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 .
DETAILED ACTION
Applicant’s Request for Reconsideration dated January 9, 2026 is acknowledged.
Claims 1, 37, 89, 91 and 94-118 are pending.
Claims 2-36, 38-88, 90, 92 and 93 are cancelled.
Claims 99 and 100 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1, 37, 89, 91, 94-98 and 101-118 as filed on January 9, 2026 are pending and under consideration to the extent of the elected species, e.g., the species of G-LM-PEG-LM-G is “poly(ethylene glycol) disuccinimidyl succinate” and the species of protein is “albumin”.
This action is made FINAL.
Terminal Disclaimer
The Terminal Disclaimer filed January 9, 2026 over Application No. 18/917,985 is acknowledged.
Withdrawn Objections / Rejections
In view of the Terminal Disclaimer and the approval thereof, the double patenting rejection over Application No. 18/917,985 is withdrawn.
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 9, 2026 was considered.
Maintained Grounds of Rejection: 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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, 37, 89, 91, 94-98, 101, 102, 105-110, 112 and 114-118 are rejected under 35 U.S.C. 103 as being unpatentable over Barrows et al. (US 5,583,114, published December 10, 1996, IDS reference filed May 3, 2022) in view of Bordoloi et al. (US 2012/0288530, published November 15, 2012, of record) and Fortune et al. (US 2009/0018575, published January 15, 2009, of record).
Barrows teaches an adhesive sealant composition formed from a two component mixture which includes a first part of a protein, preferably a serum albumin protein, in an aqueous buffer (crosslinking initiator) having a pH in the range of about 8.0 to 11.0 and a second part of a water-compatible or water-soluble bifunctional crosslinking agent of the formula G – LM – PEG – LM – G wherein LM is a fragment and G is a leaving group inclusive of succinimidyl; when the two parts are combined the mixture cures in vivo in less than about 1 minute forming a composition which bonds to the tissue (crosslinks directly to the wound) (title; abstract; claims; column 5, lines 32-52; Example 7), as required by instant claims 89, 91, 116, 118. The serum albumin is human serum albumin (claim 3), as required by instant claims 94, 95, 106, 107. The buffer is a carbonate / bicarbonate buffer (claim 4), as required by instant claims 96, 97, 108-110. The crosslinking agent is preferably a polyethylene glycol disuccinimidoyl succinate (claims 1, 7, 8; column 2, lines 16-25; Example 1), as required by instant claims 37, 91, 98, 117 and the elected embodiment. The mixed tissue sealant forms a hydrogel (Example 11).
Barrows does not teach the composition is a dry powder as required by claims 1, 37, 89, 91 and 105.
Barrows does not teach the composition is a dry powder or the protein consists essentially of particles (meaning that greater than or equal to 80 wt% of the particles fall within the stated range as defined at page 25, lines 22-24 of the instant specification) have a size of 50 to 500 microns as required by claims 115 and 117.
Barrows does not teach the composition comprises a first dry powder and a second dry powder as required by claim 101.
Barrows does not teach the first dry powder comprises the first component and the second dry powder comprises the second component as required by claim 102.
Barrows does not teach the protein consists essentially of particles (meaning that greater than or equal to 80 wt% of the particles fall within the stated range as defined at page 25, lines 22-24 of the instant specification) have a size of 50 to 500 microns as required by claims 112 and 114.
These deficiencies are made up for in the teachings of Bordoloi and Fortune.
Bordoloi teaches compositions comprising a nucleophilic plasma protein inclusive of albumin and a cross-linking agent comprising a di-acid linker (LM) on which a water soluble core such as polyethylene glycol (PEG, X) and an electrophile such as N-hydroxy succinimide (G, N-oxysuccinimidyl) are attached (title; abstract; claims, in particular 1, 6-9, 11; paragraphs [0001]-[0113], in particular [0001], [0039], [0053]-[0060]; Figures, in particular 1, 3). The compositions may be in the form of a dry powder form prior to contact with moisture or with a tissue (claim 8; paragraphs [0028], [0037]). Degradation in DI water can be titrated by addition of a basic compound to maintain a constant pH of 7.4 (paragraphs [0086]-[0087], [0113]). Bordoloi further discloses it is known to the prior art to mix electrophilic materials and nucleophilic materials in the presence of a buffer in order to maintain a pH within the reaction range (paragraph [0009]).
