DETAILED ACTION
Status of Claims
Claims 2, 4, 6, 8, 12-13, 15-16, 19, 22, 28, 30, 33-34 and 59 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. 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 Office Action: Non-Final
Claim Rejections – 35 U.S.C. § 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 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 pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 2, 4, 6, 8, 12-13, 15-16, 19, 22, 28, 30, 33-34 and 59 are rejected under 35 U.S.C. § 103 as being unpatentable over BARROWS (US RE38,158 E, Issued Jun. 24, 2003; on 01/13/2025 IDS; hereinafter, “Barrows”), in view of BORDOLOI (US 2012/0288530 A1, Publ. Nov. 15, 2012; on 03/19/2025 IDS; hereinafter, “Bordoloi”) and FORTUNE (US 2009/0018575 A1, Publ. Jan. 15, 2009; on 03/19/2025 IDS; hereinafter, “Fortune”).
Barrows is directed to:
ADHESIVE SEALANT COMPOSITION
ABSTRACT
This invention is related to an adhesive composition which may be used to bond or seal tissue in vivo. The adhesive composition is readily formed from a two component mixture which includes a first part of a protein, preferably a serum albumin protein, in an aqueous buffer having a pH in the range of about 8.0-11.0 and a second part of a water-compatible or water-soluble bifunctional crosslinking agent. When the two parts of the mixture are combined, the mixture is initially a liquid which cures in vivo on the surface of tissue in less than about one minute to give a strong, flexible, pliant substantive composition which bonds to the tissue and is absorbed in about four to sixty days. The adhesive composition may be used either to bond tissue, to seal tissue or to prevent tissue adhesions caused by surgery.
Barrows, title & abstract. In this regard, Barrows teaches adhesive composition is made of two components, a buffered basic protein solution and a bifunctional crosslinking agent:
The present invention is related to an adhesive composition which has high mechanical strength, flexibility, fast cure rate and sufficient adhesion needed to bond and/or seal tissue in vivo. The adhesive composition is made of two components, a buffered basic protein solution and a bifunctional crosslinking agent. The buffered protein solution and the bifunctional crosslinking agent are typically prepared using commercially available materials and established synthetic methods. The use of known, commercially available materials in the preparation of the adhesive composition provides a benefit in the practice of this invention because most of these materials generally have a history of clinical safety and/or use.
(Barrows, col. 3, ln. 16-28); wherein the buffered basic protein solution may include concentrated aqueous serum albumin protein mixtures that are buffered to a pH of between about 8.0-11.0:
Preferred buffered protein solutions which may be used in the present adhesive composition include concentrated aqueous serum albumin protein mixtures that are buffered to a pH of between about 8.0-11.0 where the buffer concentration is in a range of about 0.01-0.25 molar. Suitable buffer systems include buffers which are physiologically and/or clinically acceptable such as known carbonate or phosphate buffer systems, provided the buffer does not adversely react with or otherwise alter the crosslinking agent. A preferred buffer system is a carbonate/bicarbonate buffer system at a pH value of about 9.0-10.5 at a concentration in the range of 0.05-0.15 molar.
(Barrows, col. 3, ln. 41-52); and wherein suitable crosslinking agents include compounds of the formula, “G—LM—PEG—LM—G”:
A variety of suitable crosslinking agents may be used in the present invention. Preferred crosslinking agents include a polyethylene glycol or polyoxyethylene chain portion (—PEG—), an activated leaving group portion (—G) and a linking moiety (—LM—) which binds the —PEG— portion and the leaving group portion —G. Crosslinking agents include compounds of the formula
G—LM—PEG—LM—G
in which —PEG— is a diradical fragment represented by the formula
—O—(CH2—CH2—O—)a—
where a is an integer from 20-300; —LM— is also a diradical fragment such as a carbonate diradical represented by the formula, —C(O)—, a monoester diradical represented by the formula, —(CH2)bC(O)— where b is an integer from 1-5, a diester diradical represented by the formula, —C(O)—(CH2)c—C(O)— where c is an integer from 2-10 and where the aliphatic portion of the radical may be saturated or unsaturated, a dicarbonate represented by the formula —C(O)—O—(CH2)d—O—C(O)— where d is an integer from 2-10, or an oligomeric diradical represented by the formulas —R—C(O)—, —R—C(O)—(CH2)c—C(O)—, or —R—C(O)—O—(CH2)d—O—C(O)— where c is an integer from 2-10, d is an integer from 2-10, and R is a polymer or copolymer having 1-10 monomeric lactide, glycolide, trimethylene carbonate, caprolactone or p-dioxanone fragments; and —G is a leaving group such as a succinimidyl, maleimidyl, phthalimidyl, or alternatively, nitrophenyl, imidazolyl or tresyl leaving groups.
