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 an amendment filed 5/19/2026.
Claims 1-30, 32-34, 37-39 and 41-47 are pending.
The present application is a U.S. national stage of application No. PCT/JP2021/040410, filed on November 2, 2021 which claims priority to Japanese Application No. 2020- 184495, filed November 4, 2020.
Applicant cannot rely upon the foreign priority papers to overcome this rejection because a translation of said papers has not been made of record in accordance with 37 CFR 1.55. See MPEP § 201.15. Hence, the effective filing date of the instant claims is November 2, 2021.
Information Disclosure Statement
Information disclosure statements filed 4/29/2026, 5/12/2026, 5/22/2026, 5/27/2026, 6/23/2026, 7/1/2026 and 7/9/2026 have been identified and the documents considered. There are three notations on the IDS. First, if the document has been identified and considered, it is initialed. In the case that the document could not be located, it has been crossed off of the IDS. A search of the prior references as well as those submitted with this application were scanned. Those lined through could not be found in the cases. As these appear to be missing from the file, it would be remedial to include a copy and a new 1449 with their listing in the response. Third, initials indicate that the document has been considered even if the reference is lined through.
Response to Amendments
Applicants’ amendments are sufficient to place the case in sequence compliance.
The claim objections have also been overcome by amendment.
Claim objections
It is newly noted that claim 7 requires a space between “claim” and “1” and claim 18 refers to capsid and should establish the abbreviation in this claim and thereafter use the term “cap”. Appropriate correction is required.
Claim Rejections - 35 USC § 112, second paragraph
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 17 and 23 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. These are new rejections necessitated by applicants’ amendment.
Claim 17 is vague in reciting “other”. The term “other” is a relative one not defined by the claim, no single set of conditions is recognized by the art as being “other” and because the specification does not provide a standard for ascertaining the requisite degree, the metes and bounds of this claim cannot be established. There was no first moiety or original moiety to understand what this was the other moiety to.
Claim 23 recites the limitation "the helper gene" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Response to Arguments
Applicants argue the claim is cancelled thus overcoming the rejection. However, the claim is still presented.
Claim Rejections - 35 USC § 112 ¶4 rejection
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 35 U.S.C. 112 prohibiting improper multiple dependent claims], 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.
Claim 30 is rejected under 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. Claim 30 refers to host cells of B that fall outside of the scope of claim 1. .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. This is a new rejection necessitated by applicants’ amendment.
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 1-30, 32-34, 37-39 and 41-47 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. This rejection is maintained.
The claims read on components that are claimed so broadly as to lack adequate description. The following components are not adequately described.
Claims 1, 2, 3, 15 require a “nucleic acid sequence for producing a virus vector” or comprise “a method for creating a virus vector plasmid”. However, neither the method nor the sequence has structure. This function/method is “for producing a virus vector” and the structure is in claim 1 broadly any nucleic acid sequence and in claims 2 and 3, no sequence except as being a plasmid as set forth below. The claims except for claim 10-13 do not limit the virus for which the virus vector is produced. Rather any number of virus vector plasmids are intended by the scope. But, to this end, the description does not provide the details for all but AAV.
Claims 2, 3, 15 recite that the plasmid comprises “a sequence which is replicated in hay bacillus” or that “promote plasmid replication in hay bacillus”. This again is a function in search of a structure. Claim 3 further recites that a host cell comprising “the plasmid” is placed under a condition where the plasmid is amplified. The conditions are undefined in the claim and present a required functional property without providing the structure of this condition.
The written description requirement for genus claims may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with known or disclosed correlations between function and structure, or by a combination of such characteristics sufficient to show that the applicant was in possession of the claimed genus. To this end, the disclosure teaches a narrow set of structures that appear to meet these requirements.
Starting with a nucleic acid for producing a virus vector, this is a large group of nucleic acids without any structural or specific functional properties. An indication of what is intended is found in dependent claim 18. Claim 18 provides components that could be used to produce an AAV virus which are rep and cap and helper genes, although the art teaches that these components require E4orf6, E2a and VA (see Yang, abstract and page 5, ¶1). Additional components required for rAAV production for therapeutic purposes include ITR sequences flanking on the 5’ and 3’ end of a gene of interest. The disclosure demonstrates a plasmid comprising these elements.
