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 .
This Office action is responsive to Applicant’s preliminary amendment and remarks, filed 03 Aug 2026, in which claim 33 is amended to change the scope and breadth of the claim.
This application is the national stage entry of PCT/EP2021/066640, filed 18 June 2021.
Claims 19-38 are pending in the current application. Claims 19-29 and 33-36, drawn to non-elected inventions, are withdrawn. Claims 30-32 and 37-38 are examined on the merits herein.
Election/Restrictions
Responsive to Applicant’s preliminary amendment, filed 03 Aug 2026, and as detailed in the examiner’s note in the Requirement for Restriction mailed 14 May 2026, the Restriction is modified to include claims 33-36 in Group I, now claims 19-29 and 33-36.
Applicant's election with traverse of Group II, claims 30-32 and 37-38, in the reply filed on 03 Aug 2026 is acknowledged. The traversal is on the ground(s) that no lack of unity of invention was asserted for the PCT application, and that there is no serious burden to search and examine the claims together, such as in view of the record of the search for the PCT application. This is not found persuasive because as provided in 35 USC 372 under which the restriction of the national stage entry was required, the question of unity of invention may be reexamined under 35 USC 121, within the scope of the requirements of the treaty and the Regulations. Therefore, as in this case, the determination of lack of unity of invention made in the PCT application is not necessarily the same as the determination made as in the case of national applications regularly filed in the Patent and Trademark Office. Further, a serious search and/or examination burden on the examiner if restriction is not required is implicit in the determination that there is no common special technical feature of a single general inventive concept, because to search and/or examine the different special technical features of the inventive concept of each individual group of invention or species would require a different field of search such as different search queries for the different special technical features. Further, regarding Applicant’s noting the record of the search for the PCT application according to procedures in an international application, this does not eliminate the serious burden for search and/or examination of as in the case of national applications regularly filed in the Patent and Trademark Office using the procedures applicable to national applications. For example, the procedures applicable to national applications include the consideration of product-by-process claim per MPEP 2113 as detailed further herein.
The modified Requirement for Restriction is necessitated by Applicant’s preliminary amendment. The requirement is still deemed proper and is therefore made FINAL.
Claims 19-29 and 33-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 03 Aug 2026.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 30-32 and 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hauser et al. (US 2009/0011033, published 08 Jan 2009, provided by Applicant in IDS filed 22 Nov 2024).
Hauser et al. discloses a cellulose sulfate which is completely water-soluble and has an adjustable solution viscosity in aqueous solution, having ideal biological compatibility for biological and medical applications (abstract). Hauser et al. discloses the working examples of the cellulose sulfate of batch b1 having a degree of substitution of 0.54 and a viscosity of 66 mm/s2 and batch b2 having a degree of substitution of 0.48 and a viscosity of 14 mm/s2 (paragraph 123 spanning page 8-9 and table aa), meeting limitations of claims 30-32. The substitution showed regioselectivity for the C6 position, meaning the degree of substitution DS6 of at the C6 position was 0.54 or 0.48, respectively, meeting limitations of claim 32. The viscosity was measured as a 1% aqueous solution of the cellulose sulfate at 25 °C (page 8, paragraph 122). Hauser et al. discloses working example 2 of the cellulose sulfate formulated as a microcapsule encapsulating a liquid core with the shell containing the cellulose sulfate and the polycation poly(diallyldimethyl ammonium chloride) (pDADMAC) (page 10, paragraphs 135-137; page 6, paragraph 90), meeting limitations of claim 37. Such microcapsules are suitable to enclose biological objects for biomedical usage, but also for the production of pharmacologically active ingredients in biotechnological scale. They can also be used for the immobilization of pharmacologically active ingredients (page 7, paragraph 97-99), or a drug formulation meeting limitations of claim 38. The capsules are adequately stable for intravenous injections and for implanting in the human and animal tissue (example 4 at page 12, paragraph 148-154), meeting limitations of claim 38.
Regarding claim 30, the claim is interpreted as a product-by-process claim. See MPEP 2113, providing ““[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. 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)” and “Furthermore, “[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.” Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009)” In this case, Hauser et al. discloses products that appear to meet all structural limitations of the claimed polysaccharide sulfate, such as the chemical composition, the solution viscosity and degree of substitution. Therefore, the product of the product-by-process claims are anticipated even though the products of Hauser et al. were made by a different process.
Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 30-32 and 37-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 8,337,901 (reference patent) in view of Hauser et al. (US 2009/0011033, published 08 Jan 2009, provided by Applicant in IDS filed 22 Nov 2024).
Reference claims 1-11 and 24 of the reference patent are drawn to a method for the production of regio-selective substituted cellulose sulfate (CS), making obvious possession of the cellulose sulfate produced thereby.
Reference claims 12-13 are drawn to the sodium cellulose sulfate obtained by the reference method. Reference claim 12 recites the solution viscosity range of the produced SCS is adjustable between 10 and 500 mPas based on a 1% solution dissolved in water.
Reference claims 20-22 are drawn to a microcapsule comprising the reference sodium cellulose sulfate.
Reference claims 14-18 are drawn to a method for the production of microcapsules comprising the reference sodium cellulose sulfate and a cationic polymer, making obvious possession of the reference sodium cellulose sulfate used therein and possession of the microcapsules produced thereby.
Reference claim 19 is drawn to a process of encapsulating biological materials with the reference sodium cellulose sulfate, making obvious possession of the reference sodium cellulose sulfate used therein.
Reference claim 23 is drawn to a process for treating a patient with a medicament comprising the step of implanting or injecting a patient with a medicament that includes the microcapsules from the reference sodium cellulose sulfate, making obvious possession of the reference sodium cellulose sulfate used therein.
Reference claims 1-24 do not specifically recite the degree of substitution of the cellulose sulfate (claim 31-32).
Hauser et al. is the pre-grant publication of the application issued as the Reference patent, and the disclosure qualifies as prior art under 35 U.S.C. 102(a)(1). Hauser et al. discloses as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Reference claims in view of Hauser et al. in order to select the embodiments disclosed in Hauser et al. from within the scope of the Reference claims. One of ordinary skill in the art would have been motivated to combine the Reference claims in view of Hauser et al. with a reasonable expectation of success because Hauser et al. as prior art discloses the invention claimed in the Reference claims, and Hauser et al. discloses embodiments of the invention in the form of the working examples, providing motivation to select these particular embodiments from within the scope of the Reference claims.
As detailed above regarding claim 30, the claim is interpreted as a product-by-process claim. For the same reasons detailed above, the product of the product-by-process claims are made obvious even though the products taught by the Reference claims in view of Hauser et al. were made by a different process.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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