DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Preliminary Amendment filed 20 November 2024, Applicant cancelled claims 1-75 and added ten new claims, i.e., claims 76-85. Accordingly, claims 76-85 are pending.
Claim Rejections - 35 U.S.C. 112(a)
The following is a quotation of 35 U.S.C. 112(a):
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 76-81 and 83-85 are rejected under 35 U.S.C. 112(a) for lack of enablement.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States v. Telectronics, 8 USPQ2d 1217 (Fed. Cir. 1988)). MPEP § 2164.01. Whether undue experimentation is needed is not based upon a single factor but rather is a conclusion reached by weighing many factors. MPEP § 2164.01(a). These factors were outlined in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988) and include the following: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of any working examples; and (8) the quantity of experimentation necessary needed to practice the claimed invention based on the content of the disclosure. MPEP § 2164.01(a).
There is no requirement in claims 76-81 and 83-85 that the composition comprises a photoinitiator. Applicant’s specification does not reasonably provide enablement for activating (crosslinking), using visible or UV light, a methacryloyl-substituted gelatin without a photoinitiator. In sum, a person having ordinary skill in the art could not practice Applicant’s invention, as recited in claims 76-81 and 83-85, without first engaging in undue experimentation.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 76-85 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Regarding claim 76, the order of the steps implied by the claim is confusing. The methacryloyl-substituted gelatin of step (a) is already “light activated” at the time of application to the soft tissue and (more importantly) prior to step (b), which concerns exposure to light. Additionally, the claim appears to conflict with the specification, which disclose that exposure to light activates (i.e., crosslinks) the methacryloyl-substituted gelatin. This renders claim 76 and all claims depending thereon indefinite.
Regarding claim 77, what is “highly stressed elastic tissue”? Persons having ordinary skill in the art can reasonably disagree over which tissues qualify as highly stressed elastic tissues and, conversely, which do not. MPEP § 2173.04 (“a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim)”).
Claim Rejections - 35 U.S.C. 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 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(a) 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 76-82 are rejected under 35 U.S.C. 103 as being unpatentable over Nichol (“Cell-laden microengineered gelatin methacrylate hydrogels.” Biomaterials 31.21 (2010): 5536-5544) in view of Elvin (“A highly elastic tissue sealant based on photopolymerised gelatin.” Biomaterials 31.32 (2010): 8323-8331).
Nichol is directed to microengineered gelatin methacrylate hydrogels. Abstract.
In Figure 1 (page 5537), Nichol discloses a UV-crosslinked methacryloyl-substituted gelatin hydrogel (UV-crosslinked GelMA). See also page 5537 (Sections 2.1, 2.2 and 2.4), page 5538 (Section 2.5), and page 5543 (Section 5). The pharmaceutically acceptable carrier for the hydrogel is DPBS (Dulbecco’s phosphate buffered saline). Page 5537 (Section 2.4) and page 5538 (Section 2.5). Referring to claim 76 of the present application, the examiner notes that “UV-crosslinked” qualifies as light activated. MPEP § 2111 (claims must be given their broadest reasonable interpretation in light of the specification).
Nichol discloses that the GelMA is crosslinked by mixing it with the photoinitiator Irgacure 2959 and, thereafter, exposing the mixture to UV light for 60 seconds. Pages 5537-5538 at Sections 2.4-2.5. This is also shown in Figure 1 of Nichol (page 5537), which is reproduced below:
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The examiner notes that Irgacure 2959 is a tradename for 2-hydroxy-1-(4-(hydroxyethoxy)phenyl)-2-methyl-1-propanone, which is recited in the Markush group of claim 82 of the present application.
In Figure 2 (page 5538), Nichol discloses three exemplary crosslinked GelMAs. The second example has a degree of methacryloyl substitution of 53.8 ± .05 % (referred to therein as a “medium” degree of substitution), and the third example has a degree of methacryloyl substitution of 81.4 ± .04 % (referred to therein as a “high” degree of substitution). See also page 5538 at Section 3.1. Both those examples satisfy the corresponding range of “between 50% and 90%” recited in claim 80 of the present application. MPEP § 2131.03(I) (a specific example in the prior art that is within a claimed range anticipates the range).
Although Nichol discloses that the UV-crosslinked GelMA can be used as microtissue (Abstract), Nichol is silent as to whether it is suitable for use as a tissue adhesive. Consequently, Nichol does not satisfy claim 76 of the present application.
As explained below, the following references compensates for this deficiency: Elvin.
