DETAILED ACTION
Applicant’s amendment and remarks filed August 27, 2025 are acknowledged. Claims 1-20, and new claims 21-24 are under examination.
Claims Summary and Priority
In this summary of the claimed subject matter below, italicized font indicates subject matter that is newly presented in this application, which is a CIP of USSN 17/739,460. Since all claims recite some newly presented subject matter, there is no priority benefit to any earlier filed application(s).
Claims 1-5
Claim 1 is directed to a liquid rotavirus vaccine composition at a dose volume of about 0.5 ml, containing no buffer or antacid. The composition comprises:
A live attenuated rotavirus of strain 116E; the titre is about 106 FFU/0.5ml (claim 2);
Trehalose at a concentration of about 0.5%; and
Lactalbumin hydrolysate at a concentration of about 0.05%
The composition can be maintained at from about 2°C to about 8°C for up to 36 months (claim 3), or at about 25°C for 1-6 months (claim 4), or at about 37°C for 1-3 months (claim 5).
Claims 6-10
Claim 6 is directed to a liquid rotavirus vaccine composition at a dose volume of about 0.5 ml, containing no buffer or antacid. The composition comprises:
A live attenuated rotavirus of strain 116E; the titre is about 106 FFU/0.5ml (claim 7);
Sucrose at a concentration of about 30%;
Lactose or trehalose at a concentration of about 0.5%; and
Lactalbumin hydrolysate at a concentration of about 0.5%
The composition can be maintained at from about 2°C to about 8°C for up to 24 months (claim 8), or at about 25°C for 1-4 months (claim 9), or at about 37°C for 1-3 weeks (claim 10).
Claims 11-15
Claim 11 is directed to a liquid rotavirus vaccine composition at a dose volume of about 0.5 ml, containing no buffer or antacid. The composition comprises:
A live attenuated rotavirus of strain 116E; the titre is about 106 FFU/0.5ml (claim 12);
Sucrose at a concentration of about 30%;
Maltose at a concentration of about 5.0%; and
Lactalbumin hydrolysate at a concentration of about 1.0%
The composition can be maintained at from about 2°C to about 8°C for up to 24 months (claim 13), or at about 25°C for 1-4 months (claim 14), or at about 37°C for 1-3 weeks (claim 15).
Claims 16-20
Claim 16 is directed to a liquid rotavirus vaccine composition at a dose volume of about 0.5 ml, containing no buffer or antacid. The composition comprises:
A live attenuated rotavirus of strain 116E; the titre is about 106 FFU/0.5ml (claim 17);
Sucrose at a concentration of about 40%;
Lactose or trehalose at a concentration of about 0.5%;
Maltose at a concentration of about 0.5%;
Lactalbumin hydrolysate at a concentration of about 0.5%; and
Recombinant serum albumin at a concentration of about 0.35%
The composition can be maintained at from about 2°C to about 8°C for up to 36 months (claim 18), or at about 25°C for 1-8 months (claim 19), or at about 37°C for 1-6 weeks (claim 20).
