imino)methyl-1,6-hexanediamine-poly-N1amino(imino)methyl-1,6-hexane diamine (Abstract), which is a product that includes poly-N1-hydrazino(imino)methyl-1,6-hexanediamine. Ashkinazi’s antiviral agent is capable of performing the intended use of having a bioactive effect and can also be used in veterinary medicine.
Regarding claim 3, Ashkinazi teaches 0.5% solutions of poly-N1-hydrazino(imino) methyl-1,6-hexanediamine-poly-Nl-amino(imino)methyl-1,6-hexanediamine ([0081]).
Regarding instant claim 7, intended use is only given weight insofar as it limits the structure of the claimed product. Here, the intended use does not further limit the structure of the claimed product. Thus, claim 7 is also anticipated by Ashkinazi, who teaches the structure of the claimed product.
Claims 1, 3, 5, 7, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tetz et al. (Annals of Clinical Microbiology and Antimicrobials 15.1 (2016): 19; hereafter Tetz 2016) as evidenced by Tetz et al. (Antimicrobial Resistance and Infection Control (2015) 4:45; hereafter Tetz 2015).
Tetz 2016 teaches a composition comprising mul-1867, which has antimicrobial activity against multidrug-resistant Pseudomonas aeruginosa (Title). Mul-1867 is poly-N1-hydrazino(imino)-methyl-1,6-hexanediamine as evidenced by Tetz 2015 (page 2, left column, paragraph 2).
Regarding claim 3, Tetz 2016 teaches that mul-1867 is prepared as a solution (page 3, left column, paragraph 1, In vitro antimicrobial susceptibility testing).
Regarding claim 7, intended use is only given weight insofar as it limits the structure of the claimed product. Here, the intended use does not further limit the structure of the claimed product.
Regarding claims 5 and 15-20, this rejection applies to the embodiments of claims in which the product is M4 in an amount from 0.001 ug/mL to 105 µg/mL. Tetz 2016 teaches that the minimum inhibitory concentration of mul-1867 for different strains of P. aeruginosa ranges from 1 µg/mL to 8 µg/mL (Table 2), which are all values within the claimed range of 0.001 ug/mL to 105 µg/mL.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Tetz et al. (Annals of Clinical Microbiology and Antimicrobials 15.1 (2016): 19; hereafter Tetz 2016) in view of Tetz et al. (Antimicrobial agents and chemotherapy 53.3 (2009): 1204-1209; hereafter Tetz 2009) as evidenced by Tetz et al. (Antimicrobial Resistance and Infection Control (2015) 4:45; hereafter Teta 2015).
This rejection applies to the embodiment in which the product is a composition comprising M4 and DNase.
Tetz 2016 teaches a composition comprising mul-1867, which has antimicrobial activity against multidrug-resistant Pseudomonas aeruginosa (Title) Mul-1867 is poly-N1-hydrazino(imino)-methyl-1,6-hexanediamine as evidenced by Tetz 2015 (page 2, left column, paragraph 2.
Tetz 2016 does not teach that the composition further comprises DNase.
Tetz 2009 teaches compositions comprising concentrations of DNase I ranging from 0.5 to 1000 µg/mL with activity against P. aeruginosa biofilms (Table 2). 0.5 µg/mL is within the claimed range of 0.1 µg/mL to 500.0 µg/mL.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the DNase of Tetz 2009 with the Mul-1867 of Tetz 2016 in order to increase the activity against Pseudomonas aeruginosa. The person of ordinary skill in the art would have had a reasonable expectation of success given that Pseudomonas aeruginosa forms biofilms and DNase I decreases the growth of Pseudomonas aeruginosa in biofilms.
Regarding claim 3, Tetz 2016 teaches that mul-1867 is prepared as a solution (page 3, left column, paragraph 1, In vitro antimicrobial susceptibility testing).
Regarding claim 4, the claim is interpreted as a composition comprising M4 and DNase.
Regarding claim 5, Tetz 2016 teaches that the minimum inhibitory concentration of mul-1867 for different strains of P. aeruginosa ranges from 1 µg/mL to 8 µg/mL (Table 2), which are all values within the claimed range of 0.001 ug/mL to 105 µg/mL.
Regarding claim 7, intended use is only give weight insofar as it limit the structure of the claimed product. Here, the intended use does not further limit the structure of the claimed product.
Claims 1, 3, 5-6 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ashkinazi et al. (US 20170013838 A1) in view of Aziz et al. (Journal of Integrative Agriculture 18.6 (2019): 1369-1378).
This rejection applies to the embodiment in which the composition comprises M4 and zinc salts.