Elvin is directed to “a highly elastic tissue sealant based on photopolymerised gelatin.” Title.
Elvin teaches that “[g]elatin-based sealants have been suggested as suitable alternatives to bio-inspired fibrin-sealants.” Page 8323.
Elvin teaches that photochemically (UV) crosslinked gelatin “has remarkable elasticity, strong tissue adhesive properties, is thermally stable and compatible with cells and tissue in vitro and in vivo.” Page 8330; see also page 8324 (Section 2.2) and page 8326 (Section 3.1 and Figure 3).
Elvin teaches that UV-crosslinked gelatin is highly elastic (extension to break >650%) and highly adhesive (stress at break >100 kPa). Abstract; see also page 8329.
Elvin teaches that UV-crosslinked gelatin effectively sealed a wound in lung tissue from blood and air leakage, was not cytotoxic and did not produce an inflammatory response. Abstract.
Elvin concludes that the elastic properties, thermal stability, speed of curing and high tissue adhesive strength of UV-crosslinked gelatin offer considerable improvement over current surgical tissue sealants. Abstract.
Before the effective filing date of the claimed invention, the teachings of Elvin would have motivated a person having ordinary skill in the art to utilize the UV-crosslinked GelMA disclosed in Nichol as a soft tissue adhesive, which would entail — in the course of routine experimentation — administering a pharmaceutically-acceptable solution comprising the GelMA and a photoinitiator to soft tissue in need of adhesion and, thereafter, exposing the soft tissue site to light sufficient in wavelength, intensity, and duration to crosslink the GelMA. This modification of Nichol would have been made with a reasonable expectation of success, given the various positive outcomes for the UV-crosslinked gelatin sealant identified in Elvin, e.g., low cytotoxicity, no inflammatory response, and high adhesive strength. MPEP § 2144.09(I) (“rejection based on close structural similarity is founded on the expectation that compounds similar in structure will have similar properties”). Therefore, claims 76, 79-80, and 82 are prima facie obvious.
Regarding claim 77, lung tissue (Elvin) qualifies as “highly stressed elastic tissue.” Applicant is referred to MPEP § 2111 (claims must be given their broadest reasonable interpretation in light of the specification).
Regarding claim 78, the intended results recited in in this claim are not afforded patentable weight because they do not result in a manipulative difference over the prior art references (Nichol in view of Elvin), as applied above. MPEP § 2111.04(I) (a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited’”), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003)).
Regarding claim 81, Nichol discloses UV-crosslinked GelMA at concentrations of 5%, 10%, and 15% w/v. Page 5539 at Figures 3 and 4. A person having ordinary skill in the art would have been motivated to engage in experimentation that included gelatin concentrations above those disclosed in Nichol in order to increase or otherwise optimize bonding strength and/or compressive modulus. MPEP § 2144.05(II)(A) (“Generally, 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 the alternative, 15% w/v (Nichol) is close enough to 20% w/v (claim 81) to support a finding of prima facie obviousness. MPEP § 2144.05(I) (“Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”).
Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Nichol in view of Elvin, as applied above to claims 76-82, and further in view of Liebler (WO 2015/086640 A1).
This rejection is directed to silicate nanoparticles, which is recited in the Markush group of hemostatic agents set forth in claim 84. The provisional application (US 62/034,973) does not provide support for the “silicate nanoparticles” limitation. MPEP § 211.05(I)(A) (“If a claim in the nonprovisional application is not adequately supported by the written description and drawing(s) (if any) of the provisional application (as in New Railhead), that claim in the nonprovisional application is not entitled to the benefit of the filing date of the provisional application.”). With this in mind, the examiner notes that Liebler, which published on 18 June 2015, qualifies as prior art.
Nichol, as modified above by Elvin, is silent as to whether the crosslinked GelMA can further comprise silicate nanoparticles. As explained below, Liebler compensates for this deficiency.
Liebler is directed to methods for adhering tissue surfaces. Title.
Liebler teaches that silicate nanoparticles function as a tissue adhesive. Page 12, line 5; page 25, line 11; and page 66, claim 11.
Before the effective filing date of the claimed invention, the teachings of Liebler would have motivated a person having ordinary skill in the art to add silicate nanoparticles to the UV-crosslinked GelMA disclosed in Nichol (as modified above by Elvin), in an effort to yield a tissue adhesive that was even more effective in adhering tissue surfaces. Therefore, claim 83 is prima facie obvious. MPEP § 2144.06(I) (“‘It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.’”), quoting In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Nichol in view of Elvin, as applied above to claims 76-82, and further in view of Hammerslag (US 6,155,265).
