DETAILED ACTION
Non-Final Rejection
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of Group I, claims 1, 4, 6, 10-11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, and 38-39 in the reply filed on 04/28/2026 is acknowledged.
Status of Claims
3. Claims 1, 4, 6, 10-11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, and 38-40 filed on 12/18/2023 are pending.
4. Claim 40 is withdrawn from examination due to Election/Restriction.
5. Claims 1, 4, 6, 10-11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, and 38-39 are under examination.
Priority
6. This application is a U.S. National Phase Application of International Application No. PCT/US2021/061820 filed December 3, 2021, which claims the benefit of U.S. Provisional Application No. 63/121,603, filed December 4, 2020.
Information Disclosure Statement
7. The information disclosure statement (IDS) submitted on 12/19/2023 and 04/28/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections to Specification
8. Claim 6: The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The instant claim 6 directed to the pharmaceutical composition of claim 1, wherein the amino acid has a concentration of 5-35 nM, 10-30 nM, 15-25 nM, or about 20 nM.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. There is no support in the PCT filed version of original claims 6-8 (filed on 06/01/2023) for “about nM” or the instant specification for “about nM” concentration of the claimed amino acid.
The instant specification has support for “about mM” concentration of an amino acid (e.g. Histidine) (see, instant specification para [00234]).
Claim Objections
9. Claims 38-39 ARE objected to because of the following informalities:
The claims recite “HPBCD” without reciting a full form at least one time in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
10. 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.
The following is a quotation of the first paragraph of pre-AIA 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.
This is a new matter rejection.
Claim 6 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claim 6 directed to the pharmaceutical composition of claim 1, wherein the amino acid has a concentration of 5-35 nM, 10-30 nM, 15-25 nM, or about 20 nM.
There is no support in the specification for “about nM” concentration of the claimed amino acid. The original claimed filed with PCT (claims 6-9) recite concentration in “nM” (claim 6 e.g. 5-35 nM”) and not “about 5-35 nM”.
The specification has support for “about mM” concentration of an amino acid (e.g. Histidine) (see, instant specification para [00234]).
Regarding amendment and new matter. See MPEP 2163 B. New or Amended Claims "With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4, 83 USPQ2d 1373, 1376, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘ about nM concentration or about 20 nM’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported.").
Claim Rejections - 35 USC § 112
11. 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.
12. Claim 6 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.
The instant claim 6 directed to the pharmaceutical composition of claim 1, wherein the amino acid has a concentration of 5-35 nM, 10-30 nM, 15-25 nM, or about 20 nM.
There is no support in the PCT filed version of original claims 6-8 (filed on 06/01/2023) for “about nM” or the instant specification for “about nM” concentration of the claimed amino acid.
The instant specification has support for “about mM” concentration of an amino acid (e.g. Histidine) (see, instant specification para [00234]).
Therefore, it is not clear whether the instant claim 6 is directed to “nM” or “about nM” concentration of the claimed amino acid in the claimed buffer or “mM” or “about mM” concentration of the claimed amino acid in the claimed buffer.
Correction is required. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o).
13. Claims 16, and 34 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 16 contains the trademark/trade name Triton-X (Triton is a trademark of The Dow Chemical Company), SPAN (SPAN is a trademark of Span.IO, Inc), Brij (Brij is a trademark of ICI America Inc).
Claim 34 contains the trademark/trade name kleptose (Kleptose) is a registered trademark of Roquette Pharmaceuticals), captisol (captisol is a trademark of Cydex Pharmaceuticals, Inc).
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe surfactants , stabilizer or a chemical name and, accordingly, the identification/description is indefinite.
Claim Interpretation
14. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 1: The instant claim 1 is interpreted to be directed to a pharmaceutical composition comprising a viral an adenoviral based expression system, further comprising at least two excipients selected from the group consisting of an amino acid, a surfactant, a tonicity modifier, a cryoprotectant, and a stabilizing agent.
The instant independent claims 1, 38, 39 and claims dependent on claim 1 (Group I invention) are directed to a pharmaceutical composition comprising a viral an adenoviral based expression system formulated in a stabilizer, cryoprotectant buffer for preserving infectivity and prevent aggregation of the virus.
