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 .
The Group and/or Art Unit location of your application in the PTO has changed. All correspondence regarding this application should be directed to Examiner Lori Mattison in Group Art Unit 1619.
Claim Status
Applicant’s declaration, claim amendments and arguments in the response filed 05 February 2025 are acknowledged.
Claims 1-4, 6,7, 9-11, 28, 31, 33 & 35 are pending.
Claims 1-4 & 11 are amended.
No claims are withdrawn.
Claims 1-4, 6,7, 9-11, 28, 31, 33 & 35 are under consideration.
Examination is to the extent of the following species:
A) Film Composition-silver microparticles, fibrin, calcium and phospholipid
B) Film Properties-elements (ii), (iv), and (v) of claim 11
C) Wound- acute wound and extended to hernia on 05 November 2025.
Declaration Filed Under § 1.132
The declaration filed on 05 February 2026 by Applicant is acknowledged. The declaration is addressed in the response to Applicant’s traverse below.
Withdrawn Rejections
The rejection of claim 11 under 35 U.S.C. 112(d) is withdrawn due to deletion of the recitation “is stable at room temperature for at least 15 months”
New & Maintained Objections/Rejections
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11, after amendment, now has two periods.
Applicant may wish to consider whether deleting the second period would obviate the objection.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 4 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 4 depends from claim 1. Claim 1 recites “silver microparticles larger than 5 µm”. Claim 4 expands the lower limit for the microparticle size by reciting the silver microparticles “have a mean diameter ranging from 5 µm…” permitting sizes of 5 µm (i.e. less than “larger than 5 µm”) and even permitting sizes less than 5 µm for some particles, since it is a mean diameter, as long as there are a sufficient amount of larger particles to balance the mathematical equation to 5 µm.
Applicant 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.
Claim(s) 1-4, 6, 9-11, 28, 31, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel Grant Ericson (hereafter Ericson WO2017/210267; previously cited) in view of Hobart W. Harris (hereafter Harris-United States Patent Publication 2015/0030678; previously cited).
Ericson teaches plasma based films which comprise calcium and fibrin polymers, see page 6,8,11-12 and claims 1 and 27. The plasma comprises blood plasma, see claim 18 and pages 5-7,12 and 14. Because the thrombin is in alternative to calcium (i.e. addition of thrombin and/or calcium), thrombin is considered an optional component and does not need to be added, see page 6 and claim 1. This meets the limitation of less than 0.01 IU because zero thrombin can be present is it is not required and is in the alternative to calcium. The film provides mechanical stability, see pages 3, 5,8,9,11-12 and 14. The composition can further contain phospholipids, see page 13 and claim 7.
The film has a burst pressure of from 50 to 1000 mm Hg, see pages 2, 6,11-12,15 and 23. An adhesive backing can be applied to provide additional adhesion, see pages 12 and 23. The film has a thickness from 0.005-1mm, see claim 18 and 32 and 41, and pages 2,6,11,12,14-15. However, the thickness and strength of the membrane correspond to the amount of pressure placed on the top plate and the amount of plasma applied (see page 15). Accordingly, it would have been obvious to adjust the desired thickness based on the pressure applied when making the film. The film can be sterile, see claim 38 and page 12. The film composition can further contain silver as an anti-infective, see pages 9, 14 and claim 17. The at least one pharmaceutically active agent inclusive of silver can be present up to 5% w/w, see page 5. The degree of cross-linking of fibrin polymers can influence the desired release of active agents within the film, see page 11 and claim 26. Thus, it would have been obvious to adjust the amount of fibrin crosslinking to tailor the desired release amount of silver from the film upon application to a subject. The active agents inclusive of silver can be applied to the surface of the film, see pages 3, 9-10, and 14. The composition is useful for wounds or hernia repair, see pages 1-5,7,9,11,15 and claim 49 and entire document.