Ashkinazi teaches the antiviral agent poly-N1-hydrazino(imino)methyl-1,6-hexanediamine-poly-N1-amino(imino)methyl-1,6-hexane diamine (Abstract), which is a product that includes poly-N1-hydrazino(imino)methyl-1,6-hexanediamine. Ashkinazi teaches 0.5% solutions of poly-N1-hydrazino(imino) methyl-1,6-hexanediamine-poly-Nl-amino(imino)methyl-1,6-hexanediamine ([0081]). Ashkinazi teaches that the antiviral agent is active against RNA or DNA viruses in humans, animals, plants, bacteria and fungi (Ashkinazi claim 1).
Ashkinazi does not teach that the composition further comprises zinc salts.
Aziz teaches applying 235 mg Zn in 250 L in order to enhance the crop yield of wheat (Abstract, page 1371, left column, paragraph 1), which is equivalent to 0.94 mg/mL or 940 µg/mL and is within the claimed range of 0.1 µg /mL to 5,000.0 µg /mL.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to improve the composition of Ashkinazi by including micronutrients such as zinc in order to provide the additional benefit of enhancing the growth of plants in addition to fighting plant viruses. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination of zinc salts with the antiviral agent.
Claims 1, 5-6 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ashkinazi et al. (US 20170013838 A1) in view of Aziz et al. (Journal of Integrative Agriculture 18.6 (2019): 1369-1378) and Tisserat et al. (HortScience 46.12 (2011): 1650-1654.
See discussion of Ashkinazi and Aziz above, which is incorporated into this rejection as well.
This rejection applies to the embodiment in which the composition comprises M4, zinc salts, and glycerol (synonym for glycerin).
Ashkinazi does not teach that the composition further comprises from 0.1 to 500.0 µg/mL glycerol.
Tisserat teaches that a solution containing 0.5 mL/L or 5 mM of glycerol (approximately 500 µg/mL) increases the growth of carrots (Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further improve the composition by adding an additional growth stimulant such as glycerol at a concentration of 500 µg/mL. The person of ordinary skill in the art would have had a reasonable expectation of success given the teachings of Tisserat.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ashkinazi et al. (US 20170013838 A1) in view of Aziz et al. (Journal of Integrative Agriculture 18.6 (2019): 1369-1378), as applied to claims 1, 3, 5-6 and 15-20 above, further in view of Sharipova et al. (Agricultural Sciences 6.11 (2015): 1357-1366).
See discussion of Ashkinazi and Aziz above, which is incorporated into this rejection as well.
Claim 9 is interpreted as a composition of M4, zinc salts, and RNase.
Ashkinazi teaches that the antiviral agent is active against RNA or DNA viruses in humans, animals, plants, bacteria and fungi (Ashkinazi claim 1). Ashkinazi teaches that that the vast majority of plant viruses are non-enveloped RNA-containing viruses ([0066]).
Ashkinazi does not teach that the composition further comprises RNase.
Sharipova teaches an RNase from B. pumilus that has antiviral activity against phytopathogenic RNA-viruses (Title). The enzyme concentration was 1 µg/mL, 10 µg/mL, or 100 µg mL, which are all values within the claimed range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Sharipova’s RNase with the composition of Ashkinazi modified by Aziz in order to further improve the composition by enhancing antiviral activity against RNA viruses, which Ashkinazi teaches are the vast majority of plant viruses.
Claims 1, 3-12, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tetz (WO 2018/217351 A1; hereafter Tetz 2018) in view of Ashkinazi et al. (US 20170013838 A1) and Kozloff et al. (Nature 176.4494 (1955): 1169-1171).
This rejection applies to the embodiment in which the composition comprises poly-N1-hydrazino(imino)methyl-1,6-hexanediamine, zinc salts, Raltegravir, DNase, and RNase.
Tetz 2018 teaches that polyhexamethylene guanidine derivatives prevents entry of bacteriophages into the body ([0194]) and DNase inactivates bacteriophages ([0446]). Tetz 2018 teaches inactivating bacteriophages present in microbiota comprising treating the microbiota with an antibacteriophagal agent, an antifungal agent or a gene-editing nuclease (Tetz 2018 claim 9). In some embodiments, the antibacteriophagal agent is Raltegravir (Tetz 2018 claim 206).
Tetz 2018 teaches that the method comprises inactivating bacteriophages by contacting the bacteriophages with an agent comprising polyhexamethylene guanidine derivatives, which include those in U.S. Pat. Appl. Pub. No. 2017/0013838 ([0037]).
