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
Status of Application/Amendment/Claims
Applicant's response filed 01/20/2026 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 08/21/2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
With entry of the amendment filed on 01/20/2025, claims 1-5, 13, 17-29 and new claim 33 are pending.
Claims 13, 17-29 and 33 are currently under examination. Claim 13 has been rejoined because it now within the scope of the amended claims.
Claims 1-5 are withdrawn as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The previous Enablement rejection is withdrawn in view of the new rejection herein necessitated by claim amendments.
Claim Objections
Claim 13 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 17. 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 § 706.03(k). Claim 13 is drawn to a method of decreasing a size of a kidney tumor in a subject in need comprising the identical annealed AT rich ligand as in claim 17.
Applicant is advised that should claim 17 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
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.
Claims 17-29 and 33 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.
Claim 17 recites “wherein STING signaling induces IFN-b, wherein IFN-b upregulates the immune system to recognize and destroy cancer cells in the subject, wherein the destruction of cancer cells results in the size of the kidney tumor being decreased by between: a lower limit of 25%; and an upper limit of 50%”. This limitation is indefinite because the claim is in drawn to decreasing a kidney tumor and the recitation of “cancer cell” can be interpreted as the STING signaling can recognize and destroy any type of cancer cell. For purposes of examination, the claim is interpreted as the cancer cell is a kidney cancer cell.
Claim 33 is indefinite because it recites the STAV is introduced intratumorally either in vitro or in vivo however claim 17, from which it depends, is drawn to decreasing a size of a kidney tumor in a subject and it is unclear how the STAV can be introduced intratumorally in vitro.
The remaining claims are rejected as they depend from rejected claim 17.
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.
Claims 26 and 27 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.
The claims recite “wherein STING signaling induces a type I IFN cytokine” and depends from claim 17 which recites the STING signaling induces IFNb. The limitations of claims 26 and 27 fail to further limit claim 17 because an IFNb is a type I IFN and therefore the claims broaden the type of IFN instead of further limiting the scope. 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.
Claim Rejections - 35 USC § 112
Enablement
The following is a quotation 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 13, 17-29 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification,
while being enabling for methods of increasing phagocytosis, CxCl10 and IFN-beta in kidney tumor cells using a polyA and polyT dsDNA having 90 complementary nucleotides in length with each strand comprising 100% of A and T oligonucleotide residues,
does not reasonably provide enablement for methods of
decreasing the size of a kidney tumor using a polyA and polyT dsDNA having less than 90 nucleotides in length wherein the dsDNA is asymmetric with each strand between 70 and 90 nucleotides
decreasing the size of a kidney tumor using a polyA and polyT dsDNA having less than 100% A and T oligonucleotide residues on each strand or
decreasing the size of a kidney tumor by 25-50%
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 following factors have been considered in the analysis of enablement: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims and the nature of the invention:
The instant claims are drawn to a method of decreasing the size of a kidney tumor in a subject comprising administering a dsDNA having a first and second strand each comprising 70-90 nucleotides with the first strand comprising 80% or more A and T oligonucleotide residues and the second strand comprising 80% or more A and T oligonucleotide residues with the function of inducing Stimulator of Interferon Genes (STING) in a kidney tumor and decreasing the tumor by 25-50%.
The nature of the invention is drawn to dsDNA having a poly dA-dT oligonucleotide wherein each strand can be from 70 to 90 nucleotides in length, asymmetric and have at least 80% A and T oligonucleotides that are complementary to each other and have varying modification pattern wherein any of these dsDNA are capable of decreasing the size of a kidney tumor in a subject.
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
The state of the prior art:
A thorough review of the patent and non-patent literature indicates that the state of the art demonstrating a correlation between activation of STING in cells using a dsDNA and increased IFN cytokine production was known and activation of STING increased immune responses in cells. Ishikawa et al. (Nature, 2009, 461:788-792 cited on IDS filed 05/10/2023) provides experimental results using “interferon stimulatory DNA (ISD; double-stranded 45-base-pair oligonucleotides lacking CpG sequences)”, wherein ISD in Sting knockout cells fails to induce IFN- and IFN-. (See page 788; Figure 1f). Ishikawa et al. further demonstrates that mice lacking Sting gene (thus having decreased STING) have reduced ability of surviving virus infection and that the mice have reduced expression of IFN- and IFN-. See Figures 2a, 2c, 2g, and 2h. Hence, Ishikawa reports that “STING is necessary, in vivo, for the effective production of type I IFN and is essential for efficient protection against HIV-1 infection.” (emphasis added). (See page 789).
