DETAILED ACTION
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 .
Election/Restriction
Applicant’s Response to Restriction Requirement, filed 08 October 2025, in response to the Office Action dated 13 June 2025, is acknowledged.
In the Response to Restriction Requirement, Applicant has elected Group I, claims 1-14, 23-25, and 33. Claims 15 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08 October 2025.
Claim Status
Claims 1-32 were pending. As a result of a Preliminary Amendment, filed 12 October 2022, claims 3-4, 6-8, 10-14, and 23-25 were amended, claims 16-22, 26-27, and 29-32 were cancelled, and claim 33 was added. Therefore, claims 1-15, 23-25, 28, and 33 were pending. In response to the Restriction Requirement, mailed 13 June 2025, Applicant elected Group I, claims 1-14, 23-25, and 33. Claims 15 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Therefore, claims 1-14, 23-25, and 33 are currently under examination.
Priority
Acknowledgment is made of applicant's claim for priority based on a parent application
filed on 13 April 2020.
The instant application filed on 12 October 2022 is a 371 of PCT/CA2021/050494 filed
13 April 2021, which is a provisional of application 63/009,041 filed 13 April 2020 and which
finds full support for the instant claims. Therefore, the effective filing date of the instant
application is 13 April 2020.
Information Disclosure Statement (IDS)
The IDS (1) filed on 31 January 2023 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor
and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
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 3, 25, 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 3 recites the limitation “the polymer matrix of claim 1 wherein the pullulan has a molecular weight in the range of about 100,000 to about 200,000. Applicant has failed to define the units of measure for molecular weight in both the claim and specification, thereby making claim 3 indefinite as one of ordinary skill in the art could not define the metes and bounds of the claim at issue. For purposes of applying prior art and based on the current evidence provided in the art, it is assumed the molecular weight of 100,000 to 200,000 is in Da. This aligns with the example provided in the specification where pullulan is at 200 kDa ([00101]).
Claim 25 recites the limitation: “an immunogenic composition comprising an antigen, the antigen formulated in a polymer matric of claim 1.” It is unclear if this limitation intends for the antigen to be the chemical and/or biological species or if the antigen is included in the polymer matrix in addition to another chemical and/or biological species. The specification provides little insight, only to disclose that multiple PT materials, each with one or more chemical and/or biological species, are stored in the same container (e.g., one PT material may contain one antigen while another PT material contains another antigen)” ([0090]). However, in this example, there is only one antigen per PT material. Therefore, one of ordinary skill in the art could not define the metes and bounds of the claim at issue.
Claim 33 recites the limitation “the aqueous mixture” in claim 23. There is insufficient antecedent basis for this limitation in the claim as neither claim 23 nor claim 1 from which claim 23 depends recite an aqueous mixture.
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 1-4, 6, 10-11, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tian (“Orodispersible films based on blends of trehalose and pullulan for protein delivery,” published: 29 September 2018).
Tian teaches orodispersible films based on blends of trehalose and pullulan for protein delivery (title). Tian prepares protein-loaded orodispersible films (ORFs) based on blends of trehalose and pullulan that were selected because of the excellent protein stabilizing capacity of trehalose and film-forming ability of pullulan (abstract).
Regarding instant claim 1, Tian teaches a composition comprising:
A polymer matrix comprising pullulan and trehalose and one or more chemical and/or biological species: various casting solutions were prepared that include trehalose, pullulan, glycerol, tween 80, and water (Table 1, p. 105); “In the case of protein-loaded ODFs, OVA, lysozyme, or β-galactosidase was added…” (p. 105).
Wherein the one or more chemical and/or biological species are incorporated within the polymer matrix: “OVA was incorporated at a high load…Furthermore, lysozyme and β-galactosidase were incorporated to assess protein stability during ODFs preparation and subsequent storage up to 4 weeks” (p. 105).