Claim 6: In view of the instant specification para [00234] filed on 06/01/2023, for examination purpose the instant claim 6 added limitation, wherein the amino acid has a concentration of 5-35 nM, 10-30 nM, 15-25 nM, or about 20 nM is interpreted to comprise amino acid concentration to be “about mM” (e.g. about 20 mM).
The instant claim 6 will be examined in view of the instant specification para [00234] filed on 06/01/2023 for the claimed amino acid concentration in “about mM” unit.
Claim Rejections - 35 USC § 102
15. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 27-28 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) or both as being anticipated by Dicks et al 2015 (US20150044766A1, 02/12/2015).
Dicks et al 2015 anticipated instant claim 1 by disclosing a pharmaceutical composition comprising an adenoviral based expression system, recombinant adenoviral vectors wherein said capsid encapsidates a nucleic acid molecule comprising an exogeneous nucleotide sequence of interest. Compositions suitable for buccal or sublingual administration include tablets, lozenges and pastilles, wherein the active ingredient is formulated with a carrier sugar (reads on cryoprotectants) and acacia, tragacanth, or gelatin and glycerin (reads on stabilizer) (See, para [0144]). The pharmaceutical composition is preferably sterile and is preferably pyrogen-free (See, para [0148], claim 1).
Claims 27-28: Dicks et al 2015 anticipated instant claims 27-28 by disclosing cryoprotectant suitable carriers and/or diluents are well known in the art and include pharmaceutical grade starch, mannitol, lactose, magnesium stearate, sodium saccharin, talcum, cellulose, glucose, sucrose, (or other sugar), magnesium carbonate, gelatin, oil, alcohol, detergents, emulsifiers or water (preferably sterile) (See, para 0134).
Claim Rejections - 35 USC § 103
16. 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
17. Claims 1 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Dicks et al 2015 (US20150044766A1, 02/12/2015) and further in view of Croyle et al 1998 (Pharmaceutical development and technology, 3(3), 373-383), and Croyle et al 2001 (Gene therapy, 8(17), 1281-1290).
The prior art teachings that anticipated instant claims 1 and 27-28 as recited supra are incorporated here in entirety to render obvious the claims 1 and 27-28. Croyle et al 1998 and Croyle et al 2001 both are directed to buffer comprising excipients and pharmaceutical formulations that enhance physical stability of viral vectors for gene therapy (See, abstract and entire articles by Croyle et al 1998 and Croyle et al 2001) with a motivation to improve stability of AAV for gene therapy with reasonable expectations for commercial success.
18. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Dicks et al 2015 (US20150044766A1, 02/12/2015), Croyle et al 1998 (Pharmaceutical development and technology, 3(3), 373-383), and Croyle et al 2001 (Gene therapy, 8(17), 1281-1290)
as applied to claim 1 above, and further in view of Buira et al 2019 (WO2019202083A1, 10/24/2019).
Claim 4: Combined teachings of Dicks et al 2015 and Croyle et al 1998 and Croyle et al 2001 rendered obvious claim 1 as recited supra. However, do not teach added limitation of instant claim 4 on the claimed amino acid(s).
Buira et al 2019 (WO2019202083A1) teaches a stable adenovirus composition comprising a buffer system comprising tris(hydroxymethyl) aminomethane and glycine; a particular cryoprotectant mixture; albumin; and a particular mixture of inorganic salts comprising sodium chloride and magnesium chloride. It also relates to a method for preparing such pharmaceutical compositions, as well as to uses thereof (See, abstract). In some examples, the formulations are buffered with Tris-HCI and comprise histidine or EDTA, NaCI, MgCI2 or CaCI2, sucrose, polysorbate-80 and mannitol. Exemplified stable compositions after freeze and thaw cycles are Tris-buffered. Other known lyoprotectants include albumin (i.e. human serum albumin), polyethylene glycol, glycine, proline, lysine, alanine, some surfactants such as
polysorbate-20 or -80, maltodextrins and certain starches (See, p. 7 lines 26-39, claims 1-15, entire Description of invention).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to the modify the combined prior art teachings of Dicks et al 2013, Croyle et al 1998 and Croyle et al 2001 with the teachings of Buira et al 2019 on the composition comprising amino acids histidine and or glycine to with a motivation to obtain a stable adenovirus pharmaceutical composition for maintaining infectivity (replicative ability) of the recombinant adenovirus to maintain efficacy and for commercial success. The invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time of the invention. One of the ordinary skills would have been apprised of a reasonable expectation of success to arrive at the claimed invention given the combined teachings in the art as applied to claim 4 as recited supra.
19. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over combined teachings of Dicks et al 2015 (US20150044766A1, 02/12/2015), Croyle et al 1998 (Pharmaceutical development and technology, 3(3), 373-383), and Croyle et al 2001 (Gene therapy, 8(17), 1281-1290) and Buira et al 2019 (WO2019202083A1, 10/24/2019) as applied to claim 4 above, and further in view of Bourles et al 2018 (US20180214379A1, 08/02/2018).
Claim 6: The combined teachings of Dicks et al 2015, Croyle et al 1998, and Croyle et al 2001 and Buira et al 2019 teaches claim 4 as recited supra, however, do not teach the added limitation of instant claim 6, that is interpreted (see, claim 6 interpretations above) as wherein the amino acid has a concentration of 5-35 mM, 10-30 mM, 15-25 mM, or about 20 mM.
Bourles et al 2018 is in the art and is directed to a pharmaceutical composition comprising an adenoviral vector, the composition comprises an appropriate buffer may be selected from Tris, succinate, borate, Tris-maleate, lysine, histidine, glycine (see, para [0069]), the composition also comprises histidine in an amount of up to or about 20 mM, such as at a concentration of about 10 mM (see, para [0072]).
It would have been obvious to one of the ordinary skills to modify the combined prior art teachings as recited supra and incorporate teachings of Bourles et al 2018 on amino acid concentration histidine in an amount of up to or about 20 mM, such as at a concentration of about 10 mM (see, Bourles et al 2018 para [0072]) and optimize other claimed concentrations of the amino acid Histidine (or substitutable amino acids for Histidine) to arrive at the invention of claim 6 with a reasonable expectation of success with a motivation to improve the buffering and keeping quality to preserve infectivity of the recombinant adenovirus for efficacy and commercial success.
Determining or adjusting concentration of amino acid lysine, histidine to the interpreted claimed concentration of 5-35 mM, 10-30 mM, 15-25 mM, or about 20 mM is a routine laboratory approach. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382. Furthermore, according to section 2144.05 of the MPEP, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages”).
20. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Dicks et al 2015 (US20150044766A1, 02/12/2015), Croyle et al 1998 (Pharmaceutical development and technology, 3(3), 373-383), and Croyle et al 2001 (Gene therapy, 8(17), 1281-1290) as applied to claim 1 above, and further in view of Shiratsuchi et al 2012 (AU2010286187A1, 02/16/2012).
Claim 10: The combined teachings of Dicks et al 2015, Croyle et al 1998, Croyle et al 2001 rendered obvious claim 1 as recited supra. However, do not teach added limitation of instant claim 10, wherein the composition further comprises an antioxidant.
Shiratsuchi et al 2012 is in the art recombinant adenovirus and teaches antioxidants such as ascorbic acid for the composition comprising recombinant adenovirus (See, description).
It would have been obvious to one of the ordinary skills to modify the prior art teachings of Dicks et al 2015 with additional teachings of Shiratsuchi et al 2012 on antioxidant with a reasonable success with a motivation for preserving keeping quality of the composition to preserve infectivity of the recombinant adenovirus for efficacy and commercial success.