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As to the nucleic acid that promotes plasmid replication in hay bacillus, this again is a function with a limited structural designation. The disclosure teaches that it is an origin of replication functional in hay cells.
Examples of a sequence which is replicated in hay bacillus include a plasmid or a portion or replication origin point thereof or a variant thereof and the like, which are known to operate the rolling-circle-type replication mechanism, the theta-type replication mechanism, the oriC replication mechanism, or the replication mechanism using a phage or the like.
Hence, it seems an origin of replication is all that is actually required of this limitation and nothing specific to hay bacillus. As to sequences intended to constitute a virus, there are various descriptions but it would seem that a replication and capsid gene between a 5’ ITR and a 3’ ITR are necessary as well as helper genes (see page 5).
As to producer cells, the claims require that the plasmid alone can be used to create the virus vector. Again, given the lack of components provided for the plasmid, this is a limited descriptive element wherein the claims broadly and incompletely claim the claim. However, the producer cell as well lacks adequate description wherein the disclosure uses teaches producer cells that are mammalian cells that appropriately produce AAV. These include,
[0201] In one embodiment, the vector plasmid of the present disclosure is introduced into a producer cell to produce a virus vector. Examples of a producer cell include, but are not limited to, 911 cells, PER.C6 cells, E1-transformed amniocytes, E1-transformed A549 cells, GH329: HeLa cells, HEK293 cells, IT293SF cells, HEK293T, HEK293F, Vero cells, CHO cells, Sf9 cells, Freestyle™ 293-F, Expi293-F™, Expi293 inducible, Expi293 NGT-Viral Production Cells 1.0, Viral Production Cells 2.0, AAVpro® 293T Cell Line, Lenti-X™ 293T Cell Line, FreeStyle™ CHO-S cells, ExpiCHO-S™, and the like. Any known suitable producer cell can be selected depending on the type of the virus vector that is produced.
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).
Specifically, The claims lack adequate description to link structure to these required functions. The Court indicated that while applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a precise definition of a representative number of members of the genus, such as by reciting the structure. Structural features that could distinguish the compounds of the claimed genus from others not encompassed by the genus are missing from the disclosure. In this case, there are specific elements referenced but the claims reference these structures with broad generic functional terms that represent a large and diverse genus of elements. Furthermore, it is aptly noted that the Federal Circuit has decided that a generic statement that defines a genus of substances by only their functional activity, i.e., the ability to specifically bind a polypeptide and inhibit its function, does not provide an adequate written description of the genus. See the Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The claims recite nucleic acids and producer cell and cells in large and incomplete terms but require specific functions of these sequences. The disclosure is limited to methods and sequences for producing AAV vectors wherein the nucleic acid sequence for producing a virus is a sequence comprising rep/cap, helper genes and ITR sequences flanking a gene of interest. As to sequences for replication in hay bacillus, this is an origin of replication for hay bacillus.
Response to Arguments
Applicants argue requiring features of a particular virus or sequences for claims 1-3 or dependent claims 15, 28 and 41 would unduly narrow the present discovery. As an example, applicants argue one would be aware of a nucleic acid sequence for producing a virus vector and a sequence that facilitates replication in hay bacillus.