The polymer matrix preserves and/or stabilizes the one or more chemical and/or biological species: Tian prepares protein-loaded orodispersible films (ORFs) based on blends of trehalose and pullulan that were selected because of the excellent protein stabilizing capacity of trehalose and film-forming ability of pullulan (abstract).
And the polymer matrix is in powder form: “Subsequently, the film layers were either air-dried for 48 h at 30 °C and a relative humidity (RH) of 60–80% or freeze-dried for 48 hr using a Christ Epsilon 2–4 freeze-dryer” (p. 105).
Regarding instant claim 2, Tian teaches the following formulations of the composition:
The polymer matrix of claim 1 comprising about 10 wt% to about 50 wt% of pullulan and about 50 wt% to about 90 wt% of trehalose, based on the dry weight of the matrix: Table 1 shows the following weight ratios of pullulan/trehalose: 100/0, 80/20, 70/30, and 60/40 (Table 1, p. 105).
Regarding instant claim 3, Tian teaches a composition:
The polymer matrix of claim 1, wherein the pullulan has a molecular weight in the range of about 100,000 to 200,000: Materials used “Pullulan (average molecular weight 200-300 kDa)” (p. 105).
Regarding instant claim 4, Tian teaches a composition:
The polymer matrix of claim 1, wherein the one or more chemical and/or biological species are preserved at a temperature of from about -20°C to about 40°C: “…protein-loaded ODFs were sealed in plastic bags and stored at -20°C within 48 h before further analysis” (p. 105).
Regarding instant claim 6, Tian teaches a composition:
The polymer matrix of claim 1, wherein the one or more chemical species is a biomolecule chosen from one or more of a protein, an enzyme, an antibody, a peptide, a nucleic acid, an antidote and a vaccine: “In the case of protein-loaded ODFs, OVA, lysozyme, or β-galactosidase was added…” (p. 105).
Regarding instant claims 10 and 11, Tian teaches a composition:
The polymer matrix of claim 1, wherein the polymer matrix further comprises one or more additional substances or additives: various casting solutions were prepared that include trehalose, pullulan, glycerol, tween 80, and water (Table 1, p. 105).
The additives glycerol and tween 80 are suitable for injection thereby meeting the limitations of instant claim 11.
Regarding instant claim 13, Tian does not explicitly disclose the limitation where the polymer matrix, in powdered form, comprises particles having a median surface area:volume ratio of 10:1 mm-1 to about 120:1 mm-1. However, Tian discloses an identical polymer matric formulation comprised of pullulan, trehalose, and at least one chemical and/or biological species (instant claim 1). Furthermore, Tian discloses identical wt% of pullulan and trehalose within the polymer matrix (instant claim 2). Lastly, Tian discloses the identical molecular weight of pullulan (instant claim 3). Therefore, since Tian discloses an identical polymer matrix with identical properties, the limitations contained within instant claim 13 are inherent to the mixture. See MPEP 2112(I), (II), and (III).
Regarding instant claim 14, Tian teaches a composition:
The polymer matrix of claim 1, having a water content of less than 10 wt%: various casting solutions were prepared that include trehalose, pullulan, glycerol, tween 80, and water (Table 1, p. 105).
Water is taught in a quantity of up to 10 g in the composition.
Therefore, the teachings of Tian, as related to instant claims 1-4, 6, 10-11, 13, and 14, anticipate the currently claimed invention.
Claims 1-6, 10, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teekamp (“Addition of pullulan to trehalose glasses improves the stability of β-galactosidase at high moisture conditions,” published: 15 November 2017 as previously cited in prior Office Action).
Teekamp teaches the incorporation of therapeutic proteins in a matrix of sugar glasses is known in the art to enhance protein stability, yet protection is often lost when exposed to high relative humidity (abstract). Teekamp further hypothesizes that, especially in the conditions of high relative humidity, the use of binary glasses of a polysaccharide and disaccharide might yield advantages for protein stability (abstract).
