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 10/09/2025 is acknowledged. Claims 1, 3, 5-6, 8-11, 13, 15-17, and 19-20 are amended, and claims 4, 7, 14, 18, and 23 remain cancelled. Claims 1-3, 5-6, 8-13, 15-17, 19-22, and 24-25 are currently pending.
Election/Restrictions
An election of invention/species was required in the instant application as detailed in the Office action dated 05/09/2025. The election is maintained and claims 21-22 and 24-25 remain withdrawn. Accordingly, claims 1-3, 5-6, 8-13, 15-17, and 19-20 are examined on the merits herein.
Priority
The instant application is a 371 of PCT/GB2021/050546 filed on 03/05/2021 and claims foreign priority to GB2003210.8 filed on 03/05/2020 as reflected in the filing receipt dated on 04/17/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Objections and Rejections
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(b) rejections. Thus, the rejections are hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 102 rejections. Thus, the rejections are hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 103 rejections. Thus, the rejections are hereby withdrawn.
Applicant’s amendment and introduction of new claims have prompted the new/revised grounds of objection and rejection presented herein. Applicant’s arguments insofar as they pertain to any revised grounds of rejection are addressed herein.
Drawings
The drawings are objected to because 37 CFR 1.84(u)(1) states different view numbers must be preceded by the abbreviation “FIG.” Here, Applicant' s drawings refer to “Figure 1”, “Figure 2”, and “Figure 3”. The Examiner notes that changes in the drawings must be reflected in Applicant' s instant specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant’s arguments submitted on 10/09/2025 with respect to objections of the Drawings have been fully considered. While Applicant has amended the previous “Figure 1” to “Figure” in an attempt to comply with 37 CFR 1.84(u)(1), Applicant also renamed the previous view numbers “A”, “B”, and “C” to “Figure 1”, “Figure 2”, and “Figure 3”, respectively, which now represent multiple drawings rather than only one drawing. Accordingly, Applicant’s Figures 1-3 must now be renamed “FIG. 1”, “FIG. 2”, and “FIG. 3”, respectively, in compliance with 37 CFR 1.84(u)(1).
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 1-3, 5-6, 8-13, 15-17, and 19-20 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 1 recites the limitation “or any combination thereof” in line 10. Because the limitation follows the limitation “thereby obtaining a decellularized scaffold”, which is the final product obtained from practicing the method, and is not recited directly after the list of alternative steps to be practiced “after delipidation”, it creates confusion as to whether the delipidation step is actually required, or whether any combination of the recited method steps is sufficient to meet the claim. Therefore, the scope of the claim is indefinite. For the purposes of compact prosecution in the prior art rejections below, the Examiner is interpreting the claim to mean that the delipidating step is required, in addition to at least one of the instantly claimed step(s) “after delipidation…”, which together result in a decellularized tissue scaffold. Claims 2-3, 5-6, 8-13, 15-17, and 19-20 are rejected by virtue of their dependency on claim 1, as they fail to resolve the ambiguity in question.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
New Matter Rejection
Claims 8 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “w/v” has been added to claims 8 and 10 and the limitation “ethylene diamine tetra-acetic acid (EDTA)” has been added to claim 8 in the amendment filed on 10/09/2025. However, the instant disclosure does not provide support for the claimed concentrations represented as “w/v”, or the chemical name “ethylene diamine tetra-acetic acid” as recited in the amended claims. In particular, the instant specification and claims as originally filed do not disclose concentrations of tris and EDTA in hypotonic solution or amounts of tris and sodium chloride in hypertonic solution such that each component of each solution is represented as “w/v”, or that “EDTA” is an abbreviation for “ethylene diamine tetra-acetic acid”. If Applicant believes this rejection is in error, Applicant must disclose where in the specification support for the entire scope of the amendment(s) and/or new claims can be found. As a result, claims 8 and 10 represent new matter.
Response to Arguments
To the extent that Applicant’s arguments submitted on 10/09/2025 with respect to rejections under 35 U.S.C. 112(b) regarding amendments to claims 8 and 10 [see pg. 10 of Remarks] apply to the new matter rejections under 35 U.S.C. 112(a) above, these arguments were not found to be persuasive.