(Barrows, col. 4, ln. 6-37). Further in this regard, Barrows exemplifies a two-component adhesive for inhibiting post-surgical adhesions:
Example 11
Use of Two Component Adhesive to Prevent Post-Surgical Adhesions
The tissue sealant hydrogel tested was a two part liquid system. Part A was a sterile 40% (w/v) solution of human serum albumin in isotonic pH 10 carbonate buffer (0.1M). Part B was a 400 mg/ml solution of 10,000 molecular weight PEG-SS2 (polyethylene glycol disuccinimidyl succinate) in sterile distilled water prepared just prior to use. Solutions A and B were mixed in equal volumes with a dual syringe system connected to a static mixing head (Tah Industries, Inc.).
Barrows, col. 15, ln. 59 to col. 16, ln, 26, Ex. 11.
Regarding independent claims 2, 4, 6 and 8 and the requirements:
2. ([…]) A dry, powdered, crosslinking hemostatic composition, comprising:
a first component comprising a difunctionalized polyalkylene oxide-based component of the formula:
G-LM-PEG-LM-G;
wherein:
PEG is polyethylene glycol;
each LM is a difunctional linking moiety independently selected from the group consisting of a carbonate diradical of the formula —C(O)—, a monoester diradical of the formula —(CH2)b—C(O)— where b is an integer from 1 to 10, a diester radical of the formula —C(O)—(CH2)c—C(O)— where c is an integer from 1 to 10 and where the aliphatic portion of the radical may be saturated or unsaturated, a dicarbonate diradical of the formula —C(O)—O—(CH2)d—O—C(O)— where d is an integer from 1 to 10, an amide containing diradical of the formula —N(H)—C(O)—(CH2)d—C(O)— where d is an integer from 1 to 10, an amide containing diradical of the formula —(CH2)c—C(O)—N(H)—(CH2)d— where c is an integer from 1 to 10 and d is an integer from 1 to 10, and an oligomeric diradical represented by the formulas —R—C(O)—, —R—C(O)—(CH2)c—C(O)—, —R—C(O)—O—(CH2)d—O—C(O)—, —R—N(H)—C(O)—(CH2)d—C(O)—, or —R—(CH2)c—C(O)—N(H)—(CH2)d— where c is an integer from 1 to 10, d is an integer from 1 to 10, and R is a polymer or copolymer having 1 to 10 monomeric lactide, glycolide, trimethylene carbonate, caprolactone or p-dioxanone fragments; and
each G is a leaving group independently selected from the group consisting of N-oxysuccinimidyl, N-oxysulfosuccinimidyl, N-oxymaleimidyl, N-oxyphthalimidyl, nitrophenoxyl, N-oxyimidazolyl, and tresyl; and
a second component comprising a protein, wherein the second component, when dissolved in deionized water, can produce a pH of a resulting solution of greater than or equal to 8,
wherein upon exposure to an aqueous liquid, crosslinking of the first component and the second component is initiated to form a hemostatic hydrogel.