Fortune teaches compositions comprising particulate material having tissue-reactive functional groups in admixture with a particulate buffer material (title; abstract; claims, in particular 1, 4, 7-9; paragraphs [0001]-[0169], in particular [0074]-[0077]). The effect of the buffer is to enhance the reaction between the tissue-reactive material (which is an electrophile) with tissue (which is a nucleophile) (paragraph [0074]). Thus, the formulation is buffered when hydrated (paragraph [0075]). The particles that make up the formulation have a wide range of particle sizes, however, the median particle size may range from 5 to 500 microns, preferably 5 to 250 microns (paragraph [0046]), as required by instant claims 112, 114-118.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive sealant composition of Barrows to be in the form of a dry powder as taught by Bordoloi and by Fortune comprising a dry powder of the first component comprising a dry powder of a protein, preferably albumin and a dry powder of a buffer and comprising a dry powder of the second component comprising an agent of formula G – LM – PEG – LM – G, preferably polyethylene glycol disuccinimidoyl succinate for the convenience thereof, e.g., eliminates the weight and volume of the water needed to transport, to store, etc. There would be a reasonable expectation of success because Bordoloi and Fortune evidence such dry powder forms are routine and conventional in the art.
Regarding the wherein clause of claims 1 and 37 drawn to the “selection” of an amount of the crosslinking initiator to create a pH greater than or equal to 7 at a bleeding / wound site, Barrows expressly teaches inclusion of a buffer (crosslinking initiator) to achieve a pH in the range of about 8.0 to 11.0. Additionally or/and alternatively, Fortune teaches those skilled in the art recognize the reaction between electrophilic and nucleophilic compounds – such as those disclosed by Barrows – more favorably proceeds when the pH is adjusted above 7 (e.g., paragraphs [0074]-[0077]). Thus, it would have been obvious to those skilled in the art to “select” the dry powder buffer of the dry powder adhesive sealant composition of Barrows in view of Bordoloi and Fortune to generate a pH above 7 during crosslinking in vivo in order to accelerate the crosslinking reaction.
Regarding the wherein clause of claims 1 and 37 drawn to crosslinking in less than or equal to 100 seconds, Barrows expressly teaches the reactants as instantly claimed cure in vivo in less than about 1 minute and Barrows expressly teaches the product is a hydrogel.
Regarding the wherein clause of new claims 115 and 117 drawn to results upon application, Bordoloi evidences contact of a dry powder adhesive sealant reacts upon exposure to moisture in the application setting (e.g., paragraph [0028]) as is already expected from Barrows (e.g., the two parts cure when combined).
Regarding the limitation of new claims 112, 114, 115, 117 drawn to the protein particle size, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dry powder adhesive sealant composition of Barrows in view of Bordoloi and Fortune to have particles inclusive of protein / albumin particles ranging from 5 to 500 microns as taught by Fortune because particles of this size are suitable for tissue-reactive powders. In 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). See MPEP 2144.05.
Regarding the wherein clause of new claims 116 and 118 drawn to the “selection” of an amount of protein to achieve desired results upon application inclusive of crosslinking in less than or equal to 100 seconds, Barrows expressly teaches inclusion of proteins in an amount (e.g., claim 1) sufficient to cure in vivo with the crosslinking agent in less than about 1 minute forming a composition which bonds to the tissue (crosslinks directly to the wound) (e.g., abstract).
