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 .
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 Status
Applicant’s amendment of 12/29/2025 is acknowledged. Claims 1-6 and 9-11 are amended; claims 15-18 are cancelled; and claims 19-24 are new. Claims 1-14 and 19-24 are currently pending.
Election/Restrictions
An election of invention/species was required in the instant application as detailed in the Office action dated 06/09/2025. The election is maintained and claims 13-14 remain withdrawn. Accordingly, claims 1-12 and 19-24 are examined on the merits herein.
Priority
The instant application is a 371 of PCT/NL2021/050640 filed on 10/22/2021 and claims foreign priority to NL2026725 filed on 10/22/2020 as reflected in the filing receipt dated on 09/05/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Declaration Under 37 CFR 1.132
Niels Ouwerkerk provided a Declaration under 37 CFR 1.132, filed 12/29/2025. The Declaration meets the formal requirements. In the most relevant part, the Declaration presents experimental data allegedly demonstrating how different extrusion temperatures affect tablet shape and definition. A Declaration is due full consideration and weight for all that it discloses. The ultimate determination of patentability must be based on consideration of the entire record based on a preponderance of the evidence standard.
The Declaration under 37 CFR 1.132 filed 12/29/2025 is insufficient to overcome the rejection of the instant claims under 35 U.S.C. 102 as being anticipated by Seoane-Viaoño as set forth in the last Office action for the following reasons:
The Declaration presents an experimental analysis from Ouwerkerk comparing the physical characteristics of tablets produced by extruding Gelucire® 44/14 at 39°C, 40°C, 41°C, and 42°C, wherein 42°C corresponds to the temperature used in the prior art of record. Ouwerkerk states that tablets produced at an extrusion temperature within the claimed range have a defined and more regular shape than a tablet produced at an extrusion temperature outside of the claimed range, which is considered by Ouwerkerk as a definite improvement.
The Examiner notes, however, that the extrusion temperature as defined in Applicant’s claim 1 is a relative range, rather than a fixed range (for example, from 39°C to 41°C). For reasons discussed in further detail in the Response to Arguments below, the extrusion temperature of Seoane-Viaoño—even if considered to lie outside the unclaimed range of 38°C to 41.75°C, which is deduced by Applicant on Page 8 of the Remarks filed 12/29/2025—still reads on Applicant’s instantly claimed range. Thus, the Declaration fails to provide evidence that the method of Seoane-Viaoño does not anticipate the Applicant’s method as claimed. An ordinarily skilled artisan would recognize that differences in tablet shape and definition could be attributed to a variety of unclaimed printing parameters, such as extrusion speed, nozzle size, flow speed, pressure, etc.
The Examiner further notes that on page 10, second paragraph, of the accompanying Remarks filed 12/29/2025, Applicant admits that irregular tablet shape is not a clear indicator of “improvement”, which brings into question the objectivity of the evidence provided.
The Declaration and accompanying experimental examples do not overcome the prior art rejections of record at this time because, in view of the totality of evidence presented, there is no difference between the prior art method and the instantly claimed method in order to patentably distinguish one from the other. Therefore, the invention as a whole would have been anticipated by the prior art at the time the invention was made, as evidenced by Seoane-Viaoño, especially in the absence of any objective evidence to the contrary.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence fails to outweigh the evidence of anticipation.
Withdrawn Objections and Rejections
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(b) rejections. Further, Applicant’s argument that the term “hard fats” recited in claim 2 is clear and definite was found to be persuasive. Thus, the rejections are hereby withdrawn.
Applicant’s amendment and introduction of new claims have prompted the new/revised grounds of rejection presented herein under 102 and 103. Applicant’s arguments insofar as they pertain to the revised grounds of rejection are addressed herein.
Specification
The disclosure is objected to because of the following informalities:
Page 3 refers to “Figure 1” and “Figure 2” but should refer to “FIG. 1” and “FIG. 2” as labeled in the Drawings.
Appropriate correction is required.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 recites the limitation “wherein the first, and optionally one or more of the second, third and fourth drug delivery material after extrusion is deposited…”, which is missing a comma to close the “optionally” clause. The claim should read “wherein the first, and optionally one or more of the second, third and fourth, drug delivery material after extrusion is deposited…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 2, 10, 12, and 21 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.