Ericson does not teach that the silver anti-infective is silver microparticles present at a concentration from 1-50 mg silver/cm2 film or at a concentration of 2.5-25 mg/cm2 film wherein the silver microparticles have a mean diameter from 5-1000 microns.
However, Harris teaches treating wounds with a composition comprising 10mg/ml or 25mg/ml or more of silver microparticles, see paragraph [0004], [0038] and [0042] and [0049]. The composition reduces the risk of undesired side effects of wounds including hernias, see paragraphs [0037]-[0039], [0060], [0073]. The silver microparticles are combined with fibrin, see paragraph [0025], [00074] and entire document. The composition treats wounds and hernia conditions, see paragraphs [0003],[0025], [0037]-[0039], [0047], [0075], [0095]–[0098], claims 1-5, and entire document. The silver particles are applied in a surface area such as 1cm2, thus are inclusive of 10mg/1cm2 amounts, see paragraphs [0044] and [0051]. The microparticles have an average diameter from 2 to 1000 microns, see paragraph [0047]. It would have been prima facie obvious to substitute the silver of Erickson for silver microparticles in amounts from 10-25mg/ml per cm2 of fibrin film. One of ordinary skill in the art would have been motivated to do so because silver microparticles with fibrin are taught by Harris to be effective in the treatment and promoting healing of wounds including reducing the risk of incisional hernia.
There would have been a reasonable expectation of success because the fibrin films of Ericson are taught to contain silver on the surface of fibrin films and both Ericson and Harris teach healing of wounds including hernia.
Since Ericson teaches dried films with virally inactivated plasma using Octapharma plasma mixed with CaCl2, where the active agents including silver can be applied to the film surface, the film is interpreted as being storage stable due to being in the dried state and utilizing the same films as the instantly claimed invention (see paragraphs [0208] and [00229] of the instant specification). Furthermore, the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Daniel Grant Ericson (hereafter Ericson WO2017/210267; previously cited) in view of Hobart W. Harris (hereafter Harris-United States Patent Publication 2015/0030678; previously cited) as applied to all claims above, and further in view of Bjork et al. (United States patent Publication 2016/0143786; previously cited).
The teachings of the modified Erickson are discussed above.
The modified Ericson does not teach that the fibrin is present from 0.5-20mg/cm2 of film.
However, Bjork et al. teach that fibrin can be added from 0.2-20 mg/cm2 to achieve the desired promotion of wound re-epithelization, see paragraph [00295-[0029], [0038] Figures 1-3, and entire document. 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).
It would have been prima facie obvious to provide the fibrin of Ericson at 0.2-20mg/cm2.
One of ordinary skill in the art would have been motivated to do so because Bjork teaches that in this range would re-epithelization can occur.
There would have been a reasonable expectation of success as Ericson teaches the use of fibrin for wound healing.
Response to Arguments
In the traverse of claims 1-4, 6-7, 9-11, 28, 31, 33, and 35 under 35 U.S.C. 103 over Ericson in view Harris, Applicant argues the references individually (reply, pg. 4-7).
This is not persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues Ericson does not teach or disclose the use of silver microparticles in a film, only that Ericson discloses silver in a list of over 25 potential pharmaceutically-active agents that may be present on a plasma-based film (reply, pg. 5). Applicant argues Ericson does not provide a particular motivation or reason for a person in the art to select silver, and the selection of silver would not necessarily mean silver microparticles (reply, pg. 5-6).
This is not persuasive. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 550 U.S. .....82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at __, 82 USPQ2d at 1396. In the instant case, Ericson teaches the suitability of silver for use in a film for hernia repair. An exemplary rationale for obviousness set forth by The Supreme Court is that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. In the instant case both Ericson and Harris are in the same field of using silver for hernia repair. It would be obvious to use Harris’s silver microparticles in Ericson’s film because they are both useful together for hernia repair.
Applicant argues Ericson does not teach or disclose the requirement that the silver particles be larger than 5 µm (reply, pg. 6).
