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 .
Information Disclosure Statement
The information disclosure statements (IDS) filed 10/16/2023, 12/16/2024, 05/15/2025, and
10/09/2025 have been considered and the references therein are of record.
Claim Objections
Claim 20 is objected to because of the following informalities: recites the limitation "the biomaterial of claim 19,” yet claim 19 has been canceled. For purposes of examination, claim 20 will be treated as dependent on claim 17. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 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 20 recites “the hydrogel comprises the peptide at a degree of functionalization of about 10% to about 70%.” Due to the wording of the claim, it is unclear whether the hydrogel or the peptide has a “degree of functionalization,” which renders the claim indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 4, 6, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process/abstract idea judicial exception without significantly more. The claims recite the abstract ideas of comparing blood flow in the area of administration before and after administration of the hydrogel (claim 4), measuring blood flow by perfusion index (claim 4), measuring repairs to ischemia damage by using the modified ischemia score (claim 6), measuring the degree of functionalization of a peptide hydrogel by using nuclear magnetic resonance (claim 20). MPEP 2106 sets forth the multistep process for determining subject matter eligibility.
The claims are directed to a method for measuring blood flow increases in a human patient and measuring functionalization of a peptide-hydrogel composition using NMR. Methods and products are statutory categories of inventions (STEP 1:YES)
These claims recite comparing and measuring, all of which are abstract mental concepts that belong to the enumerated groups of mathematical concepts and mental processes within the Abstract Idea Groupings described in MPEP § 2106.04(a): Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations; Mental processes — concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Therefore the claims recite at least one judicial exception (STEP 2A, Prong One: YES).
According to Step 2A, Prong Two, set forth in MPEP 2106.04, the claims are next evaluated with respect to whether the judicial exception is integrated into a practical application. This analysis turns to the additional steps/elements recited by the claims. Claims 4 and 6 require a step of gathering data on blood flow (claim 4) or ischemia damage (claim 6) for use in a claimed process. Claim 20 requires a step of gathering data on the amount of valine and phenylalanine in the hydrogel for use in a claimed process.
MEPE 2106.04(d) directs to 2106.05(g) stating “when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more in Step 2B is whether the additional elements add more than insignificant extra-solution activity to the judicial exception. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information about credit card transactions, which is recited as part of a claimed process of analyzing and manipulating the gathered information by a series of steps in order to detect whether the transactions were fraudulent...As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978).” MEPE 2106.05(g) provides an example of “mere data gathering” as “performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989).”
The following prior art teaches it was well established in the field of technical expertise to measure ischemia damage repair with the modified ischemia score and to measure blood flow increases using perfusion changes (Grau-Monge et al., 2017). The following prior art teaches it was well established in the field of technical expertise to measure functionalization of a crosslinked, peptide-attached hydrogel using NMR measurements (Sallouh et al., 2015 and Zhu et al., 2016). Therefore, the additional elements in claims 4, 6, and 20 are insignificant extra-solution activities well-known by an ordinary artisan as they amount to mere data gathering that is conventional in the art and does not integrate the judicial exception into a practical application (Step 2A, Prong Two: NO)
According to Step 2B, set forth in MPEP 2106.05, the claims are next evaluated as to whether any additional element, or combination of additional elements, in the claims are sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. As stated above, Grau-Monge, Sallouh, and Zhu teach the additional elements are well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality. Therefore, the additional elements in claims 4, 6, and 20 amount to adding insignificant extra-solution activity to the judicial exception, as well as simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception and do not amount to significantly more. (STEP 2B: NO)
Therefore, claims 4, 6, and 20 a are rejected.
Claim Rejections - 35 USC § 102
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 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, 11-12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al., 2016 (see IDS).