[…]
4. ([…]) A dry, powdered, crosslinking hemostatic composition, comprising:
a first component comprising a difunctionalized polyalkylene oxide-based component of the formula:
G-LM-PEG-LM-G;
wherein:
PEG is polyethylene glycol;
each LM is a difunctional linking moiety independently selected from the group consisting of a carbonate diradical of the formula —C(O)—, a monoester diradical of the formula —(CH2)b—C(O)— where b is an integer from 1 to 10, a diester radical of the formula —C(O)—(CH2)c—C(O)— where c is an integer from 1 to 10 and where the aliphatic portion of the radical may be saturated or unsaturated, a dicarbonate diradical of the formula —C(O)—O—(CH2)d—O—C(O)— where d is an integer from 1 to 10, an amide containing diradical of the formula —N(H)—C(O)—(CH2)d—C(O)— where d is an integer from 1 to 10, an amide containing diradical of the formula —(CH2)c—C(O)—N(H)—(CH2)d— where c is an integer from 1 to 10 and d is an integer from 1 to 10, and an oligomeric diradical represented by the formulas —R—C(O)—, —R—C(O)—(CH2)c—C(O)—, —R—C(O)—O—(CH2)d—O—C(O)—, —R—N(H)—C(O)—(CH2)d—C(O)—, or —R—(CH2)c—C(O)—N(H)—(CH2)d— where c is an integer from 1 to 10, d is an integer from 1 to 10, and R is a polymer or copolymer having 1 to 10 monomeric lactide, glycolide, trimethylene carbonate, caprolactone or p-dioxanone fragments; and
each G is a leaving group independently selected from the group consisting of N-oxysuccinimidyl, N-oxysulfosuccinimidyl, N-oxymaleimidyl, N-oxyphthalimidyl, nitrophenoxyl, N-oxyimidazolyl, and tresyl; and
a second component comprising a protein in a basic state,
wherein upon exposure to an aqueous liquid, crosslinking of the first component and the second component is initiated to form a hemostatic hydrogel.
[…]
6. ([…]) A dry, powdered, crosslinking hemostatic composition, comprising:
a first component comprising a difunctionalized polyalkylene oxide-based component of the formula:
G-LM-PEG-LM-G;
wherein:
PEG is polyethylene glycol;
each LM is a difunctional linking moiety independently selected from the group consisting of a carbonate diradical of the formula —C(O)—, a monoester diradical of the formula —(CH2)b—C(O)— where b is an integer from 1 to 10, a diester radical of the formula —C(O)—(CH2)c—C(O)— where c is an integer from 1 to 10 and where the aliphatic portion of the radical may be saturated or unsaturated, a dicarbonate diradical of the formula —C(O)—O—(CH2)d—O—C(O)— where d is an integer from 1 to 10, an amide containing diradical of the formula —N(H)—C(O)—(CH2)d—C(O)— where d is an integer from 1 to 10, an amide containing diradical of the formula —(CH2)c—C(O)—N(H)—(CH2)d— where c is an integer from 1 to 10 and d is an integer from 1 to 10, and an oligomeric diradical represented by the formulas —R—C(O)—, —R—C(O)—(CH2)c—C(O)—, —R—C(O)—O—(CH2)d—O—C(O)—, —R—N(H)—C(O)—(CH2)d—C(O)—, or —R—(CH2)c—C(O)—N(H)—(CH2)d— where c is an integer from 1 to 10, d is an integer from 1 to 10, and R is a polymer or copolymer having 1 to 10 monomeric lactide, glycolide, trimethylene carbonate, caprolactone or p-dioxanone fragments; and
each G is a leaving group independently selected from the group consisting of N-oxysuccinimidyl, N-oxysulfosuccinimidyl, N-oxymaleimidyl, N-oxyphthalimidyl, nitrophenoxyl, N-oxyimidazolyl, and tresyl; and
a second component comprising an at least partially deprotonated protein;
wherein upon exposure to an aqueous liquid, crosslinking of the first component and the second component is initiated to form a hemostatic hydrogel.