Applicant argues, “One of ordinary skill in the art would be aware that tris buffers, EDTA, and sodium chloride are provided in solid (powdered) form as a standard practice. Thus, one of ordinary skill in the art would understand that the concentrations of these compounds relate to the weight of each compound as a percentage of the final volume of the corresponding solution.” This argument was not found to be persuasive. Applicant’s instant disclosure does not provide support for the recited concentrations as “w/v”, and the unitless percentages described in Applicant’s instant disclosure could be interpreted more than one way (weight percentage or volume percentage of the respective solution). While tris buffers, EDTA, and sodium chloride may be provided in solid form, these buffers are also routinely provided as stock solutions. Thus, without further guidance from Applicant’s instant disclosure, it is not inherent that the recited concentrations of tris, EDTA, and/or sodium chloride would represent “w/v”. As such, inclusion of the limitation “w/v” in the claims represents new matter.
Claim Interpretation
The terms “delipidating agent” and “DNA removal agent” recited in claim 1 are respectively interpreted to mean any agent that removes any amount of lipid materials or DNA, respectively, from a tissue.
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 1-3, 5-6, 12-13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soffer-Tsur et al. (Biofabrication, vol. 6, pg. 1-14; published: 08/27/2014; PTO-892 of instant action) as evidenced by Brink et al. (Diseases of the Abdomen and Pelvis 2018-2021, ch. 6, pg. 57-65; published: 03/21/2018; PTO-892 of 07/10/2025).
Soffer-Tsur, throughout the reference, teaches several protocols for omentum decellularization utilizing chemical, physical, and biological processes to obtain structurally and biochemically distinct scaffolds for transplantation into patients [abstract, table 1].
Regarding claim 1: Omentum is highly vascularized adipose tissue [pg. 3, l. col.]. Therefore, the methods of Soffer-Tsur meet the claim limitation “method for producing a decellularized tissue scaffold”.
Regarding the instantly claimed step “incubating a starting tissue with a solution comprising a delipidating agent…”: Soffer-Tsur further teaches Protocols #3 and #4, wherein pre-agitated and dehydrated pig omentum is incubated for 24 hours in 100% acetone for lipid extraction [pg. 3-4, “Decellularization”; table 1]. The incubating solution comprising acetone reads on the instantly claimed “solution comprising a delipidating agent” as evidenced by Applicant’s instant specification [pg. 2, lines 29-31]. While the protocols of Soffer-Tsur include agitation and dehydration steps prior to delipidation, Applicant’s instant specification indicates that the term “a starting tissue” refers to a tissue obtained from a human or animal subject [instant spec., pg. 7, lines 25-29]. Thus, under broadest reasonable interpretation and in light of the open instant claim language “comprising”, which allows the inclusion of additional unrecited steps, the dehydrated pig omentum of Soffer-Tsur is reasonably considered a starting tissue for the delipidating step of the prior art protocol.
Regarding the instantly claimed step(s) “after delipidation…”, wherein only one of the recited alternative steps is required to meet the claim: Soffer-Tsur further teaches that after lipid extraction, the tissue is rehydrated and then incubated for 2 hours in hypotonic solution, [pg. 3-4, “Decellularization”; table 1]. Next, the tissue was processed with 1% sodium dodecyl sulphate (SDS) for 24 hours, followed by two 2 hour incubations in 2.5 mM sodium deoxycholate in PBS [pg. 3-4, “Decellularization”; table 1], which reads on the instantly claimed alternative step “incubating the tissue with a solution comprising an anionic detergent” as evidenced by instant claim 6. While fat extraction is repeated in Protocol #3, the reference further teaches that the final step includes tissue agitation in a nucleic degradation solution of 50mM Tris, 1 mM MgCl--2, 0.1% BSA, and 40 units/mL Benzonase® nuclease for 20 hours, followed by washing and freezing of the resulting decellularized tissue [pg. 3-4, “Decellularization”; table 1], which reads on the instantly claimed alternative step “incubating the tissue with a solution comprising a DNA removal agent” and the step of “obtaining a decellularized tissue scaffold”.
Regarding claim 2: Omentum tissue is comprised of ligaments as evidenced by Brink, which states that the gastrohepatic and hepatoduodenal ligaments comprise the lesser omentum [pg. 58, r. col.] and the gastrocholic ligament comprises the greater omentum [pg. 60, l. col.], and thus reads on the instantly claimed starting tissue.
Regarding claim 3: Soffer-Tsur teaches that acetone is a polar solvent [pg. 5, r. col.] and thus meets the claim limitation.
Regarding claim 5: While Soffer-Tsur is silent as to the unit of measure for acetone, because the incubating solution is 100% acetone solvent, the concentration of acetone in the solution is necessarily 100% v/v.
Regarding claim 6: Each of the solutions comprising SDS and sodium deoxycholate, respectively, meet the alternative claim limitation requiring that the anionic detergent is either of these.
