DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-2 and 5-6 are pending and represent all claims currently under consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/27/2025 has been entered.
Response to Arguments
Applicant's arguments filed 08/27/2025 have been fully considered but they are not persuasive.
Applicant argues that the combination of Yuji and Yamamoto would not produce the claimed hard capsule formulation due to the amendment and because Yuji fails to disclose a band seal preparation liquid (Remarks, pages 6-7). This argument is not persuasive, because Yuji discloses an adhesive band or film (Yuji, page 7, paragraph 0059), which can be produced using a liquid sealing device (Yuji, page 12, paragraph 0103), suggesting a band seal preparation liquid as claimed. This is supported by Yamamoto, which teaches a seal device applies a seal liquid to form a band seal (Yamamoto, page 6, second paragraph). The rejection below has been modified to address the amendments.
Applicant further argues that the sealing band of Yuji is not intended to include a tag having a hologram pattern as part of the band seal and rather the hologram pattern is covered with the components of the band seal impairing the hologram’s function (Remarks, pages 6-7). This argument is not persuasive, because Yuji teaches the capsule sealed with a sealing band comprising a polynucleotide (Yuji, Claim 3) in a hologram pattern (Yuji, Claim 4), and specifically states the hologram pattern can be recognized from an outer surface side of the capsule (Yuji, claim 7).
New Claim Objections
Claim 1 is objected to because of the following informalities: “hydroxypropylcellulose” is listed in the group of seal components twice. Appropriate correction is required.
Maintained/Modified 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.
Claims 1-2 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yuji (JP 2011036278 A; IDS reference, 01/31/2022) in view of Yamamoto (JP 61068050 A; IDS reference, 01/31/2022), and evidenced by NEB and Biology LibreTexts. All references were previously cited by the Examiner in the Non-Final Office Action mailed 11/20/2024.
Regarding claim 1, Yuji teaches a capsule for medicine (i.e., capsule formulation) which is sealed with a sealing band comprising a polynucleotide (Yuji, Claim 3) in a hologram pattern (Yuji, Claim 4) for identifying a product (i.e., tags that enable a product to be identified; Yuji, Claim 7). Yuji further teaches the hologram is recognizable by an inspection device (Yuji, Claim 8) which uses a laser beam of light (i.e., irradiated with light in a predetermined wavelength region; Yuji, page 20, Paragraph 0084). Yuji further teaches the polynucleotide can be contained in an adhesive band or film (Yuji, page 7, paragraph 0059), which can comprise gelatin or pullulan (i.e., seal components from the claimed list; Yuji, page 8, paragraph 0065), and be produced using a liquid sealing device (Yuji, page 12, paragraph 0103), suggesting a liquid seal preparation as claimed.
Yuji does not specifically teach the capsule is a hard capsule, but teaches the capsule comprises gelatin (Yuji, Page 25, Paragraph 0108, Example 4). Yamamoto teaches a hard gelatin capsule (Yamamoto, Claim 1), suggesting a gelatin capsule would be expected to be hard, with a band seal (Yamamoto, Claim 3) which is applied via a seal liquid from a seal device (Yamamoto, page 6, second paragraph).
The recitation of “the hard capsule formulation is prepared by filling a hard capsule with a content, followed by fitting a cap portion and a body portion thereof together, applying the band seal preparation liquid to a formed fitted portion, and drying the band seal preparation liquid to seal the hard capsule” is considered to be a product-by-process claim. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP § 2113(I). In this case, the product is obvious over the prior art as stated above. Further, Yuji teaches the capsule body and cap are separately filled with a drug (Yuji, page 8, paragraph 0061), the capsule body and cap are fitted to the capsule containing the drug (Yuji, page 13, paragraph 0107), and the adhesive film is bonded to the capsule to cover the fitting portion of the cap and body (i.e., applied after the fitting step; Yuji, page 12, paragraph 0102), which can be done using a liquid capsule sealing device (Yuji, page 12, paragraph 0103), suggesting the process used is substantially similar to the process as claimed.
Yuji and Yamamoto are both considered to be analogous to the claimed invention, because they are both in the same field of pharmaceutical capsule formulations. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have expected the gelatin capsule taught by Yuji to be hard as taught by Yamamoto, and to have modified the band seal preparation taught by Yuji to be from a liquid preparation as suggested by Yuji and taught by Yamamoto, because Yuji suggests optimizing the capsule materials as appropriate (Yuji, Page 17, Paragraph 0074) and Yamamoto teaches the liquid band seal preparation improves the sealing property (Yamamoto, page 7, 5th paragraph).
Regarding claim 2, Yuji and Yamamoto together teach all the elements of the current invention as applied to claim 1. Yuji further teaches the polynucleotide tag to have a molecular weight of at least 1,000,000 g/mol (Yuji, Page 14, Paragraph 0057). Using commonly known mathematical conversions in the field (1 DNA nucleobase has an average molecular weight of 308.97 g/mol, as evidenced by NEB, and an average length of 3.4 angstroms or 0.34 nm, as evidenced by Biology LibreTexts), a polynucleotide with a molecular weight of at least 1,000,000 g/mol is equivalent to at least 1.1 micrometers, which overlaps the range of 400 micrometers or less for the length of the tag stated in the instant claim. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05, subsection I. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date, and absent a clear showing of evidence to the contrary.
Regarding claim 5, Yuji and Yamamoto together teach all the elements of the current invention as applied to claim 1. Yuji further teaches the hologram to be a combination of characters (i.e., letters), figures, or colors (Yuji, Page 19, Paragraph 0081).
Regarding claim 6, Yuji and Yamamoto together teach all the elements of the current invention as applied to claim 1. Yuji further teaches a film (Yuji, Page 15, Paragraph 0061) which can include gelatin and a gelling agent, reading on the claimed base and component other than the base (Yuji, Page 18, Paragraph 0074).
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613