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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 12, 2026 has been entered.
Status of the Claims
Claims 1-15 were originally filed March14, 2023.
The preliminary amendment received March 14, 2023 amended claims 3-8, 10-13, and 15.
The amendment received May 4, 2026 amended claims 1-15.
The amendment received August 12, 2026 amended claims 1, 5, and 7 and canceled claim 10.
Claims 1-9 and 11-15 are currently pending.
Claims 1-3, 8, 11, and 12 are currently under consideration.
Election/Restrictions
Applicants elected, without traverse, human tissue factor, cellulose, epoxide chemistry (particularly epichlorohydrim), and FVII/VIIa in the reply filed on December 4, 2025.
Please note: human tissue factor is considered a subgenus and not a single, specific species (e.g. 100% identity to present SEQ ID NO: 2, etc.). Therefore, the subgenus was searched.
Please note: epichlorohydrin is not part of the present claims, therefore, any art rejection of record does not require epichlorohydrin.
Claims 4-7, 9, 10, and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 4, 2025.
Please note: claim 9 is withdrawn due to the dependency on withdrawn claim 7.
Priority
The present application is a 371 (National Stage) of PCT/EP2021/075533 filed September 16, 2021 which claims foreign priority to EP 20196512.6 filed September 16, 2020.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Withdrawn Objections
The objection to claim 1 regarding “SEQ ID NO:2” should read “SEQ ID NO: 2” (i.e. a space is missing) is withdrawn in view of the amendment received August 12, 2026.
The objection to claim 1 regarding a conjunction is missing between the bullet points in claim 1 is withdrawn in view of the amendment received August 12, 2026.
Withdrawn Rejections
The rejection of claims 1-3, 8, 11, and 12 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 is withdrawn in view of the amendment received August 12, 2026.
The rejection of claims 1-3, 8, 11, and 12 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 is withdrawn in view of the amendment received August 12, 2026.
New Rejections
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-3, 8, 11, and 12 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
With regard to the written description requirement, the attention of the Applicant is directed to The Court of Appeals for the Federal Circuit which held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)] (the case is referred to herein as “Lilly”).
Additionally, it is noted that written description is legally distinct from enablement: “Although the two concepts are entwined, they are distinct and each is evaluated under separate legal criteria. The written description requirement, a question of fact, ensures that the inventor conveys to others that he or she had possession of the claimed invention; whereas, the enablement requirement, a question of law, ensures that the inventor conveys to others how to make and use the claimed invention.” See 1242 OG 169 (January 30, 2001) citing University of California v. Eli Lilly & Co.
Although directed to DNA compounds, this Eli Lilly holding would be deemed to be applicable to any compound or a generic of compounds; which requires a representative sample of compounds and/or a showing of sufficient identifying characteristics; to demonstrate possession of the compound or generic(s). In this regard, applicant is further referred to University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997); “Guidelines for Examination of Patent Applications Under the 35 USC 112, first paragraph, ‘Written Description’ Requirement” published in 1242 OG 168-178 (January 30, 2001); and Univ. Of Rochester v G. D. Searle and Co. 249 F. Supp. 2d 216 (W.D.N.Y. 2003) affirmed by the CAFC on February 13, 2004 (03-1304) publication pending.
Additionally, Lilly sets forth a two part test for written description:
A description of a genus of cDNA’s may be achieved by means of a recitation of:
a representative number of cDNA’s, defined by nucleotide sequence, falling within the scope of the genus OR of a recitation of structural features common to the members of the genus.
See Regents of the University of California v. Eli Lilly & Co. 119 F.3d 1559 (Fed. Cir. 1997) at 1569.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Additionally, Cf. University of Rochester v G.D. Searle & Co., Inc., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., No. 03-1304, 2004 WL 260813 (Fed. Cir., Feb. 13, 2004) held that:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
The present claims refer to a variant of tissue factor that has at least 59% identity to SEQ ID NO: 2 and the preamble provides the function of promoting rapid haemostasis while reducing the risk of undesirable blood coagulation. The claims do not provide a common core structure necessary for the function of promoting rapid haemostasis while reducing the risk of undesirable blood coagulation. A peptide with only 59% identity would be expected to have a very different function than SEQ ID NO: 2.
