DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to a claim set filed 4/3/2024.
Claims 16-29 are pending.
This instant application claims priority under 371 to PCT/JP2022/004063 filed 2/2/2022 which claims priority to foreign priority papers JP 2021-015724 filed 2/3/2021 and JP 2021-141461 filed 8/31/2021. Applicant cannot rely upon the foreign priority papers to overcome this rejection because a translation of said papers has not been made of record in accordance with 37 CFR 1.55. See MPEP § 201.15. Therefore, the effective filing date of the claims is 6/20/2023.
Information Disclosure Statement
Information disclosure statements filed 7/27/2026, 6/11/2026, 4/28/2026, 3/12/2026, 1/13/2026, 12/9/2025, 8/21/2025, 7/7/2025, 2/10/2025, 8/29/2023 and 6/20/2023 have been identified and the documents considered. The corresponding signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through. In the case that only an English abstract was identified, this is indicated.
Specification
The use of the terms such as Microautograph MST-1, page 70, AUTOGRAPH, STEMFIT page 71 and NucleoCounter NC-3000, page 72, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
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.
Claim 16 is 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 16 recites the limitation "the based particle impregnated" in claim 16, line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112, first paragraph
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.
Claims 16-29 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to manufacture of a cell culture microcarrier with a strength break of 1000 mN or more. The claims recite that the method requires dissolving either a polyvinyl alcohol derivative skeleton or a poly(methyl)acrylic acid ester skeleton to obtain a solution that is than sprayed on the base particle.
(abstract) The microcarrier for cell culture according to the present invention includes a base particle and a coating layer coating an outer surface of the base particle, and has a strength at break of 1000 mN or more.
The only particulars provided are for the solution formulation wherein the base particle is not described in the specification such that one can envision this element. The disclosure does teach that the material of the base particle is not limited bas it appears that the strength at break requirement seems to be conferred by the solution sprayed thereon. However, the base particles are made with DVB (divinylbenzene) with styrene except in one instance (Example 7) wherein this form uses ACR (acrylic resin). Furthermore, it is not clear the size, shape or other form of this particle and yet the preamble states that the structure must be a cell culture microcarrier. Applicants applications appears to be the sole source of this term used in microcarriers and hence the art does not elucidate the description.
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As to the solution that is sprayed on to provide the strength at break, the claims are drawn more broadly to any polyvinyl alcohol derivative skeleton or a poly(methyl)acrylic acid ester skeleton. The exemplified structures with a strength at break of 1000 mN or more are labeled as comprising a coating with either Resin X1 or Resin X2. Both of these coatings are made of polyvinyl acetal (polyvinyl butyral) comprising a peptide conjugated thereto. The only difference between X1 and X2 is the peptide,
[0186] The resin X1 has an amino acid sequence of Gly-Arg-Gly-Asp-Ser as the peptide moiety.
[0198] The resin X2 has an amino acid sequence of Arg-Gly-Asp-Phe-Lys (cyclic peptide skeleton) as the peptide moiety.
Hence, applicants claims are broadly drawn but require specific functional properties wherein the only components provided for with these properties are a DVB plus styrene base particle with an average diameter of 100 to 300 um with a layer of Resin X1 or Resin X2 (comprised of polyvinyl acetal).
To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 16-29 are rejected under 35 U.S.C. 103 as being unpatentable over Hisako et al (JO 2016171794, IDS filed 6/20/2023) in view of Kopayashi et al (WO 2020/230884, IDS filed 6/20/2023).
Hisako et al teach a microcarrier (see page 4, col 1) comprised of divinylbenzene and styrene 0-30 mass% of a structural unit derived from a divinylbenzene-based monomer and 70-90% of styrene. As established in the instant disclosure tables 1 and 2 this ratio would lead to breaking strength of 1500 mN to 2000mN using 30 parts divinylbenezene per 970 parts styrene to 800 parts divinylbenzene to 200 parts styrene (see translation page 7, col 1). This would inherently lead to the desired strength of 1000 mN or more given the overlap in range.
Hisako does not teach that the carrier is coated with either a polyvinyl alcohol derivative or poly(meth)acrylic acid ester. However, improvement of microcarriers is shown by inclusion of surface molecules wherein polyvinyl alcohol is coated on the surface (see translation page 10, last ¶). This coats the structure by spinning and allowing a film to coat in a manner akin to spraying by spinning (see page 14).
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the coating with polyvinyl alcohol as taught by Kobayashi et al on the surface of the microcarrier of Hiskao et al resulting in the method of claim 16. As noted above: 1) Hisako et al teach construction of a base particle for cell culturing with a strength of break of 1000 mN and 2) Kobayashi et al teach coating of cell culture microcarriers with polyvinyl alcohol. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the expanded method would allow improved treatment.
While Hisako et al do not teach peptides as recited in claim 19, Kobayashi et al teach that the polymer coating can involve a reaction to link peptides as recited in claims 17 and 18 (page 10, last ¶). Kobayashi et al further teach the following. As recited in claim 19-22 and 25, the polyvinyl acetal can be polyvinyl butyral with a linker (see page 5, ¶5). The linker can be a carboxyl group or acrylamide as recited in claims 23-24 (see page 8, ¶3-4). The polymer is ethylenically unsaturated group (see page 8, ¶7) which as taught by Hisako et al is DVB as recited in claim 28. Hisako teaches the particles are 100-1500 mm (see claim 8, page 3)
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 16-29 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 14-27 of copending Application No. 18/268,484.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are inherent to all that is recited in claims 14-27 of copending Application No. 18/268,484. That is, the cited claims of copending Application No. 18/268,484 and the claims of the instant method are drawn to the same steps of producing a cell culture microcarrier. The difference between the two is the required property of strength at break of 1000 mN or more in the instant claims and the specific gravity of 1.11 g/cm3 or more of copending Application No. 18/268,484. This provides only for different measurements on what appears to be as shown below the same product made by the same steps.
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Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending Application No. 18/268,484, then two different assignees would hold a patent to the claimed invention copending Application No. 18/268,484, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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