New claims 21-24, all independent claims
Claim 21 is directed to a liquid rotavirus vaccine composition at a dose volume of from 0.5 ml to 1.0 ml, containing no buffer or antacid. The composition comprises:
A live attenuated rotavirus of strain 116E;
Trehalose at a concentration of from 0.5% to 1.0%; and
Lactalbumin hydrolysate at a concentration of from 0.05% to 1.0%
Claim 22 is directed to a liquid rotavirus vaccine composition at a dose volume of from 0.5 ml to 1.0 ml, containing no buffer or antacid. The composition comprises:
A live attenuated rotavirus of strain 116E;
Sucrose at a concentration of from 40% to 70%;
Lactose or trehalose at a concentration of from 0.5% to 5.0%; and
Lactalbumin hydrolysate at a concentration of from 0.5% to 1.0%
Claim 23 is directed to a liquid rotavirus vaccine composition at a dose volume of from 0.5 ml to 1.0 ml, containing no buffer or antacid. The composition comprises:
A live attenuated rotavirus of strain 116E;
Sucrose at a concentration of 30%;
Maltose at a concentration of 5.0%; and
Lactalbumin hydrolysate at a concentration of from 0.5% to 1.0%
Claim 24 is directed to a liquid rotavirus vaccine composition at a dose volume of 0.5 ml to 1.0 ml, containing no buffer or antacid. The composition comprises:
A live attenuated rotavirus of strain 116E;
Sucrose at a concentration of 40%;
Lactose or trehalose at a concentration of from 0.5% to 5.0%;
Maltose at a concentration of 0.5%;
Lactalbumin hydrolysate at a concentration of from 0.5% to 1.0%; and
Recombinant serum albumin at a concentration of 0.35%
Concentrations of trehalose are provided at 0.5% (paragraph [0074] of US 2019/0142932 A1) and 1.0% (paragraph [0078]). There is no disclosure of trehalose at 5.0%. Concentrations of lactose are provided at 0.5% (paragraph [0074]) and 5.0% [paragraph [0098]). Concentrations of lactalbumin hydrolysate are provided at 0.05% (paragraph [0074]), 0.5% (paragraph [0076]) and 1.0% (paragraph [0080]). Concentrations of sucrose are provided at 40% (paragraph [0082]), 50% (paragraph [0074]), 60% (paragraph [0054]) and 70% (paragraph [0090]). There is no disclosure of sucrose at 30%. While some of the lower and upper values of the concentrations are disclosed, as well as some interim values, no ranges from lower to upper values appear to have been contemplated. A range is broader in scope than set values.
Response to Arguments Regarding Priority
Applicant’s arguments filed August 27, 2025 have been carefully considered but fail to persuade. Applicant argues that since the originally filed application does not have concentration ranges of the various sugars, does not have titres of rotavirus strain 116E, provides temperatures described as “normal body temperature”, “refrigerated temperatures”, and references “low dose”, etc., that one would understand these terms to encompass all concentration ranges, all titres, all temperatures, as well as those that are “about” those ranges, titres and temperatures.
In response, a broad disclosure is not evidence of the disclosure of narrower embodiments. Narrower embodiments must be disclosed with sufficient specificity at the time of filing. Without such, there is no evidence that Applicant contemplated the narrower embodiments. Therefore, the claims are not entitled to the benefit of priority to any earlier filed application.
Claim Rejections - 35 USC § 112
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.
Claims 21-24 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 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. This is a new matter rejection.
Newly presented claims 21-24 recite subject that does not appear to have been disclosed prior to the amendment filed August 27, 2025. The subject matter in question is in italics above in the claims summary section. Concentrations of trehalose are provided at 0.5% (paragraph [0074] of US 2019/0142932 A1) and 1.0% (paragraph [0078]). There is no disclosure of trehalose at 5.0%. Concentrations of lactose are provided at 0.5% (paragraph [0074]) and 5.0% [paragraph [0098]). Concentrations of lactalbumin hydrolysate are provided at 0.05% (paragraph [0074]), 0.5% (paragraph [0076]) and 1.0% (paragraph [0080]). Concentrations of sucrose are provided at 40% (paragraph [0082]), 50% (paragraph [0074]), 60% (paragraph [0054]) and 70% (paragraph [0090]). There is no disclosure of sucrose at 30%.
While some of the lower and upper values of the concentrations are disclosed, as well as some interim values, no ranges from lower to upper values appear to have been contemplated. A range is broader in scope than set values.
