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 .
This action is responsive to papers filed 11/25/2025.
Claims 1, 3-4, 8-10, and 14 have been amended. Claims 20-23 have been newly added and claims 7, 15, and 18 have been newly canceled.
Claims 1-6, 8-14, 16-17, and 19-23 are currently pending.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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.
Claims 1-6, 8-14, 16-17, and 19-23 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.
Applicants have entered the limitation “a regenerative epidermal suspension comprising about 1 cm2 tissue sample per mL of suspension” in line 11 of claim 1. There is insufficient support in the disclosure as originally filed for this limitation; thus it is being considered new matter.
An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). Applicant is required to cancel the new matter in the reply to this Office Action.
The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir.1996).
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.
Claim 13 is 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 13 recites the limitation "the treatment cells" in line 1 and recites various cell types including unmodified and gene-edited cells. However, amended claim 3 which claim 13 is dependent upon has been amended to require genetically modified cells, which is only one option from a group recited in claim 13.
This renders the scope of claim 13 unclear as to which cell types are required to be added to the bioactive suspension.
For examination purposes, the treatment cells recited in claim 13 are interpreted as genetically modified cells configured to correct a skin disease.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
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, 5-6, 8-12, 17, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Badylak et al (US 2017/0049932-previously cited) in view Tamai (US 2009/0202500), Straino et al (Journal of Investigative Dermatology, 2008) and Quick et al (US 2015/0079153-from IDS filed 06/07/2024).
Regarding claims 1, 6, 10, 19-23, Badylak teach a method of preparing an active fraction of ECM for use in a treatment method comprising obtaining a tissue sample and disaggregating the tissue sample by mincing and/or enzymatic digestion and adding an effective amount of buffer to the disaggregated tissue to produce a cell suspension (regenerative cell suspension) and allowing this cell suspension to rest an effective amount of time, separating out the cell pellet by centrifugation to produce a bioactive soluble fraction that contains at least one tissue regeneration factor and applying the soluble bioactive factor to at least one treatment site (abstract, page 2 para 14, page 6 para 51, page 8 para 66, page 18 para 131 and page 21 claims 1, 6, 20-22). Breaking down the tissue with trypsin (an enzyme) and a vortex shaker (mechanical force) is described as an option (enzymatic and mechanical disaggregation) (page 6 para 50) and thus renders obvious both mechanical disaggregation and enzymatic disaggregation. Steps for adding a buffer and allowing the cell suspension to incubate for 10 minutes to 4 hours is also taught (page 6 para 51), overlaps with the claimed ranges and thus renders obvious an incubation of the cell suspension for at least 30 minutes and/or about 5 minutes to about 5 hours (allowing the cell suspension to rest).
Badylak teach that the structural fraction of the ECM includes proteins such as collagen and the soluble fraction of ECM includes proteins such as growth factors, matricellular proteins and peptide fragments (page 9 para 78). The objective of Badylak was to separate the soluble components of an ECM from the structural components to distinguish which components retain some or any biological activity (page 9 para 79). Badylak specifically disclose using just the soluble fraction of the ECM without the structural fraction (claim 21).
While Badylak teach a specific embodiment using dermal tissue from skin as a source of their ECM (page 6 para 49) they do indicate that the ECM in their method may be isolated from any tissue from any animal without limitation (page 5 para 45). They do not indicate if the tissue sample used is fresh or not per se, but they do not teach that the tissue is cultured prior to processing steps and thus the tissue samples used by Badylak are deemed to meet the requirement for “fresh” as set by Applicant’s Specification as not having been cultured (see Applicant’s Specification page 3 para 14 and page 7 para 40).
Badylak do not teach requiring an exogenous agent in their bioactive suspension (the ECM fractions can be administered by themselves -see page 8 para 66) and therefore an embodiment that does not include one is deemed to be included in their disclosure.
Badylak do not specifically teach using skin with an epidermis, dermis and dermal-epidermal junction as their tissue source for an active fraction of ECM nor the trypsin concentration or time in trypsin required for this particular type of tissue source. Badylak also do not specifically teach including HMGB1 in their bioactive compositions.
