DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 20 February 2026. Claims 1, 2, 10, 17, 18, and 26 have been amended. Claims 3, 6, 9, and 14 have been cancelled. Claims 7, 8, and 23 remain withdrawn. Claims 1, 2, 4, 5, 10-13, 15-22, and 24-26 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/US2021/025494, filed April 2, 2021, which claims priority to U.S. Provisional Application No. 63/005045, filed April 3, 2020.
Withdrawal of Rejections:
The rejection of claims 1-6, 9-22, and 24-26 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn.
The rejection of claims 10, 17, 18, and 26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
Modified/New Rejections Necessitated by Amendment:
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, 2, 4, 5, 10-13, 15-22, and 24-26 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 as amended recites that the processed amniotic fluid has “from about 0.15 mg/ml to about 10 mg/ml protein comprising one or more anti-microbial proteins.” This limitation is indefinite, because it is unclear if anti-microbial proteins are intended to be present in the claimed amount, or instead if any proteins can be present in this amount.
Claims 2, 4, 5, 10-13, 15-22, and 24-26 are included in this rejection, as these claims depend from above rejected claim 1 and fail to remedy the noted deficiencies.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 1, 2, 4, 5, 10-13, 15-22, and 24-26 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Reems et al. (IDS; US 2018/0250343, Published 2018), as evidenced by Sattar et al. (Bacterial Pneumonia, NIH, NCBI Bookshelf, StatPearly, Feb. 26, 2024, Available online at: Accessed 6/26/2026, Available online at: www.ncbi.nlm.nih.gov/books/NBK513321/).
With regard to claim 1, Reems et al. teach a method for treating lung diseases in a subject in need thereof, including treating pneumonia (Abs.; Para. 115). The method comprising administering to the subject a therapeutically effective amount of a composition comprising a processed amniotic fluid having a therapeutically effective amount of protein, where the composition is substantially free of lanugo, vernix, and cells harvested with amniotic fluid (Abs.; Para. 45, 47, 59, 112). The therapeutically effect amount of protein in the composition is from about 0.5 mg to about 10 mg, with a volume of the therapeutic composition of from about 0.5 ml to about 10 ml per dose, or about 1 ml to about 50 ml per dose (Para. 128, 131), which are fully encompassed within from about 0.15 mg/ml to about 10 mg/ml. As the proteins inherent to amniotic fluid cannot be separated from their properties, the proteins in the amniotic fluid comprise anti-microbial proteins.
Reems et al. teach that the method is effective for treating pneumonia (Para. 115). As pneumonia is caused by bacterial infection, including infection by Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Bordetella pertussis, Mycoplasma pneumoniae (non-tuberculosis Mycobacterium), Pseudomonas aeruginosa, and Moraxella catarrhalis (see Sattar et al., p. 2-3), pneumonia is a lung disease caused by bacterial infection with any of these species. Alternatively, it would have been obvious to one of ordinary skill in the art to treat pneumonia as taught by Reems et al., where the pneumonia is caused by any known bacterial species.
With regard to claim 2, Reems et al. teach that the proteins in the amniotic fluid further comprise anti-inflammatory and immunomodulatory proteins (Fig. 4B, Para. 157).
With regard to claims 4, 10, and 11, Reems et al. teach treating lung diseases including pneumonia (Para. 115), wherein pneumonia is acute or chronic when associated with an underlying condition (see Sattar et al., p. 2, 10). Pneumonia is characterized by inflammation in lung parenchyma and alveolar spaces, and causes symptoms including coughing and chest pain (see Sattar et al., p. 1).
With regard to claim 5, Reems et al. teach or render obvious the method as claimed, including the components as claimed. As such, the results that administration of the composition reduces lung inflammation and improves lung function, naturally flow from performance of the method as taught.
With regard to claims 12, 21, and 24, Reems et al. teach that the composition is administered via intravenous injection, inhalation, or via nebulization (Para. 76, 77, 99), which is being aerosolized and administered via a nebulizer.
With regard to claim 13, Reems et al. teach that the composition comprises a therapeutically effect amount of hyaluronic acid (Abs.; Para. 45).
With regard to claim 15, Reems et al. teach that the composition is lyophilized (Para. 111).
With regard to claim 16, Reems et al. teach that the composition has an optical density of less than 0.20 when exposed to electromagnetic radiation at a wavelength of 590 nm in a liquid form (Para. 53).
