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 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 4, 6, 8, 9, 16, 105, 107, and 109 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 4 and 6 recite the limitation "The method of claim 1". There is insufficient antecedent basis for this limitation in the claim because claim 1 is a product claim.
Regarding claims 6, 8, 9, 16, 105, 107, and 109, the phrase "e.g." renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) naturally occurring lactoferrin. This judicial exception is not integrated into a practical application because although the claims recite a pharmaceutical composition, a composition that is suitable for pharmaceutical use can also be used in non-pharmaceutical applications. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because oral and intravenous formulations, including dispersions, are routine the art and could also include naturally-occurring carriers such as water, sugars etc.
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 1-2, 7-13, 16, 28, 104-105, 107, and 109 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Biffi et al. (WO 2020/250209 A2).
Biffi et al. teach a composition comprising lactoferrin for oral use as an antiviral, preferably for use in the treatment of viral infections of the respiratory system and of symptoms or disorders deriving from, or relating to, said viral infections, preferably SARS-coronavirus viral infections (e.g. COVID-19) (p. 2, paragraph 3). Biffi et al. teach that lactoferrin is a naturally-occurring protein (pp. 1-2, bridging paragraph). Therefore, Biffi et al. satisfy all of the limitations of instant claim 1.
Regarding claim 2, Biffi et al. teach that the lactoferrin compositions can be formulated, by adding specific excipients and additives, as solutions or emulsions or dispersions suitable to be atomised and administered - using a spray device - into the nose and throat for inhalation, oral or nasal use (pp. 2-3, bridging paragraph).
Regarding claim 7, Biffi et al. teach a method of treating viral infections and symptoms or disorders related to the viral infection in subjects in need thereof comprising administering the lactoferrin compositions (pp. 3-4, bridging paragraph).
Regarding claims 8-9, Biffi et al. teach that the viral infection treated using the composition of the invention is an infection caused SARS-CoV-2 (p. 4, paragraph 2).
Regarding claims 10-11, Biffi et al. teach that the composition for oral use may be formulated in a solid form selected from: tablets, chewable tablets, oral soluble tablets, granules, powder, flakes, soluble powder or granules, oral soluble powder or granules, capsules; or, alternatively, in liquid form selected from: solutions, suspensions, dispersions, emulsions, liquid which can be dispensed in spray form, syrups; or, alternatively, in semi-liquid form selected from: soft-gel, gel; preferably the composition of the invention is in solid form. (p. 5, paragraph 1).
Regarding claims 12-13, Biffi et al. teach that the daily doses of lactoferrin is in the range from 5 mg to 1000 mg, preferably from 10 mg to 500 mg, more preferably from 20 mg to 400 mg, for example from 50 mg to 350 mg, from 50 mg to 300 mg, from 50 mg to 250 mg, from 50 mg to 200 mg, from 100 mg to 200 mg, which fall within the claimed ranges (p. 5, paragraph 4).
With respect to claim 16, Biffi et al. teach that lactoferrin is exerts an anti-inflammatory response against IL-6 (p. 11, last paragraph).
With respect to claim 28, Biffi et al. teach that the symptoms or disorders deriving from or related to said viral infection of the respiratory tract (upper respiratory tract and/or lower respiratory tract), preferably a coronavirus infection as defined above (e.g. SARS-CoV, SARS-CoV-2 or 2019-nCoV, SARS-CoV-like) can be: severe acute respiratory syndrome (SARS), respiratory complications, asthma, chronic obstructive pulmonary disease (COPD), bronchitis, emphysema, cystic fibrosis, cough, pertussis, pneumonia, pleurisy, bronchiolitis, cold, sinusitis, rhinitis, tracheitis, pharyngitis, laryngitis, acute laryngotracheobronchitis, epiglottitis, bronchiectasis, difficulty breathing, dyspnoea (breathlessness, shortness of breath,) fever, fatigue, muscle ache and/or pain, nasal congestion, runny nose, sore throat, gastrointestinal symptoms such as for example nausea and diarrhoea, kidney failure, loss of appetite and/or general feeling unwell (pp. 6-7, bridging paragraph).