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 1-22 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vadrevu et al. (US 2019/0142932 A1, “Vadrevu”). Vadrevu is Applicant’s own work, however it qualifies as prior art because the instant claims are directed to broader embodiments than those disclosed in their previous work. The broader embodiments encompass the particular embodiments disclosed in their previous work, thus, Vadrevu is prior art. The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Vadrevu discloses liquid, buffer free, acid stable low dose volume live, attenuated rotavirus vaccines of 0.5 ml (see abstract and paragraphs [0031], [0033], paragraph [0039], and last sentence of paragraph [0072]) (claims 1, 6, 11, 16, 21, 22 and 24, aspects of buffer free, antacid free, and a 0.5 ml dose). The rotavirus is strain 116E (see paragraph [0034]) (claims 1, 6, 11, 16, 21, 22 and 24, aspect of strain 116E). Various formulations are disclosed, including Formulation 4C, for example, see Table 6. Formulation 4C has a target titer of 106 FFU/0.5 ml, sucrose at 50%, trehalose at 0.5% and lactalbumin hydrolysate at 0.5% (claims 2, 7, 12 and 17, aspect of 106 FFU/0.5 ml; claims 1, 6, 16, 21, 22 and 24, aspect of 0.5% trehalose; aspect of 0.5% lactalbumin hydrolysate in claims 6, 16, 21, 22 and 24). Another formulation in Sample 1 comprises sucrose at 50%, lactose at 0.5%, HAS at 0.5% and lactalbumin hydrolysate at 0.05% (claims 6, 16, 21, 22 and 24, aspect of 0.5% lactose; claims 1 and 21, aspect of 0.05% lactalbumin hydrolysate). In Example 3.1, paragraph [0052], the formulation comprises 50% sucrose, 0.5% lactose, 0.5% trehalose, 1% lactalbumin hydrolysate, and 0.4% HSA (see paragraph [0034] for recombinant HSA) (claims 16 and 24, aspect of recombinant serum albumin at about 0.35%). In another formulation, Sample 5 comprising 40% sucrose, 5.0% maltose and 1% lactalbumin hydrolysate (see paragraph [0082]) (claims 16 and 24, aspect of 40% sucrose; claims 6 and 11, aspect of about 30% sucrose; claim 11, aspect of 5% maltose). In the formulation of Sample 10, there is 50% sucrose, 0.5% lactose, 0.5% maltose, 0.5% HSA, and 0.05% lactalbumin hydrolysate (see paragraph [0092]) (claims 16 and 24, aspect of maltose at 0.05%).
As for the combinations of reagents in claims 1-5 and 21, Sample 12 (paragraph [0096]) comprises 0.5% trehalose and 0.05% lactalbumin hydrolysate.
As for the combinations of reagents in claims 6-10 and 22, Sample 6 (paragraph [0084]) comprises 40% sucrose, 0.5% trehalose and 1.0% lactalbumin hydrolysate. Claim 6 recites “sucrose at a concentration of about 30%”, which encompasses Vadrevu’s disclosure of 40%, lacking any particular limits on “about 30%”. Similarly, claim 6 recites “lactalbumin hydrolysate at a concentration of about 0.5%”, which encompasses Vadrevu’s disclosure of 1.0%, lacking any particular limits on “about 0.5%”.
As for the combinations of reagents in claims 11-15, Sample 5 (paragraph [0082]) comprises 40% sucrose, 5.0% maltose and 1.0% lactalbumin hydrolysate. Claim 11 recites “sucrose at a concentration of about 30%”, which encompasses Vadrevu’s disclosure of 40%, lacking any particular limits on “about 30%”.
As for the combinations of reagents in claims 16-20 and 24, Sample 5 (paragraph [0082]) comprises 50% sucrose, 0.5% lactose, 0.5% maltose, 0.5% HSA and 0.5% lactalbumin hydrolysate, and Table 6 formulation 4D discloses 0.35% HSA. Claim 16 recites “sucrose at a concentration of about 40%”, which encompasses Vadrevu’s disclosure of 50%, lacking any particular limits on “about 40%”.
Vadrevu’s compositions are stable at from 2-8°C for at least 36 months, or at 25°C for at least 6 months, and/or at 37°C for at least 4 weeks (see Vadrevu’s claim 23) (claims 3-5, 8-10, 13-15, and 18-20). Therefore, the claimed embodiments are anticipated by Applicant’s own work.
Applicant’s arguments filed August 27, 2025 are acknowledged. Applicant argues that Vadrevu is not prior art. As addressed above, the claims do not have the benefit of priority to any earlier filed application, thus Vadrevu remains prior art for reasons of record.
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 1-22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,351,245 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are a species of the instantly claimed genus. A species anticipates a genus.
In the reply filed August 27, 2025, Applicant requests that this rejection be held in abeyance until allowable subject matter is identified.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672