Claims 103 and 104 are rejected under 35 U.S.C. 103 as being unpatentable over Barrows et al. (US 5,583,114, published December 10, 1996, IDS reference filed May 3, 2022) in view of Bordoloi et al. (US 2012/0288530, published November 15, 2012, of record) and Fortune et al. (US 2009/0018575, published January 15, 2009, of record) as applied to claims 1, 37, 89, 91, 94-98, 101, 102, 105-110, 112 and 114-118 above, and further in view of Hendrich et al. (US 2016/0136235, published May 19, 2016, of record).
The teachings of Barrows, Bordoloi and Fortune have been described supra.
Barrows further teaches the first part comprises about 20 to 60 wt/vol% protein, the second part comprises about 50 to 800 mg/mL (about 5 to 80 wt%) bifunctional crosslinking agent, and the volume ratio of the first part to the second part is about 1:10 to about 10:1, preferably about 1:1 (claims 1, 2, 5, 6; column 2, lines 16-25).
Fortune further teaches the ratio by weight of tissue-reactive material to buffer is between 90:10 and 99:1 (claim 3).
They do not specifically teach 15 to 40 wt% of the first dry powder as required by claim 103.
They do not specifically teach 20 to 60 wt% of the second dry powder as required by claim 104.
These deficiencies are made up for in the teachings of Hendrich.
Hendrich teaches a method for producing a hemostatic composition in mixed dry form comprising placing an amount of hemostatic biocompatible polymer inclusive of albumin in dry form into a container and subsequently placing in the container an amount of hydrophilic crosslinker comprising electrophilic reactive groups (title; abstract; claims, in particular 1; paragraphs [0018], [0020], [0021]). The polymer / albumin and the crosslinker / electrophile are present in mixed dry form in a ratio from 0.1 to 50 wt% (claims 5, 6; paragraph [0051]; Example 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dry powder adhesive sealant composition of Barrows in view of Bordoloi and Fortune to comprise from 1 to 10 wt% buffer as taught by Fortune and to split the remaining 99 to 90 wt% of the composition comprising dry powder of a protein, preferably albumin, and the dry powder of the crosslinking agent, preferably a polyethylene glycol disuccinimidoyl succinate, in a ratio of from 0.1 to 50 wt% as taught by Hendrich because this ratio is suitable for blending dry albumin with dry crosslinker. There would be a reasonable expectation of success because these amounts are consonant with the amounts embraced by Barrows.
Claims 111, 113 and 115-118 are rejected under 35 U.S.C. 103 as being unpatentable over Barrows et al. (US 5,583,114, published December 10, 1996, IDS reference filed May 3, 2022) in view of Bordoloi et al. (US 2012/0288530, published November 15, 2012, of record) and Fortune et al. (US 2009/0018575, published January 15, 2009, of record) as applied to claims 1, 37, 89, 91, 94-98, 101, 102, 105-110, 112 and 114-118 above, and further in view of Wang et al. (US 2013/0316974, published November 28, 2013, of record).
Wang is applied herewith on the optional / alternative embodiment of claims 115-118 in the interest of compact prosecution
The teachings of Barrows, Bordoloi and Fortune have been described supra.
They do not teach the protein comprises particles having a tapped density greater than or equal to 0.30 g/mL as required by claims 111 and 114 and as optionally / alternatively required by claims 115-118.
This deficiency is made up for in the teachings of Wang.
Wang teaches oxidized regenerated cellulose hemostatic powders having a tapped density of at least 0.45 g/cm3 (title; abstract; claims, in particular 1, 7, 9, 10). Tapped density is a measure of increased bulk density of powder obtained by mechanical tapping (paragraph [0034]). Tapped density appears to be correlated with flowability; high flowability and high tapped density is preferred in a surgical setting for ease of deployment (paragraph [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dry powder adhesive sealant composition of Barrows in view of Bordoloi and Fortune to have particles inclusive of protein / albumin particles characterized by a tapped density of at least 0.45 g/cm3 as taught by Wang because this tapped density correlates with high flowability of hemostatic powders and is preferred in a surgical setting for ease of deployment.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant’s summary of the Applicant-initiated interview at pages 11-13 of the Remarks is acknowledged.
