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
Claim status
In the reply filed 1/30/2026, Applicant has amended Claims 1 and 14, and cancelled claims 2 and 15.
Claims 7-13 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
Claims 1, 3-6, 14, and 16-18 are under consideration.
Election/Restrictions
Applicant’s election of the following invention without traverse in the reply filed on 5/27/2025 has been acknowledged.
Group I, claims 1, 3-13, drawn to a DI virus.
Rejoinder
The restriction requirement between Groups I-II, as set forth in the Office action mailed on 3/28/2025, has been reconsidered in view of the newly discovered prior art. The restriction requirement between Groups I-II is hereby withdrawn. Claims 14, and 16-18, directed to previously non-elected Group II are no longer withdrawn from consideration.
However, Applicant’s election of the following species without traverse has been acknowledged and is maintained.
Applicant elected a DI virus with one or more deletions in segments 1, 2, or 3.
Claims 7-13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 1/30/2026 are acknowledged. Applicant argues that all the claims can be examined without undue burden.
Applicant’s arguments have been considered and are found partially persuasive. In light of the prior art, the Examiner has withdrawn the restriction between inventions directed to the composition and method of use.
However, in regard to the species election, this argument is not found persuasive because Examiner was able to provide art which satisfied the limitations of the elected species claims without being able to satisfy the limitations of non-elected species claims thereby demonstrating that a search burden exists between the restricted species. Furthermore, these species of DI viruses are structurally distinct.
Withdrawn Claim Objections
The prior objection to the claims for minor informalities is withdrawn.
Withdrawn Claim Rejections
Every ground of rejection set forth in the Office action dated 7/30/2025 is withdrawn.
New Claim Rejections - 35 USC § 112(b)
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 16 and 17 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.
Claims 16 and 17 recite the limitation that the modified viral RNA is “substantially” intact at its 5’ and 3’ end, respectively. A claim may be rendered indefinite by reference to term of degree (see MPEP 2173.05(b), I). Specifically, when a term of degree is used in the claim, the examiner should determine whether the specification provides some standard for measuring that degree. Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357, 1367, 94 USPQ2d 1385, 1391 (Fed. Cir. 2010); Enzo Biochem, Inc., v. Applera Corp., 599 F.3d 1325, 1332, 94 USPQ2d 1321, 1326 (Fed. Cir. 2010); Seattle Box Co., Inc. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826, 221 USPQ 568, 574 (Fed. Cir. 1984). In instant case, the specification does not provide some standard for measuring that degree (i.e., what constitutes substantial intact). Furthermore, given the broad genus of modifications claimed, a determination was made by the Examiner that one ordinary skill in the art could not ascertain the scope of the claim (e.g., arrive at a standard that is recognized in the art for measuring the meaning of the term of degree). For example, in Ex parte Oetiker, 23 USPQ2d 1641 (Bd. Pat. App. & Inter. 1992), the phrases "relatively shallow," "of the order of," "the order of about 5mm," and "substantial portion" were held to be indefinite because the specification lacked some standard for measuring the degrees intended.
New Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) a recombinant DI influenza A virus which is not markedly different from its naturally occurring counterpart. This judicial exception is not integrated into a practical application because the natural product is not linked to a particular technology. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are well-understood, routine and conventional in virology.
Briefly summarized here, the guidance for subject matter eligibility cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
In regard to Step 1, Claims 1, 3-6 are drawn to a composition of matter-a virus.
In regard to Step 2A prong one, Claims 1, 3-6 are drawn to a nature-based product which is not markedly different from its naturally occurring counterpart. Specifically, independent claim 1 is directed to a cloned or recombinant DI virus comprising a modified RNA derived from a native influenza A virus having an internal deletion of segments 1, 2, or 3 of a certain size. These claims encompass a naturally occurring DI influenza A virus. Furthermore, Applicant’s specification on [0046] admits that the claimed “cloned or recombinant preparation (is) based on a naturally occurring defective interfering virus. For example, samples can be taken from infected individuals, animals…for the presence of defective interfering virus particles.” This option of the claims is a naturally occurring product. Because instant claims are directed to a nature-based product, i.e., a DI virus, the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. Applicant is directed to the publication of Mann et al., (Vaccine, 2006, 24:4290-4296), which Applicant cites on [0084] as the source of the segment 2 DI (2/265) virus, and acknowledges that the deletions in the DI virus RNA “occur spontaneously during de novo RNA synthesis” (Abstract) and that “(a)ll defective interfering viruses have highly deleted genomes that arise naturally from a chance event during replication” (p. 4291, Introduction). Thus, instant claims encompass DI viruses with modified RNA cells that are identical (no difference in structural or functional characteristics) to naturally occurring DI viruses. Furthermore, the fact that instant claim recites “cloned or recombinant” does not differentiate it from the naturally occurring DI viruses because although the claimed viruses may be man-made and have had the chemical bonds at each end of an internal segment region severed in order to make an internal deletion; however, the modified viral RNA has the same nucleotide sequence as the natural DI viral gene. The claimed nucleic acid has no different structural or functional characteristics, i.e., it encodes the same internally deleted segment as the naturally occurring DI viral gene. Under the holding of Myriad, this cloned or recombinant but otherwise unchanged nucleic acid is not eligible because it is not different enough from what exists in nature to avoid improperly tying up the future use and study of naturally DI influenza a viruses. In other words, the claimed viral nucleic acid is different, but not markedly different, from its natural counterpart in its natural state, and thus is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A, prong one: YES).