The instant claims are drawn to a method of promoting arteriogenesis by administering a crosslinked hydrogel that has a chemically-attached extracellular epitope of an N-cadherin peptide with SEQ ID NOs: 1 or 2, where the hydrogel comprises 1-20% of gelatin by weight, has pores with diameters of about 20-80 um, and stiffness of about 800 Pa to 5 kPa. The method provides arteriogenesis such that artery growth, arteriole growth, or a combination thereof occurs in 1-14 days, corresponds to a vessel with a diameter of about 0.1-1 mm, increases blood flow to an area having impaired blood flow, and repairs damage caused by ischemia. The method can use a crosslinker comprising an acrylate group, a phenol group, a multivalent polyethylene glycol (PEG), or a combination thereof, or via non-covalent interactions. The method uses a biomaterial that can be administered with cells, a growth factor, or a combination thereof. The method can use a biomaterial that is administered without cells. The instant claims are also drawn to a composition comprising a hydrogel crosslinked by a multivalent polyethylene glycol succinimidyl glutarate crosslinker with an average molecular weight of about 1-40 kDa and has an extracellular epitope of a cadherin protein chemically attached to the hydrogel, which has a degree of functionalization of about 10% to about 70% as measured by the amount of valine of the peptide relative to the amount of phenylalanine of the hydrogel per nuclear magnetic resonance.
Zhu teaches a method of promoting angiogenesis (page 46, 2nd column, Section 2.5 of Results, first paragraph; Fig. 4A; Fig. S7) by administering a crosslinked hydrogel that has a chemically-attached extracellular epitope of an N-cadherin peptide with sequence HAVDIGGGC that has 100% sequence identity to SEQ ID NO: 1 and 91.4% sequence identity to SEQ ID NO: 2, where the hydrogel is crosslinked via a crosslinker comprising an acrylate group (page 50, 2nd column, Section 4.1 of Materials and Methods, first paragraph) as required by instant claims 1 and 11. The method uses a biomaterial that is administered with cells (Fig. 1) as required by instant claims 15. Alignment data between the peptide taught by Zhu and instant SEQ ID NOs: 1 and 2, respectively, are shown below.
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126
589
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118
586
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Therefore, Zhu anticipates instant claims 1, 11-12, and 15. Claims 2-10, 13-14, and 16 are rejected under 35 U.S.C. 102(a)(1) due to dependency on claims 1, 11-12, and 15.
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.
Claims 1-17 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al., 2016 as applied to claims 1, 11-12, and 15 above and in further view of Lee et al., 2014 (WO2014042463A1), Natesan et al., 2019, Carnahan et al., 2010 (EP2247645B1), and ThermoFisher, 2019 (see IDS Document and instant PTO-892).
Instant claims are recited above. See Zhu, as discussed above.
Zhu does not explicitly teach a method of promoting arteriogenesis by administering a crosslinked hydrogel that has a chemically-attached extracellular epitope of an N-cadherin peptide with 100% sequence identity to SEQ ID NO: 2, where the hydrogel comprises 1-20% of gelatin by weight, has pores with diameters of about 20-80 um, and stiffness of about 800 Pa to 5 kPa. Zhu does not teach a method that provides arteriogenesis such that artery growth, arteriole growth, or a combination thereof occurs in 1-14 days, corresponds to a vessel with a diameter of about 0.1-1 mm, increases blood flow to an area having impaired blood flow, and repairs damage caused by ischemia. Zhu does not teach a method that uses a biomaterial that can be administered without cells. Zhu does not teach a composition comprising a hydrogel crosslinked by a multivalent polyethylene glycol succinimidyl glutarate crosslinker with an average molecular weight of about 1-40 kDa and has an extracellular epitope of a cadherin protein chemically attached to the hydrogel, where the hydrogel has a degree of functionalization of about 10% to about 70% as measured by the amount of valine of the peptide relative to the amount of phenylalanine of the hydrogel per nuclear magnetic resonance. To summarize, Zhu does not explicitly teach all of the limitations of claims 2-11, 13-14, and 16-22.
