DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-43 were originally filed May 18, 2022.
The amendment received November 21, 2022 amended claims 3, 8, 10-12, 14-16, 19-21, 24, 26, 27, 30, and 32 and canceled claims 4-7, 9, 13, 22, 23, 25, 28, 29, 31, and 33-43.
The amendment received June 23, 2025 changed the status identifiers only.
The amendment received December 1, 2025 amended claims 1, 4, 10, and 12; canceled claims 2 and 3; and added new claim 44.
Claims 1, 8, 10-12, 14-21, 24, 26, 27, 30, 32, and 44 are currently pending.
Claims 1, 8, 10, 12, and 44 are currently under consideration.
Please note: claims 11 and 14-16 have improper status identifiers. The status identifiers should be “withdrawn”.
Election/Restrictions
Applicants elected, without traverse, Group I (claims 1-3, 8, 10-12, and 14-16) in the reply filed on June 23, 2025.
Claims 17-21, 24, 26, 27, 30, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected methods, there being no allowable generic or linking claim.
Applicants elected, without traverse, 6-12 mg/ml type I collagen, 18-72 mM calcium ions, 0.0125%-0.5% (w/v) riboflavin and blue light, and FBS, hEGF, FGF, and human cells as the species in the reply filed on June 23, 2025.
Claims 11 and 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Please note: claim 11 was withdrawn because ionic salts were not elected. Please note: claim 14 is withdrawn because neutralized type I collagen was not elected. Please note: claims 15 and 16 are withdrawn because both sodium and calcium ions were not elected (i.e. see conjunction of “and”).
Applicants contend that claim 11 should be examined. However, applicants do not provide a reasoning based on the elected species as to why claim 11 should be examined. Therefore, claim 11 is still withdrawn.
Priority
The present application is a 371 (National Stage) of PCT/AU2020/051247 filed November 18, 2020 which claims foreign priority to Australia 2019904331 filed November 18, 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 22, 2025 is being considered by the examiner.
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.
Withdrawn Objections
The objection to the disclosure regarding the first line of the specification should be updated to include PCT/AU2020/051247 filed November 18, 2020 is withdrawn in view of the amendment received December 1, 2025.
The objection to the disclosure regarding Figure 3b is not described (Figure 23 is described instead) is withdrawn in view of the amendment received December 1, 2025.
The objection to claim 8 regarding a conjunction is missing between the second to last and the last member of the Markush group is withdrawn in view of the amendment received December 1, 2025.
The objection to claim 10 regarding “the vitamins comprise” should read “the vitamin comprises” is withdrawn in view of the amendment received December 1, 2025.
The objection to claim 10 regarding “the matrix proteins comprise” should read “the matrix protein comprises” is withdrawn in view of the amendment received December 1, 2025.
The objection to claim 10 regarding “the hormones comprise” should read “the hormone comprises” is withdrawn in view of the amendment received December 1, 2025.
The objection to claim 10 regarding “the glycoproteins comprise” should read “the glycoprotein comprises” is withdrawn in view of the amendment received December 1, 2025.
Maintained Objections
Claim Objections
Claim 8 is objected to because of the following informalities: either articles for all members of the Markush group should be present or no articles for the members of the Markush group should be present (see “a culture medium” – lines 2 and 5). Appropriate correction is required. In addition, the members of the Markush group should correlate between claims 8 and 10. Utilization of “growth factor” or “growth factor(s)” is suggested.
Arguments and Response
Applicants’ arguments directed to the objection for claim 8 were considered but are not persuasive for the following reasons.
Applicants contend that claim 8 does not have a Markush group because the language of “consisting of” is not present.
Applicants’ arguments are not convincing since other language for Markush groups is recognized in the MPEP (see MPEP § 2117). In addition, a Markush group is a list of alternatively usable members (i.e. present claim 8). In addition, the present is an objection, not a rejection (see page 9, line 11 of the response received December 1, 2025).
Claim 10 is objected to because of the following informalities: “the growth factors comprise” should read “the growth factor(s) comprise(s)”. Appropriate correction is required.
Arguments and Response
Applicants’ arguments directed to the objection for claim 10 were considered but are not persuasive for the following reasons.
