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 .
Status of the Application
Claims 1-16 are pending.
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-4 and 15, directed to a composition, and the species of dextran in the reply filed on 11/25/2025 is acknowledged. The election was made without traverse.
The requirement is therefore made FINAL.
Claims 5-14 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-4 and 15 are under current examination.
Claim Objections
Claim 1 is objected to because the claim recites “t-PA”, which is an abbreviation, and it needs to be spelled out in its entirety because this is the first time it appears in the claim, and must be defined.
Appropriate correction is required.
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.
Claims 1-4 and 15 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1-4 and 15 are indefinite as claim 1 recites “particle comprising fucoidan and loaded by adsorption with t-PA”. This is because the claim recites both a composition and process step of “loaded by adsorption with t-PA”. It is unclear (a) does the composition of the instant claim contain t-PA; (b) or it is the property of the composition that it can be loaded by adsorption with t-PA. Given that composition claims are not typically required to perform method steps, claim 1 has been interpreted under the broadest reasonable interpretation as (b) a cross-linked polysaccharide particle comprising fucoidan which is capable of being loaded by adsorption with t-PA.
Appropriate correction required.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 15 and elected species are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Letourneur (US 2013/0171126 A1).
Letourneur discloses a cross-linked polysaccharide particle comprising fucoidan and dextran (elected species) (made by same steps of NaOH and STMP as in the abstract of the instant specification) followed by loading with t-PA:
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and a composition comprising cross-linked polysaccharide particle comprising fucoidan, dextran, t-PA and PBS (entire application, especially page 3, paragraphs 0132-0141 and claims).
Although the cited prior art is silent about word “adsorption”, the cited prior art teaches same particle composition comprising same components as in the instant claims. Thus, the composition of the cited prior art is also capable of loading t-PA by adsorption on the particle. This is because the composition is inseparable from its physical and chemical properties.
Although instant claims 1-3 and 15 recites a product-by-process limitation, the case law has established that “Even 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 (in this case a cross-linked polysaccharide particle comprising fucoidan and dextran and t-PA, process limitation of loaded by adsorption t-PA) 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). Furthermore, “because 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. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). Thus, the cited prior art reads on instant claims.
Further, if the limitation “loaded by adsorption with t-PA” is considered as intended use of the composition-since the cited prior art teaches same composition comprising same components as in instant claims, the composition of the cited prior art must be capable of being “loaded by adsorption with t-PA”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims.
Since the cited prior art reads on all the limitations of the instant claims 1-3 and 15, these claims are anticipated.
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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 15 and elected species are rejected under 35 U.S.C. 103 as being unpatentable over Letourneur (US 2013/0171126 A1) and Etman (International Journal of Biological Macromolecules, vol 147, pages 799-808, 11/2019; as provided by the applicant on IDS dated 12/08/2022) in combination.
Determining the scope and contents of the prior art
Letourneur discloses a cross-linked polysaccharide particle comprising fucoidan and dextran (elected species) (made by same steps of NaOH and STMP as in the abstract of the instant specification) followed by loading with t-PA:
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and a composition comprising cross-linked polysaccharide particle comprising fucoidan, dextran, t-PA and PBS (entire application, especially page 3, paragraphs 0132-0141 and claims).
Although the cited prior art is silent about word “adsorption”, the cited prior art teaches same particle composition comprising same components as in the instant claims. Thus, the composition of the cited prior art is also capable of loading t-PA by adsorption on the particle. This is because the composition is inseparable from its physical and chemical properties.
Although instant claims 1-4 and 15 recites a product-by-process limitation, the case law has established that “Even 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 (in this case a cross-linked polysaccharide particle comprising fucoidan and dextran and t-PA, process limitation of loaded by adsorption t-PA) 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). Furthermore, “because 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. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). Thus, the cited prior art reads on instant claims.
Further, if the limitation “loaded by adsorption with t-PA” is considered as intended use of the composition-since the cited prior art teaches same composition comprising same components as in instant claims, the composition of the cited prior art must be capable of being “loaded by adsorption with t-PA”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims.
Ascertaining the differences between the prior art and the claims at issue
Letourneur discloses a cross-linked polysaccharide particle comprising fucoidan and dextran (elected species) and t-PA, but is silent about molecular weight of fucoidan.
Resolving the level of ordinary skill in the pertinent art
With regards to the above difference- Letourneur discloses a cross-linked polysaccharide particle comprising fucoidan and dextran (elected species) and t-PA, and a method of preparing and using such composition. This deficiency is cured by Etman.
In the same field of endeavor of cross-linked nanoparticles comprising Fucoidan and polysaccharide, Etman teaches cross-linked nanoparticles comprising Fucoidan and polysaccharide and loading with t-PA (entire article). Most importantly, Etman motivates to use fucoidan of low molecular weight, especially between 6kDa-80kDa, as such LMW fucoidan has higher ability to cross biological barrier (entire article, especially section 3.2). Thus, based on the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success to use LMW fucoidan, such as 6kDa-80kDa to increase the ability of these nanoparticles to cross biological barrier. Further, a person of ordinary skill in the art would have been motivated to use LMW fucoidan, such as 6kDa-80kDa to increase the ability of these nanoparticles to cross biological barrier.
Therefore, combination reads applicants claims.
Based on the above established facts, it appears that the combination of teachings of above cited prior art read applicants’ composition.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present indicating obviousness or non-obviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Letourneur discloses a cross-linked polysaccharide particle comprising fucoidan and dextran (elected species) and t-PA and Etman teaches cross-linked nanoparticles comprising Fucoidan and polysaccharide and loading with t-PA (entire article). Most importantly, Etman motivates to use fucoidan of low molecular weight, especially between 6kDa-80kDa, as such LMW fucoidan has higher ability to cross biological barrier.
So, the combination of prior art read applicants claims.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that the LMW fucoidan, such as 6kDa-80kDa may be used in the composition to increase the ability of these nanoparticles to cross biological barrier and can be made by combination of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed composition with a reasonable expectation of success.
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 1-4 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9381250B2 (Letourneur, US 2013/0171126 A1, as discussed above) in view of Etman (International Journal of Biological Macromolecules, vol 147, pages 799-808, 11/2019; as provided by the applicant on IDS dated 12/08/2022), discussed in greater detail above).
Claims 1-11 of U.S. Patent No. U.S. Patent No. 9381250B2 discloses a method of making cross-linked polysaccharide beads comprising fucoidan and dextran etc., and loading with a drug (and thus composition of the instant claims). Although the claims of the patent are broad, the claims encompass the instant claims. Importantly, the specific examples of the specification of the patent provides cross-liked polymer comprising fucoidan and dextran and loading with t-PA. Etman teaches cross-linked nanoparticles comprising Fucoidan and polysaccharide and loading with t-PA (entire article). Most importantly, Etman motivates to use fucoidan of low molecular weight, especially between 6kDa-80kDa, as such LMW fucoidan has higher ability to cross biological barrier. Thus, based on the guidance provided by Etman and patent, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success to use LMW fucoidan, such as 6kDa-80kDa to increase the ability of these nanoparticles to cross biological barrier.
For the reasons set forth above, the instant claims are obvious.
Conclusion
No Claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623