Lee teaches a method of promoting angiogenesis (para [75, 220-224, 243, & 291-311]; Fig. 7-15) by administering a multivalent polyethylene glycol succinimidyl glutarate-crosslinked hydrogel (para [71, 106, 110, 141,223, & 235]; Fig 14) that has been functionalized (para[30-32]; claims) with a chemically-attached angiogenic peptide (para [75]; Fig. 11; claims), where the peptide can be a cadherin protein (claims 4, 6, & 10), the hydrogel can comprise gelatin (para [102]), have pores of about 10-100 μm (claim 20) in diameter that can be optimized to a desired size (para [159-161]), stiffness of 0.2k- 2kPa (claim 19) that can be optimized (para [264]), can be administered with/without cells (claims), and can be used in medical treatment and wound healing (para [12, 41, & 128-130]). Lee teaches that gelatin can be used to offer controlled elasticity of the hydrogel (para [98-102]). Lee teaches that there is an optimal pore size for cell infiltration and host tissue ingrowth of endothelial cells (table 2). Lee teaches that porosity and pore architecture plays a significant role in cell survival, proliferation, and migration and are key to the hydrogel microenvironment and that the porosity of a hydrogel depends on PEG molecular weight and concentration (para [157-163]).
Lee does not explicitly teach the specific days within which artery/arteriole growth would occur. Lee does not explicitly teach that the artery/arteriole growth would be functional and would deliver blood to a wound. Lee does not explicitly teach the method of using the hydrogel would be useful for vascular and cardiovascular repair in human patients. Lee does not teach an extracellular epitope of an N-cadherin peptide with 100% sequence identity to SEQ ID NO: 2.
Natesan teaches a method of promoting arteriogenesis by administering to a wound a PEGylated fibrinogen hydrogel comprising multivalent PEG succinimidyl glutarate (page 325, 1st column, 3rd paragraph), where the artery/arteriole growth occurs within 8 days and were functional (Figure 7). Natesan teaches these hydrogels would be useful for treating patients, especially skin wounds (Innovations).
Carnahan teaches a method of promoting angiogenesis for treating a disorder comprising administering a multivalent PEG succinimidyl glutarate crosslinked hydrogel, where the hydrogel can comprise gelatin and be used for vascular and cardiovascular repair (para [0027]).
Neither Natesan or Carnahan teach an extracellular epitope of an N-cadherin peptide with 100% sequence identity to instant SEQ ID NO: 2 (HAVDIGGGCE), which differs from instant SEQ ID NO: 1 by only an additional glutamic acid at the C-terminal of the peptide.
ThermoFisher teaches that carbodiimide compounds provide the most popular method for crosslinking to carboxylic acids (–COOH), such as occur in proteins (Introduction, Carboxyl-reactive crosslinker reactive groups, para 1-2). Thermofisher teaches that carbodiimide conjugation works by activating carboxyl groups for direct reaction with primary amines via amide bond formation (Introduction, Carboxyl-reactive crosslinker reactive groups, para 3). ThermoFisher teaches that EDC, which is a type of carbodiimide conjugation, provides the only method for crosslinking amines to carboxyl groups of peptides, using the C-terminus and/or side chain of glutamic acid (Applications for EDC crosslinking, 2. Label carboxyl groups using amine-containing compounds, para 1).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosures of Zhu, Lee, Natesan, Carnahan, and ThermoFisher. One with ordinary skill in the art would be motivated to make and use the claimed invention because Zhu teaches a peptide that promotes angiogenesis and Lee teaches an adjustable hydrogel composition that can be tuned to a specific porosity and stiffness for optimal angiogenesis; in other words, an ordinary artisan would be motivated to combine the teaching of Zhu and Lee to make an optimizable hydrogel for promoting angiogenesis. An ordinary artisan would be motivated to use gelatin in the hydrogel composition since Lee teaches that gelatin can be used to offer controlled elasticity of the hydrogel. Furthermore, an ordinary artisan would have found it obvious that the method of using the hydrogel taught by Zhu and Lee would promote functional, blood-delivering artery/arteriole growth within 1-14 days to patient’s wounds and could be used for vascular and cardiovascular repair in view of Natesan’s and Carnahan’s teachings. An ordinary artisan would be motivated to add a glutamic acid to the C-terminus of the peptide taught by Zhu in view of the ThermoFisher’s teaching that crosslinking with EDC uses the C-terminus and/or side chains of glutamic acid. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
The prior art only differs from the claimed invention with respect to the claimed amounts and/or ranges of the pore size, diameter of vessels, percentage of gelatin, stiffness, multivariant PEG molecular weight, and degree of functionalization. The Court has stated that generally such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention because an ordinary artisan would have found it obvious to optimize the hydrogel through routine experimentation. Since Lee teaches that the hydrogel composition can be optimized, an ordinary artisan would have been motivated to optimize the composition to make the most angiogenic composition. MPEP 2144 sets forth Applicant’s burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed amount. In the instant case, the specification as filed provides no evidence that the particular amount or range recited within the claims is critical because the specification teaches effective embodiments of the claimed invention that have various amounts or ranges recited for the pore size, diameter of vessels, percentage of gelatin, stiffness, multivariant PEG molecular weight, and degree of peptide functionalization, which is evidence of non-criticality to the claimed invention.