In the present instance, the specification discloses only limited examples that are not representative of the claimed genus of a variant having at least 59% identity to SEQ ID NO: 2; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus (i.e. no common core structure in provided). The instant claims define the variant thereof by the functional limitation of promoting rapid haemostasis while reducing the risk of undesirable blood coagulation. The CAFC held that a functional definition is insufficient to adequately describe a product, therefore, an adequate written description not based on a functional definition is necessary. The present specification provides SEQ ID NO: 2 (human tissue factor; 219mer), SEQ ID NO: 3 (human tissue factor; 71mer), and SEQ ID NO: 4 (human tissue factor; 124mer). However, the specification provides no information regarding the function of SEQ ID NOs: 3 or 4. In addition, at page 16, the percent identity for various other extracellular domains of mammalian tissue factors (i.e. mouse, Norwegian rat, guinea pig, cat, dog, cattle, and pig) compared to the extracellular domain of human tissue factor is provided. However, no alignments are provided and no indication of which residues are necessary for function are provided.
The Examiner further notes the present claims stated by Applicant are broader in scope that those that were held to be impermissible in Lilly because, unlike Lilly, Applicants’ claims encompass a vast number of variants (e.g. any polypeptide with 59% or more identity to SEQ ID NO: 2). The scope of these claims include a vast number of sequences because the specification and claims do not place any limit on which amino acids can be altered. Furthermore, the specification and claims do not provide a common core structure for function. Therefore, Applicants are using an inadequately described variant to inadequately describe the claimed tissue factor. Consequently, there is no teaching that would allow a person of skill in the art to determine a priori that the Applicant was in possession of the full scope of the claimed invention at the time of filing because there is no common structural attributes that can link together all of the claimed variants thereof.
While the general knowledge and level of skill in the art for making variants is high, this knowledge and level of skill does not supplement the omitted description because specific, not general, guidance is needed for the variant with 59% or more identity which will promote haemostasis while reducing the risk of undesirable blood coagulation. Since the disclosure fails to describe the common attributes or characteristics that identify all of the members of the genus or even a substantial portion thereof, and because the genus is vast and highly variant, the limited examples in the specification (e.g. no variants thereof were tested) are insufficient to teach the entire genus.
The specification discloses only limited examples that are not representative of the claimed genus of a variant with 59% or more identity to SEQ ID NO: 2; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. Therefore, the teachings in the specification are general teachings relating without guidance as to the individual components of the product. In addition, there are numerous variants that could be employed in the invention with little direction or guidance for one of skill in the art to practice the claimed invention. The expedient statements in the specification do not relate to an adequate disclosure or how to make and use the claimed invention. Consequently, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to adequately describe the vast genus. Thus, Applicant does not appear to be in possession of the claimed genus.
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 1-3, 8, 11, and 12 are 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how the tissue factor in the claims is related to SEQ ID NO: 2, if at all. The tissue factor recited in the claims is not refer to as SEQ ID NO: 2. Only the variant refers to SEQ ID NO: 2. It is unclear how the variant can be a variant of SEQ ID NO: 2 and a variant of tissue factor (i.e. variant thereof) while tissue factor is not necessarily SEQ ID NO: 2.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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.
Claims 1-3, 8, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Farrell WO 2012/142317 published October 18, 2012 (provided in the IDS); Osther WO 2016/150449 published September 29, 2016 (provided in the IDS); and Morrissey et al. WO 2006/047684 published May 4, 2006 (provided in the IDS).
For present claims 1-3, 8, 11, and 12, Farrell teaches human tissue factor (TF) impregnated in a wound dressing wherein the wound dressing can be cellulose and one or more hemostatic agents may additionally be impregnated into the wound dressing including FVIIa (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 4, 6-9, 12, 13, 20, 23, 24, 28-31, 35, 42, 54, 58, 59, 66, 67, 71, 72, 75, 76, 78, 83, 84, 98).
However, Farrell does not teach the combination of TF, FVII, and FVIIa.
For present claims 1-3, 8, 11, and 12, Osther teaches recombinant soluble human tissue factor (RshTF) and the extracellular part of TF in combination with Factor VII/VIIa coated on and/or impregnated or embedded in a carrier or scaffold including Biatain™ (i.e. cellulose) (please refer to the entire specification particularly the abstract; pages 1-3, 5-7, 10-15).
Since coated, embedded, and impregnated may be interpreted several ways, Morrissey et al. is utilized to explicitly teach attachment of TF to solid supports so that it will not be allowed to migrate freely into and/or throughout the bloodstream, and so that it will not be washed out of a wound by hemorrhaging blood (please refer to the entire specification particularly paragraph 11).
