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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-12 and 18-20, in the reply filed on 07/16/2026 is acknowledged. The traversal is on the ground(s) that Zhou no longer teaches the technical feature (see Applicant’s Remarks at pg. 5-6). The Examiner agrees that Zhou does not teach the technical feature, and the Examiner is no longer relying on the Zhou reference. However, the technical feature is still taught in the prior art, as demonstrated in the claim 1 rejection below over Taguchi and Thi (see claim 1 rejection below). Accordingly, the requirement is still deemed proper and is therefore made FINAL.
Claims 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/16/2026.
Response to Amendments
• Claims 1-5 and 7-20 are currently pending. Claim 6 is canceled. Claims 13-17 are withdrawn for being directed to a non-elected invention(s).
Claim Objections
Claim 1 is objected to because of the following informalities:
• In claim 1, there is no explicit labeling of a “formula 1.” The Examiner suggests deleting all instances of the term “1” in claim 1. For example, claim 1 can be amended as follows: “…represented by a formula [[1]]: GltnNH-R1 and includes cyclodextrin; and a second agent that includes a crosslinking agent for the gelatin derivative, wherein in the formula [[1]], Gltn represents…”
• Further, claim 1 should be amended as follows: “…and includes a cyclodextrin.”
Claim Rejections - 35 USC § 112(b)
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.
Claim 12 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.
In claim 12, the term “cold-water” is a relative term which renders the claim indefinite. The term “cold-water” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no clear indication what constitutes “cold-water.” Is it 10 °C? 20 °C? Further, “cold-water fish” can have different meanings in various contexts, e.g., in fishkeeping (in an aquarium) or in ecology (in nature). For the purposes of examination, the Examiner is interpreting any fish referred to as a “cold-water fish” in the prior art to suitably read on the claimed term.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 is currently dependent on claim 6; however, claim 6 is canceled. Thus, claim 7 does not refer to a previous claim. For examination purposes, the Examiner is treating claim 7 as being dependent on claim 1. Applicants may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 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 1-5, 7, 8, 11, 12, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Taguchi (US-20150359924-A1) (hereinafter referred to as “Taguchi”) in view of Thi et al. (Hoang Thi, Thai Thanh, et al. “Supramolecular cyclodextrin supplements to improve the tissue adhesion strength of Gelatin bioglues.” ACS Macro Letters, vol. 6, no. 2, 12 Jan. 2017, pp. 83–88, https://doi.org/10.1021/acsmacrolett.6b00841) (hereinafter referred to as “Thi”), with evidence from Haug et al. (US-20110045067-A1) (hereinafter referred to as “Haug”) as to the rejection of claim 12 only.
Regarding claims 1 and 8, Taguchi teaches an adhesive (see Taguchi at para. 0001, teaching an adhesive) comprising:
• a first agent that includes a gelatin derivative in which a hydrophobic group is bound to gelatin through an imino group represented by a formula 1: GltnNH-R1, wherein in the formula 1, Gltn represents a residue of the gelatin, R represents the hydrophobic group, wherein the hydrophobic group includes a linear or branched alkyl group having 1 to 20 carbon atoms, and NH represents the imino group binding to the residue and the hydrophobic group (see Taguchi at para. 0025-0027, teaching the adhesive to include an aqueous solution of a hydrophobically modified fish-derived gelatin; also see Taguchi at para. 0027, teaching the amino groups as part of the Lys from the gelatin are substituted with the hydrophobic group; also see Taguchi at para. 0028 and Table 7 at para. 0288, teaching the hydrophobic group may include a propyl group; accordingly, it necessarily follows that the gelatin of Taguchi is represented by the formula 1, where a propyl group (a C3 linear alkyl group) is bound to the gelatin via an imino group through the Lys of the gelatin (i.e., Gelatin-NH2 [Wingdings font/0xE0] Gelatin-NH-Propyl));
• and a second agent that includes a crosslinking agent for the gelatin derivative (see Taguchi at para. 0024 and 0045, teaching the aqueous solution of the gelatin may be mixed with an aqueous solution of a water-soluble crosslinking agent which crosslinks the gelatin);
While Taguchi teaches the adhesive outlined above, Taguchi fails to explicitly teach the first agent as containing cyclodextrin (an α-cyclodextrin, regarding claim 8).
