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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claims and Previous Objections/Rejections Status
Claims 1,2,6,9-11 and 13 are pending in the application. Claim 12 is canceled in the amendment filed 5/29/26.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
Response to Arguments
Applicant's arguments filed 5/29/26 have been fully considered but they are not persuasive.
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 (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 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.
Claim(s) 1,2,6,9-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abe et al. (US2006/0178339A1), as evidenced by Jung et al. (Analyt. Chem. 79, 2007, 5703-5710) in view of Gulle et al. (US2016/0271228A1) and in further view of Willard et al. (US 2020/0281980A1), as evidenced by Castor Oils safety data sheet 2023 as stated in the office action mailed 3/6/26.
Applicant asserts that “the first polysaccharide has been dispersed in a hydrophobic solvent,” which means that the hydrophobic solvent functions as a continuous phase (dispersion medium). Furthermore, the present composition is in the form of a “paste,” and the hydrophobic solvent, which accounts for 25% by mass to 75% by mass with respect to the total mass of the hemostatic material composition, has the function of protecting the reactive group of the first polysaccharide from water.
In contrast the vegetable oil taught by Willard is merely a plasticizer for imparting flexibility to a solid “film.” Even if a person of ordinary skill in the art were to add a large amount of vegetable oil to the composition of Abe in accordance with the teachings of Willard, the resulting product would be nothing more than a “film/sheet of a crosslinked polysaccharide composition softened by containing oil.”
It is respectfully pointed out that instant claims 1,2,6,9-11 and 13 are product-by-process limitations wherein the first polysaccharide having been dispersed in a hydrophobic solvent. 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 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). See MPEP 2113.
The reference of Abe et al. was used to teach of a hemostatic material comprising a crosslinkable polysaccharide succinimide ester derivative and a polymer, such as a polypeptide (gelatin).
The polysaccharide and polypeptide (gelatin) composition is in the form of a paste (p4, [0064]; p12, [0149]), powder, film, etc. and therefore, is not merely drawn to a film.
A paste hemostatic composition may be formed by mixing the polysaccharide in powder form with the polymer in a powder form (p12, [0144]) and then mixed into a paste by commonly used methods (p9, [0120]).
The polysaccharide and polymer composition further incorporates additives, such as plasticizers, solvent, petrolatum, paraffin, etc.
The paste may be applied to the desired spot of a subject and is used to form a sheet/film (p13, [0158]).
The reference of Gulle et al. was used to teach of a hemostatic composition that comprises a biocompatible polymer (gelatin) and a hydrophilic polymeric component comprising reactive groups.
The hydrophilic polymer is mixed with an organic solvent and the hemostatic composition is provided in a paste form that can be adjusted to the specific need and intended use, such as spreadable consistency, viscosity for shaping.
The reference of Willard et al. was used to teach of a hemostatic composition comprising crosslinked polysaccharides, such as dextran that is provided in the form of a paste, liquid, film, sheet, etc.
The hemostatic composition may be applied to skin to form a film wherein the properties,
such as durability of the resulting film may be adjusted by changing the ingredients of the composition as well as varying the relative amounts of ingredients (p4, [0036-0037]).
The hemostatic composition includes other additives including plasticizers, such as oil of
vegetable origin (such as castor oil), pine oil, etc. in an amount of 1-70 wt.% to impart flexibility to the resulting film.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vegetable oil and/or substitute a vegetable oil, such as castor oil, for paraffin within the hemostatic composition paste of Abe et al., as Abe et al. teaches that plasticizers are appropriate additives for hemostatic materials, including paste forms and Willard et al. teach that the castor oil plasticizer imparts flexibility to hemostatic materials in a paste form that are used to form a film/sheet.
Therefore, one of ordinary skill in the art would be motivated to use castor oil of Willard et al. in an amount of 1-70 wt.% in the hemostatic composition of Abe et al. to predictably impart flexibility to the resulting hemostatic composition film or sheet from a paste composition as Willard et al. teaches that changing the ingredients of the composition as well as varying the relative amounts of ingredients can adjust the properties of the composition.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the hemostatic composition of Abe et al. and the hemostatic composition of the instant claims comprise an analogous mixture of a.) a crosslinkable polysaccharide derivative comprising at least one active ester group, b.) a polypeptide or polysaccharide polymer, and c.) paraffin and/or plasticizers wherein the paraffin and/or plasticizers have the same properties and are capable of the same functions, such as dispersing a first polysaccharide to form a paste.
Furthermore, it is obvious to vary and/or optimize the amount of paraffin and/or plasticizers provided in the paste composition, such as 25% to 75%, according to the guidance provided by Willard et al., to provide a composition having the desired properties such as the desired impart flexibility to the resulting hemostatic composition film or sheet formed from a paste composition. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The vegetable oil of Willard encompasses the vegetable oil of the instant claims, has the same
properties and is capable of the same functions, such as protecting the reactive group of the first polysaccharide from water.
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
As stated in KSR v. Teleflex, “the Circuit first erred in holding that courts and patent examiners should look only to the problem the patentee was trying to solve” and "it is common sense that familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle".
Applicant asserts that the vegetable oil of Willard is merely a plasticizer for imparting flexibility to a solid “film”. Even if a person of ordinary skill in the art were to add a large amount of vegetable oil to the composition of Abe in accordance with the teachings of Willard, the resulting product would be nothing more than a “film/sheet of a crosslinked polysaccharide composition softened by containing oil.” The cited references disclose no motivation or suggestion to depart from the purpose of imparting flexibility in Willard, and to change the structure into a paste-like composition in which vegetable oil is used as a dispersion medium and a reactive polysaccharide is dispersed therein.
The reference of Abe et al. teaches that the hemostatic material composition may be in a paste form that is prepared by mixing powder polysaccharide with powder polymer wherein the paste is used to form a sheet/film. The hemostatic material paste composition may further comprise plasticizers, solvent, petrolatum, paraffin, etc. as well as that stated above.
The reference of Willard et al. teach of the hemostatic composition comprising a plasticizer that
is provided in the form of a paste, liquid, film, sheet, etc. as well as that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vegetable oil and/or substitute a vegetable oil, such as castor oil, for paraffin within the hemostatic composition paste of Abe et al., as Abe et al. teaches that plasticizers are appropriate additives for hemostatic materials, including paste forms and Willard et al. teach that the castor oil plasticizer imparts flexibility to hemostatic materials in a paste form that are used to form a film/sheet.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the hemostatic composition of Abe et al. and the hemostatic composition of the instant claims comprise an analogous mixture of a.) a crosslinkable polysaccharide derivative comprising at least one active ester group, b.) a polypeptide or polysaccharide polymer, and c.) paraffin and/or plasticizers wherein the paraffin and/or plasticizers have the same properties and are capable of the same functions, such as dispersing a first polysaccharide to form a paste.
As stated in KSR v. Teleflex, “the Circuit first erred in holding that courts and patent examiners should look only to the problem the patentee was trying to solve” and "it is common sense that familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle".
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 1,2,6,9-11 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 16 of copending Application No. 18/062,575 as stated in the office action mailed 3/6/26.
Response to Arguments
Applicant's arguments filed 5/29/26 have been fully considered but they are not persuasive.
Applicant requests that the double patenting rejection be held in abeyance.
The rejection is not held in abeyance and is maintained.
Conclusion
No claims are allowed at this time.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