Claim 2 recites the limitation “one or more of fatty alcohols, fatty acids, hard fats, one or more polyethylene glycol (PEG) mono- and/or diesters with fatty acids and optionally one or more mono, di and/or triglycerides”, wherein the non-optional components “fatty alcohols”, “fatty acids”, “hard fats”, and “one or more polyethylene glycol (PEG) mono- and/or diesters with fatty acids” are not separated by a conjunction. Accordingly, it appears that the composition only requires one of the four non-optional components. However, because the limitation “polyethylene glycol (PEG) mono- and/or diesters with fatty acids” is also modified by the limitation “one or more”, it is unclear how many components are actually required. For instance, does the composition require—at a minimum—only one of four components, e.g., a fatty alcohol, a fatty acid, a hard fat, or a polyethylene glycol (PEG) mono- and/or diester with a fatty acid? Or does the composition require one or more of “fatty alcohols”, “fatty acids”, or “hard fats” and additionally requires “one or more polyethylene glycol (PEG) mono- and/or diesters with fatty acids”? Therefore, the metes and bounds of the claim are indefinite. For the purposes of compact prosecution in the prior art rejections below, the Examiner is interpreting the claim to mean the that the composition requires—at a minimum—only one of four components, e.g., a fatty alcohol, a fatty acid, a hard fat, or a polyethylene glycol (PEG) mono- and/or diester with a fatty acid.
Claim 10 recites the limitations “the first layer” and “said optional following layers”. There is insufficient antecedent basis for these limitations in the claim. Claim 10 depends from claim 9, which does not require a particular order in which the layer(s) is/are deposited and, therefore, does not specify which layer is the first. Because it is unclear which layer is the first layer, and which layers are the following layers, the scope of the claim is indefinite. For the purposes of compact prosecution in the prior art rejections below, the Examiner is interpreting the first layer as referring to the layer of the first drug delivery material and said optional following layers as referring to the optional one or more of the layers of the second, third, and fourth drug delivery materials.
Claims 12 (line 2) and claim 21 (line 4) respectively recite the limitations followed by the terms “preferably” and “more preferably”, which introduces a narrower statement of the range/limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claims are considered indefinite because there is a question or doubt as to whether the feature following the term is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of compact prosecution, the Examiner is interpreting any limitation following the term “preferably” or “more preferably” as merely exemplary of the remainder of the claim, and therefore not required.
Response to Arguments
Applicant’s arguments submitted on 12/29/2025 with respect to rejections under 35 U.S.C. 112(b) have been fully considered in so far as they apply to the new or modified rejections of the instant Office action. Applicant states that the claims have been amended to delete “preferred” subject matter within the claims. However, claim 12 still recites “preferred” subject matter and, therefore, the rejection over this claim is maintained. New claim 21, which incorporates the “preferred” subject matter of previous claim 2 also recites “preferred” subject matter and is rejected accordingly.
Claim Interpretation
As discussed previously in the Office action dated 08/29/2025 (Page 5), the Examiner is interpreting the "first initial melting temperature" to correspond to the temperature which begins the "first melting range" recited in claim 1. For example, if the first melting range is 35°C - 45°C, then the first initial melting temperature is interpreted to be 35°C.
The limitation “essentially equally thick at all points across the layer” in claim 9 is interpreted broadly by the Examiner to mean that each layer has a 10% maximum relative deviation in thickness across the entire layer, as supported by Applicant’s instant specification (Page 15).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 12, and 19-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seoane-Viaño et al. (Asian Journal of Pharmaceutical Sciences, vol. 16, p. 110-119; published: 07/09/2020; IDS of 04/20/2023) as evidenced by Panigrahi et al. (Future Journal of Pharmaceutical Sciences, vol. 4, p. 102-108; published: 04/15/2018; PTO-892) and Gattefossé (published: 2019; cited as Exhibit B filed on 12/29/2025).
Seoane-Viaño discloses a method of manufacturing 3D-printed, immunosuppressive tacrolimus suppositories using semi-solid extrusion (SSE) (Abstract), which reads on the extrusion additive manufacturing method for forming a drug delivery device recited in instant claim 1. SSE 3D printing is based on the deposition of semi-solids, i.e. gel or paste, in sequential layers through a syringe-based tool-head nozzle to create the 3D object (Page 111, Right Col.).
