DETAILED ACTION
Claims 1-14 are currently pending. Claims 1-2, 4-8 and 10-14 are currently under examination.
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 a hydrogel and non-degradable gel, synthetic polymer, a hydrogel and degradable gel, synthetic polymer and iron oxide nanoparticles and the sensing component is located in the second gel, a third gel is not present in the reply filed on 04/06/2026 is acknowledged. The traversal is on the ground(s) that all species is sufficiently related that a thorough search for the subject matter of any one species would encompass a search for the subject matter of the remaining species. This is not found persuasive because the species election was based on PCT practice wherein unity of invention was broken. Thus the species election is proper.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/06/2026.
Priority
The instant application is a national stage entry of PCT/EP2022/051141, filed 01/19/2022 and claims priority to EP21152240.4, filed 01/19/2021.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 10/27/2023, 09/30/2025 and 05/05/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
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 1-2, 4-8 and 10-14 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 1, 6, 8 and 10 contain the limitation of “at least one sensing component”. Claim 1 contains at least one sensing component selected from a list in i) and additionally refers to at least one sensing component in ii). It is unclear if the sensing component in ii) is referring to those limited in i) or if it is different “at least one sensing component” not bound by the list in ii). The ambiguity is further a result of claims 6 and 8 referring to “at least one sensing component” which contains a list which has components from i) as well as additional components not present in i), such as aerogel particles, xerogel particles and combinations thereof, and wherein the carbide particles of claim 1 are now ‘magnetic’ carbide particles. Claim 10 additionally refers to “magnetic metal or metal oxide nanoparticles, magnetic carbide nanoparticles”. It is unclear if the magnetic version is in addition or further defining the metal or metal oxide and carbide nanoparticles in claim 1, and additionally if the magnetic extends to both the metal and metal oxide or only limits the metal nanoparticles. Claims 2, 4-5, 7, 11-13 and 14 are additionally rejected as not curing the ambiguity of claims 1, 6, 8 and 10.
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) 1-2, 4-8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0116734.
Regarding claims 1, 4, 6 and 8, the limitation of a patch for detecting by at least one non-invasive imaging technique a leak of a biological fluid at an application site, said patch comprising a layer comprising one or more first portion of a first gel, one or more second portions containing a second gel, at least one sensing component embedded within the first gel, the second gel or the first and the second gel, that at least one sensing component being selected form a group including metal nanoparticles, the first and second gel being selected form a group including hydrogel is met by the ‘734 publication teaches a biosensor which includes a substrate, a first polymer layer and a second polymer layer wherein the second polymer layer includes gold nanoparticles (abstract). Plural gold nanoparticles and plural second antibodies are imposed on a wall of each of the holes [0011]. Gold nanoparticles are distributed on a surface of each of the nanobeads [0015]. The material of the first polymeric layer and the second polymer layer can include but is not limited to hydrogel having the micropores. In one example the first polymer layer may be pHEMA or PEGDA and the second polymer layer may be PEG [0042], wherein the swelling ratio of the first and second gel would be different as no two gels of different components would have the exact same swelling ratio.
Regarding claim 2, 5, 7, the limitation of wherein the at least one non-invasive imaging technique is selected from ultrasound imaging, a compute tomography, magnetic resonance imaging, magnetic particle imaging and radio-frequency identification is met by the ‘734 publication teaching gold nanoparticles [0015], wherein the instant specification teaches gold nanoparticles [0158], thus the hydrogel containing gold nanoparticles taught by the ‘734 publication would be capable of the non-invasive imaging technique.
Regarding claim 14, the limitation of wherein the patch further comprises a backing layer is met by the ‘734 publication teaching a substrate [0037]. The instant specification does not define backing layer and therefore the substrate layer reads on backing layer.
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, a first non-degradable gel, a second non-degradable gel and gold nanoparticles) from within the prior art disclosure of the ‘734 publication, to arrive at the instantly claimed patch “yielding no more than one would have expected from such an arrangement”.
Claim(s) 1-2, 5-8, 10 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,149,992.
Regarding claim 1, the limitation of a patch for detecting by at least one non-invasive imaging technique a leak of a biological fluid at an application site, said patch comprising a layer comprising one or more first portion of a first gel, one or more second portions containing a second gel, at least one sensing component embedded within the first gel, the second gel or the first and the second gel, that at least one sensing component being selected form a group including metal nanoparticles, the first and second gel being selected from a group including hydrogel is met by the ‘922 patent teaching a patch system for use in a patient with a damaged heart the patch comprises a biodegradable engineered collagen scaffold to provide structural support and therapeutic agent. The scaffold consists of a dense collagen lamella produced by plastic compression with biomechanical properties (abstract). The compositions is a first layer of hydrated collagen attached to a second layer of compressed collagen having a dense fibrillar nanostructure (column 7, lines 25-35, claim 9) wherein the compressed layer is taught as hydrated gel (column 7, lines 30-40). The composition is taught to contain an iron oxide nanoparticle (claim 10-14) wherein the nanoparticles are added to the collagen material allowing for the ability to track the patch in the patient body over the time (Example 7A). The first and second gel have different physical characteristics and thus would necessarily result in a different swelling ratio.
