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 .
Response to Amendment
The Amendment filed 08/05/2026 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 05/06/2026. Applicant’s claims have been amended in the following manner: independent claims 1, 10, and 16 have been narrowed by inclusion of “rolling a hemostatic patch into a delivery configuration”, which is moved to these claims from the previous claim 3. Because the “rolling a hemostatic patch into a delivery configuration” was addressed in the previous Office Action by the Medtronic reference, the same ground of rejection is maintained over Fortier and Medtronic (with the minor edits related to claim numbering and providing additional detail in response to specific arguments). Furthermore, not all 112(b) issues were successfully addressed, and therefore the 112(b) section has been modified.
The following objections/rejections are withdrawn: none.
The Examiner further acknowledges the following:
Claims 1-20 are pending.
Claims 1-20 are presented for examination and rejected as set forth below.
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 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3-4 and 9 recite the term “about” and “approximate”, which are not precisely defined in the Specification. For example, at [0032] of the Specification, Applicant writes: “As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable tolerance. More specifically, “about” or “approximately” can refer to the range of values ±20% of the recited value, e.g. “about 90%” can refer to the range of values from 71% to 99%.” Therefore, the term “about” or “approximately”, when used in the manner defined by the Specification, will represent a very wide (and optional) range that makes precise definition of numerical values or even objects (i.e., “about a bleeding site of an organ of a subject” in claim 1) unacceptably vague. Furthermore, narrow and broad ranges are implied by the definition of these terms by the Specification, which is indefinite (see MPEP 2173.05(c)). The Examiner recommends removing every instant of “about” or “approximately” in the claim set, and will examine the claims on this premise.
Claim 9 recites “dihydroxy-phenyl” which is indefinite, because it does not appear to represent a single compound species and/or genus of compounds (as recognized by the Art). While the Specification names suitable examples of “dihydroxy-phenyl derivatives” at [0070], the term is written in a way, whereby the amount of derivatization that may occur upon the “dihydroxyl-phenyl” moiety is unknown and thus, the metes and bounds of the term cannot be determined. Thus, it is unclear how far one can deviate from the listed parent compounds (i.e., the term “derivative” itself does not provide structure) and yet still remain within the metes and bounds of the invention claimed.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fortier (US20110313450A1), and in further view of Medtronic (Veriset Haemostatic Patch, 2016).
Applicant’s claims are directed to a method for treating hemorrhage, based on applying a hemostatic patch comprising (including rolling the patch into a delivery configuration), a fibrous carrier structure, an electrophilic polymer carrying reactive electrophilic groups, and a nucleophilic cross-linking agent that contains nucleophilic groups.
Although the terms discussed below are given the BRI during examination, to understand terms of the claim set, the Examiner looks to the Specification for specific examples of the materials (i.e., “fibrous carrier structure” [0073-0076, 0089], “reactive polymer particles” [0068], “electrophilic polymer” [0068], “nucleophilic cross-linking agent” found at [0079, 0081]) and nucleophilic (e.g., gelatin, collagen, chitosan, etc. with nucleophilic amines, thiols, etc. [0087-0088]) and electrophilic (e.g., carboxylic acid esters, sulfonate esters, etc.[0068-0069], instant claim 9) functional groups to direct the Examiner’s attention to the meaning being the instant genii of the claims. Furthermore, Fig 2A (Hemostatic Patch 200) and Fig 2B/2C of the Specification/Drawings show examples of nucleophilic amines and electrophilic NHS-ester side chains [0050-0051]. Furthermore, Applicant defines “interstitial space” as empty space that is inherent to a fibrous carrier structure in the Specification [0040]. Thus, when a reference teaches a fibrous carrier, the interstitial space is an inherent feature of the carrier (whether it is explicitly stated by the reference or not).