The lipid excipient Gelucire 44/14 was mixed with coconut oil and the drug tacrolimus to make Gel 44 and then transferred to an extrusion syringe (Page 112, Section 2.3 and Table 1). Gelucire 44/14 exhibits a melting range between 40°C and 50°C (Page 114, last paragraph and Page 115, first paragraph; Fig. 6). Its specific melting point within that range is 44°C, as evidenced by Panigrahi (Panigrahi, Page 104, Section 1.3). The drug delivery material Gel 44, which comprises the excipient Gelucire 44/14, was extruded at 42°C (Table 1). The extrusion temperature is both within the melting range of Gelucire 44/14 and within the first 75% of the range between 40°C and 44°C, which respectively correspond to the excipient’s first initial melting temperature and first peak temperature. Therefore, the preparation of Gel 44 reads on the step of providing a first drug delivery material comprising a first major pharmaceutically acceptable excipient, and the extrusion step reads on the step of extruding the first drug delivery material as recited in instant claim 1.
Regarding instant claims 2 and 19-21, Gelucire 44/14 reads on the first major excipient as evidenced by Panigrahi, which states that Gelucire 44/14 has the chemical name lauroyl polyoxyl-32 glycerides and is derived from mixtures of mono-, di-, and triglycerides with PEG esters of fatty acids (Panigrahi, Page 102, R. Col.), and as evidenced by Gattefossé, which states that the PEG esters of fatty acids are PEG-32 mono- and diesters with C8-C18 fatty acids (Gattefossé, Fig. 1 and Fig. 4).
Regarding instant claims 3 and 22, Gelucire 44/14 has a first peak temperature of 44°C as discussed above, which lies within and thus anticipates the instantly claimed ranges. Though not required, the Examiner notes that the excipient also has a hydrophilic lipophilic balance (HLB) value of 11, as evidenced by Panigrahi (Panigrahi, Page 104, Section 1.3), which lies within and thus anticipates the instantly claimed HLB recited in instant claim 3.
Regarding instant claim 4, the drug delivery material comprises the drug tacrolimus, which is an active pharmaceutical ingredient.
Regarding instant claim 5, the drug delivery material Gel 44, which comprises Gelucire 44/14, was extruded at 42°C, which is within the first 50% of the range between 40°C and 44°C, which respectively correspond to the excipient’s first initial melting temperature and first peak temperature
Regarding instant claim 12, the transfer of the drug delivery material to an extrusion syringe meets the claim, as evidenced by Applicant’s instant specification, which states that the cartridge may be a cylindrical shaped cartridge such as a syringe (Instant Specification, Page 16, lines 6-12).
Regarding instant claims 23-24, the drug delivery material was extruded at 42°C, which lies within and thus anticipates the instantly claimed ranges.
Together, the disclosure of Seoane-Viaño anticipates at least instant claims 1-5, 12, and 19-24.
Response to Arguments
Applicant’s arguments submitted on 12/29/2025 with respect to rejections under 35 U.S.C. 102 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that Seoane-Viaño fails to anticipate amended claim 1 and its dependent claims. Specifically, Applicant argues that Seoane-Viaño fails to disclose that the extrusion temperature is within the first 75% of the temperature range between the first initial melting temperature and the first peak temperature, and provides Exhibit B as evidence that Gelucire® 44/14 has a first initial melting temperature of about 38°C and a first peak temperature of 43°C. The Examiner respectfully disagrees that the “corrected numbers” Applicant derives from Exhibit B are sufficient to overcome the anticipatory rejection of the instant claims in view of Seoane-Viaño.
First, the Examiner notes that the instantly claimed extrusion temperature is drawn to a relative range, which is dependent on the specific excipient used, rather than a fixed range. In this case, Seoane-Viaño explicitly teaches that according to its own measurements, the melting range of Gelucire 44/14 is between 40°C and 50°C (Page 114, last paragraph and Page 115, first paragraph; Fig. 6). As such, under broadest reasonable interpretation, the Gelucire 44/14 of Seoane-Viaño has a first initial melting temperature of 40°C. Because the excipient has a melting point of 44°C as evidenced by Panigrahi (Page 104, Section 1.3), which under broadest reasonable interpretation corresponds to a first peak temperature, the method of Seoane-Viaño, wherein the Gelucire 44/14 is printed at 42°C, which is within the first 75% of the range between 40°C and 44°C, reads on Applicant’s instant invention as claimed.