In regard to Step 2A prong two, the judicial exception is not integrated into a practical application. In particular, Claims 1, 3-6 recite no additional elements to integrate the claimed DI virus into a practical application. Moreover, Claim 3 recites a single additional element- that the virus is provided as an antiviral agent. However, this intended use does not change the structure of the claimed composition, and at most requires that the DI virus is in some solution that allows contact with a subject. Thus, merely placing the natural product into a generic solution so that the DI virus may be provided to a subject does not add a meaningful limitation as it is a nominal extra-solution component of the claim as is a necessary precursor for all of the uses of the DI viruses, and is nothing more than an attempt to generally link the DI virus product to a particular biotechnology. Clearly, combining the natural DI virus in a generic composition on its own does nothing to improve a technology, effect a particular treatment, or implement with a particular device to provide a meaningful limitation on the judicial exception.
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As stated supra, Claims 1, 3-6 recite no additional elements to the DI virus. In regard to Claim 3, which recites a single additional element as an intended use, as discussed above with respect to the integration of the natural product into a practical application, the additional element of preparing a generic composition does not provide an inventive concept.
Therefore, Claims 1, 3-6 are directed to a natural DI viral product, that is not markedly different from its natural counterpart, is not integrate a practical application, and does not include elements that amount to significantly more than the natural product itself and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
New Claim Rejections - 35 USC § 102
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, 14, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duhaut and Dimmock (J Virol Meth, 2003, 108:75-82).
In regard to claims 1 and 14, Duhaut teaches compositions and methods of use of two cloned recombinant DI influenza A viruses (i.e., POLI-220 and POLI-317), each comprising a modified RNA derived from a native influenza A virus segment 1, wherein said modified RNA comprises:
a length of 445 nts for POLI-220 and 585 nts for POLI-317,
a 5’ end of 220 nts and 3’ of 225 nts for POLI-220 and a 5’ end of 317 nts and 3’ end of 268 nts for POLI-317 (see p. 76, Methods, Section 2.2),
a nucleotide deletion introduced in a central portion of said segment 1,
wherein said DI viruses interfere with RNA production for native influenza A (p. 80, Fig. 6 for POLI-220 and data not shown for POLI-317, see also p. 76, Introduction, indicating that the 5’ end sequence was essential for interfering activity).
In regard to the wherein clause that the DI virus comprising the modified RNA of segment 1 interferes with the native influenza A segments 1, 2, and 3, this appears to be an inherent feature of the taught DI viruses. Although Duhaut does not demonstrate cross-segment interference, MPEP 2145, Section II, states that the mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). The court held that granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.).
In regard to claims 3 and 14, as stated supra, Duhaut teaches administering an effective amount of the DI viruses as an antiviral agent to treat mice suffering from a lethal infection of a influenza A/WNS (H1N1) virus (p. 80, see Fig. 6).
In regard to claims 4-5 and 16-17, as stated supra, Duhaut teaches a 5’ end of 220 nts and 3’ of 225 nts for POLI-220 and a 5’ end of 317 nts and 3’ end of 268 nts for POLI-317.
In regard to claims 6 and 18, as stated supra, since the size of influenza A segment 1 is 2341 nts, the nucleotide deletion introduced in a central portion of said segment 1 is approximately 1896 nts for POLI-220 (i.e., 2341-445) and 1756 nts for POLI-317 (i.e., 2341-585).
Accordingly, Duhaut anticipates instant claims.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 1/30/2026 are acknowledged.
Firstly, Applicant’s arguments directed to the prior art of De Wit are considered moot in light of withdrawal of this rejection.
Secondly, Applicant argues that the claimed DI virus exhibited unexpected results (pgs. 7-8, and 11-12 of Remarks). Specifically, Applicant argues that the claimed DI viruses having the deletion of only one of segments 1, 2, or 3 surprising interfered with RNA production form all segments 1, 2, and 3 of a native influenza A virus.
Applicant's arguments have been fully considered but they are not persuasive.
In response to Applicant's argument, MPEP 2112.01(II) recites that "products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable." In instant case, the POLI-220 and POLI-317 recombinant DI viruses of the prior art of Duhaut have all of the claimed structural elements, and appear nearly identical to the 1/244 DI virus presented in Applicant’s specification as having this functional property of cross-segment interference. Furthermore, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of filing of the invention, but only that the subject matter is in fact inherent in the prior art reference.
Since the Patent Office does not have the facilities for examining and comparing Applicants' 1/224 DI virus with the POLI-220 or POLI-317 DI viruses of the prior art reference, the burden is upon applicants to show a distinction between the material structural and functional characteristics of the claimed DI viruses and the DI viruses of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/ Examiner, Art Unit 1631
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