The rejection would not unduly narrow the present discovery as applicants have established claims that are not supported by the disclosure and hence the claims broadly and incompletely claim the inventive elements in a way that is not elucidated by the disclosure. The rejection simply limits the claims to what is commensurate in the disclosure. As to “a nucleic acid for producing a virus to form a plasmid”, this recitation is of a function required for identifying the structure. To know the structure then one must consider the structure-function relationship as disclosed in the specification. To this end, the only disclosed such sequences are Rep/Cap and helper sequences for producing AAV wherein the intent is all sequences necessary for producing the virus. These are “sequences for producing a viral vector” wherein it is not clear what the extent of nucleic acid sequences for ANY viral vector given the lack of exemplification. It could be argued that TR and Rep/Cap containing virus are described. However, the claims are drawn to ANY virus and one must determine what sequences for ANY virus are necessary to produce a virus vector. Secondly, this is complicated by reciting that the step of introducing is “to form a plasmid”. This lacks description. The only means of so achieving the results cited is to formulate a vector with an OriC. Finally, claim 15 requires a sequence required for constituting a virus. It is unclear how this sequence differs from that required in claim 1 for producing a virus. Claims 16 and on appear to define them in the same way that those producing the virus are described. This same issue arises when addressing the breadth of a plasmid characterized by alone producing a virus vector. This requires components that must be divined for any species of virus and as set forth above they are only clearly provide for TR and RepCap containing vectors must comprise an OriC. The disclosure again to this end teaches only the following,
[0300] Necessary fragments obtained from pAAV-CMV plasmid (FIG. 1), pRC2-mi342 plasmid (FIG. 2), and pHelper plasmid (FIG. 3) by cutting out by a restriction enzyme or the like (1.8 kb SbfI fragment from pAAV-CMV, 5.2 kb EagI-XmaI fragment from pRC2-mi342, and 9.3 kb BamHI-BamHI-NdeI fragment from pHelper) were linked to a plasmid for assembling, thereby constructing a recombinant plasmid.
There is no indication that the disclosed plasmid is a representative structure wherein other nucleic acid sequences for producing a virus to form a plasmid envisioned by applicants could be identified. The claims lack adequate description to link structure to the required function. The Court indicated that while applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a precise definition of a representative number of members of the genus, such as by reciting the structure. Structural features that could distinguish the compounds of the claimed genus from others not encompassed by the genus are missing from the disclosure. In this case, there are specific elements referenced by the claims reference these structures with broad generic functional terms and provide a single example wherein extrapolation is simply not possible to any virus and any sequence for producing a virus. The claims rely on generic language which is not supported by the specification. The number of embodiments disclosed in the specification must be commensurate with the magnitude of the claimed genus, particularly if the genus is to cover species that are not known in the prior art. Here, the specification describes a single species that mediates the effect. But, the claims recite the construct in generic terms. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is needed. Since the disclosure fails to describe common attributes or characteristics that identify members of the genera, and because the genera are highly variant.
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.
Claims 1-3, 6-15, 29, 30, 32, 33, 37-39, 41, 44, 45 and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strong et al (US 200600242725) as evidenced by Corsa et al (US 9,290,785). This rejection was used to support a prior rejection. However, based on amendment it now supports a 102 rejection based on the host cell being B. subtilis. It is noted that an assertion of unexpected results is not relevant for rejections under 35 USC 102.
Strong et al teach a method for creating a virus vector plasmid which is replicated in hay bacillus (also known as Bacillus subtilis).
[0099] The nucleic acid, e.g., plasmid vector, viral vector or linear DNA molecule, of the present disclosure can contain other elements, in addition to the osteoblast-specific nuclear entry polynucleotide sequence and promoter polynucleotide sequence, to direct expression and the gene (nucleic acid) of interest or RNA molecule to be delivered. For example, it can be desirable to include a bacterial origin of replication (such as oriC) for replication of the plasmid in Escherichia coli, or the origin of replication of Bacillus subtilis for replication therein, or the origin of replication of Pseudomonas aeruginosa for replication therein, etc.) so that the plasmid can be maintained and replicated in a bacterial host.
Hence, Strong et al teaches that viral vectors can be maintained and replicated in hay bacillus wherein the ability to accomplish this is afforded by an origin of replication. Thus, Strong teaches a viral vector that comprising an oriC to replicate in B subtilis incorporated into viral vectors wherein any number of virus are contemplated to be used to make viral vector plasmids.