With respect to claims 104-105, 107, and 109, Biffi et al. teach a method of administering the lactoferrin composition to a cell that is exposed to SARS-CoV-2, wherein the cell is in a culture (Example 2).
Claims 1-2, 7-16, 28, 104-105, 107, and 109-110 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serrano et al. (NL4; IDS 4/16/2024).
Serrano et al. teach a composition comprising lactoferrin for oral use in the treatment of SARS-CoV-2 infection (p. 9, Materials and Methods). Lactoferrin is a naturally-occurring protein. Therefore, Serrano et al. satisfy all of the limitations of instant claim 1.
Regarding claim 2, Serrano et al. teach that the lactoferrin compositions are formulated for drinkability (p. 9, Materials and Methods).
Regarding claims 7-9, Serrano et al. teach a method of treating SARS-CoV-2 infection in subjects in need thereof comprising administering the lactoferrin compositions (p. 9, Materials and Methods).
Regarding claims 10-11, Serrano et al. teach that the lactoferrin compositions are formulated for drinkability (p. 9, Materials and Methods).
Regarding claims 12-13, Serrano et al. teach that the daily doses of lactoferrin is in the range from 256 and 384 mg/day, which fall within the claimed ranges (p. 9, Materials and Methods).
Regarding claim 14, Serrano et al. teach administering the lactoferrin in combination with zinc (p. 9, Materials and Methods).
Regarding claim 15, Serrano et al. teach that the lactoferrin may be combined with hydroxychloroquine (p. 13, col 2).
With respect to claim 16, Serrano et al. teach that the lactoferrin reduced IL-6 activity (p. 13, col 1).
With respect to claim 28, Serrano et al. teach that the symptoms include dry cough and fatigue (Figures 3 and 6).
With respect to claims 104-105, 107, and 109-110, Serrano et al. teach a method of administering the lactoferrin composition to a cell that is exposed to SARS-CoV-2, wherein the cell is in a patient (p. 9, Materials and Methods).
Claims 1-2, 7, 10-14, 16, 28, 104-105, 107, and 109 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Latefi (US 2017/0246262 A1).
Latefi teaches a composition is for prophylaxis or treatment of a human subject suffering from, or at risk of suffering from, a respiratory infection comprising lactoferrin (paragraph [0005]). The pharmaceutical composition may be in the form of an oral spray, oral rinse, or lozenge (paragraph [0052]). [0162]). The lactoferrin may be recombinantly expressed, or purified from a natural source (paragraph [0162]). Therefore, Latefi satisfies all of the limitations of claim 1.
Regarding claim 2, Latefi teaches that the composition may be dispersed in a liquid carrier (paragraph [0005], [0052]).
Regarding claim 7, Latefi teaches a method of preventing or treating respiratory infection comprising administering the lactoferrin composition. The respiratory infection may be due to human rhinovirus and/or human influenza virus (paragraph [0027]).
Regarding claim 10, Latefi teaches that the composition may be dispersed in a liquid carrier (paragraph [0005], [0052]).
Regarding claim 11, Latefi teaches that the pharmaceutical composition may be in the form of an oral spray, oral rinse, or lozenge (paragraph [0052]).
Regarding claims 12-13, Latefi teaches pharmaceutical dosage unit forms are prepared to provide from about 1 mg to about 5000 mg, for example from about 100 to about 2500 mg of the compound (paragraph [0251]).
Regarding claim 14, Latefi teaches that the composition includes additional anti-viral agents (paragraph [0211]).
Regarding claim 16, Latefi is silent on the claimed effects. These effects are inherent to the prior art method which comprises administering the same compositions (lactoferrin), to the same patients (those in need of preventing or treating respiratory infection), in the same manner (oral).
Regarding claim 28, Latefi is silent on the claimed symptoms. However, Latefi teaches that the respiratory infection may be due to human influenza virus (paragraph [0027]), which causes fever and fatigue.
Regarding claims 104, 107, and 109, the method of preventing or treating respiratory infection taught by Latefi inherently includes exposing a cell in a living subject that is at risk for infection to the lactoferrin composition.