Therefore, claims 2-10, 13-14, and 16-22 are obvious in view of the disclosures of Zhu, Lee, Natesan, Carnahan, and ThermoFisher.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 36, 46, 48, and 51-57 of co-pending Application No. 17/429540. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are recited above.
The co-pending claims recite a method of culturing a plurality of cells, comprising; culturing induced pluripotent stem cells (iPSCs) to provide a plurality of cells including a neuron and optionally a brain endothelial cell, a glial cell, or a combination thereof: embedding the plurality of cells in a biomaterial, the biomaterial consisting of a crosslinked hydrogel, wherein the hydrogel comprises gelatin, and a peptide chemically attached to the hydrogel, wherein the peptide comprises SEQ ID NO: 1 or SEQ ID NO: 2; and culturing the plurality of cells embedded in the biomaterial for at least 3 weeks, wherein active synapses between the plurality of cells are increased by at least 80% after about 21 days of culturing compared to active synapses between the plurality of cells at the onset of culturing (claim 30). The dependent claim: the method of claim 30, wherein the plurality of cells is a brain organoid (claims 36); the method of claim 30, wherein the peptide is attached to the hydrogel at the C-terminal end (claim 46); the method of claim 30, wherein the peptide comprises an extracellular epitope of a cadherin protein (claim 48); the method of claim 30, wherein the hydrogel is crosslinked by enzymatic crosslinking, thermal crosslinking, a crosslinker, or a combination thereof (claim 52); the method of claim 51, wherein the crosslinker comprises an optionally substituted vinyl group, an optionally substituted phenol group, or a combination thereof (claim 53); the method of claim 51, wherein the crosslinker comprises a - C(CH3)=CH2 group or a phenol group (claim 54); the method of claim 30, wherein the gelatin comprises porcine skin gelatin (claim 55); and the method of claim 30, wherein the biomaterial has a stiffness of about 800 Pa to about 5 kPa, a pore size of about 20 pm to about 80 pm in diameter, or a combination thereof (claim 56).
Instant claims 1, 9-15, 17, and 21-22 encompass/anticipate co-pending claims 30, 36, 46, 48, and 51-56. Instant claim 1 encompasses co-pending claims 30, 46, and 52 by reciting a generic composition and method of using a crosslinked hydrogel with a chemically attached cadherin that encompasses the more specific hydrogel (claim 30), the specific way the peptide is attached to the hydrogel (claim 46), and specific crosslinker (claim 52). Instant claims 9-10 encompass co-pending claim 55 by reciting a generic polymeric material and gelatin that encompass the more specific porcine skin gelatin. Instant claim 11 encompasses co-pending claim 30 by reciting identical SEQ ID NOs: 1-2. Instant claim 12 anticipates co-pending claim 52 by reciting more specific crosslinkers. Instant claim 1 anticipates co-pending claim 48 by reciting an extracellular epitope of a cadherin protein. Instant claim 12 anticipates co-pending claims 53-54 by both reciting the crosslinker can comprise a phenol group. Instant claim 13 anticipates co-pending claim 56 by reciting the identical stiffness. Instant claim 14 anticipates co-pending claim 56 by reciting the identical diameter of the pores. Instant claim 15 encompasses co-pending claims 30 and 36 by reciting a generic plurality of cells that encompasses the more specific cell types. Instant claims 17 and 21-22 anticipate co-pending claim 30 by reciting the more specific multivalent PEG succinimidyl glutarate that anticipates the generic crosslinker. Therefore, claims 1, 9-15, 17, and 21-22 are rejected as being unpatentable over co-pending Application No. 17/429540. Claims 2-8, 16, and 20 are rejected due to dependency. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Advisory Information
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/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675