Fortier teaches a hemostatic patch related to the transformation of precursor solutions into solids within the patient’s body [0001-0002], whereby the benefit is an implantable device capable of adhering and providing hemostatic therapy to physiological structures to which a solid device may not easily adhere. The structural attributes of the hemostatic patch may vary [0047], and a method of use is described [0048-0049]. Additionally, Fortier depicts a bending/rolling/folding of the material in Figures 3-4, demonstrating that the material is not completely stiff [0026-0028].
Regarding claims 1-2 and 5-20: Fortier teaches a method whereby a hemostatic patch is applied (reads on delivered) to a bleeding area [0020], in dry form (as first and second hydrogel precursors that react to form biocompatible cross-linked materials that provide hemostatic effect and also adhere to the site [0032]) and is activated by the presence of aqueous physiological fluids so that in situ hemostatic therapy occurs at the site of implantation [0019-0020] (i.e., similarly to Applicant’s advantageous description in the Specification [0059, 0066]).
Fortier teaches hemostasis occurs within less than 2 minutes [0047-0049]. Fortier teaches the patch may be capable of transport in a laparoscopic deployment device [0047] (reads on “minimally invasive procedure” of claim 1, because Applicant defines laparoscopic procedures, as minimally invasive in the Specification @ [0054, 0163]).
Compositionally, Fortier also teaches a hemostatic patch, comprising a fibrous carrier (reads on “fibrous carrier structure” of claim 1, whereby a fibrous carrier inherently has “interstitial space”, which is also visualized by the patch with porous/fabric like material in Figure 9 [0031]), including natural materials and various synthetic polymers, such as PL, PG, PVP, biopolymers, etc. [0035-0038]. Fortier teaches the first and second hydrogel precursors are composed of suitable polymers such as PEG, PEO, PPO, dextran, alginates, etc. [0041-0042], that can be modified with functional groups that are nucleophilic (i.e. hydroxyl, amine, etc.; i.e., see also comparison to instant Fig 2B/2C) and electrophilic (N-hydroxysuccinimides (i.e., NHS esters), which also reads on “succinimidyl esters” of instant claim 9, and thus reads on the general electrophilic polymer/groups of claims 1-2.; i.e., see also comparison to instant Fig 2B/2C) [0041-0042], including additional examples and references for nucleophiles and electrophiles typical of this strategy (inclusive of multifunctional polymers, multi-arm PEGs, etc.) [0045-0046]. Thus, Fortier teaches the reaction of the first hydrogel precursor and second hydrogel precursor to form cross-linked polymeric products (i.e., reads on “formation of covalent bond” in instant claim 2, for example, when an amine reacts with an NHS ester) [0045]. Furthermore, Fortier teaches the obviousness of either the first or second hydrogel precursor (i.e., the use of first or second is arbitrary within the general teachings [0040-0041]) in the form of reactive particles (reads on “plurality of reactive particles” of instant claim 2) [0031].
With regard to the amount of claim 12: Fortier teaches that the first or second hydrogel precursors can be applied to the substate (i.e., the substate can be porous/non-porous foam or fiber ([0033, 0047], Fortier – claim 7 and 8), reading on 3D interconnected interstitial space) in any concentration. With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)). Thus, the instant amount at least 3 wt% is obvious. The relative amount of reactive ingredient is additionally visually demonstrated in Figure 9 of Fortier, for example [0031, 0041-0043].
Regarding claims 3-4: Fortier teaches a method to repair blood vessels, including suturing or stapling [0027-0028]. Note that the fibers can be made using biodegradable polymeric material, as listed in [0035-0038].
In summary, Fortier teaches a method for delivering a hemostatic patch comprising a fibrous carrier, nucleophilic, and electrophilic components that activates on contact with physiological liquid to provide a hemostatic and adhesive effect. Fortier is silent on the use of a trocar and applying pressure; however, Fortier teaches the patch may be capable of transport in a laparoscopic deployment device [0047]. Thus, Fortier does not teach a method involving a trocar with a diameter of 8-16 mm, including rolling the patch into a delivery configuration (instant claims 1, 4, 10, and 16), and applying pressure to the patch (instant claims 3, 10-11, and 16).