[…]
8. ([…]) A dry, powdered, crosslinking hemostatic composition, comprising:
a first component comprising a difunctionalized polyalkylene oxide-based component of the formula:
G-LM-PEG-LM-G;
wherein:
PEG is polyethylene glycol;
each LM is a difunctional linking moiety independently selected from the group consisting of a carbonate diradical of the formula —C(O)—, a monoester diradical of the formula —(CH2)b—C(O)— where b is an integer from 1 to 10, a diester radical of the formula —C(O)—(CH2)c—C(O)— where c is an integer from 1 to 10 and where the aliphatic portion of the radical may be saturated or unsaturated, a dicarbonate diradical of the formula —C(O)—O—(CH2)d—O—C(O)— where d is an integer from 1 to 10, an amide containing diradical of the formula —N(H)—C(O)—(CH2)d—C(O)— where d is an integer from 1 to 10, an amide containing diradical of the formula —(CH2)c—C(O)—N(H)—(CH2)d— where c is an integer from 1 to 10 and d is an integer from 1 to 10, and an oligomeric diradical represented by the formulas —R—C(O)—, —R—C(O)—(CH2)c—C(O)—, —R—C(O)—O—(CH2)d—O—C(O)—, —R—N(H)—C(O)—(CH2)d—C(O)—, or —R—(CH2)c—C(O)—N(H)—(CH2)d— where c is an integer from 1 to 10, d is an integer from 1 to 10, and R is a polymer or copolymer having 1 to 10 monomeric lactide, glycolide, trimethylene carbonate, caprolactone or p-dioxanone fragments; and
each G is a leaving group independently selected from the group consisting of N-oxysuccinimidyl, N-oxysulfosuccinimidyl, N-oxymaleimidyl, N-oxyphthalimidyl, nitrophenoxyl, N-oxyimidazolyl, and tresyl; and
a second component comprising a protein,
wherein upon exposure of 0.5 g of the composition to 1.0 mL of 0.01 M phosphate buffered saline, crosslinking of the first component and the second component is initiated to form a hemostatic hydrogel having a surface pH of less than or equal to 8.
Barrows clearly teaches a two-component adhesive for inhibiting post-surgical adhesions (Barrow, col. 15, ln. 59 to col. 16, ln, 26, Ex. 11), WHEREBY it is noted:
“Part B was a 400 mg/ml solution of 10,000 molecular weight PEG-SS2 (polyethylene glycol disuccinimidyl succinate) in sterile distilled water prepared just prior to use” (Barrows, col. 15, ln. 65-67, Ex. 11), a crosslinking agent of the formula, “G—LM—PEG—LM—G” (Barrows, col. 4, ln. 6-37), which is “a difunctionalized polyalkylene oxide-based component of the formula: G-LM-PEG-LM-G” of claims 2, 4, 6 and 8, as well as the requirements of claims 13, 19 and 22 for:
13. ([...]) The dry, powdered hemostatic composition of claim 2, wherein:
each LM is the same and is a difunctional linking moiety represented by the formulas -C(O)-, -(CH2)b-C(O)- where b is an integer from 1 to 5, -C(O)-(CH2)c-C(O) where c is an integer from 2 to 10 and where the aliphatic portion of the radical may be saturated or unsaturated, -C(O)-O-(CH2)d-O-C(O)- where d is an integer from 2 to 10, and an oligomeric diradical represented by the formulas -R-C(O)-, -R-C(O)(CH2)c-C(O)-, or -R-C(O)-O-(CH2)d-O-C(O)- where c is an integer from 2 to 10, d is an integer from 2 to 10, and R is a polymer or copolymer having 1 to 10 monomeric lactide, glycolide, trimethylene carbonate, caprolactone or p-dioxanone fragments; and
each G is the same and is a leaving group selected from the group of Noxysuccinimidy 1, N-oxysulfosuccinimidy 1, N-oxymaleimidy 1, N-oxyphthalimidy 1, nitrophenoxyl, N-oxyimidazolyl, and tresyl.
[...]
19. ([...]) The dry, powdered hemostatic composition of claim 2, wherein the multifunctionalized polymeric composition of the first component comprises a difunctionalized polyalkylene oxide-based component of the form:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
.
[…]
22. ([…]) The dry, powdered hemostatic composition of claim 19, wherein n is from 10 to 500.
“Part A was a sterile 40% (w/v) solution of human serum albumin in isotonic pH 10 carbonate buffer (0.1M)” (Barrows, col. 15, ln. 63-64, Ex. 11) within the scope of “[t]he adhesive composition is readily formed from a two component mixture which includes a first part of a protein, preferably a serum albumin protein, in an aqueous buffer having a pH in the range of about 8.0-11.0” (Barrows, abstract) and “phosphate buffer systems” (Barrows, col. 3, ln. 45-49, wherein “carbonate or phosphate buffer systems” are disclosed by Barrows as equivalents; see MPEP § 2144.06 (II) stating: “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)”), which relates to:
“a second component comprising a protein, wherein the second component, when dissolved in deionized water, can produce a pH of a resulting solution of greater than or equal to 8” of claim 2,
a “second component comprising a protein in a basic state” of claim 4, and
a “second component comprising an at least partially deprotonated protein” of claim 6, and
“a second component comprising a protein” of claim 8.
as well as the requirements of claims 15-16, 30 and 33-34 for:
15. The dry, powdered hemostatic composition of claim 2, wherein the protein is selected from the group of consisting of: human serum albumin, recombinant human albumin, and animal sourced albumin.