Tamai teach that free skin pieces produce HMGB1 and extract solutions of excised skin in PBS contain protein that mobilizes bone marrow-derived mesenchymal stem cells and this protein has been identified as HMGB1 (page 14 para 122-page 15 para 124). Human skin having an area of 1 cm2 was immersed in PBS and the supernatant alone was collected to be used as the human skin extract (page 16 para 128). Tamai suggest that drug development using HMGB1 enables functional tissue regeneration-inducing therapy for vital functional organs (page 15 para 124).
Straino teach HMGB1 protein may be beneficially applied to treat wounds for impaired wound healing (abstract, page 1531, column 2 first paragraph). HMGB1 was detected in the nucleus of skin cells and accumulated in the cytoplasm of epidermal cells and found to be useful in various amounts (keratinocyte is an epidermal cell) (abstract, page 1547 Figure 2).
Quick teach that stress can be induced in a skin cell suspension during disaggregation of a biopsy (via enzymatic and/or mechanical means) or otherwise dispersing the cells and under stress the cells can display a stress-induced characteristic, such as heat shock protein Hsp90 (page 10 para 102). Heat shock protein can help or augment wound healing and tissue regeneration by enhancing both re-epithelization process and recruitment of cells (page 10 para 109). Cells harvested from the entire skin sample biopsy include epidermis, dermis and dermal-epidermal junction thus include skin stem cells and/or fibroblasts and keratinocytes (epidermal cells) and other cell types (page 5 para 55). The trypsin concentration used for a skin sample that comprises both epidermis and dermis can be from about 0.25% to about 2.5% or about 0.5% and “those of ordinary skill in the art will understand that experimenting the optimal concentration of the enzyme is routine experimentation” (page 5 para 47). The tissue sample is immersed in the trypsin solution (soaked) for a time of 5 to 60 minutes which overlaps with the claimed time range and thus renders it obvious (page 5 para 48). In one example a biopsy size of 2 cm times 2 cm was taken from the donor site (page 12 para 123)
One of ordinary skill in the art would have been motivated to use full thickness skin biopsies from an entire skin sample including epidermis, dermis and dermal-epidermal junction in the method of Badylak to generate their bioactive soluble fraction because Straino teach that skin cells including both dermal and epidermal produce HMGB1 which has beneficially wound healing properties and Tamai also teach that free skin pieces produce extracts that contain HMGB1 which has beneficial healing properties with potential for use in drug development. One of ordinary skill in the art would have had additional motivation and a reasonable expectation of success because Quick teach disaggregating a full thickness skin biopsy that contains dermis, epidermis and a dermal/epidermal junction produces stress induced proteins, such as HSP90, that can help or augment wound healing and tissue regeneration by enhancing both re-epithelization process and recruitment of cells (page 10 para 109).
One of ordinary skill in the art would have been motivated to optimize the amount of HMGB1 in the skin extract in order to provide the benefits of enhanced wound healing (a result effective variable). It would appear that the amount of the HMGB1 present in the skin extract would depend on the size and amount of the skin biopsy used to create the extract and thus a larger starting biopsy, mechanically disaggregated into smaller pieces, would produce a larger concentration of bioactive factors requiring nothing more than routine optimization and experimentation to arrive at a regenerative cell suspension comprising about 1 cm2 of the tissue sample ( a suitable size of tissue as suggested by Tamai) per mL of suspension baring evidence to the contrary.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use a fresh tissue biopsy in the Badylak method because a fresh biopsy would be a better choice than an old biopsy as it would have more viable and healthy cells to produce the desired extracts.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use a trypsin concentration from about 0.25% to about 2.5% or about 0.5% (same as that claimed) and a trypsin time of 5 to 60 minutes (which overlaps with the claimed time range and thus renders it obvious) for the disaggregation of a full thickness skin biopsy that contains dermis, epidermis and a dermal/epidermal junction in the method of Badylak because Quick indicate that these are suitable parameters for using trypsin in the disaggregation of this type of tissue for the production of an beneficial active fraction. Using the same trypsin parameters on the same type of tissue sample and further including mechanical disaggregation would provide a regenerative epidermal cell suspension comprising about 1 cm2 tissue per mL of suspension including living cells through routine optimization and experimentation baring evidence to the contrary (since the steps are the same the results must be the same unless they are due to elements not recited in the claims. Since Badylak indicate that the ECM in their method may be isolated from any tissue from any animal without limitation (page 5 para 45), one of ordinary skill in the art would have had a reasonable expectation of success of incorporating the disaggregation trypsin parameters of the full thickness skin biopsy since both Badylak and Quick include the use of trypsin for their enzymatic disaggregation as well as the inclusion of mechanical disaggregation as well.
