DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to claims filed 9/7/2022.
Claims 17-34 are pending.
The instant application is a divisional filing of U.S. Serial No. 16/301,013, filed November 13, 2018, now U.S. Patent 11,473,105 which in turn is a national stage application based on International a 371 filing of PCT/EP2017/061282 filed 5/11/2017 which claims priority to EP16169284.3 filed 5/12/2016.
Information Disclosure Statement
An information disclosure statement filed 9/26/2026 has been identified and the documents considered. The corresponding signed and initialed PTO Form 1449 has been mailed with this action. The documents listed as foreign office actions have been considered but have been crossed off the 1449 so that it will not appear on the face of any patent issuing from the instant application.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities: when referring to SEQ I DNO:’s, reference should be made to –the nucleotide sequence of SEQ ID NO:--. For completeness, claim 17 and 18 should be adjusted as should claims 22, 23 and 28-30.
It is noted that once allowable subject matter is identified, abbreviations are only necessary on the first occurrence. Thereafter, only the abbreviation is used.
Appropriate correction is required.
Claim 30 is objected to under 37 CFR 1.75 as being a duplicate of claim 29. The two claims are exact duplicates of one another. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 33 is 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.
Claim 33 recites the limitation "the recombinant adenovirus" in claim 28. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22-27 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method for expressing at least two transgenes in a cell, the method comprising: directly administering to the cell with a recombinant adenovirus comprising in the E1 gene, a recombinant nucleic acid molecule comprising a bidirectional promoter operably linked to a first transgene in one direction and to a second transgene in the opposite direction, wherein the bidirectional promoter comprises: a cytomegalovirus major immediate early enhancer as an enhancer building block, flanked by a human cytomegalovirus major immediate early promoter (hCMV promoter) as a first promoter building block, and a chicken beta actin promoter as a second promoter building block, with a hybrid chicken beta actin/rabbit beta globin intron as a first intron building block adjacent to and downstream of the chicken beta actin promoter, and a human apolipoprotein A-1 intron as a second intron building block directly contiguous with and downstream of the hCMV promoter building block, wherein the bidirectional promoter comprises a sequence that is at least 90% identical to the sequence of SEQ ID NO: 4, wherein the transgenes are expressed, does not reasonably provide enablement for any other embodiment. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the patent coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is not based on a single factor but is rather a conclusion reached by weighing many factors (See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter, 1986) and In re Wands, 8USPQ2d 1400 (Fed. Cir. 1988); these factors include the following:
1) Nature of invention. The instant claims are drawn to a method of expressing transgenes in a cell using recombinant technology.
2) Scope of the invention. The scope of the invention is limited as to the promoter. However, the cell, the transgene, the delivery vector and mode of administration are broadly recited.
3) Number of working examples and guidance. The specification teaches development of adenovirus comprising bidirectional promoters and in vitro assessment of stability and potency of the vector. This construct tested comprised an E1 deletion with the bidirectional cassette inserted therein.
4) State of the art. Use of bidirectional promoters was well known and provided benefits for plasmids and vectors expression (see page 7) especially in vivo to save space and provide improved expression of dual genes (see e.g. translation of WO 0213758, page 3).
5) Unpredictability of the art. The claims can read on in vitro expression as well as in vivo expression. As well, use of a recombinant vector means the sequence can be mRNA or DNA. However, the disclosure does not provide sufficient guidance to overcome art recognized obstacles for in vivo delivery. In the absence of such guidance, one must rely on the art known methods. The art known methods for administration of nucleotides is that these must be administered directly. There simply is no other way the obstacles i.e. organ barriers, failure to persist, side-effects in other organs, neutralizing antibodies, humoral immunity, normal tropism of the vector to other organs and more (see Hosseini-Kharat, Journal of Controlled Release 378 (2025) 170–194, abstract and page 171, Honrath et al, International Journal of Pharmaceutics, 2025, page 7). The challenge is to maintain the efficiency of delivery and expression while minimizing any pathogenicity of the virus from which the vector was derived. The inability to develop an adequate means of overcoming obstacles such as humoral; responses and refractory cells limits the successful means by which the nucleic acid can be administered. The physiological art is recognized as unpredictable. (MPEP 2164.03.) In cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved. In this case, the nucleotide is broadly stated as being administered.
6) Undue experimentation. The claims have been evaluated in light of the art at the time of filing and found not to be commensurate in scope with the specification. MPEP 2164.05 teaches, “However, the examiner should carefully compare the steps, materials, and conditions used in the experiments of the declaration with those disclosed in the application to make sure that they are commensurate in scope; i.e., that the experiments used the guidance in the specification as filed and what was well known to one of skill in the art. Such a showing also must be commensurate with the scope of the claimed invention, i.e., must bear a reasonable correlation to the scope of the claimed invention. The invention recites use of a broad group of sequence. Given the unpredictability of the art, the poorly developed state of the art with regard to predicting the structural/ functional characteristics of antagonists, the lack of adequate working examples and the lack of guidance provided by applicants, the skilled artisan would have to have conducted undue, unpredictable experimentation to practice the claimed invention.”
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 28-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 28 requires induction of an immune response against two antigens. However, the source of the antigens is not provided for in the claims. Claim 31 recites that at least one transgene encodes an antigen. But, this is not part of the claim wherein inducing an immune response against at least two antigens is the goal. The disclosure
(¶0067) For example, if the two transgenes encode antigens to elicit an immune response when administered to a subject, potent expression will generate a measurable immune response against both antigens and that immune response to both antigens will preferably be the same or better than the immune response generated by a corresponding monovalent vector or rAd expressing a single antigen under the control of an hCMV promoter.
To the contrary, the claims are drawn to any transgene and yet require induction of an immune response to two antigens.
To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art). As recited, the method lacks critical elements that provide necessary function.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
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).
Claims 27-34 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. Patent 11,781,155 (copending Application No. 17/204312).
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1-5 and 8-14 of U.S. Patent 11,781,155. That is, the cited claims of U.S. Patent 11,781,155 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, the claims of U.S. Patent 11,781,155 are drawn to the construct used in the instant claims as well as overlapping methods. The difference between the two is that the instant claims limit the linkage between A-1 intron and hCMV as directly contiguous. As to the relationship of the applications, the claims are not divisional applications of one another and therefore no safe harbor exist.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. Patent 11,781,155, then two different assignees would hold a patent to the claimed invention of U.S. Patent 11,781,155, and thus improperly there would be possible harassment by multiple assignees.
Conclusion
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/MARIA MARVICH/Primary Examiner, Art Unit 1633
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