However, Thi teaches bioglues formed from gelatin which contain cyclodextrin (see Thi at pg. 83-84). Thi further teaches the cyclodextrin as improving the adhesion of the bioglues to tissue, where the hydroxyl groups of the cyclodextrin form H-bonds with the gelatin backbone and the tissue surface (see Thi at pg. 84, right column). Moreover, Thi teaches the hydrophobic cavity of the cyclodextrin has strong complex affinity to phenol groups in the glues and biomolecules on skin tissue (see Thi at pg. 84, right column). Additionally, Thi teaches the blending of α-cyclodextrins with the gelatins to improve such adhesiveness (see Thi at Abstract).
In this case, one of ordinary skill in the art would have a reasonable expectation of success that the hydrophobic group attached to the gelatin of Taguchi would associate with the hydrophobic cavity of cyclodextrin and biomolecules on skin tissue, thus improving adhesion (see Thi at pg. 84, right column). Moreover, one of ordinary skill would readily recognize the hydrophilic groups of cyclodextrin to H-bond with the gelatin backbone and the tissue surface, further improve adhesion (see Thi at pg. 84, right column).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add an α-cyclodextrin like that taught by Thi to the aqueous solution containing the hydrophobically modified gelatin of Taguchi. One of ordinary skill in the art would have been motivated to do so in order to generate supramolecular networks, e.g., hydrogen bonds and hydrophobic associations, between the gelatin and the tissue, thus improving adhesion (see Thi at pg. 83-84).
Regarding claims 2 and 5, see Table 7 of Taguchi at para. 0288, teaching example A7, where the hydrophobic group (i.e., the propyl group) is introduced at a ratio of 13.7 mol%; thus, Taguchi reasonably suggests an introduction rate of 13.7 mol% via their example embodiments.
Regarding claims 3-4 and 18-19, see Taguchi at para. 0047, teaching the gelatin as being used in an aqueous solution; the water corresponds to the claimed “solvent;” also see Taguchi at para. 0133, teaching the adhesive component may be composed of a mixed solution containing an aqueous solution of the hydrophobically modified fish-derived gelatin (i.e., hydrophobic gelatin) and an aqueous solution of a fish-derived gelatin (i.e., regular gelatin) in a ratio of 1:9 to 5:5 (hydrophobic gelatin: regular gelatin); also see Taguchi at para. 0197-0198, 0263, 0267, 0284, teaching the use of 40 wt% aqueous solutions for both the hydrophobically modified gelatin and the regular gelatin in their examples; accordingly, Taguchi necessarily suggests the use of 40 wt% aqueous solutions via their example embodiments; accordingly, in the case that 40 wt% aqueous solutions are used, the concentration of the hydrophobically-modified gelatin necessarily ranges from 0.067 to 0.333 g/mL in the first agent (a minimum concentration for the hydrophobic gelatin is present when the ratio is 1:9; a 1:9 ratio of hydrophobic gelatin:regular gelatin means that 10% of the mixture includes the aqueous solution of hydrophobic gelatin and 90% of the mixture includes the aqueous solution of regular gelatin; since both aqueous solutions are 40 wt% solutions, that means that following mixing in the above ratio of 1:9, the final mixture contains 4 wt% of the hydrophobically modified gelatin, 36 wt% of the regular gelatin, and 60 wt% of water (40% hydrophobic gelatin concentration • 0.1 ratio in total mixture = 4% hydrophobic gelatin in mixture; 40% regular gelatin • 0.9 ratio in total mixture = 36% regular gelatin in mixture; 100% total – 4% hydrophobic gelatin – 36% regular gelatin = 60% water remainder); since 4 wt% of the mixture contains the hydrophobic gelatin and 60 wt% contains water, the concentration of the hydrophobic gelatin in g/mL is 0.067 g/mL at a minimum (4% hydrophobic gelatin/60% water = 0.067 concentration of hydrophobic gelatin minimum); now, in doing the reverse, the concentration of the hydrophobic gelatin is at a maximum when the ratio is 5:5; a 5:5 ratio of hydrophobic gelatin:regular gelatin means that 50% of the mixture includes the aqueous solution of hydrophobic gelatin and 50% of the mixture includes the aqueous solution of regular gelatin; since both aqueous solutions are 40 wt% solutions, that means that following mixing in the above ratio of 5:5, the final mixture contains 20 wt% of the hydrophobically modified gelatin, 20 wt% of the regular gelatin, and 60 wt% of water (40% hydrophobic gelatin concentration • 0.5 ratio in total mixture = 20% hydrophobic gelatin in mixture; 40% regular gelatin • 0.5 ratio in total mixture = 20% regular gelatin in mixture; 100% total – 20% hydrophobic gelatin – 20% regular gelatin = 60% water remainder); since 20 wt% of the mixture contains the hydrophobic gelatin and 60 wt% contains water, the concentration of the hydrophobic gelatin in g/mL is 0.333 g/mL at a maximum (20% hydrophobic gelatin/60% water = 0.333 g/mL concentration of hydrophobic gelatin maximum); this range of 0.067 to 0.333 overlaps the claimed ranges, establishing a prima facie case of obviousness, see MPEP § 2144.05.