The recitation of “a nucleic acid sequence for producing a virus vector” refers to a sequence that is quite broad as set forth above. Looking to the disclosure, there is a single description from which art can be compared and that is a cap, gene a packaging sequence, TR and helper genes. The only known species of viruses that uses a helper gene is AAV. It is noted that broadly reading the claims means that any of these sequences are for producing a virus. To this end, Strong refers to these sequences
“The replication defective recombinant AAVs can be prepared by co-transfecting a plasmid containing the nucleic acid sequence of interest flanked by two AAV inverted terminal repeat (ITR) regions, and a plasmid carrying the AAV encapsidation genes (rep and cap genes), into a cell line that is infected with a human helper virus (for example an adenovirus). The AAV recombinants that are produced are then purified by standard techniques.”
As well, Strong teaches,
In general, in order to construct recombinant retroviruses containing a nucleic acid sequence, a plasmid is constructed that contains the LTRs, the encapsidation sequence and the construct of the present disclosure comprising a nuclear targeting signal and a coding sequence.
These referenced plasmids can be when combined with the above teachings read on a step of introducing a nucleic acid comprising a nucleic acid sequence for producing a virus vector into a host cell to form a plasmid. The host cell in Strong is B. subtilis. The reference teaches it is used introduced therein an used to replicate (amplify) the viral vector plasmid.
Strong includes genes for transgene (see e.g. ¶0009) as required of claim 6.
Strong describes serval unit to include an oriC, a marker, a promoter, enhancer, SV40 enhancer sequences, a osteoblast specific nuclear entry sequence and THEN viral components such as ITR, Rep, Cap, encapsidation sequences (found for example in ¶ 0008, 0079, 0130-0131, figure 2) thus meeting claims 7-13 and 15. As recited in claim 14, partial deletions are encompassed (see e.g. ¶0121).
As set forth in claim 29, the plasmid is purified (see ¶0166).
As evidenced by Corsa et al, Subtilis is an endotoxin free cell and hence a composition with the plasmid will be endotoxin free.
As to claim 47, it appears that this intends that only desired nucleic acids are in the vector. As only desired nucleic acids have been used to transduce the host, they will alone be part of the viral particle absent evidence to the contrary.
Claim Rejections - 35 USC § 103
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 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 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.
Claims 1-30, 32, 33, 37-39 and 41-47 are rejected under 35 U.S.C. 103 as being unpatentable over Strong et al (US 200600242725) in view of Sawada et al (CN 1018021169), Kashida et al (Polymer J, 2016, pages 781-786), Williams et al (U.S. application 20210010021), Bennett (U.S. Patent 9,249,425). This rejection is a new rejection necessitated by applicants’ amendment.
Claim 4 requires use of competent cells, this is a required component of transforming such cells but not taught by Strong et al. However, one would necessarily need to use competent cells wherein Sawada teaches that such cells are known in the art (see e.g. ¶ 0114).
Claim 5 requires that the nucleic acid is acyclic. To this end, Kashida et al teach that acyclic artificial sequences “have several advantages, including facile chemical synthesis and resistance to nuclease-mediated cleavage” (abstract and col 2, page 781).
There are several advantages of acyclic scaffolds over other XNAs. First, the synthetic costs of acyclic XNA are often low due to their simple structures. Second, chemical modification is usually facile, allowing XNAs with novel structures to be easily prepared. Third, because their chemical structures are very different from natural nucleic acids, they are highly resistant to nucleases. In addition, acyclic XNAs with phosphodiester bonds are usually highly water-soluble, in contrast to neutral XNAs. Furthermore, acyclic XNAs are candidates for genetic material in the ‘pre-RNA world’ because of their simple structures.30,31
Incorporation of acyclic nucleic acids given the benefits recited above. Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate these nucleic acids. Such a modification would have resulted in a method encompassed by claim 2 wherein an AAV sequence with ITRs meets the requirement for tandem repeats. As noted above: Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the expanded method would allow advantages of reduced cost, facile modifications as candidates for gene therapy.