Regarding instant claim 1, Teekamp teaches a composition comprising:
A polymer matrix comprising pullulan and trehalose and one or more chemical and/or biological species: “Pullulan and trehalose were accurately weighed and dissolved separately in water or HEPES buffer. Next the solutions were mixed…” (p. 375);
Wherein the one or more chemical and/or biological species are incorporated within the polymer matrix: “Incorporations of therapeutic proteins in a matrix of sugar glass…” (abstract); “β-galactosidase in HEPES dissolved in HEPEs buffer was added to each combination in a 1:249 protein:sugar weight ratio” (p. 375).
The polymer matrix preserves and/or stabilizes the one or more chemical and/or biological species: “The assessment of the biocompatible polysaccharide pullulan (Mw 200–300 kDa) as a sugar glass for protein stabilization yielded a very high Tg of 261 °C, which is an excellent attribute for protein stabilization. Yet, pullulan’s bulky nature prevents a tight molecular packing around proteins, which resulted in a process and storage stability of the model protein β-galactosidase that was inferior to the disaccharide trehalose at conditions free from moisture (0% RH). However, when moisture is present (e.g. 56% RH), as may occur in daily practice, blends of pullulan and trehalose outperformed trehalose alone” (p. 379); see also Fig. 5 on p. 379).
And the polymer matrix is in powder form: “The vials were then immersed in liquid nitrogen to freeze the solutions and placed in a Christ-Epsilon 2-4 freeze-dryer on a precooled shelf (–50 °C). Next, the samples were freeze-dried at a shelf temperature of −35 °C and a pressure of 0.220 mbar for 24 h. Secondary drying was performed by decreasing pressure to 0.050 mbar and increasing shelf temperature to 25 °C during 24 h. After freeze-drying, the 4 mL vials were closed under dry nitrogen gas to ensure 0% RH. Samples were stored at −20 °C until further analysis or subjection to a storage stability study” (p. 375).
Regarding instant claim 2, Teekamp teaches the following formulations of the composition:
The polymer matrix of claim 1 comprising about 10 wt% to about 50 wt% of pullulan and about 50 wt% to about 90 wt% of trehalose, based on the dry weight of the matrix: “Next, the solutions were mixed in the following weight ratios of pullulan/trehalose: 1/0; 5/1; 2/1; 1/1; 1/2; 1/5 and 0/1” (p. 375); see also Fig. 3 on p. 377).
Regarding instant claim 3, Teekamp teaches a composition:
The polymer matrix of claim 1, wherein the pullulan has a molecular weight in the range of about 100,000 to 200,000: Materials used “Pullulan (average molecular weight 200-300 kDa) was a kind gift of Hayashibara (Okayama, Japan)” (p. 375).
Regarding instant claim 4, Teekamp teaches a composition:
The polymer matrix of claim 1, wherein the one or more chemical and/or biological species are preserved at a temperature of from about -20°C to about 40°C: “Samples were stored at -20°C until further analysis or subjection to a storage stability study” (p. 375).
Regarding instant claim 5, Teekamp teaches a composition:
The polymer matrix of claim 4, wherein the one or more chemical and/or biological species are preserved and/or stabilized for at least 4 days at the temperatures below freezing: Fig. 5 on p. 379 shows the “stability of freeze-dried β-galactosidase, with and without various pullulan/trehalose mixtures, at different storage conditions up to 4 weeks” (p. 379).
Regarding instant claim 6, Teekamp teaches a composition:
The polymer matrix of claim 1, wherein the one or more chemical species is a biomolecule chosen from one or more of a protein, an enzyme, an antibody, a peptide, a nucleic acid, an antidote and a vaccine: Fig. 5 on p. 379 shows the “stability of freeze-dried β-galactosidase (enzyme), with and without various pullulan/trehalose mixtures, at different storage conditions up to 4 weeks” (p. 379).
Regarding instant claim 10, Teekamp teaches a composition:
The polymer matrix of claim 1, wherein the polymer matrix further comprises one or more additional substances or additives: “Pullulan and trehalose were accurately weighed and dissolved separately in water or HEPES buffer. Next the solutions were mixed…” (p. 375).
