DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 29, 2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6 and 8-13, drawn to a method of crosslinking protein fibers, and a single protein scaffold protein species such that (a) the natural aldehyde is cinnamaldehyde, (b) crosslinking solution is absent and cinnamaldehyde liquid is the crosslinking solution, and (c) protein fiber is collagen are maintained.
Claims 2, 4-5, 14-15, and 17-21 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendments to the claims filed on December 29, 2025, wherein claim 1 is amended; claims 2, 4-5, 14-15, 17-21 are unchanged; claim 23 is newly added; and claims 3, 6-11, 13, 16, 22 are cancelled.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-5, 12, 14-15, 17-21 and 23 are pending. Claims 2, 4-5, 14-15, and 17-21 remain withdrawn.
Claims 1, 12 and 23 are under examination in accordance with the elected species.
Priority
The instant application 17/281,714 filed on March 31, 2021 is a 371 of PCT/US19/54010 filed
on October 1, 2019, which claims priority to, and the benefits of U.S. Provisional Application No.
62/739,716 filed on October 1, 2018.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Action Summary
Claim 1 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 are withdrawn, because the term “about” is deleted in light of the claim amendments.
Claims 1 and 12 rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (Biomaterials, 2008. Vol. 29(8): 955–962), in view of Merriam-Webster Dictionary (“Room Temperature”[Online]), Kwon et al. (International endodontic journal, 2017. vol. 50, 1: 58-66; cited in the previous Office Action mailed on 2/22/2024) and Yannas et al. (US 4,448,718), as evidenced by Mosher et al. (An Introduction to Chemistry, 2nd edition. Springer International Publishing, 2023: 453) are withdrawn in light of the claim amendments that changes the amount of time (from “about 1 hour to 14 days” to “7 days”) and the temperature (from “about 30 °C to about 40 °C” to “30 °C to 40 °C”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 12, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (Biomaterials, 2008. Vol. 29(8): 955–962), in view of Kwon et al. (International endodontic journal, 2017. vol. 50, 1: 58-66; cited in the previous Office Action mailed on 2/22/2024) and Yannas et al. (US 4,448,718), as evidenced by Mosher et al. (An Introduction to Chemistry, 2nd edition. Springer International Publishing, 2023: 453).
Please note Yang et al., Kwon et al, Yannas et al., and Mosher et al. are each cited in the previous Office Action.
Yang et al. teaches collagen fibers prepared by electrospinning are cross-linked using glutaraldehyde vapor (see e.g., p. 956, “2.2. Cross-linking of the electrospun fibers” section). Yang et al. further teaches crosslinking is carried out by placing the substrate with the electrospun collagen fibers above 20 ml of 25 wt % glutaraldehyde solution in a sealed beaker for 24 hours at room temperature (see e.g., p. 956, “2.2. Cross-linking of the electrospun fibers” section). Yang et al. further teaches the collagen fibers are electrospun from a 8% w/v solution of acid soluble collagen type I from calf skin in 1,1,1,3,3,3-hexafluoro-2-propanol (see e.g., p. 956, “2.1. Electrospinning of collagen”). Please note the collagen fibers prepared by electrospinning as taught by Yang et al. is a plurality of protein fibers consisting of collagen electrospun from a solution with 8 wt% of the collagen fibers in 1,1,1,3,3,3-hexafluoro-2-propanol.
Yang et al. does not teach cinnamaldehyde. Yang et al. also does not teach exposing for an amount of time of 7 days at a temperature of from 30 °C to 40 °C. Yang et al. also does not teach 37 °C as claimed in claim 23. Yang et al. also does not teach the exposing is at a pressure of 7.5 PSI to 30 PSI as claimed in claim 12.
Kwon et al. teaches collagen scaffolds are sometimes cross-linked with various agents to enhance their physical properties and enzymatic resistance to bacteria derived collagenase (see e.g., page 59, left column, line 14-17). Kwon et al. further teaches glutaraldehyde is widely used for this purpose because of its short cross-linking time and long endurance period; however, glutaraldehyde is cytotoxic, which remains a significant problem preventing its use (see e.g., page 59, left column, line 17-22). Kwon et al. further teaches cinnamaldehyde, which is a pale yellow, viscous liquid found naturally in the bark of cinnamon trees, is known to act as a cross-linking agent for some materials, such as collagen and chitosan (see e.g., page 59, left column, line 40-43 and 47-50). Kwon et al. further teaches cinnamaldehyde has high anti-oxidant, antibacterial, anticancer, and anti-inflammatory activities and also plays a role in tissue repair (see e.g., page 59, left column, line 43-45). Kwon et al. further teaches the cinnamaldehyde treated collagen scaffold increases the surface roughness and compressive strength compared to the untreated collagen, as well as promoting human dental pulp cell proliferation and differentiation (see e.g., abstract; page 65, left column, 1st paragraph).
