Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This Office Action is a response to Applicant’s Election filed May 7, 2026.
Claim 1 has been amended.
Claims 1-25 are pending in the instant application.
Election/Restrictions
Applicant’s species election (without traverse) of SARS-CoV-2 in the reply filed on May 7, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-25 have been examined on the merits as detailed below:
Information Disclosure Statement
Applicant's information disclosure statement (IDS) filed May 7, 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant's IDS filed March 16, 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant's IDS filed September 8, 2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Priority
Acknowledgment is made of Applicant's claim for foreign priority based on KR 10-2021-0029927 filed March 8, 2021. The certified copy has been placed in the file.
Drawings
The Drawings filed September 8, 2023 are objected to because Figs. 1-9 of the instant application lack eligible features due to pixelation. In addition, the Y- and X-axis of Fig. 1 cannot be determined. 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.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
For the instant application, applicant uses improper section headings such as ‘BACKGROUND ART’ instead of ‘BACKGROUND OF THE INVENTION’ or ‘DESCRIPTION’ instead of ‘BRIEF SUMMARY OF THE INVENTION’.
The use of the term GreenStarTM, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 13 and 15 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 pre-AIA the applicant regards as the invention.
The claims are rejected under 35 U.S.C. 112, second paragraph, as being indefinite since the Applicant does not disclose in the claims, or the instant specification, the units associated with molecular weight. It is unclear what the units of the molecular weights recited in the instant claims refers to. Correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4.Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 3-25 are rejected under 35 U.S.C. 103 as being unpatentable over Yingshan et al. (Molecules, 2016 Vol. 21:pages 1-32) (submitted and made of record on the IDS filed March 16, 2026) in view of PYoung et al. (Journal of Biological Chemistry, 2016 Vol. 291:6433-6446) (submitted and made of record on the IDS filed March 16, 2026) and further in view of Youngren et al. (KONA Powder and Particle Journal, 2015 Vol. 33:63-85) (submitted and made of record on the IDS filed May 7, 2026).
The claims are drawn to a pharmaceutical composition for preventing or treating respiratory viral infection, pulmonary fibrosis caused by viral infection, or respiratory disease, the pharmaceutical composition comprising a double-stranded oligonucleotide structure comprising a structure represented by the following Structural Formula 1:
PNG
media_image1.png
30
144
media_image1.png
Greyscale
, wherein the pharmaceutical composition is administered using a nebulizer, wherein A represents a hydrophilic compound, B represents a hydrophobic compound, X and Y each independently represent a simple covalent bond or a linker-mediated covalent bond, and R represents a double-stranded oligonucleotide.
Yingshan et al. is a review article describing the pulmonary delivery of double stranded oligonucleotides such as siRNA molecules. Yingshan et al. teaches that such double stranded oligonucleotides can be taken up by inhalation See Tables 2 and 6, for example. Furthermore, Yingshan et al. refers to so-called SAMiRNA nanoparticles targeting amphiregulin that are used in the treatment of pulmonary fibrosis. SAMiRNA nanoparticles are formed by siRNA molecules that are conjugated to a hydrophilic moiety and a hydrophobic moiety. See Figure 1.
PYoung et al. describes in detail the structure and manufacture of the comprising siRNA molecules targeting amphiregulin and their use in the treatment of pulmonary fibrosis. See Figures 5 to 9, for example.
Youngren et al. teach siRNA delivery systems formulated as aerosols can be successfully delivered via inhalation or jet (pneumatic), vibrating mesh/membrane, and/or smart nebulizers to the pulmonary region.
Starting from Yingshan et al. and looking for further siRNA molecules suitable for the treatment of respiratory diseases the skilled person would have been motivated to use nebulizers to administer the so-called SAMiRNA nanoparticles by inhalation in such treatments of respiratory diseases. Yingshan et al. already refers to these SAMiRNA nanoparticles in the context of the treatment of pulmonary fibrosis, i.e. in the context of the treatment of a respiratory disease. As a review article, Yingshan et al. reflects the common general knowledge of the skilled person working in the field of respiratory diseases. Yingshan et al. also reflects the common general knowledge that siRNA molecules have been frequently used to treat different respiratory diseases such as asthma, pulmonary fibrosis or viral diseases caused by pathogenic viruses such as SARS-CoV-2, for example.
Before the effective filing date of the claimed invention, a pharmaceutical composition for preventing or treating respiratory viral infection, pulmonary fibrosis caused by viral infection, or respiratory disease, the pharmaceutical composition comprising a double-stranded oligonucleotide structure comprising a structure represented by the following Structural Formula 1 of the present invention was known and taught in the prior art of PYoung et al. and Yingshan et al.
It would have been prima facie obvious for a person of ordinary skill in the art to administer the pharmaceutical composition by aerosol delivery as taught and suggested by PYoung et al. and Yingshan et al.
A person of ordinary skill in the art would have been motivated to modify the teachings of PYoung et al. and Yingshan et al. to administer the pharmaceutical composition by nebulizer since Youngren et al. taught nebulizers generate liquid aerosols that can deliver saline-based solutions or suspensions of drug product at large volumes via inhalation.
Therefore, the subject matter of claims 1 and 3-25 is obvious over Yingshan et al. in view of PYoung et al. and further in view of Youngren et al.