Williams teaches that the helper plasmid is larger than 10 kB (see Table 9) as recited in claim 16. As recited in claim 17, Williams teaches ITR with transgene (see Table 7). As recited in claim 18, rep and cap and terminators are included in the plasmid (Williams ¶0097). Williams teaches that the AAV ITRs and components can be from AAV2 (see e.g. table 3) as recited in claim 19. Combined with the teachings of Strong these meet the limitations of claim 20.
As recited in claim 21-27, Williams refers to Chadeuf et al, see Table 3, genes are from Ad5 and are E2A, E4 and VA adenoviral genes to enable viral replication (see Chadeuf et al, Table 2, page 751, col 2). Williams teaches AAV2 (see Table 3).
Bennett teaches introducing the plasmid into producer cells to from the virus (see col 15, line 31-41) as recited in claim 28 and 42. It is the only plasmid introduced as required of claim 42. However, as recited in claim 43, the plasmid is integrated into the genome (see col 10, lines 57-60).
As to claim 46, which appears to indicate that the full versus empty particles are at least 65% full. Purification methods are known in the art which allow for enrichment of full versus empty capsids (see abstract, Grieger et al).
This user-friendly process can be completed within 1 week, results in high full to empty particle ratios (>90% full particles), provides postpurification yields (>1×1013 vg/l) and purity suitable for clinical applications and is universal with respect to all serotypes and chimeric particles.
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to use hay bacillus as taught by Strong et al with the competent cells of Sawada et al, the acyclic nucleic acids of Kashida et al, the plasmid components of Williams et al and Bennett et al and the purification method of Grieger et al. Such a modification would have resulted in a method encompassed by claim 4, 5, 16-.28, 42 and 43 As noted above: 1) Strong et al teach that plasmids comprising an origin of replication for Bacillus subtilis can be used to create viral vector plasmids, 2) Sawada et al teach steps missing but inherent in the method which is use of competent cells to introduce plasmids, Kashida teaches benefits of acyclic nucleic acids for plasmids 3) Williams and Bennet provide means of producing virus with plasmids known in the art that could be incorporated into Strong et al by providing related methods known in the art and 4) Grieger et al teach purification methods known to provide viral vectors desired for therapy. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the expanded method would allow means to produce the plasmid such that it is optimized for therapeutic use.
Response to Arguments
Regarding the previous rejection and for the standing rejections newly made above, the response will be addressed. Applicants argue that none of the art rejections reference hay bacillus. However, Strong in fact as set forth above does teach producing viral vector plasmids in B subtilis as well as replication thereafter (amplification). Applicants argue that the present disclosure surprisingly and unexpectedly demonstrates that plasmids produced in Bacillus subtilis consistently exceed 80% covalently closed circular (CCC) purity, reduced endotoxin levels and simplified manufacturing. As a first response, as Strong teaches use of this vector and the art recognized the properties thereto associated, they are inherent in Strong et al. As taught above subtilis is endotoxin free. And the art has shown that with subtilis ccc with almost 100% purity can be produced (see Schmidt et al, 6,664,078, Figure 3 and col 3-4).
But, more relevant is that the as to unexpected results, applicants have not provided evidence that one reviewing Strong would not have expected the reduced endotoxin level, the improved purity and ability to simplify the production of the virus. In light of the limitation of the claims to Bacillus subtilis and the teachings of strong in light of what was known in the art, this would have been an expected results. As set forth in the MPOEP 716.02, evidence must show actual evidence of unexpected results. But applicants have simply provided arguments. As well, “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.”
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 1-30, 32-34, 37-39 and 41-47 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-4, 6, 8, 11, 12, 14,15, 17, 19-21 and 23-30 of copending application 19/042,220. This rejection is maintained.
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 1-6, 8, 11, 12, 14,15, 17, 19-21 and 23-30 of copending application 19/042,220. That is, the cited claims of copending application 19/042,220 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, copending application 19/042,220 is drawn to related methods using related nucleic acids to make virus vector and virus vector plasmids. The copending claims are narrower as to characteristics of the vectors.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending application 19/042,220, then two different assignees would hold a patent to the claimed invention of copending application 19/042,220, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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 MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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