DETAILED ACTION
Claims 21-40 are pending and being examined on the merits in this office action.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claim Objections
Claims 29 and 39 are objected to because of the following informalities:
Claims 29 and 39 should be amended to recite “in vivo .
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 23, 29-31, 22, 34, 39, and 40 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.
Claims 29-31 recite the limitation "the composition". There is insufficient antecedent basis for this limitation in the claim.
The term “tropoelastin is devoid of intramolecular cross-links” in claims 23 and 34 is a relative term which renders the claim indefinite. The term “tropoelastin is devoid of intramolecular cross-links” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Respective independent claims refer to a composition comprising tropoelastin. Dependent claims 23 and 34 refer to tropoelastin by itself, not in the context of a composition. The metes and bounds of claims 23 and 34, with respect to recited compositions should be clarified.
Claims 33, 39, and 40 recite the limitation "the composition". There is insufficient antecedent basis for this limitation in the claim.
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 21-31 and 35 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“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.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“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. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
For written description, the analysis considers
(a) Actual reduction to practice,
(b) Disclosure of drawing or structural chemical formulas,
(c) Sufficient relevant identifying characteristic in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed and
(d) Representative number of examples.
Claim 21 is drawn to a kit comprising:(a) a prefilled syringe, wherein the prefilled syringe is filled with an injectable composition comprising at least one protein residue comprising tropoelastin; at least one polysaccharide residue comprising carboxymethyl cellulose; and at least one intermolecular cross- linkage between the tropoelastin and carboxymethyl cellulose; and (b) instructions for use. Dependent claim 24 recites wherein the at least one cross-linkage further comprises a spacer group.
Claim 32 is drawn to a kit comprising:(a) a syringe; (b) at least one separate container, wherein the separate container is filled with a tissue compatible composition comprising tropoelastin; carboxymethyl cellulose; and at least one intermolecular cross-linkage between the tropoelastin and carboxymethyl cellulose; (c) a needle delivery system; and (d) instructions for use. Examiner expressly notes that independent claim 32 does not recite “protein residue” or “polysaccharide residue”.
Dependent claim 35 recites wherein the at least one cross-linkage further comprises a spacer group.
Para. [0042] and [0057], respectively, of the PGPUB state:
The term “residue” may refer to that portion of molecular material or residual molecular material that remains in a reaction product. For example, the portion of protein molecular material that remains in a reaction product, such as a cross-linked product derived from reacting a protein molecule and a cross-linking agent, is called a protein residue. For example, the portion of a saccharide-containing molecular material that remains in a reaction product, such as a cross-linked product derived from reacting a saccharide-containing molecule and a protein molecule, is called a saccharide-containing residue.
The term “spacer group” may include, for example, a moiety that joins one or more individual components, such as joining a protein and a polysaccharide.
Emphasis added.
Examiner expressly notes a protein residue comprising tropoelastin is construed as a full-length protein, a fragment, or some other “portion” of tropoelastin, e.g., merely an amino group. A polysaccharide residue comprising carboxymethyl cellulose as a full-length polysaccharide chain, a fragment, or some other “portion” of carboxymethyl cellulose, e.g., merely a COOH group.
Spacer groups are not limited to any structure or physical composition, or length. Spacer groups, can include, but are not limited lipids, proteins, polysaccharides, polymers (natural, synthetic), and combinations thereof.
(a) Actual reduction to practice/ (b) disclosure of drawing or structural chemical formulas:
The specification is limited to specific cross-linked protein matrix. The specification teaches derivitization of hyaluronic acid and carboxymethyl cellulose to form reactive carboxyl groups. Matrixes of tropoelastin/hyaluronic acid and albumin/hyaluronic acid (Exs. 6-8) were reduced to practice. Each of the examples utilized full length protein, as compared to a sequence less than the full length protein.
It does not appear than any “spacer groups” were reduced to practice.
(c) Sufficient relevant identifying characteristic in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed: and (d) Representative number of examples:
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It must not be forgotten that the MPEP states that if a biomolecule is described only by a functional characteristic and/or a functional/structural characteristic without any disclosed correlation between function and structure of the biomolecule beyond the examples presented, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.” MPEP 2163.
Although a few select representative cross-linked proteins have been set forth, there is no disclosure in the specification as to which, if any other cross-linked tropoelastin protein sequences [shorter than full-length], would meet the functional and conformational requirements of the claims. The claimed cross-linked proteins are further required to be injectable and have utility in dermatological or cosmetological applications. Thus, the specification is limited to disclosure of full-length protein/tropoelastin. It is unclear from the specification as to the identity of “spacer groups” that could be incorporated into an intermolecular cross-linkage between tropoelastin and carboxymethyl cellulose without affecting the structural/functional utility of respective compounds.
