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.
Claim 9 and dependents therein 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. The limitation to gas jets and liquid surface tension “are controlled to form a plurality of droplets” describes a method step, whereas the claim is directed to an atomization device. As such, the metes and bounds of the phrase are unclear. Examiner recommends replacing the phrase with “are configured to be controlled to form a plurality of droplets” (emphasis added).
Claim Objections
Claim 1 is objected to because of the following informalities: “biological material bacteriophage” should be amended to recite “biological material or bacteriophage”. The deletion of “or” in claim 1 must be a typo, as clear from applicant’s arguments on p. 5, paras. 6 and 7 (reciting/arguing the claim language of “providing a liquid comprising a dispersed active biological material or bacteriophage”), as well as from the similarly amended claim 9. Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 1, 3 – 5, 7, and 9, and 11 - 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mezhericher (“Aerosol-assisted synthesis of submicron particles at room temperature using ultra-fine liquid atomization”), or under the alternative under 35 U.S.C. 103 as being unpatentable over Mezhericher in view of Chang (“Phage Therapy for Respiratory Infections”).
Regarding claim 1, Mezhericher discloses a method for creating aerosols of droplets, aerosols of particles, or powders, comprising: providing a liquid comprising a dispersed active biological material (see p. 607, c. 1, para. 1, p. 618, c. 2, para. 2, biotechnological precursor solution, which is left functional per p. 618, c. 1, para. 3; solutes in precursor solution are dispersed via mixing, see general teaching on p. 610, c. 2, para. 1; see also list in Fig. 8, active biomolecules such as “whey protein” or “trehalose”; examiner notes that applicant has defined “active” to refer to the product that induces the therapeutic effect, akin to “active ingredient”, see provided specification, p. 4: ll. 15 – 23; as such, the active biological material may include biomolecules such as amino acids, nucleotides, polysaccharides or simple sugars, and lipids, see p. 9: 4 - 8), aerating the liquid in an atomization chamber to form bubbles, such that the bubbles rise to a surface of the liquid (see p. 608, c. 1, para. 1, Fig. 1a, illustrating aerating gas forming bubbles that then rise to the surface; see Fig. 2a, element 1, for illustration of the atomization chamber); forming a submicron droplet aerosol by causing a gas jet to be directed through an opening in a tube towards at least one of the bubbles in the atomization chamber (see p. 608, c. 1, para. 1, Fig. 1a, illustrating gas jets passing through the bubbles to form droplets; see Fig. 1b illustrating the submicron size) and controlling a ratio of energy rates supplied by the gas jet and dissipated by the liquid surface tension of the at least one of the bubbles (p. 615. c. 1, para. 2 – c. 2: para. 1, see also equation 10; the energy rate is supplied by gas pressure of Pair, see applicant’s specification of [0074]; this is controlled with respect to the Ohnesorge number, which is a ratio of surface tension that dissipates the gas pressure as described in the cited paragraphs), thereby resulting in a plurality of droplets of the submicron droplet aerosol having a diameter of 0.2-1 um (p. 618, c. 1, para. 3, p. 608, c. 1, para. 1) optionally forming a dry particle aerosol via solvent evaporation of the submicron droplet aerosol (see Figs. 2a and 2b, drying pipe 3, p. 610, c. 1, para. 1); and optionally forming a powder of submicron or nano-structured particles by passing the dry particle aerosol through a particle collector (see Figs. 2 and 2b, trap 4, p. 610, c. 1, para. 1).