Claims 1-2, 7, 10-14, 16, 104, 107, and 109 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shatunovskiy (US 2009/0142298 A1).
Shatunovskiy teaches treating a patient infected with HCV comprising administering to said patient: a. a composition comprising human lactoferrin wherein said lactoferrin is essentially free of iron and wherein said composition is essentially free of non-human lactoferrin; and b. interferon (claim 10).
Shatunovskiy teaches that human apolactoferrin is administered intravenously in the treatment of chronic HCV infection (paragraph [0037]). Shatunovskiy teaches that human lactoferrin may be extracted from human colostrums, foremilk or milk and other human biological material, as well as received by genetic engineering or transgenic methods (paragraph [0043]). Therefore, Shatunovskiy satisfies all of the limitations of claims 1, 7, and 11.
Regarding claims 2 and 10, Shatunovskiy teaches that the apolactoferrin compositions of the invention can be in the form of a solution, suspension, emulsion of the type oil-in-water, water-in-oil, or a liposome suspension. Such well-known pharmaceutically acceptable solvents as isotonic 0.9% saline solution (normal saline solution), 5% glucose (dextrose) solution, mannite solution, etc. can be used as solvents for preparing the solution for intravenous administration. If necessary, the solution can additionally contain auxiliary components, e.g. stabilizers, surface-active substances, antimicrobial agents (preservatives), etc (paragraph [0035]).
Regarding claims 12-13, Shatunovskiy teaches that the composition is administered at 20 mg every two hours on the first and second day of the treatment regime. On days 3 through 7 of the regime, the apolactoferrin composition is administered as a daily dose of 20 mg (paragraph [0037). The total daily amount falls within the claimed range.
Regarding claim 14, Shatunovskiy teaches that the composition further contains interferon, which is an anti-viral agent (claim 10).
Regarding claim 16, Shatunovskiy is silent on the claimed effects. These effects are inherent to the prior art method which comprises administering the same compositions (lactoferrin), to the same patients (those in need of treating HCV infection), in the same manner (intravenous).
Regarding claims 104, 107, and 109, the method of preventing or treating respiratory infection taught by Shatunovskiy inherently includes exposing a cell in a living subject that is at risk for infection to the lactoferrin composition.
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.
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 14-15 and 110 are rejected under 35 U.S.C. 103 as being unpatentable over Biffi et al. (WO 2020/250209 A2), as applied to claims 1-2, 7-13, 16, 28, 104-105, 107, and 109 above, in further view of Grein et al. (Compassionate Use of Remdesivir for Patients with Severe Covid-19. N Engl J Med 2020; 382: 2327-2336; published April 10, 2020).
Biffi et al. teach a composition comprising lactoferrin for oral use as an antiviral, preferably for use in the treatment of viral infections of the respiratory system and of symptoms or disorders deriving from, or relating to, said viral infections, preferably SARS-coronavirus viral infections (e.g. COVID-19) (p. 2, paragraph 3). Biffi et al. teach that lactoferrin is a naturally-occurring protein (pp. 1-2, bridging paragraph).
Biffi et al. do not teach that the method further comprises administering remdesivir.
Grein et al. teach that in a cohort of patients hospitalized for severe Covid-19 clinical improvement was observed in 36 of 53 patients (68%) who were treated with compassionate-use remdesivir (abstract).
MPEP § 2144.06(I) states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, it would have been prima facie obvious to combine the lactoferrin taught by Biffi et al. and the remdesivir taught by Grein et al. because both were taught in the prior art to be useful for treating infection caused by SARS-CoV-2. The resulting combination would satisfy all of the limitations of claims 14-15 and 110.
Claims 14-15 and 110 are rejected under 35 U.S.C. 103 as being unpatentable over Shatunovskiy (US 2009/0142298 A1), as applied to claims 1-2, 7, 10-14, 16, 104, 107, and 109 above, in further view of Halfon (US 2013/0121965).
Shatunovskiy teaches treating a patient infected with HCV comprising administering to said patient: a. a composition comprising human lactoferrin wherein said lactoferrin is essentially free of iron and wherein said composition is essentially free of non-human lactoferrin; and b. interferon (claim 10).