Medtronic teaches standard methodology of application for a hemostatic patch, that is usable in open and laparoscopic procedures (pg 1), including unpackaging, rolling the patch (i.e., the rolling of step 3 is prior to the trocar delivery of step 4), delivery through a trocar (10 mm – 12 mm) (reads on instant claims 1, 4, 10, and 16), unrolling the patch, applying pressure (reads on instant claims 3, 10-11, and 16) (pg 2). As a demonstration of typical results, Medtronic teaches these patches to achieve hemostasis in 1 minute by holding for 30 seconds, and they can be used for arterial bleeding (pg 1). Medtronic also teaches the patch to absorb (i.e., biodegrade) after 28 days. Furthermore, saline can be used to hydrate dry portions of the patch (i.e., also suggesting that a wetting step is advantageous in patch application) with applying pressure for adherence.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Fortier to incorporate a rolling the patch, delivery through trocar, and application pressure, as taught by Medtronic, because Medtronic teaches these techniques as typical of the hemostatic patch Art to achieve hemostasis in 1 minute by holding for 30 seconds, and these techniques are used for arterial bleeding (pg 1). Furthermore, Fortier generally teaches that upon application of the patch “to a site of bleeding tissue, the hemostatic patch may affect hemostasis of said tissue” [0048], and the patch may be capable of transport in a laparoscopic deployment device [0047]. Thus, the implementation of Medtronic’s trocar method (that is usable in open and laparoscopic procedures (pg 1)), using the hemostatic patches described by Fortier that are applicable to laparoscopic procedures, is prima facie obvious. Additionally, Fortier depicts a bending/rolling/folding of the material in Figures 3-4, demonstrating that the material is not completely stiff [0026-0028].
Finally, with regard to the method outcomes (i.e., discussed in the claim interpretation section above), when the combined Prior Art (especially, Fortier) teaches a method of hemostasis, incorporating the materials and procedures discussed above (e.g., degradable polymers and functional groups such as NHS esters, chitosan, etc. [0041-0042], and hemostasis occurs within less than 2 minutes [0047-0049]), that are similar to the instant Application, then the results of Fortier’s method and the instant method of hemostasis are expected to be similar. Furthermore, Medtronic teaches hemostatic patch procedures, proprieties, and expectations, that are typical of the Art for trocar-based deliveries.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Medtronic (Veriset Haemostatic Patch, 2016):
claims 1-20 of copending Application No. 18431485 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets teach a method for treating hemorrhage with a hemostatic patch comprising a carrier structure, an electrophilic polymer, and a nucleophilic agent. The copending application differs only significantly by not including delivery of the patch via a trocar, as found in the instant application.
This is remedied by Medtronic, who teaches standard methodology of application for a hemostatic patch (point #4, pg 2, and pg 3). Medtronic teaches use of a trocar to deliver a hemostatic patch to the bleeding site, as typical of the art (pg 2), including unpackaging, rolling the patch, and delivery through a trocar (10 mm – 12 mm). One of ordinary skill in the art would have been motivated to modify the teachings of copending application ‘485, because trocar delivery of hemostatic patches is typical of the art, to achieve hemostasis in 1 minute by holding for 30 seconds, and for arterial bleeding (pg 1). Thus, it would be obvious to select this method to safely and effectively deliver a hemostatic patch into a human body to achieve hemostasis during a bleeding event.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments, see pg 10-13, filed 08/05/2026, with respect to the 103 rejection of claims 1-20 under rejection have been fully considered but they are not persuasive. The 103 maintains the same ground of rejection, because the Medtronic reference already teaches the obviousness of the amended limitation of “rolling a hemostatic patch into a delivery configuration.”