Regarding instant claim 13, Teekamp does not explicitly disclose the limitation where the polymer matrix, in powdered form, comprises particles having a median surface area:volume ratio of 10:1 mm-1 to about 120:1 mm-1. However, Teekamp discloses an identical polymer matric formulation comprised of pullulan, trehalose, and at least one chemical and/or biological species (instant claim 1). Furthermore, Teekamp discloses identical wt% of pullulan and trehalose within the polymer matrix (instant claim 2). Lastly, Teekamp discloses the identical molecular weight of pullulan (instant claim 3). Therefore, since Teekamp discloses an identical polymer matrix with identical properties, the limitations contained within instant claim 13 are inherent to the mixture. See MPEP 2112(I), (II), and (III).
Regarding instant claim 14, Teekamp teaches a composition:
The polymer matrix of claim 1, having a water content of less than 10 wt%: Teekamp teaches the pullulan/trehalose/β-galactosidase composition was freeze-dried (p. 375). It is well known in the art that the process of freeze-drying removes water content in a composition.
Therefore, the teachings of Teekamp, as related to instant claims 1-6, 10, 13, and 14, anticipate the currently claimed invention.
Claim Rejections - 35 USC § 103
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.
Claims 7-9, 11-12, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Teekamp (previously cited) in further view of Martyn (WO 00/50013; published: 13 August 2000).
The teachings of Teekamp are discussed above. Specifically, Teekamp teaches experimental results showing the potential of pullulan/trehalose blends for application as a pharmaceutical excipient in stabilizing proteins in solid form (p. 379). However, Teekamp does not explicitly teach the limitations of instant claims 7-9, 11-12, and 23-25.
Martyn discloses rapidly-soluble compositions suitable for use as vehicles for the delivery or bioactive substances (p. 1, lines 1-6). The compositions disclosed by Martyn are also suitable for use as delivery vehicles for active substances requiring rapid release (p. 1, lines 6-8).
Martyn discloses a formulation of pullulan in water and trehalose dispensed into 1 mL aliquots into the wells of a plastic blister pack (p. 8, lines 27-30). The blisters were loaded into a freeze-drier and frozen on a shelf held at -32°C before turning on the vacuum and lyophilizing the frozen solution for 24h to yield a solid matrix of carbohydrate polymer plus sugar excipient. Martyn further discloses additional embodiments of the invention: solutions containing pullulan, mannitol, and diltiazem (p. 9, lines 6-10) or pullulan, mannitol, and acyclovir (p. 9, lines 25-28), showing that chemical and/or biological species are suitable for incorporation into the polymer matrix embodiments of the disclosed invention.
Regarding instant claim 7, Martyn discloses the compositions of the invention may contain prophylactic bioactive materials and carriers (p. 6, lines 30-32) where preferred compositions include immunogens such as vaccines formulated to induce an immune response (p. 7, lines 7-15).
Regarding instant claim 8 and 9, Martyn discloses the compositions of the invention contain bioactive materials and suitable bioactive materials include subcellular compositions, cells, bacteria, and viruses (p. 5, lines 32-34).
Regarding instant claims 11 and 12, Martyn discloses the compositions of the invention are in pharmaceutical dosage form (p. 1, line 10) particularly suitable for use in mucosal delivery formulations, such as tablets for per-oral delivery, that dissolve in saliva (p. 3, lines 21-23). The scope of Martyn’s invention pertains to pharmaceutical formulations for delivery to both veterinary and human applications (p. 4, lines 7-11). Accordingly, the composition containing pullulan and trehalose provided by Martyn in the example contains no further additives (p. 8, lines 27-30).