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. In the instant case, the specification does not set forth a representative number of tropoelastin protein residues other than full-length protein, or any spacer groups that be in the claimed compositions and have functional utility in tissue/dermal applications.
In conclusion, for these reasons, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim 21, 22, 24-26, and 29-31 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weiss et al (WO2010/102337 - published 9/16/2010 (102a date); earliest effective filing date 3/10/2009 (102e date).
Weiss et al teach injectable biomaterial compositions formed from tropoelastin for tissue repair and restoration. The compositions include a coalescence-controlling agent in the form of a polysaccharide or polysaccharide derivative, in an amount effective for providing the substance with the properties of flow, enabling injection (abstract; pp. 7-10, 15; claims 34-35, 37). Cross-linking can be mediated by glutaraldehyde (e.g., p. 6, 17). Example 3 discloses cross-linking of tropoelastin and carboxymethyl cellulose (CMC) via glutaraldehyde. Weiss et al teach devices and kits comprising the compositions (pp. 18-19; pp. 32-33). The device is preferably a syringe. Id. The composition may be provided in the device in a state that is ready for use for example in a cross linked form [reads on prefilled], or in a state requiring mixing or addition of further components, such as a cross linker (if cross linking is required) (p. 18). The kits can further comprise instructions for use (pp. 18-19). The compositions can be used for tissue bulking or filling effect in dermatological or cosmetic applications [reads on tissue compatible composition] (pp. 8-9, 19-21).
Although Weiss et al. disclose kits, devices, e.g. prefilled syringes, injectable compositions comprising tropoelastin cross-linked to carboxymethyl cellulose [reads on intermolecular cross linkage], and instructions for use of the kits, the reference did not reduce to practice the claimed kits.
It would have been obvious to the skilled artisan to prepare a kit comprising a prefilled syringe wherein the syringe is filled with an injectable composition comprising tropoelastin and carboxymethyl cellulose when there is at least one intermolecular cross linkage between tropoelastin and carboxymethyl cellulose; and instructions for use.
The skilled artisan would have recognized that Weiss et al explicitly taught each of the recited elements of the claimed kits. The rationale to support a conclusion that claim 21 would have been obvious is that all the claimed elements were taught by Weiss et al and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969). It is apparent that a preponderance of evidence dictates that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made as evidenced by the teachings of Weiss et al, especially in the absence of unexpected results. Accordingly, instant claim 21 is rendered obvious.
Regarding claims 22, example 3 discloses a composition comprising 50 mg/mL tropoelastin and 1% (w/v) CMC. Fig 7 discloses 100 mg/ml tropoelastin and 1% CMC. The tropoelastin is included in the composition in an amount from about 1.5 mg/mL to about 400 mg/mL. Preferably the tropoelastin is included in an amount from about mg/mL to about 300 mg/mL. More preferably, tropoelastin is included in an amount of about 10 mg/mL to about 200 mg/mL (p. 9). The composition comprises amount of from about 0.01 to 10 percent (w/v) of CMC (p. 13). Regarding claim 24, reaction with glutaraldehyde is construed as a spacer group in the cross-linkage. Regarding claims 25 and 26, example 3 discloses that the mixture could be passed through material could be passed through a 29G needle and then a 31 G needle. The two needles used in the example 3 are construed as a needle delivery system. Weiss et further teach 16 gauge, 21 gauge, and 27 gauge needles (e.g., p. 8). Weiss et al teach that a range of needle gauges may be used [reads on needle delivery system] (pp. 20-21).
Regarding claim 29, M.P.E.P. § 2112 recites, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that who discovered the properties of a composition is immaterial to the composition’s patentability, since the composition was the same and, therefore, has necessarily always possessed all of its inherent properties).
Regarding claims 30 and 31, Weiss et al teach that the compositions can be used to "correct[] a tissue defect" refers to at least partially restoring and/or augmenting tissue structure and/or function, including supporting, enhancing, bulking, or elasticizing tissue, or facilitating tissue growth into a tissue defect. The compositions can be used for tissue bulking or filling effect (pp. 8-9, 19-21).
Claim 32, 33, 35, 37, 39, and 40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weiss et al (WO2010/102337 - published 9/16/2010 (102a date); earliest effective filing date 3/10/2009 (102e date)).
The teachings of Weiss et al are set forth above. Weiss et al further teach that with labels/instructions (pp. 15-16, 18-19). The kit can comprise a container containing the composition, a syringe and needle system. Id.