Ashkinazi (U.S. Pat. Appl. Pub. No. 2017/0013838) teaches the antiviral agent poly-N1-hydrazino(imino)methyl-1,6-hexanediamine-poly-N1-amino(imino)methyl-1,6-hexane diamine (Abstract), which is a product that includes poly-N1-hydrazino(imino)methyl-1,6-hexanediamine.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Raltegravir and DNase, which are both antibacteriophagal agents, with Ashkinazi’s poly-N1-hydrazino(imino)methyl-1,6-hexanediamine-poly-N1-amino(imino)methyl-1,6-hexane diamine in order to inactivate bacteriophages per the teaching of Tetz 2018. The person of ordinary skill in the art would have had a reasonable expectation of success given that Tetz 2018 specifically teaches polyhexamethylene guanidine derivatives as antibacteriophagal and points to exemplary derivatives as those in U.S. Pat. Appl. Pub. No. 2017/0013838 (Ashkinazi).
Tetz 2018 does not expressly teach that the agent further comprises RNase. However Tetz 2018 also teaches that RNase can be applied to the bacteriophage in an amount that affects the bacteriophage surface without inactivating the bacteriophage in order to prevent entry of the bacteriophage into the body ([0193]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add the RNase to the antibacteriophagal agent in order to further enhance the antibacteriophagal effects of the agent. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Tetz 2018 does not teach that the agent further comprises zinc salts. However, Tetz 2018 does teach that the agent is selected from a group consisting of a metal, polyhexamethylene guanidine derivatives, and antibacteriophagal agent (Tetz 2018 claim 27). However, Tetz 2018 exemplifies Cu2+ as the metal ([0345]), not zinc.
Kozlof teaches that 0.01 M (1,894 µg/mL) solutions of zinc nitrate (salts) in the presence of a complexing agent such as glycine inactivate certain bacteriophage (page 1169, right column, paragraph 1). 1,894 µg/mL is within the claimed range of from 0.1 to 5,000.0 µg/mL.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Kozlof’s zinc nitrate and glycine with the composition of Tetz 2018 modified by Ashkinazi. The person of ordinary skill in the art would have been motivated to boost the antibacteriophagal efficacy of the composition by including an additional component with antibacteriophagal activity. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Regarding the amounts of each of the components, Tetz 2018 teaches 1000 mg/L or 1 µg/mL of the polyhexamethylene guanidine derivative preparation ([0326]), which is within the claimed range of from 0.1 to 500.0 µg/mL. Tetz 2018 teaches that 10 mc/mL of DNase inactivates bacteriophages ([0446]), which is also within the claimed range of from 0.1 to 500.0 µg/mL.
Regarding the amount of RNase, Tetz 2018 does not teach the amount of RNase. However, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the amount of RNase in the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in applying a similar amount of RNase as the amount of DNase given that RNase and DNase are both nucleases.
Tetz 2018 does not teach the amount of Raltegravir. However, Tetz 2018 teaches that the therapeutically effective amount refers to the amount of a compound, composition, particle, or organism that, when administered to a subject for treatment a state, is sufficient to effect such a treatment. The therapeutically effective amount will vary depending on the agent being administered as well as the disease severity, age, weight, and physical conditions and responsiveness of the subject to be treated ([0176]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the amount of Raltegravir in the composition in order to maximize the inactivation of bacteriophage. The person of ordinary skill in the art would have had a reasonable expectation of success given that Tetz 2018 teaches that Raltegravir has antibacteriophagal activity (Tetz 2018 claims 9 and 206).
Regarding claim 3, Tetz 2018 teaches solutions of the antibacteriophagal agent ([0366]).
Regarding instant claim 7, intended use is only given weight insofar as it limits the structure of the claimed product. Here, the intended use does not further limit the structure of the claimed product.
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, 3-12, and 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 213, 216, and 220 of copending Application No. 19/074,310 (hereafter ‘310) in view of Tetz (WO 2018/217351 A1; hereafter Tetz 2018), Ashkinazi et al. (US 20170013838 A1), and Kozlof et al. (Nature 176.4494 (1955): 1169-1171).
This rejection applies to the embodiment in which the composition comprises poly-N1-hydrazino(imino)methyl-1,6-hexanediamine, Raltegravir (integration inhibitor), DNase, RNase and zinc salts (claims 1, 4-12, and 15-20).
Claim 213 of ‘310 is drawn to a method for treating a disease in a mammal comprising administering to the mammal an effective amount of an antibacteriophagal agent.
Claim 216 of ‘310 recites that the antibacteriophagal agent is an integrase inhibitor, a reverse transcriptase inhibitor, a protease inhibitor, or a combination thereof.
Claim 220 of ‘310 recites that the integrase inhibitor is Raltegravir.
Claims 213, 216, and 220 of ‘310 do not recite that the antibacteriophagal agent further comprises M4.