21. Claims 11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over combined teachings of Dicks et al 2015 (US20150044766A1, 02/12/2015), Croyle et al 1998 (Pharmaceutical development and technology, 3(3), 373-383), and Croyle et al 2001 (Gene therapy, 8(17), 1281-1290) as applied to claim 1 above, and further in view of Bourles et al 2018 (US20180214379A1, 08/02/2018), Adriaansen et al 2018 (US20180280519A1, 10/04/2018), Demoitite et al 2018 (US20180250375A1, 09/06/2018), Konz et al 2003 (US20050196854A1, 09/08/2005), Mathot et al 2020 (WO2020003126A1, 01/02/2020), and Adriaansen 2016 (US20160199426A1, 07/14/2016).
Claims 11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, 38-39: The combined teachings of Dicks et al 2015, Croyle et al 1998, Croyle et al 2001 rendered obvious claim 1 as recited supra. However, do not teach added limitation of instant claims 11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, 38-39.
Bourles et al 2018 (US20180214379A1) discloses stabilising compositions/formulations comprising simian adenoviral vector particles such as ChAd155 and further Tris 10 mM pH 8.5, polysorbate 80 0.02%, MgCl2 1mM, trehalose 9%, NaCl 8mM, sucrose 2.5%, histidine 10 mM (see e.g. Abstract; example 6, claims 1, 12, 14, 20). D1 further refers to the use of the composition in methods for inducing an immune response (see e.g. claim 37). Thus, D1 anticipates the subject-matter of claims 1 - 3, 5 - 9, 13 and 10 as water is referred to as stabilizing agent.
Demoitite et al 2018 (US20180250375A1) relates to methods of inducing an immune response and discloses formulations comprising an ChAd encoding an antigen, wherein the formulation buffer is a 10 mM TRIS buffer pH 7.4 comprising 10 mM histidine, 5% sucrose, 75 mM NaCl, 1 mM MgCl2, 0.02% polysorbate 80, 0.1 mM EDTA, 0.5% (v/v) ethanol. Example 5 discloses several prime-boost vaccination strategies, wherein the composition further comprises an adjuvant (=immune modulator) (see also [0017], [0190] - [0208]).
Konz et al 2003 (US20050196854A1) relates to methods for purifying recombinant adenovirus 5 vector particles, adenovirus 6 vector particles and adenovirus 35 vector particles purification of adenoviruses (see e.g. Abstract; page 3, line 30 - page 4, line 2) and discloses formulations comprising a recombinant Ad5 (=adenoviral based expression system), further comprising histidine, NaCl, MgCl2, 5% sucrose, PS-80, and Tris buffer (see page 53, lines 9 - 11). D3 also discloses formulations a recombinant Ad5 vector further comprising 5mM Tris, 75mM NaCl, 1mM MgCl2, 5% sucrose, 0.005% PS-80, pH 8.0 (page 42, lines 14 - 16).
Mathot et al 2020 (WO2020003126A1) relates to formulations of simian adenoviral vectors having enhanced stability and discloses aqueous composition comprising a simian adenoviral vector encoding e.g. a RSV transgene, wherein the composition further comprises 10 mM Tris pH 8.5, 10 mM histidine, 5 mM NaCl, 1 mM MgCl2 and 0.024% polysorbate 80 (w/v), with the addition of trehalose, sucrose, Vitamin E succinate (VES) and rHSA (see example 4; Table on page 20; see also claims 1, 5, 6, 8, 10, 12, 16, 45). According to the present application alpha tocopherol, which is encompassed by the term VES is considered as an antioxidant.
Adriaansen 2016 (US20160199426A1) discloses adenoviral preparations comprising 10 mM Tris, 10 mM Histidine, 1 mM MgCl2, 75 mM NaCl, 5% (w/w) sucrose, 0.02% (w/w) PS-80, 0.1 mM EDTA, 0.4% (w/w) EtOH, at a pH of 7.4 (see e.g.[0110]). According to Adriaansen 2016, the adenovirus is recombinant adenovirus (i.e., an adenovirus containing a whole or a portion of a transgene that is expressed within the target host subsequent to host administration, such as in any mammalian/human gene therapy- or gene vaccination-based methodology available to the skilled artisan), a simian adenovirus and can be used as vaccine ([0052], [0077], [0079], [0080]). Hydroxypropyl-beta-cyclodextrin (HBCD) as stabilizer, and the formulations comprising HBCD, NaCl, PS-80 and Ethanol are disclosed (see e.g. claims 12 and 19).
