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 .
Response to Amendments
The Amendment filed 6/4/026 has been entered. Claims 1-3, 5-6, 8, 14, 18, 23, 26, 29, and 31 were amended, and claims 4, 7, 9, 12-13, 19-22, 24-25, and 30 were canceled. Thus, claims 1-3, 5-6, 8, 10-11, 14-18, 21-23, 26-29, and 31 are pending in the application.
Drawings
The drawings are objected to because: Fig. 23 contains unlabeled text box 240 which should be provided with a descriptive text label (e.g. box 240 could have the label --handle--) (see MPEP 608.02(d)(a)).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “integrity” in line 2, and is suggested to read --an integrity-- in order to be grammatically correct.
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 23, 26-29, and 31 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.
Regarding claim 5, the limitation “epithelial cells” in line 4 is confusing, as it is unclear is to whether this limitation is meant to be the same as or different from “epithelial cells” in line 3. For the purposes of examination, they will be interpreted as the same limitation.
Regarding claim 23, the phrase "or an equivalent thereof" in lines 5-6 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "an equivalent thereof"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Regarding claim 26, the limitations “a cage, a brush, a balloon, a loop,…or an equivalent thereof” in lines 3-4 are confusing, as it is unclear is to whether these limitations are meant to be the same as or different from “a loop, a three dimensional (3D) cage, a brush,…a balloon,…or an equivalent thereof” in claim 23. For the purposes of examination, they will be interpreted as the same limitations. Moreover, the phrase "or an equivalent thereof" in line 4 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "an equivalent thereof"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Regarding claim 27, the limitations “a cage, a loop, or a brush” in lines 1-2 are confusing, as it is unclear is to whether these limitations are meant to be the same as or different from “a loop, a three dimensional (3D) cage, a brush” in claim 23. For the purposes of examination, they will be interpreted as the same limitations.
Regarding claim 29, the phrase "or an equivalent thereof" in line 9 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "an equivalent thereof"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Any remaining claims are rejected based on their dependency on a rejected base claim.
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, 5-6, 8, 14-15, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Danek et al. (US 2006/0137698 A1).
Regarding claim 1, Danek discloses a non-surgical method of delivering an agent to a respiratory system of a subject (The Applicant’s specification para. [0049] defines “non-surgical” as an action on the body that does not involve cutting into the body. Danek does not cut into the body, but rather scrapes the walls of an airway of a patient before advancing a treatment device for depositing a substance on the scraped wall.) (Fig. 4; para. [0077]), the method comprising in vivo perturbing of an airway surface in one or more parts of the respiratory system in the subject, thereby resulting in a perturbed airway surface, and exposing the perturbed airway surface to the agent, thereby delivering the agent to the respiratory system of the subject (the surface of the patient’s airway is scraped so as to be exposed for substances to be deposited upon it) (Fig. 4; para. [0077]).
Regarding claim 2, Danek discloses wherein the respiratory system comprises lungs of the subject (airway is within the lung) (Fig. 4; para. [0077]).
Regarding claim 3, Danek discloses wherein the perturbing of the airway surface comprises perturbing one or more of airway cells and epithelial cells of the subject (airway is scraped of epithelial tissue/cells in the airway) (Fig. 4; para. [0077]).
Regarding claim 5, as best understood, Danek discloses wherein perturbing of the airway surface comprises partial or substantially complete removal of epithelial cells of the airway surface (airway is scraped of epithelial tissue in the airway surface) (Fig. 4; para. [0077]).
Regarding claim 6, Danek discloses wherein perturbing of the airway surface comprises one or more of mechanical perturbation, and use of a device to perturb the airway surface (airway is scraped, which is a mechanical action that would require a device to accomplish) (Fig. 4; para. [0077]).
Regarding claim 8, Danek discloses wherein: (i) the airway surface is perturbed and the agent is subsequently or simultaneously exposed to the perturbed airway surface (airway is scraped, and then a substance is applied to the scraped airway surface) (Fig. 4; para. [0077]).
Regarding claim 14, Danek discloses wherein the subject is suffering from, or susceptible to, a disorder, and delivery of the agent to the respiratory system of the subject treats or prevents the disorder (the method is for a patient with asthma, and involves treating their airway wall with substances) (abstract; para. [0077]).
Regarding claim 15, Danek discloses wherein the subject is suffering from, or susceptible to, a pulmonary disorder (the method is for a patient with asthma) (abstract).