Regarding claims 2, 12-13, the limitation of wherein the at least one non-invasive imaging technique is selected from a group which includes MRI is met by the ‘992 patent teaching MRI (Example 7A).
Regarding claims 5-8, 10, the limitation of wherein the at least one non-invasive imaging technique is ultrasound imaging and wherein the sensing component is metal oxide is met by the ‘992 patent teaching an implantable patch comprising iron oxide nanoparticles (Example 7A), thus teaching the claimed structure and elected sensing component and thus would be capable of the imaging technique.
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, first compressed collagen gel, a second collagen gel and iron oxide nanoparticle incorporated into collagen) from within the prior art disclosure of the ‘992 patent, to arrive at the instantly claimed patch “yielding no more than one would have expected from such an arrangement”.
Claim(s) 1-2, 4-8 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0100830 in view of US 10,149,992 and WO 2018/106938.
Regarding claim 1, the limitation of a device for detecting by at least one non-invasive imaging technique a leak of a biological fluid at an application site, said patch comprising a layer comprising a first portion of a fist gel one or more second portions contains a second gel and at least one sensing component embedded within the first gel the second gel or the first gel and the second gel; the at least one sensing component being selected form a group including metal oxide, wherein the first gel is non-degradable is met by the ‘830 publication teaching implantable or insertable medical device comprising a substrate and a hydrogel polymer coating at least a portion of the surface of the substrate, wherein the hydrogel polymer is adapted to render the device visible under magnetic resonance imaging upon insertion or implantation of the medical device. The use of hydrogel polymer for coating a medical device is taught (abstract). Paramagnetic particles are taught to include starch-coated iron oxide particles [0020]. Hydrogel polymers area taught to include e.g. polyacrylic acid [0029]. The implantable medical device is taught to include catheter, guidewires, balloons, stents and variety of other implantable or insertable medical devices used to both diagnose and treat medical conditions [0007]. The device is taught to have an additional optional lubricous coating layer present comprises a hydrogel polymer [0051].
Regarding claim 2, the limitation of wherein the at least non-invasive imaging teaching is selected from a list include MRI is met by the ‘830 publication teaching MRI [0053].
Regarding claim 4, the limitation of wherein the first gel is non-degradable is met by the ‘830 publication teaching hydrogel polymers area taught to include e.g. polyacrylic acid [0029].
Regarding claims 5-8, 10 and 12-13, the limitation of wherein the at least one non-invasive imaging technique is ultrasound imaging and wherein the sensing component is metal oxide is met by the ‘830 publication teaching an implantable device comprising a hydrogel containing iron oxide particles (abstract, [0020]), thus teaching the claimed structure and elected sensing component and thus would be capable of the imaging technique.
Regarding claim 11, the ‘830 publication teaches the detectable species associated with the hydrogel polymer though mechanisms such as hydrogen bonding, covalent or ionic bonding to the polymer itself and include a reacting with the hydroxyl group found on the compound and hydrogel polymer [0033].
Regarding claim 14, the limitation of wherein the patch further comprises a backing layer is met by the ‘830 publication teaching a substrate (abstract) which reads on the backing layer.
The ‘830 publication does not specifically teach a patch (claim 1).
The ‘830 publication does not specifically teach the second gel is degradable (claim 1).
The ‘922 patent teaching a patch system for use in a patient with a damaged heart the patch comprises a biodegradable engineered collagen scaffold to provide structural support and therapeutic agent. The scaffold consists of a dense collagen lamella produced by plastic compression with biomechanical properties (abstract). The compositions is a first layer of hydrated collagen attached to a second layer of compressed collagen having a dense fibrillar nanostructure (column 7, lines 25-35, claim 9) wherein the compressed layer is taught as hydrated gel (column 7, lines 30-40). The composition is taught to contain an iron oxide nanoparticle (claim 10-14) wherein the nanoparticles are added to the collagen material allowing for the ability to track the patch in the patient body over the time (Example 7A).
The ’938 publication teaches lubricous coatings can comprise a hydrogel such as PVP which are biodegradable [00184] for use on implantable medical device [00171].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use iron oxide particles in nanoparticle size range as the ‘830 publication teaches the use of iron oxide particles for use in MRI and the ‘922 patent teaches iron oxide nanoparticles for use in MRI. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘830 publication and the ‘922 patent are both directed to iron oxide particles in hydrogels on implantable devices for MRI use, therefore rending the nanoparticle size range obvious for use of the iron oxide particles of the ‘830 publication.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention for the medical device taught by the ‘830 publication to be in patch form as the ‘992 patent teaches implantable patches comprising a hydrogel containing iron oxide nanoparticles and the ‘830 publication teaches medical device is not limited and contains a hydrogel coating containing iron oxide coatings. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the specific medical device taught by the ‘992 patent for the medical device taught by the ‘830 publication because the ‘830 publication and the ‘992 patent are both directed to implantable medical device comprising hydrogels containing iron oxide particles.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use degradable hydrogel coating as taught by the ‘938 publication because the ‘830 publication teaches lubricous hydrogel coating and the ‘938 patent teaches specific materials to be used in lubricous hydrogel coating on medical implants. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known lubricous hydrogel polymers on the implants of the ‘830 publication taught to contain a lubricous hydrogel polymer.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
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