Li et al. ("Regulating STING in health and disease." Journal of Inflammation 14.1 (2017): 1-21 cited on IDS filed 05/10/2023) teach there are a range of dsDNA that are known to activate STING (see Table 1) and there are numerous variants of STING (see Table 2). Thus the prior art does not teach the claimed variation in dsDNA in methods of reducing the size of a kidney tumor.
The level of one of ordinary skill:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as the prior art does not predictably teach using the claimed sequences of dsDNA to activate STING or any variant of STING to reduce the size of kidney tumors, specifically by 25-50%. Thus the prior art is not considered to provide sufficient enablement to practice the claimed invention. Because the state of the prior art does not provide evidence of the degree of predictability that activation of STING would treat kidney tumors using the claimed range of dsDNA, one of ordinary skill in the art would look for guidance or direction in the instant specification.
The level of predictability in the art:
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03).
The amount of direction provided by the inventor:
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004).
The existence of working examples:
The working embodiments illustrate increased phagocytosis in 30% kidney cells in vitro, increase in Cxc10 and an increase in Type I interferon in HEK293 kidney cells in vitro. The working embodiment further describes methods of reducing kidney tumor cells using a single dsDNA having SEQ ID Nos. 1 and 2 to activate STING in B16 melanoma tumor cells in mice.
The working embodiment in the instant application does not include experiments demonstrating reduction of kidney tumors using the dsDNA above or any variation of the dsDNA as claimed in a subject comprising administering the claimed dsDNA to activate STING and decrease kidney tumors by 25-50%. While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant invention suggests making poly dA:dT of varying sizes between 70 and 90 nucleotides on each strand and varying amounts of each A and T at 80% on each strand, administration of this dsDNA to a subject having a kidney tumor and reducing of the size of the kidney tumor, specifically 25-50% without an enabling disclosure or guidance in the prior art.
While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the role dsDNA as claimed increasing STING signaling to reduce the size of kidney tumors and it is unpredictable that the claimed breath of the dsDNA would provide treatment as broadly claimed. The specification does not provide sufficient guidance on using the claimed dsDNA and decreasing the size of kidney tumors solely based on a single dsDNA being capable of increased phagocytosis in 30% kidney cells, increase in Cxc10 and an increase in Type I interferon in HEK293 kidney cells. For an enabling disclosure, one of skill in the art must be able to make and use the invention with a reasonable expectation of success and not to make and test if the invention actually works. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004).
Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
Response to Applicant’s Arguments
In the Final Office action mailed 08/21/2025 the response to the 112(a) Enablement rejection on page 3 mistakenly left the Title 35, US code for a 112b rejection in the heading and not the correct 35 U.S.C. 112(a) for Enablement. The body of the maintained rejection was clearly drawn to the Enablement rejection which Applicant appeared to understand since they responded to the Enablement rejection and not the withdrawn 112(b) rejection. In the event this happens again, Applicant is encouraged to call the Examiner so the error can be corrected so no confusion is left unaddressed.
Applicant argues Fig. 4A that 30% of kidney tumor cells undergo phagocytosis and this efficacy is in line with the range in claim 17. This argument is not sufficient to support the enablement for the reasons above and further a measurement of phagocytosis in kidney tumor cells in vitro does not appear to correlate with a reduction of the size of a kidney tumor cell in a subject.
Applicant argues the claims do not recite any dsDNA length. As stated in the above enablement rejection, the claims as amended are drawn to a dsDNA having poly dA-dT oligonucleotide wherein each strand can be from 70 to 90 nucleotides in length, asymmetric and have at least 80% A and T oligonucleotides that are complementary to each other and have varying modification pattern. The instantly claimed invention is not enabled as explained above.
Applicant next argues that any dsDNA of sufficient length can activate STING and a person of ordinary skill in the art would not have to undertake any experimentation to determine what constitutes a STAV for purposes of practicing the invention.
This argument is not persuasive because the instant invention suggests making poly dA:dT of varying sizes between 70 and 90 nucleotides on each strand and varying amounts of each A and T at 80% on each strand, administration of this dsDNA to a subject having a kidney tumor and reducing of the size of the kidney tumor, specifically 25-50% without an enabling disclosure or guidance in the prior art. For an enabling disclosure, one of skill in the art must be able to make and use the invention with a reasonable expectation of success and not to make and test if the invention actually works. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004).