Regarding claims 2 and 11-12, Badylak teach wherein the bioactive suspension is added to at least one scaffolding element (such as a gel or with a mold for repairing damaged skin, a skin substitute) prior to the step of applying to the treatment site (page 8 para 66-68, pages 8-9, para 72-74, page 21 claim 15-16).
Regarding claims 5 and 17, Badylak teach storing fractionated soluble supernatant at negative 80°C until further use (page 10 para 83). Since further use includes contact with cells and fluids it would appear that thawing after storage would be an inherent requirement by the need for the bioactive growth factors contained in the extracted soluble fraction to be released to a treated surface.
Regarding claims 8-9, Badylak disclose that the soluble phase of ECM contains proteins such as growth factors bFGF, VEGF, and IGF (page 9 para 78) and Quick teach that stress can be induced in a skin cell suspension during disaggregation of a biopsy (via enzymatic and/or mechanical means) or otherwise dispersing the cells and under stress the cells can display a stress-induced characteristic, such as heat shock protein Hsp90 (page 10 para 102). Therefore heat shock protein Hsp90 is deemed to be inherently present to at least some degree during the disaggregation of the skin biopsy.
Therefore, the combined teachings of Badylak et al, Tamai, Straino et al and Quick et al render obvious Applicant’s invention as claimed.
Claim(s) 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Badylak et al (US 2017/0049932-previously cited) in view of Tamai (US 2009/0202500), Straino et al (Journal of Investigative Dermatology, 2008) and Quick et al (US 2015/0079153-from IDS filed 06/07/2024) as applied to claims 1-2, 5-6, 8-12, 17, and 19-23 above and further in view of Fraser et al (US 2005/0048034-from IDS filed 04/20/2022).
Regarding claims 3 and 13, Badylak teach adding treatment cells (tissue cells or allogeneic cells) to the bioactive suspension (page 9 para 74 and 76) and including hyaluronic acid (page 21 claim 14), but do not specifically disclose wherein these additional cells are genetically modified to correct a skin disease.
Fraser disclose methods of using regenerative cells to promote wound healing (Title, abstract) and specifically skin wounds caused by a disease or disorder of skin (page 4 para 48). The regenerative cells may be in native form from tissues or may be modified by gene transfer (genetically modified) and intended to enhance or supplement the function of the regenerative cell for therapeutic purpose (page 4 para 46, pages 16-17 para 131).
One of ordinary skill in the art would have been motivated to include genetically modified tissue cells configured for the treatment of a skin disease for addition to the method of Badylak because Fraser teach and suggest that these cells are a suitable alternative to native tissue cells for the treatment of a skin disease or disorder. One of ordinary skill in the art would have had a reasonable expectation of success because both Badylak and Fraser are drawn to the therapeutic treatment of skin wounds with compositions containing regenerative cells.
Therefore, the combined teachings of Badylak et al, Tamai, Straino et al, Quick et al and Fraser et al render obvious Applicant’s invention as claimed.
Claim(s) 4, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Badylak et al (US 2017/0049932-previously cited) in view of Tamai (US 2009/0202500), Straino et al (Journal of Investigative Dermatology, 2008) and Quick et al (US 2015/0079153-from IDS filed 06/07/2024) as applied to claims 1-2, 5-6, 8-12, 17, and 19-23 above and further in view of Liu et al (Biofabrication, published online April 9, 2020).