Without admitting otherwise, it is additionally noted that it would have been obvious to modify the functional biotechnological aerosol of Mezhericher to include a bacteriophage. Chang discloses a method of creating aerosols to produce viable bacteriophage at 1 um diameter for inhalatory treatment, see p. 5. Para. 3. Chang additionally discloses that the bacteriophage may be used to form a dry particle via spray drying at low temperatures to produce viable bacteriophage for inhalatory treatment, see p. 6: paras. 2 - 3. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the aerosol liquid of Mezhericher to comprise a bacteriophage as taught in Chang for the benefit of producing an aerosol or spray dried bacteriophage used in inhalatory treatments such as for bacterial respiratory infections, see abstract. The liquid and dry powder formulations for nebulization and inhalation have been extensively studied to determine safety and efficacy, see. p. 2, para. 2, as well as p. 5, para. 3, p. 6, paras. 2 - 3.
3. The method according to claim 1, wherein a pressure of a gas provided to the tube in order to cause the gas jets is based on a viscosity of the liquid (see Fig. 7b, wherein the generate flow rate of droplets depends on the ohnesorge number, a measure of viscocity, and pressure is chose accordingly; see p. 616, equation 10, and p. 615, c. 2, para. 1).
4. The method according to claim 1, wherein a viscosity of the liquid is between 5 and 1000 times the viscosity of water (p. 609, c. 2, para. 1).
5. The method according to claim 1, wherein the solvent evaporation involves subjecting the droplet aerosol a gas having a temperature between 0° C. and 120° C (p. 609, c. 2, para. 2).
7. The method according to claim 1, wherein the submicron droplet aerosol or dry particle aerosol is then provided to a patient (pharmaceuticals are by definition provided to patients).
9. A system for creating aerosols of droplets, aerosols of particles, or powders, comprising: an atomization chamber; a tube within the atomization chamber, the tube configured to be partially submerged in a liquid, the tube comprising openings through a side wall of the tube, the openings arranged such that at least some openings are configured to direct a gas jet towards a bubble on a surface of the liquid to form a submicron droplet aerosol, the liquid containing a dispersed active biological material or bacteriophage, wherein a ratio of energy rates supplied by the gas jet and dissipated by the liquid surface tension of the bubble are controlled for form a plurality of droplets of the submicron droplet aerosol having a diameter of 0.2-1 um optionally, at least one chamber configured to form a dry particle aerosol via solvent evaporation of the submicron droplet aerosol; and optionally, a particle collector configured to collect dry particles from the dry particle aerosol (see claim 1 above; examiner additionally notes that the system need only be fully capable of controlling formation of the droplets, e.g. upon selection of the appropriate pressure and liquid; see discussion in section 35 USC 112(b) above).
11. The system according to claim 9, wherein an air pressure of the gas jet is based on a viscosity of the liquid (see claim 3 above).
12. The system according to claim 9, wherein a viscosity of the liquid is between 5 and 1000 times the viscosity of water (see claim 4 above).
13. The system according to claim 9, wherein the at least one chamber is configured to subject the submicron droplet aerosol to a gas having a temperature between 0° C. and 120° C (see claim 5 above).
14. The system according to claim 9, wherein the at least one chamber is configured to subject the submicron droplet aerosol to lyophilization (claim is anticipated, because the features of claim 14 depend on an optional limitation).
15. The system according to claim 9, wherein the submicron droplet aerosol or dry particle aerosol is configured to be introduced in-line with a ventilation machine (the atomization chamber has an outlet sized as fully capable of being fitted to a T-connection introducing the aerosol in line with a ventilation machine).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mezhericher, or alternatively Mezhericher in view of Chang, in view of “Atomization of liquids by disintegrating thin liquid films using gas jets” (hereinafter “Mezhericher 2”).
Regarding claims 6, Mezhericher discloses the method according to claim 1. Mezhericher 2 discloses a similar method of producing aerosol (see Figs. 1a and 1b), wherein the aerosol formed into a dry particle via a solvent evaporation step includes lyophilization (see p. 99, c. 1, para. 1 “spray freeze drying”; see also evidencing reference to “Spray-freeze-drying: A novel process for the drying of foods and bioproducts”, spray freeze drying involves a solution being atomized, solidified and sublimed at low temperature and pressure). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the aerosol of Mezhericher according to the aerosol lyophilization disclosed in Mezhericher 2 for the benefit of a widely used process of forming dry particles that prevents against thermal degradation.
