DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
3. Claim 8 is objected to because of the following informalities: in line 2 “solder” is repeated twice in a row. This is a minor informality, as “solder” is only to be recited once. Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 3 and 4 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.
6. Claim 3 recites the limitation "the fluorescent nanothermometers" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “a fluorescent nanothermometer”, but there is no recitation of a plurality, or more than one, nanothermometers. This renders the claim indefinite. Proper correction is required.
7. Claim 4 recites the limitation "the plasmonic nanoparticles" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from Claims 1 and 2, and there is no recitation of a “plasmonic nanoparticles” in either claim. This renders the claim indefinite. Proper correction is required.
Claim Rejections - 35 USC § 102
8. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
9. Claims 1-3, 5, 8-9, 11-12, and 14-15 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rege U.S. 2022/0071613 (herein referred to as “Rege”).
10. Regarding Claim 1, teaches a composition comprising a temperature sensitive biocompatible solder (para 0007) and at least one type of nanoparticles (para 0039), wherein a first type of nanoparticles is a fluorescent nanothermometer (para 0039, “gold nanorods”), wherein the fluorescent nanothermometer exhibits an excitation maximum and a temperature dependent emission spectrum each in the range of between 650 and 1350 nm (para 0004, “With the use of exogenous chromophores in laser tissue welding materials, laser irradiation can be employed at wavelengths of 650-1350 nm; however, tissue absorbance at this wavelength is lowest for light in the near infrared range (700-1000 nm wavelength)…”).
11. Regarding Claim 2, Rege teaches the composition additionally comprises a photothermal agent (para 0039).
12. Regarding Claim 3, Rege teaches the fluorescent nanothermometers are selected from the group consisting of quantum dots, nanodiamonds, gold nanoclusters, hosted rare earth ions, upconverting nanoparticles, transition metal ions, luminescent organic dyes, luminescent organic polymers and luminescent gels (para 0039, “gold nanorods”).
13. Regarding Claim 5, Rege teaches the photothermal dyes are near-infrared absorbing dyes (para 0056).
14. Regarding Claim 8, Rege teaches the temperature sensitive solder is selected from the group consisting of serum albumin, chitosan, collagen, fibrinogen and gelatin or a mixture thereof (para 0049).
15. Regarding Claim 9, Rege teaches the temperature sensitive solder additionally comprises a biodegradable polymer selected from the group consisting of poly(L-lactic acid) (PLA), poly(glycolic acid), poly(L-lactic-co-glycolic acid) (PGA), poly([epsilon]-caprolactone) (PLGA) and polyortho esters, polyanhydrides or combinations thereof (para 0057).
16. Regarding Claim 11, Rege teaches the composition additionally comprises a therapeutic agent selected from the group consisting of antimicrobial agents, anti-inflammatory agents and angiogenic agents (para 0067).
17. Regarding Claim 12, Rege teaches the composition is formulated as paste, gel, strip, patch or viscous fluid having a viscosity of at least 2'000 centipoises at 25oC (para 0064).
18. Regarding Claim 14, Rege teaches for use in treatment of biological tissue repair (para 0036-0037), wherein the tissue is selected from the group of consisting of cornea, blood vessels, fascia, diaphragm, anastomosis of vessels and tissues, dura mater leaks, gastrointestinal tissues and nerves (para 0068).
19. Regarding Claim 15, Rege teaches for use in treatment of deep tissue wounds (para 0036-0037, 0068).
Claim Rejections - 35 USC § 103
20. 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.
21. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rege and in view of West U.S. 2003/0093092 (herein referred to as “West”).
22. Regarding Claim 4, Rege fails to teach plasmonic nanoparticles are selected from the group consisting of plasmonic metal nanoparticles, plasmonic carbon nanotubes, plasmonic organic nanoparticles, plasmonic conductive oxides and plasmonic conductive transition metal nitrides, hybrids, silica coated nanoparticles or mixtures thereof, wherein the metal is selected from the group consisting of Au, Al, Ag, Cu, Pt, and Pd.
West teaches a composition of analogous art, wherein the composition comprises plasmonic nanoparticles are selected from the group consisting of plasmonic metal nanoparticles, plasmonic carbon nanotubes, plasmonic organic nanoparticles, plasmonic conductive oxides and plasmonic conductive transition metal nitrides, hybrids, silica coated nanoparticles or mixtures thereof, wherein the metal is selected from the group consisting of Au, Al, Ag, Cu, Pt, and Pd (para 0011, 0042). It would have been obvious to one having ordinary skill in the art at the time the invention was made to selected the material of plasmonic nanoparticles from the group above, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
23. Claims 6, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rege.
24. Regarding Claim 6, Rege teaches TiN and/or gold nanorods as plasmonic nanoparticles (para 0039).
Rege fails to teach neodymium-doped BiVO4 as fluorescent nanothermometers. However, It would have been obvious to one having ordinary skill in the art at the time the invention was made to have neodymium-doped BiVO4 as fluorescent nanothermometers, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
25. Regarding Claim 7, Rege fails to teach the excitation maximum of the fluorescent nanothermometer differs from the absorption maximum of the plasmonic nanoparticle by at least 200 nm. However, It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the differences of the excitation maximum and absorption maximum be 200 nm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
26. Regarding Claim 10, Rege fails to teach the fluorescent nanothermometers and the plasmonic nanoparticles are present in a ratio of 1:1 to 5000:1 % by weight. However, selecting the size and weight ratio of the composition is routine to one of ordinary skill in the art. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the ratio of the fluorescent nanothermometers and plasmonic nanoparticles present to be within a certain range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
27. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rege and in view of Chan U.S. 2013/0158342 (herein referred to as “Chan”).
28. Regarding Claim 13, Rege fails to teach the composition is in lyophilized form.
teaches a composition of analogous art (para 0164), that is in lyophilized form (para 0164). Various forms may be used to achieve the same expected result of tissue bonding (para 0164). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rege to have the composition in lyophilized form, as this produces the same expected result of tissue bonding.
Conclusion
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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