AIA STATUS
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Reissue: Non-Final Office Action
Status of the Claims
On 08/19/2014 US Patent 8,809,293 issued to Chin et al. with claims 1-17. Claims 1-17 are cancelled; claims 18-44 are newly presented in this reissue application. Claims 18-44 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims in reissue Application No. 18/653,842.
Ongoing Duty To Disclose
Applicant(s) is/are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent 8,809,293 is or was involved. These proceedings would include any trial at the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Information Disclosure Statement
References lined-through on the information disclosure statement(s) were not considered because they were not provided. MPEP § 1406 states that in reissue applications references that have been cited during original prosecution of the patent are considered. However, should applicants wish to ensure that all of the references which were cited in the original patent are considered and cited in the reissue application, an information disclosure statement (IDS) in compliance with 37 CFR 1.97 and 1.98 should be filed in the reissue application. Note that 37 CFR 1.98 requires copies of foreign patents and other (e.g., NPL) publications to be provided. No such copies were provided with the instant reissue application.
Consent of Assignee
This application is objected to under 37 CFR 1.172(a) as lacking the written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR 1.172. See MPEP § 1410.01.
Specifically, the Consent of Assignee is signed by Robert M. Teigen, identified as "Deputy General Counsel". The MPEP states that an officer (chief executive officer, president, vice-president, secretary, or treasurer) is presumed to have authority to sign on behalf of the organization. The signature of the chairman of the board of directors is acceptable, but not the signature of an individual director. Modifications of these basic titles are acceptable, such as vice-president for sales, executive vice-president, assistant treasurer, vice-chairman of the board of directors. In foreign countries, a person who holds the title "Manager" or "Director" is normally an officer and is presumed to have the authority to sign on behalf of the organization. A person having a title (administrator, general counsel) that does not clearly set forth that person as an officer of the assignee is not presumed to have authority to sign the submission on behalf of the assignee. The Office recommends that when a person with such a title is authorized to act on behalf of the assignee, the submission should clearly indicate that person's authority. See MPEP § 324(V).
In this case, the authority of the person signing the Consent of Assignee is not clear, and the individual does not hold a title recognized by the Office as presumed to have such authority. The person who signed the submission establishing ownership interest is not recognized as an officer of the assignee, and the person who signed it has not been established as being authorized to act on behalf of the assignee. See MPEP § 324 (for applications filed before September 16, 2012) and § 325 (for applications filed on or after September 16, 2012). A proper assent of the assignee in compliance with 37 CFR 1.172 and 3.73 is required in reply to this Office action.
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was 06/18/2024.
Claim Objections
The amended claim set filed 05/02/2024 is objected to for the following reasons:
Pursuant to 37 CFR 1.173(c), each claim amendment must be accompanied by an explanation of the support in the disclosure of the patent for the amendment (i.e., support for all changes made in the claims, whether insertions or deletions, including claims added by amendment). In the remarks dated 05/02/2024, applicants state, “Support for new claims 18-44 may be found throughout the specification, for example in column 5, line 47 to column 6, line 3; column 7, lines 25-27; column 25, line 14-53; and column 26, line 1 to column 27, line 35, and the tables provide in FIGS. 1-5.” However, this statement is insufficiently specific as it does not describe how the cited portions of the application support each new (amended) claim individually. Applicants are advised to point to support for each amended claim separately in future replies. Appropriate correction is required.
Multiple Reissue Applications
The instant case is a (reissue) CON of reissue application 17/031,826 (now abandoned), which is a (reissue) CON of reissue application 15/241,733 (issued as RE48345). 37 CFR 1.177(a) requires that all multiple reissue applications resulting from a single patent must include as the first sentence of their respective specifications a cross reference to the other reissue application(s). Accordingly, the first sentence of each reissue specification must provide notice stating that more than one reissue application has been filed, and it must identify each of the reissue applications and their relationship within the family of reissue applications, and to the original patent. An example of the suggested language to be inserted is as follows:
Notice: More than one reissue application has been filed for the reissue of Patent No. 99,999,999. The reissue applications are application number 99/999,994 (the present application); and application number 99/999,995, which is a continuation reissue of Patent No. 99,999,999.
See MPEP § 1451. Therefore, applicant should file a certificate of correction in the underlying patent (case 15/241,733; RE48345) to inform the public of the presence of this application.
The specification of this reissue application properly identifies two other reissue applications: 15/241,733 (now reissue patent RE48,345) and 17/031,826 (now abandoned). The specification of reissue patent RE48,345, however, has not been amended by certificate of correction to refer to the instant reissue application. See 37 CFR 1.177(a); MPEP 1451(I) (“The examiner should object to the specification and require an appropriate amendment if applicant fails to include such a cross reference to the other reissue applications in the first sentence of the specification of each of the reissue applications.”).
Broadening Reissue
The instant reissue application was filed on 05/02/2024, and is a CON reissue application 17/031,826 (filed on 09/24/2020), which is within a CON of reissue application 15/535,454 (filed on 08/19/2016), which was filed within two years of the issue date of US Patent 8,809,293 (issued on 08/19/2014); each of these applications has a broadened claim (e.g., claim 18 in the instant case); and has clear intent to broaden the claim.
The broadening in this Reissue Application does not recapture claimed subject matter that was deliberately added, or argued to overcome a rejection in the original application or an application in the patent family.
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 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
US Patent RE48,345
Claims 18-23, 28-31, and 36-44 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 48-50 and 53-69 of US Patent RE48,345. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '345 claims anticipates or renders obvious that of the instant claims. The difference between the two claim sets is that the '345 claims recite nucleotides 1-19 of SEQ ID NO: 158 while the instant claims only require nucleotides 2-18 of SEQ ID NO: 158. Thus, the instant claims are slightly broader than, and are anticipated by, the '345 claims.
Claims 24-27 and 32-35 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 48-50 and 53-69 of US Patent RE48,345 as applied to 18-23, 28-31, and 36-44 above, and further in view of ZHU (Zhu, L., et al. Bioconjug. Chem. (2010), 21(11); 2119-2127). Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '345 claims anticipates or renders obvious that of the instant claims.
Regarding instant claims 24-27 and 32-35, Zhu reports on targeted delivery of siRNA to hepatocytes by bioconjugation (title; abstract). Zhu teaches conjugation of galactose to siRNA can stabilize the oligonucleotide, prolong its circulation time, and effect specific delivery to hepatocytes, where the delivered siRNA can efficiently silence targeted genes (p. 2; pgs. 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have conjugated dsRNA molecules to ligands such as galactose and other carbohydrates.
Conclusion
Claims 18-44 are rejected. No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at (571) 272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-9900.
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.
Information regarding the status of applications may be obtained from Patent Center. Patent Center is available to registered users regarding unpublished application information. To file and manage patent submissions, visit: https://patentcenter.uspto.gov and for more information visit https://www.uspto.gov/patents/apply/patent-center and https://www.uspto.gov/patents/docx. The fax number for the organization where this application is assigned is (571) 273-8300. For additional questions, contact the Electronic Business Center (EBC) at (866) 217-9197. If you would like assistance from a USPTO Customer Service Representative, call (800) 786-9199 or (571) 272-1000.
/Kevin S Orwig/ Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/ Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/ SPRS, Art Unit 3991
Prosecution Insights