It would have been obvious to the skilled artisan to prepare a kit comprising a) syringe; b) one separate container filled with a tissue compatible composition comprising tropoelastin, carboxymethyl cellulose, and at least one intermolecular cross linkage between tropoelastin and carboxymethyl cellulose; c) a needle delivery system; and d) instructions for use.
The skilled artisan would have recognized that Weiss et al explicitly taught each of the recited elements of the claimed kits. The rationale to support a conclusion that claim 32 would have been obvious is that all the claimed elements were taught by Weiss et al and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969). It is apparent that a preponderance of evidence dictates that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made as evidenced by the teachings of Weiss et al, especially in the absence of unexpected results. Accordingly, instant claim 32 is rendered obvious.
Regarding claims 33, example 3 discloses a composition comprising 50 mg/mL tropoelastin and 1% (w/v) CMC. Fig 7 discloses 100 mg/ml tropoelastin and 1% CMC. The tropoelastin is included in the composition in an amount from about 1.5 mg/mL to about 400 mg/mL. Preferably the tropoelastin is included in an amount from about mg/mL to about 300 mg/mL. More preferably, tropoelastin is included in an amount of about 10 mg/mL to about 200 mg/mL (p. 9). The composition comprises amount of from about 0.01 to 10 percent (w/v) of CMC (p. 13). Regarding claim 35, reaction with glutaraldehyde is construed as a spacer group in the cross-linkage. Regarding claim 37, example 3 discloses that the mixture could be passed through material could be passed through a 29G needle and then a 31 G needle. The two needles used in the example 3 are construed as a needle delivery system. Weiss et further teach 16 gauge, 21 gauge, and 27 gauge needles (e.g., p. 8). Weiss et al teach that a range of needle gauges may be used [reads on needle delivery system] (pp. 20-21).
Regarding claim 39, M.P.E.P. § 2112 recites, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that who discovered the properties of a composition is immaterial to the composition’s patentability, since the composition was the same and, therefore, has necessarily always possessed all of its inherent properties).
Regarding claim 40, Weiss et al teach that the compositions can be used to "correct[] a tissue defect" refers to at least partially restoring and/or augmenting tissue structure and/or function, including supporting, enhancing, bulking, or elasticizing tissue, or facilitating tissue growth into a tissue defect. The compositions can be used for tissue bulking or filling effect (pp. 8-9, 19-21).
Claims 21, 22, 24-33, and 35-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Weiss et al (WO2010/102337 - published 9/16/2010 (102a date); earliest effective filing date 3/10/2009 (102e date)), as applied to claims 21, 22, 24-26, 29-33, 35, 37, 39, and 40 above, and further in view of Kirchhofer et al (U.S. 6280421).
The teachings of Weiss et al are set forth above. The reference teaches kits/ syringes/needles for injecting a composition comprising tropoelastin and carboxymethyl cellulose, and at least one intermolecular cross linkage between tropoelastin and carboxymethyl cellulose, but does not expressly teach an automatic injection system.
Kirchhofer et al teach an auto injection device comprises a needle that can be used to deliver medically or cosmetically effective fluids into a patient’s skin (abstract, cols. 4-6).
It would been obvious to one of ordinary skill the art to administer the composition of Weiss et al in the automatic injection pen device of Kirchhofer et al. The skilled artisan would recognize from Weiss that the compositions can be administered via injection fraternal application. The skilled artisan further would have recognized that Kirchhofer et al provided a convenient automatic injection pen device for dermal delivery/applications. The skilled artisan would have had a reasonable expectation of success because both Weiss et al and Kirchhofer et al. taught injection methods for dermal applications.
Accordingly, claims 27, 28, 36, and 38, are rendered obvious.
Claims 21, 22, 24-33, and 35-40 are obvious in view the teachings of the cited references.
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.
Instant claims 21-31 are drawn to a kit comprising:(a) a prefilled syringe, wherein the prefilled syringe is filled with an injectable composition comprising at least one protein residue comprising tropoelastin; at least one polysaccharide residue comprising carboxymethyl cellulose; and at least one intermolecular cross-linkage between the tropoelastin and carboxymethyl cellulose; and (b) instructions for use. Instant claims 32-40 are drawn to a kit comprising:(a) a syringe; (b) at least one separate container, wherein the separate container is filled with a tissue compatible composition comprising tropoelastin; carboxymethyl cellulose; and at least one intermolecular cross-linkage between the tropoelastin and carboxymethyl cellulose; (c) a needle delivery system; and (d) instructions for use. Dependent claims 22 and 33 recite that the composition comprises about 1 mg/ml to about 250 mg/ml of tropoelastin and between about 0.01% to about 30% of carboxymethyl cellulose. Dependent claims 23 and 33 recite wherein the tropoelastin is devoid of intramolecular cross-links. Dependent claims 24 and 35 recites that the at least one cross linkage further comprises a spacer group. Dependent claims 25-28 and 36-38 recite needle gauge sizes of 18-31, needle delivery system, e.g. needle roller ball type and automatic injection pen type. Dependent claims 29 and 39 recite that the composition retains a coherent structure for resorption in vivo. Dependent claims 31 and 40 recite wherein the compositions used in a dermatological or cosmetological application.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. (hereinafter “the ‘365 patent”), in view of Ni et al (U.S. 20050084534).