With regard to claims 17 and 18, Reems et al. teach that the composition has less than or equal to 10,000 particles per milliliter of particulate matter in the composition having a particle size of 10 microns or greater; or less than or equal to 300 particles per milliliter of particulate matter in the composition having a particle size of 25 microns or greater (Para. 51-52; claim 2, 3).
With regard to claims 19 and 20, Reems et al. teach that the composition further comprises an active agent, including an anti-infective agent, including an antibiotic, an anti-tumor agent, an anti-inflammatory agent, a pain-controlling agent, an anti-rheumatic agent, a bisphosphonate, a supplementary growth factor, a supplementary cytokine, an amino acid, a protein, a vaccine, a hormone, a vitamin, a phytoestrogen, fluoride, or combinations thereof (Para. 61-62).
With regard to claim 22, Reems et al. teach that the composition is administered 1, 2, 3, 4, or 6 times per day (Para. 127), which is one or more times per day.
With regard to claim 25, Reems et al. teach that the composition is administered to the subject via inhalation (Para. 126), one time per day (Para. 127), in an amount including from about 1 ml to about 50 ml per dose (Para. 131), which is fully encompassed within at least 1 ml of the composition.
With regard to claim 26, Reems et al. teach that the composition is administered, which is further administered, to the subject intravenously (Para. 77), one time per day (Para. 127), in an amount including from about 1 ml to about 50 ml per dose (Para. 131), which is fully encompassed within at least 1 ml of the composition.
Response to Arguments
Applicant urges that Reems et al. do not teach the invention as now claimed, as Tuberculosis associated Mycobacterium has been removed. Applicant’s arguments have been fully considered, and have been found persuasive. However, a modified/new rejection is set forth above in view of Applicant’s amendments.
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, 5, 10-13, 15-22, and 24-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 11-19, and in view of the disclosure, of U.S. Patent No. 10,555,973. Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a therapeutic composition used for a method of treating respiratory conditions in a subject in need thereof, including pneumonia, which is a lung disease that causes inflammation of the lungs; the method comprising administering to the subject a therapeutically effective amount of a composition comprising a processed amniotic fluid having a therapeutically effective amount of protein, which is inherently an anti-microbial protein, where the composition is substantially free of lanugo, vernix, and cells harvested with amniotic fluid; and wherein results that administration of the composition reduces lung inflammation and improves lung function, naturally flow from performance of the method; the therapeutically effect amount of protein in the composition is from about 0.15 mg/ml to about 10 mg/ml; and the composition is lyophilized; as pneumonia is caused by bacterial infection, including infection by Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Bordetella pertussis, Mycoplasma pneumoniae (non-tuberculosis Mycobacterium), Pseudomonas aeruginosa, and Moraxella catarrhalis (see Sattar et al., p. 2-3), pneumonia is a lung disease caused by bacterial infection with any of these species; alternatively, it would have been obvious to one of ordinary skill in the art to treat pneumonia that is caused by any known bacterial species (Instant claims: 1, 5, 15; Cited patent claims and disclosure: claim 1, 11, 19; Abs., Col. 20, line 4-14).
The proteins in the amniotic fluid further comprise anti-inflammatory and immunomodulatory proteins (Instant claims: 2; Cited patent claims and disclosure: claim 1, 11; Col. 6, line 34-52). Lung diseases include pneumonia, wherein pneumonia is acute or chronic when associated with an underlying condition (see Sattar et al., p. 2, 10), and is characterized by inflammation in lung parenchyma and alveolar spaces, and causes symptoms including coughing and chest pain (see Sattar et al., p. 1) (Instant claims: 4, 10, 11; Cited patent claims and disclosure: claim 1, 4, 11, 14 Col. 6, line 34-52).
The composition is administered via intravenous injection, inhalation, or via nebulization, which is being aerosolized and administered via a nebulizer (Instant claims: 12, 21, 24; Cited patent claims and disclosure: claim 8, 18; Col. 16, line 18-20). The composition comprises a therapeutically effect amount of hyaluronic acid (Instant claims: 13; Cited patent claims and disclosure: claim 1, 11, 19). The composition has an optical density of less than 0.20 when exposed to electromagnetic radiation at a wavelength of 590 nm in a liquid form (Instant claims: 16; Cited patent claims and disclosure: claim 1, 11, 19). The composition has less than or equal to 10,000 particles per milliliter of particles having a particle size of 10 microns or greater; or less than or equal to 300 particles per milliliter of particles having a particle size of 25 microns or greater (Instant claims: 17, 18; Cited patent claims and disclosure: claim 2, 3, 12, 13).