Yannas et al. teaches a dry, uncross linked composite material is contacted with a gaseous aldehyde at a temperature of from 4°C to 150°C, preferably from 20 °C to about 100 °C, and most preferably at about 25 °C (see e.g., column 4, line 35-40). Yannas et al. further teaches term “gaseous aldehyde” not only includes aldehyde which exist in the physical state of gas at normal temperature and pressure (25 °C, 1 atmosphere), but also vapors produced from aldehyde which are liquid or even solids under the conditions used during the crosslinking steps (see e.g., column 4, line 13-18). Yannas et al. further teaches it is particularly preferred to select conditions based on the physical properties of the aldehyde being used which produce a vapor concentration of 0.5-1.0 % aldehyde in an atmosphere otherwise consisting of air (which may also contain water vapor) at a pressure of one standard atmosphere (see e.g., column 4, line 40-45). Yannas et al. further teaches the amount of exposure time will vary as is well understood to those skilled in the art with the temperature and the concentration of the gaseous aldehyde (aldehyde vapor); if the amount of for a particular set of conditions is not known, it can be determined using a simple experiment by exposing strips to a gaseous aldehyde and removing them at various time interval in order to determine the stress-strain behavior (see e.g., Col. 4, line 48 to Col. 5, line 35). Yannas et al. further teaches in Example 4, the crosslinked product is removed from the chamber and the average molecular weight between crosslinks (Mc) was determined as shown below:
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; and teaches that measurements of Mc showed that treated strips had a much lower average molecular weight between cross-links (corresponding to a much higher density of cross links) than untreated strips (see e.g., Col. 5, line 60-65; Example 4). Yannas et al. further teaches the crosslink material produced by this process is more stable toward long-term storage than similar materials prepared using other methods of crosslinking (see e.g., abstract; Col. 2, line 45-49).
According to MPEP 2144.05, I “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).”; and According to MPEP 2144.05, II “[g]enerally, 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.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)’”. In the present case, Yang et al. clearly teaches the electrospun collagen fibers is exposing to a vapor phase of 25 wt % glutaraldehyde solution for 24 hours at room temperature, wherein the collagen fibers are electrospun from a 8% w/v solution of acid soluble collagen type I from calf skin in 1,1,1,3,3,3-hexafluoro-2-propanol. Please note the electrospun collagen fibers taught by Yang et al. is a collagen prepared by electrospinning in a solution of 8% weight collagen in 1,1,1,3,3,3-hexafluoro-2-propanol. The difference between the method of Yang et al. and the claimed method is that the prior art uses glutaraldehyde as the crosslinking solution in the vapor phase rather than cinnamaldehyde as the crosslinking solution in the vapor phase; the prior art expose the collagen fibers for 24 hours at room temperature rather than 7 days at a temperature of from 30 °C to 40 °C. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of Yang et al. by substituting the glutaraldehyde with cinnamaldehyde of Kwon et al. as the crosslinking solution in the vapor phase, and then optimizing the amount of exposure time and temperature for crosslinking through routine experimentation as taught by Yannas et al. One of ordinary skill in the art would have been motivated to do so, because Kwon et al. teaches glutaraldehyde is cytotoxic and teaches the use of cinnamaldehyde as the crosslinking agent for crosslinking collagen scaffold increases the surface roughness and compressive strength as well as incorporating its known benefits, such as anti-inflammatory effect; and Yannas et al. teaches the temperature for crosslinking with gaseous aldehyde is preferably at a temperature of from 20 °C to about 100 °C, and it is preferred to select conditions based on the physical properties of the aldehyde being used, and the amount of exposure time will vary as is well understood to those skilled in the art with the temperature and the concentration of the gaseous aldehyde and can be determined using a simple experiment to determine the stress-strain behavior in order to produce a more stable crosslink material, and the increasing the amount of exposure time lowers average molecular weight (Mc) between cross-links and that corresponding to a much higher density of cross links. One would have a reasonable expectation of success to arrive at the claimed invention with the claimed amount of exposure time and exposing temperature through routine experimentation, because one would have reasonably expected that the amount of exposure time and temperature for crosslinking are known results-effective variables to give a stable crosslinked material; and therefore, by substituting glutaraldehyde with cinnamaldehyde as the crosslinking solution in the vapor phase, and then optimizing the amount of exposure time and temperature for crosslinking would have successfully crosslinking the electrospun collagen fibers with a vapor phase of cinnamaldehyde; reading on claims 1 and 23.