Claims 1-14 of the ‘365 patent are drawn to a kit comprising (a) a prefilled syringe, wherein the prefilled syringe is filled with a tissue compatible composition comprising a protein selected from the group consisting of tropoelastin and albumin; a hyaluronic acid cross-linking molecule comprising one or more carboxyl groups; and at least one intermolecular cross-linkage comprising an amide bond between an amine of the protein and a carboxyl group of the hyaluronic acid cross-linking molecule; and (b) instructions for use. Dependent claims recite needles sizes (18-31 gauge), automatic injection pen systems, and applications for bulking/augmenting tissue in dermatological or cosmetological applications (restorative surgery, plastic surgery, etc.). Dependent claim 9 recites that the protein tropoelastin. Dependent claims 10 and 11 recite that the composition retains coherent structure for resorption in vivo, and that the composition is biodegradable, bioabsorbable, etc. claim 15 of the ‘’365 patent is drawn to a kit comprising (a) a prefilled syringe, wherein the prefilled syringe is filled with a tissue compatible composition comprising tropoelastin; a hyaluronic acid cross-linking molecule comprising one or more carboxyl groups; and at least one intermolecular cross-linkage comprising an amide bond between an amine of the protein and a carboxyl group of the hyaluronic acid cross-linking molecule; (b) one or more needles of a size selected from 25 gauge, 26 gauge, 27 gauge, 28 gauge, 29 gauge, 30 gauge and 31 gauge; and (c) instructions for use. Claims 16-25 of the ‘365 patent are drawn to a kit comprising (a) a syringe; (b) at least one separate container, wherein the separate container is filled with a tissue compatible composition comprising a protein selected from the group consisting of tropoelastin and albumin; a hyaluronic acid cross-linking molecule comprising one or more carboxyl groups; and at least one intermolecular cross-linkage comprising an amide bond between an amine of the protein and a carboxyl group of the hyaluronic acid cross-linking molecule; (c) a needle delivery system; and (d) instructions for use. Dependent claim 17-25 recite overlapping claim language with claims 2-14 of the ‘365 patent.
The claims of the ‘365 patent recite a composition comprising a protein comprising tropoelastin or albumin, and a polysaccharide comprising hyaluronic acid. The claims do not expressly teach that the polysaccharide is carboxymethyl cellulose.
Ni et al teach compositions comprising gelling formulations for the delivery and sustained release of a physiological active agent to the body of an animal (abstract). Ni et al teach that pharmaceutically acceptable thickeners can include carboxymethylcellulose (“CMC”), hydroxymethylcellulose (“HPMC”), hydroxyethylcellulose (“HEC”), and hyaluronic acid (para. [0213]).
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting carboxymethylcellulose for hyaluronic acid because both are explicitly taught as being useful for the same purpose, thickening agents for gelling formulations. It is further noted that the ‘365 patent discloses that polysaccharides include hyaluronic acid and carboxymethyl cellulose (e.g., col. 3). “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Accordingly, instant claims 21-40 are rendered obvious by claims 1-25 of the ‘365 patent and the teachings of Ni et al.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,653,814 (hereinafter “the ‘814 patent”), in view of Ni et al (U.S. 20050084534).
Claims 1-12 of the ‘814 patent are drawn to a method of enhancing tissue in-growth and/or tissue re-growth in a patient in need thereof, comprising administering to the patient a tissue compatible composition comprising a cross-linked protein matrix, wherein the cross-linked protein matrix comprises i) a protein selected from the group consisting of tropoelastin and albumin; ii) a hyaluronic acid cross-linking molecule comprising one or more carboxyl groups; and iii) at least one intermolecular cross-linkage comprising an amide bond between an amine of the protein and a carboxyl group of the hyaluronic acid cross-linking molecule. Dependent claims recite that the compositions are administered by injection, extrudable through needles of 18 gauge to 31 gauge, and can be used in cosmetological application or dermatological applications. Dependent claims further the same forms of surgery and applications to skin and tissue. Dependent claims also recite that the compositions have the same stability properties. Dependent claims further recite the same saccharide-containing cross-linking residue and protein residues.
