DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. No information disclosure statement was present at the time of this office action.
Drawings
3. The drawings are objected to under 37 CFR 1.84(u)(1), which states "view numbers must be preceded by the abbreviation "FIG.". In the instant case, the view numbers of Figures 15 - 19 are preceded by the word "Figure" instead of the abbreviation "FIG.".
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
4. Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
5. The disclosure is objected to because of the following informalities:
In paragraph 0045, line 1, "showing indicating" should be indicating;
In paragraph 0086, line 1, “certain embodiments” should read “in certain embodiments”;
Paragraph 00112 has no associated text and should be removed;
In paragraph 00162, line 1, “useful” should be used;
In paragraph 00192, line 3, “indicated indicate” should be indicate.
Appropriate correction is required.
Claim Objections
6. Claims 1, 17, and 18 are objected to because of the following informalities:
The phrase “of from about” in claim 1, line 3 is grammatically incorrect;
In claim 1, lines 7 and 8; claim 17, line 2; and claim 18, line 2, the "F" acronym as part of the "RSV F-specific" is not defined in the claim. An acronym should be defined the first time it appears in the claims. For the purposes of examination, the "F" is interpreted to mean the RSV fusion protein, as defined in the specifications.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
35 USC § 112(d)
7. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
8. Claims 13 – 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 13 – 15 require the administration of two doses. Claim 7, from which claims 13 – 15 are dependent upon, requires the administration of a single dose. Therefore, claims 13 – 15 fail to further limit the subject matter of claim 7. In the interest of compact prosecution, claims 13 – 15 will be considered as dependent upon claim 8, which requires the administration of two doses as described in claims 13 – 15. However, an appropriate amendment is required. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
35 USC § 112(b)
9. 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.
10. Claims 1, 17, and 18 recite “(RSV F-specific)”. Due to the presence of parenthesis, it cannot be determined whether or not the phrase is a recited limitation. In the interest of compact prosecution, it will be interpreted that claims 1, 17, and 18 are intended to mean that there is an increase in concentrations of IgG (claim 1 and 17) and IgA (claim 1 and 18) with specificity for RSV F protein. However, an appropriate amendment is required.
Claim Rejections - 35 USC § 102
11. 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.
12. Claims 1 – 6, 8 – 11, 16 – 19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moore, M. L., et. al. (U.S. Patent No. 10,232,032; Issued 03/19/2019).
Moore, M. L., et. al. teaches an attenuated recombinant RSV that is used in a vaccine (column 28, lines 28 and 29), as recited in instant claim 1, wherein the vaccine formulation is administered intranasally, e.g., by drops, aerosol, or spray into the upper respiratory tract (column 28, lines 12 – 15), as required by instant claims 1 and 21. Column 26, lines 49 – 55 further teach that administration of the vaccine may begin within the first month of life and at intervals throughout childhood, such as at two months, six months, one year, and two years, as required by instant claim 1. Column 28, lines 4 and 5 teach that the virus can be provided in a range of about 103 – 106 plaque forming units (pfu) per dose, as recited in instant claims 1, 3 – 6, and 8 – 11. Moore, M. L., et. al. goes on to teach that the immune system of the host responds to the vaccine by producing antibodies that are specific for RSV virus proteins, e.g., F and G glycoproteins (column 25, lines 60 – 62), as recited by instant claims 1 and 16 – 18, wherein symptoms of infection, or at least symptoms of serious infection, will not occur in most individuals immunized with the attenuated RSV (column 28, lines 29 – 32), as recited in instant claim 2. Additionally, Moore, M. L., et. al. teaches an RSV genome with SEQ ID NOs: 6 (column 30, line 24), 9 (column 17, lines 25 and 26), and 20 (column 113, lines 64 and 65) that are 100% identical to the instant SEQ ID NOs: 6, 9, and 20, respectively, as recited by instant claims 1 and 19 and seen below [Figures 1 – 3].
Claim Rejections - 35 USC § 103
13. 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.
14. Claims 7 and 12 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Moore, M. L., et. al. (U.S. Patent No. 10,232,032; Issued 03/19/2019).
Moore, M. L., et. al. teaches that the virus can be provided in a range of about 103 – 106 pfu per dose (column 28, lines 4 and 5), wherein single or multiple administrations of the vaccine compositions of the disclosure can be carried out (column 28, lines 29 – 32). Moore, M. L., et. al. does not teach 107 pfu per dose, as recited in instant claims 7 and 12, or the dosing regimen for the administration of multiple doses, as required in instant claims 13 – 15. However, the compound dosage in a composition is clearly a result effective parameter that a person having ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient, i.e., the dosage and dosing regimen, needed to achieve the desired results. The principle of law states from MPEP §§ 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages," (see In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," (See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Double Patenting
14. 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.
15. Claims 1 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,232,032 (Issued 03/19/2019). Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to the same RSV genome with the same SEQ ID NO: 20. Patent claim 1 encompasses an RSV genome with at least 90% sequence identity to patent SEQ ID NO: 20. Instant claims 1 and 19 disclose that the RSV vaccine genome should be comprised of instant SEQ ID NO: 20, which has 100% sequence similarity to patent SEQ ID NO: 20, as seen below [Figure 1].
PNG
media_image1.png
699
643
media_image1.png
Greyscale
16. Claims 1 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 – 9, and 12 – 14 of U.S. Patent No. 10,792,356 (Issued 10/06/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to the same RSV genomes with the same SEQ ID NO: 6 and 9 that can be
PNG
media_image2.png
550
644
media_image2.png
Greyscale
used as a vaccine. Patent claims 1, 5 – 7, and 9 disclose a recombinant vector of the RSV genome with the NS1 gene comprising SEQ ID NO: 6; whereas patent claims 4, 6, 8, and 9 disclose the RSV genome with the NS2 gene comprising SEQ ID NO: 9. Furthermore, claims 12 – 14 indicate a vaccine from the attenuated recombinant RSV with SEQ ID NOs: 6 and 9. Instant SEQ ID NOs: 6 and 9 have 100% sequence similarity to patent SEQ ID NOs: 6, as seen above [Figure 2], and 9, as seen below [Figure 3]. See Geneva Pharms. v. GlaxoSmithKline, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer v. Teva Pharms., 518 F.3d 1353 (Fed. Cir. 2008).
PNG
media_image3.png
548
646
media_image3.png
Greyscale
Allowable Subject Matter
17. Claim 20 is objected to as being dependent upon a rejected base claim, but could be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: SEQ ID NO: 22, as recited in claim 20, was found free of the prior art. The closest sequence match is SEQ ID NO: 4 from Moore, M. L., et. al. (U.S. Patent No. 10. The instant claims do not disclose a required percent identity of the RSV genome to SEQ ID
PNG
media_image4.png
690
644
media_image4.png
Greyscale
NO: 22 and thus, is considered free of the prior art. A search for all of the sequences listed in the instant application in their entirety is prohibited by the sequence search constraints of the Scientific and Technical Information Center of the USPTO. An updated search will be conducted upon receipt of a reply, with supporting claim amendments, from the applicant.
Conclusion
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hallie N Pennington whose telephone number is (571)272-6781. The examiner can normally be reached M-Th 7-5 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet Andres can be reached at (571)272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HALLIE NICOLE PENNINGTON/Examiner, Art Unit 1671
/JANET L ANDRES/Supervisory Patent Examiner, Art Unit 1671