The specification demonstrating a single dsDNA of 90 nucleotides in length with each strand having 100% of A or T and being capable of increased phagocytosis in 30% kidney cells, an increase in Cxc10 and an increase in Type I interferon in HEK293 kidney cells in vitro does not provide enablement such that a skilled artisan would not have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to find dsDNA that reduces kidney size in a subject, particularly a specific reduction of 25-50%.
Written Description
Claims 13, 17-29 and 33 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.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art.
Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genusThe claims are drawn to a genus of dsDNA having a first and second strand comprising 70-90 nucleotides with the first strand comprising 80% or more alternating C and G oligonucleotide residues and the second strand comprising 80% or more alternating A and T oligonucleotide residues with the function of inducing Stimulator of Interferon Genes (STING) in a kidney tumor and decreasing the tumor by 25-50%.
The specification describes a single dsDNA having SEQ ID Nos. 1 and 2 that is capable of activating STING in B16 cells and reducing the tumors in mice. SEQ ID No. 1 is 90 nucleotides in length comprising all A residues and SEQ ID No. 2 is 90 nucleotides in length comprising all T residues wherein the dsDNA was capable of reducing tumor volume in mouse B16 melanoma tumor model, increased phagocytosis in 30% kidney cells, an increase in Cxc10 and an increase in Type I interferon in HEK293 kidney cells in vitro. The specification does not describe embodiments of using the broadly claimed poly dA:dT of varying sizes between 70 and 90 nucleotides on each strand and varying amounts of each A and T at 80% on each strand, administration of this dsDNA to a subject having a kidney tumor with the function of reducing of the size of the kidney tumor, specifically 25-50%.
When analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. In the instant case, a single dsDNA having SEQ ID Nos. 1 and 2 wherein SEQ ID No. 1 is 90 nucleotides in length comprising all A residues and SEQ ID No. 2 is 90 nucleotides in length comprising all T residues is described. The genus of dsDNA encompass may different molecules expected to have the same activity. The specification and claims do not indicate what distinguishing characteristics of the dsDNA that are concisely shared by the members of the genus of dsDNA and further the specification does not describe a representative number of species of the genus of dsDNA that would have the claimed function. A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination.
Then it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e. other than nucleotide sequence), specific features and functional attributes that would distinguish different members of the claimed genera. In the instant case, the only other identifying characteristics are reducing tumor volume in mouse B16 melanoma tumor model, increased phagocytosis in 30% kidney cells, an increase in Cxc10 and an increase in Type I interferon in HEK293 kidney cells in vitro Such functional limitations cannot be identifying characteristics for the claimed diverse genus of molecules since all members of the claimed genus would have different functions of increasing phagocytosis in kidney cells, increasing Cxc10 and increasing Type I interferon in HEK293 kidney cells in vitro.
Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant comprising different sequences and varying sizes of each strand of the dsDNA as well as varying amounts of each of A and T on each strand totaling 80% of the total strand, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed.
The description of a single dsDNA of 90 nucleotides in length having one strand comprising A residues and one strand comprising T residues does not adequately represent the entire genus capable of activating STING and reducing kidney tumors in a subject.
“Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
Thus one of skill at the time of the invention could not have concluded that Applicant was in possession of the genus of dsDNA as claimed.
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 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.
Claims 13, 17-29 and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/176,406 in view of Pensado et al. ("Current strategies for DNA therapy based on lipid nanocarriers." Expert Opinion on Drug Delivery 11.11 (2014): 1721-1731).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by and/or overlap in scope with the ‘406 claims drawn to a method of treating cancer comprising administering a dsDNA to active STING wherein the dsDNA is defined as a poly dA:dT (see 0198) and the cancer is defined as kidney cancer (0114). It would have been obvious to use a lipid13, based nanocarrier to deliver the dsDNA as these were known in the art for efficient delivery of DNA molecules (see page 1721 of Pensado et al.).
Claims 13, 17-29 and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/393,461 in view of Pensado et al. ("Current strategies for DNA therapy based on lipid nanocarriers." Expert Opinion on Drug Delivery 11.11 (2014): 1721-1731)
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by and/or overlap in scope with the ‘461 drawn to a method of treating cancer comprising administering a dsDNA to active STING wherein the dsDNA is defined as a poly dA:dT (see 0198) and the cancer is defined as kidney cancer (0114). It would have been obvious to use a lipid based nanocarrier to deliver the dsDNA as these were known in the art for efficient delivery of DNA molecules (see page 1721 of Pensado et al.).
Conclusion
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636