For present claims 1-3, 8, 11, and 12, Morrissey et al. teach human tissue factor (TF) incorporated, embedded, etc. into stable, soluble nanoscale particles, scaffolds, membranes, matrixes, etc. including cellulose and chemical crosslinking via esters (please refer to the entire specification particularly the abstract; paragraphs 7-9, 11, 29, 39, 40, 76, 77, 80). Morrissey et al. also teach that soluble TF is thousands of times more active when embedded in a suitable membrane (please refer to the entire specification particularly paragraph 7). Morrissey et al. teach attachment of TF to solid supports so that it will not be allowed to migrate freely into and/or throughout the bloodstream, and so that it will not be washed out of a wound by hemorrhaging blood (please refer to the entire specification particularly paragraphs 11, 77). Morrissey et al. teach covalent linkages (please refer to the entire specification particularly paragraphs 77-80).
The claims would have been obvious because the substitution of one known element (i.e. genus of hemostatic agents; FVIIa alone) for another (i.e. species of FVII, the combination of FVII and FVIIa) would have yielded predictable results (i.e. adding to benefits of TF by providing binding partners in the coagulation cascade) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. combining TF, FVII, and FVIIa in a wound dressing; impregnating/embedding TF so that TF will not be allowed to migrate freely into and/or throughout the bloodstream and so that TF will not be washed out of a wound by hemorrhaging blood; covalent linkages) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Farrell; Osther; and Morrissey et al. for claims 1-3, 8, 11, and 12 were considered but are not persuasive for the following reasons.
Applicants contend that Farrell and Osther do not teach covalent linkages. Applicants contend that Morrissey et al. do not teach that TF is covalently linked to a dressing material.
Applicants’ arguments are not convincing since the teachings of Farrell; Osther; and Morrissey et al. render the composition of the instant claims prima facie obvious.
The claims would have been obvious because the substitution of one known element (i.e. genus of hemostatic agents; FVIIa alone) for another (i.e. species of FVII, the combination of FVII and FVIIa) would have yielded predictable results (i.e. adding to benefits of TF by providing binding partners in the coagulation cascade) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. combining TF, FVII, and FVIIa in a wound dressing; impregnating/embedding TF so that TF will not be allowed to migrate freely into and/or throughout the bloodstream and so that TF will not be washed out of a wound by hemorrhaging blood; covalent linkages) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Morrissey et al. teach that tissue factor is thousands of times more active when embedded in a suitable membrane (paragraph 7). Morrissey et al. teach that “tissue factor is attached to solid supports so that it will not be allowed to migrate freely into and/or throughout the bloodstream, and so that it will not be washed out of a wound by hemorrhaging blood” (see paragraph 11). Morrissey et al. teach that covalent bonding can be utilized and that “TF is bound to a collagen sponge or similar solid support” (see paragraph 77). In addition, it is respectfully noted that the nanodiscs themselves can also be considered a “dressing material” as presently claimed.
The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing inclusion of a particular component teaches compositions that both do and do not contain that component).
Claims 1-3, 8, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Farrell WO 2012/142317 published October 18, 2012 (provided in the IDS); Osther WO 2016/150449 published September 29, 2016 (provided in the IDS); and Looney et al. U.S. Patent Application Publication 2004/0193088 published September 30, 2004.
For present claims 1-3, 8, 11, and 12, Farrell teaches human tissue factor (TF) impregnated in a wound dressing wherein the wound dressing can be cellulose and one or more hemostatic agents may additionally be impregnated into the wound dressing including FVIIa (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 4, 6-9, 12, 13, 20, 23, 24, 28-31, 35, 42, 54, 58, 59, 66, 67, 71, 72, 75, 76, 78, 83, 84, 98).
However, Farrell does not teach the combination of TF, FVII, and FVIIa.
For present claims 1-3, 8, 11, and 12, Osther teaches recombinant soluble human tissue factor (RshTF) and the extracellular part of TF in combination with Factor VII/VIIa coated on and/or impregnated or embedded in a carrier or scaffold including Biatain™ (i.e. cellulose) (please refer to the entire specification particularly the abstract; pages 1-3, 5-7, 10-15).
Since coated, embedded, and impregnated may be interpreted several ways, Looney et al. is utilized to explicitly teach hemostatic agents (TF, FVII/VIIa) irreversibly bound to the aldehyde-oxidized polysaccharide/cellulose (please refer to the entire specification particularly paragraph 69).