Adriaansen et al 2018 (US20180280519A1) relates to the use of 13-cyclodextrins for preventing deterioration of viruses, such as adenoviruses, in solutions contained in bioprocess bags (Abstract; [0005], [0015]). D6 envisages the use of the stabilized Ad based formulations as vaccine ([0067], [0068]). Ad26 vaccine vectors were tested (Example 2, [0082]). Table 1 discloses several Ad26 formulations, wherein the formulations further comprise 20mM histidine buffer pH6.5, 5% HBCD, 5% sucrose, 75mM NaCl, 0.4% EtOH, 0.02%PS-80, 0.1mM EDTA (see formulation 1 + HBCD), or 10mM Tris and 10mM histidine buffer, pH6.5, 5% HBCD, 5%sucrose, 75mM NaCl, 0.4% EtOH, 0.02%PS-80, 0.1mM EDTA,1mM MgCl2 (see formulation 2 + HBCD). According to [0087], HBCD protects adenovirus from surface induced degradation and [0092] states that HBCD has a good safety and tolerability profile, and no side effects were observed after parenteral administration of up to 24 g of HBCD daily.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to the modify the prior art teachings of Dicks et al 2013 with the teachings of Bourles et al 2018, Adriaansen et al 2018, Demoitite et al 2018, Konz et al 2003, Mathot et al 2020, and Adriaansen 2016 to arrive at the inventions of claims 11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, 38-39 with a motivation to obtain a stable adenovirus pharmaceutical composition for maintaining infectivity (replicative ability) of the recombinant adenovirus to maintain efficacy and for commercial success. The invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time of the invention. One of the ordinary skills would have been apprised of a reasonable expectation of success to arrive at the claimed invention given the combined teachings in the art as applied to claim 11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, 38-39 as recited supra.
Determining or adjusting concentration of buffering conditions comprising surfactants and stabilizer and pH, when the reagents are rendered obvious, to the optimal performance is a routine laboratory approach. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382. Furthermore, according to section 2144.05 of the MPEP, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages”).
Double Patenting
22. 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.
23. Claims 1, 4, 6, 10-11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, and 38-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 10, 14-15, 22-23, 27-30, 33-34, 37, 42, 51 and 54 of copending Application No. 18/971,208 in view of Dicks et al 2015 (US20150044766A1, 02/12/2015), Croyle et al 1998 (Pharmaceutical development and technology, 3(3), 373-383), and Croyle et al 2001 (Gene therapy, 8(17), 1281-1290) and Buira et al 2019 (WO2019202083A1, 10/24/2019).
Both instant claims 1, 4, 6, 10-11, 14, 16, 18-19, 22-25, 27-29, 33-34, 36, and 38-40 and co-pending claims 1, 4, 6, 10, 14-15, 22-23, 27-30, 33-34, 37, 42, 51 and 54 of reference Application No. 18/971,208 are directed to a pharmaceutical composition comprising an adenoviral based expression system, further comprising excipients cryoprotectants and stabilizers.
The difference is that the instant claim 1 is directed to adenoviral based expression system (adenovirus vector) whereas the co-pending claims 1 of reference Application No. 18/971,208 is directed to chimpanzee adenovirus (ChAdV)-based expression system.
The instant claims 38-39 recites limitation chimpanzee adenovirus (ChAdV)-based expression system.
Dicks et al 2015 teaches chimpanzee adenovirus (see, abstract, claim 1) and therefore it would have been obvious to one of the ordinary skills to develop variants of the instant claims into the co-pending claims to arrive at the variant invention for commercial success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
24. No claim is allowed.
25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMADHAN J JADHAO whose telephone number is (703)756-1223. The examiner can normally be reached M-F 8:00-5:00.
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/SAMADHAN JAISING JADHAO/ Examiner, Art Unit 1672
/BENNETT M CELSA/ Primary Examiner, Art Unit 1600
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