Tetz 2018 teaches that polyhexamethylene guanidine derivatives prevent entry of bacteriophages into the body ([0194]) and DNase inactivates bacteriophages ([0446]). Tetz 2018 teaches inactivating bacteriophages present in microbiota comprising treating the microbiota with an antibacteriophagal agent, an antifungal agent or a gene-editing nuclease (Tetz 2018 claim 9). In some embodiments, the antibacteriophagal agent is Raltegravir (Tetz 2018 claim 206).
Tetz 2018 teaches that the method comprises inactivating bacteriophages by contacting the bacteriophages with an agent comprising polyhexamethylene guanidine derivatives, which include those in U.S. Pat. Appl. Pub. No. 2017/0013838 (Tetz 2018 [0037]).
Ashkinazi (U.S. Pat. Appl. Pub. No. 2017/0013838) teaches the antiviral agent poly-N1-hydrazino(imino)methyl-1,6-hexanediamine-poly-N1-amino(imino)methyl-1,6-hexane diamine (Abstract), which is a product that includes poly-N1-hydrazino(imino)methyl-1,6-hexanediamine.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the antibacteriophagal agent of claims 213, 216, or 220 with the antibacteriophagal agent of Tetz 2018 comprising DNase and Ashkinazi’s poly-N1-hydrazino(imino)methyl-1,6-hexanediamine-poly-N1-amino(imino)methyl-1,6-hexane diamine in order to prevent bacteriophage entry into the body of the mammal per the teaching of Tetz 2018. The person of ordinary skill in the art would have had a reasonable expectation of success in combining these antibacteriophagal agents.
Claims 213, 216, and 220 of ‘310 do not recite that the agent further comprises zinc salts.
Kozlof teaches that 0.01 M (1,894 µg/mL) solutions of zinc nitrate (salt) in the presence of a complexing agent such as glycine inactivate certain bacteriophage (page 1169, right column, paragraph 1). 1,894 µg/mL is within the claimed range of from 0.1 to 5,000.0 µg/mL.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the antibacteriophagal agent of claims 213, 216, and 220 of ‘310 modified by Tetz 2018 and Ashkinazi with zinc salts and glycine, which Kozlof teaches are also an antibacteriophagal agent. The person of ordinary skill in the art would have had a reasonable expectation of success in combining two antibacteriophagal agents for the same purpose.
Regarding the amounts of each of the components, Tetz 2018 teaches 1000 mg/L or 1 µg/mL of the polyhexamethylene guanidine derivative preparation ([0326]), which is within the claimed range of from 0.1 to 500.0 µg/mL. Tetz 2018 teaches that 10 mc/mL of DNase inactivates bacteriophages ([0446]), which is also within the claimed range of from 0.1 to 500.0 µg/mL.
Tetz 2018 does not teach the amount of Raltegravir. However, Tetz 2018 teaches that the therapeutically effective amount refers to the amount of a compound, composition, particle, or organism that, when administered to a subject for treatment of a state, is sufficient to effect such a treatment ([0176]). The therapeutically effective amount will vary depending on the agent being administered as well as the disease severity, age, weight, and physical conditions and responsiveness of the subject to be treated ([0176]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the amount of Raltegravir in the antibacteriophagal agent of claims 213, 216, and 220 of ‘310 modified by Tetz 2018, Ashkinazi, and Kozlof in order to maximize the inactivation of bacteriophage. The person of ordinary skill in the art would have had a reasonable expectation of success in the routine optimization of the amount of Raltegravir.
Claims 213, 216, and 220 of ’310 do not recite that the antibacteirophagal agent further comprises RNase.
Tetz 2018 also teaches that RNase can be applied to the bacteriophage in an amount that affects the bacteriophage surface without inactivating the bacteriophage in order to prevent entry of the bacteriophage into the body ([0193]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add the RNase to the antibacteriophagal composition of claims 213, 216, and 220 of ‘310 modified by Tetz 2018, Ashkinazi, and Kozlof in order to further enhance the antibacteriophagal effects of the agent. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Regarding the amount of RNase, Tetz 2018 does not teach the amount of RNase. However, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the amount of RNase in the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in applying a similar amount of RNase as the amount of DNase given that RNase and DNase are both nucleases.
Regarding instant claim 3, claims 213, 216, and 220 of ‘310 do not recite that the agent is a solution.
Tetz 2018 teaches solutions of the antibacteriophagal agent ([0366]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the agent of claims 213, 216 and 220 of ‘310 modified by Tetz 2018, Ashkinazi, and Kozlof as a solution per the teaching of Tetz 2018 and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Regarding instant claim 7, intended use is only given weight insofar as it limits the structure of the claimed product. Here, the intended use does not further limit the structure of the claimed product.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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