Regarding claim 18, Danek discloses wherein the method is used to improve delivery of the agent to the subject, for administration of the agent to the subject, to deliver therapeutic cells to the subject, or to treat the subject suffering from, or susceptible to, a disorder (this method is for treating a patient with asthma; treatment can include scraping the airway to help treat the airway walls more effectively with an applied substance such as epithelial tissue, collogen, or growth factors on the scraped airway surface) (Fig. 4; abstract; para. [0077]).
Claims 1, 10-11, 15-17, 29, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Askew et al. (US 2009/0192505 A1).
Regarding claim 1, Askew discloses a non-surgical method of delivering an agent to a respiratory system of a subject (The Applicant’s specification para. [0049] defines “non-surgical” as an action on the body that does not involve cutting into the body. Askew does not cut into the body, but rather uses a device to apply a cryogenic spray therapy and drug delivery to the lung tissue of a patient.) (Figs. 1A-4; abstract; para. [0001]; para. [0011]), the method comprising in vivo perturbing of an airway surface in one or more parts of the respiratory system in the subject, thereby resulting in a perturbed airway surface, and exposing the perturbed airway surface to the agent, thereby delivering the agent to the respiratory system of the subject (delivery of an additive to cryotreated lung tissue) (Figs. 1A-4; para. [0156]; para. [0173]).
Regarding claim 10, Askew discloses wherein the agent comprises a nucleic acid, a virus, a viral vector, a nanoparticle, a gene-editing agent, a small molecule, a drug, a protein, a lipid, or a cell (agent administered can include naked or complexed nucleic acids, viruses, viral vectors, nanotechnology, gene therapy agents, aerosols, pharmaceuticals, protein molecules, lipids, stem cells, etc.) (para. [0080]; paras. [0156-0157]; para. [0166]).
Regarding claim 11, Askew discloses wherein; (i) the nucleic acid comprises naked RNA, naked DNA (substance delivered can be naked DNA, mRNA) (para. [0080]; para. [0156]); (ii) the virus or viral vector is selected from an adenovirus (virus/viral vector can include adenoviruses/adenoviral vectors) (para. [0080]; para. [0166]; para. [0176]); and (iii) the cell is a stem cell or a progenitor cell (therapeutic agent can be stem cells) (para. [0157]; para. [0166]).
Regarding claim 15, Askew discloses wherein the subject is suffering from, or susceptible to, a pulmonary disorder (asthma, neoplastic disease, COPD, and other patient conditions can be treated) (abstract; para. [0123]).
Regarding claim 16, Askew discloses wherein the pulmonary disorder is a genetic pulmonary disorder (COPD can be heredity) (para. [0004]).
Regarding claim 17, Askew discloses wherein the agent comprises a nucleic acid for expression and the method produces detectable expression from the nucleic acid in the respiratory system for at least 7 days (genes and gene delivery vehicles, such as viral vectors, can include naked or complexed nucleic acids such as DNA and mRNA; vector systems can express the desired genetic material for at least one week) (para. [0080]; para. [0157]; para. [0166]; para. [0179]).
Regarding claim 29, as best understood, Askew discloses a device for delivering of an agent to a respiratory system (bronchoscope 10 to apply a cryogenic spray therapy and drug delivery to the lung tissue of a patient) (Figs. 1A-4; abstract; para. [0001]; para. [0011]; para. [0130]), the device comprising: a component for perturbing a surface of an airway of the respiratory system (bronchoscope 10 has a catheter 20 coupled to a cryogen source to spray onto the targeted lung tissue, thereby perturbing the lung tissue surface with cold) (Figs. 1A-4; para. [0133]; para. [0140]; para. [0173]); a port for introducing the agent into the device to deliver the agent to the perturbed airway surface (bronchoscope 10 has an additional lumen 22 for an additional catheter to deliver therapeutic agents to the cryotreated lung tissue; additional lumen 22 would have to have a port outside the patient with which to insert the additional catheter with the therapeutic agents) (Figs. 1A-4; para. [0130]; para. [0173]); and an outlet to permit delivery of the agent to the perturbed airway surface, wherein the component for perturbing the airway surface comprises cold or an equivalent thereof (the additional lumen 22 for the additional catheter to deliver therapeutic agents to the cryotreated lung tissue has an outlet port inside the lung; therapeutic agents, additives, or substances for gene delivery such as plasmids or adenoviral vectors come from the outlet) (Figs. 1A-4; para. [0130]; para. [0166]; para. [0173]).