Improper Markush Groups
Claim 23 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of a gene selected from the group consisting of amphiregulin, RelA/p65, and SARS-CoV-2 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The groupings do not share a single structural similarity. Between these three different genes, they do not share a single structural similarity as they are encoded by different nucleotides.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 3-25 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12037589 B2 in view of Youngren et al. (KONA Powder and Particle Journal, 2015 Vol. 33:63-85) (submitted and made of record on the IDS filed May 7, 2026). An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the compound having a structure of Formula (3) or (4):
PNG
media_image2.png
306
600
media_image2.png
Greyscale
of U.S. Patent No. 12037589 embraces the pharmaceutical composition for preventing or treating respiratory viral infection, pulmonary fibrosis caused by viral infection, or respiratory disease, the pharmaceutical composition comprising a double-stranded oligonucleotide structure comprising a structure represented by the following Structural Formula 1:
PNG
media_image1.png
30
144
media_image1.png
Greyscale
, wherein the pharmaceutical composition is administered using a nebulizer, wherein A represents a hydrophilic compound, B represents a hydrophobic compound, X and Y each independently represent a simple covalent bond or a linker-mediated covalent bond, and R represents a double-stranded oligonucleotide as presently claimed. NOTE: The compound having a structure of Formula (3) or (4) of 12037589 is used for treating fibrosis-related diseases and respiratory diseases and is administered by inhalation. Also NOTE: The pharmaceutical composition for preventing or treating respiratory viral infection, pulmonary fibrosis caused by viral infection, or respiratory disease, the pharmaceutical composition comprising a double-stranded oligonucleotide structure comprising a structure represented by the following Structural Formula 1 of the present invention may also comprise a structure of Formula (3) or (4) of 12037589 and may form a DNA/RNA hybrid.
Youngren et al. teach siRNA delivery systems formulated as aerosols can be successfully delivered via inhalation or jet (pneumatic), vibrating mesh/membrane, and/or smart nebulizers to the pulmonary region.
The claims of U.S. Patent No. 12037589 in view of Youngren et al. overlaps in scope, encompasses and fully embraces that which is claimed in the present invention.
A terminal disclaimer disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12037589 is required, or some other appropriate action.
Conclusion
Claim 2 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims Free of the Prior Art
Claims drawn to a pharmaceutical composition for preventing or treating respiratory viral infection, pulmonary fibrosis caused by viral infection, or respiratory disease, the pharmaceutical composition comprising a double-stranded oligonucleotide structure comprising a structure represented by the following Structural Formula 1:
PNG
media_image1.png
30
144
media_image1.png
Greyscale
, wherein the pharmaceutical composition is administered using an ultrasonic nebulizer, wherein A represents a hydrophilic compound, B represents a hydrophobic compound, X and Y each independently represent a simple covalent bond or a linker-mediated covalent bond, and R represents a double-stranded oligonucleotide are free of the art.
The present application teaches and demonstrates that following ultrasonic nebulization, 144.18 ug/g (1.3%) SAMiRNA (self-assembled micelle interfering RNA) was delivered to lung tissue and the SAMiRNA was evenly distributed throughout lung tissues, such as alveoli and bronchi. See Examples 6-3 through Examples 6-6.
However, Youngren et al. (KONA Powder and Particle Journal, 2015 Vol. 33:63-85) (submitted and made of record on the IDS filed May 7, 2026) disclose, “Chemical and physical stability of the naked siRNA during the nebulization process is of high concern”; “Ultrasonic nebulizers utilize a piezoelectric crystal vibrating at high frequencies of 1-3 MHz to produce aerosols… These types of nebulizers have the limitations of large residual volumes, inability to aerosolize viscous solutions, and degradation of heat sensitive materials”; “Therefore, ultrasonic nebulizers may not be useful for suspensions of naked siRNA or siRNA nanocarriers”. See also Taylor K.M. and McCallion O.N. (International Journal of Pharmaceutics Vol. 153 (1997) 93-104) and Watts et al. (Drug Development and Industrial Pharmacy, Vol. 34:913-922, 2008). For example, Taylor K.M. and McCallion O.N. disclose: “Suspensions are generally less efficiently delivered by ultrasonic than jet nebulizers with an inverse relationship between the size of suspended particles and their output”. Watts et al. teach, “Residual formulation due to "dead" volume, inability to aerosolize viscous solutions, settling of suspensions, and degradation of heat-sensitive materials are some of the common problems encountered with traditional ultrasonic nebulizers”.
Therefore, it is considered that a person of ordinary skill in the art who has read Youngren et al., Taylor K.M. and McCallion O.N. and Watts et al. would not have been motivated to administer the claimed pharmaceutical composition for preventing or treating respiratory viral infection, pulmonary fibrosis caused by viral infection, or respiratory disease, the pharmaceutical composition comprising a double-stranded oligonucleotide structure comprising a structure represented by the following Structural Formula 1:
PNG
media_image1.png
30
144
media_image1.png
Greyscale
using an ultrasonic nebulizer, nor would it have been considered obvious.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO's Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO's Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO's PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199.
/TERRA C GIBBS/Primary Examiner, Art Unit 1635
Prosecution Insights