This is not persuasive. Harris teaches microparticles used in hernia repair have an average diameter from 2 to 1000 microns ([0047]). This overlaps with the claimed range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916). In the instant case, Applicant has not provided such a showing.
Applicant argues Harris does not cure Ericson’s deficiencies because Harris discusses using silver microparticles applied with a pharmaceutical liquid composition comprising fibrinogen and thrombin (reply, pg. 6). Applicant argues the liquid is less convenient than their dried films (reply, pg. 6).
This is not persuasive. With regard to the argument that liquid compositions are less convenient than dried films, this is not germane to the rejection. The rejection is not directed to a liquid composition. Ericson teaches a dry film which may comprise silver used in hernia repair. Harris is used to teach silver microparticles having an average diameter from 2 to 1000 microns is used in hernia repair. An exemplary rationale for obviousness set forth by The Supreme Court is that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. In the instant case both Ericson and Harris are in the same field of using silver for hernia repair.
Applicant argues secondary considerations rebut any prima facie case of obviousness (reply, pg. 6). Applicant argues the combined teachings of Ericson and Harris do not recognize that the Example 11 dried films were effective in healing the wounds of diabetic mice (reply, pg. 7).
This is not persuasive. Applicant is arguing an invention not examined (i.e. a method of use). The invention under examination is a composition (i.e. dried film).
Applicant compares the performance in healing between a liquid fibrin sealant and the Example 11 dried films (reply, pg. 7). Applicant presents the unexpected finding that planar fibrin is as effective as liquid fibrin in healing wounds (i.e. the AUC of the wounds; reply, pg. 8). This is surprising because “the hydration state and tertiary structure of fibrin in the plasma film is significantly altered due to the drying and compression during production when compared to the structure of fibrin in liquid form. A complex fibrous protein like fibrin would not be expected to maintain its biological potency and effects on wound healing after such physiochemical changes (reply, pg. 8-9).
This is not persuasive. Ericson explicitly teaches fibrin films for hernia repair (i.e. wound repair) so it is not surprising that the film functions to heal wounds. They are operating as intended. With regard to the fibrin film healing as well as the liquid fibrin, this is not persuasive. Applicant did not perform statistical tests to detect whether there was a difference between the three treatment groups (i.e. two fibrin film groups versus the liquid fibrin group).
Applicant argues they have provided experimental evidence to compare films without silver microparticles to films comprising silver microparticles as shown in Exhibit 1-Comparative Data of the declaration (reply, pg. 11; Declaration-pg. 4 & 5-Table 4). Applicant argues that the plasma film + silver microparticles is superior in promoting diabetic closure compared to plasma film alone (reply, pg. 10; Declaration-pg. 2, 4 & 5-Table 4).
This is not persuasive. While it is acknowledged that films comprising silver microparticles have a lower ulceration area and an improved healing trajectory and long term follow up, Applicant did not compare their claimed invention to that of the closest prior art which is Ericson’s film comprising silver as taught by Ericson. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential).
Declarant argues the plasma + silver film was composed of silver microparticles at a concentration of 25 mg/cm2 and a size of 15 µm (Declaration, pg. 2).
The declaration is not persuasive because it is not commensurate with the scope of the claims. All claim 1 requires is that the silver microparticles be larger than 5 µm but Declarant only evaluated a size of 15 µm (Declaration-pg. 2). The recited film of claim 1 is allowed to have some thrombin in it, “about 0.01 International Unit (IU) or less of thrombin per cm2 of film”, but Declarant only evaluated a thrombin free film (Declaration-pg. 2). Claim 1 does not recite a concentration for the fibrin, however Declarant’s film comprises 4 mg/cm2 (Declaration-pg. 2).. "[O]bjective 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).
Conclusion
No claims are allowed.
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 LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David J Blanchard can be reached at 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LORI K MATTISON/Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619