On page 10, Applicant argues against the 112(b) rejection of ‘about’ and ‘approximate’ by reciting the Application definition: “More specifically, “about” or “approximately” can refer to the range of values ±20% of the recited value, e.g. “about 90%” can refer to the range of values from 71% to 99%.” Note that “can” and “e.g.” (for example) is exemplary language that is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d). For examination purposes, the examples provided by the exemplary language are not considered limitations of the claim, and the broadest reasonable interpretation is used, and the 112(b) rejection is maintained.
Furthermore, deletion of “derivatives” provides “dihydroxy-diphenyl” in which, the term by itself, is not a known species or genus of the Art, and appears to still attempt to claim the previous “dihydroxy-diphenyl derivatives” scope by implication, and is therefore still indefinite.
On page 11-12, Applicant argues against Fortier alone, especially arguing Fortier does not teach rolling of the patch, and minimally invasive use only finds support via a “single, non-enabling sentence” regarding laparoscopic deployment (i.e., without providing any evidence supporting this argument). "[A] prior art publication cited by an Examiner is presumptively enabling barring any showing to the contrary by a patent applicant." In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). In this case, Fortier explicitly teaches laparoscopic deployment. Furthermore, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Thus, Medtronic teaches the rolling of hemostatic patches for minimally-invasive trocar delivery, and Fortier teaches the patches that are capable of transport in a laparoscopic deployment device [0047] (reads on “minimally invasive procedure” of claim 1, because Applicant defines laparoscopic procedures, as minimally invasive in the Specification @ [0054, 0163]). In this case, Medtronic provides the obvious configuration of adapting Fortier’s compositions, including the ingredients that make up Fortier’s compositions, into a rollable one. Additionally, Fortier depicts a bending/rolling/folding of the material in Figures 3-4, demonstrating that the material is not completely stiff [0026-0028]. Finally, no objective evidence has been presented to invalidate this rationale behind the modification of the 103 rejection.
On pg 12, Applicant argues that rolling the electrophilic and nucleophilic faces of Fortier’s patch to contact each other by rolling would cause premature cross-linking (i.e., which would be in the absence of external moisture/fluid). Applicant argues that the premature cross-linking would render the patch functionally inert before deployment. However, it is noted that this argument is made without evidence, where evidence is required. Further, note that Fortier’s patch is activated by the presence of aqueous physiological fluids so that in situ hemostatic therapy occurs at the site of implantation [0019-0020] (i.e., similarly to Applicant’s advantageous description in the Specification [0059, 0066]). Additionally, Figure 9 shows the first (112) and second hydrogel precursor (120) comingled within a single layer, ready for hemostatic use [0031-0032], whereby the first and second hydrogel precursors contain nucleophilic groups, electrophilic groups, or a combination thereof [0040-0041]. Thus, a patch composed of similar materials used by Fortier would be operable in a rolled state (i.e., without premature cross-linking), and Applicant has provided no objective evidence that proves the contrary.
On page 12, Applicant argues Medtronic does not teach rolling the patch. That is incorrect. Medtronic’s reference shows in Figure 3 on page 2 a rolling of the patch (i.e., whether Applicant observes the image as “folding” vs. “rolling” is a semantic argument, because sequential “folds” in the same orientation becomes a “roll”), and additionally, the Medtronic reference verbally states “roll the patch” twice (pg 2, step 3), prior to inserting the rolled patch through a trocar (pg 2, step 4).
Upon a second look at the uploaded NPL document (filed 05/06/2026), the Examiner observes a poorly resolved pdf copy (i.e., this is unfortunately a consistent issue with the office’s software uploads), whereby Applicant may have misread the “roll” as “fold” due to the poor resolution of the uploaded copy. The Examiner will e-mail a high-quality copy of the Medtronic reference to the Applicant.
On page 12, Applicant would like to hold the double patenting rejection in abeyance until later in prosecution. This is acceptable.
On page 12, Applicant concludes. The claims scope remains under obviousness rejection.
Correspondence
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 extension fee 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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/R.P./Examiner, Art Unit 1614 9/3/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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