DETAILED ACTION
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) 1, 2, 4-8, 12-16, 19 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Zuo (CN 111659370 A).
Regarding claim 1, Zuo discloses (see Figures and English translation for citations) a lyophilisate retainer for lyophilizing a substrate (the retainer is capable of holding a material for lyophilization), comprising:
a three-dimensional scaffold body having pores (Figs. 5-7; see pg. 4, “the catalyst carrier is a three-dimensional porous structure..”), wherein the pores of the scaffold body are configured to receive and hold the substrate (the pores are capable of holding particulate matter that are smaller than the pores), and
the scaffold body is made of a scaffold material providing heat transfer properties in lyophilization to enable heat transfer to the substrate held in the pores of the scaffold body (see pg. 4, “the catalyst carrier of the invention is integral…strong thermal conductivity..”).
Regarding claim 2, Zuo discloses the lyophilisate retainer of claim 1, wherein the scaffold material has a high thermal conductivity of 5 W/mK or more (pg. 4, “Further, the specific surface area…100-150 W/m/K”).
Regarding claim 4, Zuo discloses the lyophilisate retainer of claim 1, wherein the scaffold material is inert (it is partly made of SiO2, see “Technical Field”, and SiO2 is inert).
Regarding claim 5, Zuo discloses the lyophilisate retainer of claim 1, wherein the scaffold material is hydrophilic and particularly uniformly hydrophilic (top of pg. 3).
Regarding claim 6, Zuo discloses the lyophilisate retainer of claim 1, wherein the pores of the scaffold body are configured to receive and hold the substrate by dimensioning a diameter of the pores in accordance with a surface tension and a viscosity of the substrate (pg. 4). The limitation, “dimensioning a diameter of the pores in accordance with a surface tension and a viscosity of the substrate”, is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.” See MPEP 2113. In this case, the pores are the same or substantially similar to the claimed pores.
Regarding claim 7, Zuo discloses the lyophilisate retainer of claim 1, wherein the scaffold body has end sides (Fig. 5: outer sides) and each of the pores of the scaffold has an opening at one of the end sides (Figs. 6, 7 show pores on the outer sides).
Regarding claim 8, Zuo discloses the lyophilisate retainer of claim 7, wherein the pores of the scaffold body are passageways extending between at least two of the end sides of the scaffold body (see Figs 6 and 7 showing where the retainer is completely porous throughout, which means passageways extend from one end to another end).
Regarding claim 12, Zuo discloses the lyophilisate retainer of claim 1, wherein the scaffold body is a sponge-like structure (Fig. 6 shows that it looks like a sponge up close).
Regarding claim 13, Zuo discloses the lyophilisate retainer of claim 1, wherein the scaffold body has a frame structure made of the scaffold material (Fig. 6).
Regarding claim 14, Zuo discloses (see rejection of claim 1 for citations) a method of manufacturing a lyophilisate retainer for lyophilizing a substrate, comprising: equipping the lyophilisate retainer with a three dimensional scaffold body made of a scaffold material having heat transfer properties to induce heat transfer to the substrate in lyophilization, wherein equipping the lyophilisate retainer with the scaffold body includes providing the scaffold body with pores configured to receive and hold the substrate.
Regarding claim 15, Zuo discloses (see rejection of claim 6) the method of claim 14, wherein providing the scaffold body with pores comprises dimensioning the pores of the scaffold body in accordance with a surface tension of the substrate.
Regarding claim 16, Zuo discloses (see rejection of claim 6) the method of claim 14, wherein providing the scaffold body with pores comprises dimensioning the pores of the scaffold body in accordance with a viscosity of the substrate.
Regarding claim 19, Zuo discloses (see rejection of claim 5) the method of claim 14, comprising treating a surface of the scaffold body to adapt its surface properties, wherein the surface properties comprise hydrophilicity.
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.
Claim(s) 10, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zuo (CN 111659370 A).
Regarding claim 10, Zuo discloses the lyophilisate retainer of claim 1, except wherein the scaffold body has a cylindrical shape. However, the particular shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. See MPEP 2144.04(IV)(B).
Regarding claim 11, Zuo discloses the lyophilisate retainer of claim 10, except wherein a base of the scaffold body has a diameter of in between about 15 mm to about 60 mm. However, where the only difference between the prior art and the claim was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A).
Allowable Subject Matter
Claims 9, 17, 18, 21, 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/JASON LAU/Primary Examiner, Art Unit 3762