Second, the Examiner respectfully points out that Applicant’s arguments centered upon “corrected numbers” obtained from Exhibit B are in direct conflict with Applicant’s own disclosure. Applicant’s instant specification clearly states that the first number following the name of Gelucire® indicates the melting point in degrees centigrade (Page 8, lines 5-15). Therefore, Applicant apparently recognizes 44°C as the melting point of Gelucire 44/14 rather than 43°C as argued.
Further, even in view of Applicant’s Exhibit B, the Examiner maintains that the method of Seoane-Viaño reasonably anticipates the instant method. The brochure of Exhibit B reports Gelucire 44/14 as a broad endotherm with an onset melting temperature of about 38°C and a peak melting temperature of about 43°C. Clearly, Exhibit B recognizes the variability of the excipient’s melting characteristics, which may vary slightly by batch, instrument used, etc. and acknowledges that the onset melting temperature of Gelucire 44/14 is not exactly 38°C, nor is its peak melting temperature exactly 43°C.
Thus, under broadest reasonable interpretation of the term “about”, the temperature range between a first initial melting temperature and a first peak temperature taught by Applicant’s Exhibit B would encompass the values of Seoane-Viaño, as 40°C and 44°C are respectively with 5.3% of 38°C and 43°C.
Even when using a narrower interpretation of the term “about” (e.g., within 5% of the range 38°C to 43°C), the first 75% of the range between 36.1°C and 45.2°C corresponds to a range of 36.1°C to 42.9°C. Thus, the extrusion temperature of Seoane-Viaño, 42°C, still lies within the instantly claimed range.
Regarding Applicant’s argument that the printing temperature of Gelucire 48/16 is also outside of the claimed range, this argument is moot since the Examiner did not use Gelucire 48/16 to reject previous claim 5, whose limitations are now incorporated into amended claim 1.
In view of the foregoing, the 102 rejections of record are maintained.
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.
Claims 1-12 and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Seoane-Viaño et al. (Asian Journal of Pharmaceutical Sciences, vol. 16, p. 110-119; published: 07/09/2020; IDS of 04/20/2023), as applied to claims 1-5, 12, and 19-24 above, and further in view of Shin et al. (International Journal for Biological Macromolecules, vol. 109, p. 544-550; published: 12/23/2017; PTO-892) and as evidenced by Panigrahi et al. (Future Journal of Pharmaceutical Sciences, vol. 4, p. 102-108; published: 04/15/2018; PTO-892) and Gattefossé (published: 2019; cited as Exhibit B filed on 12/29/2025).
Seoane-Viaño as evidenced by Panigrahi and Gattefossé discloses the extrusion additive manufacturing method for forming a drug delivery device as recited in instant claims 1-5, 12, and 19-24 as discussed in detail above and further incorporated herein.
Seoane-Viaño further teaches that an advantage of SSE sequential layering is that it could allow for the preparation of novel lipid-based formulations with a defined dose, shape, size and drug release profile tailored to the needs of each patient, which would enhance patient adherence and consequently treatment outcomes (Page 111, R. Col.).
However, Seoane-Viaño does not expressly teach that the method further comprises: providing at least a second drug delivery material as recited in instant claims 6 and 7, or providing at least a third and a fourth drug delivery material as recited in instant claim 8. Further, Seoane-Viaño does not expressly teach that the material(s) are deposited in individual layers as recited in instant claims 9 and 10, or that the method further comprises cooling the drug delivery material(s) after extrusion and deposition as recited in instant claim 11.
Shin teaches that tacrolimus is typically available as an immediate release dosage form (Page 544, Introduction). However, to maintain a therapeutically relevant concentration of tacrolimus in the blood and to enhance patient compliance in those requiring long-term use of the immunosuppressant, a once-a-day sustained release dosage form is highly desirable (Page 544, Introduction). Therefore, Shin reports development of a drug-layered pellet coated with ethyl cellulose as a release retardant, which impedes tacrolimus release and allows for gradual increase of drug level in the blood over time (Abstract). Shin further teaches that hypromellose can be used to increase the thermodynamic solubility of the drug to support effective release of the drug by the outer ethyl cellulose coating (Page 545, L. Col.).