Regarding claim 4, Badylak teach that additional elements can be added to their ECM extract composition (page 9 para 74), but do not specifically add a JAK inhibitor.
Liu teach methods of making skin equivalents for preclinical studies and disclose that when JAK inhibitors are added to skin equivalents that model atopic dermatitis that they provide improved epidermal morphology. This restored morphology and barrier function were accompanied by increased expression of differentiation proteins, cell-cell junctions and dermal-epidermal junction and resulted in higher TEER value as compared to controls (page 9 Section 3.3).
Therefore, one of ordinary skill in the art would have been motivated to include JAK inhibitors as an additional efficacious element with the soluble fraction composition of Badylak because Liu teach that JAK inhibitors provide therapeutic effects for the treatment of atopic dermatitis and Badylak teach that therapeutic agents can be added to their soluble composition for purposes of treating wounds (damaged tissue). One of ordinary skill in the art would have had a reasonable expectation of success because both Badylak and Liu are drawn to methods of making skin equivalents for repair of damaged skin.
Regarding claims 14 and 16, Badylak teach adding treatment cells (tissue cells or allogeneic cells) to the bioactive suspension (page 9 para 74 and 76) and including hyaluronic acid (page 21 claim 14). Quick also teach that stress can be induced in a skin cell suspension during disaggregation of a biopsy (via enzymatic and/or mechanical means) or otherwise dispersing the cells and under stress the cells can display a stress-induced characteristic, such as heat shock protein Hsp90 (page 10 para 102).
One of ordinary skill in the art would have been motivated to include hyaluronic acid and heat shock protein as therapeutic additives to the therapeutic method and compositions of Badylak because Badylak and Quick teach and suggest that these are beneficial additives for a treatment composition intended for wound healing of the skin.
One of ordinary skill in the art would have had additional motivation and a reasonable expectation of success because Quick teach disaggregating a full thickness skin biopsy that contains dermis, epidermis and a dermal/epidermal junction produces stress induced proteins, such as HSP90, that can help or augment wound healing and tissue regeneration by enhancing both re-epithelization process and recruitment of cells (page 10 para 109).
Therefore, the combined teachings of Badylak et al, Tamai, Straino et al, Quick et al and Liu et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive.
Applicant argues that claim 1 is amended to recite a specific enzyme strength, clinical performance relative to the quantity of cells presented and the presence of a regenerative epidermal suspension and that this renders the claims commensurate in scope with the evidence provided in the declaration of Dr. Kashgari filed January 13, 2025. Applicant requests reconsideration of the declaration.
This is not found persuasive. The specific enzyme strength is shown to be well known in the prior art as described above. The limitation of 1cm2 tissue sample per mL of suspension is not found in the Specification and thus appears to be new matter as Applicant did not point to the location in the Specification for support for this limitation. In addition, the production of 500,000 pg/mL of HMGB1 in a matter of minutes of soaking in a solution has been disclosed in the prior art as described by Tamai in their supplemental data of the 2011 publication in Proceedings of the National Academy of Sciences of the United States of America (missing from the reference provided on the IDS filed 01/13/2025 and provided by the Examiner with this office action) and thus not deemed to be an unexpected result.
Tamai et al teach that extract solutions of excised skin in PBS contain protein that mobilizes bone marrow-derived mesenchymal cells and this protein is identified as HMGB1 (page 6611- page 6612). HMGB1 is disclosed as mobilizing bone marrow cells into the circulation and accelerating the regeneration of skin (page 6613, Discussion). Tamai specifically teach and suggest the use of the HMGB1 extract as a therapeutic strategy to recruit stem/progenitor cells to accelerate regeneration of damaged tissue (page 6613). The HMGB1 was released from the skin rapidly within a few minutes (page 6612 column 1) and epithelial tissue in the skin graft is identified as a significant source of HMGB1 (page 6612, column 2). The supplemental data of the Tamai reference discloses about 400 ng/ml of HMGB1 is secreted from the epidermis (400,000 pg/ml) and about 100 ng/ml of HMGB1 is secreted from the dermis (100,000 pg/ml) and the vast majority of this secretion is achieved within a time course of 10 minutes (see Figures S13 A and B).