Regarding claim 31, Askew discloses a non-surgical method (The Applicant’s specification para. [0049] defines “non-surgical” as an action on the body that does not involve cutting into the body. Askew does not cut into the body, but rather uses a device to apply a cryogenic spray therapy and drug delivery to the lung tissue of a patient.) (Figs. 1A-4; abstract; para. [0001]; para. [0011]) comprising using the device according to claim 29 (see rejection of claim 29 above) to perturb the airway surface in the subject and expose the perturbed airway surface to the agent, wherein the method delivers the agent to the subject (delivery of an additive to cryotreated lung tissue) (Figs. 1A-4; para. [0156]; para. [0173]).
Claims 23 and 26-27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mathis (US 2022/0346828 A1).
Regarding claim 23, as best understood, Mathis discloses a device for perturbing an airway surface in vivo in a subject (system for abrading a patient lung airway wall via a bronchoscope) (abstract), wherein the device in use produces an uncontrolled or controlled abrasive, expansive and/or distensive perturbation to the airway surface in the subject; wherein the device comprises a bronchoscope, a brush, a balloon, a scraper, or an equivalent thereof (pulmonary treatment device 13 has an expandable balloon body 80 with abrasive grit 82, 95 used to abrade off the epithelium layer 83 of airway tissue; alternatively, pulmonary treatment device 13 can have an abrasive brush 270 for the abrasion of the airway tissue; pulmonary treatment device 13 in a bronchoscope 1) (Figs. 6-8B, 16; para. [0228]; paras. [0304-0305]; para. [0314]; para. [0334]).
Regarding claim 26, as best understood, Mathis discloses wherein the device comprises an abrasive and/or an expandable component for perturbing the surface of the airway, wherein the abrasive and/or the expandable component comprises a brush, a balloon, or an equivalent thereof (pulmonary treatment device 13 has an expandable balloon body 80 with abrasive grit 82, 95 used to abrade off the epithelium layer 83 of airway tissue; alternatively, pulmonary treatment device 13 can have an abrasive brush 270 for use on lung tissue) (Figs. 6-7D, 16; para. [0228]; paras. [0304-0305]; para. [0334]).
Regarding claim 27, as best understood, Mathis discloses wherein the device comprises a brush configured for use in the respiratory system (pulmonary treatment device 13 can have an abrasive brush 270 for use on lung tissue) (Fig. 16; para. [0228]; para. [0334]).
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.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Mathis as applied to claim 23 above, and further in view of Danek and Askew.
Regarding claim 28, Mathis discloses the invention as previously claimed, but does not disclose wherein the device comprises a port to permit introduction of an agent in a vehicle into the device, and an outlet to permit delivery of the agent in the vehicle to the perturbed surface of the airway.
However, Danek teaches a treatment device for an asthmatic lung (Danek; abstract) wherein an agent is delivered to the perturbed surface of the airway, wherein the perturbation is from scraping/abrading the airway (substance is deposited on a scraped epithelial wall of an airway) (Danek; para. [0077]). Moreover, Askew teaches a bronchoscope used to hold a catheter to perturb an airway surface and a catheter to apply a substance to the perturbed airway surface (bronchoscope 10 has a lumen 18 for the catheter 20 used to apply the cryogen to the respiratory tract and an additional lumen 22 for the additional catheter used to apply an additional substance) (Askew; Figs. 1A-4; para. [0130]; para. [0153]; para. [0173]) wherein the device comprises a port to permit introduction of an agent in a vehicle into the device (bronchoscope 10 has an additional lumen 22 for an additional catheter to deliver therapeutic agents to the cryotreated lung tissue; additional lumen 22 would have to have a port outside the patient with which to insert the additional catheter with the therapeutic agents; either the additional catheter through which therapeutic substances are delivered or substances for gene delivery such as plasmids or adenoviral vectors can be considered the vehicle) (Askew; Figs. 1A-4; para. [0130]; para. [0153]; para. [0166]; para. [0173]), and an outlet to permit delivery of the agent in the vehicle to the perturbed surface of the airway (the additional lumen 22 for the additional catheter to deliver therapeutic agents to the cryotreated lung tissue has an outlet port inside the lung; either the additional catheter through which therapeutic substances are delivered or substances for gene delivery such as plasmids or adenoviral vectors can be considered the vehicle coming from the outlet) (Askew; Figs. 1A-4; para. [0130]; para. [0166]; para. [0173]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Mathis device to include delivering an agent, as taught by Danek, for the purpose of helping to promote healing, prevent infection, and/or assist in clearing mucus (Danek; para. [0077]). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the Mathis bronchoscope to include a port to permit introduction of an agent in a vehicle into the device, and an outlet to permit delivery of the agent in the vehicle to the perturbed surface of the airway, as taught by Askew, for the purpose of providing a specific mechanism with which to apply the agent using the bronchoscope (Askew; para. [0130]).