Nichol, as modified above by Elvin, is silent as to whether “the method does not comprise suturing or stapling the soft tissue to be adhered or sealed” (claim 84). As explained below, Hammerslag compensates for this deficiency.
Hammerslag is directed to “[m]ethods and compositions for closing and sealing a wound, laceration, incision, or other percutaneous opening using an adhesive.” Abstract.
Hammerslag teaches: “In accordance with the present invention, a sealing medium is used to join adjacent surfaces of skin to effect closure of a wound or incision. The gel or paste sealing media used in accordance with the present invention are typically used as the primary closure modality, to replace conventional sutures or staples. The two sides to a percutaneous incision, for example, can be held together and a layer of sealing gel can be placed on the surface to span the incision.” (Emphasis added) Column 4, lines 45-53. Furthermore, Hammerslag discloses: “If the surfaces of the wound naturally pull apart, it may be advantageous to bring the two surfaces into contact with each other and align them by use of the fingers, support structure, forceps or other suitable medical instrument. In such a case, the two surfaces are preferably held together as the medium is applied and afterwards until sufficient polymerization has taken place to allow the closure to be self-supporting.” (Emphasis added) Column 13, lines 53-60.
Prior to the time of filing the present application, the teachings of Hammerslag would have motivated a person having ordinary skill in the art to bring together two surfaces of a wound that naturally pulls apart, following administration of the tissue glue disclosed in Margel, in order to achieve more comprehensive closure and repair. mmerslag compensates for this deficiency.
Before the effective filing date of the claimed invention, the teachings of Hammerslag would have motivated a person having ordinary skill in the art to bring together any soft tissue surfaces intended for adhesion/sealing that naturally pull apart, following administration of the GelMA disclosed in Nichol, in order to achieve more comprehensive closure and repair, without the need for sutures or staples. Therefore, claim 84 is prima facie obvious.
Claim 85 is rejected under 35 U.S.C. 103 as being unpatentable over Nichol in view of Elvin, as applied above to claims 76-82, and further in view of Mehdizadeh (“Design strategies and applications of tissue bioadhesives.” Macromolecular bioscience 13.3 (2013): 271-288).
Nichol, as modified above by Elvin, is silent as to whether the crosslinked GelMA can further comprise “dopamine conjugated to the gelatin” (claim 85). As explained below, Mehdizadeh compensates for this deficiency.
Mehdizadeh is directed to design strategies and applications of tissue bioadhesives. Title.
Mehdizadeh teaches that “[t]issue adhesives must effectively function in aqueous environment in order to be able to create strong adhesion to wet biological surfaces.” Section 4.2.1 at page 282.
Medhizadeh additionally teaches that dopamine, an FDA-approved compound, can be conjugated to a polymer to provide strong adhesion to wet surfaces. Section 4.2.1 at page 283; see also Figure 7.
Before the effective filing date of the claimed invention, the teachings of Medhizadeh would have motivated a person having ordinary skill in the art to conjugate dopamine to the crosslinked GelMA disclosed in Nichol (as modified above by Elvin), in an effort to yield a tissue adhesive that was especially effective in adhering wet tissue surfaces. Therefore, claim 85 is prima facie obvious.
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, 46USPQ2d 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.2d937, 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 CFR1.321(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. Aweb-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 76-85 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1-13 of Patent No. 10,814,032 (issued October 7, 2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: The conflicting claims (the claims of the ’032 Patent) differ only marginally in scope from the claims of the present application. For example, compare conflicting claims 9-13 to present claim 76. Furthermore, conflicting claim 1 recites that the methacryloyl-substituted gelatin is cross-linked by photo-irradiation. The conflicting claims collectively recite ranges concerning degree of substitution (claim 2) and gelatin concentration (claims 1 and 3) that are overlapped by the corresponding ranges recited in present claims 80 and 81. MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”).
Claims 76-85 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of Patent No. 12,090,246 (issued September 17, 2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: The conflicting claims (the claims of the ’246 Patent) differ only marginally in scope from the claims of the present application. For example, compare conflicting claim 3 to present claim 76. Furthermore, conflicting claim 1 recites that the methacryloyl-substituted gelatin is cross-linked. The conflicting claims collectively recite ranges concerning degree of substitution (claim 1) and gelatin concentration (also claim 1) that are overlapped by the corresponding ranges recited in present claims 80 and 81. MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”).
Conclusion
Claims 76-85 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
13 June 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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