Shatunovskiy teaches that human apolactoferrin is administered intravenously in the treatment of chronic HCV infection (paragraph [0037]). Shatunovskiy teaches that human lactoferrin may be extracted from human colostrums, foremilk or milk and other human biological material, as well as received by genetic engineering or transgenic methods (paragraph [0043]).
Shatunovskiy does not teach that the method further comprises administering remdesivir.
Halfon teach methods of treating a HCV related disease comprising administering to the subject a therapeutically effective amount of hydroxychloroquine. An antiviral agent may be co-administered with the hydroxychloroquine (abstract).
MPEP § 2144.06(I) states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, it would have been prima facie obvious to combine the lactoferrin taught by Shatunovskiy and the hydroxychloroquine taught by Halfon because both were taught in the prior art to be useful for treating infection caused by HCV. The resulting combination would satisfy all of the limitations of claims 14-15 and 110.
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 1-2, 4, 6-16, 28, 104-105, 107, and 109-110 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 8, 10-11, 34, 107-112, and 115-119 of copending Application No. 17/927,093 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claim 5 recites a pharmaceutical composition for treating, ameliorating, an/or preventing a condition related to viral infection comprising mammalian lactoferrin or recombinant lactoferrin. Claim 6 requires that the composition is formulation for oral or intravenous administration. Therefore, the reference claims anticipate instant claim 1.
Reference claim 5 recites a method for treating, ameliorating, an/or preventing a condition related to viral infection comprising administering a pharmaceutical composition comprising mammalian lactoferrin or recombinant lactoferrin. Claim 6 requires that the composition is formulation for oral or intravenous administration. Claim 10 requires administering remdesivir and/or hydroxychloroquine in combination with the lactoferrin. Therefore, the reference claims anticipate instant claim 7.
Regarding claims 4 and 6, reference claim 5 recites mammalian lactoferrin or recombinant lactoferrin.
Regarding claims 8-9, reference claim 2 requires that the virus is SARS-CoV-2.
Regarding claims 2 and 10, it would have been obvious to disperse the lactoferrin in a pharmaceutically acceptable carrier in order to carry out the method of treating, ameliorating, an/or preventing a condition related to viral infection recited in the reference claims.
Regarding claim 11, reference claim 6 requires that the composition is formulation for oral or intravenous administration.
Regarding claim 12, reference claim 8 requires administering about 1 mg to about 10 g per day.
Regarding claim 13, reference claim 9 requires administering about 10 mg to about 1 g per day.
Regarding claims 14-15, reference claim 10 requires administering remdesivir and/or hydroxychloroquine in combination with the lactoferrin.
Regarding claim 16, reference claim 11 requires that administration of the pharmaceutical composition results in one or more of suppression of pro-inflammatory cytokine activity (e.g., IL 6 activity) within the subject, enhancement of NK cell activity within the subject, enhancement of neutrophil activity within the subject, and inhibition of viral entry into the subject's cells through inhibiting binding of the virus with heparin sulfate proteoglycan within such cells.
Regarding claim 28, reference claim 34 requires that the symptoms related to viral infection in a subject are one or more of fever, fatigue, dry cough, myalgias, dyspnea, acute respiratory distress syndrome, and pneumonia.
Regarding claim 104, reference claim 107 recites a method for inhibiting viral entry in a cell, comprising exposing the cell a pharmaceutical composition comprising lactoferrin.
Regarding claim 105, reference claim 115 requires that the virus is SARS-CoV-2.
Regarding claim 107, reference claim 110 requires that the cell is in a culture and reference claim 111 requires the cell is in a living subject.
Regarding claim 109, reference claim 112 requires that administration of the pharmaceutical composition results in one or more of suppression of pro-inflammatory cytokine activity (e.g., IL 6 activity) within the subject, enhancement of NK cell activity within the subject, enhancement of neutrophil activity within the subject, and inhibition of viral entry into the subject's cells through inhibiting binding of the virus with heparin sulfate proteoglycan within such cells.
Regarding claim 110, reference claim 10 requires administering remdesivir and/or hydroxychloroquine in combination with the lactoferrin.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 7 am - 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654