The composition further comprises an active agent, including an anti-infective agent, including an antibiotic, an anti-tumor agent, an anti-inflammatory agent, a pain-controlling agent, an anti-rheumatic agent, a bisphosphonate, a supplementary growth factor, a supplementary cytokine, an amino acid, a protein, a vaccine, a hormone, a vitamin, a phytoestrogen, fluoride, or combinations thereof (Instant claims: 19, 20; Cited patent claims and disclosure: claim 5-7, 15-17). The composition is administered one or more times per day; the subject receives at least 1 mL of the composition via inhalation every 24 hours; and the subject further receives at least 1 mL of the composition intravenously every 24 hours (Instant claims: 22, 25, 26; Cited patent claims and disclosure: claim 1, 11; Col. 21, line 44 to Col. 22, line 44).
Claims 1, 2, 4, 5, 10-13, 15-22, and 24-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-9, and 11-17, and in view of the disclosure, of U.S. Patent No. 11,426,433. Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a method of treating respiratory conditions in a subject in need thereof, including pneumonia, which is a lung disease that causes inflammation of the lungs; the method comprising administering to the subject a therapeutically effective amount of a composition comprising a processed amniotic fluid having a therapeutically effective amount of protein, which is anti-microbial protein, where the composition is substantially free of lanugo, vernix, and cells harvested with amniotic fluid; and wherein results that administration of the composition reduces lung inflammation and improves lung function, naturally flow from performance of the method; the therapeutically effect amount of protein in the composition is from about 0.15 mg/ml to about 10 mg/ml; and the composition is lyophilized; as pneumonia is caused by bacterial infection, including infection by Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Bordetella pertussis, Mycoplasma pneumoniae (non-tuberculosis Mycobacterium), Pseudomonas aeruginosa, and Moraxella catarrhalis (see Sattar et al., p. 2-3), pneumonia is a lung disease caused by bacterial infection with any of these species; alternatively, it would have been obvious to one of ordinary skill in the art to treat pneumonia that is caused by any known bacterial species; additionally, as the proteins inherent to amniotic fluid cannot be separated from their properties, and the proteins in the amniotic fluid comprise anti-inflammatory and immunomodulatory proteins (Instant claims: 1, 2, 5, 15; Cited patent claims and disclosure: claim 1, 2, 9, 10; Abs., Col. 20, line 15-25).
Lung diseases include pneumonia, wherein pneumonia is acute or chronic when associated with an underlying condition (see Sattar et al., p. 2, 10), and is characterized by inflammation in lung parenchyma and alveolar spaces, and causes symptoms including coughing and chest pain (see Sattar et al., p. 1) (Instant claims: 4, 10, 11; Cited patent claims and disclosure: claim 1, 2; Col. 20, line 16-25). The composition is administered via intravenous injection, inhalation, or via nebulization, which is being aerosolized and administered via a nebulizer (Instant claims: 12, 21, 24; Cited patent claims and disclosure: claim 6; Col. 16, line 25-39). The composition comprises a therapeutically effect amount of hyaluronic acid (Instant claims: 13; Cited patent claims and disclosure: claim 1).
The composition has an optical density of less than 0.20 when exposed to electromagnetic radiation at a wavelength of 590 nm in a liquid form (Instant claims: 16; Cited patent claims and disclosure: claim 1). The composition has less than or equal to 10,000 particles per milliliter of particles having a particle size of 10 microns or greater; or less than or equal to 300 particles per milliliter of particles having a particle size of 25 microns or greater (Instant claims: 17, 18; Cited patent claims and disclosure: claim 12, 13). The composition further comprises an active agent, including an anti-infective agent, including an antibiotic, an anti-tumor agent, an anti-inflammatory agent, a pain-controlling agent, an anti-rheumatic agent, a bisphosphonate, a supplementary growth factor, a supplementary cytokine, an amino acid, a protein, a vaccine, a hormone, a vitamin, a phytoestrogen, fluoride, or combinations thereof (Instant claims: 19, 20; Cited patent claims and disclosure: claim 14-17).
The composition is administered one or more times per day; the subject receives at least 1 mL of the composition via inhalation every 24 hours; and the subject further receives at least 1 mL of the composition intravenously every 24 hours (Instant claims: 22, 25, 26; Cited patent claims and disclosure: claim 7, 8; Col. 21, line 55 to Col. 22, line 55).
Response to Arguments
Applicant requests the double patenting rejections be held in abeyance until allowable subject matter is found.
The double patenting rejections are maintained.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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