Applicants contend that the object is moot in view of the amendments received December 1, 2025.
Applicants’ arguments are not convincing since the claim was not amended to include “the growth factor(s) comprise(s)” which corresponds to the utilization of “and/or”.
Claim 10 is objected to because of the following informalities: a single conjunction should be present in the Markush group (i.e. delete and/or from lines 3, 4, and 5). Appropriate correction is required.
Arguments and Response
Applicants’ arguments directed to the objection for claim 10 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment to claim 10 received December 1, 2025 negates the objection.
Applicants’ arguments are not convincing since “and/or” was not deleted from lines 3, 4, and 5.
New Objection Necessitated by Amendment
Claim Objections
Claim 8 is objected to because of the following informalities: “amino acids” is duplicated in the claim (see lines 3, 5, and 6). Appropriate correction is required.
Withdrawn Rejections
The rejection of claim 3 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 cancellation of the claim in the amendment received December 1, 2025.
The rejection of claim 3 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 cancellation of the claim in the amendment received December 1, 2025.
The rejection of claim 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 December 1, 2025.
Maintained and/or Modified* Rejections
*wherein the modification is necessitated by amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 8, 10, 12, and 44 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 presently claimed composition. For example, it is unclear if the collagen in the composition is actually crosslinked or not.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) (indefinite), for claims 1, 8, 10, 12, and 44 were considered but are not persuasive for the following reasons.
Applicants contend that the amendments received December 1, 2025 negates the rejection.
Applicants’ arguments are not convincing since the addition of riboflavin or Rose Bengal does not negate the rejection. Riboflavin and Rose Bengal require UV to crosslink collagen. Applicants should amendment “composition” or the “type I collagen” as crosslinked or uncrosslinked for clarification.
Claim 8 is 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 presently claimed composition. For example, it is unclear what “a culture medium comprising ions other than sodium ions or calcium ions, and/or amino acids” is referring to (e.g. culture medium without sodium ions or calcium ions, culture medium without sodium ions or calcium ions and/or amino acids). Utilization of a conjunction in the Markush group may help alleviate this issue. Amino acids is already a member of the Markush group (see line 3).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Darmoc et al. U.S. Patent Application Publication 2012/0230977 published September 13, 2012.
For present claims 1, 8, 10, and 12, Darmoc et al. teach compositions comprising type I collagen at 10 mg/ml, calcium ions, Rose Bengal or riboflavin (at ratios of 7.5:1 to 500:1), fibrinogen, Factor XIII, vitamin K, EGF, hormones, antibiotics, and/or mammalian cells including red blood cells and crosslinking via ionic interactions and/or UV photoinitiation (please refer to the entire specification particularly the abstract; paragraphs 4-14, 36, 41, 44, 45, 49, 59-79, 86, 87, 94, 98, 99, 101, 104-106, 108-111, 113-118, 121, 124, 134; claims).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Therefore, the teachings of Darmoc et al. anticipate the presently claimed composition.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Darmoc et al. for claims 1, 8, 10, and 12 were considered but are not persuasive for the following reasons.
Applicants contend that Darmoc et al. do not teach the specific concentration of calcium ions, riboflavin, or Rose Bengal. Applicant also contends that Darmoc et al. do not teach mammalian cells in the collagen composition.
Applicants’ arguments are not convincing since the teachings of Darmoc et al. anticipate the composition of the instant claims.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Darmoc et al. teach red blood cells trapped within the crosslinked collagen (please refer to the entire specification particularly paragraph 134; Figure 16C).
Claims 1, 8, 10, 12, and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allbritton et al. WO 2018/022548 published February 1, 2018.
For present claims 1, 8, 10, 12, and 44, Allbritton et al. teach compositions comprising type I collagen (0-49 wt %), utilizing multiple crosslinkers including ionic bonding with calcium ions and UV crosslinking with riboflavin and addition of human cells, culture medium, growth factors including EGF and FGF, hormones, fibronectin, and matrix proteins (please refer to the entire specification particularly the abstract; pages 2, 3, 9-12, 14-16, 21, 24; claims).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Therefore, the teachings of Allbritton et al. anticipate the presently claimed composition.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Allbritton et al. for claims 1, 8, 10, 12, and 44 were considered but are not persuasive for the following reasons.