Claims 13-24 of the ‘814 patent are drawn to a method of enhancing tissue in-growth and/or tissue re-growth in a patient in need thereof, comprising administering to the patient a tissue compatible composition having a cross-linked protein matrix comprising a protein selected from the group consisting of tropoelastin and albumin, and hyaluronic acid, wherein the protein and hyaluronic acid are cross-linked by at least one amide bond formed between an amine of a residue from the protein and a carboxyl group from the hyaluronic acid.
The claims of the ‘814 patent recite a method of enhancing tissue in-growth and/or tissue re-growth comprising administering a composition comprising a protein comprising tropoelastin or albumin, and a polysaccharide comprising hyaluronic acid. The claims do not expressly teach that the polysaccharide is carboxymethyl cellulose.
Ni et al teach compositions comprising gelling formulations for the delivery and sustained release of a physiological active agent to the body of an animal (abstract). Ni et al teach that pharmaceutically acceptable thickeners can include carboxymethylcellulose (“CMC”), hydroxymethylcellulose (“HPMC”), hydroxyethylcellulose (“HEC”), and hyaluronic acid (para. [0213]).
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting carboxymethylcellulose for hyaluronic acid because both are explicitly taught as being useful for the same purpose, thickening agents for gelling formulations. It is further noted that the ‘814 patent discloses that polysaccharides include hyaluronic acid and carboxymethyl cellulose (e.g., col. 3). “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”). Kits comprising a tissue compatible composition can be used in the method claims of the ‘814 patent for enhancing tissue in-growth and/or tissue re-growth in a patient. Examiner notes that instructions for use of the instant claims provides the skilled artisan with directions as to how to use the claimed kits in the method claims of the ‘814 patent.
Accordingly, instant claims 21-40 are rendered obvious by claims 1-24 of the ‘814 patent and the teachings of Ni et al.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 9,611,312 (hereinafter “the ‘312 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-23 of the ‘312 patent are drawn to a composition, comprising at least one cross-linked protein matrix, wherein the at least one cross-linked protein matrix comprises i) between 1-250 mg/mL of at least one protein residue derived from at least one amine-bearing protein; ii) at least one saccharide-containing cross-linking residue derived from at least one saccharide-containing cross-linking molecule comprising one or more carboxyl groups; and iii) at least one intermolecular cross-linkage comprising an amide bond between an amine of the at least one protein residue and a carboxyl group of the at least one saccharide-containing cross-linking molecule. Dependent claims recite that the compositions are injectable, are extrudable and have the same stability properties. Dependent claims further recite that the composition is tissue compatible and enhances tissue in-growth, enhances tissue re-growth, or combinations thereof. Dependent claim 11 recites that the saccharide includes carboxymethylcellulose. Dependent claim 12 recites that the protein includes tropoelastin.
Claims 24-40 of the ‘312 patent are drawn to a method of preparing a cross-linked protein composition, comprising cross-linking at least one amine-bearing protein with at least one saccharide-containing cross-linking molecule comprising one or more carboxyl groups to form at least one cross-linked protein matrix; wherein the at least one cross-linked matrix comprises: i) at least one protein residue; and ii) at least one saccharide-containing cross-linking residue; and iii) at least one intermolecular cross-linkage comprising an amide bond between the amine of the at least one amine-bearing protein and the carboxyl group of the at least one saccharide-containing cross-linking molecule. Dependent claims recite a composition having a cross-linked protein matrix comprising a protein selected from the group consisting of tropoelastin and albumin, and hyaluronic acid, wherein the protein and hyaluronic acid are cross-linked by at least one amide bond formed between an amine of a residue from the protein and a carboxyl group from the hyaluronic acid. Dependent claims recite that the composition is injectable and the same stability properties.
It would been obvious to the skilled artisan to prepare kits comprising the compositions claimed in the ‘312 patent. The claims of the ‘312 patent explicitly taught the specific compositions as well as that properties of the compositions, e.g., that they there were injectable and were useful in enhancing tissue ingrowth. It would been obvious to the skilled artisan in the pharmaceutical arts to have prepared a kit comprising prefilled syringe. This is deemed to be routine optimization. Examiner notes that in accordance with MPEP § 2112.01, written instructions that are not functionally related to the product do not distinguish the claimed product from the prior art.
Accordingly, instant claims 21-40 are rendered obvious by claims 1-40 of the ‘312 patent.
Conclusion
No claims are allowed.
Claims 21-40 are pending and are rejected.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654