Regarding claim 12: Soffer-Tsur’s Protocols #3 and #4 do not comprise an animal-derived protease inhibitor and thus meet the claim limitation.
Regarding claim 13: Soffer-Tsur’s Protocols #3 and #4 comprise several steps wherein the tissue is washed with PBS, double distilled water, etc. [pg. 3-4, “Decellularization”; table 1] and thus meet the claim limitation.
Regarding claim 15: Benzonase® nuclease is an endonuclease, as evidenced by Applicant’s instant specification [pg. 3, lines 15-25], and thus meets the claim limitation.
Regarding claim 16: The concentration of Benzonase® nuclease used in the prior art method lies within and thus reads on the instantly claimed range.
Taken together, the disclosure of Soffer-Tsur anticipates at least one alternative of the method recited in claims 1-3, 5-6, 12-13, and 15-16.
Response to Arguments
Applicant’s arguments submitted on 10/09/2025 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 are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-3, 5-6, 8-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Soffer-Tsur et al. (Biofabrication, vol. 6, pg. 1-14; published: 08/27/2014; PTO-892 of instant action) in view of Ansari (GB2549110A; published: 11/10/2017; PTO-892 of 07/10/2025) and as evidenced by Brink et al. (Diseases of the Abdomen and Pelvis 2018-2021, ch. 6, pg. 57-65; published: 03/21/2018; PTO-892 of 07/10/2025) and Gold Biotechnology (webpage, <www.goldbio.com>; published:04/10/2019; PTO-892 of 07/10/2025).
Soffer-Tsur as evidenced by Brink teaches the invention(s) of claims 1-3, 5-6, 12-13, and 15-16 as discussed in detail above and further incorporated herein.
As discussed above, Soffer-Tsur also teaches that after lipid extraction, the tissue is rehydrated and then incubated for 2 hours in hypotonic solution which reads on a portion of the instantly claimed alternative step “incubating the tissue at least once with a hypotonic solution and at least once with a hyper hypertonic solution”. Soffer-Tsur further teaches that short exposure to a hypertonic environment is meant to disrupt cellular membranes [pg. 5, “Rationale”].
However, the Soffer-Tsur does not expressly teach a protocol comprising both incubation with a hypertonic solution and incubation with a hypertonic solution as required by claims 1 and 8-11.
Ansari teaches a method of manufacturing a dermal tissue scaffold, comprising decellularizing the dermal tissue [pg. 5, lines 1-5]. The biological tissue may alternatively be a non-dermal tissue, including ligaments among others [pg. 20, lines 16-24]. The decellularization may comprise contacting the tissue sequentially with hypotonic and hypertonic solutions (in any order) to promote cell lysis [pg. 5, lines 8-11]. Ansari further teaches that the hypertonic solution may comprise sodium chloride along with EDTA and/or Tris-HCl [pg. 5, lines 18-23, pg. 6, lines 1-2]. For example, the hypertonic solution may comprise 1M sodium chloride, and optionally 25 mM EDTA and 50 mM Tris-HCl [pg. 6, lines 3-4].
Regarding the alternative step “incubating the tissue at least once with a hypotonic solution and at least once with a hyper hypertonic solution” recited in claim 1: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Protocols #3 or #4 of Soffer-Tsur by further including a step of incubating the tissue in the hypertonic solution of Ansari, either before or after the step of incubating the tissue with hypotonic solution, because Ansari teaches that sequential incubation with hypotonic and hypertonic solutions in any order facilitates cell lysis, which is desired in the method of Soffer-Tsur.
Regarding claim 8: Soffer-Tsur teaches that its hypotonic solution comprises 10 mM Tris and 5 mM ethylenediaminetetraacetic acid (EDTA) [pg. 3-4, “Decellularization”; table 1]. Tris has the CAS # 77-86-1 and a molecular weight of 121.14 g/mol (same as tris(hydroxymethyl)aminomethane) as evidenced by Gold Biotechnology [pg. 1, “Instructions”]. EDTA has a molecular weight of 292.24 g/mol (calculated by Examiner). Therefore, 10 mM Tris and 5 mM EDTA hypotonic solution would correspond to approximately 0.1% w/v Tris and approximately 0.1 w/v EDTA (calculated by Examiner).
Regarding claim 9: The incubation time in hypotonic solution taught by Soffer-Tsur lies within and thus reads on the instantly claimed range.
