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 .
RCE
The request filed on 02/13/2026 for a request for continued examination (RCE) under 37 CFR 1.114 (d) is acceptable and a RCE has been established. An action on the RCE follows.
Remark
The response and amendment filed on 02/13/2026 have been acknowledged.
Claims 33, 60 and 64-65 have been amended. New claims 66-67 have been added. Claims 1-32, 34-37, 45, 57-59 and 61 have been canceled. Claims 33, 38-44, 46-56, 60, 62-65 and 66-67 are pending and considered. .
Claim Rejections - 35 USC § 112
The rejection of Claims 57-59 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement read on using HA alone to induce a preventive effect for a tumor or cancer development has been removed necessitated by Applicants’ amendment.
Claim Rejections - 35 USC § 103
The rejection of Claims 33, 38-39 and 60-64 under 35 U.S.C. 102((a) (1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US Patent Application No. 2003/0049253A1 has been withdrawn necessitated by Applicants’ amendment.
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 33, 38, 40-56, 60, 62, 66 and 67 are rejected under 35 U.S.C. 112 (a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for producing an immune response against a tumor or cancer expressing the cancer antigen Her2, comprising vaccinating a patient with a therapeutically effective dose of hyaluronic acid, wherein the hyaluronic acid is an immunological adjuvant and has a molecular weight ranging from greater than 100 KDa to 500 KDa; wherein the hyaluronic acid is chemically bound to the antigen; wherein the hyaluronic acid is conjugated to Her2 and produces an enhanced humoral and T cell immune response; and wherein the hyaluronic acid fosters a cell-mediated immune response against cells expressing the antigen for said vaccinating and enables generating specific cytotoxic T-cell immunity against said tumor or cancer., does not reasonably provide enablement for producing an enhanced immune response to any tumor or cancer with a hyaluronic acid conjugated with any or even Her2 . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The test of an enablement or scope of enablement is whether one skilled in the art could make and use the claimed invention from the disclosure in the application coupled with HA hereby inducing any good response.
According to the factors in re Wands, 8USPQ2d 1400 (Fed. Cir. 1988), which are set forth below: 1). Nature of invention; 2). Scope of claims; 3). State of art; 4). Unpredictability; 5). Level of skill; 6). Number of working examples and 7). Amount of guidance presented in the specification.
The nature of invention is directed to a method for treating a oncogene neu transgenic Balb-neuT mice with rHER2/neu-HA compared to the antigen emulsified in Alum via a standard immunization schedule. A control group was represented by not-vaccinated mice that received tumor challenge. From the day of tumor challenge, tumor growth was monitored and reported in the graph as tumor volume. Mice vaccinated with the bioconjugate resulted to be completely protected from tumor growth.
However, the scope of the claims is directed to using any or all antigen , even including the Her2 to treat with cancer or tumor , hereby to produce an immune response to control/treat any or all cancer or tumor.
It is well known in the art that an immunological approach to treat a cancer or tumor can be obtained with a method for treating a subject with an composition comprising the antigen as well as its conjugated adjuvant HA, However, the antigen must be the cancer or tumor identical to the one expressed by the cancer cells or the tumor.
Therefore, given the above analysis of the factors which the courts have determined are critical in asserting whether a claimed invention is enabled, it must be considered that the skilled artisan would have to conduct undue and excessive experimentation in order to practice the claimed invention.
Claims 33, 38, 40--56, 60-62, 66 and 67 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the claimed method is directed to a method for treating any patient suffering from any or all cancer or tumor with any or all antigen that is conjugated with the hyaluronic acid (HA) with a molecular weight great from 100 KDa to 500 KDa.
The first paragraph of 35 U.S.C. requires that the specification shall contain a written description of the invention. This requirement has several objectives: 1). To clearly convey the information that an applicant has invented the subject matter which is claimed; 2). To put the public in possession of what the applicant claims as the invention; and 3). To promoter the progress of the useful arts by ensuring that patentee adequately describe their inventions in their patent specification in exchange for the right to exclude others from participating the invention for the duration of the patent term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably concluded that the inventor had possession of the claimed invention. The possession of claimed invention can be shown by describing the claimed invention with all disclosures in the specification including drawing or description of an actual reduction to practice. The written description may arise in the following situations: a). The claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention; b). The claimed invention as a whole may not adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art; and c). The invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function etc.
However, in the instant case, the claimed invention has not been described with sufficient examples such as other cancer antigen conjugated with said HA to induce an enhanced immune response to any or all cancer or tumor.
Because the specification does not either describe any other caner or tumor antigen used with HA to treat any or all cancer or tumor, the claimed invention in the current application do not have the possession of claimed invention.
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.
Claim(s) 33, 38- 41-42, 47-54, 56, 60, 62-64, 65-67 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Yang et al. (Nanoscale, 2016, Vol. 8, pp. 11543-11558).
Yang et al. teach a method for making and using an immunogenic composition for treating a cancer cell expressing a mutated oncogene of Her/Neu . In particular, the composition comprises the a dual-targeting hybrid nanoparticle (NP) system was designed and constructed to deliver the SN38 agent specifically to human solid gastric tumors bearing excessive Her2 and CD44. The hybrid NPs consist of a particle core made of the biodegradable polymer PLGA and a lipoid shell prepared by conjugating the AHNP peptides and n-hexadecylamine (HDA) to the carboxyl groups of hyaluronic acid (HA), AHNP-HA-HAD as a nanoparticle (NP) and prepared in the PBS solution , wherein the AHNP peptide is cancer related neoepitope of FCDGFYACYKDV synthesized and wherein hyaluronic acid (HA) molecules used have the molecular weight 60 kDa, 100 kDa and 200 kDa respectively comprised in different compositions (See Table I). The compositions have been used more than one times in the mice cancer models in vivo and Her2 positive cancel cells in vitro for than one times .
Finally, the cited reference concluded that in the present study, they have successfully developed a dual-targeting hybrid NP delivery system composed of the specific moieties (HA and AHNP) for targeting Her2 and CD44-overexpressing gastric cancer. They have demonstrated that the cellular uptake of the hybrid NPs can be manipulated by controlling the molecular weight of HA and the surface ligand densities. The dual-targeting hybrid NPs possessed high blood compatibility and exhibited minimal activity to induce hemolysis. These results demonstrate that the dual-targeting hybrid NPs are promising for anti-cancer drug delivery to treat tumors over-expressing Her2 and CD44.
To this context the cited reference anticipates claims 33, 38- 41, 42, 47-54, 56, 60, 62-64, 65-67 both explicitly as implicitly particular for claims 33, 60 and 66.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671