Response to Arguments
Applicant's arguments filed 6/4/2026 have been fully considered but they are not persuasive.
On pages 9-10 in the “Drawings” section of the Applicant’s remarks, the Applicant argues that the drawings have been amended to overcome the drawing objections of the previous office action. The Examiner partially agrees, and has thus withdrawn those drawing objections which were addressed. However, the unaddressed drawing objection is being maintained as detailed above.
On page 10 in the “Specification/Abstract” section of the Applicant’s remarks, the Applicant argues that the abstract has been amended to overcome the abstract objections of the previous office action. The Examiner agrees, and has thus withdrawn those abstract objections.
On page 10 in the “Claims” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the claim objections of the previous office action. The Examiner agrees, and has thus withdrawn those claim objections. However, the newly amended claims have raised a new claim objection as detailed above.
On page 11 in the “Claim Interpretation” section of the Applicant’s remarks, the Applicant argues that the claims has been amended to overcome the 35 U.S.C. 112(f) impetrations of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 112(f) impetrations.
On page 11 in the “Claim Rejections Under 35 U.S.C. 112(b)” section of the Applicant’s remarks, the Applicant argues that the claims has been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections. However, the newly amended claims have raised new 35 U.S.C. 112(b) rejections as detailed above.
On page 13 in the last paragraph to page 14 in the second paragraph of the Applicant’s remarks, the Applicant argues that their specification defines “perturbation” in para. [0052] as a treatment or action that physically conditions an airway surface so as to make the airway surface more permissive to the uptake of a therapeutic agent, and which is a mild physically disruptive conditioning of the airway surface unlike the highly destructive scraping epithelial tissue in Danek. However, the Examiner respectfully disagrees. The Applicant’s specification para. [0052] recites, “The term ‘perturbation’ as used herein in the context of the present disclosure is to be understood to refer to a treatment or action that physically conditions an airway surface so as to make the surface more permissive to the uptake of an agent. As such, the term ‘perturbation’ refers to a physically disruptive conditioning of an airway surface”. This definition does not specify or limit the degree of physical disruption which can be considered “perturbation”. As such, the scaping of epithelial tissue in Danek can be considered a “perturbation” according to the definition recited in the Applicant’s specification, especially as Danek also discusses depositing substances on the scraped wall of the airway (Danek; Fig. 4; para. [0077]). Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 14 in the last paragraph to page 15 in the second paragraph of the Applicant’s remarks, the Applicant argues that Danek does not teach the therapeutic agents being nucleic acids, genetic material, gene therapy vectors, or other nucleic acid-based therapies to target cells or stem cell, and thus Danek cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the therapeutic agents being nucleic acids, genetic material, gene therapy vectors, or other nucleic acid-based therapies to target cells or stem cell) are not recited in the claims rejected under 35 U.S.C. 102(a)(1) over Danek. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 16 in the fourth paragraph to page 17 in the first paragraph of the Applicant’s remarks, the Applicant argues that the method of Askew results in gross structural alterations that permanently modifies an airway, and so does not disclose a “perturbation” as claimed. However, the Examiner respectfully disagrees. As previously discussed above, the Applicant’s definition of “perturbation” in their specification para. [0052] does not specify or limit the degree of physical disruption which can be considered a “perturbation”. As such, the cryotreatment of the lung tissue in Askew can be considered a “perturbation” according to the definition recited in the Applicant’s specification, especially as Askew also discusses the frozen cells are more susceptible to uptaking an additive or agent (Askew; Figs. 1A-4; para. [0156]; para. [0173]). Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 18 in the first paragraph of the Applicant’s remarks, the Applicant argues that Mathis causes severe mechanical damage to the airway surface which goes beyond mere perturbation, and so cannot teach the claimed device which provided a temporary epithelial perturbation. However, the Examiner respectfully disagrees. As previously discussed above, the Applicant’s definition of “perturbation” in their specification para. [0052] does not specify or limit the degree of physical disruption which can be considered a “perturbation”. As such, the abrasion of the epithelium layer of airway tissue in Mathis can be considered a “perturbation” according to the definition recited in the Applicant’s specification (Mathis; Figs. 6-8B, 16; para. [0228]; paras. [0304-0305]; para. [0314]; para. [0334]), similarly to the Danek airway surface scraping discussed above. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
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 JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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