For present claims 1-3, 8, 11, and 12, Looney et al. teach wound dressings including cellulose and aldehyde oxidized cellulose bound irreversibly to the aldehyde-oxidized polysaccharide/cellulose with Factor VII/VIIa and tissue factor (please refer to the entire specification particularly the abstract; paragraphs 1-7, 47, 51-53, 57, 60, 62, 64, 66, 67, 69). Looney et al. also teach that hemostatic agents including TF can be covalently bound to wound dressings (please refer to the entire specification particularly paragraphs 66-70).
The claims would have been obvious because the substitution of one known element (i.e. genus of hemostatic agents; FVIIa alone) for another (i.e. species of FVII, the combination of FVII and FVIIa) would have yielded predictable results (i.e. adding to benefits of TF by providing binding partners in the coagulation cascade) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. combining TF, FVII, and FVIIa in a wound dressing; hemostatic agents (TF, FVII/VIIa) irreversibly bound to an aldehyde-oxidized polysaccharide/cellulose; covalent linkages) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Farrell; Osther; and Looney et al. for claims 1-3, 8, 11, and 12 were considered but are not persuasive for the following reasons.
Applicants contend that Farrell and Osther do not teach covalent linkages. Applicants’ comments regarding that the motivation statements do not refer to elements within independent claim 1 are unclear. Applicants contend that Looney et al. do not teach that TF is covalently linked to a dressing material since all the examples refer to thrombin and that a two-step process is present (i.e. not directly bound; Example 5). The reference has paragraph numbers, please refer to the paragraph number when discussing the reference.
Applicants’ arguments are not convincing since the teachings of Farrell; Osther; and Looney et al. render the composition of the instant claims prima facie obvious.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The motivation is reiterated below. The motivation refers to covalent linkages which is a part of independent claim 1.
The claims would have been obvious because the substitution of one known element (i.e. genus of hemostatic agents; FVIIa alone) for another (i.e. species of FVII, the combination of FVII and FVIIa) would have yielded predictable results (i.e. adding to benefits of TF by providing binding partners in the coagulation cascade) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. combining TF, FVII, and FVIIa in a wound dressing; hemostatic agents (TF, FVII/VIIa) irreversibly bound to an aldehyde-oxidized polysaccharide/cellulose; covalent linkages) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Looney et al. also teach that hemostatic agents including TF can be covalently bound to wound dressings (please refer to the entire specification particularly paragraphs 66-70). Looney et al. specifically teach that the hemostatic agent can be tissue factor (see paragraphs 66).
It appears that applicants are interpreting Looney et al. as providing cellulose first, then layering on polysaccharides. However, Looney et al. specifically teach that the wound dressing can be made from oxidized polysaccharides including aldehyde-oxidized cellulose (see paragraphs 3, 52, 57, 67, and 69). Example 5 utilizes Surgicel™ Nu-Knit (i.e. oxidized cellulose; not a two step wound dressing).
`"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
It is unclear how the results (and which specific results – data?) are unexpected?
As evidenced by Morrissey et al., tissue factor is thousands of times more active when embedded in a suitable membrane (paragraph 7). Morrissey et al. also teach that “tissue factor is attached to solid supports so that it will not be allowed to migrate freely into and/or throughout the bloodstream, and so that it will not be washed out of a wound by hemorrhaging blood” (see paragraph 11).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Regarding SEQ ID NO: 2, see:
U.S. Patent Application Publication 2002/0142373 published October 3, 2002 (SEQ ID NO: 2 is the same length – 219mer and has 100% identity with present SEQ ID NO: 2);
U.S. Patent 6,093,399 published July 25, 2000 (SEQ ID NO: 23 is the same length – 219mer and has 100% identity with present SEQ ID NO: 2); and
WO 96/01653 published January 25, 1996 (SEQ ID NO: 23 is the same length – 219mer and has 100% identity with present SEQ ID NO: 2).
Regarding epichlorohydrin (EPH) crosslinking of cellulose, see:
Mirtaghavi et al., 2020 (online August 10, 2020), Crosslinked porous three-dimensional cellulose nanofibers-gelatine biocomposite scaffolds for tissue regeneration, International Journal of Biological Macromolecules, 164: 1949-1959.
Alam et al., 2019, Sustainable Production of Cellulose-Based Hydrogels with Superb Absorbing Potential in Physiological Saline, ACS Omega, 4: 9419-9426.
Future Communications
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/AMBER D STEELE/ Primary Examiner, Art Unit 1658