14. The system according to claim 9, wherein the at least one chamber is configured to subject the submicron droplet aerosol to lyophilization (see claim 6 above).
Claim(s) 7, 8, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mezhericher, or alternatively Mezhericher in view of Chang, in view of Boehm (US 20070119449).
Regarding claim 7, Mezhericher discloses the method according to claim 1. Boehm discloses a nebulizer that generates aerosol via jet pressure, wherein the droplet aerosol is then provided to a patient (see [0025], [0070]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the atomization chamber of Mezhericher for introduction in-line with a ventilation machine as taught in Boehm for the benefit of providing the aerosol medicament while ventilating the patient, see [0002, 0003].
8. The method according to claim 7, wherein the patient is being treated with a ventilation machine, and the submicron droplet aerosol or dry particle aerosol is introduced in-line with the ventilation machine (see claim 7 above).
15. The system according to claim 9, wherein the submicron droplet aerosol or dry particle aerosol is configured to be introduced in-line with a ventilation machine (see claim 7 above).
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, 5, 6, 7, 13, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. US 10384218 B2 in view of Mezhericher. Mezhericher renders obvious an active biological material for the benefit of pharmaceutical applications, as well as controlling a ratio of energy rates supplied by the gas jet and dissipated by the liquid surface tension of the at least one of the bubbles thereby resulting in a plurality of droplets of the submicron droplet aerosol having a diameter of 0.2-1 um, for the benefit of improved manufacture, see claim 1 above, as well as p. 618, c. 1, para. 4. Examiner notes that optional limitations or dependents reciting optional limitations in the application claim(s) do not require a teaching in the reference claim(s).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
On page 2, para. 2, applicant argues that Mezhericher does not disclose a solution that contains biological materials dispersed throughout. However, p. 610, c. 2, para. 1, gives the general teaching of precursor solution preparation. The paragraph discloses mixing/dispersal of the active solute in preparation of the precursor solution. Surely, not every solute is within the purview of the paper, as clear from the paragraph, as well as Fig. 8 which compares the tested solutes against other potential materials (including biological material). The disclosure in p. 607, c. 1, para. 1 and p. 618, c. 2, para. 2, states that the formed pharmaceutical and biotechnological precursor solutions are used to produce the submicron aerosols.
On page 2, para. 3, applicant states that the amended claims require the biological material be active, which implies functionality. Mezhericher discloses exactly this – the production of functional submicron aerosols made from the pharmaceutical or biotechnological precursor, see p. 618, c. 1, para. 3 (“[A] novel aerosol-assisted technology for the synthesis of functional submicron particles was developed.” (emphasis added)). For example, the materials maintain functionality because they are not subjected to treatments such as elevated temperatures, see p. 618, c. 1, para. 5, c. 2, para. 2, as well as p. 607, c. 1, para. 1.
In page 2, para. 3, applicant states that Mezhericher does not establish “that the specific biological activity of a dispersed bacteriophage or biological material” retains its biological activity. In the event applicant attempts to argue that a viable biological material such as bacteriophage – or another, such as a virus or cell – should maintain its viability, examiner notes that such an argument relies on features not claimed. Applicant has defined “active” to refer to the product that induces the therapeutic effect, akin to “active ingredient”, see provided specification, p. 4: ll. 15 – 23. As such, the active biological material may include biomolecules such as amino acids, nucleotides, polysaccharides or simple sugars, and lipids, see p. 9: 4 – 8, rather than referring to biological viability of the biological material.
Regarding applicant’s argument on p. 6, para. 4, please see the relevant sections in Mezhericher found in claim 1 above.
As such, examiner hereby maintains rejection of claims 1, 9, and dependents therein.
Conclusion
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 BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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/BRADLEY H PHILIPS/ Primary Examiner, Art Unit 3799