Regarding the limitation of “wherein the exposing is at a pressure of 7.5 PSI to 30 PSI” in claim 12, Yannas et al. clearly teaches a pressure of one standard atmosphere to produce a vapor aldehyde. It would have been prima facie obvious for one of ordinary skilled in the art at the time the application was filed to arrive at the claimed invention by further modifying the method of Yang et al., Kwon et al., and Yannas et al. set forth above to optimize the exposing pressure through routine experimentation. One of ordinary skill in the art would have been motivated to do so, because Yannas et al. teaches it is particularly preferred to select conditions based on the physical properties of the aldehyde being used which produce a vapor concentration of 0.5-1.0% aldehyde at a pressure of one standard atmosphere. Please note 1 standard atmosphere taught by Yannas et al. is equivalent to 14.7 PSI, as evidenced by Mosher et al. (see e.g., Table 10.4 in the evidentiary reference). One of ordinary skill in the art would have a reasonable expectation of success to arrive at the claimed invention with the claimed pressure through routine optimization, because one would have reasonably expected that that the pressure is a known results-effective variable to produce vapor aldehyde; and therefore, by optimizing the exposing pressure one would have reasonably expected to produce vapor cinnamaldehyde.
Therefore, the claimed invention is prima facie obvious to one of ordinary skilled in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant's arguments filed on December 29, 2025 with respect to the rejection of claims 1 and 12 under 35 U.S.C. 103 as being unpatentable over Yang et al. (Biomaterials, 2008. Vol. 29(8): 955–962), in view of Merriam-Webster Dictionary (“Room Temperature”[Online]), Kwon et al. (International endodontic journal, 2017. vol. 50, 1: 58-66; cited in the previous Office Action mailed on 2/22/2024) and Yannas et al. (US 4,448,718), as evidenced by Mosher et al. (An Introduction to Chemistry, 2nd edition. Springer International Publishing, 2023: 453) have been fully considered but they are not persuasive.
Applicant amends claim 1 from the recitation of “for an amount of time of from about 1 hour to 14 days at a temperature of from about 30 °C to about 40 °C” to the recitation of “for an amount of time of 7 days at a temperature of from 30°C to 40°C”, and that changes the scope of the claims. Applicant further added new claim 23 that recites “wherein the temperature is 37 °C”. Each of these findings demonstrate the claim amendment changes the scope of the claims and that necessitated the new ground of rejection on the record for the reasons set forth herein.
In Summary, Applicant argues the amendments to claim 1 changes the amount of time and temperature that overcomes the rejection on the record. Applicant further directs attention to Table 1, Figs 3C and 3D of the specification, and argues shorter periods of time results in materials that dissolve in water, and changes the morphologies. Applicant further argues “[a]lthough these examples are for gelatin rather than collagen as claimed, it is common knowledge in the art that gelatin is denatured collagen and thus has the same overall proportions of amino acids and reactive groups as collagen itself, and by extension, the ordinarily-skilled artisan will expect results from gelatin to apply to the presently claimed collagen as well” (see p. 5, first paragraph of the reply). Applicant further argues Yannas et al. only teaches up to 60 hours for crosslinking time, which is about 2.5 days; and Kwon et al. teaches gelatin time for cinnamaldehyde on the order of minutes; and therefore, the cited combination suggest a much shorter gelatin time than required by the present claims. Applicant further argues Kwon teaches that the presence of cinnamaldehyde significantly shortens the setting time of collagen, thus, one would be motivated to use periods of time significantly shorter than one week as claimed because the reference provided no teachings to wait longer as required by the present claims.
In response, Applicant’s argument is not found persuasive for the reasons set forth below:
First of all, applicant’s assertion of unexpected results is not commensurate in scope with the claimed invention. According to MPEP 716.02(d), “whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. Applicant’s unexpected results rely on Table 1 listed in Example 1 (see page 10-11 of the specification), which specifically crosslink electrospun gelatin fibers (12.5 wt % solution of gelatin in tetrafluoroethylene was prepared for electrospinning) with vapor trans-cinnamaldehyde (tCA) for 7 days at 45 °C to arrive at a scaffold that is stable in water (see e.g., Table 3, “Vapor tCA crosslinking for 7 days at 45 °C”). It is noted that Example 1 does not expressly describe the exposing pressure. In contrast, instant claim(s) is drawn to exposing the plurality of protein fibers consist of collagen to a vapor phase of cinnamaldehyde for 7 days at 30 °C to 40 °C. In other words, although Table 1 uses “7 days” as the amount of time for crosslinking, applicant only exemplified unexpected results using a different plurality of protein fibers (gelatin) with a specific vapor phase of cinnamaldehyde (trans-cinnamaldehyde) at a different temperature (45 °C), and that does not provide adequate basis for concluding that similar results would be obtained when crosslinking another plurality of protein fibers (a plurality of protein fibers consist of collagen) at a different temperature (30 °C to 40 °C).