16. ([…]) The dry, powdered hemostatic composition of claim 2, wherein the protein is human serum albumin.
[…]
30. ([…]) The dry, powdered hemostatic composition of claim 2, further comprising an initiator that is a base and/or basic buffer that is non-gas-forming in aqueous solutions.
[…]
33. ([…]) The dry, powdered hemostatic composition of claim 30, wherein the base and/or basic buffer comprises a salt comprising a cation and hydroxide.
34. ([…]) The dry, powdered hemostatic composition of claim 33, wherein the base and/or basic buffer comprises sodium hydroxide.
However, Barrows DOES NOT TEACH a composition in the form of a powder in order to meet the requirements of independent claims 2, 4, 6 and 8 for a “dry, powdered, crosslinking hemostatic composition,” and similarly for claim 28:
28. ([…]) The dry, powdered hemostatic composition of claim 2, wherein the composition comprises a first dry powder comprising the first component and a second dry powder comprising the second component.
and similarly, for claim 28:
28. ([…]) The dry, powdered hemostatic composition of claim 2, wherein the composition comprises a first dry powder comprising the first component and a second dry powder comprising the second component.
Based on the state of the art, an artisan of ordinary skill would have found this feature obvious.
Bordoloi, for instance, is directed to:
TISSUE SEALANTS FROM PLASMA DERIVED PROTEINS
ABSTRACT
The present invention is directed in one embodiment to a tissue adhesive or sealant composition comprising an electrophilic group containing cross-linking compound having a linker moiety of a diglycolic acid, a water soluble core moiety and an electrophilic group that is covalently bonded to the diglycolic acid linker moiety and a nucleophilic group containing protein. In other embodiments, the present invention is directed to a delivery device or a medical device on which the composition has been applied or incorporated therein. The present invention is also directed to a method for sealing tissue using the tissue adhesive or sealant composition.
Bordoloi, title & abstract. In this regard, Bordoloi, teaches compositions comprising a nucleophilic plasma protein inclusive of albumin and a cross-linking agent comprising a di-acid linker (LM) on which a water soluble core such as polyethylene glycol (PEG, X) and an electrophile such as N-hydroxy succinimide (G, N-oxysuccinimidyl) are attached. Bordoloi, claims 1, 6-9 and 11; par. [0001]-[0113], in particular par. [0001], [0039] & [0053]-[0060]; Fig. 1 & 3). The compositions may be in the form of a dry powder form prior to contact with moisture or with a tissue. Bordoloi, claim 8; par. [0028] & [0037]. Degradation in de-ionized water can be titrated by addition of a basic compound to maintain a constant pH of 7.4. Bordoloi, par. [0086]-[0087] & [0113]. Bordoloi further discloses it is known to the prior art to mix electrophilic materials and nucleophilic materials in the presence of a buffer in order to maintain a pH within the reaction range. Bordoloi, par. [0009]. Fortune, for instance, is directed to:
TISSUE-ADHESIVE FORMULATIONS
ABSTRACT
A tissue-adhesive formulation comprises a particulate material having tissue-reactive functional groups, in admixture with a particulate buffer material. The formulation is preferably free or substantially free of materials of human or animal origin. In preferred embodiments, the formulation consists, or consists essentially of, an anhydrous or partially hydrated blend of particulate material having tissue-reactive functional groups and particulate buffer material. Also disclosed is a multilayer sheet comprising a structural support coated on at least one side thereof with such a tissue-adhesive formulation.