Applicant’s commentary on the Interview Summary at pages 13-14 of the Remarks is acknowledged. The Examiner maintains that the Interview Summary, while terse, is accurate.
Applicant’s statements regarding the disappearance and reappearance of select claims at page 14 of the Remarks is acknowledged. Applicant has already been referred to MPEP 608.01(j) for information regarding claim numbering.
Applicant’s allegation at pages 15-16 that all claim limitations must be given patentable weight is acknowledged. Applicant’s allegation is incorrect. MPEP 2143.03, as cited by Applicant, states all claim limitations must be considered. MPEP 2143.03, as cited by Applicant, expressly references types of claim language that “may raise a question as to its limiting effect”. MPEP 2111.04, as cited by Applicant, also does not support Applicant’s allegation. All claim limitations have been considered and have been appropriately addressed on the written, public record. The disputed wherein clause has been addressed throughout the narrative of the rejection of record, has been specifically addressed in the rejection of record at pages 7-8, and has been reproduced infra for the convenience of the public. As such, the disputed limitations have not been “improperly ignored” as asserted by Applicant and the rejection of record complies with legal precedent and establishes prima facie obviousness.
Applicant’s presumption of non-enablement at page 16 is acknowledged. Applicant’s representative, during the interview, raised the issue of non-enablement of the claims. As an enablement rejection has not yet been raised, Applicant’s continued commentary on this subject is moot.
Applicant’s allegation at pages 16-17 that Barrows discloses ex situ curing is unpersuasive because the entire point of Barrows is to provide an adhesive composition “to bond or seal tissue in vivo” (e.g., abstract). It is understood that the testing of Barrow is applicable to in vivo conditions. Applicant’s speculations regarding the complexity and unpredictability of powdered adhesives is unpersuasive because there is no evidence of record substantiating this allegation and because there is extensive evidence to the contrary (e.g., Bordoloi, Fortune).
Applicant’s allegation at pages 18-19 that the particle size recited in independent claim 115 is non-obvious is unpersuasive. There is no evidence of record that particles of 50 to 500 microns provide any benefit or advantage and there is extensive evidence of record that tissue sealants can be in the form of a dry powder (e.g., Bordoloi, Fortune) and that suitable sizes for particles within such a dry powder may range from 5 to 500 microns (e.g., Fortune). Applicant’s position that the particles of Fortune are not proteins is unpersuasive because it is understood from Bordoloi that the proteins therein can be in the form of a dry powder and because it is understood from Fortune what sizes constitute a powder. Applicant’s position that the claimed range of 50 to 500 microns represents a particle size distribution is unpersuasive because all that is required to render obvious a numerical range is an overlap. See MPEP 2144.05. Applicant’s position that there would be no reasonable expectation of success with respect to the adjustment of the particle size is unpersuasive because the art recognizes powders and particulates sized consistent with the range instantly claimed. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s allegation at page 20 that Hendrich fails to cure the deficiencies of the base rejection is acknowledged but not found persuasive because there are no deficiencies in the base rejection.
Applicant’s allegation at pages 20-21 that Wang fails to cure the deficiencies of the base rejection is acknowledged but not found persuasive because there are no deficiencies in the base rejection.
Applicant’s allegation at pages 21-22 that the tapped density alternatively recited in independent claim 115 is non-obvious because Wang is directed to ORC is unpersuasive. Wang is directed hemostatic powders for tissue sealing (e.g., title; paragraph [0027]). That ORC is not a protein is acknowledged, however, it is not seen how the property of a tapped density of particles depends on the organic chemistry of the particles per se. Applicant’s position that the ORC of Wang differs from the adhesive formulations of Barrows is unpersuasive because Wang expressly contemplates tissue sealants.
Therefore, the rejections of record are properly maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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