Regarding claim 7, see Example A11 of Taguchi at Table 7 at para. 0288, teaching a lauryl group as a suitable hydrophobic group; a lauryl group is an alkyl group having 12 carbon atoms; note that the lauryl group of Taguchi is relied upon in the claim 7 rejection rather than the propyl group relied upon in the claim 1 rejection earlier above.
Regarding claim 11, see Taguchi at para. 0090.
Regarding claim 12, see Taguchi at para. 0029, teaching cod as a suitable fish; cod is a cold water fish, as evidenced by Haug at para. 0008.
Regarding claim 20, see the claim 1 rejection above; it necessarily follows that once the cyclodextrin is introduced, the hydrophobic cavity of the cyclodextrin will associate with the hydrophobic group attached to the gelatin, thus resulting in at least a part of the hydrophobic groups to be included in the cavity.
Allowable Subject Matter
Claims 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With respect to claim 9, the prior art fails to reasonably teach or suggest an adhesive comprising: a first agent that includes a gelatin derivative in which a hydrophobic group is bound to gelatin through an imino group represented by a formula 1: GltnNH-R1 and includes cyclodextrin; and a second agent that includes a crosslinking agent for the gelatin derivative, wherein in the formula 1, Gltn represents a residue of the gelatin, R represents the hydrophobic group, wherein the hydrophobic group includes a linear or branched alkyl group having 1 to 20 carbon atoms, and NH represents the imino group binding to the residue and the hydrophobic group, wherein a molar-based ratio of the content of the cyclodextrin to the content of the hydrophobic group in the first agent is 0.1 or more.
The closest prior art include Taguchi (US-20150359924-A1) and Thi (Hoang Thi, Thai Thanh, et al. “Supramolecular cyclodextrin supplements to improve the tissue adhesion strength of Gelatin bioglues.” ACS Macro Letters, vol. 6, no. 2, 12 Jan. 2017, pp. 83–88, https://doi.org/10.1021/acsmacrolett.6b00841). While Taguchi in view of Thi teaches most of the limitations of claim 9, modified Taguchi fails to explicitly teach a molar-based ratio of the content of the cyclodextrin to the content of the hydrophobic group in the first agent to be 0.1 or more. There is no teaching or suggestion in the prior art regarding the concentration ratio of the cyclodextrin to the hydrophobic group, nor any teaching or suggestion to optimize such a ratio. In general, the use of cyclodextrin with an alkyl-modified gelatin is absent in the art, and thus, one of ordinary skill would not be drawn to adjusting the claimed ratio or be apprised of the variables such a ratio may impact. Consequently, claim 9 would be allowed if re-written in independent form. Claim 10 is also objected to but would be allowed if re-written in independent form, by virtue of its dependency on claim 9.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 8, 11, 12, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of U.S. Patent No. US-10064973-B2 (herein referred to as ‘973) in view of Thi.
With respect to instant claims 1 and 8, claims 1, 3, and 4 of ‘973 claim all of the instant limitations except for the presence of cyclodextrin (or α-cyclodextrin). However, although the claims at issue are not identical, they are not patentably distinct because the addition of cyclodextrin to a tissue adhesive is obvious over Thi, for the same reasons as mentioned in the claim 1 rejection above.
With respect to instant claims 11-12 and 20, although the claims at issue are not identical, they are not patentably distinct because instant claim 11 is met by claim 1 of ‘973 (4S-PEG has at least two active ester groups); instant claim 12 is met by claim 5 of ‘973 (cod is a cold-water fish, see the claim 12 rejection above); and instant claim 20 is met following the modification over Thi (see the claim 20 rejection above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Taguchi et al. (US-20130220174-A1) teach a two-component tissue adhesive (see Taguchi at Abstract).
Taguchi (US-20130211048-A1) teaches a tissue adhesive film (see Taguchi at Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey E Barzach whose telephone number is (571)272-8735. The examiner can normally be reached Monday - Friday; 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amber R Orlando can be reached on 571-270-3149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY EUGENE BARZACH/Examiner, Art Unit 1731
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