Fortune, title & abstract. In this regard, Fortune teaches compositions comprising particulate material having tissue-reactive functional groups in admixture with a particulate buffer material. Fortune, claims 1, 4 and 7-9; par. [0001]-[0169], in particular par. [0074]-[0077]. The effect of the buffer is to enhance the reaction between the tissue-reactive material (which is an electrophile) with tissue (which is a nucleophile). Fortune, par. [0074]. Thus, the formulation is buffered when hydrated. Fortune, par. [0075]. The particles that make up the formulation have a wide range of particle sizes, however, the median particle size may range from 5 to 500 microns, preferably 5 to 250 microns. Fortune, par. [0046]).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the adhesive sealant composition of Barrows to be in the form of a dry powder as taught by Bordoloi and by Fortune comprising a dry powder of the first component comprising a dry powder of a protein, preferably albumin and a dry powder of a buffer and comprising a dry powder of the second component comprising an agent of formula G- LM- PEG-LM- G, preferably polyethylene glycol disuccinimidoyl succinate for the convenience thereof, e.g., eliminates the weight and volume of the water needed to transport, to store, etc. There would be a reasonable expectation of success because Bordoloi and Fortune evidence such dry powder forms are routine and conventional in the art. See MPEP § 2144.07 stating that the selection of a known material based on its suitability for its intended use is prima facie obvious, which cites Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), wherein “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” It is further noted that the requirements of claims 2 and 8 for:
“wherein the second component, when dissolved in deionized water, can produce a pH of a resulting solution of greater than or equal to 8” (claim 2), and
“wherein upon exposure of 0.5 g of the composition to 1.0 mL of 0.01 M phosphate buffered saline, crosslinking of the first component and the second component is initiated to form a hemostatic hydrogel having a surface pH of less than or equal to 8” (claim 8),
are functional limitations. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claims 2 and 8, which achieve the resulting pH and hydrogel effects. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: intended pH and hydrogel effects of a composition that meets the structural requirements of claims 2 and 8, as discussed above. Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claims 2 and 8 will achieve the intended result of the functional limitations and fall within the boundaries of the claims.
Thus, the prior art renders claims 2, 4, 6, 8, 13, 15-16, 19, 22, 28 30, 33-34 obvious.
Regarding claim 12, it is noted that the requirements:
12. ([…]) The dry, powdered hemostatic composition of claim 2, wherein the upon exposure to aqueous liquid comprises exposure of the first component and the second component to bleeding tissue.
are recitations of intended use In this regard, it is noted that recitations of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it reads on the claim. See MPEP § 2103 (I)(C)). Since Barrows, per Bordoloi and Fortune, teach the structure for the composition of instant claim 2, then it reasonably follows that the prior art composition would be capable of performing the intended use. Further, Barrows teaches “the use of the present adhesive composition as an adhesive per se, the present composition may also be used as a sealant,” e.g., “to inhibit or prevent bleeding in other surgical procedures” (Barrow, col. 6, ln. 31-36).
Thus, the prior art renders claim 12 obvious.
Regarding claim 59 and the requirements:
59. ([…]) A kit containing ingredients from which the dry, powdered, crosslinking hemostatic composition of claim 2 can be formed, comprising the first component and the second component; wherein the first component and the second component are packaged separately.
Since it would be obvious to modify the two component adhesive sealant composition of Barrows to be in the form of a dry powder as taught by Bordoloi and by Fortune, one would be further motivated to package the two components in a manner similar to a “two-component fibrin sealant kit” (Barrow, col. 6, ln. 9-10) known in the art.
Thus, the prior art renders claim 59 obvious.
Claim Rejections - Nonstatutory 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 2, 4, 6, 8, 12-13, 15-16, 19, 22, 28, 30, 33-34 and 59 are provisionally rejected on the ground of nonstatutory double patenting over claims 1, 37, 89, 91, 94-118 of copending Application No. 17/622,198 (‘198 Application). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a dry, powdered, crosslinking hemostatic composition, comprising a first component comprising a difunctionalized polyalkylene oxide-based component of the formula, G-LM-PEG-LM-G, and a second component protein, such as albumin, that is capable of crosslinking with the first component.
Thus, claims 1, 37, 89, 91, 94-118 of the ‘198 Application anticipate claims 2, 4, 6, 8, 12-13, 15-16, 19, 22, 28, 30, 33-34 and 59.
Conclusion
Claims 2, 4, 6, 8, 12-13, 15-16, 19, 22, 28, 30, 33-34 and 59 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
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