Regarding instant claim 23, Martyn discloses the composition further contains a vaccine that is capable of inducing an immune response to the antigen of interest and/or an adjuvant sufficient to enhance an immune response to the immunogen (p. 7, lines 13-17). Furthermore, and as discussed previous, Martyn discloses the compositions of the invention are in pharmaceutical dosage form (p. 1, line 10) particularly suitable for use in mucosal delivery formulations, such as tablets for per-oral delivery, that dissolve in saliva (p. 3, lines 21-23). The scope of Martyn’s invention pertains to pharmaceutical formulations for delivery to both veterinary and human applications (p. 4, lines 7-11).
Regarding instant claim 24, Martyn discloses the polymeric matrices of the invention are capable in minimal volumes of aqueous solvent and of sufficient structural integrity to be handled as discrete units containing actives (p. 3, lines 14-19). Furthermore, Martyn discloses: “Products of the invention comprise matrices that are soluble not just at body temperatures but also at ambient and lower temperatures. They are thus suitable not just for oral or buccal delivery as solid matrices but also as soluble matrices for rapid dissolution in aqueous solvent prior to administration.” (p. 3, lines 33-37; p. 4, line 1).
Regarding instant claim 25, Martyn discloses the compositions of the invention may contain antigens (p. 6, lines 30-37).
A combination of Teekamp and Martyn disclose the limitations of instant claims 7-9, 11-12, and 23-25. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to arrive at the claimed invention. Both Teekamp and Martyn disclose a composition containing pullulan, trehalose, and a biologically active molecule. Teekamp discloses a composition of pullulan, trehalose, and an enzyme, but does not explicitly disclose additional bioactive molecules within the pullulan and trehalose composition. Martyn discloses a wide variety of biologically active molecules suitable for use in a pullulan/trehalose matrix. Therefore, one of ordinary skill would have predicted the prior art elements are capable of being combined and the combination would have worked for its intended purpose of stabilizing the bioactive molecule in a polymer matrix.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Teekamp (previously cited) in further view of Martyn (previously cited) and Carrigy (“Amorphous pullulan trehalose microparticle platform for respiratory delivery,” published: 02 April 2019).
The teachings of Teekamp and Martyn are discussed above. Specifically, Teekamp teaches experimental results showing the potential of pullulan/trehalose blends for application as a pharmaceutical excipient in stabilizing proteins in solid form while Martyn discloses rapidly-soluble compositions suitable for use as vehicles for the delivery or bioactive substances to subjects. However, neither Teekamp nor Martyn explicitly teach the limitation of instant claim 33.
Carrigy teaches spray drying biologics and small-molecule drugs can increase their thermal stability relative to liquid dosage forms (abstract). Carrigy teaches a formulation of pullulan and trehalose are a promising platform for respiratory delivery (p. 165) which removes contamination risks and disposal issues associated with needles (p. 156). Furthermore, and regarding the limitation of instant claim 33, Carrigy teaches spray dried pullulan trehalose powder within glass pressurized metered-dose inhaler canisters (p. 165) and twin-fluid atomizers (p. 161). Finally, Carrigy teaches the platform is compatible with dry powder inhalers and pressurized metered-dose inhalers and has suitable aerosol performance in a commercial dry powder inhaler exceeding that of many available commercial products (p. 166).
A combination of Teekamp, Martyn, and Carrigy disclose the limitations of instant claim 33. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to arrive at the claimed invention. Both Teekamp and Martyn disclose a composition containing pullulan, trehalose, and a biologically active molecule. Teekamp discloses a composition of pullulan, trehalose, and an enzyme, but does not explicitly disclose additional bioactive molecules within the pullulan and trehalose composition. Martyn discloses a wide variety of biologically active molecules suitable for use in a pullulan/trehalose matrix and its administration to subjects. Carrigy teaches administration of pullulan/trehalose via intranasal route by way of both atomizer and sprayer and the benefits of such administration route. Therefore, one of ordinary skill would have predicted the prior art elements are capable of being combined and the combination would have worked for its intended purpose of administration of the polymer matrix to a subject.
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 1-10 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, 10, 13, and 16 of U.S. Patent No. 11,040,015 (hereinafter ‘015).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the currently claimed invention and the claimed invention in ‘015 are drawn to a polymer matrix comprising pullulan, trehalose, and a biomolecule in powdered form.
