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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 1, 2026 has been entered.
An updated search revealed pertinent prior art.
Claim Rejections - 35 USC § 112
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 5-7 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. Claim 5, ultimately depending from and encompassing all of the limitations set forth in claim 1, states that the thermostable vaccine is for mucosal use or administration. Claim 1 recites a thermostable mucosal vaccine in line 1 “for mucosal administration” in lines 5-6. Therefore, claim 5 fails to further limit claim 1. Claims 6 and 7, ultimately depending from and encompassing all of the limitations set forth in claim 1, requires, “wherein the thermostable vaccine composition is medically effective when stored at a temperature of about 4 degrees Celsius for 28 days (recited in claim 6), or wherein the thermostable vaccine composition is medically effective after exposed to ambient temperatures for 14 days following removal from temperature-controlled storage” (recited in instant claim 7). Therefore, claims 6 and 7 fail to further limit claim 1.
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 § 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.
Claims 1 and 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over Burnam (WO 2020/247851) and Dolak (US 6,803,056).
Claims 42 and 43 of Burnam are drawn to preparing a petrolatum-based transdermal vaccine composition by providing a liquid composition comprising at least one antigen; heating petrolatum from about 37° C to about 40° C to a temperature sufficient to cause the petrolatum to melt in paragraph [0029]; heating the liquid composition comprising at least one antigen that is about 1° C to about 5°C higher than the melted petrolatum. “About 1° C” taught by Burnam encompasses an equivalent or less than 1° C since a concern of Burnam’s is denaturation and/or degradation of the antigens at higher temperatures. See paragraph [0030]. This step is followed by mixing the melted petrolatum and the heated antigen solution to give a melted mixture; and cooling the melted mixture to provide the petrolatum-based transdermal vaccine composition. These teachings correspond to instant claims 8 and 9.
Burnam does not mention the thermostable vaccine composition is medically effective when stored at a temperature of about 4 degrees Celsius for 28 days or wherein the thermostable vaccine composition is medically effective after exposed to ambient temperatures for 14 days following removal from temperature-controlled storage, as recited in instant claims 1, 6, and 7.
However, claim 37 of Burnam states: antigen maintains efficacy for at least 3 months when stored at 40°C ± 2°C and paragraph [0015] states that the antigen does not separate from the petrolatum carrier for at least six months.
Therefore, the composition of Burnam would be stable at less severe and stringent storage conditions at a temperature of about 4 degrees Celsius for 28 days or wherein the thermostable vaccine composition is medically effective after exposed to ambient temperatures for 14 days following removal from temperature-controlled storage, as required by instant claims 1, 6, and 7.
The component of the vaccine component mixed with the petrolatum carrier of Burnam is selected from a live attenuated vaccine (LAV), an inactivated (killed antigen) vaccine, a subunit (purified antigen) vaccine, and a toxoid (inactivated toxin) vaccine in paragraphs [0002, 0009, 0049] and claims 4-10, as required by instant claim 4. The vaccine component is dispersed or suspended in the petrolatum carrier in paragraph [0011] and claims 19 and 20, as required by instant claim 3.
The petrolatum carrier mixed with the vaccine component of Burnam is present in at least or greater than 80% by weight of the composition, according to paragraphs [0010, 0017, 0041, 0054] and claims 12-15, as required by instant claim 1.
The vaccine prepared by the method of Burnam is delivered by topical transdermal delivery, as evidenced by claims 1, 41, and 42. Burnam does not mention mucosal delivery, as required by instant claims 1, 5, 8, and 9.
Dolak teaches a method of treating lesions associated with viral infections by applying a composition comprising petrolatum and white petrolatum, each in quantities from about 0.5% to 50% by weight, to a mucosal membrane and more particularly, the oral mucosa, see column 2, lines 28-30; column 3, lines 16-38; and claims 1 and 9.
MPEP § 2144.05 teach:
Generally, 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)
In the instant case, Dolak teaches the range of workable percentage weights of each petrolatum component with sufficient specificity.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have modified the petrolatum and white petrolatum component percentage weights of Dolak to a total of at least 80% by weight since there is no evidence of criticality on the instant petrolatum weight percentage which may range from “at least 80%”, recited in instant claim 1. Dolak teaches petrolatum and white petrolatum, each in quantities from about 0.5% to 50% by weight. It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have optimized the weight percentage of petrolatum, as evidenced by the teachings of Dolak, absent unexpected results to the contrary to arrive at the weight percentage recited in instant claim 1.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have applied the vaccine composition prepared by Burnam to a mucosa, as taught by Dolak, to treat infections. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success have applied the vaccine composition prepared by Burnam to a mucosa, as taught by Dolak, because Figure 2, described in paragraph [0007] of Burnam, depicts penetration of antigens through corneocyte layers of skin and Dolak describes active agent delivery through the cornified layers of the skin in column 3, lines 39-43. In addition, both Burnam and Dolak incorporate active ingredients into petrolatum carriers present in at least 80% by weight and ingredients to enhance penetration through the skin, see paragraph [0013] of Burnam and column 3, lines 39-63 of Dolak.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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