Applicants contend that Allbritton et al. do not teach the specific concentrations as presently claimed. Applicant also contends that Allbritton et al. do not teach mammalian or human cells in the collagen composition.
Applicants’ arguments are not convincing since the teachings of Allbritton et al. anticipate the composition of the instant claims.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Allbritton et al. teach live cell constructs and supports (please refer to the entire specification particularly the abstract; pages 2, 3, 9-12, 24; claims).
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, 8, 10, 12, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Darmoc et al. U.S. Patent Application Publication 2012/0230977 published September 13, 2012; Pang et al., 2017, Unraveling the role of Calcium ions in the mechanical properties of individual collagen fibrils, Scientific Reports, 7: 46042 (8 pages); and McCall et al., 2010, Mechanisms of Corneal Tissue Cross-linking in Response to Treatment with Topical Riboflavin and Long-Wavelength Ultraviolet Radiation (UVA), Investigative Ophthalmology & Visual Science, 51(1): 129-138.
For present claims 1, 8, 10, and 12, Darmoc et al. teach compositions comprising type I collagen at 10 mg/ml, calcium ions, Rose Bengal or riboflavin, fibrinogen, Factor XIII, vitamin K, EGF, hormones, antibiotics, and/or mammalian cells including red blood cells and crosslinking via ionic interactions and/or UV photoinitiation (please refer to the entire specification particularly the abstract; paragraphs 4-14, 36, 41, 44, 45, 49, 59-79, 86, 87, 94, 98, 99, 101, 104-106, 108-111, 113-118, 121, 124, 134; claims).
For present claims 1, 8, 10, 12, and 44, Pang et al. teach utilizing 10 mM or 20 mM calcium ions for crosslinking collagen (please refer to the entire reference particularly the abstract; Figures 2, 3).
For present claims 1, 8, 10, 12, and 44, McCall et al. teach collagen crosslinking utilizing 0.1% wt/vol riboflavin and utilizing human cells (please refer to the entire reference particularly the abstract; “RFUVA Treatments and Tension Measurements”; Preparation of Riboflavin Solutions).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because the substitution of one known element (i.e. calcium ions; riboflavin) for another (specific concentrations of calcium ions and riboflavin) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. In addition, it is respectfully noted that the prior art may utilize different units than those presently claimed but would still read on the present claims. The claims would have been obvious because a particular known technique (i.e. utilizing a specific concentration of calcium ions or riboflavin to crosslink collagen) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. 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 Darmoc et al.; Pang et al.; and McCall et al. for claims 1, 6, 10, 12, and 44 were considered but are not persuasive for the following reasons.
Applicants contend that Darmoc et al. do not teach all of the claimed concentrations. Applicants contend that the calcium ions as claimed do not function as a crosslinker, but rather as a stabilizer
Applicants’ arguments are not convincing since the teachings of Darmoc et al.; Pang et al.; and McCall et al. render the composition of the instant claims prima facie obvious.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because the substitution of one known element (i.e. calcium ions; riboflavin) for another (specific concentrations of calcium ions and riboflavin) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. In addition, it is respectfully noted that the prior art may utilize different units than those presently claimed but would still read on the present claims. The claims would have been obvious because a particular known technique (i.e. utilizing a specific concentration of calcium ions or riboflavin to crosslink collagen) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
The calcium ions as presently claimed are indistinguishable from the calcium ions taught in the prior art. It is also respectfully noted that crosslinking with calcium would “stabilize” the presently claimed composition.
Claims 1, 8, 10, 12, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Allbritton et al. WO 2018/022548 published February 1, 2018; Lu et al., 2018, Combined effects of glutaraldehyde and riboflavin/uv365 on the self-assembly of type I collagen molecules observed with atomic force microscopy, International Journal of Food Properties, 21(1): 2181-2192; and Pang et al., 2017, Unraveling the role of Calcium ions in the mechanical properties of individual collagen fibrils, Scientific Reports, 7: 46042 (8 pages).