‘015 claim
Instant claim
Claims 1 and 16 are drawn to a polymer matrix comprising pullulan, trehalose, and one or more viruses wherein the polymer matrix preserves and/or stabilizes the one or more viruses; wherein the matrix comprises 10 wt% to 50 wt% pullulan and 50 wt% to 90 wt% trehalose; and wherein the mixture is dried (claim 16).
1, 2, 8, 9, and 13*
(*See MPEP 2112(I), (II), and (III) and above discussion regarding inherent properties of the polymer matrix).
Claim 3 is drawn to the polymer matrix wherein the pullulan has a molecular weight from 100,000 Da to 200,000 Da.
3
Claim 5 is drawn to the polymer matrix wherein the viruses are preserved and/or stabilized at a temperature from about 2°C to 40°C.
4, 5*
(*See MPEP 2144.05(I): a prima facie case of obviousness exists where the claimed ranges do not overlap with the prior art but are merely close).
Claim 7 is drawn to the polymer matrix wherein the one or more viruses are comprised in a vaccine.
6
Claim 10 is drawn to the polymer matrix further comprising one or more additional substances or additives.
10
Claim 13 is drawn to the polymer matrix further comprising one or more biomolecules selected from a protein, enzyme, antibody, peptide, and a nucleic acid.
7
Therefore, claims 1, 3, 5, 7, 10, 13, and 16 anticipate that which is currently claimed in instant claims 1-10 and 13.
Claims 11-12, 14, and 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, 10, 13, and 16 of U.S. Patent No. 11,040,015 (hereinafter ‘015) and in further view of Teekamp and Martyn.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the currently claimed invention and the claimed invention in ‘015 are drawn to a polymer matrix comprising pullulan, trehalose, and a biomolecule in powdered form.
The teachings of Teekamp and Martyn are discussed above. A combination of Teekamp and Martyn disclose the limitations of instant claims 11-12, 14, and 23-25. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to modify the claimed invention of ‘015 and arrive at the currently claimed invention. Both Teekamp and Martyn disclose a combination of pullulan, trehalose, and a chemical and/or biological species. Martyn further discloses administration of this composition to mammals. So, while ‘015 does not explicitly claim those limitations of instant claims 11-12, 14, and 23-25, these claims would have been made obvious by the teachings of Teekamp and Martyn. One of ordinary skill would have predicted the prior art elements are capable of being combined and the combination would have worked for its intended purpose of stabilizing the bioactive molecule in a polymer matrix and administration to a subject which initiates an immune response.
Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, 10, 13, and 16 of U.S. Patent No. 11,040,015 (hereinafter ‘015) and in further view of Teekamp, Martyn, and Carrigy.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the currently claimed invention and the claimed invention in ‘015 are drawn to a polymer matrix comprising pullulan, trehalose, and a biomolecule in powdered form.
The teachings of Teekamp, Martyn, and Carrigy are discussed above. A combination of Teekamp, Martyn, and Carrigy disclose the limitation of instant claim 33. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to modify the claimed invention of ‘015 and arrive at the currently claimed invention. Both Teekamp, Martyn, and Carrigy disclose a combination of pullulan, trehalose, and a chemical and/or biological species. Martyn further discloses administration of this composition to mammals. Finally, Carrigy describes the preferred embodiment of the composition is intranasal administration by way of an atomizer or sprayer. So, while ‘015 does not explicitly claim those limitation of instant claim 33, this claim would have been made obvious by the teachings of Teekamp, Martyn, and Carrigy. One of ordinary skill would have predicted the prior art elements are capable of being combined and the combination would have worked for its intended purpose of stabilizing the bioactive molecule in a polymer matrix and administration to a subject via intranasal administration.
Conclusion
Claims 1-14, 23-25, and 33 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A Rossi whose telephone number is (571) 272-0138. The examiner can normally be reached M-F 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A ROSSI/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644