Regarding instant claims 6 and 7, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Seoane-Viaño by further including a second drug delivery material comprising the ethyl cellulose of Shin. One of ordinary skill in the art would have been motivated to include ethyl cellulose as a release retardant in order to maintain a therapeutically relevant concentration of tacrolimus in the blood and to enhance patient compliance in those requiring long-term use of the immunosuppressant, as taught by Shin.
Regarding instant claim 8, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by the combination of Seoane-Viaño and Shin by further including additional drug delivery materials, i.e. a third, fourth, etc., comprising either a drug release retardant, such as the ethyl cellulose of Shin, or a drug release accelerant, such as the hypromellose of Shin. One of ordinary skill in the art would have been motivated to include additional drug delivery materials in order to prepare lipid-based formulations with a defined dose and drug release profile tailored to the needs of each patient, as taught by Seoane-Viaño.
Regarding instant claim 9, Seoane-Viaño teaches that its suppositories comprise layers of lipid excipient that are 0.50 mm thick (Seoane-Viaño, Page 112, Section 2.3), which under broadest reasonable interpretation meets the limitation wherein the first drug delivery material after extrusion is deposited in an individual layer, as the open claim language “comprising” does not exclude the inclusion of more than one layer. Because Seoane-Viaño does not teach that the layers deviate in thickness, the limitation wherein the layer is essentially equally thick at all points across the layer is also met. The Examiner notes that although the optional claim language does not require that the second, third, or fourth drug delivery materials are deposited in individual layers that are essentially equally thick, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to also deposit each additional drug delivery material (i.e. second, third, fourth, etc.) in individual layers of 0.50 mm according to the printing parameters taught by Seoane-Viaño in order to maintain the desired size and shape of the suppository while allowing each drug delivery material to individually influence the drug release kinetics, as taught by Shin, as the suppository is metabolized.
Regarding instant claim 10, as discussed above, the method taught by the combination of Seoane-Viaño and Shin comprises first, and optionally, second, third, and fourth, drug delivery material after extrusion is deposited in individual layers of 0.50 mm thickness, which lies within and thus renders obvious the instantly claimed ranges for the “first layer” and the “following layers”.
Regarding instant claim 11, Seoane-Viaño teaches that its 3D printed suppositories were allowed to solidify at room temperature and subsequently stored in the fridge at 4°C (Seoane-Viaño, Page 112, Section 2.3), which meets the alternative limitation wherein the method further comprises cooling the first drug delivery material after extrusion and deposition. The Examiner notes that although the “and/or” claim language does not require that the second, third, or fourth drug delivery materials are cooled after extrusion or deposition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to also cool each layer of additional drug delivery material (i.e. second, third, fourth, etc.) taught by the combination of Seoane-Viaño and Shin in order to maintain the desired size and shape of the suppository.
One of ordinary skill in the art would reasonably expect success in modifying the method of Seoane-Viaño with the teachings of Shin as proposed because both retardants and accelerants are known in the art to be included in drug delivery materials in order to modulate the release kinetics of drugs according to therapeutic needs, and Seoane-Viaño specifically teaches that excipients within its layered approach can be exploited to modulate drug release kinetics (Seoane-Viaño, Page 112, L. Col.). Further, both references aim to produce dosage forms of tacrolimus which increase patient compliance.
Response to Arguments
Applicant’s arguments submitted on 12/29/2025 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that the pending claims are not prima facie obvious over the cited prior art, stating that there are several advantages for extruding at an extrusion temperature within the claimed range. Because the cited prior art anticipates Applicant’s instant invention as claimed, as discussed in detail above, rebuttal evidence including secondary considerations are not considered at this time.
Regarding Applicant’s argument that the cooling period of the deposited material is minimal, resulting in faster production time and limited complexity: Applicant’s instant claims only require that the drug delivery material is cooled after extrusion and melting, which is expressly taught by Seoane-Viaño, and does not require the material to be cooled for a specific amount of time.
Lastly, as discussed in detail above, Applicant’s Declaration has been given full consideration but does not overcome the prior art rejections of record at this time because no evidence was presented to establish that there is, in fact, a difference between the prior art method and the instantly claimed method in order to patentably distinguish one from the other.
In view of the foregoing, the 103 rejections of record are maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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