For present claims 1, 8, 10, 12, and 44, Allbritton et al. teach compositions comprising type I collagen (0-49 wt %), utilizing multiple crosslinkers including ionic bonding with calcium ions and UV crosslinking with riboflavin and addition of human cells, culture medium, growth factors including EGF and FGF, hormones, fibronectin, and matrix proteins (please refer to the entire specification particularly the abstract; pages 2, 3, 9-12, 14-16, 21, 24; claims).
For present claims 1, 8, 10, and 12, Lu et al. teach collagen at 4 mg/ml and riboflavin at 0.05%, 0.10%, and 0.20% (w/v) (please refer to the entire reference particularly the abstract; “Preparation of original collagen solutions”, “Preparation of the collagen solutions cross-linked with riboflavin under UV365 irradiation”, Table 1, “Effects of riboflavin/uv365 irradiation on the collagen cross-linking”, Figure 4, “Effects of riboflavin/uv365 irradiation on the mass distribution of collagen molecules”, Figure 5, “Conclusion”).
For present claims 1, 8, 10, and 12, Pang et al. teach utilizing 10 mM or 20 mM calcium ions for crosslinking collagen (please refer to the entire reference particularly the abstract; Figures 2, 3).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because the substitution of one known element (i.e. collagen; calcium ions; riboflavin) for another (specific concentrations of collagen, calcium ions, and riboflavin) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. In addition, it is respectfully noted that the prior art may utilize different units than those presently claimed but would still read on the present claims. The claims would have been obvious because a particular known technique (i.e. utilizing a specific concentration of calcium ions or riboflavin to crosslink a specific concentration of collagen) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. 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 Allbritton et al.; Lu et al.; and Pang et al. for claims 1, 8, 10, 12, and 44 were considered but are not persuasive for the following reasons.
Applicants contend that Allbritton et al. do not teach the concentrations as presently claimed. Applicants contend that the calcium ions do not act as a crosslinker but rather as a stabilizer.
Applicants’ arguments are not convincing since the teachings of Allbritton et al.; Lu et al.; and Pang et al. render the composition of the instant claims prima facie obvious.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because the substitution of one known element (i.e. collagen; calcium ions; riboflavin) for another (specific concentrations of collagen, calcium ions, and riboflavin) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. In addition, it is respectfully noted that the prior art may utilize different units than those presently claimed but would still read on the present claims. The claims would have been obvious because a particular known technique (i.e. utilizing a specific concentration of calcium ions or riboflavin to crosslink a specific concentration of collagen) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
The calcium ions as presently claimed are indistinguishable from the calcium ions taught in the prior art. It is also respectfully noted that crosslinking with calcium would “stabilize” the presently claimed composition.
Claims 1, 8, 10, 12, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. WO 2016/178586 published November 10, 2016 and Pang et al., 2017, Unraveling the role of Calcium ions in the mechanical properties of individual collagen fibrils, Scientific Reports, 7: 46042 (8 pages).
For present claims 1, 8, 10, 12, and 44, Patel et al. teach compositions comprising type I collagen at a concentration of 3-10 mg/ml, polycationic crosslinkers (e.g. encompassing calcium ions), and UV and 0.1% riboflavin crosslinking wherein growth factors including FGF and EGF, human cells, matrix proteins, anaesthetics, fibronectin, antibiotics, and vitamins may be present (please refer to the entire specification particularly the abstract; paragraphs 15, 22, 24, 30, 35-39, 44, 48, 50, 51, 58-62, 64, 65, 69, 81-88, 96, 102, 121, 128, 134, 141-150, 161-163, 168-170, 184, 195-198, 214, 223, 224, 251, 252, 253, 254, 263, 265).
For present claims 1, 8, 10, 12, and 44, Pang et al. teach utilizing 10 mM or 20 mM calcium ions for crosslinking collagen (please refer to the entire reference particularly the abstract; Figures 2, 3).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because the substitution of one known element (i.e. genus of polycationic crosslinking) for another (calcium ion crosslinking at a specific concentration) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. In addition, it is respectfully noted that the prior art may utilize different units than those presently claimed but would still read on the present claims. The claims would have been obvious because a particular known technique (i.e. utilizing a specific concentration of calcium ions to crosslink collagen) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. 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 Patel et al. and Pang et al. for claims 1, 8, 10, 12, and 44 were considered but are not persuasive for the following reasons.