Additionally, Applicant’s unexpected results further rely on Fig. 3C and 3D, which are SEM images of gelatin nanofibers obtained in Example 2 (see e.g., p. 15, line 11-16). Example 2 specifically crosslinks electrospun gelatin fibers (10 wt% solution of gelatin in HFIP) with vapor trans-cinnamaldehyde (tCA) for 5 and 7 days. Although Example 2 describes crosslinking was carried out at room temperature and ambient body temperature for about 37 °C (see e.g., p. 14, line 7-8), it fails to expressly describe the scaffold examined in Fig. 3C and 3D, respectively, is the one that uses room temperature or ambient body temperature. It is noted that Example 2 also does not expressly describe the exposing pressure. In contrast, the instant claim(s) is drawn to exposing the plurality of protein fibers consist of collagen to a vapor phase of cinnamaldehyde for 7 days at 30 °C to 40 °C. In other words, although Example 2 uses “7 days” as the amount of time for crosslinking, applicant only exemplified unexpected results using a different plurality of protein fibers (gelatin), and that does not provide adequate basis for concluding that similar results would be obtained when crosslinking another plurality of protein fibers (a plurality of protein fibers consist of collagen) at broad range of temperature (30 °C to 40 °C).
Wirth respect to applicant’s argument that states “[a]lthough these examples are for gelatin rather than collagen as claimed, it is common knowledge in the art that gelatin is denatured collagen and thus has the same overall proportions of amino acids and reactive groups as collagen itself, and by extension, the ordinarily-skilled artisan will expect results from gelatin to apply to the presently claimed collagen as well” (see p. 5, first paragraph of the reply), this appears to be mere argument without factual evidence. According to MPEP 716.01 (c), “[o]bjective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984)”. If applicant premises the unexpected results obtained from the method of crosslinking gelatin can directly translate to the method of crosslinking collagen, the supporting evidence is respectively requested. Moreover, Applicant argues that gelatin is denatured collagen and that one of ordinary skill in the art would expect results obtained using gelatin to be applicable to collagen. To the extent Applicant’s position is accepted, such an assertion undermines the allegation of unexpected results because it indicates that the observed crosslinking behavior would have been reasonably expected to translate between gelatin and collagen. Applicant cannot simultaneously rely upon the similarity between gelatin and collagen to establish relevance of the data while asserting that the claimed collagen process exhibits unexpected properties.
Furthermore, applicant’s argument that one would not optimize the amount of time for crosslinking based on the teachings of prior arts is not found persuasive. First, the rejection on the record is form using the combinations of Yang et al., Kwon et al., Yannas et al., rather than using each prior art individually. The rejection on the record relies on Kwon et al. to teach the benefit of replacing glutaraldehyde with cinnamaldehyde, rather than the amount of time. It may well be true that Yannas et al. only exemplify the amount of exposure time starting from 0 hours to 50 or 60 hours in Table 1; However, according to MPEP 2123 II, “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971)”. In the present case, Yannas et al. clearly teaches the amount of exposure time will vary as is well understood to those skilled in the art with the temperature and the concentration of the gaseous aldehyde, and it can be determined using routine optimization experiment by exposing strips to a gaseous aldehyde and removing them at various time interval in order to determine the stress-strain behavior (see e.g., Col. 4, line 48 to Col. 5, line 35); Specifically, Yannas et al. further teaches “[m]easurements of Mc showed that treated strips had a much lower average molecular weight between cross-links (corresponding to a much higher density of cross-links) than untreated strips” (see Col. 8, line 27-30), and teaches the mean Mc in relation to the exposure time (hrs) in Table 1:
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In sum, the mere fact that Yannas et al. exemplified the exposure time up to 60 hours does not constitute a teaching away. In fact, Yannas et al. clearly teaches increasing the amount of time used for crosslinking reduces the average molecular weight between cross-links (Mc), and that correspond to a much higher density of cross-links. In other words, the claimed amount of time represent optimization of known result-effective variable, which would have been obvious. According to MPEP 2144.05, II, A "’[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Given that applicant has not present any evidence demonstrate the criticality of the claimed amount of time, the argument is not found persuasive for the reasons set forth herein. In view of the foregoing, applicant’s argument is not found persuasive; and in light of the claim amendments that changes the scope of the claims, the rejection on the record, including the prior arts, has been revisited and modified in light of the claim amendments for the reasons set forth herein.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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