Applicant argues that Badylak discloses decellularizing dermis by soaking in trypsin for 6 hours and that this is in contrast to amended claim 1. Applicant argues that Badylak, alone or in combination with the other cited references, does not teach or suggest every limitation of the instant claims.
This is not found persuasive. The teaching of Quick provides the trypsin concentration and the soaking duration for a full thickness skin biopsy that is lacking from the Badylak disclosure.
Applicant argues that the Office Action’s statement that it would be routine optimization to adjust the amount of HMGB1 by using a larger skin biopsy is overcome by the amendment to claim 1 which now requires a regenerative epidermal suspension comprising about 1 cm2 tissue sample per mL of suspension.
This is not found persuasive. The currently amended claims do not have any specific size for the initial skin biopsy used, only that after the skin sample is disaggregated and soaked in trypsin that the disaggregated tissue sample will be combined with a buffer to produce a cell suspension comprising about 1 cm2 tissue sample per mL. This does not preclude increasing the amount of tissue that is subjected to disaggregation prior to suspension in the buffer. In addition, the mechanical disaggregation will provide for an additional breakdown of the tissue into smaller size pieces as well.
Applicant argues that a method within the scope of the instant claims yielded unexpected results and had surprising efficacy as both a standalone therapeutic and an agent for delivery of cell therapies and point to Applicant’s Specification at paragraph 40 as evidence. Applicant asserts that it is surprising that the disaggregated cells released significant amount of tissue regeneration factors comparable to the amount of tissue regeneration factors released by cultured cells over the span of several days and point to paragraph 41 of their Specification as evidence. Applicant asserts that the clinical performance of the cell suspension in wound re-epithelization exceeded expectations relative to the quantity of cells presented, suggesting that tissue regeneration factors could be contributing to the mechanism of action and these could be separated from the cell suspension to produce a healing bioactive suspension. Applicant asserts that this result is surprising and unexpected because significant amounts of tissue regeneration factors were obtained in as little as 30 minutes and because it was generally believed that the presence of live cells that can proliferate is vital for tissue regeneration.
This is not found persuasive. The Tamai reference discloses that significant amounts of HMGB1 are released from skin in minutes and Quick also disclose that tissue regeneration factors are released from trypsin treated full skin biopsies as well as described above.
Applicant argues that a bioactive suspension of the instant claims was prepared and evaluated in vitro as shown in Figures 4 and 5 of the present application which show that the bioactive suspension promotes faster regeneration of tissue than traditional cell delivery techniques and enables cell seeding treatments to be effective even when the number of cells seeded is greatly reduced and point to their Specification at paragraphs 49-50 as evidence. Applicant asserts that the amount of HMGB1 of at least 500,000 pg/ml is surprising and unexpected that the bioactive suspension contained such high levels of HMGB1 and resulted in improved healing.
This is not found persuasive. The Tamai reference discloses that significant amounts of HMGB1 are released from skin in minutes and Quick also disclose that tissue regeneration factors are released from trypsin treated full skin biopsies as well as described above.
Applicant argues that the dependent claims are allowable because the independent claim is allowable.
This is not found persuasive as the independent claim has not been found allowable.
Applicant also argues that the new claims are allowable because the cited references do not teach or suggest all the features of the new claims.
This is not found persuasive as these claims have been addressed in the new rejections above.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ben-David et al., “Method to enhance progenitor or genetically-modified cell therapy”, US 2006/0167501, (paragraph 4).
Kogut et al., “Methods and Composition for Reprogramming Cells”, US 2018/0346933, (paragraphs 113, 217).
Tamai et al., “PDGFRalpha-positive cells in bone marrow are mobilized by high mobility group box 1 (HMGB1) to regenerate injured epithelia”, Proceedings of the National Academy of Sciences of the United States of America, 2011, 108(16), supplemental data, https://www.pnas.org/action/downloadSupplement?doi=10.1073%2Fpnas.1016753108&file=pnas.201016753SI.pdf
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 LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/ Primary Examiner, Art Unit 1631