Regarding claim 10: As discussed above, Tris has a molecular weight of 121.14 g/mol. Sodium chloride has a molecular weight of 58.44 g/mol (calculated by Examiner). Therefore, 50 mM Tris and 1 M sodium chloride hypertonic solution would correspond to approximately 0.6% w/v Tris and 6% w/v sodium chloride, which reads on the instantly claimed concentration of Tris. Regarding the instantly claimed concentration of sodium chloride: It would have been obvious to one of ordinary skill in the art to adjust the concentration of sodium chloride within the range taught by Ansari because the reference teaches that any amount of sodium chloride within the range of 0.5 M and 2 M, which equates to approximately 2.9% w/v – 11.7% w/v (calculated by Examiner) and overlaps the concentration recited in claim 10, is suitable for formulating a hypertonic solution for use in tissue decellularization [pg. 5, lines 18-23, pg. 6, lines 1-2]. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding claim 11: 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 Soffer-Tsur and Ansari by using 12 hours, which lies within and thus reads on the instantly claimed range, as a starting point for routine optimization of the incubation times of the tissue in hypertonic solution, as taught by Ansari. One of ordinary skill in the art would have been motivated to optimize the incubation time in order to produce the intended biological effect of cell lysing, as taught by both Soffer-Tsur and Ansari.
It is generally noted that differences in parameters such as concentrations or incubation times do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or incubation time 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that Applicant did not point out the criticality of the sodium chloride concentration or hypertonic solution incubation time within the claimed method, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration or incubation time. NOTE: MPEP 2144.05.
An ordinarily skilled artisan would reasonably expect success in modifying the prior art method as proposed because both Soffer-Tsur and Ansari acknowledge that incubating tissue in hypertonic solution helps to disrupt cell membranes (i.e., facilitates cell lysis), which is key step in producing a decellularized tissue scaffold.
The Examiner notes that the limitations of claims 8-11 are only required when the alternative step of claim 1 “incubating the tissue at least once with a hypotonic solution and at least once with a hyper hypertonic solution” is practiced.
Claims 1-3, 5-6, 12-13, 15-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Soffer-Tsur et al. (Biofabrication, vol. 6, pg. 1-14; published: 08/27/2014; PTO-892 of instant action) in view of Ingham (US9510933B2; 12/06/2016; PTO-892 of 07/10/2025) and as evidenced by Brink et al. (Diseases of the Abdomen and Pelvis 2018-2021, ch. 6, pg. 57-65; published: 03/21/2018; PTO-892 of 07/10/2025) and Chemical Entity Data Page (webpage, <http://www.chemthes.entity_datapage.php?id=739>, pg. 1; archived: 04/05/2016; PTO-892 of instant action).
Soffer-Tsur as evidenced by Brink teaches the invention(s) of claims 1-3, 5-6, 12-13, and 15-16 as discussed in detail above and further incorporated herein.
However, Soffer-Tsur does not expressly teach the step of incubating the tissue with a solution comprising an antimicrobial agent as recited in claims 17 and 19, or the ionizing radiation step recited in claim 20.
Ingham teaches a decellularization protocol to produce acellular tissue, which comprises steps of disinfection, hypotonic wash, nuclease treatment, hypertonic wash, and peracetic acid treatment [col. 6, lines 15-16; fig. 1]. A terminal sterilization step is ideally performed and includes incubation with a disinfection wash comprising peracetic acid at a concentration of about 0.1% v/v and may also include irradiation with γ or e-beams, which are ionizing forms of radiation [col. 5, lines 20-34; claim 9].
Regarding claims 17 and 20: 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 Soffer-Tsur by further including a terminalization step comprising incubating the tissue with 0.1% v/v peracetic acid solution and irradiating the tissue with γ or e-beams in order to ensure sufficient sterilization, including viral clearance and reduction of bioburden for the acellular tissue prior to storage or transplantation, as taught by Ingham [col. 5, lines 15-19]. The sterilizing agent, peracetic acid, reads on the instantly claimed antimicrobial agent as evidenced by Applicant’s instant specification [pg. 3, lines 25-30].
Regarding claim 19: Because the density of peracetic acid is 1.226 g/cm-2, as evidenced by Chemical Entity Data Page [pg. 1], 0.1% v/v peracetic acid equates to ~0.1% w/v, which lies within and thus reads on the instantly claimed range.
One of ordinary skill in the art would reasonably expect success in modifying the method of Soffer-Tsur with the teachings of Ingham as proposed because the concentrations and processes are known in the art to be sufficient for producing decellularized tissues intended for transplantation, which is the ultimate use of the decellularized tissue scaffolds of Soffer-Tsur.
Response to Arguments
Applicant’s arguments submitted on 10/09/2025 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 are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
Prosecution Insights