Applicants neglected to response to the above rejection.
Applicants’ arguments are not convincing since the teachings of Patel et al. and Pang et al. render the composition of the instant claims prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 8, 10, 12, and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 13, 14, 16-20, 32, 34, 36, 52, 53, 64-66, 69, and 103 of copending Application No. 18/551,085 (reference application) in view of Patel et al. WO 2016/178586 published November 10, 2016.
Copending Application No. 18/551,085 (reference application) claims compositions comprising type IV collagen at 6-24 mg/ml; one or more crosslinking agents activated by UV light, blue light, green light, or white light including riboflavin at 0.01-0.1 mg; endothelial cells; sodium ions at 0.04-0.15 M; and/or calcium ions at 0.008-0.4 M and also comprising platelet lysate, mammalian cells, culture medium, growth factors including EGF and FGF, hormones, matrix proteins, glycoproteins, vitamins, ions, fibronectin, amino acids, antibiotics, anaesthetics, Factor XIII, FBS, human serum, human platelet lysate, etc.
Patel et al. teach compositions comprising type I collagen at a concentration of 3-10 mg/ml, polycationic crosslinkers (e.g. encompassing calcium ions), and UV and 0.1% riboflavin crosslinking wherein growth factors including FGF and EGF, human cells, matrix proteins, anaesthetics, fibronectin, antibiotics, and vitamins may be present (please refer to the entire specification particularly the abstract; paragraphs 15, 22, 24, 30, 35-39, 44, 48, 50, 51, 58-62, 64, 65, 69, 81-88, 96, 102, 121, 128, 134, 141-150, 161-163, 168-170, 184, 195-198, 214, 223, 224, 251, 252, 253, 254, 263, 265).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because the substitution of one known element (i.e. type IV collagen) for another (type I collagen) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. In addition, it is respectfully noted that the prior art may utilize different units than those presently claimed but would still read on the present claims. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 18/551,085 (reference application) in view of Patel et al. for claims 1, 8, 10, 12, and 44 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/551,085 (reference application) in view of Patel et al. renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 8, 10, 12, and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, 12, 14, 15, 17-21, 24-26, 28, 32, 34, 35, 38, and 50 of copending Application No. 18/550,870 (reference application) in view of Patel et al. WO 2016/178586 published November 10, 2016.
Copending Application No. 18/550,870 (reference application) claims compositions comprising type IV collagen at 6-24 mg/ml; one or more crosslinking agents activated by UV light, blue light, green light, or white light including riboflavin at 0.01-0.1 mg; endothelial cells; sodium ions at 0.04-0.15 M; and/or calcium ions at 0.008-0.4 M and also comprising mammalian cells, culture medium, growth factors including FGF, hormones, matrix proteins, glycoproteins, vitamins, ions, fibronectin, amino acids, antibiotics, anaesthetics, Factor XIII, FBS, human serum, platelet lysate, human platelet lysate, etc.
Patel et al. teach compositions comprising type I collagen at a concentration of 3-10 mg/ml, polycationic crosslinkers (e.g. encompassing calcium ions), and UV and 0.1% riboflavin crosslinking wherein growth factors including FGF and EGF, human cells, matrix proteins, anaesthetics, fibronectin, antibiotics, and vitamins may be present (please refer to the entire specification particularly the abstract; paragraphs 15, 22, 24, 30, 35-39, 44, 48, 50, 51, 58-62, 64, 65, 69, 81-88, 96, 102, 121, 128, 134, 141-150, 161-163, 168-170, 184, 195-198, 214, 223, 224, 251, 252, 253, 254, 263, 265).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because the substitution of one known element (i.e. type IV collagen) for another (type I collagen) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. In addition, it is respectfully noted that the prior art may utilize different units than those presently claimed but would still read on the present claims. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 18/550,870 (reference application) in view of Patel et al. for claims 1, 8, 10, 12, and 44 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/550,870 (reference application) in view of Patel et al. renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658